ML23151A603

PR-050 - 64FR31737 - Condideration of Potassium Iodide in Emergency

ML23151A603
Person / Time
Issue date:	06/15/1999
From:	Annette Vietti-Cook NRC/SECY
To:
References
PR-050, 64FR31737
Download: ML23151A603 (1)

Text

{{#Wiki_filter:ADAMS Template: SECY-067 DOCUMENT DATE: 06/15/1999 TITLE: PR-050 - 64FR31737 - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY CASE

REFERENCE:

PR-050 64FR31737 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DockBt No.: PR-050 01/29/2001 FR Ciu: 64FR31737 In the Matter or Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Mlscellimeons Accession Number Submitted by Representing Date Date Descrlption Number 06J08/1999 06/03/1999 Federal Regi.ster Notice - Proposed Rule Roger L. Suppes Ohio Department of 06/15/1999 05001999 Chief* Bureau of Radiation Health Protection I 2 Steve Hnberman The Seacoast Anti- 06/21/1999 06/16/1999 Pollution League t:-- 3 Kathryn A. Barnes Self 07/06/1999 06fl8/1999 4 Holly R. Semple Self 07/23/1999 07/12/1999 1

Doclut No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Col)slderatlon of Potassium Iodide In Emergency Plans Comment Comment Docket Document MlscellaneoCll Acce&Sion Number Submitted by Representing Date Date Description Number 5 Walter E Wright Eme.rgrocy Management 08/02/1999 07/24/1999 Duector Agency, I1nn County, Iowa 6 Lawrence Roy Self 08J0211999 07/13/1999 (

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7 Robert a Churchman Pennsylvania Emt-.tgency 08/03/1999 07'29/1999 Actmg Duector Managemont Agency - 8 Pati Harper and Mad: Ci~ Regulatory Commission 08/04/1999 07/'}3/1999 9 Ellen M. Gordon Iowa Dept. of Public 08/10/1999 08/04/1999 Administrator Defense and Dept. of Public Health 2

Doclut No.: PR-050 01/29/2001 FR Cite: 64FR.31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 10 Robert Roy ond Kris A Elde Northern St.ates Power 01!/16/1999 08/05/1999 Company 11 Juan N Walterspiel, M.D Self 08/16/1999 08/06/1999 12 Rachel H Gl.fS!uck SeJf 08/l 7/1999 01!/13/1999 13 D W. Coleman Energy Northwest 08/18/1999 08/12/1999 14 Peter G. Crane Self 01!/19/1999 08/17/1999 3

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 15 James H McCarthy Virginia Powe.c 08/20/1999 08/18/1999 16 Judi Fnedman People's Acllon for Clean 08/23/1999 08/18/1999 F.nergy, Inc. 17 Ken Owen Sdf 08/23/1999 0stm'1999 18 Doniel M. Sibo Michigan State Police, 08/24/1999 0stm'l999 Emergency Preparedness Division 19 Patrice Granatosky Self 08/26/1999 08/21/1999 4

Docket No.: PR-050 01/19/1001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 20 Gary J. Taylor South Carolina Electric 08/30/1999 08/24/1999

• Vice President and Gas Company 21 Lynnette Hendncks Nuclear F.nergy Institute 09/03/1999 09/01/1999 Director 22 Nathan L. Haskell Consumm Energy 09/07/1999 09/02/1999 Threcto1/2Ltcensing 23 Richard Peros Self 09/10/1999 09/04/1999 24 Joseph F Myers National Emergency 09/10/1999 09/01/1999 President Management Associatlon (NE.MA)

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Docket No.: PR-050 01/29/2001 FR Cue: 64FR31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Miscellaneous Accesston Number Submitted by Representing Date Date Description Number 25 J. Barnie Beasley, Jr. Southern Nuclear 09/lU/1999 09/1C:Vl999 Vice President - Vogtle Pro.Jed Operating Company, Inc. 26 Thomas W. Ortc1ger Illinois Department of 09/13/1999 09/08/1999 Director Nuclear Safety 27 James C. Hardeman, Jr. Conference of Radianon 09/13/1999 09/1C:Vl999 Chair Control Program Di=tors, Inc., (CRCPD) Eme.rgency RCBpODSC Planning CoIIl.IIllttee (E-6) 28 MS. Tuckman Doke F.nergy Corporation 09/13/1999 08/27/1999 Exec. Vice President 29 Valerie Justm Coalition of 09/13/1999 09/13/1999 Neighborhoods for the Prese.rvation of Sag Harbor 6

Docket No.: PR-050 01129/2()()1 FR Cite: 64FR31737 In the Matter or Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Docmnent MiBcellaneous Accesslon Number Submitted by Representing Date Date Description Number 30 Woodbury P. Fogg, State of New Hampshire 09/13/1999 09/08/1999

• Director 31 Richard B. Abbott Niagara Mohawk: 09/13/1999 09/09/1999 Vice President Corporation I

32 Kenneth E Peveler JES Utilities, Inc 09/13/1999 09/10/1999 33 Susan L Hiatt Ohio Citizens For 09n4/I999 09/13/1999 Respoorn>lo Energy, Inc. 34 Francis A Laden Nebraska~ 09/14/1999 09/07/1999 Management Agency . 7

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter or Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 35 Chnstine Bacon W!Sconsin Emergency 09/14/1999 09/08/1999

• Director Management and WISCOnsin Department of Health and Family Services Radiatlon Protection 36 C. Lance Terry TXU Electric 09/14/1999 09/10/1999 Vice President and Pnnc1pal Nuclear Officer Edward J. Markey 03/2412000 ll/l<Vl999 Letter from Representative Representative from Edward J Malkey dated Mru,sachusetts 1 l/HV99 re NRC responses to his questions on potassium iodide stockpiles at the July 21, 1999 bearing on FY2000 NRC Anthoriznl1on Act before the Subcommittee on :Energy and Richard A Mesave 03/2412000 03/09/2000 Letter from Cbainhan Meserve Chrunnan to Representative Ftlward J.

Markey dated 03/09/00 respondmg to Ins 11/10/99 letter expressing concerns about about NRC's responses to his questions on potassium iodide stockpiles associated with the heanng on William D. Delahunt 03/2412000 11/15/1999 Letter from Representative Representative from Wtlham D Delahunt dated Massachusets 11/15/99 to Ch.airman Meserve asking for his support in stockpiling potassium iodide in the communities surroundmg the Pilgrim Nuclear Power Plant in Plymouth, MA 8

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number Richard A M=-ve 03/24/2000 02/29/2000 Letta from Chainnan Meserve - Chairman to Representab.ve Willillill D Delahunt dated 02J29/00 responding to his 11/15/99 regardmg stocl::pihng potassium 10chde in communities near nuclear power plants Karen L Thurman 03/24/2000 12/09/1999 Letter from Representab. ve Representab. ve from Karen L Thurman to Demus Flonda Rathbun dated 12/09/99 transmitting a letter from Kei.th A. Green regarding his concern abont stockpiling potassrnm iodide in the event of an accident at a nuclear power plant Richard A Meserve 03/24/2000 02/29/2000 Letter from Chairman Meserve Chairman to Representative Karen L Thorman dated 02J29/00 responding to her 12/09/99 lettor on behalf of Keith A Green who is con=ed about stockpiling potasst um iodide in communities surrounding nuclear powec Edward M Kennedy 03/24/2000 12/14/1999 Letter from Senator Edward M. Senator Kennedy to Chamnan Mese.rve dated 12/14/99 on behalf of Massachusetts Citizens for Safe Energy regardmg the proposed rule on the use of potassium iodide m emergency plans Richard A Meserve 03/24/2000 02/29/2000 Lettex from Chairman Meserve Chauman to Seruitor Edward M Kennedy dated 02129/00 respondmg to his 12/14/99 letter on behalf of the Massachusetts Citizens for Safe Energy regarding the proposed rule on the use of potassium 10chde in emergency plans. 9

Docket No.: PR-050 0112912001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number Peter G. Crane 05/24/2000 05/19/2000 Lc:ttec from Peter Crane to 3718070 Senator Edward M. Kennedy thanking him for bis efforts to ensure that adequate supplies of potassium iodide are provided. Peter G. Crane 06/19/2000 06/16/2000 Letter from Peter Crane to the 3724683 Commision dated 06/16/00 re no action has yet been taken on lus potassium 10dtde rulemakmg petition filed in 1995 (PRM 63 and PRM-50-63A). 37 Mary Elizabeth Lampert Massachusetts Coalition 09/14/1999 09/1 !N'l 999 to Stockpile Kl - 38 James P Riccio, Esq. Public Citiz.en 09/14/1999 09/13/1999 39 Peter G. Crane Self 09/15/1999 09/11/1999

Docket No.: PR-050 01/l9/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergencr Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 40 Jnmes C. Hardeman, Jr. Georgia Department of 09/15/1999 09/10/1999 Natural Resources - Manager 41 Hildegarde Hannum Self 09/15/1999 09/HY1999 42 MaryKuhn 09/15/1999 09/1U1999 43 Angela Scott Self 09/15/1999 09/12/1999 44 Margaret Scott Self 09/15/1999 09/12/1999 11

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 45 Name illegible Self 09/15/1999 09/12/1999 46 BrendaD. Self 09/15/1999 09/12/1999 47 Daniel DeSimone Self 09/15/1999 09/12/1999 48 Richard Cowley Washington State 09/15/1999 09/10/1999 Department, of Health 49 Ronald Pmass Kansas Department of and 09/15/1999 09/13/1999 Supervisor, Environmental EnVll'OlllDCfil Rachation and Emergency Protection Radiation Control Program 12

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Docnment Miscellaneous Accesfilon Number Submitted by Representing Date Date Description Number 50 Sue B. Avedon Sclf 09/15/1999 09/10/1999 51 Goerge Rubmo Self 09/15/1999 09/11/1999 Gloria Rubino 52 Mr and Mrs Robert J Walker Self 09/15/1999 09/13/1999 53 Karim Runnwi, Ph D. New York Department of 09/15/1999 09/13/1999 Director Health Bureau of Environmental Radiation ProtectJ.on 13

Docket No.: PR-050 01/29/2001 FR Cue: 64FR31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 54 Garth D. Richmond Nuclear Utility 09/1611999 09/14/1999 Baclditting and Reform Group (NUBARG) 55 Jeffrey E Cole Self 09/16/1999 09/12/1999 56 Sally S Booth, Ph.D. Self 09/16/1999 09/12/1999 57 Norman K. Peterson Detroit Edison 09/17/1999 09/13/1999 Director Nuclear Licensing 58 S. K. Oambhir Omaha Public Power 09n.0/1999 09/10/1999 DiVIs1on Manager District 14

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Document Miscellaneous Access:lon Number Submitted by Representing Date Date Description Number 59 KateWalkerVogel Self 09/20/1999 09/12/1999 ' 60 JeffE. Cole, Ph.D. Self 09/20/1999 09/12/1999 61 Juno Kluglein Self 09/20/1999 09/12/1999 62 K Wagner Self 09f20/l 999 09/12/1999 63 Solly S Booth, Pb.D Duplicate of Comment 09f20/1999 09/12/1999 No. 56 15

Docket No.: PR-050 01/29/2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Comment Comment Docket Docoment Miscellaneous Accession Number Submitted by Representing Date Date Description Number 64 Lou Ann Walker Self 09/20/1999 09/12/1999 65 L Hall Bohlinger State of Louisiana 09/20/1999 09/13/1999 Deputy SeCIC!ll.ry 66 A David Rossin Self 09/20/1999 09/16/1999 67 R. M. Krich Commonwealth Edtson 09/21/1999 09/13/1999 Vice President - Regulatory Company Services 68 Gary W McConnell Georgia Emergency 09/21/1999 09/10/1999 Director Mnnagement Agency 16

Docket No.: PR-050 01/29/:2001 FR Cite: 64FR31737 In the Matter of Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 69 F. M Schiele Self (Y.Jn.7/1999 09/12/1999 70 F. T. Mnzzucchell1 Self 09/27/1999 09/12/1999 71 June Oleary Harvey Self 09!2&11999 09/12/1999 72 Shirley Ruch Self 09!2&11999 09/12/1999 73 Jrunes A. Hutton, PECO Ene.gy Company 09/29/1999 09fl3/1999 Director - Licensing 17

Docket No.: PR-050 01/29/2001 FR CiJe: 64FR31737 In the Matter of Consideration of Potassium Iodide In Emergency Plans Connnent Comment Docket Document Miseellaneous Accession Number Submitted by Representing Date Date Description Number Peter G. Crane 1CV'22/1999 10/15/1999 Letter from Peter 0. Crane to Commission re Commission's answers to congres'ilonal questions John Kerry 11/04/1999 09/29/1999 Letter from Senator John Kerry to SECY wntrng on behalf of the Massachusetts Coalition to Stockpile KI concluding that the be.Defis of KI justify expense Wilham D Travers 11/04/1999 10/28/1999 Letter from William D Travers to Senator John Kerry responding to tho Senator's 09/29/99 letter re Stockpiling of KI 74 Bobby Cohen Sclf 12/02/1999 09/12/1999 01/12/2001 01/09/2001 FRN Final Rule 18

Docket No.: PR..050 01/26/2001 I' FR Cite: 64FR31737 1n the Matter or Consideration of Potassium Iodide in Emergency Plans Comment Comment Docket Document Miscellaneous Accession Number Submitted by Representing Date Date Description Number 01/12/2001 01/09n.o<ll FRN - Pinal Rule 02/16/2001 02/1 ln.o<ll Ltr. Fm. Peter Crane to U.S. FDA ro PotasitlllIIl Iochde (LTR 01-0115) 1

Peter G. Crane I 6545 2'1"' Avenue, NW I Seattle, WA 98117-5902 I 206-783-8485 I cranepbko@yahoo.com February 11, 200 I D0O~ETED Dockets Management Branch (HFA-305) US NR C U.S. Food and Drug Administration 5600 Fishers Lane "01 FEB 16 P2 :49 RockvilJe, MD 20857

                                 .                             Cot/- F 3*1'~l)oF-iC'- ,--.-: QECRET' RY Re: Docket No. 00D-1681, Draft Guidance on Potassnnn looi                i=fuL*._.v1.~:r<:i'.~GS Ato as a Thyroid Blocking Agent in Radiation Emergencies                   ADJ C;CATION              STAFF To the Dockets Management Branch:

I. Summary The draft guidance on potassium iodide{KI) newly issued by the Food and Drug Administration is a credit to the FDA and a major service to the American people, state and local governments, and the other agencies of the federal community. Scientifically objective, well-reasoned, lucid, and concise, it answers the outstanding questions on KI, and in particular provides decisionmakers at the state and local level with the information they need to determine whether stockpiling makes sense for them. It also rebuts definitively the mendacious propaganda, masquerading as science, with which the NRC technical staff, in the 1998 Congel-Mohseni report ("Draft NUREG-1633"), purported to offer a technical assessment of KI. The FDA draft guidance requires no revision and should be adopted in final form. Its issuance reinforces the need for the NRC to refrain from meddling in issues of drug safety and effectiveness, matters on which it is as little qualified to speak as is FDA on issues of nuclear power plant safety. II. The Draft Guidance The draft guidance, among other things: reaffrrms and strengthens the FDA's 1982 "safe and effective" finding on KI. makes the point that the incidence of childhood thyroid cancer in Chernobyl-affected areas has risen as much as 100-fold; that the "dramatic increase in thyroid cancer among exposed children," with a "relatively short latency," is produced even by "relatively small doses of radioiodine." stresses the Polish experience with KI, which shows the drug's "safety and tolerability." makes the point that the benefits of KI treatment for neonates to reduce the risk of thyroid cancer outweigh the risk of side effects, but also provides guidance for minimizing risks of such side effects. by lowering to 5 cGy the intervention level for KI in children, provides guidance reflective of the Chernobyl experience. stresses the time-critical nature of KI administration - an implicit argument for having supplies on hand, rather than at some distant location. emphasizes that KI is not intended to be used as the sole means of radiation protection, but rather "as an adjunct to evacuation (itself not always feasible), sheltering, and control of foodstuffs." complements and reinforces the recent decision of the Nuclear Regulatory Commission, which ( overriding a contrary recommendation of the NRC technical staff) published a final regulation requiring states to consider KI as part of nuclear emergency planning. 02/16 . .. To EDO for Information .. . Copy to: RF *** 01-0115 SECY/RAS add to Rulemaking Docket

makes apparent the wisdom of the recommendation, adopted in 1996 by the Federal Radiation Protection Coordinating Committee, that the federal government should supply KJ. to any state wishing to establish a stockpile. (The NRC, as part of its recent decision, endorsed this approach and undertook to bear at least the initial cost.) A question raised by some commenters is whether the 5cGy intervention level is sufficiently conservative, and whether the lcGy level advocated by Dr. Keith Baverstock of the World Health Organization would be more desirable. In my view, the FDA has acted wisely in following the path it has chosen, given the eminence of those whose views it reflects, including Drs. Jacob Robbins and Jan Wolff of NIB, Dr. David Becker of the New York/Cornell Medical Center, and the American Thyroid Association. If at some point in the future, evidence points more strongly than it does today to a lower intervention threshold, FDA can and no.doubt wiIJ act accordingly. For the present, however, to move immediately to a 1 cGy level, solely on the basis of the WHO report, would raise questions as to whether FDA was acting precipitately, and probably serve to impede rather than promote the widespread adoption of KI stockpiling in the United States. Accordingly, I believe that the draft guidance should be made - final without any alteration in the ScGy standard. III. The Draft Guidance in Relation to Draft NUREG-1633 The FDA draft guidance presents the strongest possible contrast with the Congel-Mohseni report of 1998 ("Draft NUREG-1633"). It is worth discussing the NRC report in some detail, because the presence of the draft guidance from FDA raises the question whether there is any continuing need for NUREG-1633, at least in anything like the form in which it was originally issued. The Congel-Mohseni report purported to be a technical analysis by the NRC staff of the safety and effectiveness of KI. In reality, it appears to have been an attempt to negate the FDA's 1982 "safe and effective" finding by creating a rival document, seemingly authoritative, that would serve to persuade NRC Commissioners and state governments that Kl was dangerous to health and that stockpiling the drng was therefore undesirable. The single best measure of the level of integrity of the Congel-Mohseni report was its handling of the FDA's 1982 "safe and effective" finding. One would naturally have expected this finding to be the starting point of their analysis, given that the FDA and not the technical staff of the Nuclear Regulatory Commission is the national authority on the safety and effectiveness of drugs. Instead, the authors dealt with this troublesome fact by never mentioning it all all. Their failure to refer to the FDA finding cannot have been for lack of space, as the report was 40 pages long. The omission speaks volumes. It is precisely as though FDA were to issue a lengthy report decrying the supposedly perilous condition of the Seabrook nuclear plant without mentioning that there was another agency, the Nuclear Regulatory Commission, that regulated such plants, and that Seabrook had met the NRC's "reasonable assurance of safety" test. Another uncomfortable fact for the report's authors was the Polish experience with KI during Chernobyl. Their response was to express doubt about the veracity of the Polish experts. "To the extent we believe the Polish data," the authors wrote at one point, without explaining what reason there was to doubt that

data. This slur on their betters was one of the most deplorable aspects of the report. I am happy to say that a more senior NRC staff manager subsequently invited the leading Polish expert on KI to come to the NRC to discuss his use of KI during the Chernobyl accident - an implicit apology for his subordinates' sorry conduct. The authors of the NRC report appear to have found their Jack of expertise in medicine and pharmacology to be no barrier to passing judgment in these areas. Bypassing the directly relevant journal literature, they relied instead on an outdated copy of the Physician's Desk Reference (PDR), which was cited selectively and out of context. For example, ominous warnings in the report on the side effects of KI turned out to be quotations not from the PDR's description of over-the-counter KI pills for thyroid protection, but from the description of a different, prescription-only drug, used for certain pulmonary diseases, that contains KI in a far more concentrated form. The ordinary reader would have had no reason to suspect that the warnings did not pertain to the drug that was the subject ofNUREG-1633. One of the quoted warnings, on the haz.ard to children with cystic fibrosis, appears either to have been made up out of whole cloth or lifted from the description of some unrelated drug. What is most remarkable is that the NRC technical staff seems to have imagined that this perverse travesty of good science would pass muster, and that its bias and distortions would go unnoticed. (It is particularly revealing of the authors' disrespect for the intelligence of the NRC Commissioners.) In reality, however, the one redeeming feature of the Congel-Mohseni report was the clumsiness of its execution. The knowledgeable reader was no more likely to be taken in than a shopkeeper presented with an eight-dolJar bill. Consider, for example, the September 28, 1998, comments on the report from Dr. Karim Rimawi, the Director of the Bureau of Environmental Radiation Protection in the New York State Department of Health, who wrote that after the state's Radiological Health Advisory Committee had "found no health related reasons why KI could not be used" for iodine prophylaxis in an emergency, the Department had begun a review to determine if there were logistical or legal reasons not to make potassium iodide an option in radiological emergencies. Dr. Rimawi, who also provided nine pages of detailed criticisms of the report, continued: The department had looked forward to NRC's report in the hope that it would assist us in the review. Unfortunately, we find the document to have been prepared to justify a position advocating against the use of KI for public protection, rather than as an objective review of the relevant information. This bias raises doubt as to the value of the document. Tendentious, unobjective, biased, and of dubious value: quite extraordinarily scathing comments from a state official on a federal agency's efforts, but then the Congel-Mohseni report was hardly an ordinary piece of work. Ohio state officials also filed highly critical comments. Fortunately, the NRC Commissioners took note of the criticisms, quickly recognized the deficiencies in NUREG-1633, and ordered the document withdrawn from circulation and taken off the NRC website. On October 12, 1998, the trade publication Inside N.R.C. published an article entitled "COMMISSION

APPROVES KI NOTICE TO FRPCC, ORDERS DRAFT NUREG W!THDRA WN." It quoted Commissioner Edward McGaffigan as follows:

          "As one staffer has pointed out to me," McGaffigan said, "it [NUREG-1633] was never intended to be supportive of the policy the Commission established in its June 26 SRM, but was instead a justification for the policy (not granting the revised petition for rulemaking) which the staff had advocated and the commission rejected .... I made the mistake of thinking no harm could come from just putting a document out for public comment. I was wrong."

Since I 998, the NRC staff has supposedly been revising the document, with the help of a "Core Group" of about 12 persons. Apart from giving a boost to the economy of Arizona - the then leader of the Core Group, Mr. Mohseni, took the group to Tempe, Arizona, for a week in February 1999 - it is hard to see what this effort has accomplished, for all the time and money that has been expended. So far, nothing has been issued. ,e In one sense, however, this may be fortunate. The FDA guidance has so thoroughly and definitively illuminated the relevant issues on Kl that no beneficial purpose would be served by having the NRC cover the same ground in its revision ofNUREG-1633. Assuming thatNUREG-1633 needs to be reissued at all, it should incorporate by reference the FDA draft guidance, making clear that NRC does not and wiJI not second-guess FDA's findings on the safety and effectiveness of drugs. (It might usefuJly discuss, however, such issues as the logistics of KI stockpiling and distribution.) It does not serve the interests of the Government as a whole, or of the FDA, or the NRC, or anyone else, to have two separate federal agencies - one possessing both jurisdiction and expertise, the other possessing neither - offering what purports to be authoritative guidance on the safety and efficacy of a pharmaceutical. The potential for confusion and mischief is too great to alJow any further poaching by the NRC staff on FDA's territory. It is therefore essential for the NRC to recognize the limits of its authority, and to curb any signs of rogue behavior on the part of its staff. At the same time, it is incumbent on FDA to maintain its vigilance against interference and intrusion by sister agencies. Sincerely,

mL0J.OJ50_367 DOCK ETED USNRC [7590-01-P] NUCLEAR REGULA TORY COMMISSION "()l JAN 12 P4 :13 10 CFR Part 50 RIN: 3150-AG11 Consideration of Potassium Iodide in Emergency Plans AGENCY: Nuclear Regulatory Commission. ACTION : Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its emergency planning regulations governing the domestic licensing of production and utilization facilities. The final rule requires that consideration be given to including potassium iodide (Kl) as a protective measure for the general public that would supplement sheltering and evacuation. Kl would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant. The final rule responds to petitions for rulemaking (PAM 50-63 and PAM 50-63A)

• submitted by Mr. Peter G. Crane concerning the use of Klin emergency plans.

_A.pr; l Iq d-00 I EFFECTIVE DATES: 90"'tfays-aftefi>~hli~n in the Federal Register. FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Comm ission, Washington, DC 20555-0001 . Telephone: (301) 415-3224. Internet: MTJ1@nrc.gov.

.r SU~ PLEMENTARY INFORMATION: Section 50.47 of the Commission's regulations establishes requirements for emergency plans for nuclear power reactors to provide reasonable assurance that adequate protective measures can ancf will be taken in the event of a radiological emergency. Section 50.47(b) contains 16 planning standards, and in particular,§ 50.47(b)(10) requires that emergency plans include "a range of protective actions" for the plume exposure pathway emergency planning zone (EPZ) for emergency workers and the public. This provision does not identify specific protective actions that must be included in these emergency plans.

                    ~he Petitioner's Requested Amendment to the NRC Regulations On November 27, 1995 (60 FR 58256), the NRC published a document announcing the receipt of a petition for rulemaking (PAM 50-63) filed by Mr. Peter G. Crane on his own behatf and requested public comment on the suggested action. In the original petition (PAM 50-63), submitted on September 9, 1995, the petitioner requested that 10 CFR Part 50 be amended to include language taken from FEMA's Federal Radiological Emergency

-. Response Plan of September 1994. The petitioner requested that the NRC amend its regulations concerning emergency planning to include a requirement that em~rgency planning protective actions include the prophylactic use of potassium iodide (Kl), which the petitioner stated prevents thyroid cancer after n~clear accidents. The petitioner proposed that Section 50.47(b){10) be amended to read as follows: (1 O) A range of protective actions including sheltering, evacuation and prophylactic use of iodine have been developed for the plume exposure pathway-EPZ [emergency planning zone] for emergency workers and the public. Guidelines for the choice of protective actions during an

                                        '     '                                J emergency, consistent with Federal guidelines, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the local!=l have been developed.

In the September 9, 1995, petition {PAM 50-63), the petitioner stated that he believes that if his proposed rule change is adopted, the plan will become an accurate description of emergency preparedness for radiological emergencies; the recommendation of the Kemeny Commission to stockpile Kl will at last b~ implemented; and the United States will be in compliance with the International Basic Safety Standards. On November 11, 1997, the petitioner submitted a revision to his original petition. (PAM 50*63A). In the revised petition, the petitioner requested that 1O CFA 50.47(b) be amended to read: (10) "A range of protective actions have been developed for the plume exposure EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal.guidelines, are developed and in place, and protective actions for the ingestion exposure. pathway EPZ appropriate to the locale have been developed." The petitioner also provided a marked*up version of the NAC staff's proposed Federal Radiological Preparedness Coordinating Committee (FRPCC) Federal Register document concerning a revision to the Federal policy relating to the use of Kl by the general public. The NRC published a document announcing the receipt of the amended petition on December 17, 1997, (62 FR 66038) and requested public comment on the amended petition. As part of the petitioner's comments on the proposed rule, the petitioner also stated that his original petition was incorporated by reference and resubmitted because the amended petition was based in part upon the June 30, 1997, Commission decision to fund State supplies for those States that request it. The petitioner also requested in PAM 50-63 that the NAC, either on its own or jointly with other ljlgencies, Issue a policy statement declaring that KJ stockpiling is a sensible and p~udent measure necessary to assure that the drug will be available in the event of a major accident. The petitioner believes that this statement would clarify that Kl can be

 --   used in conjunction with evacuation and sheltering to maximize protection to the public.

Commission Action Concerning the Petitions By staff requirements memorandum (SAM) dated June 26, 1998, to SECY 98--061, "Staff Options for ResoMng a Petition for Rulemaking (PAM 50-63 and 50-63A) Relating to Re-evaluation of the Policy Regarding the use of Potassium Iodide (Kl) by the General Public after a Severe Accident at a Nuclear Power Plant," the Commission decided to grant the reviseef/*

• e petition for rulemaking (PAM 50-63A). The Commission also directed that the preamble for the proposed rule include a statement to the effect that State and local decision makers, provided with proper informatfon, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions.

By SAM dated April 22, 1999, to SECY 98-264, "Proposed Amendments to 10 CFR 50.47; Granting of Petitions for Rulemaking (PAM 50-63 and 50-63A) Relating to a Re-evaluation of Policy on the use of Potassium Iodide (Kl) after a Severe Accident at a Nuclear Power Plant,n the Commission voted to approve publication in the Federal Register of a

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proposed rule that would grant in part both the original petition (PAM 5()..63) and the revised ( petition for rulemaking (PAM 50-63A). The proposed rule was published for public comment on June 14, 1999 (64 FR 31737). That notice provides greater detail concerning the basis for the petition and the NAC's rationale for the proposed rule language put forth for comment. Other Activities Related to the Rulemaking on Kl In its decision on June 30, 1997, the Commission endorsed the Federal offer to fund the purchase of Kl for States at their request. On June 26, 1998, in a decision on this rulemaking petition, the Commission again noted that the Federal government (most likely the NAC) is 4t prepared to fund_ the* purchase of a.stockpile of Kl for the States, upon request. 1 .However, in. its April 22, 1999, SAM, the Commission.decided: (1) not to fund State stockpiles* of Kl; (2) to dlrectthe NRC staff to work with FEMA to establish and maintain regional Kl stockpiles; and (3) to support NRC funding of the purchase and resupply of the regional Kl stockpiles to the

• extent that this cannot be covered by FEMA under its initiatives. -The Commission determined _

that notwithstanding the.June 30, .1997, and June 26, 1998, intention that "most likely the NRC~ would fund the purchase of State stockpiles of Kl, NRC was not prepared to fund State stockpiles of Kl absent Congressional funding specifically for this purpose. The Federal Radiological Preparedness Coordinating Committee (FRPCC) is responsible to coordinate all Federal responsibilities for assisting state and local governments in emergency planning and preparedness for peacetime radiological emergencies. Federal 1 This was in contrast to previous Commission statements, such as those made when the Commission amended its emergency planning regulations (45 FR 55402) on November 3, 1980, wherein the Commission stated that any direct funding of State or local governments solely for emergency preparedness purposes by the Federal government would come through the Federal Emergency Management Agency (FEMA). r agencies which participate in the FRPCC include {among others): the Federal Emergency Management Agency {FEMA), NRC, the Environmental Protection Agency (EPA), and the Department of Health and Human Services {HHS). The 1985 Federal Policy recommends the stockpiling or distribution of Kl during emergencies for emergency workers and institutionalized I persons, but does not recommend requiring pre-distribution or stockpiling for the general public. In parallel with petitioning the NRC for rulemaking, Mr. Crane requested that the FRPCC policy be reconsidered. In early 1996, the FRPCC convened a subcommittee on Potassium Iodide. The subcommittee recommended the following to the FRPCC regarding the Federal Kl policy: {1) without changing the Federal policy that it is the State's p*rerogative to make its own decisions on whether to use Kl, the Federal Government {NRC through FEMA), shou}d fund the

                                                                                          , I
                                                                                          .:J, purchase of a stockpile for a State that, hereafter, decides to incorporate Kl as a protective
        '                                                                        ~

measure for the general public; {2) the language in the 1985 policy should be softened to be more flexible and balanced, as for instance, rewording it to state "it [potassium iodide for use by the general public] is not required, but may be selected as a protective measure at the option of the State or, in some cases, local governments;" and (3) local jurisdictions that wish to use Kl r,

                                                              -                           -*~*

should consult with the State to determine if the arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include such a measure in their emergency plans. On June 16, 1997, the NRC staff forwarded to the Commission a staff version of the FRPCC- proposed Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant. In its SRM of June 30, 1997, the Commission endorsed the Federal offer to fund the purchase of Kl for States. On June 26, 1998, the Commission directed that the FRPCC proposed Policy be modified to include a statement to the effect that State and local decision makers, provided with ~roper information, may find the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. ~ noted above, the Commission also reiterated its. endorsement of the Federal offer to fund Kl stockpiles for States. Subsequently, on April 22, 1999, the Commission directed the staff to amend the draft FAN on the Federal Kl Policy to conform to the Commission decision on the petitions for rulemaking, and the decision not to fund State Kl stockpiles. On April 29, 1999, the Director of FEMA, Mr. James Lee Witt, forwarded a letter to the Commission commenting on the issue of funding of stockpiles _of Kl for States. The letter objected to the Commission's "unilateral" decision on funding, and also noted "FEMA has always opposed the notion that Federal regional stockpiles of Kl would be effective [and believes that] re,gional stockpiles would complicate, not strengthen radiological emergency preparedness." FEMA believes that if a State opts to use Kl as a supplemental protective measure, the NRC should provide the funds for such* a purchase. The NRC responded to Mr. Witt's letter on June 15, 1999. This letter noted the Commission's decision not to fund state stockpiles of Kl as well as the reasons underlying that decision. The letter also,referred to*the*Commission's direction,to "the NRC staff to work with FEMA staff to establish and maintain regional Kl stockpiles to be used in the event that local stockpiles prove to be insufficient, or when a state without a stockpile elects to use Kl on an ad hoc basis in the case of a nuclear emergency." The letter expressed con_fidence that the staffs, 4lt working together would successfully resolve the Kl supply issue. The status of the stockpile and funding issues are discussed later in this notice. NRC is working ~losely with the other Federal agencies to determine appropriate changes to the 1985 policy. A decision regarding policy changes will be reached after the conclusion of this rulemaking. In accordance with a Memorandum of Understanding between NRC and FEMA, NRC sent dra~ versions of this Federal Register notice to FEMA for its review and comment. FEMA responded by letter dated January 12, 2000. That letter reiterated their previous comments I , I opposing regional stockpiles and instead favoring NRG funding of State stockpiles. The letter also noted that the development of regional stockpiles of KI had not progressed. As discussed in the public comment evaluation, the Commission, as part of Its decision to grant in full the amended rulemaking petition, has withdrawn Its support for the funding of ( regional Kl stockpiles and has reinstated its offer to provide for NRC funding of State or, in some cases, local stockpiles. The Commission agrees to fund a State's stockpile of Kl, subject to various restrictions and limitations (see Staff Requirements Memorandum for the Affirmation Session on December 22, 2000). NRG intends to work closely with FEMA and the other

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Federal agencies in FRPCC to finalize the draft Federal Policy to replace the 1985 Federal Policy. A decision regarding changes to the draft policy will be reached after the conclusion of

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this rulemaking. The substance of the specific comments attached to the FEMA letter is addressed by the issues in the public co~ment evaluation. On September 30, 1998, the Commission also directed the staff to withdraw its guidance document, NUREG-1633 and substantially revise it, in a number of respects, including an improved discussion on how the practical problems in Kl stockpiling, distribution and use are handled by States and other nations who use Kl as a supplement To accomplish this task, the NRC formed a Kl Core Group, consisting of representatives from those States that have Kl as a supplemental protective action, the Conference of Radiation Control Program Directors, the National Emergency Management Association, the U. S. Food and Drug ,Administration (FDA), EPA and FEMA. The revised draft guidance document, NUREG-1633, "Assessment of the Use of Kl as a Supplemental Protective Action During Severe Reactor Accidents", Rev. 2 is expected to be issued for comment following receipt of the FDA's draft revised position on exposure action levels and proper dosage of Kl which was issued for public comment on January 4, 2001 {66 FR 801 ). In addition, the NRG plans to develop a public information brochure concerning the use of Kl by the generaJ public following completion of the final NUAEG. Public Comment Evaluation On November 27, 1995 (60 FR 58256), the NRC announced the receipt of the original petition for rulemaking (PAM 50-63), and requested public comment on the suggested rule amendment. A total of 65 comment letters were recelved. 2 Letters in favor of granting the petition came from 5 environmental groups, 22 members of the public (including 1 from the petitioner), and the American Thyroid Association. Letters opposed to the petition came from 20 utilities, 9 State governmental agencies, 2 utility interest organizations, a letter signed by 12 heaJth physicists, 2 State university medical centers and 1 member o(the public. On December 17, 1997 (62 FR 66038), the Commission published a request for public comment on the amended petition (PAM 50-63A) in the Federal Register. In response to several requests, the comment period was extended until February 17, 1998, by a Federal Register notice published on January 21, 1998 (63 FR 3052) .. A total of 86 comment letters were received. The letters in favor of granting the petition came from 8 public interest groups, 48 members of the public {including 3 from the petitioner), 3 physicians, 2 ,U.S. Senators, one - State Representative, FEMA, the American Thyroid Association, a Kl manufacturer, and the US Pharmacopeia Convention. Fourteen utilities, 3 State government agencies, 1 *utility interest association, and 2 members of the public opposed the petition for rulemaking. A detailed analysis of the issues raised by the public comments with the response to those issues was published in the June 14, 1999, proposed rule Federal Register notice. 2Two letters that were received in response to the notice did not address the issues in the petition and are not discussed further. On June 14, 1999 (64 FR 31737), the Commission published a proposed rule in the Federal Regjster. based on the revised petition for rulemaking (PAM 50-63A) and requested public comment by September 14, 1999. A total of n comment letters were received. 3 The letters in favor of the proposed rulemaking and the revised petition for rulemaking originated from a United States Senator; a member of the U.S. House of Representatives; 3 State agencies; 4 public interest groups; 1O members of the public (including two from the petitioner); and one letter with 529 signatures. Letters that opposed the proposed rulemaking came from 14 utilities; 13 State or local government agencies; 1 utility interest association; one letter from the Conference of Radiation Control Program Directors Standard~ committee representing 5

                                                                                                             , i committee members; a letter from the National Emergency Management Association I
                                                                                                  ,*(,,,

representing emergency management directors In 50 states; a law firm representing 15 utilities; and a former Assistant Secretary of Nuclear Energy at DOE. The FEMA letter of April 29, 1999, was submitted before the rule was published and discussed Kl stockpiles. Another 24 letters requested the Commission to grant the original petition (PAM 50-63) by requiring the use of Kl rather than the consideration of Kl in emergency planning. These letters originated from

                                                                                                   .;-~

members of the public as well as public interest groups. As part of the petitioner's co~ment

e. letter dated August 17, 1999, on the proposed rule the petitioner stated that, in light of the Commission's decision not to fund state stockpiles of Kl, the Commission should consider his original petition (PAM 50-63) to be incorporated by reference and resubmitted. He also requested the Commission to 'grant the petition as originally submitted.

3Three of the letters (those from Fl;:MA, the senator and the congressional representative) were not submitted during the comment period in response to the notice, but

  \ are being treated as comment letters for purposes of this discussion.

The following discussion addresses ,the significant comments and issues raised in the three public comment periods for the original and amended petitions for rulemaking and the I proposed rule. Issue A: Should Kl be Considered as a Supplemental Protective Action to Evacuation and Sheltering Several commenters on the proposed rule state that the rulemaking would not add

 .significant public health and safety benefit beyond the current emergency plans, because evacuation and sheltering are the best means to protect the public in the event of a radiological e emergency. According to these commenters, evacuation and sheltering are more effective at dose reduction because they reduce dose to all organs, not just to the thyroid.

Other comments express the view that the Chernobyl experience (including use of Kl in Poland) shows that (1) thyroid cancer is a major result of reactor accidents, (2) the exposure can continue for days and thus the institution of Kl blocking at any time is beneficial, (3) deployment of Kl is safe, and *(4),shelf life is extremely-long. These commenters note that EPA Manual [Manual of Protective Action Guides and Protective Actions for Nuclear Incidents, EPA-400-A-92-001 (May 1992)] quotes the FDA as stating that potassium iodide "will have 4t substantial benefit even if it is taken 3 or 4 hours after acute exposure." Thus, these commenters believe that the advantage of having a supply of Kl on hand outweighs moderate cost and that Kl should be a supplemental protective action. Further, these commenters note that just because there may be other radionuclides to which people are exposed is not a rea~on to deny them the availability of Kl. Commenters who favor the use of Kl as a supplemental protective action conclude that evacuation and sheltering alone may not be sufficient safety actions in the event that evacuation is not feasible. They state that natural disasters could occur that would make evacuation difficult and time consuming at best, as for instance, earthquakes, hurricanes, blizzards, and ice storms. According to these commenters, a point against strong reliance upon evacuation is the evacuation routes themselves. As an example, a commenter cites the area around the Seabrook Nuclear Plant, noting that during the summer tourist season especiaJly, it can be predicted that evacuees will be for~ to wait in traffic for great lengths of time. This commenter believes that ff Kl were predistributed, instances of cancer, hypothyroidism and other thyroid disorders might be avoided. Response. The Commission recognizes evacuation to be the most effective protective measure to be taken in the event of a radiological emergency because it protects thEi\vhole 4-, body (including the thyroid and other organs) from all radionuclides and all exposure pathways. The Commission recognizes that there may be situations when evacuation is not feasible or is delayed. In-place sheltering is an effective protective action in such a situation. However, it is important to note that the issue is not evacuation or sheltering versus Kl. Rather, it is evacuation or sheltering with Kl versus evacuation or sheltering without Kl. The use of Kl is (. intended to supplement, not to replace, other protective measures. This amendment ..:~ represents no change in the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the populati_on before any exposure to radiation occurs. Depending on the circumstances, Kl may offer additional protection for one radiation-sensitive organ, the thyroid, if used in conjunction with evacuation and sheltering. In developing the range of public protective actions for severe accidents at commercial nuclear power plants, evacuation and in~place sheltering provide adequate protection for the general public but the use of Kl can be a reasonable and prudent supplement. Therefore, it seems reasonable, while continuing to recognize the role of the' State and local governments in matters of emergency planning, to require explicitly that emergency planners consider the use of Kl.

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Issue B: Is There a Need for New Regulation Commenters* in favor of the proposed rule note that a host of countries-France, Germany, Belarus, Russia, Switzerland, Austria, the Czech Republic, Japan, Great Britain, Swede 11, Slovakia, and others-protect themselves with stockpiles of Kl. These commenters point to soaring rates of thyroid cancer appearing in children in the Soviet Union who were exposed to the Chernobyl nuclear accident and who received too littJe potassium iodide, and too late. Thus, these commenters support the view that there is new information that suggests the need for consideration by State and local governments. In addition, many of these commenters would go further than the proposed rule language and require the use of Kl, not just its consideration. In contrast to the above, letters from some state and local governments, and from utilities, say that the State and local governments have already considered the use of Kl. They believe that the petitioner has not provided any compelling reasons why additional Federal requirements are needed or how they would benefit the health and safety of the public. These State and local government commenters reject the view that the States have not ha~ access to . sufficient technical information regarding potassium iodide, and that without accurate and current information on Kl -- including the Chernobyl experience and the consensus of international experts - States cannot make an informed judgement. They conclude that this assertion is without merit, as there has been no shortage of information related to the use of . potassium iodide available to State radiological emergency planners, and oppose the implication that State and local governments, absent Federal actions, are incapable of making informed decisions regarding the protection of their citizens during a radiological emergency. One commenter stated that by issuing this rule, the Commission 1s ignoring the views of States where Kl has been stockpiled or pre-distributed, and where experience shows the system is ineffective. The commenters opposing the proposed rule on this basis also note that reliance on the Chernobyl experience discounts the vast technical, political, and socio-economic differences between the United States and Eastern European countries at the time of the Chernobyl accident. The efficacy of any protective measure will depend on a large number of factors, including but not limited to: the type of reactor involved; accident sequences and timing; source term; timeliness of notification; the manner in which protective action decisions are made and transmitted to the public; the mobility of the public; and the receptiveness of the general public to official instructions. These commenters believe that the above factors have already.been l' considered by State and local governments' in the development of existing emergency response

                                                                                                      . . ffi plans.

Response. The Commission did not intend to imply that States are not capable of making informed decisions regarding the protection of their citizens during a radiological emergency. In fact, the final rule calls on offsite authorities to make their own decision on this I t* ,, matter. Additionally, the Commission recognizes that most State and local govemments~have already considered the use of Kl in the event of an emergency as part of their planning. Nevertheless, the Commission believes it appropriate to provide informatio[l that may be of aid to offsite authorities in their consideration of this matter. Offsite authorities may, of cou-rse, use this information as they see fit. Several States have welcomed the NRC's efforts in developing information relating to the benefits and risks associated with using Kl as a supplemental protective- measure for the general public. This information is intended to supplement and update information already available on this subject, including experience from State and foreign governments that have made Kl available to the public. As noted earlier, this information will be in a revised NUREG-1633, which is scheduled for publication for comment after the FDA issues its draft guidance and in an information brochure. The Commission finds that Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific local conditions. Through its decision to require that the use of Kl be "considered" (rather than being required), the Commission is acknowfedging that the efficacy of any protective measure will depend upon a number of factors, including those noted by the commenter, that can vary not only between countries but in individual States. Thus, the Commission concluded that decisions on the use of Kl need to be resolved on a State-by-State basis. As part of this consideration, State and local governments can weigh all relevant factors. Issue C: The Importance of Information in the Decisionmaking Process Concerning the Public Use of Kl In the proposed rule, the Commission noted that NUREG-1633 was being revised to provide information about experience in the United States and abroad *with"distribution of Kl, and that an information brochure was also being prepared. According to some commenters, distribution of information on the benefits and risks associated with the use of Kl should not be 4t limited to people living within nuclear power plant emergency planning zones. Further, commenters note that a comprehensive public information program outlining the potential range of benefits and risks of using Kl and how to employ it most effectively in the event of a radiological emergency would be necessary to allow personal decisionmaking. Making the information and the Kl itself available directly to members of the public provides them with the ability to decide for themselves how best to take advantage of the benefits associated with the use of Kl as supplementary protection. One vehicle currently used for disseminating regular preparedness information which could be used to provide information on Kl is the public information brochures and calendars already required to be distributed annually within each emergency planning zone. In this commenter's view, making information and Kl available provides the greatest level of protection for the greatest number of people. Some State government organizations were concerned that making provisions for Kl

• might give the public a false sense of security that they are fully protected, and that the public might not evacuate. Thus, these organizations believe that there is a need for public information concerning the supplemental role that the use of Kl could play.

Several of the commenters stated that it is desirable that the NRC would work with other appropriate Federal agencies to develop and promulgate clear and necessary guidance on the subject, similar to the guidance on sheltering and evacuation. These commenters also believe that the final decision should lie at the discretion of the State and local governments. A few commenters expressed the view that the rule puts the burden of assessment on States who have fewer technical resources than the NRC, the EPA or the FDA. One commenter thought that the decisionmaking about stockpiling Kl most include rigorous assessments to ensure sufficient quantities of Kl will be available for distributio~ to - members of the public, in both the plume exposure pathway and the ingestion exposure pathway. Response. The Commission .recognizes that once a State decides to include Kl as a protective measure for the general public, it would be up to the State to decide how and when to conduct an educational program on the benefits and risks associated with using Kl and to supply Kl for appropriate distribution to the general public. Additionally, the Commission agrees that more detailed guidance on the use of Kl would be useful in assisting States to assess the merits of stockpiling Kl for the general public, including logistics, amounts and public information needs. The Commission has formed a Kl "Core Group" consisting of representatives of State, local, and Federal agencies whose responsibility Is tp develop clear guidance relating to the use of Kl. This guidance (NUREG-1633, Rev. 2) should be published for comment after FDA issues Its draft guidance, which was issued for public comment on January 4, 2001 (66 FR 801 ). The NRC is continuing to work with other Federal agencies through the FRPCC to coordinate government policies concerning radiation protection and emergency planning. Further, a public information brochure to be published later will assist States and individuals in making an informed decision on Kl. Issue D: Making Kl Available to the General Public A range of comments were submitted concerning ways by which Kl could be made available to the general public in the event of a radiological emergency. Many commenters simply asked NRC to "make Kl available" without further detail. In the proposed rule, the NAC discussed Federal stockpiles of Kl as part of Federal response to terrorist acts. One commenter indicated that expanding this* supply may be the best approach. Another-

• commenter stated that the public is not interested in stockpiles, but instead wants information to make their own decisions. Of those comments related to specific methods of availability, these can be generally grouped into individual availability, State stockpiles in the vicinity of nuclear power plants, or regional stockpiles.

Individual Availability One State submitted, as part of its comments, a report that discussed a plan they have developed that would allow citizens to gain access to Kl in advance of an accident. The plan calls for the State to secure agreements with Kl manufacturers to sell the medication directly to individuals or retail outlets, and to urge local pharmacies to stock Kl as an over-the-counter drug. Information concerning Kl availability and use would be included in the annual emergency information mailings prepared by nuclear power plant staffs and distributed to every property owner within the emergency planning zones. The State concluded that this method would allow individuals to make their own decisions about the use of Kl. This State noted that one can envision this activity being conducted in conjunction with existing programs designed to remind and encourage family members to periodicaJly check home first aid kits, smoke detectors, spare batteries for flashlights and radios, and other items that they might employ for their comfort and protection in the event of any emergency. In addition, one commenter noted that Kl is now available via the Internet from at least two vendors at an affordable price. (See also comments above in issue C about decisionmaking.) state Stockpiles. A number of commenters believe that Kl should be stockpiled in schools, fire houses or reception centers near nuclear power plants. These commenters state that this is the advice of the experts, for instance the ~orld Health Organization and Dr. Jean Temeck, from FDA.

                                                                                           :+

These commenters believe that the young are the most vul~erable; and, in the words of Dr.

• Temeck, "in an emergency you want to get it to the children as quickly as possible and the teacher is right there on the spot... You do not need to be medically trained to give Kl. A permission slip to administer Kl can be sent out by the school at the beginning of each year."

Further, it makes sense to these commenters thalthis time-critical medicine be available nearby, such as in a local school, hospital, or fire-station. Thus, these commenters believe that State stockpiles are appropriate because regional stockpiles will not adequately protect the public since Kl must be taken prior to exposure, or very shortly thereafter (within about six hours), to be an effective blocking agent. Regional Stockpiles A number of commenters, including emergency preparedness and response officials and FEMA, are concerned about the regional stockpiling and distribution process and its potential for reducing the effectiveness of measures which will provide much greater protection to the public. In their view, the complex logisti~ of storage and distribution of regional stockpiles far outweigh the usefulness of such a stockpile and that regional stockpiles of potassium iodide would complicate, not strengthen radiological emergency preparedness. These ~mmenters believe regional stockpiling has disadvantages as compared to State stockpiling. The administration of Kl is time-critical and regional stockpiling means critical time will be spent transporting the drug from a regional stockpile to the area where It is needed. For 4t these reasons, they believe that regional stockpiles should supplement, not *substitute for State stockpiles. Response. If a State decides to use Kl as a supplemental protective measure, the Commission agrees that the State should focus on the early administration of Kl to children. A decision to make Kl available to the general public will require some planning by the State for its own supplies of Kl and methods of distribution. .Such planning (for implementation of, . , protective actions) is a normal part of a State's emergency planning activities. As noted earlier, the NRC plans to issue a guidance document (NUREG-1633) to assist the States. The Commission recognizes the logistical challenges associated with the distribution of Kl to the general public. For this reason, the staff intends to include a discussion of experience with Kl distribution in the United States and abroad in the guidan~ document NUREG-1633. There are different approaches that a State can use in incorporating Kl as a supplemental protective measure for the general public. One approach is that m~ntioned by a commenter to distribute information about the over-the-counter availability of Kl. Making Kl available over the counter would provide members of the public with the opportunity to decide for themselves if they wanted to store and use Kl. In fact, some Kl manufacturers have indicated that they would make Kl available to any person who requests it, at a fee. This approach would minimize the need for State stockpiles or predistributlon and would put Kl in the hands of the public before an accident occurs, rather than attempting to distribute the Kl from stockpiles after an emergency is declared. The concerns about the effectiveness of regional stockpiles for rapid deployment of Kl to the public are also acknowledged. FEMA has stated that in its view, regional stockpiles will not enhance local radiological emergency preparedness because of complex logistics. The 4lt . Commission ,agrees. As part of Its decision on this final rule, the Commission has decided to provide funding for a supply of Kl for States that request such funding through FEMAand to discontinue support of regional stockpiles. The Commission believes that in light of logistic difficulties, it is doubtful that regional stockpiles of Kl could be effectively employed in the unlikely event of a radiological emergency at a commercial nuclear power plant. Issue E: Requiring versus Considering Use of Kl

• Several commenters thought that the proposed rule should be modified to require the use of Kl, not just the consideration by S.tate and local officials. These commenters believe, for instance, that the tragic comedy of errors surrounding attempts to distribute Kl in the wake of

                 )

the Three Mile Island partial core melt accident only serves to highlight the need for pre-. distribution. The health of our children is too important' to leave their protection to the consideration of states. These comrpenters ask that if the U.S. system is adequate, why do other industrialized nations believe that sheltering and evacuation alone are insufficient? Some of these commenters want all commercial reactor licensees to distribute Kl to all individuals within the EPZ and to make Kl available to anyone within a 50-mile radius of the \ reactor upon request. These commenters believe that the prophylactic use of Kl for the general public should be a mandatory emergency planning requirement and should not be merely an optional consideration, because, if given the choice, many States may not adequately protect their citizens. Another reason cited for wanting NRC to require Kl is that "without a federal mandate for stockpiling Kl, the nuclear industry will simply shift its fight against the policy to the State and local levels.* Response. Because the Commission believes that current emergency planning and protective measures - evacuation and sheltering - are adequate and protective of public health and safety, the Commission will not reguire use of Kl by the general public. Rather, the Commission recognizes the suppiemental value of Kl and the prerogative pf the State to decide e on the appropriateness of the use of Kl by its citizens. The Commission believes the final rule .. together with the Commission's decision to provide funding for the purchase of a State's supply of Kl strikes a proper balance between encouraging (but not requiring) the offsite authorities to ( . take advantage of the benefits of Kl and acknowledging the offsite authorities' role in such matters. The use of Kl is intended to supplement, not to replace, other protective*measures. This rule change thus represents no alteration in the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs. The Commission recognizes that there may be situations when evacuation is not feasible or is delayed. In-place sheltering is an effective protective action in such a situation. Depending on the circumstances, Kl may offer additional protection to one*radiation-sensitive organ, the thyroid, if used in conjunction with evacuation and sheltering. In addition, the Commission notes that issues surrounding the prophylactic use of Kl following such accidents do not lend themselves to across-the-board solutions. Therefore, the Cemmission has chosen to leave this decision to State an~ local emergency response planners, who may find that Kl should be a supplementary protective measure, rather than to mandate its use. Additionally, the Commission's amendment to require explicitly that planners consider the use of Kl, rather than require the use of Kl, recognizes the important role of the States and local governments in matters of emergency planning and the use of medicinal protective measures by their citizens. Issue F: Funding Some commenters, including FEMA, state that the recent decision of the nm to fund the purchase of Kl is an unfortunate reversal to the goal of, providing Commissioners

i! -ll supplementary protection for the general public. Thus, citing the Chernobyl accident, they urge the Commission to reconsider its position in light of the proven usefulness of Kl in preventing childhood thyroid cancer. One State commenter was concerned that after two years of efforts made toward-implementing this supplementary protection, the Commission's recent actions undermine that State's effort. While understanding the Commission's financial concerns leading to this decision, this commenter proposed that the Commission could approach 4I Congress for a supplemental appropriation.

Another commenter stated that the Commission's withdrawal of the offer to pay for

  . State Kl stockpiles sends a message that Kl preparedness is not important, and that States 0

who were considering plans to establish stockpiles have dropped such plans. Further, some commenters believe that the NRC reversal of position regarding funding of Kl for States that elect to stockpile it adversely affects the implementation of the policy proposed by the Federal Radiological Preparedness Coordinating Committee (FRPCq). [That draft policy currently

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provides that if a State chooses to add Kl as a supplement to its evacuation and sheltering protective actions, the State will inform FEMA, which will forward the request to the NRG for payment.] Another commenter noted that the Kemeny Commission supported stockpiling Kl, and that the Commission should fulfill an earlier NRC commitment to do so. Several States expressed the view that the requirement that use of Kl be considered is an unfunded State mandate and is contrary to an Executive Order of 8/5/99. A number of commenters stated that they thought the utilities should pay for supplies of Kl in the vicinity of the power plants. Some utilities expressed concern that the rulemaking might result in requests to the utilities from State and local organizations for such funding. Response. The Commission decision not to fund State stockpiles has been reversed as the result of public comment on this rulemaking. Promulgation of this final rule underscores the Commission's views on the importance of emergency preparedness, including consideration of e the use of Kl. The Commission has decided to fund State and, In some cases, local stockpiles of Kl, ~ubject to.certain restrictions and limitations (see Staff Requirements Memorandum for the Affirmation Session on December 22, 2000). The Commission believes that in light of logistical difficulties, it is doubtful that regional stockpiles of- Kl could be effectively employed in the unlikely event of a radiological emergency at a commercial nuclear power plant. The ( Commission's offer to fund the purchase of a supply of Kl for a State choosing to use Kl prophylaxis as a supplemental protective measure retains the FRPCC's proposal that the State remain responsible for all other funding connected with the inqorporation of Kl, such as preparing guidelines for its stockpiling. maintenance, distribution and use, and for all other ancillary costs. The Commission agrees that, in the past, licensees may have found it in their own setf interest to assist State and local governments by providing resources for emergency planning needs. The Commission expects that those States who decide to use Kl for the general public will make- suitable arrangements to fund costs other than the initial purchase of a supply of Kl. After funding the initial purchases of Kl, the Commission may consider extending the program j . to fund stockpile replenishment, but has made no commitments in this regard. As with other aspects of offsite emergency planning, the NRC will not require licensees to fund State activities, but the States can, of course, act in cooperation and coordination with licensees .

                . As to the issues whether the rule constiMes an "unfunded State mandate" or is contrary to an Executive Order of August 5, 1999, the Nuclear Regulatory Commission, as an independent regulatory agency, is not subject to the requirements of Trtle II of the Unfunded Mandates Reform Act of 1995 or Executive Order 13132, "Federalism," August 5, 1999.

Issue G: Whether this Rulemaking is a Backfit

~*

A commenter representing nuclear utilities raised a concern that if licensees would be required to expend significant resources in considering the use of Kl in emergency plans, then the proposed rule is clearly a backfit and a backfitting analysis should be performed. Thus, thJ commenter requested that the NRC either limit the specific actions which would be required to be t~en by licensees to demonstrate that the adequate consideration required by the proposed

                                                                                                .11-rule has been implemented, or the required backfitting analysis should be conducted and a

• suitably revised proposed rule should be published for comment.

Response. This notice contains a "Backfit Analysis " section, which notes that the Commission concludes that the rule imposes no new requirements on licensees, nor does it alter procedures at nuclear facilities. Rather, it is directed to States or local governments, the entities with the responsibility to determine the appropriateness of the use of Kl for their citizens, calling upon the governments to consider Kl as one of the elements of their offsite I emergency planning. The final rule imposes no binding requirement for State or local governments to alter emergency plans and procedures. Furthermore, the basic standard that emergency planning must include consideration of a range of protective actions is already set forth in the existing §50.47(b}(10). Once again, the rule does not impose new requirements on nuclear power plant licensees who are the intended beneficiaries of the Backfit Rule provisions. Therefore, no backfit is involved. Issue H: State Liabilities in Providing Kl for the General Public State and local government organizations raised concerns about legal implications should a member of the general public be given Kl at their directive or recommendation and the Individual has an extreme allergic reaction. Commenters note. that the Federal Register notice does not address legal issues for States who decide to adopt Kl and for States who do not decide to adopt or administer Kl to the public. Further, if the NRC decides to require stockpiling of Kl for the general public, the commenters ask whether NRC has considered what liability may arise from any adverse health effects. Another concern was about who would assume liability if the Kl was used prior to.a Governor ordering its use. Response. These comments focus.principally on concerns that State* and local governments involved in distribution and administration of Kl may be liable in tort if an individual receiving the Kl has a significant adverse medical reaction to the Kl. As stated in the proposed rule FR notice, the question of whether a State or locality might be liable for involvement with administration of Kl to the general public can only be answered by reference to the laws and precedents of particular States. The NRC presumes that this would be part of the "consideration". that States and localities will undertake as a result of promulgation of this rule. To the extent.that commenters are raising the potential for Federal,government liability for the promulgation of this proposed rule, the proposed rule FRN notes NRC views that whether the Commission may be subject to tort liability through the implementation of a Kl program depends upon a number of factors. However, it would appear that a Commission decision to require State and local emergency planning officials to consider stockpiling Kl for public distribution should be subject to the "discretionary function" exception to the Federal Tort Claims Act. 28 USC 2671, et seq., which protects the Federal Government from liability. The Commission's offer to fund State stockpiles would similarly be subject to the "discretionary function" exception. The Commission has directed the staff to ensure that NRC funding for Kl is accompanied by appropriate disclaimers to ensure that the NRC and_any of its employees are not to be held I responsible for any activity connected with transporting, storing, distributing, administering, using, or determining proper doses of Kl for adults and children. Issue I: FDA Input on Kl A few commenters thought that the dosage and intervention levels should be lowered from the values in the existing FDA guidance. For instance, they conclude that NRC should require using Kl prophylaxis at one rem projected dose exposure not at the current 25 rem. It was noted that Poland uses a 5 rem intervention level. The concern of these comment~rs is that continued use of the old guidance subjects children to greater risk than nece~ry. Response. The FDA is the Federal agency responsible for decisions about appropriate thresholds and dosages for use of Kl. Existing FDA guidance related to the use of Kl on dosage intervention levels is contained in a June 29, 1982 notice (47 FR 28158). As stated therein, "FDA concludes in the final recommendations that risks from the short-term use of relatively low doses of potassium iodide for thyroid blocking in a radiation emergency are outweighed by the risks of radioiodine-induced thyroid nodules or cancer at a projected dose to the thyroid gland of 25 rem." That notice also provides recommended dosages for adults arid children. New FDA guidance was published in the Federal Register for public comment on January 4, 2001 (66 FR 801 ). The Commission will incorporate it into its guidance documents. Issue J: Original Petition versus Revised Petition A few commenters state that in the proposed rule, the Commission claims to have granted the alternative submitted in the amended petition, but did not actually do so. In their view, the amended petition contained the combination of three elements-- the requirement to consider Kl stockpiling, the unequivocal recommendation that States establish stockpiles, and the offer of Federally-funded State stockpiles. Since the promise of funding removed a major impediment to States adopting a pro-Kl ,policy, the commenters believe that the petitioner felt that amending his petition to require only "consideration" of the use of Kl would likely' result in State decisions favorable to using Kl. In their view, the amended PRM was premised on the now-withdrawn NRC offer of FederaJly-funded State stockpiles of Kl, and therefore it would be entirely appropriate for the petition~r to rescind his amendment to* PRM 50-63 and to insist'that the NRC adopt what .was requested in- his original petition. Response. The Commission agrees with this comment. Since the Commission has decided to reinstate its offer to fund a supply of Kl for State or, in some cases, local governments that choose to incorporate Kl prophylaxis in their emergency plans, the Commission believes that it is granting the amended petition (PRM-50-63A) in all respects. Issue K: Meaning of "Consideration" Several commenters stated that the proposed rule is vague in that it did not define "consideration." They believe that the rule should clarify that the Kl 'consideration' within the context of radiological emergency planning and preparedness needs to be performed only once by the responsible State agency, which would provide written notice of the consideration to the Commission. Thereafter, no further 'consideration' should be required unless the State determines there is reason to reconsider its position and that the 'consideration' process is not ft subject to continuing oversight or recurring evaluation by the NRC, or any other federal agency. Another commenter questioned whether a State that considered the issue in the early 1980s, and rejected the use of Kl, could now claim that the Commission's current prop6sa1 has already been fulfilled. Reliance upon the earlier consideration would violate the intent of the petitioner's proposal. Another commenter questioned whether the following scenario would be considered

• ~

acceptable and in compliance with the rule: a State considered the use of Kl, but found the licensee unwilling to pay for it, so the State decided that although use of Kl might be a good idea, it couldn't afford it. Response. The Commission would expect that a State's "consideration" would involve at least an internal review of this notice and brief deliberation on the State's position on the use of Kl by the general pu~lic. In NRC's experience, States periodically review their emergency plans and preparedness, typically on an exercise frequency basis, to ensure that plans are up to date and account for local changed circumstances. For those States that conduct such periodic reviews, the Commission would expect the States to undertake their "consideration" of the use of Kl during the first periodic review conducted by the State of offsite emergency plans and preparedness following the effective date of this rule amendment and issuance of revised NUREG-1633 guidance. For those States that do not routinely conduct periodic reviews, the Commission would expect the States to undertake their "consideration" of the use of Kl on the same frequency as periodic emergency preparedness exercises following the effective date of this rule amendment and issuance of guidance. The rule does not require States to provide written notice of their "consideration." The Commission expects that States will inform FEMA and the NRC of the results of their consideration. Additionally, the Commission agrees that the "consideration" process is not subject to continuing oversight or recurring evaluation by the NRC or any other Federal agency. By issuing this rule, the ~mmission is stating its conclusion that consideration of the use of Kl that might have been performed many years ago, needs to be reexamined in light of e new information. Thus reliance upon such earlier evaluations would not be consistent with the rule requirement. Issue L: Federal Distribution of Kl One* commenter noted that the Commission's proposed rule would seem to support the same techniques used for forced Kl distribution that were dictated by governments in Eastern Europe during the Chernobyl accident. The commenter urged the Commission to consider e whether this posture would be endorsed by any government, be it Federal, State, or local. This commenter believes the NRC staff ignores the testimony of those States where Kl is stockpiled or pre-distributed for the public and where experience shows the system is ineffective. Additionally, a commenter thought that the proposed rule is predicated on the false assumption that even if States decide not to stockpile Kl for the general public, they will have access to Federal reserves of the drug. By the Commission's own admission, such reserves have yet to be established nor has the funding mechanism to support such reserves been identified. The proposal ~ugge~ts that states 'consider' the availability of resources that do not exist. Likewise, a commenter stated that the proposed rule implies that even when a State decides as a matter of public policy against distribution of Kl for the general population, the F~deraJ government will develop plans to override that decision. The purpose of such plans is unclear in the context of the proposed rule. Once a State has given due consideration to the use of Kl stockpiling as a supplemental protective action and determined it to be unwarranted, the commenter seeks the basis on which the Commission proposes to develop a contingency e plan. Response. The Commission has never endorsed "forced Kl distributiqn." Under this 11-*-. final rule the use of Kl continues to be a State option. Moreover, revised NUREG-1633 will discuss the benefits and risks associated with using Kl and the U.S. and foreign experience with public distribution. While the Commission has always recognized that distribution at the time of an accident will present difficulties if there has been no advance planning, the Commission believes that the States will take the distribution matters into account when they consider the use of Kl for the general public under this rule. The Commission has decided to withdraw its decision to provide funding for regional

 'Federal Kl stockpiles. However, it should be noted that Commission efforts in this regard were not intended to "override" a State decision not to use Kl during an emergency; rather, they were intended to make Kl available in the event that a particular State changed its views and decided I

to use Kl in an actual emergency, and had nowhere else to go for Kl. The Commission believes that in light of logistical difficulties, it is doubtful that regional stockpiles of Kl could be effectively employed in the unlikely event of a radiological emergency at a commercial nuclear power plant. Issue M: Importance of Emergency Planning A few comm enters feel that safe siting and Design-Engineered features alone do not optimize protection of the public-health and safety and that the Commission should not rely upon probabilistic risk assessments to obviate the need for stockpiling and predistribution of Kl. Another commenter is concerned that the premature aging of reactor components, the economics of utility restructuring, and the long-term storage of high-level waste at reactor sites all contribute to the need for Kl stockpiling. Response: The Commission agrees with the importance of emergency planning to complement site and design features and stated so in the August 19, 1980, Federal Register e Notice (45 FR 55402) which codified the NRC's emergency planning regulations following the Three Mile Island.accident: "The Commission's final rules are based on the significance of* adequate emergency planning and preparedness to ensure adequate protection of the public health and.safety. It is clear... that onsite and offsite emergency preparedness as well as proper siting and engineered design features are needed to protect the health and safety of the public. As the Commission reacted to the accident at Three Mile Island, it became clear*that the protection provided by siting and engineered design features must be bolstered by the ability to take protective measures during the course of an accident." The Commission did not rely upon probabilistic risk assessments in developing this final regulation on consideration of the use of Kl. The Commission interprets the third comment to relate to factors that the commenter believes could increase the likelihood of an accident and which, in the commenter's view, heighten the importance of emergency planning. The Commission's regulations recognize the importance of emergency planning by requiring development of a range of protective actions, \ which include sheltering and evacuation and, by this rulemaking, consideration of the upe of Kl for the general public. Issue N: Cost of Kl and Shelf-Life One commenter feels that the NRC has exaggerated the estimated cost of Kl, ignoring comments that point to the availability of inexpensive and long-lasting Kl. This commenter thinks that market forces are likely to bring down the cost of Kl and that sa'1ngs in the NRC -- budget could be effected without diminishing the safety of America's children. The U.S. Pharmacopeia wrote in its comment letter that the long-term viability bf the drug was tested and it was found that 11 years after manufacture and eight years after the expiration date, the tablets were assayed at 99.1 % of the labeled content of Kl. The petitioner expressed the view that since the U.S. is currently engaged in a $15 million study of radiation-caused thyroid disease in the Ukraine, it was' hard to understand why the government was not willing to spend a fraction of that amount to prevent radiation caused thyroid disease at home. Response. Cost estimates used in past documents were based upon informatfon "' II available at those times. NRC presently estimates the cost of Kl to be about 18 to 20 cents per tablet if purchased in bulk, with a shelf life of 7 to 1q years. As a result, the Commission finds that Kl is a reasonable, prudent and inexpensive supplement to evacuation and sheltering for the general public for specific local conditions. As noted earlier, the Commission has decided to offer to provide funding for a supply of J Kl for State or, in some cases, local governments that choose to incorporate Kl prophylaxis in their emergency plans. Issue O: Safety of Kl Commenters believe that there is new information available from Poland and Belarus regarding use of Kl following a radioactive release. They state that there were no reported serious adverse reactions. Specifically, 18 million individuals received prophylactic Kl with overall toxicity of 2.5% (mostly nausea) but with only a fraction of 1% having serious side-

   ,. effects." Commenters state that this experience has been recognized by other countries who are stockpiling Kl for use by the general public. This data has led some commenters to, say that

--- just because there are other lethal radionuclides to which people may be exposed, why deny them the availability of Kl, which can counteract the deadly effects of radioactive iodine. Every drug has contraindications and the potential for allergic reactions. In an emergency*as dire as a reactor accident where people risk illness and* death, a possible adverse reaction to Kl seems relatively minimal, and people absolutely should have the choice of making an informed decision and assuming p~tble risk. Response. The Commission did consider the experience with mass distribution"of Kl during*the Chernobyl radiological emergency (although the record on that distribution is not complete). That experience is still being investigated and evaluated by public health authorities worldwide. When the appropriate health agencies have established the applicability of the Polish experience to the United States, the findings will be followed in NRC guidance. The NRC acknowledges that Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific local conditions. The Commission guidance on emergency planning has long taken Kl into consideration (see NUREG-0654/FEMA-REP-1, "Criteria for Preparation and E\1aluation of Radiological Emergency Response Plans and Preparedness in Support of 4 Comment letter from the Massachusetts Coalition To Stockpile Kl dated September 10, 1999. Nuclear Power Plants," Rev. 1, p. 63, items e and f). The FDA has approved Kl as an over-the-counter medication and has found it effective and safe as discussed in the response to issue I. Commission Decision on the Petitions for Aulemaking Based on the foregoing, and as noted herein, the action by the Commission to approve this final rule grants In part and denies in part the original petition (PAM 50-63) and grants in all respects the amended petition (PAM 50-63A). The rule change, which requires "consideration" -- of the use of Kl, is responsive to the amended petition. Further, including in this Federal Register notice for the final rule, a statement that "Kl is a reasonable, prudent, inexpensive ,! supplement to evacuation and sheltering for specific local conditions," is also responsive to both petitions. This statement does not use the petitioner's exact language but is responsive to the petitioner's request. The Commission's final position on funding of State stockpiles grants that part of the original and amended petition to include a statement of such support in the Statement of Considerations for the rule. However, the final rulemaking would deny that part of the original petition requesting that the Commission amend 10 CFR 50.47(b)(10) to require that ti the range of protective actions developed for the plume exposure pathway EPZ include sheltering, evacuation, and the prophylactic use of iodine. The Commission has found that "[l]n developing the range of actions for severe accidents at nuclear power plants, evacuation and sheltering provide adequate protection for the general public." (Proposed Rule, 64 FR at 31745). In addition, the Commission notes that issues surrounding the prophylactic use of Kl following such accidents do not lend themselves to across-the-board solutions. Therefore, the Commission has chosen to leave such decisions to State and local emergency response planners to determine whether their emergency plans should include the use of Kl as a supplementary protective measure for the g:meral public. The Commission's decision is implemented through this final rule that changes 10 CFR

                     ,                                                                             I 50.47(b)(10). This final rule completes NRC action on PAM 50-63 and PAM 50-63A.

Rationale for the Commission Decision The Commission has considered the Kl policy question on numerous occasions since 1984. The history of the Commission deliberations shows that reaching consensus on this policy question has been an elusive goal. An important reason for this historical lack of consensus is that this policy question is not a clear-cut one. lndMdual Commissioners, past and present, have differed in their views with respect to the relative importance to be giv~n to - factors bearing on the Kl issue. These honest differences have led to dMded Commission

• views on how to resolve the policy question. The Commission agrees that its historical difficulty in reaching consensus on the Kl policy question underscores the reality that this policy question is not a simple one, is not one that is easily resolved and, as a result, has been the subject of protracted deliberation ..

After considering all public comments received, the information available in the literature, 20 years of experience gained in evaluating licensee emergency preparedness plans, and the arguments presented by the petitioner, the Commission has decided to amend 1o CFR It 50.47(b)(10), by adding a sentence similar to the one suggested in the revised petition. Specifically the following sentence is inserted in §50.47(b){10), after the first sentence: "In developing this range of actions, consider~tion has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate." The Commission finds that Kl is a reasonable, prudent and inexpensive supplement to evacuation and sheltering for specific local conditions. The Commission's guidance on emergency planning has long taken Kl into consideration (NUREG-0654/FEMA-REP-1, Rev. 1,

p. 63, items e and f). However, since the last revision of that guidance, there has been experience with the mass distribution of Kl during an international radiological emergency, and though the record on that distribution is not complete, the indications thus far are that mass distribution is effective in preventing thyroid cancer and causes few threatening side effects.

Moreover, many nations in Europe and elsewhere - nations as different in their circumstances, politics, and regulatory structures as France, Canada, and Japan -- have stockpiled Kl and planned for its use. So have some U.S. States. The World Health Organization and the International Atomic Energy Agency recommend its use., Therefore, in order to achieve greater assurance that Kl will receive due attention by planners, it is rea~nable to take a further small step and, continuing to recognize the important role of the States and local govemrrf'Snts in l ,~, matters of offsite emergency planning, explicitly require that planners consider the use of Kl. The amendment should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought. On the contrary, present indications are that nuclear power plant satety has significantly improved since the current emergency planning requirements were put in place after the Three Mile lsland-2 accident in 1979 .

• The use of Kl is intended to supplement, not to replace, other protective measures.

This amendment does not change the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any I exposure to radiation occurs. The Commission recognizes that there may be situations when evacuation is not feasible or is delayed. In-place sheltering is an effective protective action in such a situation. Depending on the circumstances, Kl may offer additional protection to one radiation-sensitive organ, the thyroid, if used in conjunction with evacuation and sheltering. In developing the range of public protective actions for severe accidents at commercial nuclear power plants, evacuation and in-place sheltering provide adequate protection for the general

public. In appropriate circumstances, Kl can provide additional protection. In addition, the Commission notes that issues surrounding the prophylactic use of Kl following such accidents do not lend themselves to across-the-board solutions. Therefore, the Commission has chosen to leave such decisions to State and local emergency response planners, who may find that Kl should be a supplementary protective measure. The NRC recognizes that any decision to use Kl as a supplemental protective measure for the general public presents issues of how best to position and distribute the medicine, to ensure: {1) that optimal distribution takes place in an emergency, with first priority given to protecting children; (2) that persons with known allergies to iodine not take it; and (3) that members of the public understand that Kl is not a substitute for measures that protect the whole e body. To date, these issues have been addressed in different ways in the numerous countries that currently use Kl as a protective measure for their citizens. The NRC is working with States and other Federal agencies to develop guidance on these and other issues relating to the use of KL The NRC believes that these implementation issues can be solved, given the level of expertise in the relevant Federal and State agencies, and the experience of numerous*nations that have built Kl into their emergency plans. Commission Decision on Funding of State Stockpiles or Supplies of Kl The Federal Register notice for the proposed rule (64 FR 31737) stated the Commission's then-held position only to support funding of regional stockpiles or other supplies of Kl as opposed to funding of State stockpiling of Kl. As described above, in its deliberations on this final rule, the Commission has withdrawn its support for funding of regional Kl stockpiles and has reinstated its offer to provide NRG funding of State or, in some cases, local stockpiles, subject to various restrictions and limitations (see Staff Requirements Memorandum for the Affirmation Session on December 22, 2000). In doing this, the Commission has responded to comments from FEMA and other commenters. The Commission is supporting the 1996 FRPCC's Ad Hoc Subcommittee on Potassium Iodide recommendation that the Federal government (NRC through FEMA) should fund the purchase of State, or in some cases local, Kl stockpiles. The Commission recognizes that this policy contradicts the Commission's historical policy that funding for State and locaJ emergency planning is the responsibility of those governments often working with licensees. 4I The Commission is making this exception to the long-standing policy on the basis of the FRPCC's recommendation and recent petitions received. The Commission has determined that for a State that has decided to stockpile Kl, NRC funding for purchase of Kl for use by that State during a radiological emergency would directly contribute to fulfilling NRC's regulatory Ji mission. The Commission aJso recognizes that any State choosing to incorporate Kl prophylaxis as a supplemental protective action in its emergency planning will face costs, other. than the cost of the purchase of Kl. Consistent with the long-standing policy, these ancillary costs will remain the respqnsibility of the State government. Depending on how the State 4' incorporates Kl prophylaxis in its emergency plans, the ancillary costs could significantly exceed the cost of the purchase of the Kl supply. Metric Policy On October 7, 1992, the Commission published its final Policy Statement on Metrication. According to that policy, after January 7, 1993, all new regulations and major amendments to existing regulations were to be presented in dual units. The amendment to the regulations contains no units.

National Technology Transfer and Advancement Act The National Technology Transfer and Advancement Act of 1995, Pub. L. 104-113, requires that Federal agencies use technical standards developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC is amending Its emergency planning regulations to require that consideration be given to including potassium iodide as a protective measure for the general public that would supplement sheltering and evacuation in the event of a severe reactor accident. This action does not constitute the establishment of a consensus standard that contains generally applicable requirements to which the provisions of the Act apply. ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT FOR COMPLETING ACTION ON THE PETITIONS FOR RULEMAKING RELATING TO THE USE OF POTASSIUM IODIDE (Kl) FOR THE GENERAL PUBLIC I. Introduction. On September 9, 1995, a petition for rulemaking (PAM 50-63) was filed with the NRG by Mr. Peter Crane. The petitioner requested that the NRG amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. In SECY-97-245, dated October 23, 1997, the NRC staff provided three options for the Commission's consideration in order to resolve PAM 50-63. On November 5, 1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resolving the petition for rulemaking. During the meeting, the Commission invited the petitioner to submit a modification to his petition in order to address views he discussed during the meeting. On November 11, 1997, the petitioner submitted a revision to his petition PAM 50-63A, that requested two things:

1. A statement clearly recommending stockpiling of Kl as a "reasonable and prudent" measure, and

2. A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate."

On June 26, 1998, the Commission disagreed with the NRC staff's recommendation in SECY-98-061 dated March 31, 1998, "Staff Options for Resolving a Petition for Rulemaking (PAM 50-63 and 50-63A) Relating to a Re-evaluation of the Policy Regarding the use of Potassium Iodide (Kl) by the General Public after a Severe Accident at a Nuclear Power Plant," to deny the revised petition for rulemaking (PAM 50-63A) and directed the NRC staff to grant the petition by revising 10 CFR 50.47 (b)(10). This final rule responds to this directive. Alternatives were essentially considered in previous documents. In SECY-97-124 (June 16, 1997), "Proposed Federal Policy Regarding Use of Potassium Iodide after a Severe Accident at a Nuclear Power Plant," the NRC staff identified three options, one of which contained three sub-options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe reactor accidents. On April 22, 1999, the Commission voted to approve publication in the Federal Register of a proposed rule that would grant the revised petition for rulemaking (PAM 50-63A). The proposed rule was published on June 14, 1999 (64 FR 31737). In the petitioner's comment letter on the proposed rule, he stated that In light of the Commission decision not to fund State stockpiles of Kl, the Commission should consider his original petition (PAM 50-63) to be incorporated by reference and resubmitted in his comment letter. He also requested the Commission to grant the petition as originally submitted. The Commission, by undertaking this 9 final rulemaklng, is denying in part the original petition for rulemaking (PAM 50-63), which would require the use of Kl for the general public. In so doing, the Commission has decided to continue to recognize the important role of the State by explicitly requiring that planners consider (PAM 50-63A) the use of Kl for the general public. The Commission Is granting in all respects the amended petition, including reinstating its support for funding State stockpiles of Kl.

11. Need for Action.

In SECY-97-245, the NRC staff proposed options for resolving the original petition for rulemaking. In an SAM on SECY-98-061, the Commission directed the NRC staff to proceed with the rulemaking. In so doing, the Commission found that Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific local conditions. The Commission's guidance on emergency planning has long taken Kl into consideration (NUREG"- 0654/FEMA-REP-1, Rev. 1, p. 63 items e and f). However, since the last revision of that guidance, there has been experience with the mass distribution of Kl during an international radiological emergency. Although the record on that distribution is not complete, the indications thus far are that mass distribution is effective in preventing thyroid cancer and causes few threatening side effects. Therefore, in order to achieve greater assurance that Kl will receive due attention by planners, it seems reasonable, while continuing to recognize the important role of the States in matters of offsite emergency planning, to explicitly require that pla11ners consider the use of Kl. The rule is needed to ensure that the States are aware of and take into consideration the costs, risks, and benefits of Kl in their decision making process in order to e: optimize emergency planning for the public health and safety. 111. Environmental Impact of the Final Action. The environmental impacts of the final action and its alternative (deny the petitions in their entirety and take no action) are considered negligible by the NRG staff, given that the final action would only add the sentence: "In developing this range of actions, consideration ,has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as 9 appropriate." The NRG staff is not aware of any environmentaJ impacts as a result of this final action. IV. Alternative to the Final Action. The alternative to the final action at tt,is time is to deny the petitions and take no action with respect to the use of Kl by the public. Should this no-action alternative be pursued, the NRG staff is not aware of any resulting environmental impact. V. Agencies and Persons Consulted. Cognizant personnel from the States, FEMA, and FDA were consulted, as was the petitioner, as part of this rulemaking activity. VI. Finding of No Significant Environmental Impact: Availability. The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the amendment is not a major Federal action significantly affecting the quality of human environment and; therefore, an environmental impact statement is not required. This amendment will require that consideration be given to evacuation, sheltering, and as a . supplement to these, the prophylactic use of Kl. This action will not have a significant impact upon the environment. Paperwork Reduction Act Statement This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C 3501 et seq.). Existing requirements were approved by the Office of Management and Budget (0MB) approval numbers 3150-0009 and 3150-0011. Public Protection Notification If a means used to impose an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection. REGULATORY ANALYSIS OF THE FINAL RULEMAKING COMPLETING ACTION ON PETITIONS FOR RULEMAKING (PAM 50-63) AND (PAM 50-63A) RELATING TO THE USE OF POTASSIUM IODIDE (Kl) On September 9, 1995, a petition for rulemaklng (PAM 50-63) was file~ with the NAC by I Mr. Peter Crane. The petitioner requested that the NAC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. In SECY-97-245, dated October 23, 1997, the NRC staff provided three options for the Commission's consideration to resolve PAM 50-63. On November 5, 1997, the Commission was briefed by the NAC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resoMng the petition for rulemaking. During the meeting, the Commission invited the petitioner to submit a modification to his petition in order to address views he discussed during the meeting. On November 11, 1997, the petitioner submitted a revision to his petition (PRM 50-63A), which requested two things: A statement clearly recommending stockpiling of Kl as a "reasonable and prudent" measure; and

                                                                                                     \.

A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium Iodide (Kl), as appropriate." In the petitioner's comment letter on the proposed rule, he stated that in light of the Commission decision not to fund State stockpiles of Kl, the Commission should consider his 1 original petition (PRM 50-63) to be incorporated by reference and resubmitted in his comment letter. He also requested the Commission to grant the petition as originally submitted. The Commission, by undertaking this rulemaking, is granting the amended petition- and is granting in I 9 part and denying in part the original petition. The Commission is denying that portion of the original petition for rulemaking (PRM 50~63), which would require the use of Kl for the general public. In so doing, the Commission has decided to continue to recognize the important role of the State in matters of emergency planning by explicitly requiring that planners consider*(PRM

                                                        \

50-63A) the use of Kl for the general public. In SECY-97-2~, ~e NRC staff proposed options for resoMng the original petition for rulemaking. By SAM dated June 26, 1998, on SECY-97-245, "Staff Options for Resolving a Petition for Rulemaking (PAM 50-63) Relating to a Re-evaluation of the Policy Regarding use of Potassium Iodide (Kl) after a Severe Accident at a Nuclear Power Plant," the Commission directed the NRC staff to revise 10 CFR 50.47(b)(10). This final rule responds to this directive. Alternatives were essentially considered in previous documents. In SECY-97-124 dated June 16, 1997, "Proposed Federal Policy Regarding Use of Potassium Iodide after a Severe Accident at a Nuclear Power Plant," the NRC staff identified three options, one of which contained three sub-options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe I I reactor accidents. Given that the Commission considered the options and directed the NRC staff to grant the amended petition, the only alternatives considered here are the Commission-approved option and the baseline, no-action alternative. The final rule does not "require" any action of licensees. States are to "consider" the use of Kl along with evacuation and sheltering as protective actions. It is estimated that no more than 30 States will need to make this consideration. The rule does not impose any substantive requirements on States to actually stockpile or plan for the use of Kl. Therefore, States would not accrue the costs associated with such actions. However, the Commission e* recognizes that consideration of using Kl as a supplemental protective measure may result in some State expenditures. The NRC staff estimates that the labor needed by the Stat¢s could range from a staff-week, to half of a staff-year. The latter would be the case !fa State decided to hold hearings on the issue. If one assumes an average hourly salary of $70 (this estimate includes benefits, prorated secretarial and managerial assistance, but not overhead), the range of estimates would be from $2800 to $63,000 per State. Using a base of 30 States, the range of impacts for the States to make the Kl consideration is from $84,000 to $1.9 million.,. The Commission notes that when it amended its emergency planning regulatiillty of Agreement State Regulations Under the "Policy Statement on Adequacy and Compatibility of Agreement State Programs" that was a~proved by the Commission on June 30, 1997, and published in the Federal Register on September 3, 1997 (62 FR 46517), Part 50 is classified as compatibility Category "NRC." The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the Atomic Energy Act or provisions of Title 1O of the Code of Federal Regulations. Plain Language The President's Memorandum dated June 1, 1998, entitled "Plain Language in Government Writing," directed that the government's writing be in plain language. This memorandum was published June 1o, 1998 (63 FR 31883). In complying with this directive, editorial changes have been made in the final revisions to improve the organization and readability of the existing language of the paragraphs being revised. These types of changes are not discussed further in this notice. Backfit Analysis The definition of backfit, as set forth in 10 CFR 50.109(a)(1 ), is clearly directed at obligations imposed upon licensees (and applicants) and their facilities and procedures. Section 50.109{a)(1) defines a backfit as:

        ... the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility, any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position ....

Section 50.109 is replete with references to "facilities" and "licensees," which in their totality make clear that the rule is intended to apply to actions taken with respect to nuclear power plant licensees and the facilities they operate. See § 50.109(a}(7), "If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written licensee commitments ... then ordinarily the applicant or licensee is free to choose the way that best suits its purposes [emphasis added}." This focus on licensees and their facilities is further confirmed by the Statement of Considerations accompanying the backfit rule (53 FR 20603; June 6, 1988), where the Commission stated that backfitting "means measures which are intended to improve the safety of nuclear power reactors .... " (53 FR at 20604). The nine factors to be considered under 10 CFR 50.109(c) further make clear that the rule is aimed at requirements applicable to licensees and facilities. These include: "(2) General -- description of the activity that would be required by the licensee or applicant in order to complete the backfit; ... (5) Installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay; [and} (6) The potential safety impact of changes in plant or operational complexity.... [emphasis added}." The final rule imposes no new requirements on licensees, nor does it alter procedures at nuclear facilities. Rather, it is directed to State or local governments, the entities with the t' important role to determine the appropriateness of the use of Kl for their citizens, calling on these governments to "consider" Kl as one of the elements of their offsite emergency planning. However, the rule imposes no bil')ding requirement to alter plans and procedures on State or local governments. Furthermore, the basic standard that emergency planning must include consideration of a range of protective actions is already set forth in the existing wording of

  §50.47(b)(10). On this basis, the final rule does not impose new substantive requirements on anyone. After consideration of these factors, no backfit is involved and no backfit analysis as defined in § 50.109 is required.

Commission precedent also makes clear that the amendment does not constitute a backfit. The Commission's position was stated explicitly in 1987, when the last major change took place in emergency planning regulations (52 FR 42078; November 3, 1887). The

                                                                                                         \..

Commission's final rule involving the "Evaluation of the Adequacy of Off-Site Emergency Planning for Nuclear Power Plants at the Operating License Review Stage Where State and LocaJ Governments Decline to Participate in Off-Site Emergency Planning" stated that the emergency planning rule change in question "does not impose any new requirements on production or utUization facilities; it only provides an alternative method to meet the Commission's emergency planning regulations. The amendment therefore is not a backfit under 10 CFR 50.109 and a backfit analysis is not required" (52 FR at 42084). Likewise, when the Commission altered its emergency planning requirements in 1987 to change the timing for full participation emergency exercises (a change that, as a practical matter, could be expected to result in licensees' modifying emergency preparedness-related procedures to accommodate 4lt exercise frequency changes}, It stated: "The final rule does not modify or add to'systems, structures, components or design of a.facility; the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct, or operate a facility. Accordingly, no backfit analysis pursuant to 10 CFR 50.109 is required for this* final rule" *(52 FR 16828; May 6, 1987). The final emergency planning rule change-is of a similar nature and similarly does not involve a backfit. It has been argued by at least one commenter on the petition for rulemaking that, although licensees are not directly burdened by the final rule, they would be indirectly burdened because they would feel called upon to explain the new policy to their customers. By this logic, almost any Commission action that led an NRG licensee to issue a press release could be considered a backfit. Such a position is unsound law and policy. Here, the burden of public information on licensees or applicants, if any, appears de minimis. It plainly does not rise to the level of the type of concrete burden contemplated by the Commission when it enacted the backfit rule. It might also be argued that, if a State or local government were to decide to stockpile and use V.1 for the general public, it would undertake interactions with the affected licensee to coordinate offsite emergency planning. Although this could result in some voluntary action by the licensee to coordinate Its planning, the final rule itself does not impose any requirement or burden on the licensee. Accordingly, the Commission concfudes that the final rule would not impose any backfits as defined in 10 CFR 50.109. Nonetheless, the Commission notes that this rule will introduce another element in the context of the emergency planning requirements that licensees are ultimately responsible for,

                \

whereby licensees have the obligation to confirm that offsite authorities have considered the use of Kl as a supplemental protective action for the general public. That ultimate responsibility

• could have practical implications, with some associated burdens, the extent of which is considered minimal when viewed in the overall licensee burden of complying with all ot the existing emergency planning requirements.

Small Business Regulatory Enforcement Fairness Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination - with the Office of Information and Regulatory Affairs of 0MB. List of Subjects 10 CFR Part 50 Antitrust, Classified Information, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements.

                                                                                               \,

For the reasons set out in the preamble and under the authority of the Atomic Energy Act for 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting the following amendment to 10 CFR Part 50. PART SO-DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES

1. The authority citation for 10 CFR Part 50 continues to read as follows:

Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936, 938, 948, 953, 954, 955, 956, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended 1244, 1246, (42 U.S.C. 5841, 5842, 5846)., Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951, as amended by Pub. L 102 - 486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851). Sections 50.10 also issued under secs. 101, 185, 68 Stat. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 91 - 190, 83 Stat. 853 (42 U.S.C. 4332). Section 50.13, 50.54(dd), and 50.103 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Sections 50.80, 50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix F also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237}.

2. In§ 50.47, paragraph (b)(10) is revised to read as follows:

§ 50.47 Emergency plans.

                                                 ..J

,J C (b) (10) A range of protective actions has been developed for the plume exposure pathway EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl}, as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidance, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been devel?ped. Dated at Rockville, Maryland, this U\t:h day of ~ , 2001. For the Nuclear Regulatory Commission.

                                      ~Vt~-~

Annette Vietti-Cook, Secretary of the Commission. Page 11 June 16, 2000 *oo JUI ' 19 A11 :16 Chairman Richard A. Meserve Commissioner Greta J. Dicus Commissioner Nils J. Diaz Re: PRM-§0-63, -63A Id Commissioner Edward McGaffigan, Jr. Commissioner Jeffrey S. Merrifield u~CKET NUMBER PR PROPOSED RULE. 5O *

Dear Chairman Meserve and Commissioners:

( 6 'I FR, irJ 3 t) The Commission still has yet to act on the rulemaking petition that I filed in 1995 on the subject of potassium iodide (KI). I would like to ask the Commission to make a decision, one way or the other. My petition asked for a change of a few words in one Commission regulation. Rulemaking does not need to take 5 years. It does not even have to take one year. When I was a Government lawyer, handling a rulemaking vastly more complex than the present one, with 38,000 comments, the entire process took 9 months. Moreover, in the case of KI, the analyses had already been performed during the 5 years (1989-1994) that my differing professional opinion, ultimately never resolved, was pending. Thi ,___. rulemaking should therefore have been exceptionally quick, rather than the opposite. After 11 years of

• waiting, I think the Commission owes the public and me a decision, favorable or unfavorable. This is an issue of fundamental procedural fairness, wholly separate from the merits of the KI issue.

It has been suggested to me that the opponents of KI stockpiling and funding are playing the role of Scheherazade: determined to make the story-telling continue forever, so that the day of decision never comes. Why might the opponents of the petition wish to postpone a resolution indefinitely? Perhaps because at this point they cannot afford either to win or to lose. They do not want a defeat, obviously enough, but a victory might present an even greater danger. 1 It would mean, for one thing, the certainty of a lawsuit in which the entire story would be presented in black and white to the Court of Appeals for the D.C. Circuit. (If the Commision wants an honest opinion of how a reviewing court is likely to regard the NRC's handling of the KI issue, it should ask its distinguished Solicitor.) Moreover, any decision, coming after so many years, might be the newsworthy event that triggers the media's renewed attention to the KI issue. And so for years, I keep reading about one or another promising solution, just over the horizon, that will make the whole problem go away, if only everyone waits just a bit longer. Take, for example, the idea of regional stockpiles under FEMA's aegis in lieu of stockpiles close to reactors, where they might do some good in an actual emergency. If anyone at NRC had thought to check with Director Witt at FEMA before publicly endorsing this idea, it would have been clear that it was a non-starter. But when Director Witt responded, in April 1999, that regional stockpiles would do more harm than good, and that FEMA would have nothing to do with this plan, why did the NRC not drop the idea? There can be no surer way to chew up time fruitlessly than to try to persuade an agency to buy a proposal that its Director has repeatedly and emphatically rejected. If the objective were to resolve the KI issue, the NRC's refusal to take no for an answer from Director Witt would be inexplicable; but if the real objective is delay itself, then this approach makes perfect sense, for it creates the appearance of activity without any risk of forward motion.

        "Justice delayed is justice denied" is an axiom no less valid for being well-worn. One need not be 1 For opponents of the petition, the ideal solution would probably be that of 1994, when the Commissioners tied 2-2 on the DPO, thereby preserving the status quo without a written decision.

rAdrla Byrdsong -244-0181.wp Page 21 a partisan on either side of the KI issue to discern a "good government" issue here. How much longer is it reasonable to ask me to wait for an up-or-down decision? Even more to the point, how much longer than 11 years is it reasonable to ask the American people -- for whom you work -- to wait for you to decide an issue that affects the health and safety of their children? Sincerely, Peter Crane cc: Director James Lee Witt, FEMA ii

,NI'- 0~ 3 7 If 7 ,-. If

                      **                               UNITED ST ATES
  **                                     NUCLEAR REG ULATORY COM MISSION

\ /\_ 1',./1 WASHINGTON, D.C. 20555-0001

~                       t,                               June   9, 2000 2- /                                                                         *oo     11 ,, * *1J"J       :22 1/f'f/JT                                                                             ~-*'"i      .P -?

CHAIRMAN u The Honorable Tom Harkin United States Senate Washington, D.C. 2051 o DOCK PRO 0

Dear Senator Harkin:

I am responding to your letter of April 10, 2000, supporting NRC funding of State stockpiles of potassium iodide (Kl} in communities near nuclear power plants. The Commission is currently considering a final rule that would amend its emergency planning regulations to require consideration of the use of Kl as a supplemental protective action for the public. We will take your comments into account in that context. The Commission has considered the Kl policy question on numerous occasions. The administration of Kl before or very soon after inhaling or ingesting radioiodine will greatly reduce the uptake of radioiodine by the thyroids of children as well as of adults, thus reducing the thyroid dose and the subsequent risk of thyroid cancer. However, other protective actions are equally important. Early evacuation is the single most effective protective action against a large release of radioactive material. It can preclude large radiation doses to the public from all radionuclides, can protect all organs, and can be effective for all pathways by which dose is delivered if evacuation is accomplished before evacuees are exposed to a large radioactive release. Therefore, when there is a potential of a large radioactive release, the NRC's primary emergency response objective is to evacuate everyone, including children, before they are exposed to any radiation. While early evacuation is the most appropriate action in the event of a serious accident, there are circumstances in which the evacuation might not be completed before arrival of the radioactive plume. These circumstances include very rapidly progressing accidents, situations in which people cannot move for some reason, such as severe weather, and situations in which the protective action decision-making process breaks down. In these circumstances, sheltering might be the most appropriate action until evacuation can be carried out. For those who are likely to be sheltered (for example, nuclear plant workers and persons in nearby hospitals or prisons}, the use of Kl is already included in emergency plans. The NRC has recently determined that Kl is a reasonable, prudent, and inexpensive supplement to evacuation for specific local conditions. Several States currently have a supply of Kl to be used as a supplemental protective action for the public. Some States have expressed concerns about freely distributing Kl during an accident. Kl , although approved by the Food and Drug Administration (FDA} since 1978 for over-the-counter use, is a drug with age-dependent doses and possible side effects. Although serious side effects are rare, some States are concerned about their responsibilities and liabilities if there were a serious adverse reaction to Kl that they had distributed. The FDA is currently reviewing its recommended dose level for Kl in light of European practice and guidelines for the World Health Organization. These matters, as well as the appropriate

mechanisms for procuring and distributing Kl , are factors to be considered in making any determination as to the use of Kl for the public. The Commission is preparing a guidance document for use by the States that will attempt to discuss all these matters, including practices in Europe and elsewhere, as fairly and comprehensively as possible. The NRC, State and local governments, and nuclear plant operators currently have robust plans, facilities, and equipment to decide on the appropriate protective actions, and to implement protective actions in the event that an accident at a nuclear power plant may result in significant releases of radioactive materia, although extensive public distribution of Kl is not contemplated in most of these plans. The plans are exercised biennially and are graded by NRC and the Federal Emergency Management Agency (FEMA). Individual Commissioners routinely participate in those exercises, and have been favorably impressed with the capabilities demonstrated by the licensees, the State and local responders, and the Federal family of responders (NRC, FEMA, the Department of Energy, and others). The Commission believes that appropriate protective actions, including the use of Kl if a State chooses to use Kl for its citizens, can and will be taken in the event of an actual radiological emergency. There have been differences between the NRC and FEMA with regard to issues such as funding of local State stockpiles of Kl and the utility of regional Federal stockpiles. Therefore, I have requested a meeting with FEMA Director James Witt to discuss this matter. The Commission will continue its deliberations on the final rule related to the use of Kl in a radiological emergency. Please contact me if I can be of further assistance.

TOM YARKIN

    ,',A llmtcd StJtcs .5rnJtc
                                                ,VAS             20 April l 0. 2000                                 .ABOR AND HUMAI\
                                                                                                         ~ESOURCES The Honorable Richard A. Meserve Chainnan U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Chainnan Meserve:

On February 13. 1998, I wrote to die then Chainnan of the Nuclear Regulatory Commission

• (NRC), Dr. Shirley Ann Jackson. to commend the NRC for its proposal to fund the purchase by any state of the antidote potassium iodide (KI). In case of a severe nuclear accident. KI, if administered quickly, would protect the general population against thyroid cancer and other diseases. Thus in 1998 I expressed concern that the proposal did not go far enough, and urged that the NRC require stockpiling, as Commissioners Diaz and McGaffigan had proposed.

I am very disappointed that the NRC seems to have retreated even from its earlier modest proposal. The NRC's actions in the intervening two years are grounds for serious concern. In that time, I am told, the NRC has: ( l) first reaffinned and then repudiated its commitment to provide potassium iodide for any state requesting it: (2) issued an **assessment" of the safety and efficacy of KI, and then had to withdraw it after its grave deficiencies were pointed out by state health departments and others; (3) continued to delay the adoption of the new federal policy on potassium iodide, unanimously approved by the entire Federal Radiological Preparedness Coordinating Committee in 1996; and ( 4) engaged in bureaucratic battle with the Federal Emergency Management Agency (FEMA). which continues to support the 1996 federal policy. Local stockpiling of KI is an inexpensive and effecti ve measure that for a fe\v million dollars would help protect Americans against thyroid diseases from nuclear accidents. The principal beneficiaries of KL in an actual emergenc~. will be young children. If stockpiles of KI are not readily available. some of those children can be expected to develop thyroid cancer. a sometimes fatal illness. Yet the NRC persists in ignoring the recommendations of the federal coordinating committee and in advocating regional stockpiles. an approach that FEMA believes will not work because the KI tablets could not be distributed quickly enough. Over the past eleven years the :'iRC has spent more time. dfort. and money pondering KI than it would take simply to buy enough tablets for the whole count~ . \1eanwhile our children remain unprotected. It is time to act. I urge you to start heeding FE\-1A

• s expertise and to start funding state stockpiles of KI n0\\

Thank you for your attention to this issue, and please keep me informed of your progress in making potassium iodide tablets available to all Americans. Sincerely, kTom Harkin United States Senator TH/lwu

    /C1 L.OO 370 3 I Ofo TOM YARKIN                                                                                                               }.J,l !.2 l 1O\.VA                                                                                                   r     f  ~  1 12l 16.B
                                                                                                         *.::ara. 11,_t'H4rl S, *. ***

J [)() .' t United States Senate APPROPR!ATIO'loS WASHINGTON. DC 2051 0-1 502 SMALL BUSINESS April 10, 2000 *oo JU;*' 13 P_? :...?2 LABOR AND HUMAN RESOURCES The Honorable Richard A. Meserve Chainnan U.S. Nuclear Regulatory Commission Washington, D.C. 20555 J C, E:T U ROPOSED 50

Dear Chairman Meserve:

(tot/FR 3173'1) On February 13, 1998, I wrote to i:he then Chainnan of the Nuclear Regulatory Commission (NRC), Dr. Shirley Ann Jackson, to commend the NRC for its proposal to fund the purchase by any state of the antidote potassium iodide (KI). In case of a severe nuclear accident, KI, if administered quickly, would protect the general population against thyroid cancer and other diseases. Thus in 1998 I expressed concern that the proposal did not go far enough, and urged that the NRC require stockpiling, as Commissioners Diaz and McGaffigan had proposed. I am very disappointed that the NRC seems to have retreated even from its earlier modest proposal. The NRC's actions in the intervening two years are grounds for serious concern. In that time, I am told, the NRC has: (1) first reaffinned and then repudiated its commitment to provide potassium iodide for any state requesting it; (2) issued an "assessment" of the safety and efficacy of KI, and then had to withdraw it after its grave deficiencies were pointed out by state health departments and others; (3) continued to delay the adoption of the new federal policy on potassium iodide, unanimously approved by the entire Federal Radiological Preparedness Coordinating Committee in 1996; and (4) engaged in bureaucratic battle with the Federal Emergency Management Agency (FEMA), which continues to support the 1996 federal policy. Local stockpiling of KI is an inexpensive and effective measure that for a few million dollars would help protect Americans against thyroid diseases from nuclear accidents. The principal beneficiaries of KI, in an actual emergency, will be young children. If stockpiles of KI are not readily available, some of those children can be expected to develop thyroid cancer, a sometimes fatal illness. Yet the NRC persists in ignoring the recommendations of the federal coordinating committee and in advocating regional stockpiles, an approach that FEMA believes will not work because the KI tablets could not be distributed quickly enough. Over the past eleven years the NRC has spent more time. effort, and money pondering KI than it would take simply to buy enough tablets for the whole country. Meanwhile our children remain unprotected. It is time to act. I urge you to start heeding FEMA' s expertise and to start funding state stockpiles of KI now.

Thank you for your attention to this issue, and please keep me informed of your progress in making potassium iodide tablets available to all Americans. Sincerely, k Tom Harkin United States Senator TH/lwu

  .Mt..OO 31lfd'D10

_;ete_r G. Crane I 4809 Drummond Avenue I Chevy Chase, Maryland 20815 I 301-656-3998 I e-mail: pgcrane@erols.com uCJL l: f U BEA u I PROP DRU .5 0 May 19, 2000

                                    ~'/F/(~1731)

Senator Edward M. Kennedy *oo H 1 24 P12 :::,4 United States Senate Washington, D.C. 20510 0

Dear Senator Kennedy:

As a former thyroid cancer patient, I wanted to thank you for your efforts to help make sure that American children do not someday needlessly suffer from this disease. Your letter of December 14, 1999 to the Nuclear Regulatory Commission (belatedly made public by the NRC on March 30, 2000) was a cogent statement of the reasons why the NRC should move expeditiously to bring the protection of A.rnerican children up to world standards by ensming REc *o e adequate supplies of the antidote potassium iodide ("KI"). Unfortunately, the RC's response to you, dated February 29, 2000, is yet another example of the half-truths that appear with depressing regularity when the RC explains its 24 handling of the KI issue. The letter describes the existing federal policy on potassium iodide, adopted in 1985, and says, "The NRC is working with FEMA, the U.S. Food and Drug Administration, and other Federal agencies in reviewing this 1985 policy." No reader could possibly guess imagine from this that in 1996, an interagency committee headed by FEMA, and including the NRC, agreed unanimously on a new policy to replace the 1985 position, which had been rendered obsolete by the Chernobyl accident. Under this new policy, the federal government would buy a supply of potassium iodide for any state that wanted it. The NRC Commissioners announced their support for the new policy, and in a press release issued July 1, 1997, declared, "The NRC will provide the funding." But the NRC first dragged its feet; then revoked its promise to pay for the drug, saying that it lacked sufficient funds; and for the last several years, has been trying to persuade FEMA to abandon the proposed 1996 policy. To his credit, FEMA Director James Lee Witt has repeatedly urged the NRC to stand by its commitment and let the new policy go into effect. The result has been a standoff. Thus the sentence quoted above from the RC ' s February 29 letter to you is not, strictly speaking, a falsehood. But neither can it be said to meet the legal standard that defines the NRC's obligation to the Congress, which is to keep it "fully and currently informed." Sadly - for Chairman Meserve has a high reputation for integrity, and I am sure would not knowingly sign his name to a letter containing half-truths - the letter includes both what rhetoricians call "suppressio veri" and "suggestio fa/si ', the suppression of truth and the suggestion of falsehood. In your own home state, we are now seeing how the NRC's obstruction of a change in federal policy has left state officials under-informed and misinformed about thyroid cancer and its prevention with potassium iodide. As I described in a recent op-ed piece in the Cape Cod Times (April 27, 2000, copy attached), the Massachusetts Advisory Council on Radiation Protection has advised Public Health Commissioner Howard Koh against recommending the stockpiling of potassium iodide in the Commonwealth. But the reasoning of some of the Council

         \ . '
      '\

l I 0/

members reveals a remarkable depth of ignorance. For example, the representative of the Massachusetts Emergency Management Agency informed the group that thyroid cancer is readily and commonl treatable, without long term consequences other than taking [medication]," and he said that the few deaths from Chernobyl-related thyroid cancer were "caused by failing to provide adequate medical care." Your colleague Senator Tom Harkin of Iowa, who lost a brother to thyroid cancer about two years ago, would see it differently. As to the absence of"long term consequences"- suffice it to say that thyroid cancer patients, of whom I am one, would not agree. The Massachusetts Department of Public Health was represented on the Advisory Council by a non-physician who sent out a document earlier this year that supposedly gave "MDPH's position" on a variety of issues related to potassium iodide, including the statement, "The thyroid is relatively insensitive to radiation induced adverse health effects." In fact, medical science has known for exactly 50 years that just the opposite is true. It is just because of the extreme sensitivity of the thyroid to radiation - especially the thyroid of children under two years old - that we are seeing more than 2000 childhood thyroid cancers in Eastern Europe, caused by the Chernobyl accident, and that EPA has separate "protective action guidelines" for radiation exposure to the whole body and to the thyroid. (There may well be accident situations, according to EPA, where evacuation is compelled not because the dose to the whole body is dangerous, but because the thyroid alone is at risk.) These Massachusetts employees are plainly misinformed. But should they bear all the blame for that? I believe that the principal fault attaches instead to the NRC. If it had not blocked the issuance of the new federal policy agreed on in 1996, states and the public would have received accurate information and sound guidance on thyroid disease and its prevention years ago. The NRC has the discretionary authority (subject to judicial review) to make policy decisions up or down on the stockpiling of potassium iodide. But that does not give it the authority to provide misleading information to the Congress, the states, or the American people. Thank you again for involving yourself in this issue. I hope that in the future, any letters you get from the NRC on the subject of potassium iodide will not require the correction, amplification, and apology that are called for in this case. Sincere! , Peter Crane cc: Chairman Richard A. Meserve, NRC Director James Lee Witt, FEMA

YVIEW t A pleato the public health commissioner 1 By PETER CRANE . , state stockpil~. ,d vide adequate medical care; and the and a world-rt1. lwned expert on the

r. Howard Kok, 'the Massa- . New Hampshire, on the other hand; rate of childhood thyroid cancer bad disease, disagrees. Writing in a med-D chusetts commlssioner of public health and a cancer specialist, has championed education and prevention in the fight against cancer.

decided in 1999 to leave it up to indi-viduals to decide whether to buy sup-plies of the drug and keep them in the home. 1bat approach is sure to save money but unlikely to save children, only increased"by a factor of 3 to 4:

                                                                                          'Ihle, the disease is normally treat-able, as I know from experience. As a 2-year-old, I was given X-ray treat-ments for enlarged tonsils, and 24 ical journal, he and other specialists reported a more than 50-fold increase in the most affected parts of Belarus.

Though the Department of Public Health has doctors on its staff, the He has made it his mission to in- especially if an accident occurs during years later I developed thyroid cancer. state's representative to the Advisoiy form the public about ways to avoid school hours. I bad surgery in 1973, and when the Council was a non-physician. certain types of cancer: explaining 'lbe Massachusetts Advisory Coun- disease recurred 15 years later, it took

• Earlier this year, be sent out a docu-that sunblock and protective dotbing cil on Radiation Protection recently five counes of radiation over three ment purporting to state"MDPH's po-can pment melanoma, for example, came down in favor of the New Hamp- years to wipe it out."No long-term sition*on a variety of Kl issues. It in-and stressing the link between lung shire solution. In Februaiy, it sent its consequences"? cluded the statement, "'lbe thyroid is cancer and smoking. , recommendations to Koh: no stockpil- 'lbe relatives of the more than 1,000 relatively insensitive to radiation-in-Koh now has an opportunity to help ing of Kl for the general public, but Americans who died of the disease duced adverse health effects.*

protect Massachusetts children better information on Kl, to allow indi- last year would have a different story No doctor would ever have made against another highly preventable viduals to decide whether to bdy it for to tell. Even for those who survive it - such a claim, which flies in the face of kind of malignanq,: childhood thyroid themselves. and the vast majority of us do - there everything known about the thyroid. cancer. He must decide whether Mass- One problem with the Advisoty are often extensive consequences, . (Koh's deputy has since confirmed achusetts should begin stockpiling a Council's recommendation is that it re- physical and psychological, as well as that the document was issued without cheap and effective antidote, potassi- lied on flawed Information. 'lbe com- the cost of a lifetime spent on medica- the commissioner's approval or um iodide (Kl), in case a nuclear acci- lDOllWt81th nudear engineer, who rep- tion. And the disease is much harder knowledge.) With such input, it is dent or act of terrorism ever occurs. resents the Massachusetts Emergency on children than on adults. small wonder that the Advisory Coun-

   'lbday, governments throughout the       Management Agency on the Council, in-          What about the commonwealth nu-        cil recommended against stockpiling.

developed world routinely keep sup- formed the group that"thyroid cancer is clear engineer's claim of only a three- Why such opposition to so sensible plies of the drug near nuclear plants. readily and commonly treatable, with- fold to four-fold increase in childhood a measure? Lobbyists for the nuclear In the U.S., however, the nuclear in- out long-term consequences other than thyroid cancers in the wake of Cher- industry have candidly admitted their dustry has so far derailed all federal *taking [medication].'The few deaths nobyl? concern that to improve emergency efforts to follow suit. from Chernobyl-related thyroid cancer Dr. Jacob Robbins, scientist emeri- preparedness with Kl could lessen In 1997, the Nuclear Regulatory were, he wrote, *caused by failing to pro- tus at the National Institutes of Health public confidence in the safety of nu-Commission promised to buy Kl for clear plants. Even if that were true, it any state that wanted it. 1wo yean lat- would not justify sbort..cbanging our er it reneged, saying it didn't have the children's health. money. Just weeks ago, the town of What happens when children don't .DuxbUl)' voted to stockpile KL The get Kl in time? A recent article in cost is low, and in an emergency, the

*cancer:publlshed by the American                                                                                                 benefit to children could be enormous.

Cancer Society, reports on childhood Ia there any doubt that this extra in-thyroid cancer resulting from the 1986 surance policy is worth having? Chernobyl accident. Doctors in Ger- *Koh must now decide whether the many, who studied 493 Belarussian children of Massachusetts will be pro-children, found that the greatest dan* tected against this extremely Pfe-ger is to those under 2. Infants are . ventable cancer. If he takes his med-more likely than older children to get ical advic:e from nuclear engineers the disease, and in almost ~thirds rather than ~ors, the common-of them, the cancer will have sprea~ wealth's youngest citizens could some-by the time it is detected. day be in trouble. New England states have wrestled with the Kl question since 1998, when Peter Crone of Chevy Chase, Md., is , Maine decided to joinThnnessee, Al- a retited Nuclear Regulatory Commis- -abama and Arizona in establishing ..,nn J,...,.,....

OFFICE OF THE SECRETARY CORRESPONDENCE CONTROL TICKET Date Printed: May 24, 2000 12:30 PAPER NUMBER: LTR-00-0343 LOGGING DATE: 05/24/2000 ACTION OFFICE: SECY AUTHOR: PETER CRANE AFFILIATION: MD ADDRESSEE: SEN EDWARD KENNEDY

SUBJECT:

COMMENTING ON SEN. KENNEDY DEC. 14, 1999 LTR AND THE NRC' S RESPONSE DATED FEB. 29, 2000 RE POTASSIUM IODIDE ACTION: Appropriate STRIBUTION: CHAIRMAN, COMRS, SECY/RAS, OCA, OGC LETTER DA TE: 05/19/2000 ACKNOWLEDGED No SPECIAL HANDLING: TO BE PLACED ON RULEMAKING DOCKET NOTES: OCM #2635 FILE LOCATION: ADAMS DATEDUE: DATE SIGNED:

fP W1 Loo .3." 't50 o/ UNITED ST ATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 J( ' February 29, 2000

!/f-'U/J'                                                                       *oo trnr 24     A7 1s CHAIRMAN The Honorable Edward M. Kennedy                                            AC United States Senate Washington, D.C. 20510

Dear Senator Kennedy:

I am writing in response to your letter of December 14, 1999, on behalf of the Massachusetts Citizens for Safe Energy regarding the U.S. Nuclear Regulatory Commission's (NRC's) proposed rulemaking concerning the use of potassium iodide (Kl) in emergency plans. Specifically, you ra_ise issues relating to stockpiling Kl in communities near nuclear power plants.

  ¥au also requested that we give every consideration to the Massachusetts Citizens for Safe Energy proposal on the Kl proposed rulemaking. As you may know, the Federal Emergency Management Agency (FEMA) and the NRC are the two Federal agencies that evaluate emergency preparedness at and around nuclear power plants.

Since 1980, when FEMA and the NRC developed the basic components of an emergency response program, Kl was recognized for its potential contribution to public health and safety. Kl, if administered before or within a few hours of exposure to inhaled (or ingested) radioiodines and accompanied by other preventative measures (such as sheltering, evacuation, or embargoing of foodstuffs), can reduce the radiological dose to the thyroid. Doses to the whole body and internal organs from other radionuclides associated with reactor accidents, such as noble gases and cesium, are not reduced or affected by the use of Kl. Current Kl Federal policy, promulgated in 1985, provides for the use of Kl by emergency workers and institutionalized persons who are expected to be exposed to radioiodines and allows the State and local decision-makers to decide on the availability of Kl for the general public. The NRC is w9Jking with FEMA, the U.S. Food and Drug Administration, and other Federal agencies in

 *reviewing this 1985 policy.

Separately, the NRC is in the process of considering a proposed amendment to its emergency planning regulations that would require that consideration be given to including Kl as a protective measure for the general public as a supplement to evacuation and/or sheltering. The proposed amendment, however, would not require that Kl be made available; that decision would be made by State and local governments. The Commission is currently considering the draft final rule and will take into consideration the public comments received in reaching its decision. In this connection, the NRC is also developing a guidance document to assist State and local decision-makers in their consideration of the role and use of Kl for the general public in their site-specific emergency plans. This guidance document is scheduled to be available for public comment in mid-2000. The NRC will consider the Massachusetts Citizens for Safe Energy proposal as part of our evaluation of public comments on the proposed rulemaking in developing the final rule. A copy of the Federal Register notice for the Commission's action on the final rule, which will provide an

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         ')FFICE OF'FHESEORETARY 0FTHE         ISSION ocument ~cs 1arkDate        3    3~                 f ~ ~.t_;,~

16S Received _ _ _____,_ __

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2 evaluation of public comments on the proposed rule, will be provided to the Massachusetts Citizens for Safe Energy when it becomes available. Your letter mentions the nuclear criticality accident in Tokaimura, Japan. According to an International Atomic Energy Agency report (available on the Internet at www.lAEA.org), effluent samples taken during and after the accident revealed that some radioactive material was released off site and that a small fraction of that material was radioiodine. However, the maximum radioiodine concentration in air outside the building in which the accident occurred was about 250 times less than the Japanese effluent concentration limit. Because of these low concentrations of radioiodines, Kl, stockpiled locally, was not distributed to the general public in the communities surrounding the accident site. Local decision-makers recommended evacuation and sheltering in place to the residents of the immediate surrounding areas, as well as a *suspension of harvesting of crops and vegetables. These emergency measures were terminated after 2 days. Based on information available to us, we thus do not believe that the Japanese incident was one in which Kl should have played a role. The NRC, together with FEMA, continues to support fully the emergency response activities of State and local governments associated with nuclear power plant sites. We will continue to work with our licensees and FEMA to ensure that the emergency response programs around plant sites continue to provide reasonable assurance that public health and safety are protected. Richard A. Meserve

EDWARD M. KENNEDY MAS5.-CHUSETTS llnitcd ~ tatcs ~cnatc WASHINGTON, DC 20510-2101 December 14, 1999 Mr. Richard A. Meserve A Chairman U.S. Nuclear Regulatory Commission Washington,DC 20555

Dear Chairman Meserve:

I am writing on behalf of the Massachusetts Citizens for Safe Energy, regarding the U.S. Nuclear Regulatory Commission's Proposed Rulemaking, Consideration of Potassium Iodide*in Emergency Plans. The stockpiling of KI is a safety measure supported by numerous organizations to protect the public in the case of a nuclear accident. Scientific;: evidence reveals the benefits of potassium iodide and its advantages in preventing any inhaled or ingested radioactive iodine from being lodged in the thyroid gland. In Tokaimura, Japan, where KI is stockpiled at local hospitals, police distributed potassium iodide tablets after a recent nuclear accident. By doing so, it is certain that Japanese authorities managed to dramatically reduce the numbers of its citizens who were adversely affected by the accident. I believe that it is incumbent upon us to take the same precautions to prevent the devastating effects that a nuclear accident would inevitably yield. Potassium iodide is one of the easiest, and least expensive means of preventing radioactive iodides from being absorbed by the thyroid. Workers in power plants should not be the only ones for whom this treatment is made available. Schoolchildren

• and other nearby residents should also be able to receive KI in the event of a nuclear accident. KI is time-critical, and the only way to ensure that residents are able to receive the potassium iodide in enough time is to order the stockpiling of KI in those communities.

I ask that you give the proposal by the Massachusetts Citizens for Safe Energy every consideration. Preventing any unforeseen nuclear disaster from claiming additional lives should not only be an option, it should be a requirement. If you have any questions, please feel free to contact Graham Shalgian at (617) 565-3170. Thank you in advance for your consideration.

?J;µ EdwardM~

vLAI YGO Nu-,::;ICJN "I GS & ADJ OICATION STAFF CFICE OFTHESEORETARY THE COMMIS ON

MASSACHUSETTS COALITION TO STOCKPILE Kl Greater Boston Physicians for Social Responsibility* C-10

• Citizens Awareness Network*

Clean Water Action " Don't l'faste Massachusetts

• MassPirg "

Massachusetts Citizens for sate Energy* Toxics Action Center* Citizens Radiological Monitoring Network* Women's Community Cancer Project It costs less than a dime; our kids are worth It! September 10, 1999 Secretary of the USNRC Attention: Rulemaldngs and Adjudlcadons Staff U.S. Nuclear Regulatory Commission Washington, DC 20555 / E*mall CAG@NRC.GOV RE: Comment PRM-50-63A. Consideradon of Potassium Iodide In Emergency Plans. and Proposed Rule Summary: ~De*June* .14 nodce of proposed rulemaking does not ensare Sufficient ' pl'OteCdon  ;,fpubllc.healih and safety. In order to do so, It must ID~te the to.Uowhi,. . . .- . ' .. . Th,f NRC' ~mt .amend Its regulations concerning .emergency_ plannlng._~ _Include a

        - - ~ ~ emerpl1CJ'                planning p r o t e c t i v e ~ - ~ - ~ ~ ~ ~     1l use:of-l)Olasllmn*lodlde (Kl) for the pubBc. _Requiring potassium Iodide will not only protect publlc health and safety It wlD simplify and streamUne payment for potassium Iodide by the licensees. The Ucensee shall take responslblllty for all costs associated with providing Kl for the pubUc, or face shutdown. This Is the financing method for other emergency planning expenses. NRC's proposal that uconslderadonH shall be given to lnduding potassium Iodide Is wOf"dl!ess*

NRC's proposal to support development of national, regional stockpUes, and to bring the Kl to dtlzens near an accident by "'fighter Jet,,. will not work. Kl must be administered before or shortly after exposure to radlolodine to be an effective block. Instead, the NRC should support the development of robust, pre-positioned state stockpiles of Kl to be used In communldes located In the ufar field,. - outside the Emergency Planning Zone. NRC should support the World Health Organizadon's Guidance. In the unear field" ( effluent pathway defined as the Emergency Planning Zone) Kl shall be stockpiled In schools, shelters, hospitals and Recepdon Centers. In addition, Kl shall be available for the public to voluntarily pick-op at a municipal office and/or local drug store. In the 11far field" (outside the Emergency Planning Zone) NRC should support the development of robust, state, stockpiles to be strategically placed to allow for prompt distribution. NRC should require using Kl prophylaxis at one rem projected dose exposure not at the current 25 rem.

I Introduction These comments are presented on behalf of state-wide Massachusetts organizations concerned with nuclear safety coDecdvely totallng many thousands of our ddzens {Boston Cbapter Pbysldans for Soda/ Respoadbl//ty, c-to Resarcb and Edaatlon Center, CJtizeas Awa/WltW' Network, CJa;m Water Action, Don't Waste Hilssac:hasetts, HASSPIRG, Hassacbasetts Citizens for Safe Energy; Toxics Acdoa Ceater, Women's Community Cam:er Project; Citizens RMllologlal Monitoring Network and a town appointed committee within PIigrim NPS's Emergency Planning Zone - the Duxbary Nuclear Advisory Committee). II. NRC Should Require the Use of Kl We oppose uthe Proposed Rule (that) would amend the current reguladons to require that consideration shall be afven to lndudlng powslum Iodide (Kl), as a protective measure for the general public that would supplement sheltering and evacuation."

• Instead, we support NRC amending Its regulations concerning emergency planning to fndude a requirement that emergency planning protective actions indude the prophylactic use of potassium Iodide (Kl) for the publlc - the original pedtion by Peter Crane.

Rationale For Requiring Kl A. To Protect Public Health and Safety Kl protects the thyroid gland, which Is highly sensitive to radiation, from radioactive iodine released In nudear accidents. Kl saturates the thyroid gland with iodine in a harmless form. By doing so, It prevents Inhaled or Ingested radioactive Iodine, which could lead to thyroid cancer, disease, and mental retardation or to other Illness, from lodging In the thyroid gland. The young are particularly at risk, as evidenced from data following Chernobyl. Kl has a long shelf lffe and causes negligible side effects. It ls currently being stockpiled In communities around nudear reactors In Europe, Japan and Canada. In the United States, Alabama, Arizona, Tennessee and Maine have decided to stockpile and numerous other states are considering doing so. The Federal Radiological Preparedness Coordinating Cqmmittee [FRPCC] ls also stodcpDlng Kl so that it can be made available to states In the event of terrorist attacks. The evidence is in. Respected International and national professionals have enough evidence and all recommend the use of Kl for the public. For example, the World Health Organization; the International Agency of Atomic Sdentlsts; the American Thyroid Assodatlon; the National Coundl on Radiation Protection; the Federation of American Physics; President Carter's Kemeny Commission following Three Mlle Island; the Greater Boston Physicians *for Social Responsibility; and numerous doctors in our nation's leading medical schools and hospitals, have all Investigated the Issue and concluded that "'stockpiling/ pre-distributing KJ 11 ls 11 worthwhlle." 2

Specifk Health/Safety Reasons for Stockp/Dnc Kl For the Publk

• Many ddzens live wfthfn the EPZ's of nuclear power plants. In Massachusetts, for example, PDgrlm NPS (Southeastern MA); Vermont Yankee NPS (Northwestern MA); and SEABROOK NPS (Northeastern MA) dlrectly affect us.
• Accidents happen - Titanic, Challenger, Chernobyl, TMI and the near accident at Dfe:SC!en in 1994. The risk of an accident is greater than In the past, due to:

unanddpated premature aging of reactor components; the economics of utility restructuring; the documented history of NRC's laxness of oversight and their unwillingness to force llcensees to adhere to their llcenslng requirements; on-site storage of high level nodear waste at reactor sites - under conditions neither designed nor analyzed for the volume and longevity of such storage; and, the Increased threat of terrorism with nudear power plants as potendal targets.

• l;tadioactive Iodine will be released in an accident
• it is released In smaller amounts under unormal" operadons.
• Chernobyl demonstrated that Infants and the young are most vulnerable to radioactive Iodine. Thyroid cancer In the young ls more aggressive - spreading to the lymph and lungs. Iodine passes the placenta freely. Mental retardation can result from radlolodlne exposure.
• Kl Is a proven thyroid blocldng agent. It provides almost complete thyroid protection by taking the recommended dose of Kl just before or at the time of exposure. If Kl Is taken within ( 1) hour after exposure, it Is 85% effective as a blocking agent; If Kl is taken during the first 3-4 hours after exposure, It Is 50%

effective as a blocking agent. There Is no protection If Kl Is taken after ( 6) hours from exposure.

• Contraindications exist only for a small populadon, and are of minimal concern.

Information now available on reactions to cough syrups and expectorants that contain Kl give an estimate of 1 In 10,000,000 risk for the lnddence of adverse reactions from a daily dose of 130 mg of Kl [NRC 1995]. Further, after Chernobyl, Poland distributed about 18 minion doses with minimal serious adverse reactions reported. It is estimated that 95.3% of children and 23% of the adult population In Poland were given one or more doses of Kl. The World Health Organization and the NRC evaluated the risks and found that the benefits of Kl far outweighed risks. Kl is FDA approved.

• Although the nuclear industry has set up 11red herrings" as reasons not to stockpile, most are public-education/planning problems. They are not problems with Kl, per se. Emergency management agendes are certainly capable of teaching the public that Kl protects against radioactive Iodine and not against other harmful radlonudldes emitted, and that Kl should be taken only when instructed to do so by emergency planning officials.

3

• UablUty ls yet another Nred herring. 11 The real liability issue would be if the request of many of ddzens that Kl be made available were ignored; or if advice (by respected health organhadons such as the World Health Organizadon and American Thyroid Association) to stockpile was turned aside In favor of the industry's fean for industry's uimage.
• Addltlonally, Kl would be taken on a strictly *voluntary" basis and Is FDA approved.
• Because of the probability of fast breaking accidenu and the variability of winds (espedally In coastal communities), Federal reguladons (10 CFR 50.47 and NUREG 0654) now speak to a range of protective actions - not simply evacuation. Kl Is an appropriate adjunct to this "rangen of response - providing addldonal protection to the public.

K. To Simplify/Streamline Payment for Potassium Iodide by Licensee The licensees should be responsible for all costs (original costs of stockpile, replenishment/and associated distribution/public education expenses) as they now are for other emergency planning expenses. Bottom line is that ratepayen pick up the bin as industry's cost of doing ~usiness. The issue always is what route the money win take from the*ratepayer's pocket to the manufacturer, distributor and emergency plannen. In 1997, it was announced that NRC would reimburse states. However, that offer was recently withdrawn - with no valid explanation. No agency wanu funding to come out of their" budget, although that money originates with the ratepayer. The ball is bounced from agency-to-agency and meanwhile the public is left unprotected. NRC's meetings to "discuss" the Issue could well have covered the cost of providing Kl for the public. We know that the cost ls not substantial and certainly not the real reason that the agency withdrew Its prior commitment. Rather, its withdrawal is simply another

• example of the NRC caving into the whims of the nudear industry. Industry saw that too many states were being asked by their public to take up NRC's 1997 announced offer of reimbursement.

The NRC noted In the Federal Register (Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rule 31746) that The overall cost is minimal when placed in the context of emergency planning and should not be a deterrent to stockpiling Kl for use by the general public ... A better funding plan, and one that we support, is to require that Kl shall be available to the public. Then, the licensee must assure that this is so or face shutdown. It is amazing how quickly the licensee and local government will get together to comply. This ls the procedure followed for other emergency planning requiremenu. Example: the NRC has ruled that the public shall be notified of an emergency within a specified dme. Hence, the licensees pay for sirens - their purchase, installation, maintenance, testing. This simple and direct pattern should be followed in funding Kl for the public. 4

XII. Regional Stockpiles wUI be Worthless - State Stock.piles are Appropriate Outside the Emergency Planning Zone.

• We do not support the NRC's announced plan to work with oeher agencies to ensure that there are established "'robust, pre-positioned regional stockpiles of Kl to be effectively and thnefy' used by states that have not established local stodcpDes and wish to make use of regional stockpiles in the event of a severe nuclear power accident."

Instead, we do support robust, pre-positioned state stockpUes of Kl to be used to protect the 11far field. n Regional stockpiles will not adequately protect the public because Kl must be taken prior to exposure, or very shortly thereafter, to be an effective thyroid block. There Is a six* hOID' window, with diminishing effectiveness over that dme period. Nor can any one seriously suggest that all accidents wtD be announced far In advance and be slow breaking; or that distribudon of Kl from a regional center to communities near the reactor wlll occur at Ugbtenlng speed. Commissioner Merrifield suggested that .,.fighter jets" could bring KI to where it was needed. Bot we know that ls foolish. In fact our nation's top emergency planner, James Lee Witt the Director of FEMA emphatically spoke to this point in an April 29, 1999 letter to the NRC Commissioners. FEMA has always opposed the notion that the Federal regional stockpDes of potaSSlum Iodide would be effective In the event of a release from a nudear power plant. The complex loglstfcs of storage and distribution far outweigh the usefulness of such a stockpile. Regional stock.piles of potassium Iodide would compllcate, not strengthen radiological emergency preparedness. Further, If you look In the archives of responses over the years of Industry's 11reasons 0 for opposing stodcplllng KI for the public, you will find industry arguing that regional stockpiles would be a waste of money because Kl coulcl not be distributed fast enough to be effective. They and the NRC can not have It ~th ways."

• IV. We support The World Health Organlzadon {WHO) Organlzadon Guidance - as described In the Federal reg:lsterNol. 64, No. 113/Monday, June 14, 1999/Proposed Rules, 31743.
• Spedflcally, the WHO recommends predistrlbution of stable iodine dose to the site and stockpiles further from the site. These stocks should be strategically stored at points such as schools, hospitals, phannades, fire stadons, or police stadons, thereby allowing prompt distrfbudon.
• The main points of the WHO Guidelines regarding the use of stable iodine are as follows:

Near Field: Stable iodine should be available for immediate distribution to all groups if the predicted thyroid dose is likely to exceed nadonal reference levels. Close to nuclear installations *iodine tablets should be stored or predistributed to fadlltate prompt utilization. 5

Far Field: Stable iod"me should be available for distribution to pregnant women, neonates, Infants and children If the predicted dose ls likely to , exceed reference levels. We support for the *near fleldn or effluent pathway defined as the Emergency Planning Zone: Kl shall be stockpiled In schools, shelters, hospitals and Reception Centers. In addldon, Kl shall be made available for the public to voluntarily pick-up at a munldpal office and/or local drug store. In general, Kl shall be added to the utool boxn as a supplement to evacuation and sheltering, especially after the lessons learned from Chernobyl. Kl would be an hnportant adlunct to evacuadon. There Is always the possibility that evaruadon may be delayed due to traffic or weather condldons. Busses for the transportation clependent may arrive late. The accident may be fast brealdng and the wind speed and direction may be such to expose evacuees en route. Kl would be an Important adhmct to sheltering. The public may arrive at the shelter already exposed to radlolodlne. Kl Is only an effective thyroid block If taken prior to or shortly after exposure - a six-hour window, with diminishing effectiveness over that time period. Kl should be stockpiled in schools. This Is the advice of the experts - WHO and Dr. Jean Temedc, FDA representative to NRC's Kl Core Group (March 4, 1999 Transaipt). Research Indicates that the young are the most vulnerable; and in the words of Dr. Temeck, In an emergency you want to get It to the chUdren as quickly as possible and the teacher is right there on the spot... You do not need to be medically trained to give Kl. A permission slip to administer Kl can be sent out by the school at the beginning\of each year. Despite the fact that emergency plans contain the "concepcn of 11precaudonary transfe~ that children will be evacuated early, there are no guarantees. An acddent can rapidly escalate. Winds may tum In an unfavorable direcdon or inaease in speed. There may be traffic delays. Bosses may not arrive or arrive late. Example: the bus contracts for the Duxbury school children have not been up-dated since the early 1990's. Some of the bus companies are now out of business. Even if bosses do arrive, evacuadon is not risk-free. According to an EPA 1992 manual on protective actions, vehicles provide only about 10% protection. The issue is not evacuation or Kl. The Issue is protecting our children by providing busses and Kl. 6

Kl should be stockpUed In schools even If a community has provided ddzens with an opportunity to purchase Kl at a local store or monldpal office. An accident may occur during school hours. Some parents may have bad the foresight to purchase Kl; however, the children would be In school and the parents at work or away from town. It is not reasonable to expect that parents would put Kl In their children's lunch boxes every day. Also, parents who had the foresight to purchase Kl and were In town may rush to the school to bring Kl to their chJldren - causing traffic logjams and havoc to emergency plans. Kl should be stockplled In shelters. The public may arrive at the shelter already exposed to radioiodlne. The shelter may have a defective v;endladon system or not provide adequate shielding - 1 00% shielding ls not likely._ Even If Kl becomes available to the public to purchase, It is unllkely that tourists would have known to do so. For example, all three Emergency Planning Zones In Massachusetts are popular tourist spots. Haw many visitors to the Mayflower, beach-goers on Duxbury Beach or leaf-peepers In the Berkshires will know to pack Kl for the trip? Transients must be protected. Kl should be stockpDed in Reception Centers. Kl should be stockpUed In Recepdon Centers for the same reasons as it should be stockpiled In shelters. Addldonally, Kl may be needed because the Reception Centers, although outside the EPZ's, may be within the plume exposure pathway. For example, the European Commission of the International Atomic Agency WHO stated In 1996 that, usigniflcant exposure to radlolodlne extended more than 1 00 kilometers from Chernobyl." Kl should be stockpiled in hospitals. I Neonates are particularly susceptible to radiolodlne. They should be protected. Pregnant women should be protected, too, because thyroid deficiency in mothers results in lower IQ's in children (Boston Globe, August 19, 1999, page 1 ). Kl should be available for the public to pick up at drug stores and/or municipal offices. Availability most be coupled with public educadon to encourage the public to obtain Kl and educate them about its benefits and proper use. We support for the "far field" - defined as outside the Emergency Planning Zone: Robust state (not regional) stockpiles are appropriate for the far field. In Massachusetts, for example, It would be appropriate to have stockpiles in the Emergency Planning Agency's Headquarters and also in their three sub-stadons, Bridgewater, Tewksbury and Belchertown. Addidonally if the topography is such that It would be necessary to travel through the reactor zone to reach an area, then that area should have its own supply. Cape Cod would be an example. Rationale: In NUREG- 1633, the NRC acknowledges that the increase In cancer caused by Chernobyl

        ...was detected In Belarus, Russia, and Ukraine. Notably, this increase, seen In areas more than 150 miles I

(l00Km) from the site, condnues to this day and 7

prfmarlly affects chlldren ... the vast majority of thyroid cancers were diagnosed among those living more than 50 km (31 mUes) from the site. The NRC admowleclged that exposure to radlolodine can occur well beyond 10 miles back In 1980 In their Document, EJumlaadoa of tbe Ilse or Potassium Iodide {Kl) as an Emergency Prot<<tlve Measare for Nae/au Re<<tor Acddeats (NUREG/CR-1433, Sandia National Laboratories, Albuquerque, New Mexico, 1980). This report descri~ the heakb effects of a nuclear accident In detaD, and provides casualty estimates at various distances from a reactor. NUREG-1433 points out that thyroid growths (nodules) and other thyroid damage would be expected to ocmr for hundreds of miles downwind after an accident through breathing. This ls desaibed In tables 3 and 4 of the report, as shown below: EFFECTS OF CORE-MELT ATMOSPHERIC ACCIDENTS BY DISTANCE Distance *in Mean Thyroid Dose Probability of Thyroid Miles (REM)for Exposed Damage to Exposed Adult Adult Outdoors Located Outdoors 1 13,500 60% 5 5,800 70% 10 3,200 70% 25 1,100 40% EFFECTS QF CORE-MELT ATMOSPHERIC ACCIDENTS BY DISTANCE Distance in Mean Thyroid Dose Probability of Thyroid Miles (REM)for Exposed Damage to Exposed Adult Adult Outdoors Located Outdoors 50 380 13% 100 100 3% 150 36 1% 200 16 0.5% For children, lnuease dose and probability of damage by an approximate factor of two. Weather conditions based on calculated probability distributions. Thyroid damage 8

includes thyroid nodules (both benip and cancerous) and ablated thyroid. Assumed risk coeffldent of 334 thyroid nodules per mflUon person-rem to the thyroid. Includes lnhaladon dose only. Does not include Ingestion. Probabllfdes condldonal on accident occurring. However, the NRC and States limft their accident planning to 10 miles. In other words, there ls nothing to protect people who, for example, are 50 miles away, despite the probability that 13% of all exposed adults (and about a quarter of the children) at this distance could be Injured. Yet use of Kl would prevent this - a fact the NRC does not dispute. Therefore In adcDdon to stockpfflng Kl In EPZ's, Kl should be stockpi)ed beyond the 10-mDe radius In each state. V. Kl Prophylaxis at One ( 1 ) Rem Projected Dose Exposure We support using Kl propbylaxls at one rem projected dose exposure. Currently, Fed4!ral pollcy ls to give Kl at 25 rem projected dose. However, based on the dose response reladonshlp reported In the 1998 Nature paper and Dr. Jean Temeck's discussion to NRC's Kl Core Group (March 4, 1999), we know that there was an lnaeased risk at a mean dose of 5 rem. Also, Poland used a 5 rem lntervendon level. The relationship of dose to disease ls a linear relationship. Therefore, even H you extrapolate down to one rem, you are not coming to .zero risk. Therefore, to protect public health and safety and to use the *precaudonary prlndple"' as the basis for publk policy, we support a one rem projected dose as the utrlgger.H VI. Summary The evidence ls In - all the experts and sdentlsts have spoken - NRC must amend its emergency planning regulations to Include a requirement that emergency planning Includes Kl for the public. The health of our children ls too Important to ~ e their protection from thyroid cancer, disease, mental retardation and other mnesses to the

• constderadon" of states. *ConstderatlonH Is a powder puff - meaningless. It requires nodilng. The NRC promises to help the states *consider.# We have bad enough experience with the NRC's help on this Issue. NUREG-1633, a Guidance Document, was prepared by the NRC to help states decide H they wanted to stockpile Kl. Fortunately, It was withdrawn because k was so biased and dear that it was written to help states decide not to stockpile Kl. In the words of New York States Director of the Bureau of Environmental Radiation Protection, .,.we find the document to have been prepared to justify a position advocating against the use of Kl for publk protection, rather than as an objective review of the relevant lnformadon.u Now, a new Guidance Document Is In the making. The same staff responsible for NUREG-1633 ls at it again. And, again, meaningful pubUc parddpadon is absent In the documents preparadon. We need Kl. We need a requirement.

The NRC's plan to support the development of regional stockpiles ls worthless. The use of uFlghter Jets," as promised by Commissioner Merriweather, must be a Joke. A very sick joke, Indeed, because everyone knows that uFlghter jets" win not deliver Kl in time. Kl Is dme-critlcal. 9

The Commissions decision to withdraw their 1997 promise to fund Kl says more about the Commissions des to Industry than the status of NRC's budget. The Ucensees should be direcdy responsible for all costs associated with Kl as they now are for other emergency planning expenses. This will happen when the NRC requires that Kl shall be made readily available to the public. It then becomes a cost of staying in business. We ask that the NRC grant Mr. Crane's original petition and require Kl stockpiling to be part of every emergency plan, as it Is In nations around the world and as the NRC promised to do so In 1979. Respectfully submitted on behalf of the Coalition, Mary Elizabeth Lampert Massachusetts ~itizens for Safe Energy

• 148 Washington Street Duxbury, Massachusetts 02332 Tel 781-934-0389 Fax 781-934-5579 e-mail jlampert@idt.net Usted below are additional individuals and groups signing on to these comments.

Selectmen, Town of Duxbury - Duxbury, Massachusetts 878 Tremont Street, Duxbury, MA 02332 - Phone 781-934-1108 Paul Gunter, Michael Mariotte, Nucledr lnfonmtloa and Resource Service, 1424 16111 Street NW, #404, Washlngton,DC 20036, Phone 202-328-0002 Email nJrsnet@nJrs.org William S. Abbott, Plymouth County Nuclear lnfonnatlon Committee, c/o William S. Abbott, P.C., 50 Congress Street, Boston, Ma 02109, Phone (617) 523-5520 Email WABB01T1@aol.com John Anderson and Roger Erikson, Cltl.zens Radiological Honltorin1 Network, 133 Washington Street, Duxbury MA 02332 Daniel Burnstein, Center for Atomic RMJ/adon Studies, Inc., (CARS), 35 Gardner Road, Brookline, MA 02445. Phone 617-738-9300

• George Crocker, North American Water Offlce/Pralrle Island Coalition P.O. Box 174 Lake Elmo Minnesota 55042
• Phone 651-770-3861 / E-mail gwillc@mtn.org Sandra Gavuds, Director, C-10 Re.search and Education Foundation, INC, 44 Merrimac Street, Newburyport, MA 01950 Phone 978-462-3959/ Email sandra@c-10.org

Steve Haberman, Seacoast And-Pollution League, P.O. Box 1136, Portsmouth, NH 03802 - Phone 603-431-5089 / Email SAPL99@aol.com Ann Hams, Executive Director, Al/lance for Publk Hed/tb and Safety, P.O. Box 40 Ten Mlle, TN. 37880 - Phone 423-376-4851 / E-mail apickel@aol.com Deborah Katz, Citizens Awanneu Network, Box 83 Shelburne Falls, MA 01379 - Phone 202-328-0002/ E-mall can@sbaysnet.com David A. Kraft, Director, Nadedr Energy /nfonnadon Service, P.0. Box 1637, Evanston, IIDnols 60204-1637 - Phone 847-869-7650 / E-mall neis@forward.net Cynthia Luppi, Cled.n Water Action, - 16 Summer Street, Boston MA 02110 - Phone 617-423-4661 - Email bostoncwa@deanwater.org Mary Lampert{ Massachusetts Otlnms for Safe Energy, 29 Temple Place, Boston MA 02111 - Phone 617-292-8057 Francis U. Macy, Director, Center for Safe Energy, 2812 Cherry Street, Berkeley, CA 94 705 - Phone 510-540-7120 / E-Mail fmacy@lgc.org Jerry Rosenthal, Concerned Citizens of Louisa County, 811 Holland Creek Road, Louisa, VA 23093 / E-mail zips@flrstva.com Dr. David Rush, Greater Boston Physicians for Soc:idl Responsibility 68 Foster Street, Cambridge MA 02138 em Smith, Flsb Unllmited, 1 Brander Parkway, Shelter Island, New York 11965 - Phone 516-749-3474 / Email bsmlth@flshunlimited.org Renee Shapiro, Womens Community CdnaJr Project, 21 Glenmont Avenue Brighton, MA 02135 - Phone 617-787-0743 I Emall kokos@javanet.com Michael Steinberg, Black Rain Press, 1009 Burch Avenue, Durham, NC 27701 - Email 1009Burch < sr12@duke.edu Michael Welch, Redwood Al/Janee, PO Box 293, Arcata, CA 95518 - Phone 707-822-7884/ E-Mail mlchael.welch@homepower.com Ted Vosk, HassP/rg, 29 Temple Place, Boston MA 02111 - Phone 617-292-4800 I EmaJI tvosk@postharvard.edu Chris Williams, Ex. Dir., Otlzens Aa/on Coalition of Indiana - 5420 N. College Ave., Suite 100, Indianapolis, IN 46220 - Phone 317-205-3535 / E-mall chrlsw@citact.org Matthew Wilson, ToxlcsAction Center, 29 Temple Place, Boston MA 02111 - Phone 617-292-4821; and 41 South Main Street, Suite #5, West Hartford CT 06107 Phone 860-233-7623 / Email mwilson@toxlcsactlon.org 11

UNITED ST ATES NUCLEAR REGULATORY COMMISSION WASHINGTON , D.C. 20555-0001 O! , .. February 29, 2000 1/n'l/:f CHAIRMAN DV E BEA PROPO ED AUL So C AD The Honorable Karen L. Thurman U.S. House of Representatives Washington, D.C. 20515

Dear Congresswoman Thurman:

I am writing in response to your letter of December 9, 1999, on behalf of Mr. Keith A. Green of Dunnellon, Florida, regarding the U.S. Nuclear Regulatory Commission's (NRC's) proposed rulemaking concerning the use of potassium iodide (Kl) in emergency plans. Specifically, you raise issues relating to stockpiling Kl in communities surrounding nuclear power plants. As you may know, the Federal Emergency Management Agency (FEMA) and the NRC are the two Federal agencies that evaluate emergency preparedness at and around nuclear power plants. Since 1980, when FEMA and the NRC developed the basic components of an emergency response program, Kl was recognized for its potential contribution to public health and safety. Kl, if administered before or within a few hours of exposure to inhaled (or ingested) radioiodines, and accompanied by other preventative measures (such as sheltering, evacuation, or embargoing of foodstuffs), can reduce the radiological dose to the thyroid. Doses to the whole body and internal organs from other radionuclides associated with reactor accidents, such as noble gases and cesium, are not reduced or affected by the use of Kl. Current Kl Federal policy, promulgated in 1985, provides for the use of Kl by emergency workers and institutionalized persons who are expected to be exposed to radioiodines and allows the State and local decision-makers to decide on the availability of Kl for the general public. The NRC is working with FEMA, the U.S. Food and Drug Administration, and other Federal agencies in reviewing this 1985 policy. Separately, the NRC is in the process of considering a proposed amendment to its emergency planning regulations that would require that consideration be given to including Kl as a protective measure for the general public as a supplement to evacuation and/or sheltering. The proposed amendment, however, would not require that Kl be made available; that decision would be made by State and local governments. The Commission is currently considering the draft final rule and will take into consideration the public comments received in reaching its decision. In this connection, the NRC is also developing a guidance document to assist State and local decision-makers in their consideration of the role and use of Kl for the general public in their site-specific emergency plans. This guidance document is scheduled to be available for public comment in mid-2000. The NRC, together with FEMA, continues to support fully the emergency response activities of State and local governments associated with nuclear power plant sites. We will continue to work

t

       ~vvLCA ,  Htut.Jlt\lVHY 0U ~11   ION 11 JLEMAKINGS &ADJUDICATION STAFF nFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics tmark Date - 2b 3 OD ~                   ~~

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2 with our licensees and FEMA to ensure that the emergency response programs around plant sites continue to provide reasonable assurance that public health and safety are protected. Richard A. Meserve

mLoo 3Jo'1 ~5 t I KAREN L. THURMAN COMMITTEE ON WAYS AND MEANS 5TH 0,STRICT, FLORIDA SUBCOMMITTEE ON HEAL TH WASHINGTON OFFICE 440 CANNON BUILDING WASHINGTON, DC 20515 00' 202/225-1002

                                                                                                                            'J cttongre~~ of tbe ~ntteb ~tate~                                      *oo   t1A1 24          A7 .1 4 Jt,ougr of l\rprrgrntatibrg                            u December 9, 1999                                 -awasbington, 1.19(( 20515 Mr. Dennis K. Rathbun Director, Office of Congressional Affairs Nuclear Regulatory Commission                                    DOCKET NU BER 017 -A3                                                               OPOSED RU Washington, D.C. 20555-0001

Dear Mr. Rathbun:

• I write to bring to your attention a letter that I recently received from Mr. Keith A. Green of Dunnellon, Florida.

As you can see, Mr. Green is concerned about preparing for the event of an accident at a nuclear plant by requiring plants to stockpile potassium iodide. Any information you could provide in helping me respond to this inquiry would be greatly appreciated. If you have any questions, please do not hesitate to contact me or Debbie Pesanti-Payson of my staff at (202) 225-1002. I look forward to your prompt reply. Sincerely,

              ~~

• aren L. Thurman Member of Congress KLT\dp enc.

222* HIGHWAY 44 WEST 5700 5.W. 34TH Sr , SUITE 425 5609 U.S. 19 SOUTH, SUITE H HOME OFFICES: INVERNESS, FL 34453 GAINESVILLE, FL 32608 NEW PORT RICHEY, FL 34652 3521344-3044 352/336-6614 727/849-4496 TOLL FREE 1-800-833-4352

IJ. . ~UvLc:t\ H l.l LAI Url Yvu iv , RULEMAKINGS &ADJ ICATIO SSTAFF OFFICE OF THE SECRETARY OFTHE ISSIO Document Statistics ostmarkDate --3.p3 DD ulc/~ f~ ~ Gopie Received _ _ _ _,-,.,.-

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                                                                                             ..~.....kSl-..*6-T Thurman                                                             Jm~r~st_ -~ ~ Q                    ..

From: Keith Green[SMTP:kgreenjess@hitter.net] Asstgned To CX? Sent: Sunday, December 05, 1999 10:23 AM Text To: Thurman; Connie Mack; bob_graham

Subject:

FW: potassium iodide pills Proofed By Pending File _____ Here is the email I received from the People in Mass. and what they are trying to do from there. Keith A. Green, Dunnellon, Fla. 34431

    -----Original Message----

From: James Lampert (mailto:jlampert@idt.net] Sent: Saturday, December 04, 1999 7:02 AM To: Keith Green

Subject:

Re: potassium iodide pills Keith Green wrote: I have been running into the same nuciear curtain in Florida that you seem to have in Mass. All info stopped about Mar. 1999 or it seem that way.

    > I am glad to see your initiative and will send a copy of your letter to all
    > I can here in Florida. It seems that our News orgs. are not concerned
    > enough to upset the nuclear apple cart. I hope that will change. Thank
    > you,                  Keith A. Green, 11745 Sw230th Av. Rd.,
    > Dunnellon, Fla. 34431, 352 465 1719
   >                       Name: winmail.dat
    >            Part 1.2     Type: application/ms-tnef
   >                    Encoding: base64 new e-mail address: lampert@adelphia.net

. i l l keep in touch - National Level: Can you get your Congressmen/Senators to take a stand? Senators Kerry (MA) and Congressman Delahunt and Markey (MA) are on board - that is writing to NRC to redo Kl rule so as to follow WHO Guidelines - Kennedy should join next week. I have Kerry's comments - often helps to send out as a "template." They are also asking our state DPH Commissioner to act locally while feds dither and delay. FDA: Talked With FDA yesterday and they hope to have up- dated Kl policy out early next year. A call from folks encouraging FDA to continue to protect the publics' health and avoid NRC's pressure to protect simply industry's would help. They have been good guys to date - Contact David Orloff FDA 301-827-6430 - recommend: stockpiling for public; trigger 1 r to thyroid; state policy that Kl should be administered when predict significant release - not wait for confirmed measurement when too late etc Good Luck M Lampert Page 1

http://ruleforum.llnl.gov/cgi-bin/downloader/KI_PETITION_public/244-0120.ht MASSACHUSETTS COALITION TO STOCKPILE KI Greater Boston Physicians for Social Responsibility* C-10

• Citizens Awareness Network* Clean Water Action* Don't Waste Massachusetts* MassPirg
• Massachusetts Citizens for Safe Energy* Toxics Action Center*

Citizens Radiological Monitoring Network* Women's Community Cancer Project It costs less than a dime; our kids are worth it! September 10, 1999 Secretary of the USNRC Attention: Rulemakings and Adjudications Staff U.S. Nuclear Regulatory Commission Washington, DC 20555 / E-mail CAG@NRC.GOV RE: Comment PRM-50-63A, Consideration of Potassium Iodide in Emergency Plans, and Proposed Rule Summary: The June 14 notice of p ~ ruliP.meldng does not ensure sufficient protection of public health and safety. In order to do so, it must incorporate the following. The NRC must amend its regulations _concerning emergency planning to include a reguirement that emergency planning protective actions"incluae'llie'prop'llylactic use of potassium iodide (Kl) for tbe public. Requiring potassium iodide will not only protect public health and safety it will simplify and streamline payment for potassium iodide by the licensees. The licensee shall take responsibility for all costs associated with providing KI for the public, or face shutdown. This is the financing method for other emergency planning expenses. NRC's proposal that "consideration" shall be given to including potassium iodide is worthless. NRC's proposal to support development of national, regional stockpiles, and to bring the KI to citizens near an accident by "fighter jet," will not work. KI must be administered before or shortly after exposure to radioiodine to be an effective block. Instead, the NRC should support the development of robust, pre-positioned state stockpiles of KI to be used in communities located in the "far field" - outside the Emergency Planning Zone. NRC should support the World Health Organization's Guidance. In the "near field" (effluent pathway defined as the Emergency Planning Zone) KI shall be stockpiled in schools, shelters, hospitals and Reception Centers. In addition, KI shall be available for the public to voluntarily pick-up at a municipal office and/or local drug store. In the "far field" (outside the Emergency Planning Zone) NRC should support the development of robust, state, stockpiles to be strategically placed to allow for prompt distribution. NRC should require using KI prophylaxis at one rem projected dose exposure not at the current 25 rem. I. Introduction These comments are presented on behalf of state-wide Massachusetts organizations concerned with nuclear safety collectively totaling many thousands of our citizens ( Boston Chapter Physicians for Social Responsibility, C-10 Research and Education Center, Citizens Awareness Network, Clean Water Action, Don't Waste Massachusetts, MASSP/RG, Massachusetts Citizens for Safe Energy; Toxics Action Center, Women's Community Cancer Project; Citizens Radiological Monitoring Network and a town appointed committee within Pilgrim NPS's Emergency Planning Zone - theDuxbury Nuclear Advisory Committee). II. NRC Should Require the Use of KI We oppose "the Proposed Rule (that) would amend the current regulations to require that consideration shall be given to including potassium iodide (Kl), as a protective measure for the general public that would supplement sheltering and evacuation." Instead, we support NRC amending its regulations concerning emergency planning to include a requirement that emergency planning protective actions include the prophylactic use of potassium iodide (Kl) for the public – the original petition by Peter Crane. 1 of8 02/07/2000 1:43 Pl\,

httpJ/ruleforum.llnl.gov/cg1-b1n/downloader/Kl_PETITION_pubilc/244-0120.ht Rationale For Requiring KI A. To Protect Public Health and Safety KI protects the thyroid gland, which is highly sensitive to radiation, from radioactive iodine released in nuclear accidents. KI saturates the thyroid gland with iodine in a harmless form. By doing so, it prevents inhaled or ingested radioactive iodine, which could lead to thyroid cancer, disease, and mental retardation or to other illness, from lodging in the thyroid gland. The young are particularly at risk, as evidenced from data following Chernobyl. KI has a long shelf life and causes negligible side effects. It is currently being stockpiled in communities around nuclear reactors in Europe, Japan and Canada In the United States, Alabama, Arizona, Tennessee and Maine have decided to stockpile and numerous other states are considering doing so. The Federal Radiological Preparedness Coordinating Committee [FRPCC] is also stockpiling KI so that it can be made available to states in the event of terrorist attacks. The evidence is in. Respected international and national professionals have enough evidence and all recommend the use of KI for the public. For example, the World Health Organization; the International Agency of Atomic Scientists; the American Thyroid Association; the National Council on Radiation Protection; the Federation of American Physics; President Carter's Kemeny Commission following Three Mile Island; the Greater Boston Physicians for Social Responsibility; and numerous doctors in our nation's leading medical schools and hospitals, have all investigated the issue and concluded that "stockpiling/ pre- distributing KI" is "worthwhile." Specific Health/Safety Reasons for Stockpiling Kl For the Public

• Many citizens live within the EPZ' s of nuclear power plants. In Massachusetts, for example, Pilgrim NPS (Southeastern MA); Vermont Yankee NPS (Northwestern MA); and SEABROOK NPS (Northeastern MA) directly affect us.
• Accidents happen - Titanic, Challenger, Chernobyl, TMI and the near accident at Dresden in 1994. The risk of an accident is greater than in the past, due to: unanticipated premature aging of reactor components; the economics of utility restructuring; the documented history of NRC's laxness of oversight and their unwillingness to force licensees to adhere to their licensing requirements; on- site storage of high level nuclear waste at reactor sites - under conditions neither designed nor analyzed for the volume and longevity of such storage; and, the increased threat of terrorism with nuclear power plants as potential targets.
• Radioactive iodine will be released in an accident - it is released in smaller amounts under "normal" operations.
• Chernobyl demonstrated that infants and the young are most vulnerable to radioactive iodine. Thyroid cancer in the young is more aggressive - spreading to the lymph and lungs. Iodine passes the placenta freely. Mental retardation can result from radioiodine exposure.
• KI is a proven thyroid blocking agent. It provides almost complete thyroid protection by taking the recommended dose of KI just before or at the time of exposure. If KI is taken within (1) hour after exposure, it is 85% effective as a blocking agent; if KI is taken during the first 3-4 hours after exposure, it is 50% effective as a blocking agent. There is no protection if KI is taken after (6) hours from exposure.
• Contraindications exist only for a small population, and are of minimal concern. Information now available on reactions to cough syrups and expectorants that contain KI give an estimate of 1 in 10,000,000 risk for the incidence of adverse reactions from a daily dose of 130 mg of KI [NRC 1995). Further, after Chernobyl, Poland distributed about 18 million doses with minimal serious adverse reactions reported. It is estimated that 95.3% of children and 23% of the adult population in Poland were given one or more doses of Kl. The World Health Organization and the NRC evaluated the risks and found that the benefits of KI far outweighed risks. KI 1s FDA approved.
• Although the nuclear industry has set up "red herrings" as reasons not to stockpile, most are public-education/planning problems. They are not problems with KI, per se. Emergency management agencies are certainly capable of teaching the public that KI protects against radioactive iodine and not agamst other harmful radionuclides emitted, ~d that KI should be taken only when instructed to do so by emergency planning officials.
• Liability is yet another "red herring." The real liability issue would be if the request of many of citizens that KI be made 2 of& 02/0712000 I .43 Pl\

http://ruleforum llnl.gov/cg1-bin/downloader/K.l_PETITI ON_pubhc/244-0120 .ht available were ignored; or if advice (by respected health organizations such as the World Health Organization and American Thyroid Association) to stockpile was turned aside in favor of the industry's fears for industry's "image." Additionally, KI would be taken on a strictly "voluntary" basis and is FDA approved.

• Because of the probability of fast breaking accidents and the variability of winds (especially in coastal communities),

Federal regulations (10 CFR 50.47 and NUREG 0654) now speak to a range of protective actions - not simply evacuation. KI is an appropriate adjunct to this "range" of response - providing additional protection to the public. K. To Simplify/Streamline Payment for Potassium Iodide by Licensee The licensees should be responsible for all costs (original costs of stockpile, replenishment, and associated distribution/public education expenses) as they now are for other emergency planning expenses. Bottom line is that ratepayers pick up the bill as industry's cost of doing business. The issue always is what route the money will take from the ratepayer's pocket to the manufacturer, distributor and emergency planners. In 1997, it was announced that NRC would reimburse states. However, that offer was recently withdrawn-with no valid explanation. No agency wants funding to come out of "their" budget, although that money originates with the ratepayer. The ball is bounced from agency-to-agency and meanwhile the public is left unprotected. NRC's meetings to "discuss" the issue could well have covered the cost of providing KI for the public. We know that the cost is not substantial and certainlynot the real reason that the agency withdrew its prior commitment. Rather, its withdrawal is simply another example of the NRC caving into the whims of the nuclear industry. Industry saw that too many states were being asked

• by their public to take up NRC' s 1997 announced offer of reimbursement.

The NRC noted in the Federal Register (Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rule 31746) that The overall cost is minimal when placed in the context of emergency planning and should not be a deterrent to stockpiling KI for use by the general public .... A better funding plan, and one that we support, is to require that KI shall be available to the public. Then, the licensee must assure that this is so or face shutdown. It is amazing how quickly the licensee and local government will get together to comply. This is the procequre followed for other emergency planning requirements. Example: the NRC has ruled that the public shall be notified of an emergency within a specified time. Hence, the licensees pay for sirens – their purchase, installation, maintenance, testing. This simple and direct pattern should be followed m funding KI for the public. XII. Regional Stockpiles will be Worthless – State Stockpiles are Appropriate Outside the Emergency Planning Zone. We do not support the NRC's announced plan to work with other agencies to ensure that there are established "robust, pre-positioned regional stockpiles of KI to be effectively and timely used by states that have not established local stockpiles and wish to make use of regional stockpiles in the event of a severe nuclear power accident." Imtead, we do support robust, pre-positioned state stockpiles of KI to be used to protect the "far field." Regional stockpiles will not adequately protect the public because KI must be taken prior to exposure, or very shortly thereafter, to be an effective thyroid block. There is a six- hour window, with diminishing effectiveness over that time period. Nor can any one seriously suggest that all accidents will be announced far in advance and be slow breaking; or that distribution of KI from a regional center to communities near the reactor will occur at lightening speed. Commissioner Merrifield suggested that "fighter jets" could bring KI to where it was needed. But we know that is foolish. In fact our nation's top emergency planner, James Lee Witt the Director ofFEMA emphatically spoke to this point in an April 29, 1999 letter to the NRC Commissioners. FEMA has always opposed the notion that the Federal reg10nal stockpiles of potassium iodide would be effective in the event of a release from a nuclear power plant. The complex logistics of storage and distribution far outweigh the usefulness of such a stockpile. Regional stockpiles of potassmm iodide would complicate, not strengthen radiological emergency preparedness. Further, if you look in the archives of responses over the years of industry's "reasons" for opposing stockpiling KI for the public, you will find industry arguing that regional stockpiles would be a waste of money because KI could not be distributed fast enough to be effective. They and the NRC can not have it "both ways." 3 of8 02/07/2000 l *43 PM

httpJ/ruletorum.llnl.gov/cg1-bm/downloader/Kl_pETITION_pubhc/244-0120.ht IV. We support The World Health Organization (WHO) Organization Guidance --as described in the Federal register/Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rules, 31743.

• Specifically, the WHO recommends predistribution of stable iodine close to the site and stockpiles further from the site.

These stocks should be strategically stored at points such as schools, hospitals, pharmacies, fire stations, or police stations, thereby allowing prompt distribution.

• The roam points of the WHO Guidelines regarding the use of stable iodine ~ as follows:

Near Field: Stable iodine should be available for immediate distribution to all groups if the predicted thyroid dose is likely to exceed national reference levels. Close to nuclear installations iodine tablets should be stored or predistributed to facilitate prompt utilization. Far Field: Stable iodine should be *available for distribution to pregnant women, neonates, infants and children if the predicted dose is likely to exceed reference levels. We support for the "near field" or effluent pathway defined as the Emergency Planning Zone: KI shall be stockpiled in schools. shelters, hospitals and Reception Centers. In addition, KI shall be made available for the public to voluntarily pick-up at a municipal office and/or local drug store. VIn general, KI shall be added to the "tool box" as a supplement to evacuation and sheltering, especially after the lessons learned from Chernobyl. KI would be an important adjunct to evacuation. There is always the possibility that evacuation may be delayed due to traffic or weather conditions. Busses for the transportation dependent may arrive late. The accident may be fast breaking and the wind speed and direction may be such to expose evacuees en route. KI would be an important adjunct to sheltering. The public may arrive at the shelter already exposed to rad10iodme. KI is only an effective thyroid block if taken prior to or shortly after exposure-a six-hour window, with diminishing effectiveness over that time period. KI should be stockpiled in schools. This is the advice of the experts - WHO and Dr. Jean Temeck, FDA representative to NRC's KI Core Group (March 4, 1999 Transcript). Research indicates that the young are the most vulnerable; and in the words of Dr. Temeck, In an emergency you want to get it to the children as quickly as possible and the teacher is right there on the spot... You do not need to be medically trained to give KI .

• A permission slip to administer KI can be sent out by the school at the beginning of each year.

Despite the fact that emergency plans contain the "concept" of "precautionary transfer" that children will be evacuated early, there are no guarantees. An accident can rapidly escalate. Winds may tum in an unfavorable direction or increase in speed. There may be traffic delays. Bosses may not arrive or arrive late. Example: the bus contracts for the Duxbury school children have not been up-dated since the early 1990's. Some of the bus companies are now out of business. Even ifbusses do arrive, evacuation is not risk-free. According to an EPA 1992 manual on protective actions, vehicles provide only about 10% protection. The issue is not evacuation or KI. The issue is protecting our children by providing busses and KI. KI should be stockpiled in schools even if a community has provided citizens with an opportunity to purchase KI at a local store or murucipal office. An accident may occur during school hours. Some parents may have had the foresight to purchase KI; however, the children would be in school and the parents at work or away from town. It is not reasonable to expect that parents would put KI in their children's lunch boxes every day. Also, parents who had the foresight to purchase KI and were in town may rush to the school to bring KI to their children - causing traffic logjams and havoc to emergency plans. KI should be stockpiled in shelters. The public may arrive at the shelter already exposed to radimodine. The shelter may have a defective ventilation system or not provide adequate shielding – 100% shielding is not likely. Even if KI becomes available to the public to purchase, it is unlikely that tourists would have known to do so. For example, all three Emergency Planning Zones in Massachusetts are 4of8 02/07/2000 1.43 Plv

http://ruleforum.llnl.gov/cg.t-b1n/downloader/Kl_PITTITION_pubi1c/244-0120. ht popular tourist spots. How many visitors to the Mayflower, beach-goers on Duxbury Beach or leaf-peepers in the Berkshires will know to pack KI for the trip? Transients must be protected. KI should be stockpiled in Reception Centers. KI should be stockpiled in Reception Centers for the same reasons as it should be stockpiled in shelters. Additionally, KI may be needed because the Reception Centers, although outside the EPZ's, may be within the plume exposure pathway. For example, the European Commission of the International Atomic Agency WHO stated in 1996 that, "Significant exposure to radioiodine extended more than 100 kilometers from Chernobyl."

• KI should be stockpiled in hospitals.

Neonates are particularly susceptible to radioiodine. They should be protected. Pregnant women should be protected, too, because thyroid deficiency in mothers results in lower IQ's in children (Boston Globe, August 19, 1999, page_ 1). KI should be available for the public to pick up at drug stores and/or municipal offices. Availability must be coupled with public education to encourage the public to obtain KI and educate them about its benefits and proper use. We support for the "far field" - defined as outside the Emergency Planning Zone: Robust state (not regional) stockpiles are appropriate for the far field. In Massachusetts, for example, it would be appropriate to have stockpiles in the Emergency Planning Agency's Headquarters and also in their three sub-stations, Bridgewater, Tewksbury and Belchertown. Additionally if the topography is such that it would be necessary to travel through the reactor zone to reach an area, then that area should have its own supply. Cape Cod would be an example. Rationale: In NUREG- 1633, the NRC acknowledges that the increase in cancer caused by Chernobyl

            ... was detected in Belarus, Russia, and Ukraine. Notably, this increase, seen in areas more than 150 miles (300Km) from the site, continues to this day and primarily affects children ... the vast majority of thyroid cancers were

• diagnosed among those living more than 50 km (31 miles) from the site.

The NRC acknowledged that exposure to radioiodine can occur well beyond 10 miles back in 1980 in their Document, Examination of the Use of Potassium Iodide (Kl) as an Emergency Protective Measure for Nuclear Reactor Accidents (NUREG/CR-1433, Sandia National Laboratories, Albuquerque, New Mexico, 1980). This report describes the health effects of a nuclear accident in detail, and provides casualty estimates at various distances from a reactor. NUREG-1433 points out that thyroid growths (nodules) and other thyroid damage would be expected to occur for hundreds of miles downwind after an accident through breathing. This is described in tables 3 and 4 of the report, as shown below: EFFECTS OF CORE-MELT ATMOSPHERIC ACCIDENTS BY DISTANCE Distance in Miles Mean Thyroid Dose (REM) Probability of Thyroid Damage for Exposed Adult Outdoors to Exposed Adult Located Outdoors 1 13,500 60% 5 5,800 70% 10 3,200 70% 25 1,100 40% EFFECTS OF CORE-MELT ATMOSPHERIC ACCIDENTS BY DISTANCE 5 of8 02)07 n.ooo I :43 PIV

http://ruleforum.llnl.gov/cgt-bin/downloader/Kl_PETITI O N_pubhc/244-0120 .ht Distance in Miles Mean Thyroid Dose (REM) Probability of Thyroid Damage for Exposed Adult Outdoors to Exposed Adult Located Outdoors

50. 380 13%

100 100 3% 150 36 1% 200 16 0.5% For children, increase dose and probability of damage by an approximate factor of two. Weather conditions based on calculated probability distributions. Thyroid damage includes thyroid nodules (both benign and cancerous) and ablated thyroid. Assumed risk coefficient of 334 thyroid nodules per million person-rem to the thyroid. Includes inhalation dose only. Does not include ingestion. Probabilities conditional on accident occurring. However, the NRC and States limit their accident planning to 10 miles. In other words, there is nothing to protect people who, for_example, are 50 miles away, despite the probability that 13% of all exposed adults (and about a quarter of the children) at this distance could be injured. Yet use of KI would prevent this

*    — a fact the NRC does not dispute. Therefore in addition to stockpiling KI in EPZ' s, KI should be stockpiled beyond the 10-mile radius in each state.

V. KI Prophylaxis at One (1) Rem Projected Dose Exposure We support using KI prophylaxis at one rem projected dose exposure. Currently, Federal policy is to give KI at 25 rem projected dose. However, based on the dose response relationship reported in the 1998 Nature paper and Dr. Jean Temeck's discussion to NRC's KI Core Group (March 4, 1999), we know that there was an increased risk at a mean dose of 5 rem. Also, Poland used a 5 rem intervention level. The relationship of dose to disease is a linear relationship. Therefore, even if you extrapolate down to one rem, you are not coming to zero risk. Therefore, to protect public health and safety and to use the "precautionary principle" as the basis for public policy, we support a one rem projected dose

• as the "trig_ger."

VI. Summary The evidence is in -- all the experts and scientists have spoken -- NRC must amend its emergency planning regulations to include a requirement that emergency planning includes KI for the public. The health of our children is too important to leave their protection from thyroid cancer, disease, mental retardation and other illnesses to the "consideration" of states. "Consideration" is a powder puff - meaningless. It requires nothing. The NRC promises to help the states "consider." We have had enough experience with the NRC's help on this issue. NUREG-1633, a Guidance Document, was prepared by the NRC to help states decide if they wanted to stockpile KI. Fortunately, it was withdrawn because it was so biased and clear that it was written to help states decide not to stockpile KI. In the words of New York States Director of the Bureau of Environmental Radiation Protection, "we find the document to have been prepared to justify a position advocating against the use of KI for public protection, rather than as an objective review of the relevant information." Now, a new Guidance Document is in the making. The same staff responsible for NUREG-1633 is at it again. And, again, meaningful public participation is absent in the documents preparation. We need KI. We need a requirement. The NRC's plan to support the development of regional stockpiles is worthless. The use of "Fighter jets," 6 of8 02/07/2000 1:43 p~

http J/ruleforum.llnl.gov/cg1-bin/downloader/K.l_PETITION_public/244-0120 .ht as promised by Commissioner Merriweather, must be a joke. A very sick joke, indeed, because everyone knows that "Fighter jets" will not deliver KI in time. KI is time-critical. The Commissions decision to withdraw their 1997 promise to fund KI says more about the Commissions ties to industry than the status of NRC' s budget. The licensees should be directly responsible for all costs associated with KI as they now are for other emergency planning expenses. This will happen when the NRC requires that KI shall be made readily available to the public. It then becomes a cost of staying ir business. We ask that the NRC grant Mr. Crane's original petition and require KI stockpiling to be part of every emergency plan, as it is in nations around the world and as the NRC promised to do so in 1979. Respectfully submitted on behalf of the Coalition, Mary Elizabeth Lampert Massachusetts Citizens-for Safe Energy 148 Washington Street

• Duxbury, Massachusetts 02332 Tel 781-934-0389 Fax 781-934-5579 e-mail jlampert@idt.net Listed below are additional individuals and groups signing on to these comments.

Selectmen, Town of Duxbury-- Duxbury, Massachusetts 878 Tremont Street, Duxbury, MA 02332 -- Phone 781-934-1108 Paul Gunter, Michael Mariotte, Nuclear Information and Resource Service, 1424 16th Street NW, #404, Washington,DC 20036, Phone 202-328-0002 Email nirsnet@nirs.org William S. Abbott, Plymouth County Nuclear Information Committee, c!o William S. Abbott, P.C., 50 Congress Street, Boston, Ma 02109, Phone (617) 523-5520 Email W ABBOTI1@aol.com John Anderson and Roger Erikson, Citizens Radiological Monitoring Network, 133 Washington Street, Duxbury MA 02332 Daniel Burnstein, Center for Atomic Radiation Studies, Inc., (CARS), 35 Gardner Road, Brookline, MA 02445. Phone 617-738-9300 George Crocker, North American Water Office/Prairie Island Coalition P.O. Box 174 Lake Elmo Minnesota 55042 - Phone 651-770-3861 / E-mail gwillc@mtn.org Sandra Gavutis, Director, C-10 Research and Education Foundation, INC, 44 Merrimac Street, Newburyport, MA 01950 Phone 978-462-3959/ Email sandra@c-lO.org 7 of8 02/07(2000 1:44 p~

http://ruleforum.11n1.gov/cgi-bm/downloader/Kl_?ETITION_pubhc/244-0120 .ht

,     Steve Haberman, Seacoast Anti-Pollution League, P.O. Box 1136, Portsmouth, NH 03802 – Phone 603-431-5089 /Email SAPL99@aol.com Ann Harris, Executive Director, Alliance for Public Health and Safety, P.O. Box 40 Ten Mile, TN. 37880
      -Phone 423-376-4851 /E-mail apickel@aol.com Deborah Katz, Citizens Awareness Network, Box 83 Shelburne Falls, MA 01379 - Phone 202-328-0002/

E-mail can@shaysnetcom David A. Kraft, Director, Nuclear Energy Information Service, P.O. Box 1637, Evanston, Illinois 60204-1637 - Phone 847-869-7650 / E-mail neis@forward.net Cynthia Luppi; Clean Water Action, – 76 Summer Street, Boston MA 02110-- Phone 617-423-4661 --Email bostoncwa@cleanwater.org Mary Lampert,Massachusetts Citizens for Safe Energy, 29 Temple Place, Boston MA 02111 -- Phone 617-292-8057 Francis U. Macy, Director, Center for Safe Energy, 2812 Cherry Street, Berkeley, CA 94705 - Phone

• 510-540-7120 / E-Mail fmacy@igc.org Jerry Rosenthal, Concerned Citizens of Louisa County, 877 Holland Creek Road, Louisa, VA 23093 I E-mail zips@firstva.com
• Dr. David Rush, Greater Boston Physicians for Social Responsibility 68 Foster Street, Cambridge MA 02138 ,

Bill Smith, Fish Unlimited, 1 Brander Parkway, Shelter Island, New York 11965 - Phone 516-749-3474 / Email bsmith@fishunlimited.org Re'nee Shapiro, Womens Community Cancer Project, 21 Glenmont Avenue Brighton, MA 02135 - Phone 617-787-0743 / Email kokos@javanet.com Michael Steinberg, Black Rain Press, 1009 Burch Avenue, Durham, NC 27701 - Email 1009Burch<sr12@duke.edu Michael Welch, Redwood Alliance, PO Box 293, Arcata, CA 95518 -- Phone 707-822-7884/E-Mail michael. welch@homepower.com Ted Vosk, MassPirg, 29 Temple Place, Boston MA 02111 -- Phone 617-292-4800 / Email tvosk@postharvard.edu Chris Williams, Ex. Dir., Citizens Action Coalition of Indiana -- 5420 N. College Ave., Suite 100, Indianapolis, IN 46220-Phone 317-205-3535 /E-mail chrisw@citact.org Matthew Wilson, ToxicsAction Center, 29 Temple Place, Boston MA 02111 -- Phone 617-292-4821; and 41 South Main Street, Suite #5, West Hartford CT 06107 Phone 860-233-7623 / Email mwilson@toxicsaction.org 8 of8 02/07f2000 1:44 PM

UNITED ST ATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 February 29, 2000 1/frf/:j' CHAIRMAN

                                                                                   -..I Al The Honorable William D. Delahunt U.S. House of Representatives Washington, D.C. 20515

Dear Congressman Delahunt:

I am writing in response to your letter of November 15, 1999, regarding stockpiling potassium iodide (Kl) in communities near nuclear power plants. As you may know, the Federal Emergency Management Agency (FEMA) and the NRC are the two Federal agencies that evaluate emergency preparedness at and around nuclear power plants. Since 1980, when FEMA and the NRC developed the basic components of an emergency response program, Kl was recognized for its potential contribution to public health and safety. Kl, if administered before or within a few hours of exposure to inhaled (or ingested) radioiodines and accompanied by other preventative measures (such as sheltering, evacuation, or embargoing of foodstuffs), can reduce the radiological dose to the thyroid. Doses to the whole body and internal organs from other radionuclides associated with reactor accidents, such as noble gases and cesium, are not reduced or affected by the use of Kl. Current Kl Federal policy, promulgated in 1985, provides for the use of Kl by emergency workers and institutionalized persons who are expected to be exposed to radioiodines and allows the State and local decision-makers to decide on the availability of Kl for the general public. The NRC is working with FEMA, the U.S. Food and Drug Administration, and other Federal agencies in reviewing this 1985 policy. Separately, the NRC is in the process of considering a proposed amendment to its emergency planning regulations that would require that consideration be given to including Kl as a protective measure for the general public as a supplement to evacuation and/or sheltering. The proposed amendment, however, would not require that Kl be made available; that decision would be made by State and local governments. The Commission is currently considering the draft final rule and will take into consideration the public comments received in reaching its decision. In this connection, the NRC is also developing a guidance document to assist State and local decision-makers in their consideration of the role and use of Kl for the general public in their site-specific emergency plans. This guidance document is scheduled to be available for public comment in mid-2000. Your letter mentions the nuclear criticality accident in Tokaimura, Japan. According to an International Atomic Energy Agency report (available on the Internet at www.lAEA.org), effluent samples taken during and after the accident revealed that some radioactive material was released off site and that a small fraction of that material was radioiodine. However, the maximum radioiodine concentration in air outside the building in which the accident occurred was about 250 times less than the Japanese effluent concentration limit. Because of these low concentrations of radioiodines, Kl, stockpiled locally, was not distributed to the general public in

L-L Ht:uULAfORY COMM1-::i~ION 11 E'vlAKINGS &ADJUDICATIONS STAFF l=FICE OF THE SECRETARY ()F TH!_= COMMISSlO Document Statistics arkDate_3p 3~ _ ~ 7d ~ [~ ~ es Receive d - - -/-- __ 'I Copies Reproduced _ __._ _ _ cial Distribution_ _ __ _ __

2 the communities surrounding the accident site. Local decision-makers recommended evacuation and sheltering in place to the residents of the immediate surrounding areas, as well as a suspension of harvesting of crops and vegetables. These emergency measures were terminated after 2 days. Based on information available to us, we thus do not believe that the Japanese incident was one in which Kl should have played a role. The NRC, together with FEMA, continues to support fully the emergency response activities of State and local governments associated with nuclear power plant sites. We will continue to work with our licensees and FEMA to ensure that the emergency response programs around plant sites continue to provide reasonable assurance that public health and safety are protected .

• Richard A. Meserve

WILLIAM D. DELAHUNT 1311 LONGWORTH 8u1L£)1NC WASHINGTON, 0C 20515 TENTH PtSTRICT, MASSACHUSETTS (202) 225-3111 www.house.gov/delahunt COMMITTEE ON THE JUDICIARY J SUBCOMMITTEES ON: COURTS ANO INTELLECTUAL PROPERTY cttongregg of tbe ~niteb ~tateg SOUTH SHORE Hl00---794---9911 COMMERClAL ANO ADMINISTRATIVE l.AW 15 COTTAGE AVENUE 1!,oust of l\tprtstntatib~& M,,~ A :i COMMITTEE ON 24 5 166 MAIN STREET INTERNATIONAL RELATIONS Ulmasbington, mete 20515-2110 BROCKTON 225 WATER STREET SUBCOMMITTEES ON: P\.VMOUTH INTERNATIONAL ECONOMIC POLICY AND TRADE INTERNATIONAL OPERATIONS u AND HUMAN RIGHTS 50 ADL CAPE COO & ISLANDS 1-SOCHl70-2626 148 MAIN STREET CO-CHAIR, COAST GUARD CAUCUS CO-CHAIR, OLDER AMERICANS CAUCUS {1,'IFR~/137) HYANNIS November 15, 1999 Richard A. Meserve Chairman REC, BY' Nuclear Regulatory Commission 0

              ~ington, D.C. 20555
       ~9 .et3ij~Chairman Meserve:

I am writing to ask for your support in stockpiling potassium iodide in the communities surrounding the Pilgrim Nuclear Power Plant in Plymouth, Massachusetts. The tragic events which occurred recently in Tokaimure, Japan, testify to the fact that nuclear accidents are potentially deadly and that our only protection is to take advanced precautions which would minimize the effects of radiation exposure. Along with the critical implementation of evacuation plans, the accessibility of Kl tablets could provide an additional line of defense against lethal radiation. The Plymouth Board of Selectmen is attempting to implement a Kl stockpiling program. Their plan calls for tablets to be available in either local pharmacies or at local medical facilities. Both of these locations are certainly suitable as they are accessible to residents should the need for Kl arise. I ask for your support and assistance in these efforts to stockpile this important medication. Thank you for your attention to this important matter. Sincerely,

                                                                                ;J~r9~1~

William D. Delahunt PRINTED ON RECYCLED PAPER

Lr\ UH ll\11 1 Kt GS & ADJUDICATIONS STAFF CE O- THE SECAETAR

              '1MMISSl0 im n Stat1st1cc:

ate Received op1es Repro Oistnbution _ _

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 9, 2000 1/fYI/J' *oo r1. ;: 24 A7 :1s

 ~HAIRMAN AD, The Honorable Edward J. Markey United States House of Representatives Washington, D.C. 20515-2107

Dear Congressman Markey:

I am responding to your letter of November 10, 1999, expressing concerns about the U.S. Nuclear Regulatory Commission's (NRC's) responses to your questions on potassium iodide (Kl) stockpiles associated with the hearing on July 21, 1999, on the Fiscal Year 2000 NRC Authorization Act before the Subcommittee on Energy and Power. In particular, you refer to a letter from Mr. Peter Crane, dated October 15, 1999, concerning alleged misrepresentations by the NRC of the Federal Emergency Management Agency (FEMA) position on regional Kl stockpiles, alleged intentionally inaccurate testimony on the cost of buying Kl, and an alleged misleading representation of the money NRC has spent studying Kl. I do not believe that the NRC misrepresented FEMA's position on regional Kl stockpiles. In a letter from FEMA Director James L. Witt, dated April 29, 1999, (Enclosure 1) to the Commission, Director Witt stated, among other concerns, that FEMA did not support establishment of regional Kl stockpiles. Former Chairman Jackson's reply (Enclosure 2), dated June 15, 1999, included a statement that she was confident that the NRC and FEMA staffs would be successful in resolving the Kl issue. The NRC's responses to the post-hearing questions reflected that NRC and FEMA were undertaking this effort and NRC's belief that the

• agencies would reach a successful outcome. The NRC never stated nor intended to imply that FEMA had indicated any change in its position. As a result of former Chairman Jackson's letter to Mr. Witt and Commission direction to the NRC staff, the NRC and FEMA staffs have been meeting to identify options for stockpiling Kl.

On January 12, 2000, the NRC received a letter from FEMA, signed by Ms. Kay Goss, Associate Director for Preparedness, Training, and Exercises (Enclosure 3). The letter reiterates the concerns expressed by Mr. Witt in his letter of April 29, 1999, including the statement that FEMA does not support regional stockpiles. (We note that this letter addresses predecisional issues and thereiore has not been released to the public.) We will provide you a copy of the NRC response. We have no communications from FEMA to the effect that it has changed its position on regional stockpiles and, as noted above, NRC did not mean to imply that FEMA had modified its position.

                                 ..,    N KNG & DJUDICATION STAFF
            !=ICE OF THE SECRETARY TH COMMISSlON oc   n Statisti a*kDate       3J.3 OtJ           u'tf ~ zr,uk juf..e*~

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2 You also requested "updated and accurate figures detailing the cost of buying potassium iodide," including "the cost per pill and ~e expected shelf-life for Kl tablets." The basis for the cost figures presented in our response to the referenced Congressional correspondence is described in Attachment 2 to NRC SECY-97-124, dated June 16, 1997, (Enclosure 4) and updated in SECY-98-264, dated November 10, 1998 (Enclosure 4a). The estimate provided in post-hearing question 16a was based on the dis1rib1..tion of two pills, costing 25 cents each, to 80,000 peoplE:: in the vicinity of each site. The total cost for 70 sites was estimated in the response at $3.25 million. However, we note that there was an error in the calculation, and the correct estimate should have been $2.8 million. Obviously, the overall cost for funding the purchase of Kl depends, among other factors, on b<;>th the current market price of Kl tablets and the number of States that would establish stockpiles. The U.S. Food and Drug Administration (FDA) is currently reevaluating its 1978/1982 Kl guidance. tf FDA proposes Kl dosages other than the current ones, the cost for Kl could change. Nonetheless, in response ,to your request, we can estimate the cost of Kl tablets when purchased in large quantities (greater than about 500,000 tablets). Mr. Crane references correspondence from a Swedish firm that offers Kl in bulk at 6 cents per pill, with a stated 10-year shelf-life (Enclosure 5). The Swedish company, RECIP AB, provided costs that ranged from 11.5 cents per tablet for 1,000,000 tablets to 6 cents per tablet for 50,000,000 tablets. These cost estimates are for 65 mg tablets, whereas the current recommended FDA Kl dosage for adults and children over the age of 1-year is 130 mg of Kl per day. The cost per 130 mg dose is twice the cost per tablet and would therefore range from 23 cents to 12 cents per 130 mg dose. This stated cost does not include shipping nor any costs associated with RECIP AB obtaining FDA approval of this Kl product for use in the United States. In the United States, two companies advertise Kl tablets that have received FDA approval for sale to the general public. ANBEX charges $10 per package of 14 Kl tablets (130 mg dose) , plus $4.00 for shipping up to 10 packages. The sh~lf-life is stated by ANBEX to be "indefinite." Based on the staffs informal inquiry, the company indicated that the cost could be reduced to about $2.50 - $2.60 per package of 14 tablets in quantities of about 1,000,000 tablets, resulting in a cost of about 18 cents to 19 cents per tablet. Car 1er-Wallace Laboratories sells Thyro- , Block Tablets, a 130 mg Kl tablet. The tablets are sold in a 98-day supply (98-130 mg tablets) for indMduals at a cost of $42.95 or in a case of 100 bottles of 14 Kl tablets (130 mg) per bottle for $560. This is about 40 cents to 43 cents per tablet. The company estimated that purchasing a million or more tablets at a time could reduce the price to about 20 cents per tablet. In sum, we believe that the cost estimate used in our response -- 25 cents per tablet -- is an appropriate (albeit perhaps slightly conservative) estimate. You* also requested that NRC provide an accurate account of the actual expended costs of studying the Kl issue. In our ar..;wer to the hearing question, we estimated that our spending tO study the Kl issue exceeded $2.6 million over the period from October 1989 to August 11, 1999. The sum for the individual items listed came to $2.64 million. This estimate is based on information available in the internal work tracking *system and estimates of staff and management overhead costs. The specific costs are detailed in the enclosed response to Mr. Crane {Enclosure?)*

3 If you would like additional infon:nation, please do not hesitate to contact me. Richard A. Meserve

Enclosures:

1. Letter to NRC Commission fm J. L. Witt, FEMA, dtd April 29, 1999

2. Letter to J. L Witt, FEMA fm Chairman S. Jackson, NRC dtd June 15, 1999

3. Letter from Ms. Kay Goss, FEMA, dtd January 12, 2000

4. NRC SECY-97-124, dtd June 16, 1997 - Proposed Federal Policy Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant 4a. NRC SECY 98-264, dtd November 10, 1998 - Proposed Amendments to 10 CFR 50.47; Granting of Petitions for Rulemaking (PRM 50-63 and 50-63A) Relating to a Reevaluation of Policy on the Use of Potassium Iodide (Kl)

After a Severe Accident at a Nuclear Power Plant

5. E-mail fm Swedish firm, dtd December 17, 1998 re Kl SUPPLIER

6. Letter to P. Crane fm W. Travers, NRC

ENCLOSURE 1 Federal Emergency Management Agency Washington, D.C. 20472 Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield U. S. Nuclear Regulatory Commission Washington, D.C. 20555-000 I Dear Madam Chairman and Commissioners* I read 'in the April 24, 1999 New York Times and in your press release that you voted to withdraw your commitment to fund.the purchase of potassium iodide for States that elect to stockpile it for use by the general public in the event of a radiological release from a nuclear power plant. In addition to deciding that the NRC would not pay for State stockpiles, you announced that FEMA should pay for both regional and state stockpiles. I strongly oppose this unilateral decision that reverses your previous position.and adversely affects the implementation of the policy proposed by the Federal Radiological Preparedness Coordinating Committee (FRPCC) The policy provides that if a State chooses to add potassium iodide as a supplement to its evacuation and sheltering

   . protective actions, the State will inform FEMA and we will forward that request to the NRC to support the purchase.

Your abrupt retreat from repeated promises to the Federal community, states and the public is apparently based on a misapprehension ofFEMA's authorizing legislation and a d,isregard of our view-and that of other FRPCC agencies-that regional potassium iodide stockpiles will not enhance local radiological emergency preparedness. On funding, we stand fast on our position that FEMA lacks authority and appropriations for acquisition of potassiuni iodide and thus, cannot and will not assume the NRC financial commitment to the States. Based on concerns expressed by States, FEMA has always opposed the notion that Federal regional stockpiles of potassium iodide would be-effective in the event of a release from a nuclear power plarit. The complex logistics of storage and distribution far outweigh the usefulness of such a stockpile. Regional stockpiles of potassium iodide would complicate, not strengthen radiological emergency preparedness. NRC and FEMA must work together with the States to implement the FRPCC policy As you may recall, this proposed policy would leave the option to the State on whether it would use potassium iodide as a supplemental protective measure for the general public If a State opted to incorporate its use as a protective measure for the general public, and the NRC fulfills its commitment, funds will be provided for such a purchase

 )

2 In light of the significance of this issue, and the concerns being raised by the States, I would appreciate a response to this letter by May 28, 1999. Sincerely, dc:!w~Director Attachments: NRC Potassium Iodide Funding Commitments Federal Radiological Preparedness Coordinating Committee proposed policy and scheme for potassium iodide request & funding cc: William Travers, EDO FRPCC Agencies

ENCLOSURE 2 UNITED SfATES NUCLEAR REGULATORY COMMISSION WASHINGTON O C 20SSS--0001 June l'J. 1999 CHAIRMAN The Honorable James Lee Witt, Director Federal Emergency Management Agency 500 C Street, SW. Washington, D.C. 20472

Dear Mr Witt:

I am responding to your letter of April 29, 1999, to the U.S. Nuclear Regulatory Commission (NRG) in which you commented on the NRC's recent action concerning the possible use of potassium iodide {Kl) as supplemental protection for the public m case of a severe accident at a nuclear power plant. As indicated in a staff requirements memorandum (SRM) (a copy is closed for your information) to the NRG staff on April 22. 1999, and in a press release on

   *1 23, 1999, ttie NRC is proposing to revise its emergency preparedness regulations to add o the protective actions that must be considered, along with evacuation and sheltering, in nuclear power plant emergency plans. The Commission also has deaded not to fund State stockpiles of Kl. We regret that we did not inform the Federal Emergency Management Agency

{FEMA) sooner of our Kl decision. A related issue that recurs in the debate on the use of Kl as a protective action for nuclear power plant accidents has been the role of the Federal government. in particular the NRG. In funding the purchase of a stockpile of Kl for those States that may wish to include Kl in their emergency plans. As previously discussed by the Comm1ss1on In the Federal Register notice on emergency planning ( 45 FR 55402, August 19. 1980) under the section on funding, the Commission stated that "any direct funding of State or local governments solely for emergency preparedness by the Federal Government would come through FEMA." Notwithstanding earlier draft positions indicating that "the Federal Government (most likely the NRC),(" would fund the purchase of State stockpiles of Kl, this previously established NRG policy precludes NRC from ing such purchases. In addition. the NRG budget t:ias continued to decrease and offers margin for the Commission to divert resources to new initiatives. According to your letter, the NRC announced that it expects the FEMA to pay for both regional and State stockpiles. This is not the case. Actually, the Commission supports the position that the Federal government should fund the purchase of Kl for Federal stockpiles at appropriately located regional centers, possibly collocated with some of the three nation.al and 27 regional stockpiles being established by FEMA to respond to possible nuclear, b1ological, and chemical (NBC) terronsm. discussed in the draft Federal Radiological Preparedness Coordinating Committee Policy Statement on Kl The Comm1ss1on supports NRG funding of the m1t1al purchase and resupply of Kl for such regional stockpiles to the extent there are no constraints on the FEMA receIv1ng money from the NRG for this purpose The Comm1ss1on beheves that funding for State stockpiles of Kl for States that elect to use rt should come from the traditional sources of funding for State and local emergency response planning rather than the Federal government Your letter also states that FEMA has always been opposed to regional stockpiles Although our staffs meet frequently and your staff has made presentations directly to the Comm1ss1on. we did not understand that FEMA opposes regional stockpiles

The Commission has directed the NRC staff to work with the FEMA staff to establish and maintain regional Kl stockpiles to be used in the event that local stockpiles prove to be insufficient, or when a State without a stockpile elects to use Kl on an ad Hoc basis in the case of a nuclear emergency. In your letter, you indicate that FEMA opposes the concept of Federal regional stockpiles of Kl and that the complex logistics of storage and distribution of KJ from regional stockpiles far outweigh the usefulness of such stockpiles. We agree that the storage and distribution of Kl are among the vexing problems associated with the use of Kl in an emergency, but belie~e that under the current draft policy that provides for only extremely limited Federal regional stockpiles, it would be difficult, if not impossible, for the Federal government to respond to requests for Kl in the event of a nuclear emergency. Irrespective of whether the Federal government offered to pay for Kl stockpiles, because States are not required to stockpile, we believe it is reasonable to assume that many States will not have stockpiles of their own. Therefore, regional stockpiles seem appropriate. The NRC and FEMA have worked together as partners in protecting the health and safety of the public since President Jimmy Carter directed the FEMA to assume the lead responsibility for State and local government emergency planning and preparedness for nuclear power reactors on December 7, 1979, eight months after the accident at the Three Mile Island facility. The role of the FEMA in the NRC regulatory process is recognized in both NRC and FEMA regulations and in a memorandum of understanding between the two agencies that became effective on January 14, 1980. Presently, the NRC, with the assistance of the FEMA, representatives from other Federal agencies, and several States and local governments, is developing a substantially revised version of a study related to Kl and an associated infonnation document to assist State and local emergency planning officials in making decisions relative to the use of Kl for the general public. -I am confident that our two staffs, working tog~ther in a spirit of cooperation and dedication similar to the ongoing FEMA strategic review of its radiological emergency preparedness program, will be successful in resolving the Kl issue. Sincerely,

                                              ~I--~

Shirley Ann Jackson

Enclosure:

Staff Requirements Memorandum

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON'. 'O C 20555-0001 April 22, 1999 MEMORANDUM TO: William 0. Travers Executive Director for Operations . FROM: Annette ~etti-Cook, Secretary ~ V;.a;;;;.:- ~

SUBJECT:

STAFF REQUIREMENTS - SECY-98-264 - PROPOSED AMENDMENTS TO 10 CFR 50.47; GRANTING, PETITIONS FOR RULEMAKING (PRM 50-63 AND 50-63A) RELATING TO A REEVALUATION OF POLICY ON THE USE OF POTASSIUM. IODIDE (Kl) AFTER A_ SEVERE ACCIDENT AT A NUCLEAR POWER PLANT . and COMJSM-98-002 - FUNDING FOR POTASSIUM IODIDE STOCKPILES ., The Commission has approved' issuance of the prop:ised rule for comments subject to the following comment and attached changes to the Federal Register Notice {FRN). The FRN should be revised and returned-to SECY for signature and publication. (EDO) ($ECY Suspense: 5/31/99) The staff should amend the draft Federal ~egister Notice on the federal Kl policy provided to

• FEMA to conform to this SRM, particularly with respect to the Commission's decision- not to fund State stockpiles.

(EDO) (SECY Suspense: 5/31 /99) The staff should work with FEMA to establish and maintain regional Kl stockpiles to be used in the event of a severe nuclear power plant accident The Commission supports the position that the federal government should fund the purchase of Kl for federal stockpiles at appropriately located regional centers. The Commission supports NRC funding of the Initial purchase and resupply of Kl to the extent that this cannot ':>e covered by FEMA under its initiatives, and to the extent that there is no Economy Act constraint on FEMA's receiving money from the NRC for this purpose. If FEMA decides after working with the States to develop any formal funding request to Congress for a program of federaUy funded grants for State Kl stockpiles, the NRC should assist 1 FEMA in developing its funding request. *

• The section entitled "Analysis of Issues raised by Public Comments* represents technical responses to questions and statements and does not represent policy decisions by the

, Commission. Therefore, the statements that are currently attributed to the Commission in this section should be changed to indicate that the responses are those of the NRC staff.

On page 17, after the last sentence, insert 'The Commission has considered the Kl policy question on numerous occasions since 1984. The voting history of the Commission Rhows that reaching consensus on this policy question has been an elusive goal. An important reason for this historical lack of consensus is th1lt this policy question is not a clear *cut Qne. Individual Commissioners, past and present, have differed In their views with respect to the relative importance to be given to factors bearing 9n the Kl issue. These honest differences have led to divided Commission views on how to resolve the policy question. The.Commission is agreed that its historical difficulty to reach consensus on the Kl policy question underscores the reality that this policy question is not a simple one, is not one that is easily resolved and, as a result, has been the subject of protracted deliberation. With that relevant background, following are the Commission's views Ofl specific issues raised by the Petition.' The FRN should Include reference to the fact that the staff is developing a final version of the NUREG related to Kl and the associated development of an information document for State and local decision makers. On page 4, at the end of the second full paragraph, add a new sentence: NRC staff is preparing a technical report and an information brochure to enable State and local

• decision makers to make an informed decision in this matter.

Attachment:

As stated cc: Chairman Jackson Commissioner Dicus Commissioner Diaz Commissione'" McGaffigan Commissioner Merrifield OGC CIO CFO OCA OIG ( OPA Office Directors, Regions, ACRS. ACNW. ASLBP (via E-Mail) PDR DCS

Changes to the FedefilJ'Reglster Notice

1. On page 1, paragraph 2, sentence 2 should be revised to read "The proposed rule would amend the current regulations to require irtdieete that consideration shall be given to including potassium iodide (Kl), along vmh sheltering ar,d e"taeuatieH, as a supplemental protective measure for the general publie: that would supplement sheltering and evacuation. Kl would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuciear power plant.

2. The FRN currently states incorrectly that the Commission granted two petitions

{PRM 50-63 and 50-63A). PRM 50-63 was replaced by PRM 50-63A which the Commission has granted. Therefore, the, FRN should be revised to clarify this fact. On page 2, paragrap~ 1 under Supplementary Information, revise to read "By undertaking this rulemaking, the Commission, while not adopting the exact language suggested by the petitioner, is proposing to grant a petition for rulemaking {PRM 50-63A) submitted by Mr. Peter Crane on November 11, 1997. That petition is a revision of a petition (PRM 50-63) that he* submitted on September 9, 1995. On page 3, line 5, insert a new sentence after 'conditions' as follows: When the Commission amended its emergency planning regulations on November 3, 1980, it stated that 'any direct funding of State or local governments solely for emergency preparedness purposes by the Federal government would come through FEMA.' Begin the next sentence with 'In its decision on June 30, ~ 997, the Commission ... .' In lines 5 and 6, delete 'consistent'with the Commission's decision on June 30, 1997,'.

4. On page 3, line 7 and 8, replace the sentence 'The NRC staff will ... K1'is established.'

with 'The Commission has determined that notwithstanding the June 30, 1997 intention thc!_t "most likely the NRC" would fund the purchase of State stockpiles of Kl, the NRC budget has continued to decrease and offers little margin for the Commission to divert resources to new initiatives. Historically, funding for State and local emergency response planning has been the responsibility of those governments usually working with licensees. The Commission notes that the Petitioner has not requested the Federal I funding of stockpiles of Kl.' Start the next sentence as follows: 'In the alternative, the NRC will_. .. .' On page 3, line 9, delete 'also'. In lines 9 and 10, replace 'procedures to enable the national' with robust, pre-positioned regional' and add an 's' to 'stockpile.§'. In line 10, delete 'for terrorist activities'. In line 11, replace 'national' with 'regional'.

5. On page 4, first full paragraph, sentence 1, insert 'NRC staffs' before 'proposed'.

6. On page 4, second full paragraph, line 1, insert 'portion of the' ~fore 'petition'. In line 2, replace 'by directing' with 'regarding'.

7. On page 6, last line, replace 'in favor of with 'which favored'.

8., On page 15, at end of second full paragraph insert: However, FEMA recently reported that the federal stockpiles of Kl are few and stocked only for first responders to terrorist action. As things stand now, needs of members of the public for Kl on an ad hoc basis would have to be supplied from other sources As stated above, the Commission

• intends to work with FEMA to assure that stockpiles contain adequate supplies of Kl.

9. On page 17, befo:-e the Analysis of Issues raised by Public Comments insert a new paragraph as follows: On November 5, 1997, the c6mmission held a public meeting with its staff, FEMA representatiVes, and the author of the 1995 rulemaking petition to consider the petition and proposed changes to the Federal policy on tt)e use of Kl. In part as a result of the meeting, the petitioner amended his petition to ask for a rule that would require that consideration would be given in the formulation of emergency plans to the use of Kl as a supplement to evacuation or sheltering, and on June 26, 1998, the Commission granted the amended petition, and directed the NRC staff to initiate the requested rulemai<ing. The Commissioners also decided that the FRPCC Federal Register notice on Federal Kl policy should include a statement to the effect that the State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions.

On September 30, 1998, the Commission approved a draft Federal Register notice and directed that it be sent to the FRPCC.

• On page 21, first full paragraph, line 1, insert 'thyroid' after 'excess'.

On page 22, second full paragraph, line 1, correct spelling of 'measures'.

12. On page 23, paragraph 2, add a footnote at end of second sentence, to read 'A "medically significanr reaction was one for which the person suffering the reaction consulted a,,physician more than once. Nautm.:m and Wolff, "Iodide Prophylaxis in Poland After the Chernobyl Reactor Accident: !3enefits and Risks," The American Journal of Medicine, Vol. 94, May 1993, p.530. About .02% of the population that received Kl had *medically significanr adverse reactions to Kl. Id. However, *[i}t should be pointed out ~hat control values for these side effects in a population not receiving Kl are not avail~ble." Id.' That is, it is not known w'"lat the incidence of such reactions would be in a population under similar stress, but not receiving Kl, and thus it is not known to what extent these adverse reactions were the result of Kl.

13. On page 24, under Conclusions from Polish Experience, line 1, insert 'In Poland' before

       '{1)'. In line 2, delete 'in Poland'.

14. On page 25, first full paragraph, line 1, insert 'In contrast to the Chernobyl experience,'

I before 'in the event'. In lines 2 and 3, remove the parentheses. In line 3 replace 'that would' with 'all of which'. In line 3, replace 'risk to' with 'risk of exposure of. Also in line 3, insert 'to all radionuclides' aft~ 'public'. In line 4, add 'or especially sheltering' after

      'evacuati~n*, and replace 'further' with 'resulting from exposure to one important group of

. radionuclides, the radioiodines.' That is why current NRC guidance discusses Kl for plant personnel, emergency workers, and institutionalized persons unlikely to be evacuated promptly. .

15. On page 25, delete the start of the second full paragraph (One public commenter .... ) to the start of Issue 3 on the next page. Replace it with 'In this light, the Commission agrees that the use of Kl may be determined by State and local emergency response planners to be a useful supplementary protective measure.'

16. On page 26, line 7 from the bottom, _correct spelling of "nod~les".

17. On page 27, under Commission Response, line 4, insert 'such as by making it available' after 'available'. In line 9, replace 'Other approaches' with 'Another approach' and replace 'could' with 'is to'.

18. On page 28, paragraph 1, replace with "The commenter is correct, in that it was difficult to obtain Kl after the Three Mile JsJand accident. ThPt is one reason why the Commission believes that planners should consider stockpiling Kl, and why the Commission supports Federal stockptles. so 1hat Ststfts that have _(?h_osen .nQt _to stockpile Kl. could f'.lave access, ~belt acf hoc and deldyed, to an ~ - ~.-!n a radl9'oglcal*emergency at a nuclear power pJant As not~ ~ i1'11hi~J1~ce;*the CornITJ~fQn wiU work with other agencies to assure that there are .F~~I ~nal stcx;kp)~ _that co~n adequate sµpplies* of Kl. t te1Ne't1er, vAth the limited Federer stoekpile of Kl fer ten:erist e't*eAt:9 a"d the wiUingness ef the Federal Ge***emment to preide a steekpile ef Kl fer any State that d~des te use it as a supplemental preteeti'te measure fer tJ,e general publie, ~orec,yer, the_ gen~. fl'l&ilablfity 9f Kl *is*g~r now than*at the time of.the TMI accident, partly l;,ecause of:~:fDA*~ ~ ,qf-f~f~, an

• over the counter drug. Some.States .tuwe elected to in~rate 19 Into ~ emergency response prans*and have obtalnecfadequate supplies for_thlsJlurpo&e.' Tt)e*.Qommission is not aware of any factors that would constrain the avaOabllity of Kl for stockplllng purposes. The Commission believes that an adequate supply of Kl could be obtained.

19. On page 32, line 7, replace the 'of after 'State' with 'or'.

20. On page 32, line 2 from the bottom, replace' NRC staff with 'Commission'.

21. On page 33, line 1, replace 'considers' with 'believes'. Delete the second full paragraph under the Commission Response.

22. On page 33, replace the Commission Decision with the following: 'Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific.local conditions. Therefore, the Commission's guidance on emergency planning has long taken Kl into consideration (NUREG-0654/FEMA-REP-1, Rev. 1, p. 63, items e. and f.).

However, since the last revision of that guidance, there has been experience with the mass distribution of Kl during a radiological emergency, and though the record on that distribution is not complete, the indications thus far are that mass distribution is effective in preventing thyroid cancer and causes remarkably few threatening side effects. Moreover, many nations in Europe*and elsewhere, nations as different in their circumstances, politics, and regulatory structures as France, Canada, and Japan, have stockpiled Kl and planned for its use. So have some U.S. States. The World Health Organization and the lritemational Atomic Energy Agency recommend its use. Therefore, in order the achieve greater assurance that Kl will receive due attention by planners, it seems reasonable to take a small further step and, continuing to recognize the authority of the States in matters of emergency planning, explicitly require that planners consider the use of Kl. The proposed rule change should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought. On the contrary, present indications are that nuclear power plant safety has improved since

the current emergency planning requirenienls were put in place after the Three Mile Island accident. The use of potassium iodide is intended to supplement, not to replace, other protective measures. This rule change thus represents no alteration in the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs, whenever that is feasible. (Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid.) Depending on the circumstances, Kl may offer additional protection if used in conjunction with evacuation and/or sheltering. The NRC recognizes that the decision to stockpile Kl presents issues of how best to

     , position and distribute the medicine, to ensure, e.g., that optimal distribution takes place in an emergency, with first priority given to protecting children; that persons with known allergies to iodine not take it; that members of the public understand that Kl is not a substitute for measures that protect the whole body; etc. To date, these issues have been addressed in different ways in the numerous countries that currently stockpile Kl.

The NRC is working with States and localities to develop guidance on these and other points relating to the use of Kl. The NRC believes that these implementation issues can be solved, given the level of expertise in the relevant Federal and State agencies, and the experience of numerous nations that have built Kl into their emergency plans. It is expected that States will inform FEMA and the NRC of the results of their consideration of whether to opt for stockp11mg. This will enable the Federal government to engage in better contingency planning for States that decide against stockpiling Kl.'

23. On page 34, first full paragraph, line 3, insert 'in part and denied in part' after 'granted'.

24. On page 34, under Commission Conclusions ... , line 1, replace 'agrees with many of with', having reviewed'. In line 2, replace the period with a comma and delete 'The Commission'. In item A., line 1, insert 'when determined by State and local emergency response planners and' after 'Kl,' .

• 25. On page 34, line 7, replace 'not~* with 'finds' and replace 'consistent with the Commission*~* with 'notwithstanding its'. In line 7, delete '(mojt likely the NRC)'. In line 8, replace 'will' with 'is not prepared to'. In line 9, replace 'The' with 'In the alternative, the' and replace 'also directed' with 'is directing'. In line 10, replace 'procedures to enable the national' with 'robust, prel)ositioned regional'. In line 12, replace 'the national' with 'regional'.

26. On page 36, in item E., line1, insert 'Although the cost of Kl tablets has doubled,' before

       'the Commission' and insert', and other nations' experience,' after 'estimate'. In line 2, insert 'relatively' after 'is'. At the end of item E., add the following new sentence:
       'However, the overall cost is minimal when placed in the context of emergency planning and si}ould not be a deterrent to stockpiling Kl for use by the general public should State and local decision makers determine that the prophylactic use of Kl as a supplement to evacuation and sheltering is appropriate.' In item F., line 1, replace 'NBC medicinal' with
      'robust, regional' and replace 'provide' with 'be established'. Replace lines 2 and 3 with
      'to enable use by States that have not established local stockpiles and wish to make use

of Kl in the everit of a severe nuclear power plant accident

27. On page 36, revise paragraph F to read *Toe Commission belie¥es will wor1< jo assure that medicinal regional Federal stockpiles aheuld will provide a~uranee te States and loeal ge'l'emments that a limited Federal steekpile ef Kl is B'f'ailable, if needed. enough Kl

       *to enable use by States that have not established local stockpiles and'wish to make use of Kl In the event of a severe nuclear power plant accident.

• 28. On page 36, replace 'Commission approval to fund Kl' with 'Commission decision to fund Kl'

29. On page 36, in the last paragraph, replace the last 2 sentences with: 'At that time it was believed that the NRC was the likely Federal agency to fund the stockpiling. Historically, funding for State and local; emergency response planning has been the respcnsibility of those governments usually working with licensees and, absent Congressional funding specifically for this purpose, NRC is not prepared to fund stockpiling of Kl.

30. On page 38, paragraph 2 from the bottom, line 1, replace 'directed' with disagreed with' and replace 'in SRM 98-061 to grant' with 'recommendation to deny'.

31. On page 39, item II., line 2, replace 'SRM 98-06' with 'SRM 98-061'. In item IV., line 1, add an 's' to 'petition.§' and replace 'require' with 'take'.

32. On page 41, paragraph 2 from the bottom, lines 1 and 2, replace 'grant the petition for rulemaking PRM*50-63A by revising' with 'revise'.

33. On page 42, second full paragraph, line 1, insert "that" after 'Given'.

34. On page 42, prior to the last paragraph, insert a new paragraph as follows: 'The Commission notes that when it amended its emergency planning regulations on November 3, 1980, the regulatory standards for emergency planning were a restatement of basic joirit NRC-FEMA guidance to licensees and to State and local governments incorporated in NUREG-0654; FEMA-REP-1, "Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants for Interim Use and Comment." This guidance was cited in the regulation and speaks to radioprotective drugs including their use. by the general public including quantities, storage and means of distribution and State and local plans for decision making with respect to their use. The Commission removed the citations of the guidance from the regulation in 1987 but the guidance has continued in use for planning purposes and by the Federal agencies for evaluating emergency plans. As a result, it is believed that all of the affected States have at some point considered the use of Kl. Some States have made the decision to stockpile Kl. Th'us, in practical terms, the projected costs will occur only in those States that have not elected to stockpile Kl and choose stockpiling in light of the Chernobyl accident, recent international practice, and the NRC requirement to consider the use of Kl.

35. On page 48, line 1, replace 'have' with 'has'.

ENCLOSURE 3

                                                                         "=

Federal Emergency Management Agency Washington, D.C. 20472 JJ;;,i 1 2 2000 Annette Vietti-Cook, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Ms. Vietti-Cook:

Enclosed is the Federal Emergency Management Agency's (FEMA) response to the Nuclear Regulatory Commiuion'1 (NR.C) draft Fmal Rule, which proposes to include in 10 CFR 50.47(bXI0) "consideration of potassium iodide (Kl)" u a supplemental protective measure in emergency planning and preparedness in support of commercial nuclear power plants. I am taking this opportunity to reiterate Director Witt' 1 coocem expressed to fonnec Chairman Jackson in an April 29, 1999, letter. The issue concerns NRC's reversal of its commitment to fund the purchase of potassium iodide (KI) for States that elect to stockpile it, locally or near the nuclear facility, for use by the general public in the event of a radiological release from a nuclear power plant. In light of the Federal policy developed and unanimously approved by the members of the Federal Radiological Preparedness Coordinating Committee (FRPCC), which includes the NRC, FEMA encourages the NRC to recomi.der the Commiasion'a reversal of its position on this matter. The policy would provide that if a State chooses to add KI as a supplement to its evacuation and sheltering protective actions, the State would inform FEMA and we would forward the request to the NRC to support the purchase. The NRC currently has the authority to efficiently carry out this policy and pus the cost on through its user fee. In changing course on this matter, the Commission took the position that it would work with FEMA to establish and maintain Federal regional KI stockpiles. I would like to emphasize that, based on input from its State and local partners in emergency ma~ment, FEMA continues to

• maintain that Federal regional stockpiles ofKI will not enhance local emergency preparedness for responding to commercial mclear power plant accidents because of the complex logistics associated with its storage and distribution.

It appears that the NRC, the trade press and the public also have the mistaken impression that FEMA has a current role in establishing the regional pharmaceutical stockpiles for responding to acts of terrorism. I should clarify that the Department of Health and Human Services, the Centers for Disease Control and the Public Health Service are respoDSl'ble for establishing these stockpiles and determining the location and composition of those resources.

I with to thank the NRC staff for the opportunity to comment on the proposed final rule on Kl We look forward to contitwing to work with the NRC to resolve this matter and in dealing with other issue, affecting the health and safety of the public.

                                                      ~ly,r1k
                                                                   ~

ADoctia'te Director for Preparedness, a&ilU.11§.aodExercises Enclosure

FEMA RESPONSE AND COMMENT ON NRC DRAFT PREDECISIONAL FEDERAL REGISTER NOTICE ON KI RULEMAKING This responds to the draft Federal R@&ister Notice containing the final Rule that was sent to FEMA for review and comment. The FEMA position remains that contained in Director Witt's April 29, 1999, letter to the Gommissioners. In summary, the FEMA-stated position is:. (1) FEMA opposes Federal regional stockpiles as proposed by the NRC. In our judgment, they will not enhance local emergency preparedness because of the complex logistics of storage and timely distribution; I (2) the Federal Radiological Preparedness Coordinating Committee (FRPCC) unanimously approved an amended Federal policy reiterating the State's authority to decide whether to stockpile locally and distn'bute KI as a protective measure for the general public on a site-specific basis; and, (3) the NRC should support the Federal KI policy and honor its commitment to provide funding for States that opt to establish local stockpiles of KI. FEMA lacks authority and appropriations for acquisition of potassium iodide and thus cannot and will not llBSllme the NRC financial commitment to the States. Although the NRC and FEMA staff have mef for the purpose of reexamining earlier, positions and policies, there have been no final agreements, and thus no dec~ions have been made. During our reexamination, the FEMA staff reiterated the agency position that the Commission reconsider its decision not to fund State stockpiles of Kl Specific items are addressed below:

• The NRC states that agreements and procedures are in place through the establishment of Federal regional stockpiles, su~h as those under the scope of the fillS/CDC/PHS for establishing stockpiles, processes and procedures for responding to acts of terrorism. However, these regional stockpiles, and other means for acquiring pharmaceutical antidotes in response to possible terrorist activities, are only in the early stages of development by HHS. The NRC incorrectly expresses the FEMA position as supporting Federal regional stockpiles. This is reflected in the NRC' s response to Issues 7 and 22.

We suggest the following language, assuming the Commission decides to fund State stockpiles of KI: "FEMA and the NRC are working together to develop detailed guidance on how a State or local government could obtain KI in accordance with the FRPCC-revised Federal policy, which provides for the NRC funding of local stockpiles when requested by the State."

In Issue 22, we suggest: "You are esseJ!tially correct, HHS/CDC is supporting the establishment of a system that would provide pharmaceuticals to biological and chemical terrorist incidents. These pharmaceuticals, which may be available, are determined by each Metropolitan Medical Strike Team. These Strike Teams may choose not to include KI even if supplied by the NRC."

• In Issue 12, with respect to the FDA' s development of possible new guidance on use of KI, i.e., dose per age group and intervention levels, it is clear that their draft *

\ guidance for publication in the Federal Re.sister will not occur this calendar year. We must also assume that when FDA does publish its draft guidance, they will receive many comments. FEMA agrees that the revised NUREG-1633 should not be published in final until FDA has completed its work and provided its updated and completed guidance. However, we also believe that the draft NUREG-1633 could be published in the Federal *Register for comment with the FDA updated guidance inserted before NUREG-1633 is issued in final. In addition, the NRC's language in

• the proposed Federal Register notice implies NUREG-1633 will be published in final

   , in early 2000, when, in fact, it will first be noticed in the Federal Register as a draft for comment to anyone who is interested.

We suggest the following language in the NRC's responses to Issues 2, 10, 16, 18, 19, and 21: "The Notice for comment should be published in early 2000, with the final version ofNUREG-1633 published after the FDA final guidance is available."

• In Issue 14, we agree with the NRC' s response to the commenter that the Rule only says a State must consider KI to be in compliance. However, it is clear that the effect of withdrawal of funding for local KI supplies could affect a State's decision on whether or not to provide a local supply or to add KI as a supplemental protective measure.
• Thank you for the opportunity for FEMA to reiterate the agency's position and to comment on the draft Federal R~ster Notice.

ENCLOSURE4

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     '                     I:-*.

POLICY ISSUE (Notation Vote) June 16, 1997 SECY-97-124 The Commissioners FROM: L.Joseph Callan Executive Director for Operations

SUBJECT:

PROPOSED FEDERAL POLICY REGARDING USE OF POTASSIUM IODIDE AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT PURPOSE: To provide the Commission with options concerning a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe reactor accidents.

SUMMARY

As part of the Federal effort to re~valuate the Federal policy on Kl based on a request by a petitioner, the Federal Radiological Preparedness Coordinating Committee (FRPCC) adopted recommendations that would result in a revised Federal policy statement. NRC staff has participated in the FRPCC activities and has worked closely with the Federal Emergency Management Agency (FEMA) in this area. There are three options that can be taken with regard to the FRPCC recommendations: (1) recommend no change in the existing Federal policy, (2) recommend the adoption of the FRPCC recommendations, with the added recognition of recent developments regarding medicinal stockpiles for nuclear, biological, and chemical events, or (3) recommend modifications to the FRPCC recommendations. CONTACT: Frank J. Congel, AEOD NOTE: TO BE MADE PUBLICLY AVAILABLE lJB.E.BN (301) 416-7476 THE FINAL SRM IS MADE AVAILABLE

The Commission The staff recommends either option 2 or option 3(b). In light of the fact that this is a national policy issue, Commission guidance is requested. BACKGROUND: Federal Policy on Kl (1985} The current Federal guidance to State and local governments on the distribution of Kl was promulgated in 1985 by FEMA in its capacity as Chair of the FRPCC (60 EB 30285) and as the Federal agency charged with establishing policy and providing leadership via the FRPCC (44 CFR 351 Subpart C). The FRPCC was established in accordance with 44 CFR Part 351 to coordinate all Federal responsibilities for assisting State and local governments in emergency planning and preparedness for peacetime radiological emergencies. Federal agencies which participate in the FRPCC are: Federal Emergency Management Agency (FEMA), Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA), Department of Health and Human Services (HHS), Department of Energy (DOE), Department of Transportation (DOT), Department of Agriculture (USDA), Department of Defense (DOD}, Department of Commerce (DOC), Department of Interior (001), Department of State (DOS), Department-of Veterans Affairs (OVA), General Services Administration (GSA), National Communication System (NCS),. and National Aeronautics and Space Administration (NASA). The 1986 Federal policy recommends the stockpiling or distribution of Kl during emergencies for emergency workers and institutionalized persons, but does not recommend requiring pre-distribution or stockpiling for the general public. It recognizes, however, that options on the distribution and use of Kl rest with the States. Hence, the policy statement permits State and local governments, within the limits of their authority, to take measures beyond those recommended or required national!*,'. DPO 119891 In 1989, Peter G. Crane, a member of the NRC staff, filed a Differing Professional Opinion (DPO) which alleged that there were deficiencies in the original cost-benefit analysis (NUREG/CR-1433) provided to the FRPCC by the NRC. The DPO suggested that the staff discussion at a November 1983 Commission briefing on Kl might have left Commissioners and members of the public wi~h insufficient understanding of the adverse consequences

• (thyroid diseas_e) that the use of Kl could avert. The DPO also suggested that the cost-benefit analysis, by simply balancing the dollar costs of a Kl program against the dollar costs of treating radiation-caused thyroid illness, did not adequately consider the non-monetary costs of an illness.

In SECY-91-321, the DPO panel developed a simplified analysis of the value and impact of the Kl policy, including revisions to several factors used in NUREG/CR-1433. The panel concluded that no change in the Federal policy was warranted. However, in order to consider all of the issues raised by the DPO and incorporate new data, the Office of

The Commission -: ' '. ~ ,,:

  .. '    ~  ,: * ~ ***      '.:; ""/ -#;.'   ...

Nuclear Regulatory Research performed a detallad update of the' 'NRC's Kl policy basis, taking Into account both qualitative and quantitative factors.

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• _,'

The staffprese~ecf its recommendation to reso~ve the DPO In SEC'Y-93-318: * (Nove,riber *2~, *1993) and SECY-94-087 (March 29, 1994). The staff recommended that the NRC/in* coordination with HHS and FEMA, revise current Federal Kl .Policy as a matter of prudency to make Kl available to the States. The Commission's vote on the above staff recommendation was split 2 to 2 (SRM dated May 6, 1994). Thus, the policy remained unchang*ect. * * *

• American Thyroid Association's Request and Establishment of Kl Subcommittee (1989)

In September 1989, the American Thyroid Association (ATA) submitted a letter to the Chairman of the FRPCC requesting that the Committee reconsider the issues involved in stockpiling Kl. The ATA proposed that: *

                                                  "As best as can be determined at this time, no substantial stockpile of potassium iodide is available for public use.

Despite the unlikely event of an emergency requiring its use, the AT A believes that the option of potassium iodide distribution should be available for consideration to those responsible for public health measures. To this end, the AT A believes that it would be prudent to have available et central locations a suitable stockpile of Kl for possible distribution should its use be contemplated." In response, the FRPCC established an Ad Hoc Subcommittee on Potassium Iodide end asked the HHS to review the medical and clinical status of the use of Kl. In an initial response, HHS reviewed the then current scientific literature on Kl and its use as a blocking agent. HHS reported to the FRPCC in February 1990 that no new scientific data had been found that would affect the basis for the 1985 guidance to refrain from stockpiling or predistributing Kl for the public. To ensure a more comprehensive review, HHS also decided to solicit new data, scientific opinions, and reports on the experience of States concerning Kl use and distribution. HHS convened a meeting of experts on July 24, 1990 in Atlanta, Georgia. Representatives of the State and Federal agencies responsible for medical resea, ch, drug regulation, and radiological emergency response, representatives of medical associations, end nationally recognized experts in the fields of endocrinology and nuclear medicine attended. Daniel A. Hoffman, Ph.D, M.H.P., Assistant Director for Science, Center for Environmental Health and Injury Control, Centers for Disease Control chaired the meeting. FoTiowing the experts' meeting, HHS made the following recommendations to the FRPCC in October 1990:

The Commission 1. The 1985 FRPCC guidance need not be changed at this time since no compelling eyi(!ence to support a modification vya~ p~esenteq. ,. ., . . , ,. :. ...

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2. Existing stores of Kl should be inventoried. The FDA would dete-rmine the locations and size of Kl supplies by identifying large custorryers of Kl manufa,cturers 1_. The FRPCC should request that the- Conference * *~ ....

of Radiation

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• identify appreciable supplies of Kl within the States by surveymg State Radiation Control Programs. * .

3. Th~ FRPCC should establish a workin~- group to address the issue of sto~kpiling.

Group objectives should be to:

• Review and catalog type, location, and expiration of existing suitable supplies of Kl.
• Review and determine feasibility of specific stockpiling recommendations made by meeting participants.
• Make final recommendations to FRPCC on U.S. Government Kl stockpiling policy.

The FRPCC Subcommittee on Kl followed up on these recommendations. An Analysis of Kl for the General Public In the Event of a Nuclear Accident Under the sponsorship of NRC's Office of Nuclear Regulatory Research, S. Cohen & Associates completed a report entitled, "An Analysis of Potassium Iodide (Kl) Prophylaxis for the General Public in the Event of a Nuclear Accident" in April 1992. The analysis was updated and published in February 1995 (NUREG/CR-6310). The analysis, whose central objective was to conduct a cost-benefit analysis of Kl, assigned monetary values to thyroid health effects. The report addressed not only the scientific aspects of the use of Kl but also the economic costs and benefits to society. The report indicated that a fair evaluation of Kl cannot be limited to an assessment of the cost-benefit ratios, but must include a thorough understanding of how these ratios were derived. 1 According to FEMA, the FDA Inquiry conducted In late 1996 showed that Carter Wallace, one of the largest manufacturers of Kl, had an inventory of 70 cases of Kl. Each case contains 1000 bottles. Each bottle contains 14 tablets, a 14-day supply. According to this Inquiry, Carter Wallace can manufacture 40-60 cases a day if necessary. Roxanne, another manufacturer of Kl, has an unknown Inventory of liquid Kl in 30 ml bottles.

The Commission The ~~afysis utiliz~ ~ technical ln~ig.hts fro~ both the National Academy ot' ~ciences,- BEIR V Committee (NAS 1990) and the National Council on Radiation Protection and ' Measurements (NCRP 1987) regarding iodine and thyroid dosimetry. -

                                                 *                                               ' ' .        '~ -.-J' The analysis ~1so* addressed the effectiveness of Kl. According to the analysis, given the rapid uptake of iodine (radioactive or stable), there is a limited 'benefit of Kl administration following exposure to radioiodines. For Kl to serve as an efficient blocking -agent,- the report continued, it must be administered in sufficient q1:,1antlties before or concurrently with radioiodine exposure.

This report estimated the cost/benefit ratio of stockpiling Kl prophylaxis as a function of estimated population within radial distances from a plant. The results of this analysis showed that the cost-benefit ratio ranged from 2.222 for populations within 6 miles to 81.8 for populations within 50 miles. This means that for the 0- to 5-mile population cell,

  $2.22 would be spent for stockpiling Kl in order to avoid the economic equivalent cost of
  $1.00. For the 0- to 60-mile population cell, $81.8 would be spent to avoid the economic equivalent of $1.00. The cost-benefit ratios for population cells increased 'nearly exponentially with distance.

As basis for the cost-benefit analysis, the authors used four accident categories postulated

,for the Surry nuclear power plant as de$cribed in NUREG-1150. The analysis used the
 -accident consequence code to calculate the thyroid dose to individuals as a function of
 .age, gender, and distance. For the worst case that was analyzed, the whole body doses close to the plant at the plume centerline were high and likely to be fatal 3

• Doses decrease with distance and away from the plume centerline. Within 5 miles, where the cost-benefit ratio for stockpiling Kl was estimated to be 2.22, the whole body doses may stiJI exceed thresholds for early health effects 4 for which administration of Kl is ineffective.

It was precisely such insights that led to tr.e NRC's recommendation for prompt evacuation of areas close to ttie plant and five miles duwnwind as the preferred protective action.

'This guidance is contained in NUREG-0654 Rev. 1 Supp. 3 entitled Criteria for Protective Action Recommendations for Severe Accidents published in July 1996.

State Survey (1994) In June 1993, the April 1992 report was provided to the representatives of FEMA and HHS who co-chaired the FRPCC Pi:itessium Iodide Subcommittee. The subcommittee re'lorted , on the NRC-sponsored analysis at a meeting of the FRPCC in September 1993. It recommended initiating two studies to secure State input on implementation strategies for providing Kl to the public: ( 1) request the Conference of Radiation Control Program 2 1n SECY-94-087, the staff applled correction factors to the cost-benefit ratios and produced a modified ratio of 11 insteJ(f of 2.2. ' J Assuming no protectlve actions, such as evacuation or sheltering.

     "The health effects Include nausea, fatigue, vomiting, epilatlon, diarrhea, and hemorrhage.

The Commission Directors (CRCPD) to survey those States with nuclear power plants for opinions regarding Federal purchase .and stockpiling of Kl and regarding the feasibility of States providing Kl to the public under emergency conditions and (2) requ_est the lnte_mational Atomic Energy Agency to provide information on existing plans and proc*edures. from member nations:.. ,, related to the storage, distribution, and dosage of* Kl. The latter study: which involved the ,fAEA, was never conducted. The first study, which consisted of a survey of St:tes in coMection *with a Federal pur~hase and stockpiling of Kl,' was**c*ompleted in mid-1994.- All 32 States with nuclear power plants res~onded, *as well as* 11 States without plants. In general, the responses were as follows: ** Yes N!2 Does your State favor a Federal Kl Stockpile?

       - SJates with nuclear power plants                               26
       - States without nuclear power plants                             J!

Total 10 33 The primary reason given by States for not supporting Federal purchase and stockpiling of Kl was that the State policy did not include Kl as a protective measure for the general public. The State use of Kl was specified only for emergency workers. Many States emphasized that the distribution of Kl to the general public would be difficult in the event of a radiological emergency. The difficulty stems from logistical challenges presented for timely distribution of Kl to permanent and non-permanent populations and the liabilities associated with the misuse of Kl. Of the 10 States that supported the Federal purchase and stockpiling of Kl, one State preferred one centrally located national stockpile, four preferred Federal regional stockpiles, and five preferred a stockpile within their State. In early 1995, the FRPCC subcommittee was prepared to recommend that: 1. 2. The FRPCC Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent (50 FR 30258), should not be changed. The Federal government should not purchase and stockpile Kl for use by the public. The basis for these recommendations were:

1. The results of the State survey,

2. The 1992 NRC cost-benefit study,

3. The lack of new data challenging the 1985 guidance on Kl stockpiling,

4. The lack of justification that the subcommittee could find for a Federal stockpile, and

The Commission 6. T-he lack of support for s~ch an initiative by the State~ and the primary Federal*- regulatory agency (FEMA). *, *

• _..

However, FEMA did not Issue the results of these findings because of a petition for reconsideration. ** ' Petition for Rulemakina {]995) On September 9, 1995, Mr. Crane, who filed the DPO, filed a petition for rulemaking (PRM-50-63) with the NRC as a private citizen. He requested that the NRC amend its emergency planning regulations to require that emergency planning protective actions include sheltering, evacuation, and the prophylactic use of Kl. The request would amend one of the 16 planning standards in 10 CFR 50.47, which licensees' and offsite agencies' emergency plans are required to meet, in order to assure that the option of using Kl is included in emergency plans. The staff's resolution of the petition is currently under consideration. The implications of the policy options on the petition are discusse~ later. Stockpile of Medicinal Supplies for Nuclear. Biological. and Chemical Agents (] 995) In June 1995, the White House issued Presidential Decision Directive 39 (PDD-39) on US Policy on Counterterrorism. The PDD-39 directed the Federal agencies to take a number of measures to reduce vulnerability to terrorism, to deter and respond to such acts, and to strengthen capabilities to prevent and manage the consequences of terrorist use of nuclear, biological, and chemical (NBC) weapons including weapons of mass destruction. The PDD-39 assigned to FEMA the task of ensuring that the Federal Response Plan (FRP) was adequate to respor.d to the consequences of t~rrorism.

• FEMA, in coordination with the Catastrophic Disaster Response Group (CDRG) 15 , developed a draft report to the President entitled, "An Assessment of Federal Consequence Management Capabilities for Response to Nuclear, Biological or Chemical (NBC) Terrorism,"

dated June 12, 1996. The report recommended, among other things, that the Federal government purchase and stockpile thyroid blocking agents (Kl) for the general public that could be used in the event of a nuclear terrorist event. The NRC was a member of the Core Group which generated the recommendations and was instrumental in adding Kl to the list of medicinal supplies to be stockpiled nationally. 5The CDRG Is the headquarters-senior-level coordinating group which addressees policy issues regarding the Federal Response Plan {FRP). The CDRG is chaired by FEMA and comprises representatives of Federal departments and agencies with responsibllltles under the FRP. The NRC is represented by the Incident Response Division Director.

The Commission The Core Group concluded that as the result of recent events, significant threats over the paJ;tJew y~a111, ~')!J .tQ,Jncr~as~d availability and proliferation of nuclear, biological, or chemical materials, there is an increasing concern for th~ *potential of-.terrprist Jncidents. NBC events, the report continued, may occur as a local event with*potentially profound national implications. In responding to these events, the first responders 'must be able to provide critical resources to the victims. These include, but _are not limited to, chemical nerve antidotes, vaccines for anthrax, and antibiotics". It was therefore determined that there .is .a need to pe,rrchase and preposition stockpiles of adequate medical supplies at the Feaeral, State, and local level. While Kl was not considered as vital as chemical nerve antidotes and vaccines, :the NRC staff was successful in getting Kl included with. other medicinal supplies**~o(~BC.events _because of the' unusual characteristics of these events:

1. NBC events *are unpredictable with many unquantifiable parameters. In contrast to nuclear power plant accidents, NBC events can occur in major metropolitan areas.

The group postulated NBC scenarios for which evacuation and sheltering were not effective or even possible.

2. NBC events can have consequences ranging from low to disastrous. Some may not escalate beyond the threat stage while others may occur without a threat stage with devastating consequences, with everything in between.

3. Even with the significant amount of planning at the Federal, State, and local level,

• NBC events still have potential for mass casualties.

Because.~f_ the special characteristics of NBC events, the Core Group recommended a broader range of protective actions. The NRC concurred in the findings of the report by letter from AEOD Director to FEMA Director dated September 25, 1996. The report was subsequently presented to the President in February 1,997 and approved for distribution in May 1997. The staff believes that such a stockpile of Kl substantially addresses the issue raised by the American Thyroid Association. FRPCC Subcommittee on Kl (1996) In parallel with petitioning the NRC, Mr. Crane also requested that FEMA review his petition and reconsider the Federal policy. In early 1996 the FRPCC convened a, Ad-Hoc Subcommittee on Potassium Iodide to request and review new information on this matter from interested parties. The subcommittee conducted a public meeting on June 27, 1996. The subcommittee evaluated all comments from the June 27 public meeting and concluded in its report to the FRPCC that "while the viewpoints presented at the public meeting were

   'Some of these medicines can save lives only when administered urgently. The timely distribution remains an issue.

The Commission compelling, the 1996, Subcommittee on Potassium l~ide heard no ,n~w information that .' seriously challenges the bases for the 1985 recomm.endation concerning public use of Kl." However, the Subcommittee made the following recommendation regarding the Federal Kl policy:

1. Without changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether to use Kl, the Federal government *(NRC, or a

through FEMA) should fund the purchase of. stockpile for a State that *decides to incorporate Kl as a protective measure for the general public;

2. The Subcommittee believes the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many intervenors observe with the Federal policy is the italicized statement "The Federal position with ... potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were rewarded to state "it

[potassium iodide for use by the general public] is not required, but may be selected as a protective measure at the option of the State or, in some cases, local governments."

3. The subcommittee recommends that local jurisdictions who wish to incorporate Kl as a protective action for the general public should consult with the State to determine if such arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl es e protective measure for the general public, they would need to include such a measure in their emergency plans.

Proposed Federal Policy on Kl ( 1996) The full FRPCC endorsed the subcommittee's recommendations with some modifications and plans to publish a revised Federal policy statement on distribution of Kl. Because of the NRC' s interest and recognized expertise in emergency planning around nuclear power plants, NRC staff agreed to work closely with FEMA to propose language that would integrate the FRPCC subcommittee's recommendations, the FRPCC's endorsement, and the recent developments in the areas regarding preparedness for terrorism. FRPCC and lnteragency Assignments Under 44 CFR 351, the FRf CC is the Federal coordinating body responsible for assisting FEMA in providing policy direction for the program of Federal assistance to State and local governments in their radiological emergency planning and preparedness activities. FEMA, as chair of the FRPCC, establishes policy and issues guidance to State and local governments. The FRPCC member agencies jointly review and evaluate the status of emergency planning periodically. Part 351.21 (f) requires the NRC to assist FEMA in developing and promulgating guidance to State and local governments for the preparation of radiological emergency plans. Part 351.21 (i) requires the NRC to provide representation to and support for the FRPCC. The NRC has fully participated in FRPCC activities. Because of its special interest in emergency planning for nuclear power plants,

The Commission the NRC staff worked closely with FEMA and other Federal agencies in devel~ping the pr,oposed Kl policy. The staff recognized the importance of working closely _with health agencies such as HHS and OVA regarding tfle use of Kl by the gen8!'81 public. '* Throughout this process, the staff worked collegially with other key Federat'age*ncies to ensure a '-':' broader consensus on the Federal policy. * * * *.~ *~"** * * * -""'"""h:' The NRC's representative to the FRPCC has _agreed to -f)ropose language that integrates what was already_ recommended and endorsed by various Federal committees _and working groups. By virtue-of its regulatory functions, the* NRC staff had to *consider some additional fine points. For example, the NRC staff considered the licensing'*impllcations of the proposed Kl policy, the need for additional guidance to the licensees or States, and the potential impact on FEMA's responsibilities in offsite emergency planning. If accepted by the FRPCC, the proposed policy will be noticed in the Federal Register. Since FEMA chairs the FRPCC, it assumes the responsibility for this publication. Options Option 1. Recommend no change in existing policy. This option would result in continuation of the present policy, i.e., stockpiling Kl tor use by emergency workers and institutionalized persons but predistribution or stockpiling of Kl tor use by the general public should not be required. This option would require that NRC staff request that the FRPCC reconsider its current recommendations and not consider the existing Federal stockpile for NBC events. The staff does not believe that other key Federal agencies on the FRPCC would be receptive to th.is option because of the activities that have taken place since 1985. This option does not update the current pc,licy to reflect the recent developments. The

• staff believes that the time is appropriate to update the present policy. A Federal stockpile of Kl, among other medicinal supplies, already was available for the Olympics and the national political conventions. There is a new national impetus for expanding the Federal preparedness to include medicinal supplies for NBC events. While the FRPCC determined that there is no new information that seriously challenges the basis of the current policy regarding reactor accidents, it did recommend that the Federal government fund the purchase of Kl for any State upon their request and soften the language in the present policy:
• Option 2. Recommend the adoption of the FRPCC recommendations recognizing the recent developments In preparation for NBC events.

This is one of the options favored by the staff. As pointed out in option 1, the staff believes that the present policy should be updated. Attachment 1 contains a proposed Federal policy on Kl that reflects the key elements of this option. It incorporates changes recommended by the FRPCC's Subcommittee on Potassium Iodide, acknowledges the

The Commission * ' .. ' - J,.. * < * *~f developments in the area of NBC ~vents regard'i~g KJ_ but' does noi*alter-the current emergency planning requirements. The principal differences between option 2 and the 1986 version are the addition of the willingness of the Federal Government to purchase a suppty of Kl for States at their request, and the establishment of a Federal stockpile. r *, The highlights of option 2 proposed policy are as follows:

• Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear facilities, the best technical information indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, the State (or in some cases,
• the local government) is ultimately responsible for the protection of its citizens.

Therefore, the decision for local stockpiling and use* of Kl as a protective measure for* the general public is left to the discretion of the State or, in some cases, the local government.

• The Federal government will establish funding for the purchase of a supply of Kl. It is recognized that the State or the local government, within the limits of their authority, can take measures beyond those recommended or required. The availability of Kl as a protective measure for the general public supplements other options for public officials responsible for protective action decisions. A few States have indeed included Kl as a protective action for the general public. The FRPCC does not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public. Therefore, to ensure that States have available to them the option to use Kl if they so elect, the Federal government will be prepared to provide funding for the purchase of a supply of Kl. Any State or local government which selects the use of Kl as a protective measure for the general public may notify FEMA and request funding for the purpose of purchasing a supply of Kl. Guidance would have to be developed in this area jointly with FEMA.
• A stockpile of Kl is being established by the Federal government. The Federal government is required to prepare for a wider range of radiological emergencies7
• To that end, and as an added assurance for radiological emergencies in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear powep plants, there is little planning possible, a stockpile of Kl is being established by the Federal government. This Federal stockpile will be available to any State for any type of radiological emergency at any time.

7 1n response to new threats, the Federal government broadened the scope of emergency response preparedness to include terrorism involving nuclear, biological, and chemical agents. As a result, and In support of State and local governments, new resources were identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMSTI are being established for response to such events. Medical supplies, including Kl, are being stockpiled nationally for the use by MMSTs In three locations: East coast (Washington, DC), Central (Denver), and West coast (Los Angeles). The quantity of supplies stockpiled uses a planning basis of 100,000 people for a period of two days.

The Commission

• Those States or local governments which opt to include Kl for the general population _will be responsible for the maintenance, distribution, and any subsequent
• costs associated with this program: " * . *.* * .:; ,**.,-,~ _:.
• The incorporation of a program for Kl stockpiling, distribution, and use by any ~tate or lot.:al government into the* emergency plans will not be subject to Feder.al .

evaluation. This is based on the recognition that the use of Kl by the State for tf:le general public is a supplemental protective measL!re, and that the existing emergency planning and preparedness guidance for nuclear power plants are effectjve and adequate to pro~ect th~ public ~ealth and safety. Analysis of Option 2 Proposed Polley To ensure that the Kl policy adheres to the principles of good public policy, NRC staff identified key factors that should be taken into account:

1. The preeminent role of State and local governments in the protection of offsite public health and safety;

2. The application of good science to the development of any new guidance regarding KJ;

3. The value added of any new guidance in the context of existing planned protective measures;

4. The recognition that Kl is not without side effects which have been discussed at length throughout the past years. Before the NRC actually participates In the purchase and supply of Kl, it will prepare through consultation with 1HHS, a suitable product warning to be used by the State and local governments.

5. The implementation challenges of any new guidance.

The NRC staff considered these factors in developing the proposed Federal policy on Kl. Furthermore the staff believes that the proposed policy does the following:

1. Integrates the subcommittee's recommendations with the recent developments in the area of preparedness for NBC events, namely the establishment of national medicinal stockpiles, including Kl;

2. Recognizes the central role of State and local governments in protecting public health and safety, and honors the State's prerogative to determine whether it wishes to add Kl as a supplemental protective measure for the general public;

3. Does not encumber the States and local governments who choose to retain their existing plans if they believe that the implementation of a Kl program may reduce

The Commission ~:~-:::-",*  :- ..... . : ... ~.' 1;*~* !-";:.._,,.**; I'. :,._,: -,,".., * ' 'J -, > A/."'f *<t'* ':,. * ' r ,,., * ,*t_~,.r

   ,, .,.          .'-.the effectiveness of implementing prompt evacuation as a preferred protective
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                   * *action for the general publ!c;                                                             ..          * -. '                  *
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4. Provides added assur~nce to those States and'local governments that 8 Federal stockpile of KJ is available, should *it.be needed(:... * * * *,,

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1

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5. *,s co~sistent with the r~ently publi~h~d draft guida~~e (NU~-EG-08~4 FEMA-REP-1 Rev. 1 Supplement 3) by NRC anci FEMA *on "Criteria *for Protective Action I. Recommendation for Severe Accidents;"

6. Does not result in a rule change which is a two-year process and may require a backfit analysis;

• 7. Maintains the foundation of offsite emergency planning by confirming that the existing guidance and requirements are adequate.

The proposed policy is also strengthened by the already existing stockpile of Kl that was available for the Olympics and the national political conventions. The staff believes that given these stockpiles, unlike the TMI experience, Kl could be made available in a more timely manner if needed in the future. This option has some fiscal implications for *the NRC associated V'!{ith p:s offer to purchase

     .Kl for any State that requests it.

• Fiscal Implications of Proposed KJ Polley The option 2 proposed Federal policy contains an offer by the Federal government ,(most
• liket'y the NRC) to fund the purchase of a supply of Kl for any State that chooses to' add Kl to its options of protective actions in response to an emergency at a NRC licensed nuclear power plant. To fulfill this proposed obligation, staff's estimate pf the range of NRC costs is given in three scenarios in Attachment 2. Currently, resources are not budgeted for the purchase of Kl and funds would have to be reprogrammed should a State (or States) request funding through FEMA. *
• The cost estimate does not include the administrative costs associated with the Kl purchase. The more likely scenario is that several sites may request funding each year for a few years. In that case, the estimate is about $50,000 each year for a period of t'.1ree years and repeated every seven years, thereafter.

Option 3. Recommend modifications to the FRPCC recommendations. There are a number of possible modifications to the FRPCC recommendations that can be recommended. The staff has prepared a limited number of ,cases to scope the wide range of possibilities. a) Endorse FRPCC recommendations without the offer to fund the purchase of Kl.

The Commission There are already two States which have Kl for the general public under the current policy. The staff is not aware of any cases where

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funding to purchase a supply of I,..,, " ~

• Kl is the obstacle for adding Kl as a protective *m~asure for*the* general pubhc. The staff believes that the costs associated with a Kl program'could ba'signlficant when activities such as public education and tf:te *logistics associated with the distribution are ad.:fed to the cost to pur~~a*se Kl supplies. The FRPCC's* offer to .fund.the -*

purchase of Kl is intended to'ciemonstrate**a good *taith efforfbn;.behalf of the Federal.government to assure that if *any State wishes to add this supplemental measure, there is no Implicit discou_r,age~_~r~ffroT the* Federal governme~. .

                                                  * **            _1  -.

• fr"':. ~,. * ' ., _,.,
• t' If this option is selected, the staff would have to request that the FRPCC reconsider its recommendation regarding Federal funding for the *purchase of Kl.

b) Recommend that the staff, in coordination with HHS and FEMA, revise currant Federal Kl 'policy to make Kl avaHabla to the States. This was recommended by the staff in SECY-94-087. The revised policy would state that: Kl will be purchased by the Federal government (most likely by the NRC) and made available through FEMA to the States. While the NRC encourages the stockpiling of Kl, the decision to stockpile, distribute, and use Kl would be the responsibility of the individual States. At the option of the State, procedures incorporating the use of Kl in State emergency plans would be developed with the assistance of FEMA. The details regarding this option would be developed and coordinated through the FRPCC. This option contains some of the essential elements of option 2 and is the other option favored by the staff. For example: (1) it is a State option to determine whether It wishes to include Kl in its plans, and -(2) the Federal government (most likely the NRC) will

• purchase Kl for the States. This option could have fiscal implications up to scenario 3 in option 2. The principal difference with option 2 is that in this option the Federal govemm_ent openly encourages the stockpile of Kl by States for prudency.

The States may perceive the NRC encouragement to stockpile Kl by the States as going beyond what is necessary. :his is based on the statements presented by States' representatives at the public meeting conducted by the subcommittee on Kl in 1996. Not only were they not convinced that there is a benefit to a Kl stockpile, but believed that it may hamper the implementation of prompt evacuation which is the preferred protective measure. Indeed, it was after these testimonies and a careful examination of issues and information presented to the subcommittee, that FRPCC recommended a position that reflected a more subtle encouragement (as reflected in option 2).

The Commission - 15

• SECY-94-087 was silent on cases where States did not opt to ha~e a local stockpile* *of Kl.

In today's environment, those States could rely on the NBC stockpjle to use Kl o~ an rut

.1:12£ basis if needed.                                   -*

• This option was favored by the staff in 19~4 and, in recognition of the NBC development, remains one of the two recommended options today.

c) Direct the staff to effect a rule that requires Kl as a protective measure for the general public. This option is-based on the presumption that stockpiling Kl for limited populations located close to operating nuclear power plants, if not cost-beneficial, is, nonetheless, prudent. The option would require that emergency plans be revised to include a Kl distribution system for the public and the criteria for its administration in an accident. This option would be at odds with the FRPCC recommendations and according to the polls, the States would not view this option favorably. The FRPCC recommendations were, in part, based on the notion that the State or local governments are ultimately responsible for the decisions regarding protective actions and their implementation. To have a national stockpile of Kl allows the States to use Kl on an ad hoc basis if needed. This option would also have wide-spread implications for emergency planning. It would require the States and local governments to make significant changes to their plans and procedures in order to ensure that Kl can be distributed to the public (permanent and transient populations) in a timely manner, preferably without reducing the effectiveness of prompt evacuation if necessary. It would require that Federal agencies develop additional guidance for FEMA evaluation of the changed plans. The NRC and staff would have to revise the existing Federal guidance on protective actions for severe accidents, such as Supplement 3 to NUREG-0654. The State and local officials would have to conduct public training for public use of Kl. Public health officials and school officials would need specific instructions for dispensing Kl to the general public and school children. For the purpose of placing this option in perspective using the two States which currently stockpile Kl for the general public, the staff contacted officials from Alabama and Tennessee. In each case, Kl supplies would be made available at reception centers following an accident. Under the direction of the Health Officer, Kl tablets would be administered to members of the public reporting to these centers. Neither State has a planned distribution system to provide Kl to the members of the public in case evacuation would not be feasible. Under these circumstances, Kl would be distributed on an ad-hoc basis.

The Commission In short, this option has the potential to undo the web of emergency planning without any sign~c!~- add~d bene~. lmpffcations of Options on the Petition for Rulemaking Before discussing -the implications of the options on the Petition for Rulemaking, the contributions o( Mr. Peter Crane of the NRC, the petitioner, should be recognized for their value in illuminating all aspects of this issue. He has persevered, over many years and in the face of technical disagreement on intangible issues, in keeping this important issue before the agency and without his efforts even the policy changes recommended in this paper would not likely have been made. No change to existing policy. If this option were approved, then the petition would be denied .. The staff could still grant part of the petition by referencing the NBC developments which will result in a Federal stockpile. Option 2: Endorse FRPCC recommendations recognizing the recent developments in preparation for NBC events. If the proposed Federal policy is accepted, there will be no rule change to amend 10 CFR 50.47 to require that Kl be included in the emergency plans. Thus, the petition would be denied. However, the staff believes that the Federal offer to fund the purchase of Kl for the States at their request and the Federal stockpile of Kl for NBC events8 substantially addresses the fundamental concerns behind the petition, without requiring changes in State and local emergency plans. There are currently two States which stockpile or distribute Kl for the general public around nuclear power plants. More States may choose to add Kl to their protective actions for the general public. Option 3 (a): Endorse option 2 with no funding. The pet~on would be denied. The Federal stockpile for NBC events partly addresses the fundamental concerns behind the petition. Option 3 (b): In coordinatior. with HHS and FEMA, revise current policy to make Kl available to the States. 1 As pointed out in the proposed Federal policy, the Federal stockpile of Kl will be available to any State for any type of radiological emergency.

The Commission The petition would be denied. The ayailability of Kl would substantially address the fundamental concerns behind the petition. Option 3 (c): Effect a rule change. This option would grant the petition by directing the staff to make the requested rule change. Coordination The Office of the General Counsel has reviewed this paper and has no legal objection. The Office of the Chief Financial Officer has no objection to the resource estimates contained in this paper. RECOMMENDATION: The staff requests that the Commission approve either option 2 or option 3(b)._ 71.~n Executive Director for Operations i, Attachments:

1. Proposed Federal Policy on Kl

2. Estimation of Cost Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Wednesday, July 2, 1997.

Commission Staff Office comments, if any, should be submitted to the Commissioners NLT June 25, 1997, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat shoudl be apprised of when comments may be expected. DISTRIBUTION: Commissioners CIO OGC CFO OCAA EDO OIG REGIONS OPA SECY OCA ACRS

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Billing Code 6718-06-P April 16, 1997 FEDERAL EMERGENCY MANAGEMENT AGENCY DRAFT Federal Polley on Distribution of Potassiu!T! Iodide Around Nuclear Power Sites for Use as a

                                                                      *      ,  ~ r , -  , - ,- :

Thyroidal Blocking Agent AGENCY: Federal Emergency Management Agency. ACTION: Issuance of Federal Policy on Potassium Iodide.

SUMMARY

The Federal Radiological Preparedness Coordinating Committee (FRPCC) is issuing this revised Federal policy concerning the purchase, stockpiling, and use of potassium iodide (Kl) as a prophylaxis for the thyroid in the unlikely event of a major radiological emergency at a commercial nuclear power plant. Taken in time, Kl blocks the thyroid's uptake of airborne radioactive iodine, and thus could help reduce thyroid diseases caused by such exposure.

The Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear facilities, the best technical information indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, the State (or in some cases, the local government) is ultimately responsible for the protection of its citizens. Therefore, the decision for local stockpiling and use of Kl as a protective measure for the general public is left to the discretion of State ( or, in some cases, local government.) ATTACHMENT 1

2 It is recognized that the State (or in some cases, the local govemmentt, within the limits of

                                  *~    *   ,    *'"                   V,, r Its authority, can take measures beyond those*recommerided or required. The availability of Kl as a protective measure for the general public st.:pplements other options for public officials r~sponsible for protective action decision~. A few States have ihdee~ included                       Kl as a protective action for the general public. The FRPCC does not warifto                     usurp the State prerogative to Incorporate the use of Kl as a protective measure for the general public.

Therefore, to ensure that States have the option to Jse Kl* if they so elect, the Federal government is prepared to provide funding for the purchase of a supply of Kl. Any State (or in some cases, local government) wh.ich selects the use of Kl as a protective measure for the general public may so notify FEMA, and may request funding for the purpose of purchasing a supply of Kl. In addition, the Federal government is also required to prepare for a wider range of radiological emergencies1

• To that end, and as an added assurance for radiological

( emergencies in which the location and timing of an emergency are unpredictable and for which; unlike licensed nuclear power plants, there is little ~lanning possible, a ~ockpile of Kl is being established by the Federal government. This Federal stockpile will be available to any State for any type of radiological emergency, at any time. 1 1n response to new threats, the Federal government broadened the scope of emergency response preparedness to Include terrorism Involving nuclear, blologlcal, and chemical agents. Al. a retult, and in support of State and local governments, new resources were Identified to be needed In response to such events. About two dozen Metropolitan Medical Strike Teams (MMSTI are being established for response to such events. Medical supplies, Including Kl, are being stockpiled nationally for the use by MMST1 In three locations: East coast, Central, and West coast. The quantity of auppfles stockpiled uses a planning basis of 100,000 people for a period of two days.

3 The policy herein incorporates changes recommended by the FRPCC' s Subcommittee on Potassium Iodide, and supersedes the 1985 Federal policy (50 fB 30268). The principal difference between this revised policy and the 1986 version sre the addition of the offer of the Federal Government to purchase a supply of Kl for States at a State's request and the establishment of a Federal stockpile. The Federal Emergency Management Agency (FEMA) chairs the FRPCC, thereby assuming the responsibility for this publication. For Further Information

Contact:

William F. McNutt, Senior Policy Advisor, Room 634, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2857; facsimile (202 646-4183.

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• This policy on use of Kl as a thyroidal blocking agent is the re~lt of a Fe~eral interagency

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• J* ..: * * ' *, ~ ,'-:. ' ' ')

effort coordinated by FEMA for the FRPCC. On March 1 1, 1982, FEMA issued a final n,~~l~~n~i~ ~ Federal Regj~er' (47 EB *,-~75~); ~hich: d~lin~at~d ~-g~ncy roles a~l *.

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responsibilities for radiological incident emergency response planning (44 CFR 351 ). One of the responsibilities assigned to the Department of Health and Human Services (HHS) and fn tum delegated to the Food and Drug Administration (FDA) was providing guidance to State and local governments on the use of radioprotective subs~ances and prophylactic use of drugs (e.g., KU to reduce radiation doses to specific organs including dosage and projected radiation exposures at which such drugs should be used. In the June 29, 1982 Federal Regjster (47 EB 28168), FDA published recommendations for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health officials should consider the use of Kl. The Federal policy on stockpiling and distribution of Kl was published in the July 24, 1985 Federal Regjster (50 EB 30258). On September 11, 1989, the American Thyroid Association requested FEMA, as Chair of the FRPCC, to reexamine the 1985 policy and to revisit the issue of stockpiling and distribution of Kl for use by the general public. In response, the FRPCC established an Ad Hoc Subcommittee on Potassium Iodide. On December 5, 1994, the FRPCC adopted the report and recommendations of the Ad Hoc Subcommittee on Potassium Iodide, which reaffirmed the Federal position as expressed in the 1985 policy.

6 On April 3, 1996, in connection with a September 9, 1995 Petition for Rulemaklng submitted to the Nuclear Regulatory Commission (NRC) on this is~e, the FRPCC

• 114,,f ~:-:

established a new Subcommittee on Potassium Iodide to review current information. The Subcommittee conducted a public meeting on June 27, 1996. Based on the information collected, the Subcommittee concluded that there was no new information that seriously challenges the bases for the 1985 recommendations concerning public use of Kl for radiological emergencies at nuclear power plants. However, several recommendations were

• made to the FRPCC. The Subcommittee's three recommendations were: 1) without changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether or not to use Kl, the Federal government (NRC, or through FEMA) should fund the purchase of a stockpile for any State that, hereinafter, decides to incorporate Kl as protective measure for the general public; 2) The Subcommittee believes the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many intervenors observe in the Federal policy is in the italicized statement "The Federal position with *.. potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were reworded to state "it [potassium iodide for use by the general public] is not required, but may be selected as a protective measure at the option of the State or, in some cases, local governments." and 3) The subcommittee recommends that local jurisdictions who wish to incorporate Kl as a protective action for the general public should consult with the State to determine if such arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include such a measure in their emergency plans.

6 The full FRPCC endorsed the subcommittee's recommendations with some modifications. Policy on Distribution of Kl Around Nuclear Power Sites for Use' as a Thyroidal Blocking Agent The purpose of this document is to provide Federal policy and guidance with regard to distribution of Kl, and its usage as a thyroid blocking agent, around operating nuclear power generating facilities. The issue has been addressed in terms of two components of the population that might require or desire Kl use: (1) Emergency workers and institutionalized individuals close to the nuclear power plant site, and (2) the nearby general population. This guidance is for those State and local governments who, within the limits of their authority, need to consider these recommendations in the development of emergency plans and In determining appropriate actions to protect the general public. The Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear facilities, the best technical information indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, the State (or in some cases, the local government) is ultimately responsible for the protection of its citizens. Therefore, the decision for local stockpiling and use of Kl as a protective measure for the general public is left to the discretion of State ( or, in some cases, local government.)

7 It is recog.nized that the State (or In some cases, the local government),

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its authority, cal'! take measures beyond those recommended or required. _The availability of IC1 as a protective measure for the general public supplements other options for public officials_responsible for protective action decisions. A few States have indeed *included Kl

                                                                                                              */.

as a protective action for the general public. The FRPCC does not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public. Therefore; to ensure that States have the option to use Kl if they so elect, the Federal government is prepared to provide funding for the purchase of a supply of Kl. Any State

                                                                         - \

(or in some cases, local government) which selects the use of Kl as a protective measure for the general public may so notify FEMA, and may request funding for the purpose of purchasing a supply of Kl. In addition, the Federal government is also required to prepare for a wider range of radiological emergencies2

• To that end, and as an added assurance, for radiological emergencies in which the location and timing of an emergency are unpredictable and .for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of KJ is being established by the Federal government. This Federal stockpile will be available to any State for any type of radiological emergency, Q__t any time.

The bases for these recommendations are given below. 2 1n response to new threats, the Federal government broadened the scope of emergency response preparedness to include terrorism, involving nuclear, biological, and chemlcal agents. As a result, and In support of State and local governments, new resources were Identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMSTI are being ~tabliahed for responae to such events .. Medical supplies, Including Kl, are being atockplled nationally for the use by MMSTs In three locations: East coast, Central, and West coast. The quantity of supplies stockpiled u1ea a planning basis of 100,000 people for a period of two days.

8 The NRC and FEMA issued guidance to State and local authorities as well as licensees of t'O I \~* .*~"t: ~ ~~~.; iih :,. *':\ 1 t>~~-~ f.: ~ ~ ~' ,. . '_ ....... ' . - . ' . . - :; -~ ,. ":. I .... . ,; * - ope.r~ting comm_!trc_lal. ~cle~r power plants in NUREG-0654/FEMA-REJ>* 1*, Revision 1, in

    '   ,     .,..1;... ~*,..!<'T'.-..,~'- ::;~..I.*' . :         --!'~~-" ~~   ~\~        *      ,

0 1980. This guidance recomme~s th~ stockpiling a~ distributlo~ ~f

                                       .      '.       '(

K~ during *.. :. emergencies to emergency workers and to institutionalized ind~ld~I~-.

• Thyroid blocking **

            - r,.              ,.           '    **  :    ,.*           "*. ' *   .. *    *                    '   " 1..   ~ - ~ *  - '  : "  : ,,,..   ~ **   ~  *  ..:;,...

• for emergency workers and institutionalized Individuals was recommended because the~e individuals are more likely to be exposed to radloiodine in an airborne radioactive release than other members of the public. In addition, the number of emergency workers and institutionalized individuals potentially affected at any site is relatively small and requires a limited supply of Kl that can be readily distributed.

For the general public, in the event of a radiological emergency at a commercial nuclear facility, evacuation and in-place sheltering are considered adequate and effective protective actions. It is well-recognized that the inclusion of Kl as a protective measure, in addition to evacuation and sheltering, is beneficial only in very remote circumstances. The use of Kl is not without controversy. On the one hand, Kl has been shown to be an effective drug for protecting the thyroid from thyroid r,odules or cancer caused by the uptake of radioiodine, especially in children fifteen years of age or younger. On the other hand, there are logistical difficulties, and potential medical side effects associated with the drug, in distributing the drug to the general public in a radiological emergency. Also, Kl effectively reduces the radiation exposure of, only the thyroid gland from ingested or inhaled radioiodines. - While this in an important contribution to the health and safety of the individual, it is not as effective as measures which protect the total body. Both in-place sheltering and precautionary evacuations can reduce the exposure to the thyroid A!Js! the total body. It is very important to remember that the use of Kl is not an effective means

9 by itself for protecting individuals from the radioactivity in an airborne release resulting from a nuclear power plant accident and, therefore, should only be considered in conjunction with sheltering, evacuation, or other protective methods. Therefore, while the use of Kl can provide additional protection in certain circumstances, the assessment of the effectiveness of Kl and other protective actions and their implementation indicates that the decision to use Kl (and/or other protective actions) should be made by the States and, if appropriate, local authorities on a site-specific, accident-specific basis. Those States or local governments which opt to include Kl for the general population will be responsible for the maintenance, distribution, and any subsequent costs associated with this program. The incorporation of a program for Kl stockpiling, distribution and use by any State or local

                                                                                             ~~'

government into the emergency plans will not be subject to Federal evaluation. This is based on the recognition that the use of Kl by the State for the general public is a supplemental protective measure, and on the Federal government's determination that the existing emergency planning and preparedness guidance for nuclear power plants is effective and adequate to protect the public health and safety. The FDA has evaluated the medical and radiological risks of administering Kl for emergency conditions and has concluded that it is safe and effective and has approved over-the-counter sale of the drug for this purpose. FDA guidance states that risks from the short term use of relatively low doses of Kl for thyroidal blocking in a radiological emergency are outweighed by the risks of radioiodine induced thyroid nodules or cancer at a projected

10 dose to the th~oid gland of 25 rem or greater. Since FDA has authorized the non~eacriptio~ sale of Kl, it is available to Individuals who, based on their own personal analysis, choose to have the drug immediately available. Attached is a list of ten references intended to assist State and local authorities in decisions related to the use of Kl. Conclusion The FRPCC did not find any new information that would require a change in the basis of the existing Federal policy concerning the stockpile or pre-distribution of Kl for the general public in the event of a radiological emergency at a commercial nuclear plant. The policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, but leaves the decision for the stockpiling, distribution, and use of Kl for the general public to the discretion of State, and in some cases, local governments. Any State or local government that selects the use of Kl as a protective measure for the general public- may so notify FEMA and may request funding for the purpose of purchasing an adequate supply. The incorporation of a program for Kl stockpiling, distribution and use by any State or local government into the emergency plans will not be subject to Federal evaluation. This is based on the recognition that the use of Kl by the State for the general public is a supplemental protective measure, and on the Federal government's determination that the

11 existing emergency planning and preparedness guidance for nuclear power plants is effective and adequate to protect the public health and s~fety. Those States or local governments which opt to include Kl for the general population will be responsible for the maintenance, distribution, and any subsequent costs or legal liabilities associated with this program. As an added assurance, for a broader range of radiological emergencies in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of Kl will be established by the Federal government. Such a stockpile would consist of individual Kl caches at VA -hospitals in major metropolitan centers across the country. This supply would be available to any State or local government for any type of radiological emergency. References

1. National Council on Radiation Protection and Measures (NCRP), "Protection of the Thyroid Gland in the Event of Releases of Radioiodine," NCRP Report No. 55, August 1, 1977.

2. Food and Drug Administration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency, 43 EB 58798, December 15, 1978.

12

3. Halperin, J. A., B. Shleien, S. E. Kehens, and J. M. Bilstad; "Background Material t - ~ ,- - - -

for the Development of the Food and Drug Administration's Recommendations on Thyroid Blocking with PotassiJ~ l~ide," FDA 'a1*-a\s0, U.S. Department ~f Health and Human Services (March 1981 ).

                                                                               \

4. Food and Drug Administration; Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency: Final Recommendations on Use (Notice of Availability) 4 7 EB 28158, June 29, 1982).

5. Food and Drug Administration; Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency: Recommendations on Use. (April 1992). Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Administration, Department of Health end Human Servic~s.

6. Nuclear Regulatory Commission; Examination of the Use of Potassium Iodide (Kl) es an Emergency Protective Measure for Nuclear Reactor Accidents (NUREG/CR-1433, March 1990). Prepared by Sandia National Laboratories for the NRC.

7. Nuclear Regulatory Commission; An Analysis of Potassium Iodide (Kl) Prophylaxis for the General Public in the Event of a Nuclear Accident (NUREG/CR-6310, February 1995). Prepared by S. Cohen and Associates, Inc. and Scientech, Inc. for the NRC.

13

8. Nuclear Regulatory Commission; Re-Evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant {SECY-93-318, _

November 23, 1993).

9. Nuclear Regulatory Commission; Addendum to SECY-93-318, Re-Evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear I

Power Plant (SECY-94-087, March 29, 1994}. ' Signed:

0. Megs Hepler, Ill Chair Feder~I Radiological Preparedness Coordinating Committee I

Estimation of the Cost to Purchase ~I _ ~ *' * , * .-J.,.1*

• k; for .,,the States in Using Three Scenarios -,* -

The option 2 proposed Federal policy contains an offer by the Federal government (most likely the NRC) to fund the purchase of a supply of,KI for any State that chooses to add Kl to its options of protective actions in response to an emergency at a NRC licensed nuclear power plant. Currently, resources are not budgeted for the purchase of Kl and funds would have to be reprogrammed should a State (or States) request funding-through FEMA. To futfill this proposed obligation, staff's estimate of the range of NRC costs is given below: No. of Cost eo.t Coat in Sites Cost in Cost in ink$ k$/yr 1($/yr

                     .Added            No. of     k$/yr    k$/yr       Year                Year. Year Each Year        Years      Year 1-3 Year 4-5    8                   9-10     11-12 Scenario 13       3                3          48                   48                  48 Scenario 2         10               5          160      160           160               160      160 Scenario 3         70               1          1,120                 1,1'20 Table: Cost of Kl purchase in $1000 for three scenarios The cost estimate does not include the administrative costs associated with the Kl purchase. Although the cost/benefit ratio to purchase Kl for the population in the 10-mile Emergency Planning Zone {EPZ) may be excessive for most sites, the NRC staff used the 10-mile EPZ population as the basis for cost estimation. The cost range is from

• $48,000/year for the first three years and repurchased every seven years, to a maximum of $1,280,000 th~ first year and repurcha.,ed every seven years. The higher estimate assumes all sites would request funding for the purchase of Kl in the first year, which staff believes is highly unlikely. The more likely scenario is that several sites may request funding each year for a few years. In that case, the estimate is about $50,000 each year for a period of three years and repeated every seven years, thereafter.

Three scenarios were used to estimate the cost to purchase Kl for the States who request such funding. The first is based on the assumption that one State per year (with thr*ee sites) requests funding for a period of three years. The second scenario assumes three States per year (with a total of 10 sites) request funding for a period of five years. The third scenario assumes every State with a nuclear power plant requests funding the first year. ATTACHMENT 2 8The three scenarios are described In Attachment 2.

2 The staff assuiped the entire 10-mile EPZ population in the cost estimation. Although. the KJ package contafns*an 'insert i~structing the user to take one. tablet .a day for 10 days unless directed otherwise by State or local public health officials, *the cost estimation was .. : .based on a two-day supply. .. Our estimate of the range of costs are as follows:

    .Scenario 1 .

One State (with three sites) per.year requests funding for a period of three years. Number of sites added per year, S: 3 Average number of people per site (within 10-mile EPZ), P: 80,000 Average number of Kl tablets/person, T: 2 Average cost/Kl tablet, c: $0.10 Average shaft life of Kl, L: 7 years The start-up cost would be: C = S*P*T*c = 3*80,000*2*0.1 = $48,000/year, or

     $146,000 over three years.

Scenario 1 1998 1999 2000 No. of Sites Added 3 3 3 Cost {$1000) 48 48 48 The replacement cost would be the same plus inflation, every seven years. sc*enario 2 Three States per year (containing a total of 10 sites) request funding for a period of five years. Number of sites added per year, S: 10 Average number of people per site (within 10-mile EPZ), P: 80,000 Average number of Kl tablets/person, T: 2 Average cost/Kl tablet, c: $0.10 Average shelf life of Kl, L: 7 years

3 The start-up cost would be: C = S*P*T*c = 10*80,000*2*0.1 = $160,000/year, or

$800,000 tor five years.

Scenario 2 . 1998 1999 2000 2001 2002 No. of Sites Added 10 10 10 10 10 I Cost ltiOOO) 160 160 160 160 160 The replacement cost would be the same plus inflation, every seven years. Scenario 3 Number of sites, S: 70 Average number of people per site (within 10-mile EPZ), P: 80,000 Average number of Kl tablets/person, T: 2 Average cost/Kl tablet, c: $0.10 Average shelf life of Kl, L: 7 years If every State with a nuclear power plant site requested funding in the first year, the start-up cost would be: C = S*P*T*c = 70*80,000*2*0.1 = $1,120,000 Scenario 3 ,1998 No*. of Sites 70 Cost ($1000) 1,120 The replacement cost would be $1, 120,000, plus inflation, every seven years.

          'Population Data withlr    '& Nuclear Power Plant Emerger

• Planning Zones

.. SITE 'PERMANENT TRANSIEN 'Total 0..2 MILES 0-5 MILES 0-10 MILE 0-10 MILE 0-10 miles ARKANSAS 853 7,320 25,394 6,000 31,394 1 BEAVER VALLEY 3,676 16,658 142,268 3,400 145,668 2 BELLEFONTE 309 4,696 25,050 2,437 27,487 . 3 BIG ROCK POINT 269 4,368 9,274 9,274 4 BRAIDWOOD 3,545 11,490 26,015 8,105 34,120 5 BROWNS FERRY 148 2,414 27,678 19,600 47,278 6 BRUNSWICK 711 4,373 10,583 21,000 31,583 7 BYRON 371 7,140 21,393 43,762 65,155 8 CALLAWAY 82 632 5,759 4,545 10,304 9 CALVERT CLIFFS 241 3,501 19,972 1,150 21,122 10 CATAWBA 340 1,058 81,423 46,879 128,302 11 CLINTON 48 918 12,666 28,472 41,138 12 COMANCHE PEAK 29 2,684 10,731 8,918 19,649 13 OPER STATION 40 830 5,417 3,000 8,417* 14 YSTAL RIVER 0 825 13,595 1,010 14,605 15 COOK 723 12,364 53,755 16,089 69,844 16 DAVIS BESSE 1,030 2,572 16,427 16,427 17 DIABLO CANYON 10 57 18,099 53,700 71,799 18 DRESDEN 613 7,498 39,289 5,900 45,189 19 DUANE ARNOLD 235 3,821 79,323 79,323 20 FARLEY 27 1,577 10,681 1,420 12,101 21 FERMI 3,004 13,460 71,517 71,517 22 FITZPATRICK 242 3,909 35,155 20,790 55,945 23 FORT CALHOUN 207 7,666 15,254. 871 16,125 24 GINNA 930

• 9,979 39,162 5,863 45,025 25 GRAND GULF 180 2,025 7,255 2,873 10,128 26 HADDAM NECK 2,345 12,129 74,080 29,415 103,495 27 RRIS 110 1,545 15,795 11,000 26,795 28 CH 107 894 5,312 150 5,462 29 OPE CREEK 0 1,209 22,556 5,539 28,095 30 INDIAN POINT 15,165 74,755 240,455, 92,852 333,307 ) 31 KEWAUNEE 163 1,600 11,,086 11,086 32 LASALLE 130 1,145 13,913 3,130 17,043 33 LIMliRICK 4,349 100,364 164,870 23,165 188,035 34 MAINE YANKEE 372 2,001 28,730 42,338 71,068 35 MCGUIRE 420 4,189 46,233 31,178 77,411 36 MILLSTONE 5,176 48,648 110,166 83,129 193,295 37
• MONTICELLO 279 7,611 20,153 20,153 38 NINE MILE POINT 242 3,909 35,155 20,790 55,945 39 NORTH ANNA ., 225 1,639 8,68.~ 1,166 9,854 40 OCONEE ., 401 4,670 50,841 20,000 70,841 41 OYSTER CREEK 4,700 14,950 71,440 73,676 145,116 42 PALISADES 959 5,203 32,773 32,773 43 PALO VERDE 10 205 761 4,000 4,761 44 PEACH BOTTOM 512 6,153 28,647 9,858 38,~05 45 PERRY 1,882 17,238 71,902 53,271 125,173 46
• PJLGRIM 1,'
• 1 15.249 41,401 83,QPt:; 124,486, 47

  - POINT *eEACH                      ~..,d    1.256       20,994   1,:;:.,  22,194      48*
 " PRAIRIE ISlAND                     290      4,228       21,462            21,462      49 QUAD CITIES                       224. 5,740       36,445  12,035    48,480      50 RIVERBEND                         601      4,053       22,872  13,700    36,572      51 ROBINSON                         1,164     10,435       26,908   5,000    31,908      52 ST LUCIE                           210      9,417       94,854  40,000   134,854      53 SALEM                                  0    1,209       22,556   5,539    28,095      54 SAN ONOFRE                       3,650     28,450       57,150  25,900    83,050      55 SEABROOK                         6,040     32,060     100,720  116,988   217,708      56 SEQUOYAH                           890      7,503       38,972  24,000    62,972      57 SOUTH TEXAS                           4        268       2,550   4,622     7,172      58 SUMMER                             220      1,883        8,869   2,000    10,869      59 SURRY                               49      1,399       73,411  63,755   137,166      60 SUSQUEHANNA                      1,177     13,317       51,232   3,720    54,952      61 THREE MILE ISLAND                2,331    27,466      161,509    6,335   167,844      62 TURKEY POINT                          0         30      92,664   4,500    97,164      63 VERMONT YANKEE                   2,086      9,231       31,909   3,544    35,45~      64

-GTLE TERFORD TIS BAR 517 914 209 1,133 13,756 2,696 2,669 60,009 13,916 200 7,000 8,000 2,869 67,009 21,916 65 66 67 WOLF CREEK 24 3,698 5,520 1,100 6,620 68 WNP-2. 0 80 1,338 11,824 13,162 69 ZION 12,981 59,247 245,006 65,750 31.0,756 70 SUM 90,946 697,696 3,111,627 1,320,238 4,431,865 These are estimates of 1982 population which were developed by NRC staff

• Transient population estimates were based on information obtained from FSARs, E Plans, NUREG/CR -1856 (1981} and on licensee estimates. Transient population data

e. considered to inclu.de a large degree of 'uncertainty verage population per site 63,312 Ave pop/site assuming 20% increas 75,975

ENCLOSURE 4a j J

POLICY ISSUE November 10, 1998 (Notation Vote) SECY-98-264 FOR: The Commissioners FROM: William D. Travers Executive Director for Operations

SUBJECT:

PROPOSED AMENDMENTS TO 10 CFR 50.47; GRANTING OF PETITIONS FOR RULEMAKING (PAM 50-63 AND 50-63A) RELATING TO A REEVALUATION OF POLICY ON THE USE OF POTASSIUM IODIDE (Kl) AFTER A SEVERE ACylDENT AT A NUCLEAR POWER PLANT PURPOSE: To obtain Commission approval to publish a proposed rule in the Federal Register for a 90-day public comment period, that would grant petitions for rulemaking (PAM 50-63 and 50-63A). These petitions* requested changing'the. NRC policy on the use ,of potassil:1m:-ioc:fide (Kl) as a radioprotective agent for the general public in the event of a severe reactor accident. BACKGROUND: On September 9, 199~. a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include haltering, evacuation, and the prophylactic use of Kl. In SECY-97-245, dated October 23, 1997, the staff presented three options to the Commission for resolving PAM 50-63. CONTACT: Mike Jamgochian, NRR/DRPM/PGEB (301) 415-3224

The Commissioners On November 5, 1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resoMng the petition for rulemaking. During the meeting, the Commission invited the petitioner to submit a modification to his petition in order to address the views he discussed during the meeting.

                                                                                \

On November 11 , 1997, the petitioner submitted a revision to his petition, PAM 5D-63A (Enclosure 1). The petitioner made two requests: A statement be made clearly recommending stockpiling of Kl as a "reasonable and prudenr measure, and A proposed rule change to 10 CFR 50.47(b)(10), which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophyiactic use of potassium Iodide (Kl), as appropriate." The petitioner also provided a marked-up version of the proposed Federal Radiological Preparedness Coordinating Committee (FRPCC) Federal Register notice concerning a revision to the Federal policy relating to the use of Kl for the general public. On June 26, 1998, the Commission directed the staff in SAM 98-061 (Enclosure 2) to grant the petition for rulemaklng PAM 50-63A by revising 10 CFR 50.47(b)(10). PUBLIC COMMENT ON THE AMENDED PETITION: On November 27, 1995 (60 FR 58256), a Notice of Receipt of the Petition for Rulemaking was published in the Federal Register requesting public comment. A total of 63 comment letters were received, of which 20 utilities, 9 State governmental agencies, 2 utility interest organizations, 1 letter signed by 12 health physicists, 2 State universities and 1 member of the public were against the granting of the petition for rulemaklng. Those letters In favor of granting the petition came from 5 envlronmental groups, 22 members of the public (Including 1 from the petitioner), and the American Thyroid Association. On December 17, 1997 (62 FR 66038), the Commission published a request for public comment on the amended petition in the Federal Register. In response to several requests, the comment period was extended until February 17, 1998, by a Federal Register notice published on January 21, 1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 utilities, 3 State government agencies, 1 utility interest association, and 1 member of the public were against granting the petition for rulemaking. The letters in favor of granting the petition came from 8 public interest groups, 46 members of the public (Including 1 from the petitioner), 3 physicians, 2 U.S. Senators, and 1 State Representative. A detailed analysis of the issues raised by the public comments along with the Commission response to those issues is in the proposed Federal Register Notice (Enclosure 3).

I I

   .

• I The Commissioners DISCUSSION:

In the revised petition (PRM 50-63A) dated November 11, 1997 the petitioner requested that consideration be given to including Kl as a protective measure for the general public. This is a change from the original petition in which the petitioner requested that the regulations be amended to require emergency plans to include Kl as a protective measure. In both the original and the amended petitions, the proposed rui'e language lists sheltering and evacuation as protective measures along with Kl. The planning standard (10 CFR 50.47(b)(10)) currently does not identify any specific protective actions, but indicates that a range of protective actions should be developed for the plume exposure pathways zone (EPZ) for emergency workers and the public, and Included in emergency response plans. Additionally, the petitioner requested that a statement be made clearly recommending stockpiling of Kl as a reasonable and prudent protective measure. On June 26, 1998, the Commission voted 3 to 1 to grant the petition for rule making. Accordingly, the staff was directed to proceed with rulemaklng to change 10 CFR 50.47(b)(10) by inserting the following sentence, or similar words, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate." In addition, the statement of considerations for the proposed rule should include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. The Commission also noted that, consistent with the Commission's decision on June 30, 1997, the Federal government (most likely NRC) is prepared to fund the purchase of a stockpile of Kl for the States, upon request. The NRC staff also was directed to work with other relevant agencies to ensure that there are established procedures to enable the national stockpile, for response to terrorism, to be effectively and timely used by States that have not established local stockpiles and wish to make use of the national stockpiles in the event of a severe nuclear power plant accident. The attached Federal Register notice implements the Commission's decision by publishing the proposed amendment to 10 CFR 50.47(b)(10) for a 90-day public comment period. RESOURCES: / Approximately one FTE is budgeted to resolve this petition by conducting a rulemaking in accordance with the Commission direction. The cost of purchasing Kl was discussed in SECY 97-124 (Enclosure 4) with the estimates ranging from $48K to $1.3M. The staff has recently found these estimates to be overly conservative by approximately a factor of 2.5 due to the increased costs of purchasing the Kl tablets. Therefore, the revised estjmate range is

     $117K to $3.25M depending on the number of States that request funding. These resources are not currently budgeted and would have to be reprogrammed from existing agency programs or carryover. A more detailed cost and funding analysis will be provided P,rlor to the final rulemaking. Additionally, prior to FEMA going forward with the issuance of the FRPCC Federal Kl policy, a letter from the NRC committing the above funds will be necessary.

The Commissioners COORDINATION: The Office of the Chief Financial Officer has reviewed this Commission paper for resource implications and has no objections. The CRGR has reviewed this Commission paper but does not agree with the staff's no backfit analysis (see Enclosure 6). The Office of the Chief Information Officer has reviewed this Commission paper for information technology impacts and compliance with the Paperwork Reduction Act and concurs in it. The Office of the General Counsel has no legal objection. RECOMMENDATION: That the Commission:

1. Approve publication of the proposed rule in the Federal Register.

2.

a. The proposed rule change would be published in the Federal Register for a 90*day public comment period.

b. Appropriate Congressional committees will be notified.

c. The Office of Public Affairs draft public announcement is attached (Enclosure 5).

d. The evaluation of a need for a backfit analysis was prepared by OGC. The EDO accepts OGC's position that this rule change does not constitute a backfit under 10 CFR 50.109; therefore, a backflt analysis is not required.

      - - e.-   - FEMA has been provided with an advance copy of this rulemaking package.
                                                              /v~J~,,.,.

• Attachments:

1. Revised Petition for Rulemaking {PRM 50-63A)

William D. Tla~ers Executive Director for Operations

2. SRM 98-061, dated June 26, 1998

3. Proposed Federal Register Notice

4. SECY 97*124

5. Draft Public Announcement

6. CRGR comment letter dtd. October 23, 1998

Commissioners' completed vote sheets/comments should be provided directly to the Office of the Secretary by COB Friday, November 27, 1998. Commission Staff Office comments, if any, should be submitted to the Commissioners NLT November 19, 1998, with an information copy to the Office of -the secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected. DISTRIBUTION: Commissioners OGC OCAA OIG OPA OCA CIO CFO EDO REGIONS SECY

Pet" G. Crane 14809 D,_,rzmond Avenue I Chevy \,.,r;,,..,e, MD .t.v~15 I J0J-656:3998 fJOCKL,EO us~~Rt: November 11, 1997 r

• Mr. John C. Hoyle, Secretary *'97 MlY 12 P4 :17 U.S. Nuclear Regulatory Commission Washington, D. C. 20555 OFFC .....

                                                                                           ,.- J RU~:

Re: Amendment to Petition for rulemak.inq [PRM-~~(

Dear Mr. Hoyle:

At the Commission meeting on potassium iodide held on November 5, 1997, Chairman Jackson asked me whether I could submit, within the week, language reflecting the modified position that I outlined during the meeting. Attached to this letter is a draft of a proposed rule change, accompanied by a statement of considerations explaining the change. ' Under the approach I outlined in the meeting, the NRC would "requu-e that consideration of potassium iodide be given in the formulation of emergency plans, 11 but 11 would not ram potassium iodide down the throat of a state that emphatically rejected it." I made clear that I was asking for two things: a statement clearly recommending stockpiling of KI as a "reasonable and prudent" measure, and a rule change identifying what is meant by a "range of protective actions" (i.e., eva.cuation, sheltering, and KI) and requirtng their consideration. In the meeting, I sometimes referred to the 11 reasonable and prudent" statement as a "statement of policy," while elsewhere I talked about "clarification which could readily be done in the statement of considerations for such a rule." (At one point, Commissioner Diaz observed, and I agreed, that I was proposing that the Commission, in a "public statement or a rule," express the belief that stockpiling was a prudent measure.) In short, there may have been ambiguity as to whether I was seeking two separate documents - a rule change and a policy statement explaining .it - or just one, a rule change with policy stated and explained in the statement of considerations. Plainly, the latter makes more sense (in any event, to propose a rule change, the NRC would have to offer its reasons for doing so) and seems most consistent with the Commission's interest in resolving the KI issue in an efficient and timely way. In the attached proposal, which represents an amendment to my petition, < the Commission's expression of policy therefore wol,tld -r take place in the context of the rule change, i.e., in the statement of considerations. I trust that no

       /

one will view this as any deviation from what I was propC'sing in the meeting. I realize that it is an ancient negotiating ploy to press for more than you think you can possibly get, as a prelude to bargaining. The fact that this proposal does not do that, but instead is squarely in line with what I described

                                                                           ., ~IJCL       i

2 on November 5, is an indication that I take this amendment of my petition very seriously, without game-playing. I would like as much as anyone to see this protracted process brought to closure, with broad consensus acceptance. Accordingly, I have tried to produce a solution that satisfies the NRC's obligations to r>rotect and inform the pubhc, that d~~ not encroaci1 unnecessarily on state prerogatives, and that enables the Com.mission to put a difficult and divisive issue behind it. I have also tried in this draft Statement of Considerations to present the KI issue in such a way that no one can accuse the Com.mission, if it adopts ,this approach, of being alarmist, or of failing to put safety issues in their proper perspective. Moreover, although I have often, in past submissions, discussed troubling past events, such as those I referred to in the November 5 meeting, I have omitted these historical matters from the proposed Statement of Considerations that I am o~fering today. This reflects a conscious decision to look forward, not to the past, in the recognition that for a health and safety agency, the central question must always be: What makes sense today, in light of what we know rulli'? I believe that if the approach I am proposing is accepted, it would be viewed as so patently reasonable that if challenged legally, it would be sustained by any reviewing court, whether the challenge came from those who thought it went too far or from those who thought it did not go far enough. In the*m.emorable words of the late Judge Harold Lev.enthal~of the U.S .. Court of Appeals for the D. C. Circuit, "When agencies make good sense, courts are loth to find that it is not good law~" On issues of litigation risk, however, . the. Com.mission should of course*. rely on the General Counsel and the Solicitor for advice. A rulem.aking of this kind need not consume significant resources. *. Though it was suggested at the November 5 Com.mission meeting that a rulem.aking would take two additional years (i.e., for a total of more than four years since the filing of the petition) , this seems exaggerated. It is a matter of public record, for_ example, that the Com.mission's last major emergency planning rulem.aki.ng, the "realism." rule of 1987, di(i not require any two years, though it involved many extremely complicated issues and elicited more than 38,000 comments (including many duplicates), all of which had to be read. In that case, a 66-page memorandum to the Com.mission was prepared in which the issues and com.m.ents wer~ analyzed and discussed in detail, with the arguments on both sides fairly presented. A Com.mission briefing was also held at which the m.e.rits of the competing arguments were discussed at length. In the end-;. the ~alysis and the final rule were sufficiently airtight, both as policy and as law, that none of those dissatisfied with the rule -- and there were many -- decided to seek judicial review. The entire process, from proposed rule to final rule, took 9 'months.

3 A KI rulemak.ing along the lines I am proposing would be a minor, not a major rulernaking. It would involve fewer issues and, to judge from the 60 or so comments filed on the petition, would probably elicit comments numbered in the dozens, not in the tens of thousands. If the staff turns to the KI rulemaking with a will, and it is given a firm deadline for turning it around, there is no reason why it could not be completed in significantly less time than the nine months that the "realism" rule require_d. I was also asked to provide for the recorp. the citation to an EnVironrnental Protection Agency document that I referred to. The document is the Manual of Protective Action Guides and Protective Actions for Nuclear Incidents, EPA-400-R-92-001, published by EPA in May, 1992. On November 11, 1995, I wrote to you, as Secretary of the Commission, that at the time I filed my rulemaking petition two months earlier, I had been unaware of this

• document. I therefore wished "to draw the Commission's attention to this document and to ask that this letter and its attachment [ a detailed discussion of the EPA Manual and its implications for the KI issue] be considered as a comment supplementing my petition. 11 This letter and its attachmer:it are in the rulernak.ing docket as comment no. 5, docketed November 13, 1995.

Finally, I was asked to provide a suggested mark.up of the draft Federal Register notice proposed to the Commission in SECY-97-124. First, I would like to put the notice in context. SECY-97-124 asked for Commission approval of an approach, not of the,1appended Federal Register notice. 1 Neither the SRM nor the vote sheets of Chairman Jackson or Commissioner Dicus, who voted for Option 2, referred specifically to the draft Federal Register notice in Attachment 1. Nor did the Commission's Staff Requirements Memorandum of

• • June 30, 1997. Thus I do not think that the Commission I s vote for Option 2 should be regarded as a vote for the Federal Register notice as drafted by the NRC staff, and my crtticisms of the notice are directed at the NRC staff, not at

"the Commission.

                                                                                     )

The NRC staff has already acknowledged, at the November 5 Conuni5m:On meeting, that SECY-97-124 misinformed the Commission as to one element of the procedural history of the KI issue: it was the, NRC, not FEMA, whose opposition to stockpiling helped produce - almost - the reaffirmation of the 1985 policy in 1995. The same lack of perspective (to use the mildest term possible) that was responsible for that misstatement can be seen in the staff's 1 All that SECY-97-124 had to say about the draft notice was the following, at p. 10: "Attachment 1 cont$s a proposed Federal policy on KI that reflects the key elements of this option. It incorporates changes recommended by the FRPCC*s Subcommittee on Potassium Iodide, acknowledges the developments in the area of NBC events regarding KI but does not alter the current emergency planning requirements."

                   .J
                    \.,. ,.               4                 )

draft Federal Register notice, both in the selection of the facts it chooses to report and in its overall tone, which is heavily slanted against KI. I would therefore be re,russ if I did not candidly advise the Commission that the draft Federal Register notice, if issued in its prese~t form, is likely to bring nothing but opprobrium to the NRC an~ to FEMA. In large measure, the. notice*~ failings speak for themselves. What is one to say about a notice that does not get around until page 8 to mentloning that the prevention of cancer is the primary purpose of using KI? What is one to say about a purported history of the KI issue that describes how the FRPCC almost reaffirmed the 1985 KI policy two years ago, but does not mention Chernobyl, even though that accident has produced an extraordinary wealth - \. of new data both on radiation-caused thyroid cancer and on the- safety and efficacy of KI? Can the NRC staff really mean to suggest'**- that it is important that the public learn all about petty bureaucratic maneuverings that occurred in 1994 and 1995, but nothing about the upsurge of .childhood thyroid cancer takmg place now in the former Soviet Union? This is the way to court not merely criticism, but also ridicule and contempt. I have tried, therefore, to offer suggestions to make the notice. more informative to the reader, more balanced in substance and tone, and less susceptible to being quoted out c,f context. For example, I think it is unwise for the N~C and FEMA to embrace too vigorously the line, "no new information that seriously* challenges the bases -for the 1985 recommendations. It is worth asking the staff to .explain* exactly what 11 that line means. The ordinary reader.is likely to interpret it to mean that there is no new information bearing significantly on the KI issue. That, however, would be demonstrably u;ntrue. Rather, the sentence seems to mean a that the 1985 policy was based on cost-benefit analysis which showed that KI was not cost-beneficial, and the Government has not received any new information suggesting otherwise. 2 But of course, the discussion of KI in the last several years, including the Government's decision to stockpile the drug for NBC terrorist events, has all been based on prudency, not on cost-benefit considerations. If the Commissioners or the EDO were sometime called upon to explain this sentence, and it turned out to mean what I suggest it seems to mean, would 2 It would not even be correct to say that there is no new information challenging the cost-benefit analysis that was the basis of the 1985 "not worthwhile" policy. The reanalysis of costs *and benefits in 1992 showed the ratio of costs and benefits to be almost equal for close-in populations, whereas the cost-benefit analysis that 'underlay the 1985 policy showed an extremely high ratio of costs to benefits.

f ** l ,

• I 5

they feel comfortable that the notice had done a good job of informing the public? Or would the sentence seem, on examination, to be a cleverly worded way of disguising the fact that an enormous amount of new information beari~g on the value of KI has emerged since 1985? I believe that Government agencies should be careful to speak so clearly and forthrightly on issues like these that they never leave themselves open to the charge, just or unjust, of having used words artfully to create a misleading impression. At one point, I have included the words "reasonable and prudent," on the assumption that the Commission would not' be proposing to offer KI to states and localities, and the Government would not be stockpiling KI now, if stockpiling of KI were not regarded as a reasonable and prudent measure. I highlight this only because I do not want to give anyone the excuse to accuse me of trying to slip something into the notice without the Commission's being aware of it. *

• Finally, I have also suggested some additions to, and one deletion from, the list of references.

Please note that this submission is, as in the past, submitted in my capacity as a member of the public, not in my official capacity as Counsel for Sped.al Projects in the NRC's Office of the General Counsel. It was written on my own time, at home, using my own computer and materials, and relying on information* available to the public in the NRC's Public Document Room. Sincerely, Peter G. Crane Attachments: Draft rule change with Statement of Considerations Markup of draft Federal Register notice from SECY-97-124 cc: Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan

            *Executive Director for Operations General Counsel Director, Federal Emergency Management Agency

6 PROPOSED RULE CHANGE r. For the reasons set forth in the Statement of Considerations, the NRC is proposing to change the planning standard in 10 CFR §50. 47 {b) ( 10) by adding one sentence, as indicated by underlining: ( 10) A range of protective actions have been developed for the plume exposure EPZ for emergency workers and the public. In developing th...s range of actions, consideration has been given to evacuation. sheltering, and the prophylactic use of potassium iodide ( KI) , as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidelines are developed and. in place, and protective actions for the ipgestion exposure pathway EPZ appropriate to the locale have been developed .

7 STATEMENT OF CONSIDERATIONS The Nuclear Regulatory Commission is, proposing to amend its emergency planning rules, codified at 10 CFR §50.47(b)(10), to clarify the requirement that emergency plans must demonstrate that a range of protective actions has II been developed for protecting the public in the unlikely event of a radiological II emergency. As amended, the regulation will spell out that in developing emergenc~ plans, states must consider the following: evacuation, sheltering, and the use of radioprotective drugs (!.&.:., potassium iodide, or KI). Potassium iodide, if taken in time, can protect against radiation-caused thyroid cancer, as well as hypothyroidism and benign thyroid nodules. Children I s thyroid glands are particularly sensitive to. these effects. Since the efficacy of KI in protecting the thyroid depends on timing (!.&.:.., administering it either before or within a few hours after the exposure to radioactive iodine) , the NRC believes that stockpiling of KI in the vicinity of nuclear power plan~ is a reasonable and prudent measure. This proposed rule change should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought. On the contrary, present indications are that nuclear power plant safety has improved since the current emergency planning requirements were put in place after the Three Mile Island accident. Rather, the rule change prtmarily reflects lessons learned from the Chernobyl disaster of 1986, both about the consequences of an accident and about the safety and efficacy of KI. The Chernobyl accident demonstrated that thyroid cancer can indeed be a major result of a large reactor accident. Moreover, although the Food and Drug

8 I Administration declared KI "safe and effectiv~ 11 as long ago as 1973, the drug had never been deployed 01:- a large scale until Chernobyl. The experience of Polish health authorities during the accident has provided .confirmation that large scale deployment of KI is indeed safe. Further reas~urance about the safety of KI comes from a U .s. study of potential adverse reactions to KI, which is an ingredient in many cough and cold medicines. This study showed 38 million equivalent doses without a single adverse reaction being reported.

                                                  ~'  :I, I                                                  ..,   \

• According to the World Health Organization, ~hildren are even less likely than adults to experience allergic reactions to KI.

The NRC therefore recommends that states make KI ~tockpiling one of their tools to prepare for the unlikely event of a major nu.qJ.ear accident, with offsite releases of radioactivity. While NRC strongly encourages the stockpiling of KI by the states, it does not mandate it under this' rule change.,. The rule change requires only that states consider KI stockpiling in developing the J

 "range of protective actions" mandated by the NRC's emergency planning rules.

The* NRC has* previously decided (on June 30, 199'.7) to support a change* in federal policy by which supplies of KI will be made available, paid for by the Federal Government, to states that request it. The I"l:11e change proposed in this notice is consistent with that change in policy, and clarifies the effect of the policy change on the NRC's emergency planning rules~ The use of potassium iodide is intended to compleqlent, not to replace, other protective measures. This rule change thus represents no alteration in

             '                                                   i the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exp~sure to radiation occurs, when that is feasible.     ( Evacuation protects the whole body, i

whereas potassium iodide protects only a single gland, ~e '.thyroid. } Depending on the circumstances, KI may offer additiona;i rtotection if used in

9 conjunction with e".*acuation and/or sheltering. The approach taken in this rule change is consistent with International Basic Safety Standards issued by the International Atomic Energy A9ency, et * ~ ; with the Federal Radiological Emergency. Response Plan, issued by the Federal Emergency Management Agency in 1996.; and with recommendations of. the President's Commission on the Accident at..Three Mile Island, the World Health Organization, and the American Thyroid Association, which represents physicians speciaUzin.g in thyroid disease. StQckpiling of the drug is currently the practice in numerous European countries, ,as well as Japan, Canada, and three U.S. states: Alabama, Tennessee, and. Maine. In the event that a state, having considered the NRC's recommendation to stockpile KI, nevertheless decides not to include KI stockpiling in its emergency plan, it would still have access, in the event of a radiological emergency, to the various stockpiles of the drug that have been created by the Federal Government as part of readiness for acts of "NBC" (nuclear, biological, and chemical) terrorism. These stockpiles will be available on an ad hoc basis for radiological emergencies of all kinds. However, because experience shows that p~planning is more effective than ad hoc responses to emergencies, and because pre-positioning of KI is likely to mean quicker access to supplies of the drug in an emergency, the NRC believes that it is reasonable and prudent to maintain stockpiles* in the vicinity of nuclear reactors and to include provisions for their distribution in emergency plans. The NRC recognizes that the decision tQ stockpile KI presents issues of how best to position and distribute the mecli~e, to ensure, ~ , that optimal distribution takes place in an emergency, wi~. first priority given to protecting children; that persons with known allergies to iodine not take it; that members of the public understand that KI is not a substitute for measures that protect

(__:- ' I 10 the whule body; etc. To date, these isst:ef have been addressed in different ways in the numerous countnes that currently stockpile KI. The NRC intends to work with states and localities to develop guidance on these and other points relating to the use of KI. The NRC believes that these implementation issues are soluble, given the level of expertise m the relevant federal and state agencies. It is expected that FEMA or the FRPCC will provide guidance to states to assist their consideration of the issue of KI st9ckpiling, and that it will offer technical assistance to help those states which decide in favor of stockpiling* to incorporate it into their emergency plans. It is expected that states will inform FEMA and the NRC of the results of their consideration of whether or not to opt for stockpiling. This will enable the Federal Government to provide KI as expeditiously as possible to states which desire it, as well as to provide any further assistance that may be called for, and it will also allow the Government to engage in better contingency planning for states that decide against stockpiling KI.

Bmina Code 1718-oe-P AprU ,e, 1197 F£J)ERAL EMERGENCY MANAGEMENT AGINCY DRAFT Federal PoDcy on 0lstribudon of Potaulum loclde Around Nuclear Power Sites fof U.. u a AGENCY: Federal Emergency Management Aganc:y. for- -rr.,.1,0;.(.. Pro-fr.,t(ok i,, t,,rJiS#.J. ~,Dt05 ,,....t ACTION: luuance of Federal Policy on Potuaium Iodide A --~t rs t,t,,tc~, s .

SUMMARY

The Federal RadiologlcaJ Preparedne11 Coordinating Commtnu IFRPCC) ill laauin; this revised Federal policy concemlng the purchan, ltOCkplDng, and un of -tk.:: drw.:, _,.

l to Pf"Ptt.d'" .,,._......_ potauium iocftde_ (KIJ 111 prophyliili~fer the thyroid"in the unlikely twnt of a ma;<< radiological emergency at a corrimerciaJ nuclear power plant. Taken in time, Kl blocta the l"tvUat ro, i:i CA. ...u r a. ~"d ort-ie ,~ thyroid'* uptake of airboml radioactive iocfn, and thul could ~thyroid diNU11 \. c~.u, iit e,Mn:.tt. caused by IUCh 1xpoan 7' Ir ,..E4-"1 ~ o r t : CO,,,,p/t.ttfft/lft t>1:'1<<r- frorct.t11k. ti e.t1011s.,,

                  .                       ~                      !.:_!;:., t v~ "1,c11t Tl ""'f 4 ....-, I* -p l.u s l,,c ftt. r, .., J &(,Sc,,d.

Q..lrw prov,MS, fo protect- f'1t:. ,c111r-..( pul,f,'c ,,,,, 4:(. 1"411,t>io, ,u...C :

    ~~                                 3                  -                                                                               .

[ ~ FtderaJ policy(ilfat Kl lhould be llOCk;>>lled a n d - ~ 'tO emergency worklra I and lnstttutlonafized peraon:a ~urinSJ radiologlcal 1m1rg1nciu. In developing the range of 4!,. -tf.it ',:"" f>"(*"c. . . ~v,u'141'9k

     &,,bfigprotKtlve 1ctiona"')or Hvert accidents at COIM\ercial nuclur facffltiN, ttwi-(J                                                          i
                                                                                                                         -1£.ee.acsP-                 I protection for the 91naraJ publlc.,1Haw111W.
                                                  ~~--

technical lnfonnl1ion lndlcatu that evacuation and In-place lhlttlrinQ provldt ~

         ...., ~ :fhc1 pr*fl.f..f' i<u., w/,.ole. '-o&t

• l<I ,,...,,nc,S ~u,t,~,u p,.tCt.t,o... &f ..., r&A1.a.flOM*llMS1'n""'

                                                              ".;I';-fie   Sutt (or In aame cam, the local             .

ttt,

                                                                                                                                  -~~.~~ ro:*~, ~

u.s.:..a t"I I

                                                                                                                                                     /

govenvnentl la uttimataly responsible for the protection of Ju cJtlzena. Therafora,  !~i;::,~~: a..,. .,. I d1cilion for local 1tockpt1Jn; and UH of Kl u

• protactfva m1atur1 for the general pubBc I i i ~1 left to the discretion of Stat* ( or, In some c1n1, local government.)

AnACKMENT 1 (t""tfJ'"'('f. Be./,cv, ~,2 +,,~'!" 1<1 stoc.kp,I*":]. ,*s 4 req_sc,~i<d.,lt. ""'A prl.,,( "tl,,('r l'1t4.s,u*c., fl,t. Fu'ifra I G11.1(t'11 ,.,tr1r w, !I ptrrct.r,st St.-11,0l,'t:s: ol t< I fol'-fil()S( sft:1Tc!; (ot ,., s"" ca:>tt, to,~, 4'1.1<l'111-+ft11CT"S) fi,ar tltc,. n> k-1"~ K< , 11 , r

                                                                                   .,                   oF _,,.,C,t- elHtr'!J~"'~'f fill.Its.

2 It ii recognized that the State (or in some cases, the local government), within the limits of its authority, can take measures beyond those [ecommended oilrequired The availability of Kl as a protective measure for the general public supplements other options for public officials responsible for protective action decisions. A few States have indeed included Kl as a protective action for the general public. The FRPCC does not want to usurp the State pr1rogative to incorporate the UH of KJ u a protective measure for the generaJ public. Therefore, to ensure that States have the option 11.1 UH -KI if they 10 1lcci. the Feaeral government is prepared to provide funding for the purchau of a supply of Kl. Any State (or in some cases, local government) which 11l1ct1 the use of Kl H a protective measure for the general public may 10 notify FEMA, and may request funding for the purpoH of purchasing a supply of Kl. In addition, the Federal goverrvnent is also required to prepare for a wider range of radiological emergenciu'. To that end, and as. an added 1uur1nca for radiological_ emergencies .in which the location and timing of an emergency are unpredictable and for

                                                                                                      /,44,+ul which, unlike licensed nuclear power planu, there ii little planning ponibfl, ~ stockpile: of -

(J(t, ~t 4 l\ic..,.>>t r -SI i"iJ a_row..,,J.. ~c. IJ.~. .r

• Kl ,. being established by the Federal govemme ~ Federal 1tock;,lle will be available 11 to any State for any type of radioJogical 1merge!'\Cy, at any time.

      'In raponae 1D new thruU, the Federal go,.anvnent broadened 1he ~ of emerowv ~ - -

pre"arednaa to Include tarTOrism lnvolvtn; nuclear, biological, Ind chemical a;enu. A.* rautt. rd In IUJlpon of State and local ;ovemmanu. new resources were ldenUfied to be needed in raponaa to IUCh evsa. Atlout twO donn Metropolitan M.cflcal Strike Tuma (MMST) . . being ~ for .,..ponu to IUCh events. Medical aupplia, including ICJ, are being atoctplled nationally for the UH by MMST1 In thrN locationa: Eut coat. .C.ntral, and Wat coat. The quantity of suppnn ltoek;liled UID I planning baaia of 100,000 people for I period oftwodaya.

1

• 3 The policy herein incorporates changes recommended by the FRPC~* Su.bcom:nittu on Potassium locflde, and supersedes the 1985 Federal policy (50 fB 30258). The principal difference betwnn this raviled policy and the 1985 version are the addition of 1he, offer of l

the Federal Government to purchase a suppfy of Kl for Statu at* State'* request,.__. the

       ---;~bliahment of a Federal stockpile;} The Federal Emerg~ Management Agency (FEM.A) l    chairs the FRPCC, thereby assuming the ruponsibffity for thil put,Jicadon.

I I For Funhet Information Contact WUJiam F. McNutt, Senior Policy Advisor, Room 534, I Federer Emergency Management Agency, 500 C S ~ SW., WashingtOn, DC 20472, (202) 645-2857; facsimile (202 548-4183. ((.\l\t\ ~ ex.r I,c..-+- rtc.03111i-ti' 01-1 "', -ftu F°(.(\(i'~l jo\Jlo"IA.~(,(..t-, nJllct,b. i.., +{"' offu* to rurcl.vtSe ~I, ft.tc..f- t'1.1:S

          ~c.A,.lillf.L   C..0..11. l06C.tpft"'ie ..:t    o*fC1t!r-   prof,,t,ut..       ~t,uurrs
         ~         -kit~            t~ l.t&11AU- pro+ec.,t,'oi,,          of tfr<_ pkb(ie

                                                                               )

4

Background

This policy on use of KJ u I thyroidal blocking agent is the result of a Federal interagency effort coordinated by-FEMA for the FRPCC. On March 11, 1 982, FEMA issued I finaJ regulation in the federal Register (47 .EB 10758), which delineated agency roles and responsibilities for radiological incident emergency rupon11 planning (44 CFR 351 ). One of the rtsponaibilitiea uigned to the Department of Health and Human Services tHHS) and in tum delegated to the Food and Drug Administration (FDA) wu providing ;uk:lance to State and local governments on the use of radioprotective substances and prophylactic use of drugs (e.g., KJ) to reduce radiation doses to specific organs including dosage and projected radiation exposures at which such drugs should be used. In the June 29, 1982 Federal Register (47 .EB 28158), FDA published recorr.mendations for State and locaJ agenciH regarding the projected radiation doH to the thyroid gland at. which State and local health officials should consider the use of Kl. The Federal policy on stockpiling and distribution of Kl was published in the Juty 24, , 985 E,dera[ Reqjster (50

   .EB 30258).      On September 11, 1989, the American Thyroid Association requested FEMA, u Chair of the FRPCC, to reexamine the          1985 poUcy and to revisit the issue of atoclcpiling and dir..ibution of Kl for use by the general public. In responu, the FRPCC established an Ad Hoc Subcommittee on Potassium Iodide. {§n December 6, 1994, _the FRPCC adopted the report and recommendations of the Ad Hoc Subcommittee on Potauium Iodide, which reaffirmed the Federal position 11 expressed in the 1985       policy.]

F' leD-.t,<<EN,: ,r ,s Ft s,t..ftN"'= lrPPl!Mc.1+ 7D 111.:.n>tZ.Y TH11T F1AJ1>s 11U: Fr2Pc.C vo,C t,.JC>/Z.TH MtAJTIO ~1A.J'1 To THC PvSt.lC.. Bvr NOT' CHE /t.A)()S r1L. rue F~Pec.. I>t-TE.tZ-M 1MiT101.J lt.J/iS IJDT PG18(..1SHcb 8Cl1/4vSe FtMft l!EttL.('2e!) TINtT Ji /-f~b BCLIV J$1t5E,.b ON IJJC,01,,(fJ(..ErC-INf"f>tt,I,( ,.,, f.>N. ittvS m,s SE/.JtC IJ(. C M IH' L. E'ltl T-ff c /2.CriC( A. rt~ rt? A""*

L~;~:-~~. r:, ~~~- E.IJS ;L.,,, -tl:lfb 1""o OAJF1J[.1 oAJ. 5 On Apn1 3, 1996, in connection with

• September 9, 1995 Petition for Rulemaking aubmitted to the Nuclear Regulatory Commission (NRC) on this issue, the FRPCC established I new Subcommittee on Potastium Iodide to review current information. The SubcommittH conducted I public meeting on June 27, 1996. Baaed on the Information collected, the Subcommittee concluded ~*t there wu~ new information that seriously challenges the bases for the 1 985 recommendations concerning public use of Kl for radiological emergenc:as at nucJear power plants. However, several recommendations were made to 1h* FRPCC. The Subcommittee's three recommerid1tiona were: 1) without

                           *                           +

fi.,a.,t i i .s changing the Federal por.cvfi.v interceding !Hthe State's prerogative to make its own decisions on whether or not to UH KJ, the Fitder1I government (NRC, or through FEMA) should fund the purchase of a 1tockpUe for any State that, hereinaft r, decldea to incorporate Kl H protective measur* for the general public: 2) The SubcommittH believes the language in the 1985 policy should be softened to be more flexjble and balanced. For example, the problem many intervenora observe in the Federal policy la in the itaJicized statement "The 'Federal position with *** potassium*iocftde. for use by the-general public. ii.

that it should not be required.* It would not be u negative if the last ptvan were

• rewordt:I to state *it {potassium iodide for un by the general public] ia not required, but may be selected 111 protective measure at the option of the State or, in aome cun, local governments.* end 3) The subcommittee recommends that local jurisdictions who wish to incorporate IO II a protectJw action for the general pubrtc ahouJd consult with thl State to determine if such arrangements are 1ppropri1t1. If local governments have the IUthority or secure the approval to incorporate Kl as a protective measure for the general public, theY would need to include such a measure in their emergency plans.

NOTE°: I ll.ECO&IJIZ[ ilf~T -ri.;1~ f$; wllftT Trfr:  ::vG(OIJ.J.c1TTF~ Slttb. THC fl!.o&L't:M. IS iHhT" 11-ff KEY Pf..lrlfiSE /$ 11 T Ht t.f6f'!. Foe. n-c 1c;g;;- (2.1:C.OM. AAeU~A-Tit>I'- ** - - ,. e-.; .cosr- et:1-..rt f- ,r Tl-le: PHIZr1/2SF II I.Jo A.Jf:t..J

 , ~PorzM~T,&>AJ"            ,s   uts,<...,, ,,:;Kct\J o.J- =>" t..01.1,e'}..T'. rr LrlrlS ,11r

~Ov1l.lJM£1.Jt Of41 ,P n..,r; U'.,1(~1({),.;, St; Nb A)fil,J IAJF'r:>6.,t,A,,o,-J t.Al1i: OvT OF C. UE ll.A.108 "IL? 11

6 The full FRPCC endorsed the subcommittee's recommendations with some modifications* Polley on Distributfon of II Around NuclHr Power Situ ~ UH u a Thyroidal BlocJm,g Agent The purpoM of this document ii to provide Federal poDcy and guidance with regard to cfiltributfC)li of Kl, and !ts usage u a thyroid blocking ;ent, around operatin; nucJur pc,wer generating faciUtia. Thi iuue ha been lddraHd in t1rm1 of two c:omponenu of the popuJation that might rlQUirl or daire Kl uu: (1) Emergency w<<kera and institutionalized incf'rviduals clou to the nuclear power pfant site, and (2) the nearby general population. This ;uidance la for thoae State and local govenvnenta who, within the limits of their authority, need to consider these recommendations in Iha dewlopment of emer;ency plans and In determining appropriate actions to protect the general public. a.Ir: tuMi.ff'

        ~ Federal policy,. that Kl 1houkl be stockpiled and distributed to emergency                 worbrl
- - and instftutionafized .persons during radiological emergenciu; In dtvlfoping the* range, of L +or- tkc qt1.1u,J, P""""
       .pulalie pr.ltective actionaJtor severe accidents It commerciaJ nuclear faclDtiu, the mt Q11'4il~t.*lc.
                                                              .                                       -Ht, beiit'"

technical Information indic1t11 that evacuation and in-place aheftering provide 1~111-. prottctlon for the ;enerat pubr~I loWit&I, q.. r State (or In acme CIIU, the local govamment) ii ultimately responsible for the protection of itl citizenl. Therlfcn, the deciaion for local stockpDing and UH of Kl U I prot~ fflluunt for the general public ii left to the diacretion of State ( or, In some cases, local ;ovemrnent.) bt~ -ftctLt f'"i>~cr -f{,i tJ,.dt. ii~,\. t:I prt>'l~S. 4dJ it1 ~'4l f\):tct,c-,_. toe- O't(. ~4{,4.*f.0&-1-~iu:ti,uc. c,r~t.*, -f'1t -f',y,..1>itA; wkc."' vs~A '"" c.&..,~\.C.t.-1c.1',~~., wirl,, tvt\C1.t'-1*cn-1 ~ui for S~cffcr;,,5.

l

                                                                                   ~ t',c. F'dtM           1°"'1 ~wei.c,+.

7 It Is recognized that the State (or In aome cuu, the Jo.cal govenvnent>, within 1hl limit.a of Jta authority, can take measures beyond those[ecomrnended G!}ntQUintd,\ The availability of ICJ u a protective meas1n for the general public supplementl other optiona for pubDc offacials responsible for protective action decisiona. A few Statea hive indeed included Kl n

• protKtMt action for the general public. The FRPCC dou not want to usurp the State prerogative to Incorporate the UH of 1CJ U I protective measure for the general public.

Therefore, to ensure that States hive the option to UN Kl ff they so eJect. thl Federal govemmeni'. ii prepared to provide fundjng for the ~ of

• IUPPiY of Kl. Any State
• (or in soma cases, local govemmentJ which nlecu the uu of Kl u a protective measure for the general public may so notify FEMA, and may request funding for the purpose of'"'

pLl"Chasing I supply of ICJ.

                                                                                                                  /

In adcrraon, the Federal government is also required to prep** for

• wider range of radiological emergencier. To that end, and II an added auurance, for radiolo;icll emergencies in which the location and timing of an emergency are unpredictable and for

    - -- - - -           -       -          -                                                        liit,iM        st which, unDke licensed nuclear power plants, there la Uttle planning pouJble,

• stockpile" of att.. .,_e,t 4. 1111*.kr Q:f, :S'.fU '(rc>t.tt1l'l f&1L V, (', 'Tl\csc. S .

Kl J'.being established by the Federal govemmentl This Federal 1tockpUe"-wll be available to any State for any type of racf10logicaf emergency, at any time. The baa for theu recommendations are given below. ltn rapotllN to new ttvuia. Iha FecS.111 tovenwnent broedaned the scope of ll'Mlgtney **PCll'IN preparednNI '° lnducl* tam:>rilm, lnvoMna ru:ta., biolo;h:al, and chemical aoema. Aa

• l'-'t. and in auppon of Stats nl local toVlf'ffller'l'tl MW l'1SOUf'C8I WWI idlntlfied IO be nMdad In 1'91ponN to such .,,.-a. AboU't iwo doz.en Metropolitan Mecfal Strfu TNffll (MMST) . . being wtabll&hed for l"Npot'IN to IUCh 1YeMa. Medical suPpliel, lnclucl1nGI KJ, are being stockpilad nationally for 1h11 me by MMSTa In 1:hrN locdona: Eat co-.

Cefflrll, and WNt coat. Tht QUan1ity of supplla stodq)ii.d usa a plannin; bau of 100,000 people tor I period of twO dayL

                                                                                                   )

B The NRC and FEMA issued guidance to State and loc:"I authorities u well u licensees of operating commercial nuclear power plants in NURE~654/FEMA*REP-1, Revision 1, in 1980. This guidani:e recommends the stockpiling and distribution of Kl during emergencies to emergency workers and to institutionanzed individuals. Thyroid blocking for emergency workers and institutionalized Individuals was recommended because these lncfrviduals are more likely to be exposed to radioiodine in an airborne radioactive releue than other members of the public. In addition, the number of emergency worker, and institutionalized individuals potentiany affected t any ft* is relatively small and reciuiru a limited 1upply of KJ that can be readily distributed. For th* general public, in the event of. 1 radiological emergency t a commercial nuclear facility, evacuation and in-place sheltering are conaidered adequate and effective protective 1 ,.._µtJf: actions. It is well-recognized that the inclusion of KJ II a protective meuure, in addition ue oF AL>--

~, P,            to evacuation and sheltering, is beneficial only in very remote circumstancu. The.UH of ICJ is not without contrOV8f!Y. On the one hand, KJ h11 been shown to be an effective C thtU(;                           a.,.J.. "'1Po-ff.:, ro,d*~~

drug for protecting the thyroid tron\thyroid nodule~ er ~ jca"uud by the upt:1k1 of raa10iodine, especially in children fiftnn yeara of age or younger. On the other hand,

~.u>-t*/f:

rz_A\SC there are logistical difficufties, and e_otential medical side effects associated with the drug, f:.:'{,t in dil1ributing the drug to the general public in radiologk;J mrgncy. Alao, Kl rtcrs effectively reduces the radiation exposure of only the thyroid gland from ingested or rMO"(

~*p ~ 1~' inhaled radioiodineI. While this in an important contribution to the health and ufety of the

.~ Pt ..sf\i! .. iJ ~f1oJf. individual, it ii not u effective u measures which protect the total body. Both in-place r (' 2.. 1~ t,'fl.,. iheltering and precautionary evacuations can reduce the exposure to the thyroid 1.DQ the

~

1 A- _ ..,.!'I.E total body. It is very important to remember that the use of Kl is not an effective means

~t\~ ~,.> ~lG:.n'f1JtS ir.ulf>it?r,~v'( .,, Q_vv'~-{ ~~\,'< ,..,r. t of ~ ~~ ~ tS L.. pA tz.~ > ~ '"' oµ :'(µ::> er ". 1 c,'1.:~-z-'t-'~ Ll' 1tJ6P 1~( fD~E\J~t\&( ~~~1it-~r-f, lfl\tJ f\~ S ,,,_(o\;'1\1.'~

;~JJ "'~s~~,J~~~~*               0~~~1.t,  ~ ~t~ 1~~ ,,lotsc.<-1~ct-

8 by itseJf for protecting individuals from the radioactivity in *an airborne rel.... resulting from

• nuclear power plant accident and, thenlfora, should only be considered in conjunC'tjon with 1heftering, evacuation, or other protective methoda. Therefore, while the use of ICJ can provide 1ckfrtional protection in certain circumstancn, the asse.sament of the affectiveneas of Kl and other protective actions and their inplementation incrJCatn that the decilion to UH Kl (and/or other protective actionlJ lhould be made by the Stataa and, ff appropriate, local authorities on a lite-specific, a~ent-spec:ffic blm.

Those States or local governments which opt to include Kl for the ;eneral population wfl1 be ruponsible for the maintenance, cfastribution, and any subsequent costs associated with 1h11 program. The incorporation of

• program for Kl stockpDing, cfsstnbution encl VH by any State or local

                                                                                                      .,,J 1'HP
     ;ovemment Into the emergency plans        wru not be subject to Federal evaluation. Thia 18      <<"J CAt.l-r baud on the recognition that 'Che u11 of Kl    bv the State for 1he general pubic II

• 15('

toUr;

     ,upplemental protective measure, and on the Federal goyernment'a determination that the                 ~.E:
                                                                                                     * ~.C.,.,91,oc-l exllting emergency plaMing and ;,reparednen guidance for nuct... power plants ii                   I ,-J &JOIJ S
                                                                                                      µCcr,t'r,.

effective and adequate to protect the public health and Hfaty. The FDA hu evaJuated the medical and radiological rilb of IClrninlstering Kl for emergency concDtionl and ha1 concluded that It is nfe and effective and hu approved over-'the-counter Ille of the drug for thil purpose. FDA guidance ~... that riau from the lhort term use of relatively low doses of Kl for thyroidal blocking in

• radiological emergency are outweighed by the riska of radioiodine induced thyroid nodul11 or cancer ll't a projected

                                                                                        }-

10

                                                                                                                          ~ \J "C~~

Lu

                                                                                                                    "- .q g dQH to the thyroid gland of 25 rem or greater. Since FDA       ha authorized the                     ....  "')        ~
                         .                     ~                                                                    ~~ ~

nonpracription sale of Kl, it Ill IVBilable to indivlduala who, band on their own peraonal

                                               ~                                             .                     ~~~

e-

                                                                                                                           ~<

analysis, choose to have the drug immediately available. ~~

                                                                                                                     \J Q             :;}

4

                                                                                                                     ~               i::.

Attached ii a list of ten references intended to assist State and local authorities in

                                                                                                                    ~~ ~
                                                                                                                    ~~ ~

decilionl rellted to the uu of ICJ. .... ~ J \... 1IL Q Lt~~

                                                                                                                   ..,j   ~""         -
                                                                                                                   ~~'.\:
                                                                                                                   ~                 ~
                                                                                             '                    *~        ~ ~
           . The FRPCC did not find any new information that would raquinl

• chang~ In tho bum of ~ °'- ~ -

the existing Federal' policy concerning the stock.pile or pre-distribution of ICI for the general ~ 'i:- ~ public in thl . ~ - of

• rad"t0logicaJ emergency It I commercial nuclear ~ant. The policy ii ~~S t.a)~

                                                                                                                   ~.....  '-(_     ~

thlt ICJ should be stockpiled and distributed to emergency workers and institutionalized

                                                                                                                  ~'u~

persona during radiological emergencies, but leaves the decision for the stoctpling, ' ~\'::!-~:-,.... l...[ d1ltribution, and use of Kl for the* general pubfte to thl d"ascretion of State, and in aom*

• CIHI, local ;ovemm1nts. Any State or local govenvnent that 111ect1 the use of Kl u a
• protective measure for the general public may so nottty FEMA and may requut funding for

             '.lf,e purpoll of purchuin; an adequate supply.

[ The incorporation of a program for Kl ltoekplling, diltribution and UN by any State or local 1 cJ t..l> government ~ the emergency pllna will not be subject to FedaraJ evaluation. Thia II

i f'1'l based on the recognition that the uu of Kl by 1he State for the general pub&c ii a

,tl't utlfl aupplemental protective measure, and on the Federal govemment"a determination that the

11 existing emergency plaMing and preparedness guidance for nuclear power pltlnts ii

 *ff*ctfv* and adequate to protect the public health and safety. J Those States or local governments which opt to include Kl for the general popwation will be responsible for the maintenance, distribution, and any subsequent coau or '89&1 flabirrties associated with this program.

Al an added assurance, for a broader range of radiological 1n,ergenciel in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little plaMinQ possible, a stockpile of Kl wffl be established by the Federal government. Such a stockpile would consist of lnc:flVidual Kl caches at VA hospital* in major metropolitan center1 across the country. This supply would be available to any State or local government for any type of radiological emergency. National Council on Radiation Protection and Meas~ (NCRP), *Protection of the Thyroid Gland In the Event of Releases of Racft0iodina,

• NCRP Report No. &5,

_August 1, 1 en.

2. Food and Drug AdmJnistratlon (HHS). ~ i u m ~de ii* Thyroid-Bt~~kk,gA;ei,t~ -~~

in I Radiation Emergency, 43 .EB 58798, December 16, 1978.

12

3. Halperin, J. A., 8. Shlelen, S. E. Kahana, and J. M. Bilstad; *Background Material for the Development of the Food and Drug Administration'* Recommendations on Thyroid Blocking with Potassium locflde,

• FDA 81 ~ 158, U.S. Department of Hulth and Human Servicaa (March 1981).

4. food and Drug Administration; Potasaium Iodide ~ I Thyroid-Blocking Agent in I Raaaation Emergency: Final Recommer.dltionl on.Un (Notice of AvaillbiDty) '!7 fB 28158, June 29, 1982).

6. Food Ind Drug Administration; Potassium Iodide u I Thyroid-Blocking Agent in 1 Radiation Emergency: Recornmendationl on u... (AprlJ 1992). Prepared by the Bureau of Radiological Health and Bureau of Dn,g1, Food and Drug Administration, Department of Health and Human Servica.

e. NuclNr Regulatory Commiaalon; Examination of the UH of Pot ulum Iodide 00) u an Emergency Protectiw M1 1ur1 for Nuclear Reactor Accidlnta (NUREG/CA-1433, March 1990). Prepared by Sandia National Laboratorial for the NRC.

7. Nuclnr Regulatory Commiuion; An AnaJya1a of Potanium Iodide (Kl) Prophytaxil for the General Public in the Event of a ldent (NUREG/CR-e31 O, February 1995). Prepared by S. Cohen and Auodatn, Inc. and Scientech., Inc. for the NRC.

g'i" A.Jot,j , Th, s !;iH o u1..JJ ~ ~ /2.t GA et>E"l:) As '])1sc12E D1TE.J). Pr, iH-C" \IE.r'l"I l £ ~ , IT HrlS 8c£1J 5w1P£:LS£hE.l) Sy tHC /2c,tAJA'--~'s ltJ tvLJl2.f:~(Cr2-~3,o { r,cJ-4. 7")~

13

8.

• Nuclear Regulatory Commissjon; Re-Evaluation of Policy Regarding UN of ,

Potauium Iodide After Severe Accident t I Nuclear Power Plant (SECY-93-318, November 23, 1993). I. Nuclear Regulatory Commission: Addendum to SECY-93-318, Re-Evaluation of J ' Policy Regarding Use of Potassium lodk.te After

• Severe Accident at
• Nuclear Power P1'1nt (ScCY-94-087, March 29, 1994).

0. Mega Hepler, Ill Chair Federal RadiologicaJ Preparedness Coordinating Committee u t>u LJ) Su, C. cs T Al)1>1N' T~ Fo U6tJ 11,J{, e ~Fell~ es

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'" Peter G. Crane I 4809 - '.tmmond Avenue I Che--..1* Chase, M. 10815 I J0J-656-3998 DOCKEiED Uv7 fC:iJOf'

                                                                                                        ,L, Novernber 12 , 1997 Mr. John C. Hoyle, Secretary                                                   YI tC'v 13 AlO :1 O U.S. Nuclear Regulatory Commission Washington, D. C. 20555                                                 OF-: .                 : ,..

R . . ,

                                                                               . L        *.

• Al'"\ 11 :,**/',

r,J,..,/1,Jl.,./tJ, I I Re: Amendment to Petition for rulernaking ( PRM-50-63)

Dear Mr. Hoyle:

On rereading my filing of earlier today ( dated November 11), I find a minor editing error ( two references instead of one to the Commission's SRM of June 30, 1997) in the third paragraph of the third page. Would you be so kind as to replace the third 'page with the attached correction? Otherwise the document is unchanged .

• • Thank you.

Sincerely,

                                     /)If-;!

l',-<.1/4 ~ Peter G . Crane

Attachment:

corrected page 3

IN RESPONSE, PLEASE REFER TO M97ll05A November 25, 1997 MEMORANDUM TO: L. Joseph Callan Executive Director for Operations FROM: John c. Hoyle /s/

SUBJECT:

BRIEFING ON PROPOSED RESOLUTION TO A PETITION FOR RUL.EMAKING RELATING TO USE OF POTASSIUM IODIDE (KI) FOLLOWING SEVERE ACCIDENT AT A NUCLEAR POWER PLANT, 9:35 A.M. WEDNESDAY, NOVEMBER 5, .1997, COMMISSIONERS CONFERENCE ROOM, ROCKVILLE, MARYLAND {OPEN TO PUBLIC ATTENDANCE) The Conunission was briefed by representatives of the Federal Emelig'ency Management Agency; by Mr. Peter Crane, author of a petition for rulemaking (PRM-50-63) on the use of potassium iodide (KI); and by the NRC staff regarding issues associated with a proposed change to the Federal policy on the use of KI as a protective measure for the general p'Lµ)lic following severe accidents. The Commission indicated that it would temporarily defer action with respect to resolution of. PRM 50-63 (SECY 97-245) and the draft Federal Register Notice on Federal KI Policy (COMSECY-97-028 pending submission by the petitioner of a revision to his petition reflecting the petitioner's comments at the meeting and the ~~aff's subsequent evaluation of che impact of the revised petition on its recommendations as reflected in SECY 97-245. (EDO) (SECY Suspense: 12/12/97)

• cc: Chairman, Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OIG Office Directors, Regions, ACRS, ACNW, ASLBP (by E-Mail)

PDR DCS

    . ' .                                                                        l Action: Collins, NRR/Martin, AE UNITED STATES                         Cys: Callan NUCLEAR REGULATORY COMMISSION                             Thompson WASHINGTON, D.C. 20555                         Thadani Norry Blaha June 26, 1998                                 Bangart, SP Knapp, NMSS OFFICE OF THE SECRETARY w    ,,s            q7 /JO            (f 3 Morris, RES Meyer, ADM Shelton, CIO l Jamgochian, NI Congel, AEOD L Joseph Callan Trottier, RES MEMORANDUM TO:

ire or for Operations e,_ FROM: ry

SUBJECT:

AFF REQUIREMENTS-SECY-97-245 and SECY-98-061 -

STAFF OPTIONS FOR RESOLVING A PETITION FOR RULEMAKING (PRM-50-63 ANO 50-63A) RELATING TO A RE-EVALUATION OF THE POLICY REGARDING THE USE OF POTASSIUM IODIDE (Kl) BY THE GENERAL PUBLIC AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT and COMSECY-97-023 - FEDERAL REGISTER NOTICE ON' POTASSIUM IODIDE The Commission has disapproved the staff's recommendation to deny the petition for rulemaking and approved Option 1. As such, the staff should proceed with rulemaking to change 10 CFR 50.47(b)(1 O} by inserting the following sentence, or similar words, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl}, as appropriate.* In addition, the Federal Regjster notice and the statements of considerations for the proposed and final rules should be modified to include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective s;;pplement is reasonable and prudent for specific local conditions. The Federal Regjster notice should be reviewed by the Commission before the notice is given to the other relevant agencies for their review. The Commission notes that, consistent with the Commission's decision on the June 30, 1997, SRM, the Federal govemmer.t (most likely NRC) is prepared to fund the purchase of a stockpile of Kl for the States upon request. The NRC staff should work with other relevant agencies to ensure that there are established procedures to enable the national stockpile to be effectively and timely used by states th~t have not established local stockpiles and wish to make use of the national stockpiles In the event of a severe nuclear power plant accident. To assist the State and local decision makers, the staff should submit its paper, *Assessment of SECY NOTE: This SRM, SECY 98-061, SECY 97-245, COMSECY-97-028, and the , Commission Voting Record for SECY 98-061 containing the vote sheets of all Commissioners will be made publicly available 5 working days from the date of this SRM.

the Use of Potassium Iodide (Kl) as a Public Protective Action During Severe Reactor Accidents,* for public comment. Staff is encouraged to submit the assessment in whole, or in part, to peer reviewed journals for publication. Following receipt and evaluation of the public comments, the staff should revise the paper, as appropriate, subject to Commission review. Using this as a basis, the staff should complete and issue a user-friendly infonnation brochure containing the essential data and analyses In the technical assessment attached to SECY 98-61 to assist State and local planners in reaching an infonned decision as to whether Kl is an appropriate protective supplement.

        ~00)-(SECY Suspense:         Draft federal Register Notice        ,1,i1,~      7/8/98   9700193 (NRR/AE0D)                   Notice of proposed rulemaking         10/29/98    10/22/98    II II Issuance of final assessment report 10/29/98      10/22/98    II Issuance of brochure          no later than final rule) cc:     Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC
       ~10 CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

PDR

       -ocs

[7590-01-P] NUCLEAR REGl)LATORY COMMISSION 10 CFR Part 50 RIN: 3150-AG11 Consideration of Potassium Iodide in Emergency Plans AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is proposing an amendment to its emergency planning regulations governing the domestic licensing of production and utilization f~cilities; The proposed rule would amend the current regulations to indicate that consideration shall be given to including potassium iodide {Kl), along with sheltering and evacuation, as a supplemental protective measure for the general public. The proposed rule responds to petitions for rulemaking submitted by Mr. Peter G. Crane concerning the use of Kl in emergency plans.

EFFECTIVE DATES: The comment period expires 90 days after publication In the Federal

• Regjster. Comments received after this date will be considered If practical to do so, but only those coinments received on or before this date ca~ be assured of consideration.

                                                                       )

[7590-01-P] ADDRESSES: Comments may be sent to the Secretary of the Commission, Attention: Rulemaking and Adjudications Staff, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or may be hand-delivered to One White Flint North, 11555 Rockville Pike, Rockville, MD 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be examined at the Commission's Public Document Room at 2120 L Street NW (Lower Level),* - Washington, DC. You may also provide comment via the NRC's interactive rulemaking web site on the NRC home page (http://www.nrc.gov). This site provides the availability to upload comments as files in any format that the NRC web browser supports. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG@nrc.gov .. FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Telephone: (301) 415-3224. Internet: MTJ1@NRC.GOV. SUPPLEMENTARY INFORMATION: By undertaking this rulemaking, the Commission is proposing to grant two petitions for* rulemaking (PRM-50-63 and 50-63A) from Mr. Peter Crane submitted on September 9, 1995, and November 11, 1997. Considering all public comments received, the information available in the literature, 20 years of experience gained In evaluating licensee emergency preparedness plans, and the arguments presented by the petitioner, the Commission has decided to grant the petition for rulemaking and to proceed with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the following sentence, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate." In addition, the preamble for this proposed rule includes a statement to the effect that State and local decision makers, provided with proper Information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. The Commission also noteq that, consistent with the Commission's decision on June 30, 1997, the Federal government (most llkely the NRC) Is prepared to fund the purchase of a stockpile of Kl for the States, upon request. The NRC staff will work to ensure that the process for States to obtain funding for K! Is established. The NRC staff will also work with other relevant agencies to ensure that there are established procedures to

• enable the national stockpile of Kl, for terrorist activltie*s, to be effectively and timely used by states that have not established local stockpiles and wish to make use of the national stocikplles in the event of a severe nuclear power plant accident.

        , On November 27, 1995 (60 FR 58256), the Nuclear Regulatory Commission (NRC) published a Notice of Receipt of a petition for rulemaking {PRM-50-63) flied by Mr. Peter G.

Crane on his own behalf. The petitioner requested that the NRC amend Its regulations concerning emergency planning to include a requirement that emergency planning protective actions Include the prophylactic use of potassium iodide (Kl), which the petitioner notes prevents thyroid cancer after nuclear accidents. On November 11, 1997, the petitioner submJtted a revision to his original petition (PRM-50-63A). The NRC published-a Notice of Receipt of the amended petition on December 17, 1997 (62 FR 66038). In the amended petition, the petitioner requested that: A statement [be made] clearly recommending stockplllng of Kl as a "reasonable and prudent' measure, ,and; A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the

                                                                        , }

first ~entence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate." The petitioner also provided a marked-up version of the proposed Federal Radiological Preparedness Coordinating Committee (FRPCC) Federal Register notice concerning Federal policy relating to the use of Kl for the general public. On June 26, 1998 (SRM 98-061 ), the Commission decided to grant the petition for rulemaklng PRM-50-63.A by directing the requested amendment to 10 CFR 50.47(b)(10). The Commission also directed that the preamble for the proposed rule include a statement to the effect that State and local decision 'makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. Petitioner's Basis for Requesting Potassium Iodide The petitioner stated that potassium iodide (Kl) protects the thyroid gland, which is highly sensitive to radiation from the radioactive iodine that would be released in extremely serious nuclear accidents. By saturating the gland with Iodine in a harmless form, Kl prevents any inhaled or ingested radioactive iodine from lodging In the thyroid gland, 'where it could lead to thyroid cancer or other Illnesses. The petitioner stated that the drug itself has a long shelf-life, at least 5 years, and causes negligible side effects. The petitioner further stated that, in addition to preventing deaths from thyroid cancer, Kl prevents radiation-caused Illnesses. The petitioner notes that thyroid cancer generally means surgery, radiation treatment, and a lifetime of medication and monitoring. The petitioner asserted that the changes in medication that go with periodic scans put many patients on a physiological and psychological roller coaster. The petitioner stated that hypothyroidism can cause I permanent retardation in children and, if undiagnosed, can condemn adults to a lifetime of fatigue, weakness, and chills. The Petitioners Discussion of the Three*Mile Island Accident (TMI) The petitioner noted that in December 1978, the FQOd and Drug Administration {FDA) announced that It had determined that Kl was safe and ',effective for thyroid protection in nuclear* accidents. The petitioner stated that the issue attracted little attention, that the NRC and the Federal Government as a whole took no public position 9n the drug, and that three months after

• the FDA announcement, on March 28, 1979, the TMI accident began to unfold. The petitioner stated that Federal and State officials, searching for supplies of Kl in case It should be needed, discovered that none was to be had and that a supply had to be manufactured, literally overnight The petitioner Indicated that at 3:00 a.m. on Saturday, March 31, 1979, an FDA official arranged with the Mallinckrodt Chemical Company for the immediate production of 250,000 doses of KJ.

                                                                  'i The petitioner also discussed the Report of the President's Commission on the Accident at Three Mile Island (the Kemeny Commission report), issued In October 1979, and stated that

• the report was strongly critical of the failure to stockpile Kl. The petitioner noted that .among the Kemeny Commission's major recommendations was that an adequate supply of the radiation protective agent, KJ for human use, should be available regionally for distribution to the general population and workers affected by a radlologicaJ emergency.

                                                                          )

l. ,

The Petitioner's Discu~ion of the Potassium Iodide Polley The petitioner stated that In NUREG-0632, *NRC Views and Analysis of the Recommendations of the President's Commission on the Accident at TMl,n ~ued in November 1979, the NRC agreed with the findings of the Kemeny Commission and planned to require nuclear power plant licensees to have adequate supplies of Kl available for nuclear power plant workers and the

                                                             "'"', l general public as part of State emergency response plans:

According to the petitioner, the three agencies most concerned, the FDA, the NRC, and the Federal Emergency Management Agency (FEMA), favored the stockpiling of KJ tor the next several years. The petitioner stated that the Atomic Industrial Forum, a nuclear industry trade association, declared Itself against the stockpiling of Kl in May 1982. The petitioner indicated that the NRC staff was strongly in favor of Kl stockpiling as late as September 27, 1982, when the NRC staff submitted a memorandum to the Commissioners proposing that the Commission agree with a draft interagency policy statement supporting Kl stockpiling. The petitioner further stated that on October 15, 1982, less than 3 weeks after _ .sending. the draft policy statement to the Commission for approval, the NRC staff sent a supplementary memorandum withdrawing the memorandum of September 27. The later memorandum informed the Commissioners that NRC's Office of Nuclear Regulatory Research (RES) could, by January 1, 1983, produce a paper showing that Kl was significantly less cost - beneficial than previously assumed. The NRC staff proposed sending this document to the FDA and FEMA With the recommendation not to stockpile and distribute Kl. The petitioner indicated that the NRC staff briefed the Commission in November 1983 on the NRC staff's proposal to take a strong position against Kl. A policy statement was later issued that disposed of the Kemeny Commission's recommendation in favor of stockpiling Kl. According to the

 ,,, petitioner, only a year later, the Chernobyl accident would give tangible proof of the value of the drug In radiologlcal emergencies.

The Petitioner's Discussion of the Effects of Chernobyl The petitioner stated that during the Chernobyl accident of 1986, the damaged reactor spewed radioactive iodine over a wide area of what was then the Soviet Union and Poland. The petitioner further stated that in Russia, the Ukraine, and Belarus, where the distribution of Kl was Inadequate and untimely, the population In these countries is now experiencing extraordinarily high levels of childhood thyroid cancer. However, in Poland, where Kl was administered to 97 percent of the nation's children, there has been no similar increase In .~ryroid cancer. The petitioner noted that Poland Is a proof-positive example of the benefits of a well-prepared Kl program. The petitioner stated that the U.S. Government Is spending money to study radiation-caused thyroid cancer in the Ukraine and Belarus, and the Department of Energy (DOE) announced a $15 million, 15-year program that will foUow 70,000 children In the Ukraine, 'i

                                                                                                           \

to understand the thyroid cancer risk of exposure to radioiodine. The petitioner further stated that the U.S. Government has spent generously to bring Ukrainian doctors to the United States for training In thyroid surgery because mishandled operations can result in ~maged nerves and larynxes, rendering patients p~{manently mute., The petitioner discussed post-Chernobyl developments on Kl policy. He stated that the Chernobyl accident demonstrated that Kl worked and that countries that failed to stockpile and distribute It are experiencing serious public health problems. The Petitionl!r's Discussion of the NRC's Reconsideration of Potassium Iodide The petitioner notes that In June 1989, the NRC reconsidered the Kl Issue after the . petitioner filed a differing professional opinion urging a:change in policy. On November.27, 1989, the American Thyroid Association wrote to the NRC urging Kl stockpiling on a nationwide basis and, In 1990, the NRC announced that It was reconsidering the *existing Federal policy: .In April 1992, a contractor under the sponsorship of the NRC Office of Nuclear Regulatory Research issued a report that Included a revised cost-benefit analysis of the use of Kl. The petitioner described the report as concluding that stockpiling Kl continued to be not cost-effective, but that the difference between costs and benefits was narrower than had been calculated by the NRC staff,in the 'early 1980s. The petitioner further indicated that, In ** - December 1993, an industry trade group, the,Nuclear Utility Management and Resources Council, sent a report entitled *Review of Federal Policy on Use of Potassium Iodide: to the Commission arguing against any change in current Kl policy. The petitioner noted that, in March 1994, the NRC staff declared its support for Kl stockpiling. However, the NRC staff proposal for a change in policy was not adopted, the Commissioners having voted 2 to 2. on the staff's proposal in May 1994. (Under Commission procedures, a tie vote means that a proposal falls.) The Petitioner's Discussion of Additional Support for Granting the Petition for Rulemaking , The petitioner described a September 1994, FEMA publication proposing* a *Federal Radiological Emergency Response Plan* that envisioned the use of.Kl during radiological emergencies. Under the plan, the NRC would be the lead Federal agency during emergencies at nuclear power plants and would advise State and local governments whether or not to distribute Kl (based on advice received from an interagency panel). The States and localitles

• would th~n administer the Kl, if necessary.

The petltioner also indicated that the Board of Governors of the International Atomic Energy Agency, with U.S. Government support, adopteq new International Basic Safety Standards in 1994. The petitioner stated that these standards represented the consensus of the world's experts on radiation safety and the standards provide, among other things, that intervention levels of Immediate protective actions, including sheltering, evacuation, and iodine prophylaxis, shall be specified in emergency plans. Thus, the petitioner stated, the international radiation protection community, like the Kemeny Commission in 1979 and the short-lived draft

• Federal policy statement of 1982, recogn_ized that effective preparedness for radiological emergencies means having three actions to consider [evacuation, sheltering and iodine '*

prophylaxis]. The Petitioner's Discussion of the Merits of the Petition for Rulemaking The petitioner believes the NRC should Implement the recommendation of the Kemeny Commission and that the United States should maintain the option of using the drug Kl for public thyroid protection during nuclear accidents. The petitioner requested that the Commission definitively review and decide on the issue rather than simply having the NRC staff decide not to propose it to the Commission. The petitioner stated that evacuation is not necessarily the protective measure of choice in every emergency, and even when it is the preferred option, it is not always feasible. The Kemeny Commission report explained that different types of accidents, and the particular circumstances presented, may call for different protective measures. The petitioner notes that

                                                                       . J maintaining a Kl option ensures that responsible authorities have the option of additional protection at their disposal.

The petitioner Indicated that NRC has made it clear that a finding of adequate emergency planning does not translate Into a guarantee* that the entire affected public can be evacuated, but that evacuation is generally feasible. The petitioner believes that sometimes, either by,choice or necessity, authorities may decide to shelter people or tell them to remain indoors rather than evacuate them. The petitioner points out that it may be desirable to administer Kl any time people are sheltered or told to stay Indoors, when evacuation routes would take people through areas of radiological contamination, and when there has been a large airborne release of radioactive Iodine to the atmosphere. The petitioner believes that the decision on stockpiling Kl should tum on whether, given the enormous consequences of being without it in a major accident, the drug Is a prudent measure; not on whether It will necessarily pay for itsetf over time. The petitioner further believes that Kl represents a kind of catastrophicxoverage insurance policy offering protection for events which, while they occur only rarely, have such enormous consequences that it is sensible to take speciaJ precautions. The petitioner stated that the estimates of Ki's cost-effectiveness depend on estimates that are no more than informed guesses about the probability of severe accidents and that the NRC's cost-benefit analysis of the early 1980s was based on the assumption that a severe accident with a major release of radioactMty could occur In this country only once every 1 or 2 thousand years. The petitioner believes that if it were really true that serious accidents with a release of radioactivity were 8<? unlikely, there would be good reason not only to reject stockpiling of Kl but also to dispense with all emergency planning. The petitioner also stated that if Kl Is not

                                                 *10-

cost-effective, then the rest of nuclear emergency planning Is probably not cost-effective either. The petitioner believes that cost-benefit analysis is a technique that should be applied with good sense, especially where public health measures are concerned. According to the petitioner, the cost-benefit analysis of Kl proceeded fror:n.the assumption that there was-no difference in desirability between prevention of radiation-caused thyroid disease and cure. Thus, the only factor to be considered in evaluating Kl was the cost. The petitioner aJso believes that the U.S. Government determined that Instead of spending money to prevent radiation-caused thyroid disease, society should spend Its money treating the disease If and when It occurs. The petitioner believes that the existing policy on Kl was defective from the start because It was based, In part, on inaccurate information provided to the NRC Commissioners. He stated that the Information provided to the NRC Commissioners seriously understated the significance of radiation-caused thyroid disease and thereby understated to an equal degree the value of Kl. The petitioner also believes that it was not clear that the Commission had any idea of the real nature of post-accident thyroid disease at the time It adopted an anti-Kl position. The petitioner stated that existing policy left the judgment on stockpiling Kl to the States. The petitioner asserts that this policy also ensures that the States do not have an adequate basis for making informed decisions. He believes that the Federal Government, and NRC in particular, has failed to provide the States with sound technical advice on the subject. The petitioner also believes that without accurate and current information on Kl-including the . Chernobyl experience and the consensus of international experts-States cannot make an Informed judgment. The petitioner believes that no State or local official or member of the public could imagine that in a real emergency, there would be no Kl to administer. The petitioner raised the l : question: If Kl stockpiling is not worthwhile, why is the administration of the dru~ one of the protective measures identified in the 1994 Federal Emergency Re~pons,e Plan? He also asked why, If Kl Is worthwhile, as the plan implies. something is not being done to make sure1hat it is available. The petitioner believes that the Federal Government should elth~r change the 1985 policy and make the use of Kl a viable option In a real emergency, or it should explain why the United States ~as decided that Kl will not be an option. ~:: *, The Petitioner's Proposed Amendment to the NRC Regulations In the original petition (PRM-50-63) that was submitted on September 9, 1995. the ' petitioner requested that 10CFR Part 50 be amended to Include language taken from FEMA's Federal Radlologlcal Emergency Response Plan of September 1994, and recommended the following revision to the regulations. The petitioner proposed that Section 50.47(b)(10) be amended to read as follom: (1 O) A range of protective actions Including sheltering. evacuation and prophylactic use of Iodine have been developed for the plume exposure pathway EPZ [emergency planning zone] for emergency workers and the public.. Guidelines for the choice of protective actions during an

• 12
• emergency, consistent with Federal guidelines, are ~eveloped *.

and in place, and protective actions for the Ingestion exposure

pathway EPZ appropriate to the locale have been developed.

In the revised petition (PRM-50-63A) that was submitted on November 11, 1997, the petitioner requested that 10 CFR 50.47(b) be revised to;read: (1 O) A range of protective action have been developed for the plume exposure EPZ for emergency workers and the public. 1n

• developing this range of actions. consideration has been given to evacuation, shelterjng, and the prophylactic use of potassium iodide (Kl). as appropriate. Guidelines for the choice of protective actions during an emergency, consistent I

with Federal guidelines, are developed and In place, and protective actions for the ingestion exposure pathway c:PZ appropriate to the locale have been developed .

• The petitioner believes that if this revised change is adopted, the plan will become an accurate description of emergency preparedness for radiological emergencies; the recommendaJion of the Kemeny Commission will at last be implemented; and the United States will be in compliance with the International Basic Safety Standards.

The petitioner suggested that the NRC, either on its own or jointly with other agencies, ( issue a policy statement declaring that Kl stockpiling is a reasonable and prudent measure that is necessary to ensure that the drug will be available In the event of a major accident. The petitioner believes that this statement would clarify that Kl can be used in conjunction with evacuation and sheltering to maximize protection to the public. The petitioner also believes that the policy statement would show the willingness of the NRC to provide a stockpile of the drug to States and localities upon request, and would support the Kemeny Commission's recommendation to create.regional stockpiles of the drug as a backup for emergencies. Discussion Stockpile of Medicinal Supplies for Nuclear, Biological, and Chemical Agents (1995) In June 1995, the President Issued Presidential Decision Directive 39 (PDD-39) on U.S. Policy on Counter Terrorism. The PDD-39 directed Federal agencies to take a number of measures to reduce vulnerability to terrorism, to deter and respond to such acts, and to strengthen capabilities to prevent*and manage the consequences of terrorist use of nuclear, biological, and chemical (NBC) weapons, including weapons of mass destruction. The PQD-39 assigned to FEMA the task of ensuring that the ,Federal Response Plan (FRP) was adequate to respond to the consequences of terrorism. FEMA, In coordination with the Catastrophic Disaster Response Group (CDRG) 1 , developed a draft report to the President entitled, "An Assessment of Federal Consequence Management Capabilities for Response. to Nuclear, Biological or Chemical (NBC) Terrorism," dated June 12, 1996. The report recommended, among other things, that the Federal Government purchase and stockpile thyroid blocking agents: (Kl) for the general public that 1 The CDRG is the headquarters senior-level coordinating group which addressees policy issues regarding the Federal Response Plan (FRP)*.

• The CDRG is chaired by FEMA and comprises representatives of Federal departments and agencies with responsibilities under the FRP. The NRC is represented by the Incident Response 'Division Director, AEOD.

could be used In the event of a nuclear terrorist event. The NRC was a member of the Core Group which generated the recommendations and was instrumental In adding Kl to the list of medical supplies to be stockpiled nationally. The Core Group concluded that as the result of recent events, significant threats over the past few years, and the increased availability and proliferation of NBC materials, there is an increasing concern for the potential of terrorist Incidents. NBC events, the report continued, may occur as a local event with potentially profound national Implications. In responding to these events, the first responders must be able to provide critical resources to the victims. These Include, but are not limited to, chemical nerve antidotes, vaccines for anthrax, and antibiotics. The Core Group Identified the need to purchase and preposition stockpiles of_ adequate medical supplies at the Federal, State, and local level. While Kl was not considered as vital as chemical nerve antidotes and vaccines, the NRC staff was successful In getting Kl included with other medical supplies for NBC events because of the unusual characteristics of these events. Because of the special characteristics of NBC events, the Core Group recommended ~ broader range of protective actions. The NRC concurred in the findings of the report In a letter dated September 25, 1996, from the Director of NRC's Office of Analysis and Evaluation of Operational Data to FEMA's Director. The report was subsequently presented to the President In February 1997, and approved for distribution in May 1997. FRPCC Subcommittee on Kl (1996}. Along with petitioning the NRC, Mr. Crane also requested that FEMA review his petition and reconsider the Federal policy. In early 1996, the FRPCC convened an Ad-Hoc Subcommittee on Potassium Iodide to request and review new information on this matter from interested parties. The subcommittee conducted a public meeting on June 27, 1996. The subcommittee evaluated all comments from ~e June 27 public meeting and made the followirg recommendation regarding the Federal Kl policy:

1. Without changing the Federal policy by interceding In the State's prerogative to make its own decisions on whether to use Kl, the Federal Government (NRC, or through FEMA) should fund the purchase of a stockpile for a State that decides to incorporate Kl as a protective measure for the general public;

2. The Subcommittee believes the language In the 1985 policy should be softened to be more flexible and balanced. For example, the*problem many intervenors observe with the Federal policy is _the italicized statement "The Federal position with ... potassium Iodide for use by the general public is that it should not be required.* It would not be as negative If the last phrase were reworded to state "it [potassium Iodide for use by the general public] is not required, but may be selected as a protective measure at the option of the State or, in some cases, local governments.*"

3. T.he subcommittee recommends that local jurisdictions that wish to incorporate Kl as a protective action for the general public should consult with the State to determine if these arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include this measure In their emergency plan~.

Analysis of Issues Raised by Public Comments

• On November 27, 1995 (60 FR 58258), a Notice of Receipt of the Petition for Rulemaking was published In the Federal Register requesting public comment. A total of*

63 comment letters were received, of which 20 utilities, 9 State governmental agencies, 2 utility interest organizations, 1 letter signed by 12 health physicists, 2 State universities and 1 member of the public were against the granting of the petition for rulemaklng. Those letters in ,, favor of granting the petition came from 5 environmental groups, 22 members of the public (including 1 from the petitioner), and the American Thyroid Association. On December 17, 1997 (62 FR 66038), the Commission published a request for public comment on the revised petition in the Federal Register. In response to several requests, the comment period was extended until February 17, 1998, by a Federal Register notice published on January 21, 1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 utilities, 3 State governmental agencies, 1 utility interest association, and 1 member of the public were against granting the petition for rulemaking. :The letters in favor of granting the petition came from 8 public interest groups, 46 members of the public (including 1 from the petitioner), 3 physicians, 2 U.S. Senators, and 1 State Representative. The following issues were raised by the public commenters with an accompanying Commission response: Issue 1 Nearly all nations with nuclear power protect their citizens by having Kl readily available and the logistics of distribution do not seem to pose any significant problems. Would implementing a policy of using Kl for the general public be so difficult? Commission Response At the November 5, 1997, Commission meeting, senior NRC staff members told the Commission: "We recognize that there are difficulties in distribution, but they are not insurmountable. If a decision is made by the State to do it [stockpile and/or predistribute Kl] we can figure out a way to do it.* It is the Commission's perception that .if the State decides to include Kl as a supplemental protective measure for the general public, one possible method of implementation could be that the State could make Kl readily available where other over-the-counter drugs can be purchased. The public could be informed of the drug's availability through the yearly emergency preparedness information brochure that is malled out to all residents throughout the 1O mile EPZ. It would then be up to lndividuaJ members of the public to obtain and store this supply of Kl, which should then be available for use in the event of an emergency. The administration of the Kl could be at the direction of the State Medical Officer. Issue 2 It Is "factual that the 1986 Chernobyl accident clearly demonstrated the benefit of having Kl readily available. In Poland, where authorities expediently administered 18 million

• • ( )

doses of Kl, 97 percent of all Polish children were protected-from thyroid disease. In contrast, there are soaring rates of childhood thyroid cancer, 200 times pre-Chernobyl levels, in the former Soviet republics,of Russia, Belarus, and the Ukraine because very little KJ was administered, too long after exposure." Commission Response The Chernobyl reactor (a RBMK-1000 design) Is located in the Ukraine close to Belarus. The accident occurred at 01 :23 on Saturday, 26 April 1986, when explosions destroyed the reactor core and reactor building. The explosions sent, debris from the core flylng

    . into the air and exposed the reactor core to the atmosphere. The heavier debris f~om the plume was deposited close to the site. In general, the initial release is thought to have risen to over 1 km in altitude, thereby resulting in much lower doses close to the site than those expected from a ground level release. The major release lasted* 10 days, during which most of the noble gases and more than 40 percent of the iodines are estimated to have been released. The varying meteorological conditions, release rates,,.,
      .and release heights resulted In very complex dose and ground deposition patterns.

• It is often assumed that ingestion was the major source of thyroid dose early in the accident However, the contribution of Inhalation cannot be assessed because air sampling was not effectively conducted early in the accident. As of 1996, except for thyroid cancer, there has been no confirmed increase in the rates of other cancers, including leukAmla,*among the first responders, llquidators,2 or the public, that have been attributed to release from the accident.

Belarus Experience. With the Chernobyl plant *1ocated only 4 miles (7 km) away, Belarus was heavily impacted by the accident. This impact was heightened by the fact that protective actions were not Implemented in Belarus durihg the first six days after the accident. Several authors have stated that Kl was distributed to the population in Belarus during the first week following the accident.3 However, there is no confirmed published data on the dosage, coverage, or other details concerning the implementation of the thyroid blocking In Belarus.'4 In addition, cows typically grazed in Belarus at the time of year when the accident occurred, and yet no efforts were taken*to restrict the consumption of contaminated milk for the first 10 days following the accident On May 2 (day 7 following the accident) the decision was made to evacuate the areas of. Belarus and Ukraine within 18 miles (30 km) of the plant (30 km zone). The evacuation was I completed on May 5, 1986. Since 1990, a rapid increase has been observed in the incidence in thyroid cancer among Belarus children who were O to 14 years old at the time of the accident. Before the accident, the rate of thyroid cancer among this cohort was about 0.4 per 100,000; by 1996, this 2 Uquidators are a large number (about 200,000) of workers and military personnel who performed cleanup, construction of the sarcophagus, and other operations In the contaminated zones following the accident. I

• 3 Personal communication, E. Buglova M.D., Head Laboratory of Radiation Hygiene and Risk Analysis, Ministry of Health, Republic of Belarus, December 1997.

        ""Thyroid Cancer In Children LMng Near Chernobyl, Expert Panel Report on the Consequences of the Chernobyl Accidenr - Williams D. et al., K.H. ECSL-EAEC, Report EUR 15248 EN, Brussels-Luxembourg, 1993, p. 108.              **

rate had risen to 3.9 per 100,000.5 *6 This included approximately 3,000 chlldren, 0 to 18 years old, that were evacuated from the 30-km zone within Belarus. Among this group, four thyroid cancer cases have been detected since the accident. All of these cases were registered after the end of the latent period for radiation-induced thyroid,cancer. Taking into account the spontaneous rate of this disease In this age group and the number of evacuated persons, all of these cases are considered accident-Induced. The total number of excess cancers In Belarus children Is currently about 750, and is estimated to reach a maximum of more than 3500 over the lifetime of this cohort. M.s The vast majority of the thyroid cancers were diagnosed among ttiose living more than 50 km (31 miles)

• from the site.

The increase in the rate of thyroid cancers in Belarus Is concentrated among those who were youngest at the time of the accident. Fortunately, these cancers respond favorably to early treatment; to date, two or three of the Belarus children diagnosed with thyroid cancer have ' died as a result of that disease.6 Poland Experience. Poland detected increased levels of airborne radioactive contamination on the night of April 27, 1986 (day 2). Although there was no official notification of the accident by the USSR, it was assumed, on the basis of Tass News Agency reports, that the increase were attributable to the accident at Chemobyf. On April 28 (day 3), the country formed a governmental commission to recommend ,protective actions. Among these actions, 5 E. Buglova et al., "Thyroid Cancer in Belarus After the Chemobyf Accident; Incidence, Prognosis, Risk Assessment." Low Doses of Ionizing RaJfiation: Biological Effects and Regulator Control, Spain, November 1997, Contributed Paper, pp. 280-284.

          ~yrold Cancer Incidence Rate In the Republic of Belarus." Okeanov A. et al.,

Radiation and Risk Bulletin of National Radio-Epidemiological Registry, Obninsk., 1995, Issue 6, pp. 236, 239. the commission re~mmended intervention levels for taking protective actions on the morning of April 29 (day 4). 7 On April 29, Poland's Minister of Health gave orders to prepare and*dlstrlbute Kl to the 11 provinces most affected. Kl was to be made available through hospltals, public health centers, schools, and kindergartens. The country used its mass media to announce the protective action and to appeal for volunteers to assist In the nationwide distribution. The Commission then instituted the following additional protective meases:8

• Feeding of cows on pastures or with fresh fodder was banned countrywide until May 15, 1986.
• Fresh milk with radioactivity concentration above 1,000 Bq/L was banned for consumption by children and pregnant or lactating women.
• All children under the age of 4 were given powdered milk-through numerous distribution centers.
• Children and pregnant or lactating women were advised to eat a minimum of fresh leafy vegetables (until May 16, 1986).

The distribution of Kl was Initiated on April 29 (day 4) and was virtually completed by May 2 (day 7). This included the distribution of Kl to more than 90 percent of the children under I the age of 16 and about a quarter of the adults. A total of 10.5 million doses of Kl were given to children and 7 million doses were given to adults. Multiple doses, although not recommended, were taken in a number of cases. Because of diminishing air contamination, the Kl prophylaxis was not repeated. In the second phase of the response, powdered milk was made available to all children less than 4 years of age. This program effectively started on May 3 (day 8). It is estimated that approximately a 40-45 percent reduction in thyroid burden was achieved by thyroid blocking and milk restrictions in the 11 provinces treated.7 Had the Russian

• authorities given prompt warning, the 24- or 48-hour gain in time might have improved the effectiveness of their response.

There were no reported serious adverse reactions except for two adults with known iodide sensitMty. About 36,000 medically significant reactions were also reported (mostly nausea). Because of the low iodine concentrations in Poland it is doubtful that epidemiological studies could detect excess cancers resulting from Intake of radloiodine. 8 International Practices - During this assessment, the NRC staff examined the current

                                                                                                \

policies and practices regarding the use of thyroid blocking during Nuclear Power Plant -:. accidents for a number of countries. The NRC staff accomplished this task primarily through personal communication with colleagues in each country. In general, the countries either are following or intend to implement systems that are consistent with the guidance promulgated by the World, Health Organization (WHO). Specifically, the WHO recommends predistribution of stable iodine close to the site and stockpiles further from the site. These stocks should be:. strategically stored at points such as schools, hospitals, pharmacies, fire stations, or police stations, thereby allowing prompt distribution. A further description of the WHO.guidance is provided below, followed by a discussion of the guidance promulgated by IAEA and a comparison between U.S. and international practice. 7The Implementation of Short-term Countermeasures After a Nuclear Accident, Proceeding of an NEA Workshop Stockholm," Sweden, 1-3 June 1994, OECD 1995. 8 Manual on Public Health Actions in Radiation Emergencies, WHO, European Center of Environmental and Health,. Rome Division, 1995. World Health Organization (WHO) Guidance. The main poln~ of the WHO Guidellnes9*10 regarding the use of stable Iodine are as follows:

• Near field: Stable Iodine should be available for Immediate' distribution to all groups if the predicted thyroid dose is:likely to exceed l'.lational reference levels. Close to nuclear installations iodine tablets should be stored or predistributed to facilitate prompt utillzatlon.
• Far field: Stable Iodine should be avalia.ble for distribution to pregnant women, neonates, infants, and children If the predicted dose lsjlikely to exceed reference levels.

Conclusion from Polish Experience. (1) Small amounts of radioactive Iodine were deposited In Poland as a result of the Chemobyt accident, (2) no protective actions were taken for the first 2 days of the accident, and (3) protective actions (except sheltering or evacuation) were taken after the first 2 days of the accident. Because of the low .iod_lne concentrations in Poland and the protective actions Implemented, Poland has not detected excess cancers resulting from intake of radioiodines. Overall Chernobyl Conclusion. The World Health OrganizatiQn, almost every Industrial country in the world with nuclear power plants, and the American Thyroid Association, l believe that the low iodine concentrations, the banning of the consumption of fresh milk and the distribution and administration of 90 million doses of Kl contributed to the observed lack of "International Basic Satety Standards for Protection Against Ionizing Radiation and for Safety of Radiation Sources, Safety Series No. 115, IAEA, 1996.

• 10 "Method for the Development of Emergency Response Preparedness for Nuclear or Radiological Accident,* Tecdoc-953, IAEA, July 1997.

increase of childhood thyroid cancers In Poland. Most industrial nations with nuclear power plants have decided to stockpile Kl around nuclear power for use by the general public. In the event of an accident in the United States, our emergency planning calls for protective actions, (sheltering, evacuation, and removaLQf contaminated food from consumption) that would significantly reduce the risk to the public. Making Kl available to the public for use during evacuation could, under certain conditions, reduce the risk further. One public commenter articulated the conclusion of the Chernobyl experience by stating:

        "Early arguments against the stockpiling of Kl .for use In such an event have focused on the issues of possible toxicity from widespread use of potassium iodide, the difficult logistics of early distribution of Kl and the question of cost/benefit ratio. Although all of those arguments have some cogency, the recent Chernobyl experience has nullified their pertinence. To date, over 1200 children in the Chernobyl area have developed               ,,

papillary thyroid cancer requiring major medical Intervention. Although the certainty of the fallout initiation of these cancers cannot be fully confirmed until current* dose assessment studies are completed, the remarkable coincidence and extraordinarily high incidence of this rare tumor in the Chernobyl area is convincing enough to require some action."

        "The concern about significant toxicity from potassium iodide in emergency blocking doses has been made moot by the extensive Polish experience where 18 million individuals received prophylactic potassium iodide with overall toxicity of .2 percent (mostly nausea) but with only a fraction of 1 percent having serious side-effects.

Current packaging of Kl in Europe has appeared to resolve the problems about shelf life and the blister packing that Is used. in Sweden Is certainly effective and inexpensive. There are admittedly problems in effective and complete rapid early distribution and certainly in predistrJbution. However, should a reactor accident occur In the U.S. requiring Kl and it not be available because of an overly heavy emphasis on perceived difficulties, the resultant medical and pollticaVsociologlcal imP,act will be disastrous."

        "One cannot minimize.the significance of a cluster*of 1200 children with this serious and fortunately rare cancer. Although with modem Intensive therapy results are good, such treatments often have very serious disrupting effect upon the life of the individual and such effect cannot be minimized."
        "The simplicity of having available a simple, inexpensive agent that can greatly lower the likelihood of this disease occurring Is a fact that cannot be overlooked. Indeed, Kl will not decrease whole body radiation and evacuation clearly is an optimal initial response to an accident, but it Is not always posslble and supplementation of evacuation with potassium Iodide Is undoubtedly useful. The Polish study showed that potassium iodide administration decreased the potential thyroid radlatlon dose by as much as 40 percent and this was given as late as 3 to 5 days after the initial exposure to fallout from the continuing fire at the Chernobyl plant."

Issue 3 "Stockpiling or predistrfbutlon of potassium iodide {Kl) as a protective action would not add any significant public health and safety benefit to the current level of protection provided by existing emergency plans for commercial nuclear power plants. Our emergency plans focus on evacuation as the key protective action to prevent exposure since it protects against exposure to all radionucUdes, not just iodine. In addition, the potentlaffor misadministration of Kl is present when predistributed to the general public, and Incidents of misadministration have been Informally reported at industry meetings by states which predistributed Kl to the public: Commission Response The Commission agrees that it Is the State's prerogative to decide to include stockpiling or predistribution of Kl as a protective action for the general public. The FDA concluded that risks from short term use of relatively low doses of Kl are out weighed by the radiologically induced thyroid modules or cancers at a projected dose to the thyroid gland of 25 rem or: greater. In so doing, the FDA approved Kl as an over-the-counter drug. The American Thyroid Association fully endorses the use of Kl and, as previously discussed, there were only 2 significant adverse reactions and 36,000 medically significant reactions {nausea) in 90 million doses of Kl after the Chernobyl accident. The taking of Kl should *require precautions similar to those associated with any other over-the counter drug, and, of course, the packaging instructions should be followed. .. I Issue 4 "Evacuation is more feasible and practicable. Stockpiling of Kl has logistical problems which we feel renders this idea Impracticable and unmanageable." Commission Response: The Commission agrees that evacuation is usually, "feaslble and practicable" and is most effective protective action. If the State decides to .Include KJ as a supplemental protective measure for the general public, one possible method of implementation could be that the State could make Kl readily available where other over-the-counter drugs can be purchased. The public could be informed of the drug's availability through the year1y emergency preparedness informatil:)n brochure that is mailed out to all residents throughout the 1O mile EPZ. Individual members of the* public would be responsible for obtaining and storing this supply of Kl, which could then be available for use in the event of 1an emergency. Other approaches to predistrlbutlon could Include stockpiling at

• reception centers for distribution during an evacuation. Other countries have found ways to effectively distribute Kl when needed and the distribution issue is certainly not unsurmountable. The administration of the KJ should be at the direction of the State Medical Officer.

Issue 5 The Three Mile Island experience has shown us that it Is not easy to obtain an adequate supply of Kl in an emergency. Commission Response: The commenter is correct, in that It was difficult to obtain Kl after the'*Three Island accident. However, with the limited Federal stockpile of Kl for terrorist events and the willingness of the Federal Government to provide a stockpile of Kl for any State that

• decides to use it as a supplemental protective measure for the general public, the Commission believes that an adequate supply of:1(1 could be obtained.

Issue e Even though Kl administration before any exposure Is Ideal, the Chernobyl experience also has shown that the exposure can continue for days. Is the Institution of Kl blockade at any time in this period beneficial? Commission Response The administration of Kl is most effective if done before or Immediately after (within 2 to 4 hours) a release. Nonetheless, during a chronic exposure of several days, the administration of Kl any time during the exposure period may block some uptake of radioactive Iodine. However, the benefit diminishes quickly over time and may be very small If administered late. If a release is expected to continue for several days, the NRC anticipates that the public would be evacuated or other protective action would be taken, depending on the level of release. Kl could nevertheless serve as a useful supplemental and complement to these primary protective actions. 1~ue7 l

                                                                                            ~

KJ Is an effective thyroid blocking agent only when administered immediately before or after an exposure to radioactive Iodine (that Is, within one to two hours). Distribution of KJ In a timely fashion to the general public followir:19 an accident could further complicate and decrease the effectiveness of implementing evacuation or residential sheltering. Commission Response

• The Commission disagrees with this position. If a State chooses to Include Kl as an additional protective measure, It is anticipated that the State could make Kl readily available to the public where other over-the-counter medicines are available or by other

                                                                                               '1 distribution means and that the public be made aware of Its (the Kl) availability, not at the time of an emergency, but K1 could be made available year round.

Issue a One of the major Impediments to distribution of Kl to school children is coordination and administration of the program, e.g., the actual decision making process to administer Kl or evacuate, parental approval and recordkeeping; identification and documenting allergic reactions, and the availability of a qualified. medical professional to administer the potassium iodide.

• I Commission Response The Commission disagrees. Upon declaration of a general emergency there should be NO decision "to administer Kl or evacuate.~ The *preferred protective action for the close-in population should be evacuation. The administration of Kl should be treated in the same fashion as any other over-the-counter medication that might be gfven to children while away from home, after observing the instructions provided with the Kl packaging. Prior parental approval to administer Kl in the event of an emergency can and should be addressed in the planning process for any State that decides to use Kl.

The indMdual State may provide the appropriate guidance and establish a system for obtaining parental approval before the taking of other protective actions that are currently being followed in the EPZ around nuclear power plants. Issue 9 Does the post-Chemoby1 Polish experience show that large-scale deployment of Kl is safe? Commission Response Approximately 18 million doses of Kl were distributed primarily, but not exclusfvely, to children. The bulk of the distribution took about three days. There were no reported serious adverse reactions except for two adults with known iodide sensitivity. The rate of serious side effects {10*1 ) is consistent with the frequency seen during routine use of 1 Kl for medical treatment of respiratory disease. The Incidence of medically significant, .I but not serious, reactions to this single dose of Kl was also very low (0.2 percent). In addition, no detectable long-term disturbance in children's thyroid function was detecte~ as of 1989. , Additionally, the FDA has approved Kl for over-the-counter distribution. The Commission, therefore, agrees that the post~Chemobyl experience has shown that large-scale deployment of Kl is relatively safe. Issue 10 Several comments raised the question of liability:-',ls the NRC prepared to address the

• number of legal Implications should a member of the general public be given Kl at their directive or recommendation and the indMdual have an extreme allergic reaction, .

possibly death?; " "The Federal Register Notice does not address legal Issues for states who decide to adopt Kl and states who do not decide to adopt or administer Kl to the public."; "The issue of legal liability should not be dismissed lightly. If the NRC decides to require stockpiling of Kl for the general public,. has NRC considered what liability* may arise from any adverse heaJth effects? No initiative such as this should be undertaken without resolution of this issue."; 'Who would assume liability if the Kl was used prior to

• the Governor ordering its use?"

Commission Response: The comments focus principally on concerns that1State and local governments involved in distribution and administration of Kl may be liable in tort if an individual receiving the Kl has a significant adverse medical reaction to the Kl. To the extent that commenters are raising the potential for federal government liability for the promulgation of this t proposed rule, the NRC believes that whether the Commission may be subject to tort llablllty through the Implementation of a Kl program depends upon a number of factors. However, It would appear that a Commission decision to. require State and local  : emergency planning officials to consider stockpi~inq,,KI for public distribution should be subject to the "discretionary function" exception to the Federal Tort Claims Act, 28 USC. 2671, et seq.,11 which protects the Federal Governm,ent from liability. The q~estion of whether a State of locality might be liable for lnvolv~ment with administration of Kl to the general public can only be answered by reference to the laws and precedents of particular States. The NRC presumes that this would be part of the "consideration* that States and localities will undertake if this rule is promulgated. The NRC has not undertaken this analysis. Issue 11 Does the NRC staff consider stockpiling and using Kl as a reasonable and prudent protective measure for the general public? 11 This exception from waiver of sovereign immunity provides that: Any claims based upon an act or omission of an employee of the Government, exercising due care, In the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused. 28 USC 2680(a). United States v. Varig Airlines, 467 U.S. 797, 808 (1984); Berkovitz v. United States, 486 U.S. 531 (1988). Commission Response The Commission considers that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement to evacuation and sheltering is reasonable and prudent for specific local conditions. The 1998 proposed Federal Policy on use of Kl as an emergency preparedness measure for commercial nuclear power plant accidents is being developed by the FAPCC. FEMA plans to publish this policy in the:Federal Register in early 1999, nonetheless, it currently is proposed to state that: The revised Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons for radiological emergencies, but leaves the decision on whether to stockpile, distribute and use Kl for the general public to the discretion of State and, in some cases, ll'\('a) governments. Any State or local government that selects the use of Kl as a protective measure for the general public may so notify the appropriate FEMA Regional Director, and may request funding for the purpose of purchasing a supply. The Federal offer to fund purchases of Kl for the States represents an explicit recognition that this medicine can, under certain conditions, supplement other protection measures and thereby enhance p_rotection of . the public. State and local governments that opt to Include Kl as a protective measure for the general public will be responsible for preparing guidelines for its stockpiling, maintenance, distribution and use. State and local governments may also contact FEMA when the shelf life of the drug has expired and the supply needs to be

• replenished. It should also be noted that medical supplies, including Kl, will be stockpiled in 27 metropolitan areas and In three national stockpiles across the country in support of State and local government response to emergencies caused by acts of terrorism invoMng nuclear, chemical and biological agents. For radiological emergencies resulting from any cause, including accidents at commercial nuclear power plants, this additional stockpile can,be acquired ad hoc by State or local government officials Hthey determine Its use would be beneficial.

Commission Decision On June 26, 1998, the Commission decided to gr!3nt the petition for rulemaklng. Accordingly, the NRC staff was directed to proceed with rulemaklng to change 1O CFA l _50.47(b)(10) by inserting the following sentence, after the first sen!ence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate." In addition, the preamble for the proposed rule was to Include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. The Commission also noted that, consistent with the Commission's decision on June 30, 1997, the Federal government (most likely the NRC) will fund the purchase of a stockpile of Kl for the States upon request The Commission aJso directed the NRC staff to work with other relevant agencies to ensure that there are established procedures to enable the national stockpiles to be effectively and timely used by States that have not established local stockpiles and wish to make usEfof the national stockpiles in the event of a severe nuclear power plant accident. The Commission decision is implemented by publication of this proposed rule that would change 10 CFR 50.47(b)(10) with a 90-day public comment period. If the proposed rule is adopltid in final form, the petition would be granted and NRC action would be completed on PAM 50-63 and PRM 50-63A. Commission Conclusions or Issues Rajsed by the Petitioner and Public Commenters The Commission agrees with many of the issues raised by the petitioner and the public commenters. The commission has reached the following conclusions: A. The Commission agrees t,hat Kl, If administered In a timely fashion, could protect the thyroid gland from exposure to radioiodines Inhaled or ingested following a major radiological accident. This is the basis for stockpiling It-and distributing It to emergency workers and instlMionallzed persons during radiologlcaJ emergencies. The petitioner believes that the distribution of Kl was inadequate and untimely in the Ukraine an~ Belarus after the Chernobyl accident In 1986 and that this accounts for the increased incidence of thyroid cancer In these areas. He aJso argues that distribution of Kl in Poland was timely and effective and that no similar increase in the incidence of thyroid cancer was s~~n. The Commission considered aJI of the above information in deciding to grant the petitioner's requested actions. B. The Kemeny Commission criticized the failure l to stockpile Kl and recommended that regional stockpiles be established. The Kemeny Commission's report recognized that evacuation was not Invariably the preferred response to an emergency and that even when evacuation was desirable, it might not be feasible. The Commission believes that prompt evacuation and/or sheltering are the generally preferred protective measures for severe

                                                                                                ,,' I reactor accidents. In developing the range of public protective actions for severe accide')ts at commercial nuclear power plants, evacuation and in-place sheltering provide adequate protection for the general public. The Commisaion believes that Kl for the general public should     ,;

not replace evacuation and sheltering, but supplement them. 't' C. The Federal Radiological Emergency Response Plan (FRERP) is the plan that would be used by the Federal Government to support State and local officials in responding to any peacetime radiological emergency. Such emergencies range from transportation

• accidents invoMng radioactive materials to terrorist events involving nuclear materials. The FRERP includes a range of protective actions commensurate with the risks associated with the range of emergencies for the general public and emergency workers. These protective actions include evacuation, sheltering, and the prophylactic use of stable iodine. With respect to protective actions for nuclear power plants, the NRC and, FEMA have issued Draft Supplement 3 to NUREG-0654/FEMA-REP-1, Rev. 1, to ,provide updated gui~nce for the development of protective action recomme~datlons for severe reactor accidents. This

( I document emphasize~ that prompt evacuation is the preferred protective; action for actual or projected severe core damage accidents. D. The Commission recognizes that in 1994 the Board of Governors of the IAEA adopted new International Basic Safety Standards. With' respect to emergency planning, these l standards provide, among other things, "intervention levels for Immediate protective action, including sheltering, evacuation, and iodine prophylaxis." It Is important to note that each country bases its response plans on local and regional cti'aracteristics. F;or example, Italy and I France, using the same International standards and guidelines, impleme~t them differentty. E. The Commission agrees with the NRC staff estimate that the purchase of Kl tablets is inexpensive. Kl-related costs Increase when the cost of maintenance, distribution, and public education are- considered. F. The Commission believes that NBC medicinal stockpiles* should provide assurance to States and local governments that a limited Federal stockpile of Kl Is avallable, If needed. Commission approval to fund Kl:

                                                                ,            l On June 30, 1997, the Commission voted to approve the NRC stBiff recommendation to endorse the FRPCC recommendations for the Federal Government to fu~d the purchase of I

potassium iodide (Kl) for States at their request and endorsed the FRPC~ recognition of the availability of the Federal stockpile of Kl to State and local governments for purposes of mitigating the consequences of'terrorist use of nuclear, biological, or chemical (NBC) weapons. Under this endorsement, the Federal Government would fund the purchase of Kl, and State and local governments would be responsible for maintenance, distribution, and subsequent ( costs. As part of their emergency response planning, NRC licensees sho_uld discuss this matter with State and local governments that make decisions on protective mea~ures in planning for responses to emergencies. Findings Metric Policy On October 7, 1992, the Commission published Its final Policy Statement on Metrication. According to that policy, after January 7, 1993, all new r~gulatlons and major amendments to existing regulations were to be presented in duaJ units.- The amendment to the regulations contains no units.

• ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT FOR GRANTING THE PETITION FOR RULEMAKING RELATING TO THE USE OF POTASSIUM IODIDE (Kl)

         )

I. Introduction On September 9, 1995, a petition for rulemaklng (PAM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend Its emergency planning

• regulations to require tharemergency plans specify a range of protective actions to lnciude sheltering, evacuation, and the prophylactic use of Kl.

In SECY 97-245, dated October 23, 1997, the st~ff provided three options for the Commission's consideration In order to resolve PAM 50-63. On November 5, 1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), ar:ad the petitioner regarding the options available for resolving the. petition for rulemaking. During the meeting, the Commission invited the petitioners to submit a modification to his petition In order to address views he discussed during the meeting. On November 11, 1997, the petitioner submitted a revision to his petition PRM 50-63A, which requested two things:

1. A statement clearly recommending stockplllng ,of Kl. as a "reasonable and prudenr measure, and

2. A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic-*

use of potassium Iodide (Kl), as appr_opriate." On June 26, 1998, the Commission directed the staff in SRM 98-061 to grant the petitlo,, for rulemaklng -PRM 50-63A by revising 10 CFR Part 50.47 (b)(10).

• This proposed rulemaklng Is in response to this directive.

Alternatives were essentially considered In previous documents. In SECY-97-124 (June 16, 1997), on tt:ie "Proposed Federal Polley Regarding Use of Potassium Iodide after a

                                                                                              \_

Severe Accident at a Nuclear Power Plant* The staff identified three options, one of which contained three sub-options, concerni,ng a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe reactor accidents. Next, in an SRM dated June 30, 1997, the Commission approved an option that endorsed the Federal offer to fund the purchase of 1:(1 for States at their request and endorsed Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local governments of the Federal stockpiling of Kl. II. Need for Action In SECY-97-245, the staff proposed options for resolvlng the refere need petition for rulemaking. In SRM 98-06, the Commission directed the staff to proceed with the rulemaklng. Ill. Environmental Impact of the Proposed Action The environmental impacts of the proposed action and its alternative are considered negligible by the NRC staff. Given the proposed action would only add the sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophyfactlc use of potassium iodide (KJ), as appropriate." The staff Is not aware of any environmental impact as a result of this proposed action. IV. Alternative to the Proposed Action The alternative to the proposed action at this time is to deny the petition and require no action with respect to the use of Kl by the public. Should this no-action alternative be pursued, the staff Is not aware of any resulting environmental impact. V. Agencies and Persons Consulted Cognizant personnel from the Federal Emergency.Management Agency were consulted, as was the petitioner, as part of this rulemaking activity. ,:* ( f I \, VI. Finding of No Significant Impact:: Availability

                                                                                               \

The Commission has determined under the National Environmental Polley Act of 1969, as amended, and the Commission's regulations In Subpart A of 10 CFR Part 51, that the amendments are not a major Federal action significantly affecting the quality of human environment, and therefore, an environmental Impact statement is not required. This* amendment will require that emergency plans specify a range of protective actions to Include sheltering, evacuation, and the prophylactic use of Kl. This action will not have a significant Impact upon the e~ronment. Paperwork Reduction Act Statement

• This proposal rule does not contain a new or amended information collection requirement subject to the Paperwork.Reduction Act of 1995 (44*U.S.C 3501 et seq.). Existing requirements were approved by the Office of Management and Budget (OBM) approval
• numbers 3150-0009 and 3150-0011.

Public Protection Notification If an information collection does not display a currently valid 0MB control number;the NRC may not conduct or sponsor, and a person is not required to respond to, the Information collection. Regulatory Analysis of the Proposed Rulemaking Granting Petitions for Rulemaklng ' (PRM 50-63 AND 50-63A) Relating to the Use of Potassium Iodide (Kl) ,. ' .' ,.) ' \ I On September 9, 1995, a petition for rulemaking (PAM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend Its emergency planning \ regulations to require that emergency plans specify a range of protective actions to Include sheltering, evacuation, and the prophylactic use of Kl *..:- In SECY 97-245, dated October 23, 1997, the staff provided three options for the Commission's consideration in order to resolve PAM 50-63. On November 5, 1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency {FEMA}, and the petitioner regarding the options avallable for resolving the petition for rulemaklng. During the meeting,, the Commission invited the petitioners to submit a modification to his petition In order to address views he discussed during the meeting. On November 11, 1997, the petitioner submitted a revision to his petition PAM 50-63A, which requested two things: A statement clearly recommending stockpiling of Kl as a '"reasonable and prudent" measure, and A proposed rule change to 10 CFR 50.47(b}(10) which would be accomplished by Inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic us of potassium Iodide (Kl), as appropriate." On June 26, 1998, the Commission directed the staff in SAM 98-061 to grant the petition for rulemaklng PAM 50-63A by revising 10 CFR'Part*50.47 {b)(10). This proposed rulemaking is In response to this directive. Alternatives were essentially considered in previous documents. In SECY-97-124 (June 16, 1997}, on the "Proposed FederaJ Policy Regarding Use of Potassium Iodide after a Severe Accident at a Nuclear Power Plant." The staff identified *three options, one of which contained

three sub-options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe reactor accidents. Next, in an SRM dated June 30 1 1997, the Commission approved *an option that endorsed the Federal offer to fund the purchase of Kl for-:States at their request and endorsed Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local governments of the Federal stockpiling of Kl. In SECY-97-245, the staff proposed options for res~lving the referenced petition for rulemaking. In SAM 98-06, the Commission directed the staff to proceed with the rulemaklng. Given the Commission considered the options and directed the staff to grant the petition, the only alternatives considered here are the Commission approved option and the baseline, no-action alternative. The proposed rulemaking does not "require" anything of licensees, but States are to have shown "consideration" of the use of Kl along with evacuation and sheltering as protective actions. It Is estimated that 30.States.will need to make this consideration. -Further, the staff estime~3S that the labor needed by the States could range from a staff-week, to a half staff-year. The latter being the case If a State decided to hold hearings on the issue. If one assumes an average hourly salary of $70 (this estimate includes benefits, pro-rated secretarial and managerial assistance, but not overhead), the range of estimates would be from $2800 to $63,000. Again using a base of 30 States, the range is from $84,000 to $1.9 million. It Is difficult to estimate the benefit of a State's consideration to stockpile Kl. However, we believe the benefit of such an action by the States is summed up by the petitioner who stated that the decision to stockpile Kl should tum on whether, given the enormous consequences of being without Kl in a major accident, the drug is a prudent measure; not on whether It will necessarily pay for itself over time. As the petitioner further noted, Kl represents a kind of catastrophic-coverage insurance policy offering protection for events which, while they occur only rarely, can have such enormous consequences that it is sensible to take special precautions, espectally where, as here, the cost of such additional precautions is relatively low. As stated above, this analysis focuses on the rule being proposed as the result of a petition. Also, since the Commission has directed the staff to pursue the FRPCC results with respect to Kl and has directed the staff to pursue the rulemaking, the regulatory analysis

. presented here is for the edification of the decision makers so they can make an informed decision on the proposed rule.

The above constitutes the regulatory analysis for this action. Regulatory Flexlblllty Certification In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission hereby certifies that this rule, If adopted, will not have a significant economic Impact on a substantial number of small entities. This proposed rule would affect only the licensees of nuclear power plants. These licensees, do not fall within the scope of the deflnitiqn _ of "~~II ~ntities" set forth in the Regulatory Flexlblllty Act. 5 U.S.C. 601, or the size standards adopted by the NRC (10 CFR 2.810). Backfrt Analysis The definition of backfit, as set forth in 10 CFR 50.109(a)(1 ), is clearly directed at obligations Imposed upon licensees (and app!icants) and'thelr facilities and procedures. Section 50.109(a)(1) defines a backftt as:

                                                                          )
        ..* the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility, any of which may.

result from a-new or amended provision In the-Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position .... '*

• Section 50.109 is replete with references to "facilities" and iicensees," which In their totality make clear that the rule is Intended to apply to actions taken with respect to nuclear power plant licensees and the facilities they operate. ~ Section 50.109(a){7), "If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or- with written licensee. commitments ... then ordinarily the applicant or licensee is free to choose the way that best suits.Its purposes [emphasis added]." This focus on, licensees and their facilities is further confirmed by the Statement of Considerations accompanying .the backfit rule, 53 FR.20603 (June.6, 1988), where.the Commission stated that backfitting "means measures which.are intended to improve.the safety of nuclear.power reactors . ., .." 53 FR at 20604. The nine factors to be considered under 10 CFR 50.109(c) further make clear- that the rule is aimed at requirements on licensees and facilities. These.

Include: *(2) General description of the activity that would be required by the licensee or applicant in order to complete the backfit; ... (5) Installation and continuing costs associated with the backflt, including the cost of facility downtime,or the cost of construction delay;*[and] (6) *. The potential safety impact of changes In plant or operational complexity..... [emphasis - added]" The proposed rule Imposes no new requirements on licensees, nor does It alter procedures at nuclear facilities. Rather, It Is directed to,States or local governments -- the entities with the authority to determine the appropriateness of the use of Kl for their citizens - calling upon the governments to 'bonsider" Kl as one of the elements of their offslte emergency planning. Even as to states or local governments, It Imposes no bindi11g requirement to alter plans and procedures. Furthermore, the basic standard that emergency planning must include consideration of a range of protective actions, Is already,. set forth In the existing wording of section 50.47(b)(10). On this basis, the proposed rule In reality does not Impose new requirements on anyone. On a consideration of all of the. above factors, no backflt Is Involved and no backflt analysis is required. Commission precedent ~lso makes clear that the proposed rule change does not constitute a backfit. The Commission's position was ~ted explicitly In 1987, when the last major change took place In emergency planning regulations. 52 FR 42078 (Nov. 3, 1987). The Commission's final notice of rulemaklng on this rule Involving the "Evaluation of the Adequacy,\ of Off-Site Emergency Planning for Nuclear Power Plants at the Operating License Review Stage Where State and Local Governments Decline to Participate In Off-Site Emergency Planning" stated~that the emergency planning rule change In question "does not impose any new requirements on production or utilization facilities; It only provide .. an alternative method to meet the Commission's emergency planning regulations. The amendment therefore Is not a backflt under 10 CFR 50.109 and a backflt analysis is not required.* 52 FR at 42084. Likewise, when the Commission altered its emergency planning requirements In 1987 to change the timing requirements for full participation emergency exercises (a change that, as a practical matter, could be expected to.result In licensees' modifying emergency preparedness-related procedures to accommodate exercise frequency changes), It stated: "The final rule does not modify or add to systems, structures, components or design of a facility; the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct, or operate a facility. Accordingly, no backflt analysis pursuant to 10 CFR 50.109 Is required for this final rule." 52 FR 16828 (May 6, 1987). The Instant proposed emergency planning rule change is of a similar nature and similarly does not Involve a backfit. It has been argued by at least one commenter on the petition for rulemaking that, although licensees are not directly burdened by the proposed rule, they would be Indirectly burdened because they would feel called upon to explain the new policy to their customers. By this logic, almost any Commission action that led an NRC licensee to Issue a press release could be considered a backflt. Such a position would represent unsound law and policy. Here, the burden of public information on licensees or applicants, if any, appears de mlnimls. It plainly does not rise to the level of the type of concrete burden contemplated by the Commission when it enacted the backfit rule. It might also be argued that, if a State or local government were to decide to stockpile and use Kl for the general public, it would undertake interactions with the affected licensee to coordinate offsite emergency planning. Although this could result in some voluntary action by the licensee to coordinate its planning, the proposed rule itself does not impose any requirement or burden on the licensee. Accordingly, the Commission concludes that the proposed rule, if adopted, would not impose any backfits as defined In 10 CFR 50.109. List of Subjects 1o-cFR Part so Antitrust, Classified Information, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements. For the reasons set out in the preamble and under the authority of the Atomic Energy Act for 1954, as amended, the Energy Reorganization Act of 1974, as amended, the National Environmental Policy Act of 1969, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendment to 10 CFR Part 50. PART SO-DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES

1. The authority citation for 10 CFR Part 50 continues to read as follows:

Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936, 938, 948, 953,954,955,956, as amended, sec. 234, 83 Stat. 444, as amended {42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 State. 1242, as amended 1244, 1246, (42 U.S.C. 5841, 5842, 5846). Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951, as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851). Sections 50.10 also Issued under secs. 101, 185, 68 State. 936,955, as amended (42 U.S.C. 2131, 2235); sec. 102, Pub. L. 91 -190, 83 Stat. 853 (42 U.S.C."4332}. Section 50.13, 50.54(dd), and 50.103 also Issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix a also issued under sec. 102, Pub. L. 91-190, 83 Stat. 853 (42

• U.S.C. 4332). Sections 50.34 and 50.54 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152).

Sections 50.80, 50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix Falso issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237}.

2. In§ 50.47, paragraph (b){10) is revised to read as follows:

         § 50.47 Emergency plans.

(b) * * * * * (10) A range of protective actions have been developed for the plume exposure pathway

                                                                         )

EPZ for emergency workers and the public. In developing this range of Ej.ctidns, consideration has been given to evacuation, sheltering, and, as a supplement to these,~ the prophylactic use I of potassium iodide (Kl), as appropriate. Guidelines for the choice of profactive actions during

                                                                         ' and protective an emergency,--conslstent with Federal guidance, are developed and in pl.ace, actions for the ingestion exposure pathway EPZ appropriate to the locale::have been developed.

I Dated at Rockville, Maryland, this _ _ day of _ _ _ _, 1998. For the Nuclear Regulatory Commi~ion. I l John C. Hoyle Secretary of the Commission The Commissioners COORDINATION: The Office of the Chief Financial Officer has reviewed this Commission paper for resource implications and has no objections. The CRGR has reviewed this Commission paper but does not agree with the staff's no backfit analysis (see Enclosure 6). The Office of the Chief  ; Information Officer has reviewed this Commission paper for information technology impacts and compliance with the Paperwork Reduction Act and concurs In it. The Office of the General Counsel has no legal objection. RECOMMENDATION: That the Commission:

1. Approve publication of the proposed rule in th~ Federal Register.

2. Note:

a. The proposed rule change would be published in the Federal Register for a 90-day public comment period.

b. Appropriate Congressional committees will be notified.

c. The Office of Public Affairs draft public announcement is attached (Enclosure 5).

d. The evaluation of a need for a backflt analysis was prepared by OGC.-1

• T~e EDO accepts OGC's position that this rule change does not constitute a backfit under 10 CFR 50.109; therefore, a backfit analysis is not required.

e. FEMA has been provided with an advance copy of this rulemaklng package.

William D. Travers Executive Director for Operations Attachments:

1. Revised Petition for Rulemaking (PAM 50-63A)

2. SAM 98-061, dated June 26, 1998

3. Proposed Federal Register Notice

4. SECY 97-124

5. Draft Public Announcement

6. CRGR comment letter dtd. October 23, 1998 cc w/atts:

SECY, OIP, OCA, OGC, CFO, CIO DOCUUENT NAMl!:0.:\JAMOOCHNODIDE\CPA.PER.WPO OFC "OAPW'GEB I "ORPMl'GEB

                                                               'SN-- I  "TECHED          I  "ORPM.PGEB         I NAME                 w- ----  L  --

RAuluck 'T&alo DATE 1Cl1()'98 I 198 1CY20t'98 10/21/98 OFC "DRPM*EPRP l "ADORPM I *o.f&ISS I "OGC I NAIE CMllllr JRoe CPallD!'U>llo .JGnn/ DAT! ,omwa 1CV121/98 1M0/'98 10/21198 Ol'C -CFO I "ClO I "0 NRR I ncnJ -> I

                                                                                                * ..Rf},,,

NAME JF~ BShel10n SColri. DATIi 10/23/98 Ot'20fSl8 ~ 10/23198 ll ~ I ~

                                                             ,     I
                                                          ,~

OFC *AEQO nf;

                                                       )1    '

n--*y;,-f NAME TI'Mal1ln w~~ DATE 1Qlll0/98 {l I

ENCLOSURE 5 From: Harvey Brugger <HBRUGGER@GW.ODH.State.OH.US> To; GATED.nrcsmtprpgcrane@erols.com"} Date: Thu, Dec 17, 1998 3:26 PM

Subject:

Kl supplier in Sweden -Reply -Forwarded Peter. In response to Ms. Hiatt's request, I am forwarding information to you regarding our conta<::ts with the Swedish company.that provides Kl. Two letters are appended to this message directly. (They should also r appear as Wortfperfect 6.1attachments in the mall forwarded to Ms. Hiatt. which is also attached.) Harvey ATTACHMENT 1 lt#i!##iUl#'l#ll#'l#-JI.Uf/6.tJ"i!HtUll##l#tt#H#iU#U!JllftJ#llfl.##!I From: <allan.skolfman@recip.se> To: ODH_OMIS.DPM1(COSTROVE) Date: 11/3/98 10:04am Subject Potassium Iodide -your e-mail dated october 30, 1998

Dear Ms.Ostrove,

Thank you very much for your above message which we duly have taken care of. We would like to give you the following information*

1. Our product is registered in Europe.

2. All formal export rights from Sweden can be obtained.

3. In many countries reglstrabon is not a necessity as the authorities have the responsibility for the storage and the distribution of the tablets.

4. Potassium Iodide tablets are generally not to be found at pharmacies demanding a regular registration procedure.

5. Does the product have to be registered In the United States as the state of Ohio is having the responslbility for the handling of the product?

If so is the case we will arrange J for any authorisation needed, Including the FDA This may, however, take a considerable time to accomplish and also be associated with costs.

6. The availability of the product 1s tc,rally dependent upon the volumes to be shipped. Consequently we would like to have ,

your input in order to present the most adequate answer to you.

7. Pricing. This is also totally dependent upon volumes However below please find our general price list.

100,000 packs (blister of 1a tablets) *USD 1.15 per pack

500,000 " - " 0.90 " " 1,000,000 " "

• fl 0, 70 n II 7 C/1) I<..

5,000,000 II " - " 0.60 " " ::: ) l\,'J

8. Shipping costs. Generafly we are selling at Ex Works (lncoterms 1990). However we are always open for discussion. in order to facilitate your on:tenng procedure.

9. Payment conditions. Generally Irrevocable Letter of Credit For us customers we may consider cash on Dellvery or Stand by Letter of Credit

• 10. Ordering address:

RECIPAS Branntngevagen 12 120 54ARSTA SWeden

11. We have, as you may know, furnished not only Sweden with our product but also other European countries as well as Latvia and Belarus. A number of countries are just about to change from the old 200mg product to the new one of 65mg. A positive interest has been shown from International organi-sations.

12. As can be seen from our pamphlet our product does follow the VVHO recommendations. We can also guarantee a shelf-life of up to 10 years. (Some of our batches have been tested even up to 12-14 years).

We hope that the above information will be of assJstance to you. If there are additional questions to be answered by us, please do not hesitate to contact us whenever you want Telephone number. Switchboard +48 8 6025200 drrect +46 8 6025329 Telefax number. " ..-45 8 818703 " +46 8 6025302 We look forward to hearing from you. vVith kmd regards, Allan Skolfman Export Manager

                                                             .t CC:     OOH REMOTE.SMTP(uhans-henrik.bark@recip.se", "thoma...

ATTACHMENT 2 ll#IJ.li#tl~'ff#####li#if.tlA*'lfJl####:YN/,1#fi;\t/l#H#.¥/J#;Vt!lf,¥ifilll##f!.ll MEMORANDUM TO: Harvey B. Brugger, Supervisor FROM: Dwain C. Baer, Health Physicist Ill

SUBJECT:

Potassium Iodide [Kl] Manufacturers DATE: October 30, 1998 Based on the research conducted by Connie Ostrove and myself, the only company which manufactures and distributes tablet Kl specifically for use as a thyroid protection product is Carter-Wsllace Laboratones, located on Half A,cre Road in Cranbury, New Jersey 08512. Current cost per case of 100 bottles [fourteen tablets per bottle} is $250.00 [17 8 cents per tabletJ. This cost has increased over 80% from last year, based on the anticipated increase of sales. Roxane Laboratories, located at 1809 Wilson Road in Columbus, Ohio 43228-8601, produces a liquid solution labeled for use as an expectorant. However, the Food and Drug Administration [FDA] has approved this product for use as a thyroid protection method during a nuciear power plant radiological release. Roxane has never produced tablet Kl for use as an expectorant, or for use as a thyroid protective method Several other companies within the United States were researched for thyroid blocking Kl. However, all of the companies researched market Kl for expectorants of various bronchitis problems only, and have not been approved by the FDA for thyroid blocking usage. A company in Sweden called ~ip AB, Branningevagen, has provided a cost estimate via e-mail. A pack of ten Kl'tablets can cost as much as $1.15 per pack [11.5 cents per tablet] plus the cost of shipping to the United States, and the cost of any authorization which may be required cc: Connie Ostrove, Librarian R.AS./KI File

Date: Mon, 14 Dec 199813:00:09 ..0500 . From: Harvey Brugger <HBRUGGER@GW.ODH.STATE.OH.US> To. susan.hlatt@hamradio.org Cc: dbaer@GW.OOH.STATE.OH.US,rsuppes@GW.ODH.STATE. OH. US, shelmer@GW.OOH.STATE.OH.US

Subject:

Kl supplier In SWeden -Reply Susan, I am attaching two Wordperfect 6.1 documents. Since their preparation, one additional contad with the SWedish supplier, Recip AB, indicates their disinclination to provide Ki tablets at any different dosage that they currently manufacture. However, this is not necessarily an Impediment In fact tor purposes of public distribution, the Export Manager. Mr. Allan Skolfman, indicatad that the f35 mg size may be more useful. Their tablet can be diVided at score lines in order to comply with World Health Organization recommendations for dosages to children. On a cost basis, companng the Swedish Product with the Carter-Wallace product follows: Carter Wallace Product 130 mg tablets packaged In a bottle of 14 tablets with a shett life of 5 years cost $2.50 per bottle. Recip AB (Swedish) Product 65 mg tablets packaged In a blister pack of 10 tablets with a shelf life of 10 years cost $1.15 per package in the quantities contemplated. If one were not contemplating the subdMslon of a bOttle or packet then it would be cheaper using the Swedish product to dispense one product per person. Emergency workers and institutionalized are given a ten day supply plus extra tablets'equlvalent of a 14 day supply. If a five day supply without extra tablets wou!d suffice, then they could be given one blister packet. Even if they were given two packets, in order for them to take two 65 mg tablets per day for 10 days, it would stiH be cheaper to use the Swedish product On strictly a comparison of cost/mg/year, the Swedish product is also cheaper: $1.n E-4 versus $2.75 E--4 Harvey Harvey CC; GATED. nrcsmtp("susan. hiatt@hamradio.org")

ENCLOSURE 6 UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20ll65-0001 March 3, 2000 Mr. Peter G. Crane 4809 Drummond Avenue Chevy Chase, MD 20815

Dear Mr. Crane:

This is in response to your letter dated October 15, 1999, in which you raised issues regarding the interactions between the Federal Emergency Management Agency (FEMA) and the U.S. Nuclear Regulatory Commission (NRC). In addition, you asked several questions concerning the NRC's efforts in dealing with potassium iodide (Kl} policy making. First, I do not agree that the NRC misrepresented FEMA's position on regional Kl stockpiles. In a letter from FEMA Director James L. Witt, dated April 29, 1999 (Enclosure 1), to former NRC Chairman Shirley Jackson, Commissioner Dicus, Commissioner Diaz, Commissioner McGaffigan, and Commissioner Merrifield, Director Witt stated, among other concerns, that FEMA did not support establishment of regional Kl stockpiles. Chairman Jackson's reply (Enclosure 2), dated June 15, 1999, included a statement that she was confident that the NRC and FEMA staffs will be successful in resolving the Kl issue. The NRC's responses to the post-hearing questions reflected that NRC and FEMA were undertaking this effort and NRC's belief that the agencies would reach a successful outcome. The NRC never stated nor intended to imply that FEMA had indicated any change in its position. As a result of Chairman Jackson's letter to Mr. Witt and Commission direction to the staff, the NRC and FEMA staffs have been meeting to identify options for stockpiling Kl, consistent with the views of each agency. On January 12, 2000, the NRC received a letter from FEMA, signed by Ms. Kay Goss, Associate Director for Preparedness, Training, and Exercises. The letter reiterates the concerns expressed by Mr. Witt in his letter of April 29, 1999. The letter also provided comments on a predec1s1onal final rulemaking package not available to the public, and we cannot be more specific regarding its contents until these documents become publicly available. We will place a copy of the FEMA letter and NRC response on the NRC website after they are publicly available. I You also stated that the Commission withdrew draft "NUREG-1633, in the face of withering criticism from the health departments of New York State and Ohio, and from me." In the staff requirements memorandum (SAM) dated June 26, 1998, the Commission stated, in part, "To assist the State and local decision makers, the staff should submit its paper, 'Assessment of the Use of Potassium Iodide (Kl) as a Public. Protective Action During Severe Reactor Accidents,' for public comment. Staff is encouraged to submit the assessment in whole, or in part, to peer reviewed journals for publication. Following receipt and evaluation of the public comments, the staff should revise the paper, as appropriate subject to Commission review." In conformance with this directive (COMSECY 98-016, dated July 13, 1998), the staff announced the availability of NUREG-1633 in the Federal Register and solicited public comments.

Mr. Peter G. Crane 2 By the end of September 1998, the staff received about 80 comment letters from individuals, organizations and States. All comments received on draft NUREG-1633 are attached for your information and review (Enclosure 3). In an SAM dated September 30, 1998, the Commission directed the staff to withdraw draft NUREG-1633, and "in light of the many useful public comments on draft NUREG-1633, a substantially revised document that takes those comments into account will be issued in its place, and that the draft NUREG is therefore being withdrawn." The staff is currently developing an updated NUREG-1633 that conforms to the direction of the SAM. You also raise the issue of a staff apology at the Commission meeting held on November 5, 1997, regarding the accuracy of the information upon which the Commission's policies on Kl are based. The meeting transcript pages addressing this issue (Enclosure 4) show that, in response to a specific question, the staff requested that the record reflect correction of an error in one statement in a Commission paper, dated June 16,1997 -- SECY-97-124, "Proposed Federal Policy Regarding the Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant" (Enclosure 5). The statement mistakenly implied that FEMA [where correctly it was the NRG] was the primary Federal regulatory agency [on Kl] that did not support the purchase and stockpiling of Kl by the Federal government. Another issue you raised concerned the cost of Kl. The basis for the cost figures presented in our Congressional response is described in Attachment 2 to SECY-97-124 (see Enclosure 5) , and updated in SECY-98-264, dated November 10, 1998 (Enclosure 5a). At this time, the U.S. Food and Drug Administration (FDA) is reevaluating its 1978/1982 Kl guidance. If FDA proposes Kl dosages other than the current ones (130 mg per day for adults and children over 1 year old), the cost for Kl could change. It is not practicaJ or possible at this time to provide an exact total cost of Kl. You also raised a question regarding the staff's representation of these costs. All costs presented refer to the annual costs for purchasing Kl. In the situation where it was assumed that all of the potential purchases of Kl occurred in one year, that total cost was attributed to one year, consistent with budget implementation. Even if the cost did not recur for 10 years, the cost per year is still the total amount for the first year, zero cost for the next nine years, with the total cost occurring again in the tenth year. Notwithstanding these limitations, the cost of Kl tablets when purchased in large quantities (greater than about 500,000 tablets) was estimated. As you stated, a Swedish firm offers Kl in bulk at 6 cents per pill, with a stated 10 year shelf life. The Swedish company, RECIP AB, provided costs that ranged from 11.5 cents per tablet for 1,000,000 tablets to 6 cents per tablet for 50,000,000 tablets. It should be noted that these costs are for 65 mg tablets whereas the current recommended FDA Kl dosage tor adults and children over 1~year old is 130 mg Kl per day. The cost per 130 mg dose is twice the cost per tablet stated above and would th,erefore range from 23 cents to 12 cents per 130 mg dose. Additionally, this cost does not include shipping nor any costs associated with RECIP AB obtaining FDA approval of this Kl product. In the United States, we have located two companies advertising Kl tablets on the internet for purchase by the general public that have received FDA approval. ANBEX charges $10 per package of 14 Kl tablets (130 mg dose) plus $4.00 for shipping up to 10 packages. The shelf-life is stated by ANBEX to be "indefinite." Based on the staff's informal inquiry to the company, it was indicated that the cost could be reduced to about $2.50 - $2.60 per package of 14 tablets in quantities of about 1,000,000 tablets, resulting in a cost of about 18 cents to 19 cents per tablet. Carter-Wallace Laboratories sells Thyro-Block Tablets, a 130 mg Kl tablet. The tablets

Mr. Peter G. Crane 3 are sold in a 98-day supply (98 130 mg tablets) for individuals at a cost of $42.95 or in a case of 100 bottles of 14 130 mg Kl tablets per bottle for $560. This is about 40 cents to 43 cents per tablet. It is estimated that purchasing a million or more tablets at a time could get the price down to about 20 cents per tablet. You also requested that NRC provide an accurate account of the actual e:xpended costs of studying the Kl issue. In our answer to the hearing question, we estimated that our spending to study the Kl issue exceeded $2.6 million in period from October 1989 to August 11, 1999. The precise sum for the individual items listed came to $2.64 million. The response to the hearing question 16(8) represents the staff's best estimate of costs associated with the Kl issue over the last 10 years (1989

• 1999). On the basis of the records available from our internal work tracking system, the staff was able to detennine the cost of preparing the cost*benefit study entitled, "An Analysis of Potassium Iodide (Kl) Prophylaxis for the General Public in the Event of a Nuclear Accidenr (NUREG/CR.S310) and the number of NRC full*time equivalent (FTE) positions associated with its publication. In addition, the cost associated with the Kl rulemaking was detennined with the aid of the internal tracking system. The cost to the NRC for providing travel funds to State members of the group preparing and reviewing the document, "Assessment of the Use of Potassium Iodide (Kl) As a Protective Action During Severe Reactor Accidents", draft NUREG-1633, in December, 1998, and March, 1999, totaled about $9,100.

Other Kl activities involving offices and regions were not captured here because they did not necessarily have a specific tracking number referencing Kl efforts over the 10-year period being evaluated. Furthennore, all Commissioner and management involvement is considered "overhead' with no specific reference to projects. Therefore, on the basis of a review of the records to the extent possible and discussions with principal staff members, the staff estimated that approximately 5 FTEs of lead technical staff time (through 1999) and 3 FTEs of lead coordinator time were expended. The other 12 FTEs represent the sum of the following estimates: (1) the management overhead cost at 0.2 FTE per year, subtotal - 2 FTE; (2) direct staff (other than lead staff), for example, development of the staff's technical reports on Kl (for example, various versions of draft NUREG*1633), and Commission correspondence, at 0.8 FTE per year, subtotal - 8 FTEs; (3) technical staff assistance with reviews of reports, meetings with the Federal Radiological Preparedness Coordinating Committee and FEMA, and correspondence review at 0.2 FTE per year, subtotal - 2 FTE. These estimates result in the total of approximately 20 FTEs, which was provided in the response to question 16(6). It should be noted that the management overhead cost estimate is somewhat uncertain and could be higher than 0.2 FTE per year but the staff does not have a basis to make a better estimate. In addition to NRC staff and its contractors, it is important to note that other Federal agencies have also expended FTEs and incurred other costs associated with Kl, together with the efforts expended by States and local governments. None of these costs for work on the Kl issue by government entities outside the NRC have been included in the staff's estimates noted above (with the exception of the state travel cost reimbursement stated above). You also asked, "Who must consider Kl under the proposed rule?" The proposed rule is directed principally to States and local governments, the entities with the important role to determine the appropriateness of the use of Kl for their citizens, calling on these governments to 'consider' Kl as one of the elements of their offsite emergency planning.

Mr. Peter G. Crane 4 I hope this addresses your concerns. Sincerely,

                                                  \i...:S.l-~'-------..

William D. Travers

• Executive Director for Operations

Enclosures:

1. Letter to NRC Commission fm J. L. Witt, FEMA dtd April 29, 1999

2. Letter to J. L. Witt, FEMA fm Chairman S. Jackson; NRC dtd June 15, 1999

3. Comments on draftNUREG-1633

4. November 5, 1997 Meeting Transcript Pages

5. NRC SECY-97-124, dtd June 16, 1~97 - Proposed Federal Policy Use of Potassium Iodide after a Severe Accident 'at a Nuclear Power Plant 5a. NRC SECY 98-264, dtd November 10, 1998 - Proposed Am.endments to 10 Cfr 50.47; Granting of Petitions for Rulemaking (Prm 50-63 and 50-63a) Relating to a Reevaluation of Policy on the Use Of Potassium Iodide (Ki) after a Severe Accident at a Nuclear Power Plant

2108 RAYBURN BUILDING EOWf'RD'~'. MARKEY WASHINGTON, DC 20515--2107

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November 10, 1999 A t'.. Chairman Richard A. Meserve U.S. Nuclear Regulatory Commission Washington,D.C.20555 5?)

Dear Chairman Meserve:

I n..,n writing to express concerns about the NRC rerpomes to my questions on potassi*.Jlll iodide stockpiles at the July 21, 1999 hearing on the FY2000 Nuclear Regulatory Commission Authorization Act before the Subcommittee on Energy and Power. These concerns were also addressed in a letter to the NRC from Peter Crane, a recently retired NRC employee. A copy of this letter is attached. He raises questions regarding: misrepresentations of the FEMA position on regional stockpiles by the NRC, intentionally inaccurate testimony on the cost of a buying potassium iodide (KI) and a misleading representation of the money NRC has spent studying KI. I am most troubled by the apparent misrepresentation by the NRC of FEMA' s opposition to regional KI stockpiles. As Mr. Crane indicates, the FEMA position is clearly represented in the letter from FEMA Director Witt dated April 29, 1999. The NRC response indicates, however, that the NRC disagrees with that clearly stated position. On this point, I would appreciate an explanation of the reason the NRC has denied the content of that letter. In addition, I would like copies of any communications that would support the implied NRC claim that FEMA has modified their position. With regard to the remaining points, I would appreciate updated and accurate figures detailing the cost of buying potassium iodide. This information should include the cost per pill and the expected shelf-life for KI tablets. In addition, I request that the NRC provides an accurate account of the actual expended costs of studying the KI issue. Specifically, the NRC should indicate how much more than $2.6 million has been spent on the NRC research to establish KI stockpiles. I would appreciate a prompt response to the issues raised by Mr. Crane with an emphasis on the specific points which I have addressed in this letter. Thank you for your consideration. Sincerely, ("'.)

                                                                                                                    ~

.> 0 cc: Hubert T. Bell, Office of the Inspector General, NRC

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lJ v vvLt.i-\ LU Lr\ r v , 11 0 Rll' EM KINGS&ADJUOICATIONSSTAFF OFFICE OF THE SECRETARY 01= THE COMMISSJON Doc* men Statisti SlmarkDate_,3/;)J oo ~u 1d ~ l~ <).~ Copies Receivet' - - --' dd'I Copies Reproduceo _ _ t/ Mecial Distribution,_ _ _~ --- -

Pett*r G. rror,e i 4809 Drummnnd Avenue I ( 'he\'\' Clime. MD .'OH I j / 301-656-J<J'JII ,' email: pgcrn11<'1alernl.t cnm October 15. 1999 Chairman Greta J. Dicus Commissioner Nils J. Diaz Commissioner Edward McGaffigan, Jr. Commissioner Jeffrey S. Merrifield U.S. Nuclear Regulatory Commission Washingt~.,n. O.C. 20555

Dear Chairman Dicus and Commissioners:

I have had the opportunity to review the Commission's answers to Congressional questions dealing with potassium iodide (Kl). (These were forwarded by letter of September I 0~ 1999, frorn Chairman Dicus to Chninnan Joe Barton cifthe Subcommittee on Energy and Power of the House Commerce Committee.) The answers are troubling in several respects, in particular the way they represent. or purport to represent. the views of the Federal Emergency Management Agency (FEMA). For example. question 15(8) asked whether, if there was an)1hing in NRC policies barring NRC from paying for state stockpiles of Kl. the NRC had reexamined those policies. The NRC's reply stated that both the NRC and FEMA **are currently reexamining earlier positions and policies regarding Kl." t wonder whether this answer was cleared with Director Witt of FEMA. His ktter to the NRC of April 29, 1999, could hardly have been blunter: Y1,ur abrupt retreat from repeated promises to the Federal community, states and the public is apparently based on a misapprehension of FEMA *s authorizing legislation and n disregard of our view -- and that of other FRPCC agencies** that regional potassium iodide stockpiles will not enhance radiological emergency preparedness .... FEMA has always opposed the notion that Federal regional stockpiles of potassium iodide would be effective in the event of a release from a nuclear power plant. ... Regional stockpiles of pt)tassium iodide would complicate. not strengthen radiological emergency preparedness I have not seen a word from FEMA since April 2~. 1999, to suggest that Director Witt is reconsidering his position. Perhaps the Commission knows something I do not know, but if this answer was n{)t cleured with FEMA, and we are seeing yet nnother misrepresentation by the NRC of FEMA 's stance, someone should quickly apologize to Director Win and correct the record with the Congress. I'm sure thnt FEMA has not forgotten the memorable Commission meeting of November 5, 1997. when the NRC stnff had tn apologize humbly for hnving "misrepresented"** the NRC stafr$ own wMd ** FEMA 's position on Kl. (If the Commission had only been willing to draw the 1)hvious conclusion from that unprecedented day in the agency's history, and assign the Kl issue to a new team, it might not have found itself, less than a year later. having to withdraw the staffs assessment of Kl. NUREG-1633, in the face of withering criticism from the health departments of New York State and Ohiq, and from me.) Question 17 quoted Director Witt's letter of April 29, 1999, and then asked why the NRC disputed FEMA *s position. The NRC's answer ;ncluded the following: (T]he NRC believes that regional stockpiles may be n pnrdent and reasonable approach to making KI availahle to emergency response l)fficials in the very unlikely event of a severe reactor accident that includes a significant early radioiodine component. The NRC Is confident, based on a long record of coordination and cooperation between the two agencies, that the NRC llnd FEMA staffs will successfully resolve the Kl !ltockpllc issue. [~mphasis added.]

.. . *I This amounts to a statement that regardless of Director Witt's unequivocally stated positi~n. the NRC is Cltnfident from past experience that it can bring the FEMA sea ff around. If r were Director Witt and f saw thi~. I would not be pleased to have my views so casually nicked aside, nor would I appreciate th~ s\1ggcstion that my staff can be induced to take positions contrnry to my own. My experience'of the 1-'EMA staff is that it has been principled and responsible on Kl, an~ I see no reoson why it should want to compr<ttnise away its Director's firmly held position. But it would not surprise me to learn that the NRC staff was attempting lo msh the FEMA staff into such a deal, perhaps hoping to present Or. Meserve. the incoming NRC Chainnan, with a/ail accompli. Is it likely, though. that any such plan would receive Director Witt's approval, after his letter of April 29? lt seems. regrettably, that nothing can penetrate the present Commission's cocoon of self-deception where Kl is concerned. Director Witt did everything to make the Commissioners understand FEMA 's position ~hort of physically shaking them by the shoulders. Surely at this point he must be asking himself.

    .. Whnt part of *NO!' didn't they understand?"

Let me offer a few additional comments on the NRC's answers:

              -- Cost of buying Kl.

The NRC was asked in question 16(A) what Kl would cost. One needs to know something of the background to appreciate how artful and evasive the NRC's answer was. Instead of answering the question directly ** that is, with a simple declarative sentence saying that

    ..the cost would hex** - the Commission reported what the staff said in November 1998 that a Kl program would cost. It also reported that at that time. the NRC staff reported an increase in the price of Kl.

The problem is that there is reason to doubt whether the NRC's staffs November 1998 figures were accurate even when first provided. For just a month later, in December 1998, I sent the Commissioners a memo, attaching an e-mail from Harvey Brugger of the Ohio o~partment of Health, which in tum attached an e-mail from a Swedish firm that was offering Kl in bulk at six cents per pill, with n I 0-year shelf life. These documenLi are in the rulemaking docket. If the NRC is not now using.a orice of six cents oer pill as the estimated <:<'St ~f Kl, what price i:1 it using. and wll,)' ! If the Commission, despite tts nominal commitment to **openness," (lee lines to answer the question. then let this letter be construed as a Freedom of lnfonnntion Act request for the following infonnation: (I) the estimated price per pill. at current price.~; (2) the estimated number of pills that would be required; and (3) !t,<: ,scimated shelf life. The Commission's statutory obligation is to keep the Congress "fully and currently" info~ed. Using outdated information that may not have been accurate even when it was current falls far short of that. The NRC also said that according to the 1998 figures. the cost of supplying Kl to all states with nuclear power plants would be "about $3 .25M in a given year. with replacements every seven years." The "given year" is the first year; :,pread over seven years, the nnnual cost is $450.000. and over ten years. it is

    $.325.000. llnfortunately, I know all too well how cleverly the NRC sometimes crafts sentences when KI is the subject, and the way snippets of these sentences later get quoted in misleading ways. (See. for example.

the NRC staff's use of the phrase **no new infonnation." when it was trying. even after the flood of Chemohyl-rclated childhood thyroid cancers in Eastern Europe. to stave off any reexamination of the 1985 federal policy on Kl.) In future, we can ex.peel to see statements that the NRC has advise.d the Congress that the cost ofa Kl program would be *'about $3 .25M in a given year," when the real answer should be the cost per year, a fraction of that $3 .25M figure.

              - Money spent by NRC studying Kl.

The first sentence of the answer to Question 16(8) said that the "total amount of NRC soending on

   !he_ Kl 1s'- 11 c exceeds $2.6M for Inst IO ye11rs." No doubt it does exceed $2 .oM ; but the real question 1s, t,,,

ho'l<I* nwc*h does it exceed that figure? If the answer i,; thAt it exci-eds it tu* :i suhstantial amount. then this

• answer docs not seem to meet the standard of "fullf' informing Cong_ress.

The detailed answer that followed this first sentence spoke only of NRC staff i:nd contractor expenditure, leaving the reader to assume that this was the sum totolof the agency"s c,,sts. In fnct. a grcnt deal of time has also been spent on the issue by Commissioners. their staffs. and. presumobly, agency lawyers a.-. well. How much did their time cost the agency'? And what about the cost of producing draft NUREG-1633, the staff assessment that had to be withdrawn? Why lenve l)Ut the cost of the 12-mcmber Kl Core Group, created to try lo revise end rehabilitate that document? Why omit the price of that group's week-long trip - what some would call a boondoggle -- to Tempe, AriZl,na. last winter? And what about th~ cost of all the NRC's interactions with FEMA and the FRPCC on Kl issues over the last ten years? The casual reader will have no reason to know or suspect any of this. however. The busy Congressional staffer will think that the NRC has answered the question. and will understand the NRC to ha~ said that it spent $2.6 million dollars studying Kl, a figure safely below the 53.25 million estimated Cl)St of buying Kl. No doubt it would have bee11 awkward and embarrassing if the answer had con tinned lht~ NRC staff's 1994 prediction -- made at n time when the wind from the NRC Chainnan's l,ftice was temporarily blowing in a different direction -- that it wt.'>uld be cheaper to buy Kl for the nation than go on studying whether to do so. (Any Commissioner needing a copy of that 1994 staff paper can undoubtedly get one from Dr. Congel, who is listed on it as the contact person.) Before leaving the subject of the cost of studying Kl, I should nlso mention. though this is not within the scope of the Congressional question, the substantial extra costs that FEMA and all the other agencies of the FRPCC have had to bear, thanks to the NRC's grievous mishandling l)f the Kl issue. NRC misinfomiation, delay, and broken commitments on Kl have not only resulted in leaving American children inadequately protected, compared to the children of other developed countries, they have also placed unnecessary additional financial burdens on either agencies of the Federal community. In the name of saving money on Kr, the NRC has wasted an extraordinary amount ofits own and others' resources.

             -- Who must consider KI under the proposed rule?

The rulemaking petition dealt with Cn'IP.rgencv "lans..which..are normallv r,renRred bv states. (Only when a state refuses to prepare a plan does a utility-prepared plan come into the picture.) hut t,

• answers to questi(,ns I6(B) And 17 referred to thc:..nr.QD.osed_rule as requiring {iC£Dsccs tl) Cl)nsidcr usin~ K1..ait-pPrl-Of tfie1r _eme~encv plannn. *. Was this an innocent mistake, \,r was the Commission trying to b<)lster claims that the NRC's proposed rule burdens licensees ond _is therefore a hal'ldit?

t nm S(>rT)' to say that the answers to the Congressional questions suggest that the present leadership of the Commission has learned nothing at all from past embarrassments or from Director Witt's efforts to make it comprehend its folly. Oblivious to all warnings, it has once again taken a bad situation for itself and managed to make it even worse. Sincerely, Peter Crane cc: James Lee Witt. Director. FEMA The Honorable Joe Barton, Chairman Representative Ralph M. Hall Representative Edward J. Markey Senator John Kerry Dr. Richard Meserve

FROM P2 Ol

                                                                                           '99    I][' -2 P 2 :58 September 12, 1999 Secretary, U.S. Nuclear Regulatory Commission Rulcmaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50-63A Con:iideration of Potassicm Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused lo ex tend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. l w;mt to urge that the emergency planning regulation b~ amended ro REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The rcgulauon as it is new worded .. . " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. u has no teeth and must be changed. 11\e nuclear .- i.nd.u_srry should bear the t:ost; government agencies should have the responsibility ~f'_seein, that poten.tially effe::ted communities have Local !to<:kpiles of potassium "iodide. NRC's'arinounced.;,lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; Kl is not effective after six

       ~ hours~*it must *be stockpiled in schools,hospitals~fire, police and other municipal centers.
                              '   ' ~\

There is no reason why the NRC should not make: these changes. Yollr mission is to prbtect the public's- health and* safety. *Please consider the people of Long Island who a.re not protected and who cannot, given our topography and highway system, evacuate in the case of

    .., an a¢cic!ent at Millstone.

Sincerely yours,

U. , NUCLEAR REGULATORY CUMMl~v I RU GS& UDI SSTA EOFTHE ~v THECOMMI n.v..,........ St . o 9'9 ~

DOCKET NUMBERPR PROPOSED RULE. 5V UNITED STATES t,'fFR"3l-; 3 ?) NUCLEAR REGULATORY COMMISSION WASHINGTON, O.C. 20555-0001 October 28, 1999

                                                                                  *99 NO\ -4 A8 :25 OF:

The Honorable John F. Kerry R_ United States Senate ADJ : Washington, DC 20510-2102

Dear Senator Kerry:

I am writing in response to your letter of September 29, 1999, on behalf of the Massachusetts Coalition to Stockpile Kl (Potassium Iodide). Your letter concerns the NRC's rulemaking responding to petitions for rulemaking (PRM-50-63 and PRM-50-63A) submitted by Mr. Peter G. Crane concerning the use of Kl in emergency plans. Specifically, you raise issues relating to the location and funding of Kl stockpiles as well as whether Kl should be made an

• emergency planning requirement.

The discussion below, as well as the enclosed Federal Register notice for the proposed rule, addresses these issues. The NRC is working closely with the Federal Emergency Management Agency (FEMA), the Food and Drug Administration (FDA) and other Federal agencies in developing a revision to the Federal policy on the use of Kl. In addition, the NRC is in the process of developing a final amendment to its emergency planning regulations that would require that consider,ation be given to include Kl as a protective measure for the general public to supplement sheltering and evacup,+ion. The NRC is also developing a guidance document to assist State ?nd local decision makers in their consideration of the role and use of Kl for the general public in their site-specific emergency plans. Kl, if properly administered and under certain conditions may reduce thyroid exposure from inhalation of radioiodines in the unlikely event of a major release of radioactive material from a r1uclear power plant. As part of the rulemaking process, the Commission published a proposed rule in the Federal Register on June 14, 1999, for a 90-day public comment period. A total of 74 comment letters were received expressing many diverging view points, some of which were consistent with the concerns that you focused on in your letter. The Commission is currently in the process of evaluating those comment letters as it develops the final regulation. The Commission has long recognized that individual States may find that Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific local conditions. In fact, prior to the recent Federal effort, at least three States had opted to include Kl as a supplemental protective measure for the general public. The Commission's current guidance on emergency planning took Kl into consideration (NUREG-0654/FEMA-REP-1 , Rev. 1, p. 63, Items e and f). Since the last revision of that guidance, there has been experience with the mass distribution of Kl in Poland as a result of the Chernobyl accident, and though the record on that distribution is not complete, many nations have stockpiled Kl and planned for its use.

Postmalk Date CopiesRaaalvad _ _ _ _ _ __ Add'f Copiesffep!OOIIC8d _ _ _ __ Special OislrlMion_ _ _ _ __

The Honorable John F. Kerry The use of Kl is intended to supplement, not to replace, other protective measures. The rule change thus represents no alteration in the NRC's view that the primary and most desirable protective action In a radiological emergency is evacuation of the population before exposure to radiation occurs, whenever that is feasible (evacuation protects the whole body, whereas Kl protects only a single gland, the thyroid). Depending on the circumstances, Kl, may offer additional protection if used in conjunction with evacuation and/or sheltering. In developing the range of public protective actions for severe accidents at commercial nuclear power plants, evacuation and in-place sheltering provide adequate protection for the general public. The NRC recognizes that the decision to stockpile Kl presents Issues of how best to position and distribute Kl to ensure that optimal distribution takes place. The FDA is currently reviewing its policy on the proper usage of Kl during radiological emergencies. The NRC Is working with States and localities to develop guidance on these and other points relating to the use of Kl. The NRC believes that these Implementation issues can best be addressed by States and local agencies involved in emergency planning. The Commission supports NRC funding of the initial purchase and resupply of Kl at regional stockpiles to the extent that there is no Economy Act constraint on FEMA receiving moneyJrom the NRC for this purpose. However, with respect to funding at the State and local level, the Commission notes that the NRC" budget has continued to decrease and offers little margin for the Commission to divert resources to new Initiatives such as funding of Kl stockpiles for individual States. Historically, funding for State and local emergency response planning has been the responsibility of those governments usually working with licensees. Therefore, the NRC will work with other appropriate agencies to ensure resolution of this Issue. Sincerely, l~1~ William D. Travers Executive Director f?r Operations,

Enclosure:

Federal Re,gister Notice

Federal Register/Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rules 31737 peanuts during the period from August Amended Refenmdnm Order faciliti88. The proposed rule would 1, 1997, through July 30, 1998 It is hereby directed that a referendum amend the current regulations to require (representative period). The voting be conducted among peanut producers that consideration shall be given to period for the referendum will be May to determine whether they favor including potassium iodide (KI), as a 10 through July 2, 1999. implementation of the Peanut protective measure for the general ADORESSB: Daniel R. Williams II, Promotion, Research, and Consumer public that would supplement Research and Promotion Branch, Fruit Information Order. sheltering and evacuation. KI would and Vegetable Programs, Agricultural The referendum shall be conducted help prevent thyroid cancers in the Marketing Service, U.S. Department of from May 24 through July 2, 1999. unlikely event of a major relaase of Agriculture, Room 2535-S, Stop 0244, Ballots were mailed to all known radioactivity from a nuclear power Washington, OC 20250--0244. eligible peanut producers on or before plant. The proposed rule responds to May 17, 1999. Eligible voters who do petitions for rulemaling submitted by FOR FURTHER INFORMATION CONTACT: not receive a ballot by mail should call Mr. Peter G. Crane concerning the µse Daniel R. Willia.ms II at the above address or telephone toll free (888) 720- the following toll-free telephone number of KI in emergency plans. 9917. to receive a ballot: 1 (888) 720-9917. All DATES: Submit comments by September ballots will be subject to verification. 13, 1999. Comments received after this SUPPLEMENTARY INFORMATION: Prior' date will be considered if practical to do Ballots must be received by the documents in this proceeding: Proposed referendum agents no later than July 2, so, but only those comments received Rule published in the November 6, 1999, to be counted. on or before ttiis date can be assured of 1998, issue of the Federal Register [63 Daniel R Williams II and Martha B. consideration. FR 59893]; and Proposed Rule and Ransom, Research and Promotion ADDRESSES: Comments may be sent to Referendum Order published in the Branch, Fruit and Vegetable Programs, the Secretary of the Commission, pril 23, 1999, issue of the Federal Agricultural Marketing Service, U.S. Attention: Rulema.kings and r (64 FR 20107] and Referendum Department of Agriculture, Room 2535- Adjudications Staff, U.S. Nuclear Procedures published on the same day S, Stop 0244, Washington, DC 20250- Regulatory Commission, Washington, [64 FR 20102). 02~4. are designated as the referendum DC 20555, or may be hand-delivered to The April 23, 1999, referendum order agents of the Secretary of Agriculture to One White Flint North, 11555 Rotlville [64' FR 20107) specified that the voting conduct the referendum. The Procedure Pike, Rockville, MD 20852, between period would be from May 24, 1999, for the Conduct of the Referenda in 7:30 a.m. and 4:15 p.m. Federal through June 11, 1999. However, the Connection with the I'eanut Promotion, workdays. Copies of comments received mailing list used for the referendum Research. and Consumer Information may be examined at the Commission's consisted of a large amount of rural Order, 7 CFR 1216.101-1216.107, which Public Document Room at 2120 L Street route deliveries. This has resulted in a were published separately in the NW (Lower Level), Washington, DC. large amount of the ballots amving later Federal Register [64 FR 20102]. shall be You may also provide comment via than expected or not all of the used to conduct the referendum. the NRC's interactive rulema.king web referendum ballot pack.ages have been site on the NRG home page (http:// delivered to potentially eligible voters. List of Subjects in 7 CFR Part 1216 www.nrc.gov). This site provides the In addition, the U.S. Department of A~ministrative practice and availability to upload comments as files Agriculture (USDA} has received procedure, Advertising, Agricultural in any format that the NRC web browser numerous telephone calls from research. Marketing agreements, supports. For information about the ) otentially eligible voters who did not Peanuts. Reporting and record Jceepmg interactive rulemaJdng site, contact Ms. ive ballots. Therefore. in order to requirements. Carol Gallagher, (301) 415-6215; e-mail tter facilitate full voter participation Authority: l' SC 7401-7425 CAG@nrc.gov. in the referendum, USDA 1s extending Dated June 9. t'ggq, FOR FURTHER INFORMATION CONTACT: the voting period through July 2, 1999 Michael T. Jamgochian, Office of Ennque E Figueroa. In addition, USDA will contmue to mail Nuclear Reactor Regulation, U.S.

                                            /1dmm1strator ballots to those potentially ehg1ble                                                      Nuclear Regulatory Commission, voters who request a ballot and others       IFR Doc 99-15112 Filed 6-11-99. 8 45 am!

Washington, DC 20555--0001. as they become known. BU.UNG CODE 341o--02-P Telephone: (301) 415-3224. Internet: Section 518 of the Commoditv MTJl@NRC.GOV. Promotion, Research. and Information SUPPLEMENTARYINFORr-fATION:By Act of 1996 (Act) requires that a NUCLEAR REGULATORY undertaking this rulemaking, the referendum be conducted among COMMISSION Commission, while not adopting the eligible peanut producers as to whether exact language suggested by the they favor the Order. The proposed 10 CFR Part 50 petitioner, is proposing to grant a Order [64 FR 20107] would become RIN 3150-AG11 petition for rulemaking (PRM-50-63A} effective if it is approved by a ma1onty submitted by Mr. Peter Crane on of producers votlng in the referendum, Consideration of Potassium Iodide In November 11. 1997. That petition 1s a which 1s currently ongoing. Emergency Plans revision of a petition (PRM-50-63) that Ballots to be cast in the referendum. AGENCY: Nuclear Regulatory he submitted on September 9, 1995. and anv related matenal relevant to the Commiss10n Considering all public comments referen.dum. will be mailed bv the ACTION: Proposed rule received, the information available in referendum agents to all known peanut the literature, 20 years of experience producers. Should any eligible producer

SUMMARY

The Nuclear Regulatory gained in evaluating licensee emergency not receive a ballot and related material, Commission (NRC) is proposing an preparedness plans, and the arguments such producer should immediately amendment to its emergency planning presented by the petitioner, the contact the referendum agents at the regulations governing the domestic Commission has decided to grant the telephone number that follows. licensing of production and utilization petition for rulemaking and to proceed

31738 Federal Register/-1 64, No. 113/Monday, June 14, 1999/C,..,,-posed Rules

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with rulemaking to amend 10 CFR (62 FR 66038). In the amended petition, The Petitioner's Discussion of the Three 50.47(b)(10) by inserting the following the petitioner requested that: Mile Island Accident (TM() sentence, after the first sentence: "In A statement [be made] claarlv The petitioner noted that in December developing this range of actions, recommendlng stockpiltng of KI as a 1978, the Food and Drug Administration consideration has been given to "reasonable and prudent" measure, and: (FDA) announced that it had evacuation, sheltering, and, as a A proposed rule change to 10 CFR determined that KI was safe and supplement to these, the prophylactic 50.47(b)(10) which would ha accomplished by inserting the following sentence after the effective for thyroid protection in use of potassium iodide (KI), as nuclear accidents. The petitioner stated appropriate." In addition, the preamble first sentence: "In developing this range of actions, consideration bas been given to that the issue attracted little attention, for this proposed rule includes a evacuation, sheltenng, and the prophylactic that the NRG and the Federal statement to the effect that State and use of potassium iodide (Kl], as appropnate " Government as a whole took no public local decision makers, provided with position on the drug, and that three proper information, may find that the The petitioner also provided a mark:ecl-up version of the NRG staffs months after the FDA announcement, use of KI as a protective supplement is on March 28, 1979, the TMI accident reasonable and prudent for specific proposed Federal Radiological Preparedness Coordinating Committee began to unfold. The petitioner stated local conditions. When the Commission that Federal and State officials, amended its emergency planning ' (FRPCC) Federal Register notice regulations on November 3, 1980, 1t concerning Federal policy relating to the searching for supplies of KI in case it stated that "any d1rect funding of State use of KI for the general public. should be needed, discovered that none or local governments solely for On June 26, 1998 (SRM 98--061), the was to be had and that a supply had to emergency preparedness purposes by Commission decided to grant the be manufactured, literally overnight. the Federal government would come portion of the petition for rulemak::ing

• The petitioner indicated that at 3:00 through FEMA." In its decision on June PRM-5G--63A regarding the requested a.m. on Saturday, March 31, 1979, an 30, 1997, the Commission also noted amendment to 10 CFR 50.47(b)(l0). The FDA of:ficial'arranged with the the Federal government (most Commission also directed that the Mallinckrodt Chemical Company for the y the NRC) is prepared to fund the preamble for the proposed rule include immediate production of 250,poo doses hase of a stockpile of KI for the a statement to the effect that State and of KI. '

tates, upon request. The Commission local decision makers, provided with The petitioner also discussed the has determined that notwithstanding proper information, may find that the Report of the President's Commission - the June 30, 1997, intention that "most use of KI as a protective supplement is on the Accident at Three Mile Island likely the NRC" would fund the reasonable and prudent for specific (the Kemeny Commission report}, purchase of State stockpiles of KI, the local conditions The NRC staff is also issued in October 1979, and stated that NRC budget has continued to decrease preparing a techmcal report and an the report was strongly critical of the and offers little margin for the information brochure to enable State failure to stockpile KI. The petitioner Commission to divert resources to new and local decision makers to make an noted that among the Kemeny initiatives. Historically, funding for informed decision in this matter. Commission's major recommendations State and local emergency response was that an adequate supply of the Petitioner's Basis for Requesting radiatlon protective agent, KI for human planning has been the responsibility of Potassium Iodide those governments usually working use, should be available regionally for with licensees. The Conurussion notes The petitioner stated that potassium distribution to the general population that the Petitioner has not requested the iodide (KI) protects the thyroid gland. and workers affected by a radiological

  ,Federal funding of stockpiles of KI ln         which is highly sensitive to radiation                  emergency, ,

the alternative, the NRC will work with from the radioactive iodine that would be released in extremely serious nuclear The Petitioner's Discussion of the other relevant agencrns to ensure that Potassium Iodide Policy re are established robust, pre- accidents. By saturating the gland with itioned regional stockpiles of Kl. to iodine in a harmless form, KI prevents The petitioner stated that in NUREG-effectively and timely used by states any inhaled or ingested radwactive 0632, "NRC Views and Analysis of the t have not established local iodme from lodgmg in the thyroid Recommendations of the President's stockpiles and-wish to make use of the gland. where it could lead to thvroid Commission on the Accident at TMI," regional stockpiles in the event of a cancer or other illnesses. The petitioner issued in November 1979, the NRC severe nuclear p~er plant accident stated that the drug itself has a long agreed with the findings of the Kemeny On November Z'J, 1995 (60 FR 58256), shelf-hfe. at least 5 vears, and causes Commission and planned to require the Nuclear Regulatory Commission negligible side effects. nuclear power plant licensees to have (NRC) published a Notice of Receipt of The petitioner further stated that, in adequate supplies of KI available for a petition for rulemaking (PRM-50-63) addition to preventing deaths from nuclear power plant workers and the filed by Mr. Peter G. Crane on his own thyroid cancer, Kl prevents rad1ahon- general public as part of State behalf. The petlt10ner requested that the caused illnesses. The petitioner notes emergency response plans. NRC amend its regulations concerning that thyroid cancer generally means According to the petitioner, the three emergency planning to include a surgery, radiation treatment, and a agencies most concerned, the FDA, the requirement that emergency planning lifetime of medication and monitoring. NRG, and the Federal Emergency protective actions include the The petitJoner asserted that the changes tvlanagement Agency (FEMA}, favored prophylactic use of potassium iodide in medication that go with periodic the stockpiling of KI for the next several (KI}, which the petitioner notes prevents scans put many patients on a years. The petitioner stated that the thyroid cancer after nuclear accidents. phys1olog1cal and psychological roller Atorruc Industrial Forum. a nuclear On November 11, 1997, the petitioner coaster The petitioner stated that 1Ddustry trade association, declared submitted a revision to lus original hypothyroidism can cause permanent itself against the stockpiling of KI in petition (PRM-50--63A). The NRC retardatwn m children and. if Mav 1982. published a Notice of Receipt of the undiagnosed, can condemn adults to a The petitioner indicated that the NRC amended petition on December 17. 1997 lifetime of fatigue, weakness, and chills staff was strongly in favor of KI

Federal 11.egister/Vol 64, No. 113/Monday, June 14, 19!:t.;, Proposed Rules 31739 stockpiling as late as September 27, and larynxes, rendering patients Government support, adopted new 1982, when the NRC staff submitted a permanently mute. International Basic Safety Stanaards in memorandum to the Com.missioners The petitioner disCUBSed post- 1994. The petitioner stated that these proposing that the Commission agree Chernobyl developments on KI policy. standards represented the consensus of with a draft interagency policy He stated that the Chernobyl accident the world's experts on radiation safety statement supporting KI stockpiling. demonstrated that KI worked and that and the standards provide, among other The petitioner further stated that on countries that failed to stocl:pile and things, that intervention levels of October 15, 1982, less than 3 weeks after distribute it are experiencing serious immediate protective actions, including sanding the draft policy statement.to the public health problems. sheltering, evacuation, and iodine Commission for approval, the NRC staff The Petitioner's Dfscussion of the NRC's prophylaxis, shall be specified in sent a supplementary memorandum Recomideration of Potassium Iodide emergency plans. Thus, the petitioner withdrawing the memorandum of stated, the international radiation September 27. The later memorandum The petitioner notes that in June 1989, protection community, like the Kemeny informed the Commissioners that NRC's the NRC reconsidered the KI issue after Commission in 1979 and the short-lived Office of Nuclear Regulatory Research the petitioner filed a Differing draft Federal policy statement of 1982, (RES) could, by January 1, 1983, Professional Opinion urging a change in recognized that effective preparedness produce a paper showing that KI was policy. On November 27, 1989, the for radiological emergencies means significantly less cost-beneficial than American Thyroid Association wrote to having three actions to comider previously assumed. The NRG staff the NRG urging KI stockpiling on a [evacuation, sheltering and iodine proposed sending this document to the nationwide basis and, in 1990, the NRC prophylaxis). FDA end FEMA with the announced that it was reconsidering the recommendation not to stockpile and existing Federal policy. In April 1992, a The Petitioner's Discussion of the distribute KL The petitioner indicated contractor under the sponsorship of the Meribi of the Petition fur RuJemaking that the NRG staff briefed the NRC Office of Nuclear Regulatory The petitioner believes the NRC Commission in November 1983 on the Research issued a report that included should implement the recommendation NRC staffs proposal to take a strong a re"ised cost-benefit analysis of the use of the Kemeny Commission and that the position against KI. A policy statement of KI The petitioner described the United States should maintain the wa.s later issued that disposed of the report as concluding that stockpiling KI option of using the drug KI for public Kemenv Commission's recommendation continued to be not cost-effective, but thyroid protection during nuclear which favored stockpiling KI. According that the difference between costs and accidents. The petitioner requested that to the petitioner, only a year later, the benefits was narrower than bad been the Commission definitively review and Chernobyl accident would give tangible calculated by the NRC staff in the early decide on the issue rather than simply proof of the value of the drug in 1980s. The petitioner further indicated having the NRC staff decide not to radiological emergencies that, ln December 1993, an industry propose it to the Commission. trade group. the Nuclear Utility The petitioner stated that evacuation The Petitioner's Discussion of the is not necessarily the protective measure Effects of Chernobyl Management and Resources Council, sent a report entitled "Review of Federal of choice in every emergency, and even The petitioner stated that dilling the Policy on Use of Potassium Iodlde," to when it is the preferred option, it is not Chemoby1acc!dentof1986,the the Commission arguing against any always feasible. The Kemeny damaged reactor spewed radioactive change m current KI policy. Commission report explained that iodine over a wide area of what was The petitioner notea that, in March different types of accidents, and the then the Soviet Umon and Poland. The 1994, the NRG staff declared its support particular circumstlinces presented, may petitioner further stated that in Russia. for KI stockpiling. However. the NRG call for different protective measures. the Ukrame, and Belarus. where the staff propos'al for a change in policy was The petitioner notes that maintaining a distribut10n of KI was inadequate and not adopted, the Commissioners having KI option ensures that responsible untimely, the population in these voted 2 to 2 on the staffs proposal in authorities have the option of additional countries 1s now experiencmg Mav 1994 (Under Commission protection at their disposal. extraordinarily high levels of childhood procedures. a tie vote means that a The petitioner indicated that NRG has thyroid cancer. However. m Poland. proposal fails ) made 1t clear that a finding of adequate where KI was admm1stered to 97 emergency planning does not translate percent of the nation *s children. there The Petitioner's Discussion of into a guarantee that the entire affected has been no similar mcrease in th\Toid Additional Support for Granting the public can be evacuated, but that cancer. The petitioner noted that Poland Petition for Rulemaldng evacuation is generally feasible. is a proof-positive example of the The petitioner descnbed a September The petitioner believes that benefits of a well-prepared KI program 1994, FEMA publication proposing a sometimes, either by choice or The petitioner stated that the U S "Federal Radiological Emergency necessity, authorities may decide to Government 1s spending money to study Response Plan" that envisioned the use shelter people or tell them to remain radiation-caused thvroid cancer in the of Kl dunng radiolog1cal emergencies. indoors rather than evacuate them. The Ulcrame and Belarus, and the Under the plan. the NRC would be the petitioner points out that it may be Department of Energy (DOE) announced lead Federal agency dW'ing emergenc10s desirable to administer KI any time a $15 million, 15-year program tnat will at nuclear power plants and would people are sheltered or told to stay follow 70.000 children in the Ukrame, ad\'lse State and local governments mdoors, when evacuation routes would to understand the thvroid cancer risk of whether or not to distribute KI (based on take people through areas of radiological exposure to radio 10dme The petitioner advice received from an mteragency 1 contamination, and when there has been further stated that the U.S. Government panel). The States and localities would a large airborne release of radioactive has spent generously to bring Ukramian then admiruster the KI. if necessary. iodine to the atmosphere. doctors to the United States for training The petitioner also indicated that the The pebtioner believes that the in thyroid surgery because mishandled Board of Governors of the Internal.!onal decision 011 stockpiling KI should tum operations can result in damaged nerves Atomic Energy Agency, with U.S. on whether, given the enormous

31740 Federal R.egister/vu1. 64, No. 113/Monday, June 14, 1999/ L-.... posed Rules consequences of being without it in a States do not have an adequate basis for actions during an emergency, consistent with II!aJor accident, the drug is a prudent making informed decisions. He believes Federal guidelines, are developed and in measure; not on whether it will that the Federal Government, and NRC place, and protective actions for the ingestion necessarily pay for itself over time. The in particular, has failed to provide the exposure pathway EPZ appropriate to the locale have been developed.  ; petitioner further believes that KI States with sound technical advice on represents a kind of catastrophic- the subject. The petitioner also believes Thef etitioner believes that if this coverage insurance policy offering that without accurate and currant revise change is adopted, the plan will protection for events which, while they information on KI-including the become an accurate description of occur only rarely, have such enormous Chernobyl experience and the emergency preparedness for radiological consequences that it is sensible to take consensus of international experts- emergencies; the recommendation of the s~al precautions. States cannot make an informed Kemeny Commission will at last be The petitioner stated that the judgment. implemented; and the United States will estimates of Ki's cost-effectiveness The petitioner believes that no State be in compliance with the International depend on estimates that are no more or local official or member of the public Basic Safety Standards. than informed guesses about the could imagine that in a real emergency, The petitioner suggested that the probability of severe accidents and that there would be no KI to administer. The NRC, either on its own or jointly with the NRC's cost-benefit analysis of the petitioner raised the question: If KI other agencies, issue a policy statement early 1980s was based on the stockpiling is not worthwhile, why is declaring that KI stockpiling is a assumption that a*savere accident with the administration of the drug one of the reasonable and prudent measure that is a major release of radioactivity could protective measures identified in the necessary to ensur& that the drug will be occur in this country only once every 1 1994 Federal Emergency Response Plan? available in the event of a major or 2 thousand years. He also asked why, if KI is worthwhile, accident. The petitioner believes that The petitioner believes that jf it were as the plan implies, something is not this statement would clarify that KI can y true that serious accidents with a being done to make sure that it is be used in-conjunction with evacuation lease of radioactivity were so unlikely, available. and sheltering to maximize protect.ion to ere would be good reason not only to The petitioner believes that the the public. reject stockpiling of KI but also to The petitioner also believes that the Federal Government should either

• dispense with all emergency planning. policy statement would show the change the 1985 policy and make the The petitioner also stated that if KI is use of KI a viable option in a real willingness of the NRG to provide a not cost-effective, then the rest of stockpile of the drug to States and emergency, or it should explain why the localities upon request, and would nuclear emergency planning is probably United States has decided that KI will not cost-effective either. support the Kemeny Commission's The petitioner believes that cost- not be an option.

recommendation to create regional benefit analysis is a technique that The Petitioner's Proposed Amendment stockpiles of the drug as a baciup for should be applied with good sense, to the NRC Regulations. emergencies. especially where public health measures In the original petition (PRM-50-63) are concerned. According to the Discussion l that was submitted on September 9, f petitioner, the cost-benefit analysis of KI 1995, the petitioner requested that 10 Stockpile of Medicinal Supplies for C proceeded from the assumption that CFR Part 50 be amended to include Nuclear, Biological, and Chemical there was no difference in desirability Agents (1995) language taken from FEMA's Federal Q between prevention of radiation-caused Radiological Emergency Response Plan In June 1995, the President issued r, thyroid disease and cure. Thus, the only of September 1994, and recommended Presidential Decision Directive 39 p actor to be considered in evaluating KI the following revision to the regulations. (PDD-39) on U.S. Policy on Counter ir s the cost. The petitioner also The petitioner proposed that Section Terrorism. The PDD-39 directed Federal d ieves that the U.S. Government agencies to take a number of measures 50.47(b)(10) be amended to read as D etermined that instead of spending follows: to reduce vulnerability to terrorism, to , E money to prevent radiation-caused deter and respond to such acts, and to F thyroid disease, society should spend its (10) .-\ range of protecll\ e actions including sheltering O\ acuation and prophylactic use strengthen capabilities to prevent and St money treating the disease if and when manage the consequences of terrorist lr of JOdme ha\e been developed for the plume it occurs. use of nuclear, biological, and chemical d. exposure pathwa} EPZ {emergency planning The petitioner believes that the zone] for emergency wor!.:ers and the pubhc. (NBC) weapons, including weapons of F; existing policy on KI was defective from Guidelines for the choice of protective mass destruction. The PDD-39 assigned st the start because it was based. in part, acllons during an emergency .. cons1stent w1th to FEMA the task of ensuring that the Ol on inaccurate inform'ation provided to Federal guidelines, are developed and m Federal Response Plan (FRP) was ac the NRC Commissioners. He stated that place. and protectrve actions for the inge~t10n adequate to respond to the m the information provided to the NRG exposure pathv.ay EPZ appropriate to the consequences of terrorism. he Commissioners seriouslv understated loLale ha\e been developed FEMA. in coordination with the fr, the significance of radiation-caused in the revised petition {PRM-50-63A) Catastrophic Disaster Response Group Cc thvroid disease and therebv understated that was submitted on November 11. (CDRG) 1 , developed a draft report to the F1: to.an equal degree the value of KI. 1997, the petitioner requested that 10 President entitled, "An Assessment of aa The petitioner also believes that it CFR 50.47(b) (10) be revised to read: Federal Consequence Management was not clear that the Conumssion had Fl (10) A range of protect!\ e action ha\ e been any idea of the real nature-of post- 1 The CDRG 1s the headquarters senwr-\e, el developed for the plume e,posure EPZ for accident thyroid disease at the time it emergency \\ori._ers and the pubhc In coordmatmg group "h1ch addreSBees pollc1 issues C1 adopted an anti-KI position. The petitioner stated that existing dt>\*elopmg thi~ range of actlons. regarding the Feden,J Response Plan (FRP) The CDRG ts chaired b, FEM:\ and compnses of ru wn~1d'erat10n has been gnen to evacuat10n. representa11, es of Federal departments and agencies p( policy left the judgment on stockpilmg ,heltenng, and tht> proph, lactic use of "nh respons1b1lmes und1>r the FRP The NRG is cc KI to the States. The petitioner asserts potassium 1od1de (Kil. as appropnate represented bv the Incident Response Dn,srnn Pc that this policy also ensures that the Guidelines for the choice of protective Director. AEOD n<

Federal Register/V~l. 64, No. 113/Monday, June 14, 1999/rroposed Rules 31741 Capabilities for Response to Nuclear, interested parties. The subcommittee the petitioner amended his petition to Biological or Chemical (NBC) conducted a public meeting on June 27, ask for a rule that would require that Tenorism," dated June 12, 1996. The 1996. The subcommittee evaluated all consideration would be glven in the report recommended, among other comments from the June 27 public formulation of emergency plans to the things, that the Federal Government meeting and made the following use of Kl as a supplement to evacuation purchase and stockpile thyroid blocking recommendation regarding the Federal or sheltering, and on June 26, 1998, the agents (KI} for the general public that KI policy: Commission granted the amended could be used in the event of a nuclear 1. Without changing the Federal policy by petition, and directed the NRC staff to terrorist event The NRC was a member interceding in the State's prerogative to make initiate the requested rulemaking. The of the Cora Group which generated the its own decisions on whether to use KI, the Commissioners also decided that the recommendations and was instrumental Federal Government (NRG, or through FRPCC Federal :Register notice on in adding KI to the list of qiedical FEMA) should fund the purchase of a Federal KI policy should include a supplies to be stockpiled nationally. stockpile for a State that decides to statement to the effect that the State and The Core Group concluded that as the incorporate KI as a protl'Ctive measure for the local decision makers, provided with result of recent events, significant general public; proper Information, may find that the

2. The Subcommittee believes the language threats over the past few years, and the in the 1985 policy should be softened to be use of KI as a protective supplement is increased availability and proliferation more flexible and balanced. For example, the reasonable and prudent for specific of NBC materials, there is an increasing problem many lnterveners observe with the local conditions. On September 30, concern for the potential of terrorist Federal policy ls the italic1zed statement 1998, the Commission approved a draft incidents. NBC events, the report "The Federal position with * *

• potassium Federal Register notice and directed continued, may occur as a local event iodide for use by the general public is that that it be sent to the FRPCC.

with potentially profound national it should not be required." It would not be On November 27, 1995 (60 FR 58256), implications. In responding to these , as negative if the last pj:lrase were reworded a Notice of Receipt of the Petition for to state "lt [potassium 1odlde for use by the events. the first responders must be able general pubhcl 1s not required, but may be Rulemak.ing was published in the to provide critical resources to the selected as a protective measure at the option Federal Register requesting public victims. These include, but are not of the State or, m some cases. local comment. A total of 63 comment letters limited to, chemical nerve antidotes, governments." were received, of which 20 utilities, 9 vaccines for anthrax. and antibiotics. 3 The subcommittee recommends that State governmental agencies, 2 utility The Core Group identified the need to local 1unsd1ct1ons that wish to incorporate KI interest organizations, 1 letter signed by purchase and preposition stockpiles of as a protective action for the general public 12 health physicists, 2 State universities adequate medical supplies at the should consult with the State to determine 1f and 1 member of the public were against these arrangements are anoropnale rf local Federal, State, and local level While Kl governments have the authority or secure the the granting of the petition for was not considered as vital as chemical approval to incorporate KI as a protecllve rulemalcing. Those letters in favor of nerve antidotes and vaccines. the NRC measure for the general pubhc. they would granting the petition came from 5 staff was successful in getting KI need to mclude this measure in their environmental groups, 22 members of included with other medical supplies emergency plans. the public (including 1 from the for NBC events because of the unusual Analysis of Issues Raised by Public petitioner), and the American Thyroid characteristics of these events. Comments Associ~*!on. Because of the special characteristics On December 17, 1997 (62 FR 66038), of NBC events. the Core Group The Commiss10n has considered the the Commission published a request for recommended a broader range of Kl policy question on numerous public comment on the revised petition protective actions. The NRG concurred occasions since 1984. The voting history in the Federal Register. In response to in the findings of the report m a letter of the Commission shows that reaching several requests, the comment period dated September 25. 1996, from the consensus on this pohcy question has was extended until February 17, 1998, Director of NRC's Office of Analysis and been an elusive goal. An important by a Federal Register notice published Evaluation of Operational Data to reason for this historical lack of on January 21, 1998 (63 FR 3052). A FEMA's Director. The report was consensus 1s that this policy question is total of 82 comment letters were subsequently presented to the President not a clear cut one. Individual

• received, of which 13 utilities, 3 State in February 1997, and approved for Comm1ss10ners. past and present. have governmental agencies, 1 utility interest distribut10n in May 1997. However. differed rn their v1ews with respect to association, and 1 member of the public FEMA recently reported that the federal the relative importance to be given to were against granting the petition for stockpiles of KI are few and stocked factors bearmg on the Kl issue These rulemaking. The letters in favor of only for first responders to terrorist honest differenc"ls have led to divided granting the petition came from 8 public action. As things stand now. needs of Commission views on how to resolve interest groups, 46 members of the members of the public for Kl on an ad the policy question. The Com.mission is public {including 1 from the petitioner),

hoc basis would have to be supplied agreed that Its historical difficulty to 3 physicians, 2 U.S. Senators. and 1 from other sources. As stated above. the reach consensus on the Kl policy State Representative. The following Commission intends to work with quest10n underscores the reality that issues were raised by the public FEMA to assure that stockpiles contain this policy quest10n 1s not a simple one. commenters with an accompanying adequate supplies of KI 1s not one that is easilv resolved and, as NRC staff response: a result. has been the sub1ect of Issue 1 Nearly all nations with FRPCC Subcommittee on Kl (1996) protracted deliberation. nuclear power protect their citizens by Along with petitioning the NRC. Mr On November 5. 1997, the having Kl readily available and the Crane also requested that FEl\.1A review Comrmss10n held a public meetmg with logistics of distnbution do not seen to his petition and reconsider the Federal its staff. FEMA representatives. and the pose any significant problems. Would policy In early 1996. the FRPCC author of the 1995 rulemakmg petition implementing a policy of using Kl for convened an Ad-Hoc Subcommittee on to consider the petit10n and proposed the general public be so difficult? Potassium Iodide to request and review changes to the Federal policy on the use Staff Response: At the November 5, new information on this matter from of Kl In part as a result of the meeting, 1997, Com.mission meeting, senior NRC

31742 Federal Register/Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rules staff members told the Commission: cancer, there has been no confirmed cancer. Taking into account the "We recognize that there are difficulties increase in the rates of other cancers, spontaneous rate of this disease in this in distribution, but they are not including leukemia, among the first age group and the number of evacuated insurmountable. If a decision is made by responders, liquidators, 2 or the public, persons, all of these cases are the State to do it [stockpile and/or that have been attributed to release from considered accident*induced. predis1rlbute KI) we can figure out a the accident. The total number of excess thyroid way to do it." It is the staff's perception Belarus Experience. With the cancers in Belarus children is currently that if the State decides to include KI as Chernobyl plant located only 4 miles (7 about 750, and is estimated to reach a a supplemental protective measure for km) away, Belarus was heavily maximum of more than 3500 over the the general public, one possible method impacted by the accident. This impact lifetime of this cohort.3, 4, 6 The vast of implementation could be that the was heightened by the fact that majority of the thyroid cancers were State could make KI readily available protective actions were not diagnosed among those living more than where other over-the-counter drugs can implemented in Belarus during the first 50 km (31 miles) from the site. be purchased. The public could be six days after the accident. Several The increase in the rate of thyroid informed of the drug's availability authors have stated that KI was cancers in Belarus is concentrated through the yearly emergency distributed to the population in Belarus among those who were youngest at the preparedness information brochure 'that during the first week following the time of the accident. Fortunately, these is ~ed out to all residents throughout accident. 3 However, there is no cancers respond favorably to early the 10 mile EPZ. It would then be up to confirmed published data on the dosage, treatment; to date, two or three of the individual members of the public to coverage, or other details concerning the Belarus children diagnosed with thyroid obtain and store this supply of KI, implement,ation of the thyroid blocking cancer have died as a result of that which should then be available for use in Belarus. In addition, cows typically disease. 6 in the event of an emergency. The grazed in Belarus at the time of year Poland Experience. Poland detected administration of the KI could be at the when the accident occurred, and vet no increased levels of airborne radioactive

• direction of the State Medical Officer. efforts were taken to restrict the
• contamination on the night of April 27, Issue 2. It is "factual that the 1986 consumption of contaminated milk for 1986 (day 2). Although there was no Chernobyl accident clearly the first 10 days following the accident. official notification of the accident by demonstrated the benefit of having K1 On May 2 (day 7 following the the USSR, it was assumed, on the basis readily available. In Poland, where accident) the decision was made to of Tass News Agency reports, that the authorities expedmntly administered 18 evacuate the areas of Belarus and increases were attributable to the million doses of Kl, 97 percent of all Ukraine within 18 miles (30 km) of the accident at Chernobyl. On April 28 (day Polish children were protected from plant (30 km zone). The evacuation was 3), the country formed a governmental th:;TOid disease. In contrast, there are completed on May 5, 1986. , commission to recommend protective soaring rates of childhood thyroid Since 1990, a rapid increase has been actions. Among these actions. the cancer, 200 times pre-Chernobyl levels, observed in the mcidence in thvro1d commission recommended intervention in the former Soviet republics of Russia, cancer among Belarus children *who levels for taking protective actions on Belarus, and the ')kraine because very were O to 14 years old* Rt the time of the the morrung of April 29 (day 4). 7 little KI was administered. too long after accident Before the accident. the rate of On April 29, Poland's Minister of exposure." thyroid cancer among this cohort was Health gave orders to prepare and Staff Response* The Chernobyl reactor about 0.4 per 100,000: by 1996, this rate distribute Kl to the 11 provinces most (a RBMK-1000 design) 1s located in the had risen to 3.9 per 100,000.\6 This affected. KI was to be made available Ukraine close to Belarus The accident included approximately 3,000 children, through hospitals. public health centers, occurred at 01:23 on Saturday, 26 April O to 18 vears old, that were evacuated schools, and kindergartens. The country 1986, when explosions destroyed the from the 30-km zone within Belarus used its mass media to announce the reactor core and reactor butldmg. The .\mong this group. four thyroid cancer protective action and to appeal for explosions sent debris from the core cases hd\ e been detected since the volunteers to assist in the nationwide flying into the air and exposed the accident. All of these cases\\ ere distribution reactor core to the atmosphere The registered after the end of the latent The Commission then instituted the heavier debris from the plume was penod for radiat10n-induced thyroid following additional protective deposited close to the site. In general, measures: 8 the initial release is thought to have 0 Liquidators lll1! a large number (about 200.000)
• Feedmg of cows on pastures or with risen to over 1 km m altitude, thereby oh,orl.ers and m1!Hary personnel "ho performed fresh fodder was banned countrywide until cleanup, ronstruc!lon of the sarcophagus. and other Mav 15, 1986 resulting in much lower doses close to operallon, in thP contaminated zones folio,.., mg the the site than those expected from a arcident  ; Fresh milk with radioactivity

 -ground level release The major release                'Persvnal commumcanon. E Buglova '-.1 D Head concentrallon above 1.000 Bq/L was banned lasted 10 days, durmg *which most of the Labor at al"\ of Radiation H, g.icne and RJsl Anal, s1>, for           consumptrnn by children and pregnant or lactating women of Health Republic or Belarus. Decembt?r noble gases and more than 40 percent of \!mhtn     1qq~

• All children under the age of 4 were 1

the iodines are esUmated to have been * 'Th\'toid ,.an err ,n ChildrPn Ln mg ,ear g1\'en po\, dered milk through numerous released. The \'arymg meteorological Chemob, I E,p,>rt Panel Report on the distribution centers. conditions, release rates, and release Con~uences of the Chernobyl Accident' -

• Children and pregnant or lactating heights resulted in very complex dose \\ilhams D et al K H ECSL-E:\EC Repor1 El'R women were advised to eat a m!mmum of 15248 E'\ Bruw*ls-Lu,~moourg 1993 p 108 fresh leafy \egetables (until May 16. 1986) and ~ound deposition patterns
• E Bu~Ju, a ,*t al Th\ roid Cancer m Belarus It 1s often assumed that ingestion was -\fter th~ Chemnb, I -\cc1dent. lnc1dPnce. f'ru~no!is.

the major source of thvro1d dose earlv "The Implementation of Short-term Risi. -\,,,e~,m*nl Lo" Dn,<'S of loniz,ni,: Rdrl1a!lon Countermeasures .-\fter a ~uclear .\cc1dent. m the accident. Howe~*er. the

• Biulog,cal Eff~rh and Re~ulator Cuntrol, Spam.

Proceed mg of an NEA Workshop Stod..holm

• contribut10n of inhalation cannot be ,o, ember 1gq;. Contnhut"d i'dper pp 280-284 Sv.eden. 1-3 June 1\lll4, OECD 1995

                                                       " 'Th, ro1d ,.mcer lnndence Rate in the Republic assessed because air samplmg was not               of Belarus* Oledno, ,-\ et &I . Radiation and Rigl         * \lanual on Public Health Action! m Radiation effectively conducted earlv in the                  Bulletm of '\allon&I Radio*Ep1dern1olog1cdl            Emergencies. WHO. European Conter or accident. .As of 1996, except for thyroid           RP21>tr.. Obninsl 19q5 IssuP 6 pp 236. 239             Em 1ronmental and Health. Rome O1\'lS!0n. 1995

Federal Register,-,.-ol. 64, No. 113/Monday, June 14, 199!,.~,.mposed Rules 31743 The distribution of KI was initiated on stations, thereby allowing prompt resulting from exposure to one April 29 (day 4) and was virtually distribution. A further description of the important group of radionuclid!ll:, the completed by May 2 (day 7). This WHO guidance is provided below, radioiodines. That is why current NRC included the distribution of KI to more followed by a discussion of the guidance discusses KI for plant than 90 percent of the children under guidance promulgated by IAEA and a personnel, emergency workers, and the age of 16 and about a quarter of the comparison between U.S. and institutionalized persons unlikely to be adults. A total of 10.5 million doses of international _practice. , evacuated promptly. KI were given to children and 7 million World Heafth Organization (WHO) In this light ilie Commission agrees doses were given to adults. Multiple Guidance. The main points of the WHO that the use of KI may be determined by doses, although not recommended, were Guidelines 10. 11 regarding the use of State and local emergency response taken in a number of cases. Because of stable iodine are as follows: planners to be a supplementary diminishing air contamination, the KI

• Near field* Stable Iodine should be protective measure.

prophylaxis was not repeated. In the available for Immediate distribution to all Issue 3: "Stockpiling or second phase of the respollBe, powdered groups if the predicted thyroid dose ls likely predistribution ol potassium iodide (KI) milk was made available to all children to exceed national reference levels. Close to as a protective action would not add any nuclear installations Iodine tablets should be less than 4 years of age. This program stored or predistributed to facilitate prompt significant public health and safety effectively started on May 3 (day 8). utilization. benefit to the Clll'I'8Ilt level of protection It is estimated that approximately a

• Far field: Stable iodine should be provided by existing emergency plans 4Q....45 percent reduction in thyroid available for distribution to pregnant women, for commercial nuclear power plants.

burden was achieved by thyroid neonates, infants, and chlldren if the Our emergency plans focus on blocking and milk restrictions in the 11 predicted dose ls likely to exceed reference evacuation as the key protective action provinces treated. 7 Had the Russian levels. to prevent exposure since it protects _ authorities given prompt warning, the Conclusion from Polish Experience. In against exposure to all radionuclides, 24- or 48-hour gain In time might have Poland (1) Small amounts of radioactive not just iodine. In addition, the improved the effectiveness of their iodine were deposited as a result of the potential for misadm.inistration of KI is response. Chernobyl accident, (2) no protective present when predistributed to the There were no reported serious actions were tal:en for the fust 2 days of general public, and incidents of adverse reactions except for two adults the accident, and (3) protective actions misadministration have been informally with known iodide sensitivity About (except sheltering or evacuation) were reported at industry meetings by states 36,000 medically significant reactions taken after the first 2 days of the which__P.red.istributed KI to the public." were also reported (mostly nausea). 9 accident. Because of the low iodine Staff Response: The Commission Because of the low iodine concentrations in Poland and the agrees that it is the State's prerogative to concentrations in Polana it is doubtful protective actions implemented, Poland decide to include stockpiling or that epidemiological studies could has not detected excess cancers predistribution of Kl as a protective detect excess cancers resulting from resulting from intake of radio iodmes. action for the general public. The FDA intal:e of radio iodine. 8 Overall Chernobyl Conclusion. The concluded that risks from short term use International Proct1ces-DUiing this World Health Organization, almost of relatively low doses of KI are out assessment, th'.l NRC staff examined the every indwtrial country in the world weighed by the radiologically induced current policies and practices regarding with nuclear power plants, and the thyroid nodules or cancers at a the use of thyroid blocking during American Thyroid Association, believe projected dose to the thyroid gland of 25 Nuclear Power Plant accidents for a that the low iodine concentrations, the rem or greater. In so doing, the FDA number of countries. The NRG staff banning of the consumption of fresh approved KI as an over-the-counter accomplished this task primarily milk and the distribution and drug. The American Thyroid through personal communication with administration of 90 million doses of Kl Association fully endorses the use of KI colleagues in each country. In general. contnbuted to the observed lack of and, as previously discussed, there were the countries either are following or increase of childhood thyr01d cancers in only 2 significant adverse reactions and intend to implement systems that are Poland Most industrial nations with 36,000 medically significant reactions consistent with the guidance nuclear power plants have decided to (nausea) in 90 million doses of KI after promulgated by the World Health stockpile KI around nuclear power for the Chernobyl accident. The taking of Kl Organization (WHO). Specifically. the use by the general public should require precautions similar to WHO recommends predistribution of In contrast to the Chernobyl those associated with any other over-the stable iodine close to the site and expenence, in the event of accident an counter drug, and, of course, the stotlpiles further from the site. These , in the United States, our emergency packaging instructions should be stocks should be strategically stored at planning calls for protective actions, followed. points such as schools, hospitals. sheltering. evacuation, and removal of Issue 4: "Evacuation is more feasible pharmacies, fire stations, or police contammated food from consumpt10n and practicable. Stockpiling of KI has all of which significantly reduce the risk logistical problems which we feel

   *A* medically significant" reacuun ,-as one for    of exposure of the public to all                         renders this idea impracticable and which the per,son suffenng the reaction coruultt><l a physician more than once :-.auman and \\olff.       radionuclides.        Making    KI  available  to        unmanageable."
"Iodide Pro phyla.xis 1n Poland After the Ghernob, I  the public for use during evacuation or                      Staff Response. The staff agrees that Reactor Accident Benefits and R.Lslu." The            especially sheltering could, under                       evacuation ls usually "feasible and Amencan Journal of ~fod1cme Vol 94 \la\* 1993         certam conditions. reduce the risk                       practicable" and is the most effective

p. 530. About 2'\, of the population that received Kl had "medically s1gmflcant" adverse reactions to protective action. If the State decides to Kl Id However, "hlt should be pointed out that '" lnternauonal Basic Safet\ Standards for include Kl as a supplemental protective control values for these side effects ma population Protecuon ".gamst !on1Z1ng Rad1auon and for Saf~t\ measure for the general public, one not receiving Kl are not 8\ a,lable " Id That 1s. ti of Rad1at10n Sources Safet\ Senes :-.:o 115, I.".E.",..

• 1996 possible method of implementation ts not known what the incidence of such reactions would be m a population under similar stress. but "\!ethod for thP De\elopment of Emergenc, could be that the State could make Kl not receiving Kl, and thus Hts not known to what Response Preparedness for \,uclear or Radtolagical readily available such as by mal:ing it extent these adverse reacttons were the result of KI .",.cc1dent .. T ecdoc-953. IAEA, July 19il7 available where other over-the-counter

31744 Federal Register/ Vol. 64, No. 113 /Monday, June 14, 1999 / Proposed Rules drugs can be purchased. The public benefit diminishes quickly over time Staff Response: Approximately 18 could be informed of the drug's and may be very small if administered million doses of KI were distributed availability through the yearly late. U a release is expected to continue primarily, but not exclusively, to emergency preparedness information for several days, the NRG anticipates children. The bulk of the distribution brochure that is mailed out to ail that the public would be evacuated or took about three days. There were no residents throughout the 10 mile EPZ. other protective action would be taken, reported serious adverse reactions Individual members of the public would depending on the level of release. Kl except for two adults with known be responsible for obtaining and storing could-nevertheless serve as a useful _. iodide sensitivity. The rate of serious this supply of KI, which could then be supplemental and complement to these side effects (10- 7 ) is consistent with the available for use in the event of an primary protective actions. frequency seen during routine use of KI emergency. Another approach to Issue 7: KI is an effective thyroid for medical treatment of respiratory predistribution is to include stockpiling blocking agent only when administered disease. The incidence of medically at reception centers for distribution immediately before or after an exposure significant, but not serious, reactions to during an evacuation. Other countries to radioactive iodine (that is, within one this single dose of KI was also very low have found ways to effectively to two hours). Distribution of KI in a (0.2 percent). In addition, no detectable distribute KI when needed and the timely fashion to the general public long-term disturbance in children's distribution issue is certainly not following an accident could further thyroid function was detected as of unsurmountable. The administration of complicate and decrease the 1989. Additionally, the FDA has the.KI-should be at the direction of the effectiveness of implementing approved KI for over-the-counter State Medical Officer. evacuation or residential sheltering. distribution. The staff, therefore, agrees Issue 5: The Three Mile Island Staff Response: The staff disagrees that the post-Chernobyl experience has experience has shown us that it is not with this position. If a-State chooses to shown that large-scale deployment of KI y to obtain an adequate supply of KI include KI as an additional protective is relatively safe. nan emergency. meaBure, it is anticipated that the State Staff Response: The commenter is Issue 10: Several comments raised the could make KI readilv available to the question of liability: "Is the NRC correct, in that it was difficult to obtain public where other over-the-counter KI after the Three Mile Island accident. prepared to address the number of legal medicines are available or by other implications should a member of the That is one reason why the Commission distribution means and that the public believes that planners should cons{der be made aware of its (the KI) general public be given KI at their stockpiling KI. and why the availability, not at the time of an directive or recommendation and the Commission supports Federal emergency, but KI could be made individual have an extreme allergic stockpiles, so that States that have available year round. reaction, possibly death?"; "The Federal chosen not to stockpile KI could have Register Notice does not address legal Issue 8: One of the major access, albeit ad hoc and delayed, to an issues for states who decide to adopt KI adequate supply in a radiological impediments to distribution of KI to school children is coordination and and states who do not decide to adopt emergency at a nuclear power plant. As or administer KI to the public."; "The noted elsewhere in this notice, the admmistration of the program, e.g., the actual decision making process to issue of legal lidbility should not be Commission will work with other dismissed lightly. If the NRC decides to agencies to assure that there are* Federal administer KI or evacuate, parental. approval and recordkeeping, require stockpiling of KI for the general regional stockpiles that contain public, bas NRC considered what adequate supplies of KI. Moreover, the identification and documenting allergic reactions. and the availability of a liability may arise from any adverse eneral availability of KI is greater now health effects? No initiative such as this an at the time of the TMI accident, qualified medical professional to administer the potassiwn iodide. should be undertaken without y because of the FDA 's approval of resolut10n of this issue."; "Who would as an over the counter drug. Some Staff Response The staff disagrees. assume liability if the KI was used prior States have elected to incorporate KI Upon declaration of a general into the emergency response plans and emergency there should be NO decision to the Governor ordering its use?' have obtained adequate supplies for this **to admm1ster KI or evacuate." The Staff Response: The comments focus purpose. The Commission 1s not aware preferred protective action for the close- principally on concerns that State and of any factors that would constrain the m population should be evacuation. The local governments involved in availability of KI for stockpiling admimstration of KI should be treated distribution and administration of KI purposes. The Commission believes that m the same fashion as any other over- mav be liable in tort if an individual an adequate supply of KI could be the-counter medication that might be receiving the KI has a significant obtained. given to children while away from adverse medical reaction to the KI. To Issue 6: Even though KI home. after observing the instructions the extent that commenters are raising administration before any exposure 1s provided with the KI packaging. Prior the potential for federal government ideal, the Chernobyl experience also has parental approval to administer KI in liability for the promulgation of this shown that the exposure can continue the e\*ent of an emergency can and proposed rule, the NRC believes that for days. Is the institution of KI should be addressed in the plannmg whether the Commission may be subject blockade at any time in this period process for any State that decides to use to tort liability through the beneficial? KI The mdmdual State may provide implementation of a KI program Staff Response* The admm1stration of the appropnate guidance and establish depends upon a number of factors. KI is most effective if done before or a system for obtaimng parental apprm*al Howe,*er, it would appear that a immediately after (within 2 to 4 hours) before the taking of other protective Commission decision to require state a release. Nonetheless, during a chronic actions that are currently being followed and local emergency planning officials exposure of several days. the in the EPZ around nuclear power plants to consider stockpiling KI for public administration of KI any time during the Issue 9* Does the post-Chernobyl distribution should be subject to the exposure penod may block some uptake Polish experience show that large-scale "discretionary function" exception to of radioactive iodine. However. the deployment of KI is safe? the Federal Tort Claims Act, 28 USC

Federal Register/Vol. 64, No. 113/Monday, June 14, 19!:lt.f/Proposed Rules 31745 2671, et seq., 12 which protects the step and, continuing to recognize the completed on PRM 504i3 and PRM 50-- Federal Government from liability. The authority of the States in matters of 63A. question of whether a State or locality emergency planning, explicitly require might be liable for involvement with Commission Conclusions or Issues that planners consider the use of KI. Raised by the Petitioner and Public administration of KI to the general The proposed rule change should not public can only be answered by be taken to imply that tlie NRC believes Commenters reference to the laws and precedents of that the present generation of nuclear The Commission having reviewed the particular States. The NRC presumes power plants is any less safe than issues raised by the petitioner and the

• that this would be part of the previously thought. On the conµ-ary, public commenters, has reached the "consideration" that States and present indications are that nuclear following conclusions:

localities will undertake if this rule is power plant safety has improved since A. The Com.mission agrees that KI. promulgated. The NRG nas not the currant emergency planning when determined by State and local undertaken this analysis. requirements were put in place after the emergency respoDBe planners and if Issue 11: Does the Commission Three Mlle Island accident. administered in a timely fashion, could consider stockpiling and using KI as a The use of potassium iodide is protect the thyroid gland from exposure reasonable and prudent protective intended to supplement, not to replace, to radioiodines inhaled or ingested measure for the general public? other protective measures. This rule following a major radiological accident. Staff Response: The Commission change thus represents no alteration in This is the basis for stockpiling it and believes that State and local decision the NRC's view that the primary and distributing it to emergency workers and makers, provided with proper most desirable protective action in a institutionalized persons during information, may find that the use of KI radiological emergency is evacuation of radiological emergencies. The petitioner as a protective supplement to the population before any exposure to believes that the distribution of KI was evacuation and, sheltering is reasonable radiation occurs, }Vhenever that is inadequate and untimely in the Ukraine and prudent for specific local feasible. (Evacuation protects the wnole and Belarus after the Chernobyl conditions. body, whereas potassium iodide accident in 1986 and that this accounts protects only a single gland, the for the increased incidence of thyroid Commission Decision th~Toid.) Depending on the cancer in these areas. He also argues KI is a reasonable. prudent. and circumstances. KI may offer additional that distribution of KI in Poland was inexpensive supplement to evacuation protection 1f used in conjunction with timely and effective and that no similar and sheltering for specific local e\*acuation and/or sheltering. increase in the incidence of thyroid conditions. Therefore. the Comrn1ss10n*s The NRG recognizes that the decision cancer was seen. The Commission guidance on emergency plannmg has to stockpile KI presents issues of how considered all of the above information long taken KI into considerat10n best to position and distribute the in deciding to grant the petitioner's (NUREG-o654/FEMA-REP-1, Rev 1. p medicine. to ensure, e.g., that optimal requested actions. 63, items e and f) However. since the distribution takes place in an B. The Kemeny Commission criticized last revision of that guidance. there has emergency. with first priority given to the failure to stockpile K1 and been experience with the mass protecting children; that persons with recommended that regional stockpiles distribution of KI during a radiological known allergies to iodine not take it; be established. The Kemeny emergency, and though the record on that members of the public understand Commission's report recognized that that distribution is not complete, the that KI is not a substitute for measures evacuation was not invariably the indications thus far are that mass that protect the whole body; etc. To preferred response to an emergency and distribution is effective in preventing date, these issues have been addressed that even when evacuation was thyroid cancer and causes remarkable m different ways in the numerous desirable, it might not be feasible. The few threatenmg side effects. Moreover, countries that currently stockpile KI. Commission believes that prompt many nations m Europe and elsewhere. The NRC 1s working with States and evacuation.and/or sheltering are the nat10ns as different m their localities to develop guidance on these generally preferred protective measures circumstances. politics, and regulatory and other points relating to the use of for severe reactor accidents. In structures as France, Canada. and Japan, KI The NRC believes that these developing the range of public have stockpiled KI and planned for its 1mplementahon issues can be solved, protective actions for severe accidents at use. So have some U.S States The given the level of expertise in the commercial nuclear power plants, World Health Organization and the relevant Federal and State agencies. and evacuation and in-place sheltering , International Atomic Energy Agency the experience of numerous nations that provide adequate protection for the recommend its use Therefore. m order have bwlt KI into their emergency general public. The Commission to achieve greater assurance that KI will plans. believes that KI for the general public receive due attention by planners, it It is expected that States will mform should not replace evacuation and seems reasonable to take a small further FEMA and the NRC of the results of sheltering, but supplement them. their consideration of whether to opt for C. The Federal Radiological "This exception from "a" er of s0Hre1gn stockpiling This will enable the Federal Emergency Response Plan (FRERP) is 1mmumt, pro,1des that government to engage m better the plan that would be used by the An} clauns based upon an act or mmss1on of dn contingency planning for States that Federal Government to support State employee of the Go,,emment exercising due <:are. decide agamst stockpilin~ KI. and local officials in responding to any m the execution of a statute or regulallon. \>hether or not such 5latute or reguldt1on be \ql,d ,,r baS<>d The Commission decis10n is peacetime radiological emergency Such upon the exercise or performance or the failure to implemented by publication of this emergencies range from transportation e>.erc1se or perform a d1scret1onan funcllon or dul\ proposed rule that would change 10 accidents involving radioactive on the part of a federal agenc\ or an ~mplo:ee o! CFR 50.47(b)(10) with a 90-day public materials to terrorist events involving the Go"emment. "hether or not the d1scret1on comment period. If the proposed rule is nuclear materials. The FRERP includes involved be abus~d 28 USC 2680(al c.:n,tl!!'d Stall's, i*arie .~irlines adopted in final form. the petition a range of protective actions 467 U S 797 808 ( 1984). Ber>.m*rtz \' l '111/Pd StalP> would be granted in part and denied in commensurate with the risks associated -186 lJ S 531 (1988) part and NRC action would be with the range of emergencies for the

31746 Federal Register/\,_.- 64, No. 113/Monday, June 14, 1999/l _.,osed Rules general public and emergency workers. agency to fund the stockpiling. rulemaking is in response to this These protective actlom include Historically. funding for State and local; directive. evacuation, sheltering, and the emergency response planning has been Alternatives were essentially prophylactic use of stable"iodine. With the responsibility of those governments considered in previous documents. In respect to protective actions for nuclear usually working with licensees and, SECY-97-124 ijune 16, 1997), on the power plants, the NRC and FEMA have absent Congressional funding "Proposed Federal Policy Regarding Use issued Draft Supplement 3 to NUREG->, specifically for this purpose, NRC is not of Potassium Iodide after a Severe 0654/FEMA-REP-1, Rev. 1, to provide prepared to fund stockpiling of Kl. Accident at a Nuclear Power Plant." The uf dated guidance for the development staff identified three options, one of o protective action recommendations Findings which contained three sub-options, for severe reactor accidents. This Metric Policy concerning a proposed change in the document emphasizes that prompt On October 7, 1992, the Commission Federal policy regarding the use of evacuation is the preferred protective published its final Policy Statement on potassium iodide (KI) as a protective action for actual or projected severe core Metrication. According to that policy, measure for the general public during damage accidents. after January 7, 1993, all new severe reactor accidents. Next, in an D. The Commission recognizes that in regulations and major amendments to SRM dated June 30, 1997, the 1994 the Board of Governors of the existing regulations were to be Commission approved an option that IAEA adopted new International Basic endorsed the Federal offer to fund the presented in dual units. The Safety Standards. With respect to purchase of KI for States at their request emergency planning, these standards amendment to the regulations contains no units. and endorsed the Federal Radiological provide, among other things, Preparedness Coordinating Committee "intervention levels for immediate Environmental Assessment and Fmdrng of No S1gnlftcant Impact for Grantmg the (FRPCC) recognition of the availability protective action. including sheltering, to State and local governments of the Petition for Rulamakmg RE!IJ;1trng To the Use acuation, and iodine prophylaxis." It of Potassium Iodide (Kl) Federal stockpiling of KI.

• portant to note that each country es its response plans on local and I. Introduction 11. Need for Action gional characteristics. For example,
• On September 9. 1995, a petition for In SECY-97-245. the staff proposed Italy and France, using the same rulernak:.mg (PRM 5D-63) Wds filed with options for resolving the referenced international standards and guidelines. the NRC bv Mr. Peter Crane. The petition for rulema.kmg. In SRM 98-061, implement them differently. petitioner requested that the NRC the Comrniss10n directed the staff to E. Although the cost of KI tablets has amend its emergency planmng proceed with the rulema.king.

doubled, the Commission agrees with regulations to require that emergency the NRC staff estimate and other III. Environmental Impact of the plans specify a range of protective Proposed Action nations' experience, that the purchase of actions to include sheltering. KI tablets is relatively inexpensive. KI- evacuation. and the prophylactic use of The environmental impacts of the related costs increase when the cost of KI. proposed action and its alternative are maintenance, distribution, and public In SECY 97-245, dated October 23. considered negligible by the NRG staff. education are considered. However, the 1997, the staff provided three opllons Given the proposed action would only overall cost is minimal when placed in for the Commission's consideration in add the sentence: "In developing this the context of emergency planning and order to resolve PRM 5D-63. range of actions. consideration has been should not be a deterrent to stockpiling On November 5, 1997, the given to evacuation, sheltering, and the Kl for use by the general public should Commission was briefed by the NRC prophylactic use of potassium 10dide State and local decision makers staff, the Federal Emergency (KI). as appropriate." The staff is not ermine that the prophylactic use *of Management Agency (FEMA). and the aware of any environmental impact as a s a supplement to evacuation and petitioner regarding the opt10ns result of this proposed action. taring is appropriate. available for resolving the petition for F. The Comm1ss1on belie,*es that IV. Alternative to the Proposed Action rulemakrng. Durmg the meeting, the robust regional stockpiles should be Comm1ss10n mvited the petitioner to The alternative to the proposed action established to enable use by States that submit a mod1f1cation to his pel!tion m at this time 1s to deny the petitions and have not established local stockpiles order to address views he discussed take no action with respect to the use of and wish to make use of Kl in the event durmg the meetmg

• KI by the public. Should this no-action of a severe nuclear power plant On November 11, 1997, the petitioner alternative be pursued, the staff is not accident. submitted a rev1s10n to his petition PRM aware of any resulting environmental Commission Decision To Fund Kl 5D-63A, which requested two things: impact.

On June 30, 1997, the Comm1ss10n 1 ,-\ statement clear!~ recommending V. Agencies and Persons Consulted voted to approve the NRC staff stod.pdmg of KI as a "reasonable and prudent measure and Cognizant personnel from the Federal recommendation to endorse the FRPCC 2 :\ proposed rule rhange to 10 CFR Emergency Management Agency were recommendations for the Federal 50 47(bl(I0) \,h1ch \\ould be accomplished consulted, as was the petitioner, as part Government to fund the purchase of b1 msertmg the folio\\ mg s13ntence after th1: of this rulemaking activity. potassium iodide (KI) for States at their first sentence. "In de1 eloping this range of request and endorsed the FRPCC actions. consideration has been given to VI. Finding of No Significant Impact: recogrution of the availabihtv of the e1arnat10n sheltermg. ;md the proph:, lRclH Availability Federal stockpile of Kl to State and local u~t> of po1a,;s1um 10d1Je (Kl), as appropriate The Commission has determined governments for purposes of mitigating On June 26, 1998. the Commission under the National Environmental the consequences of terrorist use of disagreed with the staff Policv Act of 1969, as amended. and the nuclear, biological. or chemical (NBC) recommendation to deny the petition for Comm1ss1on's regulations in Subpart A weapons. At that time it was believed rulema.kmg PR.:tvf 5D-63A by re\*1sing 10 of 10 CFR Part 51, that the amendment that the NRC was the likely Federal CFR Part 50 4 7 (bl(lO). This proposed 1s not a major Federal action

Federal R.egisufl'/Vol. 64, No. 113/Monday, June 14, L_d/Proposed Rules 31747 significantly affecting the quality of On June 26, 1998, the Commission Response Plans and Preparedness in human environment, and th6i8fore, an directed the staff in SRM 98--061 to Support of Nuclear Power Plants for environmental impact statement is not revise 10 CFR Part 50.47 (b)(10). This Interim Use and Comment." This required. This amendment will require prcposed rulemaldng is in response to guidance was cited in the regulation and that emergency plans specify a range of this directive. speaks to radioprotective drugs protective actions to include sheltering, Alternatives were essentially including their use by the general public evacuation, and the prophylactic use of considered in previous documents. In including quantities, storage and means Kl. This action will not have a SECY-97-124 Oune 16, 1997), titled of distribution and State and local plans significant impact upon the "Proposed Federal Policy Regarding Use for decision ma.Icing with respect to their environment. of Potassium Iodide after a Severe use. The Commission removed the Accident at a Nuclear Power Plant," the citations of the guidance from the Paperwork Reduction Act Statement staff identified three options, one of regulation in 1987 but the guidance has This proposal rule does not contain a which contained three sub-options, continued in use for planning purposes new or amended information collection concerning a proposed change in the and by the Federal agencies for requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C 3501 Federal policy regarding the use of potassium iodide (KI} as a protective evaluating emergency flans. As a result, it is believed that all o the affected et seq.}. Existing requirements were measure for the general public during States have at some point considered approved by the Office of Management severe reactor accidents.* Next, in an the use of KI. Some States have made and Budget (OBM} approval numbers SRM dated June 30, 1997, the the decision to stockpile KI. Thus, in 3150-0009 and 3150--0011. Commission approved an option that practical terms, the projected costs will Public Protection Notification endorsed the Federal offer to fund the occur only in those States that have not purchase of KI for States at their request -elected to stockpile KI and choose If an information collection does not and endorsed Federal Radiological stoc.lcpiling in light of the Chernobyl display a currently valid 0MB control Preparedness Coordinating Committee accident, recent international practice, number, the NRG may not conduct or (FRPCC) recognition of the availability and the NRG requirement to consider sponsor, and a person is not required to to State and local governments of the the use of KI. respond to, the information collect10n Federal stockpiling of KI. It is difficult to estimate the benefit of Re,ptlatory Analysis of the Proposed In SECY-97-245, the staff proposed a State's consideration to stockpile KI. Rulemaking Granting In Part A Petition options for resolving the referenced However, we believe the benefit of such for Rulemaking (PRM 60-63A) Relating petition for rulemiling. In SRM 96---06, an action by the States is summed up by to the Use of Potassium Iodide (KI) the Comm1Ssion directed the staff to the petitioner who stated that the proceed with the rulemaling. decision to stoc.lcpile KI should turn on On September 9, 1995, a petition for Given that the Commission whether, given the enormous rulemaking (PRM 50-63) was filed with considered the options and directed the consequences of being without KI in a the NRG by Mr. Peter Crane. The staff to grant the petition, the only major accident, the drug is a prudent petitioner requested that the NRG alternatives considered.here are the measure; not on whether it will amend its emergency planning Comrrussion approved option and the necessarily pay for itself over time. As

  ~ations to require that emergency               baseline, no-action alternative.              the petitioner further noted. KI plans'speclfy a range of protective                 The proposed rulemaldng does not          represents a .kind of catastrophic-actions to include sheltering,                   "require" anything of licensees, but          coverage insurance policy offering evacuation, and the prophylactic use of States are to have shown                               protection for events which, while they KI.                                              "consideration" of the use of KI along        occur only rarely, can have such Iri SECY 97-245, dated October 23,          with evacuation and sheltering as              enormous consequences that it is 1997, the staff provided three options          protective actions. It is estimated that 30 sensible to take special precautions, for the Commiss10n's consideration in           States will need to malce this                especially where, as here, the cost o_f order to resolve PRM 50-63.                     consideration. Further, the staff             such additional precautions is relatively On November 5, 1997, the                     estimates that the labor needed by the        low.

Commission was briefed by the NRC States could range from a staff-week, to As stated above, this analysis focuses staff, the Federal Emergency a half staff-year The latter being the on the rule being proposed as the result Management Agency (FEM1\), and the case if a State decided to hold hearings of a petition. Also, since the petitioner regarding the options on the issue. Commission has directed the staff to available for resolving the petition for If one assumes .µi average hourly pursue the FRPCC results with respect rulemaking. During the meeting, the salarv oL570 (this estimate includes to KI and has directed the staff to pursue Commission rnvited the pelltioners to benefits, pro-rated secretarial and the rulemaking, the regulatory analysis submit a modification to his petition m managerial assistance, but not presented here is for the edification of order to address views he discussed overhead), the range of estimates would the decision malcers so they can malce during the meeting be from S2800 to $63,000 Agam using an rnformed decision on the proposed On November 11, 1997. the pelltioner a base of 30 States, the range is from rule submitted a revision to his petition PRM S84.000 to S1.9 million The above constitutes the regulatory 50-63A, which requested two thmgs* The Commission notes that when it analysis for this action. A statement clearlv recommending amended its emergency planning a stod.pihng of Kl as *reasonable and regulations on November 3. 1980, the Regulatory Flexibility Certification prudent" measure. and regulatory standards for emergency In accordance with the Regulatory A proposed ruie change to 10 CFR planning were a restatement of basic Flexibility Act of 1980, 5 u.s.n 605(b). 50 47(b)(10) which would be accomplished joint NRC-FEMA guidance to licensees the Commission herebv certifies th.at b\ msertmg the following sentence dfter !he first sentence "In de\elopmg th1, range of and to State and-Jocal governments this rule, if adopted, will not have a actions. consideration has been given to incorporated m NUREG-o654, FEMA- significant economic impact on a evacuallon. sheltering. dnd the prophylactic REP-1. "Criteria for Preparation and substantial number of small entities. use of potassium 10dide [KI), as appropriate

• Evaluation of Radiological Emergency This proposed rule would affect only

31748 Federal Register/' 64, No. 113/Monday, June 14, 1999// )osed Rules the licensees of nuclear power plants. governmenrs-the entities with the rulemak.ing that, although licensees are These licensees, do not fall within the authority to determine the not directly burdened by the proposed scope of the definition of"small appropriateness of the use of KI for their rule, they would be indirectly burdened entities" set forth in the R~atory citizens-calling upon the governments because they would feel called upon to Flexibility Act. 5 U.S.C. 601, or the size to "consider" KI as one of the elements explain the new policy to their standards adopted by the NRC (lo CFR of their offsite emergency planning. customers. By this logic, almost any 2.810). Even as to states or local governments, Commission action that led an NRC it imposes no binding requirement to licensee to issue a press release could be Bacld'lt Analym  : alter plans and procedures. considered a backfit. Such a position The definition ofbackfit, as set forth Furthermore, the basic standard that would represent unsound law and in 10 CFR 50.109(a)fl), is clearly emergency planning must includff policy. Hare, the burden of public directed at obligations imposed upon consideration of a range of protective information on licensees or applicants, licensees (and applicants) and their actions, is already set forth in the if any, appears de minim.is. It plainly facilities and procedures. Section existing wording of section 50.47{b)(10). does not rise to the level of the type of 50.109(a}(l} defines a backfit as: On this basis, the proposed rule in concrete burden contemplated by the

        * *

• the modification of or additlon to reality does not impose new Commission when it enacted the backfit systems, structures, components, or design of requirements on anyone. On a rule. It might also be argued that: if a a facility; or the design approval or consideration of all of the above factors. State or local government were to manufacturing license for a facility; or the no back.fit is involved and no backfit , decide to stoclcpile and use KI for the procedures or organization required to analysis is required.

design, construct or operate a facility, any of general public, it would undertake Commission precedent also makes interactions with the affected licensee to which may result &om a new or amended clear that the proposed rule change does coordinate offsite emergency planning. provis1on in the Commission rules or the not constitute a back.fit. The imposioon of a regulatory staff position Although this could result in some nterpreting the Commission rules that 1s Commission's position_was stated voluntary action by the licensee to ltber new or different &om a previously explicitly in 1987, when the last major coordinate its planning, the proposed ppl!cable staff position * * *. change took place in emergency rule itself does not Impose any

• planning regulations. 52 FR 42078 (Nov, requirement or burden on the licensee.

Section 50.109 is replete with 3, 1987). The Commission's final notice Accordingly, the Commission concludes references to "facilities" and of rulemaking on this rule involving the "licensees," which in their totality make "Evaluation of the Adequacy of Off-Site that the proposed rule, if adopted, clear that the rule is intended to apply would not impose any back.fits as Emergency Planning for Nuclear Power defin,ed in 10 CFR 50 109. to actions taken with respect to nuclear Plants at the Operating License Review power plant licensees and the fa lities Stage Where State and Local List of Subjects in 10 CFR Part 50 they operate. See Section 50.109(a)(7), Governments Decline to Participate rn "If there are two or more ways to Antitrust, Classified Information, Off-Site Emergency Planning" stated Criminal penalties. Fire protection, achieve compliance with a license or that the emergency planning rule the rules or orders of the Commission, Intergovernmental relations, Nuclear change in question does not impose power plants and reactors, Radiation or with written licensee commitments any new requirements on production or protection. Reactor siting criteria,

     * *

• then ordinarily the applicant or utilization facilities; it only proviqes an licensee is free to choose the way that Reporting and recordkeeping alternative method to meet the requirements.

best suits its purposes femphasis Commission's emergency planning added]." This focus on licensees and For the reasons set out in the regulations. The amendment therefore is preamble and under the authority of the their facilities is further confirmed by not a backfit under 10 CFR 50,109 and Statement of Considerations Atomic Energy Act for 1954, as a backfit analysis is not required," 52 FR ompanying the back.fit rule, 53 FR at 42084 Likewise. when the amended, the Energy Reorganization 603 (June 6, 1988), where the Commiss10n altered its emergency Act of 1974, as amended. the National Commission stated that back.fitting Environmental Policv Act of 1969, as planning requirements rn 1987 to "means measures which are mtended to change the timing requirements for full amended. and 5 U.S C. 553, the NRC is - proposing to adopt the following improve the safety of nuclear power participation emergency exercises (a reactors * * *." 53 FR at 20604. The change that, as a practical matter, could amendment to 10 CFR Part 50. nine factors to be considered under 10 be expected to result in licensees' PART SO-DOMESTIC LICENSING OF CFR 50.109(c) further ma.Ice clear that modifying emergency preparedness- PRODUCTION AND UTILIZATION the rule is aimed at requirements on related procedures to accommodate FACILITIES licensees and facilities. These include: exercise frequency changes), it stated:

   "(2) General description of the activity            "The final rule does not modify or add            1. The authority citation for 10 CFR that would be required by the licensee              to systems, structures, components or         Part 50 continues to read as follows:

or applicant in order to complete the design of a facility; the design approval Autbbritv: Secs, 102. 103, 104, 105, 161, back.fit; * * * (5) Installation and or manufacturing license for a facility: 182, 183, 186, 189. 68 Stat 936, 938, 948, continuing costs associated with the or the procedures or organization 953. 954. 955, 956, as amended, sec 234. 83 back.fit, including the cost of facility required to design. construct, or operate Stat 444, as amended (42 U s,e, 2132, 2133, downtime or the cost of construction a facihty Accordmgly. no back.fit 2134, 2135. 2201, 2232, 2233, 2239, 2282). delay; [and) (6) The potential safety analysis pursuant to 10 CFR 50.109 is secs 201. as amended. 202, 206. 88 Stats reqmred for this final rule." 52 FR 1242, as amended 1244, 1246, (42 U.S C, impact of changes in plant or 5841, 5842, 5846). operational complexity. * *

• 16828 (May 6. 1987). The proposed Section 50 7 also issued under Pub L 95-

[emphasis added]" emergency planning rule change is of a 601, sec 10, 92 Stat 2951, as amended by The proposed rule imposes no new similar nature and similarlv does not Pub L 102-486, sec 2902. 106 Stat. 3123, requirements on licensees, nor does it involve a bad:.fit * (42 USC 5851) Secl!ons 50 10 also issued alter procedures at nuclear facilities. It has been argued by at least one under secs 101, 185, 68 State 936, 955, as Rather, it is directed to States or local commenter on the petition for amended (42 U.S.C 2131, 2235): sec. 102,

Federal Register/Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rules 31749 Pub. L. 91-190, 83 Stat. 853 (42 U.S.C. 4332). Most of the proposed changes amend Part 7-lnterpretive Ru.lings Section 50.13, 50.54(dd], and 50.103 al'IO the 00::'s regulation codifying Issued under sec. 108, 68 Stat. 939, as Messenger Service{§ 7.1012) interpretive rulings. These proposed amended (42 U.S.C. 2138). Sections 50.23, amendments clarify certain existing Under 12 U.S.C. 36(1), a "branch" of 50.35, 50.55, and 50.56 also Issued under sec a bank is defined to include any branch 185, 68 Stat. 955 (42 U.S.C. 2235). Sections interpretive rulings and add new 50.33a, 50.55a and Appendix Q also Issued interpretive rulings based cm recent bank where deposits are received, or under sec. 102, Pub. L 91-190, 83 Stat. 853 statutory changes, judicial rulings, OCC checks paid, or money lenl Current (42 U.S.C. 4332). Sections 50.34 and 50.54 decisions, and other developments. The § 7.1012(c) sets forth circumstances also Issued under Pub. L 97-415, 96 Stat. remaining proposed changes would under which a national bank and its 2073 (42 U.S.C. 2239). Section 50.7B also clarify in the OCC's regulation on customers may use a messenger service issued under sec. 122, 68 Stat 939 (42 U.S C. investment securities its long-standing for various purposes without the 2152). Sections 50.80, 50.B1 also issued treatment of instruments secured by messenger service being deemed a under sec. 184, 68 Stat. 954, as amended (42 Type I securities, and make technical "branch" under section 36. Thes'a U.S.C. 2234). Appendix Falso issued under criteria are derived from caselaw. sec. 187, 68 Stat. 955 (42 U.S.C. 2237). amendments to the OCC's regulation on corporate activities to update the names However, the criteria do not reflect two

2. In§ 50.47, paragraph (b)(lO) is of offices within the OCC, to clarify recent federal court decl.sions. 1 This revised to read as follows: certain definitions, and to amend proposal amends§ 7.1012(c) to reflect references to the CAMEL rating system these recent cases.

150.47 Emergency plans. Under the current rule, in order to to reflect the addition of the sixth

    *       *    *       *

• element for sensitivity to market risk. ~void being treated as a bank branch, a (b) * *
• messenger service, includlng both a This proposal reflects the OCC's (10) A range of protective actions has continuing commitment to assess the messenger service affiliated with a bank been developed for the plume exposure effectiveness of our rules and to make, and a service that is independent of a pathway EPZ for emergency workers further changes where necessary. bank, generally must both make its and the public. In developing this range services available to the public, of actions, consideration has been given DATES: You should submit written including other depository institutions, to evacuation, sheltering, and, as a comments by August 13, 1999. and retain the ultimate discretion to supplement to these, the prophylactic ADDRESSES: You should direct written determine which customers and use of potassium iod1de (Kl}, as comments to the CommUIDcations geographic areas it will serve. 12 CFR appropriate. Guidelines for the choice of Division, Attention: Docket No. 99--08, 7.1012(c){2)(ii)(A) and (B}. The recent protective actions during an emergency, Third Floor, Offic_ ;:,f the Comptroller of cases indicate that this test should apply consistent with Federal guidance, are the Currency, 250 E Street. SW, differently depending on whether the developed and in place, anc:I protective Washington, DC 20219. In addition. you service is affiliated with a bank.

actions for the ingestion exposure may send comments by facsimile Pursuant to these cases, a nonaffiliated pathway EPZ appropriate to the locale transmission to (202) 874-5274, or by service need show only that it has the have been developed. electronic mail to discretion to determine, in its own

  * *                  *

• regs.comments@occ.treas.gov. b11~'ness judgment, which customers it Dated at Rockville, Maryland, this 3rd day will serve and where. In contrast, an of June, 1999. FOR FURTHER INFORMATION CONTACT: You affiliated service, because it may be For the Nuclear Regulatory Comm1ss1on. can request additional information on more likely to favor its affiliates as a Annette Vietti-Cook, this proposal by calling Jacqueline result of Its common ownership or Secretary of the Camm1ss1on Lussier, Senior Attorney, or Mark control. must show that it actually Tenhundfeld. Assistant Director, serves the public generally, including

[FR Doc 99--14584 Filed 6-11-99: 8 45 amJ Legislative and Regulatory Activities nonaffiliated depository institutions. BIUJHG CODE 7590---01--l' Division. (202) 874-5090. You can The OCC concludes that this ~alysis inspect and photocopy the comments at is appropriate when determining if a the OCC's Public Disclosure Room, First messenger service is a bank branch. DEPARTMENT OF THE TREASURY Floor. 250 E Street, SW. Washington, DC Accordingly. the proposal combines the 20019. between 9:00 am and 5.00 pm on criteria in § 7.1012(c)(2)(il)(A) and Office of the Comptroller of the business days. You can make an (c)(2)(ii)(B) into one new paragraph and Currency dppomtment to inspect the comments applies the resulting criteria differently 12 CFR Parts 1, 5, and 7 by calling (2a2) 874-5043. depending on whether or not the SUPPLEMENTARY INFORMATION: messenger service is affiliated with the [Docket No. 99-08] bank. This means that a nonaffiliated RIN 1557-AB61 Section-bv-Section Analvsis of messenger service need only Proposed°Changes

• demonstrate that it has the discretion to Investment Securities; Rules, Policies, determine, in its mvn business As previously noted, most of the and Procedures for Corporate judgment, whom it will serve and changes proposed amend part 7. The Actlvltld; and Interpretive Rulings where. In contrast, since the operations OCC proposes to amend part 7 to clarify and supplement its provisions where of a messenger service that is affiliated AGENCY: Office of the Comptroller of the Currency. Treasury. necessan In addit10n. the OCC , Stte Cadi,s v H &- R Block. 43 F 3d 669 (4th Ctr.

ACTION: Notice of proposed rulemak.rng proposes to add new interpretive 199-t), cert derued. 515 US 1103 (1995), rulmgs. based on recent statutory Chnst,ansen v Beneficial Nat'/ Bank. 972. F Supp

SUMMARY

The Office of the Comptroller changes. 1ud1c1al rulings, OCC 681 (S D Ga 1997) The5e casea addressed the issue of the Currency (OCC) is proposing to decis10ns, and other developments. of" hether a third part} should be considered to be a branch of a national bank where a tax preparation update and clarify its rules regarding These changes Me described below, company onginated tax refund anuc1pallon loans Investment Securitiei::, Corporate followed by a discussion of the between a national bank and taxpayers and Activities, and Interpretive Rulings proposed changes to parts 1 and 5. conveyed the loan proceeds to the customers.

DOCKET NUMBER

                                                                                                'nL Lf '13 ;;ioo ;i,1        7 I*

JOHN KERRY M,,.SSACHUSETTS

  ,. #    ..                            PROPOSED AULF                                       5'0
                                                                                       /,AFR 31131)

COMMITTEES BANKING, HOUSING, URBAN AFFAIRS COMMERCE SCIE '<'.:E

                                                                                                                                               )

1anitrd ~ totrs ~ cnotc AND TRANSPORT A TIOI FOREIGN RELAT 0'<5 WASHINGTON, DC 20510-2102 INTELLIGENCE SMALL BUSINESS September 29, 1999 )> 0 o -;- c r ~ C)

z 0 Ms. Annette Vietti-Cook q Cn U>- -

Secretary I

                                                                                                                    .i::,.

7 U.S. Nuclear Regulatory Commission Washington, D.C. 20555  :;:i::,

co

Dear Ms. Vietti-Cook:

                                                                                \J1 I am writing on behalf of the state-wide Massachusetts Coalition to Stockpile KI (Potassium Iodide). They have written a petition and collected a number of signatures regarding the U.S. Nuclear Regulatory Commi s sion's Proposed Rulemaking (PRM                 63A), Consideration of Potassium Iodide in Emergency Plans.

After reviewing the scientific evidence, the benefits of potas s ium iodide (KI) appear to justify the expense. Since nuc l ear accidents are unforeseeable, our only protection is unabridged preparation. We must learn from the tragedies of the past, such as Chernobyl and Three Mile Island, in order to prevent them from occurring in the future. We cannot guarante e that there will never be another Chernobyl, but we can take every possible precaution known to us to contain the devastating effects of such a disaster. KI must be administered either prior to exposure or up to six hours after exposure in order to be effective. Due to the time-sensitive success rates of KI, it should be stockpiled in every shelter, school, reception center, and hospital within the effluent pathway defined as the Emergency Planning Zone. It must also be available for purchase in pharmacies that are within the near field. State stockpiles would be appropriate for the far field, and could be located in the Emergency Planning Agency's Headquarters and sub-stations. The question remains of who should provide the fundin g for the stockpiling of KI, replenishment, and associat ed distr ibut ion and public education costs. Perhaps, this responsibil i ty should be borne by the individual plants as part of their respons ibil i ty for emergency preparation. I ask that you reconsider the petition submitted by Mr . Crane on behalf of the Massachusetts Coalition to support the use of KI as an emergency planning requirement. The NRC is in a position to prevent a future disaster from claiming additional lives. Please rise to the occasion and make KI a requirement. ema,1 o"n 1te,ry@kerrv ,;ena1e go.,. WWW r,np W'ft,\11, ,e11e1tr C,IJY ,.,, ...,

 .v.1 UCLEAR REGUlATORYCOMlll81illCN RULEMAKINGS &

OFFICE<J=1'E OFTHE Sllb Postmalk Deta 10/ 1 /c;t:J 1 {(.k cl ~ C!../-,.<'""' Cop~ R&Qwad _ _ _ _ _ __ Add'I Special - *.. - ._ _ _ _ _ __

If you have any questions, please feel free to cuntact Betsy McEvoy at (617} 565-8519. Thank you in advance for your cons;i.deration. erely, John*7/:$ United Stat es Senator JFK/bm

MASSACHUSETTS COALITION TO STOCKPILE Kl Sreacer Boston Ph y s icians foC' Social Responsibility

• C-10
• Citizens Awarenes.s Networr.
• Clean WateC' Action
• Don't Waste Massachusetts
• Mas.sPi rg
• Massachusetcs Citizens for Safe Energy* Toxics Action Center*

Citizens Radiological Monitoring Network

• Women's Community Cancer Projecc It costs less than a dime; our kids are worth it!

August 30 , 1999 Senator John Kerry 1 Bowdoin Square Boston , MA 02114 RE: Request to Sign On to / or Support Enclosed Comment to US Nuclear Regulatory Commission's Proposed Rulernaking (PRM-5 0-63A), Consideration of Potassium Iodide in Emergency Plans due September 13 th

Dear Senator Kerry:

Enclosed is a copy of the Nuclear Regulatory Commission's proposed rule on the Consideration of Potassium Iodide K: in emergency plans . Massachusetts public interest groups and physicians have joined together to comment. Our remarks to the NRC are enclosed. We hope that you will join us by either sign ing on to ou r comments or voicing similar conc erns to the NRC . By doing so, you will help our fight to prevent unnecessary suffering and disease. Thank you in advance for your consideration . If you have any further que s tions, please do not hesitate to call . Sincerely on behalf of the coalition , Mary Lampert Massachusetts Citizens for Safe Energy 148 Washington Street Duxbury MA 02332 Tel 781 - 934 - 0389/ Fax 781-934-5579/ E-mail lampert@idt . net

(Y\ L qq 30 [}.OU ,;..c, Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, MD 208I5 I 301-656-3998 I email: pgcrane@erols.com October 15, I S-99 O(Ji...! ETED I l I I Chairman Greta J. Dicus Commissioner Nils J. Diaz KET N BER *99 OC"'" 22 AlO :45 Commissioner Edward McGaffigan, Jr. PROPOSED RULE So Commissioner Jeffrey S. Merrifield (tp'IF~g/731) U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Dear Chairman Dicus and Commissioners:

I have had the opportunity to review the Commission's answers to Congressional questions dealing with potassium iodide (Kl). (These were forwarded by letter of September l 0, 1999, from Chairman Dicus to Chairman Joe Barton of the Subcommittee on Energy and Power of the House Commerce Committee.) The answers are troubling in several respects, in particular the way they represent, or purport to represent, the views of the Federal Emergency Management Agency (FEMA). For example, question 15(B) asked whether, if there was anything in NRC policies barring NRC from paying for state stockpiles of KI, the NRC had reexamined those policies. The NRC's reply stated that both the NRC and FEMA "are currently reexamining earlier positions and policies regarding Kl." I wonder whether this answer was cleared with Director Witt of FEMA. His letter to the NRC of April 29, 1999, could hardly have been blunter: Your abrupt retreat from repeated promises to the Federal community, states and the public is apparently based on a misapprehension of FEMA' s authorizing legislation and a disregard of our view -- and that of other FRPCC agencies -- that regional potassium iodide stockpiles will not enhance radiological emergency preparedness .... FEMA has always opposed the notion that Federal regional stockpiles of potassium iodide would be effective in the event of a release from a nuclear power plant. ... Regional stockpiles of potassium iodide would complicate, not strengthen radiological emergency preparedness .

• I have not seen a word from FEMA since April 29, 1999, to suggest that Director Witt is reconsidering his position. Perhaps the Commission knows something I do not know, but if this answer was not cleared with FEMA, and we are seeing yet another misrepresentation by the NRC of FEMA s stance, someone should quickly apologize to Director Witt and correct the record with the Congress. I'm sure that FEMA has not forgotten the memorable Commission meeting of November 5, 1997, when the NRC staff had to apologize humbly for having "misrepresented" -- the NRC staffs own word -- FEMA's position on Kl. (lf the Commission had only been willing to draw the obvious conclusion from that unprecedented day in the agency's history, and assign the KI issue to a new team, it might not have found itself, less than a year later, having to withdraw the staffs assessment of Kl, NUREG-1633, in the face of withering criticism from the health departments of New York State and Ohio, and from me.)

Question 17 quoted Director Witt's letter of April 29, 1999, and then asked why the NRC disputed FEMA's position. The NRC's answer included the following: [T]he NRC believes that regional stockpiles may be a prudent and reasonable approach to making Kl available to emergency response officials in the very unlikely event of a severe reactor accident that includes a significant early radioiodine component. The NRC is confident, based on a long record of coordination and cooperation between the two agencies, that the NRC and FEMA staffs will successfully resolve the KI stockpile issue. [Emphasis added. J

l.J.S. NUCLEAR REGUlATORYWMMASSION FUJlEMAIQNGS &ADIIJICATDBll'AFF OFF1CEm:1'1E11DE'Al;1Y OFTfE OJ a I Cs PosllMlltlJIIB It>/ ~ ':i /'1 'I tf.u 1,l ~ C ~~ ~ s Rapr;i~~-=-==~~====

  ,....i,.1-...........

This amounts to a statement that regardless of Director Witt's unequivocally stated position, the NRC is confident from past experience that it can bring the FEMA staff around. If I were Director Witt and 1 saw this, I would not be pleased to have my views so casually flicked aside, nor would I appreciate the suggestion that my staff can be induced to take positions contrary to my own.* My experience of the FEMA staff is that it has been principled and responsible on Kl, and I see no reason why it should want to compromise away its Director's firmly held position. But it would not surprise me to learn that the NRC staff was attempting to rush the FEMA staff into such a deal, perhaps hoping to present Dr. Meserve, the incoming NRC Chairman, with afait accompli. ls it likely, though, that any such plan would receive Director Witt's approval, after his letter of April 29? It seems, regrettably, that nothing can penetrate the present Commission's cocoon of self-deception where KI is concerned. Director Witt did everything to make the Commissioners understand FEMA' s position short of physically shaking them by the shoulders. Surely at this point he must be asking himself, "What part of 'NO!' didn't they understand?" Let me offer a few additional comments on the NRC's answers:

          -- Cost of buying KI.

The NRC was asked in question 16(A) what KI would cost. One needs to know something of the background to appreciate how artful and evasive the NRC's answer was. Instead of answering the question directly -- that is, with a simple declarative sentence saying that the cost would be X" -- the Commission reported what the staff said in November 1998 that a KI program would cost. It also reported that at that time, the NRC staff reported an increase in the price of Kl. The problem is that there is reason to doubt whether the NRC's staff's November 1998 figures were accurate even when first provided. For just a month later, in December 1998, I sent the Commissioners a memo, attaching an e-mail from Harvey Brugger of the Ohio Department of Health, which in tum attached an e-mail from a Swedish firm that was offering KI in bulk at six cents per pill, with a 10-year shelf life. These documents are in the rulemaking docket. If the NRC is not now using a price of six cents per pill as the estimated cost of Kl, what price is it using, and why? If the Commission, despite its nominal commitment to "Openness," declines to answer the question: then let this letter be construed as a Freedom of Information Act request for the following information: (1) the estimated price per pill, at current prices; (2) the estimated number of pills that would be required; and (3) the estimated shelf life. The Commission's statutory obligation is to keep the Congress "fully and currently" informed. Using outdated information that may not have been accurate even when it was current falls far short of that. The NRC also said that according to the 1998 figures, the cost of supplying KI to all states with nuclear power plants would be "about $3.25M in a given year, with replacements every seven years." The "given year" is the first year; spread over seven years, the annual cost is $450,000, and over ten years, it is $325,000. Unfortunately, I know all too well how cleverly the NRC sometimes crafts sentences when KI is the subject, and the way snippets of these sentences later get quoted in misleading ways. (See, for example, the NRC staff's use of the phrase "no new information," when it was trying, even after the fl ood of Chernobyl-related childhood thyroid cancers in Eastern Europe, to stave off any reexamination of the 1985 federal policy on KI.) In future, we can expect to see statements that the NRC has advised the Congress that the cost of a KI program would be "about $3.25M in a given year," when the real answer should be the cost per year, a fraction of that $3.25M figure.

         -- Money spent by NRC studying KI.

The first sentence of the answer to question 16(8) said that the "total amount ofNRC spending on the KI issue exceeds $2.6M for last 10 years." No doubt it does exceed $2.6M; but the real question is, by how much does it exceed that figure? If the answer is that it exceeds it by a substantial amount, then this answer does not seem to meet the standard of"fully" informing Congress.

The detailed answer that followed this first sentence spoke only of NRC staff and contractor expenditure, leaving the reader to assume that this was the sum total of the agency's costs. In fact, a great deal of time has also been spent on the issue by Commissioners, their staffs, and, presumably, agency lawyers as well. How much did their time cost the agency? And what about the cost of producing draft NUREG-1633, the staff assessment that had to be withdrawn? Why leave out the cost of the 12-member KI Core Group, created to try to revise and rehabilitate that document? Why omit the price of that group's week-long trip-- what some would call a boondoggle - to Tempe, Arizona, last winter? And what about the cost of all the NRC' s interactions with FEMA and the FRPCC on KI issues over the last ten years? The casual reader will have no reason to know or suspect any of this, however. The busy Congressional staffer will think that the NRC has answered the question, and will understand the NRC to have said that it spent $2.6 million dollars studying Kl, a figure safely below the $3.25 million estimated cost of buying KI. No doubt it would have been awkward and embarrassing if the answer had confirmed the NRC staff's 1994 prediction -- made at a time when the wind from the NRC Chairman's office was temporarily blowing in a different direction -- that it would be cheaper to buy KI for the nation than go on studying whether to do so. (Any Commissioner needing a copy of that 1994 staff paper can undoubtedly get one from Dr. Congel, who is listed on it as the contact person.) Before leaving the subject of the cost of studying Kl, I should also mention, though this is not within the scope of the Congressional question, the substantial extra costs that FEMA and all the other agencies of the FRPCC have had to bear, thanks to the NRC's grievous mishandling of the KI issue. NRC misinformation, delay, and broken commitments on KI have not only resulted in leaving American children inadequately protected, compared to the children of other developed countries, they have also placed unnecessary additional financial burdens on other agencies of the Federal community. In the name of saving money on Kl, the NRC has wasted an extraordinary amount of its own and others' resources.

        - Who must consider KI under the proposed rule?

The rulemaking petition dealt with emergency plans, which are normally prepared by states. (Only when a state refuses to prepare a plan does a utility-prepared plan come into the picture.) But the answers to questions 16(8) and 17 referred to the proposed rule as requiring licensees to consider using KI as part of their emergency planning. Was this an innocent mistake, or was the Commission trying to bolster claims that the NRC's proposed rule burdens licensees and is therefore a backfit? I am sorry to say that the answers to the Congressional questions suggest that the present leadership of the Commission has learned nothing at all from past embarrassments or from Director Witt's efforts to make it comprehend its folly. Oblivious to all warnings, it has once again taken a bad situation for itself and managed to make it even worse. Sincerely, Peter Crane cc: James Lee Witt, Director, FEMA The Honorable Joe Barton, Chairman Representative Ralph M. Hall Representative Edward J. Markey Senator John Kerry Dr. Richard Meserve

OO~f\~,- .:J U~, i~C PECO NUCLEAR PECO Energy Company 965 Chesterbrook Boulevard A Unit of PECO Energy Wayne, PA 19087-5691

                                                  *99 SEP 29 P3 :4 1 September 23, 1999 t*

DOCKET NUMBER Secretary of the Commission U.S. Nuclear Regulatory Commission PROPOSED RULE PR So Attention: Rulemakings and Adjudications Staff (&,'/Fl? 317 31] Washington, DC 20555

Subject:

Comments Concerning Proposed Rule 10 CFR 50,

                   *consideration of Potassium Iodide in Emergency Plans*

(64FR31737, dated June 14, 1999)

Dear Sir/Madam:

This letter is being submitted in response to the NRC's request for comments concerning Proposed Rule 10CFRS0, *consideration of Potassium Iodide in Emergency Plans,* which was published in the Federal Register (i.e., 64FR31737, dated June 14, 1999). The proposed rule would amend the current regulations to require that consideration shall be given to including potassium iodide (Kl), as a protective measure for the general public that would supplement sheltering and evacuation. PECO Energy Company appreciates the opportunity to comment on th is proposed rule. We offer the following comments for consideration by the NRC: At the present time, PECO Energy does not see the need for this proposed rule. PECO Energy believes that, under the appropriate circumstances, evacuation is still the best option. In addition, there is a limited shelf life associated with Kl and there may be potentially serious side effects if Kl is not taken properly. Lastly, the use of Kl could lure individuals into a false sense of security. Furthermore, we endorse the Nuclear Energy lnstitute's (NEl's) response to this proposed rule. If you have any questions, please do not hesitate to contact us. Sfp 3 o 199

                                                                *eknowtedged by card . ' ""         I   fl  I .. -

U. . 1 UCLEAR R ~ RULEMAKINGS FFIC OF

FROM FAX NO.  : Mar . 12 1938 a7 : 27PM P2 @

)OCKET NUMBER PROPOSED AUL So

( IIJ 'lrl<:il- 737

                                                                                           *99 SE~ 28 P 3 :53 September 12, 1999 Secretary, U.S . Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50*63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East. End. l want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The

       ~cgulauon as it is new worded ** . " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed .

• ~

The nuclear *~ndu~try should bear the c:ost; gov~mment agencies should have th~ responsibility qf.seein& ihat potentially effe::ted communities have local stockpiles of potassium iodide. NRC's'announc!(i;!)lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after sh hours**it must :be stockpiled in schools,hospitals;fire, police and other municipal centers. There is no reason why the NRC should not make: these changes. Your mission is to prbtect the public's* health and* safety. *Please con~ider the pe.ople of Long Island who arc not protected and who cannot, jiven o\.lr topography and highway system, evacuate in the case of

       ~ a¢Cident at Millstone.

Sincerely yours, f P 3 O1

                                                                        ~cknowfedged by card_............ ~

I. FR011 l'lar. 12 1'398 .:17:27PM P2 onS\"\ET~D

                                                                                                             *us pc So

( fl<IFR3t737) *g9

• SCP 28 P3 :5 3 0

September 12, 1999 AD... Secretary, U.S. Nuclear Regu~tcry Commission Rulcmaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50--o3A Con;ideration of Potassium iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Sin~ Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended co REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The rcguladon as it is new worded.. . " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide.. M has no teeth and must be changed .

• . T1'e nuclear .- i.ndu_stry should bear the ~ost; gov~mment agencies should have the responsibilfry ~fsean, that potentially effe::ted communities have local !tockpiles of potassium

               *iodide. NRC's* announced.!)lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is .not cff~c:ivc after sh
       ' ~ hours--it musfbe stockpiled in schools,hospitals~fire, police and          orhcr municipal centers.

There is no reason why the NRC shodd not make these changes. Yo'l.!r mission is to

               .prbtect  the public,s- health and* safety. *Please consider the people of Long Island who arc not protected and who cannot, given O\lr topography and highway system, e\*acuate in the case of
       **, an 24cident at Millstone.

s;ncerely vours, ~ ckno gedby

qfaL//99

      ~

~~p~

FROM Mar. 12 1938 ~7:27PM P2 @ DOCKET NUMBER PROPOSED RU

                               *99 SG' 27 AlG 52 0,,

September 12, 1999 ADJl Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudication~ Staff Washington, D.C . 20555 Re: Comment PRM-50-63A Con:;ideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island ~,roergency p!2.nr.ing is of extreme i:iter-.!st to th~ re.sidenrs of the East £ud . 1 want to urge that the emergency planning regulation be amended ro REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The regulation as it is new worded .. . " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed. The nuclear indu_stty should bear the cost; government agencies should have the. responsibility qf .seein; that potentially effected communities have local stockpiles of potassium iodide. NRC*s*announce{i.?lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after sil hours:. *it must *be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make: these changes. Yowr mission is to prbtect the public,s health and safety. Please consider the people of Long Island who are not protected and who canr.ot, given our topography and highway system, evacuate in the case of an a¢Cident at Millstone . Sincerely yours,

                                                                     ~ T, f'f\_a--'2 1- Ul.L /r.QW/

3H\nJ (\ 5ov- ( f. D. .?,o(, (' _S~~V)N { Ni ~~b.)

                                                            ~cknowfedged y.

FROM FAX NO. Mar. 12 1993 a7:2?PM P2 DOCKET NUMBER

                                   *99 SEP 21 AlG :52              PRO OSED RU o~

ADJ September 12, 1999 Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C . 20555 Re: Comment PRM-50*63A Con~ideration of Potassium lodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to ex tend the lO mile emergency zone to include Long Island emergency planning is of ~xtreme interest to the residents of the East End. I want to urge that the emergency planning regulation b~ amended co REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The regulation as it is new worded .. . 11 the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed .

• Tl\e nuclear *~nd.u_stry should bear the cost; gov~rnment agencies should have th~

responsibility qf.seein& that potenti~lly effected communities have local stockpiles of potassium iodide. NRC's announced.,Ian for regional stockplling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after sh. hours-*it must *"be stockpiled in schools,hospitals,flre, police and other municipal centers. There is no reason why the NRC should not make these changes. Yo~r mission is to

     .prbtect the public's health and* safety. Please consider the people of Long Island who arc not protected and who cannot, given ol.lr topography and highway system, evacuate in the case of an a¢Cident at Millstone.

Sincerely yours,

                                                                ~ M . f~~

f. D. 3065'

                                                                        .Sc,..) ~lo.vi N!-f. !l'iO
                                                                 ~eknowfedg

lJ.S. NUCLEAR RULEMAKINGS &,-:.11',-,R',-U:"'4~.,_..,., OFFICE OF OF THE ~:m:M!S:Stt~

OFFICE OF THE GOVERNOR ROYE. BARNES GOVERNOR Georgia Emergency ManagemenJ ~gency P.O. Box18055 Atlanta, Georgia 30316-0055 Tel: (404) 635-7000 In Georgia 1-800-TRY- GE~ FAX: (404) 635-7205

                                                                           'IS.'

SEP 21 p 3 :l S 0 GARY W. McCONNELL DIRECTOR Or. September 10, 1999 ADJ Ms. Annette Vietti-Cook Secretary of the Commission United States Nuclear Regulatory Commission Rulemaking and Adjudication Staff Washington, D.C. 20555-0001

Subject:

Comments on "Consideration of Potassium Iodide in Emergency Plans" (64 Fed. Reg. 31737-June 14, 1999)

Dear Secretary Vietti-Cook:

It has been previously stated and continues to be the position of the Georgia Emergency Management Agency (GEMA) that the predistribution and stockpiling of potassium iodide (Kl) as a protective measure in the event of a severe reactor accident will not significantly reduce the risk to the citizens of Georgia. If the Commission's proposed amendment to the emergency planning regulations of 10 CFR 50 (b)(10) is changed to require that state and local governments consider the use of Kl as a supplement to evacuation and sheltering for the general public, it may actually have a negative impact on the primary defensive measure, evacuation. Clearly, the most efficient and effective strategy to protect the public is to remove them from the danger. Any requirement that may delay evacuation would be considered counterproductive. Kl is well recognized for its ability to protect the thyroid gland from exposure to radioactive iodine. As you are surely aware, Kl offers no protection for any other organs and provides no protection from whole body dose exposure. Care must be taken to ensure the public is not lulled into a false sense of security that a pill will provide all the protection they may need and that evacuation is not necessary. Evacuation, again, is the optimum protective measure and is the key to protecting the public. The benefits of the use of Kl by emergency workers who may be required to remain in an affected area is well recognized. Georgia's plans already incorporate keeping appropriate levels of Kl inventory at the local level for distribution to the emergency workers when required. EP 4 1999

                                                                                          ..................  ~~

,I I

Ms. Annette Vietti-Cook Page Two September 10, 1999 Extensive planning, coordination and preparedness have been accomplished across the spectrum from the utilities through the local communities and at the state level. Federal authorities, including the Federal Emergency Management Agency (FEMA) and the Nuclear Regulatory Commission, regularly evaluate all of these plans and preparations. These emergency plans consider every possible tool for protecting the general public and are well evaluated. When these plans of the state and local governments are implemented, it is felt by this agency that potassium iodide, at best, will not offer any significant protection to the population and, at worst, may negatively impact on the execution of other important aspects of those emergency plans .

• We appreciate the opportunity to provide comments and opinions prior to the implementation of this amendment. Should any additional information be required please contact Patrick Cochran, Manager, Radiological and Hazardous Materials Programs, at (404) 635-7233.

Sincerely, Director GWM/hpc

Commonwealth Edison Compan) 1400 Opus Place Downers Grove, IL 60515-S-"'0 l

                                         *99   EF' 21 A9 :so       ComEd C

September 13, 1999 AD Secretary of the Commission DOCKET NU BEA U.S. Nuclear Regulatory Commission PROPO DRU Washington , D.C. 20555-0001 Attention : Rulemakings and Adjudications Staff

Subject:

Proposed NRG Rule, "Consideration of Potassium Iodide in Emergency Plans"

References:

(1) Volume 64 , Federal Register, Page 31737 (64 FR 31737) , dated June 14, 1999 (2) Illinois Department of Nuclear Safety letter, "Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Federal Register 31737 - June 14, 1999) Request for Comments," dated September 8, 1999 (3) Nuclear Energy Institute letter, "Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Fed . Reg . 31737 dated June 17, 1999) Request for Comments," dated September 1, 1999 This letter provides Commonwealth Edison (ComEd) Company comments on the proposed rulemaking in Reference 1 to amend the emergency planning standards in 10 CFR 50.47, "Emergency Plans." The proposed ru lemaking modifies the planning standard for protective actions to require explicit consideration of the prophylactic use of potassi:.:m iodide (K!) for the general public. This proposed rulemaking is a particularly sensitive issue to many stakeholders of the nuclear energy industry including the public, state and local governments jointly acting as emergency response providers, and licensees. The nuclear power plant emergency response program in the ComEd Nuclear Generation Group and U.S. programs, in general, are built on the premise that evacuation is generally feasible and is more effective at dose reduction because it reduces dose to all organs, not just the thyroid . The proposed rule and supplementary information do not provide any new evidence that stockpiling or pre-distribution of Kl as a protective action will add significant public health and safety benefit to the adequate level of protection currently provided by existing emergency planning at and around commercial nuclear power plants. Guidance A Unicom Company

p

September 13, 1999 Secretary of the Commission Page 2 is already available for states and local governments that wish to make Kl available to the general public if they feel it is appropriate. Furthermore, the use and application of Kl as a thyroid blocking agent in a radiation emergency has been debated for almost 20 years, including policy and technical considerations, cost/benefit, implications of Chernobyl experiences, source term work, distribution and timeliness, and industry experience. Numerous scientific and regulatory bodies have consistently concluded that adoption of the stockpiling concept provides no significant public health and safety benefit. ComEd concurs with the NRC position that the decision as to the need for stockpiling Kl belongs solely with the involved states. The States of Illinois and Iowa have consistently provided comments opposing this change. ComEd has reviewed and supports those positions as most recently expressed in the comments provided by the State of Illinois regarding this proposed rulemaking in the Reference 2 letter. In addition, ComEd has reviewed the generic industry position provided in the Reference 3 letter from the Nuclear Energy Institute and concurs with the position defined in that letter. We appreciate the opportunity to comment on the proposed rulemaking. If you would like to discuss our comments further, please contact Mr. Martin Vonk, Emergency Preparedness Manager, Nuclear Generation Group, at (630) 663-6535. Respectfully,

 /( a t2r for R. M. Krich Vice President - Regulatory Services

1.'JOCKET NUMBER n9 @ PROPOSED RULE!..,!::...~ ~ ~ ht/~Rit737 DOCKETED A. DAVID ROSSIN us~Rc 24129 HILLVIEW DRIVE LOS ALTOS HILLS, CA 94024 (650) 948-7939 FAX (650) 941-7849 "99 SEP 20 P3 :06 e-mail: ADRossin@msn.com Cente ~Viliated Scholar Center tor\ 16,ternational Security and aabperation at Stanford 1 September 16, 1999 Secretary of the Commission U.S. Nuclear Regulatory Commission

 -Mail Stop 0-16 Cl Washington, DC 20555-0001

• ATTENTION:

SUBJECT:

Rulemakings and Adjudications Staff Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Fed. Reg. 3173- June 17, 1999) Request for Comments To the Commissioners: I realize that the deadline noted in the Federal Register has passed, but I wish to submit comments for your consideration, and I hope they can be included despite the late date. After the extensive public debate on the matter of requiring potassium iodide (KI) to be stored for distribution near each nuclear plant, I am deeply disappointed that this issue has again been raised. I will be blunt: There is no jus~ification for this proposed rule. There is no public health or safety justification. After all the safety requirements that the licensing basis calls for, one could not find a probabilistic risk that calls for stored KI at an NRC licensed nuclear power plant. The only people or organizations which have called for such a rule are opponents of nuclear power. They have shown no interest in public health nor any recognition of the safety requirements and risk assessments that are part 'o f the record for every plant. The reason for this proposal is to build even more distrust and skepticism for nuclear power among the American people. The Commission should never have certified such a proposed rule for public comment.

ll.S. NUCLEAR REGULAl vn: J *- *.:..-. " flll.EMAKINGS &ADJUDICATfONS t OFFICE OFlHESECRETARY OF THE COMMISSION OocllnantStatlslk:s Po&bR&fk Dale Copies q I ll bl9tJ { / I

• s

The Commission has made public statements about its progress in use of probabilistic risk assessment in its regulatory process. Failure to weed out this obviously politicized proposal when it was raised by the staff makes a mockery of the Commission's initiatives. Even the publicity surrounding public comment, let alone a public hearing would accomplish the objectives of the people who submitted this proposal. I urge the Commission to act responsibly with regard to this proposed rule and reject it. The reasons for its rejection are obvious and should be clearly stated so that the public and Congress can understand them. Sincerely, A.!.1,:{ ~ For identification: I was Assistant Secretary for Nuclear Energy, U. S.D. 0 .E. 1986-87, Director of the Nuclear Safety Analysis Center at EPRI 1981-86, and President of the American Nuclear Society 1992-93. I am an independent consultant on nuclear power safety, energy policy and non-proliferation. Cwrently I am Center Affiliated Scholar at the Center for International Security and Cooperation at Stanford, working on a book on the U.S. policy dating back to President Jimmy Carter to oppose reprocessing of civilian nuclear power reactor spent fuel.

OOCY,:. rro State of Louisiana US~!HC'

• Department of Environmental Quality

                                                                                              *gg    srn 20 M.J. "MIKE" FOSTER, JR.                                                                                               J. DALE GIVENS GOVERNOR                                                 September 13, 1999                                        SECRETARY Secretary of the Commission Attention: Rulemakings and Adjudications Staff U.S. Nuclear Regulatory Commission Washington, D.C. 20555 D CKET NUMBER Sub:      Consideration of Potassium Iodide (KI) in Emergency Plans Ref:      Federal Register/ Vol. 64, No. l 13/ June 14, 1999                      PROPOSED AULE~SO

(~lf-F1?3l73 7

Dear Madam/ Sir:

The purpose of this letter is to provide comments on the above-mentioned subject. The proposed rule would amend the current regulations to require that "consideration" shall be given to including Potassium Iodide (KI), as a protective measure for the general population that wou ld supplement sheltering and evacuation. The State of Louisiana's comments are as follows: I) It is desirable that the NRC would work with other appropriate federal agencies to develop and promulgate clear and necessary guidance on the subject, similar to the guidance on sheltering and evacuation. The final decision should lie at the discretion of the state and local governmental authorities. The requirement of stockpile and distribution of KT should not be imposed upon the states or locals directly or by regulations through the utilities.

2) The State of Louisiana is cognizant of the use of KI. The Department of Environmental Quality (DEQ) and the Department of Health and Hospitals (DHH) of the State of Louisiana always work together in paying proper attention to considering KI as the thyroid blocking agent. In our emergency plan development, proper attention has been paid to this issue. We do not feel that the current U.S. regulations need to be revised. The need for considering KI for the general population, residing within the EPZ of the three nuclear power plants affecting Louisiana, will be assessed if and when necessary, and a decision on whether to stockpile KI and distribute it will be made jointly by DEQ and DHH.

In light of the above points, the State of Louisiana does not believe that a rulemaking on the subject is necessary. Should you have any questions regarding our position on the subject issue, please contact Prosanta Chowdhury at 225-765-0139. JZ;J.11Ld L. Hall Bohlinger, Sc.D. Deputy Secretary LHB:PC C: Col. Mike Brown, Louisiana Office of Emergency Preparedness Dr. Jimmy Guidry, State Health Officer, La DHH Mr. Jim LeGrotte, FEMA R VI Mr. Charles Hackney, NRC RIV Mr. Jack Lewis, W-3 SES EP ,, ') 1 Mr. Mike Bakarich, RBS '- '- _ __ Mr. Fred Guynn, GGNS CknO ed. ed by C&fd ______,......,,. 0 recycled paper OFFICE OF THE SECRETARY P.O. BOX 82263 BATON ROUGE, LOUISIANA 70884-2263 TELEPHONE (504) 765-0741 FAX (504) 765-0746 AN EQUAL OPPORTUNITY EMPLOYER CONT A.INS SO'IOIL ~

U.S. NtJCl.l:M REGULATORY COMMISS1lJ, RUlEMAKIN8S&NM~r:i-:,._ STAFF R COMMISSION Dneummtt8tmi9tics Pom,aft< Date qf G/ 91 _ _

...opies Received _ _ _..._ /_

dd'I *

 ,oeeial

FROM FAX NO. Mar. 12 19'38 t:,7 :27PM P2 DOCKET NUM ER PROPOSED RULi: SO ( fl'lfR31131)

                                                                                          *99  SEF 2U P3 :09 Secretary, U.S. Nuclear Regulatory Commission Ruh:making and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50*63A Con:;ideration of Potassium Iodide in Emergency Plans. Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of ~xtreme interest to the residents of the East End. l want to urge that the emergency planning regulation b~ amended ro REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The

           ~egulation as it is new worded .. . " the proposc.d rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed .

• The nuclear *ind.u~try should bear the ~ost; gov~mment agencies should have th~

responsibility <;f .seein& that potentially effected comm.unities have local stockpiles of potassium iodide. NRC's'announced.,Ian for regional stockpiling should be amended; local stockpiling is ne<:essary to make the distribution of KI possible in an emergency; KI is not effective after sh:

• hours'-*it must *be sw,ckpilcd in schools,hospitals;tire, police and other municipal centers.

                                  '  '. ~ ....

There is no reason why the NRC should not make these changes. Yol.lr mission is to prbtect the public's* health and* safety. *Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an i4Cident at Millstone. Sincerely yours, cknowfed(J d ...- -..- - ......... ,.:.c

U.S NUCLEAR REGULATORY COMMISS .~ RUL MAKINGS &ADJUDICATIONS STAFF FACE OF'FHE SECRETARY OFTHE SSION atistics Po 5/q9 ~o Ad So

FROM Fh>-'. NO . 11ar. 2 1'3'38 07 :2?PM P2 @ DOCKET NUMBER PROPOSED AUL So f,'/FR3t737) S£ 20 P3 *.08

                                                                                        ~

September 12, 1999 Secretary, U.S. Nucle.ar Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50-63A Con:;ideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused lo extend the 10 mile emergency zone to include Long Island emeigency planning is of e. treme interest to the residents of the East. End. I want to urge that the emergency planning regulation b~ amend~ ro REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The

     ~cgulation as it is now worded .. . " the proposed rule wo ld require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed.

The nuclear ind_ustry should bear the cost; government agencies should have th~ responsibility 9f .seeing that potentially effe:::ted communiti s have local stockpiles of potassium iodide. NRC's announced .;,lan for regional stockpiling should be arnended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six "hours- *it must 'be :,toc~iled in schools,hospiu ls, flre, police and other municipal centers. There is no reason why the NRC should not make: these changes . Your mission is to prbtect the public' s health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an a¢~ident at Millstone.

FROl1 FAX NO. r1ar. 12 1938 a7 :27PM P2 @ DOCKET NUMBER DC Cr,i:- f FO PROPOSED RU So US' ~

                                                                                            '99   SEP 20 P3 :07 0

September 12, 1999 R-ADu l Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50*63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused lo extend the 10 mile: emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended ro REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The

regulation as it is now worded .. . " the proposed rule would r~uire that CONSIDERATION shall be given* t.0 include potassium iodide .. " has no teeth and must be changed.

Th~ nuclear 'ind.u_stry should bear the cost; gov~rnment agencies should have th~ responsibility c;,f.seein& that potentially effe:ted communities have local !tockpiles of potassium iodide. NRC's' announce.d.!)lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after sh. hours**it must *be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Yol-!r mission is to prbtect the public;s health and safety. Please con~ider the people of Long Island who are not protected and who cannot, 1iiven o-ur topography and highway system, evacuate in the case of an a¢¢ident at Millstone. Sincerely yours,

          /tll J : -/ ( W I.I     s   Z( I\

a, s .L f A .L ,.. l.f~4e,( M Sa 5 )f~ (' {,,/'/ /ti i 1"rl1

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. - '&Di

FROM FAX NO. Mar. 12 19'38 07 :27PM P2 @ DOCKET N BER DCC ' I 0 5b II~

                                                                                      ..,~   C PROPOSED RU
                                                                                 *99 S:T 20 P 3 :o?

0 September 12, 1999h AD0L1 Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation b~ amended to REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The

    ~egulation as it is now worded .. . " the proposed rule would rC'luirc that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed.

Th~ nuclear 'i.nd.ustry should bear the cost; gov~rnment agencies should have th~ responsibility ~f .seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announce.d.!)lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours;.*it must '.be stockpiled in schools,hospitals;fire, police and other municipal centers. There js no reason why the NRC should not make these changes. Your mission is to

    .protect the public's health and* -safety. *Please con~ider the pe.ople of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an 24cident at Millstone.

Sincerely yours,

FROM FAX NO. Mar. 12 1998 ~7 : 27PM P2 @ DOCKET NUMBER PROPOSED RU 50 rR3l737 *99 SEF 20 P3 :O? 0 , September 12, 1999 R' AOJL Secretary, U.S. Nuclear Regulatory Commission Rulcmaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. 1 want to urge that the emergency planning regulation b~ amended ro REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The

      ~egulation as it is new worded ** . " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed.

Tl\e nuclear i.nd.u.stry should bear the t:ost; government agencies should have th~ responsibility ~f'.seeini that potent4\lly effected communities have local stockpiles of potassium iodide. NRC's' announce.(1.?lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours-*it must *be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to prbtect the public's health and safety. Please coMider the people of Long Island who are not prote.cted and who cannot, given ol.lr topography and highway system, evacuate in the case of an ~cident at Millstone. Sincerely yours, i.(f ~\t "l_~ .(, (.6\12 ~.~,

                                                                            \1.q. \,\.~~"'      <;,.

5,;.\ \~1/2cv < }-)'\ \ \\Cu3

U.S. NUCLEAR REGUlATORY RULEMAKINGS & OFFICEOF'ftERSSl'at:ff" OFTHE OS ~op rid

             ------T---*

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        -       7                .

FROM FAX NO. : Mar. 12 1993 07 : 2?PM P2 DOCK TED I JS J Er 20 P3 :06 G September 12, 1999 Ao'v, Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50w63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End . I want to urge that the emergency planning regulation b~ amended co REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The regulation as it is now worded ** . " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed. Tl\~ nuclear 'i.nd.u.stry should bear the cost; gov~rnment agencies should have th~ responsibility 9f',seein; th.at potentially effected communities have local stockpiles of potassium iodide. NRC's' announce-(1 .:,lan for regional stockpiling should be amended~ local stockpiling is necessary lO make the distribution of KI possible in an emergency; KI is not effective after sh hours-*it must *be :stockpiled in schools,hospitals,fire, police and other municipal centers. The.re is no reason why the NRC should not make these changes. Your mission is to protect the public' s health and* safety. Please consider the people of Long Island who arc not protected and who cannot, jiven O\.!r topography and high way system, evacuate in the case of

    ** an a¢Cident at Millstone.

• Sincerely yours, Kate Walker Vogel IO Latham Street PO Box 2131 Sag Harbor, New York I 1963

                                                                       /

U.S. NUa.EAR REGULATORY COMMISSIC I PIUU:=MMNiS&,..,,..,,IINnl AFF

DOCKET U BER PROPOSED RU SO ( ~</PR.3173 7 OOCK ~TE D US I September 13, 1999 REVISED VERSION- i ~ 9~EP ZO AlO:ZS 0 -f COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENERGY , FO{_C_~ ( "OCRE" ). ON PROPOSED RULE, "CONSIDERATION OF POTASSIUM IOD ~ GI.N EMERGENO¥ PLANS," 64 FED. REG. 31737 (JUNE 14, 1999) OCRE supports this proposed rule, to the extent that it is the best the NRC will accept . However, OCRE would prefer a stronger rule that would mandate the use of KI in radiological response emergency planning, with the nuclear power plant licensees paying the costs of the KI pr ogram. In July 1997, through a news release, the NRC promised the states and the public that it would pay for the purchase of KI for any state which wanted to use it. Based on this promise, the State of Ohio developed a draft KI policy that favored providing KI to the general public. Now that the NRC has reversed itself on the promise to pay, it is unclear whether Ohio's policy can be imple-mented. Under this proposed rule, if a state considered the use of KI, but found the licensee unwilling to pay for it, and since the NRC won't pay for it, the state decided it might be a good idea but they couldn't afford it, would this be considered acceptable and in compliance with the rule? It is my understanding that the petitioner compromised based on the NRC's promise to fund KI purchases by states. Since the promise of funding removed a major impediment to states* adopting a pro-KI policy, the petitioner felt that amending his petition to require only "consideration" of the use of KI would likely result in state decisions favorable to using KI. Now the NRC has failed to live up t o its part of the bargain. So it would be entirely appropriate for the petitioner to rescind his amendment to PRM-50-63 and to insist that the NRC adopt what was requested in his original petition. Respectfully submitted,

     ~~

Susan L. Hiatt, Director, OCRE 8275 Munson Rd . Mentor, OH 44060 t.#1-1 t; SS - 3t~

U.S.N RU~ *1111Mn*1 v-, OF1:W};.f~ttl'ARV

Uiiiiii -- DOCKET NUMBER DOCKETED

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Omaha Public Power District 444 South 16th Str86t Mall PROPOSED AU U ,N~, Omaha, Nebraska 68102-2247 *99 S P 20 A10 :25 September 10, 1999 C LIC-99-0082

                                                                                                                                   'I Secretary of the Commission Attention: Rulemaking and Adjudications Staff U. S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

References:

1. Docket No . 50-28'.'

2. Federal Register Volume 64 dated June 17, 1999 (64 FR 31737)

Subject:

Comments on Proposed Revision to NRC Emergency Preparedness Regulations on Use of Potassium Iodide in Emergency Plans In Reference 2, the NRC proposes to amend its emergency planning regulations governing domestic licensing of production and utilization facilities. The current regulations would be amended to require that "consideration" be given to including potassium iodide (KI), as a protective measure for the general public that would supplement sheltering and evacuation. The Omaha Public Power District (OPPD) does not support the proposed revision. It is OPPD's position that the proposed rule will not provide a substantial increase in the protection of the public health and safety. OPPD believes that the proposed rule requiring the states to give "consideration" to the use of KI is inappropriate. The proposed rule fails to provide clear and concise guidance on the administration of KI to the general public and puts the burden of assessment on the states, which have fewer technical resources and expertise than the NRC, EPA, and FDA. The proposed rule does not define "consideration," which is likely to result in various interpretations. One state might interpret "consideration" to mean that Emergency Management and Radiation Protection staff should meet and document their decision. Another state might interpret "consideration" to involve a formal notice and comment process with public hearings. The wording of the proposed rule leaves the meaning of "consideration" to be decided by the courts, post-incident, and does not constitute effective guidance. In addition, OPPD does not support the stockpiling of KI for distribution to the general public in the event of a nuclear power plant accident for the following reasons: E 2 2 199 f<'lowfedged bveard .......... ::--...---..-**-"" 41 71 Employment with Equal Opportunity

NUCLEAR REGlJLAlun v E~AKINGS & ADJUOICATIO

 'JFFICE OF THE SECRETARY OFTHECOMMI Df\Cum~m S

. ,,

• U.S. Nuclear Regulatory Commission LIC-99-0082 Page2
• Evacuation of potentially affected areas within the 10-mile Emergency Planning Zone is the preferred protective action to protect the health and safety of the general public. Distribution of KI to the general public could inhibit orderly evacuation and divert limited local resources during the early stages of an incident.
• The distribution of KI to the general public could impart a false sense of security regarding the prevention of severe health effects resulting from radiation exposure. KI is not effective unless administered prior to or shortly following inhalation or ingestion ofradioiodines.

Also, KI does not limit dose due to whole body exposure from other radioisotopes potentially present in a radiological release from a nuclear power plant incident.

• KI is contraindicated for some groups of people.
• Emergency plans will not be able to address legal liabilities associated with the drug's administration. State and local governments will be unable to control dosage or provide medical supervision for the administration to schoolchildren.
• International experience with the drug is not necessarily useful in assessing the appropriateness of the protective measure in the United States because of the differences in reactor designs and emergency preparedness capabilities.
• The cost associated with stockpiling KI for the general public out-weigh the benefits.

The NRC, in conjunction with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) has the responsibility to develop and promulgate guidance to state and local governments on the appropriateness of various protective measures. These federal agencies have developed clear and concise guidance for when evacuation, sheltering, and ingestion protective actions are warranted. States maintain the authority to adopt stricter guidelines than those of the federal government. Please contact me if you have any questions .

• (1\erely,l,,i{

      ~~

Division Manager Nuclear Operations Attachment SKG/mle c: E. W. Merschoff, NRC Regional Administrator, Region IV L. R. Wharton, NRC Project Manager W. C. Walker, NRC Senior Resident Inspector Document Control Desk Winston & Strawn

Fermi 2 6400 North Dixie Hwy., Newport, MI 48166 t Detroit Edison

                                                                                     *99    EP 17 P2 :44 C. r I

AD~ September 13, 1999 DOCKET NUMBERPR NRC-99-0080 PROPOSED RULE SO f,L/ FR 317 3 7 Secretary

• U. S. Nuclear Regulatory Commission Attention: Rulemakings and Adjudication' s Staff Washington D C 20555-0001

References:

1) Fermi 2 NRC Docket No. 50-341 NRC License No. NPF-43

2) Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 FR 31737),

dated June 14, 1999

Subject:

Detroit Edison's Comments on Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 FR 31737). dated June 14, 1999 Detroit Edison has reviewed the Proposed Rule "Consideration of Potassium Iodide in Emergency Plans" as published in the Federal Register on June 14, 1999 (Reference 2). The Proposed Rule amends the planning standard for protective actions to require explicit consideration of the prophylactic use of potassium iodide (KI) for the general public. Detroit Edison strongly urges the NRC to not issue this amendment to 10 CFR 50.47. Potassium Iodide can be effective in protecting the thyroid from radiation due to inhaled radioactive iodine. However, any accident that resulted in a release of radioactive iodine would also include other radioactive elements for which KI would not offer protection. Risk due to thyroid dose is of significantly less concern than the risk associated with whole body exposure from noble gases. Detroit Edison, along

• with the State of Michigan, believes that evacuation is the most effective protective UP ?. I

                                                              ~cknowfedoed bv card ...................:::::::~

A DTE Energy Company

r NUCLEAR REGULATORY \AIR!~ AULEMAKINGS & OFFICE OF OFTHE

1 USNRC NRC-99-0080 Page2 action to protect the public in an accident involving these releases. In addition, we fear that the pre-distribution of KI to the public might create a false sense of security and undermine the effectiveness of an evacuation order. We appreciate the opportunity to comment on the proposed rule. Should you have any questions or require additional information, please contact Kevin J. Morris of my staff at (734) 586-4327. z~

• cc: A. J. Kugler Director - Nuclear Licensing A. Vegel NRC Resident Office

DOCKET NU BER PROPOSED RU so t,t./ FR31737 September 12, 1999 Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The regulation as it is now worded... " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed. The nuclear industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced plan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and .who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone. Sincerely yours,

                                                                 ~ ~--~--ri f
         ~ctmo daed bv cam ..._ ...:....~__ . ., .,.

REGULA nU1.JC:M111M'f\:IS &ADJ OFRCEOFl'HE OFTHE J .\d Sp_::;*~ ~ ~

KET NUMBER PROPOSED RU

                                                                                       *99 sEr 16 P 2 *zs September 12, 1999          Ot F

ADJ Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adjudications Staff Washington, D.C. 20555

• Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The regulation as it is now worded... " the proposed rule would require that CONSIDERATION

• shall be given to include potassium iodide.. " has no teeth and must be changed.

The nuclear

• industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced 2lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers.

There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone. Sincerely yours ,

                                                                         £. ~

u U LEAR REGULATOR COMMISSION RUL AKINGS&ADJUOICATI SSTAFF OFFICE OF THE SECRETARY OFTHECO Cop* ~dd'I Sped _

DOCKET NUMBER PROPOSED RU OOCI\ETEO

                                                            ~    r*

WINSTON & r 16 Pi 56 Electronic STRAWN 1400 L STREET, N .W ., WASHINGTON, DC 20005-3502 Letterhead 202-3 7 I -5 700 35 W. WACKER DRIVE 200 PARK AVENUE 43 RUE DU RHONE 2 I AVENUE VICTOR HUGO CHICAGO, IL 6060 I -9703 NEW YORK, NY I 0 I 66*4 I 93 I 204 GENEVA, SWITZERLAND 75 I I 6 PARIS, FRANCE 3 I 2*558-5600 2 I 2*294-6700 41-22-3 I 7-75-75 33* 1*53-64-82*82 September 14, 1999 Ms. Annette L. Vietti-Cook Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Re: Comments on Proposed Rule, Consideration of Potassium Iodide in Emergency Plans, 64 Federal Register 31,737 (June 14, 1999)

Dear Ms. Vietti-Cook:

The following comments are submitted on behalf of the Nuclear Utility Backfitting and Reform Group (NUBARG) 1 on the captioned rulemaking. The proposed rule would amend 10 C.F.R. § 50.47(b)(10), which currently requires licensees to demonstrate that, for their onsite and offsite emergency response plans, a "range of protective actions have been developed for the plume exposure pathway EPZ for emergency workers and the public." Under the proposed rule, the provision would further specify that: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate." 64 Fed. Reg. at 31749. Accordingly, NUBARG believes that either the final rule should limit the extent of licensee actions necessary for compliance or, a backfitting analysis should be conducted and a suitably revised proposed rule be published for comment by the Nuclear Regulatory Commission (NRC) if licensees are required to conduct extensive reviews or otherwise expend significant resources to implement the required consideration. NUBARG is a consortium of 15 utilities (representing 43 power reactors) which was formed in the early 1980s and actively participated in the development of the NRC' s backfitting rule (10 C.F.R. § 50.109) in 1985. NUBARG has subsequently monitored the NRC's implementation of the backfitting rule.

                                                                                                      ?
                                                                  ~ckno rlt     oed bv ca

Ms. Annette L. Vietti-Cook September 14, 1999 Page 2 It is not clear what additional actions would need to be taken to demonstrate compliance with the proposed rule. The original petition for rulemaking as submitted to the NRC in November 1995 would have required licensees to include KI as a protective measure in emergency plans. The petitioner revised the petition in December 1997 so that the provision would, instead, direct licensees to give consideration to the use of KI as part of their emergency plans. Upon review, the Staff initially concluded that no "compelling basis" exists to support the rulemaking and accordingly recommended that the petition for rulemaking be denied.2 The Commission however, disapproved the Staffs recommendation and directed the Staff to proceed with the rulemaking to adopt the language currently proposed. In their consideration of the merits of the petition for rulemaking, neither the Commission nor the Staff addressed the backfitting implications of the proposal. However, the Staff did note that the effect of the rule would be to "require licensees to work with state and local governments to ensure that KI is considered as part of the emergency plan process" and concluded, therefore, that the rule would have "resource implications for licensees ... ."3 Notwithstanding these observations, the NRC now states that the "proposed rule imposes no new requirements on licensees, nor does it alter procedures at nuclear facilities." 64 Fed. Reg. 31748. The NRC states that nothing is required of licensees to demonstrate compliance, and that instead, under the proposed rule, state and local governments will be expected to have shown "consideration" of the use of KI as a protective action in emergency planning. 64 Fed. Reg. 31747. Thus, the NRC concludes that the proposed rule does not constitute a backfit. The Committee to Review Generic Requirements (CRGR) determined that the proposed rule "appears to be a backfit" and recommended that a backfitting analysis be performed.4 The Commissioners split (3-2) on the backfitting issue, with Chairman Dicus and Commissioner Merrifield asserting that the proposed rule would be a backfit. 5 Commissioner Merrifield concluded that requiring licensees to document their compliance with the proposed rule would be a backfit and 2 SECY-98-061 , "Staff Options for Resolving a Petition for Rulemaking (PRM-50-63 and 50-63A) Relating to a Re-evaluation of the Policy Regarding the Use of Potassium Iodide (KI) by the General Public after a Severe Accident at a Nuclear Power Plant" (March 31 , 1998) at 5. 3 Id. at 4. The Staff also noted that, as part of the rulemaking, it would be necessary for the NRC to decide "what sanctions it is prepared to invoke in the event compliance with the new rule is not achieved." 4 October 23, 1998 Letter from Thomas T. Martin, CRGR Chairman, to William D. Travers, Executive Director for Operations (Enclosure 6 to SECY-98-264 at 44 (November 10, 1998)). 5 Commission VotingRecord,Decisionltem: SECY-98-264, "Proposed Amendments to 10 CFR 50.47; Granting Petitions for Rulemaking (PRM 50-63 and 5063A) Relating to a Reevaluation of Policy on the Use of Potassium Iodide (KI) after a Severe Accident at a Nuclear Power Plant," April 22, 1999.

Ms. Annette L. Vietti-Cook September 14, 1999 Page3 suggested that it be revised to encourage licensees to consider the use of KI in their emergency plans. Commissioner Dicus discussed the backfitting implications of the proposed rule at length: [l]t is obvious the proposed rule does impose new requirements on licensees within the meaning of the backfit rule, 10 CFR 50.109. Licensees' are required, under the proposed rule, to assure that KI h~ been considered as part of the emergency planning process. This implicitly means that licensee's, in coordination with State or local governments, may need to develop analyses related to KI use, including potential distribution of KI and must have some method (perhaps documentation) to demonstrate compliance with the new requirement.

              . . . [T]he requirement that that KI distribution be included in the process of developing emergency plans amounts to a modification or reinterpretation of the existing requirement. Whether a modification or a reinterpretation, previous OGC analysis has made it clear that such a change amounts to a backfit which must meet the backfit requirements of 10 CFR 50.109.

[l]t would be facetious to argue that there is not a change in requirements being proposed or to argue that there will not be an expenditure of licensee resources to comply with this new requirement. The backfit rule was specifically designed to assure that new requirements or new interpretations that required action by licensees were justified. Even if earmarked as a "clarification" of existing regulations, unless it can be shown that all licensees already included the consideration of KI distribution in their emergency plans and/or consent to the requirement, such a clarification would constitute a "change in staff interpretation" of the regulations that would constitute a backfit. In essence, absent a showing that the proposed rule meets the backfit analysis requirements, it is an impermissible backfit as written. 6 6 Response Sheet from Commissioner Dicus on SECY-98-264 at 2-3 (citations omitted).

Ms. Annette L. Vietti-Cook September 14, 1999 Page4 We agree with Commissioner Dicus' analysis of the issue. As the Chairman observed, if licensees would be required to expend significant resources in "considering" the use of KI in emergency plans then the proposed rule is clearly a backfit and a backfitting analysis should be performed. Accordingly, we request that the NRC either limit the specific actions which would be required to be taken by licensees demonstrate that the adequate consideration required by the proposed rule has been implemented, or the required backfitting analysis should be conducted and a suitably revised proposed rule should be published for comment. Sincerely, Sheldon L. Trubatch Garth D. Richmond Counsel to the Nuclear Utility Backfitting and Reform Group

September 15, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher /) ;f jlj ~ L~

                                                .A ADM, DAS 11 U},-h'-{, ri--   

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking website on September 15, 1999. The submitter's name is Garth D. Richmond, Winston & Strawn, 1400 L St. NW, Washington, DC 20005. Please send a copy of the docketed comment to Michael Jamgochian (mail stop O-1 lF-l ) for his records.

Attachment:

As stated

• cc w/o attachment:

M. Jamgochian

         ~ - STATE OF NEW YORK                                                                            DOCK'" ED IY' m,...

_, DEPARTMENT OF HEALTH

                                                                                                                   .5'  3:J!:/',.

Flanigan Square, 54 7 River Street, Troy, New York 12180-2216

                                                                                                     *99     Er  11    P~

Antonia C. Novello, M.D., M.P.H. Dennis P. Whalen Commissioner E~putive Deputy Commissioner H ADJL September 13, 1999 Secretary DOCKE U BER Rulemakings and Adjudications Staff PROPOSED RU 50 U.S. Nuclear Regulatory Commission ( IP</F/?317 37 Washington, DC 20555

Dear Secretary:

Re: Proposed Rulemaking to Amend 10 CFR 50.47 (b)(lO) Docket# fr14jn99-13 This is to express our support to NRC's proposal to amend its regulations to require that the prophylactic use of KI be considered as a protective measure for the general public that would supplement sheltering and evacuation. We concur with NRC's position of recognizing the state's ultimate authority in deciding if KI is to be included as one of the protective measures available in such an emergency. The planned NRC guidance document, as well as FEMA's requirements and FDA's revised criteria for when KI use is indicated, are key to how this rule is to be implemented by state and local governments. The importance of these documents cannot be overemphasized and we would welcome the opportunity to review and comment on them. Sincerely, I~~ Q~.;., Karim Rimawi, Ph.D. Director Bureau of Environmental Radiation Protection C:\MyFiles\kirevie2.doc ckno ed ed b ea **------..,

U.S. NUCLEAR R RULEMAKING ni.NU'O:~~","'"" OFACE OF

DOCKET NUMBER OO(YFT ... O PROPOSED RULE p o L'

                                                 '(<,,l./~R31?37 September 13, 1999
                                                                      *99 SEP 15 P3 :15 Secretary of the Commission U.S. Nuclear Regulatory Commission Mail Stop 0-16 Cl Washington, _DC 20555-0001 Although models and predictions regarding anticipated health consequences from atmospheric dispersion of radionuclides from a severe nuclear accident were established by the finest minds in health physics, these models have been proven to have been flawed. Specifically, with regard to exposure to radioiodines, cases of confirmed thyroid cancers in children of Belarus and Ukraine have exceeded by 10 to 50 times scientists' predictions of incidence that existed at the time of the Chernobyl nuclear power plant accident in 1986. Onset of childhood thyroid cancers has also been found to occur at an earlier time than anticipated, with 50 to 60% of the cancers invasive in surrounding tissue with lymph node metastasis.

We have heard and read statements that nuclear reactors in the United States are designed to be safer than the reactors in Chernobyl. However, engineering reports prepared by the former Soviet Union indicate their confidence in the fail-safe dependability of the Chernobyl reactor design prior to the accident. Many lessons can be taken from the unfortunate disaster at Chernobyl, not the least of which is that an unanticipated emergency caused by human factors can occur at a nuclear reactor, despite confidence in the perceived robustness of the physical plant. While prudent oversight can minimize the probability of an accident, it cannot eliminate one, and pre-planning for what are known consequences of such an event can reduce subsequent cancer. These concerns, together with consideration of recommendations by the American Thyroid Association, form the basis for us to urge the Nuclear Regulatory Commission to act affirmatively on the petition by Peter Crane to amend emergency response planning regulations to include not only the requirement to consider stockpiling of KI for distribution to members of the public, but to modify the petition to require stockpiling. Furthermore, we urge that considerations for stockpiling KI include rigorous assessments to ensure sufficient quantities of KI will be available for distribution to members of the public, in both the plume exposure pathway and the ingestion exposure pathway, in vicinities where radioiodines are used and stored in quantities requiring development of an emergency plan under current rules. Mr. and Mrs. Robert J. Walker 79 East Side Drive Concord, NH 03301

lJ.S NUCLEAR REGULATOR Cu RU EMAKI GS &n&.N,1U1CATION . OFFICE OF C RY OFTHE

September 14, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM, DAS fl .. IJ A.. V~ L/47v ru~- --

• 0

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Attached for docketing is a comment letter related to the subject proposed rule. This

• comment was received via the rulemaking website on September 13, 1999. The submitter's name is Robert J. Walker, 79 East Side Drive, Concord, NH 03301. Please send a copy of the docketed comment to Michael Jamgochian (mail stop 0-1 lF-l) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

From: Gloria Rubino Gloria Dodd Rubino Inc. Far: 516-2670104 Voice : 516-2670104 To: ~*cretaryUSNRC Pap* 1 DI' 1 Monaay, ~*p11m01r 1J, ,~:ni .:, :ue:u., rrw DOCKET NUMBER PROPOSED RU oq,*:t- '- Tro U() ,,, ,,

                                                                                                      *99 S[P 15 p 3 :JS POBox20 Amagansett, NY 11930 September 11. 1999                                                                    Or Secretary of U.S. Nuclear Regulatory Commission Attn: Rulemakings and Adjudication's Staff US Nuclear Regulatory Commission Washington, D.C. 20555
            *fhis letter is to urge that the nuclear emergency planning regulation be amended to ~ the availability of potassium iodide (Kl) a.c; a protective measure for the public in the event of nuclear accidents. The amendment's current wording, calling for the consideration that KI be made available, i.<1 too vague and not meaningful.

In addition, Kl should be stockpiled in all local communities within a 50-mile tadius of a nuclear facility. Regional stockpiling, the NRC's current announced plan. is inadequate because KT must be taken immediately after exposure to prevent thyroid disease. KI should be stockpiled in schools, 8hclters, drug stores, municipal offices, hospitals and fire or police stations for immediate dissemination. Furthcnnore, the public should be fully educated about the use and manner of distribution of KI. Emergency drills would assist in public preparedness should an accident occur. We know that the NRC does not want to ala.an the public. But keeping them in the dark and not providing them with adequate emergency preparation would be criminal and inhumane.

tJ S \IUCLEAR A l=lU AKINGS OFFICE OFTH

rOCKET RO OSED RU Secretary USNRC Att: Rulemakings and Adjudication's Staff U.S. Nuclear Regulatory Comm. Washington D.C. 20555 RE: Comment PRM-50-63A, Consideration of Potassium Iodide in Emergency Plans, Proposed Rule.

Dear Mr. Secretary,

I am writing to urge that nuclear emergency planning regulation be amended to require the availability of potassium iodide (Kl) as a protective measure for the public in the event of nuclear accidents. I oppose the amendment as it is now worded: " ... the proposed rule would require that consideration shall be given to including potassium iodide ... "in that this is too vague to be meaningful. Further, KI should be stockpiled in all local communities potentially effected (preferably within a 50 mile radius of a nuclear facility) by a nuclear accident. I do not support the NRC' s announced plan for regional stockpiling because KI can only be effective in preventing thyroid disease if taken before, or immediately after exposure. The effectiveness of the medicine diminishes with time so that there is only a 6-hour window during which it can be helpful. To count on speedy distribution from miles away (even assuming immediate pub~ic notification of an accident) is foolhardy to say the least. For greatest effectiveness~ KI could be stockpiled in schools, shelters, drug stores, municipal offices, hospitals and fire or police stations-to mention just a few locations. The public should be fully educated about the use and manner of distribution of KI; emergency drills (such as fire drills) would assist in public preparedness should an accident occur. Arguments have been made that widespread distribution of KI would be a costly and complicated undertaking. Given the huge profits made by this industry as well as the danger to which the public is subjected, cost and logistics should be of no consequence. The industry should bear the cost and responsible~overnmental agencies should hopefully have the capacity to deal with the logistics. The NRC's mission is to protect the public against the dangers posed by the nuclear industry. There is no rationale to refuse to take this simple, common sense measure which could potentially save the lives of numerous citizens. Sincerely, Sue B. Avedon 6~,~ 174 Buckilill Rd East H~pton New York 11937

DOCKET NUMBER PROPOSED AUL So ooc ttt:T ED Ms. Annette L.Vietti-Cook US L Secretary of the Commission U.S. Nuclear Regulatory Commission 1 White Flint North *99 E 15 P3 :15 11555 Rockville Pike Rockville, MD 20852-2738 0 September 13, 1999 Dear Ms. Vietti-Cook I recommend that the NRC not amend its current emergency planning regulations governing the use of potassium iodide (Kl) as a protective measure. The current regulations governing protective actions in the communities around nuclear power plants are adequate to protect the health and safety of the public and workers so far at the policies concerning use of KI are concerned. Kansas protective action guides include the use of KI to protect workers and special populations that may be exposed to radioactive iodine through their emergency response duties or because they cannot be easily evacuated from an area of risk. The petitioner's arguments for following the protocols developed by the IAEA do not take into consideration the differences in notification systems and low probability that US Citizens will consume food contaminated with radioactive iodine above established limits. The arguments for the safety of KI have been used is formulating our current plans for using KI for workers and special populations. That a drug is basically safe, does not argue for its use in spite of positive effects. Evacuation provides complete protection of potentially exposed individuals rather that offering partial protection to a single organ. All literature cited about the efficacy of KI in blocking the thyroid indicate that it should be taken prior to or during exposure for maximum effectiveness. Even if the drug were distributed to all individuals living within approximately 10 miles of power plants, there are significant problems with appropriate use of the drug. Some supplies would be lost, others outdated, and others used instead of evacuation when directed because KI is incorrectly seen as a general-purpose radio protective drug. Therefore the proposed rule amending the preface and 10 CFR 50.47(b)(10) should not be adopted. Sincerely, Ronald Fraass Supervisor, Environmental Radiation and Emergency Protection Radiation Control Program Kansas Department of Health and Environment Forbes Field, Bldg 283 Topeka, KS 66620-0001 rfraass@aol.com rfraass@kdhe.state.ks.us (785) 296-1569

                                                                                                      ,EP _ , 199

u UCLEAR REGULATORY \Affl1MK> RULEMAKI GS&ADJUOO:ATllONS OFFICEOF OFTHEa:w~ ~ON

September 14, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ~-l /1 {}!}A , J,.-, ADM, DAS r~'--'11

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking website on September 13, 1999. The submitter's name is Ronald Fraass, Radiation Control Program, Kansas Department of Health and Environment, Forbes Field, Bldg 283, Topeka, KS 66620. Please send a copy of the docketed comment to Michael Jamgochian (mail stop 0-1 lF-1 ) for his records.

Attachment:

As stated cc w/o attachment: M.Jamgochian

From: "Cowley, Richard" <rrc0303@doh.wa.gov> To: OWFN_DO.owf2_po{MTJ1) Date: Fri, Sep 10, 1999 4:38 PM

Subject:

comments on Proposed Ru lemaking on Kl Please accept the comments I am submitting to you on behalf of the Washington State Department of Health regard ing the proposed ru lemaking on the Consideration of Potassium Iodide in Emergency Plans. I tried to submit our comments via the interactive rulemaking site but was unable to do so.

  ********                         DOCKET NU BER PROPOSED RU                  60 September 7, 1999                                         ( 1,4,:~31'/31)

Secrtary of the Commission Attn: Rulemakings and Adjudications Staff US Nuclear Regu latory Commission Washington , DC 20555 OOQCIIEO Re: Proposed Rulemaking on the Consideration of Potassium Iodide in SEP 1 5 1999 RUU:MAIQNGSAND Emergency Plans STAFF

Dear Sirs:

The Washington State Department of Health has reviewed the proposed ru lemaking and would like to make the following comment: Whi le Washington has not adopted the policy of providing Potassium Iodide (Kl) to the general public in the event of a radiolog ical emergency at its commercial reactor site, it does support the NRC's decision to make Kl available from the federal government. However, one issue that th is raises is not addressed in the proposed ru le. That is, if the state or

• local government desires to acquire Kl from the federal government for distribution to the general public, to whom should they make their request (which agency and division)? Will th is be addressed in the final rule or in some supporting document to follow later? Also, will this point-of-contact be different during an event than that for routine requests?

We appreciate the opportunity to review and comment on this document. Sincerely, Richard Cowley Nuclear Engineer Wash ington State Department of Health Division of Rad iation Protection (360)236-3272 rrc0303@doh .wa.gov

LEAR fltllULA O YGOM,v1,...,

 ~u EMAKINGS & ADJUDI ATIONS STA OFFICE OF THE SECRETARY OF THE COM IS 10 Docli1lent q /!). '/7 ~(e(_~ ~r.-,.f ~~

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                                                                              *99 Sff 15 P 3 *.1 6 September 12, 1999 O,;-L, ADJl 1 Secretary, U.S. Nuclear Regulatory Commission Rulemaking and Adj udications Staff Washington, D.C. 20555

• Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles fro m the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The regulation as it is now worded ... " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed . The nuclear industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced ,1an for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone. Sincerely yours,

                                                       ~,J        ~-SL,f-1...Q'N.._,
                                                 ?0~              lf'10 EP 22 1999             ~~,                      ~(f~63 4ckn wfedged by card * * - - - ~

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                                                                       *99 StP '\ 5 P3 *. 16 September 12, lett9i    ,

Fi,, ADJ 1J Secretary, U.S. Nuclear Regulatory Commission DOCKET NUMBER Rulemaking and Adjudications Staff PROPOSED RULE ,,-,.-:!,~.....6 ~ - Washington, D.C. 20555 t-l/FR31737) Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (Kl) for the public in the event of nuclear accidents. The regulation as it is now worded... 11 the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. 11 has no teeth and must be changed. The nuclear industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced !,)lan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone.

U.S. NUCLEAR REGULATORY COMMIS 4 RULEMAKINGS&ADJUD!CATIONS STAFF OFRCE OF"FHESECRETARY OFTHE OoCII Postmark te q 13/q t:f' Copies Received ' ~/

• dd'I C es Reproduced _ __..4___

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                                                                            *99   su 1 1s P3 :zs September 12, 1999 O; dL.

ADJ. 1 Secretary, U.S. Nuclear Regulatory Commission DOCKET NUMBER p Rulemaking and Adj udications Staff PROPOSED RULE 1 SO ,\

                                                                                    \1,4 FR3J 731.)

Washington, D.C. 20555 Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The regulation as it is now worded... 11 the proposed rule would require that CONSIDERATION shall be given to include potassium iodide.. 11 has no teeth and must be changed. The nuclear industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced ,1an for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone. Sincerely yours, SEP 22 1999 cm wledged by card ._..,_ *..,."'

Ll.S. NUCLEARREGULATORYCOMMlSSI 1 RULEMAKINGS &ADJllllCA'l'DiS STAFF OFFlCEOFltEB:RETNW OFTHE

iostmark Date _ _q--1r/_ 41_3_f_9~9_ _

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S[,, 15 p 3 28 Ot i September 12, 1999 R ADJ I DOCKET NUMB A Secretary, U.S. Nuclear Regulatory Com mission PROPOSED RU Rulemaking and Adjudications Staff Washington, D.C. 20555 Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (KI) for the public in the event of nuclear accidents. The regulation as it is now worded ... " the proposed rule would require that CONSIDERATION shall be given to include potassium iodide .. " has no teeth and must be changed. The nuclear industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced !Jlan for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone. Sincerely yours ,

                                                    //1)13/J'IYA     M fJt 0;z ;rro ar, ~rr 1 11fo b car

  .S. NUCLEAR REGULATORY COMMISSION ULEMAKINGS &ADJUDICATIONS STAFF OFFICE OFlHE SECRETARY OF THE COMMISSION Doctlmm.t Statistics Po v0pie qjrs/;1

.\dd'I produced _ __ _ _ Speci *on,_ _ _ _ _ __

                                                                             *99 SEP 15 P3 :2 8 September 12, 1999 0 F,

ADJ I Secretary, U.S. Nuclear Regulatory Commission DOCKET NUMBER Rulemaking and Adjudications Staff Washington, D.C. 20555 PROPOSED RULE 50 (~t/FR~/731 Re: Comment PRM-50-63A Consideration of Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn., and since the NRC has refused to extend the 10 mile emergency zone to include Long Island emergency planning is of extreme interest to the residents of the East End. I want to urge that the emergency planning regulation be amended to REQUIRE the availability of potassium iodide (Kl) for !he public in the event of nuclear accidents. The regulation as it is now worded... 11 the proposed rule would require that CONSIDERATION shall be given to include potassium iodide.. 11 has no teeth and must be changed. The nuclear

• industry should bear the cost; government agencies should have the responsibility of seeing that potentially effected communities have local stockpiles of potassium iodide. NRC's announced ,1an for regional stockpiling should be amended; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI is not effective after six hours- it must be stockpiled in schools,hospitals,fire, police and other municipal centers.

There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot, given our topography and highway system, evacuate in the case of an accident at Millstone.

U.S. NUCLEAR REGULATORY COMMIS

• AUlEMAKINGS &ADJUDICATIONS STAFF OFRCE OF'FHE SECRETARY OF THE COMMISSIO Doctlnent Statistics Postm rk te _ _..:..,..i...:::ot.,J-L..' J Copie Received _ _ __

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DOCKET NUMBER PROPOSED RULE So b'IFR~/737) P. 0. Box 190 D'H' , f J Old Lyme, CT O r371 ,- September 10, 1999

                                            '99 S[,, 15 P J 28 Rule-Making and Adjudication Staff U.S. Nuclear Regulatory Commission o ,

1 White Flint North F 11555 Rockville Pike AD,J J Rockville MD 20852 Re: Consideration of Potassium Iodide in Emergency Planning It is gross negligence that potassium iodide is not available to the public in case of a nuclear accident. This subject is of special concern to me because my family, including my grandchildren, lives just a few miles from the Millstone nuclear plants in Waterford, onnecticut. I strongly urge that potassium iodide be made avaiable in Connecticut for at least a minimum of protection. Sincerely, EP 2 2 t9 Vcard * ,, r r **N ~ L

Georgia Department of Natural Resources 4244 lnti.'Rf\tior@~ay, Suite 114, Atlanta, Georgia 30354 J - - Lonice C. Barrett, Commissioner

                                                           ), ,                      Harold F. Reheis, Director Environmental Protection Division (404) 362-2675
                                               *99 S~F' 15 P 3 :1S Ms. Annette L. Vietti-Cook                    0                               September 10, 1999 fl_

Secretary of the Commission ADJ' U.S. Nuclear Regulatory Commission 1 White Flint North DOCKET NU BER 11555 Rockville Pike Rockville, MD 20852-2738 PROPOSED AU ( 50_

                                                                        /,</FR3l731)

Re: Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 FR 31737, June 14, 1999)

Dear Ms. Vietti-Cook,

The Environmental Protection Division of the Georgia Department of Natural Resources appreciates the opportunity to comment on NRC's proposed rulemaking regarding potassium iodide (Kl), as referenced above. This rulemaking, if approved in its current form, would amend 10 CFR 50.47 to require that offsite response organizations consider the administration of potassium iodide to the general public as a supplement to evacuation and sheltering in development of their emergency plans. The Georgia Environmental Protection Division strongly urges NRC to discontinue the current Kl rulemaking effort. The discussion of the proposed rule in the Federal Register notice provides no new or compelling evidence that stockpiling or predistribution of Kl would add significantly to the level of safety already provided by existing offsite emergency planning efforts, and in fact igpores the logistical difficulties experienced by states that have predistributed Kl to the public. The proposed rule relies heavily on the experiences of Eastern European countries following the Chernobyl accident as justification for requiring consideration of the use of Kl as a supplement to evacuation and sheltering, ignoring the vast technical, political and socio-economic differences between the United States and Eastern Europe at the time of the Chernobyl accident. The combination of conditions that may have resulted in large thyroid doses from the Chernobyl accident (i.e., lack of reactor containment, lack of notification, lack of prompt protective measures, lack of interdiction of contaminated foodstuffs, etc.) does not exist for domestic commercial power reactors. In addition, available dosimetry and environmental monitoring data following the Chernobyl accident are incomplete, and do not fully support the conclusions that exposures to radioiodine led to childhood thyroid cancers, or that the use of potassium iodide would have partially mitigated the effects of the accident. We should exercise caution in justifying the use of potassium iodide in the U.S. based on the experiences in Belarus, Russia and Ukraine during and after the Chernobyl accident. t- , 1 99

                                                        .~ckno ~edged by card **-*--       ....._ .,,,,_._

J S. NUCLEAR REGULATORY WMM55fON

 '"*I JI E AKINGS&ADJ1uuN.-nU11w~STAfF OFFICE OF THE SECRETARY OFTHEC        I Dor    ntstRTI~

• 5tma Date j; q 3 / 9 '1 e Rec ved ' ' /

dI Copi Reproduced </ ecial Distribution._ _ _ _ _ __

Letter to Annette L. Vietti-Cook September 10, 1999 Page 2 of 2 The proposed rule is unnecessary, as offsite response organizations have, in developing plans consistent with NUREG-0654/FEMA-REV-1 and approved by FEMA pursuant to 44 CFR 350, already considered the administration of Kl , primarily, but not exclusively, for emergency workers and institutionalized populations. Making Kl available to the public was only one of many issues that the State of Georgia considered during the development of its Radiological Emergency Plan, and based on our overall assessment of the conditions surrounding each of our reactor sites, it was determined that making Kl available to the public would add little, if any, to the protection afforded by evacuation and sheltering. In addition, we determined that the resource requirements and logistical difficulties associated with making Kl available to the public would not result in optimal use of state or local resources. In summary, we strongly urge NRC to discontinue the rulemaking effort on Kl , as the proposed rule is unnecessary, is based on findings from the Chernobyl accident that have limited application to the United States, and is not supported by new or compelling evidence that stockpiling or predistribution of Kl will increase the level of safety already provided by existing offsite emergency planning efforts. Thank you again for the opportunity to comment on the proposed rulemaking. Please call me at (404) 362-2675 if you have any questions. ely, ,,,.J ~

                                                  ~ .9fir~;p                              "

s C. Hardeman, Jr. , Manager Environmental Radiation Program JCH/jh

Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, MD 20815 I 301-656-3998 I email: pgcrane@erols.com September 11, 1999 oou,  :=* rr. n l * :.: * .{i: Ms. Annette Vietti-Cook ETNU *99 sr:r 15 A8 :27 Secretary of the Commission OSED . So (~t/P/?31137) U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Critique of NEI Comments on Proposed Rule on KI {PRM-50-63.63A) 1

Dear Ms. Vietti-Cook:

In its comments of September 1, 1999, on the proposed rule, NEI offers a history of the Federal Government's consideration of the KI issue that includes the following: In October 1995, the subcommittee of the inter-agency Federal Radiological Preparedness Coordinating Committee reaffirmed its position pf not advocating widespread stockpiling and distribution of Kl for the general public. In June 1997, Commissioners voted (3-2) to support FRPCC's recommendation. This is misleading, and a fuller explication of the facts may therefore be helpful. After the NRC Commissioners deadlocked 2-2 in 1994 on a change in KI policy, the NRC staff pressed the FRPCC to declare opposition to any change in the 1985 policy. 2 An Ad Hoc Subcommittee on KI of the Federal Radiological Preparedness Coordinating Committee, which operates under the aegis of FEMA, recommended endorsement of the 1985 policy. (This was hardly surprising, given the facts before them.) Before the full FRPCC could act on that recommendation,

• however, I wrote to FEMA Director James Lee Witt, enclosing a copy of my rulemaking petition.

FEMA and the FRPCC discovered at that point just how inadequately the facts on KI had previously been presented to them. Director Witt ordered the Ad Hoc Subcommittee on KI reconstituted -- it had disbanded, thinking its work was done -- and the result of their new consideration of the KI issue was a recommendation in October 1996 for a new KI policy, under which the Federal Government would provide a supply of KI to any state requesting it. The full FRPCC approved the subcommittee's recommendation in ovember 1996, and the Commission 1 The following comments are submitted, as always, in my private capacity, and were prepared at home, on my own time. 2 Shortly before a Commission meeting on KI in November, 1997, FEMA learned to its considerable surprise that the NRC staff, in a publicly available memorandum, was representing to the Commissioners that the opposition to changing the 1985 policy had come from FEMA, rather than the NRC staff. At that Commission meeting, the NRC staff had to apologize for having "misrepresented" (the staffs word) the facts on that point.

endorsed it in June 1997, a decision announced in a July 1, 1997, press release, in which the NRC declared explicitly that it would provide the funding. What reader, not otherwise acquainted with the facts, would imagine from the passage from NErs letter quoted above that the FRPCC's consideration did not end in 1995? And what reader would imagine that the Commissioners voted in 1997 to support stockpiling, rather than to oppose it? For anyone interested in understanding why nuclear power in the United States has failed to live up to the promise it seemed to have in the 1960's and early 1970's, these comments of NEr s are instructive. The fact that NEI so misstates the relevant history means that it is lacking either in competence, if it has failed to ascertain the facts, or in integrity, if it knows the facts but misrepresents them. 3 Either way, it does not inspire confidence in those who run America's nuclear power plants. Just a few years ago, when the industry's lobbying group misrepresented facts about KI to the Commission -- it portrayed Dr. David V. Becker of the American Thyroid Association, a leading advocate of KI stockpiling, as casting doubt on the drug's value, and he complained to the NRC -- it got a strong rebuke from the NRC. (In fact, it got two; after it brushed aside the first one, a much tougher letter followed.) Will that happen today? For anyone who cares about the NRC as an institution, it can only be depressing that the industry's principal lobbying group seems now to have so little respect for the NRC, and so little fear of its displeasure. If NEI had as much good sense as it has political muscle, it would understand that the nuclear industry* s long-term self-interest lies in having a strong, credible Nuclear Regulatory Commission. The industry* s long decline will be accelerated, not reversed, if the NRC is perceived not as the public' s watchdog but as NErs poodle. Sincerely, Peter G. Crane cc: Chairman Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield Mr. Richard Meserve Director James Lee Witt, FEMA Mr. William Travers 3 Does NEI know the actual facts? All I can say is that when the reconstituted FRPCC Ad Hoc Subcommittee on KI held a public meeting on June 27, 1996, Alan Nelson of NEI addressed it (as did I). It is hard to imagine that the events of 1996 have vanished from NEr s institutional memory.

September 13, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM, DAS ~

                                   ~    ., tJ. rn-~

_j J p j ,,-, A ~ 0

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via the rulemaking website September 11, 1999. The submitter's name is Peter G. Crane, 4809 Drummond A venue, Chevy Chase, MD 20815. Please send a copy of the docketed comment to Michael Jamgochian (mail stop 01 lF-l) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

Qubll~ DOC 'r if o LI , .' r, (1t1zeti *99 Sff 14 p 4 :1

                                                                                                 *tigation Group 2

Buyers Up

• Congress Watch
• Critical Mass
• Global Trade Watch
• Health Research Group
• I -

Joan Claybrook, President t ~ ADJ' R UNITED STATES OF AMERICA RUL SO NUCLEAR REGULATORY COMMISSION ( [p'fFR 317 37) Proposed Rule:-- IO CFR Part 50 ) Docket No. PRM-50-63-A ) Consideration of Potassium Iodide in Emergency Plans )

                                                                             )

64 Fed. Reg. 31737 ) COMMENTS OF PUBLIC CITIZEN'S CRITICAL MASS ENERGY PROJECT The Nuclear Regulatory Commission (NRC) is proposing an amendment to its emergency planning regulations governing the domestic licensing of production and utilization facilities. The proposed rule would amend the current regulations to require that consideration shall be given to including potassium iodide (Kl), as a protective measure for the general public that would supplement sheltering and evacuation. Public Citizen supports the proposed rule as an incremental improvement over the NRC's current policy. However, the current proposal like its predecessor does not go far enough. The :N'RC has failed to provide for the pre-distribution of KI and as a result has once again failed to fulfill its statutory obligation to protect the public health and safety from the dangers posed by nuclear reactors. The supposition that regional stockpiles of KI will be distributed in time to protect the exposed population is unsupported and unsupportable. It ignores the lessons of TMI and Chernobyl and reveals the NRC as little more than callous supporters of this failed technology. Public Citizen has long advocated the stockpiling and distribution of potassium iodide (Kl) to populations living in a 50 mile radius of all commercial nuclear reactors. However, the NRC has failed to require the pre-distribution of KI. Over the twenty years since the meltdown at Three Mile Island the NRC has obfuscated, inveigled and distorted the issues surrounding the stockpiling and distribution of potassium iodide. The NRC' s failure to act is inexcusable. The Commission's latest attempt to obscure the issue gives the illusion of action when none really exists. Merely telling the states that they shall consider KI is a pathetic attempt to address the issue by an ineffective regulator. The NRC's plan to use regional Ralph Nader, Founder 2 15 Pennsylvania Ave SE

• Washington, DC 20003 * (20 2) 546-4996
• www.citizen.org *~ - * ,, @ Printed on Recycled Paper

stockpiles of KI ignores reality; it fails to recognize the lessons learned from Three Mile Island and will not protect the public health and safety. Perhaps, those at the NRC who have blocked the distribution of KI have never looked into the eyes of a child from the Chernobyl region suffering from the effects thyroid cancer. Perhaps they have never contemplated what they will say to American children the next time the U.S. commercial nuclear industry melts down one of its reactors and KI is unavailable. Perhaps they should look into the eyes of their own children and consider their fate and whether they're worth the ten cent cost of a KI pill. Unfortunately, the NRC long ago determined it would do nothing on this issue and that is precisely what it has done. I am disgusted and disheartened that the U.S. government would again fail to protect its citizenry from the radioactive iodine released from a nuclear reactor accident. I ask that my previous comments be incorporated into the current rulemaking as most of the issues and unfortunately the conclusions are the same. I have attached a copy of my 1996 comments for your convenience. Submitted the 13th of September 1999, mes P. Riccio Staff Attorney Public Citizen' s Critical Mass Energy Project

Public Citizen Southeast Regional Office 4340 Georgetown Square, Suite 612 Atlanta, GA 30338 (404) 451-2901 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION Proposed Rule: 10 CFR Part 50 Docket No. PRM-50-63 Peter G. Crane, Petition for Rulemaking 60 Fed. Reg. 58256 COMMENTS OF PUBLIC CITIZEN'S CRITICAL MASS ENERGY PROJECT Introduction Public Citizen has long advocated the stockpiling and distribution of potassium iodide (Kl) to populations living in a 50 mile radius of all commercial nuclear reactors. Public Citizen supports the petition put forth by Mr. Crane to amend 10 CFR 50.47 to include the use of potassium iodide (Kl) as one action to be considered in emergency situations under licensee emergency plans. However, we believe that the language of the petition should be strengthened to ensure that each reactor site has stockpiled and distributed KI to the population within the Emergency Planning Zone (EPZ). The long standing failure of the NRC to require all commercial reactor licensees to provide KI to surrounding populations is a disgrace. The nuclear industry and its lobbyists have successfully quashed previous attempts to require the stockpiling and distribution of KI. The Commission has acquiesced to industry pressure much to the detriment of the public health and safety. The industry's argument that stockpiling and distribution of KI would unreasonably raise the fears of the public, is both specious and self serving. The public is already well aware of the dangers posed by nuclear reactors. Providing an additional level of radiation protection in the event of an accidental release will not unduly raise the fears of those who already live in the shadow of a reactor. Potassium iodide should be stockpiled as a measure consistent with general public expectation and belief that potassium iodide should and would be available if needed.

I. Safe Siting and Design-Engineered Features Alone Do Not Optimize Protection Of The Public Health And Safety In the aftermath of the partial core-melt accident at Three Mile Island, the NRC acknowledged that safe siting and design-engineered features alone do not optimize protection of the public health and safety. The NRC added that although emergency planning had previously been considered a secondary and additional means of protecting the public, its perspective had been, "severely altered by the unexpected sequence of events that occurred at Three Mile Island." (44 Fed. Reg. 75167.) The Commission concluded that, "the protection provided by safe siting and engineered safety features must be bolstered by the ability to take protective measures during the course of an accident." (44Fed. Reg. 75169.) As Mr. Crane's petition notes, the Kemeny Commission report on the TMI accident was highly critical of the failure to stockpile KI. Among the Kemeny Commission's major recommendations was that an adequate supply of the radiation protective agent, potassium iodide, should be available regionally for distribution to the general population and workers affected by a radiological emergency. (60 Fed. Reg. 58257). The Commission has already recognized that in the event of an accident, potassium iodide could prove effective and useful under certain conditions. Therefore, the NRC's unwillingness to implement the Kemeny Commission recommendations regarding the stockpiling and distribution of KI is an abrogation of the Commission's statutory responsibility to protect the public health and safety. The decision by former Commissioners DePlanque and Remmick to block the stockpiling and distribution of KI can not be supported and is both arbitrary and capricious. II. NRC's Cost-Benefit Analysis Is Flawed And Fails to Reflect the History Or Reality Of Severe Accidents At U.S. Nuclear Reactors. The cost-benefit analysis upon which the current policy is based relies on unrealistic assumptions about the probability of severe accidents. The probabilistic risk assessment which underlies the cost-benefit assumptions concludes that a severe accident could occur only once in 1000 years. However, the NRC has acknowledged that severe accidents might be 100 times more likely. Shortly after the 1986 Chernobyl disaster, NRC Commissioner James Asselstine testified to Congress that there was a 45% chance of a severe core meltdown at a commercial nuclear reactor within twenty years. (James K. Asselstine, Testimony before the Energy Conservation and Power Subcommittee of the House Committee on Energy and Commerce, May 22, 1986.) However, we need not rely on probabilistic analysis. The history of severe accidents at U.S. reactors reveals that the NRC's PRA's are overly optimistic. Rather than one severe accident in 1000 years, the nuclear industry has experienced five partial core melt accidents in 40 years.

Reactors that have experienced partial core melts include: EBR-1 on Nov. 29, 1955; WTR on April 3, 1960; SL-1 on Jan. 3, 1961 ; Fermi 1 on Oct. 5, 1966 and Three Mile Island 2 on March 28, 1979. In light of this fact, the Commission's reliance upon PRAs to obviate the need for stockpiling and predistribution of KI is at best specious and at worst constitutes an abrogation of NRC's statutory responsibility to protect the public health and safety. ID. The NRC Can Not Justify The Disparity In The Level Of Radiation Protection Provided To Surrounding Populations By Its Licensees. The Commission's Failure To Require All Part 50 Licensees To Stockpile And Distribute KI Is Both Arbitrary And Capricious. The intransigence of past Commissioners, in light of the staffs support for rewriting NRC's policy on KI, is both arbitrary and capricious. It reveals that the NRC and the nuclear industry have learned little from the costly accidents at TMI and Chernobyl. A decade and a half after Three Mile Island, the findings of NRC's own Special Inquiry Group still hold true. The NRC ... treats radiation protection as secondary in importance to production (of electricity) .... The NRC safety reviews have been hardware oriented. The focus of those reviews has been on equipment and engineering safeguard features to mitigate and safeguard against accidents. As a result, the belief that "accidents can't happen" has colored the agency's approach to radiation protection.... We find that the attitude that radiation protection was of secondary importance was held by the NRC. (J. Rogovin et al., Three Mile Island: A Report to the Commissioners and the Public, U.S. Nuclear Regulatory Commission, January 1980.) Although many licensees have KI on site to protect their workers, we know of only one state that has actually stockpiled and pre-distributed KI for public use in the event of an accident. The State of Tennessee stores KI at strategic locations and will distribute it to people within a five mile radius of a reactor site. Tennessee also issues KI to those residents within the 10 mile EPZ who volunteer to come and get it. (U.S. Nuclear Regulatory Commission, Safety Evaluation Report related to the operation of Watts Bar Nuclear Plant Units 1 and 2, Dockets 50-390 and 50-391, SSER 13, April 1994, p.13-13). While several other states (Alabama, Arizona, California, Kentucky, Michigan and Vermont) have "plans" to distribute KI to the general public, the efficacy of these plans is questionable. Potassium Iodide is most effective if administered prior to radiation exposure. Seemingly, this would make pre-distribution of KI imperative. The tragic comedy of errors surrounding the attempts to distribute KI in the wake of the Three Mile Island partial core melt accident only serves to highlight the need for predistribution.

The petitioners proposal would bring the Commission into line with what has become, especially since the Chernobyl accident, a generally accepted practice among many nations. Furthermore, it would help provide an equal level of radiation protection to all U.S. citizens residing in the vicinity of a nuclear power plant. IV. The Language Of The Petition Should Be Strengthened To Ensure That KI Is Stockpiled And Pre-distributed Around Every Commercial Reactor Site. Public Citizen has long advocated the stockpiling and distribution of potassium iodide (Kl) to populations living in a 50 mile radius of all commercial nuclear reactors. While Public Citizen supports Mr. Crane's petition we believe the language of the proposed amendment could be stronger. Given the industry's opposition to stockpiling and distribution of KI, the NRC will likely have to force its licensees to comply with any re-write of NRC policy regarding potassium iodide. While use of the FEMA language may be helpful in ironing out inter-agency coordination of the KI policy, it may also allow for too much interpretation by licensees and thus stifle implementation. While allowing for the use of KI, the proposed language would not necessarily result in the stockpiling and distribution of potassium iodide to at risk populations. Toward this end, Public Citizen suggests the following language: ALL COMMERCIAL REACTOR LICENSEES SHALL STOCKPILE KI FOR USE BY THE GENERAL PUBLIC. ALL COMMERCIAL REACTOR LICENSEES SHALL DISTRIBUTE KI TO ALL INDIVIDUALS WITHIN THE EPZ AND MAKE Kl AVAILABLE TO ANYONE WITHIN A 50 MILE RADIUS OF THE REACTOR UPON REQUEST. Public Citizen not only supports a policy of stockpiling and distribution of potassium iodide, but would like to see it acted upon expeditiously. Toward this end and in the performance-based regulatory spirit which is now in favor with the Commission, we suggest that the NRC hold the licensees to a specific date for implementation. Given the modest expenditures necessary to stockpile and distribute KI, approximately 10 cents per person, the Commission should expedite the implementation of such action. CONCLUSIO The Commission has already concluded that siting and design are not enough to protect the public in the event of a nuclear accident. The Commission and almost all experts acknowledge that potassium iodide can be an effective ancillary protective action if taken during a nuclear power plant accident. However, the NRC does not require stockpiling or predistribution of KI so that it could be made available to provide protection to members of the public. This logical inconsistency can no longer be tolerated. The NRC's obfuscation and delay in implementing the Kemeny Commission recommendations to stockpile and distribute potassium iodide constitutes an abrogation of the Commission's statutory responsibility to protect the public health and safety. The

Commission's previous decisions not to require licensees to stockpile and distribute KI are arbitrary and capricious; and should amended. Respectfully Submitted the 12th of February, 1996. James P. Riccio Staff Attorney Public Citizen's Critical Mass Energy Project

September 13, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ADM,DAS

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via e-mail on September 10, 1999. The submitter's name is Mary Elizabeth Lampert, Massachusetts Citizens for Safe Energy, 148 Washington Street, Duxbury, MA 02332. Please send a copy of the docketed comment to Michael Jamgochian (mail stop OllF-1) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

DOCKET NUMBER PR PROPOSED RULE 5o (<P'IPR31737) DO C .,'" T,,.0 MASSACHUSETTS COALITION TO STOCKPILE Kf 1 Greater Boston Physicians for Social Responsibility* C-10

• Citizens Awareness Network" Clean Water Action "Don ' t Waste Massachusetts
• MassPirg" *99 SIT 1~ PJ2 :1 Q Massachusetts Citizens for Safe Energy* Toxics Action Center" - -

Citizens Radiological Monitoring Network" Women ' s Community Cancer Project It costs less than a dime; our kids are worth it! ,-...-

                                                                                  *i' September 10, 1999                                                           ADJLL*

Se cretary of the USNRC Attention: Rulemakings and Adjudications Staff U. S. Nuclear Regulatory Commission Washington, DC 20555 / E-mail CAG@NRC.GOV RE : Comment PRM-50-63A, Consideration of Potassium Iodide in Emergency Plans, and Proposed Rule Summary: The June 14 notice of proposed rulemaking does not ensure sufficient p rotection of public health and safety. In order to do so , i t must incorporate the following . -, , The NRC must amend its regulations concerning emergency planning to include a requirement that emergency planning protective actions include the prophylactic use of potassium iodide (KI) for the public . Requiring potassium iodide will not only protect public health and safety i t wil l simplify and streamline payment for potassium iodide by the licensees . The licensee shall take responsibility for all costs associated with providing KI for the public , or face shutdown . This is the financing method for other emergency planning expenses. NRC's proposal that "consideration" shall be given to including potassium iodide is worthless. NRC's proposal to support development of national , regional stockpiles , and to bring the KI to citizens near an accident by

      " fighter j et ," will not work . KI must be administered before or shortly after exposure to radioiodine to be an effective block .

Instead , the NRC should support the development of robust , pre-positioned state stockpiles of KI to be used in communities located in the " far field" - outside the Emergency Planning Zone . NRC should support the World Health Organization ' s Guidance . In the "near field" (effluent pathway defined as the Emergency Planning Zone) KI shall be stockpiled in schools , shelters , hospitals and Reception Centers. In addition , KI shall b e available for the public to voluntarily pick-up at a municipal office and/or local drug store . In the "far field" (outside the Emergency Planning Zone) NRC should support the development of robust , state , stockpiles to be strategically placed to allow fo r prompt distri but ion . NRC should require using KI prophylaxis at one rem projeo ted dose exposure not at the current 25 rem. rp 2 2 991 cknowtedged vcard.. ....... .. ,.

IJ. NUCLEAR REGULATOR~ PULEMAKINGS &ADJUDICATIONS S OFFICE OF THE SECRETARY OF THE COMMISSION

I. Introduction These comments are presented on behalf of state-wide Massachusetts organizations concerned with nuclear safety collectively totaling many thousands of our citizens (Boston Chapter Physicians for Social Responsibility, C-10 Research and Education Center, Citizens Awareness Network, Clean Water Action, Don't Waste Massachusetts, MASSPIRG, Massachusetts Citizens for Safe Energy; Toxics Action Center, Women's Community Cancer Project; Citizens Radiological Monitoring Network and a town appointed committee within Pilgrim NPS's Emergency Planning Zone - the Duxbury Nuclear Advisory Committee). II. NRC Should Require the Use of KI

• We oppose "the Proposed Rule (that) would amend the current regulations to require that consideration shall be given to including potassium iodide (KI), as a protective measure for the general public that would supplement sheltering and evacuation."

Instead, we support NRC amending its regulations concerning emergency planning to include a requirement that emergency planning protective actions include the prophylactic use of potassium iodide (KI) for the public - the original petition by Peter Crane. Rationale For Requiring KI A. To Protect Public Health and Safety KI protects the thyroid gland, which is highly sensitive to radiation, from radioactive iodine released in nuclear accidents. KI saturates the thyroid gland with iodine in a harmless form. By doing so, it prevents inhaled or ingested radioactive iodine, which could lead to thyroid cancer, disease, and mental retardation or to other illness, from lodging in the thyroid gland. The young are particularly at risk, as evidenced from data following Chernobyl. KI has a long shelf life and causes negligible side effects .. It is currently being stockpiled in communities around nuclear reactors in Europe, Japan and Canada. In the United States, Alabama, Arizona, Tennessee and Maine have decided to stockpile and numerous other states are considering doing so. The Federal Radiological Preparedness Coordinating Committee [FRPCC] is also 2

stockpiling KI so that it can be made available to states in the event of terrorist attacks. The evidence is in. Respected international and national professionals have enough evidence and all recommend the use of KI for the public. For example, the World Health Organization; the International Agency of Atomic Scientists; the Ame can Thyroid Association; the National Council on Radiation Protection; the Federation of American Physics; President Carter's Kemeny Commission following Three Mile Island; the Greater Boston Physicians for Social Responsibility; and numerous doctors in our nation's leading medical schools and hospitals, have all investigat~d the issue and concluded that "'stockpiling/ pre-distributing KI" is

 ~worthwhile."

Specific Health/Safety Reasons for Stockpiling KI For the Public

• Many citizens live within the EPZ's of nuclear power plants. In Massachusetts, for example, Pilgrim NPS (Southeastern MA); Vermont Yankee NPS (Northwestern MA);

and SEABROOK NPS (Northeastern MA) directly affect us.

• Accidents happen - Titanic, Challenger, Chernobyl, TMI and the near accident at Dresden in 1994. The risk of an accident is greater than the past, due to:

unanticipated premature aging of reactor components; the economics of utility restructuring; the documented history of NRC's laxness of oversight and their unwillingness to force licensees to adhere to their licensing requirements; on-site storage of high level nuclear waste at reactor sites - under conditions neither designed nor analyzed the volume and longevity of such storage; and, the increased threat of terrorism with nuclear power plants as potential targets.

• Radioactive iodine will be released in an accident - it is released smaller amounts under ~normal" operations.
• Chernobyl demonstrated that infants and the young are most vulnerable to radioactive iodine. Thyroid cancer the young is more aggressive - spreading to the lymph and lungs. Iodine passes the placenta freely. Mental retardation can result from radioiodine exposure.

3

• KI is a proven thyroid blocking agent. It provides almost complete thyroid protection by taking the recommended dose of KI just before or at the time of exposure. If KI is taken within (1) hour a exposure, it is 85% effective as a blocking agent; if KI is taken during the first 3-4 hours after exposure, it is 50%

effective as a blocking agent. There is no protection if KI is taken after (6) hours from exposure.

• Contraindications exist only for a small population, and are of minimal concern. Information now available on reactions to cough syrups and expectorants that contain KI give an estimate of 1 in 10,000,000 sk for the incidence of adverse reactions from a daily dose of 130 mg of KI [NRC 1995]. Further, after Chernobyl, Poland distributed about 18 million doses with minimal serious adverse reactions reported. It is estimated that 95.3% of children and 23% of the adult population in Poland were given one or more doses of KI. The World Health Organization and the NRC evaluated the risks and found that the benefits of KI outweighed ks. KI is FDA approved.
• Although the nuclear industry has set up 'red herrings" as reasons not to stockpile, most are public-education/planning problems. They are not problems with KI, per se. Emergency management agencies are certainly capable of teaching the public that KI protects aga t radioactive iodine and not against other harmful radionuclides emitted, and that KI should be taken only when instructed to do so by emergency planning officials.
• Li lity is yet another 'red herring." The real liability issue would be if the request of many of citizens that KI be made available were ignored; or if advice (by respected health organizations such as the World Health Organization and American Thyroid Association) to stockpile was turned aside in favor of the industry's fears for industry's 'image."

Additionally, KI would be taken on a strictly 'voluntary' basis and is FDA approved.

• Because of the probability of breaking accidents and the variability of winds (especi ly in coastal communities), Federal regulations (10 CFR 50.47 and NUREG 0654) now speak to a range of protective ions - not 4

simply evacuation. KI is an appropriate adjunct to this "range" of response - providing additional protection to the public. B. To Simplify/Streamline Payment for Potassium Iodide by Licensee The licensees should be responsible for all costs (original costs of stock.pi , replenishment, and associated distribution/public education expenses) as they now are other emergency planning expenses. Bottom line is that ratepayers pick up the bill as industry's cost of doing business. The issue always is what route the money will take from the ratepayer's pocket to the manufacturer, distributor and emergency planners . In 1997, it was announced that NRC would reimburse states. However, that offer was recently withdrawn with no valid explanation. No agency wants funding to come out of "their" budget, although that money originates with the ratepayer. The ball is bounced from agency-to-agency and meanwhile the public is left unprotected. NRC's meetings to "discuss" the issue could well,have covered the cost of providing KI for the public. We know that the cost is not substantial and certainly not the real reason that the agency withdrew its prior commitment. Rather, its withdrawal is simply another example of the NRC

• caving into the whims of the nuclear industry. Industry saw that too many states were being asked by their public to take up NRC's 1997 announced offer of reimbursement.

The NRC noted in the Federal Register (Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rule 31746) that The overall cost is minimal when placed in the context of emergency planning and should not be a deterrent to stockpiling KI for use by the general public... A better funding plan, and one that we support, is to require that KI shall be available to the public. Then, the licensee must assure that this is so or face shutdown. It is amazing how quickly the licensee and local government will get together to comply. This is the procedure followed for other emergency planning requirements. Example: the NRC has ruled that the public shall be no fied of an emergency within a specified time. Hence, the licensees pay for 5

sirens their purchase, installation, maintenance, testing. This simple and direct pattern should be followed in funding KI for the public. III. Regional Stockpiles will be Worthless - State Stockpiles are Appropriate outside the Emergency Planning Zone. We do not support the NRC's announced plan to work with other agencies to ensure that there are established "robust, pre-positioned regional stockpiles of KI to be effectively and timely used by states that have not established local stockpiles and wish to make use of regional stockpiles in the event of a severe nuclear power accident." Instead, we do support robust, pre-positioned state stockpiles of KI to be used to protect the "far field." Regional stockpiles will not adequately protect the public because KI must be taken prior to exposure, or very shortly thereafter, to be an effective thyroid block. There is a six- hour window, with diminishing effectiveness over that time period. Nor can any one seriously suggest that all accidents will be announced far in advance and be slow breaking; or that distribution of KI from a regional center to communities near the reactor will occur at lightening speed. Commissioner Merrifie suggested that ,.fighter jets" could bring KI to where it was needed. But we know that is foolish. In fact our nation's top emergency planner, James Lee Witt the Director of FEMA emphatically spoke to this point in an April 29, 1999 letter to the NRC Commissioners. FEMA has always opposed the notion that the Federal regional stockpiles of potassium iodide would be effective in the event of a release from a nuclear power plant. The complex logistics of storage and distribution far outweigh the usefulness of such a stockpile. Regional stockpiles of potassium iodide would complicate, not strengthen radiological emergency preparedness. Further, if you look in the archives of responses over the years of industry's ,. reasons" for opposing stockpiling KI for the publ , you will find industry arguing that regional stockpiles would be a waste of money because KI could not be distributed t enough to bee ctive. They and the NRC can not have it ,.both ways." 6

IV. We support The World Health Organization (WHO) Organization Guidance - as described in the Federal register/Vol. 64, No. 113/Monday, June 14, 1999/Proposed Rules, 31743.

• Specifically, the WHO recommends predistribution of stable iodine close to the site and stockpiles further from the site. These stocks should be strategically stored at points such as schools, hospitals, pharmacies, fire stations, or police stations, thereby allowing prompt distribution.
• The main points of the WHO Guidelines regarding the use of stable iodine are as follows:

Near Field: Stable iodine should be available for immediate distribution to all groups if the predicted thyroid dose is likely to exceed national reference levels. Close to nuclear installations iodine tablets should be stored or predistributed to facilitate prompt utilization. Far Field: Stable iodine should be available for distribution to pregnant women, neonates, infants and children if the predicted dose is likely to exceed reference levels. We support for the "near field" or effluent pathway defined as the Emergency Planning Zone: KI shall be stockpiled in schools, shelters, hospitals and Reception Centers. In addition, KI shall be made available for the public to voluntarily pick-up at a municipal office and/or local drug store. In general, KI shall be added to the ~tool box" as a supplement to evacuation and sheltering, especially after the lessons learned from Chernobyl. KI would be an important adjunct to evacuation. There is always the possibility that evacuation may be delayed due to traffic or weather conditions. Busses for the transportation dependent may arrive late. The accident may be fast breaking and the wind speed and direction may be such to expose evacuees en route. KI would be an important adjunct to sheltering. The public may arrive at the shelter already exposed to radioiodine. KI is only an effective thyroid block if taken prior to or 7

shortly after exposure a six-hour window, with diminishing effectiveness over that time period. KI should be stockpiled in schools. This is the advice of the experts - WHO and Dr. Jean Temeck, FDA representative to NRC's KI Core Group (March 4, 1999 Transcript). Research indicates that the young are the most vulnerable; and in the words of Dr. Temeck, in an emergency you want to get it to the children as quickly as possible and the teacher is right there on the spot You do not need to be medically trained to give KI. A permission slip to administer KI can be sent out by the school at the beginning of each year. Despite the fact that emergency plans contain the ~concept" of ~precautionary transfer that children will be evacuated early, there are no guarantees. An accident can rapidly escalate. Winds may turn in an unfavorable direction or increase in speed. There may be traffic delays. Busses may not arrive or arrive late. Example: the bus contracts for the Duxbury school children have not been up-dated since the early 1990's. Some of the bus companies are now out of business. Even if busses do arrive, evacuation is not risk-free. According to an EPA 1992 manual on protective actions, vehicles provide only about 10% protection. The issue is not evacuation or KI. The issue is protecting our children by providing busses and KI. KI should be stockpiled in schools even if a community has provided citizens with an opportunity to purchase KI at a local store or municipal office. An accident may occur during school hours. Some parents may have had the foresight to purchase KI; however, the children would be in school and the parents at work or away from town. It is not reasonable to expect that parents would put KI in their children's lunch boxes every day. Also, parents who had the foresight to purchase KI and were in town may rush to the school to bring KI to their children - causing traffic logjams and havoc to emergency plans. KI should be stockpiled in shelters. The public may arrive at the shelter already exposed to radioiodine. The shelter may have a defective ventilation system or not provide adequate shielding - 100% shielding is not likely. Even if KI becomes available to the public 8

to purchase, it is unlikely that tourists would have known to do so.' For example, all three Emergency Planning Zones in Massachusetts are popular tourist spots. How many visitors to the Mayflower, beach-goers on Duxbury Beach or leaf-peepers in the Berkshires will know to pack KI for the trip? Transients must be protected. KI should be stockpiled in Reception Centers. KI should be stockpiled in Reception Centers for the same reasons as it should be stockpiled in shelters. Additionally, KI may be needed because the Reception Centers, although outside the EPZ's, may be within the plume exposure pathway. For example, the European Commission of the International Atomic Agency WHO stated in 1996 that, 'Significant exposure to radioiodine extended more than 100 kilometers from Chernobyl." KI should be stockpiled in hospitals. Neonates are particularly susceptible to radioiodine. They should be protected. Pregnant women should be protected, too, because thyroid deficiency in mothers results in lower IQ's in children (Boston Globe, August 19, 1999, page 1). KI should be available for the public to pick up at drug stores and/or municipal offices. Availability must be coupled with public education to encourage the public to obtain KI and educate them about its benefits and proper use. We support for the "far field" - defined as outside the Emergency Planning Zone: Robust state (not regional) stockpiles are appropriate for the far field. In Massachusetts, for example, it would be appropriate to have stockpiles in the Emergency Planning Agency's Headquarters and also in their three sub-stations, Bridgewater, Tewksbury and Belchertown. Additionally if the topography is such that it would be necessary to travel through the reactor zone to reach an area, then that area should have its own supply. Cape Cod would be an example. Rationale: In NUREG- 1633, the NRC acknowledges that the increase in cancer caused by Chernobyl

    ...was detected in Belarus, Russia, and Ukraine. Notably, this increase, seen in areas more than 150 miles (300Km) from the site, continues to this day and primarily affects children .. the 9

vast majority of thyroid cancers were diagnosed among those living more than 50 km (31 miles) from the site. The NRC acknowledged that exposure to radioiodine can occur well beyond 10 miles back in 1980 in their Document, Examination of the Use of Potassium Iodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents (NUREG/CR-1433, Sandia National Laboratories, Albuquerque, New Mexico, 1980). This report describes the health effects of a nuclear accident in detail, and provides casualty estimates at various distances from a reactor. NUREG-1433 points out that thyroid growths (nodules) and other thyroid damage would be expected to occur for hundreds of miles downwind after an accident through breathing. This is described in tables 3 and 4 of the report, as shown below: EFFECTS OF CORE-MELT-ATMOSPHERIC ACCIDENTS BY DISTANCE Distance in Mean Thyroid Dose Probability of Thyroid Miles (REM)for Exposed Damage to Exposed Adult Adult Outdoors Located Outdoors 1 13,500 60% 5 5,800 70% 10 3,200 70% 25 1,100 40% EFFECTS OF CORE-MELT ATMOSPHERIC ACCIDENTS BY DISTANCE Distance in Mean Thyroid Dose Probability of Thyroid Miles (REM)for Exposed Damage to Exposed Adult Adult Outdoors Located Outdoors 50 380 13% 100 100 3% 150 36 1% 200 16 0.5% 10

For children, increase dose and probability of damage by an approximate factor of two. Weather conditions based on calculated probability distributions. Thyroid damage includes thyroid nodules (both benign and cancerous) and ablated thyroid. Assumed risk coefficient of 334 thyroid nodules per million person-rem to the thyroid. Includes inhalation dose only. Does not include ingestion. Probabilities conditional on accident occurring. However, the NRC and States limit their accident planning to 10 miles. In other words, there is nothing to protect people who, for example, are 50 miles away, despite the probability that 13% of all exposed adults (and about a quarter of the children) at this distance could be injured. Yet use of KI would prevent this - a fact the* NRC does not dispute. Therefore in addition to stockpiling KI in EPZ's, KI should be stockpiled beyond the 10-mile radius in each state. V. KI Prophylaxis at One (1) Rem Projected Dose Exposure We support using KI prophylaxis at one rem projected dose exposure. Currently, Federal policy is to give KI at 25 rem projected dose. However, based on the dose response relationship reported in the 1998 Nature paper and Dr. Jean Temeck's discussion to NRC's KI Core Group (March 4, 1999), we know that there was an increased risk at a mean dose of 5 rem. Also, Poland used a 5 rem intervention level. The relationship of dose to disease is a linear relationship. Therefore, even if you extrapolate down to one rem, you are not coming to zero risk. Therefore, to protect public health and safety and to use the ~precautionary principle" as the basis for public policy, we support a one rem projected dose as the ~trigger." VI. Summary The evidence is in - all the experts and scientists have spoken - NRC must amend its emergency planning regulations to include a requirement that emergency planning includes KI for the public. The health of our children is too important to leave their protection from thyroid cancer, disease, mental retardation and other illnesses to the ~ consideration" of states. ~ Consideration" is a powder puff - meaningless. It requires nothing. The NRC promises to help the states ~consider." We have had enough experience with the NRC's help on this issue. NUREG-1633, a Guidance 11

Document, was prepared by the NRC to help states decide if they wanted to stockpile KI. Fortunately, it was withdrawn because it was so biased and clear that it was written to help states decide not to stockpile KI. In the words of New York States Director of the Bureau of Environmental Radiation Protection, ~we find the document to have been prepared to justify a position advocating against the use of KI for public protection, rather than as an objective review of the relevant information." Now, a new Guidance Document is in the making. The same staff responsible for NUREG-1633 is at it again. And, again, meaningful public participation is absent in the documents preparation. We need KI. We need a requirement. The NRC's plan to support the development of regional stockpiles is worthless. The use of ~Fighter jets," as promised by Commissioner Merriweather, must be a joke. A very sick joke, indeed, because everyone knows that ~Fighter jets" will not deliver KI in time. KI is time-critical. The Commissions decision to withdraw their 1997 promise to fund KI says more about the Commissions ties to industry than the status of NRC's budget.* The licensees should be directly responsible for all costs associated with KI as they now are for other emergency planning expenses. This will happen when the NRC requires that KI shall be made readily available to the public. It then becomes a cost of staying in business. We ask that the NRC grant Mr. Crane's original petition and require KI stockpiling to be part of every emergency plan, as it is in nations around the world and as the NRC promised to do so in 1979.* Respectfully submitted on behalf of the Coalition, Mary Elizabeth Lampert Massachusetts Citizens for Safe Energy 148 Washington Street Duxbury, Massachusetts 02332 Tel 781-934-0389 Fax 781-934-5579 e-mail jlaropert@idt.net 12

Listed below are additional individuals and groups signing on to these comments. Selectmen, Town of Duxbury - Duxbury, Massachusetts 878 Tremont Street, Duxbury, MA 02332 Phone 781-934-1108 Paul Gunter, Michael Mariette, Nuclear Informa on and Resource Service, 1424 16 th Street NW, #404, Washington,DC 20036, Phone 202 328-0002 Email nirsnet@nirs.org William S. Abbott, Plymouth County Nuclear Information Committee, c/o William S. Abbott, P.C., 50 Congress Street, Boston, Ma 02109, Phone (617) 523-5520 Email WABBOTTl@aol.com

• John Anderson and Roger Erikson, Citizens Radiological Monitoring Network, 133 Washington Street, Duxbury MA 02332 Daniel Burnstein, Center for Atomic Radiation Studies, Inc., (CARS}, 35 Gardner Road, Brookline, MA 02445. Phone 617 738 9300 George Crocker, North American Water Office/Prairie Island Coalition P.O. Box 174 Lake Elmo Minnesota 55042 - Phone 651-770-3861 / E-mail gwillc@mtn.org Sandra Gavutis, Director, C-10 Research and Education Foundation, INC, 44 Merrimac Street, Newburyport, MA 01950
• Phone 978-462-3959/ Email sandra@c-lO.org Steve Haberman, Seacoast Anti-Pollution League, P.O. Box 1136, Portsmouth, NH 03802 - Phone 603-431-5089 / Email SAPL99@aol.com Ann Harris, Executive Director, Alliance for Public Health and Safety, P.O. Box 40 Ten Mile, TN. 37880 Phone 423-376-4851 / E-mail apickel@aol.com Deborah Katz, tizens Awareness Network, Box 83 Shelburne Falls, MA 01379 Phone 202-328-0002/ E-mail can@shaysnet.com David A. Kraft, Director, Nuclear Energy Informa on Service, P.O. Box 1637, Evanston, Illinois 60204-1637 -

Phone 847-869-7650 / E-mail neis@forward.net 13

Cynthia Luppi, Clean Water Action, - 76 Summer Street, Boston MA 02110 - Phone 617-423-4661 - Email bostoncwa@cleanwater.org Mary Lampert, Massachusetts Citizens for Safe Energy, 29 Temple Place, Boston MA 02111 Phone 617 292-8057 Francis U. Macy, Director, Center for Safe Energy, 2812 Cherry Street, Berkeley, CA 94705 - Phone 510-540 7120 / E-Mai 1 frnacy@igc.org Jerry Rosenthal, Concerned Citizens of Louisa County, 877 Holland Creek Road, Louisa, VA 23093 I E-mail zips@firstva.com Dr. David Rush, Greater Boston Physicians for Social Responsibility 68 Foster Street, Cambridge MA 02138 Bill Smith, Fish Unlimited, l Brander Parkway, Shelter Island, New York 119 - Phone 516-749-3474 / Email bsmith@ shunlimited.org Renee Shapiro, Womens Community Cancer Project, 21 Glenmont Avenue Brighton, MA 02135 - Phone 617-787-0743 / Email kokos@javanet.com Michael Steinberg, Black Rain Press, 1009 Burch Avenue, Durham, NC 27701 - Email l009Burch<srl2@duke.edu Michael Welch, Redwood Alliance, PO Box 293, Arcata, CA 95518 - Phone 707-822-7884/ E-Mail michael.welch@homepower.com Ted Vosk, MassPirg, 29 Temple Place, Boston MA 02111 Phone 617-292 4800 / Email tvosk@postharvard.edu Chris Williams, Ex. Dir., Citizens Action Coalition of Indiana 5420 N. College Ave., Suite 100, Indianapolis, IN 46220 - Phone 317-20 3535 / E-mail chrisw@citact.org Matthew Wilson, ToxicsAction Center, 29 Temple Place, Boston MA 02111 Phone 617-292-4821; and 41 South Main Street, Suite #5, West Hartford CT 06107 Phone 860-233-7623 / Email mwilson@toxicsaction.org Lampert 14 148 Washington Street

                                             .. *DJJXbury, MA 02332

TXU Electric C. Lance Terry Comanche Peak Senior Vice President & Principal Nuclear Officer Steam Electric Station P.O. Box 1002 *99 S[F 14 Pi 2 :11 Glen Rose, TX 76043 Tel: 254 897 8920 Fax: 254 897 6652 lterryl@txu.com Af Log # TXX-99207 File# 10185 KET NUMBER PROPOSED RU so September 10, 1999 ft,l/FR 3113?) Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN: Rulemakings and Adjudications Staff

SUBJECT:

COMMENTS ON PROPOSED RULE: CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS REF: (1) 64 FR 31737 - June 17, 1999 (2) 62 FR 66038 - December 17, 1997

Dear Mr. Secretary:

(3) 60 FR 58256 - November 27, 1995 TXU Electric has reviewed the subject proposed rulemaking to amend the emergency planning standards in 10 CFR 50.47 (Reference 1). The proposed rulemaking is based on previous petitions filed by Mr. Peter G. Crane (References 2 and 3) and would amend the current regulations (10 CFR 50.47(b)(10)) to require that explicit consideration be given to including potassium iodide (KI) as a protective measure for the general public that would supplement sheltering and evacuation.

TXX-99207 Page 2 of3 TXU Electric has previously written comment letters in response to References 2 and 3 which agreed with the Nuclear Energy Institute (NEI) position and opposed the petitions for rulemaking. Now that the Commission has decided to grant a portion of the latest (amended) petition from Mr. Crane does not change TXU Electric's basic position on this issue. Accordingly, TXU Electric recommends that the rulemaking proposed in Reference 1 not be adopted. TXU Electric also endorses the comments being provided by the NEI on this Federal Register Notice. With respect to the consideration of use of Kl, the current federal policy formulated by the Federal Radiological Preparedness Coordinating Committee (15 federal agencies) in 1985 regarding stockpiling and distributing Kl during emergencies for emergency workers and institutional persons, but not the public, should remain in effect. U.S. programs for emergency preparedness at nuclear power plants are based on evacuation of the general public as the preferred protective action. Evacuation is generally feasible and is more effective at dose reduction because it reduces dose to all organs, not just the thyroid as with the use of Kl. The 1985 federal policy provided guidance to state and local governments that wish to make Kl available to the general population if appropriate under their unique circumstances. Those states that believed KI was appropriate have used this guidance. The State of Texas currently does not recommend the use of Kl by members of the general public, and Texas neither supplies nor will administer Kl to members of the general public. Instead, the Texas Department of Health recommends that persons in areas affected by an accidental release ofradioactive materials follow the advice of local officials and evacuate or seek shelter when instructed to do so.

A TXU

                                                                    ~

TXX-99207 Page 3 of3 The proposed rule if adopted, would require states to document why they chose not to distribute KI. The proposed rule provides no new information or justification for subjecting states to the added burden ofreconsidering their emergency preparedness plans. In addition, the recent approval by the Commission of a portion of the amended petition as this proposed rule was not based on scientific or safety evidence contained in the exhaustive policy and technical reviews that have been performed over the past 20 years. As summarized in the NEI comments being provided to this proposed rule, several re-evaluations ofU. S. Policy on distribution of KI since the 1985 federal policy lead to the conclusion that the current policy is sound and will provide adequate protection of public health. Sincerely, e,~. ~ C. L. Terry By (8 rt;ft;/.i. rt!~ Roger~lker Regulatory Affairs Manager

• CLW/clw c - Mr. Alan Nelson, NEI

   - Mr. Scott Flowerday, Texas Department of Health

OOC LTEJ 1 DEPAR"fM*T OF MILITARY AFFAIRS STATE OF WISCONSIN \ Wisconsin Emergency Management

                                                         *99  ~er   14 Pl2 :06       2400 Wright St P.O. Box 7865 Madison, WI 53707-7865 Telephone (608) 242-3232 Facsimile (608) 242-3247 24 Hour Emergency Hotline:

1-800-943-0003 September a, 1999 DOCKET PROPOSE 50 (1Pl/fR31737) Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN: Rulemakings and Adjudications staff

SUBJECT:

Proposed Amendment to 10 CFR 50.47(b) " Consideration of Potassium Iodide in Emergency Plans"

Dear Secretary:

The Nuclear Regulatory Commission is proposing an amendment to its emergency planning regulations governing domestic licensing of production and utilization facilities. The proposed rule would amend the current regulations contained in 10 CFR 50.47(b) to require that "consideration" shall be given to including potassium iodide (Kl) as a protective measure for the general public that would supplement sheltering and evacuation. Wisconsin Emergency Management and the Wisconsin Department of Health and Family Services Radiation Protection Section feel that the distribution of Kl to the general public is not an appropriate protective measure. While Kl is effective in blocking the uptake of radioiodines, its distribution to the general public is likely to lessen the overall effectiveness of State and local response. We also feel that the proposed rule requiring States to give "consideration" to the use of Kl inappropriate. We request that the NRC not adopt the proposed rule. Little has changed with regard to the Kl issue in the nearly 20 years since State and local offsite radiological emergency preparedness programs have been in place. "Consideration" has already been given on this issue and with a few exceptions, States and locals decided not to use Kl as a protective measure for the general public. Asking States to reconsider the issue at this time constitutes an unfunded mandate that we feel would be a poor use of staff time and taxpayer dollars. Additionally, the proposed rule is vague and puts the burden of assessment on States who have fewer technical resources and expertise than the NRC, EPA and FDA. The proposed rule creates a liability for the States. It does not define *consideration,* leaving room for varied interpretations. One state might interpret "consideration* to mean that Emergency Management and Radiation Protection staff should meet and document their decision. Another

"'0pi (irl'I

state might interpret "consideration* to involve a formal notice and comment process with public hearings. The wording of the proposed rule leaves the meaning of *consideration* to be decided by the courts, post-incident, and does not constitute effective rule-making. The Nuclear Regulatory Commission (NRC), in conjunction with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), has the responsibility to develop and promulgate guidance to State and Local governments on the appropriateness of various protective measures (44 CFR 351.21 - 351.23). These federal agencies have developed clear and concise guidance for when evacuation, sheltering and ingestion protective actions are warranted. The guides for evacuation, sheltering and ingestion protective measures were developed in spite of divergent opinions and exist in the EPA "Manual of Protective Action Guides and Protective Actions for Nuclear Incidents." States maintain the authority to adopt stricter guidelines than those of the Federal government if deemed necessary. Beyond the scope of the proposed rule, we do not support the stockpiling of Potassium Iodide (Kl) for distribution to the general public in the event of a nuclear power plant accident for the following reasons:

• Evacuation of potentially affected areas within the 10-mile Emergency Planning Zone is the preferred protective action to protect the health and safety of the general public.

Distribution of Kl to the general public could inhibit orderly evacuation and divert limited local resources during the early stages of an incident.

• The distribution of Kl to the general public could impart a false sense of security regarding the prevention of severe health effects resulting from radiation exposure. This is because Kl does not limit dose due to whole body exposure from other radioisotopes potentially present in a radiological release from a nuclear power plant incident. Additionally, Kl is not effective unless administered prior to or shortly following inhalation or ingestion of radioiodines.
• Kl is contraindicated for some groups of people because a portion of the population experiences an allergic reaction to the drug.
• Emergency plans will not be able to address legal liabilities associated with the drug's administration. State and local governments will be unable to control dosage or provide medical supervision for the administration to schoolchildren.
• International experience with the drug are not necessarily relevant in assessing the appropriateness of the protective measure in the United States because of the differences in reactor designs and emergency preparedness capabilities.

Thank you for the opportunity to provide comment. If you have any questions, please contact Stephen Malmberg, from Wisconsin Emergency Management, at (608) 242-3243. Sincerely, Christine Bacon, Director Paul Schmidt, Chief Bureau of Technological Hazards Radiation Protection Section Wisconsin Emergency Management Department of Health and Family Services

pc: Steve Sell, WEM WEM REP Staff DHSS-RPS REP Staff Lori Husek, Kewaunee County Nancy Crowley, Manitowoc County Gary Brown, Pierce County Linda Johnson-Ladd, NSP Mark Findlay, WEPCo David Seebart, WPS

• STATE OF NEBRASKA EMERGENCY MANAGEMENT AGENCY Stanley M. Heng Adjutant General 1300 Military Road "99 SE'"' 14 P12 :06 Lincoln, Nebraska 68508-1090 Phone(402)471-7421 or~

Mike Johanns Hu Af) I Governor September 7, 1999 Secretary of the Commission ATTN: Rulemakings and Adjudications Staff U.S. Nuclear Regulatory Commission Washington, D.C. 20555

Subject:

Consideration of Potassium Iodide in Emergency Plans as a Protective Measure for the General Public

Dear Sir or Madam:

The State of Nebraska's Emergency Management Agency (NEMA) has reviewed the proposed rule and would like to include these comments for the Nuclear Regulatory Commission (NRC) to consider. The guidance for evacuation, sheltering, and ingestion pathway protective measures was developed in spite of differing opinions and exists in the EPA "Manual of Protective Action Guides and Protective Actions for Nuclear Incidents". States maintain the authority to adopt stricter guidelines than those contained in the manual, if deemed appropriate. The State of

• Nebraska emergency plans provide for the initiation of evacuation prior to a release from the nuclear power plant.

NEMA feels that the cost associate with stockpiling potassium iodide (Kl) for the general public outweigh the benefits. NEMA also feels that the proposed rule requiring States to give "consideration" to the use of Kl is inappropriate. We would request that the NRC not adopt the proposed rule. If the Commission feels that Kl is an appropriate protective measure for the general public, then the NRC should work with other federal agencies to develop clear guidance detailing when it's administration is warranted and other details contained therein. The proposed rule is vague and puts the burden of assessment on States who have fewer technical resources than the NRC, the EPA, or the FDA. Also, the proposed rule creates a liability for the States. It does not define "consideration", leaving room for many different possible interpretations and does not constitute effective guidance. The Nebraska Emergency Management Agency does not support the stockpiling of Kl for distribution to the general public in the event of a nuclear power plant incident for the following reasons: An Equal Opportunity/ Affirmative Action Employer

                                                     @ printed on recycled paper

• Evacuation of potentially affected areas within the 10-mile emergency planning zone is the preferred protective action to protect the health and safety of the general public.

Distribution of Kl to the general public could inhibit orderly evacuation and divert limited local resources during the early stages of an incident.

• The distribution of Kl to the general public could impart a false send of security regarding the prevention of severe health effects resulting from radiation exposure. Kl is not effective unless administered prior to or shortly following inhalation or ingestion of radioiodines. Also, Kl does not limit dose due to whole body exposure from other radioisotopes potentially present in a radiologica l release from a nuclear power plant incident.
• Kl is not a viable means for those with allergic reactions.
• Emergency plans would not be able address the legal liabilities associated with the drug's administration. State and local governments would be unable to control dosage amounts or provide medical supervision for the administration to school children. This, in turn, also presents the problem of dosage. There are no clear guides for age appropriate dosages. Babies, toddlers and children should be given Kl in liquid form; however, dosage amounts are not clearly defined. There is also no clear guidance on liabilities associated with administration of this drug without parental consent.
• International experience with Kl has shown the drug may not be a useful protective measure because of differences in reactor designs and emergency preparedness capabilities in the United States.

The Nebraska Emergency Management Agency appreciates the opportunity to contribute to the other comments the NRC may receive from other agencies. Should you have questions please contact Jonathan F. Schwarz at 402/471-7420. Assistant Director

NUMBER u~C 'EfED 11 ~ 1P . PROPOS RU So ( l,'/F/?3173 7) ~ 1 At/:J1

                                                   *99 Sffl 1~ ~

September 13, 1999 I 0~ i; COMMENTS OF OHIO CITIZENS FOR RESPONSIBLE ENl OOY, INC. C"O<eRE" > ON PROPOSED RULE, "CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS," 64 FED. REG. 31737 (JUNE 14, 1999) OCRE supports this proposed rule, to the extent that it is the best the NRC will accept. However, OCRE would prefer a stronger rule that would mandate the use of KI in radiological response emergency planning, with the nuclear power plant licensees paying the costs of the KI program. In July 1997, through a news release, the NRC promised the states and the public that it would pay for the purchase of KI for any state which wanted to use it. Based on this promise, the State of Ohio developed a draft KI policy that favored prodding KI to the general public. Now that the NRC has reversed itself on the promise to pay, it is unclear whether Ohio's policy can be impl e - mented. Under this proposed rule, if a state considered the use of KI, but found the licensee unwilling to pay for it, and since the NRC won't pay for it, the state decided it might be a good idea but they couldn't afford it, would this be considered acceptable and in compliance with the rule? It is my understanding that the petitioner compromised based on the NRC's promise to fund KI purchases by states. Since the promise of funding removed a major impediment to states* adopting a pro-KI policy, the petitioner felt that amending his petition to require only "consideration" of the use of KI would likely result in state decisions favorable to using KI. Now the NRC has failed to live up to its part of the bargain. So it would be entirely appropriate for the petitioner to rescind his amendment to PRM-50-63 and to insist that the NRC adopt what was requested in his original petition. Respectfully submitted,

  ~~

Susan L. Hiatt, Director, OCRE 8275 Munson Rd. Mentor, OH 44060 440-255-3158

DOC KE NU BER p DOC K~TEO PROPOSED RULE 5° ll';' " (p'fFK.31737) Septemb~r 13, 1999 *99 SEr 14 Pl :27 COMMENTS OF OH 10 CIT I ZENS FOR RES PONS IBLE ENERGY ON PROPOSED RULE, "CONSIDERAT ION OF POTASSIUM !OD~ *j i N EMERGENCY

                                                                   ?'~~p. (        "OCRE " )

PLANS," 64 FED. REG. 31737 (JUNE 14, 1999) u.* OCRE 8upporte this proposed rule, to the extent that it is the best the NRC ~ill accept . Ho~ever, OCRE would prefer a stronger rule that vould mandate the use of KI in radiological response emergency planning, ~ith the nuclear power plant licensees paying the costs oft.he KI program. In July 1997, through a news release, the NRC promised the states and the public that it would pay for the purchase of KI for any sta.1..e wliich llanted to use it . Based on this promise. the State of Ohio developed a draft KI policy that favored prodding KI to the general public . No~ that the NRC has reversed itself on the prc.,miee to pay. it is unclear whether Ohio

• s policy can be imple-mont.od.

Under t.hie proposed rule, if a state considered the use of KI, but found the licensee unwilling to pay for it, and since the NRC wun ' *1:. pay i.or it, the state decided it might be a good idea but they couldn't aftord it, would this be considered acceptable and in compliance wlth the rule? It is rny understanding that the peti t1oner compromised based or1 th& NRC's promise to fund KI purchases by states. Since the prom!~., vi funding removed a aiajor impediment. to states* adopting a pro-KI policy. the petitioner felt that amending hie petition to re~ulx*e only "consideration" of the use of KI would likely reeult in state decisions favorable to using Kl. Now the NRC has failed to live up to its part of the bargain. So it vould be

• entirely appropriate for the petitioner to rescind his aruendraent to PRM-50-63 and to insist that the NRC adopt what was requested in his original petition.

Respectfully submitted,

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Sui:J~u L. Hiatt, Director, OCRB: 8275 Muneon B.d . Mentor, OH 44060 440-255-,) 158 cknow1edged by ca

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I ALLIANT ENERGY ~ *99 er 13 P J :4 7 Alliant Energy Corporation Alliant Tower 200 First Street SE P.O. Box351 J Cedar Rapids, IA 52406-0351 NG-99-1263 September 10, 1999 AL Office: 319.398.4411 www.alliant-energy.com Secretary of the Commission DOCKET NUMBER Attention: Rulemakings and Adjudications Staff PROPOSED RUL ,. 5 o , U. S. Nuclear Regulatory Commission \. lo'IFR 317 3 7;1 Washington, DC 20555-0001

Subject:

Duane Arnold Energy Center Docket No: 50-331 Op. License No: DPR-49 Comments on Proposed Change to 10 CFR 50.47, Emergency Plans, 64 FR 31738 - June 14, 1999

Reference:

Letter from L. Hendricks (NEI) to NRC, "Proposed Rule: Consideration of Potassium Iodide in Emergency Plans", dated September 1, 1999 File: A-100, A-119 In a Federal Register Notice on June 14, 1999 (64 FR 31738), the NRC requested comments by September 13, 1999 on a proposed change to 10 CFR 50.47(b)(10), Emergency Plans. In addition to endorsing the referenced letter, IES Utilities submits the following public comments on the proposed change to 10 CFR 50.47(b)(10). We would like to begin by reiterating our commitment to protecting public health and safety via our Emergency Plan. The design of all United States (US) nuclear plants must be sufficient to meet the requirements of 10 CFR 100. In addition, 10 CFR 50.47 requires plants to develop Emergency Plans to protect the public health and safety in the event of a beyond-design-basis event. These Emergency Plans, based on evacuation and sheltering actions, have been reviewed and approved by the NRC as adequately protecting the public in the event of a beyond-design-basis event. Since adequate protection has already been established, and the use of KI is not supported by the design basis of the plant or by adequate scientific evidence, we feel the proposed rule change is unnecessary. EP 2 2 1999 ftft..l a,tf..J'r>- CknO edged Y \.oQIU ... II ,., I

U. vv ... t:J-\H 11EGULAI ORY COMMISSION f-' -MAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Da Copies Received _ _ _ q f o/ 91 1\dd'I Copies Reproduced-----,..- - Spe *a1

September 10, 1999 NG-99-1263 Page2 We also are concerned that the proposed wording is vague and confusing to the point of being ineffective for the following reasons. The first two sentences of the rule read as follows: A range ofprotective actions has been developed for the plume exposure pathway EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use ofpotassium iodide (Kl), as appropriate. When read together, these two rule sentences could be misconstrued as meaning the range of protective actions developed is now supplemented by the option to use Kl. In other words, the use of KI could now be implemented instead of evacuation and sheltering. This would have the detrimental result of exposing the public to other radionuclides. Another concern is vagueness of the term "as appropriate" in the proposed rule. The proposed wording sets no safety based standard on when KI should be used. Furthermore, there is no scientific data on which to base such a determination. A final concern with the proposed wording is that it appears to be merely guidance. Such guidance is more appropriately contained in a guidance document, not a rule. The logistics of KI distribution also is an area of concern. We feel that pre-distribution is the only timely and orderly manner in which to distribute Kl. Pre-distribution, however, severely limits the ability of state and local authorities to determine if use of KI as a protective action has, in fact, been implemented. Specifically, state and local authorities will not be able to determine if individuals have taken the Kl, or taken it appropriately. Pre-distribution also has implications with regards to proper storage by members of the public, proper disposal of expired KI when new supplies are distributed, and even such concerns as liability if small children were to ingest several doses of the pre-distributed Kl. In the current litigious climate of the US, even the distribution of an over-the-counter medication has legal implications for state and local agencies. We appreciate the opportunity to comment on the proposed rule and thank you for your consideration of our comments. Sincerely, ~~ Kenneth E. Peveler Manager, Regulatory Performance

September 10, 1999 NG-99-1263 Page3 KEP/LBS cc: L.B. Swenzinski E. Protsch D. Wilson B Mozafari (NRC-NRR) J. Dyer (Region III) NRC Resident Office Docu Com~~----------'---------------- Address~----~-~~--------------- DeptjRoor/Suite/Room City F .. - State _ _ ZIP _ _ __ _ _ __

Niagara ~ Mohawk. J Richard B. Abbott Phone: 315.349.1812 Vice President

                                                                                                                 *99    Er 13 p .3 : a.3: 315.349.4411 Nuclear Engineering September 9, 1999 i

AG il Secretary of the Commission U.S. Nuclear Regulatory Commission D Washington, DC 20555 p so Attention: Rulemak.ings and Adjudications Staff (rJ/FP. 31737}

Subject:

Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64/113 Federal Register, P.31737, June 14, 1999) Request for Comments Gentlemen: Niagara Mohawk Power Corporation (Niagara Mohawk) submits the following comments on the proposed rulemaking to amend the emergency planning standard in 10 CFR 50.47 (b)(lO) (64/113 Federal Register, P.31737, June 14, 1999). The proposed rulemak.ing is in response to a petition that emergency planning protective actions include explicit consideration by the state of the prophylactic use of potassium iodide (KI) by the general public. Niagara Mohawk, as the licensee for Nine Mile Point Units 1 and 2, strongly urges the NRC to reconsider its decision to grant the petition. The discussion published with the proposed rule does not present any new evidence that stockpiling or predistribution of KI as a protective action will add a significant public health and safety benefit. An adequate level of protection is already provided by existing emergency planning procedures at and around commercial nuclear power plants. Adequate guidance is available to states and local governments that feel it is appropriate to make KI available to the general public. The petitioner has not proved the claimed increase in benefits of using KI as a thyroid blocking agent in a radiological emergency, on the basis of current scientific data. U.S . programs are built on the sound premise that evacuation is generally feasible and is more effective at dose reduction than use of KI because evacuation reduces the dose to all organs, not just the thyroid. Niagara Mohawk believes that the cost of purchasing KI and developing pians and procedures to meet any new requirements promulgated by the proposed rule should not be the responsibility of the nuclear industry. Niagara Mohawk agrees that state and local authorities should make the appropriate determination and be financially and administratively responsible regarding stockpiling and distribution of KI, as is the current practice. Niagara Mohawk supports the Nuclear Energy Institute (NEI) position urging the NRC to deny the petition. We appreciate the opportunity to comment on the proposed rulemaking. Very truly yours,

                                    ... £P         1999        ....._

Richard B. Abbott Vice President Nuclear Engineering Nine Mile Point Nuclear Station P.O. Box 63, Lycoming, New York 13093-0063

• www.nimo.com

u ,. ,dJCLEA AKII OFFI 0 DOI'* Postmark Date _ __!!jlD/ CJ 9 C£ Cop*~ ~lved / Ade (C, ~ qe-~" ¥ r 12 lll.r .

STATE OF NEW HAMPSHIRE EXECUTIVE DEPARTMENT Office of Emergency Management DOC K 1E State Office Park South . C 107 Pleasant Street Concord, New Hampshire 03301-3809 603-271-2231 JEANNE SHAHEEN 1-800-852-3792 ,.tr 1-:. P 1 :51 J - WOODBURY P. FOGG, P.E. Governor FAX 603-225-7341 Director DOCKET NUMBER PROPOSED RULE PR 50 September 8, 1999 wl/P/?317~1) Ms. Annette Vietti-Cook, Secretary U.S. Nuclear Regulatory Commission Attn: Rulemaking and Adjudication Staff U.S. Nuclear Regulatory Commission Washington DC 20555 RE: Petition for Rulemaking - Proposed Rule NRC 10CFR Part 50 RIN 3150 AG 11, Consideration of Potassium Iodide in Emergency Plans

Dear Ms. Vietti-Cook:

Enclosed please find New Hampshire's comments on the petition captioned above. We have also enclosed, for the Commission's consideration, a copy of the report and recommendation of the NH Potassium Iodide Advisory Group. This group included the N.H. Office of Emergency Management, the N.H. Division of

• Community and Public Health, the Seacoast Anti-Pollution League, the N.H.

Radiation Advisory Council, the Governor's Office, Massachusetts Emergency Management Agency and representatives of Seabrook Station and Vermont Yankee. This group labored for nearly six months reviewing the issues associated with the stockpiling and distribution of KI. Sincerely, w Woodbury P. Fogg, P.E. Director WPF/cjr Enc. U: \NAWOJ\USNRC_KI COMMENTS.doc SEP 2 2 1999 State of New Hampshire TDD Access: Relay NH 1-800-735-2964

U.S. NUCLEAR REGULATORY COMMISSION R - &ADJUDICATIONS STAFF OFRCE "fHESECRETARY OFTHEt,1.~t=:~ION DOCUmefflStatistics 0 ~

                 .,RESPONSE OF THE STATE OF NEW HAMPSHIRE,-',

TO U.S. NUCLEAR REGULATORY COMISSION

                               )PROPOSED RULE PRM-50-63-A:

CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS

                                             )

New Hampshire is familiar with the discussions of the merits of Potassium Iodide (Kl) as a supplementary protective measure for radiological emergencies. The benefits and

• r
• risks of using Kl to provide protection to the thyroid gland from uptake of radioiodine are well documented. Kl was considered in the development and litigation of the New Hampshire Radiological Emergency Response Plan for Seabrook Station in 1980-86.

In June of 1996, the New Hampshire Office of Emergency Management (NHOEM) presented testimony on behalf of the states of New Hampshire, and Vermont and the Commonwealth of Massachusetts outlining the three states' positions with respect to Kl a.nd offering their comments concerning the proposed rule. This occurred at the Federal Radiological Preparedness Coordinating Committee hearing in ,Washington, D.C. That position -has been reviewed and remains the basis for the current policy with respect to I - the distribution of Kl for the Stat~ of New Hampshire. In December 1998, New Hampshire convened a Kl Policy Study Group. That group presented its report to the Governor of New Hampshire in May 1999. The executive summary follows; the report in its entirety is attached: 1 "Executive Summary"

       - In June 1998, the U.S. Nuclear Regulatory Commission (NRC) voted to change Emergency Planning Regulations to include consideration* .of KI (Potassipm Iodide) as a pn;>tective measure for the general public. Media and public interest was raised by this action.

During the development of the New Hampshire Radiological Emergency Response Plan (NHRERP), KI was considered as a protective measure, but is provided only for emergency workers and institutionalized persons who might not be able to be evacuated. Evacuation is the prim¥Y and most effective protective action for the general public. The State does not provide KI for the general public, recognizing that finite State and local emergency response resources would be diverted from implementing the most effective protective action: evacuation. jJNEW HAMPSHIRES COMMENTS ON PRllll50-63-A page 1

In response to the renewed interest in KI, New Hampshire formed a KI Policy Study Group which included representatives from the 0ffice of the Governor,- Office of Community and Public Health, Bureau of Radiological Health; the New Ilampshire, Radiation Advisory Council; Office of Emergency Management; the Seacoast Anti-Pollution League and representatives from* Seabrook Station and Vermont Yankee Nuclear Power Stations. The Policy Study Group held two public information meetings in December 1998. One in the Seabrook Station EPZ (Exeter) and one in the Venp.ont Yankee EPZ (Chesterfield, NH). Written comments were also received. The Group was briefed on the status of KI by the NRC and FEMA in January. Based on the information and comments received :ft'om these meetings and letters, the Study Group is recommending that New Hampshire:

• Provide the public with information on how KI can best be used in response to radiological emergencies
• Encourage members of the public who are considering using KI to consult -with their health

    --- care providers to see if KI is safe for them to use

• Obtain agreements with manufacturers of KI to make it available over the counter to interested members of the public

 .*     Monitor the evolving federal policies with respect to KI* and the KI 'policies of neighboring states These recommendations supplement and clarify current New Hampshire policy."

With respect to this petition for rulemaking, The. Commission took great care and due consideration in choosing the language in the proposed revision to the regulation. With respect to current radiological emergency planning in the United States, in most jurisdictions the* use of Kl has already been as carefully considered. Kl is provided for use by emergency workers and institutionalized persons. State, local and federal emergency planners have 'also considered Kl as a supplementary protective measure for the general public. Emergency preparedness planners have, in most in*stances, decided that Kl could not be effectively deployed even as a supplementary protective measure for the general public. No compelling new information has been offered to warrant a change in the current policies. Reconsideration of Kl use to include an

                  )

, additional responsibility for state or local officials to stockpile and distribute Kl to the public is unlikely. The resources for such an undertaking are just not available. The

  .potential for liability far outweighs the benefit.

JJ NEW HAMPSHIRES COMMENTS ON PRMS0-63-A page 2

) In Petition PRM-50-63A, the petitioner focuse~, on the benefits of Kl stockpiling but does npt weigh the practical details involved in endeavoring to craft an effective stockpiling and distribution plan. When_ considered as a practical matter, stockpiling of Kl for distribution to the public in the event of a radiological emergency quickly loses its luster. Large uncertainties and long time in.tervals are involved in the process of determining whether or not a radiological accident sequence will produce the level of radioiodine that l would warrant the use of Kl. These confounding elements cause prudent officials to

 , plan for and implement protective actions that are far more reliable and effective in the protection they offer to the public.

In the United States, Radiological Emergency Plan protective action schemes are anticipatory in nature and are based on plant conditions. In most instances, this means that well before a decision maker has the information needed to justify the consideration of Kl as

• a protective measure, other more effective -protective measures such as evacuation have already been* implemented.

Kl protects the thyroid gland only by preventing the incorporation of radioiodine into its processes. Kl does not protect a person or the thyroid from direct ,gamma radiation exposure either from radioiodine or the many other radionuclides that m~y be released in the event of a radiological emergency. Iodine is neither the most likely nor the most abundant nuclide that could be released.

  -To be most effective, Kl should be administered before or immediately after exposure has occurred. Kl stockpiles put in place with the idea that they will be distributed by state or local emergency response personnel during an emergency ignore the limited capability of emergency response resources. To further burden emergency responders with the task of 1.) Determining the need for Kl and 2.) Implementing a Kl distribution scheme in the midst of implementing ot~er more effective response efforts during a radiological emergency, and expect to have that response be effective, is unrealistic.

jJNEW HAMPSBIRES COMMENTS ON PRM60-6a-:A page 3

  ~urther, if conditions exist where evacuation can not be implemented, it is equally likely that an attempt at the distribution of Kl from a stockpile would be ineffective as well .
 .During an emergency, if there is enough time to distribute Kl, it probably won't be needed. If Kl is really needed, there won't be enough time t~ distribute it.

The current policies, which provide Kl for -emergency workers and institutionalized persons, should not be construed to mean that emergency preparedness or public health officials wish to prevent or deny the public access to Kl as a protective measure. These policies simply recognize the finite resources available to emergency responders. The concern of emergency preparedness and response officials is* not with Kl per se but with the stockpiling and distribution process and its potential for reducing the l effectiveness of measures which will provide much greater protection to the pu~lic we serve. We as public ~fficials are duty b,ound to determine a sound basis for the protective

 .actions we recommend. A case in point was the contemplated use' of Kl at Three Mile Island. There, in the midst of the emergency, heroic efforts were made to get Kl. Then it was found to not be necessary for that accident because little or ~no Iodine was released.

If Kl were readily available in the public market place, the public could . make the determination for themselves based on available emergency public information, their own intuition and recommendations previously secured* from their own health care provider. We do the --public an injustice when we presume that they desire government intervention at any level with respect to Kl. During the public information gathering sessions held in New Hampshire, it was quite clear that the public was not interested in government stockpiles. Many expressed no confidence in such schemes. What they _wanted was information about Kl and the identification of an available pathway to get it for them and their families. They want to make their own decision. JJ NEW H.AMPSHIRES COMMENTS ON PRMS0-63-A page 4

Having discussed the issues with respect to the merits of stockpiling Kl, other options for offering its benefits to the public may be considered. The FDA determined in 1978 that Kl was a safe and effective non-prescription medication for thyroid protection from radioiodine exposure that may occur during radiological emergencies. Until just recently, however, Kl was not readily available at retail outlets. In New Hampshire at least, manufacturers of Kl are establishing a retail . market distribution network. In addrtion, Kl is now available via the Internet from at least

  -two vendors at an affordable price.

As with emergency preparedness in general, radiological emergency preparedness operates at different levels. Family or personal preparedness is often overlooked and under emphasized. The aim of emphasizing a personal preparedness approach is to respect the ability and right of the public to participate in the development of their own emergency preparedness. A personal preparedness approach would allow each person or family to determine for themselves if Kl would be effective, safe and appropriate for them. A comprehensive public information program outlining the potential range of benefits and risks of using Kl and how to employ rt most effectively in the event of a radiological emergency would be necessary. The ready availability. of Kl through retail outlets, over the counter, would be the key

  -element in this approach to preparedness.             This would have a positive effect on emergency preparedness as a whole. One can envision this activity being conducted in conjunction with existing programs designed to remind and encourage family members to periodically check home first aid kits, smoke detectors, spare batteries for flashlights

• and radios and other items that they might employ for their comfort and protection in the event of any emergency.

One vehicle that is currently used for disseminating these regular preparedness reminders and could be used to provide information on Kl are the public information brochures and calendars already required to be distributed annually within each emergency planning zone pursuant to NUREG 0654 section G. JJ NEW HAMP8HIRE8 CO~TS ON PRMS0-63-A page 5

However, distribution of Information on the benefits and risks associated with the use of Kl should not be limited to people living within nuclear power plant emergency planning zones. Neither should the availability of Kl be limited just to those who live in the vicinity of nuclear power plants. It should be available over - the counter to anyone who ,'1ants it. By facilitating the availability of Kl for purchase by members of the public, the need for ma,intaining stockpiles of Kl for the public in each emergency-planning zone is diminished. If some stockpiling of Kl were deemed appropriate, modestly sized regional stockpiles of Kl could be maintained, perhaps as part of the Federal Joint Terrorism Task Force Initiative. Regional stockpiles could be located so as to be deployed in support of a number of _nuclear power plant emergency planning zones as well as for other radiological - emergencies as the need arose. Regional stockpiles -could be deployed in support of either a planned or an ad hoc response and would offer an economy of scale not available if state or local stockpiles were implemented. Maki~g the information and the Kl itself available directly to the public _provides them

        \

with the ability to decide for themselves how best to take advantage of the benefits associated with the use of Kl as a supplementary protection. This approach provides the greatest level of protection for the greatest number of people. If the Commission is

                                            ,                                                 (

to recommend or require the states to do or consider anything more than they have already, then encourage them to consider this approach. r We also urge the Commission to work "Yfih the rest of the federal community and the states to establish strategically located regional stockpiles of Kl and antidotes to deal with tlie numerous type~ of em~rgencies Wfr are more likely to face. U,\nawof,kl_1tockptlng doc Rev,-!7.23.99 jJNEW HAMPSHIRES COMMENTS ON PRMS0-63-A page 6

REPORT TO THE GOVERNOR of the New Hampshire Potassium Iodide (Kl) Policy Study Group

STATE*OF NEW HAMPSHIRE EXECUTIVE DEPARTMENT JEANNE SHAHEEN Governor Office of Emergency Management State Office Parle South 107 Pleuant Street Concord, New Hampshire 03301-3809

                                                   '     603-271-2231 1*800-852-3792 FAX 603-225-7341 e

WOODBURY P. FOGG, P.E. Director May 18, 1999 Her Excellency, Governor Jeanne Shaheen State House Concord, New Hampshire 03301

Dear Governor Shaheen:

The New Hampshire Potassium Iodide (KI) Advisory Group has been working since December 1998 on a review of the Kl issue. The group's report and recommendations are attached. I would like to take this opportunity to thank the members of the group for their efforts in assembling this report. They are:

• Division of Community and Public Heal~ Office of Health Management, Bureau of Radiological Health:

Dianne Tefft, Bureau Chief Peter Paiton, Senior Planner New Hampshire Radiation Advisory Council: Elizabeth Thibodeau, Chair James Cherniack, Member Ken DeHart, Jr., M.D., Member Seacoast Anti-Pollution League: Steve Haberman, Field Director Vermont Yankee Nuclear Power Corporation: Al Chesley North Atlantic Energy Service Corporation:

• Don Tailleart John Baer State of New Hampshire TDD Access: Relay NH 1-800-735-2964
• Her Excellency, Governor Jeanne Shaheen Page Two May 18, 1999 Office of the Governor:

Susan Arnold, Policy Director Office of Emergency Management: Woodbury P. Fogg, P.E., Director Richard G. Tuck, Deputy Director Michael Nawoj, Chief: Technological Hazards James Van Dong en, Public Information Officer Massachusetts Emergency Management Agency: Deborah Yeager I would also like to thank those members of the U.S. Nuclear Regulatory C~mmission and

• Federal Emergency Management Agency who assisted us in the review process .

From the U.S. NRC: Frank CongeL Director, Incident Response, NRC Aby Mohseni, NRC Headquarters Robert Bores, NRC Region I, State Liaison FromFEMA: William McNutt, Senior Policy Advisor, Chairman FRPCC, FEMA Headquarters Daniel McElhinney, RAC Chairman, FEMA Region I Deborah BelL FEMA Region I Robert Poole,,FEMA Region I Ifl can answer any questions concerning this report, please let me know, Woodbury P. Fogg, P.E.

• WPF/cjr Attachments U \FOOO\GOVBRNOR SHAHB!lN_IJ IU!l'Oi,T DOC Director -

REPORT TO THE GOVERNOR ofthe New Hampshire Potassium Iodide (KI) Policy Study Group

• /

REPORT TO THE GOVERNOR

• of the New Hampshire Potassium Iodide (KI) Policy Study Group Table of Contents Table of Contents Executive Summary 11 I. Introduction 1 II. History of Potassium Iodide Policy 1 A. State of New Hampshire Policy 1 B. Federal Policy 2 C. Other State KI Policies 2 D. International Policies 3
• Ill. Potassium Iodide Policy Development Process A. Why Review the New Hampshire KI Policy 3

3 B. The New Hampshire KI Policy Revi~ Process 3 IV. Summary of the Results of the KI Policy Study Group Process 4 V. Recommendation of the KI Policy Study Group 5 VI. Where Do We Go from Here 5 VII. Appendices A. Public Meeting Presentation B. Public Meeting Summaries C. Written Public Comments D. Selected Review Materials

• WHO Working Paper
• Hanford Study Executive Summa:ry
• E.

F. G. Letter to Wallace Laboratories/Reply Availability of KI Over the Counter/Other Sources New Hampshi:re State Radiation Advisory Committee Memorandum (4/15/99) and Letter (5/3/99) to Governor Jeanne Shaheen NRC KI Core Group Charter 1

• 'Executive Summary

                                        -              ~     ~        -- -

In June 1998, the U.S. Nuclear Regulatory Commission (NRC) voted to change Emergency Planning Regulations to include consideration of KI (Potassium Iodide) as a protective measure for the general public. Media and public interest was raised by this action, During the development of the New Hampshire Radiological Emergency Response Plan (NHRERP), KI was considered as a protective measure, but is provided only for emergency workers and institutioruilized persons who might not be able to be evacuated. Evacuation is the primary and most effective protective action for the general public. The State does not provide KI for the general public recognizing that

• finite State and local emergency response resources would be diverted from implementing the most effective protective action: evacuation.

In response to the'renewed interest in KI, New Hampshire formed a KI Policy Study Group which included representatives from the Office of the Governor; Office of Community and Public Health, Bureau of Radiological Health; the New Hampshire

• Radiation Advisory Council; Office of Emergency. Management; the Seacoast. Anti-Pollution League and representatives from Seabrook Station and Vermont Yankee Nuclear Power Stations. The Policy Study Group held two public information meetings in December 1998. One in the Seabrook Station EPZ (Exeter) and one in the Vermont Yankee EPZ (Chesterfield, NH). Written comments were also received.

The Group was-briefed on the status of KI by the NRC and FEMA in January. Based

 -.on the information and comments received from these meetings and letters, the Study Group is recommending that New ltampshire:                                 -
       -*  Provide the public with information on how KI can best be used in response to radiological emergencies

• En.'courage members of the public who are considering using KI -to consult with their health care providers to see if KI is safe for them to use

       -*  Obtain agreements with manufacturers of KI to make it available over*the counter to interested members of the public

• Monitor the evolving federal policies with respect to ~ and the KI policies of neighboring states These recommendations supplement an.4 clarify current New Hampshire policy.
• 11

REPORT TO THE GOVERNOR

• ofthe New Hampshire Potassium Iodide (KI) Policy Study Group L Intro.diictioii -- - - ..

On June 26, 1998, the United States Nuclear Regulatory Commission (NRC} voted to change the emergency planning regulation for commercial nuclear power plants to include potassium iodide (KI) among protective actions that states should consider for the public in a radiological emergency. KI is a medication that, when used properly, can prevent uptake of radioactive iodine by the thyroid gland. The NRC's action was a depjlI'ture from previous federal policy 'that had recommended consideration of KI for emergency workers and persons in institutional settings (i.e., hospitals and nursing homes) only. The NRC's action has caused the States to reconsider policies conceming KI in radiological emergency planning. Up to now, states, with few exceptions, have considered the use of KI to be appropriate only for emergency workers and persons in institutional settings. New Hampshire is among states now considering whether and how to make KI available to the public with.in nuclear power plant emergency planning zones _(EPZs). IL History ofPotassium Iodide Policy A. State of New Hampshire Policy

• The State of New Hampshire, in accordance with RSA 107:B, and in cooperation with affected municipal governments, developed and has maintained the New Hampshire Radiological Emergency Response Plan (NHRERP). The NHRERP ~ developed for response to radiological emergencies at Seabrook Station and V ennont Yankee Nuclear Power Plants with input from affected local governments.

The Federal Emergency Management Agency (FEMA) and the NRC reviewed the plan. The basis for the NBRERP was litigated before an NRC administrative lilw panel (Atomic Safety and Licensing Board) during the licensing proceedings for Seabrook Station. This process allowed for a rigorous and thorough review of the plan by the various parties to the licensing proceedings. FEMA made a finding in accordance with Title 44 Code of Federal Regulations, Part 350, that t h e ~ provides reasonable assurance that the public health and safety can and will be protected. The New Hampshire policy with respect to KI was considered during the development of the NHRERP protective action decision-making strategies. The policy incorporated into the NHRERP is that KI is provided for emergency workers, who are trained in its proper use, and for persons in health care institutions, who would _ be administered KI with the approval and under the supervision of their personal physicians. The current New Hampshire KI policy was articulated in a letter dated January 9, 1990, from William T. Wallace Jr., M.D., M.P.H., Director, New Hampshire Division of Public Health Services, to Colonel GeoJ:1$e L.

• Iverson, Director, New Hampshire Office of Emergency Management In the letter, Dr. Wallace said that KI

      ~shall not be m:ade available by this, division to the general public", but "shall be made available ... to emergency ~ork:ers ... and to institutionaliz.ed individuals."

This policy has been misconstrued by some members of the publip as prohibiting personal use of KI. While the state has and continues to promote evacuation as the most effective protective action, the recommendations included here are intended to clarify that personal use is not prolnbited.

• 1

B. Federal Policy

• The use of KI as protection for emergency workers against uptake of radioiocline by the thyroid was recognized by U.S. Environmental Protection Agency (EPA) guidance on protective actions for nuclear incidents: (Manual of Protective Action Guides and Protective Actic;ms for Nuclear Incidents, USEPA, September 1975). The Food and Drug Administration (FDA) established a recommended radioiodine exposure threshold and KI dosage recommendations for the use of KI as a thyroid blocking agent in 1982. FDA is currently re-evaluating these recommendations in hght of a World Health Orga.niz.ation (WHO) working paper (draft guidance). The WHO working paper, unlike current FDA recommendations, varies recommended dosage for different age groups.

The limited efficacy of KI to block uptake of radioactive iodine by the thyroid gland is generally recognized in federal guidance. KI, as a thyroid blocking agent, is effective only if taken immediately prior to exposure or within 3-4 hours following inhalation of radioactive iodine. The initial federal policy on use of KI in the event of a severe nuclear power plant accident was established by the Federal Radiological Preparedness Coordinating Committee (FRPCC) in 1985. This committee, chaired by FEMA, is a group of federal agencies (NRC, EPA, FDA and others) that coordinate federal radiological emergency preparedness policy. The FRPCC initially recommended that KI should be stockpiled for emergency workers and persons in institutions only, but not for the general public. The FRPCC policy

• recognized that the final determination on use of KI rests with the states and permitted states to take measures beyond those recommended by the FRPCC.

Most state and local governments adopted the FRPCC policy, and included use of KI in radiological emergency

    ~nse plans for emergency workers and persons in institutional settings.

In 1994, the FRPCC reconsidered and reaffirmed its 1985 policy on KL In 1995, an NRC staff member, acting as a private citizen,,petitioned the NRC to amend the emergency planning regulations for commercial nuclear power plants to include a requirement to consider the use of KI as a protective action for the general public. In

• 1996, the FRPCC again reconsidered its KI policy, and concluded that state and local governments should consider use of Kl as a protective action for protection of the public.

On June 26, 1998, the NRC voted to grant the petition to amend the emergency planning regulations to include consideration of KI as a protective action for the pubhc. The NRC instructed its staff to publish a proposed rule in the Federal Register for public comment and to develop a guidance document for state and local governments to use in considering whether they should proVIde KI to the public. The proposed rule has not yet been published. The NRC staff has formed a working group, known as the NRC KI Core Group, that is currently engaged in developing a guidance document The NRC expects to publish the guidance document in December 1999. C. Other State KI Policies In the United States, the States of Alabama and Tennessee have implemented policies of either distnbuting or stockpiling KI for public use in the event of a severe nuclear power plant accident These programs have been implemented for residents within the EPZs of Tennessee Valley Authority nuclear power plants in those states. In Alabama, the KI ic; maintained in public health offices in the vicinity of the plants for distnbution by public health nurses at reception centers. KI would only be made available for evacuees from sectors that would have been exposed to radioiodine before or during their evacuation following a severe accident In Tennessee, attempts were made to pre-distnbute KI to households within a five-mile radius of the plant Initially, in 1981, 66% of the households accepted KI that was personally delivered to the homes. In subsequent years, residents were advised by mail that KI was available at local health department offices for residents to obtain. A diminishing number of residents sought to obtain KI from the health department offices in subsequent years. In 1996, less than 15% of the eligible population obtained the KI .

• The characteristic demographics of these EPZs are that they are rural and have relatively low populations.

2

D. International Policies The Nuclear Regulatory Commission KI Core Group is loolang at KI distribution policies in Canada and Europe to include France, Britain, Switzerland, Poland, and other eastern European countries. These experiences will be documented in the KI Core Group report due to be published in late Fall 1999.

m. Potassium Iodide Policy Development Process A. Why Review the New Hampshire KI Policy State of New Hampshire officials are reconsidering the state's KI policy in light of the recent NRC action to grant a petition to revise the emergency planning regulations to include consideration of KI as protective action for the general public. However, the revised NRC regulation has yet to be published for public comment, NRC's revised guidance on the use of KI as a public protective action has yet to be published, and U.S. EPA and FDA policies on how KI should be used are still evolving in light of the WHO working paper on KI usage.

The State of New Hampshire elected to begin reviewing the KI policy at an early stage. Many factors must be considered. Among them are:

• level of protection provided by KI
• probability of an accident that would warrant its use
• potential side effects of KI (e.g., allergic reactions)
• how to make KI available
• storage, shelf life and disposal of expired supplies
• who would authorize its use
• appropriate intervention levels that would trigger its use
• legal liability for adverse consequences how to inform the public of benefits and risks of KI effect on evacuating the public from an area at risk rmsettled federal policies To address these considerations, New Hampshire engaged in a process to obtain public comments, to include broad representation in the review and further development of New Hampshire's KI policy, and to connect with the federal policy development process.

B. The New Hampshire KI Policy Review Process In December 1998, the Governor's Office and the New Hampshire Office of Emergency Management sponsored two public meetings on Kl One public meeting was held in the Seabrook Station EPZ (Exeter), and the other in the Vermont Yankee EPZ (Chesterfield). A panel representing various perspectives on the KI issue presented an overview of current state and federal policy, radiological considerations, physiological considerations, logistical issues and policy development considerations. The panel was composed of representatives from the Health and Human Services Office of Health Management, the Office of Emergency Management, the New Hampshire Radiation Advisory Council, the Seacoast Anti-Pollution League, and the nuclear power plant operators. Public comments were invited and obtained. During the first quarter of 1999, the Office of Emergency Management convened a KI Policy Study Group to review the public comments and other information pertaining to the aforementioned factors and considerations. The group's purpose is to review the current KI policy and to formulate a KI policy recommendation for New Hampshire. The group will then oversee the implementation of any changes to the existing KI policy and continue to monitor the evolving federal and international policies and guidance. The group is composed of representatives of the Governor's Office, Office of Emergency Management, Health and Human Services

• Office of Health Management Bureau of Radiological Health, the New Hampshire Radiation Advisory Council, the Seacoast Anti-Pollution League, and the operators of Vermont Yankee and Seabrook Station.

Representatives of the Commonwealth of Massachusetts and FEMA attend meetings cifthe New Hampshire KI Study Group as well. 3

The KI Policy Study Group met three times during the months of January, February, and March 1999, and agreed to a KI policy recommendation for New Hampshire. During that time, New Hampshire gained representation on the NRC KI Core Group that is developing the NRC guidance document for use of KI as a

• public protective action. The New Hampshire KI Policy Study Group's policy recommendation is based primarily on public comments submitted as a result of the December 1998 public meetings and on the current status of federal policy.

IV. Summary of the Results of the Kl Policy Study Group Process The Exeter and Chesterfield public meetings were attended by approximately 65-70 people. A summary of the presentations made at the public meetings is attached at Appendix A. A summary of comments received from the public at the meetings is attached at Appendix B. Written comments were submitted to the state for consideration in development of a KI policy. The Policy Group reviewed written comments from a broad spectrum of interested persons and groups. Comments came from private citizens, the initiator of the NRC rule change (Peter G. Crane), a neighboring state public health official, the Nuclear Energy Institute, a nuclear licensing intervenor group, a nuclear power plant operator, local emergency management officials, and local elected officials. Written comments submitted to the state are attached at Appendix C. The infonnation obtained from the public meetings brought forth a number of issues with respect to the role of KI. The issues arose from different perspectives. Among the views expressed at the meetings were:

• KI should be available to the public;
• information on how KI works and what protection it offers, should be readily available to the public;
• if evacuation were not possi"ble, should KI be available for public use?;
• information on how to get KI should be available to the public;
• neither state nor municipal emergency response agencies have the resources to store, maintain or distn"bute KI during an emergency; there would be significant potential for liability to emergency response officials involved in the distn"bution ofKI; the likelihood of an accident where significant levels of radioiodme would be released is small but not zero; the public does not have a good understanding of how KI would protect them.

The Policy Group reviewed the recent Hanford Thyroid Disease Study results, medical reference materials on KI, current federal guidance documents, World Health Organization guidance, and reports on the recent NRC KI Core Group dehl>erations. The group queried the FDA about FDA restrictions on procurement of KI by the public (there are none) and Carter-Wallace Laboratories, Inc., a manufacturer of KI, about sale of KI directly to the public. Carter-Wallace has, up to now, had a policy of selling KI in bulk only to states and nuclear power utilities. Carter-Wallace has indicated that it has changed its policy to now make KI available for acquisition by members of the pubhc. Selected materials reviewed by the KI Policy Group are attached at Appendix D. In its review and discussions, the Policy Group remained cognizant of concerns about

• potential improper use of KI from failure to understand how it is effective, what it is effective against, under what conditions it should be used and its limitations;
• potential medical side effects for certain persons and in combination with other medications;
• potential for unnecessarily delaying evacuation;
• logistical difficulties with timely distn"bution at the time of an emergency;

       *

• legal liabilities potentially incurred by persons who would distnbute it or who would recommend that people use it;
• the proper role of government in providing a medication to the public at large for protection against a potential risk no matter how remote; and
• the indeterminate status of federal policy and guidance on how and when KI should be used.

4

Throughout its discussions, the KI Policy Group remained focused on one particular recommendation of a private citizen who attended one of the public meetings. This recommendat10n contained three essential elements:

• Improve public information on KI;
• Allow members of the public to make their own informed decision whether KI will benefit them and their families based on consultation with their own health care professionals;
• Monitor developments at the state and federal level, and make adjustments to the New Hampshire policy where appropriate .

This course of action best reflects the New Hampshire character and preference for individual choice. V. Recommendation of the KI Policy Study Group The KI Policy Study Group recommends:

• Supplementing the annual emergency public information materials that are distnbuted every year to all households in the New Hampshire portion of the Vermont Yankee and Seabrook Station EPZs. The supplemental information will explain what KI is, what its benefits are, what its limitations are, potential medical side effects, how it should be used in the event of a radiological emergency, when it should be used, how it can be obtained, how it should be stored, and precautions in its use .

The supplemental material will encourage anybody considering acquiring KI for themselves and their families to consult their personal physician about potential benefits and detriments of KI for them. The State of New Hampshire will obtain an agreement with manufacturers of KI to make it available for over-the-counter purchase by members of the public. The state will encourage retail pharmaceutical outlets in New Hampshire to maintain supplies of KI for purchase by members of the public.

• The State of New Hampshire will monitor the evolving federal policies and guidance on KI, and the KI policies adopted by its neighboring states, and make appropriate adjustments to the New Hampshire policy .

The policy recognizes that attempting to distnbute KI to the public would be an inappropriate and ineffective use of state and municipal emergency response resources. In the event of a radiological emergency, those resources would be required to implement the primary, preferred and most effective protective action - evacuation of the public at risk. To the extent, and under the narrow set of circumstances for which KI may be used effectively, KI should be available to any person who would benefit from its use. New Hampshire's current policy of providing KI for emergency workers and persons in institutions only is sound and has a sound basis. VI. Where Do We Go From Here There are a number of outstanding issues and evolving developments pertaining to use of KI as a protective measure for the public. The outstanding issues involved in implementing the recommended New Hampshire KI policy are:

• Obtaining a written commitment from KI manufacturers to make KI available for over-the-counter purchase (Carter-Wallace Laboratories, Inc. of Cranberry, New Jersey and Anbex Inc. of Palmdale Florida are suppliers of KI that the group is aware of);
• Obtaining agreements from local pharmaceutical outlets to stock it for sale to the public;
• Encouraging appropriate.-groups to assist people who cannot afford to purchase KI on their own to acquire it If they decide they want it;
• Encouraging physicians to educate themselves on the radio-protective properties of KI so as to be able to advise their patients of its potential benefits or detriments for them and their families and on its proper use.

5

New Hampshire emergency preparedness officials will continue to work on these efforts and to develop the supplemental KI information for distribution to EPZ households before the end of this year. New Hampshire emergency preparedness officials will monitor developments at the federal and international levels and in other states. The group is particularly interested in KI policy developments in Massachusetts and Vermont with which New Hampshire shares EPZs. The group wants to ensure that actions taken by New Hampshire and its neighboring states do not cause confusion, and do not conflict with or disrupt each other's emergency response plans. Tl:irough its representation on the NRC KI Core Group, New Hampshire emergency preparedness officials will monitor the evolving federal policy and guidance. Of particular interest will be the yet to be published revised emergency planning regulation, the NRC guidance document, and the U.S. EPA and FDA threshold criteria and dosage recommendations. The New Hampshire KI Policy Group will be reconvened if necessary to review further issues with respect to KI that may be raised. VII. Appendices Appendix A. Public Meeting Presentation Appendix B. Public Meeting Summaries Appendix C. Written Public Comments Appendix D. Selected Review Material Appendix E. Letter to Wallace Laboratories/Reply- Availability of KI Over the Counter/Other Sources Appendix F. New Hampshire State Radiation Advisory Committee Memorandum (4/15/99) and Letter I (5/3/99) to Governor Jeanne Shaheen

• Appendix G. NRC KI Core Group Charter
• 6

APPENDIX A

• PUBLIC MEETING PRESENTATION

           \

POTASSIUM IODIDE (Kl) PUBLIC INFORMATION SESSION MODERATOR Susan Arnold, Director of Policy --

Governor Shaheen's Office

• PANEL Peter Paito~Supervisor, Emergency Response Section -

  - Bureau of Radiological Heal~ NH Department of Health and Human Services James Chemiack, Certified Health Physicist--
  - US Public Bealth Service (assigned to Region 1 USEPA as Radiation Program Manager)

Ken DeHart, Jr., M.D., Radiologist & Chief of

 . Staff-
  - Lakes Region General Hospital

• I

• * - -PANEL (cont'd) -~-

Frank Helin, Nuclear Engineer, Dir.of Operations - Vermont Yankee Joe Grillo, Sr. Licensed Operator, Technical Support Manager-- Seabrook Station Steve Haberman, Field Director - Seacoast Anti-Pollution League WQ.Qdbtcy Fogg, Licensed Professional Engineer, Urrector-NH Office of Emergency Management

• NRC POLICY ON Kl
• July 24,1985 Voluntary guidance to state and local health authorities:

  Consider stockpiliµg and distributing KI for emergency workers and-institutionalized persons, but does not recommend .... for the general public."

• 2

• - * -*- - * --*New* Hampshire Policy on KI-January 9, 1990 William T. Wallace Jr., M.D., MP.H. Director, New Hampshire Division of Public Health Services to Colonel

                                    . George Iverson, Director, New Hampshire Office Of Emergency Management KI

• " ..*.shall not be made available by this division to the general public."' "shall be made available ....to emergency workers." " ... shall be made available ... to institutionalized individuals."

             ,WHAT IS:

• A Nuclear Reactor ?

Fission? The Fission Curve? The Inventory?

• 3
• Nuclear Reactor and Fission 2

o-e-

• c.-..i.....,._,

I

                                                         ~  ---

• The Fission Curve

 *     ~    Proc1Jds af    Rs~ion, Fission Ft"Q.gme.r:,ts Assynid-ric. Fission cf U-m 11"!:      "'-'I'.

LO O-CIO)I ,__~':ID~--UD--_~--.--+--..J fr-_~

                                    -      IIO no ~201,, ~ l'i Ma.ss    N~\cr; A ,-;.;_

• I 4

• - - -- ---The Reacto.r Ccfolant Inventory Made up ofNoble Gases, Corrosion Products and Fission Products accounting for a total of200.137 uci/ml of activity Iodine is a fission product and accounts for a total of 6.51 uci/ml of activity This is 3.25% of the total activity available
• Average Annual Exposure Per Person in the U.S. Population Natural Sources Millirem Radon 200 Internal Radiation 39 Cosmic Radiation 31 Terrestrial Radiation 28 Manmade X-rays, and nuclear medicine 50 Consumer products 11

("mclnding drinking water) Miscellaneous 1 Total 360

         *Source: U.5.E.P.A. Radiation Risks and Realities, August 1993

• 5
• High .Dose Effects Dose (Rad) Effects Obsenred 15-25 Blood count changes in a group of people 50 Blood co_unt changes in an individual 100 Vomiting (thres~old) 150 Death (threshold)
• Radioactive Iodine Releases in Perspective
• #1 Ave.Annual Reactor Release (1975-1979)

 #2 TMI Accident Release March 1979
  #3 Chernobyl Accident April ~986 Iodine       Iodine 13            15 curies        curies
                                   #3
    #1       #2 t

• 6
• CONSIDERATfONS~ --

FOR POLICY DEVELOPMENT On Potential Stockpiling and/or- Distribution of Potassium Iodide (Kl) in New Hampshire 1998 .

• (This is simply a list of considerations; it is not a discussion of pro's and con's and we will not attempt to review pro's and con's at tonight's meeting. It is for the Working Group's use in ensuring we give full and fair consideration to the important issues in developing a recommended policy for New Hampshire.)
• 7

• -CONSIDERATIONS I. Level and scope of protection provided byKI Against what forms of radiation does it provide protection

      'What protection  (what organs and systems) does it provide

• When must it be taken to be effective CONSIDERATIONS
• 2. Potential side effects (contraindications) from taldng KI

      *Level of seriousness
      *Probability of side effects occmring as percentage of general population

3. Probability of a release of radioactive iodine

• 8
• _, __ -CONSIDERATIONS

4. Criteria/Protective Action Guidelines for decision to evacuate the EPZ

5. Storage of Kl

          *SlielfLife
          *Special environmental conditions required

• *Replacement/disposal of expired KI
• CONSIDERATIONS

6. Stockpile or Not

            *'Where
            *Under whose respoilSl"bility

7. Who authorizes distribution

            *How is that decision communicated

8. Liability Issues

• 9
• CONSIDERATIONS

9. Predistribute or not

     *To whom
     *How to cover new residents, young children, transients and visitors

10. Who authorizes the advising of the population to ingest KI

• CONSIDERATIONS
• 11. How to inform the public of the benefits/risks of ingesting KI

12. What effect on speed of evacuation will distribution and ingestion of KI have

13. What about people who are away from their supply of Kl

• 10
• CONSIDERATIONS

14. Overall costs

15. Comparisons with policies of other states, countries

     *KI policies
     *Evacuation policies and Protective Action Guidelines
     *Plant design and safeguards

• NOW WHAT!?

Written comments and suggestions may be sent up until 1 January 99 to:

    - Woodbury Fogg, P.E., Director NH Office of Emergency Management 107 Pleasant Street Concord, NH 03301

• 11
• AND THEN WHAT?

W orldng Group considers all these issues and comments Develops policy recommendation for State ofNew Hampshire by March 1999

• WHAT'S NEXT?
• This policy recommendation will also be shared and discussed with the other Northeastern States
• 12
• APPENDIXB PUBLIC :MEETING SUMMARIES

POTASSIUM IODIDE {KI) PUBLIC INFORMATION SESSION

• Exeter Town Hall December 8, 1998 6:00 p.m.

Susan Arnold, Director of Policy for Governor Shaheen and moderator for the evening, opened the session. Approximately 60 individuals were in attendance. Ms. Arnold introduced the panel that consisted of the following individuals: James Cherniack, Certified Health Physicist - U.S. Public Health (assigned to Region I U.S. EPA as Radiation Program Manager) Ken DeHart, Jr., M.D., Radiologist & Chief of Staff- Lakes Region General Hospital Joe Grillo, Sr. Licensed Operator, Technical Support Manager, Seabrook Station

• Steve Haberman, Field Director Seacoast Anti-Pollution League (SAPL)

Peter Paiton, Supervisor, Emergency Response Section - NH Office of Health Management, Bureau of Radiological Health Woodbury Fogg, P.E., Director- NH Office of Emergency Management

• A presentation was given by the above panel.

Peter Paiton, NH OHM, explained the NRC and the State of New Hampshire's policies on KI. Jim Chemiack, U.S. EPA, explained a nuclear reactor, fission, the fission curve, reactor coolant inventory, average annual exposure rates, and radioactive iodine releases in perspective. Dr. DeHart, Lakes Region General Hospital, explained the effects of radiation and complications from taking KI. Woodbury Fogg, NHOEM, explained considerations for policy development, which included the level and scope of protection provided by KI; potential side effects (contraindications) from taking KI; probability of a release of radioactive iodine; criteria/ protective action guideµ.nes for decision to evacuate the EPZ; storage of KI; stockpile or not; who authorizes distribution; liability issues; predistribute or not; who authorizes the advising of the population to ingest KI; how to inform the public of the benefits/risks of ingesting KI; what effect on speed of evacuation will distribution and ingestion of KI have; .what about people who are away from their supply of KI; overall costs; and comparisons with policies of other state and countries. Woodbury also explained what the next steps in this process would be. The session was then opened to the floor with the following comments: Wayne Loosigian - Exeter - Stated "It's a no brainer that people, adults and children, on the seacoast, should have access to Potassium Iodide". If there was a place where he could go to get Potassium Iodide, then that is all he needs to know and he would go and do that. People, as adults and parents, should be held responsible. Also, given the choices, he would rather be ingesting the pill and have the minor side effects than not have the pill. 1

Jim Tocci - UMA/ Amherst - Stated that KI appears to be helpful, but not enough is known about the side effects of KI and that it should not take away the importance of evacuation. Is concerned that making KI available would take the focus off evacuation. He would like added to the list of considerations - who administers KI to the children in schools. Amy Praded - Kensington - Uncomfortable with relying on evacuation only. Would like a 2nd plan other than evacuation. - More confidence-in our own abilities to decide. Chris Nord - Exeter - Concerned with evacuation feasibility and time to do so. Stated concerns about beach population. Mark Trafton - PEA/Exeter - Concerned with evacuation plans. Questioned the presence of a nuclear power plant on the seacoast. Hopes cost will not be a factor with the KI issue. Later stated that at this moment, radiation monitoring is not being done in New Hampshire, nor are those figures readily available to the public that are being monitored by NAESCO at the plant in Seabrook. We should join SEA-10 with Massachusetts. Kathleen McAllister - Concord - Does not believe in fail safe systems. Has grandchildren who live in the ingestion pathway. Has an interest in the childhood thyroid cancers as a result of Chernobyl. Is concerned about the volatility of iodines and apparent cancers caused as a result of thyroid uptake. Stated that unless we have it available, there will be no dose reduction. Suggested looking at dose reduction. Later stated that there's a need to look at stockpiling KI. Joan Pratt - Brentwood - Questioned whether KI could be distributed through a family physician. She feels an individual's doctor may know more about the person's side effects or medical repression they might have. Charles Pratt - Brentwood - Weather conditions could effect evacuation. Questioned ingestion pathway issues, i.e., food contamination. Questioned whether there is consideration for only distributing KI in the 10-mile radius or further up . Chris Mertinooke - Kensington/EMD - Time of ingestion is an issue. Spoke about EMDs duties to protect citizens and handling the responsibilities of distribution of KI with very

   ~ted resources. He would opt to work toward evacuation rather than distribute Kl.

Bill Cash - Seabrook Station - Concerns in regards to distribution of KI to the general public. KI should not be used as a remedy instead of having to evacuate. Need to ensure that people understand that when KI is distributed to them that they clearly understand that it does not generally provide protection from radiation exposure externally. Dixie Hummel - Exeter - Disappointed with the time of the meeting. Stated that a lot of people who should be here are not because of the choice of time. Would like another meeting at a more convenient time. Questioned what other states with such plans have done. Jim Martin - Would not give KI to his children. If given choice of evacuation or KI, he would leave. Steve Haberman - SAPL - Stated that KI should be an adjunct to the existing emergency plan. Backs evacuation and feels KI should be considered as part of the plan. Susan Cameron- PEA Student - Not aware of the PEA emergency plan, but would like it. 2

Chris Soave - Exeter /EMD - Responded to PEA student, stating that the Academy has been well-drilled and participates in all Exeter's drills and should see Security to review their plan. Thinks 30% of the population would have trouble following directions for administering KI and would need to be supervised when taking it, i.e., elderly citizens. Cannot be stockpiled because there would not be enough time to distribute it. Barbara James - PEA-: _Stated the plan won't work and the need to eliminate the problem (Seabrook Station). Evacuation is the concern. Wants the option to reduce risk. Peter Paiton - OHM - Seacoast is being monitored from Portsmouth to the Massachusetts line for many years now using TLDs. Sandra Gavutis -SEA-10 Rep. - Kensington - Stated that TLDs are not real time monitoring. Feels as citizens of this State, we should know of any increases in cancer and stated that if they (Three Mile Island) had KI available they might not have had so much thyroid cancers show up. Wants cancer registry data sent to Massachusetts for analysis. Al Chesley - Vermont Yankee - Questioned the shelf life of KI. What happens to it? Dr. DeHart r~sponded that it becomes less soluble . Linda Haskins - PAE - Feels the plan is not workable. Seabrook Station is a threat to the health and safety of the citizens and it is their responsibility to educate the public on taking KI. Un/mown - One gentleman stated that until a full-scale evacuation is done, there would always be doubt . A short discussion was held on the shelf life of KI and it being a liability issue. The meeting ended at 8:05 p.m. 3

POTASSIUM IODIDE (KI) PUBLIC INFORMATION SESSION

• Chesterfield, N.H.

December 15, 1998 6:00 p.m. Susan Arnold, Director of Policy for Governor Shaheen and moderator for the evening, opened the session. Approximately 30 individuals were in attendance. Ms. Arnold introduced the panel that consisted of the following individuals: James Cherniack, Certified Health Physicist - U.S. Public Health (assigned to Region I U.S. EPA as Radiation Program Manager) Ken DeHart, Jr., M.D., Radiologist & Chief of Staff- Lakes Region General Hospital Frank Helin, Nuclear Engineer, Director of Operations, Vermont Yankee Steve Haberman, Field Director- Seacoast Anti-Pollution League (SAPL) Peter Paiton, Supervisor, Emergency Response Section - NH Office of Health Management, Bureau of Radiological Health Woodbury Fogg, P.E., Director - NH Office of Emergency Management

• A presentation was given by the above panel:

Peter Paiton, NH OHM, explained the NRC's and the State of New Hampshire's policies on KI. Jim Chemiack, U.S. EPA, explained a nuclear reactor, fission, the fission curve, reactor coolant inventory, average annual exposure rates, and radioactive iodine releases in perspective. Dr. DeHart, Lakes Region General Hospital, explained the effects of radiation and complications from taking KI. Woodbury Fogg, NHOEM, explained considerations for policy development, which included the level and scope of protection provided by KI; potential side effects (contraindications) from talcing KI; probability of a release of radioactive iodine; criteria/protective action guidelines for decision to evacuate the EPZ; storage of KI; stockpile or not; who authorizes distribution; liability issues; predistribute or not; who authorizes the advising of the population to ingest KI; how to inform the public of the benefits/risks of ingesting KI; what effect on speed of evacuation will distribution and ingestion of KI have; .what about people who are away from their supply of KI; overall costs; and comparisons with policies of other state and countries. Woodbury also explained what the next steps in this process would be. The session was then opened to the floor with the following comments: Rich Garant - Brattleboro, VT- Questioned what other countries (Soviet Union) have done in regards to the distribution of KI after an incident. Peter Paiton, OHM, responded. 1

David Piles - New England Coalition Against Nu~lear Pollution - Feels advanced distribution of KI is necessary in homes and in workplaces. It should be made available everywhere. Stated that KI saturates the thyroid within 30 minutes and that taking it quickly makes sense. Later stated that NRC is afraid of KI delaying evacuation. Chuck Edwards - Vernon, VT - Discussion of protection by IPZ food embargoes. Later talked about how I-131 actually got out at Three Mile Island. In regards to Y2K there's no link between computer and plant operations. VY is hardwired for safety systems. Evacuation not feasible but thinks the plants are safe. Ifatra Faust - Citizen Awareness Network - KI should be available ASAP to all communities; meteorological effects on tri-state communities have not been explained to people; needs adequate notification for handicapped and homebound individuals. Greg Brede - Swanzey, NH Lives vn.thin EPZ and works at Vermont Yankee. Questioned what kind of accident could possibly produce such a release. Frank Helin, VY, responded. Roy Swain - Westmoreland, NH - In regards to the Considerations List, stated that there was no mention of how to deal vn.th bringing up the issues of the dangers. Steve Haberman, SAPL, and Susan Arnold, Governor's Office, responded. Tom Sintros - Keene - Discussed thyroid cancer. Bob Jeffries and Woodbury Fogg, NHOEM, Peter Paiton, OHM, and Susan ,Arnold, Governor's Office, responded with a discussion about Maine's problem with stockpiling KI and discussed school issuance of KI as a liability issue . Rep. McKim Mitchell Y2K. Chesterfield - Questioned whether timing of this issue is related to Unknown Woman - Had questions about stockpiling and in what amounts. design an action plan? Who will Bob Jeffries - NHOEM - Responded to above woman in regards to plan administration of KI. Unknown Woman - Spoke about negative effects of KI and how do institutionalized individuals avoid this. Lisa Stockwell- Spofford, NH- Works at VY. Is against stockpiling and believes it is highly unlikely Three Mile Island would happen again elsewhere. Feels best thing is to evacuate and use plans. Overemphasized drug interactions to KI. Al Chesley - Vermont Yankee - Suggested reading the KI package insert. False sense of security using KI. Not in favor of issuing KI. Unknown Man - Questioned if there are any other substitutes for KI. Dr. DeHart responded with KI being the only good one. The meeting ended at approximately 7:40 p.m .

• 2

APPENDIXC WRITTEN PUBLIC COMMENTS r

The Commonwealth of Massachusetts Executive Office of Health and Human Services Department of Public Health Radiation Control Program 174 Portland Street, 5th Floor, Boston, MA 02114 ARGEO PAUL CELLUCCI (617) 727-6214 (617) 727-2098 - Fax GOVERNOR

    -  JANESWJFT UEUTENANT GOVERNOR.

WIWAM D. O'L.EARY SECRETARY HOWARD K. KOH. 11D, MPH COMMISSIONER Janua:ry 27, 1999

• Woody Fogg, Director Office of Emergency Management 107 Pleasant Street Cop~qrd, NH 03301-3809

          -D~ar Director Fogg: - -- : - --- -

It -ha_.s come *to our attention-- that th; *~~~ --~~shire Radiation Advisory Committee, in conjunction with the Governor'*s office and your off ice, recently conducted two public hearings and have an open comment period to receive comments and public input on the issue of distribution of potassium iodide (KI) to the general public for nuclear power plant emergencies. Since Massachusetts shares a common border with New Hampshire, and we jointly share responsibilities in the vicinity of both the Seabrook and Vermont Yankee nuclear power plants, we would like to offer comments from the Massachusetts Department of Public Health (MDPH) concerning this issue. The MDPB assists the Massachusetts Emergency Management Agency (MEMA) in car:rying out emergency response functions around nuclear power plan.ts for the Commonwealth of Massachusetts. In this emergency planning process, MDPH is responsible for recommending protective_ actions (PAs) during emergency *situations for implementation by the MEMA. When NUREG-1633_ was published for comment in July ~998, the MDPH, like many other state ageJ.?,ci_~~- responsible for emergency functions, reviewed the draft report.arid, *as the report suggested, reconsidered the issue of distribution of KI for the general public in Massachusetts. Massachusetts has had in place a policy since 1982 on the use of

• l'*: :.-*-:.:*.*-J:-.:1;-;. -*-:-.:;_~¥e~::;rt*- ;-~;'-~.::

          . ...  . ~                    .

I ' I Page 2 KI during incidents/accidents at nuclear power plants. That policy was essentially one of not stockpiling KI for distribution to the general public and not recommending that KI be used by the general population. The policy did adopt the Federal Emergency Manag~ent Age~cy's_(~) guitjanc~ so that KI would be available for emergency workers and institutionalized patients, but only under the direction of the Commissioner of MDPH. The MDPH continues to believe that KI should not be distributed to the general public for use in severe accidents at nuclear power plants. Massachusetts recommended protective action would be evacuation of individuals rather than leaving them in an area in which they might receive not only exposure to radioactive iodine but also any radioactivity. We believe that the ingestion or exposure to other radionuclides from an accidental release are

                          -equally important from a protective action perspective. The use of KI is not an alternative to evacuation .

• The Environmental Protection Agency 1 s (EPA) PAGs manual is based upon projected effective dose ~quivalents and clearly spells out primary PAs of evacuation, sheltering, and secondly the administering of KI. Massachusetts conservative implementation of the PAs allows us to recormnend evacuation even when a-fraction of this effective dose equivalent is projected, thus further
• decreasing any need.for KI, except for t~o~e not evacuated .

Other issues of concern are that KI, as a pharmaceutical, may present side effects and allergic reactions; difficulties exist in communicating when and how KI should be. taken; -logistical difficulties exist in stocking and distributing KI; possibilities exist with people taking KI on their own without direction; the .

• possibility exists of children taking KI alone without supervision; and, the distribution of KI to the public may give individuals a false sense of security so as to not take other protective actions. Lastly, and very importantly,. the actual levels of radioiodines released off-site from severe nuclear power plant accidents are project~d to be so low that the ac.ministration of a thyroid blocking agent as a protective action would not be warranted.

In conclusion, the MDPH recormnends, and MEMA. concurs, that KI should not be stockpiled for distribution to the general public for emergencies around nuclear pow~r plants. We are *especially concerned that in our Tri-State emergency planning activities with New Hampshire and Vermont for the Vermont Yankee nuclear power plant, and our Bi-state activities with New Hampshire around the Seabrook nuclear power plant, that the public would be receiving mixed and conflicting messages if public distribution

• was adopted in New Hampshire. We appreciate the opportunity to
• i,.

Page 3

• • off er our cormnents and would be happy to answer any questions that you may have. I can be reached at 617-727-6214.

Sincerely,

                                - ,f:.,..__, Q'Q, " ~

Robert M. Hallisey, Director Radiation Control Program

pjd

• cc: Nancy Ridley, MDPH Peter LaPorte, MEMA Diane Tefft, NH RCP

!I. f. New England Coalition on Nuclear Pollution, Inc. PO Box 545, Brattleboro, Vermont 0.5302

;~                                        (802) 257--0336           necnp@necnp.org Statement of David N. Pyles On The Stockpiling_ of _p~um Iodide in the Evacuation Areas Around the Seabrook and Vermont Yankee Nuclear Power Plants At a Public Meeting in the West Chesterfield (NH) Town Hall .
                              .                       December 15, 1998 My name is David Pyles. I am the office manager for the New England Coalition on Nuclear Pollutioo, *a Brauleboro, vr, based anti-nuclear advocacy organization.

It is the position of the New England Coalition that Potassium Iodide {KI) should be made available to the people living and working in the evaal31:ioo zones around both the Seabrook: and Vermont Yankee nuclear power plants. Indeed, we believe that st.ockpiling id not enough. We would advocate that sufficient Potassium Icxlide be made available to every house.bold and workplace in both evacuation zones. Potassium Iodide is a vezy effective and inexpensive preventative to the uptake by the thyroid of iodine 131 (I-131) a radioactive isotope that could be released in significant qmmtities in a criticality accident The effectiveness of KI is dependant on is being administered quickly. According to RxMed, a peer reviewed World Wide Web site providing information for primary care physicians: Potassi10n iodide, an ionic lhyroid blocking agent, acts on the tran.spo11 of iodide into and out of tire thyroid. When given in sujficienJ amounts, entry ofradi.oiodide inJ.o the gland can be 1'irtually preventf!d. The onset ofinhibilion is rapid and is readily demonstrated 30 minutes after oral administration. An important factor in obtaining satisfactory acute block of radi.oiodin.t uptake is tire speed ofioault administration after exposure to radi.oiodine. It is dear from standard uptake curves that. after a single pulse of radi.oiodin.t, the bulk of it has enJered ti~ glantl b)' 10 to 12 hours and littk bazejiJ may be o:pected by blocking beyond this time. A substantial benejiJ (e.g. a block of50%) is attainable only during tlzejirst 3 to 4 lwurs. For more prolonged iodine 131 exposure, iodide will be useful. at any time during the exposure and hence should still bt given ~n iftlze drug mzs not given shortly after the release of radioactivity.

• It is this need for prompt administration for KI to be an effective 1-131 blodrec that lefil.ls us to advocate for the "drug" to be issued to people in their homes and workplaces prior to an accident at one of the plants.

We ran see no case there the delay of processing people to administer the doses after the fact of a nuclear accident would do anything but dilnte the effectivenes.5 of the compound. Officials in workiilg for the Slate of New Hampshire have expressed concern that there might be lawsuits if Potassium Iodide were distributed widely and some people who were allergic took the drng. I wonder if lhey have considered the cost of.the "pain and suffering" lawsuits that might come about if this compound were stockpiled and its administration were less effective because of the time it took after an accident to have it administered. Toe Nuclear Regulatory Commission's RTM-96: Response Technical Manual (NUREGJBR-0150, Vol 1, Rev. 4) states that 'i:be thyroid dooe from inha.laticm ran be a hmidred or more times higbe.r than the dose from external exposure." Wlth that in mind it is imperative that a program to help protect those who might be downwind of a nuclear accident be designed that will allow for the fastest possible administration of the "drug." ToankYou.

• David N. Pyles Educating the Public in Safe, Clean Alternatives to Nuclear Power for over 25 years

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  .-                                                  The City of Portsmouth Fire Department 170 Court Street Portsmouth, NH 03801-4122                                                             .:

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TOWN OF STRATHAM Incorporated 1716 I I I 10 Bunker Hill Avenue* Stratham. NH 03885 (603) 772-4741 Deces:rber 21, 1998 Woodbury Fogg, P .E. , Director NH Office of Emergency Mallaganent 107 Pleasant street Concord, NH 03301 RE: Public Distribution of Potassium Iodide (Kl)

Dear Mr. Fogg,

We have been following the public discussion regarding the distributi.CJD. of KI to the general public as part of New Banpsh:ire's Radiological Energency Response Plan (mm>) for Seabrook statian. Although we have our doubts regard-ing the purpose of such a program, we are not in a positiOll to cri.tically critique the effectiveness of the distributiOll of KI to the general public. Rather, it is the logistics of such a distributiOll that concerns us *

• l\n,Y plans developed to i:nplement this change in policy should not involve the towns within the Emergency Planning Zeme (EE'Z) in the distribution of KI to the general public. The burdens of storage 'BDd/ or distribution of KI, of instructian in its use, and of notification to use KI is an inpositiOll that the Town of stratham bas no desire or interest in shouldering. The towns within the *EPZ have enough to do currently tmder the existing RERP without addjng
• this task. To do so will anly cmpranise our current abilities to respcmd to an emergency, thus negating any perceived benefit fran the general distribution of KI.

We hope :you will give due cansideraticm to our positicm in this matter as you deliberate your next course of action.~ We all share the camrn interest of

                                                                                                          \

insuriDg the public's safety during a radiological incident. However, we do know our limitatiaas and feel J'OU should be apprised of this fact before a decision is reached. We do seose *that the potential benefits gained do not warrant the liabilities assmed in providing this additional but questionable level of protecti~ ~ t h e ~ ~ a c e *

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 " Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, JvfD 20815 I 301-656-3998 I pgcrane@erols.com

• Mr. Woodbury Fogg, Director New Hampshire Office of Emergency Management 107 Pleasant Street January 15, 1999 Concord, New Hampshire 03301

DearMr. Fogg:

I appreciate the opportwrity to submit comments on the issue of potassium iodide stocli>iling. In the interest ofbrevity, I will cite documents already in the public record and ask that they be considered incorporated by reference. In this letter, I would ffke to concentrate on supplying information about some pertinent recent events. The basics of the potassium iodide question are outlined in a December 8, 1998, article that I wrote for the Keene Sentinel (attached). A fuller discussion of the issue, and an account of its handling by the Federal Government over the past 20 years, may be found in the talk I gave in July 1998 to an international conference on radiation and thyroid cancer, held at Cambridge University in England. It appears on the NRC's rulemaking website at the following address: http://roleforum.llnl.govlcgi-bin* 'rolemake?source+ Kl_?ETIJJON_public&jile=244-0092. htm. The following are some specific points about recent events. 1 NOREG-1633 withdrawn, revised version in preparation In my Cambridge talk, I praised the NRC Commissioners for having approved, by a 3-1 vote, an amended petition for rulemak:ing,, filed by me, under which the NRC will require that states with nuclear power plants consider including potassium iodide along with other protective measures (evacuation and sheltering) in their radiological emergency plans. (See NRC press release of July I, 1998.) I also called on the Commission to withdraw "NUREG-1633,"' the draft technical assessment~ by certain members oftheNRC technical staff: and to remove it from the NRC' s website before its misinformation and bias caused any more harm. The NRC's technical analyses are normally of high quality, but even a highly competent agency can have an off day, and NUREG~ 1633 represented the NRC' s work at its worst See, for example, the September 28, 1998, *comments on it from Dr. Kari:rJ?. Rimawi, the Director of the Bureau of Environmental Radiation Protection in the New York State Department of Health,, who wrote that the sfate?J; Radiologica.I Health Advisory Committee 1:tad "found no health related reasons why KI could not be used" for iodine prophylaxis in an emergency. Consistent with the Advisory Committee's recommendation, Dr. Ramawi said, the state had begun a review to determine if there were logisticaJ or legal reasons not to make potassium iodide an option in radiological emergencies. He continued: The department [of health] had looked forward to NRC's report in the hope that it would assist us in the review. Unfortunately, we find the docmnent to have been prepared to justify a position advocating against the use of KI for public protection, rather than as an objective review of the relevant information. This bias raises doubt as to the value of1he document In nine pages of detailed comments, the Department of Health then proceeded to catalog

• NUREG-1633's many defects. Ohio state officials also filed highly critical comments. 1 I am pleased to report~ !he NRC Comnµssioners took note of the comments,

 * -*recogiiiied tlie deficiendes in NUREG-1633, and ordered the document withdrawn from circulation and taken off the NRC website. On October 12, 1998, the trade publication Inside N.R.C. published an article entitled "COMMISSION APPROVES KI NOTICE TO FRPCC, ORDERS DRAFT NUREG WTI1IDRAWN."' It quoted Commissioner Edward McGaffigan as follows:
              "As one staffer has pointed out 10 me,'" McGaffigan said, "it [NUREG-1633] was never intended to be supportive of 1he policy 1he Commission established in its 1lllle 26 SRM, but was instead a justification for the policy (not granting the revised petition for nilemaking) vmich 1he staff had advocated and 1he commission rejected --* I made the mistake of fuinking no harm cmtld come :from just putting a document out for public comment. I was wrong."

The Commission directed the NRC staff to revise NUREG-1633. This task has been undertaken by a so-called "Core Group." This group includes some of the same NRC staff members responsible for preparingNUREG-1633 in the first place. We shall have to see how good a job they do, and at this point, they should be given the benefit of the doubt Nevertheless, it is troubling to read Mr. Charles Willis of the NRC staff saying, on the transcript of the December 1, 1998, meeting ofthe Core Group, the following:

• I don't know how 10 phrase this in a politically correct manner, but I have to question basing onr decisions on 1he Poland experience.

As we all know, it was a commmrist country at the time. I've had the privilege of J:tvmg in two dictatorships, and 1 kn_ow ~ y.,hen the order comes down to do something, the report goes back up that it was done. Whefuer it was done or not is another matter.

                       . And we have a little experience in the United States that, at TMI, there was an

• effort made to get KI for use fucre, and we were unable to come up with the few thousand doses that were needed Yet, in Poland, in BJ1 admittedly advanced state of development, could suddenly come up with millions of doses of KI. . .

S~ I have to ask how valid we believe these data are. 2 The suggestion that the Poles faked the distnbution of potassium iodide, and that the data on the Polish experience with the drug is therefore fiction, is on a par with the theory that Neil Armstrong's landing on the moon took place on a Hollywood set It seems to explain why NUREG-1633 contained the- unsubstantiated and insulting insinuation that an eminent Polish doctor's report in an American medical journal on his country's use of potassium iodide_ should 1 My own critique ofNUREG-1633 is available on the NRC's rulemaking website at http://ruleforum.llnl.govlcgi~binlrulemake?source+KI_PETITION_puhlic&file=244-0092.htm

• 2 This transcript may be found on the NRC website at

    'Hrww.nrc.govlNRC/PUBL/ClKi/19981201.htm:

• I .

not be believed.3 Regrettably, Mr. Willis's co-authors did not speak up to take issue with his comment Rather~ it was left to Mr. Aubrey Godwin,of the Arizona Radiation Regulatory Agency, to say gently that the Polish data had "hung on pretty well"; that other countries had also given out potassium iodide during Chernobyl, and that if the administration of drug in Poland had been an invention of the Com.mt.mists, that fact would have come to light after the fall of Commtmism. 4 3 There is special irony in these \\rild charges. NUREG-1633, after all, was a doclllilent rife with errors both of omission and commission. It managed never to mention, in its 40-odd pages, that potassium iodide had been ruled "safe and effective" by the Food and Drug Administration and approved for over-the-counter sale. It did, however, include lurid quotations from the Physician's Desk Reference, designed to play up the haz.ards of potassium iodide. But what the authors failed to mention, and no reader could have guessed, was that three of the four quotations purportedly descnbing the hazards of potassium iodide did not refer to the form of the drug used for thyroid blocking, but to a vastly more potent prescription medicine used to treat pulmonary diseases. The fomth quotation, on risk to children with cystic :fibrosis, cannot be found in any of the Physician's Desk Reference writeups on potassium iodide. Readers can judge for themselves whether this crossed the line that separates science from propaganda. 4 The NRC experts' statements on the Polish experience with KI seem to oscillate. In a July 8, 1998, message to RADSAFE (an internet forum for persons interested in health physics i~y~), Mr. Willis_wrote: "I'do_n~have the full story but our understanding is that ... (6) after Chernobyl, Poland distnbuted KI to almost their entire population ( too late to do much good, but the doses were quite low anyway). The Polish experience is said to be encomaging because there were only about 35,000 medically significant adverse reactions to the KI." The transcript of the December I, 1998, meeting records Mr. Willis telling the Core Group members: "We did go to more than a little trouble to let people know about this issue [potassium iodide]," and he cited RADSAFE as one example. Thus we can presume that when Mr. Willis writes to RADSAFE on this subject from his NRC web address, on NRC time, without any disclaimer, he is speaking in his official capacity. On July 21, 1998, Mr. Willis wrote to RADSAFE: Another concern is the hazard from KI itself Properly administered, KI seems to be a relatively safe drug. According [to] 1he recent draft WHO recommendations, proper administration includes carefully adjusting the dose according to the age of the individual and not giving KI to people with certain medical problems or to people who are taking certain other medications. Some people (those who are allergic to iodine-) know about these limitations: at the Minneapolis meeting, several people made remmxs to the effect that "130 mg of KI would kill me in an hom." Other people do not know about their vulnerability. In fact, one of the authors <Cog~ did not realize untH a couple of weeks a,~ that bis medication makes KI QJJW'- dag!:'erons to him, £"cardiac arrest9' is a decidedly adverse reaction}. [Emphasis added.] If potassimn iodide is going to cause Mr. Congel to go into cardiac arrest, it is surprising that it took him until July 1998 to learn this fact, when he has been studying the issue intensively at

. I TI. NRC Commissioners approve draft new Federal policy on potassium iodide _ _ As mentiQ:Q.ed mth~ headline of the Inside N.R C article quoted above, the NRC Commissioners have also approved a draft of a new Federal policy on potassium iodide. It is a public document, and a copy is attached. It provides the balanced, reasoned discussion of the benefits and limitations of potassium iodide that was so signal]y absent from NUREG-1633. The draft was sent to the Federal Radiological Preparedness Coordinating Committee, a multi-agency group headed by FEMA. Ill Commissioner Greta Dicus endorses stockpiling of potassium iodide On December 1, 1998, as Inside N.R.C reported in its issue of January 4, 1999, Commissioner Greta Dicus told the "Core Group" that though she had been the dissenting vote in the Commission's 3-1 decision to grant my rulemaking petition, she now supported KI

• stockpiling. 5 Th.is is welcome news indeed.

least since 1989. (He was on the panel that reviewed my June 1989 "Differing Professional Opinion.") It is also strange that the NRC should continue to require that supplies of the drug be maintained for plant personnel and emergency workers. Preswnably they include individuals who are at as great a risk of cardiac arrest from potassium iodide as Mr. Congel is. It is strange, too, that no one has asked the Food and Drug Administration to revoke its "safe and effective" finding for potassium :iodide. I asked a prominent medical ex-pert about Mr. Congel' s newly discovered risk "Absurd," was his answer. He JX>iri.ted out that hypertension (the illness for which Mr. Congel takes a potassium-sparing diuretic) is the most common heart-related complaint in Poland, with 4.5 million patients. lfJX)tassium iodide caused cardiac arrest in persons taking such

• medication, there would have been cardiac eff~ seen in the Polish population. In fact, only two Poles required hospitalization - briefly, for transient allergic reactions. Both had known allergies to iodine and took the medicine despite having been ~mned not to.

51:be transcript records Commissioner Dicus as follo\\is; I will quote at length, to ensure that the context is unambiguous:*

• I was pleased tn be asked tn come down just tn make a couple of comments, and I really am only going 1D make a couple of comments, and it may be a little bit smprising that I came down and say some of the things rm going tn say, because I think yon all know the vote on KI at the Commission level was tbree--one, I was the dissenting voice, but I do believe in stockpµing KI.

So, yon may say, well, then why did yon vote against wha:t I voted on, and I'm going to go a little bit into that, because Jdo believe mthe stoclQ)ilin2. I just have some thoughts about where that might go. . Yon have a very impommt as.qgnment Yon are, first of all, tn develop a revised draft of the teclmical docament 1hat lays out the teclmical considerations behind the

• Commission's recent decisions regarding the role of KI in emergency response planning, and your second task is tn descnoe those considerations in a brochure that can support state and local decision-making cm the role of KI in site-specific emergency response
• IV. World Health Organization moves toward Jowering intervention IC\*eJs for potassium iodide On the same December 1, 1998, transcript cited earlier, Mr. Aubrey Godwin descnoes the move on the part of the World Health Organization to recommend intervening with potassium iodide at much lower levels of radiological exposure th.an previously contemplated -

as low as one rad to children. Vvhether this will be the ultimate standard is not yet clear. What is clear, however, is that the world scientific community is moving in the direction of using potassium iodide more aggressively in the event of radiation e~-posure, based on concern over the proven suscepnbility of children - especially children four years old and younger - to radiation--caused thyroid cancer. V. New figures on cost and shelf life I recently received, from Mr. Harvey Brugger in the Ohio Department of Health, copies of e-mails from a Swedish supplier of potassium iodide. 6 This company is guaranteeing a 10-year shelf life and is offering blister packs of the drug, ten pills per pack, at$. 70, for orders of one million packets. For orders of 10 million packets, the price drops to $.60 per packet. The Polish data is based on the administration of just one pill. If one packet is enough to supply enough medication for ] 0 peop1e for l 0 years, we are talking about an annual cost of as

• .. as low six-tenths of a cent per person. Over the years, the NRC staff has spent vastly more money studying this issue than the drug itself would cost. According to New Hampshire's official website, the population of the state is 1,162,000. If my arithmetic is right, that puts the annual cost of protecting every child, worn~ and man in the state a1 $6972. (I express it in that order not to be "politically correct," but because children and pregnant women are the first priority for thyroid protection in a nuclear accident) -
• Officially,_ Unitf:(i States policy, adopted in 1985, still holds that potassium iodide is "not worthwhile'" - that is, too expensive for us to afford. 7 Yet the Core Group seems to have found planning, and clearly, these projects tluit yon have before you and the task that yon have before you came out of the Commission's recent decisions with respect to the role of KI in emergency plarrning, and as I have said, I fullv support the Commission's decision in this regard, even though I did vote against what I had in front of me at the time.

I favor the stockJ,ilig: of KI for possible use in a nuclear emergencv as a supplement to other protective me.asnres. [Emphasis added.] 6 These may be found on the NRC website a1 http://rolefonon.llnl.gov/cgi-binlrul~?~ce"""-KI_PE11110N_puhlic&fzle=2-ff-0093.htm. 7 In principle, the decision to change that policy, and to purchase the drug for any state requesting it, was made by the Federal Radiological Preparedness Coordinating Committee in 1996, and endorsed by the NRC Commissioners the following year (see NRC press release of

• the money to fly its members to Phoenix, Arizona, for their ne}..'t set of meetings, at the beginning of March. Preswnably their understanding o~the po~iurn iodide issue will be enlianced by meeting withm the boundaries ~fa state where the drug is currently stockpiled.

Thus while the Government pinches pennies - even fractions of pennies - on an antidote against childhood thyroid cancer, the NRC's potassium iodide e}..°perts apparently think that cost is no object when it comes to studying whether to buy our children that protection. The Core Group's midwinter excursion would not be half so offensive, therefore, if not for the fact that hundreds of thousands, perhaps IDillions, of American children could be protected against childhood thyroid cancer with the money that wiJI instead be spent on plane fares, hotels, meals, and rental cars in sunny Arizona Sincerely, Peter Crane Attachments:

1. Article, Keene Sentinel, December 8, 1998

• 2. Commission-approved draft Federal policy statement, September 30, 1998

 -- cc:     - ChairmanJackson __

Commissioner Dicus Commissioner Diaz Commissioner McGa:ffigan

          . . Commissioner Merrifield Senator Tom Harkin Senator Joseph l Lieberman NRC Secretariat Docket File, No. PRM-50-63A July 1, 1997). But in contrast to states such as M.aine and Ohio, which have moved swiftly and decisively once they took up the potassium iodide issue, the Federal Government has proceeded at a crawl                         -

6 The Keene Sentinel* 'I\168d11y, December 8, 1998 tlfhe !(eene , Jentinel OPINION .PAGE Edited by Guy Ma~illin Peter Crane , _ . Keene, New H~mpshire . . Establi5hed In 1799 1

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Nuclear safety question:' Are kids' lives*are Worlh*7 centS1'! oat Americana probably In fad., the 1lngl1 mo<<t slgnlft* of the erlenalve 111tgery needed 1.6 box of aalL: It Is the chemical added

• coats only about '1 C611tl l)i!r child
• liven wllh the' beat ot plannln
• M auume lhal when IL comet cant health Juaon learned from Lo en1unn1 our chlldnm'a

      *afuly m cue of a nuclear accident, our government provldu prot&o-Chernobyl ttirnt out lo be the efTec-Uvanou and *afe~y of powalum lotlide. Wo know thla from Lho nmove the affected lymph nodes.

Even In adulta, thyroid cancer la to aalt to lodlui It. not a trlvlal lllneu. More U11m lltock 11mg the drug almOl!l two 1,000 Amerl~na die of It aech year. dacad61 ago. In 1978, the Food and protecud, this policy has left for-The Unlled Btatea came cl0111 to . elgn heall h aulborlUes ahaldng their hew al tt1'1 baffling priori-there ii no guarantee that In a

• emergency, potaaalum Iodide wl 1 eel lo everyono, But if a major 111:1: '

lle_s of the American go~ernment.. If de.rlt occurs, aud then, la no pota

• t1on eecond to none. IL aillluld be uporlenco of Poland, where hoallh Th0&e who have had the dllM!au Drug Administration declared It
• poverty-stricken Annenla can llnd ium lodld11 lo glvo out, then IL ,

tnie, but 1t Isn't.. Ono key olomont authorltloa were ready wllh a and been cured of It - I'm one of . "safe and effaeUve* for wu, by the tho money to protect illl chlldren . guaranued I.bat tho drug will 1111'1. of nuclear emergency planning -'

• et.ockplla of 90 lllllllon doaea of the them - wUI toll you that IL can bo general
• publlo during nuclear . from cancer, I.hoy ,uk, how can the' I.a no on~. lfU1at happen1, we know the rad1allon antidote potaulum drug, When their r11dl11Llon monl* a profoundly dl1111greeahle expetl*,. , emergenclu. In 19?Q all.er federal rlcheat country In the world cold* ~ frotn Chernobyl . what wo c.an 1 Iodide, to prevent thyroid CAncer - ', tora dlacovtred airborne r11dlo11c* ence, bringing ph)'lllcal and omo- and elate aulhorltlea lookad In vain bloodedly decide that chlldhood
• expllCt to aee a fewyeara later: chll- ,

Is et.andard In Euro!'H,, Japan* and tlve Iodine In the atmoephere, the Uonal hardahlp to paUent.s and for the drug durln& the Three Milo . cancer la more affordable than can* ,

• dren with thyroid cancer that could .

Cftnad11 but lackmg In' all but a

• Polea contlud&d, notwllb1lahdlna:.
• their families. . . Island accident, a preeidenllal com* ,
• cor Pf!!VenUon? , * ,,
• have be~ avemd. If alate.s w1U1t few U.S. llatea, Thal l1111Larlln11 lo , Mo1M:Ow'a denials, th11 t a Soviet
• Fortunately, the u.a'. Nuclear mlee!on cullgaled the NRO for , The doct4r* or the American !
• to worry about legal llaWllty, they .

  chan11e, however. Now Hampahlra

• 1*, react;ir had experienced a major Regulatory Commlaalon bu heed- falling to tmaure I.hat atockplloa ' Thyroid Anocletfon underitand
• ahould ba thlnldng about tho law* : . *
• will soon be deciding wh.ether to
• accident.. 'l'boy I quickly began ,* ed the data from Chernobyl. Under were available. 1,ie NRO promllllld
• beat of all tho loll that thyroid can* ' sulla thou,. llhlldren'1 puenh*'
• begin atockpillng' the drug, as admlnlaterlng pol.auliim Iodide to a proposed new, policy, recenUy
• l-0 requlni arockplllng orthe drug aa cer can take, eapeclally ou cbl!dron. *
• would ftle. ' . , , ,, . 1 Maine did Jual two ylllira ago.
• virtually all lhe nallon'II 10 *6 mil* , approved by thii commla11loners, 11 condlllon for llcenalng nuclear , ,* For 10 years, they havo been plead* * * . . * , i'

' Why h1v a drug that prof.6Cl.a , lion chll rllD. A network of govern- , the government will'make the drug* power plants, but In -1982, It

• Ing with tho federd government l-0 , ~ Th argue !'or pot.uelum kid111e 11 d Ju1t th6 thfe:ld gland, when i '
• tnent worker1 and civilian volun* available, at fedtral expenae, t.o
• reversed it.aelf. (The nuclear lndua- brlnl U.S. po!loy on potualum
• aoe., not lnllllll being 1111 alannlat

    =~e:[ riat? B~~~~e~: ~~~~ f. ~k:;, :!::~ln~~u4:~ui:n1o; *,. :i~!~le ~::;~;;!: ~it~ : ~a 1                                                                14                    th                    1

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unusually aehalUve to radlaUon, \. even th e r&mottat vUlagea recelvo , 1 required* to con.alder makln1* the ' becauae It lmpl!M that accldenb

• atandanh. At lat, the NBO and ..;;- u are major Nil dl1aeter1. But 11 epecially In youni children. The . 11 d01 e: Some 7.15 nllllion adull.ulao drug part or t.h611' 11veral! emer- could happen.) Thua whll11 the
• other roderal *gonclea m t:ufn1
• unlikely" !** not tho aama u

  , 1986 Chernobyl dlaaeter hH                      fi 0 t tha drur. Bide elfeclll were min* ' gency plartnlng program, but the *1 NRC tequlroa nuclaar power pl art ta . alePII lo mako that happen.                          *,     , "lmpoaalblo, and In 1111 era ol glob- .

proved thla beyond II hadow of a ,

• mal, *Today, Poland la apthared the *: drug will not ha forud on a al.ale t.o keep auppllea on hand for 1,>lant . But lhe opponeuta or 1aa'.a1um. al lerTorttm, IL inak1111 all lhe more,'

      .uiubL Since 1991, well over 1,000            uhlurge of thyroid cancl!r at now           Uuil decllnaa It. . *                      ' personnel and enlergency wor,u,ra          lodld loclrnllln, h II pot ,                 . 111n111 t.o err on tba aide ofcaullon, CHM' of childhood thyroid cancer th11 I'   ~ lcr ' B~lllr'WI, . Ru~ala ' . and.:                                                                                                                  ti New Hampehtre' haa' begun the

• no euch provWona ar11 made for uul ~ up; Tt!y aie nir aUlah-0 b!t°i: . Juat u ll would be Imprudent to \ .

hav~ appeanid In tharea* ofl~~ ' ra ne. ' * *

• proce1111 oldocldlug whether to take *general public. ' , ,, seara elates awa from the offer of ' operUale paaaenger ahlpa. wlthont former Soviet Union at rece vcu * * , *. J,t:,

the brunt of airborne radlaUon ..... ,'Compared ft'ILII other tyllea or from Chernobyl. The uaea may ' canc.ir, thyroid canter la relatively',, pu

                                                                                      ,       I tho bl,:vei;::en m nga t

i!\ II.a l1i At II ldoto~ ht: Why not?

omc1.a11yt U.B.

                                                                                                                                                                                 ' .

• ih d pbllcy, g *, adopt.ed In 1985, ho[da that It Is : 11 rug the rir, U4l Lt ':f L: d !nu h t
• feboata and llfo Jaclr.et, it 11 llll>> a d ~
• Imprudent lo OJN!rate ~uclurl angaroua ,\an . plant, without having 1deq111te I' ulUmalely number In the te11J1 of
• curable, end In adulta It la U&ually
• In Exetu
• nd Dec. Hi In Cheater- "not worthwhile" - that la, too expo,te the at&lea lo decaaea of!aw- '1uppllea ofpot.adlum todld wllhl lhouaanda. . ' . ,* alow,moving. In children, on the ' field, cillz:en1 will have the oppor* exporulve-loprotectourchndren aulta. Tb6y alto point lo problema reach. New Ham shire *~uun':

Almoat all the po,t-Chemobyl other hand, µie dlaeaH tanda Co be tunity to ftnd out more about potas-, , wlU1 pot.Mslum Iodide, The raUo- In dlatribuUni the drug In an now have an ow!tunlt . to a

• thyroid cancera moroover have appeared In children who ~ere '

aggreulve, aproadlng rapidly Into

• alum Iodide,
• nearby lymph nodl!S 11nd ome*

nd I.be trt It can nale la that In the long nm, ll'wlll play In protecting chi dren from

• be cheaper lo treat the thyroid can*

emergancy, and ugue that lheae ll'lefll at 110 coat l-0 t1ietna'!.tvei1 ~e

• dlffleulllea are 80 h111uperable' that aafet; ot lbelr chJldr It ~ 1

   , years old or younger at tho Ume of tlmda to the lung* aa well. Pho-                         cancer.                                      cer caBea that reault from nol hav*       It la u.seloaa to atocltplle pota.elwn           chanca they should not°n. 11 u                     '

lhe accldant. Accordingly, moat tograph1 of the young Chernobyl , Potanlum Iodide la probably In Ing pota111lum iodide than to pr&- Iodide at. all, , p.a P.

• expetls on radiation protactlon pellenl.a llhow children wllb ~ra, ~ moat New llampahlre houua v1111t thoae cancera wllh potaaalum These argumeniil an! fliv~lou.a. Petu Cran,, a Mar;ylarut' atlomt:y
• believe it la euenllal thnt polllflBI* reaching from e~r t.o ur - whot already, though not in a form thet Iodide. Olven that childhood thy* . Certainly, there 1r11 ta.sue.a a!UI to with the 'NRC, follow, the potiwl.. ,

    . um lodh:le be av1il1blo to protect             the locals, In* I biller joke, refer lo    would be useful In an emergency.              rold cancer la a potenllally falal        bo worked out a'pout. the he.at                  um /oduk inue In hi, capadty a, a thl1 highly vulnerabl11 age group.            aa the "Belarna neckta~* becaW111           Look at the Ingredient.a liat on tout

• dlsea118, end that. polaaalum Iodide meana of dlstrlhuUng tho llru1r. prl11at, citlun, ,

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 September 30, 1998 SECRETARY MEMORANDUM TO: L Joseph Callan ExeCJZire~J for Operations FROM: Jo~fioyi~~

SUBJECT:

STAFF REQUIREMENTS - COMSECY-98-016 - FEDERAL REGISTER NOTICE ON POTASSIUM IODIDE The Commission has approved the attached revision to the Federal Register Notice (FRN) on potassium iodide (Kl). The draft FRN should be provided to FEMA for distribution to other Federal Agencies that are members of the Federal Radiological Preparedness Coordinating Committee (FRPCC) for their review. (EDO) C (SECY Suspense: 10/2/98) The staff should issue a Federal Register notice that states that, in light of the many useful

• public comments on draft NUREG-1633, a substantially revised document that takes those comments into account will be issued in its place, and that the draft NUREG is therefore being withdrawn [rt should also be withdrawn from the NRC's Website). The reissued document should include an improved discussion of how the practical problems in Kl stockpiling, cfistribution~ and use-are*handlealfi thestates wti1cnalreadyuseKI as a supplemenfand in the numerous nations who use Kl as a supplement. A discussion, in some detail, of the various guidance documents *of the World Health Organization and International Atomic Energy Agency, as_ well_ ~-the U.S. Food and Drug Administration, would be very useful to state and local ..

decisionmakers. The guidance document should be consistent with the policy adopted by the Commission in response to the petition for rulemaking and should fairty cfiscuss the factors that need to be weighed in the state and local decisions. The revised document should be submitted to the Commission as a SECY information paper. \ (EDO) (SECY Suspense: Date Draft Fmal Rulemaking is Provided To the Commission)

Attachment:

Revised FRN on potassium iocflde

cc: Chairman Jackson I Commissioner Diaz Commissioner McGaffigan OGC 1 CIO CFO. OCA OIG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail) PDR DCS

DRAFT -i

• Billing Code 6718-0G~P _ _

FEDERAL EMERGENCY MANAGEMENT AGENCY

    ~~.fj~     Federal Policy on Use of Potassium Iodide :(q~y;-'g!,d Pro~ec~a5 an Emexgenc:;i Prepaxedne55 Hea5ure for l!Il Radl.~Qgt°~~e~enc~at Commercial Nuclear Power-Plants Acc.:.cient5 AGENCY:      Federal Emergency Management Agency.

ACTION: Issuance of ~~yi~ea Federal Policy on Potassium Iodide .

• (

ATTACHMENT

• ATTACHMENT

1 "

• f~ff}:>f;-µie-':'g;~~:i?.1-iP~~-F'a:_jna:J *0~;~¥ff~*9a)!

       ~e_rgen~j,!'~

• FOR FUR'l'BER INFORMATION CONTACT: William F. McNutt, Senior Policy Advisor,. room 634, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2857:

facsimile (202) 646-4183 *

• SUPPLEMENTARY INFORMATION

Background

This policy on the use pf KI as a thyroidal blocking agent is the result of a Federal interagency effort coordinated by the Federal Emergency Management Agency for the Federal Radiological Preparedness Coordinating Committee. On March 11, 1982, FEMA issued a final regulation in the Federal Register (47 FR 10758), which delineated agency roles and responsibilities for radiological incident emergency response planning (44 CFR 351). One of the responsibilities assigned to the Department of Health and Human Services {HHS) and in turn delegated to the Food and Drug Administration (FDA) was providing guidance to State and local Governments on the use of radioprotective substances and prophylactic use of drugs (e.g., potassium iodide), including dosage and projected radiation exposures at which such drugs should be used to reduce radiation doses to specific organs. In the June 29, 1982, Federal Register, 47 FR 28158, the Food and Drug Administration published recommendations for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health official~ ATTACHMENT

I* should consider the use of KI. The Federal policy on stockpiling and distributing KI was published in the July 24, 1985, Federal Register, 50 FR 30258. This policy recommended stockpiling or distribution of KI during emergencies for emergency workers and institutionalized persons, but,~*on *cost-

    ~ef~t~~~~as~ did not recorranend predistribution or stockpiling for the general public.

On September 11, 1989, the American Thyroid Association requested FEMA, as Chair of the FRPCC, to reexamine the 1985 policy and to revisit the issue of stockpiling and distributing KI for use by the general public. *rn response, the FRPCC established ff;~~p~~~~ka:.:'";ies:,9'na mt Ad Hoc Subcommittee on Potassium Iodide. On Decexnbe:c: 5, 1994, the FRPCC adopted the :c:epo:c:t and r:ecommendation5 of the Ad.Hoc Sabcornm+/-ttee 011 Pot.~55ium Iodide, which :c:eaffi:c:nced the Fede:c:al po5ition a5 expr:e55ed in the 1905 policJ. On Ap:c:il 3, 1996, in connection with a Septexnbe:c: 9, 1995, petition fo:c: :c:ulexnaking 5ubinitted to the !iRC on this is5ae, the PRPCC e5tablished a new Ad Hoc Subcommittee on Pota55iwn Iodide to r:eview ca:c::c:ent info:c:mation. The SfaAOilg Subcommittee conducted a public meeting on June 27, 1996. Ba5ed on the info:c:mation collected, the Sabcozmnittee concladed that ther:e

• wa5 rio. new information that se:c:ioaslJ challenged the bases fo:c:

the 1905 :c:econmtendations* conce:c:ning pablic ase of fCI f:o:i:: radiological exne:c:~1cie5 at comme:c:cial naclea:c: _POwe:c: plant5. Howeve:i:: ~segue;}t1y.1~7:made three recommendations we:c:e rnade to the FRPCC bJ the Sabconunittee: (1) Without changing the Federal* policy bJ inte:c:ceding in ~~:i~~is the State's prerogative to make its own decisions on whether or not to use KI, the Federal government (NRC, or through FEMA) should fund the purchase of a KI stockpile for any State that, hereafter, decides to incorporate KI as~ protective measure for the general public; (2) the Sabc'onunittee believed the language in the 1985 policy should be softened to be more flexible and balanced. Fo:c: exo:mple, the p:c:oblem ~n} inte:i:: veno:c:s ob5e:c: ve in the Fede:c:al policJ is in the italicized 5tatement, "':Phe Pede:c:al po5ition with .*. pota55icm iodide fo:c: a5e bJ the gene:c:al pablic i5 that it 5hoald not [be] :c:eqai:c:ed." It woald not be a5 negative if the la5t ph:c:a5e we:c:e :c:ewo:c:ded to 5tate "it [pota55ium iodide fo:c: a5e by the general public] i5 not

c:eqai:c:ed, but :m?J.} be selecteo. a5 a p:c:otective rrteasa::i::e at the option of the State o:c:, in 5ome ca5e5, local gov e:c:muents", and (3) 'i'he Sabcormn+/-ttee :c:eco:mmends that local jurisdictions who wish to consider the option of incorporating the use of KI in their protective measures slioil'fa consult with the State to determine if such arrangements are appropriate ~g'i§:_~:r;f°Ri. H ATTACHMENT

local go ueimnent5 ha u-e the aathorit:y oi 5ecare the appio oal to incoipoiate lCI a5 a piotectioe inea5aie foi th~e ge11eial pablic, they wocld need to include such a measure in their emergency plans. In addition to the FRPCC actions, the Federal government has

• broadened the scope of* emergency prep*aredness to include resources to respond to terrorist acts involving nuclear, biological and chemical agents. Included among these resources are stockpiles of KI, which would be located in 27 metropolitan areas throughout the country and in three national stockpiles located in the east, central and western areas of the United States. These stockpiles would be*

available on an ad hoc basis, in the event of an accident at a commercial nuclear power plant.

• However~+/-neE.l:it'ockp11:es=-are" ~ { 1-1_ 1ro_1_§c:i~~~§:~not:~1~f:keiy~~pr7>~c{~~- ~i;!-~µ~~lq~~p~se -~.Y ~t:~~

g~e_ra;l~~~i~J.ji~_l~a'.~pJQg;CJiJ'..~~e.r_g_~_q~; On October 24, 1996, the full FRPCC endorsed the Subcommittee's recommendations with some minor modifications. On June 30, 1997, the NRC [Conmri55ion] approved the i~s staf f_,:s recommendation to endorse the FRPCC position and to recognize the availability to State and local governments of the- ,,~~~~~Federal stockpile of KI in connection with preparedness for *_ acts of terrorism. The NRC Commissioners

• also asked that licensed nuclear power plant operators to discuss this revised Federal policy on KI with their counterparts in State ci!!d local ~gencies.

   ~ov its~~sta c                                 *        -1~m,~etmg-:wftli 1~~~~~~ifrJ:::;,fiff~~:::;:!:~~~ . ~ufno To         -*,. ._. sea5..,..___ --~

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Po1:i.cy on Use of Potassimn. :Iodide as an Emergency Preparedness

• ATTACHMENT

Measure for Commercial Nuclear Power Plant Accidents The purpose of this document is to provide Federal policy and guidance with regard to distribution of KI and its use as a thyroiaal blocking'agent in response to commercial nuclear

  ---~- pQwer plant accidents. - The issue has been addressed in terms of two components of the population within the 10-rnile Emergency Planning Zone that might require or desire KI use:

(1) emergency workers and institutionalized individuals, and (2) nearby general populations. This guidance is intended for those State and local governments who, within the limits of their authority, should consider these recommendations in the development of emergency plans and in determining appropriate actions to protect the general public *

                                                      -en~      *s
                                                            -.-,,,i._...,,-p,..,,....,._..,._r=~
                                                                                  --       - **:v=

It is recognized that options on t h e ~ distribution, and use of -KI for the general public rest with

• ATTACHMENT

Any State, or in some cases, local government, that selects the use of KI as a supplemental protection measure for the general public may so notify the FEMA Regional Director from the FEMA Region i~,which the State is located, and may request funding for the purpose of purchasing a supply. State and local governments that opt to include KI as a suppiemental protective measure for the general public will be responsible for preparing guidelines for its stockpiling, maintenance, distribution and use. 'fhe incorpo1.ation of a progral'l:t fo:r MI

stockpiling, di:stribution and 11:se b:y an:y State or local go11ernment into the emergency plan:5 will not be :5abject to

• Federal e11aluation, except for the deci5ion making pI:oce:ss on it.s c:!5e. The State and local government may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished
• Policy Considerations The NRC and FEMA have issued guidance to State and local authorities as well as to licensees of operating commercial
• ATTACHMENT

nuclear power plants in NUREG-0654/FEMA-REP-l, Rev.1, recommending the stockpiling and distribution of KI for thyroidal blocking during emergencies to emergency workers and to institutionalized individuals. That guidance is endorsed as an available protective action in the event of an incident ____at_ a _c_Qmm_e_rc;_i£l_l_nt.tcl~~Q\l[_er plant. Thyroidal blocking for emergency workers and institutionalized individuals was recommended because these individuals are more likely to be exposed to the radioiodine in an airborne radioactive release than other members of the public .. In addition, the number of emergency workers and institutionalized individuals potentially affected ~t any site is relatively small and requires a limited supply of KI that can be readily distributed *

• Tn+/-s:

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r_~~~~~~~

      -.~~~~P"\a:Jt:~::"!Pl~~~

• ATTACHMENT

JI . ~ I

                                                                                                   )

I

                                                               ~            *~           -~
                                                                            ~
                                                                            -~i~
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P.~- su

                                                                    ~--~~al
                                                               ~u~oca<T ci_tfridi't:..:;.::;J:='.....o=-,                     . ):~~~d may dissuade some States and jurisdictions from its use.

-e*

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                                                                          ~ ... :r--,.... .. *.. -

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         --- .. .:,a__.....__               -

• ATTACHMENT

                                                                                )

cp$inati~ri\~}jereof ;-~~--~e~_e(~°¥~ ~hile the use of KI can clearly provide additional protection in certain circumstances, the assessment of the effectiveness of KI and other protective actions and their implementat~on indicates that the decision to use KI' (or other protective actions)

  *should _be_made __ by_ -the States and, if appropriate, local authorities on a site-specific basis. It is recognized that State or local decision makers, provided with proper in£oz:mation, "!fJ&Y find that the use of KI as a protective supplement is reasonable and prudent for specific loca1 conditions. It is :recognized that the exercise of options to di5t:ribute and o5e ICI fo:c thj':coidal blocking to protect the poblic he.alth and 5afetj' :resides with the State and, in '5on"te ca:se:s, local health actho:citie:5. '3:1herefore, the deci5ion on 5e of fCI bj' the gene.cal pablic, do.ring an actaal eme:cgenc:9 is the :re5pon5ibilitj' of the5e aotho:cities.

It should be noted that the timelj' - 5e of fCI effectioely

redoces the :radiation expo5a:ce of only the thyroid gland.

   'ii'hile this is an impo:rtant contribution to the health and 5afety of the indioidaal, it i:5 not as effective as niea5a:ce5 r:hi ch p:c otect the total body of the indi oidaal fz om

cadioactioity. Both in place 5heltering and pzecautiona:r:y

 ,eoacuation5 can reduce the expose.re to the th3'roid and total
 /bod:5'.                              '
   !he c5e of KI fo:c thj'roidal blocking is not an effectioe mean.5 bl it5elf fo:c pzotecting indioidoal5 fzom the radioactioit,l in an airborne :celea5e :ce5 lting fzom a nocleaz powez plant accident, and the:cefo:ce, shoald onl:9 be con5idezed in conjanction with 5helte:cing o:c eoacaation oz a combination

• thezeof.

   !he Food and Drug Administzation ha.5 eoaluated the medical and zadiological zi5b' of admini5tezing KI £oz e:rnezgency co.1ditions and ha.5 concloded that it i:5 5afe a:nd effect+/- 11 e and he.5 app::cooed ooer the coonte::c sale of the dzcg foz thi:5 pw:po5e. Food and Drag' Ad:ministzation guidance 5tate5 that

ci5b fzom the 5ho:rt term a5e of ::celatioelj' low do:se.5 of fez:

ICI fo:c thyroidal blocking in a zadiological e1T1ezgencl aze outweighed b:9 the zi5k5 of :cadioiodine indaced th:y:roid nodules oz cancez at a p:rojectfed] do5e to the th_j1:roid gland of 25 zem or g ... eate:r. Since the Food m1d Dzag Adm+/-nist::cation ha:5

  .autho:r:i:z:ed the nonp:ce.sc::ciption 5ale of !CT, it ma.l be a oail able to indioidaal:s who, ba5ed on their ow11 pe:r:sonal analy:sis, choo:se to ha 1.1 e the d::c cg immediatell a oail able.

Other considerations and problems to be evaluated by the State ATTACHMENT

and local authorities in deciding whether to institute a program for the use of KI by the general public include: (1) Whether the KI should be distributed to the population before an accident occurs or as soon as possible after an accident occurs; (2) whether the risks of exposure to radioactivity will be lower if the evacuation of the general population is

                   ~:.;:.....-,-.. ~.**-::---     . . . . . . I' . . . . . . . . - - ,.... , ....... -* .~ ... , .,.

initiated :-..:-;.~j:J:i --~~W~tho~t-, t_h~ .JlS_e__-(?_f_ .~*"-_;-;: or if the general population is sheltered and the administration of KI initiated; (3) how the KI will be distributed during the emergency; (4) if KI is predistributed, what assumptions should be made about its actual availability and use in the event of an incident; (5) what medical assistance will be available for the individuals who may have some adverse reaction to KI; {6) how medical authorities will advise the population to take KI and under what circumstances this advice will be given, i.e., methods for public education, information and instruction; and (7) how the authorities will ~provide KI to transient populations

• In addition, there are some site-specific considerations to evaluate. Whether KI should be stockpiled and distributed to the general public around a particular site may depend on local conditions. Decisions on its use and the use of alternative protective measures during an emergency may depend on pr~vailing accident and environmental conditions
• In summary, the r~ci~Federa~ policy is that KI should be stockpiled and distributed to'emergency workers and institutionalized persons for radiological emergencies, but leaves the decision on whether to stockpile, distribute and use KI for the general public to the discretion of State and, in some cases, local governments. 'Any State or local government that selects the use of KI as a protective measure fqr the general public may so notify the appropriate FEMA Regional * .,..,,,,...~ ~---,::-,,,= o..._f.

p~~~~::s,::~~~""i::~ ~~~~ ~~[i~s~~~~~~ fJ

      ~
                    ~;~::~~E?.~~~~~~~~~~~:tr'"i'~ili~~~~:~~*-*

E.,i:zb1~

• State and local governments that opt to include KI as a protective measure for ~he general public will be responsible for preparing guidelines for its stockpiling, maintenance, distribution and use. State and local governments may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished. It
• ATTACHMENT

should also be noted that medical supplies, including KI, will be stockpiled.in 27 metropolitan areas and ~n three national stockpiles across the country in ~upport of State and local government response to emergencies caused by acts of terrorism involving nuclear, chemical and biological agents. For radiological emergencies resulting from any cause, including accidents at commercial nuclear power plants, this additional stockpile can be acquired ad hoc by State or local government officials if they determine its use would be beneficial. The following references are intended to assist State and local authorities in decisions related to use of KI:

1. National Council on Radiation Protection and Measures (NCRP) Protection of the Thyroid Gland in the Event of Releases of Radioiodine. NCRP Report No. 55, August 1, 1977.

2. Food and Drug Administration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency, 43 FR 58798, December 15, 1978.

  ~*- Nuclear* Regulatory _Commission, Examination of the Use of Potassium Iodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents. NUREG/CR-1433, October 1980.

Prepared by Sandia National Laboratories for the NRC.

  -,tS. Halperin, .j.A., B. Shleien, S.E. Kahans, and J.M.

Bilstad, Background Material for the Development of the Food and Drug Administration's Recommendations on Thyroid Blocking with Potassium Iodide. FDA 81-8158, U.S. Dept. of Health and Human Services, March 1981.

6. Food and Drug Aqministration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency:

Recoipmendations on Use. April 1981. Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Administr?tion, Department of Health and Human Services.

 --I. Food and Drug Administration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency: Final.

Recommendations on Use. (Notice of Availability 47 FR 28~58, June 29, 1982 *

 .:;i-~. Federal-Emergency Management Agency, Federal Policy on Distribution of Potassium Iodide Around Nu~lear Power Sites

• ATTACHMENT

I for Use as a Thyroidal Blocking Agent, 5,0 FR 30258, July 24,

• 1985.

      -S-13. Nuclear Regulatory Commission, Re-Evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant. SECY-93-318, November 23, 1993.

• l}:;~~~~.El~~~iy~'§._§i;~Re~Ev.afiiarun~~~T'O- ..

       ~~~a.f~. g~~:P~~;i,µnfr_~~~dei=~.J'f~~a~'t:f,a1:~~
      ~ucJ:ear~PowerJ.PJ.an~~9,2::,3~ov.emt5e£2~~~

5-15. Nuclear* Regulatory Commission, Supplemental Information Regarding the Cost-Benefit of KI Prophylaxis, February 1994-. Prepared by S. Cohen and Associates, inc., for the NRC.

      -3:-&l~.       Nuclear Regulatory Commission, Addendum to SECY-93-318, Re-Evaluation of Policy Regarding Use of Potassium Iodide.

After a Sever Accident at a.Nuclear Power Plant. SECY-94-087, March*29, 1994.

      -H:-g.         Federal Radiological Preparedness Coordinating Cormnittee, Ad Hoc Subcommittee on* Potassium Iodide, Subcormnittee Report and Recommendations, September 15, 1994.

1*Ef~or!~eifu:rcran+/-zat°1:b.B_~tia~~9?iibr:E'31Hea3.iffi

       *:*T1q,;,::;;1:;:;:~~ ! : - , ~ ~ ~ - - . . , : : , ~~"'Jfi:,.,...~,-~""I -

Actigp.si#-n-:..Ra.Y+atio~e;r;:gerfcies,,;r;l 9!15~

      -3::-z-}"j. Nuclear Regulatory Commission, An .Analysis of Potassium Iodide {KI} Prophylaxis for the General Public in the Event of a Nuclear Accident. NOREG/CR-6310, February 1995. Prepared by S. Cohen and Associatesf Inc., and Scientech, Inc., for the ATTACHMENT

I! NRC *

   . -3:-3-21. Federal Radiological*Emergency Preparedness Coordinating Cormnittee, Ad Hoc Subcommittee on Potassium Iodide, Public Meetings: Federal Policy on the Purchase and Stockpiling of Potassium Iodide for. Use by the General Public in R~diological Emergencies at Commercial Nuclear Power Plants. !ranscript, June 27, 1996.

• T't2f.. Federal Radiological Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide,*

Subcoxmnittee Report and Recommendat~ons, October 3, 1996.

        '3:-5-2~.          Nuclear Regulatory Commission, Proposed Federal Policy Regarding Use Potassium Iodide After a Severe Accident at a Nuclear Power Plant. S~CY-97-124, June 16, 1997.

24 .'7t:Yrree:rn:a*£~~~¢:-Enerciv.J!

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         ~V:.~}f>~~~£~.g~gyF~~?~~~..~~I?-a~~~~~#.~9..,;;;J~~£:J.;~~~-- or R..?_g_i'§Jp~ic* ** -. *dciaen~'.recdJ;ic.~ 9 S?.:&"J~~~~-'7;j

• Dated:

O. Megs Hepler, 111 Chair Federal Radiological Preparedness Coordinating Committee DRAFT

• ATTACHMENT

North North Atlantic Energy Service Co:tporation P.O. BoxSOO

• Atlantic Seabrook, NH 03874 (603) 474-9521 The Northeast Utilities System SEP980172 December 30, 1998 Woodbury P. Fogg, P.E.

Director New Hampshire Office of Emergency Management State Office Parle South 103 Pleasant Street Concord, NH 03301 Re: Comments on ~ o~ New Hampshire Potassium Iodide Poncy

Dear Director Fogg:

Thank you for the opportunity to submit comments for consideration by the State of New Hampshire in the review and development of policy recommendations regarding the role of potassium iodide (Kl) in radiological emergency response plans for the Seabrook Station and Vermont Yankee nuclear power plants. North Atlantic Energy Service Corporation (North Atlantic) was represented at the December 8, 1998, public meeting on this subject in Exeter, NH. North Atlantic staff has reviewed pubfic comments and other information related to the Nuclear Regulatory Commission's decision to grant a rulemaking petition caffing for consideration of Kl as a protective action for the general public in the event of a radiological emergency at a commercial nuclear power plant North Atlantic's posttion on this subject can be stated succinctly: Prompt evacuation at the first indication of core damage is the most effective protective action that can be taken by the public. Our radiological emergency response procedures clearly direct our personnel to recommend ~acuation of the pubfic in the vicinity of Seabrook Station at t,he first indication of potential damage to the reactor core Q.e., deci!=lJBtion of a General Emergency). Immediate evacuation is the most effective action for whole body protection from all forms of raaiation exposure. Potassium iodide, in conbast, offers protection only from a single type of radiation exposure *(radioiodine) to a single organ (the thyroid gland) under very specific conditions (a level of exposure that is higti enough to offset concerns with potential side effects - set by current Food and Drug Administration (FDA) guidance as 25 rem to the thyroid). We are concerned that consideration of administering Kl to the public during an emergency would delay evacuation, delay aissemination of clear emergency instructions to the pubfic, and lead to. pubfic confusion. We believe that local emergency management directors spoke effectively to this concern at the Exeter public meeting.

Page2 Seabrook Station's radiological emergency response procedures, as are those of New Hampshire and Massachusetts, are based on the guidance of NUREG 0654/FEMA-REP-1, Rev. 1, Supplement 3, dated July 1996. This guidance, entitled

       **crtterta for Protective Action Recommendations for Severe Accidents*, states that stucfies of severe reactor accidents and their consequences have led the NRC staff to conclude that the preferred initial protective action for a severe (core damage) accident is to evacuate promptly, baning any constraints to evacuation. This guidance is consistent with US Environmental Protection Agency protective action guidance in its
        *Manual of Protective Action Guides and Protective Actions for Nuclear Incidents* (EPA
. \

400-R-92-001 }. It is also consistent with protective action guidance followed by NRC's Protective Measures Team documented in "RTM-96, Response Technical Manuar, NUREG/BR-150, Vol 1, Rev. 4, March 1996.. North Atlantic recommends that the New Hampshire working group begin its rrterature review with the three documents referenced abov~. EPA 400 includes a cflSCUSSion and analysis of early phase protective actions for nuclear power plant accidents, including the use of thyroid blocking agents. Generally, EPA400 concludes that evacuation and sheltering ~re preferred alternatives to administration of potassium iodide for most situations because they provide protection for the whole body and avoid the risk of misapplication of potassium iodide (EPA 400, Appendix C, page' C-13). EPA 400 references a Food and Drug Administration analysis of the risk of l radioiodine-induced thyroid cancers and the incidence and severity of side effects from potassium iodide. Trns reference is entitled *Food and Drug Administration. Potassium . Iodide as a Thyroid-Blocking Agent in a Radiation Emergency: Final Recommendations on Use. Federal Register. 47, 2815B - 28159; June 29, 1982. The FDA analysis concluded that "risks from the short-term use of relatively low doses of potassium iodide for thyroid blocking in a raalation emergency are out-weighed by the risks of radioiodine-induced thyroid nodules or cancer at a projected dose to the thyroid gland of 25 rem.* , (EPA 400, Appendix C, page C-13). .

                                                                              \

The problem with recommending use of Kl by the general public is in knowing when and where those dose concfrtions exist To quote a long passage from EPA 400:

       *After the release and the release ~ is measurable and/or when plant conditions or measurements can be used to estimate the characteristics of the release and the release rate as a function of time, ~ these factors, along with abnospheric stabifrty, wind speed, and wind direction, can be used to estimate integrated concentrations of radioactive contamination as a function of location downwind. Although such projections are useful for initiating protective action, the accuracy of these methods for estimating projected dose will be uncertain prior to confirmatory field measurements because of unknown or uncertain factors a_ffecting environmental pathways, inadequacies of computer modefmg, and uncertainty in the data for release terms." (EPA 400, Chapter 5, page 5-4). Confirmatory measurements can take hours to obtain and analyze following the initiating concfrtions of a severe accident These are valuable hours that the public at risk can use in taking the most effective protective action available - evacuation.

I I 4 Page3 Potassium iocfide should not be recommended as a precautionary measure or under uncertain conditions. It is effective against thyroid uptake of radioactive iodine only within a limited span of time. It is most effective if taken 1 to 2 hours prior to exposure, and somewhat effective up to 3 to 4 hours after exposure. (EPA 400, Appencfrx G, page C-13). Because of _the IT!any uncertainties that would almost certainly exist in the earty phase of a severe accident, the potential for spurious ingestion of potassium iodide by the public would be very high.

                             /

Ingesting Kl can produce side effects. Dr. DeHart, a panelist at the Exeter public meeting, spoke of heart arrhythmia A review of public comments submitted to the NRG reveal other potential side effects (e.g., hyperthyroidism, hypothyroidism, anaphylactic shock). These are in addition to potential side effects cited on manufacturers' labels, such as skin rashes, swelling, joint pain and fever. A speaker at the Exeter public meeting pointed out correctly that, even though there were relatively few reports of medical side effects from Kl ingestion in the post-Chernobyl Polish experience, significant, long-term studies of Kl side effects have not been done. Toe working gr,oup should consult current editions of standard* medical references, such as the Physicians' Desk Reference and the USP Drug Information for the Health Care Professional, for further information on characteristics and potential side effects of the drug. EPA 400 contains a plethora of adcfrt:ional references that may be useful for helping the working group complete its task. Appendix B cites at least six medical and scientific references that deal cfirectly with effects of radiation on the thyroid. Even though the NRG has officiaDy withdrawn draft NUREG-1633, aAssessment of the Use of Potassium Iodide (Kl) As a Public Protective Action During Severe Reactor Accidents"', it should not be ignored. Draft NUREG-1633 contains a long fist of medical, scientific and governmental references, some of which post-date EPA 400, that may be useful The fist of references from draft NUREG-1633 and examples of the pubHc comments submitted to the NRC are attached for your consideration. ,1 North :Atia.ntic supports the work of the New Hampshire working group on potassium iodide policy, and appreciates the opportunity of participating on the working group. North Aflantic recommends that, notwithstanding the results of the New Hampshire working group's review, *New Hampshire delay any change to its current p,ollcy until the work of a simDar group impaneled by the NRG is completed. The NRC group has been tasked with rewriting draft NUREG-1633. The NRC group has been given 1Dmonths (untJ1 approximately September, 1999) to complete the task. The NRG group is comprised of representatives of the NRG, FEMA, EPA, FDA, Department of Agtjcutture, 1he National Emergency Management Association, and other persons experienced in Kl policy issues. Several nevv issues have arisen early on within the NRG group which could impact the New Hampshire policy review. For example, the FDA representative has expressed uncertainty about recommended dosage for different age groups. The FDA may be reconsidering ns recommendations. Differences could be recommended for as many as four age groups - under 3 months of age, 3 months to 18 years, 18 to 40 years, and persons over 40. 1llere is some question as to whether persons over 40 should be

• advised to ingest Kl *at an because of the relatively high level of radiation exposure from radioiodine necessary to inflict damage to 1he 1hyroid at that age. EPA may reconsider its protective action guides (PAGs) as they pertain to use of Kl to make them more age sensitive. In other words,. some basic issues involved in the question of an appropriate

 .                             (

Page4 policy concerning use of Kl as a -protective measure for the pubnc are being now recons~dered by the *responsible federal agencies. Methods for distnbution of Kl to the public present further perplexing issues. Pre-distribution _to 1he public risks encouraging Its indiscriminate or inappropriate use. Pre-distnbution to emergency planning zone (EPZ) households does not take into consideration availability to transient populations and employees who live outside of the EPZ. Would pre-distribution also involve mass distribution of 1he drug to all hotels, motels, inns, restaurants, recreational facilities, schools and EPZ businesses? Who at these facifrties would distribute 1he drug at the time of an emergency? If the drug were to be stockpiled for distnbution at the time of an emergency, the task of ensuring ~ distribution to every person in the EPZ would be virtually impossible. If a severe reactor accident were to occur at the same time severe weather constrains evacuation {the only scenario 1hat would warrant public use of Kl), timely distnbution of Kl would be impeded as well. To simply make Kl available at a designated location for acquisition by anyone who wants it sets up a situation of

          ~couraging different protective actions amoflg the same potentially affected population.

Guidance for cfistribution of Kl is virtually non-existent. The NRC working group includes personnel who have experience with public cfisbibution ,of Ki near nuclear power plant sites. Again, any change in the current KI poficy should await whatever guidance the NRC working group provides after September, 1999. Further age-based refinements in the FDA dosage recommendations for KI would argue for the need for medical supervision for ingestion of Kl, particularly in day care center and school settings. The current poficy' of limiting use of Kl to emergency workers and hospital and nursing home patients addresses this concern. Children are obviously not included in these *populations. In the case of emergency workers, they are trained annually in the proper use of Kl; and they would be supervised in Its use at the time of 811 emergency by radiologically trained personnel. The administration of Kl in hospital and nursing home facilities is subject to the medical supervision in place at those faalitles. Ensuring medical supervision of Kl ingestion in all potentially affected locations and facil~ presents an additional complication for emergency management officials. Even emergency management officials who are experienced with public distribution of Kl around sites in Tennessee and two other states have little or no experience with meeting additional medical supervision needs for Its administration. Fina]ly, it is critical that whatever poficy is adopted by New Hampshire be shared by the Commonwealth of Massachusetts and the State of Vennont. Nothing would be

       , more confusing to the public, or more difficult to administer fairiy and effectively, than cfafferent policies for each of the sta!£m sharing the 10-mile EPZs around Seabrook
   . ___ Station~d-~rm_Q"'1"(an~_..__                  _ __ ---        -- - -

The best policy is prompt evacuation of the pubfic atihe first indication of potential core damage, with earfler consideration of evacuating schools and day care centers based on prevaifmg concfrtions. Potential use of Kl in a radiological emergency should be limited to emergency workers who must remain in an impa~ area and to hospjta)/nursing home patients for whom the decision to ingest Kl is medically supervised.

Page 5 I Thank you again for the opportunity to submit com_ments for consideration in the review of New Hampshire Kl poflcy. I look forward to working with the able group you have assembled to develop poflcy recommendations. If you have questions on these comments, please do not hesitate to contact me at 773-7359. Sincerely,

                                              ~~-t Donald R. Tailleart Emergency Preparedr:,ess Manager Enclosures
                                                                                          . -* \:' .

I,  :-- I NUREG-1633 Assessment of the Use of Potassium Iodide (IQ) As a Public Protective Action- During Severe Reactor Accidents Draft Report for Comment Mmmscript Coo,pletcd* March 1998 Date Published: July 1998 Prcparedby F. J. Congcl/AEOD AS. Mobscm!AEOD C. A Willis/NRR

• T. J. McKcama/.AEOD MT. Jamgocbian/NRR Incident Response Division

.fficc.for Analysis and Evaluation of ~~nal Data Division. of Reactor P r o g r a m ~      .    * *
     .:.- ~*-or:Nudm- Reactor.Regulation.*:*.~ * * * ** *

• U.S. Nuclear Regulatory Commission Washington. DC 20555-0001

ABSTRACT

• The use of potassium iodide as a supplemental protective action within the plume pathway emergency planning zone during severe reador accidents is evaluated. A brief history of reactor accidents is given, leading to an overview of severe reador accident source tenns.

Thyroid and whole body dosimetry, their assotjated risk assessment. and their relationship to severe accident source terms are discussed. The offsite doses for several accident scenarios with and without Kl are estimated. The Chernobyl accident and its consequences are aiscussed. The Ew"opean practices, along with the World Health Organization's and the International Atomic Energy Agency's recommendations within the plume pathway emergency 1 planning zone, are reviewed. *

                                      . . . ....                 1 .. ;

• -iii- DRAFT NUREG-1633

CONTENTS

• CONTRIBUTORS EXECUTIVE

SUMMARY

ACKNOWLEDGMENTS

                                                                                                                                    *

• viii

                                                                                                                                        .xii ABBREVIATIONS      .................................................................... .xiii I. INTRODUCTION . * . . . . . . . . . . . . . . . . * . . . . . . . . . . . . . . . . . * . . . . . . . . . . . . . . . . . . . ... 1 IL SEVERE ACCIDENTS *****.**********************************.****.******.* 2 Ill HEAL11-1 EFFECTS .............................................................                                          ..... 4 A. Thyroid and Whole Body Doses as Functions of Distance Downwind **.**.                                                        5 B. Doses. .............................................................. .                                                . .. 5

• C. Thyroid Blocking Effectiveness ****.*****

D. Thyroid Uptake and Thyro!d Dose ......*. E. Risk as a Function of Thyroid Uptake ******. F. Medical Aspects of Potassium Iodide *******

                                                                                                                     ~

10 7 7 9 IV. EMERGENCY PREPAREDNESS . ..............* 11 J V. EXPERIENCE RS..ATED TO TI-IE CHERNOBYL ACCIDENT 13

                                                             -                          ,c' A. Belarus Experience ................... .............................................. . 15 B. PeJaJ"ldEx:J>erience ................................................................... . 17 VI. INTERNATIONAL PRACTICE REGARDING THE USE OF IODINE PROPHYLAXIS "                                                                 19 A. World Health Organization (WHO) Guidance * * * * * * . * * * * * * * * * . * * * . * * . * * * *

• 19 B. International Atomic Energy Agency (IAEA) Guidance *.*** -. * *
• 21 C. Comparison Between U.S. and International Practice * * * * . * . * *
• 21 VII. SAMPLE CALCULATJONS ******.***** ... -...... -...... .. -.... -

VnL INSIGHTS AND coNCLUS10Ns

                                -. -.... ..   . ..- ~. -:                                                                      .. . . 23

• 27 IX. REFERENCES ...... - - ............... - . - - . - ....... . 29 APPENDICES

 --APPENoof1--=-,NTERNA110NAL PRAcncE oN 11-1e usE oF 1OD1NE PROPHYLAXIS                                                                32 APPENDIX 2 - GLOSSARY ************                      . . . . . . -. .
                                                                          *                                                        ** 36

• -v- DRAFT NUREG-1,633

AGURES

1. Percentage of Thyroid Blocking . . . * . . * . * . . . . . . * . . * * * . * . * . * . . . * . * . . * * . * * * . . . * . . 8

'I 2. -LocaJ Cs Contamination- ~veJ£oll~n.g the Chernobyl Accident . * * * * * . * * * . * * . * . * .

• 14

                 - - ~- - ~-- -~- - -

3. Regional Cs Contamination Level Following the Chernobyl Accident * * * * * * * . * * * * . . *

• 15

4. Annual Number of Thyroid cancers Among Children (0-14 Years Old) **...***.**.... 16

5. Total Number of Thyroid Cancers in Belarus Among Those 0-18 Years Old At.

the Tune of the Chernobyl Accident * * * * * * * * . * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

• 17

6. Distribution of Excess Thyroid cancer as a Function of Age at the Time of the Chernobyl Accident * * . * * * * * * * * * * * * * * * * * * * * * . * * * * * * * * * * * * * ** ,* * * * * * * * ******* 19 TABLES

• 1. Thyroid Cancer in Belarus Children Under 6 Years of Age at the TltTie of the
• Chernobyl Accident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... 18

2. Summary of lntemati~nal Practice on the Use of Iodine Prophylaxis. * * * * * . * * * * * * * * *

• 20

3. Plant Damage States for Surry Nuclear Plant (Ref. 1 and 2) . * * * . * * * . * * * . * * . . * . . . .

• 25

4. Source Terms qerived for Severe Accidents at Surry (Ref. 1 and 2). * * * * * * * * * * * * * * *

• 25

5. Comparison of Doses {Rem) for Normal and 95% Blocked Thyroid Uptake * . . * * * * * . .

• 26 DRAFT NUREG-1633 -vi-

IX. REFERENCES

1. Brucer, M., Chronology of Nuclear Meateine. St Louis, MO: Heritage Press, 1990.

2. "Protection of the Thyroid Gland in the Event of Releases of Racfioiodine," NCRP-55, Bethesda. MO: National Council on Racfiation,Protection and Measurements, 1977. '

3. Hall, per and Lars-Erik Holm, "Cancer Incidence and Mortarrt:y After locfme-131 Therapy for Hyperthyroicfism,* Radiation and PubDc Perception: Benefits and Risks. Jack P. Young and Rosalyn Vallow, Eds., Washington, DC: American Chemical Society, 1995.

4. "Induction of Thyr9id Cancer by I ~ Racfiation,* NCRP..SO, Bethesda, MD; National Council on Radiation Protection and Measurements, 1985.

5., Shore. Roy E., issues and Epidemiological Evidence Regarding Radiation-Induced

         ,  Thyroid cancer,* Radiation Research, 131. pp 98-111, 1992.

Report of ICRP Committee on Permissible Dose for Internal Radiation. ICRP-2, Oxford: 6. Pergamon Press. 1959.

7. Recommendations of the International Commissf.on on Radiological Protection. ICRP-26, Oxford: Pergamon P~. 1977.

                                                                             \

8. Recommendations of the International Commission on Rad"IOlogk:sl Protection. ICRP-60, Oxford: Pergamon Press, 1990. *

• 9. Radiation Dose to Patients from Radiopharmaceutical JCRP-53, Oxford: Pergamon Press. 1988..

10. Parker. G. W., G. E. Creek. C. J. Barton. W. J. Martin, and R. A Lorentz, '"Out-of-Pile Studies of FISSion-Product Release from Overheated Reactor Fuels at ORNL, 1955-1965,*

Oak Ridge National Laboratory Report ORNL-3981, July 1967*

11. Lorenz. R. A, and M. F. Osborne. *A Summary of ORNL FISSion Product Release Testswith Recommended Release Rates and Diffusion Coefficients,* Nuclear ReguiaFY Commission Report NUREG/CR-6261, May 1995.

12. Soffer, L, S. a Burson, C. M. Ferrell. R. Y. Lee, and J. N. Ridgely, *Accident Source Terms for Light-Water Nuclear Power Plants.* Nuclear Regulatory Commission Report NUREG-1465., February 1995.

13. "The International Chernobyl Pro~ Technical Report,* IAEA, 1991

                                             ---- -*-- --~ -  ~ w
 ---14:-~afvoiume 47,pp. 41073--47083. October22.*1982. *Accidental Radioactive \

Contamination of Human Food and Animal Feed; Recommendations for stateR and Local Agencies.. ~

15. "Distribution of Dose Received in RW'al Areas by the Chernobyl Accidenf', NRPB-R277, draft 1996 DRAFT NUREG-1633

I

• I'

16. *one Decade After Chernobyl, Proc_eedings of an International Conference*, 4-12 Apnl 1996, lAEA. 1996

17. 1. 0robyshevskaya. L.Astakhova, ANalivko et al., "Thyroid Cancer in Children of Belarus Following the Chernobyl Accident.* Nagataki Symposium Radiation and Human Health:

     .. ___ Proposal_from_N_~g~.__1995. _ ... ____ -*                  -- .    - - ---- - --    -'           .

1B. Personal communication, E. Buglova M.D., Head Laboratory of Radiation Hygiene and Risk Analysis, Ministry of Health, Republic of Belarus, December 1~7

19. "Thyroid Cancer in Children Living Near Chernobyl, Expert Panel Report. on the Consequences of the Chernobyl Accidenr - Williams D. et al, K.H. ECSL-EAEC, Report EUR 15248 EN, Brussels-Luxemburg, 1993, p.108

20. E. Bugiova et. al, -rhyroid Cancer in Belarus After the Chernobyl Accident; Incidence, Prognosis. Risk Assessment.* Low Doses of Ionising Radiation: Biological Effects and Regulator Contro~ Spain, November 1997, Contnbuted Paper, pp. 280-284

21. *--rnyroid Cancer Incidence Rate in the Republic of Belarus- Okeanov A et al., Radiation

_and Risk Bulletin of National Radio-Epidemiological Registry, Obninsk.. 1985, Issue 6, pp. 236-239

22. Janusz Nauman. M.D. Warsaw Poland, Jan Wolff, M.D. Bethesda Maryland; *todine Prophylaxis in Poland after the Chernobyl Reactor Accident Benefits and Risks*; Am

• Journal of Medicine, Vol 94, May 1993, pg. 524-532.

23. Jan Wolff, M.D. iodide Prophylaxis for Reactor Accidents,* Proceedings of the Nagasaki Symposium 1995, SO- Anniversary Meeting of the Atomic Bomb in Nagasaki, Nagasaki, Japan. September 19, 1995.

24. , "The lmplena811tation of Short-tenn Cot.mtermeasures After a Nuclear Accident.

Proceeding of an NEA Workshop Stockholm,* Sweden, 1-3 June 1994, OECD 1995.

25. Manual on Pubfic Health Actions in Radiation Emergencies, WHO, European Center of Environmental and Health. Rome Division, 1995.

26. lntematioual ~ Safety Star.dards for P1otection Against Ionizing Radiation and for Safety of Radiation Sources, Safety Series No. 115, IAEA, 1996.

    .. Zl. "'Method for the Development of Emergency Response Preparedness for Nuclear or
               ~ Accident.* Tecdoc-953,               1AEA. July-1997.

I --- - - -- ------- - - ---- -- ------- --- --- -

      -28.- - *Generic Assessment. Procedures -for Determining Protective Actions During a Reactor Accident,* Tecdoc-955, 1AEA. August 1997.                           .

29. NUREG-1150, *Severe Accident Risk: An Assessmentfor Fwe U.S. Nuclear Power Plants,. 1990.

                                                                   \

30. NUREG-6310. *An Analysis of Potassium Iodide (Kl) Prophylaxis for:the Genera! Public in the Event of a Nuclear Accident,* 1995.

DRAFT NUREG-1633

31. *Emergency Planning in the NHS: Medical Services Arrangements for Dearmg with Major Incidents,* Vol. 2, Accidents Involving Radioactivity Source, UK

• 32. Thomas, Clayton L, Ed., Taber's Cyclopedic Medical Dictionary, 16th Ed., Philadelphia: F.

A. Davis Co., 1989*

• DRAFT NUREG-1633

ht!p:111>.?-""'.mc.govfRES/cag/NRC-PIPBlbiappJXt htlp;//www.DI'C,EOV/RES/cag/NRC-PIPB/Jai

 -1
 .,..""s January 23, 1996 Mr. John C. Hoyle Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 ATTENTION:              Docketing and Services Bn.nc:h

SUBJECT:

Request for Comments on Petition for Rulemaking Filed by Mr. Peter G. Crane (Docket No. PRM-50-63) Volume 60 Federal Register 58256 - November 27, 1995

Dear Mr. Boyle:

             *The undersigned Certified Health Physicists with over 300 years of combined radiological protection experience submit these comments on the proposed petition to amend the emergency planning standard in 10CFR50.47, (60 Fed. Reg.

58256 - November 27, 1995), "Peter G. Crane, Receipt of Petition for Rule.making." The proposed petition recommends that the planning standard for protec:ti ve actions for the general public include the preventative stockpiling of potassium iodide (KI). We strongly urge the NRc* to deny this petition. We believe that stockpiling or predistribution of potassium iodide will not add any significant public health and safety benefit to the already high level of protection currently provided by existing emergency planning at commercial nuclear power plants. Potassium iodide can be effective in protecting the thyroid gland from radioactive exposure from inhaled radioactive iodine, however, it must be taken just*prior to exposure or within several hours after exposure to be effective. Any program involving stockpiling or predistribution of KI would be difficult to administer and could lead to misuse. Excessive amounts of KI can lead to, among others, hypothyroidism, one of the illnesses against which Mr. Crane states KI will protect. Further, some individuals are extremely allergic to non-dietary administration of iodine and may be unaware of their sensitivity. For these reasons, only individuals who are carefully monitored and evaluated should be given KI. Additionally, any radioactive release which was significant enough to require KI would also contain other radionuclides for which KI offers no ~rotection. NEI has provided a white paper to the Commissioners (originally sent on December 7, 1993 and revised in December 1995) stating why the industry believes that stockpiling or predistribution of KI for public use will not add any significant health and safety benefit~ We are in agreement with NEI 's review and believe that there is sufficient guidance available to the state and local governments that wish to make KI available to the general population if they feel it is appropriate. Many studies have been conducted that make a strong case for maintaining the current policy on the use of KI. ~ 1 2 5 l , .Final Report, Vol. 1,* April 1989,

             ..!'Implications of the Accident at Chernobyl for Safety Regulation of CammerciaJ.

Nuclear Power Plants in the United States," Chapter 4., 11 Emergency Planning, n found that the use of KI for the Chernobyl incident should not alter current

u. s. govenrment policy on predistribut.ing or stockpiling KI for use by the general public. CUrrent policy recommends stockpiling or predistti.bution of KI for emergency workers and institutional persons, but does not recommend the same for the public. EPA 400-R-92-001, May 1992, "Manual of Protective Action Guides and Protec:tive Actions for Nuclear Accidents, " recommends sheltering or evacuation over the administration of KI for most situations. Studies done on l of2 12/18/9& 10:4i

  ~/wwv.;'.tll'C.gov/RES/cagtNRC-PIPB/kaapp.txt                              bttp-Jfww-w.mc.gov/RES/cag!NRC-PlPB/i;nl
    ....    -"I the cost and administration of' KI to the public cont:inue'to show that is not cost effective.

Given the cost without associated benefit of stockpiling or predistribution of KI, the potential for misadministration, the safety record of the U.S. commercial nuclea.z; power progrm:n, and demonstrated strength of its current emergency preparedness programs, we strongly urge the NRC to deny the proposed petition and retain the current policy as providing adequate protection of public health and safety. We appreciate the opportunity to comment on the Petition for Rulemaking filed by Mr. Peter G. Crane. Sincerely, Peter J. Knapp Richard V. Warnock Eric M. Goldin E. Scott Medling R. Scott Schofield Terry L. Cooper Mark M. Lewis Linda G. Bray. Toshihide Ushino Michael J. Russell Steve En.right* William W. Strom

• 2of2 12118198 11h46

       . ~                    .
   ".http:/~.mc.govlRES!cag/NRC-PIST/califo:Jxt                                      bttp:/~.mc.gov/RES/cag/'NRC-PlST/cal:ifc STATE OF CALIFORNIA GOVERNOR'S OFFICE OF EMERGENCY SERVICES 2800 ME'JU>OWVIEW ROAD SA.CRAMENTO, CALIFORNIA      95832 (916) 262-1800 F.AX: 262-1677 Februa....-y 9, 1996 Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention:           Docketing and Services Branch

SUBJECT:

PETITION FOR RULEMAKING, PETER G. CRANE; STOCKPILING KI The State of california and its local governments and agencies have completed their review of the Peter G. Crane, Receipt of Petition for Rulemaking. The State of California and all its Emergency Planning Zone Counties unan.imously object to Peter G. Crane's proposal. We believe that stockpiling and distributing Potassium Iodide would be at best, ineffective, and possibly dangerous as a protective action during a nuclear power plant incident. State policy is against the distribution of Potassium. Iodide to the general. public and ...':i..1.1 continue to be so. If the Nuclear Regulatory Commission adopts a policy of issuance of KI to the genera1 public as a protective action recommendation, i t w::Ul be considered as being contrary to state policy and w:ill not be accepted. This will have the net result of negating much of the planning and preparedness effort of federal, state and local governments since Three Mile Island.

                                                                  \

our comments on the petition cim be summarized in the following ways :

1. The added function of distributing KI during an evacuation will increase the time required to complete the evacuation. This increase in evacuation time during a release from a nuclear power plant will result in an increased .radiation exposure to evacuees and emergency workers.

2. The distribution of KI to large populations (both of Ca1ifornia' s Emergency Planning Zones have populations greater than 120,000 people) will result in negative health effects, i.e., allergic reactions. These reactions, including anaphylactic shock, c::an be life threatening and still not yield a measurable protection from thyroid cancers.-

3. Local stockpiling of KI would put additiona1 burdens on resources in both the maintenance of a KI stockpile and its associated programs and the distribution of KI during an emergency would cause other functiorus to suffer. Regional stockpiles would have an inherent;_ ~

delay that miDimizes the effectiveness of the drug.

4. A plan to stockpile and distribute KI to the general public would involve a full scale public education program. In the event of an accident, public perception, in spite of the education, may still tend toward a belief that KI offers total protection from radiation *

• 1 of7 We appreciate the opportunity to comment on the petition.

Sincerely, l2118/98 ll:04;;

 , http://www.mc.gov/RES/c:aglNRC-PISTlcalifouxt                                  http-J~..nrc.gov.lRESlcag!NRC-PIST/ailifi VINCE MONTANE, MANAGER Radiological Preparedness Unit Attachment CC:    Ken Bellis, Southern California Edison Ed Waage, Pacific Gas & Electric.

Vince Morici, San Luis Obispo County George Brown, San Luis Obispo County Frank Carillo, Orange County Ralph Perry, San Diego County Mac McKeough, City of San Clemente Brian Perry, City of San Juan capistrano Mark Johnson, City of Dana Point Jack Roggenhuck, State Parks and Recreation Major John Misiewicz, U.S. Marine Corps. Steve Woods, Department of Health Services County of San Luis Obispo COUNTY GOVERNMENT CENTER, RM. 370 SAN LUIS OBISPO, CALIFORNIA 93408 (BOS) 781-5011 February S, 1996 Secretary, U.S. Nuclear Regulatory COllllll.i.ssion Washington, DC 20555-0001 ATTN: Docketing and Services Branch RE: Conmients on [Docket No. PRM-50-63] Petition for Rulemaking, Peter G. Crane; Stockpiling of lCT Deax Sirs: This letter is subm.i tted on behalf of the Office of Emergency Services for the County of San Luis Obispo. San Luis Obispo County is the Responsible Off-site Emergemcy Organization for an emergency at the Diablo Canyon Nuclear Power Plant. The following are comments on the Petition for Rulemaking to require stockpiling of Potassium Iodide for use by the public at off-site locations around nuclear power plants. In general, we are not in favor of the proposed rule. The basis for our opposition ~s as follows:

1. The preferred protective action in nuclear power plant actions are evacuation or sheltering in place. Attempting to distribute KI to the public wouJ.d likely conflict with the evacuation or sheltering of the public. If emergency conditions warrant the distribution of KI, then they would certrinly meet the conditions and guidelines for mandatory evacuation. Trying to get people to go to centralized locations around the County to pick up KI will likely interfere with the intent to rapidly

_InOve_ the public from the _designated evacuation area. The public may receive greater ~osure by remaining in the area while attempting to pick up KI rather than immediately exiting the area.

2. Although not extremely common, allergic reactions to KI cannot he discounted as insignificant. Anaphylactic shock is one of the possible reactions. The distribution of KI to thousands or tens of thousands people will result in some cases of allergic reaction. Medical response to cases of allergic reaction will be difficult as most medical resources will be allocated to assisting with the evacuation of special care populations in bospi tals and nursing homes.

2of7 12/1 &198 11:04

 .. hnp:/tvlww.nrc.gov/RES/cag/NRC-PIST/califor.txt                               , bttp-Jfwt>:w.mc:gov/RES/cag/NRC.PlST/cali populations in hospitals and nursing homes.

3. The,distribution of KI will require that emergency workers that are involved in assisting with evacuation, be reallocated to KI distribution

• This may hinder evacuation or other protective actions that are being undertaken. The effect could be to stretch local resources beyond the point of effectiveness.

4. The-- stockpiling- and distribution of irr*a:round-the cotiritry; ana here in San Luis Obispo, will pose potentially significant logistical problems. KI must, be changed out as it is a drug that has an expiration date for effectiveness. Tracking each stockpile of KI will require additional efforts being allocated to record keeping, destruction of expired stockpiles and replacement of stockpiles. Examined on a national perspective, there exists the potential for a half dozen to a dozen stockpiles around each nuclear power plant site, with the distribution of several million doses of KI to perhaps hundreds of entities. If adopted, the NRC will likely -establish strict guidance for implementation and monitoring of the entities compliance with the proposed rule. As such hundreds of thousands man hours will be applied annually to comply with this rule.

If a stockpile of KI is determined to be a necessity by your agency, a more reasonable approach would be to centralize stockpiles of KI so that they could quickly be delivered to locations_ where KI is requested. KI could be treated as a federal resource by distributing i t to each NRC Region Headquarters. Tbis would minimize the amount of money and time necessary to track, exchange, and certify that KI stockpiles are in place. However, all jurisdictions would be aware of the readily available nature of the KI stockpile and could place a request to access the stockpile if needed. The costs and logistical difficulties associated with the concept of centralized stockpiles will likely be an order of magnitude less than stockpiling resources at each site.

5. California has a policy that stresses other protective actions and does not recognize the use of KI as a protective action for the general populace. The Protective Action Guidelines for the issuance of KI are the same as that for evacuation. Evacuation is the preferred alternative. KI use for emergency workers, whose duties may require them to remain in the plume pathway, is clearly justified and is included in our emergency plans. However, when dose projections indicate that the PAG levels for radioactive will be reached, a protective action decision to evacuate will be made. The California policy is consistent with this concept of operations.

These comments are being forwarded to the California State Office of Emergency Services for inclusion in the comments by the State. Thank you for the opportunity to comment on this issue. Sincerely, Vincent Morici Emergency Serv:ices Coordinator STA!l'E OF CALIFORNIA - HEALTH AND WELFARE AGENCY DEPARTMENT OF HEALTH SERVICES 714/74.4 P STREET P.O. BOX 942732 SACR11MEN'l'O, CA 9-4234-7320 February 7, 1996 Petition for Rulemaking 3 of7 12118/98 11:0t

 *bt!JrJ~.mc.govlR.ES/cag/NRC-PIST/califor.txt                                 lrttp:/~.mc.gov/RESlcag/NRC-PIST/calil Docket Number PP.M-50-63 Published - Federal Register Vol 60, No. 227 Monday, November 27, 1995 Proposed Rules The following comments are submitted by the State'of California, Department of Health_ Servi~~~~-~~;~~~ta!_~agement ~~nch~_Nuclear El:D£!rgency Response Program:

1. STATEMENTS: " *** the prophylactic use of potassium iodide, which prevents thyroid cancer after nuclear accidents", " *** in addition to preventing deaths from thyroid cancer, KI prevents radiation caused illnesses."

RESPONSE: These statements imply that Kl is a protection against an individual acgm..ring cancer of other organs or illnesses following exposure to radioactive iodine from. the potential release during a nuclear incident. Where is the supporting data that proves KI prevents other radiation caused illnesses? A list of this data should be made available to all states. The generalized statements do not reflect exposure limits, dose levels at which such effects may occur nor t h e ~ limited window for therapeutic administration. There is no mention of side effects, even death for someone who is allergic to iodine

• If the FDA has detel:Illined that this drug is "safe and effective", why are allergies a controlling factor in issuing Kl to Workers, let alone the General Public? Obviously there are only potential estimates for the levels of iodine that could cause a reaction or it would not be classified as a prescription drug. Prior to issuance to Workers, there is a determination of any potential or possibility that the individual may be allergic to iodine which would prohibit that individual from being classified as a worker and these individuals no.onally receive training in the scope of hazards from KI a,long with the potential exposure to radiation. The training of the General Public
• in these same areas has not been addressed. These situations appear to be over looked in the petition. Is the NRC prepared to address the mllllher of legal implications should a member of the General Public be given KI at their directive or recommendation and the individual have an extreme allergic reaction, possibly death? This appears to be a 'no win situation.

The State'of California policies cu.trenUy prohibit the blanket issuance of KI to the General Public *

• This option should be left to the local or State health authorities as currently indicated in the U.S. Nuclear Regulatory Commission, Response Technical Manual RTM-93 Vol. 1, Rev. 3. In contradiction to the petitioner's opinion of the State and local gove.i::mnent' s in£o.o:ned judgement, most decisions of this nature would most likely be derived from a multitude of input from all levels of expertise.

2. STATEMENTS: * ..* potassium iodide for human use, should be available regionally for distribution to the general population and workers." " **. the NRC staff declared its support for Kl stockpiling. " "The Atomic Industrial Forum, a nuclear industry trade association, declared itself against the stockpiling of KI *** "

RESPONSE: The distribution of KI to the General Public within a short ti.me (1-4 hou even if stockpiled quantities were available locally. "KI should not be distributed to the general population if it will delay other immediate protective actions. 11 , RTM-93, reflects the anticipated problems. Therefore, the next alternate approach is pre-distribution to the General Public. This approach is not prudent due to the potential for misuse of the prescription drug, thus adding to the risk factor. Allegations pertaining to the Cost/Benefit analysis are unfounded and rational reasoning would make it unconscionable to distribute a prescription drug without adequate training, education and controls for the recipient. The State of Tennessee attempted this method and called it a success with only a 66% effectiveness, NUREG 6310. 4of7 12/lB/98 11:04

_bttp-Jlwww.nrc.gov/RES/cag!NRC-PISTIC8lifor.txt http-J~.mc.gov/RES/cag/NR.C-PIST/cali this method and c:alled it a success with only a 66% effectiveness, NUREG 6310. This should not be construed as an expense problem but as an insu.IJUOuntable task. The effectiveness of KI in blocking uptake of radioiodine by the thyroid depends strongly on the ti:ming of the dose of KI relative to the exposure to radioactive iodine. KI is most effective when taken just before or within 1-2 hours after exposure **. ", RTM-93. This time table cannot be met in a realistic approach or even within 3-4 hours for a 50% e:j:fecti veness

• Proper administration of the drug :may not be assured without adequate training for an entire population. - - - --*

Distribution to the General Public in a timely manner to accomplish the suggested results should not be viewed as a Cost/Benefit initiative but as a Risk vs. Benefit evaluation. Accomplishment of the task is a logistical

            .unpossibility and adds risk with m:iniroa] -benefits.

3. STATEMENTS: Three Mile Island, Potassium iodide Policy, Effects of Chernobyl, " ... petitioner asserts that the changes in medication that go with periodic scans put many patients on a physiological and psychological roller-coaster.n, " ... that Potassium. iodide was safe and effective for thyroid protection ** ", "The release of radioiodine is likely t6 figure prOJilinently in any nuclear power plant: disaster and knowledge of its ca-rcinogen potency is inadequate, especially in children."

RESPONSE: Comparison of the results of Three Mile Island (T.MI) with the results of Chernobyl appears .to go along with the roller-coaster example, only in this situation, it becomes the use of a fear tactic. This tactic is deplorable. There were releases of radioactive iodine at T.MI, but to compare the situations of the minima] amounts of release to that of Chernobyl, is -once again unconscionable. To imply that the type of reactors and mjnirnal containment barriers like Chernobyl in anyway compare with those in the U S. is strictly a fear tactic. The results of TMI and Chernobyl should not reasonably be compared since there were no actual effects to the general public from the release at TMI. There has been minimal effort to report or even follow up on events of allergic reaction to KI in either Poland or the previous Soviet Union since there are minimal records and no intent to publish such negative effects by those countries. We may never know of many of those effects, therefore, the petitioner may be very comfortable in the allegations referring to Chernobyl. However, what need was indicated for KI at the TMI incident? M:inirnaJ- to none. Would it have been distributed to the General Public if available? Not effectively. Had the KI been* available for distribution at TMI, could i t have been distributed in a timely manner? Probably not. What studies have projected thyroid injury or-incidence of increased thyroid cancer in the vicinity of TMI? Basically none. Evacuation and sheltering are adequate protective measures of choice for U.S. emergency response protective actions as were adequately demonstrated at the TMI incident. The use of KI should remain the .responsibility of local and state authorities whether for Workers or General Public. If the NRC wishes to assume full responsibility as the lead Federal agency, and make recommendations, the State and local authorities will openly receive such recommendations. The decision to authorize the use of KI will remain at the direction of the Loc:al Health Officer, when prudent and as the law allows.

4. STATEMENTS: " .. _. nuclear power -plant -licensees to have a'de-gilate supplies of KI available for nuclear power plant workers and the general public.",

           " ... should he available regionally for distribution to the general population and workers *** ", " *.. that the United States maintain the option of using the drug potassium iodide for thyroid protection during nuclear accidents."
           " *** rnaintain5ng a KI option ensures that responsible authorities have an additional type of protection at their disposal", "the NRC will provide advice to the state and local governments on *** a, "that the States do not have an adequate basis for making infonned decisions.", " ... that without accurate and current infoJ:IDation on KI *.. States cannot make an informed judgment."

5of7 12/lB/98 11:0-<

• C * ~

_.hnp;J/www.mc.gov!RESlcag/NR.C-PIST/califorJxt http;Jfww:"-=~/RES/CllglNRC-PIST/cali RESPONSE: The petitioner's intent appears to be twofold, (a) assure adequate availability of KI through stockpiling and (b) adding a requirement for the use of KI specifically for the general public. (a) Availability of KI may well be an issue for the federal agencies to address. There should be no argument with the fact that stockpiling of KI by the Federal Government may be a sensible and prudent measure to assure its availability since i~ has been demonstrated that i t was not available during a

            -potential- need. The Federal Government has made radioactivity monitoring instrumentation available to and maintained by the States for distribution and local stockpiling. This type of program for KI would probably be less expensive than that which has been expended through out the Cold War period, during which, no need for use has developed, and was basically propagated by the fear factor. Stockpiling will not be an answer to the distribution problems and the avaiJ.ability of KI should not be considered in the same scope as actual use by the general public.

{b) If it is the intent of the NRC is to direct the use of KI for the general public, because of assertions made by the petitioner, i t appears that the NRC is exceeding its legal authority and confusing advice with a mandate or regulation. The States are quite willing to work hand in hand with all Federal agencies during any incident. Implication to the contrary by the petitioner or that KI is not a viable option within limitations is ludicrous. The current directions indicated in RTM-93 for KI provide adequate guidance with in an acceptable, workable frame work for all levels of government and their legal jurisdictions. The NRC should not have to be reminded that the State of Ca.lifornia also provides a ntllllher of qualified experts in the field and are available for such decisions. Stockpiling of KI and distribution may need to be addressed; however, the current protective action issues must remain in proper perspective and not be changed. The existing issues have been previously addressed by a benefit versus risk not a cost versus benefit initiative as indicated by the petitioner. *

5. STJ\.TEMENTS: None RESPONSE: Without questioning the motives of the petitioner, the NRC must be aware of the eminent expense created by the time and research propagated by this exercise. The entire industry and government as well must once again be

• penalized for the ineffectiveness demonstrated by the NRC in its failure to resolve this issue early on. It may well be a necessary means to an end, however, in this time of financial restraint, i t behooves the NRC to bring this issue to an effective end .

            .ADDITIONAL NOTES

1. The Federal Register notice does not address studies on how KI can be realistically administered to large populations in an emergency situation in a smficient time frame to be effective.

2. The Federal Register Notice does not address the iss~e of cost effectiveness of training for states who adopt the policy of stockpiling KI.

            -3 .*-- The--Federal Register Notice i:l.oes not adpress the issue of states who adopt stockpiling KI on how it will affect emergency planning and exercise play.

4. The Federal Register Notice does not address legal issues for states who decide to adopt KI and states who do not decide to adopt or administer KI to the public *

• 6 of7 Sincerely, 12/18198 11:()1

_!ittP=f~~JR.ES/~C-PIST/califor.txt .I http-J/www.nrc.govlRES!caglNRC-PIST/calif Stephen A. Woods Senior Health Physicist Nuclear Emergency Response Program.

. f" I

                                                           - __ .. f  ,,

• I 7of7 l.2/18/98 11:04

79 East Side Drive Concord, NH 03301-5460 January 12, 1998 Woodbury Fogg, P.E.. Director NH Office of Emergency Management 107 Pleasant Street Concord, NH 03301

Dear Mr. Fogg:

Although models and predictions regarding anticipated health consequences from atmospheric dispersion of radionuclides from a severe nuclear accident were established by the finest minds in health physics, these models have been proven_ to have been flawed. Specifically, cases of confirmed thyroid cancers in children of Belarus and Ukraine have exceeded by 10 to 50 times scientists' predictions of incidence existing at the time of the Chernobyl nuclear power plant accident in 1986. Onset of childhood thyroid cancers has also been found to occur at an earlier time than anticipated following exposure to radioiodines, with 50 to 60% of the cancers invasive in surrounding tissue with lymph node metastasis. This is the basis for our urging you to accept 1he US Nucle.ar Regu1atmy Commission's offer of Potassimn Iodide (KI) for stockpiling. and including advanced distnoution of KI to members of the public in the plume exposure pathway, and distnoution as needed to members of the public in the ingestion pathway, as protective actions in New Hampshire's emergency response plan. We have beard and n:ad statements that nuclear reactors in the United States are designed to be safer than the reactors in Chernobyl. However, engineering reports prepared by the former Soviet Union indicate their confidence in the fail..safe dependability of the Chernobyl reactor design prior to the accident Many lessons can be taken from the unfortunate disaster at Chernobyl, not the least of which is that an unanticipated emergency caused by human factors can occur at a nuclear reactor, despite confidence in the perceived robustness of the physical plant While prudent oversight can minimize the probability of an accident, it cannot eliminate one, and pre-planning for what are known consequences of such an event can reduce subsequent cancer. Uncertainties have also been put forth whether KI will be perceived as a substitute for evacuation and cause its delay, and whethft' members of the public will comprehend and follow instructions on administration. To this, we comment that a simple brochure can address these issues as long as it is kept in mind that information provided to the public needs to communicate in simple language. Directions on ways to mitigate the consequences of ah accident do not need to be complicated by the illusive abstractions of particle physics, but they do need~be cl~_J?ld

 - -con:cise. --Ensm:i:Qgth*e availability of K.4 and providing* corresponamgresponsl1lle mstmctions to members of the public on its administration as an adjunct to evacuation and sheltering is not only a reasonable duty of government, it would also shift responsibility to the individual member of the public for following these instructions for themselves and their children.

Woodbury Fogg, P.E., Director January 12, 1999 Page2of2 Argument has been put forth regarding fear of liability due to an adverse reaction from ingesting adequate quantities of KI to afford protection. However, if a nuclear accident involving large quantities of radioiodines released to the atmosphere were to occur, and stable iodine was not rapidly available to them, members of the public would have virtually no possibility of reducing dose to theirs and their children's thyroids. This would be particularly injurious in the event of uncontrolled or unforeseen factors slowing or preventing evacuation during the plume phase of the accident Data obtained during ingestion pathway and recovery phases of the Chernobyl accident indicate that ingestion of contaminated foods and dairy products was a contnouting factor in the high incidence of childhood thyroid cancers. Although successful interdiction of food is thought to be possible in th~ Unin:'1 States, ~ is ~ model that * - _ has not been proven on a very ~ scale. High doses from inhalation and/or mgestion of '* * * ,,,. radioiodines contributing to thyroid cancers in children could potentially result in liability actions brought against state government for its failure to meet an adequate standard of care in

--- the presence of compelling evi_dence on the efficacy of KI, and willingness by the federal government to fund its availability. Conversely, KI is a relatively benign compound, and the probability of liability claims from an adverse reaction is low because the probability of adverse reaction is low.

This is the time, when there is no irnrne,cliate urgency, to work out logistics to assure that stockpiles of KI are maintained in sufficient quantities and locations in the state to ensure members of the public will have access to adequate doses within four hours of exposure to radioiodines from a nuclear power plant accident or terrorist activity, and for continued radiological dose reduction to the thyroid following introduction of radioiodines into the food

• chain.. .

Sincerely,

                                                                                     ,;::'""iP***~ l       l" * .-} .....,_ '"'"'l
                                                                                     *     ..   - ~    * :    I  -. ..., ~ 1 -J, "'-,
                                                                                              - " : --- *...; --' t . .r
                                                                                               '!'!c: '::i ,' * ,,. ~ ~

NUClEAi ENEi6Y INSTITUTE Alan Nelson SENIOR PRO.ECTMANAGER, Pt.ANT S'IJPf'ORi" NUClEAR GENERATION DMS10N January 11, 1999 Mr. Woodbury P. Fogg, P.E. Director New Hampshire Office of Emergency Management State Office Park South 107 Pleasant Street Concord, NH 03301

SUBJECT:

Consideration of the Use of Potassium Iodide for the Public

Dear Mr. Fogg:

Please consider the following submittals providf;ld by the Nuclear Energy Institute* to the Nuclear Regulatory Commission regarding the use of potassium iodide for the public. In summary, the industry believes that the stockpiling or predistrihution of potassium iodide will not add any significant public health and safety benefit to the adequate level of protection currently provided by existing emergency preparedness at and around commercial power plants. Events that have occurred and studies initiated since the 1985 federal policy make a strong case for maintaining the current policy. If you have any questions regarding the industry's position please call me at (202) 739-8110 or e-mail (apn@neiorg). APN/tnb Enclosures

• NEI is the orgmrimtion J:Pf'IPOD!PDle fur eatab~ unified nuclear industry policy on matters ~ the nuclear enexgy indnstxy, inchiding regulatory aspects of generic operational and t<<:hnicaJ issues. NEI members include all utilities licensed to operate commercial nuclear power plants :in the United States, nuclear plant designers, major architeetleng:ineering :firms, fuel fabrication facilities, materials licensees, and other organizations and in~uals : i n ~ in the nuclear energy industcy.

1776 l STREET, NW SUITE -*IOO WASHINGTON, OC 20006-3708 PHONE 202.739.8000 FAX 202.785 AO 19

t

• JoeF.COMn

"'!-C ........... ~* : - ;

NUCLEAR MANAGtM9ll' A.ND RESOURCES COUNCll .

~__:..e ..:,- ::

Dec::nber 7. 1993 The Honorable Ivan Selin Ourirrnan U.S. Nuclear Regulatory Commission

• Wasbingxon.. DC :0555

Dear !-Jr. C"bairrnan:

The Nuclc::!I Rcguiatory Comntission announced in the Federal Regmer ( (SS Fcd.Rq. 3976&) on September !t 1990, that'it is reconsidering the fedcm policy issued in July 198S on distribution and nsc of potassinm iodide (KI) dmmg an emcrgem:y. The pn:scm federal policy is that predistribmion or stockpiling ofKI far use by the genml public shall not be required. \Ve undersrmd the Commission is ptesemiy considering mpnt from the staff on this subjcet coniained in SECY*93-318., "ReevalDatit of Policy Regarding Use of Potassium Iodide *.c\ftcr a Severe *.\ccid.em at a Nuclm Powe Plant.a . We completed a review of evens that have occmrcd since July 1985 tbatmay suppan changing the presem policy. The results of that review are provided in 1hc: e22cJ0sed whm: paper. "Review of Federal Policy on Use of Potassimn Iodide." The industry believes 1hat the stockpiling or prcdistribution of potassium iodide will not add any signi:ficam public bezdtb and safety benefit to the adequate levd of prmecrion amcntly provided by emtmg cmergcncy preparedness at and around commercial nuclear power plants. Events that have occurred and studies imrlm:d !laDla _jlu;_ ~~" f~_policy make among-case-for maumrinmg the cmttnrpolicy: In addm

                                 *to the substantial cost impaas to om industry that we believe are unjustifiable.

stOCkpilin.g or prcdistriburion and the associated public education wouid result in a

                      .           p~aUy significant negative public perception. The industry strengiy urges NRC to retain its ccn~ policy as -providing adequate protection of public hc.aith and safety*

The Eonorabic h-:m 5:En Dec=b:r 7. 1993 Ifthc Commjss1on ruis any quesnons regarding~= ::-.cioscci ,..,irite paper. please , call me or Tom Tipnm. Sinc:::ly, c'lrl-'+b.ol

                                                 ~ F. Colvin .

• JFC";ET:pig Enclosure c: Commissioner Kenneth C. Rogers Commjssioner Forrest J. Remick C-OIDIIrissioner Gail De Planquc
• James M. Taylor. E.'tCCUtive Director of Operations

I . .I REVIEW OF FEDERAL POLICY ON

• USE OF POTASSIUM IODIDE DECEMBER 1993 Nuclear Management and Resources Council 1776 Eye Stree1-= N.W.
• Suite 300 Washington~ DC 20006
• INDUSTRY \VHl'l E PAPER _,

REVlE\V OF FEDERAL POLICY ON USE OF POTASSIU\1 IODIDE INTRODUCTION On September 28, 1990, the Nuclear ReguJatory Commission (NRC) announced in the Federal Regiszer (55 Fed. Reg. 39768) that it is reeonsidering the federal policy on the clistn'bution and use of potassium iodide (Kl) during an emergency. The purpose of of this industry white paper, "Review Federal Policy on Use of Potassium Iodide," is to discuss technical a;id historical perspectives pertinent to reconsideration of the policy for stockpiling and public use of pota.ssimn iodide for hypothesized nuclear power reactor accidents. Study of these issues clearly demonstrates that stockpiling and public use of potassium iodide will not add any signifiQnt public health and safety benefit to the adequate level of protection cummly provided by plant safe operations and on.site and off-site emergency preparedness activities. The industry strongly urges NRC to close rceonsidetation of this issue and to retain the current policy. FEDERAL POLICY CONSIDERATIONS The use and application of potassium iodide as a thyroid blocking agent in a radiation emergency has been debated for at least 15 years. On December 15, 1978, the Food and Drug Administration (FDA) issued a notice in the Federal Regiszer (43 Fed. Reg. 58798) announcing its conclusion that potassium iodide was safe and effe;tive for use as a thyroid blocking agent in a radiation emergency under ccnain specified conditions. The final recommendations noted that uncertainties Still exist about its use and side effects. The FDA noticed the availability of potassium iodide in its final recommendation and stated that*[eJach state is respODSiole for formulating guidance on when. if at aa the public should be supplied with potassium iodide along with instrnctions on how to use itr FDA also emphasized that "[t]liese final recoromendarions on potassium iodide use must be seen in the context qf radiation emergency planning as a whole. The use of potassium iodide in radiation emergencies is not a panacea.* The ___ NRCs~-lmpact-of-Nnclear-Reactor-Accident*S*ource T eDllAssuinpii~.,--- NUREG-0771 June 198 l~ supponed the FDA's position and recommended that emphasis be placed on other. more comprehensive emergency protection measures .

              . NUREG/CR-1433, ~uclear Remtlatorv--        Commission. E.'(amination of the Use of
 . ~     --     ""                                      .,

Potassium Iodide (KI)-~ An Emergency Protective ?vieasure for )!uclear Reactor Accidcms." :March 1980. prepared by Sandia National Laboratories for the NRC. stated that based on cost cffccri\'CilCSS the use of po~ium iodide was not worthwhile. This rcpon also emphasized that pomssium iodide was not a panacea and that its use-needed to be balanced againsi: the cost and effectiveness of other protective measures such as sheltering and evacuation. The Federal Emergency Management Agency (FEM.A) and the ~1RC have been considering stockpiling potassium iodide since 1981. Richard Krimm 1 ofFB*IA testified on the issue before Senator Simpson's Subcommittee on Nu.clear Regulation in April 1981, and again before Representative Markey's Subcommittee on Oversight and Investigations in March 1982. At both hearings FEMA was supponivc of the use of potassium iodide for the general public in an emergency, but recognized that its use should be evaluated by each state or local jurisdiction and that specific plans for distnouti.~ administrative and medical assistance would be needed by these governments if potassimn iodide were to be effective. FEMA published a notice of issuance of Federal Policy, "Federal Policy on Distribution of Potassium Iodide .A.round Nuclear Power Sites for Use as a Thvroidal , - Blocking Agent," (50 Fed. Reg. 30258, July 24.. 1985). The guidance provides justification for the use of potassium iodide for emergency workers and institutionaiiz.ed individuals *and stated that, *[t]he Federal position with regard to the predistnoution or stockpiling of potassium iodide for use by the general public is that it should not be fJ required." The Federal Register notice also idenri:fi~d issues regarding stockpiling and

• distribution that remain pertinent today, "[a]ny decision by state and local authorlbes to use KI should be based on the conditions and site environment for the specific operating commercial nuclear power p~ and should include detailed plans for distrlbm:ion, administration, and medical assistance."

The NRC ann01DlCCd that it is reconsidering the cment federal policy on the

• disttibution of KI (55 Fed. Reg. 39768, September 28, 1990) based on a request by the*

American Thyroid Association in September 1989 for the establishment of a national stockpile program. The NRC stated in the Fedual Register notice thllt it believes that the cost/benefit ratio supporting the cmrent policy may have IlBII'Owed. based on expericncc during the Chernobyl accident. and a reduction in the cost and increase in the shelf-life of potassimn iodide. As part of its reconsideration, the NRC released astndy in June 1993, *A.n

       ~           of Potassium Iodide (KI) Phrophylaxis for the General Public in the Event ofa 1  *,.mss:am Assodme Dirc:cmr. Office ofNamr.11 and Tccbnologicll Hmn::ls. Federal Emergency Mlnagcmr::m Agency. 9Potassmm lodide Stoc:kp,Jing,* AIF Confercnc:c. October 6. 1982.

       ~uclcar Accident..* April 1992.: In Chapter 7, "The Applicability 9f KI Cost-Benefit

• Ratios to Policy Decisic>n" the analysis document stateS "tt]he unencumbered and direct application of the dem:ed cost-benciit ratios for Kl in a policy decision can in fact be justified only under the following two conditions." A valid policy decision must ( 1) weigh the potential impact of model uncertainties and (2) the prophylactic use of KI in' the context of other proteetive measures. The repon goes on to state that. "these two conditions do not exist." The rep on concludes by stating, "Although these cost-benefit ratios as crcdt"ble and objective as cunent data allow, caution mUst be exercised in using these values in a policy decision.*

CHERNOBYL IMPLICATIONS TheNRCs NUREG-1251, Fmal Rcpon, Vol 1. April 1989, "Implications of the Accident at Chernobyl for Safety Regulation of Commercial Nuclear Power Plants in the United S~" Chapter 4, "Emergency Planning," reviewed facts about the Chernobyl accident and their impact on emergency planning and preparedness around U.S.

• commercial nu.clear power plants. It addressed the contrasts in emergency planning, noting the more advanced levels of emergency planning and response capabilities around U.S. plants. It also discussed specifics of the releases unique to the RBMK design, 1 noting that radioactive material potentially released would be considerably less for U.S.
• plants because they have substantial containments. Chapter 4 also stated that, 1a]lthougb.

low-probability, fast-moving accident sequences arc possible., seven: accidents at U.S. plants WOllld, in gen~ progress more slowly, resulting in 1onger times before release." This allows for employing sheltering or immediate evacuation as a more prudent protective action.

• ' Thc 11Conclusion and R.ecommenda.tions" ponion (Section 4.2.4) ofNUREG-1251, states that the use of potassium iodide for the Chernobyl incident does not alter the U.S.

govcmmcnt's policy on predistnouting or stockpiling KI for use by the general public; it should not be required. NUREG 1251, Section 4.2 "Medical Servi~" reexamined the use of pota!tSDDD iodide for the public around U.S. nuclear power facilities based on the Chernobyl experience. Section 4.2.3 "Assessment* ~ "[f]or members of the general public, however., these conditions [exposure to release over an extended period] g ~ _ ~ ~~_

  ---- - -applicab~oecausc:~~cmis*gcnm11y-feasi0fcana,-whcn cmnetfoui. fs more effective in dose reduction than administration of KI. since it can reduce the dose for all 2 S. Cohen & Asscoates Inc. Comma No. NRC"'°'"'90-070. prepared for U.S. Nudc:lr R.egulalosy
          -Comnrissirm llcacmr and Pl:mt Safety Issm:s Br.mch. Division of Safety lssuc Resohnion. Offic: ofNudc:a:r R:grd.atocy R:s:arch
                                                                      \.

bodv.. on.rans and not mcrclv. the thvroid. -clanci.

• Because of these consider:mons. the policy statement concludes that a nationwide requirement for the prcdistribution or stockpiling for use by the general public would not be worthwhile. It funhcr concludes that the decision to use Kl should be made by the States and. if appropriate. by local authorities on a ~ite-specific basis.... The apparently successful use of KI at Pripyat docs not alter the validity of guidance that recognizes that evacuation of the general public in the affected area could result in a grcmer overall dose reduction."

The NRC's most recent repon3 also reviewed the Chernobyl experience and in Appendix E, "Kl Experience in Past Nuclear Emergencies"' it concluded that while KI was distributed to the public.. * ... the bulk of iodide prophylaxis was restricted to the

• avoidance of thyroid bmdens from the ingestion of contaminated food products.* The rcpon reeogni:zes that use of KI to counter some effects due to people eating cmrtaminated food'was more necessary at Chernobyl than would be the case in the U.S.

due to differcnccs in food distribution systems. The repon states. "[f]or U.S. populati~ there is a lack of dependency on localized food products in the event of a nuclear emergency which therdore. limits the value of iodide prophylaxis to plume inbaJatinn of radioiodinc." Wnh the less localized food distribution simarion in the U.S.., food , interdiction is more possiole. and indeed is preplanned and periodically exercised. As with evacnation, interdiction is preferable to use of potassium iodide because ~ provides protection for the whole body.

• The report also recognized additional circmnstances that could decrease the value of public use of potassimn iodide in the U.S. in comparison 1;0 the Chernobyl scrring These include:
• Design of the RBMK vs. l)'pical U.S. LWR .. specifically the accident scenario including release fraction, release rate.. dumion of release.

(Section 7.1.1 "Reactor Accident Frequencies" states., "the values of reactor accident frequencies used in this repon must be regarded as the single most

 /

significant nnccrtainty affecting the cost-benefit ratio ...");

                                               '                                             I

• Housing densities in the Soviet Union .. "[p]opulation densities affected by multifamily residents in the Soviet Union have a profound affect on
• distnoutioriproccdmc~ methods, and distribution efficiencv"; and

                                                                                  \            -
                *        "Dietary intake of iodine. A low dietary intake of iodine (is common
                       --miong Emop_ean_countries: the opposfre illetary snuanon applies1ii the 3

An Analysis ofpPtmrom Iodide cK,D Prpphvlans for the Gcpcml Public in the E\"ent pf a Nucl;ar Accidr:p;r April 1992. I

U.S.) incre:ises the thyroid uprake :md thyroid dose for a given exposure

• condition. The prophylactic beneiit of stable iodide i~ therefore.. enhanced by low dietary intakes,.,

The fact that potassium iodide distribution is fairly common practice in Europe is not a valid reason for chang,:og rlie-cumnt policy in the Enited States (V.S.). There arc significant differences in the level of U.S. and European emergency preparedness (e.g., organization, training, facilities, equipment. and regulatory oversight) that need to be considered in evaluating the relative additional benefit of potassium iodide within the

 )-     U.S. programs which stress rapid capability for notification and evacuation if needed.

Study ofiodine prophylaxis associated with the Chernobyl accident hlghligbts these and significant societal differences. Review of Chernobyl indicates potassium iodide would be ofless benefit in_ the U.S. due to the ~ditional protective features of our preparedness programs. SOURCE TERM \VORK A comparison of the 1975 WASH-1400 results (the current basis for the federal policy) with NUREG-1150, "Severe Accident Risks: ...\Ii Assessment for Five U.S. Nuclear Power Plants." October 1990, shows that 1fie ~cident frequencies and source

• tCims were originally ovt:1stated by one to two orders of magnitude, Draft NUREG-11 1465, "Accident Somce Tenns for Light-Water Nuclear Power P ~ June l ~ notes the differences compared with WASH-1400 in the chemical transpon of iodine; thus the iodine available for release to the environment is also lower. These advancements in understanding ofacci~ source tcnn argue against source term as a justification for change to the cmrcnt federal policy on KI.

EPA PROTECTIVE ACTION GUIDELINES The Environmental Protecri-on Agency (EPA) issued its final guidance on protective action guidelines. "Manual of Protective Action Guides and Protective Actions for Nuclear Accidents," EPA 400-R-92-001, May 1992 EPA reviewed the use and application of potassium iodide in Appendix C, "Protective Action Guides for the Early Phase: Supporting Information," Section C ~ 3_ "'Thyroid Blocking." EPA agreed with

    ---- FE>A-thal:-use of potassium* iodide has been-identifietraslllf effectiveptotective-acti~ bttt:-

noted. "[e]vacuarion and sheltering arc. however. preferred alternatives for most situations because they provide protection for the whole body and avoid the risk of misapplication of potassium ii;,dide." INDUSTRY E..'\."PERI~CE

• As a result of the Three Mile Island accident. the State of Tennessee decided to predistributc KI to residents within a five-mile radius of the nuclear power station.

Appendix E of the ~"R.Cs report' describes. "The Tennessee Experience." and its "Program Eiiectiveness.* In 1981. Kl was distributed to 66 percent (3022) of the total households (5591) at an esti.mared cost of S125,000.

               - In the fall of 1984, three years after the initial door-to-door predistribnti~

residents were contacted that a new supply of KI was available for pick-up at identified rea:ption centers. Thiny-tWo percent of the eligiole households responded. Based on

• recent di~ssioilS wilh TV~ it is our understanding that less than five percent of the households retrieved their replacement KI in 1992. The Tennessee state officials had considered the pilot program a success, but based on the volunteer retrieval rate dropping from 66 percent to less than 5 percent, the program's continued validity is questionable.

Another issue revealed as a result of this experience was that the thousands of vials no longer useful due to shelf life expiration are now considered hazardous waste., thus adding additional cost and administrative burdens not previously considered. The lessons learned from the Tennessee experience regarding the administration and cost of either stockpiling or predistnlrution of KI should be considered in the reevaluation of the cm1 ent policy. OTHER PAPERS ON THE ISSUE At the Atomic Industrial Fomm Conference, "Radiation Issues for the Nuclear Industty,* October 3-6, 1982, a special session was held*regarding "Use of Potassimn Iodide in Emergency Planning for Nuclear Power Plants." Dr. Bernard Sbleien from the Bureau of Radiological Health of FDA (FDA Project Mmiager. "Potassium Iodide as a Thyroid Blocking Agent in a Radiation Emergency: Fmal Recommendation on use* 47 Fed. Reg. 28158. June 29. 1982). who dispositioned public comments to the Federal Register notice regarding final recoI111Dendatibns on use of potassium iodide spoke during this session. Dr. Sbleien stated in his presentation, "Issues Concerning the Use of

• Potassium Iodide *as a Thyroid-Blocking Agent in a Radiarion Accident," that several cpntroversial issues regarding potassium iodide were unresolved. These include:

4 An Analysis of the Potassium Iodide cKJ) proph\"latjs for.the General Public jn the Event ofa Nm::Jm Aa:idem. April 1992.

 .l .
    * ~

I

• ls the probability of a nucle:u- power plant accident resulting in a hazardous release of iodine so small that the consideration of the administration of Kl I to the public is mmeccssary?

                     .        ls stotkpiling and distnlmtion of KI f casible and cost effective?

• What other protective actions are possible and does their employment negate the need for using KI?

While these questions can likely never be answered with cenainty, the inf?Jll'Wion gathered in the past 11 years point to less, not more. potential benefit and workability of KI use in emergency situations. I Dr. Beck~ Chsinnan of the American Thyroid Association. published a paper.,

              "Reactor Accidents. Public Health Strategies and Their Medical Implications;* in the Joumal of the American Medical Association _on August 7~ 1987. It recognized problems in public distnlnn:ion and the public's misconception of KI as a radioprotccrive agent.

The paper also discussed the handling of special populations.. and indicated that far the general public if radiation levels reach values at which KI use would be recom.niended. administrative evacuation may be the protection of choice.

                                                                                                          \

In Dr. Becker's paper refercnccd above he also reviewed the predistriburi.on option - and noted the considerable effort and cost associated with the Tennessee experience. noting that extra stockpiles would need to be made available for'those that may have misp~ their supply or never received it. The paper discusses the "Distn'"buri.on at the TUDC of the Accident" scenario "noting a concern as to how timely emergency workers could distribute KI at the time of an event. 11 Dr. Becker concludes by stating that *[i]n most accident scenm:ios. the ovm.ll gain from KI use seems to be marginal" INDUSTRY PERSPECTIVES In this section of this paper we provide the nuclear power industry's .perspective reganling1his reconsideration. z In.May 1982, the Atomic Industrial Forum issued. ..Statemcmt on the Use of

---

Potassmm foaide By thePi:.tcmiiclruiiisttiaJ.roruiru ConmYitte.e orfEnvifonmcm.-"-Inits--

                "Recommcndarions" the statement said "fw]e believe that pre-distribution to individual members of the public is inadvisable" because, among other reasons.. "[t]here may be a false sense of security given to tjle recipiems of KI from a perception that its use would also reduce the radiation dose to -other critical body organs. e.g., bone marrow, lung, etc.*
*

• Additionally, "[tJhe pre-distribution of KI and the maintenance of an adequate supply

 . among individual members oi th: population have numerous adminjsmmYe ::.'1d logistic problcms...[mcluding} possible utilization at the wrong time. loss of the Kl by indhiduals. and overuse of Kl in the belief that larger doses are benenciai. **

The purchase cost and implementation of a policy ?upporring potassimn iodide stoclq>iling or predistribution to the public would add substantial com to utilities ratepayers. These costs would be realized both directly due to utilities modifying emergency plans and required public information materials to address these added protective actions., and indirectly through NRC and FEM.A use fees billed for development., maintemmcc, and exercise of the stockpile and distributing system, as well as ~ review of modified state and local emergency plans and procedures. Due to the shelf life of Kl a full replacement and distribution would need to take place through the remaining operating license of the facility. The program also needs to be maintained for transient populations -as well as resident turnover. Based on the cwxcnt age of the U.S. nuclear industry ,ve might e.--cpect that this would occm rwo to three more times during the license life of the facilities.. resulting in substantial cost across the industry. In the past KI has been a high profile issue of great public interest. It is reasonable to expect high levels of media and public interest associated with any change in federal policy on this issue and the associated public educarion. Members of the public will want to know if the federal policy is being changed beeause the plants are less safe. Public confidence in the technology could be affected by the decision. It is our understanding that one of the reasons given to pre distribute Kl is,public opinion and confidence regarding the safety of nuclear power in this counny. Quite to

• the conttmy, smveys taken by Bnskin/Goldering Associates5 indicated more favorable public opinion *after the Chernobyl accident. "The percentages of Americans who rated nuclear energy plants "unsafe" dropped from 48 percent just before the accident to 34 percent just afterward (Februmy 1986 vs. May 1986)." This was confirmed by surveys done for the National Science Folllldarion. It was documented that fom months prior to the event Americans thought that the benefits of nuclear power outWeighed tlic risks by 51 percent to 40 percent. One month after the accident it was 56 percent to 38 pcccnt.

The smvey also stated. "Americans now give higher safety ratings for nuclear energy: plants than they did a decade ago. Only 27 pc:rcent rated them tmSafe in May 1993., compared.Vlith. 4&_~ in_F_ebruazy 12&4~"

                 ' Peapcaivcs on Publit: Opjmon. prepared by USCEA. "'On Nudc:J.r Power S:lfety." July 1993 .

The nuclear power industry's emergency response capabilities l defense-in-depth) have mamred as a result of twenty-three years of emergency preparedness cxpcri~ bcginnjng in 1970 with the-issuance of IOCFRS0.34. embodying the first emergency preparedness rules. It has been thincen years since implementation of 1OtFRso. A.ppcndix E.. and NUREG-0654/FEh.1A REP-1, Revision l. providing for substantial expansion ofboth onsite and offsite emergency.preparedness programs. Over the past 13 years annual exercises and actual non-radiological events have tested the adequacy of these programs. This has demonstrated an acceptable state of emergency preparedness capable: of adequately protecting the health and safety of the public. CONCLUSION The predistripution or stockpiling of potassium iodide will not add any significant

• public heahb. and safety benefit to the adequate level of protection currently provided by existing emergency preparedness at and around commercial nu.clear power plants.

Considcrarion of the realirles regarding potential release of radioiodincs and of the practicality of implementing an effective potassium iodide distribution program lead to this conclusion of no significant additional benefit There would be substantial' cost impacts to om industry that we believe arc unjustifiabl~ in addition to the potcDtial

• negative public perception impact that predistriburion or stockpiling .and the associated public educarlon would cause~

Technical, practical implementation. cost/benefit and political considcrations*.make potassium iodide predistribution or stockpiling inappropriate. Events that have occmred and stodie$ initiated since the 1985 federal policy ,make a strong case for rnaime;,,;ug 1he

• cw.tent policy. Given the safety record of the U.S. comm.crcial nuclear power program and the demon.sttated strength of n3 CWlent emergency preparedness programs., the industry mongiy urges NRC to retain the CW'.I ent policy as providing adequate protection of public health and safety.

NUCLEAR ENERGY INSTITUTE Lynnen. Hendiic:b DffCTOR. PUNTSUPPCl'IT NJCtEAR GENERATIJN DMSION r September 11, 1998 Mr. David L. Meyer Chiet: Rules Review and Directives Branch Mail Stop T-6 D69 Office of Administration United States Nuclear Regulatory Commission Wasbingt.on, D.C. 20555-0001

SUBJECT:

Draft NUREG-1633, "Assessment of the Use of Potassium Iodide (KI) As a Protective Action During Severe Reactor Accidents,"

Dear Sir:

(63 Fed. Reg. 38865, July 20, 1998) The Nuclear Energy Institute CNEir submits these comments on behalf of the nuclear energy industry in resp<rf1.Se to the subject notice. We have reviewed draft

 ~ -NUREG-1633 *Assessment of the Use of Potassium Iodide (KI) As a Protective Action During Severe Reactor Accidents,* (63 Fed. Reg. 38865, July 20, 1998). The draft NUREG reviews the historical use, tecbnir.al basis, and industry experiences with KI as a supplemental protective action for the general public.

Draft NUREG-1638 supports the industry position that *considering" stoclqn7ing or predistribu1ion of KI as a protective act.ion will not aftd any significant public health and safety benefit to the adequate level of protection currently provided by existing emergency planning at and around commercial nuclear power plants. NEI strongly urges the NRC to reconsider it's approval ofthe'J)roposed ruJemak:ing

  --petitiOD:-- ---- -- - - - --- -- - --                                                - -- -- - -- --- - -- -- ----- _ ~--* _____ _

l

    '"NE! is the organization T"ftSJM)Dlrih1e for Hteblisbing unified nuclear indmtry policy on matters affecting the nuclear energy imhutry, including reeulatory aspects of generic operational and technical iuues. NEI membeni include all utilities licensed to operate commercial nuclear power plants in the United States.

nuclear plant designen, major architect/engineering firms, fuel fabrication facilities, materials lincsees, IUld 11Ll1L'I' Ull::Wliz.uLiuiui wul imliviilll11ki iuvulvL.J in I.he nudcur etll."l:Y indub1.ry. 1776 I STIEfl. NW SUITE *OO WASHINGTON. DC 20006-3701 PHONE 202.739.1000 FAX 202.785.*DIQ

. ,: Mr. David L. Meyer September 11, 1998 I

   '       Page2 The industry endorses those conclusions in the draft NUREG which indicate careful consideration should be given to whether the use of KI for the public during an emergency is advantageous. The industry agrees with the staff's assessment in
          . SECY 98-061 "Staff Options for Resolving a Petition for Ru leroaking Relating to Re-evaluation of the Policy Regarding the Use of Potassium Iodide {KI) by the General Public After a Severe Accident at a Nuclear Power Plant.* Accordingly, we endorse Option 2 which recommends denying the petition and supports the FRPPC policy statement discussed in COMSECY 97-028 which maintains that evacuation apd sheltering are the primary protective actions.                                   '

Con.sequences of Chernobyl are often cited as a reason the United States (U.S.) should distn"bute potassium. iodide. Studies have found that evacuation is more effective and will reduce the dose to all body organs. The study concluded that a nationwide requirement for KI predi.stribution or stockpiling for use by the general public would not be worthwhile as an add-on to evacuation and sheltering. The fact that KI distribution is a fairly common practice in Europe is not a valid reason for changing the current policy. There are significant differences in the level ofU.S. and European emergency preparedness (e.g., organizatjon, training facilities, equipment, and regulatory oversight). In ihe absence of detailed plans many countries distribute KI as the first line of defense. Review of these

• preparedness programs indicates distribution of KI would provide marginal or benefit in the United States.due to the protective defense-in-depth features ,

           -contained in our preparedness programs.

1 This protective defense-in-depth philosophy is demonstrated by the fact ~ most I no emergency plans suggest precautionary evacuation of schools and day care facilities

• at declaration of a Site Area Emergency. Under these conditions, there is no imminent release of radioactive material that will exceed EPA Protective Action Guidelines beyond the site boundary. If cbildren are evacuated, there is no opportunity to further reduce risk tb.roug}i distribution of potassium iodide.

A major impediment to KI distribution t.o school children is coordination and administration of the program, e.g., the ~ decision-making process to administer KI or evacuate, parental approval and record keeping, identification and mitigation of allergic reactions, and the availability of a qualified medical

      --- -~~*-
           ---~essional
                    -     to --administer
                         --               the 't.assium iodide.
                                ---* -- --- --~- - -      - - --- . .- **- -* ----  -- -

The U.S. fe'deral agencies, nuclear i,ndnst:ry and state and local emergency response organimtions have developed the most effective and sophisticated emergency preparedness plans in the world. The U.S. model recognizes that evacuating an area is the most effective response for prot.ecting the public health ~ safety.

• Where evacuat.ions are performed, potassium iodide would not add any measure of

Mr. David L. Meyer September 11, 1998 Page3 safety to this proven approach, and could actually complicate and hinder emergency response. If there are any questions regarding the comments provided please contact me at (202) 739-8109 or by e-mail (lxh@nei.org), or Alan Nelson at (202) 739-8110 or e-mail (apn@nei.org). NEI is available to meet with the NRC and discuss these

    .issues further if desired.

Sincerely,

     ~

Lynnette Hendricks APN/LB/tnb c: Aby S. Mohseni. U.S. Nuclear Re~ry Commission I i

                                                                                                                                         .    ~

Sent. By:- PNS CODE 105. 2; 2074382726; Page 2/3 From:-, Clim ~--*=* _j Mct1mook.e;;. ~

                           ,:*~*ManaiemcmDirector. Tf._cn!J~~*

24HighlmiRoad  !. ~ I *' Kcnsi~ lffl 03827 '~~ (603)394-0033 To: Woodbury Fogg, Director NHOEM 107 Pleasant. St Concord, NH 03301 ir1,::..- - ., " - --: * * * * ..... * .. * .- :'" ....

                 *Re:* Potassium Iodide (Kl) pill 11SC for imclear accidents .*

Sir: AJ1er attending the Exeter public infurmatfon session Oll;. 8 .* I;>ccember.: 1998

• regarding Kl use. I have scvcm1 commen:ts which I wish to make. -~~:

my own, and not those ofthe town of Kensington.

• i Accordmg to the info, O!IDQQ. pnmdcd by the panel. it is my miderstandini tha4**....

during a ~ accident, I-131 is a. small ftaction of the 1otal pcy;tnI~ ~ ,

                 .release. Ingc$6on of I-131, ~ would oDly account for a: small fraction of the dose tommcfu.
                                                                                                               *f. .,.: *~ *\ ~--
                                                                                                                                  --~
                                                                                                                                    ~*

are. ; to the ))1lblic rernaming within the plume. The use of KI _pills would not make the difference between a pcal01l teeeiwiog a fatal or non-fatal dos:. TheiJ' use is also highly time dcpcodant, in-lhat 1hey 11e most. efi'ecfivc if lak=i prior lo a relemc.* The lo:ngec the

• time a&:t n:k:asc m:1 bcginmng 1o take the pills. the 1=m cffcctivc they .an:.; 11:ie- smg1e most effective method of 111i11i111i zi,ig 1hc dose 1D 1bc public is to cvacua:tc 1hca1 a-way from 1hc pb:unc. These facts lead to scvcm1 conc:ems essociatcd with ~-disb:ibiition ofKl pills; .. .

                          . Fll'Sf,. if fiie*pills. are pn:-distn"buti::d to the public; 1bcn some one will have to be in                           \

• charge* af local distribmion, emming tbat the people nndcnanod 1hc pro_pcr 1lSC and stm:agc*of th: pWs: "the .rlsb associated w.uh fhmr use, and CDDtro.lliDg fheir ~ e n t as their useful dafl:s cxp:iie. It sc=:ns like it'Will 'blkc a lot of dfi>rt to do COUeC11y (i.e. in

              . a *way that rnroir,,jn:s the .liabi1ny risk to 1hc tow.n). As a local Emcrgcncy Management Director (EMD) of a completely vobum:cr mgan:i?31ian,. I do mt hav~ enough people a:vm'labJe to 1akc this project on. I also do oot fflJti

• ate being able to fin.a. CDOugh-:

volllDtCCrS to be_ able to implcmem sueh a policy. lf~ State wis1ics t(;* ~ cii;i this.* admloistrativc bmdc:n (even though it seems to be a hugely wasttmJ1 expc:n,e),, tlmt *rs ::om:: . I wm not take on this bm:dcn at the local~ wi1hmlt significant funding fiom ~ State . or.+:r:....,..

                     ~,                        *      '
                                                                                                              ,.; * **.** -~

af **.,* *

                      - --Lalso-have-ac:oncc:m-jf.fbcsc_pills were.to be ~-in-a-cc:IItral-Jocation -for--

dist:n'bution dming mt accidcot. S"mcc.: time .is such mi ~ ~ in* fbc pill c:ffcctiveness, aih;r a release. notifications_ WDDld bavc :to go ~ qaicldy; and the c:m:in,

• cnmrmmity almost instantly mobilized 10. take 1hc pills to :hayc an:y positive effect. A3 EMD, I -would have_ to me a sigmfk:ant ~ of m y ~ pme and *energy to make

                                                   .     .                   j:*                ... . =:..     -{

• DEC-29-1998 03:12

                                                                                                       *1 P.002

gcu11.. 01* rn.;;, ~ eu-..1.c., Dec-29:98  ;-1r~j ,1~{. ' .~1?~

                                                                                                               . ,:,11                 ~

3/3

                                                                                                      .-        ,; ~                   ~~   . .~ r*
                                                                                                   * *. ~fl-~                    °J.:{i/     . *
                                                                                                         '      l. ! ~;          ~~..        . .:

l  ! _!,: I :i,1 .... ... .. f ,..

• lb.is distribution in a manner that is qDick enough to be cdfcctivc. U ~ ~ * : I ha.ye ~ )

few people helping in 1hls group. Once a reactor accldr:nt happens.~m/,*~o.d EMD~ as arc to protect the citizms of Kensington to the greatest cacm practicable:. ~ means' 1het 1 hive,10*maJie j ~ similar to 1bc medical pbilosppby-or lrl,ie(cootroJ ihe

                                                         - **- - * -         ..   .       --"i:              -**                     -     .
               . biggest arui most urgent problems ~ 1liin deal witli ~ e r problems lstcr).h£t to" distn"bution ofKI reduces total dose by 5%, and evacuation~ dCl:!IC by lOOo/'o, then
                    *evm::uation.makcs the most sense to accopiplish msC         l'lmvc*~ use my                       lirnitr4 TeSOUrCeS

{i.e. people) in the way that protcc:ts the population the most.~ Being forced to distribtde KI pills will dd'a:y my cffarts ~ ~ I do not have~ pcDODllCl available to do both functiom (evacuate and distribute KI) at 1be same time. One or the other lJlllSt take , . the back seat Given a choice,. I vn11 ALWAYS make eyacuatlon *~y nunibc::r ODC : r : priority. with KI distribution the lowest priom;y* .:._t~ Kl distribation:during a reactor :* accident

                           . as  increasing  themk 1o the  public BD.d causing   great=' harm than not disin"buting
                                                                                                             .       ~       ..                                  \

the pi1:)s;-;- -- . .. . .- . ,. Since the use of KI is so minimally cffcctive, it seems that the cost mid cdfort to ~ distnDUte and ad:roinistcr1bcse pills is a waste oftime. It scc:ms to dchir1e the public mto*~ thinking they have a magic pt11 that pi e v e n t s ~ from hmting them, mid clouds =::~

• the real issues that have to be dealt with in fhc 1:\1:tlt of a n:a:.tm: accident. It will make.. '
• the job of cmcrgcncy management significantly mo.re difficult. Sim::c m&ey' of~' EMDs -..

in the 10 mile EPZ arc volnrncen, it seems 1hat increasing their \VOl'k wm ma.kc th=n. less .*

• likely to pmticipatc in emeigcncy management 'Ul:d reduce the ~:a!,~ io*_ci;ipe. -~-

with casualties. Even tboogh 1be pills are relatively * * : ~ Kl fur- the gcnmf public will be costly in 1cmls of time, ~e:!:~ "perception.' *.i would rccommcndnatdistrlbutingK.1forthc,pcmlpublic. t,.:.,.: * ~ If *. ~*:*::: *

                                -   - ~         ~ ,,.            -.~r                .. a::I* *            .. *       *i
                  ~~                                                = -             ,*:§/* .-/* . *,j.

Chris Mcrtinooke

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1

• I
• IEC-29-1998 09:12 2074382',26 P.003

1-CRTH 1-lAMPTrn .FIRE E '. PAGE 02 01/13/1994 15:55 6039&47249 I

• I
• - -j.~29,U198

                                                      !              Town of Nortlr llampton OFFICE OF EMERGENCY MANAGEMENT-                                        1
                                                                                                             -1/4-r l

r f) W.""'11rYP, Fogg. Dnctor

                                     ~ Manapmem Pari::Souln nt $tree¢
              --~~NH03301
              -lfDiirectorFogg.

_re,pect to the matter oftbe distribution of.KI Tablets. it is my fceiing that our

              ._,me u BmerpDcy ~ Direotors in the Seabrook zone RERP is for the safe r
               .            * *011 of residmJll;m guests in the area. All of our available resoorces are directed t
              ~ *d the accomplimmem oftbc evacuation. It would create an additional burden to ~
                            ~anymore tub usi~nments ~ t h e ~ number of personnel
              ..., qsmstions come to mind ifBUch a ptt>gIBill were required of the local officials:
               .                                       l                                                                       ;.

t How would the KI be distn"buted? ,;.

• L..:::::11

t. Who wouJd ~ thD KI? -- ~

tho JiabiJ,iy and fflljlODll1'bility fur overdoses or allcl]iic .I .

              ~ time and with~ infbtmation I have available, I can not endorse or support the .f

• --~,\>*s~
• dittribution.of,tlbJats.

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• JAN-04-1~ 11:29

                                                .  ..       i ***
                                                          ;:.!fi~:~

6039647249 P.002

r RR.#3, Box 1060 r Putney, Vermont 05346 December 29, 1998 Woodbury Fogg, P.E.,Director NH Office of Emergency Management 107 Pleasant Street Concord, N.H. 03301

                                                     , ~-       ** f

Dear Mr\ Fogg,

t :,. ; - . ..__ ' - The following are the comments and suggestions that were presented by myself on behalf of the Citizens Awareness Network in Chestedield, N.H. at the public infonnatiot;t session on potassium iodide (KI) - Our stand is that KI should be predistnlmted and the public should be fully educated about the benefits/risks of ingesting Kl The following health and safety issues to the residents of the tri-state area-Vermont, Massachusetts, and New Hampshire make it imparative that this distrlbotion and education be done as swiftly and extensively as possible.

1. the lack of an adequate evacuation or emergency management plan

2. the meteorological effects of an accident on the tri-state community

    .3. the systemic design f1a:ws in Marlc I reactors which renders Vermont Yankee's cc,a1 ainmf,rt inadequate in the event of an accident(and would force the direct release of radionuclides into the enviromnem)                                      .

4. the potential health effects :from exposure to an acciedent at Vermont Yankee

5. the systemic mismanagement of the reactor and the chilled work atmosphere at VY.

Sincerely,

   .4~~
    ~Faust CAN in Vermont

Keith H. Dinger, CHP Occupational and Environmental Radiation Health Consulting 23 Prospect St.

• Somersworth, NH 03878-2708 January 5, 1999 Mr. Woody Fogg, -Director Office of P.mergency Management 107 Pleasant Street Concord, NH 003301-3809 RE: USE OF POTASSIUM IODIDE (KI) BY THE GENERAL PUBLIC
• FOLLOWING A SEVERE REACTOR ACCIDENT

Dear Director ~ogg:

The media has recently reported on an initiative under the auspices of the Office of Emergency Management (OEM) to evaluate the use of potassium iodide (KI) by the general public following a severe reactor accident. It is my understanding two public

• hearings were conducted to receive public input on this initiative. ~ough the reports did not indicate that OEM: was requesting submittal of additional public comments, I assume you* are interested in rece.iving COIDinemS from individuals that were unable to attend the public IJ1PP.tings I am a health physicist Certified by the American Board of Health Physics, am a Fellow of the Health Physics Society, and am currently President of the national Health Physics Society. As you probably know, the Health Physics Society is a scientific organivrrinn of professionals that are specialists in radiation safety and health. I cmrently hold an appointment as Instructor, Environmental Science and Engineering, Department of Environmental Health, Harvard School of Public Health, Harvard University, Boston. I have obtained expertise in the area of nuclear emergency response planning during my twenty-three year career as a health physicist. For eighteen yea.rs I served as Director of Radiation Health at the Portsmouth Naval Shipyard. In this capacity I served as the Head of the Radiological Assessment Team in the Shipyard's radiological emerg~ response organivrtion, wbicli included the responsibility for advising the states on recommended

 - --- -- --protective-adions-fullowing a radiological.emexgency. __ For_the pastfiye y~ J ~ _ _ __ __ ____ ~ ___ _

conducted professional continuing education comses at the Harvard School ofPublic Health in the area of radiological and nuclear technology. In this time I have directed ten courses related to nuclear emergency planning and response.

• Tel: (603) 692-4270 Fax: (603) 692-3760 e-mail: kdinger@ttlc.net

Therefore, as a resident of the State ofNew Hampshire with expertise in the area of

• emergency response and protective actions for a nuclear reactor accident, I am submitting the enclosed comments for your consideration.

   . Please do Ilot ~ to ~~-!J!C if you~ _any questions about these comments or need any further information on this topic.                           -* - -*

• s~

     ~~.

KeithH. Ding~:~~ Enclosure I J

                                                                                               /

COMMENTS BY KEITH R. DINGER, CBP,

• ON THE USE OF POTASSIUM IODIDE (KI) BY THE GENERAL PUBLIC AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT The State Qi:~~ Hampshire should not incorporate into its-radiological emergency

 --response plan the use of potassium iodide (KI) by the general public after a severe accident at a nuclear power plant.

Evacuation and in-place sheltering provide adequate protection for the general public during the early phases of a severe accident at a nuclear power plant. Relocation and food/water controls provide adequate protection for the general public in later phases of recovery from such an accident.

                                                                                       )

Lurrent guidance for taking actions to protect the general public in the event of a rarliological accident, including a severe accident at a nuclear power plant, has been well developed since the heightened awareness of the need for such plans following the accident at the Three Mile Island nuclear power plant in 1979. The most recent evolution of this guidance is contained in the Environmental Protection Agenr;i s Manual or. Protective Action Guides and Protective Actions For Nuclear Incidents (EPA 400-R-92-001 ), and other regulatory and guidance documents issued by the Nuclear Regulatory Commission and Fedenu Emergency Management Agency. This guidance incorporates action levels based on the projected dose to the entire body and all organs through the Effective Dose Equivalent methodology. (This methodology uses the latest s c i ~ knowledge to account for the radiation sensitivity of individual organs in determining the potential harm from rarliation exposure. This resuhs in a measme of overall risk that is not skewed by a high dose to an organ of low sensiti:vity, and it properly accounts for a low dose to an organ ofhigh sensitivity.) The action 1eve1s are based on the projected Effective Dose Equivalent at which the primary protective actions of evacuation and in-place sheltering should be taken. The guidance also provides action levels at which the dose to a single organ, the thyroid, would be more controiliag (ie., provide a greater risk of injury) than the Effective Dose Equivaleot and at which the thyroid protective action- of administration ofKI mey be warranted. Receotly, ~ Nucle.ar Regulatory Commission has received Petitions for RuJernak:ing (PRM-50-63 and PRM-50-63A) ~ the regulatory requirements for nuclear power plants be changed. The intent ofthese petitions is to increase the pressure on states such .

fua!_~ ~uld .give a greater consideration to the use of KI for the general public. As part of the Nuclear R.egrilatcuy-eo, ru111smon's-evainmon ofihese-petiiions, their stmi'----

 *developed a Draft documem: emit.led ".Assessment of the Use ofPotassnnn Iodide (KI) As a Public Protective Action Daring Severe Reactor Accidents"' (NUREG-1633) .

• \

NUREG-1633 provides a technically sound assessment of various scientific and technical issues related to the use ofKI by the general public. The assessment of these issues supports the position that Clllll!'JJt guidance provides adequate protection and that no change in the emphasis on KI administration to the general public is appropriate. Some key points from NUREG-1633 related to the issue of public health that support this r

 '    position are:

• KI is a pharmaceuticm which is contraindicated in several situations. Taking KI in these situations can resuh in problems of major clinical significance. It should not be administered to an individual without proper medical supervision and evaluation of each recipient.
• Severe reactor accident plans are design¢ to give action points at which protective actions are taken prior to actual release of radioactivity to the environment. If the ensuing emergency response actions taken by the reactor operators are effective and no release actually occurs, this could resuh in an unwarranted administration of KI with riBks of adverse medicm effects. Similarly, the protective actions of evacuation and sheltering could be taken unwammtedly. However, unlike the administration of KI there is neglig,'ble risk associated with taking these actions.

     * . Use of KI is not an a1terna:tive to evacuation and could, in fact, potentia11y delay evacuation for a net detriment to public health.

Effective evacuation and sheltering, the primary protective actions, provide protection for the thyroid.

• The pathway for uptake of radioiodine in the absence of other more hazardous radionuclides is through .subsequent intake of contaminated food and water. New .,

Hampshire emergency response plans have adequate and appropriate controls for the interdiction of coo1amioated water and food to prevent this pathway from occurring. Other points related to public health which are not completely covered by NUREG-1633 are:

• The thyroid is relatively insensitive to radiation induced adverse health effects.
• Thyroj<ldiseases a r e ~ easyto diagnose and are effectively treated by New Hampshire medicm faciftfies. -- -- . -- -- .__, -- - ---- -- -

• • Points which are not directly related to public health, for which I do not profess to be an expert, but which I have concern as a tax-paying resident are:

  * .. _The stockpjlmg_and_~_OJ'.l. _of KI necessary to implement general public use in an emergency involves costs that will add to the tax or cost burden ofNew Hampshire residents. These will be costs involved in the development of an implementation plan by State officials, implementation of the stockpiling plan, certification*ofthe adequacy of the plans by Federal agencies, and periodic testing of the adequacy of the plans.

• The State 'Will assume an unnecessary financial liability by making KI available to the general public. Adverse medical outcomes in individuals that take KI can result in litigation requiring State funds to compensate iajured persons from improper, or ill advised administration.

To summary, the public health risks and economic burden imposed by the general use of KI in the event of a severe reactor accident outweigh the potential benefits gained by its use.

   ----------- ---               603:..964-9894 I

le 563 W.ASHINGTON ROM> 8USINESS (603) ~-!5!96 FAX TRAHSl{ISSION FORM NOTE': Th* 1n.tc:-1nation contai.n*d in tM.a :fac::si.m.11* mea**GJ* u 1nt*nd*d only igr th* u** of th* 1nd1viduai er *nt:1.ty na..,d below. If you ar* net th* intendad :-.o1p1~nt, or an ,*pl.of. . or agent g1'

• the intended rtt01p1ent who ia :x-.apanai~l* ~0r,eel1ver~g it ta tba
• add~**we, you ar* not1%1ed that any di***min,tion, diatr~button.

or c0p:,1ng cf t.hi.a c01111unioat10n 1* *tr:l.0tl~proh.:l.bit.*d*.- U you hav* r*oeiv.,d t.b:La 00. .u.n~_a:t,io1f :l.n *r:-oi;-~ nct1~y th* **nd*~ abcv* addr***** by U.S. ~~*~ by t*l*phon* (collec::t.) and'nrturn t.h* Fil to tlw

                                                                                 ~-.]r pl.****-**

i .;f : 1 _ _ _ _ _ _;.;......,.;,;;;;.;;.;;;;;;,_._ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __

iW111N'11&tltJ.y TO Director, JmOEM COPY TO: SL FIELD .REP,, GEORGE MOSLER -i f f. ~ ""'lJ .~ . . ,. *. {:*,.: . . ".:. * *rl ., ,

• FAXmunbvr:

Humblif.;- 0£

                        ------------~b~~t) 603-225-7341 pagira Uncludi.ng cover

*-~q ., DATE:;

                                                                       ~        -------------

1____

29 December 1998 t;. -~- ***.

1 _ _ _ _ _ _ _ _ __ I~ complete t:"anamaa10n i* not r1PC<<:l.ved, plea. . te1*phona 11111D1td:l.*t.*lf, (&03) 96,1-6411. -'!'°J' *.

• Copy of fax to Goe.:rge Musler *
• DEC-29-1998 15:31 603 964 9894

Qochester fire Department Oty of Qochesler

37. Wakdidd olreet.

• Qochesler. Ntt 03867
• Hrui:.Ddlner Chief of Depart.menl (603) 335-7545 December 28, 1998 Woodbury P. Fogg, P.E. Director N.H. Office of Emergency Management 107 Pleasant Street Concord, New Hampshire 03301-3809
• Dear Director Fogg; I am concerned about a possible protocol that is being developed which will require Host Community staff and personnel to supply P ~ Iodide (KI) tablets to evacuees in the Seabrook Nuclear Plant evacuation zone.
• As you know, Rochester is a host conmnmity for the Portsmouth area in the event of an actual emergency at the plant Should we be required to issue these pi11s, I feel it would severely bog down our process in Rochester, not to mention a severe liability issue in administering any oral medication without prior patient history. Allergic reactions to KI and distn"bution methods are a concern of mine.

In closing, I wish to notify you ofRochesters opposition to this proposal and om decision

• to not participate in this proposed KI program.

I respectfully urge you and your office to reconsider this program as you have an excellent history of being responsive to the concerns of the local comrrnrnities. Sincerely, rll~y..J20~ MarkDellner Rochester Frre Chief cc: Rochester City Manager Gary Stenhouse

                                                                                     -~-:-     ... ~ ),-*
                                                                      .      .,,,.,.   ,-~J .......,-".

66 :iowell ** Rd. 3rentwood, NH 03833 :*;** Dec. 27, 19BEf :_ * *- -~

Dear-Mr. Fogg,

We write to comment on the distribution of potassium. iodide as a precautionary measure in case of an accident at a nuclear power plant. We attended the public hearing in Exeter Dec. 8, and this meeting reinf'orced our belief that such distribltion is the only prudent and appropriate couxse. The arguments raised against the distribution of potassium iodide were that this responsibility would interfere with the other, more important functions of emergency response personnel and (the point raised by the visitor from Massachusetts) that evacuatio:r;i was and. should be the chosen defense in case

 -of accident.

In response to the :fi:rst point, the potassium iodide should have been distributed in advance, certainly to schools and also to individuals desiring it. As to any concern that the predistribution of pills would create a false sense of security, it would in fact have the effect of making people more aware of and knowledgeable a.rout evacutation plans rather than less. It -was clear at the meeting that many ordinary citizens (as opposed to emergen~spon.se personnel), even ordinary citizens who had concerns about Seabrook Station, were ignorant about evacuation plans. We have heard of one private preschool in Ex.eter whose administ:ration refuses even to consider evacutation planning, because the whole issue is too disturbing and controversiai. The distribution

• of potassium iodide provides an opportunity for educating the public that should not be passed up.

Evacuation may be the :primary available response, but it isn't the only one. In some accidents, the ra{iiation release might be too little and too temporary to warrant evacuation. Weather oondid:.ions -- a severe winter storm, a hurricane -- may well make evacuation impossible. And those outside the ten mile zone in the ingestion pathway also deserve the protection potassium iodide may provide. Radiation won't stop at the ten-mile ba:rrl.er, and i-& our understanding of the evacuation plans that they anticipate that those outside the ten mile zone will stay put so as not to congest roadways. "If Sea.hrook blows, these pills are not going to really do anything for anybody, " Dr. De1Iart has been quoted as saying (ExeterNewsLetter, Dec. 8, 1998) -- anybody close to the plant, a.t least. But potassium iodide is believed to have been protective in Poland after Chemo byl. Our conclusions are that the State should 1) distribute potassium iodide as widely as possible; 2) distribute it as much as possible directly to those who want it and will take the trouble to understand it: its side effects, what it will and rlll::.not do; 3) most important, make certain that all schools have a supply and the training and necessary permissions to use it if necessary:. The most difficult task will be appropriate education. Let's hope that a better job can be done than has been done up to now with education about evacuation plans. Sincerely,

• c~\e...,. ~ '-Jc.a:..,,... .P~---

Charles and Joan Pratt

• 1** -.

 .- -~=*

David F. Bibber., Chief CITY OF DOVER Municipal Building

• 288 Central Avenue Dover., New Hampshire 03820-4169 ..,

FIRE & RESCUE Telephone:* 603-742-4646 Fax: 603-743-6146 fire&rescue@ci.dover.nb.us December 22, 1998 Woodbury P. Fogg, P .R, Director Office ofEmergency Management 107 Pleasant Street Concord, New Hampshire 03301-3809

Dear Director Fogg:

• It has recently been brought to' my attention that protocol is being developed that will require our orgaoirn1ion upon request to distnmtte Potassimn Iodide (Kl) tablets to those who live in the area of the Seabrook Nuclear Plant. This correspondence is to document my opposition to. this decision and the likelihood that we will not participate in the distnlmtion program.
• This issue coupled with toruef s litigious society leads me to believe that this program is
• opening the door for om department and the city to \>e liable for something over which we have no control; and that is, "How do we know if someone is allergic to KI and how do we control distribution?" A classic example that supports my concerns is om liability for using latex gloves on ambulance patients who may be allergic to latex. We now have to provide a special and expensive kit to be used on these special patients provided we are aware of their allergy. However, the legal door is still open as to when or how we should know if our patjent suffers :from this malady when we provide emergency service to them for other injuries or illnesses.

In additio11, as a Host Comm1mity, we *provide a Decontamination and Reception Center. If we were to participate in this KI project, I foresee the entire operation being slowed down and hampered by paperwork that would be required for issuing pills. I hope you understand my concerns and will support om personnel in the field who will make themselves even more valnerable to legal action if they are forced to comply with this protoco1

                                                                                             --~--- --     - - - --- -
                                                                                       .   ~-,,:_':*;-:

vid F. Bibber, EMO ; ~ --*- . -=

• City of Dover Emergency~

                        - - Telecommunication for the Deaf (603) 742-4646

• Emergencies - 911

194 Paine Road Westmoreland. NH 03467 December 17, 1998 Woodbmy Fogg, P.H., Director . NH Office of Emergency Management 107 Pleasant Street Concord, NH 03301

Dear Mr. Fogg:

I attended the public information session in Chesterfield. I am a mechanical and human factors engineer. I am a former part-time employee of the Atomic Energy Commission. and I have toured and interacted with the labs at Argonne, Oak Ridge, and Idaho. Regarding potassium iodide:

• 1. The probability of another nuclear accident in this country like TMI or Browns Ferry is greater than zero. How much greater is a moot point, since agencies such have yours have determined that it is likely enough to require emergency planning. For pwposes of disCUSilon, we might consider it as likely a

as San Francisco 1906 earthquake in New England.

• 2. The public is poorly informed of this risk (or, for that matter, the earthquake risk). Emergency plans and rehearsals involve only government officials and emergency personnel No disclosure of proximity to the nuclear

         -plants is required before purchasing a nearby house (in contrast to the warnings and disclosure required for radon, for example) .

• 3. Evacuation plans are probably hopelessly optimistic. Therefore, if there is an accident, many people may be straJlded too close to the site.

4. Tnnely ingestion of potassi:t1m iodide has a demonstrated beneficial effect in minimizing the absorption of radioactive iodine. Potassium iodide will also have side effects for certain individuals.

5. Nuclear proponents deny the risk of an accident They don't want to alarm the public, and therefore don't want KI distributed or promoted in any

 - *----way.-Toeybelieve no-one-needs KI-because there won't be-an-accident - * ---

6. Nuclear opponents want the plants shut down by aey means possible.

If distributing KI gets the public aware of nuclear plant risks, and riled up, so

much the better. Opponents also believe the risk is real and significant, and

• would like to protect the public from damage where possible.

Therefore, I conclude that New Hampshire's policies should be: A Provide much better information to the public on the nuclear plant risk. and other emergencies for which your office is planning. Once a year, for example, you could mail out to every family in the state a "hazard of the year" I info packet Your packet should include useful info for those who choose to take I. an extra interest in that particular hazard For example, about Weatb.eradios with SAME alert, or radiation monitors, or DIY earthquake seismic bracing. You should also require disclosure bf nuclear plant proximity (and other potential hazards) for real estate purchases and for renting. B. In that spirit, allow citirens so interested to go to their doctors and get prescriptions for KI. They will solve their own logistical problems as to what to do about the kids, etc. C. Longer term. make realistic revisions to the evacuation plans. and if they show that lots of people will be stranded. then bite the bullet and get KI out to people via their doctors as part of their periodic medical check-ups. Thank you for your attention to this matter. Sincerely,

• Roy Swain, p .E.

TOWN OF HAMPTON FALLS

• TOWN OFFICES, 1 DRINKWATER ROAD 603-926-4618 NEW HAMPSHIRE 03844 December 30, 1998 Mr. Woodbu:ryFogg New Hampshire Office of Emergency Management State Office Park south 107 Pleasant Street Concord, NH 03301 Re: Proposed distribution of po'tBSSium iodide

DearMr. Fogg:

Our Emergency Management Director Robert Gale bas briefed us about 1he proposed distn'bution of potassium iodide to 1he public.

         \                                  .

We do not believe that distribution during a radiological emergency would be in 1he best :interest of 1he public. Distribution of KI on an amma1 b¢s 1D be taken if a radiological emergency were to occur is not a concept that 1he Town of Hampton Falls supports. We believe that 1he resources dedicated to 1he radiological cmcrgency response plan con1d be better utilized in an edncation and awareness program. Sincerely yoms, Hampton Falls Board of Selectmen cc: Robert Gale Potassium iodide/emergency mma.gementfcns

1 * ,.. ~.__,.-*-~:~" "'-<***- . ~ .." ---~~*-:~h~-~~-

• 1/)1! .

DIVll510N Of'" CA~R-WALl.ACI!:, INC. HALF-ACRE: ltOAD

• P. 0. BOX 1001 Janumy 6, 1999 As part of its nuclear--disaster planning program, 1he U.S. Nuclear Regulatory Commission (NRC) has

          . issued a recommendation that smtes consider stoclq,iling potassium iodide for the prevention of thyroid
 )

cancer. Since January 1980, Wallace Laboratories bas been 1he leading supplier oipotassium iodide tablets (fHYRO-BLOCK.11, potassimn iodide tablets,. USP) to government agencies and nuclear power plants. Many government agencies and public utili1y compmlies involved with nuclear reactors have assumed that quantities of this medication are stockpiled at some central location and are* available to the public in case of a nuclear emergency. This is to advise you that. to 1he best of our knowledge. no agency has assumed widespread responsibility for providing potassium iodide to 1he public should a nuclem- accident occur. Rather, each state or nuclear facility needs to address this issue independently.. In addition, in case of exposure to radiation, for max;imum protection, THYRO-BLOC.K. should be 131::en within 1hree to four hours of such exposme, necessitating that the medication be locally available. TB.YRO-BLOCK is packaged in bottles of 14 tablets and shipped in cases of I 00 bottles. ' Comse of therapy= 1 tablet daily for IO to 14 days

• $250.00 per case (I 00 bottles of 14 tablets; per person cost $2.50) 5 years product shelf &re Jfyou have any questions, or require additional information, please call Steve Varon at (609) 655-6744.

To place an order for TB.YRO-BLOCK, please call Susan Wood at (609) 655-6147 or mail your order to Wallace Laboratories, P.O. Box 1001, Cranbury, NJ 08512."

               *t_c~*

Thomas G. Geisiinyet- - - -- President. Wallace Laboratories

• ~

         ~ 

Attachment:

               ~"1nstruction Sheet
                           ~** *r ...... t I           '         *

   ,,   APPENDIXD SELECTED REVIEW MATERIALS

                                                         ' ' v*ftt.l.U.f, _...,.._M.U.J.WA&I.                         L

• GUIDELlNESFORSTABLEIODINEPROPHYLAXIS FOLLOWING NUCLEAR ACCIDENTS The final tide yet to be agned between WHO and IAEA FOREWORD i::aeds ::-::b~r:; :: ::a:lec: ::.=~' ::.acisie:: ::: lc-,*al of docUE:.:mt i*!d :s -I

_ ~ .. t ... :.: "b:s: p.. -C::a:* :: *=-..::& . :. This publication has been prepared jointly by WHO Headquarters in Geneva and the WHO Regional Office for Europe in Copenhagen, and co-sponsored by the International Atomic Energy Agency. This publication supersedes the Guicif:lines for Stable Iodine Prophylaxis following Nuclear Accidents, published by the WHO Regional Office for Europe. in 1989. The aims and objectives of the document are: J

• to summarise the current assessment of the benefits and risks of stable iodine prophylaxis to block the uptake by the thyroid gland of radioactive iodine released
• to the environment in accidents and emergencies
• to provide information on appropriate dosage and contraindications for the administration, as a public health measure, of stable iodine to various population groups
• to.aid the planning of such an administration in an emergency situation
• to give guidance on the practical aspects of the storage and distnoution of stable iodine The potential readership of the document includes:
• nuclear emergency planners, emergency management personnel
• public health authorities and physicians at national and local levels,
• emergency aid administrators
• civil defence personnel It should be noted that the term "iodine prophylaxis" refers to the blocking of the uptake of radioiodine after nuclear accidents and not the correction of dietary iodine deficiency.__________ _ _ _ _ __ ___ __ _ _ _______ _

The decision to plan for short term prophylaxis against inha.lad radioactive iodine should not be influenced by dietary iodine status. Dietary iodine deficiency increases

• the uptake of radioactive iodine in the thyroid. However. a normal iodine status would not reduce the need for prompt stable iodine prophylaxis in case of a nuclear 1 10/19/9827/09/0525.9.199805/08/981 n

emergency. While dietary iodine supplementation in deficiency areas is important in its own right, it does not eliminate the need to plan for stable iodine prophylaxis. The purpose of this document is to make available the latest information on the use of stable iodine prophylaxis in the context of radiation protection of the thyroid, and in particular as* part of the emergency response preparedness for *nuclear accidents. It should be stressed that it has no applieations in implications for the routine trea.-tment (diagnosis end tberap,*) of thyroid sancer and other th:;'Foid disorders '*'*'!th mdioiodme. medical use of radioiodine in diagnosis and treatment of thvroid disorders. The information cont;uned here~ following a period of time that will be allowed for feedback from national authorities and for the building of international consensus. wilt form the basis for updating the formal standards of the IAEA. The latest New information on thyroid cancer among those exposed in childhood and on the risk of side effects from stable iodine; suggests that averting doses to the thyroid is safely and effectively achieved by ~le iodine propbylaxi~ and that the

• risks of side effects from stable iodine are minimal.

On the basis of the latest information evidence, it is prudent to consider the implementation of stable iodine prophylaxis according to different criteria for neonates, children, young adu1ts; and adults over about 40 years of age. Interv~tion levels for emergency response are for national authorities to decid~ but the latest information suggests that stable iodine prophylaxis for children up to the age of 18 years be considered at lOmGy, that is 1110th of the generic intervention level expressed in the FAO, IAEA.* ILO. OECD/NEA, PAHO. WHO International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. . For adults over 40, the la1:est in:fermatiOB. scientific evidence suggests that stable iodine prophylaxis not be recommended tmless doses to the thyroid from inhalation are expected to exceed levels that would threaten thyroid function. This is because the risk for radiation induced thyroid carcinoma in this group is very low while, on the other band, the risk for side effects increases with age. to The latest information on the balance of risks will also need be properly considered in the plans for any distnoution and storage of stable iodine. It suggests that stockpiling is warranted, when feasible, over mu.ch wider* areas than normally encompassed by emergency planning zones, and th.at the opportu:rtity for voluntary purchase be part of national plans.

                                                           ---- . . . . . , n It
                                                                                     " _l'
                                                            -~- -------.., -

• 1. Introduction 10/19/9827/09/0625.9.199805/08/982 n

Despite rigorous safety systems, there remains a finite probability that an accident can occur in a nuclear reactor that can lead to the fuel in the core overheating or melting. If such an event were to occur, there is a chance that radioactive fission products may

• be released into the environment. The potential radiation exposure of the population will be influenced by the amounts of various radionuclides released, by the meteorological conditions affecting the dispersion and deposition of the released radioactive material, by human and environmental factors, and the effectiveness of any protective actions taken.

Protectiye actions are taken in order to l) prevenl:i to the extent poSSiole.,. so-called deterministic effects (e.g. hypothyroidism) from high levels of radiation exposure and 2) to reduce the risk of stochastic effects (e.g. thyroid cancer and benign nodules) from exposure to as low as reasonably achievable. However, during and shortly after the onset of an accident, there are very large upcertainties concerning the levels and ' extent of potential radiation exposure of the population, and in order, to protect effectively people close to the reactor from deterministic effects, precautionary protective actions are usually planned to be implemented close-in.:. based on plant conditions.,. before any potential (DN Is this correct- it should be anv release?) release occurs. If a release has started, measurements can be ta.ken that can help to bound the

       ~ of risk to the population, nevertheless it is extremely difficult to predict accurately the time variation and length of the release from the damaged reactor, its dispersion and subsequent doses to the population at greater longer distances. After the release stops, measurements of deposition and concentrations of radioactive materials in foodstuffs can be taken to aeourately confirm accuratelv any future

• protective actions.

In order to be able to respond rapidly, consistently and appropriately, national authorities '-'!ill have an emergency plan. This plan will talce into account the potential magnitude and likelihood of re,eases. and distances from reactors. It sets out responsibilities and authorities for decision-making and for protective actions, and also lays down -so-called intervention levels for the various protective actions, which can be used in preparing detailed emergency response plans. The various protective actions for which detailed plans are made include sheltering and evacuation, which can reduce both the external and internal radiation exposure of the population, and food and amicultural countermeasures to restrict ingestion of radioactive material, as well as BM stable iodine f!'Cophylaxis Isotopes of iodine (I-131, I-132, including that arising from the decay of Te-132, I-133; see annex for table of half-lives) are 'predicted to likely be important components of the release from a severe accident. Radioactive iodines can provide both external exposure and internal exposure (from inhalation and ingestion). Stable iodine __ ___p_r~pl!y~ *is 8: ~tectjv~_~.!)J;l__ for -~ch ~ e s s _aromgements can_be made as part of the overall emergency response plan, and' that can protect specifically against internal exposure from inhalation and ingestion ofradioiodines.

                                        ~
                                          - . -,  -:::] -:;-:,

3 10/19/9827/09/0625.9.199805/08/983 n

n ' U l ~ UUCWilt::i:IL

2. Radiation risk from radioactive iodine 2.1 Exposure to radioactive iodine The radioactive isotopes of iodine along \\-ith other radionuclides give rise to external radiation exposure from radioactive material present in the cJoud. deposited on the ground and on skin and dothing. In the case of the radioactive isotopes of iodine, a major concern is the internal radiation exposure following incorporation and uptake in the thyroid. This v.rill occur through inhalation of contaminated air and ingestion _9f contaminated food and drink. Absorption through the skin is a possible route, but negligible in comparison with inhalation. "

2.2 Deterministic and stochastic effects Deterministic effects from thyroid exposure are hypOthyroidism and acute thyroiditis. S;tochastic effects from' thyroid exposure are thyroid cancer and benign thyroid nodules. The selective and rapid concentration and storage of radioactive iodine in the thyroid gland results in internal radiation exposure of the thyroid, which may lead to an increased rj.sk of thyroid cancer and benien nodules and, at high doses, hypothyroidism. These risks can be reduced or even prevented. by proper implementation of stable iodine prophylaxis.

 *                 . Hypothyroidism; is caused by a radiation' dose of the order of several, gray to the thyroid. A dose that large coul~ in practice.. be incurred through inhalation only near the point of the accidental release. Because. exposures from other radionuclides are also likely to be large in such cases., plans will usually include options to evacuate and/or shelter the population, and stable iodine can be a useful adjunct to, these actions.

In regions where only the likelihood of stochastic effects are a cause for: concern, stable iodine prophylaxis should be considered for sensitive population groups-if po!ential exposure to radioactive iodine by inhalation or exposure by ingestion is expected to approach the reference levels given in Table 1, and cannot be prevented by sheltering or food and milk countermeasures. In severe accidents such situations may occur in areas' quite far from the accident site. Intake through ingestion of contaminare.d food. particularly milk, begins after deposition and transfer to the food chain. In the absence of any counterrheasures., ingestion is likely to be the main route of intemaI radiation exposure to radioactive'- r

• ---- - - -- ---*odin*e.:--Toe-exposure is-iikely-to-continue-for-a longer-period, coveF- a-18fgef-area-and-- -- - -- - ---

affect a larger populatio~ than exposure by inhalation. I 2.3 Experience from the Chernobyl accident .

                                          \ -

Evidence of a marked excess of thyroid cancer in children exposed to the fallout from the Chernobyl accident has been established.l.l::[l. In the most affected area m 4 10/19/9827/09/0625.9.199805/08/9B4 n

Belarus, the yearly incidence has risen close to one hundrc:d per million children,

    \,hich is more than hundred-fold ~s compared to the siruation before the :J.ccident ~l].

It is now generally accc:pted that this excess has resulted from exposure to the

• radioactive iodine released in the accident. The largest part of the dose to the thyroid was caused by iodine-13 l although the shorter lived isotopes of iodine and tellurium-132 may have contributed significantly to the inhalation dose in some instances.

FollO\ving the Chernobyi accident there were several thousands of children who accumulated a dose to the thyroid of several gray. Nevertheless, most of the chil~~n that have developed thyroid cancer were exposed to an estimated dose to the thyroid of less than -300 mGy--P-;:"B. An excess thyroid cancer incidence has been seen even in areas where the mean dose to the thyroid in children was estimated at ~p.Gy-£4-l The increase has been observed up to 500 km from the accident ..sfrf £This is undersatandable in the light of the large number of children e.xposed. Even if the lar2:est doses to the thvroid

                                        .      in the more remote affected areas were due to ingested radioacti,1e iodme, the The Chernobyl accident demonstrated that significant doses from radioactive iodine can occur hundreds of kilometres from the site, beyond
    ~mergency planning zones. A sharp distinction in the requirements for stable iodine prophylaxis based on distance from the accident site cannot be made. For example.: no region in Europe is situated so far from a nuclear reactor as to preclude any potential need for stable iodine prophylaxis against inhaled or ingested radioactive iodine.

Another important insight gained from the Chernobyl accident concerns the side

• effects from stable iodine. In Poland stable iodine.: as single doses,. was given to ten million children [~.2]. No serious side effects were seen, though gastrointestinal effects and minor skin rash were reported. Of new-born infants, receiving 30 mg potassium iodide in their first two days of life, 0.37 per cent (12 infants) showed a transient increase in serum TSH, combined with a decrease in serwn free T4. This transient thyroid inhioition has bad no known consequences to date. Seven million adults took stable iodine although it had not been recommended. Among these, only two severe reactions were seen, both in persons with known iodine allergy. In summary, the incidence of severe side effects from one single dose of iodine was less than 10*7 in children and less than l 0-6 in adults.

                                                                      -    --:-J 2.4 Estimates of cancer risk Risk estimates for thyroid cancer attributable to radiation exposure have been made for populations exposed to external irradiation. According to NCRP [-elO] the excess absolute risk (EAR) is 2.5*l(r per Gy per year for persons exposed under,tbe age of

18. For adults the risk per year is taken as half this value. The lifetime risk for adults

_would be 1(4 of the~Jor cbil~ because ofrl!e smaller n~ber of years at risk. _ The most current estimate, based upon a pooled analysis of five cohort studies, gives an EAR of 4.4*l(r per Gy per year for persons exposed before the age of 15 [+l1.] .

• The study indicated the relative risk to l?e heavily dependent Uf>On age at exposure, yonnger children being at significantly higher risk than older ones. From the Lifespan 5 10/19/9827/09/0625.9.199805/08/985 n

Study (LSS) of atomic bomb survivors in Hiroshima and Kagasaki it is kn0\\.11 th~t

             ]ittie risk is indicated after the age cf 20 and virtually none after the age of -+0 .

• \\'hile internal exposure ro radioactive iodine in medical use has nor been shown ro cause thyroid cancer in adults. the clinical experience in the case of small children is very limited. The experience from the Chernobyl accident shows the risk to be real.

While the thyroid sensitivity in adults to both external radiation and I- l 31 seems to be minimal... or even absents in the elderly,_sensitivity in small children is high. According to a recent dose-response-analysis based on combined data from Belarus,

' \          the Ukraine and Russian Federation... the three countrjes most affected by the Chernobyl accident., the risk for those aged 0-15 at exposure \Vas 2.3

• 10 -' ~ Gy p~r year (ref. JB£ob et al 98)[ 12]. If this risk persisrs unchanged for 40 to 50 years the lifetime risk of cancer wou.1d be 1%/Gy Since the confidence limits of this study overlap with those of the estimate from _

the pooled analysis, for public health purposes in emergency planning and respons~ it is prudent to assume equivalence of carcinogenic effect between X-i:-ays and radiation from I-131. Radiation induced thvroid cancer is not a trivial disease, although it has a verv low morralitv if properlv treated. It causes simificant morbiditv and the treatment is lifelong. putting a considerable burden on the health care svstem.

• 3. Stable iodine prophylaxis as a protective measure 3.1 The rationale for stable iodine administration Stable iodine administered before... or promptly afyer.:. intake of radioactive iodine... can block or reduce the accumulation of radioactive iodine in the thyroid.

Intake of radioactive iodine by inhalation begins when the radioactive cloud has arrived at a location and continues during the passage of the cloud. Action to implement stable iodine prophylaxis and thereby reduce the dose to the thyroid will be required promptly. The decision will most probably have to be made in a situation when reliable data for calculating the potential dose to the thyroid are not available. Exposure by ingestion can also be considerably reduced by amcultural countermeasures such as removine 2:ra.zim~ animals from contaminated pasmre or bv the impositiQI! of appropriate controls on agricultural products. In general food controls would be easier to implement and more effective in the long term in reducing ________the_coJl~ 9,gse_ tl@l~l_e _i~~ __pr_ophy!~s. .Jb~fo~_ ae:ricultural and fq_aj_J control measures are preferable in lieu of repeated dosage of stable iodine. Stable iodine could also be used as prophylaxis against ingested radioactive iodine from contaminated food. However, because the risk of exposure from ingestion of iodine wilI extend for a longer timerimde., iodine prophylaxis will also be required for a longer period of time, leading to a need for repeated doses. The side effect rate from 6 10/19/9827/09/0625.9.199805/08/986 n

                                                      ** - .. ~ ~1.M.£.J.w-U-1,                           L...J multiple doses wouid be higher, but the frequenc:.-, is !lOt known. It is probably low in children but ma~* be significant in adults, especially in areas with dietary iodine deticiency .

3.1.a Side effects from stable iodine: General considerations Thyroidal side effects may result from stable iodine administration. especially in iodine deficient regions. The risk is accentuated in connection with thyroid disord~~. such as auto-immune thyroiditis, Graves disease and nodular goitreeoiter. Such disorders are common in the adult rooularion and in the elderly but relatively rare in children. The risk for thyroid blocking in the newborn deserves special attention and is rreated in more detail below. Side effects in other parts of the body, like gastrointestinal effects or hypersensitivity reactions, may occur but are generally mild and can be considered of minor importance. Dermatitis herpetiforntjs and hypocomplementemic vasculitis entail an increased risk for severe hypersensitivity reactions. The Polish experience, cited above in point 2.3, showed the risk for severe *side effects from single doses of stable iodine to be minimal (less than l 0* 1 in children and less than llr' in adults). However, for repeated doses. there is no direct human experience that tan be used for reliable numerical estimate of side effects .

• In order to keep the risk for side effects among the population to a minimum, ilie following are contraindications:
• present or past thyroid diseases
• known iodine hypersensitivity
• qermatitis berpetiformis
• hypocomplementemic vasculitis 3 .2 Consideration of exposed population groups Exposed population groups _differ markedly in their risk of radiation-induced thyroid cancer from a QIVen radiation dose. Neonates, infants and small children m:e the most sensitive groups. The risk for side effects from stable iodme prophylaxis is also different, albeit generally small in the li~t of the latest experience. Because of these differences it is important to consider potentially exposed population groups separately when deciding on plans for stable iodine prophylaxis.

In general, the potential benefit of iodine prophylaxis will be greater in the young, - ~ - - - _____firstly_J,ecause_the_smalLsize_ of_the_thyroid_means_ thaLa higher-radiation-dose-is---- __ accumulated per unit intake of radioactive iodine. Secondly, the thyroid of the fetus, neonate and ymmg infant have a higher yearly thyroid cancer risk per unit dose than the thyroid of an ad.uh and, thirdly, the young will have a longer time for the

• expression of the increased cancer risk. '

7 10/19/9827/09/0625.9.199805/08/987 n

TT UUJ.1..1!!, \.IUl,."\ll.U<.JU,. Individual radiation doses "vill also differ marked]y v,.:ithin any exposed group. The intake of radioactive iodine through inhalation will be influenced b: breathing rates and intake throueh in2estion ""ill be influenced b'-*~ dietarv - habits. In the fo11owing, the risks from radiation,. exposure and the risks from stable iodine prophylaxis respectively are examined in more detail for the various population groups. Pregnant women During pregnancy, the maternal thyroid gland is stimulated, especially during the first trimester. The fraction of radioactive iodine taken up by the thyroid is increased as compared to other adults. Thus, the need to protect the thyroid gland of the pregnant woman is accentuated. During the second and third trimester, the thyroid gland of the developing fetus takes up and stores iodine in increasing amowns. Iodine passes readily across the placenta, and thl:15, after the first trimester, the fetal thyroid gland can be exposed to radioactive 1 iodine through the placenta, but it can also be protected by stable iodine taken by the mother. However, the risk of blocking the fetal thyroid function by a prolonged overload of stable iodine must be kept in mind, especially in areas with inherent dietary iodine deficiency.

• I Wlule there are physiological differences berween the trimesters, outlined above, there is no need for a different policy of intervention, which would create substantial problems in practice. In all periods of pregnancy, the number of stable iodine doses should be kept to the minimum needed to ~ovide adequate protection against inhaled radioactive iodine. After one or two doses of stable iodine no negative consequences are to be _expected. However, especially in areas with dietary iodine deficiency.

prolonged dosage could lead to maternal and/or fetal thyroid blockage, with possible consequences for the fetal development It is important therefore that this be avoided. To protect against ingestion of radioactive .iodine, appropriate food control measures wil1 be given priority. If*stable iodine is given late in pregnancy, the need to monitor the new-born for thyroid fimction is emphasised, but would be met with routine screening programmes already existing in most cmmtries. It is impommt that pregnant women with active ~hyperthyroidism do not take stable iodine because of the risk of fetal thyroid blockage. Neonates New-born infants are quite likely the critical group when deciding the implementation

 - of stable* iodine prophylaxis:*In the first-few days-of life they-are-at-special-risk both-of radiation exposure from radioactive iodine and blocking of thyroid fimction by an overload of stable iodine.

• After birth, there is a dramatic increase in thyroid activity, lasting only a couple of days. The fraction of radioactive iodine intake that will be incorporated into the thyroid at this critical stage can be fourfold as compared to all other age groups [813).

8 10/19/9827/09/0625.9.199805/08/988 r

L On the other hand, during this period the th:Toid :s espt!cially sensitive to rhe functional blockimi: caused bv an overload of 5table iodine. The most critical period for developing thyroid blockage lasts for less than a week e\"en in prematures. Even transient hypothyroidism during the critical period of brain development can result in loss of intellectual capacity t&a1[14]. The potential for harmful influence on neuro

    ;-:.:ire intellectual development:; w~ however, n?t confirmed in the Polish studey referredrefered to in section 2.3seetion 3.:.

When indicated, stable iodine will be promptly given to all neonates. The dosag~_is critical. A single administration of 12.5 mg iodine ( 16mg KI) should not be exceeded. If stable iodine is given, close follow-up is important. KI as solution should be kept in maternity hospitals. This will enable prompt and exact dosage to the critical group of new-borns still in the ward. A few days later the sensitivity for blockage of thyroid function will have decreased and dosage may be performed at home, by dividing crushing and suspending tablets in milk or water. In infants who have been administered stable iodine in the first weeks of life, TSH levels and, if indicated, T4 levels, will be monitored and appropriate replacement therapy given. Infants. children and adolescents (1 month to 18 years) These groups are at high risk from exposure to radioactive iodine but at very low risk from stable iodine. The dose to the thyroid from radioactive iodine in a given siruation will be higher in this group :than in adults because of the smaller size of the gland, which is only partly compensated for by a smaller breathing volwne. The highest dose from inhalation, up to threefold as compared to adults, will be in children about the age of three. The dose from ingestion may be several rimes higher compared to adults, because of the generally high consumption of milk in relation to thyroid mass in th.is group. When intervention is decided upon, based on the emergency plans and pre-determined operational intervention levels , stable iodine should promptly be given to all children. If intake of radioactive iodine through inhalation is prolonged, the recommended single stable iodine dose (cf. Table .1) -will be repeated daily. This would most probably ca.use no harm. However, in children showing skin reaction to the first dosage, the stable iodine administration should not be repeated. In general, appropriate control of foodsruffs is to be given priority as the com1termeasure against ingestion of radioactive iodine. In the exceptional case that

 -this is not possible, or would-lead to-deficiency of essential nu.t:cients such as milk.

prophylaxis with daj]y doses of stable iodine can be continued for a few days or even weeks in this group, as necessary.

• Lactating mothers 9 10/19/9827/09/0625.9.199805/08/989 n

ff Ul ~ UU'\.,,Ll.l-li""""""

• L!J Iodine is actively transponed to the milk. As much as l , of the iodine ttl.an by the mother may be .seecreted in the milk \i,,ithin ~- h [.Q 15]. An excess of stable iodine can block the transpon to a certain extent. Howe\*er. if the infant is administered stable iodine, it will be protected from radioactive iodine in the milk for the next day.

Therefore, stable iodine prophylaxis for lactating mothers can be decided upon by the same criteria as for other young adults, to protect the woman herself. Repeated dosage is to be avoided.-

• Adults under 40 years In young adu.lts, the risk for radiation-induced thyroid cancer is low [-l-G.1§]. On the other hand, the risk for serious side effects from one single dose of stable 'iodine is also low. Stable iodine as *a single dose can be ~ven to this group if intervention is decided upon . The dose criteria for intervention will in principle be significantly higher than for children. It will be important that contraindications (known iodine allergy, present or past thyroid disease of any kind, dermatitis herpetiformis, and

           'hypocomplementemic vasculitis) be taken into consideration.

Repeated administration of stable iodine for protection against ingested radioactiv~

           'iodine is not indicated in this group,    as  the risk for side effects will be increased.

Appropriate control of food may also be easier for adults than for children. Adults cou.ld, for example, completely abstain from drinking milk during the contamination period, with~ut fear of nutritional effects.

• Adults over 40 years I

The risk for radiation-induced thyroid CMCinomacancer in this group is probably extremely low and may even be zero [-W.l§J. The risk for side effects from stable iodine increases with increasing age as the incidence of thyroid diseases is increased.-: Stable iodine prophylaxis is not indicated for this group; unless doses to the thyroid from inhalation may rise to levels threatening thyroid function. that is of the order of about 5 Gy. Such radiation doses will not occur tar from an accident site (cf. 2.2}.

4. Implementation of stable iodine prophylaxis 4.1 Intervention levels According to the basic system of radiological protection, intervention to protect the public should be undertaken if serious deterministic effects are projected or if there is a high individual risk of stochastic effects; and protective actions should achieve more

 ---- -good-than-harm-and-reduce-lhe-risk-of stochastic-effects-to- as--low-as---reasonably--- - - -

achievable. The decision to initiate stable iodine prophylaxis should generally be made on the basis of predetermined conditions specified in the emergency plans. These conditions

• can include the accident classification and levels of measurable quantities that will trigger response. These conditions and levels are precalculated,. in part on the basis of 10 10/19/9827/99/0625.9.299805/08/9810 n

 ,,                                                                                                      L..J so-wlled intervention ie\*els. which themsel\'es :ire specified in terms cf avertable dose. The ~vertable dose is dt!fiP.ed as rhe dose to be saved by the particular protecti\ e action: in this case the difference between the dose to be expected \\'irh stable iodine prophylaxis and that to be expected without ir. In the FAO, IAEA, ILO, OECDi~""EA, PAHO, WHO International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources ( Safety Series N. 115) lllLa generic intervention level of l 00 mGy avertable dose is recommended for all age groups.

Notwithstanding the generic recommendation, when developing detailed emergency plans, it is appropriate that due consideration be given as to the desirability and practicability to implement stable iodine prophylaxis separately for children. young adults and adults over 40 years of age and how such plans will complement plans for evacuation, sheltering and food control, and take into account doses to any workers involved in distribution. It is important not to withhold stable iodine from children for fear of side effects in the elderly.

• As side effects from shon term stable iodine prophylaxis are now known to be minimal, the decision to plan for prophylaxis will depend mainly on the estimated social and economic costs. Provided predistribution of stable iodine to strategic sites has taken place and iodine tablets are readily accessible, the costs will be low.

Nevertheless.. consideration will need to be given to the psycho-social consequences of iodine prophylaxis, both from the reassurance it may provide and possibly any anxiety it may create among the population. 4.2. Balance between risk and benefit The lifetime cancer risk for exposed children can be taken to be 1 % per Gy (See section 2.4) and the risk of severe side effects from single administration of stable iodine to be 10 _,_ Then a risk-benefit analysis (ignoring other factors) indicates that there is a benefit in averring doses as small as 0.0lmGy. In practice, this means that the risk of severe side effects can be ignored ~en deciding on the intervention level. Minor side effects, like skin rash or gastrointestinal complaint, constitute no major problem. Assuming a severe accident and applying the risk estimates for children cited in section 2.4 and the generic intervention level of 100 mGy without regard to age group, the incidence of thyroid earoinoma cancer among those most exposed might be of the order of 20 to 50 per million children per year. This is to be seen against the background of spontaneous childhood thyroid cancer of about I ~el million children _ _ ___per year. The corresponding lifetime risk would be 0.1-0.3 % for all children and even more for small children of the most sensitive age. On the other hand, applying an age-specific intervention level of 10 mGy radiation dose to the thyroid, the incidence of thyroid eeremoma cancer among those most exposed might be some 2-5 extra cases per rmllion children per year, still a severalfold increase compared to the generally encmmtered background incidence. Themeidence.The corresponding individual lifetime risk would be of the order of 1-3

• 10-4.

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                                                                                            *,. s....;,..,

7 In view of the established relarively high risk for th),TOtd cancer among :hose exposed in childhood, planning for stable iodine prophyla"<.iS for children should ideally be considered at I/10th of the generic intervention level, that is at 10 mGy_:a\'ertable dose to the thyroid. This level is appropriate also for pregnant women. Even if an avertable dose were grossly overestim~ted in a real emergency situation, no significant health hazard would result from stable iodine administration. It has not been possible to make a corresponding risk-benefit analysis for adults, as the carcinogenic effect from I-131 in adults has not so fur been confirmed. For young adults, however, in light of the low frequency of severe side effects (IO _,,) from single doses of stable iodine, prudence argues in favour of applying the generic intervention level given in the Basic Safety Standards. For adults over 40, the risk for radiation-induced thyroid cancer is presumably close

• - to zero. For this group, the implementation of stable iodine prophylaxis is determined by the need to ensure prevention of deterministic effects. This is guaranteed by an action level of 5Gy projected dose to the thyroid (but see section 5)

Table 1 summarises the reference *1evels for

• different population groups for cons!deration in planning stB;ble iodine prophylaxis..
• 12 10/19/9827/09/0625.9.199805/08/9812 r

T::1ble I. Reference levels for different population groups for consideration m planning stable iodine prophylaxis~

• Population group Exposure pathways to be considered Reference levels neonates,infamsneonat Inhalation (and ingestion°) IO mGyc es, if!:fast:s, children, avertable dose adolescents and to .the thyroid pregnant and lactating women adults under 40 Inhalation IOOmGy avertable dose to the thyroid adults over 40 years Inhalation 5 Gy<l projected dose to the thyroid Notes
• These idealised levels do not take into account the practicalities involved in planning to respond to an accident involving many radionuclides in tmknown quantities in real time. For this reason a generic intervention level of I 00 mGy has been specified in the International Basic Safety Standards. Nevertheless this does not preclude the need to consider the practicality of planning to implement iodine prophylaxis for specific age groups.

b ingestion of milk by infants where alternative supplies cannot be made available Adherence to these values would ensure that doses for all age groups would be well below the threshold for deterministic effects. intervention for this group is undertaken to ensure prevention of deterministic effects in the thyroid 5 Considerations in planning the use of iodine prophylaxis in conjunction with other countermeasures In emergencies involving a release to the environment of radioactive iodine there is a need for an early warning and rapid response so that measures that prevent or mitigate exposure can be implemented. Such measures include evacuation, sheltering and food - controls as well as iodine prophylaxis. The optimum response will often involve the combined use of these -countermeasures.

• It should be noted that while the other countermeasures protect against most radionuclides and external exposure, iodine prophylaxis protects only against inhaled or ingested radioiodine.

13 10/19/98-7/09/0625.9.199805/08/9813 n

5. l E \*::icuation E\*acuation means temporarily moving people out of the area predicted to be affecred by the radioactive release. Evacuation is most effective when implemented before the passage of the radioactive cloud. Precautionary evacuation will pre-empt the need for stab]e iodine administration, but instructions to take iodine tablets when pre-distributed should be considered in planning.

Evacuation will be decided primarily on the basis of plant conditions ~-d meteorological <Jara. However, plans shou1d consiqer that persons to be evacuated

• may have been exposed to the cloud.

5 .2 Sheltering Advising the population *to stay indoors is a relatively simple protective measure in the early phase of an accident. The decision to implement sheltering will be considered in nuclear emergency planning as a means of protection against external

• radiation as well as against inhalation of all radionuclides.

Inhalation of radioactive iodine from a passing cloud 'Nill be reduced to some degree by sheltering indoors with closed windows and any forced ventilation shut off, but sheltering is not completely effective at avoiding inhalation dose. Realistic dose estimates n,eed .to be taken into account when considering plans for the implementation of stable iodine prophylaxis . It is important that planning for the simultaneous implementation of stable iodine prophylaxis be seriously considered as a supplement to sheltering plans where the expected avertable inhalation dose to the thyroid approaches those in Table I, and for those accidents where radioactive *iodine is a major compPnent of the release .

• 5.3 Food control The principal protective measures against internal exposure through ingestion are firstly, agricultural cotmtermeasures (such as putting grazing animals onto stored feed) followed by the banning of potentially contaminated foodstuffs or locally produced agricultural products. For this pathway, food control is generally preferable to the use of stable iodine prophylaxis.

However, withholding milk from infants ,md yonng children is not without penalties and, in

• some circumstanc:es, it may be foreseen that the rapid dis1rfbution of

 - -rmcontaminated milk-to infants or -trans:fer of mri:mals ~to- stored feed_ can:no:L~

arranged and planned. Therefore, in considering plans for stable iodine prophylaxis for infants and ~ung children, it is important that this issue be taken into account.

• For othec population groups, the removal of milk from the diet for several days is an inconvenience but is no argument to plan for iodine prophyl.µis as an alternative to food control or agricultural countermeasures.

1,1*,

      ~       10/19/9827/09/0625.9.199805/08/9814 n

w

6. Logistics of ::;table iodine prophyla.\is.

6. l Chemical fonn "'

• Stable iodine can be used either as potassium iodide or potassium iodate. Potassium iodide (Kl) is the preferred alternative, since potassium iodate -(K.103 ) has the disadvantage of being a stronger intestinal irritant:- (l~)illl There is no decisive difference in shelf life for K.1O 3 and KI. If storage conditions .are adequate, the expected shelf life of the tablets is at ~east five years.

After 5 years the iodine content may be checked and the shelf life extended if indicated. 6.2 Fonnulation storage and packaging ( Stable iodine can be given in either doubly scored tablet or liquid form. Tablets have the advantage of easy storage and distribution, including predistnoution. Also, stable iodine is likely to cause less gastrointestinal irritation if administered in tablet form. Tablets can be crushed and mixed with fruitjuice,jam. milk etc. Tablets should be stored pr<?tected from air, heat. light and moisture. Age dependent dosage and contraindications should be on the labelling.

• Tablets packed in a hermetic alufoil and kept in dry and cool places preserve fully their iodine content for 5 years [+;..191 .

6.3. Availability, predistnoution and distribution As the time of implementation of prophylaxis is most important, prompt availability of the tablets to individuals has to be ensured if they are to be e:ffective. In the vicinity of nuclear reactors, predistnou.tion to households should be seriously considered raking into accmmt plans for evacuation and sheltering, with provision for storage in places that can be controlled by the responsible people authorities. Clear instructions should be issued with the tablets, and the public awareness of the procedures should be ascertained on a regular basis. Medical personnel likely to be consulted by the public should be provided-with more detai]ed information. At greater distmlces from the site of release there is likely to be ~ore time for decision-making If predistnburion to households is not considered feasible. stocks of stable iodine should be stored strategically at points that may include schools, ____ __hospitals._::.pha.rmacies,_ fire_stations,_.police __ stations .and-civil -defence-rentres. --- Widespread storage may be warranted at considerable distances from the potential accident site. Storage should preferably be at places where stock controls are normal procedure. Plans-should consider redtmdant distnoution areas to minimise delays in implementing stable iodine prophylaxis. Due c;onsideration should also be given that the benefits of stable iodine distnourion outweigh the penalties associated with any additional exposure of responsible emergency personnel. 15 10/19/9827/99/0625.9.199805/08/9815 n

Working document \ ..!...!J 1'iationa1 authorities are advised that, because of the benefits of stable iodine prophylaxis and the generally minima] risks of side effects, voluntary purchase of iodine tablets by the general public should be a1Iowed.. However, within the framework of the overall nuclear emergency plan, the responsibility for distribution of stable iodine and instructing the public to use it should still be clearly designated to the appropriate authorities. 6.4 Dosage and contraindications For adequate suppression, the dosage scheme given in table 2. which is based on a single dose for adults of 100 mg equiva1ent mass of iodipe, is recommended. Table 2. Recommended single dosage of stable iodine according to age group

• Age group Adults and adolescents 100 Equivalent Mass of mass iodine mg of KI Mg 130 Mass of K.I03 mg 170 Fraction of lOOing tablet

                                                                                    ~

I (over 12 years)

• Children (3-12 years)

Infants ( 1 month to 3 years) Neonates 50 25 12.5 65 32 16 85 42 21 112 1/4 1/8 (birth to 1 *month)

  .!ii eesee BB taelet:s eBfltBffliag I 00 mg eeil3/4i:,*ale9t fMS5 ef iedine.

The tablet divisions indicated in table 2 are easy to achieve with a tablet stamped by a cross, except that the exact dosage of 1/8 tablet, required for neonates is difficult to ensure. However, for neonates over one week of age living at home, an approximate division would be satisfactory. The most sensitive group of new-boms, those less than one week: old, should preferably have a more exact dosage. This can be achieved with

\ KI solution prepared from crystals. It is therefore recommended that maternity wards keep KI in storage in crystal form. As an alternative, tablets containing 50 mg equivalent mass of iodine (65 mg KI or 85 mg KIO.3°"}_can be used:,. correspondingly doubling the tablet dosage (cf. Table 2).

It is recognised that some iodine tablets are too small to subdivide effectivelvefeetF;ely and it is advised -te- that tablets are manufactured to be of I

• sufficient ~

The contraindications for use of stable iodine are: 16 10/19/9827/09/0625.9.199805/0B/9816 n

Past or present thyroid diseas~ (e.g. active hypenh~roidism) kno\vn iodine hypersensiti\*ir:.. dermatitis herpetiformis,

• hypocomplemememic vasculitis .

These should be clearly stated on the labelling. 6.5 Timing of administration and dw-ation of prophylaxis T0 obta:r: :i.?.il ~ effectiveness of stable iodine for thyroidal blocking requires th~_ it be administered shortly before.,. or as soon after.. exposure as possible. However, uptake is blocked by 50 % even after a delay of several hours. The figure shows the effectiveness of thyroid blocking achieved by administering stable iodine at different times before or after an instantaneous exposure to radioiodine. To protect against inhaled radioactive iodine. one single dose of stable iodine would generally be sufficient. as it gives adequate protection for one day. This may well be enough to protect from inhaled radioactive iodine present in a passing cloud. In case of a prolonged release. however, repeated doses might be indicated. In some circumstances stable iodine administration may be practical also in limiting the dose to the thyroid from ingested radioactive iodine, especially to children via the milk pathway where alternative sources cannot be found. In that case, a daily dose of stable iodine may be given for the time period needed to those children who sho"" no adverse reaction. Repeated administrations should not be given for neonates, pregnant

• and lactating women (see section 3.2).

Due consideration should be giv~ in preparing emergency plans.,. to try to mitigate any adverse psycho-social reactions to the implementation of iodine prophylaxis. It is recognised that there may be considerable adverse reactions if the distribution and

• instruetions for different age groups, if deemed appropriate, is not orderly and consistent. There are advantages in consulting with neighbouring countries with regard to their national policy in order to avoid discrepancies of approac~ especially where reactors are close to national borders. -
• 17 10/19/9827/39/0S25.9.199805/08/9817 n

               \

EFECTIVENESS OF THYROID BLOCKING AFFORDED! BY 100 MG OF IODINE (130 MG OF Kl)

• Must be taken befonl or ahortly lllft-<<-

inhalation to b& effective

                                             , O()'-;.

en 70

                                                       .l r.J+

Hours before inhalation

J,o+/-

10 Hours after inflalation _________._' -- -- J I 50 .. ..:.Q -30 -20 -in O iO ,o 30 11\l'E:: AF rER ,r,.T,O..KF. o: ?Jl 1 {hri

• \
• 18 10/19/9827/D9/0625.9.199805/08/9818 n

u References DN: Noteboon refs to be added)

                                           -    ~ -

KAZAKOV VS et al. Tbvroid cancer after Chemobvl. Nature 359:21( 1992). 1. STSHJAZHJ(O VA et al. Childhood thyroid cancer smce accident at Chernobyl. British Medical Journal 310: 801 ( 1995).

  .)      LIKHTAREV IA et al. Thvroid cancer in the Ukraine. Nature 3 75:365(1995) .

TRON"KO N et al. Thyroid Cancer in Children and Adolescents in IJkraine after the Chernobyl Accident ( 1986-1995). In: The radiological consequences of the Chernobyl accident Proceedings of the first international conference. Minsk. Belarus. 18-22 March 1996. Ed: Karaoglou A et al. ECSC-EC-EA.EC. Brussels"'Luxernbourg 1996, pp 683-690. TSYB AF et al. Thvroid Cancer in Children and Adolescents of Brvansk and

                              ~                                                J KaJuga Regions. In: The radiological consequences of the Chernobyl accident.

Proceedings of the first international conference. Minsk, Belarus. 18-22 March 1996. Ed: Karaoglou A et al. ECSC-EC~EAEC, Brussels*Luxembourg 1996, pp 691-697. 4.§. SOBOLEV B et al. Radiation Risk Assessment of the Thyroid Cancer in

        . Ukrainian Children Exposed due to Chernobyl. In: The radiological consequences of the Chernobyl accident. Proceedings of the first international conference. Minsk, Belarus, 18-22 March 1996. Ed: Karaoefou A et al.

ECSC-EC-EAEC, Brussels*Luxembourg 1996, pp 741-748. - ,

7. BUGLOVA E et al. Thvroid cancer in Belarus after. the Chernobvl accident:

• incidence. prognosis of pro!?reSS. risk assessment. In: Low doses of ionizing radiation: biolo!fical effects and ref!Ulatorv control. Contributed papers.

Intemariorial conference. Seville. Spain. 17-21 November 1997. IAEA-TECDOC,976. IAEA. Austria. 1997.

8. A.STA.KHOVA LN et aL Chernobvl-Related Tbvroid Cancer in Children of Belarus: A Case-Control Studv. Rad Res 150:349-356(1998).

 ~.2. NAUMAN J and WOLFF J. Iodine Prophylaxis in Poland After the Chernobyl Reactor Accident: Benefits and Risk. The American Journal of Medicine, 94: 524-532 (1993).

el 0. NCRP REPORT NO. 80. Induction of Thyroid Cancer by Ionising Radiation. Bethesda, National Council on Radiation Protection and Measurements, 1985.

• -+Jl.

19 RONE et al. Thyroid Cancer after Exposure to External Radiation: A Pooled Analysis of Seven Srudies. Rad Res 141: 259-277, 1995. 10/19/9827/09/0625.J.199805/08/9819 n

                                         ,,-.. --0-----*                                ......
  ..;.:i.:-endix 1 Half-lives of the imoor..ant radioisotooes of iodine found in fission -:::roducts Nuclide                                        Half-life I-131                                          8.04 davs I-132                                          2.3 hours I-133                                          20.8 hours                         -*

I-135 6.61 hours Te-132 3.26 davs

• 21
• 10/19/9827/09/0625.9.'99805/08/9821 r

work:ing document

        +512. Jacob, Pet al Thyroid cancer risk to Children calculated. Nature 392: 31 to 32 (1998)

• &13. MORREALE DE ESCOBAR G &-ESCOBAR DEL REY F. Thyroid Physiology in Utero and Neonatally (review). In: Iodine Prophylaxis Following Nuclear Accidents. Proceedings of a joint \VHO,CEC Workshop, July 1988. Eds: R.ubery E and Smales E. Per~on Press, Oxford 1990, pp 3-32.

        -&al4. Calaciura Fetal Childhood IQ measurements in infants with transient congenital hypothyroidism. Clinical Endocrinology 43. 473-477. (1995)

I

        -915.    'wl:AVER JC, K.A..:\lllvl ML & DOBSON RL. Excretion of Radioiodine in Human Milk. J Am Med Ass 173 (8): 872-875. 1960.

MJ.Q. THOMPSOM DE et al. Cancer Incidence in Atomic Bomb Survivors. Pan II: Solid Tumors, 1958-1987. Rad Res 137, Sl 7-S67, 1994.

      . H17. FAO/IAENILO/OECD(NEA)/PAHO/WHO; International Basic Safety                          I Radiation Sources, IAEA, Vienna, 1996.

Standards for Protection BJ!ainst Ionizimz Radiation and for the Safetv

                                                                                           . of
        -P-:ll: R.ubery ED. Practical aspects of Propraylactic Stable Iodine Usage In: Iodine Propraylaxis FoIJowing Nuclear Accidents." Proceedings of a joint WHO/CEC Workshop. July 1988. Eds: Ruhery E and Smales E. Pergamon Press, Oxford 1990, pp 141-150.]
        +.3,19. 13: Turai I ~t al. Public Health Importance of Mass Iodine Prophylaxis (in      -I Hungarian). Izot6ptechnika. 28: 28-41, 1985 20       10/19/9827/09/0625.9.199805/08/9820 r

worxmg aocumcnt LJ

• Half-lives of the impor..ant radioisowoes of iodine found in fission -croduc'!S Nuclide I-131 Half-life 8.04 davs 1-132 2.3 hours I-133 20.8 hours ..

I-135 6.61 hours Te-132 3.26 davs I 21 10/19/9827/09/0625.9.199805/08/9821 r

• L Background Executive Summary

) The Hanford Thyroid Disease Study (HTDS) was mandated by an act of Congress in 1988. The Centers Foc Disease Control mid Prevention (CDC) was directed by Senate Bill 2889 to conduct a study of 1hyroid morbidity among persons who lived near the Hanfurd Nuclear Site between 1944 and 1957. A team of investigators a!: the Fred Hntthinson Cancer Rcscan:h Center (FHCRC) and the University of Washington in Seattle was sclectf:!] by 1he CDC to conduct 1he stndy, and a contract was awarded to the FHCRC on September 19, 1989. The primm:y pmpose of the study was to detennine whether thyroid morbidity (including, but not limited to hypothyroidism, benign neoplasia, and malignant neoplasia) is increased among persons exposed to releases of nidioactive iodine :frmn the Hanford Nuclear Site between 1944 and 1957. The study was also designed to further detcnnine in wha!: way any increase in. thyroid morbidity was related to 1he dose of

• radiation received (Le., the cbaracterisncs of any dose-response relationship). Secondary objectives of the study incb1ded the following: I) To determine~ hypeiparathyroidism is increased among persons exposed to 1he Hanford radiation and, if so, to determine in what way the increase is related to the dose of radiatirm received; 2) To provide infunnation to :resideuts of the communities smrouncling the Hanford Site regmding the objectives, design. and conduct of the study, as well as the findings and results of the 1esemch; and 3) To assess the appropriateness of1hc methods employed and the degree to which such an investigation could be soccessfu1ly planned and executed, given the long interval since exposure and the uncertainties iegmdin& radiation dose. .
• This study was conduded as a follow-up prevalence stndy. That is, a group of individuals (a cohort) was selected on the basis ofpresumed past cxpomre to radioactive iodines :from Hanford, based on place and year of birth, were located, had a dose estimate calculated :from answers to a dosimetxy questionnaire, and were examined for the presence oc histmy ofthyroid disease. The primary analyses focused on living participants who received medical emninatioos to dotect thyroid disease, and for whom 1hyroid radiation doses were estimareil using the dosimetry system developed by the Hanford Enviromnc:nm.l Dose R.econstmction (HEDR) Project. Although the effects of primmy interest are defined by three categories of1hyroid disease (hypothyroidism benign thyroid nodules, and thyroid cancer),

infrnroatiOT1 regarding all forms of1hyroid disease was recorded as part of the study and is inclnded in 1he overall analysis. In addition, primary byperpmathy,oidism was evalt:tab=d by screening individuals for hypercalcemia. The work was conducted in. two stages. The first was a Pilot Study, the primmy purpose of which was to evalaate 1he feasibility ofthe methods proposed, and to develop the specific operational procedures and data collection instruments needed for a full study. The second stage was to implement the remaining fieldwork to complete such a stDdy. Tub appioach allowed the accumulation of information and experience prior to initiation of the more costly full...scale study. The Pilot Study was completed ip December 1994, with a report issued January 14, 1995. Reviews of the Pilot Study by the National Research Cooncil's Board ofR.adiation Effects Research*oftbe

   *- - * * -o:mmission <m Life Sciences and the :fede:ra.l -Advism:y nmmi:Ur:e for the HmS-concluded timt-a full- -* -

scale epidc:miologic study should be undertaken. The fieldwork for the Full Study was completed in December 1997. This document summarizes 1he Final Report of the Hanford Thyroid Disease Study. H1DS DRAFT Fmal Report: Execptjvp Smmnmy -SENSJTIVE- page I of18 Sc:ptcmbcr- 2B, 1998

• n.

A. Fieldwork Cohort Definition and Subject Selection Given the primary objective of the stndy, it was important to identify a cohort within which there would be the greatest likelihood of detecting an association between Hanford radiation exposure and thyroid disease, if sw::h a relationship exists. This was tQ be accomplished by defining a cohort that would contain adequate numbers of persons with the highest possible radiation doses to the thyroid :from Hanford,

      -as well as per:sons with very low radiation doses to the thyroid :from Hanford
                 ~ e attempts were made to i n ~ different sources of information that would enable one to constroct a comprehensive list of persons who might have been exposed. Ideally, such a list would consist of all persons in a relatively large populatioo. surrounding the Hanford site who were resident during the time pc-nod that atmospheric releases occurred, and would con1am enough identifying information for each person to allow them to be located DOW {several decades after exposure). Only birth records provided a viable smm:e for identifying a cohort By abstracting information ciirectly from birth certificates, it was poss1ole to construct a roster of individuals corresponding to specific geographic areas and time periods most relevant: to the Hanford releases. This met the objectives of defining a cohort of persons potentially exposed to Hanford radiation at vmying levels.

Fm the purposes of subject selection only, residence at time of birth acted as a smrogate for the anticipated radiation dose to the thyroid from Hanford, which could only be estimated :from data collected during the study. To select study snbjects for the Pilot Stndy, a birth roster was constructed based on all births to mothm rcsidem in the counties. of Benton, Franklin, Walla Walla, Okanogan, Ferry, and Stevens. Following the Pilot Stndy, and based oo the dose estimms for Pilot Study participants, ,Adams Comrty was added :fur the Full S1ndy selections, in order to ma:rimm 1be numbers of subjects with high doses.

      .Aqcqaate numbers of subjects with DO or very law dose were obtained in the Pilot Study selections from Stevens, Fe:cy, and Okanogan counties, and.no fm1hcr so1ections WCIJ:'C made :from these areas.

Preliminary estimates from the BEDR project suggested that the highest thyroid doses were likely to be in pe:rsons exposed as infants or children during the first years of Hanford operations. This is because infants and cbildrc::n receive higher thyroid doses per unit exposure due primarily to the small size of their thyroid glands. Existing litcnmne suggests that radiatio:n:induced thyroid disease (and possibly hypeiparathyroidism) is greatest among those exposed at youngest ages. For this reason, the Pilot Study was limited to pemm born :from 1942-46, since the large majority of releases of radioactive iodine from the Hanford mcili1y occmred in 1944-46. For the Full Study, additional selecticms :from the years 1940 and 1941 in Barton, Fnmk:1in, and Adams COUIJties weze included to maximize the DDmber of potentially high dose subjects. Thus, the cohort conmined persons with exposure beginning as early as the prcnataI period, and as la:te as age three. An additional benefit of choosing this group was that mothm and close relatives of persans born during 1940-46 would more likely be alive and available for interview compared to those of persons born earlier. Selection ofpoteDtial participants from the Birth Roster was stratified by geographical area, year ofbirth. and SClC. The pmpose of stratijication by geographical area and birth year was to assure that _.__ ~ nmnbe:rs of high dose and low dose participal:lt$~ed,_and_as wide a mnge.o:t:doses as. -- possible was obtained. Stratification by sex also reduced the possibility of confounding by sex that coo1d reduce the efficie:ocy of the study. Geographical areas 'Were defined to distinguish areas that are predominantly rural from those 1hat are predominantly mban because it was reasonable to expect that persons from predominantly nmd areas may have been more likely to consume :fresh raw milk than their more urbanized ~ This distinction allowed :further selections :from those most likely to have HlDS DRAFT Final Report: Exegltjye SWJPPWY - SENSITIVE- pagc2of18 Scptcmbc-z- 28, 1998 '

higher doses (drinkers of raw milk) while excluding additional selections of probably lower dose subjects (drinkers of processed milk) in the Full Study. A total of 5199 births were selected in the total cohort. From this, it was projected that 3277 living evaluable subjects would participate in the stndy, which would result in statistical power of at least 80% to detect an incrense in total thyroid neoplasia ofS°/4 pc;- Gray of_radiation dose to the thyroid. B. Tracing and Locating Study Subjects Because members of the stndy cohort were identified based on location ofbirth in the early to mid-1940's, c:xtensive effort was required to locate cohort members as adults nearly fifty years later. 1n addition, in order to identify all past and present thyroid disease in cohort members, participation in the study could not be limited to telephone contact, but required in-person attendance for medical evaluation regardless of the participant's cm:rent area of residence. Thus, the primary objective of the tracing component of1he study was to identify a cmrent address and telephone nmnbcr for all living cohort members., so they could be recruited to participate in the study. A second objective was to obtain confirmation of deafb, as well as date and cause of death for all those deceased. Several approaches were ntilized to trace potential participants. Initially, relatively easy to use and readily a.cccs.dble sources were used. Subsequently, the more di:fficalt to locate individuals were scacbed for using more resomce intensive and costly resoun:cs. A final attempt to locate 1hc most difficult to locate potential participants was made-by using cstablimed professionai locating services and militmy locating services. Of the 5199 individuals sought, 4350 living individuals were located and 525 individuals were confirmed deceased. Thus, nearly 94% of the original sample were locamd a:iid 1heir identity confirmed. Only 324 potential participants (6.2%) remained "nnable to locate" at the end of1he study. )11 addition, 1he ability to locate well over 90% of all potential participants did not vary substantially by sex, or geographic region of birth, or year of birth. Ahn.est 84% of all poo:mial participants were located as living and evaluable and their identity (whedler they agreed to participate or not) was confirmed directly by comact

    ,with 1he potential participants 1hemselves or with a close relative who could verify 1heir identity and a currcm: address. An additional 12 potmtial participants (0.2%) were located to a. c:mrcnt address using

• other reliable somccs providing enough infon:nation to verify that they were the selected poteD:tial participant (located, not confimtedby conmct).

 ' rola:tive Five hnndred twenty-five (10.1%) of all selected potential participants were confimted by a. close and/or other reliable SOllI'CC (such as death certificate) as deceased. Death certificates were obtained on over '93% of1hese individnals. A larger proportion of males was confirmed decca.sed (12.60/4) 1han females r,2'%), Sixteen potmtial participants (03%) were located as living, but died dming 1he study prior to completing a clinic. An additional 22 (0.4%) potential participants were located as living but required a surrogate due to mental or physical conditl011S. These potential participants were unable to participate in clinics, but were positively identified. One potential participant was detemi fuea to be ineligible because he had actually hem bmn to a mother whose wma1 residence was in Spokane County, and bad only been adopted within 1he study area.

At least one potential participant was located in every stat.e in the U.S. except for Rhode Island. Fifty-four pen:em-or thei,articipamir ~ae-tt-in-Wash.ii:igtonStme;'9:4%-m ~9-:_--1 '3/4i ~ - - ~--- - Oregon and 2.1% in Idaho. The only other state where more than 2% of1he located potml1:ial participants resided was Texas (2.2%). Thirty-six participants (0.8% of those locat.cd) ~ in countries outside of the U.S. Potential participants were located in Canada, Dubai, Ecnad.o:r, Germany, Mexico, Saudi Arabia,

• South Africa, and South Korea.

   .H1DS DRAFT Fmal Report: Exe;:gtiye Srmpmrry September 28, 1998
                                                                                   -SENSITIVE-             pagc3 ofl8

• C. Recruiting Study Participants The objectives of the recrniting portion of the stndy were to conmct and obtain agreement of living potential participants to participate in the study, and to identify an appropriate dosimetiy respondent pnce a potential participant was locmep through the tracing procedure, initial contact was made by mail. In some instances a prelim.ina:ry letter or phone call was necessary to confirm the potcotial participant's identity.

Each living potential participant located received an initial contact letter, fi1ct sheet, and a description of what participation in the study would e:ntail. A recmitcr called each located potential. participant five to seven days after the first conmct letter was mailed. A minimum of 10-15 evening attempts were made at various weeknight and weekend (generally Sunday evening) time periods, and a minimum of three daytime (weekend and weekday) calls were attempted. If the potential participant could not be contacted by phone after 20-25 attempts. a second letter was sent ~aining that the study had been unable to reach them at 1he phone number on file, and asking them to call the toll-ftee HIDS number. After 40-45 attempts resulting in no contact wiih either the potential participant or a household member, the pote.ntial participant was considered "unable to contact" and no further atttmpts were made. When a potential participant refused, the recroiter asked the potential participant to complete a R.efusal/Demogniphic Qoestiannaire. Twelve demographic questions relating to race, ethnic origin. income, religion, and edncation level Wtte asked in order to obtain a general profile of1hose persons who refused to participate (or who later wiihdrew). The recmitcr also completed a Refusal Assessment after the call in order to record the nature and strength of the refusal from the recroite.r' s pe.rspective. In all. 4240 potential participants (97 5% of all living. located subjects) were r.ontacted by telephone to request particlpatic:m. An additional 93 (2.2% of all living, located subjects) were located to an address, and were sent one or more letters, but conld not be "".ontacted by telephone. Three thousand eight blllldred sixty-five potential participants (84.1% of the subjects who were contacted by telephone, 82% of all located, living subjects) agreed on either a first or a second attempt. The remaining 3565 (84.1 % of 1hose r.ontacted hy phone, or 82% of the total number of located, living snbje,cts) agreed to participate in the study. Of those located alive, 634 (14.6%) refused to participate. Willingness to participate did not diffi:r snbstautially by sex, year ofbirth, or geographic region of birth. Forty-one potential participants were determined to be non-evaluable (unable to fully participate) during the recnrlting process. Ovi::rwhelming)y, "not interested" and/~ "no time" were the reasons given far most refusals, making np 64.8% of all reasons for refusals. The second most commonly cited reasons wc:re "illn~ and "impamnenf' (J.6%).

• D. Computer Assisted Telephone Interview The primary objective of the Compater-1/2..s.mted Telephone Interview (CATI) was to collect infonnation that would be used as input for calculating a:radiation dose to 1he thyroid gland for each study participant. A CATI is conducted by an interviewer who reads the interview text and questions from a computer screen, and records the responses as they are given. Because 1he content of1he dosimetry interview far this study was so complex, and the computer program needed to construct and support such a

 --- -- -.A-Il-would-be-cxiremely complicated; the HIDS desigijea its own *CAn syst:em... - - - - -- - - -

The CATI was designed to collect in.fmmation ftom the early yems of the participants' lives, including time in utero, from 1944 to 1957. The interview was "locaticm-d:rivcn" so 1hatthe in:funnmion collected would be specific to locmions and p~ods of time directly relevant to the mdiation :releases from Hanford. The following topic areas were included in the CATI interview: 1) genenil demographic HIDS DRAFf Fmal Report: Exe:gmyc 8tl!TJDPID' - SENSITIVE- page4ofl8 Sc:ptcmbct- 28., 1998

chatacteristics of the participant and family; '2) a resjdentia) history of1he participant from birth through 1957, and fur1he mother while pregnant and breastfeeding; 3) sources of milk consumed by the participant from birth through 1957, and for the participant's motbei' while pregnant and breastfeeding (including sources;-4) milk COD.SllDlption patterns furtbe participant from birth through 1957, and for the mothC"X during pregnancy and breastfeeding; and 5) certain otb=' patterns. of food consmnptlon, e.g., green and leafy vegetables, for the participant from birth through 1957, and for the mother while pregnant and breastfeeding. In addition, medica.l history information was obtained for both the mother and the participant, to include the following: I) thyroid diseases and selected other medical conditions diagnosed and treated in the participant; 2) history of radiation t:rca1ment, either diagnostic or thetapeutic, for the participant, and for tbe mother during pregnancy and ~ g . In order to assist respondents in being able to accnrately report detailed informatiOIJ about their child (or sibling) from very long ago, several elements of the cognitive approach to interviewing were incorporated into the design of the CAn The cognitive interview is a teclmique developed to enhance recall. It is based on principles of cognition and memcay -retrieval theory. The key elements to 1his approach are to mcmally take the responde:nt back to the time period in question, and have them :remember as mucl:i about that time as possible. As more memories of the time in question are recalled by the respondent, the likelihood of remembering answen; to specific questions increases. Memory materials were developed to help the'respondent prepare for answering the interview questions. Backgrowid infurmatirm was provided to encourage memory about specific topics. The memory materials were organized into a booklet that was sent with a reside:nce history questionnaire to respondents in advance of the interview. In addition, the text of the interview was refined to include references to , specific parts of the memory materials at key points during 1he interview. , n Of the 2713 participants who identified a CA :respondent, interviews were completed for 2267 (83.6%). Of the 3448 study participants who completed the clinic, 2134 (61.9%) had a CATI interview. In. 29 instances, CATI interviewers determined the quality of the data provided by respondents was too poor to be considered reliable. Expanded interviews were pedormed at the clinic for these participants. E. Dose Determination

• The primacy analyses of dose-respmise relationships were based on individual estimates of radiation dose to 1he thyroid, specifically organ doses to the thyroid which were estimated ftom data collected during the CATI and/m- Exp-IPL The dose estimate data produced by CIDER for the in-area participan:ts W$ derived from infmmation collected during the CATI and/or Expanded-In-Person Intcrview. After review and editmg, these data wc::rc formatted iuto sca:tmio files whiclJ. served as input to the CIDER progiam. The CIDER output for each in-area participant consisted of I 00 realizations of 1he estimated cmnulative total organ dose to 1he thyroid :frcm 1311, as well as corresponding sets of realizations of dose by year and by pafhway.-

Each of1he 100 realizations of dose was allculatcd for a fixed set of conditions regarding the somce tetm., environmental transport, and uptake of 131 I, and these conditions for a given realization WC'Xe the same for every participant. Toe 100 realizatioos wc::rc obtained by randomly varying 1he conditions, i.e.., 1he uncertain parameters in 1he HEDR models far somce ~ 1nmsport, etc.. in order to characterize 1he uncertainty in the resulting dose estimates. Thus it is useful to view each realization as consisting of a

 - - - ---sct-ofdoses,-one fon:ach iIF-area pmticipant.-For many~ it was i:isc:fill*toliive a single number or "point estimate" to 1epreStnt each participant's dose. For each in-area participant, 1he median of1he 100

realizatioos of dose, c\ - median(Di,i. .*. , D-i,.100) for participant i. was used as a summmy measure ofthat participaDt's dose. In particular, the median doses were used for descriptive purposes that required categorization of participants by dose. Two other point estimates we:re also cal~culated for each in-area

• participant: the geometric mean and the arithmetic mean.

HIDS DR.A.Ff Fmal Report: Excc:gtjye Summpry -SENSITIVE- page 5 of18 Scptmiba-28,1998

F. Scheduling The primary objective of the scheduling activity was to provide each participant with at least three options for clinic attendance, with the least pOSSJble inconvenience to 1he participant. A schedule of clinic dates and locations was developed based on 1he current residences of participants. Clinics were held in Seattle, Pasco, Spokane. Walla Walla, Yakima, Wenatchee, Colville and Vancouver, Washington. Most parti~ from outside Washington State attended clinics in Seattle.

• Multiple attempts were made to contact all participants and every participant was offered several options for clinic dates. All participants, including those scheduled in 1he final few months of the study, were offered at least three options for clinics. Each scheduled participant was sent a letter 1hat included:

I )The date and time of clinic appointment; 2) Location of clinic and directions; 3) Travel arrangements smnmary and/or tickets C,.f applicable); and 4) Interview preparation wm::ksheet. If a participant canceled a clinic appointment, 1he schedulers attempted to reschedule 1he participant. A participant who canceled a clinic appointment would be rescheduled an unlimited. nmn~ of times. If a participant decided not to participate in the study during the scheduling process, the scliedul~ assessed 1he reason for 1he withdrawal and addressed 1he participant's concerns in an attempt to retain participation. If1he participant persisted in 1he withdrawa!, s/he was asked tb complete a refusal questionnaire. .

                                                                        )

The process developed for scheduling participants proved to be extremely effective with. nearly 90% of those who initially agreed to participate completing a clinic. The number of participants who withdrew after initially agreeing to participate was 298 (J. 7%). The schedulers m:nmged travel., including airline and/or hotel arrangements, for 1323 (380/4) of the 3448 participants attending a clinic.

• G. Clinics The objective of1he clinical oomponem: of the study was to provide a 1horough clinical examinatio:p. of each study participant to dc:termine the presence of thyroid disease, or primary hyperparathyroidism. Each participant was administered an interview prior to the clinic eram:inations.

Following 1he interview, each participant undel'we:nt a full complement of examinations to determine the presence or absence of any thyroid disease or primacy hyperparathyroidism. The exam inatinns included thyroid ultrasound, independent thyroid palpation by two study physicians, and blood tests for thyroid and parathyroid :function, and anti-thyroid immune response. Additional studies were requested if indicated by 1he presence of palpable thyroid nodules. The physical examination was conducted sq,aralely by two study physicians. The results of their exams were reviewed, and if there was IIDY disagreoment, the two examiners conferred and re-examined 1h~ participant together to reach a conseosus. The findings of each physician were recorded separately, as wese 1he findings of any consensus ex:amination. The physical findings were discussed with 1he participant. Participants found to have discrete, palpable, solitmy thyroid nodules or dominant nodules within a multinodular gland upon exam were asked to undergo fine-needle aspiration (fNA) of the nodnle. Participants who wanted to delay the procedme could eith~ return to 1he HIDS clinic site on another clinic

 ~~ ~-I:_the ~ - ~ e d by_a I~ P.hYsi~ in ~cl:£ COIIll?!-~*                               _.. ___ __ ________ _
           'All clinics were hold in Washington S1Bte (except for one in Portland, Oregon early in the study).

A total of3448 participants were seen in the H1DS clinics. Of the 3448 participants, 3439 (99.7%>) had blood drawn for thyroid function studies, and 3447 had thyroid ultrasound. Ofthe 272 participants for whom FNA was recommended, 259 (95.2%) underwent the procedure, while 28 of1he 29 (96.6%) HIDS DRAFT Fmal Report: Exccptiye Summary - SENSITIVE- page6of18 September 28, 1998

participants recommended to have a nuclear scan complied. Of the 5199 cohort members selected, 3448 (66.3%) were seen in the H1DS clinics, and 3441 (662°/o) were classified as living evaluable participants. H. In-Person Interview The pmpose of the In-Person Interview was to obtain infoxmation directly from the study participant regarding his/her past radiation exposure through occupational or medical exposures, any history of thyroid disease, and general demographic in:fmmation. In addition. for those participants who could not identify a respondent for the dosimetry internew, an expanded version of the In-Person Interview would provide details regarding residence history and limited information on the type of milk consumed in order to determine a Hanford radiation dose. The In-Person Interviews were conducted before the participant went through the medical components of the clinic (ultrasound, blood draw, and physical examination). This was done to ensure that the participant's responses could not be influenced by knowledge of exam results. All intemews were conducted in person by trained, experienced Jntenriewers at the time of the participant's visit to the HIDS clinic. The interview was always completed before the thyroid examination to eliminate 1he possibility that the participant's answers to the inteiview questions might be influenced by the results of the thyroid exam. Prior to the initiation of the interview, eacl:J. participant was required to read and sign a consem fonn agreeing to participate in the study. The questionnaire inclnded questicms for the participant from age 15 to the present on the following topic areas: 1) General detnographic charactcristics; 2) residential history, including dates and locations of residences, 3) Occllpational history, focusing on occupations and industries with potential of exposme to any form of ionizing radiation; 4) Military histmy as obtained in both the residential and occupational sections, especially regarding possible exposures to nuclear weapons tests (e.g., in Nevada or the Marshall Islands); 5) Medical history, inclnding dates and places for all thyroid-related diseases and symptoms; 6) History of medical and dental X-ray exposures; 7) History of nuclear medicine procedmes;

8) History of radiation 1hcrapy; 9) Selected lifestyle factors, such as patterns of tobacco use; and 10)

Familiarity/Bias questicms to assess knowledge of the Hanford releases and any strongly-held beliefs about their possible health effects.

                 - All 3,448 participants attending a H1DS clinic completed an In-Person Interview. FOlII' questionnaires were judged to have insufficient reside.nee hi$Iy information to calculate a dose estimate.

One participant was unable to complete the interview because of developmental disabilities, however the participant's father (who was 1IllBhle due to illness to participate in a CATI dosimetiy interview) was mailed a modified version of the expanded interview and provided the dosimetiy and In-Person Interview information in this manner. Ovcrail, 61 % of participants completed the S1lmdard In-Person Interview, while 39% completed the Expanded version. I. Clinic Medical Review and Final Diagnosis Determination The objectives of the Clinic Medical Review and Final Diagnosis Determination processes were to: 1) Evaluate each participant's clinical thyroid examination results from the H'IDS clinic visit; 2) Communicate clinic results to ~ ~ a timely mmme:r and, when indicated, to the participant's

 -------~~provider, 3) Assign the final diagnoses for each casc~accordm.gtolhe-foriruitaevelopeifiismg- - - - - - -          ,

all information available prior to ann inclnding the HIDS clinic. Following each clinic, resa1ts from the laboratory, pathologist, and radiologist were received in the HIDS office within 5-6 days. Physicians reviewed each participant's clinic results, and a letter informing the participant of the results was sent. A Final Diagnosis Determination Form was completed for all HIDS DRAFT Final Report ExcaJtive Snmmmy -SENSITIVE- page 7 ofl8 Scptcmbcr 28. 1998

remaining participants. All participants received their clinic results within 3-4 weeks following their clinic appointment. Lettm were also sent to each participant's health care provider, if the participant indicated this was to be done. If follow-up tests had been recommended to a participant, that participant's clinic and follow-up results were reviewed at miothcr Clinic Medical Review once the results were received in the HIDS office. A second results letter was mailed to the participant and their health care provider, descn'bing the results of the follow-up tests. The Fmal Diagnosis Detenninaticm Form was then completed. The total number of cases undergoing medical review throughout the study was 3,448. Eighty percent of participants had a Final Diagnosis Determination Form completed at the time of their Clinic Medical Review. The remaining 20% had either historical medical records or post-clinic recommendations for further diagnostic procedures, and had final diagnosis performed following compilation and review of the records from those providers. A total of259 participants had FNA procedures performed at the clinic or on the recommendation of the BIDS physicians. Ofthese, 62 were recommended at Clinic Medical Review to have further biopsy or surgical procedmes to rule out a diagnosis of thyroid nooplasm. In addition, 29 participants with thyroid nodules or suppressed TSH were recommended to undergo thyroid nuclear scan. Twenty participants had an abncmnal calcium level and were recommended to have additional blood drawn for parathyroid hormone (PTil) studies to confirm or rule out a diagnosis ofhyperparathyroidism. Thirty participants were ' requesied to have additional blood drawn due to abnormal or borderline thyroid :function. J. Historical and Post-Clinic Medical Records Review

• The primary objectives ofthe medical record component were to; 1) document thyroid problems reported by stndy participants and CA.TI respcmdents; 2) obtain any cytological or histological specimens from previous biopsies or surgeries for revi~ by the study's pathologist; and 3) obtain the results (mclnding histological specimens) of any further diagnostic or sorgical procedures recommended by RIDS as a resuh of finding at the H1DS clinic. A secondary objective of the medical record component was to obtain cause of dea1h information on all cohort members located *deceased, in ordez- to assign cause of death codes and perform a mortality analysis.
• During 1he CA.TI interview, respondents were asked to provide the names (and addresses, if known) of any physician who saw the participant for diagnosis or treatment of thyroid disease. At the time of the In-Person Intenriew, the participant was asked to provide the names and addresses of physicians or institnti.ons whelC they had been diagnosed or treated for thyroid or parathyroid disease, and to sign a consem fDim for the release ofinfmmation from each of these providers.

For each subject located deceased, 1he death certificate or informant information was used to complete a Cause of Death Fmm.. In addition, 1he*primmy cause of death was coded using the ICD9-CM system. For those whose dam of death preceded the use of the ICD9-CM system, the primary cause of death was also back-coded using 1he system in use at 1he time of death. Reports of historical medical records we.re obtained for 694 participants, with a total of 1259 +- -- - ---- - --- - consent fcmns completed to obtain medical records from diffei:ent providers. While the vast majority of

                    - reports were mine iiiiiing tlie IB-Person-hitciview, CA.U-Interviews yielded 30-ofthese reports:- - - -          -

Of1he 1259 Medical Record Consents obtained, a total of795 (63.1%) sepmate medical records were received by 1he H1DS. No records were received for 464 requests (36.9%). In 103 (82%) cases, records could not be requested because the physician was deceased, retired or a current address conld ]JOt be identified. For U7 (10.1 %) requests, records were unavailable due to the destruction of records, the HIDS DRAFT Fmal Report Executiyc Smnmmy -SENSITIVE- page 8 of18 Scptcmbcr 28, 1998

inability of the provider to identify the patient, or an inability to locate the records. In 231 (183%) cases, records were not received after several contacts, without explanation as to why they were not available. In only one case was consent to obtain the records not given by the participant. Of the 694 participants identifying historical medical records to be requested, pathology or cytology slides were requested for 52 (7.5%). In a few cases, more than one set of slides was requested, for a total of 58 separate requests. A total of 42 sets of historical pathology or cytology slides were received for 42 (80.8% of those for whom slides were requested). Medical records documenting further diagnostic studies recommended as a resuh of the RIDS clinic findings were requested for 35 participants, with a total of72 separate requests. All but two of these records were obtained, with at least one record obtained for each of the 35 participants. Thirty-three of these participants also had histology or cytology slides requested, for a total of 3 5 separate requests. Thirty-1hrec of these specimens we:-e obtained, with histological specimens on two participants still pending at the time of this report, for surgical procedures performed in mid-1998. Cause of death was coded for 541 subjects who were located deceased. Death certificates were received for 502 of the 54-lsubjects locaicd deceased. K.. Data Management The primary objective of the Data Managem~ Plan. was to specify the procedures that would be used to develop and maintain the study databases, and the procedures that would be used to ensure data quality. Principal components of the plan included duplicate entry for all data forms, range checks encoded in the data entzy programs, and consistency check programs nm on the data a:ftel' entry. A second objective of the Data Management Plan was to mainrnin the confidentiality of the data. This included data in computerized form through the use of passwords and control oflimitcd access to directories and data files; and to bard copies of data, ie., paper records, which were stored in locked files in locked offices or in a file room which ha4 limited access via keycard. In order to ensure high data quality, all forms were entered and verified, with the exception of the CATI and Tracking System entries. As these entricswere made directly into the computer, and not data entered :from forms, no dual-entry verification was poss1"ble. Programs were written to check and crosscheck all of the data, both within a data form and a.cross data forms. For example, the diagnoses coded on the Fmal Diagnosis Dctcrmination Forms were compared to all the other data collected [Le., f'!YBIDinatinn forms, ultrasound fmms, CATI data, In-Person Interview data, and the tracking system) to ensure that all apptop1iate diagnoses weze included. All inconsistencies were investigated by review of1he participant's records ("mcluding amftnt:apc of the CATI interview, as appropriate). Corrections were made on 1hc fmms in green ink, and were dated and initialed by 1hc person making 1he change. Once 'any changes had been made to the databases, check programs were nm to ensure all corrections had been made correctly. [ Ill. Special Considerations A Coordination with 1he Advisory Committee In June of 1990, an Advismy Committee was appointed by the Secretary of the Department of Health and Hnman Services to advise and consult with 1he CDC regarding the design and conduct of the

• study. The r-.mnmittee was established pmsuant to the Federal Advisory Committee Act, (5 U.S.C.

Appendix 2). The role of1he committee was to review 1hc dcvclopm~ of1he study protocol and conduct H1DS DRAFT Final Report Execgtjye Smnmmy -SENSITIVE- page 9 oflB September 28, 1998 .

.lI I I of the Pilot Study, assist in determining the feastoility and design ofa full-scale epidemiologic study, and advise CDC on the analysis of the study results. Initially, meetings of the committee were to be held on a quarterly basis in-Atlanta. In recognition of the interest in the Pacific Northwest in such proceedings, however, the committee asked that at least one meeting per year be held in Washingtcm State. Following completion of the Pilot Study, meeting frequency was reduced to approximately once per year, with the majority of these held in Seattle, Washington. Meetings of the Advisory Committee were uniformly open to the public. All materials presented to the committee became public record, with copies available for members of the public at the meetings. Meetings held in Washington State were nearly always accompanied by an evening Public Meeting to allow.members of the public to attend and ask questions regarding the study. Each meeting of the Advisory Committee began with an update on the progress of the study since the previous meeting. These presentations included the status of preparations for the study field work, or later, the numbers of study participants completing each phase of the study. Updates on the separate work concerning Native American populations were also included. Requests for further information from the committee were docmnented, and infonnation provided by study staff and investigators, as necessary. B. Public Information An important aspect of this research was the provision of prompt, accurate, and complete infmmation to the public. In this context it was crucial that contacts be established with members of the populations most interested in (and potentially affected by) the work. Interested parties included representatives of the States of Washington, Oregon, and Idaho; the Native American Tn"bes and Nations in the study areas, and local area residents. The public information activities of the study were designed to accomplish the following goals: 1) To assure that residents of the region understood the issues that led to the initiation of the study, the pmpose and objectives of the study, its basic epidemiologic design, and the time schedule within which it was to be condncted; 2) To provide opportnnities for the public to express concerns and comments regarding the design and conduct of the study, and to answer public questions regarding all aspects of the project; 3) To create public interest and support for the study, particularly in ways that such support might enhance participation by persons selected to be study participants; and 4) To assure broad dissemination and proper inte!Jll etation of final study results. Throughout the study, and particularly in the early phases, the study investigators participated in public meetings held dming the bimonthly meetings of the TSP, and contributed to the planning activities

   - of the Communications subcmnmittee of the TSP. The HTDS also supplied the TSP with a Fact Sheet that was included with TSP fact sheet mmlings- This written material was updated periodically as the study progressed.

Several separate approaches were also 1l!ken to proyide information to the public regarding the HTDS. Initiaily, the study protocol was made available for public review and comment prior to its submissiOJ1 to the CDC and 1he Advismy Committee. In conjunction with this activity, a series of public (town) meetings were held throughout the Northwest to discuss the protocol with 1he public and to answer specific questions. Similar public meetings were held in conjunction with each meeting of the Advisory Committee held in the Pacific Northwest. In addition to the study fact sheet mentioned above, several study brochures were developed and a

• newsl~ desaibing the progress and statns of the study was initiated. The brochares included the following: 1) H1DS Fact Sheet; 2) Questions and Answers about the Study; 3) Questions and Answers HIDS DRAFT Fmal Report: Executjye Smrrrnmy September 28, 1998

                                                                                  -SENSITIVE-             page 10 of 18

about Radiation and Thyroid Disease; and 4) Review of Thyroid Disease and Approach to Diagnosis. A master mailing list. which included the lists previously maintained by the FHCRC, the CDC, and the HEDR Project, was assembled to mail the newsletter and brochures to interested individuals. At the time of this report, the study mailing list contains nearly 9700 names. Early in the study, the newsletter was published on a quarterly basis. Following the Pilot Study, however, yemiy updates have been used to keep interested parties apprised of the study's progress. A total of 15 issues have been published to date, including the most recent, dated September 1998. A final issue summarizing the study results will be mailed at the time the results are made available to the public. Fmally, study investigaton: and staff have been available to answe.r questions on a regular basis. A phone line was designated in the Seattle study office for public inquiries, and a toll-free telephone numbe.r was established at the Freel Hutchinson Cancer Research Center for the Hanford Thyroid Disease Study (1-800-638-HlDS). Persons selected as study participants, and members of the gcne:ral public, were encouraged to use the toll-free number to comact the study office if they have questions or scheduling conflicts. As access to the World Wide Web via the internet became more common, a web site for the study was established at the FHCRC. All stndy brochnres and newsletters have been available at that site since January, 1997, and arc updated as necessmy. To date, a total of 16,005 inquiries have been made to the HIDS web site. Links to the FHCRC, Cente.rs for Disease Control and Prevention, and Hanford Health Information Network sites have bem established. The RIDS web site can be accessed at http:J/www.fhcrc.org/scienceJphs/htds C. Native American Component

                             ~

Nme Native American tribes and nations have reservations and ceded lands in the region around Hanford: Colville, Coner d'Alene, KalispeII, Kootenai, Nez Perce, Spokane, Umatilla, Wann Springs, and Yakama Members of these tribes and naticm were exposed to I-131 from Hanford, and the original congressional mandate that led to the HIDS called specifically for the inclusion of"Indian tnoes and tribal organiwinns". The approach taken in the BIDS regarding the Native American populations was determined by two important c.baractaistics of those populations. First, the lifestyles of many Native Americans were qnite different in many respects from those of the non-Native population. In particular, many Native Americans followed traditimal ca1turaI practices. especially regarding diet and sources of foods, which might in:ftoence the doses they received from Han:ford's I-131, but which were not explicitly modeled in the CIDER program. Moreover mmy Native Americans maintained s seacumaJ migratmy pattern of residence. Second, becanse the tribes and nations have sovereign rights recognized by the United States, conduct of a research project such as HIDS would require the approval and active coope.ration of each tribal govemment. Thus, the objective of the H1DS with respect to the Native American populations was to assess the :feasibiley of conducting a study to determine whether thyroid disease has increased among Native Americans exposed to I-131 ~ Hanford. Sample size and power calculations were carried out tn detennine whether it would be feasible to conduct a retrospective cohort stndy using individual dose estimates, similar to that being conducted for the HTDS Full Study. These calculations were based on data provided by eight of the nine tribes regarding tribal-specific lifestyle and dictmy practices. These dam are likely to more accurateJ:y account for lifestyle patterns and practices specific to eacl:i. tribe than using non-Native assumptions, and therefore the representative dose estimates are likely to more acauately approximate the doses members of each tribe would have likely received :frmn Hmrford. Similarly, the demographic data provided by each tnbe are likely

 ** to more accurately reflect the size and dem.ographic makeup of each tribe around the time of the Hanford releases.

Even under the most h'beral assumptions regaxding the numbm- of tribal members who might be available to participate in a study, and the possible level of radiation dose Native Americans could have received from Hanford, a study nearly double in size as the HIDS Full Stndy (6426 living evaluable participants) would have only 50% power to detect an effect of the magnitude considered scientifically HIDS DRAFT Fmal Report Execptiyc Snmmtny -SENSITIVE- page 11 of18 I Scptcmbcr 28, 1998

sotmd (a 5% increase in total thyroid neoplasia per Gray). Even under a more extreme assumption that the baseline probabilities for thyroid neoplasia are only half of those assumed in the HTDS Full Study, a study ( of 6426 living evaluable participants would only have 71 % power to detect the same magnitude of effect. Thus, it was recommended that a study of the design of the HIDS full study would not be feasible in the Native American population encompassed by the nine tribes in the Hanford region. I ID. Statistical Methods

                                                                                                                      \

In the primmy dose-response analyses, the exposure for each individual was represented by the estimated radiation dose to the thyroid from 1311, as calculated using the CIDER program created by the Hanford Environmental Dose Reconstruction Project. The primacy dose-response analyses for disease outcomes were based on regression models in which the probability ofhaving the outcome of interest varies as a linear fimction of thyroid dose. In particular, this primacy model permitted backgroond probability of the outcome (Le., the intercept parameter) to depend on sex, but assumed a common regression coefficient (slope) for dose. The regression coefficient can be interpreted as the change in the . probability of the disease outcome, per unit change in dose. Estimation of the magnitude of the exposure-response relationship was accomplished by estimating the regression coefficient of this stratified linear exposme--response model. Since the purpose of the study was to determine whether thyroid disease has been increased, significance testing focused on the mill hypothesis that the probability of having the outcome of interest does not vary with dose (Le., that the regression parameter has value zero) and the one-sided alternative bypotbcsis that the probability ina:eases with increasing dose (i.e., that the regression parameter is greater than zero). Idcntificatioo. and analysis of confounding and effect modifying filctors was accomplished through the analysis ofgeneralizations of the linear exposure-response models mentioned above. For disease outcomes, these generalizations allowed the background probabilities of the outcome of interest (Le., the intercept parameters) and/or the regression parameters to vary as functions of a number of fitctors that might potcntial1y confound the relationship between Hanford :radiation dose and the outcome of interest.

   , Investigation of the mapes of dose-i'esponse relationships was accomplished through the analysis of generalizations of and altrmatives to the primary linear e:x:posore-response model, including linear-quadratic and logistic models, and through the emroimrt:icm of diagnostic residual plots. Uncertainty of dose estimates for in-area participants was illustrated graphically, including cumulative distribution functions of ratios of the 95th percemile to the median dose, and of geometric standard deviations (GSD) of dose, and sca:tterplots of the 95th percentile-to-median dose ratio (on the vertical axis) by median dose (horizontal axis, on logarithmic scale), and of GSD by gemietric mean dose.

h cannot be assmned that the out-of-area participants were unexposed to 1311 from Hanford. Indeed, reso1ts of the HIDS Pilot Stndy suggested that many out-of-area participapts lived in locations near the HEDR domain at varions times during 1945-1957. Altemative methods of assigning a dose estimate for out-of-area partcipants were developed, and these do.sf'! estimates were used to assess the sensitivity of dose-response results to assumptions about the doses for out-of-area participants. The disl;ributi.on of doses was quite skt,wed, with large numbers of comparatively low doses and small numbers of quite high doses. Therefore analyses were performed to assess whether the regression coefficient indicating dose effect might be inordinately influenced by the high dose participants. In part:i.cular, two empirical checks were made to Z1SSCSS whether the esrimatr-d regression coefficient _ ~ - l y ~ the dose-~ relaticm.ship ove:r the lower ~se range. Infomurt:ion released by the U.S. National Cancer Institute (NCI) shortly before and during October, 1997, indicated fuat Jiving in the ca:rt:iguous 48 states during the 1950s and 1960s were exposed to various Jevcls o f ~ from the NTs. The material released by NCI included estimates of dose fur representative individDals in all comm.es in the 48 states, as well as more detailed data regarding estimated dose by soot (ie., by individual test detonatioo.), county, and age. Limited preliminary ffiDS DRAFf Fmsl Report: Exccgtjye Summary - SENSITIVE- page 12ofl8 September 28, 1998

comparisons for HTDS participants suggested that in many cases the reported NfS dose estimates were_ comparable to or even greater than the estimated Hanford doses. Therefore it was judged necessary to add exposure to 1311 from the NI'S to the list ofp<enti.al coofounding factors. For each participant in the HIDS, the "estimated NTS dose" was defined specifically as the thyroid dose from 1311entering the atmosphere from tests conducted at NI'S between 1951 and 1957, inclusive, as estimated from data made publicly available by NCL A categorical variable' representing each 131 living evaluable participant's relative level of exposure to 1 from the NI'S was calculated for use in the analyses of potential confounding. IV. Overall Summary of Study Accomplishments The field components of the HIDS were highly successful. A roster of 12,706 births was constructed from Washington State birth certificates, and 5199 individnals were selected for inclusion in the cohort. Of these, 4350 individuals (94%) were located and their i d ~ confirmed, and 525(10%) were confirmed as deceased. Importantly, success in locating individuals did not vary appreciably by sex, geographic region at the time of birth, or year of birth. Of those known to be deceased, a death certificate was obtained for verification of cause of death for 502 (93%).

• Similarly, once contacted, individuals were very cooperative and interested in participating. Of 4,240 people l".nntac:ted by phone to request participation, 3,361 (91%) agreed to participate. Only 338 (8%)

refused. Agreement to participate also did not vary appreciably according to sex, geographic region at the time of birth, or year of birth. Despite significant obstacles, the CATI component of the study was quite successful A total of 2713 participants identified a possible CATI respondent. Interviews were completed for 2267 (84%). Of the 3,441 living evaluable participants included in the analysis, 2134 (6211/o) bad a CATI interview. Overall, the quality of the data obtained in the CATI interview was rated as very high by the interviewers.

• Toe clinical component of the study was highly snrcessful It proved feasi"ble to bold all clinics in the Pacific Northwest (all but one site in W ~ ) , and participants_were willing to travel from throughout the United States and even from abroad to attend clinics. Of those who agreed to participate, and who did not withdraw from the study at a later time, 89% (3,448 of3,572) attended a RIDS clinic.

Success in scheduling people for clinics did not vary substantially by sex, goographic area of birth. year of birth. or even current residence. Of those attending a clinic, almost all participated in all aspects of the evaluation: in-pexson interview, thyroid nltrasonnd, blood tests, and clinical examination. Of the 272 participants for whom a fine needle aspiration was recommended, 259 (95%) underwent the procedure. It also proved feasible to locate and retrieve prior medical records and materials. Attempting to locate and obtain~ from as long ago as fifty years was expected to be one of the most difficult aspects of1he H1DS. A total of 709 participants identified prior medical records of potential interest, and provided consent to the HTDS to request 1261 separate medical records. Of these, 785 (62%) were received by the H1DS. Pmhology or cytology slides w e r e ~ for 47 of the 709 individuals identifying historical mate.rial. Oftb.ese, sli~ were received from 37 (Tl%). These results of the :field components of the HIDS reflect a relatively uniform and high level of success in acl:rieving the objectives set forth for each. h proved feasible to ide¢fy a large group of people __ exposed at vmying levels to radiation releases from.Hanford, to 1 ~ and contact them, to enroll them hi. the study, to collect information needed to estimate their individual radiation dose to the thyroid, to c:xam.ine them for the presence or bi.story of thyroid disease, and to review prior medical records relevant to prior evaluations or diagnoses of thyroid disease. Given the eligibility criteria fur inclusion in this study, thC"J"e was no evidence that success in 1hese various tzlSks varied appreciably according to a person's sex, where they were born, when they Well? born, or where they currently live.

• HIDS DRAFI' Fmal Report: Exccutiyc SPIDID!IY -SENSITIVE- page 13 of 18 September 28, 1998
• V. Summary of Dose-Response Results The primary evaluation o f ~ relationships focused on eleven categories of thyroid disease. ultrasound-detected abnormalities of the thyroid, and b.ypc:rparathyroidism.. For each of these 13 outcome categories a primmy definition was specified. The principal dose-:response analysis used this primmy definition of outcome, and individual radiation dose estimates (the median for each individual) based on individual residence history, dietary consumption data from the CATI or expanded in-person interview when available, and HEDR defimlt values wbea sudi data were not available. Alternative definitions were also specified for each outcome category, coi.:responding to the basis on which the diagnosis was made. Dose-~ analyses were also conducted for each of these altema:tive definitions.

In those instances where an alte:rnative definition resulted in a substantially greater number of people in the analysis than the prlmmy definition, the dose-response results for the a.ltemative definition are also presented in the Results section. In addition, dose-response analyses were conducted for six outcome categories based on the results oflabora.tmy assays, and for thyroid mas.s estimated from ultrasound. All dose-response analyses for all outcome definitions were repeated using two alternative sets of individual dose estimates: l) individual residence histmy, dietary consumption data from the CATI or expanded in-person interview when available, and defiru1t values based on the H1DS CATI data when such individual data were not available; and 2) individual residence histmy, and only HEDR default data regarding di.etmy consumption (i.e., no data from the CATI or expanded in-person intcrveiw). Fmther, two altemative represenmtions of exposure were defined which did not use the HEDR models to estimate individual radiation dose. In overall smnmary, there*was no evidence of a relationship between thyroid radiation dose from Hanford and the cmnulative incidence of any of the 13 primary .outcomes. There was also no evidence of any dose-response ~oosbip for any of the altemati:ve definitions of outcome. These results were remarlotbly uniform.'The findings were essentially unchanged for analyses based on either of the two

• altemative sets of individual dose estimates. The results remained the same after taldng into account (aqjusting for the effects of) seven fiu::tors that could potentially confound the relationship between radiation dose and the outcome of interest. There was no evidence of any dose-response for any outcome that might be difli:rcnt from the linear model used in the prim.my analyses (e.g., a linear quadratic relationship). Summarized below are the main*findings from the primmy analyses of dose-response.

Thyroid Carcinoma: Twenty participants (0.6%) were diagnosed with thyroid cancer; 13 women (0.7°/4) and 7 men (0.4%). The diagnosis was based on the HIDS evaluation or prior histologic evidence in nineteen of the twenty individuals. Using the prim.my definition (19 total cases; 14 in-area). 1here was no evidence that the cumulative incidence of thyroid cancer increased with inaeasing dose.

  ~         Thyroid Nodule:

A total of297 participants (8.6%) were diagnosed with a benign thyroid nodule; 200 women (11.4%) 8Ild 97 men (5.7%). The diagnosis was based cm the RIDS evaluation or prior histologic or cytologic evidence in250 (84%) of the cases. Using the prim.my definition (250 total cases; 236 in area). there was no evidence that the cmnnlative incidence of bmign thyroid nodule increased with increasing dose (slope of the dose-respcme =: -.01 l +/- .012; p-valne '"" 0.79). Similar rcsuJ:ts were obtained when an al:tt::marive definition of benign nodule was used to exclude cases which might have a specific non-neoplastic etiology (Le., those with a diagnosis of autoimmune tbyroidi:tis, Grave's disease.

 *hyperlhyroidism with an etiology of toxic nodular goiter or solitary antonomousnodule); A total of 175" participmrts (5.1 %) had a diagnosis of benign nodIJle according to this alternative definition; 117 women (6.7%) and 58 men (3.4%). The diagnosis was based on the RIDS evaluation or prior histologic or cytologic evidence.

• H'.IDS DRAFTFmal Report: Execg:tjye Smnmm Scptanbcr 28, 1998

                                                                                - SENSITIVE -          page 14 of 18

Arrv Thyroid Nodnle:

• A total of330 participants (9.6%) were diagnosed with any thyroid nodule (benign nodule. thyroid cmcinoma, or nodnJe suspicious for maligmmcy}. This included 224 women (12.8%} and l 06 men (6.3%}.

The diagnosis was based on the H1DS evaluation or prior histologic or cytologic evidence in 282 (85%) of 1he cases. Using the primary definition (282 total cases; 262 in-area). there was no evidence 1hat 1he cumulati.ve incidence of any nodule increased with increasing dose (slope of1he dose-response= --0.014 +/- 0.011; p-value = 0.85). These results were unchanged when an altcmative definition was used that specified any nodule us cith=- a benign nodnle and/or a nodule suspicious for malignancy. A total of 313 participants (9.1 %) had a diagnosis of any n ~ according to 1his alternative definition; 2l4 wcmen (12.2%) and 99 men (5.8%). The diagnosis was based on the HIDS evaluation or prior histologic or cytologic evidence in 266 (85%) of1he cases. Hypothyroidism: A total of 595 participants (I 7.3%) were diagnosed with hypothyroidism; 481 women (27.5%) and I 11l men (6.7%). The diagnosis was based on 1he H1DS evaluation or medical records with supporting documentation in 267 (44.9%) of the cases. Using this prima:ry definition (267 total cases; 245 in-area), 1hcre was no evide.nce that the cumulative incidence of hypothyroidism increased with increasing dose (slope oftb.e dose-response= 0.003 +/-0.020; p-valne* 0.93). Each of three a1tem.a.tive do:finitions of hypothyroidism added S1.1bst:antial numbers of cases. The first aite:rnative added to tb.e prima:ry definition diagnoses without supporting medical doemnentation. Based on 344 in-area cases, th.ere was no evidence that the cmnulati.ve incidence of hypothyroidism defined in this way increased with increasing dose (slope, of the dose-response ""!' 0.017 +/- 0.023; p-value = 0.22). The second a.ltema:tive added diagnoses to tb.e first aiternative definition that were inferred :from past or current therapy. Based on 370 in-area cases, there was no evidence that the cmnulati.ve incidence of hypothyroidism defined in this way increased with increasing dose (slope of1he dose-response= 0.017 +/- 0.024; p-value-= 0.24). The 1hird altemative added diagnoses to

• the second altcr:native based on participant report only. Based on 552 in-area cases, there was no evidence that the cumulati.ve incidence of hypothyroidism defined in this way increased with increasing dose (slope of the dose-respansc = 0.024 +/- 0.027; p-value = 0.18).

Autoimmune Outcomes: A total of 652 participants (18.9%) were diagnosed with autoimmune tb.yroiditis; 425 women (24.3%) and 227 men (13.4%). The diagnosis was based on the HIDS evaluation or medical records with supporting docmne:ntation in 648 (99%) of the cases. Using this prima:ry definition (648 total cases; 605 in-area), there was no evidence that the cmnnlative incidence of autoimmune thyroiclitis increased with increasing dose (slope of tb.e dose-response= --0.007 +/- 0.028; p-value =- 0.60). Two alternative definitions of autoimmune 1hyroiditis were specified based cm the results of an assay for serum thyroglobulin auto-antibody (anti-Tg ,may). The first defined autoimmune tb.yroiditis as present if either tb.e AMA, anti-TPO,

 , or anti-Tg results were positive; the second defined autoimmune thyroiditis as present iftb.e anti-Tg were positive. regardless of tb.e ICSU1t ofthe AMA or anti-TPO assays. There was no evidence of a dose-response relationship using either of these two altemat:i:ve definitions. Three additional outcomes were defined to nmrow the definition of autoimmune tbyroiditis to include both an immune marker for tb.yroiditis as well as hypothyroidism. The :fimt included all those with a diagnosis of both autoimmune tb.yroiditis and hypodiyroidism (according to theprimmy definitions of each specified above). One hundred eighty seven cases met this definition. The second additional outcome excluded front the first group tb.ose with a diagnosis of Grave's disease (leaving 173 cases). The 1hird outcome exclnded from 1he first group tb.ose with an iatrogenic amse of hypothyroidism or tb.ose with transient b.ypoth:yroidis (leaving 160 cases).

no Thcni was evidence that 1he cumnlative incidence of autoimmune thyroiditis increased with increasing . Hanford :radiation dose using any ofthese three additianaI definitions. A tom! of 674 participants (19.6%) were diagnosed w;ith autoimmune tb.yroid disease (autoimmune thyroiditiB and/or Gmve's disease). This,included 442 women (25.3%) and 232 men (13.7%,). The diagnosis was based on tb.e H1DS evaluat;ion or medical records with supporting documentation in 659 HIDS DRAFT Fma.l'Rqx>>t Execgtjve Smnmmy - SENSITIVE- page 15 of18 Septmtber 28. 1998

                                       \

(96%) of the cases. Using this primary definition (659 total cases; 613 in-area), there was no evidence that. the cumulative incidence of autoimmune thyroid disease increased with increasing dose (slope of the dose-response -0.004 +/- 0.028; p-value 0.57). CE C ' Graves' Disease: ' A total of50 participants (1.5%) were diagnosed with Grave's disease; 37 women (2.1%) and 13 men (0.8%). The diagnosis was based on the'H1DS evaluation or medical records with supporting documentation in 34 (68%) of the cases. Using this primacy definition (34 total cases; 32 in-area), there was no evidence that the cumulative incidence of Grave's disease* increased with increasing dose (p-value = 0.68). Hypothyroidism: A total of 196 participants (5.7%) were diagnosed with hyperthyroidism; 157 women (9.0%) and 39 men (2.3%). The diagnosis was based on the HIDS evaluation or medical records with supporting documentation in 161 (82%) ofthe cases. Using this primacy definition (161 total cases; 155 in-area), there was no evidence that the cumulative incidence of hyperthyroidism ina-eased with increasing dose (slope of the dose-response= -0.008 +/- 0.015; p-value., 0.69). Mµltinodnlar Goiter and Simple Goiter. A total of 115 participants (3.3%) were diagnosed with multinodular thyroid gland; 90 women (5.1%) and 25 men (1.5%). The diagnosis was based cm the H1DS evaluation in 95 (83%) of the cases. Using this primary definition (95 total cases; 85 in-area), there was no evidence that the cumulative incidence ofmultinodularthyroid gland increased with increasing dose (p-value - 1.0).

• No dose-response relationship was found for simple goiter. Using the prim.my definition (HIDS evaluation, 14 cases), there was no evidence that the cumulative incidence of simple goiter increased with increasing dose (p-valne = 0.85). The results were similar using the most broad alternative definition which included any diagnosis or participant report (70 total cases, 65 in-area; p-value "" 0.81).

Other and Unspecified Thyroid Disease:

         . There was no evidence of a dose response for the category "other and unspecified thyroid disease". Using the broadest altcmative definiticm of this outcome (26 total cases; 22 in-area), there was no evidence that the cumulative incidence of other thyroid disease increased with increasing dose (slope of the dose-response= 0.001 +/- 0.007; p-valne = 0.38).          .

Ultrasound: Ultrasound :findings were available for 3430 of the 3441 living evaluable participants. A _total of 1596 participants (46.5%) had one or more ultrasound-detected abnormalities; 964 women (55.4%) and 632 men (37.4%). There was no evidence that the cumulative incidence of ultrasound-detected abnormalities inc:reased with increasing dose (slope ofthe dose-response= 0.0041 +/- 0.037; p-value"" 0.13). These

findings werr.*essentially unchanged when the analysis was restricted to palpable ultrasound-detocted abnmmalities only (224 total cases, 204 in-area; p-value = 1.0), non-palpable ultrasmmd-detected abnmmalities (1309 total cases, 1217 in-area; slope of the dose-response"" 0.047 +/- 0.037; p-value- 0.097),

or diffuse nltrasound-dotected abnormalities (458 total cases, 428 in-area; slope of the dose-response= 0.026 +/- 0.026; p-value = 0.15). - - - - - Bypero..pdbyroidism:

• A total of 14 participants (0.4%) were diagnosed with hype:rparathyroidism; 10 wom~ (0.6%) and*

4 men (0.2%). The diagnosis was based cm the H1DS evaluation or medical records with supporting BIDS DRAFT Final Report Executjyt. $pmmpry September 28, 1998

                                                                             - SENsrnvE-           page 16 of18

documentation in 12 (86%) of the cases. Using the broadest definition of this outcome (14 total cases; 13 in-area), there was no evidence that the cumulative incidence of hyperthyroidism increased with increasing dose {slope of t h e ~ = 0.000 +/- 0.006; p-valne

• 0.50). *

 , Laboratory Tests:

Of the 3441 living evaluable participants. 3182 (92.5%) provided a blood specimen at the HIDS clinic. Several laboratory assays were conducted to evaluate thyroid function, anti-thyroid antibody response, and sc:mm calcium level. Statistical analyses were conducted to investigate whether there were associations between laboratory values from these tests and estimated thyroid radiation dose from Hanford. Thyroid stimulating hormone (TSH) levels were detennined according to three diffe:rent tests over the course of the smdy. In addition, total thyroxine (f4). triiodothyroxine (T3) uptake, and free thyroxine index (FTI) were determined. There was no evidence that any of these measures were related to increasing radiation dose to the thyroid. Anti-thyroid antoimnnme response was evaluated using two different assays. There was no evidence of a relationship to dose for results from eithei- test. Serum calcium levels were measured in an effort to identify persons with hypercalcemia which might be sooondmy to hypeq,arathyroidism. There was a statistically significant trend of decreasing serum calcimn levels in relation to increasing thyroid radiation dose (p=0.0026) for both men and women. Although there is no readily apparent explanation for this result, this finding deserves further comment Frrst:, it should be noted that the laboratory test used measured the total serum calcium and not ionized calcium. wfilc.h is the true measme of normal calcium levels in the blood. Thus. it cannot be certain that a dose effed: would be present if ionized calcium mtha.- than total calcium had been measured. Second, the outcome for which calcium was being measured, hypc2pmathyroidism, was not fmmd to be associated with radiation dose. Third, the dose effect occm:red primarily in the nonnal calcimn range. The mean calcimn level for the entire H1DS cohort was 9.2, consistent with the nOII11al range of the 'test (8.4-10.2); Only 0.9% of the coharthad lOW' calcimn levels less than 8.4 (hypocalcemia). There-was no statistically

• significa:at relatiooship between hypocalcemia and :radiation dose. Fourth, even for persons with a relative]y high dose of 1,000 mGy to the thyroid, the mean serum calcium decreased only to a value of9.l, clearly anomial value and very near the mean calcium level ofthe e:nti:re cohort (9.2). Therefore, despite the statistically significant decrease in calcium levels with increasing dose, the resulting effect or clinical impact does not appear to be clirdcall:y significant.

VL Summary Comments The H1DS was designed to detennine whether exposure to atmospheric releases of primm:ily I-131 from the Hanford Nuclear Site between 1944 and 1957 resulted in increased thyroid disease among those exposed. The study evaluated nine categories of thyroid disease, the results of several laboratory tests for thyroid :function, anti thyroid mrt:ibody and scrum calcium level, ultrasound-detected thyroid abnormalities, thyroid mass, and hypetparathyroidism. The prim.my analysis utilized all estimate of thyroid radiation dose fir each individual based on infurmatim about their residence history and dietary ccmsmnption patterns during the times of1he Hanford releases. Additional analyses were also condncted using several alternative methods fir estimating dose, both quantitative and qualitative. The pri:mmy analyses were based on a linear dose-response model, adjusting for the effects of differences in response by sex, although alternative models for the shape of1he dose-response were also investigated. The poteJitial effect on any dose--respon9C of a number of lifestyle iactors and indicators of other radiation exposure were evaluated as covariates in 1he models. This study found no evidence in any of the analyses 1hat increasing dose to -toe thyroid-from Hanford radiation was associated with an incrc:ased cumulative incidence of any of the disease outcomes, or thyroid 1aboratmy tests. There was also no evidence of a dose-response for hyperparmhyroidism, although a positive dose-response was seen fir serum calcium. An increasing thyroid dose was

• significantly associated with a deaease in serum calcium. Although the c:xphmation for this result is not clearly apparc:nt, the finding does not appear to be of clinical significance (discussed more fully above).

HIDS DRAFfFmal Report: F..xegttiye Smpp:my - SENSITIVE- page 17ofl8 September 28. 1998

These results :remained the same when altcmative methods of assessing radiation dose were used. There is no evidence that this absence: of a dose relationship is due to bias fa selection of the cohort, loss to follow-up, or enrollment and participation. h is also not the case that the study was of insufficient size to detect a reasonable level of dose--response if it exists. The study had 95% power to detect an increase in cumulative incidence of 5% per Gy for any benign nodule; 96% to detect an increase of25% per Gy for thyroid carcinoma; and 93% power to detect an increase of 12% per Gy for any ultrasound-detected thyroid abnonnality. Given the principal differences between the radiation exposure circumstances at Hanford and those of othe:r populations studied in relation to radiation-induced thyroid disease, the findings of this study are not inconsistent with the CUJ.Tent published literature regarding the effect of exposure to radioactive iodine and the risk of thyroid and parathyroid disease. This is particularly so given the relatively small magnitude of the estimated thyroid radiation doses in members of the HIDS cohort (median-= 104 mGy) and the relatively protracted nature of the exposure over time. There is little evidence in the lite.t ature to suggest that persons exposed to radioactive iodine at the levels found in this study over a period of months or years would experience higher rates of thyroid or parathyroid disease as a resuh of their exposure. Thus, given that 1he H1DS had adequate statistical power to detect reasonably small effects. and , the rigor of th.e study design. these results provide rather strong evidence that exposures at these levels to I-

• 131 do not increase 1he risk of thyroid disease or hyperparathyroidism. These results should consequently provide a substantial degree of reassmance to 1he population~ to Hanford radiation that the exposures are not likely to have a:ffccted their thyroid or parathyroid health. (
• )

HlDS DRAFf Fmal Report: Execgtjve Smmnary September 28, 1998

                                                                               -SENSITlVE-              page 18 ofl8

APPENDIXE LETTER TO WALLACE LABORATORIES/REPLY RE: AVAILABILITY OF KI OVER THE COUNTER and OTHER SOURCES

STATE OF NEW HAMPSHIRE EXECUTIVE DEPARTMENT Office of ErMrgency U.nagement 6tllte Offlc:a Park South 107 Pleaant SttMt Concord, New HMDpahlre 03301~3809 603-,271-2231 JEANNE SHAHEEN 1-800-852-3792 WOODBURY P. FOGG, P.E. Governor FAX 603-225-7341 Du-ector March 25, 1999 Mr. Tom Halvorson Vice-President, Marketing Wallace Laboratories P.O. Box 1001 crartbury, NJ 08512

Dear Mr. Hatvorson:

For the past several months the State of New Hampshire has been reconsidering our policy concerning the use of potassium iodide (KI). A Working Group was formed with representatives from the Governor's Office, the Office of Emergency Management, the Radiological Health program and a citizens group. We held public meetings, solicited wri~ten comment an~ conducted research on the issue *

• Recently we determined to recommend KI be available to m~ers of the general pl,lblic at their choice. We were extremely pleased to hear Peter Paiton*s report of his conversation with you whereby Wallace Labs will make THYRO-BLOCK available to the general public. Peter did fill us in on some of your concerns with making THYRO-BLOCK available and the Working Group is now asking that you take the time*to think about; how Wallace Lahs can make it generally available.

We recognize you have a concern as to the demand that might exist for the product. We believe there will be sufficient demand to make distribution worthwhile from your perspective. As soon as we can assure the public KI is indeed available .w.e will publicize our*recommendation and proceed to develop material for inclusion in the 100,000 + calendar/brochures we distributie within ten miles of each power plant. We believe there will be interest but don't want to generate demand until there is a supply available. New Hampshire has recently become active in the NRC's KI Study Group and are in continuing contact with other states throughout the. country._. Many people.are very impressed with our approach*to making KI available to the general public and would likely replicate our efforts. We believe the private sector should, and must, make KI available to the public in the same manner you lllake other pharmaceuticals available to the public. You are uniquely positioned to do this and we will support your efforts. State of New Hampshire TDDAccess: Relay NH 1-800-735-2964

Mr. Tom Halvorson Page Two March 25, 1999 ( We need for your company to reiterate your willingness to distribute THYRO-BLOCK to the general public and to explore with us a timetable for its distribution. Once you are ready to go forward, we will proceed to get the word out to the public of New Hampshire, and, through our own networks, throughout the country. We are truly excited to have the opportunity to make KI available to persons that wish to purchase it. Please give me or Peter Paiton a call should you have any questions as to how we might make this happen. Sincerely, Wc-nliJk~1 .J'.-. ~t' Woodbury P. Fogg, P.E. Director WPF/sjp

• cc: Peter Paiton, Radiological Health Susan Arnold, Governor's Office Steve Haberman, SAPL

WALLACE LABORATORIES DIVISION OF" CARTER-WAL.LACE, INC

• HALF"-ACRE ROAD * ?. o. eox 1001 May 14, 1999 Mr. Woodbury P. Fogg P.E. Director, Office of Emergency Management State of New Hampshire Executive Department State Office Park South, I 07 Pleasant Street Concord,

    ,,         New Hampshire 03301-3809

Dear Mr. Fogg:

This letter is in response to your request for a written summation of our May 6, 1999 phone conversation concerning the availability ofTHYRO-BLOCK.e (potassium iodide) Tablets for distnlmtion to New Hampshire residents. As we discussed, it is Wallace Laboratories' intent to make THYR0-BLOGK.4' available to interested members of the general public in cooperation with your office. As you know, TIIYRO-BLOCIC" is an over-the-coW1ter product that is approved for distnbution

• to nuclear :facilities and to federal and state agencies for use in the event of a radiation emergency.

THYRO-BL0~ is labeled and packaged for distribution by these agencies in such emergencies. The state ofNew ffiµnpshire, which stockpiles potassium iodide for workers at its nuclear power plant, recently determined to recommend that ,potassium iodide be made available to the general public, based on the Nuclear Regulatory Commissions' policy encouraging this practice. As we discussed, Wallace Laboratories wishes to cooperate with your office in making THYR0-BL0c:ice directly available to the public, and we currently are developing a direct-to-consumer program utilizing independent distnbutors to implement this. Our direct-to-consumer program will comprise a THYR0-BLOcr website and an 800 number. The THYR0-BL0CIC" website will be a component of the Carter-Wallace website, hyperlinked to our THYRO-BL0CK. distnbutors, thus enabling direct, on-line purchase. For those who do not have access to our website, our toll-free number will enable direct purchase of TIIYR0-BLOCK via phone :from these distnbutors. It is our understanding that your office will publicize Wallace Laboratories' policy to make THYR0-BLOCK directly available to the general public, and that you will include information on our product in the calendar/brochure distn'buted to New Hampshire residents living in a ten-mile radius of nuclear power plants. The state of New Hampshire can be assured that we will make every reasonable effort to have THYRO-BLOcIC" available to consumers. However, since

 ) it is impo~ble to forecast the impact of your publication on the availability ofTHYR0-BL0CK:",

some backorders may occur. Consequently, our distnl>utors have assured us that back.orders, if

• they occur, will be filled as soon as produd is available.

Mr. Fogg, Wallace Laboratories currently is in contract development with our THYRO-BLOCK (potassium iodide)Tablets distn'butors to implement the above plan. If you need :further information, please contact me at 609-65 5-619 I. David S. Dwyer Associate Product Manager cc: Tom Halvorson

Enclosure:

Full Prescn'bing Information for TIIYRO-BLOCit"' (potassium iodide) Tablets .

imall Search Results for Emergency Essentials Page 1 of 1 Home ~ck I ~oofflng Cart Customer Seivlce earch Emergency en als Search Results for

                                                                           -Emergency Essentials For more Information about this product or to see more products from this company, visit the Emergency Essentials web site.

THYRO BLOCK ThyroBlock potassium tablets block the absorption of radioactive iodine by your thyroid gland during a nuclear emergency. It doesn't have to be a nuclear war to create an emergency. A nuclear power plant accident or a radioactive waste spill could release radioactive iodine into the air. One bottle contains a 2-week supply for one person .

• _[JTHYRO BLOCK Your Price: $5.50 each Quantity:

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• Safety.Side Eff~1 Dosage YES: I Hope I'll Never Need It but It's Foolish Not to Have It.

Send me IOSAT' as indicated Total Number of Packages ordered HISTORY/USAGE First 10 Packages, at $10.00 Per Package___,,,,----,---,,--,,-- Shipping and Handling Per Order $4.00 ,_$ 4.00_ Early Findings TOTAL ORDER 3 Mlle Island Chernobyl Check Enclosed (Payable to Anbex) MasterCard or Visa Currerit Status Account Number - - - - - - -- HOME Expiration:

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• http://www.anbex.com/order_by_mail.htm 4/19/99

APPENDIXF

• NEW HA1VIPSB1RE STATE RADIATION ADVISORY CO1\1l\1ITTEE

MEMORANDUM (4/15/99) and LETTER (5/3/99)

TO GOVERNOR JEANNE SHAHEEN

NEW HAMPSHIRE STATE RADIATION ADVISORY COMMIITEE

• Jem:me Shaheen MEMORANDUM Diane E. Tefft, Sec'y Governor Elizabeth Thibodeau, Chair Aptjl 15, 1999 Her Excellency, Governor Jeanne Shaheen State House Concord, New Hampshire 03301
• Attn: Susan Arnold, Director of Policy Governor Jeanne Shaheeii's Office Following, is a pos111on statement from the State Radiation Advisory Comm~ for your consideration in the development of a state policy relative to the distribution of Potassium Iodide to the general public in New Hampshire .
• Respectfully submitted, Diane E. Tefft Technical Secretary cc: Woodbury Fogg Dianne Luby DET:eab t.:\rad\gronp\data\admin\wpwori-\radadvcm\s_ arnold.doc James Cherniack, CHP Roben A. Fralick, Ph.D. David C. Frost, DMD Charles G. Leutzinger, MD Kenneth E. Mayo, CHP Edward P. Rooney, DVM James P. Tarzia, CHP Elizabeth A. Thibodeau, Chair

State Radiation Advisory Committee Position on the Distribution of Potassium Iodide to the General Public in New Hampshire The Sta:te of New Hampshire (NH) is currently considering the need to stockpile and pre-distribute potassium iodide (KI) tablets to members of the public for consumption during a nuclear accident. The issue of distributing KI bas been debated for several years in the scientific community, the Federal Government, and some states. In light of the recent considerations in NH, the NH Sta:te Radiation Advisory Committee bas studied and reviewed this matter and prepared the following recommendation regarding this issue. This paper provides the justification apd results of that recommendation. I Recommendation The NH Sta:te Radiation Advisory Committee (SRAC) bas carefully researched and evaluated issues regarding the distribution of KI to the general public. Careful thought has been given to the potential benefits and risks of self administering this drug. After consideration, it was determined that the likely negative aspects of pre-distributing KI to NH residents outweigh the potential dose savings even during a worst-case US reactor accident Therefore, it is the opinion ofthis committee that a decision to stockpile and pre-distribute KI to the general public is not in the best interests of residents in the State of NH.

• Background During a reactor accident, one of the gases that may be released is radioactive iodine, or radioiodine.

The human body, specifically the thyroid, requires a certain amount of non-radioactive, or stable, iodine to function properly. Iodine is routinely absorbed by the thyroid where it is incorporated into various hormones. If radio iodine is introduced into the body, it follows the same pathway as stable iodine and, if present in a large enough quantity, can damage the thyroid. A variety of chemical substances have been shown to block the accumulation of radioiodine in the thyroid if administered in a controlled and timely fashion prior to an exposure to radioiod~e. Potassium Iodide, or KI, is believed to be the most *suitable form of chemical for this purpose. This drug can saturate the thyroid with non-radioactive iodine for a short period of time so that it cannot absorb radioiodine when exposed. A number of factors must be considered prior to taking KI in the event of an emergency. First, the potential blocking effects of KI depend on when the drug is taken. In order for KI to be effective, it must be taken within a relatively short time period before or following an intake of radioiodine. Secondly, the drug has been shown to create adverse reactions in the thyroid and other membranes, especially in chil~n. It shoul~ only b~ taken wfien the savings in dose-outweigh the potential risks from the short-- term use,ofthe drug. The US Food and Drug Association (FDA) has performed extensive studies on this subject and has concluded that the use of KI is only warrented if the potential dose to 1he thyroid is projected to equal or exceed 25 rem .

There are many considerations that must be reviewed prior to making a decision to stockpile and

• distribute KI to members of the public. A few of these consi~erations are listed below:
• A decision to pre-distribute KI should be based on the probability that an *accident will release iodine. in an amount that will cause adverse health effects. There have been reactor accidents that have resulted in the release of large a.mounts of radioiodine (eg. Wmdscale and Chernobyl),

however, both of these reactors have been dry, graphite moderated reactors which caught fire dwing their accidents. *

• Reactors in the US are water moderated and it has been shown that the presence of water plays an important role in detemining what will be released into the environment. WaterJimits and delays the release of iodine during an accident During the Wmdscale accident, almost 6% of the gas released was radioiodinc. During the TMI-2 accident, only 0.00017 % of the radioactive gases release was iodine. If was shown that the doses received from iodine during. wet reactor accidents are very small in comparison to dry reactors.
• The highest public dose from TMI is estimated to be 83 millirem, which is far below levels that have shown any adverse health *effects.
• During the Chernobyl accident, it was shown that the majority of dose from iodine came from the consumption of contaminated milk and foodstuffs and not from inba]ation of air.
• Additional safety systems installed in US reactors after TMI make it even more improbable that an accident will occur releasing large amounts of radioiodine.
• Most of the dose frorp. US reactors comes from the release of noble gases which is not prevented by tbe use of KI.

A decision .to distribute KI to the public must be accompanied by a plan to notify the Pl!blic of releases and ensure the public takes the drug appropriately. KI is not a miracle drug and will not,protect against external radiation. An appropriate *dosage regimen and a program of medical contact, and assisamce should be available. Jne drug may also cause side effect in some users including, hyperthyroidism, iodide goiter, hypothyroidism, mucous membrane reactions, and vascular reactions. Significant side effects have been reported due to Kl when taken routinely or in high doses. A communications and education prosra:m must accompany the distn"bution of KI to ensure that residen~do not panic and take KI following the announcement of a reactor incident or unusual event that does not release iqdirie. The cost and liability of maintaining a program to distribute KI should be considered.. If a decision to pre-distn"bute KI is made for communities around commercial reactors,,other communities, s_µch 115 those around naval shipyards, should be considered. A program to make KI publicly available could result in a significant cost It is likely that the potential public dose savings achievable during even an extremely bad accident will not justify the cost. Jq]las a sh_elflif~_.A decisicm to pre~istrib_me i;nust inclµµe_13; pro~s for.the_inventory-and.replacement. oflarge quantities of expired Kl. Other, more effective, measures of saving total dose during a reactor accident, such as effective

• sheltering and evacuation, should be weighed against the risks and benefits of KI .

References Crocker, D.G., "Nuclear Reactor Accidents", The Use of KI as a Blocking Agent Against Radioiodine

• Uptake in the Thyroid\rdblquote-, Journal of Health Physics, Vol 46. No. 6., 1984.

   ~ J.A., "Potassium Iodide: Pre-distribution or Not? The Real Emergency Preparedness Issue",

Journal of Health Physi~ Vol. 49, No. 2, 1985. Pahuja, D.C. et al, "Potassium Iodate and its Comparison to Potassium Iodide as_ a Blocker of I-131 Uptake by the 'I'hyroid in Rats", Journal of Health Physics, Vol 65. No. 5, 1993.

• Shleien, B., "Preparedness and Response in Radiation Accidents", U. S. Department of Health and Human Services Publication FDA 83-8211, 1983.

U.S. Nuclear Regulatory Commission Response Technical Manual, RTM-93, "Use of Potassium Iodkie (Kl) and 'I'hyroid Monitoring", PMT-103, 1992*

NEW HAMPSHIRE STATE RADIATION ADVISORY COMMIITEE

• Jeanne Shaheen Governor Diane E. Tefft, Sec'y E1h:aheth Thloodeau, Chair May 3, 1999 Her Excellency, Governor Jeanne Shaheen State House Concord, New Hampshire 03301 Attn: Susan Arnold, Director of Policy Governor Jeanne Shaheen's Office This is to infonn you that the New Hampshire State Radia:tton Advisory Committee bas reviewed and concurs with the recommendations made by the New Hampshire Potassium Iodide (KI) Policy Study Group in its "Report to the Governor", relative to development of a state policy on distribution of KI to the general public.

The Committee has been actively involved in the discussion of the technical and philosophical issues which formed the basis for the stated recommendations presented in this report. Retention of the current policy of providing KI for emergency workers and persons in institutions combined with the concept of allowing members of the public to make their own informed decision on their use of KI agrees with the Committee's philosophy on this subject. The Committee clearly supports the recommendation to supplement the annual emergency public information materials with supplemental information on KL Additionally the Committee suggests that this recommendation be expanded to include the media and other possible avenues of communication. The New Hampshire State Radiation Advisory Committee is pleased to have been part of this policy development process and looks forward to working with the KI Policy Study Group and your office in the future mo~ring of evolving federal and state J?Olicies and guidance _on KI.

                                                                      ~OWLU   A. Thibodeau, Chair Radiation Advisory Committee CC: Members, State Radiation Advisory Committee Dianne Luby WoodburyFogg James Cherniack, CHP        Robert A. Fralick, Ph.D. David C. Frost, D.M.D.       Charles G. Leutzinger, M.D.

• Kenneth E. Mayo, CHP Edward P. Rooney, DVM James P. Tarzia, CHP Elizabeth A. Tluoodeau

                                                            .f

APPENDIXG NRC KI CORE GROUP CHARTER

• FROM THE TRANSCRIPT OF THE NRC KI CORE GROUP 12/1/98 (Page 5 of 77)

        , The goal of the Kl core group is to develop a revised draft NUREG and an accompanying draft user-friendly brochure to support emergency planning decisions on the role and use of Kl in site-specific emergency plans.

The revised NUREG will take into account the many useful public comments received and will discuss the factors that need to be weighed in state and local decisions on the role of Kl under their specific local conditions. The revised NUREG will also discuss in some detail the various guidance on the issue in the World Health Organiz.ation, IAEA, and FDA documents and will include a discussion on how the practical problems in KI stockpiling, distnbution, and 'use are handled in the states and numerous nations which already plan to use KI as a supplemental public protective action. The proposed user-friendly brochure will provide an abbreviated discussion of the factors which need to be considered by emergency planning decision-makers in recommending general

• public use of Kl and practical solutions to potential problems with stockpiling, distnbution, and use.

                                                                .)

Sep 99 09 : 55A Val e r i e Justi n 51 6 - 725 - 5263 P. 0 1

                                                                                      *99   S[P 13 A11 :Q2 COALITION OF N EIGHBO RHOODS FOR THE PRESERVATION OF SAG HARBOR CITIZENS ADV!SQRV COMMITTEE TO THE TOWNS OF SOUTHAMPTON AHO £A.IT   kAMPTN

• PO Box 2143
• Sag Harbor
• New York
• 119CS3 *

 ")')Cl(ET NU B                            Secretary, U.S. Nuclear Regulatory Commission Att: Rulemakin9s and Adjudications Staff NOPO ED RU                               Washington,D.C. 20555

• Re: Comment PRM-50*63A. Considerat,onof Potassium Iodide in Emergency Plans, Proposed Rule

Dear Madame Secretary,

Our organization Is a Coalition of more than 20 neighborhoods working together on mutual issues. Our Newstetter goes out 10 ti mes a year to 500 homes and organiz-ations. Since Sag Harbor is less than 20 miles from the Millstone Nuclear Plant in Waterford, Conn, and since the NRC has refused to extend the 10 mile emergency zone to Include Long Island emergency planning is of extreme interest to our memembers. We want to urge that the emergency planning regulation be amended to REQUIRE the avllability of potassium iodide (Kl) for the public in the event of nuclear accidents, The regulation as it is now worded ... "the proposed rule would require that CONSIDERATION shall be given to Including potassium Iodide ... " has no teeth and must be changed. The nuclear industry should bear the cost; government agencies should have the responsibility of seeing that Potentially effected communities have local stockpiles of potassium iodide. NRC's announced plan for regional stockpiling should be amended ; local stockpiling is necessary to make the distribution of KI possible in an emergency; KI Is not effective after six hours - it must be stockpiled In schools, hospitals, fire, Police and other municipal centers. There is no reason why the NRC should not make these changes. Your mission is to protect the public's health and safety. Please consider the people of Long Island who are not protected and who cannot , given our topography and highway system, evacuate in the case of an accident at Millstone .

                           .r ,

Sincet:f~~ Valerie Justin, Issue~n;-g;r for Millstone SEP I 4 1999

                                                            ~ kn w1 qedbycard ......... - * , - ~

U.S. NUCLEAR REGULATORY RULEMAKINGS&~ OFRCE M OFTHEWWWIISSII - - 1 ! ~ ~~ ~ _:L~!:6 7lL/Js

. . Duke Duke Energy Corporation ,_ Energy... 526 South Church Street P.O. Box 1006 (EC07H) Charlotte, NC 28201- 1006 (704) 382-2200 OFFICE M. S. Tuckman (704) 382-4360 FAX Executive Vice President Nuclear Generation *99 S[r 13 A11 :03 Or 1 1 August 27, 1999 AC L Secretary DOCKET NUMBER U. S. Nuclear Regulatory Commission PROPOSED RU 50 Washington, DC 20555-0001 Attn.: Rulemakings and Adjudications Staff

Subject:

Comments on Proposed Rule, "Consideration of Potassium Iodide in Emergency Plans" (64 FR 31737, June 14, 1999) Duke Energy Corporation wishes to offer the following comments on the Proposed Rule on Consideration of Potassium Iodide in Emergency Plans (64 FR 31737, June 14, 1999). Duke Energy Corporation opposes the proposed rule. Duke Energy agrees with and endo rses the comments submitted on behalf of the industry by the Nuclear Energy Institute. Requiring that the State and local governments consider the prophylactic use of potassium iodide (KI) as a protective action for the general public will not add any significant public health and safety benefit to the adequate level of protection currently provided by existing emergency planning at and around commercial nuclear power plants. U.S. emergency pre p aredness programs are built on the premise that evacuation is generally feasible and is more effective at dose reduction because it reduces dose to all organs, not just the thyroid. Potassium iodide can be effective in protec t ing the thyroid gland from radiation dose due to inhaled radioactive iodine during an accident. But, the pills must be taken shortly before or within several hours after the exposure to the radioactive iod i ne. Any large release from a nuclear power plant would also incl ude other radioactive elements for which KI would not offer protection. Risk due to thyroid dose is of significantly less concern relative to the risk associated with external radiation from noble gases. The current "Federal Policy on Distribution of Potassium Iodide for Use as a Thyroidal Blocking Agent" provides sufficient SEP 999

                                                ~cknowledqed bv card *.. _..    .....~w-.::

v COMMIS~1v.~

ATIONS STAFF RY g_fe-LLq_Cj - -

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t Secretary, USNRC August 27, 1999 Page - 2 guidance to State and local governments. It recommends the stockpiling or distribution of KI during emergencies for emergency workers and institutional persons, but does not recommend that pre-distribution or stockpiling be required for the general public. The current policy is sound and will provide adequate protection of public health and safety. The safety record of the U.S. commercial nuclear power program and demonstrated strength of its current emergency preparedness programs support those conclusions. Yours truly, M. S. Tuckman

DOCKET NUMBER PR PROPOSED RULE 50 fot./FR3t7 37 From: Jim Hardeman <Jim_Hardeman@mail.dnr.state.ga.us> To: OWFN_DO.owf5_po(AVC) *99 S[P 13 A7 :53 Date: Fri, Sep 10, 1999 4:51 PM

Subject:

Cements re: Kl rulemaking (64 FR 31737) or Ms. Vietti-Cook -- .' AO,,_ Please find below an advance electronic copy of comments regarding NRC's proposed rulemaking on Potassium Iodide (Kl). I will place a hard copy of these comments into outgoing mail this afternoon. Thank you very much. James C. Hardeman, Jr., Chair Emergency Response Planning Committee (E-6) Conference of Radiation Control Program Directors, Inc. c/o Environmental Protection Division Georgia Department of Natural Resources 4244 International Parkway, Suite 114 Atlanta, GA 30354 (404) 362-2675 fax: (404) 362-2653 Jim_Hardeman@mail.dnr.state.ga.us Ms. Annette L. Vietti-Cook Secretary of the Commission U.S. Nuclear Regulatory Commission 1 White Flint North 11555 Rockville Pike Rockville, MD 20852-2738 September 10, 1999

Dear Ms. Vietti-Cook,

The Conference of Radiation Control Program Directors, Inc, (CRCPD) Emergency Response Planning (E-6) Committee appreciates the opportunity to comment on the above-referenced proposed rule. As Chair of the CRCPD E-6 Committee, I have had the pleasure to serve on the potassium iodide (Kl) Core Group, and to work with NRC staff, staff of other federal agencies, and my colleagues in other states on this issue. I would like to address three issues that we feel are important: (1) that the proposed rule is unnecessary, as states have already *considered* the use of potassium iodide in their emergency response plans; (2) that the Comm ission relied heavily on the Chernobyl experience in developing this proposed rule, without due consideration of the limitations of available Chernobyl dosimetry and environmental measurements or the vast technical , political, and socio-economic differences between Eastern Europe and the United States; and, (3) that the Sf P 4 1999

                                                      ~cknowfedged by card ................"..*-=-

U.S. UCLEAA REGULATORY COMMISSr .~ RU 1 EMAKINGS &ADJUDICATIONS STAFF OFFICE O THE SECRETARY OF THE COMMISSION Document Statist~ Po, Cop1 Add'

Commission implies that absent federal action in this matter, that states are incapable of making informed decisions regarding the protection of their citizens during a radiological emergency. As you know, the offsite planning basis for commercial nuclear power plants in the United States is found in NUREG-0654 / FEMA-REP-1 , Rev. 1 *Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants*, originally published in November 1980, and modified by Supplement 1 in November 1987. I refer you to two (2) separate sections of NUREG-0654: the planning basis for the plume exposure pathway (pp. 8-9 of Rev. 1), and the planning standards and evaluation criteria for protective response (pp. 18-19 of Rev. 1, Supp. 1, criteria J.10.e and J.10.f) . Our read ing of the language in these sections of NUREG-0654 leads us to conclude that approval of an emergency plan by FEMA pursuant to 44 CFR 350 is a definitive statement that the use of Kl has already been considered in the development, implementation, and evaluation of that plan, making NRC*s proposed additional language for 10 CFR 50.47(b)(10) of little effect, and in our opinion, unnecessary. Please note also that the language in criterion J.10.e contains the phrase *particularly for emergency workers and institutionalized persons ... *. We note that the word *particularly* does not mean *exclusively*. We are also concerned that the Commission has chosen , as part of the basis for the proposed rule change , to rely heavily on the experiences of Eastern European countries following the Chernobyl accident. External and internal dosimetry and contemporary environmental measurements immediately following the accident are lacking, particularly during the peri od prior to implementation of protective measures, and we caution against drawing conclusions regarding the efficacy of potassium iodide from the available Chernobyl data. We also note that reliance on the Chernobyl experience discounts the vast technical , political , and socio-economic differences between the United States and Eastern European countries at the time of the Chernobyl accident. The efficacy of any protective measure will depend on a large number of factors, including but not limited to: the type of reactor involved, accident sequences and timing , source term , timeliness of notification, the manner in which protective action decisions are made and transmitted to the public, the mobility of the public, and the receptiveness of the general public to official instructions. All of these factors have already been considered in the development of existing emergency response plans. The Commission appears to have adopted the petitioner*s view that the states have not had access to sufficient technical information regarding potassium iodide, and *that without accurate and current information on Kl -- including the Chernobyl experience and the consensus of international experts -- States cannot make an informed judgment.* This assertion is without merit, as there has been no shortage of information related to the use of potassium iodide available to state radiological emergency planners. In adopting this assertion, directing the development of federal guidance on this subject, and in proposing this rule, the Commission seems to imply that state and local governments, absent such federal actions, are incapable of making informed decisions regarding the protection of their citizens during a radiological emergency. As mentioned above, radiological emergency planners have a number of factors to consider, and we take exception to the implication that states are incapable of obtaining technical information on their own and making a rational decision based on their own find ings.

In summary, the offsite radiological emergency planning guidance that has been in effect since 1980 currently addresses the issue of the availability of Kl for members of the general public. We are confident that we have had access to sufficient technical information upon which to base a decision as to whether to make potassium iodide available to the public, and that our existing plans currently provide sufficient documentation that *consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl).* In addition, we feel that the technical basis for the proposed rule, by relying heavily on the Chernobyl experience, is flawed. For these reasons, we urge the Commission to discontinue this rulemaking. Thank you again for the opportunity to comment on this matter. Please call me at (404) 362-2675 if you have any questions. James C. Hardeman, Jr., Chair Emergency Response Planning Committee CRCPD CC: GATED.nrcsmtp("shawn.seeley@state.me.us","kevin.sc ...

Committee on Emergency Response Planning Conference of Radiation Control Pro r~~ t tors, Inc. (CRCPD)

                          "A Partnership Dedicate 6' Radiat,i               ~tection"
                                                                 ~

Ms. Annette L. Vietti-Cook OOCKETFD September 10, 1999 Secretary of the Commission U.S. Nuclear Regulatory Commission Sf P 1 3 1999 RULE=MA '~GS ANO 1 White Flint North UDICATIONS STAFF SECY-NRO ~ 11555 Rockville Pike Rockville, MD 20852-2738 so {,f/~/?'31737 Re: Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 FR 31737, June 14, 1999)

Dear Ms. Vietti-Cook,

The Conference of Radiation Control Program Directors, Inc, (CRCPD) Emergency Response Planning (E-6) Committee appreciates the opportunity to comment on the above-referenced proposed rule. As Chair of the CRCPD E-6 Committee, I have had the pleasure to serve on the potassium iodide (Kl) Core Group, and to work with NRC staff, staff of other federal agencies, and my colleagues in other states on this issue. We strongly urge the Commission to discontinue the current rulemaking in this matter, and would like to address three issues in the notice that we feel are important: (1) that the proposed rule is unnecessary, as states have already "considered" the use of potassium iodide in their emergency response plans; (2) that the Commission relied heavily on the Chernobyl experience in developing this proposed rule, without due consideration of the limitations of available Chernobyl dosimetry and environmental measurements or the vast technical, political, and socio-economic differences between Eastern Europe and the United States; and, (3) that the Commission implies that absent federal action in this matter, that states are incapable of making informed decisions regarding the protection of their citizens during a radiological emergency. As you know, the offsite planning basis for commercial nuclear power plants in the United States is found in NUREG-0654 / FEMA-REP-1 , Rev. 1 "Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants", originally published in November 1980, and modified by Supplement 1 in November 1987. I refer you to two (2) separate sections of NUREG-0654: the planning basis for the plume exposure pathway (pp. 8-9 of Rev. 1), and the planning standards and evaluation criteria for protective response (pp. 18-19 of Rev. 1, Supp. 1, criteria J.10.e and J.10.f). Our reading of the language in these sections of NUREG-0654 leads us to conclude that approval of an emergency plan by FEMA pursuant to 44 CFR 350 is a definitive statement that the use of Kl has already been considered in the development, implementation, and evaluation of that plan, making NRC's proposed additional language for 10 CFR 50.47(b)(10) of little effect, and in our opinion, unnecessary. Please note also that the language in criterion J.1 0.e contains the phrase "particularly for emergency workers and institutionalized persons ... ". We note that the word "particularly" does not mean "exclusively". Office of the Committee Chairperson, James C. Hardeman, Jr. Georgia Environmental Protection Division* 4244 International Parkway, Suite 114

• Atlanta, GA 30354 Telephone: (404) 362-2675
• Fax: (404) 362-2653
• E-mail: Jim_Hardeman@mail.dnr.state.ga.us

U NUCLEA nLuulAI l.ln l v\J1V11v1 .... J RULEMAKINGS & ADJUDICATION STA - OFFICE OF THE SECRETAR OF THE COM ~ISSIO~ 0 C . M Sp

Letter to Ms. Annette L. Vietti-Cook September 10, 1999 Page 2 of 2 We are also concerned that the Commission has chosen, as part of the basis for the proposed rule change, to rely heavily on the experiences of Eastern European countries following the Chernobyl accident. External and internal dosimetry and contemporary environmental measurements immediately following the accident are lacking, particularly during the period prior to implementation of protective measures, and we caution against drawing conclusions regarding the efficacy of potassium iodide from the available Chernobyl data. We also note that reliance on the Chernobyl experience discounts the vast technical, political, and socio-economic differences between the United States and Eastern European countries at the time of the Chernobyl accident. The efficacy of any protective measure will depend on a large number of factors, including but not limited to: the type of reactor involved, accident sequences and timing, source term, timeliness of notification, the manner in which protective action decisions are made and transmitted to the public, the mobility of the public, and the receptiveness of the general public to official instructions. All of these factors have already been considered in the development of existing emergency response plans . The Commission appears to have adopted the petitioner's view that the states have not had access to sufficient technical information regarding potassium iodide, and "that without accurate and current information on Kl -- including the Chernobyl experience and the consensus of international experts -- States cannot make an informed judgment." This assertion is without merit, as there has been no shortage of information related to the use of potassium iodide available to state radiological emergency planners. In adopting this assertion, directing the development of federal guidance on this subject, and in proposing this rule, the Commission seems to imply that state and local governments, absent such federal actions, are incapable of making informed decisions regarding the protection of their citizens during a radiological emergency. As mentioned above, radiological emergency planners have a number of factors to consider, and we take exception to the implication that states are incapable of obtaining technical information on their own and making a rational decision based on their own findings . In summary, the offsite radiological emergency planning guidance that has been in effect since 1980 currently addresses the issue of the availability of Kl for members of the general public. We are confident that we have had access to sufficient technical information upon which to base a decision as to whether to make potassium iodide available to the public, and that our existing plans currently provide sufficient documentation that "consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl)." In addition, we feel that the technical basis for the proposed rule, by relying heavily on the Chernobyl experience, is flawed . We strongly urge the Commission to discontinue this rulemaking . Thank you again for the opportunity to comment on this matter. Please call me at (404) 362-2675 if you have any questions. Si~ (!_ ~ 7/ Uv ~

                                                                          ~ ~ ( (

1 ames C. Hardeman, Jr. , Chair Emergency Response Planning Committee CRCPD JCH1h

DEPARTMEN 1035 OUTERP LINOIS 62704 2 ' D) George H. Ryan Governor Attention: Rulemakings and Adjudications Staff

SUBJECT:

Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Federal Register 31737-June 14, 1999) Request for Comments The Illinois Department of Nuclear Safety appreciates the Commission's efforts and apparent intent to preserve the discretion of the responsible state and local governments in determining whether the use of KI is prudent for the general population under their jurisdiction. However, a key issue needs clarification prior to adoption of the proposed rule. The Commission asserts that the proposed change to 10 CFR Part 50.47 (b) (10) does not require any action by licensees but that states must show "consideration" has been given

• to the use of KI as a potential supplemental protective action. In determining that the proposed rule is exempt from the backfit requirements, the Commission states: "Even as to states or local governments, it (the proposed rule) imposes no binding requirement to alter plans and procedures." However, there is no explanation of how the Commission expects that "consideration" process to be demonstrated.

The Commission should clarify that the KI "consideration" within the context of radiological emergency planning and preparedness needs to be performed only once by the responsible state agency, which would provide written notice of the consideration to the Commission. Thereafter, no further "consideration" should be required unless the state determines there is reason to reconsider its position. The State of Illinois believes this clarification is imperative to avoid any suggestion that the "consideration" process is subject to continuing oversight or recurring evaluation by the NRC, or any other federal agency. EP 1 4 1999

                                                             ~ekn('Wfedged by card---....... ,....

U.S. NUCLEAR REGULATORY CO ON RULE . KINGS&ADJUOICATIOOSSTAfF FFICE 'fHE ERETARY OFTHE COMMISSION or, S'11istlcs Postmark D te Copi ece* ed qµ{)/qq / FE ~ Add'I ,..cpies Rtproduc d _ ___ __

Secretary of the Commission U.S. Nuclear Regulatory Commission Page2 September 8, 1999 In addition to the "consideration" issue that must be clarified, the Commission's proposed rule still fails to adequately address several key issues related to the KI stockpile debate.

1. The Commission has directed NRC staff to develop (federal) guidance for states regarding the basis for making informed decisions about the use of KI. This appears to reflect the Commission's adoption of petitioner's assertion that the states cannot make an informed judgment. There is no testimony in the record to support the contention that any state is incapable of making such a judgment. The assertion is insulting and should be removed from the Commission's justification.

The effort to substitute federal guidance for what is clearly a state prerogative amounts to de facto regulation. Moreover, the Commission's authority in this area is limited to the actions of licensees.

2. The Commission's decision suggests that states are expected to inform the NRC and FEMA on any decision regarding KI stockpiling to "enable the federal government to engage in better contingency planning for states that decide against stockpiling KI." The statement implies that even when a state decides as a matter of public policy against distribution of KI for the general population, the federal government will develop plans to override that decision. The purpose of such plans is unclear in the context of the proposed rule. Once a state has given due consideration to the use of KI stockpiling as a supplemental protective action and determined it to be unwarranted, on what basis does the Commission propose to develop a contingency plan?

3. The Commission's conclusions and narrative supporting the proposed rule also indicate acceptance of the argument that KI stockpiling is justified based on the experience at Chernobyl, yet the Commission staff provides no technical explanation for how a Chernobyl-type accident might occur at a nuclear plant in the United States. The issue is not whether KI was or could have been effectively used during the Chernobyl accident, but whether similar circumstances exist in the U.S. Further, references to the TMI accident are equally irrelevant since there was no KI distribution to the public at TMI nor was any subsequently deemed necessary. The relative risk of thyroid cancers resulting from a nuclear power plant accident in the United States is no greater today than it was three decades ago.

Secretary of the Commission U.S. Nuclear Regulatory Commission Page3 September 8, 1999 What is often missed in the KI debate is that the decision to provide KI for the public has to be part of a total picture where a government considers what kind of reactors are involved, their accident sequences and timing, the source term, what sort of notification systems are in place, how decisionmaking authority is divided among various levels of government, what information is available and how timely, whether the public have cars or whether they depend on mass transit, whether the roads are generally good or often impassable due to weather, how well the public responds to instructions from government officials, and a host of related questions pertaining to each location's specific situation. Because its efficacy depends so heavily on the timing of administration, KI, like other protective measures, will be appropriate in some areas and not in others, for a number of site-specific reasons. Any attempt by the NRC to craft an "internationalist" policy on the use of KI will fail because it will not address such site-specific attributes.

4. A key argument against stockpiling is that distribution at the time of an accident becomes logistically impractical. In the Commission's proposed rule, the staff appears to agree by suggesting that KI be made available over-the-counter for purchase or pre-distributed to fixed locations. The staff adds: "Other countries have found ways to effectively distribute KI when needed and the distribution issue is certainly not unsurmountable."

a. The statement suggests the Commission staff is prepared to support the same techniques used for forced KI distribution that were dictated by

• federal governments in Eastern Europe during the Chernobyl accident. The Commission should carefully consider whether this posture would be endorsed by any government, be it federal, state, or local.

b. KI is already an "over-the-counter" drug by FDA definition, but few pharmacists stock it unless a customer requests its availability based on a physician's order. Likewise, the staff ignores the testimony of those states where KI is stockpiled or pre-distributed for the public and where experience shows the system is ineffective.

5. The proposed rule is predicated on the false assumption that even if states decide not to stockpile KI for the general public, they will have access to federal reserves of the drug. By the Commission's own admission, such reserves have yet to be established nor has the funding mechanism to support such reserves been identified. The proposal suggests that states "consider" the availability of resources that do not exist.

Secretary of the Commission U.S. Nuclear Regulatory Commission Page4 September 8, 1999 The State of Illinois believes the debate over KI stockpiling has gone on long enough and consumed far more time and energy than was necessary. The Commission's proposed rule, if modified to satisfactorily address the issues identified above, reasonably resolves the issue with respect to emergency preparedness requirements. In adopting this rule, the Commission should declare that all remaining issues in this debate are fully resolved. Thank you for the opportunity to comment.

                                         \Q Thomas W. Ortciger Director TWO:mcs cc:     Dave Smith, IEMA Marty Vonk, ComEd Ken Evans, Clinton Power Statation

J. Barnie Beasley, Jr., P.E. Southern Nuclear Vice President Operating Company, Inc. Vogtle Project 40 Inverness Center Parkway P.O. Box 1295 DO*" ;:. LO l I Birmingham, Alabama 35201 Tel 205.992.7110 M-> o 3:oC:, Fax 205.992.0403 *99 SEP 11 P2>i42 .. SOUTHERN~ September 10, 1999 Or COMPANY PL Energy to Serve Your World"" ADJ DOCKET NU BER Secretary of the Commission United States Nuclear Regulatory Commission PROPOSED RU 50 Washington, D. C. 20555 ( t,, I/PR 3173 7 Attention: Rulemaking and Adjudications Staff

Subject:

Conuncnts on "Consideration of Potassium. Iodide in Emergency Plans" (64 Fed. Reg. 31737. June 14. 1999) Southern Nuclear Operating Company (Southern Nuclear) has reviewed the Nuclear Regulatory Commission's proposed amendment to the emergency planning regulations of 10 CFR 50 (b)(I0), which if changed, would require that when developing a range of protective actions, State and locals consider the use of potassium iodide (Kl) as a supplement to evacuation and shelter for the general public. In accordance with the request for comments, Southern Nuclear endorses comments submitted by the Nuclear Energy Institute (NEI) which also accurately convey Southern Nuclear's position on the proposed rule change. Southern Nuclear would like to emphasize that the Chernobyl experience does not provide adequate grounds for changing the current emergency planning rule to require consideration of the use of potassium iodide. By contrast, robust U. S. emergency planning programs require prompt notification of offsite authorities; alerting the exposure pathway zone population; implementing protective actions such as shelter, evacuation, and agricultural quarantine; and administration of KI for emergency workers and institutionalized persons. These plan elements have been extensively tested, exercised, and evaluated for 20 years by both the Federal Emergency Management Agency and the Nuclear Regulatory Commission.

• It is recognized that KI can be effective in protecting the thyroid from inhaled radioactive iodine in aerosol form However, KI must be taken shortly before or within several hours of exposure for effectiveness, and KI offers no protection from nuclides other than radioactive iodine which might be released in a severe reactor accident Additionally, for the drug to be administered safely, KI should be dispensed in fractionated doses based upon the age of the recipient and only after the recipient has been made aware of the medical risk involved with ingestion.

Southern Nuclear believes that the current "Federal Policy on Distribution of Potassium Iodide for Use as a Thyroidal Blocking Agent" provides sufficient guidance to State and local governments. The current policy is sound and has provided adequate protection for the public's health and safety over the years and therefore should not be changed. The nuclear industry's demonstrated safety record of over two thousand (2000) reactor-years of operation supports these conclusions. IBB,Jr./NMM EP-99-041 SEP 1999 ckr,OW,edged by card - ........ .,__,,,..

U 11.JUCLEAR R IJL.l"llunY UJ , f RU EMAKINGS & AOJUOICATI N TAFF QFl=f CE O THE SECRET R OF THf: COMMI 10 Postmark 01te __,_,_...~,..- - ___ Core~ * / Ad I Co. ',c ,..,...';:,:~~~~.c.-n -

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Page Two U. S. Nuclear Regulatory Commission cc: D. N. Morey H. L. Sumner REES Files: G.02.33; EP.01.27

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON DC 20555--0001 OFFICIAL BUSINESS PENALTY,-------. PENALTY FOR PRIVATE USE$

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• JOSEPH F. MYERS. PRESIDENT PBM~R

,t NATIONAL EMERGENCY MANAGEMENT ASSOC C/0 THE COUNCIL OF STATE GOVTS .

2760 RESEARCH PARK DR ./BOX 11910 LEXINGNTON. KY 40578 -1910 CMT DATE: 09/01/99 ( 64FR31737) 24 5TATOOOW 405112016 1698 12 09/20/99 FORWARD TIME EXP RTN TO SEND

COUNCIL OF STATE GOVERNMENTS PO BOX .1.19.10 LEXINGTON KY 40578-.19.10 RETURN TO SENDER

We have received your recent correspondence regarding the subject referred to below. Please be advised that your correspondence has been forwarded for consideration by the Commission. Thank you for your interest. CONSIDERATION OF POTASSIUM IODIDE IN EMER PLANS PR -050 FEDERAL REGISTER1C'ITE: 64FR31737 COMMENT DATE : 09J!lll/99 COMMENT NUMBER: '24 Rulemakings and Adjudications Staff Office of the Secretary of the Commission NRC FORM 532B (7-1998)

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President Ms. Ellen Gordon national emergenc~ mmntrgir-h~t association Administrator Emergency Management Division Department of Public Defense Hoover State Office Building, Level A Des Moines, IA 50319-0013 (515) 2B 1-3231 FAX (515) 28 1-7539 President-Elect September 1, 1999 DOCKET NUMBER Mr. Joseph F. Myers, FL Secretory PROPOSED RULE ft 5O

                                                                                                                                                  )°"'

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                                                                                                                                                              ~

Mr. Patrick Ralston, IN ( lD<IFR 317 31 Ci C/.1 _Q Annette V ieni-Cook I '7

                                                                                                                                                                          ;c:*

Treasurer - .J Mr. Gary Whitney, SD Secretary of the Commission __. ATTN: Rulemakings and Adjudications Staff 0 t-President Nuclear Regulatory Commission -0 n McKinney, SC i"'-J Washington, DC 20555 onol Vice Presidents 0i 0:l Region/

Dear Secretary Vietti-Cooke:

Mr. Peter LaPorte, MA RE: Proposed Rule KI: Federal Register Vol. 64, Number 113 Region/I Mr. Edward Jacoby, Jr., NY Please accept these comments from the National Emergency Management Association (NEMA) Region/II regarding the NRC's proposed rule requiring states to consider the use of KI as a supplementary Mr. Charles Wynne, PA action to sheltering and evacuation as a protective measure relating to a potential nuclear power Region IV plant incident. NEMA represents the state emergency management directors in the 50 states, Mr. Jim Maher, MS U.S. territories and District of Columbia. Region V Mr. Steven Sell , WI The states have already considered the use of KI and therefore should not be required to do so

     . n VI                      again. This amounts to an unfunded mandate and is contradictory to the Executive Order on ert Ashwood, OK          Federalism issued on August 5, 1999. Among other things, the Executive Order encourages egionV/1 federal agencies to defer to states on issues which they are best equipped to address and prevents Mr. Jerry Uhlmann, MO             agencies from imposing costs on state and local governments that are not required by statute.

Region VIII Mr. James Greene, MT Further, evacuation of potentially affected areas within the 10 mile Emergency Planning Zone is the preferred protective action to protect the health and safety of the public. Distribution of Kl to Region IX Mr. Michael Austin, AZ. the general public could inhibit orderly evacuation and divert limited local resources during the early stages of an incident. The distribution if KI to the general public could impart a false sense RegionX of security regarding the prevention of severe health effects resulting from radiation exposure. Mr. John Cline, ID KI does not limit dose due to whole body exposure from other radioisotopes that could be Pacific Caucus present in a radioactive release from a nuclear power plant incident. Additionally, KI is not Mr. Roy C . Price, Sr. effective unless administered prior to or shortly following inhalation or ingestion of radioiodines. Also, KI is contraindicated for some members of the general population due to a portion of the NEMASlaff population experiencing allergic reactions to the drug. Ms. Trina Hembree Executive Director Emergency plans will not be able to address legal liabilities associated with the drug's M r. Richard Dieffenbach administration. State and local governments will be unable to control dosage or provide medical Policy Analyst supervision for the administration to schoolchildren. EP I 4 1 99 Ms . Marcia Hensley Administrative Secretory

                                                                                                                     ~cknowtedged bv card...                       .....  "-.r.<"

NEMA OFFICES: The Council of Stole Governments, Tri ne Hembree Executive Director 2760 Research Pork Drive, ~O. Box 11910, Lexington, KY 40578-1910, (606) 244-8000, FAX (606) 244-8239 WASHINGTON OFFICE: Holl of the Stoles, 444 North Copilol Street , SUite 401 , Washington, D.C . 20001 , (202) 624-5460

1J S NIJCl AR REGULATO ON I t'MAKIN STAFF f:FI ~RY 0 O~.'lrir~~ION

International experience with the drug is not necessarily a relevant issue in assessing the appropriateness of the protective measure in the United States because of the differences in power reactor safety system designs, emergency preparedness capabilities, and ingestion pathway protective measures (i.e. the embargoing of agricultural products) utilized in this country. Finally, it is NEMA's belief that should there be any additional stockpiling of KI in the future, the cost should be borne by the Nuclear Regulatory Commission rather than FEMA or any other government body. Thank you for the opportunity to comment. Sincerely,

   )}"..,.,., ? ' . , ~

• Joseph F. Myers NEMA President Cc:

NEMA State Directors James Lee Witt, Director, Federal Emergency Management Agency

DOCKETED u l'<"' 719New Jersey Avenue Lyndhurst, New Jersey 0707 99 SEP 10 A9 :L1 2 September 4th, 1999 ~ Of I RI - AD . . Ms. Annette Vietti-Cook Secretary of the Commission U.S. Nuclear Regulatory CoI1BI1ission DOCKET NUMBER Washington,D.C. 20555 PROPOSED RULE.Pl So 1 ~4Fk 311 a1)

Dear Secretary Vietti-Cook:

I am writing in support of the U.S. Nuclear Regulatoiy Commission (NRC) proposed rulemaking PRM-50-63A, "Consideration of Potassium Iodide in Emergency Plans." Based upon the evidence presented on both sides of the issue, the NRC should adopt this proposal, iffor no other reason than it is simply the common sense thing to do. Furthermore, there should be revisions made to strengthen this proposal. A review of the record reveals that most of the argwnents against adoption make the same argwnents, namely:

1. Ct.DTent reliance on evacuation and sheltering is sufficient in meeting safety objectives

2. There may be potential negative side effects from KI ingestion

3. The logistics of distributing the pills presents too many problems and

4. Liability issues The petitioner has more than adequately presented sufficient evidence to refute all of these argwnents. I will not take up the CoIIBllission's time by repeating all of the petitioner's coI1BI1ents, but I will elaborate on certain points.

All of the comments arguing that evacuation and sheltering alone are sufficient safety actions consistently fail to address one veiy important scenario: what if evacuation is not feasible? Given the geographic distribution of rwclear power plants, there are numerous natural disasters which could occur that would make evacuation difficult and time consuming at best HtDTicanes, blizzards, and ice stonns can easily cut off evacuation routes and limit, ifnot eliminate, the possibility of evacuation. Such occtDTences, though remote, are certainly feasible probabilities. An even more sudden natural disaster would be an earthquake severly damaging a reactor. Under such circumstances, there would be little if any lead time to implement a calm, complete, and orderly evacuation A final point against such strong reliance upon evacuation is the evacuation routes themselves. Any automobile accident on a major arteiy could leave many people, both the public and SEP 14 1999--

                                                            ~eknowfedged bv card .................~

U.S. NUCLEAR REGULATORY COMMISSI01 RULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE C,v11HV11~10N Oocllnent Statistics Postmafk Date q1/ 71/ q CJ Copies Rece /. A I s

emergency responders, stranded at the worst possible time. As the petioner states, evacuation is. the best action to take in most emergencies, as it will best limit any exposure an individual may receive. However, such excessive reliance upon it is not a prudent idea Iffor any reason evacuation cannot occur, or it has been decided to evacuate at a later time, sheltering would come into play. Should this occur, there is no valid argument against the use of KI to block/reduce any dose to the thyroid Granted, this action will not reduce the whole body dose, but the record clearly shows that it will reduce the chance of developing thyroid cancer. Distribution of KI can occur at the on-set of an event, before an order to evacuate or take shelter is given, or previously through a letter to residents in the EPZ to go to their local fire/health/police department to pick up an adequate supply for their families. As the petitioner successfully argues, cost, shelf-life, and proper storage of KI are simply not overwhelming issues. For all those who claim logistics present too great a problem, I would submit that if most of the industrialized world can work out the details, then the U.S. also has enough knowledgable and talented people to do so. Ifthe challenge appears to be too large, an appeal for assistance to the international commtmity would bring any needed help. Many of those against the proposal, notably many State govermnents and the utilities, all make the claim that the current system is all that is needed Neither of these groups have presented adequate rebuttal to the argmnent that if the U.S. system is adequate, then why does most of the remaining industrialized world believe that evacuation and sheltering alone is insufficient. The governments of Canada, Great Britain, France, Germany, and Japan, as well as numerous other industrialized nations, the IAEA, the World Health Organization, well respected members of the National Institute of Health, the American Thyroid Association, FEMA, the FDA and the EPA all believe in and/or acknowledge the use and benefit ofKI in conjunction with evacuation and sheltering. To take the position that everyone else is wrong and the cWTent U.S. NRC policy is right is simply not a credible position. Such a stance could easily damage our credibility relating to emergency planning in the worldwide scientific cormmmity. Preventing thyroid cancer is a far better strategy than having to go through the cure. Having personnally worked with numerous thyroid cancer patients as the deputy radiation safety officer at a New York metropolitan area medical center, I speak :from experience. The procedure such patients have to go through encompasses exactly what the petitioner describes: surgery, mood swings, weight gain/loss, possible nrultiple radioiodine therapies, life-long dependency on prescription medication (which can be many decades long for patients in their pre-teens/teens), alteration of diets, special precautions/restrictions after both diagnostic tests (which need to be repeated each year for many years) and therapies, etc. If a single action could be taken to prevent an individual, especially a child, :from having to endure such things, and the Commission fails to, at the very least, strongly encourage that action, then the Commission is negligent in its duty of ensuring the health and safety of the citizens of this co1U1try.

With these facts in mind, the Commission should not only adopt the proposed rulemaking, but strengthen it As it stands, a state could have considered the issue in the early 1980's, rejected Kl, and now claim that the Commission's current proposal has already been :fulfilled While such a statement would be in keeping with the letter ofthe proposal, it would clearly violate the intent of the petitioner's proposal. Therefore, the proposal should be revised by the addition of the following or similar language:

       "'Those states that assert that they have considered the use of KI in their emergency plans must present evidence that such consideration occurred after a thorough review of the relevant scientific data post-Chernobyl. Ifthe consideration occurred prior to the publication of data from the Chernobyl accident, those states must re-consider the use of KI as part of their emergency plan based upon an analysis of the scientific data obtained/discovered from the Chernobyl accident" Without this statement in the rulemaking itsel( or in an advisory made by the Commission, the residents of those particular states would be living 1D1der an emergency plan that is based on less than current information.

In addition to the above wording, the Commission should fulfill its previous statements and restore the federal (i.e. NRC) fimding for states that wish to include KI in their emergency plans. This fimding was 1D1ceremoniously removed at the last moment, even though the Commission, throughout the length of the petition's proposal history, has consistently indicated/intimated that they would fund state stockpiles. As has been demonstrated, such fimding costs very little. Granted all agencies have fiscal restraints, the NRC can still ask Congress for an additional appropriation for this purpose. The KI issue has already garnered the support of Senators and at least one House representative. The reason for the additional monies may enjoy bi-partisan support. The utilities, instead of expressing steadfast opposition, should actually welcome this proposal. It would give them the perfect opportunity to demonstrate their civic responsibility and concern for the residents located near their facilities by providing the residents with every reasonable safety measure available. The proposed use ofKI is very reasonable. This is actually an issue where the utilities and environmental groups can work together. The utilities can show their desire to keep the public safe, environmental groups can contribute their outreach capabilities, and together they can educate the public on the reason for, and use of; potassimn iodide. Put simply, the Commission should adopt the proposal, with the changes specified, for the overriding reason that it is the common-sense, prudent action to take. The availability of KI at the local (i.e. State) level would provide emergency workers with another option at their disposal in the event of an emergency. There would be no need to scramble during the emergency (as happened during Three Mile Island) in the quest for Kl, nor any delay waiting for it to arrive from the "regional" stockpile. The KI may have even been previously distributed depending upon the form of the emergency plan. Use of the KI would have been practiced during the various emergency drills. Potassimn iodide simply provides another layer of protection which can be used in the event of an emergency.

As the petioner pointed out in his feny/lifejacket scenario, you hope never to have to use the lifejackets aboard the boat, but you are happy they are there. To deny the requirement that mates consider the use ofKI, mi stipulated by the petitioner, and continuing on with evacuation and sheltering alone, would show a complete lack of forethought It would be like a person buying a car and asking for the air bags to be taken out because the car already has seat belts and anti-lock brakes. Just as that person would be considered foolish, so would it be foolish to deny this petition. Thank you. UJ~ Richard Peros, M.S.

ConsumersEnelJW~ c~

                                       *rt r

A CMS Energy Company Palisades Nuclear Plant , Tel: 616 164 2gJ6 *

                              '99 SEP - 7 P4 :15   27780 Blue Star Memorial Highway    _ ax: f/i;F,6~65     P4 .1 5 Covert, Ml 49043 Nathan L. Haskell Director, licensing 0t '

tu r

                                                 -                                 AD 1 1 September 2, 1999                        DOCKET NU PROPOS.ED Secretary of the Commission U. S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Rulemakings and Adjudications Staff

Subject:

Comments on Proposed Rule, Consideration of Potassium Iod ide in Emergency Plans (64 Fed. Reg. 3173) Consumers energy Company is pleased to submit the following comments regarding a proposed change to 10 CFR 50.47 published in 64 Fed . Reg . 3173. This proposed change would create a new requirement for licensee emergency plans to explicitly address the preventive use of potassium iodide by emergency workers and the general public. Consumers Energy Company urges the NRC not to make the proposed change. The explicit treatment of potassium iodide in the rule is not only unnecessary; it could be harmful to state and licensee e.fforts to protect the public. The explicit treatment of potassium iodide in the rule would artificially exaggerate its importance and efficacy in an emergency situation . Its inclusion in the rule could be construed as an indication that the NRC has concluded that potassium iodide should be administered in an emergency, but either lacked authority to require its use, or chose to make the rule language ambiguous due to some unstated concern . These perceptions, whether or not founded in fact, could lead to nonconservative decisions by members of the public in choosing not to evacuate when ordered based on an assumption that potassium iodide would provide adequate protection; it could also lead to unnecessary use of or public panic to obtain potassium iodide (whether or not it would be of value) in the event of a plant emergency or a perceived emergency. In short, the explicit mention of potassium iodide in the rule would provide de facto NRC endorsement of its use even though the Commission has repeatedly failed to reach consensus with this policy.. The resulting national prominence given to potassium iodide could have unintended negative consequences. Therefore, inclusion of the proposed language in the rule SEP 13 199

                                                           ~cknowledged by card ........ .......- . -

U.S. NUCLEAR REGULATORY COMMISSI01 RUlEMAKINGS &ADJUDICATIO SSTAFF OFFICE O lHE i\R OFTHE SSION Po C Add'ICopies Spec! I . .

would not be good public policy. In the near future the Nuclear Energy Institute, on behalf of the nuclear industry, will be submitting comments on the proposed rule and urging that it not be adopted. Consumers Energy has reviewed those comments, and hereby endorses them. In addition, by letter dated August 20, 1999, the State of Michigan commented on the proposed rule and recommended that it not be ad opted . Consumers Energy also endorses those comments.

DOC F.:TEO If J' NU CL EAR ENE RGY INST IT UT E

                                                          *99 SU' -3 A8 :56 Lynnette Hendricks DIRECTOR, PLANT SUPPORT o:r                            NUCLEAR GENERATION n._ .

ADJ, - September 1, 1999 DOCKET NUMBER Secretary of the Commission PROPOSED RULE.PR 50 U.S. Nuclear Regulatory Commission ( t,,l/ FR3/7 37) Mail Stop 0-16 CI Washington, DC 20555-0001 ATTENTION: Rulemakings and Adjudications Staff

SUBJECT:

Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Fed. Reg. 3173-June 17, 1999) Request for Comments The Nuclear Energy Institute (NEI) submits these comments on behalf of the nuclear energy industry. We have reviewed the proposed rulemaking to amend the emergency planning standard in 10 CFR 50.47 (64 Fed. Reg. 31737- June 17, 1999). The proposed petition recommends that the planning standard for protective actions require explicit consideration of the prophylactic use of potassium iodide (KI) for the general public .

• The industry strongly urges the NRC to deny the petition. U.S. programs are built on the premise that evacuation is generally feasible and is more effective at dose reduction because it reduces dose to all organs, not just the thyroid. The proposed rule fails to provide any new evidence that stockpiling or predistribution of potassium iodide as a protective action will add significant public health and safety benefit to the adequate level of protection currently provided by existing emergency planning at and around commercial nuclear power plants. Furthermore, guidance is already available for states and local governments that wish to make KI available to the general public if they feel it is appropriate.

To date, the Nuclear Regulatory Commission has established itself as a conscientious regulator of emergency preparedness. In the past NRC has utilized reasonable scientific analysis and risk-informed approaches. The use and application of KI as a thyroid blocking agent in a radiation emergency has been debated for almost 20 years, including: policy and technical considerations, cost/benefit, implications of Chernobyl experiences, source term work, distribution SEP 13 1991-

                                                                ~cknowtACIQed by card ~..................., ..~

I 776 I STREET NW SUITE 400 WASHINGTON, DC 20006-3708 PHONE 202 739.8000 FAX 202 785 4019

U.S NUCLEAR REGUlATO YCOMM!SSlv,~ RULEMAK GS &ADJUDICATIONS STAFF-ACE 'FHE SECRETARY OFTHEvvmMN:JO!O 1 tistic

         - - - -#7)

Secretary of the Commission September 1, 1999 Page 2 and timeliness, and industry experience. The recent approval of the petition as proposed is not based on scientific or safety evidence contained in the exhaustive policy and technical reviews performed over the past 20 years. The industry agrees with the stipulation in the proposed rule that the state and local authorities should make the determination regarding stockpiling and distribution of KI. The cost of purchasing and development of plans and procedures should not be the burden of the nuclear industry. KI would not meet tests contained in the backfit rule. Enclosed is "Review of U.S. Policy on KI," supporting the recommendation to deny the rule. We appreciate the opportunity to comment on the proposed rulemaking. If you would like to discuss our comments further, please do not hesitate to contact

• me at (202) 739-8109 or Alan Nelson at (202) 739-8110 or by e-mail (apn@nei.org).

Sincerely,

  ~~

Lynnette Hendricks LH/APN/tnb Enclosure

Review of U.S. Policy on KI The NRC decided in September 1990, to reconsider the existing federal policy on use of potassium iodide. The NRC's decision was prompted by a request for the establishment of a national stockpile program by the American Thyroid Association in September 1989. In October 1995, the subcommittee of the inter-agency Federal Radiological Preparedness Coordinating Committee reaffirmed its position of not advocating widespread stockpiling and distribution of KI for the general public. In June 1997, Commissioners voted (3-2) to support FRPCC's recommendation. Following is a discussion of the key points relevant to consideration of the petitioner's request. Potassium iodide can be effective in protecting the thyroid gland from radiation dose due to inhaled radioactive iodine during an accident. It accomplishes this by blocking" the thyroid with a large amount of stable (nonradioactive) iodine. But the pills must be taken shortly before or within several hours after the exposure to the radioactive iodine. Any large release, which is highly improbable, from a nuclear power plant would also include other radioactive elements for which KI would not offer protection. Risk due to thyroid dose is of significantly less concern relative to the risk associated with external radiation from noble gases. The population at risk are children through age fifteen. In this regard, most emergency plans suggest precautionary evacuation of schools and day care facilities at the "Site Area Emergency." Under these conditions there is no imminent release of radioactive material that will exceed EPA Protective Action Guidelines beyond the site boundary. Therefore, there should be no health and safety concerns. One of the major impediments with distribution of KI to school children is coordination and administration of the program, e.g., the actual decision making process to administer KI or evacuate, parental approval and record keeping, identification and documenting allergic reactions, and the availability of a qualified medical professional to administer the potassium iodide. The relationship between events at Chernobyl and the European community's state of emergency preparedness, when reviewed carefully, are found not to be applicable to the U.S. situation. NUREG -1251 , April 1989, reexamined the use of potassium iodide for the public around United States (U.S.) nuclear power facilities based on the Chernobyl experience. The assessment states, "[f]or members of the general public, however, these conditions [exposure to releases over an extended period] generally are not applicable, because evacuation is generally feasible and when carried out, is more effective in dose reduction than administration of KI, since it can reduce the dose for all body organs and not merely the thyroid gland. Because of these considerations, the policy statement concludes that a nationwide requirement for predistribution or stockpiling for use by the general public would

not be worth while. It further concludes that the decision to use KI should be made by the States and, if appropriate, local authorities on a site-specific basis. The apparently successful use of KI at Pripyat does not alter the validity of guidance that recognizes that evacuation of the general public in an affected area could result in a greater overall dose reduction." The fact that KI distribution is a fairly common practice in Europe is not a valid reason for changing the current policy in the U.S. There are significant differences in the level of U.S. and European emergency preparedness (e. g. , organization, training facilities, equipment, and regulatory oversight). Review of these preparedness programs indicates KI would be of less benefit in the U.S. due to the additional protective features (defense in depth) in our preparedness programs. The current "Federal Policy on Distribution of Potassium Iodide for Use as Thyroidal Blocking Agent" provides sufficient guidance to state and local governments that, within the limits of their authority, should consider FRPCC recommendations in the development of emergency plans in determining appropriate actions to protect the general public. In summary, several re-evaluations of U.S. policy on distribution of KI since the 1985 federal policy lead to the conclusion that the current policy is sound and will provide adequate protection of public health. The safety record of the U.S. commercial nuclear power program and demonstrated strength of its current emergency preparedness programs support those conclusions. The industry strongly urges the NRC to deny the proposed amended petition and to retain the current policy as providing adequate protection of public health and safety.

DOCKET NUMBER PROPOSED RULE PR So ( {pl/F/<317 3 7

                                                                                                    *99  AUG 30 A8 :11 August 24, 1999
                                                                                                ~-~9-0172 A SCANA COMPANY                                                     ")

• I PJ~1 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555 Attention: Rulemakings and Adjudications Staff Gentlemen:

aylor

Subject:

VIRGIL C. SUMMER NUCLEAR STATION V, .~en/ DOCKET NO. 50/395 Nuclear Operations OPERATING LICENSE NO. NPF-12 Proposed Rule: CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS (64 FED. REG. 31737, JUNE 14, 1999) REQUEST FOR COMMENTS South Carolina Electric and Gas submits these comments on behalf of South Carolina Electric and Gas (SCE&G). We have reviewed the proposed rulemaking to amend the emergency planning standard in 10 CFR 50.47 (64 Fed. Reg. 31737 - June 14, 1999). The proposed petition recommends that the planning standard for protective actions South Carolina Electric & Gos Co require explicit consideration of the prophylactic use of potassium iodide (Kl) for the Virgil C. Summer Nuclear Station general public. P. 0. Box 88 J ., South Carolina Stockpiling or predistribution of Kl as a protective action will not add any significant public health and safety benefit to the adequate level of protection currently provided by existing emergency planning at and around commercial nuclear power plants. 803.345.4344 SCE&G urges the NRC to reconsider its proposed rule. 803.34 5.5209 www.scono.com SCE&G has given thorough consideration to the use of Kl for the general public during an emergency. SCE&G maintains that evacuation and sheltering are the primary protective actions and are the best means to assure public health and safety in the unlikely event of a general emergency with a significant radiological release at a nuclear power plant. It is understood that if administered promptly, Kl can be effective in blocking the thyroid and preventing radioiodine uptakes. The population most at risk in the situation is children through age 15. However, emergency plans recommend precautionary evacuation of schools and day care facilities at declaration of a Sire Area Emergency. Under these conditions, there is no imminent release of radioactive material that will exceed EPA Protective Action Guidelines beyond the site boundary. If children are evacuated, there is no opportunity to further reduce risk through distribution of potassium iodide. SEP

• 2 19S

                                                                                     ~cknowledged by card ... .. fl  I   -~

NUCLEAR EXCELLENCE - A SUMMER TRADITION!

U.S. UCLEARREGULATORY COMl,USSION RlJLEMAKINGS &ADJ~ STAFF OFFICE O 'fHE SECRETARY OF THE COMM155ION Post C . A s

Secretary of the Commission PR 990011 RC-99-0172 Page 2 of 2 Events and circumstances that would make evacuation difficult would also hinder the distribution of Kl to the public, even from a locally stored stockpile. This would also have a negative effect of putting limited emergency response workers, who would have the added responsibility for the distribution of the drug to the public, at even greater risk through unnecessary additional exposure. Therefore, a stockpile of Kl is not effective as an immediate and supplemental measure of protection. Predistribution of Kl, through over the counter availability of the drug, as suggested, will also have negative effects. Public perception could easily regard taking a pill makes them immune to the effects of radiation. This perception would tend to make the public less sensitive to the need to evacuate. Evacuation, the only true mechanism of protection from exposure to all radioactive isotopes, would become even more difficult and thereby less effective. There may also be associated time delays to evacuation time estimates due to the self-administering of Kl at home. Delays in evacuation could mean the difference between personal and vehicular contamination and would contribute to the spread any resultant loose surface contamination. A major impediment to Kl distribution to school children is coordination and administration of the program, e.g., the actual decision-making process to administer Kl or evacuate, parental approval and record keeping, identification and mitigation of allergic reactions, and the availability of a qualified medical professional to administer the potassium iodide. The US federal agencies, nuclear industry, state and local emergency response organizations have developed the most effective and sophisticated emergency preparedness plans in the world. The US model recognizes that evacuating an area is the most effective response for protecting the public health and safety. Where evacuations are performed, potassium iodide would not add any measure of safety to this proven approach, and could actually complicate and hinder emergency response. Should you have questions, please call Mr. Ricky Myers at (803) 345-4384. RAM/GJT/dr c: J. L. Skolds W. F. Conway R.R. Mahan R. J. White K. R. Cotton NSRC RTS (PR 990011) File (811.02; 50.083) DMS (RC-99-0172)

DOCKET NUMBER R PROPOSED RULE .P so OOCl,ETED US.,RC t,,t./ F'R3I731

                                                                          *99   AUG 26 P3 :51 30 North Prospect St.                                                  Ohl RU'  I Groton, CT 06340                                                        ADJU[

August 21 , 1999 U.S. Nuclear Regulatory Commission Attn: Rule Making and Adjudication Staff One White Flint North 11555 Rockville Pike Rockville, MD 20852

Dear Sir or Madam:

I am writing in regard to the Nuclear Regulatory Commission document entitled Consideration of Potassium Iodide in Emergency Planning. Currently, in Connecticut Potassium Iodide is unavailable for public use in the event of a nuclear emergency. I support the availability of Potassium Iodide in states, such as ours, which have nuclear power stations. Sincerely,

~~

Patrice Granatosky f c 1999

                                                              ~cknowfedged by card *--*----~

   -* n tl:iULATOAY COMMISSJO '

, AKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETAR OFTHE ISSI D

STATE OF MICHIGAN 4000 COLLINS ROAD P.O. BOX 30636 JOHN ENGLER, Qoverno r *99 Al lJ N22f*1>0~§1l6 DEPARTMENT OF STATE POLICE COL. MICHAEL D. ROBINSON. Director August 20, 1999 DOCKET UMBER Secretary of the Commission PROPOSED RULE SO Attention: Rulemakings and Adjudications Staff (lr!F~31737) U. S. Nuclear Regulatory Commission Washington, DC 20555 Re: 10 CFR 50 RIN 3150-AGl 1 Consideration of Potassium Iodide in Emergency Plans

Dear Secretary:

The Michigan State Police, Emergency Management Division is the agency charged with the responsibility for emergency planning and response to nuclear power plant accidents in Michigan. It is our conclusion that this proposed amendment of emergency planning regulations governing domestic licensing of production and utilization facilities is 1) not necessary, and 2) potentially confusing to the public. First, states have always had the option of offering potassium iodide to the general public. It is the policy and intent of the State of Michigan to evacuate the public immediately upon recognition that a nuclear power plant has declared a General Emergency or whenever radiological dose analysis indicates that a population will receive any dose in excess of Environmental Protection Agency Protective Action Guides . Thus, issuance of potassium iodide is unnecessary. Second, the effects and benefits of potassium iodide are not well understood by the general public. Our considered judgement leads us to conclude that some individuals may elect to remain in an affected area under the erroneous assumption that potassium iodide will protect them from radiation in general. Given this potentiality, we believe that the issuance of potassium iodide to the general public may add confusion to a hazard that is already not well understood. In our view, the existing NUREG 1633 provides appropriate guidance related to the use of potassium iodide as a protective measure during a radiological emergency. Further proposed modification adds an additional layer of unneeded regulation and may further confuse the public. Based on these items, the State of Michigan recommends that the proposed amendment not be approved. Sincerely, Daniel M. Sibo, AICP Preparedness Section Manager A PROUD tradition of SERVICE through EXCELLENCE, INTEGRITY, and COURTESY. oa PfUHTEOON AECY0..£0,.APt.R

From: "Ken Owen" <kenowen@eowen.com> To: TWFN_DO.twf2_po(NRCWEB) Date: Fri, Aug 20, 1999 10:44 AM *99 AU, ? p 1 .

Subject:

Comment on Consideration of Potassium Iodide in Emergency ra ning' .S 0 Currently, in Connecticut Kl is unavailable for public use in the event f a,,nuclear emergency. support the availability of Kl in states, such as ours, which have nucle.a~69,wer stations. AUJ[), F Ken Owen Director People's Action for Clean Energy Box 310 Canton, CT 06019 email: kenowen@pace-cleanenergy.org Q' 2 81999-

                                                               ~cknow!edged by card .................... **"",.,."

u. - R ULATORY COMMISSION G A SSTAFF E y C

f August 20, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ~ /2.A I }.A "'j r-' ADM, DAS ~-7!--../

SUBJECT:

DOCKETING OF COMMENT ON PROPOSED RULE - CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Attached for docketing is a comment letter related to the subject proposed rule. This comment was received via e-mail August 20, 1999. The submitter's name is Ken Owen, Director, People's Action for Clean Energy, Box 310, Canton, CT 06019. Please send a copy of the docketed comment to Mike Jamgochian (mail stop O 1 lF-1) for his records.

Attachment:

As stated cc w/o attachment:

• M. Jamgochian

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                                           '99 AUG 20 P2 :52 August 18, 1999 0

I Al, VIRGINIA POWER GL99-038 DOCKE NUMBER Secretary of the Commission PROPOSED RULE 5 () U.S. Nuclear Regulatory Commission '14FR31131) Washington, D.C. 20555 Attn: Rulemakings and Adjudications Staff 10 CFR PART 50; CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS Virginia Power appreciates the opportunity to comment on the NRC's proposed amendment to its emergency planning regulations that would require that consideration be given to including potassium iodide (Kl) , as a protective measure for the general public that would supplement sheltering and evaluation. Notice of the proposed rule was published in the Federal Register (Vol. 64, No. 113) on Monday, June 14, 1999. Virginia Power previously provided comments on this issue. Our position remains the same. A copy of our February 13, 1996, letter is attached for your convenience. If you need further information, please contact either: Bill Renz Bill_Renz@vapower.com or (804) 273-3142 Gwen Newman Gwen_Newman@vapower.com or (804) 273-4255 Respectfully,

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O(X) Dominion Bouk't'llrd Glen Allen. \ 'iTRillia 23fX>(J February 13, 1996 Secretary U. 5. Nuclear Regulatory Commission Washington, DC 20555-0001 NL&OS/EJL VIRGINIA POWER Serial No. GL 95-083 Attn

Docketing and Services Branch

Dear Sir:

10 CFR PART 50 PETER G. CRANE RECEIPT OF PETITION FOR RULEMAKING FEDERAL REGISTER/ Vol. 60, No. 227 / NOVEMBER 27, 1995 / p. 58256 This letter provides Virginia Power's comments regarding the subject petition for rulemaking filed by Mr. Peter G. Crane. The petitioner has requested that the Nuclear Regulatory Commission (NRC) amend its regulations concerning emergency planning corrective actions to include the prophylactic use of potassium iodide (Kl). The request would amend one of the 16 planning standards in 10 CFR 50.47 by which licensee emergency plans are evaluated in order to assure that the option of using potassium iodide is included in emergency planning. We disagree with the petitioner, and respectfully recommend that the NRC deny the petition. We believe that a federal requirement to stockpile Kl will not significantly increase the level of protection of the public's health and safety that is currently provided

• through existing regulation. Our reasons for recommending denying the petition follow:
• Kl is an effective thyroid blocking agent QD.)¥ when administered immediately before or after an exposure to radioactive iodine (that is, within one or two hours).

It would be extremely difficult to distribute Kl in a timely fashion to members of the general public following an accident, particularly during implementation of evacuation or residential sheltering.

• The Environmental Protection Agency's Manual of Protective Action Guides and protective Actions for Nuclear Incidents (EPA-400) recommends evacuation and sheltering as preferred alternatives to thyroid blocking for most situations.

Evacuation and sheltering are preferred because they provide protection for the whole body, not just the thyroid gland, and avoid the risk of misapplication of Kl.

• The Federal Emergency Management Agency has published the Federal Policy on the Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroid Blocking Agent. The policy recommends the stockpiling of Kl and distribution during emergencies to emergency workers and institutionalized persons. However, the policy does not recommend requiring stockpiling or

Peter G. Crane, Petition for Rulemaking Serial No. GL 95-083 page2 of3 distribution to the general public. The policy goes on to recognize that options on the distribution and use of Kl rests with the States, and permits State and local governments to take measures beyond those recommended or required nationally.

• The Virginia State Emergency Response Plan contains specific provisions regarding the procurement, storage, and use of Kl. The Kl options have been specifically considered by the State and are addressed by the Plan. The Plan stipulates that

                -Kl tabJets be available for local and State emergency workers
                -The responsibility for the care of institutionalized persons includes the utilization of Kl
                -Supplies of Kl are not available for the general public.

Virginia has already achieved the objective of the petitioner, that is, the State and local governments have considered and provided for the use of Kl. We believe that this is generally true for the other States with commercial nuclear power plants. The petitioner has not provided any compelling reasons why additional federal requirements are needed or how they would benefit the health and safety of the public. Finally, we fully endorse the comments sent separately to the NRC by the Nuclear Energy Institute. We appreciate the opportunity to provide comments on this petition for rulemaking .

• Very truly yours, JN_g~

M. L. Bowling, Manager Nuclear Licensing & Programs

Peter G. Crane, Petition for Rulemaking Serial No. GL 95-083 page3 of 3 cc: Mr. Alan Nelson Project Manager, Radiological Protection, Emergency Preparedness, and Waste Regulation Department Technical/Regulatory Division Nuclear Energy Institute 17761 Street N.W. Suite 400 Washington, DC 20006-3708 Mr. Les Foldesi Bureau of Radiological Health

• Room 104A 1500 East Main Street Richmond, Virginia 23219

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Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, MD 20815 I 301-656-3998 I -email:* pgcrane@erols.com August 17, 1999 *99 ~UG 19 P4 :Q 7 Ms. Annette Vietti-Cook, Secretary Q II U.S. Nuclear Regulatory Commission r.. _ Washington, D.C. 20555 AO,.). Re: PRM-50-63, -63A (Potassium Iodide in Emergency Plans)

Dear Ms. Vietti-Cook:

Summary: The June 14 notice of proposed rulemaking, though its analysis is a vast improvement over the NRC's hastily withdrawn 1998 study of KI, NUREG-1633, nevertheless reaches a conclusion that fails to ensure adequate protection of America's children. There is no good reason why children in the United States should continue to be denied a protection that most governments in the developed world, including nations as impoverished as Armenia, would not consider denying to their children. The Commission's plan to support development of regional KI stockpiles rather than stockpiles close to nuclear plants, and to bring the KI to the scene of an accident by "fighter jet" or otherwise, is a guarantee of delay in administering a drug conceded by all to be time-critical. It is also a guarantee of inadequate pre-planning. The Commission's claim to have granted my amended petition cannot be reconciled with what it actually did, which fell far short of what I proposed. Having declined to adopt the alternative that I offered in my

• amended petition, the Commission should now grant the petition as originally submitted, and require KI stockpiling to be a part of each emergency plan, just as it promised to do in 1979.

I. Introduction The NRC's June 14, 1999, notice of proposed rulemaking on potassium iodide (Kl) includes much that deserves commendation, especially when it is compared to NUREG-1633, the NRC staffs 1998 assessment of potassium iodide. Its overall intent is plainly to inform rather than to mislead the interested public. It goes methodically through the arguments that have been raised against KI and shows that some are invalid altogether, while others describe problems that are readily soluble; it does not exaggerate difficulties to make them appear insuperable. Finally, it offers what is in general a fair and intellectually honest technical analysis, not propaganda

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masquerading as science. In all these ways, the June 1999 notice is in welcome contrast to NUREG-1633, which the Commissioners ordered withdrawn in September 1998 after they were made aware of its distortions and biases by comments from, among others, the health departments of New York State and Ohio. 1 Anyone who reads the June 1999 notice ofrulemaking and NUREG-1633 side by side may find it hard to believe that the same agency produced both. It would be a pleasure to be able to end these comments here, with a ringing endorsement of the June 1999 notice and praise for Mr. Michael Jamgochian of the NRC staff (he is listed as contact person on the rulemaking) and anyone else who may have helped to write it Regrettably, however, the notice also contains much that is ill-advised; for this, the Commissioners themselves are to blame. The outcome described in the notice represents a major retreat from the position espoused by the Commission as recently as September 1998, and constitutes a rejection not only of the original petition of 1995 but also of the alternative approach offered in the amended petition of 1997. To explain, it may be helpful to some readers to review how the NRC arrived at where it is today with respect to the KI petition. I will omit the history of the NRC's handling (or mishandling) of the KI issue between 1979 and 1989; it may be found, however, in the paper I gave at a conference on radiation and thyroid cancer at Cambridge University in 1998. This paper is available on the NRC rulemaking website, among the comments on the petition, and in book form, in the recently published Radiation and Thyroid Cancer, a selection of papers given at that conference. 1 The authors ofNUREG-1633 responded to the Commissioners' repudiation ofth'e document by doing their best to paper over the fact that it had occurred. (This was in a sense appropriate; a principal criticism of the document was its penchant for mischaracterizing or omitting facts that did not suit the authors' z;eal to portray KI in a bad light.) Thus the Federal Register notice announcing the withdrawal of the docume.nt gave the impression that it was merely being revised in accordance with helpful comments from the public. It was left to Commissioner McGaffigan, at the December 7, 1998, meeting of the "KI Core Group," to make the point that NUREG-163 3 had been withdrawn, and withdrawn for cause.

II. Background A. The "Differing Professional Opinion" In June 1989, in my capacity as an NRC employee, I filed a "differing professional opinion" asking for a change in agency policy on Kl. I asserted that (a) new information since , Chernobyl made such a change desirable, and (b) in any case, the existing 1985 policy was defective from the start, as it was based on inaccurate, misleading information provided to the Commissioners and the public by the NRC staff in November 1983. 2 The matter dragged its way through the NRC, ultimately leading to a staff recommendation, early in 1994, that the Commission change its policy and declare KI a "reasonable and prudent measure. The staff commented that the cost of a comprehensive KI program, which it put at several hundred thousand dollars at the most, was probably less than the cost of continuing to study the issue. However, in the spring of 1994 the Commissioners divided 2-2 on the staff's recommendation, l and under NRC practice, this was interpreted as a rejection of any change in the status quo. NRC procedures also provide that where a proposal fails by a tie vote, the matter can be brought back to the Commission when the circumstances that produced the tie change (e.g., by the arrival of a new Commissioner). For some reason, that did not happen in this case, and I was formally advised, a few weeks after the Commission's vote, that agency action on my differing professional opinion was at an end. 2 Raising the latter point was probably a tactical error, as it called for the NRC staff to admit that NRC staff members provided incomplete and misleading information at the November 1983 briefing - for example, by failing to mention that accidental releases of radioiodines can cause thyroid cancer, and that the principal purpose of KI is to prevent those cancers. I should probably have realized that the NRC, not unlike many other organiz.ations, has extreme difficulty admitting error, especially willful error. Though the charge that the NRC staff misinformed the Commissioners and the public has been before the NRC repeatedly in the intervening decade, the NRC has steadfastly declined to state or even ascertain whether it is accurate. (Commissioner McGa:ffigan asked the staff, at a December 1997 Commission meeting on KI, whether the charge ofmisint:_ormation was correct; the staff professed not to~'have an.answer.") As of today, if a judge of the Court of Appeals were to ask the NRC's attorney at oral argument whether the accusation is true, he or she would be unable to answer yes or no. Ten years is a long time to let so serious a charge go unexamined and therefore unrebutted.

B. Petition for rulemaking Having spent the years between 1989 and 1994 pursuing the KI issue through NRC channels with nothing to show for it -- not even a decision. articulating why the status quo should be maintained -- I resolved that if I raised the issue again, it would be in a form that would yield a decision reviewable in the Court of Appeals. In 1995, this time in my private capacity, I prepared a petition for rulemaking and filed it with the NRC. 3 It asked for a change in the NRC's emergency planning rules to specify that the "range of protective actions" that must be provided for in an emergency plan include evacuation, sheltering, and the use of potassium iodide. 4 Given that the NRC staff had prepared analyses of the KI issue just the previous year, I optimistically imagined that it would take only weeks for the NRC staff to make the necessary revisions in its 1994 decision paper and resubmit it to the Commission. I had not reckoned with the depth of opposition to KI stockpiling within parts of the NRC staff, or with the power of the bureaucracy to use delay as a weapon. C. Request to FEMA Soon after submitting the rulemaking petition, I wrote to the Director of the Federal Emergency Management Agency (FEMA), James Lee Witt, pointing out the deficiencies in U.S. 3 The NRC deserves considerable credit for tolerating with good grace a campaign of this kind by an NRC employee. In the summer of 1998, I made a similar comment in the course of a talk before an international conference on radiation and thyroid cancer at Cambridge University in England. Several attendees commented afterwards how impressed they were that I was still employed, for public dissent of this type by a government employee would be unthinkable in their own countries. This was, one said to me, "proof of the strength of American democratic institutions." 4 Long ago, when emergency planning was a heated issue in nuclear power plant licensing cases, intervenor groups would sometimes argue that evacuation from a given site was impossible. At the time, the NRC's position was that evacuation was not essential, and that sheltering was often a more desirable response. In my 1995 petition, I made the point that whenever people are sheltered in the vicinity of a nuclear power plant during an accident, it makes sense that they have the additional protection of po1;assium iodide. In 1996, the NRC staff revised its emergency planning guidance to declare that whatever positive things might have been said about sheltering in the past, it was now clear that evacuation was always the preferred alternative.

policy on KI, and attaching my petition for rulemaking. 5 FEMA proved to be as vigorous in its response as the NRC had been sluggish. Director Witt quickly reconstituted the Ad Hoc Subcommittee on KI of the Federal Radiological Preparedness Coordinating Committee (FRPCC), under an admirable public servant, William McNutt, and gave it the rulemaking

• petition to study. Mr. McNutt convened a public meeting of the KI Subcommittee a few months later, in June 1996. All shades of opinion were represented, and members of the public in attendance were free to speak. The Nuclear Energy Institute, at least one nuclear utility, and a number of state agencies sent representatives. Public interest groups also were at the table, as was Dr. Jan Wolff of the National Institutes of Health. From the floor, Dr. Jacob Robbins, Scientist Emeritus at NIH and a world-famous expert on thyroid cancer, spoke with quiet force on behalf of the American Thyroid Association.

The result of the Subcommittee's deliberations, in October 1996, was a unanimous recommendation, later adopted by the full FRPCC, that the federal government purchase stockpiles of KI for any state that wanted it. 6 All but one of the members of the Ad Hoc Subcommittee reportedly wanted to go further, with a plan to create regional stockpiles for states that had no supplies of the drug, but the uncompromising opposition of the NRC representative scuttled this proposal. On July 1, '1997, the NRC issued a press release announcing its support for the proposed new federal policy, and declared, "The NRC will provide the funding." 7 Several states thereupon began studying whether to avail themselves of the offer. 5 FEMA chairs the Federal Radiological Preparedness Coordinating Committee (FRPCC), which is responsible for overall federal policy on radiological emergency preparedness.* Seventeen federal agencies belong to it. 6 The Subcommittee's recommendations also included a vain plea to the NRC to act expeditiously on the petition for rulemaking, submitted more than a year earlier. 7 The June 14 notice did not mention the July 1, 1997, press release, and strongly implied that the NRC never went beyond suggesting that it would,~probably" supply funds for state stockpiles of KI. This was the wishful thinking of a Commission majority in denial. The press release can be viewed on the NRC's Internet website, www.nrc.gov.

D. The revised rulemak.ing petition The Commission at length turned to my rulemaking petition. In November, 1997, approximately 2 1/2 years after the petition was filed, the NRC held a lengthy meeting, in open session, to discuss KI. 8 In advance of it, the American Thyroid Association asked whether Dr. Robbins, the NIH Scientist Emeritus who had spoken at the FEMA meeting the year before, could address *the Commission for 15 minutes. The Commission turned down the request, apparently preferring to rely for medical expertise on the non-physicians of the NRC staff. 9 Dr. Robbins, who has treated and studied radiation-caused thyroid cancer from the Marshall Islands to the former Soviet Union, and whose views are sought all over the world, sat in the audience, a silent spectator. At that meeting, I was asked by then Chairman Jackson what I "really" wanted. Believing that I did not have the necessary three votes to secure approval of the petition as it then stood, I offered, as a compromise, what amounted to an alternative means of meeting the petition's request. 10 I said that instead of requiring Kl stockpiling at the state level, I would accept a requirement that KI be "considered" in state emergency plans, provided that this was linked to an unequivocal declaration that stockpiling was a "reasonable and prudent" measure, 8 The meeting was notable for the NRC staffs apologizing for having "misrepresented"

• FEMA' s position at a critical juncture in the consideration of KI. At the time in question, it had been the NRC staff itself, not FEMA, opposing any change in the 1985 federal policy on KI.

9The Commission would later learn, after receiving comments on NUREG-1633, that the staff's medical knowledge turned out to consist in large part of an outdated copy of the "Physician's Desk Reference," cited selectively and out of context. For example, ominous warnings in NUREG-1633 on the side effects of KI turned out to be quotations not from the

 , PD R's description of over-the-counter KI pills for thyroid protection, but from the description of a different, prescription-only drug, used for certain pulmonary diseases, that contains KI in a form orders of magnitude more concentrated. The ordinary reader would have had no reason to suspect that the warnings did not pertain to the drug that was the subject ofNUREG-1633. The same document neglected to mention, anywhere in its 40 pages, that as long ago as 1978, the Food and Drug Administration found KI for thyroid protection to be "safe and effective."

10 I was careful not to withdraw the original petitiqn, as I explained to Mr. Jamgochian of the NRC staff, who at the request of his management called me to ask for clarification of that point. I have no doubt that he would confirm this. It will be noted that the June 14 notice makes no claim that the original petition was withdrawn.

recommended by the NRC. I explained that when these elements were combined with the offep of federally funded KI -- at that time a settled matter, to all appearances -- it was hard to imagine that any rational state would reject the drug. Chairman Jackson, seemingly eager for a rapid resolution of the petition, asked me to submit an appropriately amended petition within seven days, and I did so, complete with a draft Federal Register notice. (As with my other KI work, this was written at home, on my own time.) This amended petition then languished before the NRC for the next 16 months. E. The Commission reverses itself on state stockpiles of KI In September 1998, the Commission approved and sent to FEMA a draft Federal Register notice that would have given details of the Government's new KI policy, including the commitment to federal funding of state stockpiles. The following month, however, a new appointee to the Commission, Jeffrey S. Merrifield, took office. Only weeks later, the junior Commissioner wrote, to his colleagues that he would not have approved the NRC' s decision on KI policy if he had been a member of the Commission at the time, and he therefore proposed to undo it. The result was a 3-2 decision, announced in April 1999 in a "staff requirements memorandum" and a press release, that declared that the Commission (1) no longer approved Federal support for state stockpiles; (2) no longer supported the draft Federal Register notice it

• had sent to FEMA seven months before; (3) favored federal funding of regional stockpiles, preferably p.ud for by FEMA, but with NRC funding a possible last resort; and (4) offered assistance to FEMA in drafting legislation to obtain funding and authority to buy KI, if legislation were necessary. Commissioner McGa:ffigan, who along with Commissioner Diaz voted to stand by existing policy, warned in vain that a Commission that touted "Consistency" as one of its "Principles of Good Regulation" should not lightly repudiate a position so recently reaffirmed.

One might expect that the Commission majority, before wreaking havoc on an interagency federal policy developed under FEMA's leadership over the course of more than three years, would have secured that agency's approval, or at the very least informed it. But the Commission majority, like a novice driver who forgets that there are other vehicles on the road,

made its abrupt U-turn seemingly without a moment's thought to the effect on FEMA and the FRPCC. "Those rascals," a FEMA official commented to the New York Times. A few days later, the Commission received a strongly worded letter fr6m FEMA Director Witt which said that the NRC approach would impair safety, not improve it, and that the NRC should fulfill its-often-repeated commitment to fund state stockpiles of KI. Apparently familiar with the NRC's not infrequent memory lapses regarding Kl, Director Witt attached some ten documents in which the NRC or its representatives had reiterated this commitment. 11 Director Witt's letter also made clear that the first notice he had received of the NRC's reversal came from reading the New York Times. It similarly does not seem to have occurred to the Commission that states such as Ohio, which in reliance on the NRC press release of July 1, 1997, had invested resources deciding whether to accept the o~er of Kl, might also have an interest worth taldng into account. A surprised and dismayed representative of the Ohio Health Department told the press that all that state's planning had been premised on the Commission's pledge to provide KI on request. III. The June 14, 1999, notice of proposed rulemaking As noted at the outset, the June 14, 1999, notice is praiseworthy in many respects. The problems with the document are virtually all attributable to the three Commissioners of the majority. Briefly, these problems are as follows:

1. Withdrawing federal funding of state stockpiles The most striking aspect of the Commission's decision is that it withdrew the promise of NRC funding of state stockpiles of Kl, which the NRC had,explicitly set forth in its press release of July 1, 1997. As of today, the Commission is opposed to any federal funding of state

              \.

stockpiles, whether by the NRC or any other agency. How, it may be asked, did the Commission deal with the July 1, 1997, press release? It

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11 Director Witt seems also to have formed an ophri~n on the NRC's timeliness on matters relating to KL He asked for a reply within one month of the date of his letter. The NRC missed the date by several weeks.

dealt with it by not mentioning it, consigning it to the Orwellian "Memory Hole" for facts that have become inconvenient, in the same way that NUREG-1633 failed to mention the FDA finding that KI is "safe and effective." 12 How might the NRC have handled it? One possibility would have been to declare frankly that the Commission had changed its mind. Alternatively, it might have declared that the July 1, 1997, press release was issued in error, and failed to reflect the Commission's real views. But the NRC did neither. Instead, it chose to offer an account that gamely tried to wish a central fact out of existence. In a free society, this is *rarely a viable approach. The June 14 notice shows the Commission's eagerness to portray its decision as based not upon caprice or the politics of the moment but upon some principle, however tenuous. Toward that end, it cited a statement from a 1980 rulemaking notice which said that any direct funding of states for emergency planning '"would come through FEMA." This is all well and good, but if that statement was a sufficient basis for the Commission (including then Chairman Jackson) to withdraw the offer of NRC funding in 1999, why did it not deter the Commission (including then Chairman Jackson) from making the offer in the first place, just two years earlier? The Commission is making excuses, and any reader can see it; the only surprise is that they are so patently feeble. Just as the Government's offer to pay for KI stockpiles sent a message that the drug was a sensible measure, the withdrawal of that offer sends a message that KI preparedness is not particularly important The NRC's reversal has already had pernicious effects. In budget-minded New Hampshire, which was considering whether to take up the NRC on its offer of KI, state officials promptly dropped plans to establish stockpiles. Instead, they said that they would seek to ensure that pharmacies near nuclear plants stocked the drug. A moment's reflection should make clear that this is a recipe for chaos. Imagine an accident occurring during school hours in the vicinity of the Seabrook plant in New Hampshire. As schools prepare to evacuate 12 Even the June 1, 1997, press release was not \tjthout its flaws. It announced the availability of KI to any state that wanted it, but neglected to mention that the purpose of KI is to prevent thyroid cancer in the event of a nuclear emergency. As I have pointed out elsewhere, this was like announcing the availability of Sabin vaccine without mentioning polio.

pupils (possibly through an atmosphere already contaminated with radioactive iodine), parents who keep KI in their medicine cabinets will be descending on the schools to find their children and give them the drug, while people without KI, instead of evacuating immediately, may be besieging local pharmacies. The Commission offers one more explanation for its reversal: that the cost of KI has doubled, and that the NRC's declining budget does not allow money to be "diverted to new initiatives." This contention also has its problems. First, it is questionable whether keeping a promise made two years earlier constitutes a "new initiative." Second, it appears that the NRC has exaggerated the estimated cost of KI, resolutely ignoring comments that pointed to the availability of inexpensive and long-lasting KI (six cents per pill, with a 10-year shelf life) from a Swedish pharmaceutical company located by th~ Ohio Department of Health. (Commissioner Diaz, in dissent, also observed that market forces were likely to bring down the domestic price of KI.) Third, even a casual review of the NRC's budget might reveal other areas where savings could be effected without thereby diminishing the safety of American children. Discretionary travel, international and domestic, is one such area. For example, the twelve members of the "KI Core Group" engaged in revising NUREG-1633 held a week-long meeting in Tempe, Arizona, at the beginning of March, 1999. The cost of that midwinter excursion might well have paid for enough KI to protect every child in New Hampshire . Does all this mean there were no reasons whatever for the Commission's action, which hinged on former Chairman Jackson's switching sides? Not necessarily. Anyone who follows the trade press might have suggested an explanation along the following lines: that in the latter half of 1998, the Senate committee that controls the NRC budget, at the prompting of the nuclear industry's lobbyists, threatened to cut the agency's budget by a third; that the NRC duly kowtowed; that the extreme budget cuts were thereby averted; that KI was part of the price the agency paid to keep its core safety programs from being affected; and that the Commission might_ rationalize its retreat by telling itself that it had embraced a lesser evil to avoid a greater one. Whether any such reasoning played a part in the decision is neither here nor there, however; the soundness of the decision must be judged by the rationale the Commission offered in its Federal Register notice.

2. Regional rather than state stockpiling The Commission's decision supports the creation of fede~y funded regional stockpiles rather than state stockpiles. This approach may have advantages for nuclear utilities, in that state stockpiling would increase the risk that the adequacy of emergency planning became an issue in proceedings for the renewal of operating licenses. For the public, however, and especially for children, it has numerous disadvantages.

The administration of KI is conceded by all to be time-critical; indeed, years ago one of the common objections to stockpiling KI was that in an emergency, it would never be possible to get it to people in time to do them any good. Today, the Commission.proposes that if an accident occurs, some period of time, presumably measured in hours, will be spent transporting the drug from a regional stockpile to the area where it is needed. It is not clear whether Commissioner Merrifield was speaking only for himself or for the Commission as a whole when he told the Keene Sentinel that "fighter jets" could bring the KI wherever it was needed. His views deserve special attention because ofliis leadership role, only weeks after taking office, in reversing a well-settled Commission decision, and proposing to reverse an equally well-settled interagency decision. The speed with which he cut the Gordian knot of KI may strike some readers as inconsistent with the explanation in the June 1999 notice that the reason if.has taken the Commission since 1984 to decide the KI issue was that it was:so difficult and complex. Ifwe nevertheless take the Commission's statement at face value, and successive Commissioners have really been racking their brains about KI for 15 years, then it is not too much to ask that such protracted deliberations yield a more realistic and mature solution than fighter jets zooming to the rescue. 13 For a moment, let us think in practical, real world terms. In an accident, the population at greatest risk will be children of school age and younger. If an accident takes place while school is in session, children close to the plant will presumably be evacuated - assuming, of course, that 13 In an op-ed piece in the Keene Sentinel. I made.the*point that by the same reasoning, the NRC could discontinue the requirement of emergency:sirens in the vicinity of nuclear power plants; instead, portable sirens could be kept at a few regional locations, and brought by fighter jet to the scene of any nuclear plant accident. Both KI and sirens must be employed quickly to be effective.

weather conditions make evacuation feasible. But evacuation is not always feasible, and even when it is possible, it is not risk-free; according to the 1992 EPA manual on.protective actions, vehicles provide minimal protection (about 10%) against,fJidiological exposure. Thus the issue is not evacuation versus Kl; rather, the issue is evacuation with Kl versus evacuation without Kl. In such a case, it makes sense for this time-critical medicine to be available nearby, in a local school, hospital, or fire,,station, not far away at some regional stockpile. This is not to say that regional stockpiles are worthless. Chernobyl showed how far from a nuclear accident radioiodines can cause thyroid cancer. In the unlikely event of a major accident at Indian Point that sent a plume of fallout toward New York City, evacuation would not be feasible. The same is true of an accident at Calvert Cliffs sending a plume toward W ~hington. In such a case, the only viable protective measure may be sheltering, and sheltering coupled with Kl will afford more protection that sheltering without Kl. For such eventualities, it makes sense that regional stockpiles exist. The children and grandchildren of NRC staff members would be among the beneficiaries. Regional stockpiling makes sense, however, not as a substitute for state stockpiles but as a supplement to them. The notion of the Commission majority that regioruµ stockpiles are an adequate alternative to state stockpiles is folly. FEMA, which understands the necessity both of having Kl nearby and of planning in advance for its use, was right to reject it out of hand. This brings ~ to the next point, the role of FEMA.

3. Role of FEMA The NRC's June 14 notice was a continuation of the decision announced in April, under which federal funding would go to regional, not to state, stockpiles, and would come from FEMA. The fact that FEMA Director Witt had skewered the idea in his letter of April 29 and categorically refused to go along with it was nowhere reflected in the notice. His letter became yet another item destined for oblivion in the NRC's "Memory Hole." The Commission majority seems to assume that FEMA and the other federal agencies will invariably bow to the NRC's Kl policy du jour; the fact that FEMA's Director said otherwise, in the most forceful terms, did not

even get mentioned.

4. Did the Commission actually grant the petition?*

The Commission claims in the June 1999 notice to have granted the amended petition for rulemaking. I only wish this were true. My 1995 petition was modest enough. All it asked was that the Commission live up to a commitment it made in 1979, in response to the President's Commission on the Accident at Three Mile Island, and on which it later reneged. In 1997, the actions of the FRPCC compelled the NRC to address the KI issue, and the NRC then offered to fund KI for any state that wanted it (Though the Commission chooses to ignore its press release of July 1, 1997, it does not dispute that it endorsed the FRPCC-proposed KI policy, or that it volunteered that it would "probably supply the funds with which stockpiles would be purchased for any state requesting them.) Later in 1997, in the probably naive belief that the Commission was too far committed to federal funding of KI stockpiles to renege once more, I offered the Commission an alternative: a requirement that KI be considered, coupled with an unequivocal recommendation that states adopt this "reasonable and prudent" measure, and premised on the offer of federally funded KI. It now seems that my offer was the triumph of hope over experience," in Samuel Johnson's famous phrase. The misgivings of the American Thyroid Association, Senator Joseph Lieberman, and other commenters, who feared that compromise was a mistake, have proved all too well-founded. Since the Commission majority now claims to have granted my petition, let us compare the June 1999 notice with what I asked for. First, the June 1999 notice contains, to be sure, the requirement that states "consider" KI, but it also suggests that many states have already done so. The fact that this consideration may have taken place almost 20 years ago, before Chernobyl demonstrated the drug's value and safety, seems not to matter, from the Commission's point of view. Nor does the Commission take into account the possibility that inadequate and inaccurate information from the federal government might have skewed the states' judgment of many years ago. No, for a Commission eager to discourage states from establishing stockpiles, consideration is consideration, regardless of how out of date and ill-informed it may have been. The

Commission's approach seems to open the way for states to satisfy the rule by reporting that they considered KI and rejected it, once and for all, in 1980. Second, the endorsement of KI is qualified to the point of tepidity. One will search the notice in vain for any statement that the NRC recommends that states establish stockpiles. The Commission is willing to go no further than to say that state and local decisionmak:ers may find the use of KI to be reasonable and prudent under specific local conditions. One could say the same about life preservers and life boats on an ocean liner, the fire extinguisher in your kitchen, or the airbag in your car. That is the nature of most emergency measures: they are useful only under specific local conditions, but if those conditions arise, and the protection is absent, grave harm may result. Finally, the offer of federal funding of state stockpiles has been revoked. The June 14 notice makes a point of saying, as did the Commission's "staff requirements memorandum" of ' April, that I never requested federal funding of KI. This claim is untenable. One need only look at the transcript of the December 5, 1997, Commission meeting and at the draft Federal Register notice that I submitted a week later to see that the alternative set forth in the amended petition was explicitly premised on the offer of KI paid for by the Federal Government The Commission's claim, like the assertion that the petition was granted, seems to be directed to possible judicial review. Though it knows full well that the pre-existing commitment to federal funding of KI was integral to the amended petition, the Commission appears to be positioning itself to argue that if I did not request such funding in the petition, I cannot claim to have been aggrieved by the breach of that commitment. In point of fact, I have no intention of asking the Court of Appeals to order the Commission to spend money on one program rather than another. But I may w~ll have to ask the Court of Appeals to find that the Commission denied both the original and the amended petition, and at that point, the withdrawal of the offer to fund state stockpiles will be germane to the question. What I envisioned in the amended petition, as I described in the public Commission meeting, was a combination of three elements - the requirement to consider KI stockpiling, the unequivocal recommendation that states establish stockpiles, and the offer of federally-funded

stockpiles -- that would lead any sensible state to stockpile. What we have instead is a proposed rule seemingly designed to ensure minimal disturbance of the status quo. Under such circumstances, it is hard to see how any petitioner, no matter how credulous or susceptible to I. flattery, could be led to believe that his or her petition had been fully granted. The Ill(?st that can be said is that the Commission granted the amended petition in part and deJ?ied it in part. That entitles me to seek review in the Court of Appeals. 14 N. Conclusion Since the Commission has d~lined to adopt the alternative means I offered it,of,granting the petition, it should do now what it should have done in the first place: grant the pe'tition in the form in which I originally submitted it. 15 There is no need for me to restate here the manifold reasQns for doing so; they are all laid out in the petition, my other filings, and the comments of the American Thyroid Association and others. Suffice it to say that the Commission's irresponsibility on KI has damaged the agency's credibility at home and our country's reputation abroad as a leader in radiation protection measures. 16 At international conferences, foreign experts on radiation and health find it difficult to understand how the richest country in the world cannot find the money to provide its children with a protective measure that is standard in developed nations around the globe, including many that are far from affluent They have trouble comprehending that for the last 14 years, U.S. policy on KI has been based on a cold-blooded 14 If the Commissioners and their legal assistants believe that to defeat judicial ~view, all that is necessary is to say that a petition has been granted, they may be in for a surprise. There are innumerable court cases standing for the proposition that an agency's characterization of a given action is not decisive in determining whether, where, and when that action is reviewable. Substance, not form, is controlling. The Commission need not and should not take my word for this. It has the good fortune to have a Solicitor of uncommon experience, judgment, and

• wisdom. It would be well advised to seek his counsel.

15 I hope that the Commission does not now try to claim that the original petition is no longer before it. But just in case it does choose to make that claim, it should consider that the petition is hereby incorporated by reference and resubmi~. { 1 -:

                                                                                            !    ! i*

16 For example, a recent BBC news story on KI preparedness in Britain commented dn how the U.S. had only begun to move on KI, "after years oflobbying."

actuarial computation that it wil1 be cheaper to treat radiation-caused thyroid disease after an accident than to prevent it with a medicine costing only pennies. (The fact that those calculations are worthless is beside the point; civilized, humane, rational people do not judge the value of measures to prevent disease in children solely by the relative dollar cost of prevention and

                                                                                                      )

treatment) The measure of the Commission's success in fulfilli~g its obligations is not what scientists, physicians, and regulators in other countries think of it, however. Rather, the measure is whether the agency is doing what it should to protect the health and safety of the American people. With regard to Kl, it plainly is not. After 20 years of broken promises, evasions, and delay, it is all too apparent that the Commission is failing the Am~can public, and America's children most of all. Especially in the last year, official Commission announcements have talked endlessly about greater NRC responsiveness to "stakeholders." This repellent term means, primarily, the regulated industry: those with a stake in the outcome of Commission decisions. It is entirely appropriate that the NRC should have a due regard for the effect of NRC actions on the nuclear power industry, but it should not lose sight of the fact that it regulates the industry and not the other way around. The ultimate "stakeholder," the one whose interests should be paramount, is the public. If the NRC becomes perceived not ~ serving the public, but '"as the captive of the nuclear industry, controlled rather than controlling, it wil1 imperil its very existence, as the example of the Interstate Commerce Commission shows. Fortunately, the likelihood of a serious nuclear accident in this country is small. 0Ne have no way of judging the probability of an act of nuclear terrorism.) The relative safety of nuclear power has one attendant cost, however: that it is all too easy for decisionmakers to think, perhaps unconsciously, that nothing is likely to go seriously wrong on their watch. But Commissioners who will spend five ,or ten years at the NRC and then move on should take a longer view, and think of the interests of the institution as a whole. They should ask themselves this question: If a major nuclear accident or act of terrorism were ever to occur, and American children developed thyroid cancers because the NRC had failed to ensure adequate nearby stockpiles of KI, what would the likely consequences be for the NRC? Once the public and

Congress discovered that the NRC had spent decades fighting off a major recommendation of the President's Commission on the Accident at Three Mile Island, would the Commission be given another chance? Or would it be abolished, and its functions assigned to some new entity? Let us I hope, for the sake of our children, that we never have cause to find out. Sincerely, kf~ Peter G. Crane cc: Chairman Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield Mr. Richard Meserve

Peter G. Crane I 4809 Drummond Avenue I Che Chase, MD 20815 I 301-656-3998 I email: ero/s.com August 17, 1999

                                                                                   *99    4UG 19 p 4 :Q 7 Q,   I

Dear Annette,

p AD--'- It's another beautiful day in southern New Hampshire, and while Beatrice and the kids swim and kayak, their foolish husband/father fi nishes up comments on the Commission's proposed rule on KI. With my handy little laser printer, I've made copies for all the

                                                                        ~

Commissioners. Would you be so kind as to pass them around? I've also included a disk, in the

• hope that Carol Gallagher can get this onto the website with a minimum of hassle. Could you see that she gets it?

Many thanks. Now it's time to have a swim and not think about the NRC. All the best, 1k

EMERGY NORTHWEST DOCKE TE D P.O. Box 968 Richland, Washington 99352-0968 August 12, 1999 *99 AUS 18 P12 :09 002-99-154 So ( "l/F1(3 l731) AD,ll Docket No. 50-397 Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 ATTENTION: Rulemakings and Adjudications Staff

SUBJECT:

PROPOSED RULE: CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS (64 Fed. Reg. 31737-JUNE 17, 1999) RESPONSE TO REQUEST FOR COMMENTS Energy Northwest submits these comments in response to the Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Fed. Reg. 31737-June 17, 1999). We have reviewed the proposed rulemaking to amend the emergency planning standard in 10CFR50.47 (64 Fed. Reg. 31737-June 17, 1999). The proposed petition recommends that the planning standard for protective actions require explicit consideration of the prophylactic use of potassium iodide (KI) for the general public. We strongly urge the NRC to deny the petition and to retain the current policy for KI usage. U.S. programs are built on the premise that evacuation is generally feasible and is more effective at dose reduction because it reduces dose to all organs, not just the thyroid. Energy Northwest and the majority of commercial nuclear power plants have adopted the protective actions described in the NRC Response Technical Manual (NUREG/BR-0150) to evacuate the general population in the event of severe core damage. The Response Technical Manual also goes on to recommend the stockpiling or distribution of KI during emergencies for emergency workers and institutionalized persons but does not recommend requiring predistribution or stockpiling for the general public. Energy Northwest strongly believes that the current policy on distribution of potassium iodide for use as a thyroid blocking agent is sound and will provide adequate protection of public health. The safety record of the U.S. commercial nuclear power program and demonstrated strength of its current emergency preparedness programs supports the continuation of current practices for the distribution of KI. 2 6 1999 J\"k ~e g d vca ......- ..- ~

U.S. Nuclear Regulatory Commission Page2 PROPOSED RULE: CONSIDERATION OF POTASSIUM IODIDE IN EMERGENCY PLANS (64 FED. REG. 31737-JUNE 17, 1999) RESPONSE TO REQUEST FOR COMMENTS In addition, the proposed rule fails to provide any new evidence that stockpiling or predistribution of potassium iodide as a protective action will add significant public health and safety benefit to the adequate level of protection currently provided by existing emergency planning at and around commercial nuclear power plants. Furthermore, guidance is already available for state and local governments that wish to make KI available to the general public if they feel it is appropriate. Energy Northwest agrees with the stipulation in the proposed rule that the state and local authorities should make the determination regarding stockpiling and distribution of KI. The cost of purchasing and development of plans and procedures should not be the burden of the nuclear

• industry.

We appreciate the opportunity to comment on the proposed rulemaking. If you would like to discuss our comments further, please do not hesitate to contact Tim Messersmith at (509) 377-8568. R~~ectfu~ ,1 JY -zJ.~ D .W. Coleman (Mail Drop PE20) Manager, Regulatory Affairs DWC:rej

OCKE NUM EA POSED ~ULE 5D (r,,'l~RJ/131)

                                                                               *99      AUG 17 A11 :33
                                                                                                       'I
                                                                                                      -F Rachel H.Glrshlck P.O.Box22 Hampton, ct. 06247

• U.S. Nuke Reg.Corn.

Rule Making & Adjudication staff 1 White Flint North Aug.13,1999 11555 Rockville Pike Rockville, Md.20852 RE: Consideration of Potassium Iodide in Emergency Planning Dear Nukes Commission; In as much as you have failed to protect (us) citizens of Connecticut from the unsafe, highly dangerous, operating nuclear power plants, and in as much as we (the citizens of Conn., and potentlaly, N.Y.&(C), R.I., & Mass.and depending on the prevailing winds other states as well) from the (very real) threat of a NUKE accident, it would be good if you could find It In your hearts & minds, to allow Potassium Iodide (Kl) to be available to the public during a nuclear emergency. Thank You Very Much for your time and consideration. Sincerely,

 ~~~

R.H. Girshick AUG 19 1999

                                                    ~cknowle ged *Y card ...............__.,. ., _.__

DOCKET UMBER PR FOSED RU "" w _Q DO'"'KETEO l/'"' 'p.l.,

                          *     . ( f,'/f~ 3/731)

Juan N.Walterspiel MD FAAP '99 AUG 16 P4 :29 18 Rose Lane East Lyme CT, 06333 OF Tel/Fax (860) 739 7614 ,.__, AO,}_ E mail: W ADBC@ aol.com 8-6-99 Secretary, US Nuclear Regulatory Commission Washington DC 20555-001 Re: Comments on KI

Dear Sirs,

Enclosed my comment and suggestion on the issue of KI. Sincerely, n N.Walterspiel MD FAAP ll I 19S ned ca!'d ...... -*-- ,**

EMERGENCY POTASSIUM IODIDE FOR DAY-CARE. KINDERGARTEN AND SCHOOLCHILDREN One of the mailings we have received is the official booklet describing emergency evacuation plans and instructions for our families in case of an accident at NU's Millstone nuclear power plants. Newspaper articles on whistleblowers, crowded storage tanks, valves, C-clamps, terrorists and the familiar view of nuclear submarines on the Thames River, seem to suggest that a responsible approach is to never assume never. This view has recently been supported by the Nuclear Energy Advisory Council. Some of the short-lived radioactive fission products that are released into the atmosphere during nuclear accidents are iodine isotopes. These radioactive iodine isotopes are quickly taken up by the human thyroid gland, where they deliver a concentrated radiation dose. Observations in populations exposed in Nagasaki and Hiroshima, downwind of nuclear tests on the Marshall Islands, and in Eastern Europe after the Chernobyl disaster proved repeatedly that thyroid abnormalities and thyroid carcinomas were induced and occurred years later. This was most pronounced in children who were under the age of ten at the time of exposure. A way to prevent this is the immediate ingestion of small and non-toxic amounts of the salt potassium iodide - abbreviated KI where K stands for potassium and I for iodine. The timely ingestion of non-radioactive iodine fills (saturates) all the storage sites in the thyroid gland. Any radioactive iodide that is ingested or inhaled thereafter is excreted in the urine. Nuclear plants, ships, and submarines, as well as some neighborhoods of nuclear plants in Europe are stocked with potassium iodide tablets. Single doses were given to 16 million persons in Poland after the Chernobyl accident with only rare occurrence of side effects. This preventive measure resulted in a calculated reduction of 40% of the projected thyroid radiation dose. The dose of potassium iodide that is effective in case of an accident is :

130 mg/day for adults and children, 65 mg/day (1/2 of 130 mg ) for infants, and according to safety experiments done in chimpanzees, 100 mg/day for pregnant women. KI tablets can be stored for prolonged periods of time when kept dry. This is accomplished by using tightly sealed containers. KI tablets can also easily be dissolved in milk or orange juice for administration to small children. A protective dose should be given as soon as possible and before an anticipated exposure. However a period of within two hours is still considered to offer significant protection and periods of up to 4 hours still offer a 50% blocking activity. Acute allergic reactions do not occur as KI is a salt whose two components, a potassium ion (K) and an iodine ion (I) are natural constituents of the human body. Untoward and non lethal effects to a single dose have been estimated to occur in less than one in ten million. The population should also be made aware that the risks in delaying any ordered evacuation in order to individually obtain KI by far outweighs the potential benefits .

• A household distribution experiment around the Sequoia nuclear plant in Chattanooga TN showed that the population was willing and able to understand this issue without widespread mistrust against the nuclear industry or the military.

The pros and cons of stockpiling or predistribution of potassium iodide to households are difficult to assess and there will be a two-year trial period in Connecticut to address the practical issues involved. Because the highest protective effect would be in children, we should explore the possibility of having a single dose available for our children at their respective day care centers, Kindergarten and schools first. Official authorization to administer such a timely and virtually side effect-free first dose would require only a minimum amount of reliable

assessment of the estimated magnitude of release during an ongoing accident. Further decisions on the necessity of subsequent doses can be then be made when details are known and once the areas of precipitation have been mapped. The experience in Eastern Europe has shown that areas of radioactive precipitation can be spotty and that precipitation certainly will not follow neat 5, 10 or even 20 mile circles around the source(s) of release. Juan N.Walterspiel MD FAAP lives in East Lyme and has three children in the school district. He is a faculty member ( Assistant Clinical Professor )of the Department of Pediatrics at Yale. Opinions stated in this article are his own. Literature reviewed: Protection of the thyroid gland in the event of release of radioiodine. Recommendations of the National Council on Radiation Protection and Measurements. NCRP Report No.55. 7910 Woodmont Ave. Bethesda, MD 20814 August 1, 1977 and March 31, 1991 Becker DV, Zanzonico P. Potassium iodide for thyroid blockade in a reactor accident: administrative policies that govern its use. Thyroid 1997,7: 193-197 Crocker DG Nuclear reactor accidents - The use of KI as a blocking agent against radioiodine uptake in the thyroid -A review. Health Physics 1984; 46: 1265-1279 Lewinski A, Swietoslawski J , Wajs E et al. [ Effects of prophylactic doses of potassium iodide on the course of thyroid diseases ( 1986-1990) diagnosed due to the atomic accident at Czernobyl in adult patients at the outpatient endocrinologic hospital clinic in Lodz] Endokrynol Pol 1991 ;42: 321-351

Halperin JA Potassium iodide as a thyroid blocker - Three Mile Island to day. DICP 1989; 23: 422-427 Noteboom JL, Hummel VA,Broerse JJ et al. Protection of the maternal and fetal thyroid from radioactive contamination by the administration of stable iodide during pregnancy. An experimental evaluation in chimpanzees. Radiation Res 1997; 146: 691-697 Fowinkle EW,Sell SH,Wolle RH. Predistribution of potassium iodide-The Tennessee experience. Public Health Rep. 1993;98: 123-126

Robert Roy Northern States Power Co. Sr. Corp. Emergency Planner DOC FTELI us ! ..; Kris Eide State of Minnesota "99 AUG 16 A7 :24 Assistant Director Division of Emergency Management OF* R . ADJL I JOCKET IMBER Secretary of the Commission Augusts, 1999 U.S. Nuclear Regulatory Commission PROPOSED AU Washington, D.C. 20555-0001 ATTENTION : Rulemakings and Adjudication Staff

SUBJECT:

Proposed Rule: Consideration of Potassium Iodide in Emergency Plans (64 Fed . Reg. 3173-June 17, 1999) Request for Comments Northern States Power Company and The State Of Minnesota submit these comments on behalf of our interests in the nuclear energy industry. We have reviewed the proposed rulemaking to amend the emergency planning standard in 10 CFR 50.47 (64 Fed. Reg. 31737-June 17, 1999). We fully support NEl's position letter concerning the proposed petition recommendations. We strongly urge the NRC to deny the petition and we reiterate NEl's view that our Emergency Planning programs are built on the premise that evacuation is generally feasible and is more effective at dose reduction or elimination. We agree that local authorities should maintain the responsibility of making the determination regarding stockpiling and distribution of Kl and that the cost of purchasing and development of plans and procedures should not be the burden of the nuclear industry We appreciate the opportunity to comment on the proposed rulemaking. If you would like to discuss our comments further, please do not hesitate to contact Robert Roy at (612) 330-7903, e-mail Robert.L.Roy@NSPco.com or Kris Eide at (651) 297-2970 ,e-mail Kris.Eide@state.mn.us. Sincerely, (jl{~

                                                                                        . Eide tant Director Northern States Power Company 414 Nicollet Mall Minneapolis, Minnesota 55401-1993 9

I!I

DO KET UMBE PROPOSED AUL * .so [ CtJC/FR31731) DOC KETED us me THOMAS J . VI LSACK *99 AUG 10 P4 : DEPARTMENT OF PUBLIC DEFENSE GOVERNOR EMERGENCY MANAGEMENT DIVISION ELLEN M . GORDON, ADMINISTRATOR SALLY J. PEDERSON r-LT. GOVERNOR O'i-RL.Ji ADJL' - August 4, 1999 Annette Vietti-Cook Secretary of the Commission ATTN: Rulemakings and Adjudications Staff Nuclear Regulatory Commission Washington, DC 20555

Dear Secretary Vietti-Cook:

RE: Proposed Rule KI: Federal Register Vol. 64, Number 113 Please note the attached recommendation with respect to the above. We support and concur with the thoughts expressed by the Iowa Department of Public Health. Sincerely,

• Ellen M. Gordon Administrator EMG/lkm cc: Rick Bamsey Don Flater HOOVER STATE OFFICE BUILDING/ LEVEL A/ DES MOINES, IOWA 50319-0113 / 515-281-3231

.- R J(;, . { l, V *l -:, Jl DI ATION V SECRETARY MIS ION D ent tiRf s

THOMAS J. VILSACK DEPARTMENT OF PUBLIC HEALTH GOVERNOR STEPHEN C . GLEASON , D . O ., DIRECTOR SALLY J. PEDERSON LT. GOVERNOR TO: RickBamsey

• FROM:

RE: Emergency Management Division Donald A. Flater, Chief ~ Bureau of Radiological Health KI for the General Public DATE: July 26, 1999 In the last 45 days, the U.S. Nuclear Regulatory Commission has come out with statements saying that KI should be made available for the "General Public" in the vicinity of Nuclear Power Stations. We believe that this is an unreasonable recommendation when one considers the feasibility of an accident occurring, storage costs, maintenance, etc. As the Iowa Department of Public Health is responsible for dose assessment we believe that stock piling of KI for the general public is not a good idea. LUCAS STATE OFFICE BUILDING/ 321 E . 12TH ST . / DES MOINES , IOWA 50319-0075 DEAF RELAY (HEARING OR SPEECH IMPAIRED) 1-800-735-2942 / INT ER NET : HTTP : //IDPH . STATE . IA . US/ FAMILY & COMMUNITY HEALTH ADMINISTRATION & REGULATORY AFFAIRS SUBSTANCE ABUSE & HEALTH PROMOTION EXECUTIVE STAFF DIRECTOR'S OFFICE 515-281-3931 515-281-5784 515-281-3641 515-281-5604 515-281-5605 FAX/515-242-6384 FAX/515-281-4958 FAx/515-281-4535 FAX/515-281-4958 FAx/515-281-4958

DOCKET NUM ER PROPOSED RU So (l#'IFR3/731) DOC f,,-o Secretary of the Commission CRC Emergency Prep ici'n ss Nuclear Regulatory Commission 18 Yorkshire Drive Attn: Rulemakings and Adjudications Staff Waterford, CT %38 UG _4 All :QB Washington DC 20555-0001 July 23, 199 fRLI AD. . 1_,

Dear Sir,

We support the recent NRC proposed rulemaking change entitled "Consideration of Potassium Iodide in Emergency Plans". We are enclosing signed petitions from Connecticut citizens who desire that Potassium Iodide be available to the general public . AUG 51 knowfe ged by

u S NUCLEAR REGULAlun "'"'., RULEMAKI GS&ADJUOICATIONS ST OFFICE O THE SECRETARY OF THE COMMISSIO

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. {860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel (860)444-0113 Email: crcnukewatch@snet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

H,1(

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Please mail by January I 0, 1999 to: Citizens Regulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions \ The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens.

• We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

 "It is better to have it and not need it, than to need it and not have it."
                                                    -                .                  .          (.

-.I-Y~16fl1--~~~GIJ~~t.,H-.::14."'H~L..dld.l.1'~----IJ.l,t;...~~l,J:l..r,tlb~-R-,..:L,,.~Sl:.laZ; I Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford,Connecticut06385*1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government bas offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."
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Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great-Neck Road, Waterf'ord, Connecticut 06385 Tel. (860)444-0113 Email: crcnukewatch@snet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and LocaJ authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

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;.c,,,~~~;;;;._...,;..,,,,.~~~~!.EL.A~~l4/..!:i.qm.'.iU.:..~U-~~7 Please mail by January 10, 1999 to: Citizens Regulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission

                                             ~ ;,46~ Q.uutlmt6 180 Great Neck Rd., Waterford, CT. 06385 Tel. 860 444 0113 Fax: 860 447 1241 e-mail crcnukewatch@snct.net The World Health Organization, the International Atomic Energy Agency, and our own federal government have stated that Potassium Ioidide (KI) is a prudent measure for protecting the thyroid during a radiological accident The federal government has offered to fund the purchase of KI when required by state or local authorities. At the present time, KI is not readily available to Connecticut's citizens.

We the undersigned are asking the state of Connecticut to request KI from the federal government and stockpile and distnbute it to interested citizens.

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e(lS: ~ ?0>: fu1/4\, ~-~ Please mail to: CRC Petition Drive 18 Yorkshire Dr. Waterford, CT. 06385 - 1715 "It's better to have it and not need it than to need it and not have it"

Citizens Regulatory Commission

                                                  ~        :Ag~ Quutlon6 180 Great Neck Rd., Waterford, CT. 06385 Tel. 860 444 0113 Fax: 860 447 1241 e-mail crcnukewatch@imet.net The World Health Organization, the International Atomic Energy Agency, and our own federal government have stated that Potassium Ioidide (KI) is a prudent measure for protecting the thyroid du.ring a radiological accident The federal government has offered to fund the purchase of KI when required by state or local authorities. At the present time, KI is not readily available to Connecticut's citizens.

We the undersigned are asking the state of Connecticut to request KI from the federal government and sto ile an distribute t to in,,.Al"0<.01-..d citizens. Please mail to: CRC Petition Drive 18 Yorkshire Dr. Waterford, CT. 06385 - 1715 "It's better to have it and not need it than to need it and not have it."

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The World Health Organization, the lnternanonal Atomic Energy Agency and our own feder.ll government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident The federal government has offered to fund the purchase of Kl when requested by state or local authorities. At the present time. KI is not readily available lo Connecticut's citizens. We the undersigned arc asking the state of Connecticut to request KI from the federal government and stockpile and distribute it to interested citizens. 0 "It is better to have it and not need it, than to need it and not have it *

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Ct'.*f3'l Please mail by Jan.1 o. 199.9 to: Petition Drive 18 Yorkshire Dr.

Waterford CT. 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 0638S Tel. (860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent merusure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens.

• We the undersigned are asking the State CJf Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

 "It is better to have it and not need it, than to need it and not have it."

Fet.,,u.-:;;i Please mail by-Jaan..- 10, 1999 to: Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860) 444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and hot need it, than to need it and not have it."

Printed Name Signature Address

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JI) 47 ~~~~~~~~~~~~~~~-~~~~~~L--::~w j;;a Please mail by January 10, 1999 to: Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undenigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

 "It is better to have it and hot need it, than to need it and not have it."

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_ ~ .S _ , ,.,;}a~-:~:!1?:,, -fr_ _:i, ,' ~- _/"" :iJ~/4. '-- Please mail by January 10, 1999 to: Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

 "It is better to have it and not need it, than to need it and not have it."
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~~lo.......;._--..U.~~""""'+--~~~~L.._:..+~~___i._;,..~----f-Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

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Citizens Regulatory Commi~~ion 17-C) ' - ' / j' 180 Great Neck Road, Waterford, Connecticut 06385 TeL (860) 444~0113 .. . '.,Jc,,...(,.r,,,.

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Neighbors Asking Questions

                                                                                                                                                                            . I' The World Health Organi7Jltion, the International Atomic Energy Ag~ncy and onr own Federal Government have stated that Potassium Iodide (Kl) Is a prudent measure for protecting the thyroid during a radiological accident. The Federal Gov~rnment ba1 offered to fund the purchase of KI when requested by State and Local authorities. At the present tim&, KI is not readily available to Connecticut'* citizens.                                                                                                         *

• I We the undersigned are uking the State of Connecticut to request Kl from the Federal Government and stockpile and distribute it to interested citizens. * :

               "It ii better to have it and not need it, than to need it and not have it."

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Please mail by January I 0, 1999 to : Petition Drive 18 Yorkshire Drive Waterfom. Connecticut 06385-1715 I

• I I

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860) 444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

 "It is better to have it and not need it, than to need it and not have it."

Please mail by January 10, 1999 to : Petition Drive

                                    '18 Yorkshire Drive Waterford, Connecticut 06385-1715

I Citizens Regulatory CommiS~ion 180 Great Neck Road, Waterford, Connecticut 06385 TeL (860) 444:0I 13 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Ag~ncy and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent m'easure for protecting the thyroid during a radiological accident. The Federal Gov~rnment hH offered to fond the purchase of KI when requested by State and Local authoritfe,. At the present time, KI is not readily available to Connecffeat'a citizens. *

• I We the nndersigned are asking _the State of Connecticut to request Kl from the Federal Government and stockpile and distribute it to interested citizens.  ; *

"It ii better to have it and not need it, than to need it and not have it."

Please mail by January 1O, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-171.S I ' I I

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel (860)444-0113 Email: crcnukewatch@soet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI i.! not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens. "It is better to have it and not need it, than to need it and not have it." Address by January I 0, I

• Citi ns egulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385~ 1715

w

• Citizens Regulatory Commission

                                              ~ .,4:1~ Quutlmul 180 Great Neck Rd., Waterford, CT. 06385 Tel. 860 444 0113 Fax: 860 447 1241 e-mail crcnukewatch@snet.net The World Health Organization, the International Atomic Energy Agency, and our own federal government have stated that Potassium Ioidide (KI) is a prudent measure for protecting the thyroid during a radiological accident The federal government has offered to fund the purchase of KI when required by state or local authorities. At the present time, KI is not readily available to Connecticut's citizens.

We the undersigned are asking the state of Connecticut to request KI from the federal government and stockpile and distribute it to interested citizens. Si,_.. .,h.... Printed Mr.me 71 ...,..,........~~....""-'=i::::;...---.,..;..:~.,.;;;,;,,,;,-------~'"""'-'----aK.I.WiAl.'1.~~~~ ~ ---~~":a..J...::t.::~------L~U-!;;~~----'-.1...Jr.~~~~~~~~~

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 TeL (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

  "It is better to have it and not need it, than to need it and not have it."
                                                           <       t ../:u1'2'e C Fe1'~

Please mail by .Nl'ffll8f')' I 0, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-171 S

The World Health Organization, the International Atomic Energy Agency and our own federal government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The federal government has offered to fund the purchase of KI when requested by state or local authorities. At the present time; KI is not readily available to Connecticut's citizens. We the undersigned are asking the state of Connecticut to request KI from the federal government and stockpile and distribute it to interested citizens.

   "It is better to have it and not need it, than to need it and not have it .
                                                                                                                                <te-c:.,o:s-.2_

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1 ~I "'II 7 Please mail by Jan.IO, 1998 to: Petition Drive 18 Yorkshire Dr. Waterford CT. 06385-1715 r

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We iiu~ undersignPfl are asking the State of Connecticut to request KI from the Federal Government and stockpile and distrib~.te :! to inter-ested citizens.

"Ii is h&ttu to have it ano' not neeti it, tilan lo need h; ano not have it."

ii Si ature ddress

                                                                                           ;It.. ct I l

Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385*1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Printed Name Signature Address Jee_ SJ,._lliJJ,efk: A-1.- k J ER-f"Z. e ___________,...............___-------==--------'~--==--=-a=_,._~,___....,.,,_'-"".w..;=rrb

                                                                                        .......~er.
                                                                                      ,,,;f~Jt I Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road. Waterford, Connecticut 06385 TeL (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Please mail ey Jont.tm; 1e, 1~99 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 TeL (860)444-0113 Email: crcnukewatch@snet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

 "It is better to have it and not need it, than to need it and not have it."

Address J e mail by January IO, 1999 to: Citizens Regulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860)444-0113 Email: crcnukewatch@snet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Printed Name Address MeC!:>tiA,.J w @....(...l+/- ~ ~ Please mail by January I 0, 1999 to: Cittzens Regulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 TeL (860)444-0113 Email: crcnukewatcb@snet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it" h      I)

Please mail by January I0, 1999 to: Citizens Regulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Printed Name i 1/J.- Please mail by January 10, 1999 to: Petition Drive 18 Yorkshire Drive Waterford, Connecticut 063 85-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel.

                                                                                  , -0113 (86(' 4.:.

• Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prutlent measure for protecting the thyroid during a radiological accident. The Federal Govei'll,f/1 t:11s offered to fund the purchase of KI when requested by State and Local authoritie:i. ~ , *be present time, KI is not readily available to Connecticut's citizens.

We the undenigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."
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r , e s-c? Tr--,,-.hvlf s-f Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860)444-0113 Email: crcnukewatch@snet.net Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

   "It is better to have it and not need it, than to need it and not have it."

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  ~LC:::::.J...~:_µ~-A~:.ot=~~~~~p.:..::.~::::=::__J_~~~..l.4-0&357 Please mail by January 10, 1999 to: Citizens Regulatory Commission Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Conmicticut 06385 Tel. (860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undenigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

    "It is better to have it and not need it, than to need it and not have it."

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v' r:...::::L~~--1..~LA.l:::J::gl_~~~~~~~-~-!.d~~~L!:.:::f:i.:.~ Please mail by January 10, 1999 to: Petition Drive 18 Yorkshire Drive Waterfo~ Conne<"ticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undenigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

  "It is better to have it and not need it, than to need it and not have it."

Printed Name

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-=--y-_;;;;;...;:~:::.:.;.:,_::--~~~~~~-~~~~!!s.-..f.::::::..!:=.-,,::,A~~::.J...!fll ... ( a t,6 ../L.LL!.JJar::t=a:J&:C:22!;.&._....f::.::Q.!~:I..~.L:.~~;__.2:_:2..,~~:.!l.l~...1.t~..J.:JJ..~~c.c:..r o '-1 -+-w,~.w:..w..iu-'------l~~~:...J..----i...,L~~.u.J....L::,j~~~C;,,J,.J,i t~ ~S} ..trJl..u..:a.~..;.:_..:::;,_J~..DJ.1::l!::L_,:;,;.~~u:s...~~~~~:=::...;.~"'""'~~a..J~~...:.<&::i'.lilµ.~ C)'. () o. ~<:.- ~-+--=--;..;;_.~....,.;i,.,..:w;=-¥-----------1--=-.;.._;;;:~;;;;.-.-:.__;,,_.;..:.._:.....=--:f o(,3:;i 1 Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 063 85-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Printed Name Sipature Address Please mail by January l 0, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."
   'nted Name                                              ddress I'.)

Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

The World Health Organization. the International Atomic Energy Agency and our own feeler.ii government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The federal government ha..:i offered to fund the purchase of Kl when requested by state or local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the state of Connecticut to request Kl from the federal government and stockpile and distribute it to interested citizens.

  ~It is better to have it :ind not need it. than to need it and not have it.

Please mail by Jan.10, 199,9 to: Petition Drive 18 Yerk.shire Dr. Waterford CT. 06385-1715

            '!'he World Health Organization, the lnternationaJ Atomic Energy Agency and our own federal government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiologicnJ accident The federal government ha..,

offered to fund the purchase of Kl when requested by state or local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the state of Connecticut to request Kl from the federal government and stockpile and distribute it to interested citizens.

  "It is better to have it ~d not need it, than to need it and not have it0

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1'/ Please mail by Jan.10, 1999 to: Petition Drive 18 Yark.shire Dr. Waterford CT. 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, C~nnecticut 06385 Tel. (860),444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undenigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

P~ntedName Address j;shvCA..., '4a Ue.12 35 Cia,u-e,.l St,. f1/4s b.c. G cx;;'":js5

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Please mail by January 10, 1999 to : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385~1715

The WorJd Health Organization. the International Atomic Energy Agency and our own federal government have stated that Potassium Iodide (Kl) is a prudent measure for protecting the thyroid during a radiological accident. The federal government has offered to fund the purchase of Kl when requested by state or local authorities. At the present time. KI is not readily available to Connecticut's citizens. We the undersigned are asking the state of Connecticut to request Kl from the federal government and stockpile and distribute it to interested citizens.

   "It is better to have it and not need it, than to need it and not have it.
  -{;-1,1.J.J..---t~~L4-J!,.___.a.~~"4~~ifl.l.4-----2~...t:t!il!~L!;...~~                                                 c.r     ~
  .J.J.~~'-il,,d..4,,t.i.,.,,,fl,.J.I.L,l/1,,i"'4-..:.../,JllldlP.,Ui.d~~,Ll~~_:_.L:!:.1.i!_2.!!.1C.I.l....Q~b:.lill'.lQolc. c.,T O <i,, 4.f O ..

l...oZ:F2JaJ[Ua.ic;u.L....C..~~==::\,.......;-i~!d::!!..l,dJ,JLL.&)..5~~::!.!:~~:t.L...J.l).l.~l:t!!fqa~~c t1/<n Please mail by Jan.10, 1999to: Petition Drive 18 Yorkshire Dr. Waterford CT. 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 TeL (860)*444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium lodide*(KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undenigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to Interested citizens.

"It ls better to have it and not need it, than to need it and not have it."

Please mail &)' JBffl!mJ t e, 1~~~ tu : Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

Citizens Regulatory Commission 180 Great Neck Road, Waterford, Connecticut 06385 Tel. (860}444-0113 Neighbors Asking Questions The World Health Organization, the International Atomic Energy Agency and our own Federal Government have stated that Potassium Iodide (KI) is a prudent measure for protecting the thyroid during a radiological accident. The Federal Government has offered to fund the purchase of KI when requested by State and Local authorities. At the present time, KI is not readily available to Connecticut's citizens. We the undersigned are asking the State of Connecticut to request KI from the Federal Government and stockpile and distribute it to interested citizens.

"It is better to have it and not need it, than to need it and not have it."

Address Please mail by January 10, 1999 to: Petition Drive 18 Yorkshire Drive Waterford, Connecticut 06385-1715

(j) PENNSYLVANIA EMERGENCY MANAGEMENT AGENCY BOX 3321 OOCKE*1 ED HARRISBURG , PENNSYLVANIA 17105-3321 USNRC DOCKET UMBER *99 AUG -3 P4 :52 PROPOSED RULE 5o July 29, 1999 ( c, 'IFR~l137) OF*-. RL' ADJU' ,1. Annette Vietti-Cook Secretary of the Commission ATTN: Rulemakings and Adjudications Staff Nuclear Regulatory Commission Washington, DC 20555

Dear Secretary Vietti-Cook:

RE: Proposed Rule KI: Federal Register Vol. 64, Number 113 The proposed rule appears to be innocuous in that it requires the states to consider the use of KI as a supplementary action to sheltering and evacuation as a protective measure relating to a potential nuclear power plant incident. This is something the states have already done. The converse is that the rule is obfuscatory in that it is not needed and only adds to unnecessary federal regulation. Sincerely, R bert E. urc man Acting Director REC:ARS:bea cc: Michael Cline, State Coordinator, Virginia Department of Emergency Services Sean Mulhern, Director, Delaware Emergency Management Agency David McMillion, Director, Maryland Emergency Management Agency John W. Pack, Jr., West Virginia Office of Emergency Services Ellen Gordon, President, NEMA Mike Austin, NEMA,PTE, Co-Chair Eric Tolbert, NEMA, PTE. Co-Chair

lJ.S ~LCLEAR REuULATORY COMMISSl01 AKINGS &ADJUOICATIO STAFF FFICE O 'FHE SECRETAR FTHE SSION

                     ;J     7 dd'I         - - 'if produceti __      _

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DOCKET NUMBER PROPOSED AUL 50 971 Johnson Road Mineral, VA 23117 July 13, 1999

                                          *99  AUG -2 P2 :54                          (540) 894-0339 email: Laurel@firstva.com Ot*

Secretary R~- U.S. Nuclear Regulatory Commissio DJl 1 Washington, DC 20555-0001 AlTN; Rulemakings and Adjudication staff An article in the Richmond Times Dispatch (July 13, 1999) mentioned that comments should be sent to your attention regard the Kl pill to be used in the event of a nuclear accident. According to the article, the local authorities would be responsible for the distribution and training in the use of this particular medication. First, you need to know that I live four miles from the North Anna Nuclear Power Plant operated by the Virginia Power Company in central Virginia. The road I live on (State Route 700) is a direct route to the plant. What you are proposing is just another boondoggle to appease the people who reside near these facilities. I say this because of some communications I had with your Atlanta, Georgia office regarding the notification policies set forth for North Anna. As a result of retiring from work, I found myself at home and in a position to hear the test signals for the plant. I checked the schedule and waited to hear the siren go off. It never came! Finally, I called the public relations office of the plant. I never received a return call. When after a time I had not heard from them, I called the NRC representative at the plant. The substance of the report from him and from Atlanta was this: that in the case of an accident at the plant all people within a ten mile radius of the plant would be personally notified by individual workers from the plant and members of the volunteer fire and rescue organizations. That is the most bogus system possible. In the first place what employees at the plant are paid enough to risk their own lives to run from house to house notifying everyone? In the second place the volunteers are paid even less and for the most part should an accident happen during the daytime most of those people would not be available. I also found out that there was a siren placed about a mile from my home and it was never hooked up to the plant. I feel that it would make more sense to have the siren available and then it would give the local population a fighting chance to get away. If we have to wait for the possible arrival of personnel from the plant, we could all be dead or dying by the time they got to us. Many of the homes in this area are located in densely wooded areas. They are invisible from the road. The plant workers do not live in the area and hence would not be familiar with all of the locations. (They also would not be that caring.) The first line of defense in a nuclear accident is notifi cation. That is sorely lacking for the North Anna plant for those in the most vulnerable area of Louisa County. U6 199

U.S. NUCLEAR REGUlATORY COMMISS!ON RUI.EMAKINGS &ADJtlEATIONS STAFF FICEOFMSl!DETA OF

By all means I would welcome any available medication or help should there be an accident, but I think that your agency has not truly thought out the entire problem, and certainly have not taken in account human nature. A frighten worker or volunteer is not the best first line of notification. I would welcome a response from you and some action on this matter. Lawrence Roy cc: Patrick Nickerson, author of above mentioned article with Charlottesville's The Daily Progress

. ... Linn County Emergency Management Ageney, L1 . 50 2nd Avenue Bridge IS I Cedar Rapids, Iowa 52401-1256 "99 AUG -2 Atj :38 Phone: (319) 363-2671 Day or Night* Fax: (319) 398-5316

• E-Mail: linnema@jmbest.net Of '

24 July 19 9~ 'lL AO._. Nuclear Regu.l.atory Commission DOCKET NUMBER Washington, DC 20555-0001 0 OPOSED RULE So { ~'/FR 3/131

SUBJECT:

Response on the Use of Potassium Iodide for Emergencies at Nuclear Power Plants Dear Sirs; I wish to provide input to the NRC from the local Emergency Management Agency level concerning the stockpiling of Potassium Iodide (KI) for public use in the event of an emergency at a nuclear power plant. X strongly recommend this NOT be adopted and that the existing policy of using KX only for emergency workers remain in effect . I am the Director of Emergency Management for Linn County, Iowa. I am responsible for the protection of the general population within the Emergency Planning Zone of the Duane Arnold Energy Center, located in Palo, Iowa. My county has a ~opulation of approximately 160,000 in the effected EPZ that I would have to address providing KI to over and above the 2,500 emergency workers I currently am prepared to support . There are several reasons why requiring the stockpiling of KI for the general population is not the best way to protect the public from the effects of a radiological accident. First, Evacuation has been shown to be the best way to protect the public. This keeps the public from exposure by removing them from the source of the radiation. I feel it is better to move the public away from the problem instead of treating the public

• after exposure. Our plans are very extensive in alerting the public in the event of an emergency and I believe we can quickly and effectively evacuate our population out of harms way. This is especially true for our plan to protect the children, who are at the greatest risk of radiation exposure. Much of our planning and training is oriented on moving the children out of the EPZ early on in an emergency situation.

                                              *.I

" UCLEAR REGULATORY COMMISSION ULEMAKINGS & AOJUOICATI STAFF OFFICE OF THF SECRETAR OFTHE 1~10 3()/&Jlf ~ttf ~ C (--1('

              ~     I

Page 2 Second, the logistics of storage and distribution of KI is tremendous, especially for the potentially affected population that I serve. There is a great deal of effort to store over 1,650 boxes of KI for the general population and the emergency workers, maintain accountability, and rotate the stock as required. This amount of effort does not address the problems of distribution of the KI to the general population and the necessity to instruct the population on how and when to take the KI and to inform them of the potential health risks. Again, the utility and the emergency management community put forth a great deal of effort annually, to train the emergency workers on the use of KI. This task would be multiplied many times to serve the general population at the minimum standard that would be expected. Also it sends a message of false security to the public which implies that individuals can stay in an affected area instead of evacuating and the government will provide them a pill that will solve all of their problems. This implied message does more to hurt the public safety than helping it. The only real value I see in adopting this proposal would be the benefit to the pharmaceutical companies, and would be a job security benefit. Both the local emergency management agencies and the utility emergency planning departments would have to hire additional staff to administer this program and the bottom line is "Will the public be any better served?" I feel it would not! In closing I believe this draft proposal is without merit and does not meet the reality check of meeting the public safety needs. 'l'his proposed regulation should NOT be adopted! If you have any questions, please contact me. Thank you for your support. Respectfully; WALTER E. WRIGH , CEM Director of Emergency Management

DOCKET NUMBER PROPOSED RULE 5o (,'/fR3l 131) JUL 2 3 1999 N10 lrAFF

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U.S. UClEAR REGULATORY Corvi,v RUI.EMAKINGS&ADJUDICATIONS c: CEO THESECRETAI:. OFTHEC MMISSIO~ Document Sta ate -, t.3/19

        "' ived _ _ l Add          Reprod 1 Ce'  f

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DOCKET NUMBER PR June 28, 1999

Dear Sir:

PROPOSED RULE 5o  ;\ ft:JI/F~~/731,; The proposed amemdment to NRC's emergency planning regulations to include . JUL _ A .*: the possible use of potassium iodide as a supplemental protection for the 99 6 9 _ public in case of a severe nuclear powere plant accident was published in the June 13 edition of the Federal Register and is open for comment until 0 September 13. The NRC issued a press release on April 23 AO,J1 announcing the proposed rule, which would amend Paart 50.47(b) (10) of Title 10, Code of Federal Regulationss. Why do different states report and monitor so differently.? Why have published results of radionuclide monitoring changed so dramatically in the past decades? Three Mile Island plants have to tell the public when they do routine releases. The horrible history of routine releases in Michigan and the Great Lakeg,-., i.e. the three million curies released by Big Rock the first 10 years they were on line ( Consumers Powers's figures ) ~ The big releases of tritium by Zion and the Candu reactors.~ The big releases of krypton 85 that affect weather and lightning.~ The unplanned over-the-limit releases ofradioactive iodine from Palisades in the 70's - when Consumers Power realized they were way over the limits, they kept on releasing! Fisherman on Lake Michigan were stopped and their fish were checked. Some radionuclides cross the placenta. Many concentrate in the food chain. Some are made more potent by the presence of other toxins. Governments should phase out radionuclides that meet the IJC's definition of persistent toxin. i.e. Any toxic substance with a half life of8 weeks in water, that also bioaccumulates. Reactors that are being decommissioned and after nuclear accidents should be made to safely retain all radioactive water and other materials and NOT release them into the Great Lakes/environment. There is no excuse for the continued, perpetual contamination of the Great Lakes/environment by the nuclear industry. Sincerely,

                                         ~~~

Kathryn A.Barnes R 1 Sherwood,MI 49089

 . 1~UCLEAR REGULATORY COMM6SSK)N 8ULEMAKINGS & ADJUDfl'_..ATIONS OFACE OFTHESEaEARY OF THE COMMISESION

The Seacoast An ti-Pollution League DOCKET NUMBER OJ .- TEJ SAPL PROPOSED RULE. 5() 7~l/F/?31131)*99 OUI)Oe

                                                                               .,.    \',I JUN 21 A7 :48 1969 P.O. BOX 1136 P O R T S M O U T H ,        N H    03802 603-431-5089 Secretary of the Commission,                                                         June 16, 1999 Attn: Rulemakings and Adjudications Staff U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Secretary of the Commission,

Please accept this letter as support for the proposed amendment to the Commission's emergency planning regulations governing the domestic licensing of production and utilization facilities to include Potassium Iodide (KI) as a protective measure for the general public. SAPL, a non-profit citizen environmental advocacy group, represents over 300 people, most of whom live within the I 0-mile emergency planning radius of the Seabrook Station nuclear power plant. I also represented SAPL on New Hampshire's KI working group that recently presented recommendations to Gov. Jeanne Shaheen concerning the inclusion of KI in this state's emergency planning process. The New Hampshire group was made up of representatives of state emergency planning and public health agencies, as well officials from both the Seabrook Station and Vermont

• Yankee nuclear power plants. The group developed a plan that would allow citizens of New Hampshire to gain access to KI in advance of an accident at either plant.

The plan calls for the state to secure agreements with KI manufacturers to sell the medication directly to individuals or retail outlets, and to urge local pharmacies to stock KI as an over-the-counter drug. Information concerning KI availability and use would be included in the annual emergency information mailings prepared by nuclear plant staffs and distributed to every property owner within the emergency planning zones. Ho~ever, the New Hampshire Seacoast region, in particular, also draws a large number of tourists during the summer and early fall months, and no process for making these individuals aware of KI availability was included in the state's recommendations. SAPL, therefore, urges the NRC to push for the establishment of regional KI stockpiles, either as separate entities or as part of federal terrorist response depots. It is critical that Kl, in sufficient amounts to distribute to the over 100,000 summer residents and tourists that can be within the I 0-mile planning zone on any given day of the tourist season, be available. JUN 22 111

                                                                       ~cknowfedged by card        *-----------~,n

lJ.S NUCLEAR REGULATORY COMMJSti1v,~ RU MAKINGS &ADJUDICA~ STAFF OFACE OFlffEIIDETARY OFTHE

Whether those supplies are paid for by the Commission, FEMA or the Department of Justice matters little to those thousands of people who would be left without the medication if an adequate stockpile was not available and a nuclear accident took place. As was mentioned in the Federal Register listing, the cost of obtaining sufficient amounts of KI to protect, particularly the children living within emergency planning zones, is minimal compared to the consequences of an act of nuclear terrorism or an accident at a nuclear power plant. SAPL is confident that these minimal funds can be found somewhere in the huge federal budget our tax dollars go to fund. We urge the Commission to push for those funds and will support any legislative effort to add that money to either the Commission's budget or that of any other federal agency that is charged with the responsibility of developing regional KI stockpiles. Sincerely, Steve Haberman Field Director

(J) OHIO DEPARTMENT OF HEALTH ~D

                                                                                                      !; P2
                         - - - - - - - - - - - - - - - - - - - - - - - - - -~H+-+--'                    'r.

May 26, 1999 '~:,: : ~~:'.!~;:~:!: ra1 ~~;~;: *99 24 Ms. Annette L . Vietti - Cook Office of the Secretary of the Commission L~ O' - U.S. Nuclear Regulatory Commission, Mail Stop 0-16Cl Washington, DC 20555-0001 ATTENTION : Docketing and Services Branch DOCKET NUMBER

Dear Ms. Annette L. Vietti-Cook:

PROPOSED RULE .PR S 0

Subject:

Public Distribution of Potassium Iodide l lPl/FR.3/731 Ref. 1: Proceedings of the NRC KI Core Group meetings, March 1 through 5, 1999, in Tempe, Arizona, as downloaded from the Internet .

• Ref. 2: Letter from Ohio Department of Health to USNRC, u Transmittal of Comments by Dr. Ernest L. Mazzaferri to Ohio Department of Health KI Policy and Comments to KI Core Group Proceedings", February 19, 1999.

The recent decision of the Commissioners to not fund the purchase of KI, in our view, is an unfortunate reversal to the goal of providing supplementary protection for the general public. We urge the Commission to reconsider its position in light of the proven usefulness of KI in preventing childhood thyroid cancer. The information gained as a result of Chernobyl should not be ignored in this country. It is not being ignored in countries around the World. Nor in Ohio are we content with the situation that after two years of efforts made by us toward implementing this supplementary protection, the Commissions recent actions undermine our effort. We understand the Commission's financial concerns leading to this decision; however, the Commission could approach Congress for a supplemental appropriation. We urge that you review and reconsider your action on this matter. We unde rstand from a review of the KI Core Group (Ref. 1) proceedings that the NRC Staff is planning to use old (1982) FDA guidance on dosage of KI and intervention levels, absent any new published guidance from FDA. While we understand that the NRC Staff is bound to the timelines that the Commission has set for this task; nevertheless, we would urge the NRC to seek new gui dance on dosage and intervention level from FDA for the next publication of NUREG-1633. Our concern is that continued use of the old guidance subjects children to greater risk than necessary. Roger L. Suppes, Chief Bureau of Radiation Protection RLS/HBB/hb . IJ81ffl File: ki \core-grp. 2 nd mtg. com. doc

                                                                                            ~owledged by card-,,_,--*--=

HEA 6413 (Rev 1/99) An Equal Opportunity Employer/Provider

U.S. UCLEAR REGULATORY COMMI Siu.~ AUl..EMJWM3S&ADJU0tCATI S STAFF OFRCE OF'fHE SECRETARY OFTiiE COMMISSION

pc: Ernest L. Mazzaferri, OSU Deborah L. Arms, ODH, Prevention Harvey B. Brugger, ODH-BRP Frank J. Congel/Aby S. Mosheni, NRC-AEOD Jean Temeck, FDA

DOCKETN BER PROPOSED RULE p SD {& ti FR31131) NUCLEAR REGULATORY COMMISSION "9CJ JUN - 8 A10 :1 2 10 CFR Part 50 RIN: 3150-AG11 Consideration of Potassium Iodide in Emergency Plans AGENCY: Nuclear Regulatory Commission.

• ACTION:

SUMMARY

Proposed rule. The Nuclear Regulatory Commission (NRC) is proposing an amendment to its emergency planning regulations governing the domestic licensing of production and utilization facilities. The proposed rule would amend the current regulations to require that consideration shall be given to including potassium iodide (Kl), as a protective measure for the general public that would supplement sheltering and evacuation. Kl would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant. The proposed rule responds to petitions for rulemaking submitted by Mr. Peter G. Crane concerning the use of Kl in emergency plans.

                                            ~                         /31 l'l'l'I DATES: The comment period expires gg       eaye after p11blication.in the Federal Register.

Comments received after this date will be considered if practical to do so, but only those comments received on or before this date can be assured of consideration.

ADDRESSES: Comments may be sent to the Secretary of the Commission, Attention: Rulemakings and Adjudications Staff, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or may be hand-delivered to One White Flint North, 11555 Rockville Pike, Rockville, MD 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be examined at the Commission's Public Document Room at 2120 L Street NW (Lower Level), Washington, DC. You may also provide comment via the NRC's interactive rulemaking web site on the NRC home page (http://www.nrc.gov). This site provides the availability to upload comments as files in any format that the NRC web browser supports. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG@nrc.gov. FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 . Telephone: (301) 415-3224. Internet: MTJ1 @NRG.GOV. SUPPLEMENTARY INFORMATION: By undertaking this rulemaking, the Commission, while not adopting the exact language suggested by the petitioner, is proposing to grant a petition for rulemaking (PRM-50-63A) submitted by Mr. Peter Crane on Novembt. r 11, 1997. That petition is a revision of a petition (PRM-50-63) that he submitted on September 9, 1995. Considering all public comments received, the information available in the literature, 20 years of experience gained in evaluating licensee emergency preparedness plans, and the arguments presented by the petitioner, the Commission has decided to grant the petition for rulemaking and to proceed with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the following sentence, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KJ), as appropriate." In addition, the preamble for this proposed rule includes a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. When the Commission amended its emergency planning regulations on November 3, 1980, it stated that "any direct funding of State or local governments solely for emergency preparedness purposes by the Federal government would come through FEMA." In its decision on June 30, 1997, the Commission also noted that, the Federal government (most likely the NRC) is prepared to fund the purchase of a stockpile of Kl for the States, upon request. The Commission has determined that notwithstanding the June 30, 1997, intention that "most likely the NRC" would fund the purchase of State stockpiles of KJ, the NRC budget has continued to decrease and offers little margin for the Commission to divert

• resour~ to new initiatives. Historically, funding for State and local emergency response planning has been the responsibility of those governments usually working with licensees. The Commission notes that the Petitioner has not requested the Federal funding of stockpiles of Kl.

In the alternative, the NRC will work with other relevant agencies to ensure that there are established robust, pre-positioned regional stockpiles of Kl, to be effectively and timely used by states that have not established local s_tockpiles and wish to make use of the regional stockpiles in the event of a severe nuclear power plant accident. On November 27, 1995 (60 FR 58256), the Nuclear Regulatory Commission (NRC) published a Notice of Receipt of a petition for rulemaking (PRM-50-63) filed by Mr. Peter G. Crane on his own behalf. The petitioner requested that the NRC amend its regulations concerning emergency planning to include a requirement that emergency planning

                                                                                               \,

protective actions include the prophylactic use of potassium iodide (Kl), which the petitioner notes prevents thyroid cancer after nuclear accidents. On November 11, 1997, the petitioner submitted a revision to his original petition (PRM-50-63A). The NRC published a Notice of Receipt of the amended petition on December 17, 1997 (62 FR 66038). In the amended petition, the petitioner requested that: A statement [be made] clearly recommending stockpiling of Kl as a "reasonable and prudent' measure, and; A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate." The petitioner also provided a marked-up version of the NRC staffs proposed Federal Radiological Preparedness Coordinating Committee (FRPCC) Federal Register notice concerning Federal' policy relating to the use of Kl for the general public. On June 26, 1998 (SRM 98-061 ), the Commission decided to grant the portion of the petition for rulemaking PRM-50-63A regarding the requested amendment to 10 CFR 50.47(b)(10). The Commission also directed that the preambte for the proposed rule include a statement to the effect that State and local decision makers, provided V with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. The NRC staff is also preparing a technical report and an information brochure to enable State and local decision makers to make an informed decision in this matter. Petitioner's Basis for Requesting Potassium Iodide The petitioner stated that potassium iodide (Kl) protects the thyroid gland, which is highly sensitive to radiation from the radioactive iodine that would be released in extremely serious nuclear accidents. By saturating the gland with iodine in a harmless form, Kl prevents any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead to thyroid cancer or other illnesses. The petitioner stated that the drug itseH has a long sheH* life, at least 5 years, and causes negligible side effects. The petitioner further stated that, in addition to preventing deaths from thyroid cancer, Kl prevents radiation*caused illnesses. The petitioner notes that thyroid cancer generally means surgery, radiation treatment, and a lifetime of medication and monitoring. The petitioner, asserted that the changes in medication that go with periodic scans put many patients on ~ physiological and psychological roller coaster. The petitioner stated that hypothyroidism can

• cause permanent retardation in children and, if undiagnosed, can condemn adults to a lifetime of fatigue, weakness, and chills.

The Petitioner's Discussion of the Three Mile Island Accident (TMI) The petitioner noted that in December 1978, the Food and Drug Adminis,ration (FDA) announced that it had determined that Kl was safe and effective for thyroid protection in nuclear accidents. The petitioner stated that the issue attracted little attention, that the NRC and the Federal. Government as a whole took no public position on the drug, and that three months after the FDA announcement, on March 28, 1979, the TMI accident began to unfold. The petitioner stated that Federal and State officials, searching for supplies of Kl in case it should be needed, discovered that none was to be had and that a supply had to be manufactured, literally

                                                                                                       \

overnight. The petitioner indicated that at 3:00 a.m. on Saturday, March 31, 1979, an FDA official arranged with the Mallinckrodt Chemical Company for the immediate production of 250,000 doses of Kl. The petitioner also discussed the Report of the President's Commission on the Accident at Three Mile Island (the Kemeny Commission report), issued in October'1979, and stated that th.e report was strongly critical of the failure to stockpile Kl. The petitioner noted that among the K~meny Commission's major recommendations was that an adequate supply of the radiation protective agent, Kl for human use, should be available regionally for distribution to the general population and workers affected by a radiological emergency. The Petitioner's Discussion of the Potassi_um Iodide Policy The petitioner stated that in NUREG--0632, uNRC Views and Analysis of the Recommendations of the President's Commission on the Accident at TMI,* issued in November " 1979, the NRG agreed with the findings of the Kemeny Commission and planned to require nuclear power plant licensees to have adequate supplies of Kl available for nuclear power plant workers and the general public as part of State emergency response plans. According to the petitioner, the three agencies most concerned, the FDA, the NRG, and the Federal Emergency Management Agency (FEMA), favored the stockpiling of Kl for the next several years. The petitioner stated that the Atomic Industrial Forum, a nuclear industry trade association, declared itself against the stockpiling of. Kl in May 1982. The petitioner indicated that the NRG staff was strongly in favor of Kl stockpiling as late as September 27, 1982, when the NRG staff submitted a memorandum to the Commi$Sioners proposing that the Commission agree with a draft interagency policy statement supporting Kl stockpiling. The petitioner further stated that on October 15, 1982, less than 3 weeks after I sending the draft policy statement to the Commission for approval, the NRC st&ff sent a supplementary memorandum withdrawing the memorandum of September 27. The later memorandum informed the Commissioners that NRC's Office of Nuclear Regulatory Research (RES) could, by January 1, 1983, produce a paper showing that Kl was significantly less cost - beneficial than previously assumed. The NRC staff proposed sending this document to the FDA and FEMA with the recommendation not to stockpile and distribute Kl. The petitioner indicated that the NRC staff briefed the Commission in November 1983 on the NRC staff's proposal to take a strong position against Kl. A policy statement was later issued that disposed of the Kemeny Commission's recommendation which favored stockpiling Kl. According to the petitioner, only a year later, the Chernobyl accident would give tangible proof of the value of the drug in radiological emergencies. The Petitioner's Discussion of the Effects of Chernobyl The petitioner stated that during the Chernobyl accident of 1986, the damaged reactor spewed radioactive iodine over a wide area of what was then the Soviet Union and Poland. The petitioner further stated that in Russia, the Ukraine, and Belarus, where the distribution of' Kl was inadequate and untimely, the population in these countries is now experiencing extraordinarily high levels of childhood thyroid cancer. However, in Poland, where Kl was administered to 97 percent of the nation's children, there has been no similar increase in thyroid cancer. The petitioner noted that Poland is a proof-positive example of the benefits of a well-prepared Kl program. The petitioner stated that the U.S. Government is spending money to study radiation-caused thyroid cancer in the Ukraine and Belarus, and the Department of Energy (DOE) announced a $15 million, 15-year program that will follow 70,000 children in the Ukraine,

                                                                                                  \

to understand the thyr0id cancer risk of exposure to radio iodine. The petitioner further stated that the U.S. Government has spent generously to bring Ukrainian doctors to the United States for training in thyroid surgery because mishandled operations can result in damaged nerves and larynxes, rendering patients permanently mute. The petitioner discussed post-Chernobyl developments on Kl policy. He stated that the Chernobyl accident demonstrated that Kl worked and that countries that failed to stockpile and distribute it are experiencing serious public health problems. The Petitioner's Discussion of the NRC's Reconsideration of Potassium Iodide The petitioner notes that in June 1989, the NRC reconsidered the Kl issue after the petitioner filed a Differing Professional Opinion urging a change in policy. On November 27, 1989, th.!:) American Thyroid Association wrote to the NRC urging Kl stockpiling on a nationwide basis and, in 1990, th~ NRC announced that it was reconsidering the existing Federal policy. In April 1992, a contractor under the sponsorship of the NRC Office of Nuclear Regulatory-Research issued a report that included a revised cost-benefit analysis of the use of Kl. The petitioner described the report as concluding that stockpiling Kl continued to be not cost-effective, but that the difference between costs and benefits was narrower than had been calculated by the NRC staff in the early 1980s. The petitioner further indicated that, in December 1993, an industry trade group, the Nuclear Utility Management and Resources Council, sent a report entitled *Review of Federal Policy on Use of Potassium Iodide," to the Commission arguing against any change in current Kl policy. The petitioner noted that, in March 1994, the NRC staff declared its support for Kl stockpiling. However, the NRC staff proposal for a change in policy was not adopted, the { Commissioners having voted 2 to 2 on the staffs proposal in May 1994. (Under Commission procedures, a tie vote means that a proposal fails.) The Petitioner's Discussion of Additional Support for Granting the Petition for Rulemaking The petitioner described a September 1994, FEMA publication proposing a *Federal Radiological Emergency Response Plan* that envisioned the use of Kl during radiological emergencies. Under the plan, the NRC would be the lead Federal agency during emergencies at nuclear power plants and would advise State and local governments whether or not to

• distribute Kl (based on advice received from an interagency panel). The States and localities would then administer the Kl, if necessary.

The petitioner also indicated that the Board of Governors of the International Atomic Energy Agency, with U.S. Government support, adopted new International Basic Safety Standards in 1994. The petitioner stated that these standards represented the consensus of the world's experts on radiation. safety and the standards provide, among other things, that intervention levels of immediate protective actions, including sheltering, evacuation, and iodine

• prophylaxis, shall be specified in emergency plans. Thus, the petitioner stated, the international radiation protection community, like the Kemeny Commission in 1979 and the short-lived draft Federal policy statement of 1982, recognized that effective preparedness for radiological emergencies means having three actions to consider [evacuation, sheltering and iodine prophylaxis].

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The Petitioner's Discussion of the Merits of the Petition for Rulemaking The petitioner believes the NRC should implement the recommendation of the Kemeny Commission and that the United States should maintain the option of using the drug Kl for public thyroid protection during nuclear accidents. The petitioner requested that the Commission definitively review and decide on the issue rather than simply h~ving the NRC staff decide not to propose it to the Commission. The petitioner stated that evacuation is not necessarily the protective measure of choice in every emergency, and even when it is the preferred option, it is not always feasible. The Kemeny Commission report explained that different types of accidents, and the particular circumstances presented, may call for different protective measures. The petitioner notes that maintaining a Kl option ensures that responsible authorities have the option of additional protection at their disposal. The petitioner indicated that r NRC has made it clear that a finding of adequate emergency planning does not translate into a guarantee that the entire affected public can be evacuated, but that evacuation is generally feasible. The petitioner believes that sometimes, either by choice or necessity, authorities may decide to shelter people or tell them to remain indoors rather than evacuate them. The petitioner points out that it may be desirable to administer Kl any time people are sheltered or told to stay indoors, when evacuation rou:~s would take people through areas of radiological contamination, and when there has been a large airborne release of radioactive iodine to the atmosphere. The petitioner believes that the decision on stockpiling Kl should tum on whether, given the enormous consequences of being without it in a major accident, the drug is a prudent measure; not on whether it will necessarily pay for itself over time. The petitioner further believes that Kl represents a kind of catastrophic-coverage insurance policy offering protection for events which, while they occur only rarely, have such enormous consequences that it is sensible to take special precautions. The petitioner stated that the estimates of Ki's cost-effectiveness depend on estimates that are no more than informed guesses about the probability of severe accidents and_that the NRC's cost-benefit analysis of the early 1980s was based on the assumption that a severe accident with a major release of radioactivity could occur in this country only once every 1 or 2 thousand years. The petitioner believes that if it were really true that serious accidents with a release of radioactivity were so unlikely, there would be good reason r:tot only to reject stockpiling of Kl but also to dispense with all emergency planning. The petitioner also stated that if Kl is not cost-effective, then the rest of nuclear emergency planning is probably not cost-effective either. The petitioner believes that cost-benefit analysis is a technique that should be applied* with good sense, especially where public health measures are concerned. According to the petitioner, the cost-benefit analysis of Kl proceeded from the assumption that there was no difference in desirability between prevention of radiation-caused thyroid disease and cure. Thus, the only factor to be considered in evaluating Kl was the cost~ The petitioner also believes that the U.S. Government determined that *instead of spending money to prevent radiation-caused thyroid disease, society should spend its money treating the disease if and when it occurs. The petitioner believes that the existing policy on Kl was defective from the start because it was based, in part, on inaccurate information provided to the NRC Commissioners. He stated that the information provided to the NRC Commissioners seriously understated the significance of radiation-caused thyroid disease and thereby understated to an equal degree the value of Kl.

                                                                                                       )

The petitioner also believes that it was not clear that the Commission had any idea of the real nature of post-accident thyroid disease at the time it adopted an anti-Kl position. The petitioner stated that existing policy left the judgment on stockpiling Kl to the States. The petitioner asserts that this policy also ensures that the States do not have an adequate basis for making informed decisions. He believes that the Federal Government, and NRC in particular, has failed to provide the States with sound technical advice on the subject. The petitioner also believes that without accurate and current information on Kl-including the Chernobyl experience and the consensus of international experts-States cannot make an informed judgment. The petitioner believes that no State or local official or member of the public could imagine that in a real emergency, there would be no Kl to administer. The petitioner raised the question: If Kl stockpiling is not worthwhile, why is the administration of the drug one of the protective measures identified in the 1994 Federal Emergency Response Plan? He also asked why, if Kl is worthwhile, as the plan implies, something is not being done to make sure that it is available .

       . The petitioner believes that the Federal Government should either change the 1985 policy and make the use of Kl a viable option in a real emergency, or it should explain why the United States has decided that Kl will not *be an option.

The Petitioner's Proposed Amendment to the NRC Regulations In the original petition (PRM-50-63) that was submitted on September 9, 1995, the petitioner requested that 10 CFR Part 50 be amended to include language taken from FEMNs Federal Radiological, Emergency Response Plan of September 1994, and recommended the following r~vision to the regulations. The petitioner proposed that Section 50.47(b)(10) be amended to read as follows: (10) A range of protective actions including sheltering. evacuation and prophylactic use of iodine have been developed for the plume exposure pathway EPZ [emergency planning zone] for emergency workers and the public. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidelines, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed. In the revised petition (PRM-50-63A) that was submitted on November 11, 1997, the petitioner requested that 1o CFR 50.47(b) be revised to read: (10) A range of protective action have been developed for the r plume exposure EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate. Guidelines for the

• choice of protective actions during an emergency, consistent with Federal guidelines, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed.

The petitioner believes that if this revised change is adopted, the plan will become an accurate description of emergency preparedness for radiological emergencies; the recommendation of the Kemeny Commission will at last be implemented; and the United States will be in compliance with the International Basic Safety Standards. The petitioner suggested that the NRC, either on its own or jointly with other agencies, issue a policy statement declaring that Kl stockpiling is a reasonable and prudent measure that is necessary to ensure that the drug will be available in the event of a major accident. The petitioner believes that this statement would clarify that Kl can be used in conjunction with evacuation and sheltering to maximize protection to the public. The petitioner also believes that the policy statement would show the willingness of the NRC to provide a stockpile of the drug to States and localities upon request, and would support the Kemeny Commission's recommendation to create regional stockpiles of the drug as a backup for emergencies. Discussion

• Stockpile of Medicinal Supplies for Nuclear, Biological, and Chemical Agents (1995)

In June 1995, the President issued Presidential Decision Directive.39 (PDD-39) on U.S. Policy on Counter Terrorism. The PDD-39 directed Federal agencies to take a number of measures to reduce vulnerability to terrorism, to deter and respond to such acts, and to strengthen capabilities to prevent and manage the consequences of terrorist use of nuclear, biological, and chemical (NBC) weapons, including weapons of mass destruction. The PDD-39 assigned to FEMA the task of ensuring that the Federal Response Plan (FRP) was adequate to respond to the consequences of terrorism. FEMA, In coordination with the Catastrophic Disaster Response Group (CDRG) 1 , developed a draft report to the President entitled, "An Assessment of Federal Consequence 1 The CDRG is the headquarters senior-level coordinating group which addressees policy issues regarding the Federal Response Plan (FRP). The CDRG is chaired by FEMA and comprises of representatives of Federal departments and agencies with responsibilities under the FRP. The NRC is represented by the Incident Response DMsion Director, AEOD. Management Capabilities for Response to Nuclear, Biological or Chemical (NBS) Terrorism," dated June 12, 1996. The report recommended, among other things, that the Federal Government purchase and stockpile thyroid blocking agents (Kl) for the general public that could be used in the event of a nuclear terrorist event. The NRC was a member of the Core Group which generated the recommendations and was instrumental in adding Kl to the list of medical supplies to be stockpiled nationally. The Core Group concluded that as the result of recent events, significant threats over the past few years, and the increased availability and proliferation of NBC materials, there is an increasing concern for the potential of terrorist incidents. NBC events, the report continued, may occur as a local event with potentially profound national implications. In responding to these events, the first responders must be able to provide critical resources to the victims. These include, but are not limited to, chemical nerve antidotes, vaccines for anthrax, and antibiotics. The Core Group identified the need to purchase and preposition stockpiles of adequate medical supplies at the Federal, State, and local level. While Kl was not considered as vital as chemical nerve antidotes and vaccines, the NRC staff was successful in getting Kl included with other medical supplies for NBC events because of the unusual characteristics of

• these events.

Because of the special characteristics of NBC events, the Core Group recommended a broader range of protective actions. The NRC concurred in the findings of the report in a letter dated September 25, 1996, from the Director of NRC's Office of Analysis and Evaluation of Operational Data to FEMA's Director. The report was subsequently presented to the President in February 1997, and approved for distribution in May 1997. However, FEMA recently reported that the federal stockpiles of Kl are few and stocked only for first responders to terrorist action. As things stand now, needs of members of the public for Kl on an ad hoc basis would have to be supplied from othe:- sources. As stated above, the Commission intends to work with FEMA to assure that stockpiles contain adequate supplies of Kl. FRPGG Subcommittee on Kl (1996). Along with petitioning the NRG, Mr. Crane also requested that FEMA review his petition and reconsider the Federal policy. In early 1996, the FRPCG convened an Ad-Hoc Subcommittee on Potassium Iodide to request and review new information on this matter from interested parties. The subcommittee conducted a public meeting on June 27, 1996. The subcommittee evaluated all comments from the June 27 public meeting and made the following recommendation regarding the Federal Kl policy: 1: Without changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether to use Kl, the Federal Government (NRG, or through FEMA) should fund the purchase of a stockpile for a State that decides to incorporate Kl as a protective measure for the general public;

2. The Subcommittee believes the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many interveners observe with the Federal policy is the italicized statement "The Federal position with ... potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were reworded to state "it [potassium Iodide for use by the general public] is not required, but may be selected as a protective measure at the option of the State or, in some cases, local governments."

3. The subcommittee recommends that local jurisdictions that wish to incorporate Kl as a protective action for the general public should consult with the State to determine if these arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include this measure in their emergency plans.

Analysis of Issues Raised by Public Comments The Commission has considered the Kl policy question on numerous occasions since 1984. The voting history of the Commission shows that reaching consensus on this policy question has been an elusive goal. An important reason for this historical lack of consensus is that this policy question is not a clear cut one. Individual Commissioners, past and present, have differed in their views -with respect to the relative importance to be given to factors bearing on the Kl issue. These honest differences have led to dMded Commission views on how to resolve the policy question. The Commission is agreed that its historical difficulty to reach consensus on the Kl policy question underscores the reality that this policy question is not a simple one, is not one that is easily resolved and, as a result, has been the subject of protracted deliberation. On November 5, 1997, the Commission held a public meeting with its staff, FEMA representatives, and the author of the 1995 rulemaking petition to consider the petition and proposed changes to the Federal policy on the use of Kl. In part as a result of the meeting, the petitioner amended his petition to ask for a rule that would require that consideration would be given in the formulation of emergency plans to the use of Kl as a supplement to evacuation or sheltering, and on June 26, 1998, the Commission granted the amended petition, and directed the NRC staff to initiate the requested rulemaking. The Commissioners also decided that the FRPCC Federal Register notice on Federal Kl policy should include a statement to the effect that the State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. On September 30, 1998, the Commission approved a draft Federal Register notice and directed that it be sent to the FRPCC. On November 27, 1995 (60 FR 58256), a Notice of Receipt of the Petition for Rulemaking was published in the Federal Register requesting public comment. A total of 63 comment letters were received, of which 20 utilities, 9 State governmental agencies, 2 utility interest organizations, 1 letter signed by 12 health physicists, 2 State universities and 1 member of the public were against the granting of the petition for rulemaking. Those letters in favor of granting the petition came from 5 environmental groups, 22 members of the public (including 1 from the petitioner), and the American Thyroid Association. On December 17, 1997 (62 FR 6138), the Commission published a request for public comment on the revised petition in the Federal Register. In response to several requests, the comment period was extended until February 17, 1998, by a Federal Register notice published on January 21, 1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 utilities, 3 State governmental agencies, 1 utility interest association, and 1 member of the public were against granting the petition for rulemaking. The letters in favor of granting the petition came from 8 public interest groups, 46 members of the public (including 1 from the petitioner), 3 physicians, 2 U.S. Senators, and 1 State Representative. The foll~wi,1g issues were raised by the public commenters with an accompanying NRC staff response: Issue 1 Nearly all nations with nuclear power protect their citizens by having Kl readily available and the logistics of distribution do not seen to pose any significant problems. Would implementing a policy of using Kl for the general public be so difficult? Staff Response At the November 5, 1997, Commission meeting, senior NRC staff members told the Commission: "We recognize that there are difficulties in distribution, but they are not insurmountable. If a decision is made by the State to do it [stockpile and/or predistribute Kl] we can figure out a way to do it." It is the staffs perception that if the States decides to include Kl as a supplemental protective measure for the general public, one possible method of implementation could be that the State could make Kl readily available where other over-the-counter drugs can be purchased. The public could be informed of the drug's availability through the yearly emergency preparedness information brochure that r is mailed out to all residents throughout the 1O mile EPZ. It would then be up to individual members of the public to obtain and store this supply of Kl, which should then be available for use in the event of an emergency. The administration of the Kl could be at the direction of the State Medical Officer. Issue 2 It is "factual that the 1986 Chernobyl accident clearly demonstrated the benefit of having Kl readily available. In Poland, where authorities expediently administered 18 million doses of Kl, 97 percent of all Polish children were protected from thyroid disease. In contrast, there are soaring rates of childhood thyroid cancer, 200 times pre-Chernobyl levels, in the former Soviet republics of Russia, Belarus, and the Ukraine because very little Kl was administered, too long after exposure." Staff Response The Chernobyl reactor (a RBMK-1000 design) is located in the Ukraine close to Belarus. The accident occurred at 01 :23 on Saturday, 26 April 1986, when explosions destroyed the reactor core and reactor building. The explosions sent debris from the core flying into the air and exposed the reactor core to the atmosphere. The heavier debris from the plume was deposited close to the site. In general, the initial release is thought to have risen to over 1 km in altitude, thereby resulting in much lower doses close to the site than those expected from a ground level release. The major release lasted 10 days, during which most of the noble gases and more than 40 percent of the iodines are estimated to have been released. The varying meteorological conditions, release rates, and release heights resulted in very complex dose and ground deposition patterns. It is often assumed that ingestion was the major source of thyroid dose early in the accident However, the contribution of inhalation cannot be assessed because air sampling was not effectively conducted early in the accident. As of 1996, except for thyroid cancer, there has been no confirmed increase in the rates of other cancers,

Including leukemia, among the first responders, liquidators,2 or the public, that have been attributed to release from the accident. Belarus Experience. With the Chernobyl plant located only 4 miles (7 km) away, Belarus was heavily impacted by the accident. This impact was heightened by the fact that protective actions were not implemented in Belarus during the first six days after the accident. Several authors have stated that Kl was distributed to the population in Belarus during the first week following the accident. 3 However, there is no confirmed published data on the dosage, coverage, or other details concerning the implementation of the thyroid blocking in Belarus. 4 In addition, cows typically grazed in Belarus at the time of year when the accident occurred, and yet no efforts were taken to restrict the consumption of contaminated milk for the first 10 days following the accident. On May 2 (day 7 following the accident) the decision was made to evacuate the areas of Belarus and Ukraine within 18 miles (30 km) of the plant (30 km zone). The evacuation was completed on May 5, 1986. Since 1990, a rapid increase has been observed in the incidence in thyroid cancer among Belarus children who were O to 14 years old at the time of the accident. Before the accident, the rate of thyroid cancer among this cohort was about 0.4 per 100,000; by 1996, this 2 Liquidators are a large number (about 200,000) of workers and military personnel who performed cleanup, construction of the sarcophagus, and other operations i.n the contaminated zones following the accident. 3 Personal communication, E. Buglova M.D., Head Laboratory of Radiation Hygiene and Risk Analysis, Ministry of Health, Republic of Belarus, December 1997. 4 "Thyroid Cancer in Children Living Near Chernobyl, Expert Panel Report on the Consequences of the Chernobyl Accident" - Williams D. et al., K.H. ECSL-EAEC, Report EUR 15248 EN, Brussels-Luxembourg, 1993, p. 108. rate had risen to 3.9 per 100,000.5 *8 This included approximately 3,000 children, Oto 18 years old, that were evacuated from the 30-km zone within Belarus. Among this group, four thyroid cancer cases have been detected since the accident. All of these cases were registered after the end of the latent period for radiation-induced thyroid cancer. Taking into account the spontaneous rate of this disease in this age group and the number of evacuated persons, all of these cases are considered accident-induced. The total number of excess thyroid cancers in Belarus children is currently about 750, and is estimated to reach a maximum of more than 3500 over the lifetime of this cohort. 3 *4 *8 The vast majority of the thyroid cancers were diagnosed among those living more than 50 km (31 miles) from the site. The increase in the rate of thyroid cancers in Belarus is concentrated among those who were youngest at the time of the accident. Fortunately, these cancers respond favorably to early treatment; to date, two or three of the Belarus children diagnosed with thyroid cancer have died as a result of that disease. 8 Poland Experience. Poland detected increased levels of airborne radioactive contamination on the night of April 27, 1986 (day 2). Although there was no official notification of the accident by the USSR, it was assumed, on the basis of Tass News Agency reports, that the increase were attributable to the accident at Chernobyl. On April 28 (day 3), the country formed a governmental commission to recommend protective actions. Among these actions, 5 E. Buglova et al., "Thyroid Cancer in Belarus After the Chernobyl Accident; Incidence, Prognosis, Risk Assessment." Low Doses of Ionizing Radiation: Biological Effects and Regulator Control, Spain, November 1997, Contributed Paper, pp. 280-284. suThyroid Cancer Incidence Rate in the Republic of Belarus." Okeanov A. et al., Radiation and Risk Bulletin of National Radio-Epidemiological Registry, Obninsk., 1995, Issue 6, pp. 236, 239. the commission recommended intervention levels for taking protective actions on the morning of April 29 (day 4). 7 On April 29, Poland's Minister of Health gave orders to prepare and distribute Kl to the 11 provinces most affected. Kl was to be made available through hospitals, public health centers, schools, and kindergartens. The country used its mass media to announce the protective action and to appeal for volunteers to assist in the nationwide distribution. The Commission then instityted the following additional protective measures: 8

• Feeding of cows on pastures or with fresh fodder was banned countrywide until May 15, 1986.

Fresh milk with radioactMty concentration above* 1,000 Bq/L was banned for consumption by children and pregnant or lactating women. All children under the age of 4 were given powdered milk through numerous distribution centers.

• Children and pregnant or lactating women were advised to eat a minimum of fresh leafy vegetables (until May 16, 1986).

The distribution of Kl was initiated on April 29 (day 4) and was virtually completed by May 2 (day 7). This included the distribution of Kl to more than 90 percent of the children under the age of 16 and about a quarter of the adults. A total of 10.5 million doses of Kl were given to children and 7 million doses were given to adults. Multiple doses, although not recommended, were taken in a number of cases. Because of diminishing air contamination, the Kl prophylaxis 7 The Implementation of Short-term Countermeasures After a Nuclear Accident, Proceeding of an NEA Workshop Stockholm," Sweden, 1-3 June 1994, OECD 1995. 8 Manual on Public Health Actions in Radiation Emergencies, WHO, European Center of Environmental and Health, Rome Division, 1995. was not repeated. In the second phase of the response, powdered milk was made available to all children less than 4 years of age. This program effectively started on May 3 (day 8). It is estimated that approximately a 40-45 percent reduction in thyroid burden was achieved by thyroid blocking and milk restrictions in the 11 provinces treated.7 Had the Russian authorities given prompt warning, the 24- or 48-hour gain in time might have improved the effectiveness of their response. There were no reported serious adverse reactions except for two adults with known iodide sensitivity. About 36,000 medically significant reactions were also reported (mostly nausea). 9 Because of the low iodine concentrations in Poland it is doubtful that epidemiological studies could detect excess cancers resulting from intake of radio iodine. 8 International Practices - During this assessment, the NRC staff examined the current policies and practices regarding the use of thyroid blocking during Nuclear Power Plant accidents for a number of countries. The NRG staff accomplished this task primarily through personal communication with colleagues in each country. In general, the countries either are following or intend to implement systems that are consistent with the guidance promulgated by the World Health Organization (WHO). Specifically, the WHO recommends predistribution of stable iodine close to the site and stockpiles further from the site. These stocks should be strategically stored at points such as schools, hospitals, pharmacies, fire stations, or police stations, thereby allowing prompt distribution. A further description of the WHO guidance is 9 A "medically significant" reaction was one for which the person suffering the reaction consulted a physician more than once. Nauman and Wolff, "Iodide Prophylaxis in Poland After the Chernobyl Reactor Accident Benefits and Risks," The American Journal of Medicine, Vol. 94, May 1993, p.530. About .2% of the population that received Kl had "medically significant" adverse reactions to Kl. Id. However, "[i]t should be pointed out that control values for these side effects in a population not receMng Kl are not available." Id.' That is, it is not known what the incidence of such reactions would be in a population under similar stress, but not receiving Kl, and thus it is not known to what extent these adverse reactions were the result of Kl. provided below, followed by a discussion of the guidance promulgated by IAEA and a comparison between U.S. and international practice. World Health Organization (WHO) Guidance. The main point$ of the WHO Guidelines 10*11 regarding the use of stable iodine are as follows:

• Near field: Stable iodine should be available for immediate distribution to all groups if the predicted thyroid dose is likely to exceed national reference levels. Close to nuclear installations iodine tablets should be stored or predistributed to facilitate prompt utilization.
• Far field: Stable iodine should be available for distribution to pregnant women, neonates, infants, and children if the predicted dose is likely to exceed ref ere nee levels.

Conclusion from Polish Experience. In Poland (1) Small amounts of radioactive iodine were deposited as a result of the Chernobyl accident, (2) no protective actions were taken for the first 2 days of the accident, and (3) protective actions (except sheltering or evacuation) were taken after the first'2 days of the accident. Because of the low iodine

• concentrations in Poland and the protective actions implemented, Poland has not detected excess cancers resulting from intake of radio iodines.

Overall Chernobyl Conclusion. The World Health Organization, almost every industrial country in the world with nuclear power plants, and the American Thyroid Association, beli9ve that the low iodine concentrations, the banning*of the consumption of fresh milk and the distribution and administration of 90 million doses of Kl contributed to the *observed lack of 10 lntemational Basic Safety Standards for Protection Against Ionizing Radiation and for Safety of Radiation Sources, Safety Series No. 115, IAEA, 1996. 11 "Method for the Development of Emergency Response Preparedness for Nuclear or Radiological Accident," Tecdoc-953, IAEA, July 1997. increase of childhood thyroid cancers in Poland. Most industrial nations with nuclear power plants have decided to stoekplle Kl around nuclear power for use by the general public. In contrast to the Chernobyl experience, in the event of an accident in the United States, our emergency planning calls for p.rotective actions, sheltering, evacuation, and removal of contaminated food from consumption all of which significantly reduce the risk of exposure of the public to all radionuclides. Making Kl available to the public for use during evacuation or especially sheltering could, under certaln conditions, reduce the risk resulting from exposure to one important group of radionuclides, the radioiodines. That is why current NRG guidance discusses Kl for plant personnel, emergency workers, and institutionalized persons unlikely to be evacuated promJ?tly. In this light the Commission agrees that the use of Kl may be determined by State and local emergency response planners to be a supplementary protective measure. Issue 3 "Stockpiling or predistribution of potassium iodide (Kl) as a protectiye action would not add any significant public health and safety benefit to the current level of protection provided by existing emergency plans for commercial nuclear power plants. Our emergency plans focus on evacuation as the key protective action to prevent exposure since it protects against exposure to all radionuclides, not just iodine. In addition, the potential for misadministration of Kl is present when predistributed to the general public, and incidents of misadministration have been informally reported at industry meetings by states which predistributed Kl to the public." Staff Response The Commissio11 agrees that it is the State's prerogative to decide to include stockpiling or predistribution of K~ as a protective action for the general public. The FDA concluded that risks from short term use of relatively low I. doses of* Kl are out weighed by the radiologically induced thyroid nodules or cancers at a projected dose to the thyroid gland of 25 rem or greater. In so doing, the FDA approved Kl as an over*the-counter drug. The American Thyroid Association fully endorses the use of Kl and, as previously discussed, there were only 2 significant adverse reactions and 36,000 medically significant reactions (nausea) in 90 million doses of Kl after the Chernobyl accident . The taking of Kl should require precautions similar to those associated with any other over*the counter drug, and, of course, the packaging instructions should be followed., Issue 4 "Evacuation is more feasible and practicable. Stockpiling of Kl has logistical problems which we feel renders this idea impracticable and unmanageable." Staff Response: The staff agrees that evacuation is usually "feasible and practicable" and is the most effective protective action. If the State decides to include Kl as a supplemental protective measure for the general public, one possible method of implementation could

• be that the State could make Kl readily available such as by making it available where other over*tha.counter drugs can be purchased. The public could be informed of the drug's availability through the yearly emergency preparedness information brochure that is mailed out to all residents throughout the 10 mile EPZ. Individual members of the public would be responsible for obtaining and storing this supply of Kl, which could then be available for use in the event of an emergency. Another approach to predistribution is to include stockpiling at reception centers for distribution during an evacuation. Other countries have found ways to effectively distribute Kl when needed and the distribution issue is certainly not unsurmountable. The administration of the Kl should be at the direction of the State Medical Officer.

Issue 5 The Three Mile Island experience has shown us that it is not easy to obtain an adequate supply of Kl in an emergency. Staff Response: The commenter is correct, in that it was difficult to obtain Kl after the Three Mile Island accident. That is one reason why the Commission believes that planners should consider stockpiling Kl, and why the Commission supports Federal stockpiles, so that States that have chosen not to stockpile Kl could have access, albeit ad hoc and delayed, to an adequate supply in a radiological emergency at a nuclear power plant. As noted elsewhere in this notice, the Commission will work with other agencies to assure that there are Federal regional stockpiles that contain adequate supplies of Kl. Moreover, the general availability of Kl is greater now than at the time of the TMI accident, partly because of the FDA's approval of Kl as an over the counter drug. Some States have elected to incorporate Kl into the emergency response plans and have obtained adequate supplies for this purpose. The Commission is not aware of any factors that would constrain the availability of Kl for stockpiling purposes. The I Commission believes that an adequate supply of Kl could be obtained. Issue 6 Even though Kl administration before any exposure is ideal, the Chernobyl experience also has shown that the exposure can continue for days. Is the institution of Kl blockade at any time in this period beneficial? Staff Response The administration of Kl is most effeptive if done before or immediately after (within 2 to 4 hours) a release. Nonetheless, during a chronic exposure of several days, the administration of Kl any time during the exposure period may block some uptake of radioactive iodine. However, the benefit diminishes quickly over time and may be very small if administered late. If a release is expected to continue for several days, the NRG anticipates that the public would be evacuated or other protective action would be taken, depending on the level of release. Kl could nevertheless serve as a useful supplemental and complement to these primary protective actions. Issue 7

• Kl is an effective thyroid blocking agent only when administered immediately before or after an exposure to radioactive iodine (that is, within one to two hours). Distribution of Kl in a timely fashion to the general public following an accident could further complicate and decrease the effectiveness of implementing evacuation or residential sheltering.

Staff Response The staff disagrees with this position. If a State chooses to include Kl as an additional protective measure, it is anticipated that the State could make Kl readily available to the public where other over-the-counter medicines are available or by other distribution means and that the public be made aware of its (the Kl) availability, not at the time of an emergency, but Kl could be made available year round. Issue 8 One of the major impediments to distribution of Kl to school children is coordination and administration of the program, e.g., the actual decision making process to administer Kl or evacuate, parental approval and recordkeeping, identification and documenting allergic reactions, and the availability of a qualified medical professional to administer the potassium iodide. Staff Response The staff disagrees. Upon declaration of a general emergency there should be NO decision "to administer Kl or evacuate." The preferred protective action for the close-in population should be evacuation. The administration of Kl should be treated in the same fashion as any other over-the-counter medication that might be given to children while away from home, after observing the instructions provided with the Kl packaging. Prior parental approval to administer Kl in the event of an emergency can and should be addressed in the planning process for any State that decides to use Kl. The individual State may provide the appropriate guidance and establish a system for obtaining parental approval before the taking of other protective actions that are currently being followed in the EPZ around nuclear power plants. Issue 9 Does the post-Chernobyl Polish experience show that large-scale deployment of Kl is safe? Staff Response Approximately 18 million doses of Kl were distributed primarily, but not exclusively, to children. The bulk of the distribution took about three days. There were no reported serious adverse reactions except for two adults with known iodide sensitivity. The rate of serious side effects (10*1 ) is consistent with the frequency seen during routine use of Kl for medical treatment of respiratory disease. The incidence of medically significant, but not serious, reactions to this single dose of Kl was also very low (0.2 percent). In addition, no detectable long-term disturbance in children's thyroid function was detected as of 1989. Additionally, the FDA has approved Kl for over-the-counter distribution. The staff, therefore, agrees that the post-Chernobyl experience has shown that large-scale deployment of Kl is relatively safe. Issue 10 Several comments raised the question of liability: "ls the NRG prepared to address the number of legal implications should a member of the general public be given Kl at their directive or recommendation and the indMdual have an extreme allergic reaction,

• possibly death?"; "The Federal Register Notice does not address legal issues for states who decide to adopt Kl and states who do not decide to adopt or administer Kl to the public."; "The issue of legal liability should not be dismissed lightly. If the NRG decides to require stockpiling of Kl for the general public, has NRG considered what liability may arise from any adverse health effects? No initiative such as this should be undertaken without resolution of this issue."; 'Who would assume liability if the Kl was used prior to the Governor ordering its use?,"

Staff Response The coml"T"ents focus principally on concerns that State and local governments involved in distribution and administration of Kl may be liable in tort if an individual receiving the Kl has a significant advers~ medical reaction to the Kl. To the extent that commenters are raising the potential for federal government liability for the promulgation of this proposed rule, the NRC believes that whether the Commission may be subject to tort liability through the implementation of a Kl program depends upon a number of factors. However, it would appear that a Commission decision to require state and local emergency planning officials to consider stockpiling Kl for public distribution should be subject to the "discretionary function" exception to the Federal Tort Claims Act, 28 USC 2671, et seq., 12 which protects the Federal Government from liability. The question of whether a State or locality might be liable for involvement with administration of Kl to the general public can only be answered by reference to the laws and precedents of particular States. The NRC presumes that this would be part of the "consideration" that States and localities will undertake if this rule is promulgated. fhe NRC has not undertaken this analysis. 1 2This exception from waiver of sovereign immunity provides that: Any claims based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused. 28 USC 2680(a). United States v. Varig Airlines, 467 U.S. 797, 808 (1984); Berkovitz v. United States, 486 U.S. 531 (1988). Issue 11 Does the Commission consider stockpiling and using Kl as a reasonable and prudent protective measure for the general public? Staff Response The Commission believes that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement to evacuation and sheltering is reasonable and prudent for specific local conditions. Commission Decision Kl is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific local conditions. Therefore, the Commission's guidance on emergency planning has long taken Kl into consideration (NUREG-0654/FEMA-REP-1, Rev. 1, p. 63, items e and f.). However, since the last revision of that guidan::e, there has been experience with the mass distribution of Kl during a radiological emergency, and though the record on that distribution is not complete, the indications thus far are that mass distribution is effective in preventing thyroid cancer and causes remarkable few threatening side effects. Moreover, many nations in Europe and elsewhere, nations as different in their circumstances, politics, and regulatory structures as France, Canada, and Japan, have stockpiled Kl and planned for its use. So have some U.S. States. The World Health Organization and the International Atomic Energy Agency recommend its use. Therefore, in order to achieve greater assurance that Kl will receive due attention by planners, it seems reasonable to take a small further step and, continuing to recognize the authority of the States in matters of emergency planning, explicitly require that planners consider the use of Kl. The proposed rule change should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought On the contrary, present indications are that nuclear power plant safety has improved since the current, emergency planning requirements were put in place after the Three Mile Island accident. The use of potassium iodide is intended to supplement, not to replace, other protective measures. This rule change thus represents no alteration in the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs, whenever that is feasible. (Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid.) Depending on I the circumstances, Kl may offer additional .protection if used in conjunction with evacuation and/or sheltering. The NRC recognizes that the decision to stockpile Kl presents issues of how best to position and distribute the medicine, to ensure, e.g., that optimaJ distribution takes place in an emergency, with first priority given to protecting children; that persons with known aJlergies to iodine not take it; that members of the public understand that Kl is not a substrtute for measures that protect the whole body; etc. To date, these issues have been addressed in different ways in the numerous countries that currently stockpile Kl. The NRC is working with States and locaJities to develop guidance on these and other points relating to the use of Kl. The NRC believes that these implementation issues can be solved, given the level of expertise in the relevaht Federal and State agencies, and the experience of numerous nations that have built Kl into their emergency plans. It is expected that States will inform FEMA and the NRC of the results of their consideration of whether to opt for stockpiling. This will enable the Federal government to engage in better contingency planning for States that decide against stockpiling Kl. The Commission decision is implemented by publication of this proposed rule that would change 10 CFR 50.47(b)(10) ~ a 90-day public comment period. If the proposed rule is adopted in final form, the petition would be granted in part and denied in part and NRC action would be completed on PRM 50-63 and PRM 50-63A. Commission Conclusions or Issues Raised by the Petitioner and Public Commenters The Commission having reviewed the issues raised by the petitioner and the public commenters, has reached the following conclusions: A. The Commission agrees that Kl, when determined by State and local emergency response planners and if administered in a timely fashion, could protect the thyroid gland from exposure to radioiodines inhaled or ingested following a major radiological accident. This is the basis for stockpiling it and distributing it to emergency workers and institutionalized persons during radiological emergencies. The petitioner believes that the distribution of Kl was inadequate and untimely in the Ukraine and Belarus after the Chernobyl accident in 1986 and that this accounts for the increased incidence of thyroid cancer in these areas, He also argues that distribution of Kl in Poland was timely and effective and that no similar increase in the I incidence of thyroid cancer was seen. The Commission considered all of the above information in deciding to grant the petitioner's requested actions. B. The Kemeny Commission criticized the failure to stockpile Kl and recommended that regional stockpiles be established. The Kemeny Commission's report recognized that evacuation was not invariably the preferred response to an emergency and that even when evacuation was desirable, it might not be feasible. The Commission believes that prompt evacuation and/or sheltering are the generally preferred protective measures for severe reactor accidents. In developing the range of public protective actions for severe accidents at commercial nuclear power plants, evacuation and in-place sheltering provide adequate protection for the general public. The Commission believes that Kl for the general public should not replace evacuation and sheltering, but supplement them. C. The Federal Radiological Emergency Response Plan (FRERP) is the plan that would be used by the Federal Government to support State and local officials in responding to any peacetime radiological emergency. Such emergencies range from transportation accidents invoMng radioactive materials to terrorist events involving nuclear materials. The FRERP includes a range of protective actions commensurate with the risks associated with the range of emergencies for the general public and emergency workers. These protective actions include evacuation, sheltering, and the prophylactic use of stable iodine. With respect to protective actions for nuclear power plants, the NRC and FEMA have issued Draft Supplement 3 to NUREG-0654/FEMA-REP-1, Rev. 1, to provide updated guidance for the development of protectiv~ action recommendations for severe reactor accidents. This document emphasizes that prompt evacuation is the preferred protective action for actual or projected severe core damage accidents. D. The Commission recognizes that in 1994 the Board of Governors of the IAEA adopted new International Basic Safety Standards. With respect to emergency planning, these standards provide, among other things, "intervention levels for immediate protective action, including sheltering, evacuation, and iodine prophylaxis." It is important to note that each country bases its response plans on local and regional characteristics. For example, Italy and France, using the same international standards and guidelines, implement them differently. E. Although the cost of Kl tablets has doubled, the Commission agrees with the NRC staff estimate and other nations' experience, that the purchase of Kl tablets is relatively inexpensive. Kl-related costs increase when the cost of maintenance, distribution, and public education are considered. However, the overall cost is minimal when placed in the context of emergency planning and should not be a deterrent to stockpiling Kl for use by the general public should State and local decision makers detennine that the prophylactic use of Kl as a supplement to evacuation and sheltering is appropriate. F. The Commission believes that robust regional stockpiles should be established to enable use by States that have not established local stockpiles and wish to make use of Kl in the event of a severe nuclear power plant accident. Commission decision to fund Kl: On June 30, 1997, the Commission voted to approve the NRC staff recommendation to endorse the FRPCC recommendations for the Federal Government to fund the purchase of potassium iodide (Kl) for States at their request and endorsed the FRPCC recognition of the availability of the Federal ~tockpile of Kl to State and local governments for purposes of mitigating the consequences of terrorist use of nuclear, biological, or chemical (NBC) weapons. At that time it was believed that the NRC was the likely Federal agency to fund the stockpiling. Historically, funding for State and local; emergency response planning has been the responsibility of those governments usually working with licensees and, absent Congressional

• funding specifically for this purpose, NRC is not prepared to fund stockpiling of Kl.

Findings Metric Policy On October 7, 1992, the Commission published its final Policy Statement on Metrication. According to that policy, after January 7, 1993, all new regulations and major amendments to existing regulations were to be presented in dual units. The amendment to the regulations contains no units. ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT FOR GRANTING THE PETITION FOR RULEMAKING RELATING TO THE USE OF POTASSIUM IODIDE (Kl) I. Introduction On September 9, 1995, a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. In SECY 97-245, dated October 23, 1997, the staff provided three options for the Commission's consideration in order to resolve PRM 50-63. On November 5, 1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resoMng the petition for rulemaking. During the meeting, the Commission invited the petitioner to submit a modification to his petition in order to address views he discussed during the meeting. On November 11, 1997, the petitioner submitted a revision to his petition PRM 50-63A, which requested two things:

1. A statement clearly recommending stockpiling of Kl as a "reasonable and prudent" ,

measure, and

2. A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate."

On June 26, 1998, the Commission disagreed with the staff recommendation to deny the petition for rulemaking PRM 50-63A by revising 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in response to this directive. Alternatives were essentially considered in previous documents. In SECY-97-124 (June 16, 1997), on the "Proposed Federal Policy Regarding Use of Potassium Iodide after a Severe Accident at a Nuclear Power Plant." The staff identified three options, one of which contained three sub-options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe* reactor accidents. Next, in an SRM dated June 30, 1997, the Commission approved an option that endorsed the Federal offer to fund the purchase of Kl for States at their request and endorsed the Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to St:lte and local governments of the Federal stockpiling of KJ.

11. Need for Action ,

In SECY-97-245, the staff proposed options for resolving the referenced petition for rulemaking. In SRM 98-061, the Commission directed the staff to proceed with the rulemaking. II. Environmental Impact of the Proposed Action The environmental impacts of the proposed action and its alternative are considered negligible by the NRC staff. Given the proposed action would only add the sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate." The staff is not aware of any environmental impact as a result of this proposed action. IV. Alternative to the Proposed Action I The alternative to the proposed action at this time is to deny the petitions and take no action with respect to the use of Kl by the public. Should this no-action alternative be pursued, the staff is not aware of any resulting environmental impact. V. Agencies and Persons Consulted Cognizant personnel from the Federal Emergency Management Agency were consulted, as was the petitioner, as part of this rulemaking activity. VI. Finding of No Significant Impact: Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the amendment is are not a major Federal action significantly affecting the quality of human environment, and therefore, an environmental impact statement is not required. This

amendment will require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. This action will not have a significant impact upon the environment. Paperwork Reduction Act Statement This proposal rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C 3501 et seq.). Existing requirements were approved by the Office of Management and Budget (OBM) approval numbers 3150-0009 and 3150-0011. Public Protection Notification If an information collection does not display a currently valid 0MB control number, the NRC may not conduct or sponsor, and a persor is not required to respond to, the information collection .

• Regulatory Analysis of the Proposed Rulemaking Granting In Part A Petition for Rulemaking (PRM 50-63A) Relating to the Use of Potassium Iodide (Kl)

On September 9, 1995, a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. In SECY 97-245, dated October 23, 1997, the staff provided three options for the Commission's consideration in order to resolve PRM 50-63. On November 5, 1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resoMng the petition for rulemaking. During the meeting, the Commission invited the petitioners to submit a modification to his petition in order to address views he discussed during the meeting. On November 11, 1997, the petitioner submitted a ,revision to his petition PRM 50-63A, which requested two things: A statement clearly recommending stockpiling of Kl as a "reasonable and prudent" measure, and A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate." On June 26, 1998, the Commission directed the staff in SRM 98-061 to revise 10 CFR Part 50.47 (b){10). This proposed rulemaking is in response to this directive. Alternatives were essentially considered in previous documents. In SECY-97-124 (June 16, 1997), titled "Proposed Federal Policy Regarding Use of Potassium Iodide after a Severe Accident at a Nuclear Power Plant," the staff identified three options, one of which contained three sub-optio~, concerning a proposed change in the Federal policy regarding the use of potassium iodide (Kl) as a protective measure for the general public during severe reactor accidents. Next, in an SRM dated June 30, 1997, the Commission approved an option that endorsed the Federal offer to fund the purchase of Kl for States at their request and

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endorsed Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local governments of the Federal stockpiling of Kl. In SECY-97-245, the staff proposed options for resoMng the referenced petition for rulemaking. In SRM 98-06, the Commission directed the staff to proceed with the rulemaking. Given that the Commission considered the options and directed the staff to grant the petition, the only alternatives considered here are the Commission approved option and the .baseline, no-action alternative. The proposed rulemaking does not "require" anything of licensees, but States are to have shown "consideration" of the use of Kl along with evacuation and sheltering as protective actions. It is estimated that 30 States will need to make this consideration. Further, the staff estimates that the labor needed by the States could range from a staff-week, to a half staff-year. The latter being the case if a State decided to hold hearings on the issue. If one assumes an average hourly salary of $70 (this estimate includes benefits, pro-rated secretarial and managerial assistance, but not overhead), the range of estimates would be from $2800 to $63,000. Again using a base of 30 States, the range is from $84,000 to $1.9 million. The Commission notes that when it amended its emergency planning regulations* on November 3, 1980, the regulatory standards for emergency planning were a restatement of basic joint NRC-FEMA guidance to licensees and to State and local governments incorporated in NUREG-0654; FEMA-REP-1, "Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants for Interim Use and Comment." This guidance was cited in the regulation and speaks to radioprotective drugs including their use by the general public Including quantities, storage and means of distribution and State and local plans for decision making with respect to their use. The Commission removed the citations of the guidance from the regulation in 1987 but the guidance has continued in use for planning purposes and by the Federal agencies for evaluating emergency plans. As a result, it is believed that all of the affected States have at some point considered the use of Kl. Some States have made the decision to stockpile Kl. Thus, in practical terms, the projected costs will occur only in those States that have not elected to stockpile Kl and choose stockpiling in light of the Chernobyl accident, recent international practice, and the NRC requirement to consider the use of Kl. It is difficult to estimate the benefit of a State's consideration to stockpile Kl. However, we believe the benefit of such an action by the States is summed up by the petitioner who stated that the decision to stockpile Kl should tum on whether, given the enormous consequences of being without Kl in a major accident, the drug is a prudent measure; not on whether it will necessarily pay for itself over time. As the petitioner further noted, Kl represents a kind of catastrophic-coverage insurance policy offering protection for events which, while they occur only rarely, can have such enormous consequences that it is sensible to take special precautions, especially where, as here, the cost of such additional precautions is relatively low. As stated aoove, this analysis focuses on the rule being proposed as the result of a petition. Also, since the Commission has directed the staff to pursue the FRPCC results with respect to Kl and has directed the staff to pursue the rulemaking, the regulatory analysis presented here is for the edification of the decision makers so they can make an informed decision on the proposed rule. The above constiMes the regulatory analysis for this action. Regulatory Flexibility Certification In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission hereby certifies that this rule, if adopted, will not have a significant economic impact on a substantial number of small entities. This proposed rule would affect only the licensees of nuclear power plants. These licensees, do not fall within the scope of the definition of "small entities" set forth in the Regulatory Flexibility Act. 5 U.S.C. 601, or the size standards adopted by the NRC (10 CFR 2.810). Backfit Analysis The definition of backfit, as set forth in 10 CFR 50.109(a)(1 ), is clearly directed at obligations imposed upon licensees (and applicants) and their facilities and procedures .

• Section 50.109(a)(1) defines a backfit as:

          ... the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility, any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position ....

Section 50.109 is replete with references to "facilities" and "licensees," which in their totality make clear that the rule is intended to apply to actions taken with respect to nuplear power plant licensees and the facilities they operate. See Section 50.109(a)(7), "If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written licensee commitments ... then ordinarily the applicant or licensee is free to choose the way that best suits its purposes [emphasis added]." This focus on licensees and their facilities is further confirmed by the Statement of Considerations accompanying the backfit rule, 53 FR 20603 (June 6, 1988), where the Commission stated that backfitting "means measures which are intended to improve the safety of nuclear power reactors ...." 53 FR at 20604. The nine factors to be considered under 10 CFR 50.109(c) further make clear that the rule is aimed at requirements on licensees and facilities. These include: "(2) General description of the activity that would be required by the licensee or applicant in order to complete the backfit; ... (5) Installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay; [and] (6) The potential safety impact of changes in pl~t or operational complexity.... [emphasis addedf The proposed rule imposes no new requirements on licensees, nor does it alter procedures at nuclear facilities. Rather, it is directed to States or local governments - the entities with the authority to determine the appropriateness of the use of Kl for their citizens - calling upon the governments to 'tonsider" KJ as one of the elements of their offsite emergency planning. Even as to states or local governments, it imposes no binding requirement to alter plans and procedures. Furthermore, the basic standard that emergency planning must include consideration of a range of protective actions, is already set forth in the existing wording of section 50.47(b)(10). On this basis, the proposed rule in reality does not impose new requirements on anyone. On a consideration of all of the above factors, no backfit is involved and no backfit analysis is required. Commission precedent also makes clear that the proposed rule change does not constitute a backfit. The Commission's position was stated explicitly in 1987, when the last major change took place in emergency planning regulations. 52 FR 42078 (Nov. 3, 1987). The Commission's final notice of rulemaking on this rule involving the "Evaluation of the Adequacy of Off-Site Emergency Planning for Nuclear Power Plants at the Operating License Review Stage Where State and Local Governments Decline to Participate in Off-Site Emergency Planning~ stated that the emergency planning rule change in question "does not impose any new requirements on production or utilization facilities; it only provides an alternative method to meet the Commission's emergency planning regulations. The amendment therefore is not a backfit under 10 CFR 50.109 and a backfrt analysis is not required." 52 FR at 42084. Likewise, l when the Commission altered its emergency planning requirements in 19~7 to change the timing requirements for full participation emergency exercises (a change that, as a practical matter, could be expected to result in licensees' modifying emergency preparedness-related procedures to accommodate exercise frequency changes), it stated: "The final rule does not modify or add to systems, structures, components or design of a facility; the design approval or manufacturing license for a facility; or the procedures or organization required to design, , construct, or operate a facility. Accordingly, no backfit analysis pursuant to 10 CFR 50.109 is required for this final rule." 52 FR 16828 (May 6, 1987). The proposed emergency planning rule change is of a similar nature and similarly does not involve a backfit. It has been argued by at least one commenter on the petition for rulemaking that, although licensees are not directly burdened by the proposed rule, they would be indirectly burdened because they would feel called upon to exp1ain the new policy to their customers. By this logic, almost any Commission action that led an NRC licensee to issue a press release could be considered a backfit. Such a position would represent unsound law and policy. -Here, the burden of public infonnation on licensees or applicants, if any, appears de minimis. It plainly does not rise to the level of the type of concrete burden contemplated by the Commission when it enacted the backfit rule. It might also be argued that, if a State or local government were to decide to stockpile and use Kl for the general public, it would undertake interactions with the affected licensee to coordinate offsite emergency planning. Although this could result in some voluntary action by the licensee to coordinate its planning, the proposed rule itself does not impose any requirement or burden on the licensee. Accordingly, the Commission concludes that the proposed rule, if adopted, would not impose any backfits as defined in 10 CFR 50.109. List of Subjects 10 CFR Part 50 Antitrust, Classified lnfonnation, Criminal penalties, Fire protection, Intergovernmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements. For the reasons set out in the preamble and under the authority of the Atomic Energy Act for 1954, as amended, the Energy Reorganization Act of 1974, as amended, the National Environmental Policy Act of 1969, as amended, and 5 U.S.C. 553, the NRC is proposing to adopt the following amendment to 10 CFR Part 50. PART 5~-DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES

1. The authority citation for 10 CFR Part 50 continues to read as follows:

Authority: Secs. 102, 103, 104, 105, 161, 182, 183, 186, 189, 68 Stat. 936,938,948, 953,954,955,956, as amended, sec. 23d, 83 Stat. 444, as amended (42 U.S.C. 2132, 2133, 2134, 2135, 2201, 2232, 2233, 2239, 2282); secs. 201, as amended, 202, 206, 88 State. 1242, as amended 1244, 1246, (42 U.S.C. 5841, 5842, 5846). Section 50.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951, as amended by Put:5. L. 102- 486, sec. 2902, 106 Stat. 3123, (42 U.S.C. 5851). Sections 50.10 also issued under secs. 101, 185, 68 State. 936, 955, as amended (42 U.S.C. 2131, 2235); sec. J

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1l02, Pub. L. 91 -190, 83 Stat. 853 (42 u.s.c. 4332). Section 50.13, 50.54(dd), ~nd 50i103 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35, 50.55, and 50.56 also issued under sec. 185, 68 Stat. 955 {42 U.S.C. 2235). Sections 50.33a, 50.55a and Appendix Q also issued under sec. 102, Pub. L 91-190, 83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under Pub. L. 97-415, 96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). , Sections 50.80, 50.81 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Appendix Falso issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

2. In§ 50.47, paragraph (b)(10) is revised to read as follows:

 § 50.47 Emergency plans.

(b} * * * (10) A range of protective actions has been developed for the plume exposure pathway EPZ for emergency workers and the public. In developing this-range of actions, consideration has been given to evacuation, sh~ltering, and, as a supplement to these, the prophylactic use of potassium iodide (Kl), as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidance, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed. Dated at Rockville, MaryJand, this 3 day of June, 1999. For the Nuclear Regulatory Commission. b \/1.P?<:5-w--J nette\fietti:C6ok, Secretary of the Commission.

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