ML23156A078

PRM-50-063A - 62FR66038 - Peter G. Crane; Receipt of an Amended Petition for Rulemaking

ML23156A078
Person / Time
Issue date:	12/17/1997
From:	NRC/SECY
To:
References
PRM-050-063A, 62FR66038
Download: ML23156A078 (1)

Text

{{#Wiki_filter:ADAMS Template: SECY-067 DOCUMENT DATE: 12/17/1997 TITLE: PRM-050-063A - 62FR66038 - PETER G. CRANE; RECEIPT OF AN AMENDED PETITION FOR RULEMAKING CASE

REFERENCE:

PRM-050-063A 62FR66038 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PRM-050-063A {62FR66038) In the Matter of PETER G. CRANE; RECEIPT OF AN AMENDED PETITION FOR RULEMAKING DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/12/97 11/11/97 LTR FM PETER G. CRANE SUBMITTING A DRAFT OF A PROPOSED RULE CHANGE ALONG WITH A STATEMENT OF CONSIDERATION EXPLAINING THE CHANGE 11/13/97 11/12/97 LTR FM PETER G. CRANE SUBMITTING CORRECTED PAGE 3 OF CORRESPONDENCE DATED 11/11/97 12/08/97 12/07/97 LTR FM PETER G. CRANE TO HOYLE REQ. INCLUSION OF STATEMENT HE SUBMITTED TO NY RADIOLOGICAL HEALTH COMMITTEE & RESPONSE TO ROGER SUPPES DTD 12/6/97 12/11/97 12/11/97 FEDERAL REGISTER NOTICE - RECEIPT OF AMENDED PETITION FOR RULEMAKING 12/12/97 12/12/97 LTR FM PETER G. CRANE TO HOYLE RESUBMITTING CORRESPONDENCE DTD 12/7/97 WITH CORRECTIONS AND ADDITIONS 12/19/97 12/17 /97 E-MAIL MESSAGE FROM PETER G. CRANE RE PUBLIC OBTAINING COPY OF PETITION WITHOUT DIFFICULTY BEFORE COMMENT PERIOD EXPIRES 12/31/97 12/20/97 COMMENT OF JOAN 0. KING { 1) 01/08/98 01/08/98 LTR FM PETER G. CRANE TO HOYLE REQ. PRESS RELEASE, WEBSITE ACCESS FOR ORIGINAL &AMENDED DOCKET FILE AND 30-DAY EXTENSION OF COMMENT PERIOD 01/09/98 01/04/98 COMMENT OF CONNIE KLINE { 2) 01/09/98 01/09/98 COMMENT OF THE CITIZENS AWARENESS NETWORK, ET AL. {MARY ELIZABETH LAMPERT) { 3) 01/12/98 01/09/98 COMMENT OF NUCLEAR ENERGY INSTITUTE {LYNNETTE HENDRICKS) { 4) 01/12/98 01/08/98 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY {THOMAS W. ORTCIGER, DIRECTOR) { 5)

DOCKET NO. PRM-050-063A (62FR66038) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 01/12/98 01/09/98 COMMENT OF AMERICAN THYROID ASSOCIATION, INC. (MARTIN I. SURKS, M.D.) ( 6) 01/13/98 01/11/98 COMMENT OF PROPOSITION ONE COMMITTEE (ELLEN THOMAS, DIRECTOR) ( 7) 01/13/98 01/09/98 COMMENT OF SCOTT D. PORTZLINE ( 8) 01/13/98 01/12/98 LTR FM SCOTT D. PORTZLINE TO HOYLE REQUESTING 30-DAY EXTENSION OF COMMENT PERIOD 01/13/98 01/13/98 COMMENT OF SEACOAST ANTI-POLLUTION LEAGUE (JANE DOUGHTY) ( 9)

• 01/15/98 01/08/98 COMMENT OF COMMONWEALTH EDISON COMPANY (MICHAEL J. WALLACE, SR. VP) ( 10) 01/15/98 01/09/98 COMMENT OF FAWN SHILLINGLAW ( 11) 01/15/98 01/12/98 COMMENT OF RICHARD COBERLY ( 12) 01/15/98 01/12/98 COMMENT OF D. J. GARNETT ( 13) 01/15/98 01/12/98 COMMENT OF JOSEPH INTRIONI ( 14) 01/15/98 01/12/98 COMMENT OF DAVE LAZORCIK ( 15) 01/15/98 01/12/98 COMMENT OF MARK MULLEY ( 16) 01/15/98 01/12/98 COMMENT OF JACK NISSLEY ( 17) 01/15/98 01/12/98 COMMENT OF EVELYN 0. PHOENIX ( 18) 01/15/98 01/12/98 COMMENT OF STEVE & ANDREA RUDOLPH ( 19) 01/15/98 01/12/98 COMMENT OF DON SENDI ( 20) 01/15/98 01/12/98 COMMENT OF LEE C. SWARTZ ( 21) 01/15/98 12/27/97 COMMENT OF MARVIN I. LEWIS ( 22) 01/15/98 01/14/98 FEDERAL REGISTER NOTICE: AMENDED PETITION FOR RULEMAKING: EXTENSION OF COMMENT PERIOD 01/16/98 01/14/98 COMMENT OF CAROLINA POWER & LIGHT COMPANY (DONNA B. ALEXANDER) ( 23) 01/16/98 01/15/98 COMMENT OF SOUTHERN NUCLEAR OPERATING COMPANY, INC.

(H. L. SUMNER, JR., VP - HATCH PROJ.) ( 24)

DOCKET NO. PRM-050-063A (62FR66038) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 01/16/98 01/15/98 COMMENT OF PEACE RESOURCE CENTER OF SAN DIEGO (CAROL JAHNKOW, EXECUTIVE DIRECTOR) ( 25) 01/20/98 01/11/98 COMMENT OF Z DRESCHER KRIPKE, M.D., M.P.H. ( 26) 01/20/98 01/13/98 COMMENT OF ELAINE ETHRIDGE ( 27) 01/20/98 01/12/98 COMMENT OF ERNEST GOITEIN ( 28) 01/20/98 01/14/98 COMMENT OF ENTERGY OPERATIONS, INC. (JERROLD G. DEWEASE, VP - OPS) ( 29) .01/20/98 01/16/98 COMMENT OF TU ELECTRIC (C. LANCE TERRY, GRP. VICE PRESIDENT) ( 30) 01/20/98 01/14/98 COMMENT OF BARBARA A. GERSHENSON ( 31) 01/20/98 01/15/98 COMMENT OF BARBARA STEPHENS ( 32) 01/20/98 01/05/98 COMMENT OF DUKE POWER COMPANY (M. S. TUCKMAN, EXEC. VICE PRESIDENT) ( 33) 01/20/98 01/13/98 COMMENT OF OHIO CITIZENS FOR RESPONSIBLE ENERGY, INC. (SUSAN L. HIATT, DIRECTOR, OCRE) ( 34) 01/20/98 01/14/98 COMMENT OF TENNESSEE VALLEY AUTHORITY (MARK J. BURZYNSKI) ( 35) 1/20/98 01/14/98 COMMENT OF BRUCE SMITH, PA HOUSE OF REP. ( 36) 01/20/98 01/15/98 COMMENT OF SOUTHERN CALIFORNIA EDISON (E. S. MEDLING) ( 37) 01/20/98 01/15/98 COMMENT OF NORTH ATLANTIC ENERGY SERVICE CORPORATION (TED C. FEIGENBAUM, EXEC. VP & CNO) ( 38) 01/20/98 01/15/98 COMMENT OF MARY STAMOS OSBORN ( 39) 01/20/98 01/16/98 COMMENT OF ENVIRONMENTAL HEALTH COALITION (LAURA HUNTER, DIR., CLEAN BAY CAMP.) ( 40) 01/20/98 01/16/98 COMMENT OF MISSOURI DEPARTMENT OF HEALTH (GARY W. MCNUTT) ( 41) 01/20/98 01/16/98 COMMENT OF DETROIT EDISON (NORMAN K. PETERSON, DIR., NUC. LIC.) ( 42) 01/21/98 01/12/98 COMMENT OF VIRGINIA POWER (JAMES P. 0 HANLON, SR. VP) ( 1 43)

DOCKET NO. PRM-050-063A (62FR66038) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 01/21/98 01/14/98 COMMENT OF DINI SCHUT ( 44) 01/22/98 01/15/98 COMMENT OF EDITH B. PHILLIPS ( 45) 01/22/98 01/17 /98 COMMENT OF LINDA BRAASCH ( 46) 01/26/98 01/15/98 COMMENT OF PECO ENERGY COMPANY (G. A. HUNGER, JR.) ( 47) 01/26/98 01/20/98 COMMENT OF MARYS. WEGNER ( 48) 01/27/98 01/23/98 COMMENT OF GUNNAR M. ERICKSON ( 49) 01/28/98 01/21/98 COMMENT OF RUTH M. HEIFETZ, M.D., M.P.H. ( 50) 01/28/98 01/28/98 LTR JULIAN TO ELAINE ETHRIDGE RE 30-DAY EXTENSION OF COMMENT PERIOD 01/29/98 01/17 /98 COMMENT OF PALO VERDE NUCLEAR GENERATING STATION (JAMES M. LEVINE, SR. VICE PRESIDENT) ( 51) 01/29/98 01/27/98 COMMENT OF SENATOR JOSEPH I. LIEBERMAN ( 52) 01/29/98 01/28/98 LTR JULIAN TO CAROL JAHNKOW RE 30-DAY EXTENSION OF COMMENT PERIOD 02/02/98 01/28/98 COMMENT OF THOMAS PARETTI ( 53) 01/14/98 COMMENT OF DON'T WASTE MICHIGAN (ALICE HIRT) ( 54) 01/28/98 COMMENT OF DAN I. BOLEF ( 55) 02/03/98 01/30/98 COMMENT OF PAULA FORD ( 56) 02/04/98 01/28/98 COMMENT OF PATRICIA B. AND KARL J. NOVAK ( 57) 02/04/98 01/31/98 COMMENT OF MARO LEWIS ( 58) 02/04/98 01/31/98 COMMENT OF PETER G. CRANE ( 59) 02/04/98 01/30/98 COMMENT OF THE UNITED STATES PHARMACOPEIAL CONVENTION, INC. (JEROME A. HALPERIN, EXEC. VP-CEO) ( 60) 02/09/98 02/02/98 COMMENT OF JUDITH LICKERT ( 61) 02/09/98 02/04/98 COMMENT OF LISA O'CONNELL ( 62) 02/09/98 02/06/98 COMMENT OF SUES. WHITE ( 63) 02/09/98 01/29/98 COMMENT OF APRIL GENTH ( 64)

DOCKET NO. PRM-050-063A (62FR66038) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 02/11/98 02/05/98 COMMENT OF DEBORAH DOLAN ( 65) 02/11/98 02/10/98 COMMENT OF PAUL AND CHRYSTAL ESHELMAN ( 66) 02/13/98 02/09/98 COMMENT OF ARLENE STEFFEN ( 67) 02/13/98 02/09/98 COMMENT OF ANBEX, INC. (ALAN MORRIS, PRESIDENT) ( 68) 02/13/98 02/10/98 COMMENT OF STEVEN D. URELES, DMD, MS ( 69) 02/13/98 02/13/98 COMMENT OF JEROME M. GLASSMAN, PH.D. ( 70) 02/13/98 02/09/98 COMMENT OF MARY ANN PAVLIC ( 71) 02/13/98 02/13/98 COMMENT OF DAVID V. BECKER, M.D. ( 72) 02/17/98 02/09/98 COMMENT OF LAURA BLAIN ( 73) 02/17/98 02/11/98 COMMENT OF NEW JERSEY DEPARTMENT OF ENVIRONMENTAL PROTECTION (KENT TOSCH, MANAGER) ( 74) 02/17/98 02/13/98 COMMENT OF NIAGARA MOHAWK POWER CORPORATION (JOHN H. MUELLER, SR. VP & CNO) ( 75) 02/18/98 02/16/98 COMMENT OF BARBARA SIROIS ( 76) 02/19/98 02/18/98 COMMENT OF WILLIAM J. KRAMER ( 77) 2/19/98 02/13/98 COMMENT OF THEODORE SCHULZ ( 78) 02/20/98 02/05/98 COMMENT OF ELIZABETH F. LISKA ( 79) 02/24/98 02/15/98 COMMENT OF BILLIE STAUB ( 80) 02/27/98 02/26/98 COMMENT OF J. E. MACDONALD ( 81) 03/03/98 02/13/98 COMMENT OF SENATOR TOM HARKIN ( 82) 03/10/98 03/05/98 CHAIRMAN JACKSON LTR TO SEN. JOSEPH I. LIEBERMAN RESPONDING TO HIS 1/27/98 LTR URGING THE NRC TO REVISE ITS CURRENT POLICY RE AVAILABILITY OF Kl 03/10/98 03/09/98 CHAIRMAN JACKSON LTR TO SENATOR TOM HARKIN RESPONDING TO HIS 2/13/98 LTR URGING THE NRC TO REVISE ITS CURRENT POLICY RE AVAILABILITY OF Kl 04/09/98 04/09/98 COMMENT OF FEDERAL EMERGENCY MANAGEMENT AGENCY (KAY C. GOSS) ( 83)

DOCKET NO. PRM-050-063A (62FR66038) DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 04/24/98 04/13/98 LTR FM PETER G. CRANE TO KAY C. GOSS, FEMA RESPONDING TO HER 3/25/98 LTR RE FEMA S POSITION 1 ON THE ISSUANCE OF THE KI POLICY 08/06/98 08/05/98 COMMENT OF PETER G. CRANE ( 84) 08/28/98 08/28/98 NOTE FM PETER G. CRANE TO HOYLE TMTG COPIES OF COMMENTS HE SUBMITTED ON NUREG-1633 AND LETTERS HE SENT TO FDA AND EPA ON POTASSIUM IODIDE ISSUE 12/21/98 12/18/98 COMMENT OF PETER G. CRANE ( 85) 04/27/99 04/26/99 COMMENT OF SCOTT D. PORTZLINE ( 86)

From: Carol Gallagher To: GATED.nrcsmtp. 11 pgcrane@erols.com 11 Date: 9/3/98 9:59am

Subject:

posting of August 20 comments on NUREG -Reply Mr. Crane, Your August 20, 1998 memorandum containing comments on NUREG-1633 was transmitted via a note from you to the Secretary dated August 28, 1998. That note was docketed August 28; I received my copy via mail on September 1. I have finished scanning the document and creating the document in WordPerfect format. I hope to finish converting the document into html and posting it to the KI Petition conference by the end of the day. Carol Gallagher >>> Peter Crane <pgcrane@erols.com> 09/03/98 07:26am >>>

Dear Ms. Gallagher:

Sometime last week, I wrote to the Secretary, asking that my August 20 comments on NUREG-1633 be considered as a comment on PRM-50-63/63A and posted on the website. It hasn't yet appeared on the site, and I wondered whether there had been any delay in getting the documents to you. Thanks, Peter Crane CC: WND1.WNP2.ATB1, WND2.WNPS.MTJ1

DOCKET NUMBER PETITION RULE PAM 5(), t, 3A ( t, :i. Fl</,,t,038) Secretary, U.S . Nuclear Regulatory DOCKETED Commission, Washington, DC 20555-0001 L'S */RC Attention: Rulemakings and Adjudications Staff '99 APR 27 p 5 :09 Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D .C. 20555 Re: PRM-50-63 Mr. Hoyle, The NRC's arrogance is contemptuous. Time after time the NRC stalls, delays, fails to regulate and promotes the nuclear power industry. Announcing the withdrawal of funds for KI on the anniversary of Chernobyl has been noted. Very few citizens trust the NRC. I hope the thoughtless ones amongst you lose your jobs during the cutbacks. But, I'm certain that the card-carrying NRC promoters will remain. Hopefully, conscie~tious former NRC employees will join forces with the Union of Concerned Scientists or other groups. If a 7 cents pill is too much money for you, it indicates nuclear power safety is severely jeopardized. You must reinstate your decision to fund the pills and make it effective immediately. ScottD. Portzline, 3715 N. 3rd St. Harrisburg PA 17110 April 26, 1999 MAY - 4 1999

                                                            ~owtedged by card ......................,. -~

U.S. NUCLEAR REGULATORY COMMISSION AU LEM INGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics PostmarkOate '-l/ ?7/qc; /4 1 d. ~~~ Copies Rece ed _ _ _;;___ __ Add'I pies Special Dlstribution..;.:d!!!::?:?:2.!i:1!:.~~c_- ~/Uh.A/. fJ);e

*T7

April 26, 1999 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher 11 /J Ll,,,Jlj~~ ADM, DAS ~/ - - -rf"

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION (PRM-50-63A) Attached for docketing is a comment letter related to the Amended Petition on Potassium Iodide (PRM-50-63A). This comment was received via the rulemaking website on April 26, 1999. The submitter's name is Scott D. Portzline, 3715 N. 3rd Street, Harrisburg, PA 17110. Please send a copy of the docketed comment to Mike Jamgochian (mail stop O11-F-1) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

Peter G. Crane

• 4809 Drummond Avenue Chevy Chase, MD 20815 30 l-656-3998 pgcrane@erols.com DOC KET 0 December 18, 1998 I i~ I,.,

NOTE TO: Chairman Jackson

                                                                            '98 OEC 21 P5 :Q2 Commissioner Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield iE:C' l> BY SEC'(

FROM: Peter Crane j~ ~ DOCKET NUMBER PETITION RULE PAM 5D-~3A !l DEC 98 11

SiJBJECT: COSTS OF POTASSIUM IODIDE { f,:l FR/,/,038) @

On December 8, 1998, in my private capacity, I attended a public meeting on potassium iodide in Painesvi11e, Ohio. The meeting was called by the Ohio Department of Health to

• present its current thinking on the potassium iodide issue to counties and the public. In the past year, Ohio has circulated a first and then a second draft of its proposed new policy on potassium iodide. Its approach is two-track: stockpiling for the general population near nuclear plants, coupled with predistribution for those who affirmatively request the drug. They reason that people who are well enough informed to ask for the drug can be depended on to understand its limitations as well as its benefits. The Ohio officials explained that their policy focuses primarily on ensuring that the drug is available in an emergency to children and pregnant women.

At one point, there was discussion of how the anticipation of greater demand for potassium iodide had driven up the price of the drug. The Ohio officials responded that they had found a Swedish supplier offering the drug at half the cost anq with twice the shelf life. At my request, Susan Hiatt of the Ohio Citizens for Responsible Energy followed up, and last night, I received an e-mail from Mr. Harvey Brugger of the Ohio Department of Health, attaching mail he had received from the Swedish company. The correspondence is attached. You will see that this Swedish company is offering a million IO-pill blister packs at $.70 apiece, and S million at

               $.60 apiece, with a guaranteed shelf life of up to 10 years. It is also offering to take the responsibility of securing approval from the Food and Drug Administration.

My purpose in writing this note is information, not advocacy, but I will not hide my belief that six-tenths to seven-tenths of a cent per child per year is not an.exorbitant price to pay to bring the protection of American children up to world standards. This note is written in my private capacity, at home, on my own time. I would ask the

           \ Secretary to add it to the docket file of PRM-50-63A as a comment and forward a copy to Ms.
            ! Carol Gallagher for posting on the NRC rulemaking website.

Attachment:

E-mail from Mr. Harvey Brugger, Ohio Department of Health, December 17, 1998 (with attachments) .. . .

LJ.S. NUCLEAR REGUlATORV 001 ..ISSION RULEMAKINGS &AllU>OVDt81Wf OFFICE OFnESIDENW OF THE OOlll88ION DocllnalMlllol Postmafk Date Jr;,j;}J /q8 f(R.t!- 1c/.~ e_ ,1-~ Coples Rec8lwd L Add'I ~ Reproduced j 3 Special Dtstrlbuoorl

                ~
£~          , ~

7( t'DS r 7

   \ 

Subject:

KI supplier in Sweden -Reply -Forwarded Date: Thu, 17 Dec 1998 15:26:14 -0500 From: Harvey Brugger <HBRUGGER@GW.ODH.State.OH.US> To: pgcrane@erols.com CC: susan.hiatt@hamradio.org Peter, In response to Ms. Hiatt's request, I am forwarding information to you regarding our contacts with the Swedish company that provides KI. Two letters are appended to this message directly. (They should also appear as Wordperfect 6.lattachroents in the mail forwarded to Ms. Hiatt, which is also attached.} Harvey ATTACHMENT 1 From: <allan.skolfman@recip.se> To: ODH OMIS.DPMl(COSTROVE) Date: 11/3/98 10:04am

Subject:

Potassium Iodide -your e-mail dated october 30, 1998 ear 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 registration 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 tate of Ohio is having the responsibility for the handling of the product?

f so is the case we will arrange 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 is totally 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 10 tablets) -USO 1.15 per pack 500,000 " II II 0.90 II U 1,000,000 " "II 0.70 " " 5,000,000 " It 0.60 " "

8. Shipping costs. Generally we are selling at Ex Works (Incoterms 1990). However we are always open for discussion. in order to facilitate your ordering procedure.

of4 12/18/98 6:32 A

9. Payment conditions. Generally Irrevocable Letter of Credit.

For US customers we may consider Cash on Delivery or Stand by Letter of Credit.

10. Ordering address:

RECIP AB Branningevagen 12 120 54 ARSTA 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 WHO 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 assistance 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 +46 8 6025200 direct +46 8 6025329 Telefax number: " +46 8 818703 " +46 8 6025302 We look forward to hearing from you . With kind regards, llan Skolfman

• Export Manager CC: ODH_REMOTE.SMTP("hans-henrik.bark@recip.se","thoma ...

ATTACHMENT 2 M E M O R A N D U M TO: Harvey B. Brugger, Supervisor FROM: Dwain C. Baer, Health Physicist I I I

SUBJECT:

Potassium Iodide [KI) Manufacturers DATE: October 30, 1998 2 of4 12/18198 6:32 A'

      . ~*****************************************************************************

Based on the research conducted by Connie Ostrove and myself, the only company which manufactures and distributes tablet KI specifically for use as a thyroid protection product is Carter-Wallace Laboratories, located on Half Acre Road in Cranbury, New Jersey 08512. Current cost per case of 100 bottles [fourteen tablets per bottle] is

        $250.00 (17.8 cents per tablet]. This cost has increased over 80% from last year, based on the anticipated incr~ase 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 nuclear power plant radiological release. Roxane has never produced tablet KI 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 KI. However, all of the companies researched market KI for expectorants of various bronchitis problems only, and have not been approved by the FDA for thyroid blocking usage. A company in Sweden called Recip AB, Branningevagen, has provided a cost estimate via e-mail. A pack of ten KI tablets can cost as much as

        $1.15 per pack [11.5 cents per tablet] plus the cost of shipping to the nited States, and the cost of any authorization which may be required.

cc: Connie Ostrove, Librarian R.A.S./KI File Date: Mon, 14 Dec 1998 13:00:09 -0500 From: Harvey Brugger <HBRUGGER@GW.ODH.STATE.OH.US> To: *susan. hiatt@hamradio.org Cc: dbaer@GW.ODH.STATE.OH.US,rsuppes@GW.ODH.STATE.OH.US, shelmer@GW.ODH.STATE.OH.US

Subject:

KI supplier in Sweden -Reply

  .san, I am attaching two Wordperfect 6.1 documents. Since their preparation, one additional contact 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, for purposes of public distribution, the Export Manager, Mr. Allan Skolfrnan, indicated that the 65 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, comparing the Swedish Product with the Carter-Wallace product follows: Carter Wallace Product 130 mg tablets packaged in a bottle of 14 tablets with a shelf life of 5 years cost $2.50 per bottle. 3 of 4 12/18/l>R 6:32 Af

KI supplier m Swede,, -Keply -Forwarded

*\       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 subdivision 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 equivalent of a 14 day supply. If a five day supply without extra tablets would 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 still be cheaper to use the Swedish product. On strictly a comparison of cost/mg/year, the Swedish product is also cheaper: $1.77 E-4 versus $2.75 E-4 Harvey Harvey Name: POTASSIU.SWE fl>~rt 1.2 Type: unspecified type (application/octet-stream) Encoding: x-uuencode Name: SUPPLY.KI 1 llleart 1.4 Type: unspecified type (application/octet-stream) Encoding: x-uuencode Name: POTASSlU.SWE 9lrart 1.6 Type: unspecified type (application/octet-stream) Encoding: x-uuencode Name: SUPPLY.KI IIIIPart 1. 8 Type: unspecified type (application/octet-stream) Encoding: x-uuencode tof4 12/18198 6:32 N

Peter G. Crane * -1809 Drummond Avenue ' Chevy Chase, MD 20815

• 301-656-3998 pgcrane@erols.com u CK-1 NUMBER DOCKETED PETITION RULE PR 5o,, 3 USNRC August 28, 1998

                           &1.FR!o~o38)
                                                                          '98 AUG 28 A10 :24 NOTE FOR:      John C. Hoyle, Secretary, USNRC FROM:           Peter G. Crane    ~~                              OFF!(:

RUU:, .o ' J ADJUO:(,..  ; r.1 r-F

SUBJECT:

ADDITIONS TO DOCKET PRM-50-63/63A Attached please find copies of comments that l submitted on NUREG-1633, as well as letters to the Food and Drug Administration and Environmental Protection Agency, all dealing with the potassium iodide issue. A letter to FEMA will follow shortly. I would appreciate it if you treated them as additional comments for inclusion in the docket. Thank you .

• Attachments: Comments on Draft NUREG-1633 (August 20, 1998)

Letter to Michael Friedman, FDA (August 24, 1998) Letter to Lawrence Weinstock, EPA (August 24, 1998)

Peter G. Crane -1809 Drummond Avenue Chevy Chase, MD 20815 301-656-3998 pgcrane@erols.com

• I August 20. 1998 MEMORAKDUM FOR: John C. Hoyle, Secretary. USKRC FROM: Peter Crane If,!;:;~

SUBJECT:

SUPPLEMEJ\T AL COMMEJ\TS 01\ 1\RC STAFF TECHNICAL ASSESSMENT OF POTASSIUM IODIDE (DRAFT KUREG-1633) I. Introduction The NRC staff has published for comment the draft ofNUREG-1633, which purports to be a technical assessment of potassium iodide. (The comment period expires September 15, 1998.) ln announcing the availability of this document in the July 20, 1998. Federal Register, the staff omitted to mention that the Commission had granted my petition for rulemaking on KI a few weeks earlier. Can the actions of the Commission be of so little import to the NRC staff -- more precisely. to certain elements within the NRC staff -- that they can be ignored or disregarded altogether'l 1 I sincerely regret the need to submit these supplementary comments on !".'UREG-1633. 2 I am sure that the Commissioners are tired of reading my submissions on KL but they cannot be half as tired of reading them as I am of having to write them. I had hoped that the Kl issue was behind me . I had also hoped, for the NRC's sake, that the contention over Kl was largely behind the agency (notwithstanding that a rulemaking would still have to be conducted), and that it would cease to be a distraction from the agency's other pressing responsibilities. It is high time that the 1\RC moved on to other matters. If all the money that the agency has spent studying and debating the Kl issue during this period, including the salaries of all the people in different parts of the organization who have had to devote time to it, had been applied instead to buying KL this country would probably have an abundance of Kl for many years to come. Nevertheless, I am submitting these comments, principally because. on closer review, I believe that N1JREG- l 633 has the potential to cause actual harm to the public in the event of an accident. through

• its discussion of tincture of iodine, as I shall explain below. At the same time, I will also offer some comments on other aspects of the document. As will be seen. my criticisms of l\UREG- I 633 focus on 1

I have already pointed out one remarkable omission from NUREG-1633 in a letter to the docket dated August 5, I 998, that attached my recent talk on Kl in Cambridge, England. The Food and Drug Administration's I 978 approval of Kl as *'safe and effective" goes unmentioned, as though it never happened, though this should be the starting point of any evaJuation of Kl's safety by a federal agency. (In other staff documents on Kl, we have seen the omission of such other key events as the Kemeny Commission's recommendation in favor of Kl stockpiling; the Chernobyl accident and the use of Kl by the Poles; the upsurge of thyroid cancer in the former Soviet Union; and so on.) Contrary to the impression that readers of the August 17 issue of Inside NRC may have formed, my criticism was not that the NUREG failed to *'explicitly acknowledge the FDA position, it was that the NUREG contained not the slightest hint, explicit or implicit, that the FDA had made a finding on the safety and effectiveness of Kl. 2 As always, these are submitted in my private capacity. and are written at home on my own time.

the way that it represents the facts . You cannot expect a productive public debate on the merits of a policy issue if the public is denied the accurate and complete factual information that is necessary for an infonned decision. I would like to make c1ear to readers of what follows that I do not regard l\uREG-1633 as representative of the NRC as a whole or of its most senior management If1'.1JREG-l633 were typical of the NRC's overall approach to factual issues relating to public health and safety, there would be reason for the gravest concern, but there is no reason to think that is the case. On the contrary, I believe that NUREG-1633, and the handling of the KI issue by the NRC staff, at levels below that of the staffs most senior management, are an aberration. (To be sure, the NRC's most senior managers bear some responsibility for the fact that the deficiencies in their subordinates' product were not noticed and corrected before J\iuREG-1633 was allowed to see the light of day, but that is a separate issue.) At the most senior level, the NRC staff is led, I believe, by people of integrity and good will. who do not and would not misrepresent or withhold facts that affect the health and safety of the American people. nor disregard the decisions of the Commission that they work for. IL Tincture of Iodine Ors. Janusz Nauman and Jan Wolff, in their May 1993 article in the American Journal of Medicine ("'Iodine Prophylaxis in Poland After the Chernobyl Reactor Accident : Benefits and Risks**. Vol. 94, p. 524 ), reported that "a surprising 6.14% [of Polish children] were given diluted tincture of iodine by their parents before the start of the [KI] program and then took a single dose of Ki:* adding. This was confirmed by the brisk increase in sales of tincture of iodine in pharmacies." (At p. 528 .) In their discussion of side effects, they report that "those children receiving diluted tincture of iodine had about twice the incidence of vomiting as the remainder of the group." (At p. 530.) Dr. Nauman, at the Cambridge symposium, made the point that the fact that parents were willing to administer tincture of iodine to their children from bottles clearly labeled as containing poison suggested that people will not always behave rationally in a radiological accident. and that planners need to take that into account In a private conversation with me, he said. "We said to these people. 'How could you do this, when it says ' POISo~

• on the bottle?'", and they would say, ' Well, we thought it was a matter of life and death.,, .

One moral to be drawn from this is that if you do not have Kl available in an accident. some people will medicate their children and themselves with what is at hand, i.e .. tincture of iodine. NUREG-1633, in an apparent effort to discount the value of the Poles' use of Kl, has this to say at

p. 18: "In addition, about 6 percent of the prophylaxis resulted from self-administered tincture of iodine before the Kl program was initiated." At page 37, in the "Glossary" section, it says this of "iodine tincture": "Disinfectant and gennicide; 50 percent alcohol, 2 percent iodine, about 45 percent water; 3 drops in a quart of water kills amebas and bacteria in 30 minutes: a 4 oz. bottle contain.-. enough iodine to block 22 thyroids." [Emphasis added.] There is not the slightest suggestion that there is anything inadvisable about giving tincture of iodine in lieu of Kl in an emergency; on the contrary, one reasonable reading of these two passages is that KI stockpiling is unnecessary, because in a pinch. tincture of iodine can be used instead.

I recently telephoned the Georgetown University Hospital Poison Control Center and spoke to Ms. Jane Elshami . She told me that tincture of iodine. if taken by mouth. is rarely fatal. It is more likely to have caustic effects than systemic. The usual scenario for iodine tincture poisoning. she said. is an accidental pediatric ingestion, resulting in corrosive gastroenteritis. followed by vomiting. There can be

cardiac effects and renal toxicity. There is data, she said, on how much is a fatal dose. For adults, the probable mean lethal dose is 2-4 grams of free iodine or 1-2 0W1ces of a strong tincture. Reported lethal doses vary from a few tenths of a gram to more than 20 grams. She suggested that I could speak to one of their toxicologists if I wanted more detailed information, but it seemed to me that her information was sufficient for present purposes. If ever there were a serious nuclear accident - unlikely as that is - and a state or local health official, in the excitement of the moment were to come upon NUREG- 1633 and decide, because of the absence of stockpiled KI, to advise parents to give their children tincture of iodine, the NRC would have much to answer for. I do not believe that the agency should take the chance of allowing the document to remain in circulation. I plan to suggest to the Georgetown University Poison Control Center that it submit its comments on the draft, assuming that it has not already been withdravm . Maybe if the staff hears directly from the toxicologists, it will pay attention. III. The Physician's Desk Reference and the Safety of Kl With my concerns raised by the iodine tincture issue, it occurred to me to question some of the other factual representations in the document. At page 11. NUREG-1633 says: The staffs review of the Physician *s Desk Reference (45 th Edition, published by E.R. Barnhart, 1991) suggested that the safety of Kl is far from absolute, especially if the drug is taken without medical supervision. The various reports concerning the medications containing Kl are as diverse as the companies that produce the medications: however, these reports consistent(r state that the products are contraindicated for various groups of people (principal(v pregnant women; nursing mothers: and people with hyperthyroidism, enlarged thyroids, or sensitivity to iodine.'* In addition to the consistent contraindications. the reports include a variety of other warnings:

         *        "Potassium iodide can cause fetal harm. abnormal thyroid fWlction and goiter when administered to a pregnant woman. Because of the possible development of fetal goiter, if the drug is used during pregnancy or if the patient becomes pregnant during therapy. apprise the patient of the potential hazard _** ....

[Emphasis added.] I recently consulted the 1997 Physician's Desk Reference and copied the only listing l foWld for potassium iodide tablets: Thyro-Block, manufactured by Carter-Wallace.3 The section entitled "Who Should Not Take Potassium Iodide" reads as follows, in its entirety: The only people who should not take potassium iodide are people who know they are allergic to iodide. You may take potassium iodide even if you are taking medicines for a thyroid problem (for example, a thyroid hormone or antithyroid drug). Pregnant and 3 A copy of this listing, which says that it was last revised in May 1994, is attached.

nur.\*ing women and babies and children may also take this drug. [Emphasis added.] Later on in NUREG-1633, the NRC staff acknowledges (in a commendably full statement of the WHO position) that the World Health Organization and international practice call for administering Kl to children and pregnant women in emergencies, but it reiterates the claim that U .S. sources recommend the opposite. The very last paragraph of the document, at p. 28, reads as follows : International Practices

• Other countries and major international organizations, including the IAEA and WHO, endorse the use of Kl. The international policies, in some cases, are significantly different from the U.S. policies. The principal example is the recommendation by the \VHO to administer KI to pregnant women and children.

whereas U.S. references specifical{r warn against administering Kl to that same group. Cultural and legal differences between the L'.S . and other countrie s may be the basis for differing perspectives on general drug use. [Emphasis added.] 1 have not researched everything that may have been said about KI in every edition of the Physician's Desk Reference, but the quoted excerpt should suffice to refute the proposition that l.S . sources "'consistently'* advise against giving KI to children and pregnant women. IV. Miscellaneous Other Comments The following comments I will make only very briefly. Many of them deal with points that I have made at length, often repeatedly, in earlier submissions, and that have been repeatedly been ignored by the NRC staff. I am making them not because I think that at this late date, the same staff members who are responsible for the draft ofJ\.'UREG-1633 will start responding to them. but for the Commissioners. '\RC' staff management at the highest levels, the public, and the record. A. When must Kl be given to be beneficial? [p. 2] According top. 2 of NUREG-1633 , "'the potential benefits can be realized only if the compound is administered just before the inhalation of ingestion of radioiodines. [Emphasis added.] Let us compare this with what the Food and Drug Administration said in its final recommendations on KI, published in the Federal Register on June 29, 1982 (47 FR 28158): FDA concludes in the final recommendations that risks from the short-term use 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. FDA recommends that potassium iodide in doses of I 30 milligram~ (mg) be considered for thyroid blocking in radiation emergencies in those persons who are likely to receive a projected radiation dose of 25 rem or greater to the thyroid gland from radioiodines released into the environment. To have the greatest effect in decreasing the accumulation of radioiodine in the thyroid gland, these doses of potassium iodide should be administered immediately before or after exposure . If a person is exposed to

radioiodine when circumstances do not permit the immediate administration of potassium iodide, the initial administration u-ill still hai*e substantial benefit even if it is taken 3 or -I hours ajier acute exposure. [Emphasis added.l1 Readers can decide for themselves whom they believe : the federal agency with the responsibility for making judgments on the safety and effectiveness or drugs, or the authors of NUREG-1633 , who for some reason did not think it appropriate to inform them that the FDA had spoken to the Kl issue. B. How widespread is the use of Kl internationally? [pp. ix. 19-20] The 1\TLTREG says that "to complete the picture, it includes advice as to the KI policies of the United Kingdom, Sweden, Switzerland, Finland, France, the WHO, and the IAEA. (In fact. it also deals with Germany.) The casual reader might understand this to be a complete list of the countries that stockpile KI, since there is no reference to the fact that many other countries also maintain supplies of the drug. Reference should therefore be made to Norway, Austria. the Czech Republic. Slovakia. Poland. Japan, Russia, Belarus, Ukraine, Armenia, Canada, etc. The reader should be made aware that FS . policy is the exception rather than the rule. I would draw particular attention to the case of Canada. (As long ago as April 1994. in a letter to the Commission that was brushed aside at the time. Senators Joseph Lieberman and Alan Simpson pointed out that Canadian provinces with nuclear power plants are among the governmental authorities that stockpile KI.) In view of all the staffs efforts in the :\l:REG to explain away the use of Kl in other countries by pointing to the cultural. legal. and dietary differences bem*een Europe and America, perhaps the staff should address what the differences are bem*een. say. Ontario and Connecticut. C. What is the discussion of .. ablation" about? [p. ix] The l\1)REG suggests that the "reduction in the risk of thyroid cancer obviously does not apply if the thyroid is ablated (dose greater than about 25,000 rads). This is an argument that surfaced back in the 1980's: that if the thyroid dose is high enough. the thyroid is ablated (burned out). and thus all the risk of cancer disappears. The l\1UREG should make clear that even if you were to get an ablating thyroid dose without simultaneously getting enough whole-body dose to kill you, the consequences of being deprived of a functioning thyroid are not insignificant. For this and other medical questions, l suggest that the NRC staff should consult professional thyroidologists . When we have a Public Health Senice whose expertise is presumably available to a federal agency, and NIH (which has been studying thyroid cancer for decades) is literally just down the street from NRC , why not call on their expertise'.' D. Evacuation vs. sheltering [pp. ix, l) I have on numerous occasions cited the EPA "Manual of Protective Action Guides and Protective Actions for Nuclear Incidents,** EPA 400-R-92-001 (May 1992) for its discussion of sheltering. thyroid dose, etc. It is, I think, a thoughtful and balanced discussion of the pros and cons of evacuation and sheltering. (Rather than characterize what the EPA Manual says, 1 will anach the relevant pages.) I have tried to persuade the NRC staff to respond to what the Manual has to say: so far it hasn't. Even if the KRC staff does not like what it says. the EPA Manual should be listed among the

         -1 A copy of the FDA Federal Register ~otice is attached.

references. It isn't. As with the FDA "safe and effective'" notice, the J\RC staff has chosen to ignore what a sister agency has had to say on the very issue now under discussion. Just to make my position crystal clear, the question as l see it is not whether Kl is bener than evacuation - it isn't, if complete evacuation is feasible -- but rather. given that emergencies often develop unpredictably, whether you want your emergency authorities to have three arrows in their quiver or only two. I feel strongly that it is better to have three, for greater flexibility in dealing with whatever may arise. If the third arrow were extremely expensive, it might be a harder question, but this one is so cheap that the issue is, or should be, a no-brainer. E. How easy is evacuation? [p. i, 1-2] The NUREG advises that "evacuation is relatively commonplace" in the U.S., since "'people largely have their own means of transportation. travel routes are general~v well suited to the movement of large nwnbers of people, and people have places to go." [Emphasis added]. The staff contrasts this with administration of a medicine to the general public, which "has no precedence [sic] in the United States ... l do not think that this kind of generalization, seemingly plucked out of the air, is a substitute for addressing issues. What does it mean that people "largely have their 0\\11 means of transportation') What does it mean that travel routes are "generally" well suited to moving large numbers of people') It would be considerably more useful if the staff addressed actual conditions in the vicinity of C .S. nuclear power plants, rather than offering Pollyannaish observations on the general state of life in the C .S. F. Carcinogenicity ofl-131 (pp. 7. 9) The authors ofl\11.JREG-1633 twice quote the following 1985 (i.e., pre-Chernobyl) statement in NCRP-80: "Because l-131 has not been shown to be carcinogenic in people, a comparison of the thyroid cancer risk from l-131 with that from x-ray exposure is difficult." (The first time they quote it. they note. however, that the Chernobyl studies "indicate that internal and external dose may be equally effective in producing thyroid cancer.) The world ' s leading expert on the long-term effect ofl- I 3 1 used in medical treatment is Dr. L. E. Holm of Sweden. As he has reported in journal articles, and as he described at the recent conference in England, he has not found any increase in thyroid cancer in persons who received l-131 treatments in a medical setting. ln the question period that followed his talk, l asked the following question: *'Jn the United States, iodine prophylaxis with potassium iodide is a contentious issue, and some people are citing your work for the proposition that 1-131 is not carcinogenic and that there is therefore no point in stockpiling KI . Would you care to comment')" His response was that his study did not establish whether or not 1-131 was carcinogenic, but dealt on1y with this type of medical exposure to 1-131. He added that he himself favored stockpiling of KI. The crucial fact here is the one that the staff alludes to in the footnote : that in light of the disease appearing since Chernobyl, few experts now doubt the capacity of 1-131 to cause cancer, especially in children aged 0-4 at the time of exposure. G. "Tendency of papillary cancer to recur in a more aplastic form some 10-20 years later." [p. 9] If the same thyroid cancers whose gravity the authors ofNlJREG-1633 are downplaying. because they "respond favorably to early treatment'" [p. 17]. tend to "recur in a more aplastic form some l 0-20 years later," this puts radiation-caused papillary carcinoma in a new and more ominous light. Again, this is a question for medical experts, and J\IH is down the street.

H. Just two or three deaths') [p . 17] The reader could get the impression from this that the radiation-caused thyroid disease in the former Soviet Union is not all that significant. Sadly, that is not the case. Fatality figures alone give a very partial measure of the real significance . You need also to address such issues as the following: How many of the patients are likely to die of the disease at some point in the future? What is the quality of life like for those who have the disease but do not die of it? What is the frequency of metastasis? (At the Cambridge conference, a team from the Thyroid Cancer Center in Minsk, Belarus, reported metastases in more than 70% of cases, with distant metastases (i.e., more extensive) in 14.7% of the patients.) What kinds of treatment are required? \\hat are the health effects and quality of life impacts of those treatments') If all you are willing to talk about is fatalities, you are giving an incomplete picture of the real significance of the disease, and thereby misleading the reader. One of these years, the J\RC must finally begin to address, in a meaningful way, what non-fatal thyroid cancer entails, because this is an essential part of the factual basis for deciding whether it is sensible policy to have Kl. Since l 989, l have been trying to explain to the staff that there is more to disease than whether you die of it, and that as a society. we regularly protect our children not only against diseases that are commonly fatal, but also against illnesses that normally are non-fatal, because we are concerned not just with saving life but also with preventing needless suffering. The staff has yet to address that point. But fatalities are what 1\1.JREG- l 633 wants to focus on. lt says. at p. 9. of the risk of radiogenic thyroid cancer: *'Even with external sources, however, the risk is difficult to assess for several reasons. First, the less-reliable incidence data must be used because tl~vruid cancer is on(r infrequentlyjatal."' [Emphasis added.] From a scientific agency. this is truly an extraordinary statement. The authors of NUREG- l 633 are telling us that the data on radiogenic th)Toid cancer is more reliable if it ends in a fatality than if it doesn't. How can such a claim be made with a straight face? The crux of the policy question is not hov.* many people will ultimately have "thyroid cancer** on their death certificates if there is an accident or act of terrorism and no KI is available, but whether it is worth seven cents to protect American children. especially those four years old and younger. from a disagreeable disease that will mean suffering for all of them and death for a few .5 I'm sure I'll be accused of emotionalism for saying this, but 1' ve shared a lot of hospital waiting rooms with children who haw various types of cancer, and with their parents. I also once had a long telephone conversation with a distraught woman who called me and described the four-year battle of her daughter, then in her early teens, with thyroid cancer: initial surgery, radiation treatment, further surgery to clean out the cancerous lymph nodes from the length of her torso, followed by further radiation treatments. (This young woman will probably survive, but that doesn't mean that she and her mother have not suffered terribly already .) These experiences have helped inform my understanding of what cancer entails for young patients and 5 Perhaps the difference in viewpoint was summed up best by an exchange that took place in October, 1997, at the meeting in Paines\-ille, Ohio. I made the point that the cancers in the Belarussian children have tended to be aggressive, with spread to the lymph nodes that leaves the children with surgical scars going from ear to ear. The J\i"RC representative observed that this was in part a result of the limitations of surgical expertise in Belarus, and that in the U.S ., the scars would be smaller. But the real issue is not whether American children will have long scars or short scars on their necks. it is whether at minimal cost we can take a step that will help ensure that they need have no scars.

their families. 6 The American Thyroid Association*s support of KI stockpiling also has a lot to do with the fact that its members are thyroidologists: they see the patients and their families, and they know what thyroid cancer involves. 1 can't help thinking that if the staff members responsible for 'l\l_]REG-1633 had had similar experiences, they might be less impressed with the low fatality rates for childhood thyroid cancer and more inclined to agree with the Europeans, Canadians, Japanese, 'WHO. American Thyroid Association, Senator Lieberman, Senator Harkin, former Senator Simpson, and me that childhood thyroid cancer is a disease well worth preventing. I. Seismic events? [p. 13] The NUREG says of evacuations, "In addition, seismic events or traffic accidents could block some evacuation routes.'" Years ago, when intervenors in a California reactor licensing case tried to raise the issue of the complicating effects of earthquakes on emergency planning, the NRC dismissed this possibility, and was upheld in court . This NUREG may prove to be a boon to would-be filer~ of 2.206 petitions .

• J. "U.S. officials conducted a study" [p. 21]

The KUREG discusses the TMJ accident but fails to mention the Presidem*s Commission on the Accident at Three Mile Island (Kemeny Commission) and its recommendation in favor of Kl stockpiling

 - a recommendation that the KRC initially endorsed enthusiastically. However. the Kl.JREG does mention that after Chernobyl, "U.S. officials conducted a study .. that determined that no changes in emergency planning were necessary. There is no citation to that study. In fact, it was a staff paper prepared by the NRC staff. (This is a maner of public record. because 1 criticized that staff paper in my Differing Professional Opinion, which is now a public document.) Here again we see the authors of the Nl.JREG picking and choosing their data, inflating the significance of an ordinruy l\RC staff paper until it sounds like an authoritative lJ .S. Government position, while silently tiptoeing around the extensive.

detailed, authoritarive report of the Presidential Commission. K. Fast Food [p. 8) NUREG-1633 makes the point that Americans* thyroids are already partially blocked because of the high intake of iodine in the typical American diet. It says: **in recent decades, stable iodine has also become an important additive to bread and fast foods (especially hamburgers). In fact, most Americans do have a high intake of iodine, certainly as compared with the iodine-poor areas of Eastern Europe. The higher the individual's dietary intake of iodine, the less critical is the need for administration of KI in an emergency. So far, so good. Where I disagree with the authors of the NUREG is their apparent assumption that because millions of Americans have partially blocked thyroids, we can afford to ignore those who don't. l\iot everyone eats mass-produced bread or fast-food hamburgers. L. National Stockpiles [p. 28] 6 I also saw many thyroid cancer patients professionally when I was an administrative judge on the Nuclear Claims Tribunal in the Republic of the Marshall Islands. Many of them had had their hes blighted by radiation-caused thyroid disease.

NUREG-1633 says: "'J\i ational stockpiles of Kl have been recommended along with chemical antidotes, serin vaccines and antibiotics for response to nuclear, biological, and chemical weapons. As an added assurance, these stockpiles are available to State official s, should there be a need for Kl on an ad-hoc basis. The reader should be informed that these stockpiles are supposed to amount to at most 4,000 pills in at most 27 sites. This minuscule amount is not enough to be of significant value to the general public in the event of a nuclear power plant accident or act of terrorism . Moreover, at the November 5, 1997, meeting at the NRC, FEMA officials said that no plans had been made for transferring KI from these stockpiles to the vicinity of nuclear power plants in an emergency. M. Legal Aspects (p. 2) NUREG-1633 says that it "does not address the ... legal factors associated with the use (or non-use) of KI:* but then proceeds to do just that. It infonns us. at p. 22, that [t]he tort system in the C.S i!-. also quite w1ique, that in the l'..S., "the implementation of a protective action may entail litigation and liability for long after the accident,"' and that administration of Kl on a mass basis would certainly entail litigation in th.is country .. ..** 1t would be helpful to know whether these legal judgments represent the considered view of the :'\RCs Office of the General Counsel or of the authors of 'i\L:REG- 1633. If the latter view themselves as better qualified than the FDA to judge drug safety. perhaps they also see themselves as better qualified than the J\RCs lav,yers to offer legal advice . V. Conclusion NUREG-1633, as 1 suggested in my comments filed on August 5. 1998. is a seriously defective document. It is, I submit. an advocacy piece. seemingly written to justify a particular policy position (one that the Commission has since rejected), rather than what was needed, which was a dispassionate analysis of the facts relating to KI. In its discussion of tincture of iodine, J\UREG-1633 has sufficient potential to result in harm to the public that the printed copies of the document should be recalled and sent to the recycler. (Electronic versions should be taken off the l\'RCs website.) But the discussion of iodine tincture is just one of many, many problems with the document. What the authors of 'I\uREG-1633 may not understand is that a document as slanted as this one

  - if they recognize it to be slanted_ which they may well not - is a reflection not only on them but also on the entire l\iRC and all the work that the agency does. It is far easier for individuals and organizations to lose their credibility than to regain it once it is lost. Persons intimately familiar with the NRC's work may have (and rightly so) high confidence that the agency would not suppress or manipulate safety data to keep an unsafe plant running; but what is the public at large to think when it reads a document like this one? One can imagine members of the public asking themselves, "Why should we trust the l\iRC staffs evaluation of the safety of Millstone if we can't trust its evaluation of KI?" ~'UREG-1633 is a bad apple, and it should be removed from the barrel quickly.

The next question is whether the document should be rewritten or held in abeyance for now. 1 believe that the defects in NUREG-1633 are too pervasive to be patched up with an edit here and an edit there. I respectfully suggest to the Commission that the best course of action would be for the staff to proceed expeditiously with the rulemaking that the Commission has directed, and not be distracted from that effort by having simultaneously to try to make a silk purse out of the sow*s ear that is NUREG-1633. When the rulemaking is complete. then and only then the staff should prepare a document that explains the basis of the final rule (in whatever form that final rule may take) and provides clear, honest, balanced_

                                                       - l 0-understandable, concise, and user-friendly guidance to help state and local authorities make informed choices regarding Kl. Such a document does not need to be anywhere near 40 pages long. as is '\:UREG-1633. On the contrary, so long as the information in it is sound, a much shorter document would probably be far more helpful to state and local officials, because they are much more likely to read it through. (For the san1e reason, it is also mote likely to get careful review \vithin the NRC.)

In sum, I recommend that 1\1UREG-1633 be shelved. lfthe information that was developed for it can be useful sometime in the future, when a new guidance document is prepared, well and good; if not, the whole episode nevertheless should have value to the NRC as a learning experience. Attachments:

1. FDA Federal Register Notice (June 29, 1982)

2. Excerpt from 1997 Physician's Desk Reference

3. Excerpt from EPA Manual of Protective Action Guides and Protective Actions for'\; uclear Incidents cc:

Chairman Jackson Commissioner Diaz Commissioner McGaffigan Senator Joseph Lieberman Senator Tom Harkin Georgetown University Poison Control Center L. Joseph Canan, EDO Hugh Thompson, Deputy EDO Karen D. Cyr, General Cowisel

28158 Federal Resbt* / Vol. 47, No. 125 ,1 Tu11day, June 29. 1082 / Notlctt ltnte announc:lnt the andabllf tJ or dtah (111bl ma Health (HFX-t). Food and 0rut recommendations about 1dmlnl1tertn, Admlnltrallon. 1800 Flaben Lant, pot111fum Iodide to the ,meral public In Rockville. MD 20157, aot-443-Q20 or a ndlatton ~ C J . The dran per Edwin V. Dutra. Jr., Bureau or Dnap ncommedatlona wen made available (HF0-30), Food and Dnaa for public c:ommlftt to provide FDA with Admlnl trallon. 1800 Flafien Lane, ' Tlewa to be considered a, It developed Rockville, MO 20857, '°1-'43-0490. Its nnal recommlftdatlon1 on this a11 or IUP'l'I.Dmff AllY INPOMIAT'ION: 1n the pota11lum Iodide. The comlMllt period Federal Rlllat* or October Z2. 1910 (41 a. doaed on October 1981 (11e the FR 8990C), ihe Federal P.merpncy Federal aeptar or Stptmber ta. 1881: Manaaement A,ency (FEMAl outlined 48 FR 48402). the re1ponalblllU11 of ,even Federal FDA recelnd commffltl from apnclea concemtn, emnpncy* Individual cltlsena. profnalonal and re1pon11 plannln, pldance that the consumer 1dYOC1t1 sroupa. Stat, and agenclt1 should provide to State and local he11ltb apncln. and other Federal local authorities. The October Z2. 1980 apncfea. The laaun they ral,ed ere notice updated an earlier notice on the dl1cu11ed in the ,-c:qround" section aubject that tha General Service* of the nnal recomme-ndatlona. Administration (CSA) publl hed In the One purpoae of FDA'* final ral Federal Re1illff of December 24, 1C75 recommendations la to facilitate a Fo (40 FR 59494). (CSA re1pon1lblllty for naUonal contenaua on the use or S2S emergency management was tranaferred potassium Iodide dwin, a radiation to FEMA by Executive Order 12148.) emerpncy. Another I* lo provide e nal The Department of Health and Human information and ruldance to Sate and n Service' (HHS) responalbllltle for local public health apnclea and other emergency-response plaMtn, Include persona re1ponalble for lonnulatlng a11f1ting State and local authorltle in emergency-response plans for radiation developing plans for preventing adverse accidents. effect from exposure to radiation In the Uncertalntie till exJat 111bou1 the even! that radioactivity 11 releHed Into do1e-re1ponse for radlolodine-lnduced the environment. The,e plans Include thyroid cancers and tht Incidence and the prophylactic uae or drug, that would 1everlty or aide effects from pota11lum reducD the radiation doe to specific Iodide. The,e uncertainties. which are (Docket No.11N-OOl71 organ from the sudden releHe Into the dl1cu11ed In the flnal recomm,mdallona. environment of large quantltlea of are unlikely to be resolved soon. PotaAlum Iodide *** Thyroid- radioactivity that might include several Blocklng Agent In a Radiation Baaed on Its consideration or radioactive Isotopes of Iodine. Emergency: Flnal RKOmmendatlons comments received and Its 1naly1l1 of As one step toward meeting the On Use Department's reaponalbllltie, FDA availf.ble informetlon. FDA concludes In the final recommendations that rilc., AGENCY: Food and Drug Administration. luued a notice In the Federal Regl ter of December 15, 1978 (43 FR 58798) . from the ahort-term use of relatively low 'ACTION: Notice or availability. dose, or pot111ium Iodide for thyroid announcing 111 conclu,lon that potaaslum Iodide Is afe and effective blocking In a radiation emergency an, UMMAltY: The Food and Drug outweighed by the risks of radlolodlne-dministration (FDA) aMouncea the for use a a thyroid-blocking agent In a radiation emergency under certain lnduced thyroid nodules or cancer at

• vailability or final recommendations projected dose to the thyroid gland or 25 about administering pot81clum Iodide to specified condition of uae. The notice al8o announced. however. th,-t* rem. FDA recommer.Ja that pota11lum the general public In a radiation Iodide In doaet or 130 mllllg:rama (mg) emergency. The final recommendaliona pota11lum Iodide haa not been u,ed to such an extent or for such a period of per day for adult, and children above 1 prepared by FDA 's Bureau of time under radiation emergency year and es ma per day for children RHdiological Health and the Bureau of conditions to pennlt the col"clualon that below t year or age be considered for Dru11s are being made available to aaalat thyroid blocking ln radlaUon Slltlc and local authorltlea In developing the drug may ba marketed without an approved new drug application (NOA). emergencies In those persona who .are emergency-response plans for Thus. in the lnteret of public safety, the likely to receive a projected radiation preventing advel'le effect from notice encouraged Interested pertona to dose or 25 rem or greater to the thyroid exposure lo radiation in the event that submit to *.he agency NDA'a for gland from fadiolodln~ released Into
• radioactivity It accidentally releHed the environmenL To ban the ,reate,t Into the environment. potaaalum Iodide in oral dosage form, ADDflUS: The final recommendations for use H a thyroid-blocking agent:"ln effect in decreasing the accumulation or the l11ue for February 22. 1980 (45 FR radlolodine ID the thyroid stand. lheae are on diaplay in. and comments may be doses of pota11lum Iodide should be aubmilted lo. the Dockets Management 11912), FDA aMounced that potaaalmn Iodide H a thyroid-blocking agent la admlnlatered Immediately before or Branch (HFA-305). Food and Drug aner exposure. U
• penon b exposed to available commercially in both tablet Administration, Rm. 4-62, 5600 Fishers radfolodlne when c:ircmMtancea do nol and solution form. (Since that time, FDA Lane, Rockville. MD 20857, and coplet permit the Immediate 1dmlnJ1tratfon of mny be obtained from Bernard Shlelen haa approved an addlUonat NDA for pota11lum Iodide In solution fonn for potaulum Iodide, the Initial
• at lhe addrese below. administration wlll still have substantial use as a thyrold-blockh*11 *rent.)

FOIi FURTMER INFORMATION CONTACT: In the Federal Register o June 5. 1981 benefit even lflt la taken 3 or 4 houn Bernard Shleien. Bureau of Radiological (46 FR 30199). FDA l11ued a notice afterJlCUle exposure. .

Federal Resbt.r / Vol 47, No. 125 / Tueaday, June 29. 1982 / NoUcea 28159 Taken together, the commenll written commmta on lhttt final NaUonal lnltltutta of Health received durlna the public comment ncommmdatlona to the Docket, .s,trlod and the actiona o! na tlonal and Manapmmt Branch (addrua above). forelp recllatlon protection ,roupa mab Dated: J11D1 ZZ. 1111.. thne ncommendatlona prudent Al1Jla Hal Ha,.... Jr., becaan. althoaah 1llahU1 above the Purnant toi"u . 8M83, notice 11 Cotnaii.,lotw ofhod ond Orv,-. hereby sf vcn the m11t1n1 o( the range pretentecfln drafl ncommendeUona (10 to 20 rem). a za.. ,.DN. .. 17_ . . . . . . . . . . . . ., Cancer er Support Rtvlilw rem projected do11 to the thJrOld la a.LalOCOOI*...,_. Comm e. National Cancer J ltute, equal numerically to the Environmental Jul 18. 198%. Bulldln1 3 ProtecUon A,ency'a (EPA) upper nference Roome. Na nal ln1litulo1 Protrc:Uve Action Guidance level for the IDoclltt No. l2P-0111J of Health, De1ha1da aryland 20205. pneral fubllc and the United ICln,dom't Thia meetlna wU t open to the public Union Cart>lde Corp.; FIUng of F Natlona ~dlaUon Protection Board'* on July U fro :30 a.m. to 10;00 a.m. to Addtttvt Petition upper level J>ropoHd for pota11lum review ad nl1lratfva de1all1, an Iodide UH, (EPA Protective Action AOINC't: Food and Dnaa Ad latratlon. i,re11n port* by th* Dlvlalo !rector Culdea call for ahellertna, evacuation. AcnoN: Notice. an a Branch Chief. Atta ance by the and controlled acceaa II protective lie will be limited to ace available. action, when the total ,1ccwnulated IUIIIWm Tb~F and Dru1 In accordance wl provl1lon1 101 thyroid doaea are profected *ta to 25 Admlnlatratlon A) la annou.nlna th rorth In Section, 2b(c:)(4) and rem for the 1eneral population. The EPA UnJon Carbl Corp. baa nted a P1! on 652b(c)(8), n 5, U.S. Coda and r.lion

 ,ulde1 do not 1pecllically note the UH of  propoln        al the food addltlv                             lO(d) of       . L 92-463. the m ng will potoulwn Iodide u a protective action       re,ula na be amended to                      vlde for          be clo                                 y 15. from for the general population.) Theae                                                                                      10 the public on ap     cation changes In                 ysulfone                                                     d        1 agenciea would expect aeme protective         *Ina u article or c ponenlJ or                              10-p(J a.m. to adjoumm t, an on Jru Y h action to be taken al 25 rem projected      artlclu Intended r repeated use In                           ,.ffl, from 8:30 a.m. t        djoumme~t. or t e dose to the thyroid. Use of a single       contact with f                                           /      review, dlscu11           and evaluation or recommended value also eliminate,                           /                                    .         Individual           t applications. These queationed by State and local public       FOIi "-"'THIii rNl"OIIMATlON COHT¢,                             applicat I and the discuuions could health agenclea about whether to use       Julia L H'o, Bureau of Foods {}-JPF-334),                       reve confidential trade ae

• or the upper or the lower part of a range of Food-ind Drus Admlnl tra!Wri, 200 C S ~ e r c i a l pro .. erty uc
• patentale values. fWI .. Wahington. D.C. _JJd.04. 202-4 72- aterlal and pe;.onal formation FDA further recommend, that officTlll1 5690
• concemlna lndlvl I a11oclatod with responsible for radiation emergency IUPPUMENTAll'Y OIIMATlOIC: Und the application . c!lsclosure of which response planning Include In the the Federal F c!. Drug. and Coe tic would cons ute a clearly unwarr tcd emergency response planning a 1y1tem Act (eec. b)(S). 72 Stat. 17 (21 lnva lo peraonal privacy.

or public Information on the u1e of U.S.C. B(b)(Sl)). notice I ven that a Winifred Lumade e potassium Iodide and a system of pemt6n (FAP 2.83629) Ms been nted by

• n.

medical contact, reporting. and J)filon Carbide Co :.'River Road, Bound mmlttee Managomen mcer, a11islance. Brook. NJ 08805~po,lng that Part 177. National Cancer Ina te, Building 31, Each Stale Is re1pon1ible for (21 CFR Parp17) or the food addllf~*-/ Room 10A06. Na nal Institutes of formulating ,uldance on when. If at all, regulallonfbe emended to prov_!,s!e"for a Health, Beth a, Maryland 20205 (301/ the public 1hould be 1upplled with chanp'ln the molecular weight 496-5708 I provide 1ummarle1 or the potassium Iodide along with lnstructiona 1prclncatlon1 and te Ung~ufrement, meetl!)f"and roetera of committee on how to use It. In preparln3 ,uldance for polyutrone resin* uartfcle or m¢ber,, upon request. and maklns rule

• State and local component, or artlcl4!"1 Intended for / ,,. Dr. Robert L Manning. ecutlve agencies 1hould Inform citizen or the repeated use In contact with food. / Secretary, Cancer Cen Support nature or the radiation hazard and or the The agencyli11 carefully conald~ Review Commillee sti1,n11I Cancer potential benefits and adverae effects of the potenU1ll environmental eIT11m1 of Institute, Weal od Building. Room 803, pota11ium Iodide. 1h11 pt9Po1ed action and ha~ncluded National I11-M'llute1 or Health. Bethesda, These nnal recommendation* on th_Jt'tha action will not hafl a Maryla,Pd"20205 (301/ 96-7721} will pota11ium Iodide u1e must ba 1een In sfgnlficant Impact on)h'e human (uJ'TPffi 1ub1tantive program the context of radiation emergency environment and that an environmental ~nnaUon.

planning u a whole. The u111 of Impact 1tatem¢l1 not required. The_ ./. Dted: June 17 l982. potaulum Iodide In the radiation agency'* flpd(ng or no 11gnfficant lmp..act

• emergency 11 not a panacea. Jt doea not and lh~dence 1upportfna that}lndlng Betty J. lfferidp.

reduce the uptake by the body of other 1na7)1e teen In the Doclteta , Commlll# Man m*nt 0/fiCl!r, National radioactive material, or provide fJ"nagement Branch (HFA405), Food ln11/tu,-of)lfalth. protection agalnat external racllatlon. and Drug Admlnl1tratior(Rm. 4-82. 5600 (C tat-6CFeder I Dom"llc A11l11 The co1t and effectiveneaa 0£ other Fiahera Lane, RoclcviUe, MD 20857, Nulllf'>er 13.397, profect gr nt1 In cer protective measures 1uch II aeeklng between 9 a.m. and 4 p.m., Monday ~nter inrpport. Ntion l ln,11 es of Health) ,helter, evacuation. or respiratory protection also need to be considered. through F~81' * / (NlH prngr ma re not ered by 0MB Although FDA received written Dated;..fune 18. 198Z */ Circular A-95 becau ey fit the description comments on the draft S.glord A. Mlller, / of "pn>gr ma not nsldered appropriate" In recommendation, and considered them a{~tor, Bur<<1u of Food,. / section ll(b) (~and (SJ of the Circular) In formulation of these rmal rn Dae. a-11m l'll..l t-a-az: a ~ IFK Dae. ~SAM nw t-Zl-4 e,u *ml recommendaUona, under 21 CFR 10.90 KUNQ C:00C 4teCMMI / at.LINO'COOl 41. . . MI Interested peraona may 1ubmit further

51 EDITION 1997 PHYS CANS' DESK REFERENCE Medical Consultant Ronald Arky, MD, Charles S. Davidson Professor of Medicine and Master. Francis Weld Peabod, Society. Harvard Medical School Executive Vice President, Directory Services: Paul A. Konowitch Vice President of Product Management: Stephen B. Greenberg Vice President of Production: David A. Pitier Product Managers: Cy S. Caine. Mark A. Friedman Vice President , Contract Services/Fulfillment: Steven R Andreazza National Sales Manager: D1kran N. Barsamian Contracts and Support Services Director: Mariorie A. Duf1/2 Senior Account Manager: Anthony Sorce Manager, Database Administration: Lynne Handler Account Managers Director of Production, Annuals: Carne Williams Donald V. Bruccoleri Manager of Production, Annuals: Kimberly H1ller-V1vas Lawrence C. Keary Senior Production Coordinators: Amy B. Broohs. Dawn B. McCall Jeffrey M . Keller Production Coordinator: Mary Ellen R. Breun Jeffrey F. Pfohl Index/Format Manager: Jeffrey D. Schaefer P. Anthony Pinsonault Senior Format Editor: Gregory J. Westle y Trade Sales Manager: Robin B. Bartlett Assistant Index Editor: Eileen C. ldzik Trade Sales Account Executive: Bill Gaffney Art Associate: Joan K. Akerl1nd Direct Marketing Manager: Robert W. Chapma n Electronic Publishing Coordinator: Joanne M. Pearson Marketing Communications Manager: Maryann Malorg10 Senior Digital Imaging Coordinator: Shawn W. Cahill Director, Professional Support Services: Mukesh Mehta. RPh Digital Imaging Coordinator: Frank J. McElroy. Ill Drug Information Specialists: Thomas Fleming, RPh, Manon Gray. RPh Editor, Special Projects: David W. Sitton ~ Copyright~ 1997 and published by Medical Econom ics Company. Inc at Montvale . NJ 07645-1742 All right s reserved. None of the conter,t cf thi s pub*

• licat1on may be reproduced. stored In a retrieval system. resold . redistributed . or transm,ned in any form or bv an) means IeIectronrc. mechanica:. ph0 tocopying. recording. or otherw1se1 without the prior wrrtten permission of the publlst1er PHYSICIANS* DESK REFERENCE . PDRI!. PDR For Nonprescript,or.

Drugs(!!), PDR For Ophthalmology. Pocket PDRe. and The PDR Family Gu1dt: to Prescription Drugs are registered trademarks used herein under license . PDR Guide to Drug Interactions, Side Effects , Indications. Contraind1ca11ons 1M. PDR Generics 1M. PDR Medical D1ct,onary 1~. PDRe Nurse's Handboo~. 1", PDR@ Nurse*s Dictionary"', The PDR Family Gui de to Women *s Health and Prescription Drugs'". The PDR Family Guide to Nutrition and Health"'. PDR~ Erec1ron1c Library'". and PDRI!!) Drug REAX'M are trademarks used herein under license Officers of Medical Economics Company: Presioenr ano Chief Executive Officer: Curtis B. Allen: Vice Pres11Jen1. Human Resourc es Pamela M 61Iast-.. Vice President . Finance, and Chief Financ1a1 Officer: Thomas w. Ehardt : E,ecu11ve Vice President Richard F. K,err.a~ : Executive Vice Presioe .~:. Drrecron Sen*1ccs Pau

• A. Konowitch; Executive Vice President. Magazme Puo11sh1ng* ThOma~ F. Rice: Senior vice Pres11Jent. Opera11ons John R. ware: \*ice Presioen, 1ntormat!0~

Services. ano Chief Information Officer. Edward J. Zecch1n 1 ISBN 1 56363 201 2

2716/PHYSICIANS' DESK REFERENCE@ Wallace Laboratories-Cont. baa liahed relati"" to

• e -effecta l~ abould not be VASCOR brand of bepridll hyd Pcaible aide effecta include Ilk.in rMbea, ,welling al' the uli- tienta, toft.bephy-ftJ'J irlanda. and "iodimn" <-tallic tute, burning mouth . be le huarda. Tableta and throat., aore lath and cu-. aympt.om, al' a bead cold, .I .

and I O ~ ltomacb upeet and diarrhea). datromethorp Marketed jointly by A few people have an alJersic r'NCtion with more 1erio111 manydnip i..horatoria Sae mation . aymptoma. n- could be fr,er and joilit pains. or ,welling uerc:iaed when are *

• or pana of the race and body and at tima Wftre lhortn- of wvman and ~ o n llbould be made
• n-brath requiring immediate medical attention. tinue nlll'li!lg or to diacontinue the dnJa-;1aking into account Tu.in& iodide may rarely cauae overactivity of the thyroid rtance of the clruc to tb<<Dother.

VoSoL rland. underactivity of the thyroid eland. or en.larrement of Tat lnwaction*: Qoireneain or ita OTIC SOLUTION the thyroid Jland (loiter). y color interfere;ice with the VMA ( lac.tic acid otlc IOlutlon. UIP) WHAT TO DO IF IIDE EFFECTS OCCUR clelic acid) tat for catecllola. It may allo falaaly lnel of urinary &-HIAA (~ydroxyindol *

• acid) in cer- VoSoL HC I If the aide effecta are lleftre or if you have an allercic nec-tain aerotonin.-metabolite chemical ~ u a e or color OTIC SOLUTION tion, llop taking potaalium iodide. Then, if pcaible, call
• doctor or public health authority for imtnlctiona. iDterferen;e.' /

(hyd-111one and -tic ' BOW SUPPLIED DrM, IMitvctiona: Serious tasicitpnay rwult if demometh-THYRO-BLOCK Tablet.a <Potuaium Iodide Tableta, USPJ ia coadminiltered wi_l,h-'monoamine ondue inhibi- DESCRIPI'ION are white, round tableta, one aide acored, other lide deboaed Ola). The uae of .deirtromethorphan bydrobromide V6&L (acetic acid otic aolutiatl,* 472 WAU.ACE, each containing lXl me potulium iodide. t in additiv..--cNS dep,-nt effect, when coed- acid (2%), in a propylene glyail Available in bottl* of 14 tableta CNDC 0037-0472-~). red with _altiohol, antibi8taminea, paycbot *CII or glycol diacetate (3%), be,Dll!'tlllllibii WALLACE LABORATORIES ch produce CNS de IOdiwn acetate (0.015%). Dit>iaion of

• for l'omnt&.* Pati ed not t.o acid ia CH,OOOH. with a CARTER-WALLACE, INC. product if they are ....."""wv on mono- rtructural formula ia:

Cranbury, New Jer.ey 08512 ollidue inbibito for depre. IN-0472-03

• tric o or Parkinaon *,

                                                                             ), or for 2                                      MAOI dnl&- If pa-tienta are un                                          *ption drua MAOI,                                              to coMUlt a lional bei                              a product.                                     V6&L ia a'fllilable u a AD                                   NS                                                pH 3 for uae in the uterna1      4r V6&L HC (h~_lllll Gue.a lllin ii well tolerated an                                   *de margin of       USP) ii a 10lution containinJ **

aafefy. Nau.a and vomit:inc are eca that oocur acid (2%), in a propylene Jlycol

                                                                 /         commonly . 0th                             ""l"R reaction. have in-         glycol diacetat.e (3%),

dimn-. . (including urticaria). disturbe.n are dium acetate (0.015%) and citrk fonnulu for acetic acid and de~~in and C,1H,o0&, with a molec:war ions) / respectively. The structunl ly to produce toxic (i eain, when admini&- l+<~-

                                                                                                                            ~ up t.o 5      crams/                                    t re -       of overd0&-

at reducing further abeorp-ptyi.ng (emem and/or pstric 100n u paaible aft.er *

• ethorphan ma cite-

n. Very

• uce cue rac-11dit.o r in-doae of11lu1:roa~iorn bas ON not to Uceed 12 .__,,,..iFuhcH;n 6 ,.,an 1o ruid.er 12 :,mr, of age.: 1 tea-Oblw four boura not to uceed 6 teaSl>Ol1011lrw boun.

OuJdren 2 lo und6 6 ,.,an of every four boun not to boura. Childms 6 mo. IC r 2 .)0IDl'I o f ~ A common ~ is

                                                                ~ teMpoonful                   , teaapoon{ul (0.6 mL to 1.25 mL) every 4 hocu1I or, ~ *feupoonfu.1 (2.5 mL) every 6--8 hours, not to ezceed,)--:5 teaspoonful.I C"l.5 mL) in 24 bows. lndividualiied                        V6&L-Acetic acid is
                                                                ~ abould be determined by evaluation of patienl

• ene glycol is hydrophili bemetho.niwn chloride BOW SUPPLIED motes contact of the .,

Gw.ifeneaiD 100 mg and de:rtromethorphan hydrobromide V6&L HC-Atietic aci 10 me per 5 ml of clear yellow liquid in bottles of one pint drooortiaone ii an ti_. CNDC 0037-4714-10) and one gallon (NDC 0037-4714-~). and ritic; propylene glycol

• 4 fl oz (NDC 003771'-0ll labeled TUSSI-ORGANIDIN@ face tenlion; benzetho ON.St NR' . that promotel contact S ~ t . o r e at controlled room temperat11~15'-30'C (59'~. Protect from l.iiht. Keep bottle tightly cl~. . INDICATIONS AND _ l!SA fl'USSl-ORGANIDIN@ DM-S NR' ii TIJSSI-ORGANI- V6.5oL-For the treatment DINDM NR' uquid either in a 4 fl cnunitofuaecontainer eiimial auditory canal ca with a .10 mL .Jnduated oral syringe and flt.ment or in a the action of the a n ~

30 ml ample container . V6.5oL HC-For the .tna TUSSI-ORGANIDIN@ DM NR' ('Newly Reformulated) of the external auditory " Liquid ii diltribut.ed br tible to the action of the ,

                                                                ... . . ,. " ... l"T' A   'R/'YRAT()lHF...C:.                                           inflammation.

PRODUCT INFORMATION/2785 . rIJlf1Y"OZDM -large d - of *piriq vomiting, conatipation, mio- Stwwgr. Ston! at tro¥.::ed roo t.emperat Hi'-30'C / have been reported. (69'...an'}. Prot.ect mo* /

                                                                                                                                  /Shown/ z*

• effect of both dnip. Renal a n

 ,0   be reduced.                                                                DEPENDENCE                                        Diapenae in a

• t oontainer

 ,,,. ~cement of h                                                        ,_-Schedule C-m <- PRECA                                                    WALLACE AIORATQl{IES                   /

Abu#: In *

• uae, abuae baa been rare. vision of C,4RTERZW :ZCE, INC./

pH, ant- Dll_,,~!d'- I.a clinical uae, dependence * 'Soma' Com- New J y 08512 ally ~ p alieylate COD* / Rev. 9/93 th Codeine baa been rare and re baw been no ely, their wi~wal can rault in a of lipific:ant abatinence

• Nn-erthel-, the in t /J tion . ~ 339 owing information on the *
• ual incredienta ahould

    -t.hia   ~"1-r      drup that acidify a        be kept in mind.                       /                                        THYIIO-BLOCK                                                  OTC
 .irin~ elnate plaama alicyla                      Cariloprodol-1.a dop, n~thdrawal IYJllploma occurred

• TABLETS aft.er abrupt -tion pf cariaoprodol from doa&l'S * * (POTASSIUM IODIDE TAILETS. USP) ui"'cec! aspirin-indllced fecal b loa
• 1 IJll/kg/day. Ip/a lltlldy in man, abrupt -
• n of Cpronounoecl s-,T Ass+um EYE-oh-dyed) 100 mg/kg/day ,('1,out five timel the recomme daily labbnvlatad: Kl) cylate plaama levell * /y be *

                        ~

adult doaagy1nl followed in aome lllhject, mild with-a.I c:orticmteroidl and may drawal .,mptoma 111ch u abdominal pa. inlOmnia, itially when the)'-ire diacontinued. ~ b e , and 1111111ea. Delirium d con'nlllion1 did TAKE PCYl'AS.5IUM IODIDE ONLY WHEN PUBLlC

 - i . _ lmpejmtMt of Frillty: No                   not"'OCC11r  <-    PRECAtmONS).                                                    HEALTH OFTICIAU; TELL YOU. IN A RADIATION
 , been ~~ with 'Soma' Compound ,-0,cki.M Pha,pha~Drug depen nee of the morphine type                                                  EMERGENCY, RADIOACTIVE IODINE COULD BE may result.                                                                        RELEASED INTO THE AIR. PCYl'ASSIUM IODIDE <A
   ~ ~ - l"ngnancy Cattgoty -t:. OVER.DOSAGE                                                                                           FORM OF IODINE) CAN HELP PRCY1'ECT YOU.
  ~ ; ; ~ d i

• have not IIIJt!f con- Any of the following whi IF YOU ARE 'roLD 'ro TAKE THIS MEDICINE.

mpound with Codeine. It .ii' alao not been reported wi e individual ingred.ientl a::.:,-flccur TAKE IT ONE TIME EVERY 24 HOURS. DO NOT

   ' Compound with Codeine can ca111e              may be m

• to a nrying degree by th ectB of the TAKE IT MORE OITEN. MORE WILL NOT HELP

iiltered to a p ~ woman or can other* *enu preaent in 'Soma'C.Om d with Codeine. YOU AND MAY INCREASE THE RJSK OF SIDE EF-acity. 'Soma' Compound with Codeine Can,o I-Stupor, coma, ahock,

• tory dep~ion FECI'S. DO NOT T.AKE THIS DRUG IF YOU KNOW

 ,cuant woman only if clearly needed.              and, ry rarely, death. Overd                      with cariaoprodol in               YOU ARE ALLERGIC TO IODIDE (SEE SIDE EF-e abown aalicylata to be teratogenic                     ination with alcohol, other           S dein-ant.1, or psycho-              FECI'S BELOW.)
 ,rta

• and embryoc:idal wben given .c apnta can have addi
• effects, even when one of e erably IJ"Mter than agent, baa been taken ~ IIIUally recommended d Aapu,n-Headache, t,i,linitua. i-ring difficulty, . INDICATIONS

                   **inwomenwb~k                                                                                                   THYROID BLOCKING IN A RADIATION EMERGENCY not dmnm,.atrata.Van in-          diain-, Lulitu~hyperpnea, rapid brea *
                                                   - . vomiting, -.ting and occuionally

• are char- ONLY.

almormali

• the of!'-

                                                    ==*

acteristic oj.Gilld to moderate aalicylate

• ni.ng. Salicylate DIRECTIONS FOR USE

ipltion of MPirilt-1§ear poiaoni9('ahould be considered in

• n with ll)'Dlptoma of Uae only u directed by State or local public health authori-

  >Ill delnery                                                                                                                      ti* in the event of a radiation emergency.

ate. Ji hyperpnea, and ea ii an early liin . h rmia.

                                                                                               *cylate poiaoni.ng, but dya- DOSE pnea 111pervene11 at pl.umalevela above 50 mg/di. Th-
 .              ii acmed in human milY respiratory cha.nr* ev_.Jntually lead to aeriollB acid-GUI!f t                              Tablet&: ADULTS AND CHILDREN 1 YEAR OF AGE OR
 .o-foar timee that in maternal      pl.umL         turbancea. Metabolincidom ii a colllt.8.nt finding injmants OLDER One (1) tablet once a day. Cruab for amall
  , IIDWI milk in moderate amouafa and                                                                                                           children but occun in ,9lder children only with aeve~iaoning; tendency in nuning in!apta.'Becauae             adult.I ~ ahibit rwpiratory alkalom * 'tially and                                            BABIES UNDER 1 YEAR OF AGE
 ;o.11 ildvene l"NCtiODl*ifi nlll"ling in- acidolia µrm.inally.                                                                                  One-half (1/2) tablet once a day. Crush fu'lt.

Jd be made wbet.ber' to diacontinue OtheH1ympto1111 of aevere aalicylate~ni.ng include hy- Take for 10 days uni* directed otherwiae by State or local ilinc into acc:o1111i the importance of ptrthermia, dehydration~deliri, and mental distur- public health authorities

r. **'bancea. Skin eruptions, GI mO?Tbage, or pulmonary Store at controlled room t.emperaturs between 15' and 3CY'C and effecti_.. in children bela,, edema are lea common. y CNS atimulation ii replaced (59' to 86"F). Keep container tightly cl~ and protect from

• not Meil *abliahed .-

      .,,-                                          by inereaaing$EEpreai,irtllpor, and coma. Death ii IIIUall                      light.

due to rspiratory

• ure or cardiovaacular collapee WARNING lNS . O:xkiM Pht. inpoint pupila, CNS dein-i ma,

                                                                                                                                    .Potaauun iDdid.t ahould not M Mad by peop~ olkrgic tc '°'

ll', dilc:ontinue 'Soma'. Compound with rwpiratory ,dei>r-ion, and abock.. r... ~ Gfflmu-Provide IYJllpl.omatic c! 111pportive allerpc duJe. Keep out af the reach of children. In - of ovenloee or ppropriate IYDIJJ!omatic and 111pport- ruction., contact a phyaician or the public health trN~nt, - indicated. NJ.y dru& r e ~ in the ltomacb authority. d be removed uaing appropriate _prfioedurs and caution to protect the airway and preve,9Vupiration, *pecially in DESCRIPTION ia the 1tuporo11B or comatoae paJieit. Incomplete gastric emi>- F.acb white, round. acored, monogrammed THYRO. r, *the tying with delayed=on of cariloprodol baa been BLOCK Tablet contains 130 mg of potulium iodide Other mt one with other CJil!'efl'ecta ported

• a cauae for pee. Should rspiration o oocl ingredient,: ma,neirium ltearate, mic:roceysta!line celluloee,

 -dw:tion.' Olaenwd lea bliquently are              in-ure become              promiaed, rwpiratory

• ce, cen- llilica gel. and IOdium thioaulfate.

atuia. -rr-r, ~ irritability, tral nenoua.,_.eematimulanta, a n d ~ abould be HOW POTASSIUM IODIDE WORKS

 -.ctioaa, IIYJICllpe(and ~ haft                    adminilteNCI' cautioualy,

• indicated. Certain fon111 << iodine help :,our thyroid gland work right.

ce. / ~ - T b e followiDg~haft irw:c-'ull:, in Mast i-11le get the iodine they need from fooda, lilr.e iodized cratic re,i:tiom are -..ry rve. They ~ with the ralated eprobamate: diuretil:a, aalt or fiah. Tbe thyroid can "atore" or bold only a certain n the pmod or the tint to faurth daae .Ainotic (mannitoD d i ~ . . dialysia, and bemodi- amwnt or iodine.

 ~ CODtact with the cine<-                          al,-ia<-e CLINICAL                        001.00Y). Careful monitor-            In a radiation emergency, radioectiw iodine may be releued
                                          /          inc fl urinary autput,ia' ~ and caution UlOll!d be                              in the air. 'nlia material may be brNtbed or nallowed. It
 ,ythema multilorme, pnvitua,aiilo-                  taken to noid over},aration. Cariaoprodol can be                                maJ mt.er the thyroid eland and damage it. The damage eruptiom with ~ to 1MJ>-                          iD biolap:al f l ~ pa chromatocraphy (Dougl.aa,                                wowd probably not abow itaelf for :,ean. Children are moat reported. If a1Jersic tNCtiaaa occur,             al: J P1ionrJ,8ci 68: 146, 1989).                                                likely to baff thyroid damage.

mpowid with Clodeia and tnat ,ymp- ~ there are no lp8Cific an

• aalicylate If you take pitaEum iodide, it will fill up :,our thyroid

 *tine pcaible IBersic Nldiom, alao ~ . the aim ol'trNtment ii to                                               elimination of       gland. 'nlia red- the chance that bannful radioactive cipienta (information an acipienta ii             ,-licylate and pre,ent or red110e                     u.orption; to cor-         iodine will enter the thyroid gland.
 .a - ~ ~

• t ) . . Net any fluid, electrolyte or lie imbalance; and to WHO SHOULD NOT TAKE POTASSIUM IODIDE

  ~ pomiral ~ - -8                                   prDride pneral and             .        . tory 111pport. Uacidolia ii           Tbe anly people who abould not take potaaium iodide an
                                      /              ...-it, intn'ftllOUI             .      bicarbonate must be gi                  people who know they are allergic to iodide. You may tab
 - . 90mitin&, epipatric - ~ and                     alanc with adequate ~tion, until lalicylate

• potaaum iodide even if you are taking medic:inee for a thy-

                                                     -        to within ~rapeutic range. To                             el.imina-    roid problem (for eumple, a thyroid hormone or antithyroid
  >IIB blood d ~ v e baen attrib-                    tiaii. forced d i ~ and alkalinization of

• may be dru&). Pregnant and nuraing women and babi* and children alone. LeukoPf!JID and pancytopenia bae6cial~ need for hemoperfuaion or'nemodialywia ia may allO take thil drug.

 ,ry rvely, ill-.ituatiom in which other             rve 11)11- ibould be uaed anly when_,,,ofher IIINlll1'S haft                    HOW AND WHEN TO TAKE POTASSIUM IODIDE
 ,n1 may,)laft baen rapomible.                       failJd_"'                *                  ,,                                  Potulium iodide ahould be ta.ken

• 1100n
• paaible aft.er

 ~ admw NaCtiollll                 -.tee!          ,.Qiacw ~Narcotic,...aht.gouiata, 111ch u nalor-                                  public '-1th afficiala tell you. You lhould take' one doee ev-
 . l&'ft been patrointatiml, including,, phine and leval.lorphan, ~ be indicated.                                                    ery 24 houri. More will not help you beca111e the thyroid caD critia,   occ:wt bleedinc, COllltipatioa.a~         DOSAGE AND ADMINJSTRATION                                                       "hold" only limited amounta of iodine. arpr dca. will in-
 ~on,been angioedema,   ut!:,~ratiJruri*

report,ed lea , i Tinni- U-1 Adult 0-,,.: 1 or 2 tab!eta. ,,our timee . y. creue the riak af aide efl'ecta. You will probably be told not to take the drug for more than 10 day&. e aerum aalicylate ln.ia <- OVER- Not rac:ommended for 111e in chil~n uncle~ twelve. SIDE EFFECTS

                        ~./           - 1*            BOW SUPPLIED

• Ullllally, aide elfecta of potaalium iodide happen when i-ple Allerp: t y p e ~ in apirin<<ui- 'Soma'.Compound with C o ed e ~ *(cariloprodol. USP take higher de.- for a long time. You ahould be careful not in-.olft tj)e' rapiratory*tnct or the _300 me, aspirin 326 mg, and
• e phoepbate, USP 16 mg) to take more than the recommended doee or take it for longer

 ,e f ~ range from rbinon-bea and                     are oval. convex, two-laye              and inacribed on the white             than y011 are told. Side efl'ecta an unlilr.ely becauae of the low O _rere       ~        and _the_ latter  my ~'.'; *~ "~~ -~~--~~ __th~ .!~A~. -'-~r:: _;'?~                                         doee and the abort time you will be taking the drug.

armer PA osure on many factors, such as how rapidly it lrovides on can be implemented and the nature of

 !ompar                                ew       the accident. For accidents where the M                                     ."       principal source of dose is inhalation, i                                    ted       evacuation could increase exposure if it
                                 , which        is implemented during the passage of a or nuclear       short-term plume, since moving vehicles provide little protection wide          of      against exposure (DO-90). However, AG for           oid      studies (NR-89a) continue to show that, n the ther hand,           for virtually all severe reactor accident applica90n o these PAGs to                     scenarios, evacuation during plume eer,*t*ng radionucr (s lea                     passage does not increase the risk of di rent derive respons                 m       acute health effects above the risk t ose based       earlier h         ysics      while sheltering. Sheltering, which in considera

• ns, becaus of new dose most cases can be almost immediately

          *on facto      d the weighting        implemented, varies in usefulness assigned         exposed organs       depending upon the type of release, the
         ).                                     shelter available, the duration of the plume passage, and climatic conditions.

5.5 Protective Actions Studies have been conducted to evaluate shelter (EP-78a) and This section provides guidance for evacuation (HA-75) as protective implementing the principal protective actions for incidents at nuclear power actions (evacuation and sheltering) for facilities. Reference EP-78b suggests protection against ~he various exposure one method for evaluating and pathways resulting from an airborne comparing the benefits of these two plume. Sheltering means the use of actions. This requires collecting e closest available structure which planning information before and data 11 provide protection from exposure following an incident, and using an airborne plume, and evacuation calculations and graphical means to - means the movement of individuals evaluate whether evacuation, away from the path of the plume. sheltering, or a combination of sheltering followed by evacuation Evacuation and sheltering should be recommended at different provide different levels of dose locations. Because of the many reduction . for the principal exposure interacting variables, the user is forced pathways (inhalation of radioactive to choose between making decisions material, and direct gamma exposure during the planning phase, based on from the plume or from material assumed data that may be grossly deposited on surfaces). The inaccurate, or using a time-consuming effectiveness of evacuation will depend more comprehensive process after the 5-17

incident when data may be available. where radioiodine inhalation is ii In the former situation, the decision projected. may not have a sound basis, whereas in the latter, the decision may come too The following sections discuss key late to be useful. factors which affect the choice between evacuation and sheltering. The recommended approach is to use planning information for making early decisions. The planned response 5.5.1 Evacuation should then be modified following the incident only if

• timely detailed The primary objective of evacuation information is available to support such is to avoid exposure to airborne or modifications. deposited radioactive material by moving individuals away from the path The planner should first compile of the plume. Evacuation, if completed the necessary information about the before plume arrival, can be 100 emergency planning zone (EPZ) around percent effective in avoiding future the facility. For the case of power exposure. Even if evacuation coincides I

I reactors, some of this information is described in NUREG-0654 (NR-80). It should include identifying the population distribution, the sheltering effectiveness of residences and other with or follows plume passage, a large reduction of exposure may be possible. In any case, the maximum dose avoided by evacuation will be the dose not avoidable by sheltering. structures, institutions containing I I population groups that require special Some general conclusions

I consideration, evacuation routes, logical regarding evacuation (HA-75) which I: boundaries for evacuation zones, transportation systems, may be useful for planning purposes are summarized below:

communications systems, and special problem areas. In addition, the 1. Advanced planning is essential to planner should identify the information identify potential problems that may that may be available following an occur in an evacuation. incident, such as environmental monitoring data, meteorological 2. Most evacuees use their own conditions, and plant conditions. The personal transportation. planner should identify key data or information that would justify specific 3. Most evacuees assume the protective actions. The evaluation and responsibility of acquiring food and planning should also include the shelter for themselves. selection of institutions where persons should be provided with stable iodine 4. Evacuation costs are highly for thyroid protection in situations location-dependent and usually will not 5-18

                                                                                          , I I

i  !

                                                                                            .i be a deterrent to carrying out an              to the point of an atmospheric release.

evacuation. Because of the above difficulties, medical and other institutions located

5. Neither panic nor hysteria has within the EPZ should be evaluated to been observed when evacuation oflarge determine whether there are any areas is managed by public officials. logical categories of persons that should be evacuated after the public

6. Large or small population groups (or, when time permits, before).

can be evacuated effectively with minimal risk of injury or death. 5.5.2 Sheltering

7. The risk of injury or death to individual evacuees from transporta-tion does not change as a function of the number of persons evacuated, and can be conservatively estimated using ational Highway Safety Council Sheltering refers here to the use of readily available nearby structures for protection against exposure to an airborne plume.

atistics for motor vehicle accidents Sheltering may be an appropriate ubjective information suggests that protective action because: - the risks will be lower).

1. It positions the public to receive Evacuation of the elderly, the additional instructions when the handicapped, and inhabitants of possibility of high enough doses to medical and other institutions may justify evacuation exists, but is small.

present special problems. When sheltering can provide adequate 2. It may provide protection equal to protection, this will often be the or greater than evacuation. protective action of choice. However, if the general public is evacuated and 3. It is less expensive and disruptive hose in institutions are sheltered, than evacuation. ere is a risk that attendants at these titutions may leave and make later 4. Since it may be implemented evacuation of institutionalized persons rapidly, sheltering may be the difficult because of a lack of protective action of choice if rapid attendants. Conversely, if evacuation evacuation is impeded by, a) severe of institutions is attempted during environmental conditions--e.g. severe evacuation of the public, traffic weather or floods; b) health conditions may cause unacceptable constraints--e.g. patients and workers delays. If evacuation of institutions is in hospitals and nursing homes; or c) attempted before evacuating the public, long mobilization times--certain increased risk to the public from a industrial and farm workers, or delayed evacuation could occur, unless prisoners and guards; d) physical the incident is very slow in developing 5-19 j nn

.I constraints to evacuation--e .g . 2. Number of stories overhead, and

• l inadequate roads.

3. Use of a central location within

5. Sheltering may be more effective the structure.

against inhalation of radioactive particulates than against external If a major release of radioiodine or gamma exposure, especially for short- respirable particulate materials occurs, term plumes. inhalation dose will be the controlling pathway. For releases consisting The use of large structures, such as primarily of noble gases, external shopping centers, schools, churches, gamma exposure will be most and commercial buildings, as collection important. However, when inhalation points during evacuation mobilization is the primary exposure pathway, will generally provide greater consideration should be given to the protection against gamma radiation following: than use of small structures.

1. Ventilation control is essential for As with evacuation, delay in taking effective sheltering.

shelter during plume passage will reduce the protection from exposure to 2. Dose reduction factors for radiation. The degree of protection sheltering can be improved in several provided by structures is governed by ways for the inhalation pathway, attenuation of gamma radiation by including reducing air exchange rates structural components (the mass of by sealing cracks and openings with walls, ceilings, etc.) and by cloth or weather stripping, tape, etc. outside/inside air-exchange rates. Although the risk to health from the action could be a constraint If external dose from the plume or (particularly for infants and the from deposited materials is the infirm), using wet towels or controlling criterion, shelter handkerchiefs as a mask to filter the construction and shelter size are the inhaled air will reduce dose from most important considerations; inhalation. ventilation control and filtering are less important. Although sheltering will 3. Following plume passage, people reduce the gamma exposure rate from should open shelters to reduce airborne deposited materials, it is not a suitable activity trapped inside, and they should protective action for this pathway for leave high exposure areas as soon as long duration exposure. The main possible after cloud passage to avoid factors which reduce whole body exposure to deposited radioactive exposure are: material.

4. Consideration should be given to

1. Wall materials and thickness and the prophylactic administration of size of structure, potassium iodide (KI) as a 5-20 l'

I I' l

• • 1 thyroid-blocking agent to workers evacuation may be the only effective performing emergency services and protective action close to the facility.

other groups in accordance with the PAGs in Table 2-1 and the provisions 2. Evacuation will provide total in reference FD-82. 3 protection from any airborne release if it is completed before arrival of the plume. 5.5.3 General Guidance for Evacuation and Sheltering 3. Evacuation may increase exposure if carried out during the plume The process of evaluating, passage, for accidents involving recommending, and implementing inhalation dose as a major contributor. evacuation or shelter for the public is far from an exact science, particularly 4. Evacuation is also appropriate for in view of time constraints that prevent protection from groundshine in areas thorough analysis at the time of an with high exposure rates from incident. Their effectiveness, however, deposited materials. can be improved considerably by planning and testing. Early decisions 5. Sheltering may be appropriate should be based on information (when available) for areas not collected from the emergency planning designated for immediate evacuation zone during the planning phase and on because: information regarding conditions at the nuclear facility at the time of the a. It positions the public to receive incident. Best estimates of dose additional instructions; and projections should be used for decisions between evacuation and sheltering. b. It may provide protection equal to or greater than evacuation. The following is a summary of planning guidance for evacuation and 6. Sheltering is usually not sheltering, based on the information in appropriate where high doses are Sections 5.5.1 and 5.5.2. projected or for exposure lasting longer than two complete air exchanges of the

1. For severe incidents, where PAGs shelter.

may be significantly exceeded,

7. Because sheltering may be implemented in

• less time than 3

Each State has the responsibility for evacuation, it may be the temporary fonnu1ating guidance to define when (and if) protective action of choice if rapid the public should be given potassium iodide. Planning for its use is discussed in "Potassium evacuation is impeded by a) certain Iodide as a Thyroid-blocking Agent in a environmental conditions--e.g. severe Radiation Emergency: Final Recommendations weather or floods; b) health on Use" (FD-82). constraints--e.g. patients and workers 5-21

in hospitals and nursing homes; or c) reduce whole body external dose are; a) long mobilization times--e.g. certain wall thickness and size of structure, b) industrial and farm workers, or number of stories overhead, c) central prisoners and guards; d) physical location within the structure, and d) constraints to evacuation--e.g. the height of the cloud with respect to inadequate roads. the building.

8. If a major release of radioiodine or particulate materials occurs, inhalation 5.6 Procedures for alculating Dose dose may be the controlling criterion Conversion Facto for protective actions. In this case:

This se *on provides information

a. Breathing air filtered through used in e developme of the DCFs in common household items (e.g., Tabl 5-1 and 5- . Three expo e folded wet handkerchiefs or towels) p ways are

• eluded: whol ody may be of significant help, if exposure to ma radiatio om the appropriate precautions are taken plume, i ation from t plume, and to avoid possible suffocation. whole ody expos e to gamma ra
• tion from osited materi s.

b. After confirmation that the though expo e of the skin plume has passed, shelters should beta radia

• n could be si ficant, be opened to avoid*airborne activity evaluati s show that ot r exposure trapped inside, and persons should path7 ys will be ,,,..e6ntrolling for leave high exposure areas as soon e~cuation and ~tering decisions.

as possible after cloud passage to Therefore, DQF's for skin are ot avoid exposure to deposited provided. _.,,1fidividual DCFs ~ the radioactive material. three e~posure pathways ar rovided in t)le following sectio . They are

c. Consideration should be given to each expressed in s of the time-the prophylactic administration of integrated ~r y centration so that potassium iodide (KI) as a they may ,!)e" combined to yie a thyroid-blocking agent to emergency co~posiDCF for each radi uclide workers, workers in critical that ects all three path ys. These industries, or others in accordance d may be used to£ itate revising with the PAGs in Table 2-1 and the DCFs in Tabl -1 and ?*2 ~

reference FD-82. more specifi<:,P technically ~ov~d assumptio are available~well as to

9. If dose from external gamma evalua the rela~*ve i rtance of the radiation is the controlling criterion, i

• dual pathw s for specific shelter construction and size are the radionuclide mix s.

most important considerations; ventilation control and filtering are less important. The main factors which 5-22

Peter G. Crane ., -1809 Drummond Avenue . Chevy ('hase, MD 20815 30/-656-3998

• pgcrane@erols.com August 24, 1998 Lawrence G. Weinstock Acting Director, Office of Radiation and Indoor Air 6601J U.S. Environmental Protection Agency 401 M Street, S.W.

Washington, D.C. 20460

Dear Mr. Weinstock:

As the New York Times reported on August 21, the Commissioners of the Nuclear Regulatory Commission voted in late June to initiate a rule change by which states will be required to consider the radiation antidote potassium iodide (KI) as part of nuclear emergency planning. This is to be coupled with an offer by the Federal Government to make Kl available, at Federal cost, to any state wishing to establish a stockpile of the drug. This commendable action by the Commissioners comes 20 years after the Food and Drug Administration declared KI to be "safe and effective" and approved it for over-the-counter sale, and 19 years after the President's Commission on the Accident at Three Mile Island recommended creation of regional stockpiles of the drug. As the Federal Emergency Management Agency pointed out to the NRC in an April 9, 1998, letter from Assistant Administrator Kay C. Goss, the validity of the 1978 FDA finding was reinforced empirically by the Polish experience in administering millions of doses of Kl during and after the Chernobyl accident, with minimal side effects. The NRC Commissioners took this action - the grant of a rulemaking petition which I filed in 1995 - despite a recommendation from the NRC technical staff that the petition be denied. In support of its recommendation, the NRC staff prepared a "technical assessment," which has been published in draft form as NUREG-1633 with a request for comment. Curiously, the July 20 Federal Register notice announcing the availability of the document made no mention of the Commissioners' recent action in support of Kl stockpiling. The NRC staff's "technical assessment" has many !:,TTave flaws, but none so glaring or so revealing of the authors' mindset as the omission of any reference to what sister agencies -- primarily FDA, but also EPA -- have had to say on the potassium iodide issue. Ordinarily, it might be assumed that the FDA ' s "safe and effective" finding of 1978 would be the starting point for any evaluation of KI by another federal agency. But NUREG-1633 is no ordinary evaluation, and it does not even mention the FDA position. Instead, the authors seem to have set themselves up as a sort of rump FDA, making their own judgments on drug safety, based on selective and misleading citations to a long outdated edition of the Physician's Desk Reference. It would all be comical if it the underlying issue - the protection of American children from

cancer - were not so serious. 1 EPA, in 1992, published a "Manual of Protective Action Guides and Protective Actions for Nuclear Incidents, EPA-400-R-92-001. This includes an extensive, thoughtful analysis of the pros and cons of different protective actions ( evacuation, sheltering, iodine prophylaxis) and the circumstances under which each might be appropriate. For several years, in comments l have filed with the NRC, I have tried to persuade the NRC staff to come to grips with the EPA analysis. The NRC staff has never acknowledged its existence, and if you look in the list of references in NUREG-1633, you will find no mention of it. l do not believe that the NRC staff should run roughshod over the other agencies that have addressed the KI issue. By the same token, I do not believe that these other agencies should sit passively by as the NRC staff ignores what they have had to say on important health and safety issues within their sphere of responsibility. I therefore urge EPA to review NUREG-1633 and present its comments to the NRC in the most straightforward terms. (I am making the

• same suggestion to FDA.)

The failure to mention the FDA finding and the EPA study seems explicable enough, however. NUREG-1633 appears calculated to raise such apprehensions about KI' s safety, and about the risk of lawsuits over side effects, that states will reject the offer of free KI. The EPA study makes clear that the issue is not one of evacuation vs. KI, as the NRC staff would like to portray it, but of whether KI can provide additional protection in those situations in which evacuation is impracticable or inadvisable, or where there is a risk of exposure to radioiodines during evacuation. I have called on the NRC Commissioners to withdraw and disavow NUREG-1633 . I hope they will do so; I do not think it serves the NRC's interest to have its name associated with so defective a study. I am enclosing a copy of a talk I recently gave at an international symposium on the subject of radiation and thyroid cancer, held at Cambridge University in England under the joint sponsorship of the European Commission, the Department of Energy, and the National Cancer Institute. The talk is a case study of the handling of the KI issue by the U.S . Government over the past 20 years. It contains background information that may perhaps be helpful. In addition, I am enclosing a copy of comments I recently filed with the NRC on the subject ofNUREG-1633 . I hope that you will review them, and also review NUREG-1633. If you do so, l believe that you will agree with me that such a document should be withdrawn from public circulation - not 1 The unfitness of the authors to venture into the evaluation of drug safety is further illustrated by their discussion of tincture of iodine. They report that it was used by 6% of parents in Poland to administer iodine prophylaxis to their children, and they say that a 4-ounce bottle "contains enough iodine to block 22 thyroids," from which statements they reader could well infer that tincture of iodine is an acceptable substitute for Kl. Tincture of iodine is, of course, a poison, but the reader of NUREG-1633 would have no way of knowing that.

because of its policy viewpoint, but because of the way in which it represents, or fails to represent, relevant facts. From September 9-11, 1998, EPA will be holding an "International Radiological Post-Emergency Response Issues Conference" in Washington. My understanding is that one of your keynote speakers is the NRC staff official who as technical director of NUREG-1633 oversaw its preparation. (However, you are fortunate to have on your probrram Dr. Janusz Nauman of Warsaw, the distinguished Polish thyroid specialist who oversaw Poland's successful use of KI during the Chernobyl emergency.) I believe it might be useful for your audience to be informed briefly and accurately about the current status of the Kl issue in the U.S. and about the bTfave flaws in NUREG-1633, which might otherwise appear to the unwary as the U.S. Government's definitive statement on the KI issue. If you can find just 10 or 15 minutes someplace to fit me in to the schedule, I'll adapt my Cambridge remarks and my comments on NUREG-1633 and give a talk that is to the point and doesn't run over the time limit. (I had just ten minutes in Cambridge.) Needless to say, I would prepare and give this talk on my own time, in my capacity as a private citizen. Please let me know what you think. With best regards, Sincerely, Peter G. Crane Attachments:

1. Talk at Cambridge (July 22, 1998), with cover note to Commissioners (August 5, 1998)

2. Comments on NUREG-1633 (August 20, 1998) cc: (w/o enclosures)

Chairman Shirley Ann Jackson Commissioner Nils J. Diaz Commissioner Edward McGaffigan L. Joseph Callan, Executive Director for Operations Hugh L. Thompson, Deputy Executive Director for Operations

Peter G. Crane i .:/809 Drummond A venue .* Chevy Chase, MD 20815 .* 301-656-3998 . pgcrane@erols.com August 24, 1998 Michael A Friedman, M.D. Lead Deputy Commissioner US. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857

Dear Dr. Friedman:

As the New York Times reported on August 21, the Commissioners of the Nuclear Regulatory Commission voted in late June to initiate a rule change by which states will be required to consider the radiation antidote potassium iodide (Kl) as part of nuclear emergency planning. This is to be coupled with an offer by the Federal Government to make Kl available, at Federal cost, to any state wishing to establish a stockpile of the drug, This commendable action by the Commissioners comes 20 years after the Food and Drug Administration declared KI to be "safe and effective" and approved it for over-the-counter sale. As the Federal Emergency Management Agency pointed out to the NRC in an April 9, 1998, letter from Assistant Administrator Kay C. Goss, the validity of the 1978 FDA finding was reinforced empirically by the Polish experience in administering millions of doses of KI during and after the Chernobyl accident, with minimal side effects. The NRC Commissioners took this action - the grant of a rulemaking petition which I filed in 1995 - despite a recommendation from the NRC technical staff that the petition be denied. In support of its recommendation, the NRC staff prepared a "technical assessment," which has been published in draft form as NUREG-1633 with a request for comment. Curiously, the July 20 Federal Register notice announcing the availability of the document made no mention of the Commissioners' recent action in support of Kl stockpiling. The NRC staff's "technical assessment" has many !:,>Tave flaws, but none so glaring or so revealing of the authors' mindset as the omission of any reference to the FDA' s "safe and effective" finding of 1978. Instead, the authors seem to have set themselves up as a sort of rump FDA, making their own judgments on drug safety, based on selective citations to a long outdated edition of the Physician' s Desk Reference. The failure to mention the FDA finding seems explicable enough: the document appears calculated to raise such apprehensions about KI's safety, and about the risk oflawsuits over side effects, that states will reject the offer of KL The unfitness of the authors to venture into the evaluation of drug safety is further illustrated by their discussion of tincture of iodine. They report that it was used by 6% of parents in Poland to administer iodine prophylaxis to their children, and they say that a 4-ounce bottle "contains enough iodine to block 22 thyroids," from which statements they reader could well infer that tincture of iodine is an acceptable substitute for KL Tincture of iodine is, of course, a poison, but the reader ofNUREG-1633 would have no way of knowing that. I have called on the NRC Commissioners to withdraw and disavow NUREG-1633 , I

hope they will do so; I do not think it serves the NRC's interest to have its name associated with so defective a study, or one that treats a sister agency with such disrespect. I strongly urge the Food and Drug Administration to examine the document and make its views known to the NRC. l believe it is incumbent on the FDA to do so, for two reasons: first, because the health of American children is involved, and second, because ofFDA's own institutional interest in not allowing its role as the arbiter of drug safety questions for the Federal Government to be bypassed or ignored. I am enclosing a copy of a talk I recently gave at an international symposium on the subject of radiation and thyroid cancer, held at Cambridge University in England under the joint sponsorship of the European Commission, the Department of Energy, and the National Cancer Institute. The talk is a case study of the handling of the Kl issue by the U.S. Government over the past 20 years. It contains background information that may perhaps be helpful. In addition, I am enclosing a copy of comments I recently filed with the NRC on the subject of NUREG-1633. I hope that you will review them, and also review NUREG-1633. lfyou do so, I believe that you will agree with me that such a document should be withdrawn from public circulation - not because of its policy viewpoint, but because of the way in which it represents, or fails to represent, relevant facts. Sincerely, Peter G. Crane Attachments:

1. Talk at Cambridge (July 22, 1998), with cover note to Commissioners (August 5, 1998)

2. Comments on NUREG-1633 (August 20, 1998) cc: (w/o enclosures)

Chairman Shirley Ann Jackson Commissioner Nils J. Diaz Commissioner Edward McGaffigan L. Joseph Callan, Executive Director for Operations Hugh L. Thompson, Deputy Executive Director for Operations

Peter G. Crane , -1809 Drummond Avenue Chevy Chase, MD 20815 ,- 301-656-3998 pgcrane@erols.com August 5, 1998 MEMORANDUM FOR: Chairman Jackson

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Commissioner Diaz c::, Commissioner McGaffigan ==- C co (.I')(") C,

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TALK AT SYMPOSIUM ON RADIATION Ll 0 AND THYROID CANCER On July 22, 1998, I gave a talk at the first annual international symposium on radiation and thyroid cancer, held at Cambridge University in England, A copy of the talk is attached, in the form in which it is being sent to the printer. As you will see, I applaud the Commission's decision to grant the rulemaking petition. I also praise FEMA for its willingness to speak up and correct factual errors and omissions by the NRC staff and others. I strongly criticize the NRC staff's "technical assessment," now out for public comment, which was part of SECY-98-061 . Among other things, I highlight the almost incredible omission from the document of any mention of the finding by the U.S. Food and Drug Administration that potassium iodide is "safe and effective," although this finding might have been expected to be the starting point of any assessment of the drug. In addition, I point to the authors' suggestion, unsupported by any evidence, that the report by Drs. Janusz Nauman and Jan Wolff on the Polish experience with KI after Chernobyl should not be believed. I suggest in the paper that the NRC should withdraw the document, apologize contritely to Drs. Nauman and Wolff, and ensure that those principally responsible for the "technical assessment" are excused from further involvement with the KI issue. cc: Senator Joseph Lieberman Senator Tom Harkin L. Joseph Callan, EDO Kay C. Goss, Associate Director, FEMA Dr. Janusz Nauman, Medical Center for Postgraduate Research, Warsaw, Poland Dr. Jan Wolff, NIH Dr. Jacob Robbins, NIH Dr. David V. Becker, New York Hospital/Cornell Medical Center Dr. Keith Baverstock, WHO, Rome, Italy Docket File, PRM-50-63, -63A AUG 1 3 1998 Acknowledged by card ..------- ....-

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POTASSIUM IODIDE PROPHYLAXIS AND THE UNITED STATES GOVERNMENT: A CASE STUDY PETER G. CRANE 1 On Juh I. 1998. the U.S. Nuclear Rcgu\aton* Commission (NRC) announced that it had vot<:d to grant a petition for ru\emaking that will require states lo consider potassium iodide (Kl\ proph,Iaxi s. along ,,ith c,*acuati,sn and sheltering. in emergencv planning for nuclear power plant accidents. This decision, h, a 3-1 , *otc of the Commissioners. represents a major step in the U. S. Go,ernment's 20-,ear consideration of the Kl issue . A rc,ic,, of the l\'RC's actions O\'CT this 20-ycar peno<l 1x,int;. up senou,, defi,ic11cie, iu tlre hau<lli11g nftl,e i,,uc b, tl,e ~'RC au<l ih technical staff. with the result that the United States is now far behind other de,eloped countries in ensuring comprehensi,e protection for its citizen,. especial}\ its children. in the e,ent of a maj or release of radioi,)(fines. The re,ie\\ suggests that m gn,crnmrntnl decision making conccrnmg public health effect s of nuclear pmwr plant e111cr!?enc1cs_ llH: vie\\, of public healtli <l!,(t:11<.:ic, and c111crgt:1IC\ management agencies should be given dominant weight. On July 1, 1998, the U.S Nuclear Regulatory Commission (NRC) announced that it had granted a petition for rulemaking, filed by me, that would require states to consider the drug potassium iodide (KI) as part of their emergency plans for radiological mishaps at nuclear power plants." In voting to begin rulemaking, NRC Chairman Shirley A Jackson and Commissioners Nils J Diaz and Edward McGaffigan, Jr, rejected the recommendation of the NRC's own techrucal staff that the petition be denied. 3 KI stockpiling is also bitterly opposed by the U.S .

• nuclear power industry. The rule change will be coupled with a new US policy, not 1 Counsel for Special Projects, Office of the General Counsel, U.S Nuclear Regulatory Commission; former Member, Nuclear Claims Tribunal, Republic of the Marshall Islands This paper, submitted in the author's private capacity, represents his personal views only.

2 See NRC Press Release of July I, 1998. 3 The vote was 3-1 . Commissioner Greta J Dicus, whose term expired June 30, 1998, sided with the NRC staff

yet final, under which stocks of KI will be given to any U.S. state that requests it The grant of the petition did not bring an instant change in the NRC's rules Before that can happen, the ~'RC must publish a proposed rule, receive and analyze comments from the public, and issue a final rule. Thus the three Commissioners' commendable decision represents not the end, but perhaps the beginning of the end, of the U.S . Government's protracted consideration of the KI issue, a process that began some 20 years ago. To the international community, it is well known by now that Kl stockpiling is routine throughout the developed world ; that some nations, notably France and Switzerland, go further, with house-to-house predistribution4; that Kl has long had the backing of the World Health Organization! and the American Thyroid Association; that it is an element of the International Basic Safety Standards6 sponsored by the International Atomic Energy Association and other organizations; and that its safety in actual use was proved in Poland, as Drs Janusz Nauman and Jan Wolff described in their seminal l 993 paper. 7 The question that an international audience may be asking is how the United States could contrive to spend 20 years resolving an issue so straightforward and obvious that 20 weeks should have been more than enough time for a reasoned decision . I will try to offer an answer to that question, through a case study of the handling of the Kl issue by the United States Government. My purpose is to suggest the problems that can arise when public health decisions relating to radiation are placed in the hands of an agency whose primary expertise is not health, but nuclear technology. I should interject that I am a lawyer, not a physician or a scientist. I make

• 4 Electricite de France and the Swiss Government both publicize their Kl policies through Internet sites.

5 World Health Organization, EUR/ICP/CEH 102(S), § 4.3.3. (1991) 6 International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources (interim edition), International Atomic Energy Agency (Vienna, 1994) 7 J. Nauman & J. Wolff, "Iodine Prophylaxis in Poland after the Chernobyl Reactor Accident Benefits and Risks," American Journal of Medicine, Vol 94, p. 524 (May, 1993 ).

no pretensions to medical expertise, except insofar as I have gained it as a patient with thyroid cancer, presumably radiogenic_s My 15-year involvement in the KI issue stems from my conviction, born of experience, that thyroid cancer is a disease well worth preventing, especially if prevention can be achieved easily and cheaply. Benjamin Franklin once wrote, "A child thinks that 20 shillings and 20 years can never be spent." Let me offer now a brief chronology of where the last 20 years went in the U.S. Government's consideration of KI.

           -- 1978 The U.S Food and Drug Administration (FDA) declares KI "safe and effective" for use in nuclear power plant emergencies, and approves its over-the-counter sale. 9
           -- 1979 During the Three Mile Island accident, federal and state officials, fearing a major release, search for supplies of KI and discover none exist. Later, the President's Commission investigating the TMJ accident castigates the Government's failure to stockpile KI and recommends stockpiling for the public and radiation workers. 10 A month later, the NRC announces its agreement, declaring its intent to make the availability of KI a "necessary part of an acceptable State emergency response plan." 11
           -- 1982: The NRC technical staff recommends that the Commissioners approve an interagency U.S. Government policy endorsing the use of KI as a "useful 8 I was part of the cohort of some 5000 children who, some 50 years ago, received head and neck radiation -- in my case, 750 rads ofx-ray to my enlarged tonsils and adenoids -- at Michael Reese Hospital in Chicago, Illinois In 1973, I had a partial thyroidectomy for papillary thyroid cancer; in 1983, had the thyroid remnant ablated; in 1988, was diagnosed with a recurrence; and in 1992, after five courses of radioiodine therapy, totaling 700 millicuries ofl-131, was given a clean bill of health.

9 Food and Drug Administration, "Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency," 43 Federal Register 58798 (Dec 15, I 978). 10 Report of the President's Commission on the Accident at Three Mile Island ("Kemeny Commission"), at 41-42. 11 NUREG-0632, "NRC Views and Analysis of the Recommendations of the President's Commission on the Accident at Three Mile Island" (November, 1979)

ancillary protective action. "12 Nineteen days later, without explanation, the NRC technical staff withdraws that recommendation, saying that it plans to prepare a new paper that will recommend against stockpiling and distribution of KI on cost-benefit grounds.13

           -- 1983

• The NRC technical staff briefs the Commission in a public meeting on its new, anti-KI position. The gist of the NRC staff's argument is that though KI is cheap, it will be even cheaper in the long run to treat radiation-caused illnesses after an accident than to spend even a small amount to prevent them with KI . The comparison is exclusively in dollar terms: dollars for KI pills vs. dollars for medical treatment, as though illness had no burdens other than the expense involved. The briefers mention neither cancer nor the possibility offatalities.1i

           -- 1985

• The U.S. Government issues a national policy on Kl 15 Referring to the NRC's "cost-benefit analysis," it dismisses the idea of requiring KI as "not worthwhile "

           -- 1989 As NRC internal rules allow, I file a "Differing Professional 12 SECY-82-396, "Development of a Federal Policy Statement on the Distribution and Use of Potassium Iodide for Thyroidal Blocking in the Event of a Nuclear Power Plant Accident" (September 27, 1982), Attachment 3, at 3-4.

13 SECY-82-396A, "Withdrawal ofSECY-82-396 (Federal Policy Statement on Use of Potassium Iodide)" (October 15, 1982). The memorandum notes that the Federal Emergency Management Agency (FEMA) has just dropped plans to buy a large amount of KI for stockpiling. Unlike the NRC, which is an independent regulatory agency, FEMA is part of the Executive Branch, i.e., under Presidential control. 14 The briefers refer instead to "nodules." They convey the impression that any thyroid illness resulting from an accident would be trivial "There's a few days loss from -- it's a relatively simple operation that's involved in removing the thyroid or removing the nodules." Transcript of November 22, 1983 meeting, at 52-53 . When the NRC Chairman suggests that ifhe survives an accident because of KI, he will think the$ 20 cost of the pills to be money well spent, the NRC staff corrects him, telling him that "the surviving question is not the question." Transcript at 63 . 15 "Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent," 50 Federal Register 30258 (July 24, 1985).

Opinion," challenging the agency's Kl policy. I argue that new information warrants reconsidering the Kl issue, and that existing policy was tainted from the start by NRC staff misinformation to the Commissioners and the public.

           -- 1994

• The NRC staff, while not addressing the issue of misinformation, recommends to the Commissioners that stockpiling Kl in the vicinity of nuclear plants "appears prudent "16 It proposes a new federal policy to buy KI and encourage states to establish stockpiles. The staff estimates that it would cost less ( a few hundred thousand dollars) to buy a national stockpile of Kl than go on studying whether to do so. But the Commissioners then in office tie 2-2. so the old policy remains in place

           -- 1995

• Acting as a private citizen, on my own time, I file a petition for rulemaking, asking the NRC to require that KI be among the "range of protective actions" included in state emergency plans. I also write to the Director of the Federal Emergency Management Agency, which chairs the interagency committee responsible for overall Kl policy

           -- 1996 At a public meeting called by FEMA several state officials describe Kl stockpiling as undesirable and unnecessary. An Illinois official explains, "Loss of the thyroid is not life-threateningl' 17 Several months later, the interagency committee headed by FEMA calls for a new federal policy that would give Kl at federal expense to any state requesting it. 18 16 SECY-94-087, "Addendum to SECY-93-318 Re-evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant" (March 29, 1994), at 2 .

I 7 The identical sentence appears in a separate statement filed by a South Carolina official. Later, the Illinois Department of Nuclear Safety, offended by my criticism of it, writes to the NRC that the State of Illinois "stands firmly behind its contention that hundreds of thousands of people live normal, healthy lives without functioning thyroid glands." Letter from Thomas W. Ortciger, Director, January 8, 1998. 18 Despairing of persuading the Government to provide the states and the public with accurate and up-to-date information on Kl, I decided in early 1996 to try to reach the public directly through newspaper articles. The first, in the New York Times, was designed to coincide with the tenth anniversary of Chernobyl. Other articles followed (I did not accept payment for them.) They helped stimulate citizen action at the state level, which in turn led to state meetings, in which I participated, in

                                                           -- 1997: The NRC staff proposes a draft federal policy statement on KI to the Commissioners. 19 While the policy would make Kl available to states requesting it, the notice includes no recommendation that they do so. It does not refer to Chernobyl or the Polish experience with Kl; states that there is "no new information" warranting a change in existing policy; and mentions only near the end of the notice that the purpose of using KI is to prevent cancer. After a protest from FEMA, the NRC staff apologizes in a public Commission meeting for having "misrepresented" FEMA's position on Kl in its June 1997 paper 20
            -- 1998 : The NRC staff recommends to the Commission that it deny my petition. 21 It offers a 40-page "technical assessment" of Kl, offering its own highly equivocal judgment of the drug's safety. Although the obvious starting point for any such analysis by a U.S. Government agency is the Food and Drug Administration's finding that KI is "safe and effective," the NRC staff "technical assessment" omits even to mention it The "technical assessment" appears calculated to raise alarm that Kl will have severe side effects., and that these side effects will expose state governments to legal liability For example, it warns: "In the U.S ., the implementation ofa protective action may entail litigarion and liabiliryfor long aier the accident. The TMI accident is a case in point One can expect that admi11istratio11 of Kl 011 a mass basis would certainZv e11tail li!i[!ation in this co11111ry. whereas the government of Poland, which administered Kl on a mass-basis, did not appear to be faced with such Maine, Ohio, and New York. Maine and Ohio have decided in favor of stockpiling.

and the issue remains under active consideration in New York State In each of these states, great weight has been given to the advice of thyroid cancer experts from the American Thyroid Association 19 SECY-97-124, "Proposed Federal Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant," June 16, 1997. 20 At this meeting, believing that I did not have the votes to gain approval of my petition as written, I stated that I would be satisfied if states are required by rule to "consider" Kl in developing their emergency plans. At the Commission's request, I submitted an amended petition a week later. 21 SECY-98-061, "Staff Options for Resolving a Petition for Rulemaking," March 31, 1998.

litigation." [Emphasis added .f 2 The authors of the "technical assessment" evidently recognize that the strongest empirical evidence for the safety of Kl is the very low incidence of adverse

• medical reactions observed in Poland. Accordingly, in an apparent effort to disparage Nauman and Wolff's report, the NRC "technical assessment" says ofit in passing, "to the extent that we believe the report .... "23 The authors of the "technical assessment" cast this aspersion upon two internationally renowned medical experts without offering any evidence to support the insinuation that the report should not be believed.2~

While the staff's paper is pending before the Commission, a FEMA official writes to the NRC to point out an erroneous statement about FEMA' s position on KI by the NRC staff and "misleading" comments by a nuclear industry lobbying group and an Illinois state agency 25 Her letter refers to the FDA ' s 1978 approval of KI, and adds pointedly, "This FDA approval was empirically reinforced by the 22 Technical assessment, at p. 22. Why a legal judgment of this kind has any place in what purports to be a technical assessment of a particular medication, and what qualifications the authors have to offer any legal opinion -- particularly one as sweeping as that just quoted -- are unexplained . The authors ' effort to invoke the specter oflegal liability may help explain the absence from the "technical assessment" of any reference to the Food and Drug Administration's finding on KI. If state governments were made aware that the FDA had approved KI as "safe and effective," that fact would be doubly reassuring to them . First, it would indicate that the drug was safe. Second, it would mean that even if, as the NRC staff confidently predicts, use of Kl in a radiological emergency were to lead to lawsuits over side effects, states could defend themselves by showing that they had relied on the FDA's finding . The NRC staff "technical assessment" is careful not to address the point, often made by supporters of Kl stockpiling, myself included, that states concerned about possible exposure to lawsuits relating to Kl should probably worry most about a different type oflawsuit: those that would be brought if an accident occurred and children developed thyroid cancer because Kl had not been stockpiled. 23 Id. at 11 . 24 The NRC, which has made the "technical assessment" public, should withdraw the document and offer Drs. Nauman and Wolff a deep and contrite apology. 25 Letter from Kay C. Goss, FEMA Associate Director, April 9, 1998.

experience in Poland with Kl, subsequent to the Chernobyl accident ." It appears to be an implicit warning to the NRC that FEMA will not be a party to withholding key information on the safety of KI from the public. As I mentioned at the outset, the Commissioners rejected the staff recommendation and directed the NRC staff to begin a rulemaking that would incorporate into the NRC's rules a requirement that states "consider" iodine prophylaxis as a part of radiological emergency planning. This requirement would be coupled with an offer of free KI from the Federal Government. As oflate July, 1998, Commission action on the draft policy statement was expected shortly Thus in the end, the Commissioners decided wisely, and the United States may no longer be at odds with the rest of the civilized world on whether it is "worthwhile" to protect children from thyroid cancer. In such cases, it is common to declare that "the system worked ." But did it? To be sure, it speaks well for the American democracy that the citizen's right to seek redress of grievances is not an empty phrase. Likewise, it reflects no small credit on the N'R.C that it tolerated with such good grace the campaign that an NRC employee was conducting in his spare time. By any other measure, however, the system did not work. First and foremost, there is no excuse for American children still to have second-class protection, so many years after the recommendations of the WHO. When nations rich and poor, from Japan to Armenia, can afford to buy KI, surely the U.S. can do the same. It is or should be a reproach to the richest nation on earth that its policy on protecting children from cancer should be based on the notion -- a fallacious notion at that -- that cure is cheaper than prevention The safety of American children should also not depend on citizens hammering on their Government to do what it promised to do almost 20 years ago . Moreover, a system for allowing interested citizens to seek regulatory change that takes nine years even to approach fruition cannot be said to be working satisfactorily. Finally, the record shows too many instances in which the NRC staff provided information to the Commissioners and the public that lacked balance, accuracy, and completeness. 26 I have offered examples of the way in which facts that did not support the desired result have disappeared down the "Memory Hole, 11 in George Orwell's well-known phrase. The NRC staff's treatment of pro-KI 26 FEMA is to be commended for having brought some of these lapses to the NRC Commissioners' attention.

• comments, including those from internationally known medical experts representing the American Thyroid Association, is another example. The opportunity to submit views to a federal agency is of little value if the technical staff ignores those comments it finds difficult to rebut. 27 I have high confidence in the NRC staff to make sound, well-supported and intellectually honest judgments about nuclear safety hardware, conditions of reactor operation, and the like. Sadly, the record does not permit a similar statement about the NRC staff's past handling of the Kl issue.2~

One can speculate that part of the underlying problem may be that the technical experts involved in nuclear safety decisions do not in their hearts view major accidents as credible, at least in the United States, and therefore regard all emergency planning as no more than a political concession to the public's irrational fears of nuclear power. If one starts from the premise that emergency planning is a pointless charade, then any upgrading of planning, even one as inexpensive as Kl, may seem worth resisting. By the same token, it may seem unnecessary to be overly punctilious in how one analyzes a health issue that one believes will never arise. The cause of the phenomenon is beside the point, however; the issue is what to do about it. I believe that one part of the answer is to ensure a proper division of governmental responsibilities among different agencies The primary responsibility for radiological emergency planning must be placed (or kept) in the hands of agencies whose mission is emergency preparedness, not nuclear regulation. In the U.S. context, this means FEMA Such agencies know from experience that accidents can happen and can develop unpredictably, and they plan accordingly Likewise, decisions affecting human health should be made in the first instance by health agencies and health professionals It seems unlikely, for example,

• 27 The NRC staff's recent memoranda to the Commissioners on the KI issue illustrate how essential it is that Commissioners and their personal staffs read the actual comments that are submitted to the NRC on controversial issues, rather than relying on the NRC staff to summarize the comments for them 28 Now that the Commissioners have voted, it is reasonable to expect that the highest levels ofNRC staff management will loyally accept the direction they have received . The more problematic issue concerns NRC staff management below the highest levels. Suffice it to say that the deficiencies of the "technical assessment" are of such a nature that it would be prudent to excuse the individuals principally responsible for that document from any further involvement with the Kl issue

that any medical doctor, answerable to his or her peers, would ever discuss the consequences of radiation-caused thyroid disease in a public meeting without mentioning cancer. Nor would medical doctors presume to discuss the safety of a drug without reference to the Food and Drug Administration's judgment that it is "safe and effective" The line between nuclear regulation and nuclear promotion is not an easy one to maintain, and needs to be guarded vigilantly, as must the line between science and propaganda. Here, something went seriously wrong, not once but repeatedly Thanks to the three NRC Commissioners now in office, the US. Government's long mishandling of the KI issue may now be nearing its end. Nevertheless, it should be an object lesson within the US. and for authorities in other countries as well.

References Journal Article: Nauman J, Wolff J. Iodine Prophylaxis in Poland after the Chernobyl Reactor Accident Benefits and Risks. Am J Med 1993; Vol 94, p. 524 . Publications of lntemational Orga11izatio11s: International Basic Safety Standards for Protection Against Ionizing Radiation and for the Safety of Radiation Sources (interim edition), International Atomic Eners,y Agency (Vienna, 1994) World Health Organization Report EUR/ICP/CEH I 02(S) ( 1991) U.S. Nuclear Regulatmy Commission Puh/icarions: NUREG-0632, "NRC Views and Analysis of the Recommendations of the President's Commission on the Accident at Three ]\,file Island" (November, 1979). SECY-82-396, "Development of a Federal Policy Statement on the Distribution and Use of Potassium Iodide for Thyroidal Blocking in the Event of a Nuclear Power Plant Accident" (September 27, 1982) SECY-82-396A, "Withdrawal of SECY-82-396 (Federal Policy Statement on Use of Potassium Iodide" (October 15, 1982) SECY-94-087, "Addendum to SECY-93-318 Re-evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant" (March 29, 1994) SECY-97-124, "Proposed Federal Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant" (June 16, 1997) SECY-98-061, "Staff Options for Resolving a Petition for Rulemaking" (March 31 , 1998)

Other US. Govemment Publications: "Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent," 50 Federal Register 30258 (July 24, 1985) "Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency," (U.S. Food and Drug Administration), 43 Federal Register 58798 (Dec. 15, 1978) Report of the President's Commission on the Accident at Three Mile Island (1979)

l Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, Ml) 208/ 5 I 30/[)~eKE.9f ~ 6 pgcrane@erols. com USNRC April 13, 1998 "98 APR 24 Al 1 :58 Ms. Kay C. Goss Associate Director for Preparedness, Training, and Exercises Federal Emergency Management Agency Washington, D.C. 20472

Dear Ms. Goss:

Thank you very much for your kind letter of March 25, 1998. It was gratifying to know that FEMA understands that it is "concern for the integrity of the FRPCC and its revised Kl

• policy" that has prompted my letters, and that it appreciates my efforts. It was likewise gratifying to receive FEMA's confirmation that "some interests may have taken advantage of the delay in the issuance of KI policy by using a misleading interpretation when describing the revised policy," and also to learn that FEMA would take steps to make its actual position clear.

FEMA has now done that, by your April 9, 1998, letter to the NRC, which corrected a series of distortions of the positions of FEMA and the FRPCC on the subject of KI. Of the various items you listed, I was especially pleased that you included the draft Federal Register notice included by the NRC staff in SECY-97-124. This was an NRC product, although presented in such a way -- with "FEDERAL EMERGENCY MANAGEMENT AGENCY" as the heading and a signature block for FEMA's 0. Megs Hepler at the end -- that any reader would

• have been led to think it came from FEMA. As your letter points out, it has not been approved either by FEMA or the FRPCC.

Though your letter was too diplomatic to say so explicitly, the NRC staffs draft Federal Register notice was permeated by distortions and errors of omission -- unworthy of the NRC or any other agency whose employees are paid by the American public. I very much appreciate, therefore, the fact that your letter took pains to mention some crucial facts that were conspicuously absent from the NRC staff draft. These included the Food and Drug Administration's finding that Kl is "safe and effective," FDA's approval of KI for over-the-counter sale, and the fact that, to quote your letter, "[t]his FDA approval was empirically reinforced by the experience in Poland with KI, subsequent to the Chernobyl accident." I take those references as a strong hint to the NRC staff that its draft Federal Register

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notice, which mentioned neither the FDA nor Chernobyl 1, i~ a non-starter. Moreover, your letter makes clear that the approval of a draft federal policy on Kl can take place only .a..tk[ the NRC acts on the petition for rulemaking. FEMA deserves the thanks of every American, and of American parents most of all. It has shown that it will not be a party to misinforming the American public on matters of health and safety, nor will it sit passively by while others misrepresent its position. Your letter makes clear FEMA's recognition that if it comes to a choice, protecting millions of American children from cancer is more important than protecting a few bureaucrats from embarrassment. I am confident that we can count on FEMA to go on looking out for the well-being of American children and the truthfulness of our Government's statements. With FEMA's help, perhaps American children will someday be protected as well against radiation-caused thyroid cancer as children in other countries. Sincerely, Peter G. Crane cc: Senator Joseph I Lieberman Senator Tom Harkin Chairman Shirley A. Jackson Commissioner Greta J. Dicus Commissioner Nils J. Diaz Commissioner Edward McGaffigan, Jr. 1 At the November 5, 1997, Commission meeting on Kl, Chairman Jackson asked me to submit in writing my suggestions for improvements in the Federal Register notice, and I did so in my filing of November 11, 1997. Preswnably the NRC staff, in the paper on Kl recently sent to the Commission, will have revised the notice to correct some of the more egregious problems that I pointed out. (I have not seen this memorandwn, but FEMA might be able to obtain a copy from NRC.) l feel sure, given your letter, that FEMA will give any NRC staff product on KI the most careful scrutiny for accuracy, completeness, and balance.

agement Agency Mr. John C. Hoyle, Secretary APR 9 1998 Nuclear Regulatory Commission Washington, D.C. 20555 DOCKET NUMBER PETITION RULE PRM 50-- 3 A

Dear Mr. Hoyle:

( &;~FRt,~o3g) It has come to my attention that there may be some confusion regarding the Federal Emergency Management Agency's (FEMA) and the Federal Radiological Preparedness Coordinating Committee's (FRPCC) positions and proposed policy on the issue regarding the use of potassium iodide (KI) by the general public in the event of a radiological emergency at a commercial ~uc!e= po".ve::- plan!. I a.'TI 'Nriting this !etter to dear u, :my n:fr~uJ>t:lersta11ding or confusion regarding the FEMA and FRPCC positions on this issue. First, on page 7 of the Nuclear Regulatory Commission's (NRC) SECY-97-124, dated June 16, 1997, the NRC staff presented five reasons that, purportedly, the second FRPCC Ad Hoc Subcommittee on Potassium Iodide used as a basis to develop its recommendations for the plenary FRPCC. These reasons included reference by the NRC staff to the September 15, 1994, Subcommittee report and the following statement: "a lack of support for such an initiative by the states and the primary Federal regulatory agency. (FEMA)." As you are aware, FEMA is not a regulatory agency, nor has FEMA taken a position of supporting or not supporting the use of KI by the general public in a radiological emergency. This statement was meant to refer to the lack of the NRC staff's support, not FEMA' s lack of support. This matter was addressed at the November 5, 1997, public meeting with the NRC Commissioners, and the NRC staff did acknowledge that they were in error in making that statement. As indicated by Mr. 0. Megs Hepler, III, Chairman of the FRPCC, during the November 5, 1997, public meeting, FEMA supports the current proposed FRPCC revised policy that states "the use of KI to prevent radioiodine from accumulating in the thyroid gland can be an effective supplemental or ancillary protective action during a nuclear power plant accident." Secondly, I want to address a comment from the Nuclear Energy Institute (NEI) in their response a1,U

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                                                                                                                                                                                                ~ffi.-m,.,l its position of not advocating widespread stockpiling and distribution of KI for the general public." I am concerned that this statement could be misleading. Although the FRPCC Subcommittee did not affirmatively recommend widespread stockpiling, and, in fact, left the decision-making authority on use of KI by the general public with the State, and in some cases, local governments, the FRPCC Subcommittee did propose as part of the policy that if any State
                                                                                                                                                                                                                   <n chooses to incorporate the use of KI as a protective measure for the general public then the                                                                                                                             :

Federal government would provide the funding for the purchase of such a supply. The plenary U) FRPCC unanimously approved this revised Federal policy. If Cl; I a A third statement I want to comment on was made by the Illinois Department of Nuclear Safety (IONS). IONS was quoted, in an April 3, 1997, Commonwealth Edison Press Release, that "it is expected that a certain percentage of the public would have a negative allergic reaction to i

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potassium iodide" and that a "joint federal task force" (presumably the FRPCC) agreed with that statement. Although that statement, on the surface, is not incorrect, it is somewhat misleading. The position of the FRPCC on the use of the drug is that it is safe and effective. The Food and Drug Administration (FDA) approved KI as a prophylaxis for the thyroid (to prevent that organ from absorbing radioiodine) in the December 15, 1978 Federal Register, and, at that time, KI was approved for purchase as an over-the-counter drug. This FDA approval was empirically reinforced by the experience in Poland with KI, subsequent to the Chernobyl accident. Finally, when the NRC noticed the amended Petition for Rulemaking in the December 17, 1997, Federal Register for comment, it also referenced a draft April 15, 1997, Federal Register Notice, "Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent." It should be made clear that this document is a revised version of an earlier FRPCC draft Federal Register Notice, and while it accurately reflects the Subcommittee's 1 * ., .1,._,. -r.--r.J'*,.,,.. :. W.: 11 s*:ll *._.,.,.11 *~, 1.,. .r.~.-.... ,.llv ppr"V""~ recommerla.all0ilS, w*ru*c*11 were a,!op-ed 0 v I,. ,I 1 Ul"' .1. _.,'-A '--', *1, 111. &.J.al .a.w'-A.i 1,-..., u~ ...........-.....J w. 0

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by FEMA and the FRPCC once the funding issue and the petition are addressed by the NRC. Please include these clarifications as part of the official NRC docket and record .

• Sincerely, ~

A rector for Preparedness, and Exercises

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555--0001 DOCK ETED USNRC March 9, 1998

                                                                          '98 HAR 10 P12 :10 DOCKET N BE P      O UL PR           50-'13A

( '1 ~ Fl? t,t,o"'iij The Honorable Tom Harkin United States Senate Washington, D.C. 20510

Dear Senator Harkin:

Thank you for your February 13, 1998, letter that urged the Commission to revist: its current policy regarding the availability of potassium iodide (Kl) for use by the general public in the event of an emergency at a nuclear power plant. Your letter has been included in the record of rulemaking. We have also posted it on the Nuclear Regulatory Commission (NRC) Web Page with other comments from the public received on the petition. As a result of the petitioner revising his petition, the Commission published a request for public comments in the Federal Register on December 17, 1997 (62 FR 66038). The comment period was subsequently extended until February 17, 1998, by a Federal Register notice published on January 21, 1998 (63 FR 3052). Following receipt of the staff's recommendation, which we anticipate will be provided in the near future, the Commission will make its decision on the disposition of the petition. We anticipate publishing a revised policy regarding the stockpiling and availability of potassium iodide for the general public shortly after the Commission makes its decision on the petition.

• For your information, I am enclosing a copy of the January 16, 1998, press release that the NRC issued on this matter. The Commission appreciates your interest in this matter.

Sincerely, J0~~ Shirley Ann Jackson

Enclosure:

As stated

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           .nrc.gov/OPA/gmo/nrarcv/98-12.htm                                      http://www .nrc.gov/OPA/gmo/nrarcv/98-12.htm Nuclear Regulatory Commission Office of Public Affairs Washington DC 20555 Telephone: 301/415-8200 - E-mail: opa@nrc.gov No. 98-12 January 16, 1998 NRC SEEKS COMMENT ON PETITION FOR RULEMAKING CONCERNING USE OF THYROID-PROTECTING DRUG IN El\.1ERGENCY RESPONSE The Nuclear Regulatory Co:.unission is seeking public comment on a petition for rulemaking which asks that the NRC modify its regulation, 10 CFR 50.47 (b) (10), to require that nuclear power plant mergency plans consider the inclusion of the use of potassium iodide, a thyroid-protecting drug, for the

• general public.

The deadline for comments is February 17. Current Federal policy, published July 24, 1985, calls for potassium iodide to be stockpiled for distribution during emergencies to emergency workers and institutionalized persons. If taken in time, the substance blocks most of the thyroid gland's uptake ofradioactive iodine. It could thus help reduce the risk of thyroid cancer and other diseases that might otherwise be caused by exposure to radioactive iodine which could be dispersed in a severe nuclear accident. The Commission last year voted to approve a proposed revision to the current Federal policy which would offer to provide funding for states which want to stockpile potassium iodide for use by the general public in the event of a nuclear power plant emergency . The rulemaking petition now pending before the Commission calls for a change in NRC regulations to pecify that states and licensees consider the use of potassium iodide, as well as evacuation and

• sheltering, in the preparation of nuclear power plant emergency plans.

The petition was filed by Peter G. Crane, an NRC staff attorney who took the action as a private citizen. The original January 16 deadline for comments has been extended by 30 days to allow sufficient time for public comment. Persons wishing copies of the petition may write: Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy of the petition and other related documents are also available at the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, DC. The petition also may be accessed on the Internet at http://ruleforum,llnL~oy/c~i-bin/rulemake?source=KLPETITION. Comments should be mailed to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments also may be delivered to 11555 Rockville Pike, Rockville, MD, between 7:30 a. m. and 4:15 p. m. on Pederal workdays. They also may be provided through the NRC's interactive rulemaking website, which may be reached via the Internet at http://www.nrc.gov by looking for rulemaking under the heading "Public Participation and School Programs." I of2 02/24/98 09: 19:32

TO~~ HARKIN IOWA ,2021 224- 3254 TTY 1202 1 224- 4633

, To m Hark in@ Hark in .Sen ate .Gov COMMITTEES :

ilnitrd ~rates ~rnatr AGRICULTURE APPROPRIATIONS WASHINGTON, DC 20510--1502 SMALL BUSINESS LABOR AND HUMAN RESOURCES February 13, 1998 The Honorable Shirley Ann Jackson Chairwoman, The Nuclear Regulatory Commission Washington D.C. 20555

Dear Dr. Jackson:

I applaud the Nuclear Regulatory Commission's (NRC) proposal to modify its approach to stockpiling potassium iodide (KI) as a measure to protect the general population in case of a severe nuclear reactor acc!dent. I am, however, concerned that this proposal does not go far enough. I believe that the NRC's proposal to federally fund the purchase of KI for any state requesting is correct. This being said, I also believe that the NRC should do more and make stockpiling mandatory, as proposed by Commissioners Diaz and McGaffigan. The distribution of KI to the general public in the event of a nuclear emergency is a broadly accepted protective measure. KI is an extremely effective means in the prevention of the uptake of radioactive iodine by the thyroid. For example, the World Health Organization has recommended its use for people living near a nuclear power plant if radiation levels are expected to exceed a predetennined dose. A number of foreign governments - the United Kingdom, the Czech Republic, Switzerland, Canadian provinces with nuclear power plants, and the former Soviet Union - stockpile KI for distribution to, and use by, the population in the event of a nuclear emergency. Several states include the use of KI in their emergency planning and this proposed measure would prove most effective in the protection of those citizens living and working near nuclear power plants. Thank you for your ongoing efforts to ensure the safety of the U.S. population in case of nuclear accidents. I look forward to hearing from you in the future. Sincerely, Tom Harkin United States Senator 150 FIRST AVENUE, NE 210 WALNUT ST. 131 E. 4TH ST. 350 WEST 6TH ST. SUITE 370 733 FEDERAL BLDG . 320 6TH ST. 314B FEDERAL BLDG . 315 FEDERAL BLDG . CEDAR RAPIDS, lA 52407--4884 110 FEDERAL BLDG . DES MOINES. IA 50309 DAVENPORT, IA 52801 (3191 365-4504 DUBUQUE, IA 52001 SIOUX CITY, IA 51101 (5151 284-4574 13191 322-1338 13191 582-2130 17121 252- 1550

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555--0001 DOCK ETED March 5, 1998 USNRC "98 MAR 10 Pl 2 :1O DOCKET NUMBER P L ct 5D-iP3A ( &, 'J. FR. &&o3 g-) The Honorable Joseph I. Lieberman United States Senate Washington, D.C. 20510

Dear Senator Lieberman :

Thank you for your January 27, 1998, letter which urged the Commission to revise its current policy regarding the availability of potassium iodide (Kl) for use by the general public in the event of an emergency at a nuclear power plant. As you requested, your letter has been included in the record of the rulemaking . We have also posted it on the Nuclear Regulatory Commission (NRC) Web Page which includes the comments from the public received on the petition. As a result of the petitioner revising his petition, the Commission published a request for public comments in the Federal Register on December 17, 1997 (62 FR 66038). The comment period was extended until February 17, 1998, by a Federal Register notice published on January 21, 1998 (63 FR 3052). Following receipt of the staff's recommendation, which we anticipate will be provided in the near future, the Commission will make its decision on the disposition of the petition. We anticipate publishing a revised policy regarding the stockpiling and availability of potassium iodide for the general public shortly after the Commission makes its decision on the petition .

• For your information, I am enclosing a copy of the January 16, 1998, press release that the NRC issued on this matter. The Commission appreciates your interest in this matter.

Sincerely, Shirley Ann Jackson

Enclosure:

As stated ~ - - - - - -- - - - - - - -

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United States Nuclear Regulatory Commission Office of Public Affairs Washington, DC 20555 Phone 301-415-8200 Fax 301-415-2234 Internet:opa@nrc.gov No. 98-12 January 16, 1998 NRC SEEKS COMMENT ON PETITION FOR RULEMAKING CONCERNING USE OF THYROID-PROTECTING DRUG IN EMERGENCY RESPONSE The Nuclear Regulatory Commission is seeking public comment on a petition for rulemaking which asks that the NRC modify its regulation, 10 CFR 50.47 (b) (10), to require that nuclenr power plant emergency plans consider the inclusion of the use of

• potassium iodide, a thyroid-protecting drug, for the general public.

The deadline for comments is February 17. Current Federal policy, published July 24, 1985, calls for potassium iodide to be stockpiled for distribution during emergencies to emergency workers and institutionalized persons. If taken in time, the substance blocks most of the thyroid gland's uptake of radioactive iodine. It could thus help reduce the risk of thyroid cancer and other diseases that might otherwise be caused by exposure to radioactive iodine which could be dispersed in a severe nuclear accident. The Commission last year voted to approve a proposed revision to the current Federal policy which would offer to provide funding f0~ states which want to stockpile potassium iodide for use by the general public in the event of a nuclear power plant ~mergency. The rulemaking petition now pending before the Commission calls for a change in NRC regulations to specify that states and licensees consider the use of potassium iodide, as well as evacuation and sheltering, in the preparation of nuclear power plant emergency plans. The petition was filed by Peter G. Crane, an NRC staff attorney who took the action as a private citizen. The original January 16 deadline for comments has been extended by 30 days to allow sufficient time for public comment. Persons wishing copies of the petition may write: Rules and Directives Branch, Division

of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy of the petition and other related documents are also available at the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, DC. The petition also may be accessed on the Internet at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=KI_PETITION. Comments should be mailed to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments also may be delivered to 11555 Rockville Pike, Rockville, MD, between 7:30 a.

m. and 4:15 p. m. on Federal workdays. They also may be provided through the NRC's interactive rulemaking website, which may be reached uia the Internet at http://www.nrc.gov by looking for rulemaking under the heading "Public Participation and School Programs."

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h n p -.senatc.;ov/-r;ei,e,rnan/ January 27, 1998 The Honorable Shirley Ann Jackson Chairman The Nuclear Regulatory Commission Washington, D.C. 20555

Dear Dr. Jackson:

• I am writing to com.mend your agency for proposing to modify its approach to stockpiling potassium iodide (KI) as a protective measure for the general public in case of a severe nuclear reactor accident. However, I am concerned that the proposed rule does not go far enough. Senator Alan Simpson and I wrote to the NRC about this matter on April 20, 1994.

I applaud the NRC' s proposal to federally fund the purchase of KI for any state requesting it. However; I believe that the record supports going further, as advocated by Commissioners Diaz and McGaffigan: stockpiling KI should be mandatory. As you know, it is well-established scientifically that KI is extremely effective in preventing the uptake of radioactive iodine by the thyroid. If taken in the proper dose prior to exposure to radioactive iodine, KI can completely block the uptake of the radioactive

• iodine.

The distribution of KI to the general population in the event of a nuclear emergency is a widely accepted protective measure. The World Health Organization has recommended its use for people living near a nuclear power plant if radiation levels are expected to exceed a predetermined dose. A number of foreign governments -- the United Kingdom, the Czech Republic, Switzerland, Canadian provinces with nuclear power plants, and the former Soviet Union -- stockpile KI for distribution to and use by the general public in the event of a nuclear emergency. Several states include the use of KI in their emergency planning.

• Thank you for your consideration of this matter. I request that these comments be included in the record of the rulemaking consistent with applicable legal standards.

s~.1~

                                            ~ I. Lieberman cc:     Commissioner Greta J. Dicus Commissioner Edward McGaffigan, Jr.

Commissioner Nils J. Diaz

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                                                                                                                                                                               *Esou~CES February 13, 1998 The Honorable Shirley Ann Jackson Chairwoman, N M ER The Nuclear Regulatory Commission                         p                                R        5D-&3A Washington D.C. 20555                                           (r,,:U'tV.,l,038)@                                             r.-: * -::n 111
                                                                                                                                               ,:J(

Dear Dr. Jackson:

                                                                                                                                              - '                    .h:

• I applaud the Nuclear Regulatory Commission's (NRC) proposal to m6aify.its app~ach 10 st ockp1*1*mg potass1um . 10d toe (~J as a mc::tu1ute *o pw~e&..~ ~u" a,¥11-.;u

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• nuc,Jcar reactor ~ccidcnt. I am, however, concerned that this proposal does nnt go far enough .

I believe that the NRC's proposal to federally fund the purchase of KI for any sll1ti:; r¢questing i~ correct. This being said, I also believe that the NRC should do more and make stockpiling mandatory, as proposed by Commissioners Diaz and McGaffigan. The distribution of KI to the general public in the event of a nuclear emergency is a broadly accepted protective measure. KI is an extremely effective means in the prevention of (he uptake uf radioactive iodine by the thyroid For example, the World Health Organization has recommended its use for people living near a nuclear power plant if radiation levels are expected to exceed a predetennined dose, A number uf fun:ign governments- the United Kingdom, the Czech Republic, Switzerland, Canadian provinces with nuclear power plants, and the former Soviet Union - stockpile KI for distribution to, and use by, the population in the event of a nuclear emergency. Several states include the use of KI in their emergency planning and thi~ proposed measure would prove most effective in the protection of those citizens living and working near nuclear power plants. Thank you for your ongoing efforts to ensure the safety of the U S. population in case of nuclear accidents. I look forward to hearing from you in the future. Sincerely, Tom Harkin United States Senator MA~ - S 1998 Acknowledged by card.*-*-***-************--

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DOCKET NUMBER PETITION RULE PAM 5 O- '1 3 A (<,,:z. Fl<foCo03f1) From:

• JIM MACDONALD* <macdonj e@songs . see. com>

DOCKETED US NRC To: TWD2 . TWP9(CAG),GATED .nrcsmtp(" NUC .MACDONJE_at_SMTP ... Date : 2/26/98 11: S0am Subject : Potasium Iodide "98 FEB 27 A8 :46 February 26, 1998

                                  .      b                b       . Off ICl I suggest t h at t h e KI issue e put to rest y storing eru:1J1l1Gl
                                                                                   , f c.' KI. o r r:~,

nl71 1.\1 , \1 1 the largest population near a nuclear unit at a centra M 3 i:ri i , !'.,J If KI were stored near a large airport in the center of US, e.g., Chicago or St Louis, it could be flown to the site of the nuclear emergency in more than enough time. One stash of KI could be maintained fresh less expensively than if every nuclear unit were required to store a supply. J E Macdonald 2121 Camino Laurel San Clemente, CA 92673 maclube@aol.com MAR - cknow1edged by card*********-**-- -

U.S. NUCLEAR REGULATORY COMMI RULEMAKINGS & ADJUDICATIONS ST - OFACE OF THE SECRETARY OF THE COMMISSIO~ Postmark oats ~ f- ~~ ,,D>, 4:),1,/qs, Copies A808M,. _ / .. b

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"KIDS_

February 26. 1998 NOTE TO: Emile Julian Chief . Docketing and Service~s Branch FROM : Carol Gallagher ~~ ..h RES . ORA l,(P1 -

SUBJECT:

DOCKETING OF COMMENT ON AMENDED KI PETITION Attached for docketing is a comment related to the Amended Petition on

• Potassium Iodide (PRM-50 -63). This comment was received via e-mail on February 26 . 1998. The commenter's name is J. E. Macdonald. 2121 Camino Laurel. San Clemente. CA 92673. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment : As stated cc w/o attachment : M. Jamgochian

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                                      '98 FEB 20 Al 1 :32 Elizabeth F. Liska 596 Juneway Drive Bay Village, OH 44140 a.a.-...a           F'EB 2 6 1998 NUVIUWI   ecf by  ..- - ~ -

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RULEMAKlN & ~~:tlO::C~,l'V'lll,i& OFACE OF THE SECRETARY 0FnE

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FROM AROUND THE REGION I I What price to protect our children? I By PETER CRANE I ost Americans probably assume that when it M I* comes to safeguarding our children against the risks of a nuclear accident, the U.S. gov-ernment ensures protection second to none. If so, they are wrong. In countries throughout the developed world, the ra-diation antidote potassium*iodide is now a standard el-

         .ement in nuclear emergency planning. Taken in time, a potassium iodide pill costing as little as seven cents can prevent thyroid cancer and other diseases of the thyroid gland, especially in children.

American children still lack this protection, howev-er, 19 years after the President's Commission on the Accident at Three Mile Island strongly recommended that the government establish regional stockpiles of the medicine. (During the TMI accident, authorities had searched for supplies of potassium iodide and found that none existed.) At the time, the Nuclear Regulatory Commission (NRC) and the Federal Emergency Management

          ~gency (FEMA) readily agreed that potassium iodide should be stockpiled, and made plans accordingly. Lat-er, after the nuclear industry raised objections, and an-ti-nuclear groups tried to make the drug an issue in re-actor licensing proceedings, the agencies quietly re-versed themselves.

Today the issue is again before the commission. As a former thyroid cancer patient who would like others to be spared the same experience, I have petitioned the NRC to make potassium iodide part of emergency planning. Citizens have until Feb.17 to send their com-ments to the NRC on this proposed rule change.

    ,u pebuaut: a1e NRC tllo.l uw C,lllilien Ues1;1 ve Jus, as much protection as children in Britain, Switzerland,                 unwilling to store pills to prevent cancer in the event of a nuclear accident.

Canada, the Czech Republic, and the former Soviet Union, among others. Why have a drug to protect just the thyroid, when

                                                               -       iodide, an industry trade.group warned the that to stockpile the medicine could lead peopl~

a illnesses, no one who has experienced the disease first-hand would wish it on their children. Testing and ideally no part of the body should be exposed to radia- doubt the safety of nuclear plants. As the industry put treatment involve shifts of medication that leave pa-tion? Because the gland is highly sensitive to radia- it: "Public confidence in the technology could be affect- tients weak, exhausted, and chilly for weeks, not to tion, particularly in children. The risk to the thyroid ed by the decision." mention the anxiety that goes with any cancer. from radiation includes not only cancer, but also hy- Opponents point out that evacuation is preferable to I formally asked the NRC to revise its position on pothyroidism (underactivity of the gland), which can use of potassium iodide, as it protects the whole body. potassium iodide in 1989. After almost five years of cause retardation in children. The greatest danger of That is undeniable - if evacuation is feasible. But if studying the issue, the NRC's technical staff essential-brain damage is to the developing fetus, between the an ice storm or a hurricane made evacuation impossi- ly agreed with me, advising the commissioners in ear-eighth and 15th weeks of pregnancy. ble, or if winds unexpectedly blew fallout toward a ly 1994 that stockpiling potassium iodide would be All these harmful effects can be prevented by potas- populated area, evacuation might not be possible. prudent. The staff calculated that the government sium iodide, if the pill is taken in time during a nu- Moreover, you can get a dose of radiation while evacu- could buy enough potassium iodide to protect all clear accident. The medicine blocks the absorption of ating, as automobiles provide minimal protection. Americans living in the vicinity of nuclear plants for a inhaled or ingested radioactive iodine by saturating total of'at most "several hundred thousand dollars." the thyroid with iodine in a harmless form: Potassium Why label stockpiling as 'not wortbwbile'? Then Sen. Lieberman, in a joint letter with his Re-iodide pills have a shelf life of at least five years. Current government policy does not forbid states to publican colleague Alan Simpson of Wyoming, wrote The best evidence of potassium iodide's effective- stockpile potassium iodide, but says such a practice is to the NRC about potassium iodide. Marshaling the nu-ness, and the potential consequences of being without "not worthwhile." What does it mean that it is "not merous arguments for stockpiling, the senators noted it, comes from the 1986 Chernobyl accident. worthwhile" to spend seven cents apiece to protect our the NRC staff's calculation that the cost of stockpiling In Poland, health authorities had 90 million doses of children from thyroid cancer? Translated from bu- potassium iodide was "probably less than the cost of the drug stockpiled when the Chernobyl plant explod- reaucratese, it means that a nuclear accident is so un- the continued studies." They also pointedly reminded ed. When radiation sensors detected airborne radioac- likely that it would be cheaper to cure radiation- the NRC of its "moral responsibility to provide the tive iodine entering Poland's atmosphere, officials caused cancers if they occur than to spend even a tri- public with complete and accurate information." I I quickly gave out 18 million doses of potassium iodide, fling amount to prevent them. They did not succeed. The four commissioners tied I ' mostly to children. Side effects were minimal. Today; This policy was unveiled by the federal government 2-2. Under NRC rules, the recommendation therefore Poland has seen no increase in thyroid cancer. Health in July 1985, just nine months before the Chernobyl failed, and the old policy remained in place. authorities credit their prompt use of the chemical. catastrophe made hash of its complacent assumptions. In 1995, I filed a petition for rule making with the In the former Soviet Union, it is a different story: It was based on an NRC staff "cost-benefit analysis" NRC, ffi1d also asked FEMA to reconsider national pol-There, distribution of potassium iodide during the that balanced the cost of potassium iodide pills on the icy. In 1996, a committee headed by FEMA recommend-Chernobyl accident was insufficient and untimely. one hand against the medical costs of treating thyroid edthat the federal government should offer to buy Since 1991, health authorities in Russia, Belarus, and disease on the other. Only the dollars and cents in- potassium iodide for any state that wanted it. More Ukraine have been seeing an upsurge of aggressive volved were considered. The analysis did not take into than a yBar later, FEMA still has not announced the thyroid cancer in children. Well over 1,000 cases have account that illnesses have non-financial costs as well: new policy to the public. been diagnosed to date, often spread to the adjacent suffering, fear, and the danger of death. Now the NRC is considering my petition for a rule lymph nodes. In Belarus, where the incidence is high- If we applied this approach to deciding any other change. The comment period is open through Feb. 17. est, people speak bitterly of the "Belarus necklace" - health issue, its absurdity would be obvious. Take the Members of the public can obtain the background doc-the ear-to-ear scar that is left when surgeons remove question of whether to immunize children against po- uments and submit comments electronically through the cancer. lio. the NRC's excellent rule making website, These cancers were preventable. In .Ablaze," his ex- First we would calculate the cost of the vaccine, "ruleforum.llnl.gov." (Comments can also be submit-cellent book on the Chernobyl accident, Piers Paul then the odds that an unvaccinated child will get the ted by mail.) In the "public comments" file, you will Read describes how Leonid Ilyn, a Soviet radiation disease, and then the cost of treating the average case find a letter from Sen. Lieberman, dated Jan. 27, 1998. specialist, had tried to improve preparedness for nu- of polio. If iron lungs and crutches turned out to be He urges the commission to agree with the two newest clear accidents before the disaster. He wrote a pam- cheaper than vaccine, our children would go unimmu- Commissioners - Republican Nils J. Diaz and Democ-phlet stressing "the need to protect the thyroid gland nize,d. Rational people, and rational governments, rat Edward McGaffigan - that potassium iodide stock-from radioactive iodine 131 by taking KI pills of stable don't make decisions that way. piling should be mandatory. iodine [potassium iodide]." But the Soviet government As cancers go, thyroid cancer is one of the least But Commissioner Greta Dicus is an outspoken op-quashed wide distribution of the document. Read ex- grave. In adults, it has been called a "disease in slow ponent of stockpiling. The deciding vote may there-plains: "To prepare too well for an accident might lead motion." Even in children, in whom the cancer tends fore belong to Chairman Shirley A Jackson. Connecti-people to believe that it could happen." to spread quickly, survival rates are quite high. Never- cut residents, and indeed all Americans, can be grate-The American nuclear industry seems to think theless, the disease has serious impacts on the quality ful to Sen. Lieberman for going to bat for their safety along the same lines. In a 1993 "White Paper" on potas- of life even for those who survive it. and their children's. I first had thyroid cancer in my 20's, undoubtedly But one senator's letter is not enough; the NRC caused by X-ray treatments of my tonsils and adenoids turned a deaf ear once before. Help him out. If you Peter Crane is an NRG attorney who lives in Mary- when I was two years old. In my 40's, the cancer re-land. This article is written in his capacity as a priuate think your children deserve first-rate protection, not turned, and it took five courses of radiation over a second-rate, and that the foot-dragging must stop, let citizen. four-year period to cure it. While there are many worse the NRC and FEMA know it, now.

Feb-18-98 03:SOP s;11 Kramer 301-229-9157 P.01 7d . /1'Ji~-<- v"o.--;rci.1~ - WILLIAM J. KRAM.ER DOCKETED USNRC

                                                                                                    '98 FEB 19 Pl2 :20 February 18, 1998 Mt. John C Hoyle Nuclelll' Regulatory Commission Office. of the Scnetacy Wii13hington DC 20555 DOCKET NUMBER Re: Amemlcd Rulcmakiog Petitition on Powsium Iodide by Peter G. Crane P~JITION RULE PAM 5 D- '73 A

(" ~ F~ tp~ o 3'3) ~

Dear Mr. Hoyle:

                                                                                        '            <I!/

l wish to add my '10ice to othcn who implore the Nuclear Regulatory C..ommis$ion to serve the American people well by adopri.ng rhe amended petition named above. History and experience demand it. No reputable medical body would contend mat thyrotd cancer u a negligible public healrh iuue, hut it appcars that the N.R.C staff would him: us believe otherwise. 1\. "cost-benefit" analysis which concludes that a ten-cc.nt dose of KI is not a worthwhile public investment reveals a shocking lack of sensitivity and analytical honesty. An agency which docs not aggressively promote - through all the meaos at irs disposal - a cheap and cffccti~ remedy to II potential problem Wlder: its regulatory authority should seriol!l;ly re-examine ici legal and ethical responsibilities. The N.RC. exists only to protect the public interest Ler !he Depattmcnt of E.11ergy promote the: economic wcll*bcing of the nuclear industry. If rhe N.R.C fails to expand irs role in the distribution of Kl, it would condemn inelf bolh in fact and in public perception to the mle of industry promoter - and c) n an issue over which theic is no ical legal, medical. or public policy argument to suppon its ioc>t-draggio!; So far as I can rell, it is largely industry" paranoia, fed by disingenuous N.R.C staff reports, which has led ro a view of Kl distribution as unnecessary, too costly, or unwise. The facts tell a different srory. 1 further bc:1icve rruu the American people aie vllStly mote sopbisticared on this issue than industry. We wan,. cheap 11nd efficient power l&lld we understand rhe health md safety risks of nuclear. All we ask is that public and private of6cials Jo what is sensible and pnctical ro serve both et1ds. France is a srriking esample of a counrry which promotes its nuclear industry aggressively, wbc-<< nuclear power enjoys great public confidence, and where KI is univenally ~rodtpiled. All three thing5 can, and do, co-exist. The Commission will do itself a great favor to get out front on the KI issue, even at this lare date. The N.R.C. should not undea:esrimate the power it bas to eohance - or desnoy - public confidence ,ri those to whom we entnac our safery. I w:ge the Commis,ioa.cn to vore for the amended petition. Sincerely, William J. Kramer 7507 .11.llDllN RU/\U

• C.l\l:llN JOHN* MD 20818 PHONE: 301-229-'567
• I'AX: JOl 229-9157 rEB 1 9 1998

                                                                                            ~bycma u,1                     J .,,, .,. C ... ,

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 Ft C 01N' ~tj- ~ fi-<: J'{r / ~i 'tl ""'" -fn yu l--e11rtt..1~ ~ it5 ,. ,f1M~~0~

 ~~          PUBLIC AFFAI
                                ~

DOCKETED USNRC 245 E. 19th Street New York, N. Y. 10003

                                                                   '98 FEB 18 A9 :23 Mr. John C. Hoyle Secretary, U.S. N . R . C .

0 KET NuMDlc;n QFFI( L *') r - *H Washington, D. C. 20555 ULE PR 50-~,1 RULE:..!:.. '/ J ( fJJ:). F£ '11P038) ADJUD'CA. I l' ,lAFF

Dear Mr. Hoyle:

My husband and I strongly support the petition for rulemak.ing on potassium iodide now pending before the NRC. Stockpiling of this radiation antidote should have been made mandatory many years ago. The failure of the NRC and the Federal Emergency Management Agency to implement the recommendation of the President's Commission on the Accident at Three Mile Island, and to act on the advice of the medical community, raises the question of what the first priority of these agencies is: protecting the public or safeguarding the image of the nuclear industry. The NRC and FEMA should be ashamed that American children are currently deprived of a protection that is standard in Europe, Japan, and Canada. We can be grateful to Senator Joseph Lieberman of Connecticut for having pressed the NRC on this issue for four years. I intend to ask my representatives in Congress to ask the NRC and FEMA why, after so many years of studying the issue, it has yet to be resolved. If my understanding of the cost of potassium iodide is correct, Americans could be protected for a few pennies apiece, and the Government could have bought enough of the medicine for every American with the money it has spent trying to justify why not to buy it. I recognize that the principal argument against potassium iodide is that evacuation is better. Does anyone think that New York City, or any of the other cities that could be affected by an accident at Indian Point, is evacuable? If the NRC's position is that evacuation is the only acceptable response to an accident, then it has raised the question of whether plants close to urban areas should be allowed to go on operating. Perhaps the best solution would be a Congressional hearing at which the whole issue could be explored, with testimony from the medical community and the agencies involved. Sincerely,

                                       ~~

Barbara Sirois cc: Sen. Daniel Patrick Moynihan Sen. Alfonse D I Amato Rep. Carolyn Maloney F'EB 1 9 1998 Acknowledged by card .._ _ _._..,

L, ..,..,1.cAR REGULATORY COMMISSI RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSI Document Statlstta Postmark Date ,£2 '" 18' Copies Received / rl'

• Niagara Mohawk DOCKETED February 13, 1998 USNRC John H. Mueller Office: (315) 349-7907 Senior Vice President and Fax: (315) 349-1321 Chief Nuclear Officer e-mail: muelaj@lwno.com "98 FEB 17 PJ :37 DOCKET NUMBER PETITIO ULE PRM 50.:.f.3 A

( <t,~ F~~&,o3 r) Mr. John C. Hoyle , Secretary file code: 98-EP-005 U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Docketing and Services Branch

Subject:

Amended Petition for Rulemaking filed bv Mr. Peter G. Crane (62 Fed. Reg~ 66038: December 17, 1997) Request for Comments

Dear Mr. Hoyle:

Niagara Mohawk Power Corporation submits these comments on the proposed petition to amend the Emergency Planning Standard in 10 CFR 50.47, "Peter G. Crane, Receipt of Amended Petition for Rulemaking", (62 Fed. Reg. 66038 - December 17, 1997). The proposed petition recommends that the emergency planning standard for protective actions require consideration of the prophylactic use of Potassium Iodide (KI) for the general public. Niagara Mohawk Power Corporation, Nuclear Power Plant Licensee for Nine Mile Point Nuclear Stations 1 and 2, strongly urges the NRC to deny the petition. We agree with the NEI industry position that evacuation programs already in place are generally more effective than using KI to protect just the thyroid. The petitioner fails to provide any new evidence that stockpiling or redistribution of KI will add any significant public safety and health benefit above that already permitted in the emergency planning programs for nuclear power plants. Guidance already exists for states or local governments to make KI available to the general public if they feel it is appropriate. Niagara Mohawk also agrees with the NEI nuclear industry position that any new requirement for states to explicitly reconsider their plans for KI consideration can not be justified by benefits derived. We appreciate the opportunity to comment on the Amended Petition for Rulemaking filed by Mr. Peter G. Crane. Sincerely,

~ 1 J ~

John H. Mueller Senior Vice President and Chief Nuclear Officer GS/ksj Acknowledged by card m 1 9 1998 Nine Mile Point Nuclear Station, P.O. Box 63, Lycoming, New York 13093 www.nimo.com

.:, CL A REGULATORY CO RULEMAKINGS & ADJUD~ S OFFICE OF THE SECRETARY OF THE CO ISSI ostmark Date___.~ ~........- - - - opies R ived _ _--'-_ _ _ _ dd'I Copies Re al iStri .

DOCKETED USNRC-

                                        ~tat£ .of ~£fu W£rs£y Chris tine Todd Whitman            Department of Environmental Protection                           "9B Governor Division of Environmental Safety, Health, and Analytical Programs Radiation Protection Programs Bureau of Nuclear Engineering CN 415                                                                        -F F Trenton, NJ 08625-0415 Telephone (609) 987-2032 Fax (609) 987-6354                        DOCKET NUMB PETITION RULE PRM SD-'1 3A February 11, 1998 US Nuclear Regulatory Commission Washington DC 20555-001

( (p~ Fl< t,IP03 g) Attention: Docketing and Services Branch

Subject:

Petition for Rulemaking on Use of Potassium Iodide, Docket No. 98-12, January 16, 1998 The New Jersey Department of Environmental Protection (NJDEP) hereby submits its comments on the above-referenced petir.ion. The NJDEP does not support this petition for several reasons, which are elaborated below. The current issues brought to the Commission with regard to potassium iodide require careful consideration by emergency planners and public health officials. The petitioners have modified their request for a change in rulemaking regarding potassium iodide. The modification not only includes a recommendation to states that potassium iodide is considered when making protective action decisions, but is also prudent. The Commission has agreed to modify the language in the rule change based upon the request of the petitioners and is again out for public comment. The supportive arguments made by the petitioners focussed on the use of potassium iodide to reduce exposure to the public. They used the internationally accepted ALARA concept as a basis. Addir.ionally, the petitioners pointed to the reduction in the number of potential cancers if potassium iodide were ingested by the public during a nuclear accident. The risk/benetir studJ.es compiled in i2oland were used as the basis for this argument. These arguments are difficult to refute in the context in which they are presented. However, we should look at all protective measures when considering the administration of potassium iodine. The NJDEP believes that the petitioners have not considered all aspects of the endorsement of potassium iodide use during nuclear emergencies. Clearly, money can no longer be an issue. No one can argue that the price of one potassium iodide tablet can outweigh the potential benefits it may have. Obviously, if potassium iodide can significantly reduce the number of potential cancer deaths then distribution is prudent. However, there are a number of issues that have been overlooked that may impact the decision on the use of potassium iodide. First, radioactive iodine is not the predominant nuclide expected to be released from a nuclear power plant during an accident. The release of noble gasses will far exceed the amount of radioiodines Ne w Jersey is an Equal Opportunity Employer ru 1 s 1998 Acknowledged by card __,..,..,.............,...,...........- Recycled Paper

U.S. NUC t:GULATORY CO ISSION RULEMAKINGS & ADJUDICATI STAFF OFFICE OF THE SECRETARY OF THE CO MISSION Do ntStallstlce Postmark Date _ ..::;t!J __,_~i....~ Copies Received _ _--:- - __ pr1; "opias Reprod ~ DIStribUtiOn..,..¥J,~~~~9'), - ~ ~ ~ ~ , & . ! l ~~

released. Nuclear power plants are equipped with sophisticated systems of filtration that ensure releases of radioparticulates will be minimal in the unlikely event of an accident. Radioiodines can be filtered quite effectively prior to a release of radiation from a nuclear power plant. Noble gas however can not be filtered. The consideration of public protection should address the most likely risk, which is exposure to noble gas. The preferred and only effective measure to protect from the radioactive gas is evacuation. Thus, for the most likely cases, evacuation is the primary and most effective method of public protection. Second, consider the unlikely instance that a release occurs from a nuclear facility which bypasses the filtration system. To quantify risk, the NRC should provide the site specific probability of radioiodine release that would exceed 25 REM to the thyroid of an individual within the 10 mile zone, with or without ingestion. Are the radioiodines released the primary health risk to the public? The half life of radioiodine is relatively short and the contribution to the total exposure during a filtration bypass release will be minimal compared to the long term committed dose potential from cesium, strontium, or many other longer-lived radionuclides. The use of potassium iodide may significantly reduce the potential for the development of thyroid cancer or hyperthyroidism, however, but any delays which contribute to acute exposure to other longer-lived radionuclides will have more significant health effects and possibly terminal cancers. It is the argument of numerous states that the distribution of potassium iodide to the general public will instill a false sense of security in individuals that ingest the drug. Many individuals may neglect to educate themselves regarding potassium iodide and the potential benefits and its total effectiveness. It may not be commonly recognized that potassium iodide only protects one organ from one radionuclide and the greater risk to radiation is staying in an effected area. It is believed by many emergency planners that the distribution of potassium iodide could, therefore, create an image of a 'wonder' drug which protects the public from all types of radiation. If this happens and the public may ignore the recommendation to evacuate quickly because they feel 'protected.' Several states have attempted to include distribution of potassium iodide in their emergency plans. To date, none have been successful. For the distribution of potassium iodide to be effective, guidelines and testing methods must be offered to the states so they can properly fit this protective measure into their existing plans. Without uniform guidelines and a comprehensive public education program, the planning and implementation of potassium iodide as a protective measure will not be coherent and could be counterproductive. If these are not part of the planning basis, then the NJDEP feels that this is not a prudent path to pursue to protect the health and safety of the public. It has been the position of New Jersey that a timely evacuation is the preferred method for public protection. Sincerely,

                                         ~                , /o::,,c:/4_ _

Kent Tosch, Manager Bureau of Nuclear Engineering

DOCKET NUMIDU1i PETITlON RULE PR S0-'1 3 ,4 DOCK ET ED US NRC RR1 Box 125 Cfr; /J..F fl.. lt,ftJo3i) Ulster PA 18850

                                    '98 FEB 17 P3 :02               9 February 1998 Mr. John C. Hoyle, Secretary U.S. ~uclear Regulatory Cof1151¥ ~io~- ~:::, _ :1 ,

Washington, DC 20555-0001 RUU- !*, ,if ADJUD 1CA_r' 0

                                                    ,:: *u

, 1AFF Attention: Rulemakings and Adjudications Staff Re: PRM-50-63 Mr. Hoyle, I expect the NRC to decide favorably the petition by NRC attorney Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency

• responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations.

Potassium Iodide has been proven effective if taken in a timely manner, therefore stockpiling is a sensible answer in the event of another nuclear accident . The President's Commission on the Three Mile Island Accident recommends stockpiling. The American Thyroid Association also recommends stockpiling. The reluctance of the nuclear industry to provide stockpiling is nothing short of irresponsible, and perhaps should be considered criminal! A 10 cent pill can prevent the uptake of radioactive iodine to our thyroids. Arguments that people will be evacuated in a timely manner are strictly conjecture. The NRC can't dictate that an accident won't happen during a snowstorm or that some evacuees will be traveling with the radioactive wind, to name but a few scenarios. With all else that is foisted upon us unwillingly from the nuclear industry, this ounce of prevention is but a small consideration to demand. Laura Blain Acknowl ged b can2 .....~8 "l 9 _1?~

1 J U.S. NUCLEAR REGULATORY I RULEMAKI GS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Doct

(212)7~580 525 EAST 88th STREET, NEWYORK, N.Y. 10021 THE NEW YORK HOSPITAL-CORNELL M~ E N T ER USNRC DEPARTMENT OF RADlOLOGY ./f.i /3 DOCKET NUMBER DIVISION OF NUCLEAR MEDICINE

                                                ' "      Lr RM 5D-to3A
                                                                                   '98 FEB )>( PJ            :'ta February 13, 1998

( "a FR IPh038 Dr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Hoyle:

I am az; senior endocrinologist and nuclear medicine specialist with long experience in the management cf thyroid disease ai,d thyroid cai"1cer. I have been particularly interested in the issues of radiation induction of thyroid cancer and have been a major participant in a wide range of studies on this issue ranging from the DOE/Brookhaven Marshall Islands Study, to studies of the effect of diagnostic and therapeutic radioiodine in the Thyrotoxicosis Followup Study and for the last 15 years have been working with the National Cancer Institute as a participant in their 1-131 Risk Assessment Studies and currently the Chernobyl/Children Thyroid Cancer Studies. I have been a member of the NCRP Committee that published monograph #80 on "The Induction of Thyroid Cancer by Ionizing Radiation" and am a member of the current NCRP Committee 1-8 revising that monograph. I have published extensively in the medical literature on thyroid cancer and its management, medical use of radioiodine and the usefulness of potassium iodide for thyroid blocking in the event of reactor accidents. Early arguments against the stockpiling of KI 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 KI 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 2.5% (mostly nausea) but with only a fraction of 1% having serious side-effects. Current packaging of KI in Europe has appeared to resolve the probl:~_+"~ 9.-~. ,Q."! FEB 1 9 1998 Acknowledged by card .............,_ __

U.S. NUCLEAR REGULATORY MISSION RULEMAKINGS &ADJUDICATIONS STAFF OFRCE OFntE SECRETARY Of THE COMMISSION Oocllnent Statistics Po ~ 13 'f 'i I

shelflife 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 predistribution. However, should a reactor accident occur in the U.S. requiring KI and it not be available because of an overly heavy emphasis on perceived difficulties, the resultant medical and political/sociological impact will be disastrous. One cannot minimize the significance of a cluster of 1200 children with this serious and fortunately rare cancer. Although with modern intensive therapy results are good, such treatments often have very senous disrupting effect upon the life of the individual and such effects cannot be minimized. Long experience in personally taking care of hundreds of patients with thyroid cancer has convinced me of the importance of the <lis1uption of the iife of the individual witkhis dist!ase. 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, KI will not decrease whole body radiation and evacuation clearly is an optimal initial response to an accident, but it is not always possible and supplementation of evacuation with potassium iodide is undoubtedly useful. The Polish study showed that potassium iodide administration decreased the potential thyroid radiation dose by as much as 40% 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. It is difficult for me to understand the logic of not endorsing such a simple inexpensive prophylactic procedure as stockpiling KI. I strongly urge that you and the members of the Commission very seriously consider the potential impact of an admittedly unlikely accident in a nuclear power plant when the needed KI is not available. One can only go back to the Three Mile Island Accident and remember the frantic efforts to produce KI on short notice. The pharmaceutical industry responded remarkably to the sudden demand (which fortunately in the end was not needed) but the product they delivered had many defects including leakage from the caps, poor calibration of the dropper and a package that was difficult to use. Although fortunately such an event is unlikely, it nevertheless is potentially a or, edical, socio~og* and political disaster waiting to happen. Sinc~re , /1 I I eek: r, Professor of Radiology and Medicine fs

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U.S. Nuclear Regulatory Commission Washington, D.C. 20555-000 l Attn.: Rulemakings & Adjudications Staff Re.: Potassium Iodide availability and distribution: protection against radioactive fallout due to nuclear plant catastrophy. I respectfully urge favorable consideration regarding the proposal to make potassium iodide available to the public to prevent the ill effects due to the fall out from a nuclear plant accident. Every community containing a nuclear plant should have the protect.ion that this drug (Kl) can provlde. Alternative plans,such as evacuation and shelters will be useless during the crisis of the nuclear plant catastrophy. Availability of Kl presupposes an adequate distribution system. There has to be a satisfactory means for getting the drug to the exposd population in the shortest possible time. Please make this requirement part of your proposed rule making. Sincerely.y:u]/ /2

        .7~C>-JJ'---

a.M. Glassman, Ph.D. 280 Sleepy Hollow Rd., P0B 23 Briarcliff Manor (Westchester), NY 10510-0023 (91'1} Jfj.. .s-s i 2... Aeknowfedged by card ....f!~_lJ. .19~8

  ~               EGULATORYCOMMJSSI h-,     AKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION DocumentStatlsb Postmark Date                 * [-fl')a,J ~ ~,O),') :;./1.3/~a-Copies Received           /

Add'I Coples A Sp ..

I agree with Senator Liberman and Commissioners Diaz and McGaffigan that potassium iodide stock piling should be mandatory. Over the last year Connecticut has had quite a few problems with their nuclear power plants. I think any measures that can be taken to reduce exposure, in the event of accident, should be taken. Submitter:

                                                                              ~:o~

c_c..,., DOCKET NUMBER C ,~ ,-) ~ Steven D. Ureles, DMD, MS 190 Hempstead St. PSTITI N RULE PRM so~ ~3A Orn r :

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                                                                            .,., 3;1 Acknowfedqed by card ....~... 9...!._   ! 99s_

U.S. NUCLEAR REGULATORY ISSION RULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Docllnent Statistics Postmark Oate ~ ~ ~ ~ 2 ? : > ~ ~ rn :/;3/9g, Coplas R8ClillV8d / _ Add'I Reproduc;_ed 3 Special Dlstrlbutioo

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February 12. 1998 NOTE TO: Emile Julian Chief. Docketing and Services Branch FROM: Carol Gallagher RES. ORA

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment related to the Amended Petition on - Potassium Iodide (PRM-50-63). This comment was received via the rulemaking website on February 10. 1998. Please note that the commentor loaded this comment in the description area of the submittal form: the commentor did not load it as a file . The commenter's name is Steven D. Ureles . 190 Hempstead St .. New London. CT 06320. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records. e

Attachment:

As stated cc w/o attachment: M. Jamgochian

ANBEXINC. ALAN MORRIS 2885 BRIDLEWOOD DRIVE, PALM HARBOR, FL 34683 DOCKETED PRESIDENT 102747.3311@CompuServe.com USNRC 813-784-7889 February 9, 1998 '98 FEB 13 Al 1 :11 Secretary United States Nuclear Regulatory Commission Washington, DC 20555-0001 ATTN : Rulemakings and Adjudications Staff DOCKET NUMlw:N Re: PRM-50-63A I PAM 50-~3,1 ((p~F;? (,/,03~) This is in response to the request for comments on Peter Crane's Amended Petition for Rulemaking concerning the use of Potassium Iodide (Kl) in emergency planning. Anbex is one of only two companies approved by the FDA to manufacture and sell Kl for radiation protection. The question of whether the NRC should encourage stockpiling has never been satisfactorily resolved-despite widespread recognition of Ki's known safety and effectiveness, its low cost and long shelf life, and the effective use of the product following Chernobyl. Although the Three Mile Island experience indicated the difficulty in obtaining adequate supplies in the absence of pre-planning, the nuclear industry continues to resist steps that would assure the availability of Kl if it is ever needed. Yet few would dispute the value of the drug, or the likelihood of increased casualties in its absence should another serious accident occur. Because of its potential value, organizations such as the FDA, the American Thyroid Association , the National Council on Radiation Protection, The Presidential Commission that investigated TMI, the New England Journal of Medicine-along with numerous other public and private groups-- have called for the acquisition, stockpiling, and/or distribution of Kl. But notwithstanding this overwhelming endorsement by independent experts, the NRC has retreated to a neutral position. While not disputing Ki's value, or explicitly forbidding its acquisition, the agency has failed to properly communicate its benefits to local officials who look to Washington for guidance in these matters. Thus, very few states have acted on their own to assure supplies, and few in the general public realize either the value of Kl, or the certain lack of its availability if ever called for. Opposition to Kl stockpiling comes primarily from the nuclear industry and others who appear to be more concerned about public relations than public safety. They argue that stockpiles would erode the public's confidence in nuclear power and that "the debate over the prudent use of Kl has served no useful purpose other than to unduly undermine the effectiveness of nearly two decades of sound radiological emergency planning and preparedness." This position ("sound radiological emergency planning and preparedness") is maintained in the face of the TMI experience (where requested Kl did not arrive at the site until six days after the accident occurred), and despite the fact that recommendations to correct deficiencies in response planning have not been implemented. While current plans call for distribution of radiological protective drugs under specified release conditions, the acquisition of these drugs has never been addressed. Unfortunately, the industry *appears to view Kl more as a threat to its reputation and policies, than as a key element in a comprehensive emergency response strategy designed to reduce the impact of a serious accident. ckn ed ed card ...!_~B 1 9 1998

I U.S. NUCLEAR REi*LATO YCOMMISSION RULEMAKINGS & A IJUDICATIO S STAFF OFACE OF ESECRETARY OFTHE MMISSION

Other arguments against Kl have been based on "cost-benefit" studies, which are premised on highly unlikely, overly optimistic, and officially repudiated accident probabilities. It is, of course, correct that if accidents are assumed to be virtually impossible, then there is no need for Kl (or for any emergency planning, for that matter). But one has to wonder how industry and government officials can support this view given the responsibilities and obligations they shoulder and the events of history. Further, the cost-benefit analysis itself is purely economic and indifferent to the best interests of the American public. It is based on imprecise calculations and arbitrary assumptions, (such as assigning a dollar value to the worth of one's thyroid) that have been used to justify a disturbing policy that most people would find unacceptable-that it is cheaper to let people be harmed by radio-iodine poisoning and treat them afterward than to prevent the problem in the first place. This callous attitude to the victims of accidents was neatly summed up by one official (printed elsewhere in these comments) who noted that his agency "stands firmly behind its contention that hundreds of thousands of people live normal, healthy lives without functioning thyroid glands." Yet there are serious issues regarding Kl stockpiling which need to be addressed if a successful program is to be undertaken. The question is not, should we stockpile Kl as part of our efforts to mitigate an accident (of course we should--presuming the strategy is effective), but rather, which issues require exploration and resolution to determine if a Kl strategy can add materially to our level of preparedness. These issues include:

• the cost and administration of stockpiling
• quality assurance over the life of the stockpile
• the degree to which Kl distribution can be coordinated to enhance other accident-response plans (such as evacuation or sheltering), and
• can effective logistical plans be developed and implemented to assure rapid distribution.

These are all solvable issues. For example, in large stockpiling quantities, Anbex will sell packages containing 14 Kl tablets at an annual cost that is less than half the cost of a first-class postage stamp. This cost would be guaranteed for up to 14 years. Further, Anbex would work with states and local governments to develop distribution plans, administer the stockpile to assure product integrity, conduct assays on random samples, and replace any product that fails to meet or exceed all FDA specifications over the life of the contract. The logistics of effective stockpiling are easier than most imagine. Kl, manufactured by Anbex, is packaged in small lightweight foil pouches which are easily stored and ideal for stockpiling. An ordinary residential two-car garage could house enough product for a city of 1,000,000 people. These modest space requirements mean that a school would need less than 2 cubic feet of space for enough Kl to protect all of its pupils. The top shelf of a closet in a library could hold 5 to 10 thousand packages. Every police station, firehouse, school, or other public building in a city could easily hold enough for tens of thousands of people. And distribution, if ever required, could be done very quickly at the local level, requiring minimal personnel. Toll booths and service areas on major highways could also serve as effective distribution points should an evacuation be ordered. These are realistic, reasonable, inexpensive, and highly effective steps to assuring a supply of Kl if it is ever needed. Plans along these lines would, at least, bring us to the level of the Russians or the Poles who distributed millions of Kl doses following Chernobyl, and whose efforts were credited with safeguarding hundreds of thousand of people from injuries that would otherwise have occurred. Surely, Americans are entitled to that same level of protection.

By refusing to mandate Kl stockpiling-or, at the very least, to issue a strong recommendation to states and local governments that Kl stockpiling is both reasonable and prudent---the NRC is acting in a manner that is inconsistent with its responsibilities to the hundreds of millions of Americans living within 200 miles of any operating nuclear power plant. Should an accident occur, and thousands of people suffer cancer or other thyroid damage as a result, one wonders how the agency will respond . Will they point at a some small town mayor and say, "it's your fault-after all, we never said you shouldn't have it." It is an interesting, though little known fact, that a substantial pharmaceutical stockpile to treat radiation poisoning already exists, though for purposes one might not suspect. According to the Defense Logistics Agency (as reported in Harper's Magazine, August, 1991), 32,000 pounds of opium to treat radiation sickness have been stockpiled by the Department of Defense, presumably to ease the pain of those dying from exposure. It is somewhat comforting to know that the needs of the dying have been considered, but, until now, we seem unable to craft a similar approach for the benefit of the living. Fortunately, though, the recent agreement by the NRC to federally fund state procurement of Kl is a sign that we are moving in this direction. And a strong endorsement by the NRC of the need for mandatory stockpiling would seem like an obvious next step. Not to do so would represent a continuation of a policies that should have ended long ago. Sincerely, Alan Morris

DOCKETED DOCKET M ER us me PETITI Al. L PR 50*"3A (t,2F~<A,038) 02-09-9~ FEB 13 All :12 U.S. NUCLEAR REGULATORY COMMISSION SECRETARY WASHINGTON, D.C. 20555-0001 AFF ATTENTION: RULEMAKING AND ADJUDICATION STAFF NOTING THE RULES IN THE RESPONSE TECHNICAL MANUAL (NUREG/0150, VOL.l, REV. 3), I FEEL YOU MAY KNOW LESS ABOUT THE AFFECTS OF RADIATION THAN I DO. I'M A DOWNWINDER THAT HAS BEEN STUDYING AND I HAVE BEEN TOLD MY GRANDCHILDRENS CHILDREN ARE LIKELY TO BE DEFORMED. IN 1984 THE D.O.E.(DEPARTMENT OF ENERGY) STARTED THE GENOME PROJECT. SOMEONE MUST KNOW THAT RADIATION IS A MUTANT - THE LITTLE FROGS HAVE BEEN TELLING YOU .. ARE YOU AWARE THAT THE LARGEST PART OF A NUCLEAR DISASTER IS RADIOACTIVE IODINE-131. RADIOACTIVE IODINE-131 IS VERY LIGHT AND IS CARRIED A VERY LONG WAYS ON THE WIND WITH A HALF LIFE OF 8.04 DAYS.RADIATION ACCUMULATES IN THE BODY - CAN CHANGE YOUR DNA WHICH CAUSES GENETIC DAMAGE. YES, I KNOW (SOMETIMES) YOUR BODY CAN HEAL THE DAMAGE - BUT IF NOT - IT IS NOT A PERMISSIBLE HEALTH EFFECT TO THOSE THAT HAVE A DAMAGED CHILD. MANY PEOPLE FEEL THAT IN CASE OF A NUCLEAR WAR THERE IS NOTHING THAT CAN BE DONE. WHAT A SHAME THAT THE SCHOOLS AND PARENTS ARE NOT INFORMED. THEY KNOW NOTHING ABOUT SHELTERING, POTASSIUM IODINE, FALLOUT .. FINDING OUT THEY KNOW NOTHING - TELLS ME THAT SOMEONE ISN'T DOING THEIR JOB. ARE YOU AWARE THAT THE DEVELOPING CHILDS THYROID HAS SOMETHING TO DO WITH THE DEVELOPING BRAIN, THE PACE THEY GO AT THINGS AND THEIR PHYSICAL DEVELOPMENT - THE CHILD MAY BE EITHER BORN WITH CANCER OR CANCER DEVELOPES LATER - OFTEN LEUKAEMIA WITHIN THE FIRST 5 YEARS AFTER BIRTH - IF YOU ARE 35 YEARS OLD OR YOUNGER - YOU ARE LIKLY TO GET THE CANCER BEFORE YOU DIE, UNLESS YOU DIE OF SOMETHING ELSE. ONE THING FOR SURE - WE ALL DIE SOMETIME .. BUT WILL THERE BE ANY TO REPRODUCE. IF THIS DOESN'T CONCERN YOU - IT SHOULD. 110 NUCLEAR PLANTS, 22,000 NUCLEAR FACILITIES, 49 PUREX PLANTS AND NOTHING BUT DANGER WHEN TRANSPORTING AND STORING THE WASTE. YOU CAN SAY - SAFE - SAFE, NO FEAR, WE DON'T BELIEVE YOU ANYMORE. IF WE AREN'T CONCERNED - WE SHOULD BE. WHY CAN'T THE PEOPLE BE TESTED TO SEE IF THEY ARE ALLERGIC TO KI (POTASSIUM IODINE) . KI IS ON PRESCRIPTION. HOW NICE OF YOU , BUT I UNDERSTAND - YOU CAN'T GET IT IF YOU WANT IT. ARE YOU SURE YOU KNOW WHAT YOU ARE DOING? PLEASE PROVE IT TO THE AMERICAN PEOPLE , BY TELLING THE TRUTH. ARLENE STEFFEN 2 CHRONICLES 7:14

  /J A                      1818 RALSTON
  ~ £ )-~            INDEPENDENCE, MO. 64052 tEB 1 9 1998

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date t:2,/20/ t; F Copies Received _ _. .,;.,_ __ R

DOCKETED @ USNRC Nuclear Regulatory Commission

                                                                      '96 FEB 11 P4 :16 DOCKET NUMBER To whom it may concern:     PETITI   RULE PAM 5D-'73A

( fo~Ff{/pfpD3'i) We are in support of Peter Crane's petition and it should be accepted that Potassium Iodide should be stockpiled as it is in other countries. Sincerely, - Paul and Chrystal Eshelman Paul and Chrystal Eshelman 20185 Rockwell Road Corona. CA 91719 02/10/98 FEB 1 2 1998 Acknowledged by card********.........~

U.S. NUCLEAR REGULATORY COMMISSION AULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSIO Document Statistics Pos1malkDate ~~~L$.~~ ~~ ~ tM d;,,(~? Coptes Rec&lved----~ Add'l Coples ReOf'OdlJcad v ~ """~ ;e;

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February 11. 1998 NOTE TO: Emile Julian Chief. Docketing and Services Branch FROM: Caro 1 Ga 11 agher /1 _ /J 11 ~ /) ()_,,1,,Jlr' RES. ORA ~ U.,  ?~-0

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment letter related to the Amended - Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on February 10. 1998. The commenters' names are Paul and Chrystal Eshelman. 20185 Rockwell Road. Corona. CA 91719. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

      /dt)ictrv

• 35

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U.S. NUCLEAFI REGULATORY COMMISSIO RULEMAKINGS &A9JOOICATIONS STAFF OFACE Of THE SECRETARY

        -OFm-lE COMMISSION Postmalk Cq,le&Reelifflid--.....'- - - -

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DOCKETED USHRC April Genth DOCKET NUMBER FEB -9 p4 :od24 Shawnee Ln. Apt. 3

                                                       '98                  Slippery Rock, PA 16057 PETITION RULE PRM 5o--~3A                                                        Jan. 29, 1998

( IQ~ FR. ~t,O 3 'ii) Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555

     "' Re: PRM-50-63

Dear Mr. Hoyle,

I am writing in reference to the treatment for radiation exposure, should an accident occur in this state of Pennsylvania. My strong concern is the fact that we might need the emergency treatment in the first place. I would hope to God, and whoever else runs this country, that strict regulations and moral leadership is guiding every nuclear power plant in every part of this country. If there is even so much as a glimmer of doubt in any informed persons head that there is a real risk of meltdown ... , then appropriate measures like the argued prescription should be available to every living person. I don't care what the private power plant businesses say about defamation if there is a risk involved. I would hate to be the person who withheld life from anyone just because the

   -    image of a private interest business might be in jeopardy. Thank you for your time.

Sincerely, April Genth d** K).~ FEB 1 2 1998 AcknowfP.doed by card ........ ........._ _

U.S. NUCLEAR REGULAT RULEMAKINGS & ADJ OFACE OF THE-- OF THE COMMISSION DocunentStatlallca Postmark Date - ~ 1-""i~ ~ - - - Copies Received _ __..;,~ - Add'I Copies Reprod 1al Distribution~_';df!::.~~~ ~ ~ *_ .&:l~ ~~ - ~~

DOCKETED USNRC February 6, 1998 DOCKET NUMBER PETITIO RULE PR (ft,~ F~ (p(,03g) 5 o- "3 ;t "98 FEB -9 AlO :11 Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by NRC attorney, Peter Crane, for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KT and the United States should have no less protection than other nations. Potassium Iodide has been proven effective if taken in a timely manner. Therefore, stockpiling is a sensible answer in the event of another nuclear accident. TI1e President's Commission on the Tiuee Mile Island Accident recommends stockpiling. The American Thyroid Association also recommends stockpiling. The reluctance of the nuclear industry to provide stockpiling is puzzling. A pill costing ten cents can prevent the uptake of radioactive iodine to our thyroids. Arguments that people will be evacuated in a timely manner are strictly conjecture. The NRC can't dictate that an accident won't happen during a snowstorm or that some evacuees will be traveling with the radioactive wind

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Sue S. White P.O. Box72 Ulysses, PA 16948 F'EB 1 2 1998 AeknowledQed by card ................,.....................-

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKtNGS &ADJUOICAT10NS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION DocllnentStatlsb Postmark Date -2 /IP /z 8: Copies Received _ _____./_,,,,..._ __ Add'I Copies Reprod~ S Special Distribution_ ~ o7'_~ ~. ~ _ ?!.ID

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                                                                                                       '98 FEB -4 P4 :QB The United States Pharmacopeial Convention, Inc.

January 30, 1998 The Honorable Shirley Ann Jackson Chairman U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Chairman Jackson:

I am writing in regard to the Petition for Rule Making (PRM-50-63) Relating to a Reevaluation of the Policy Regarding Use of Potassium Iodide (Kl) After a Severe Accident at a Nuclear Power Plant. At the-outset, I believe it is appropriate to state my previous experience with Kl for prophylaxis of radio-iodine absorption in connection with potential releases from nuclear reactors. In 1979, while deputy director of the Bureau of Drugs of the Food and Drug Administration, I directed the effort to get Potassium Iodide Solution, USP, manufactured and stockpiled in Harrisburg, Pennsylvania during the Three Mile Island incident. Subsequently, I wrote a paper about preparedness relating to stockpiling Kl published in the Annals of Pharmacotherapy , Volume 23, May 1989. This paper is referred to in Peter G. Crane petition of September 1995 (footnotes 6, page 7 and 35, page 23). He also referred to that paper in oral testimony before the Commission's Open Meeting on Potassium Iodide on November 5, 1997. The purpose of this letter is not to set forth my personal views on stockpiling Kl; those views are on record in ttie paper and in comments from the floor at an open meeting in Atlanta Georgia on Kl sponsored by the Centers for Disease Control in the early 1990s. Rather, this letter provides some data on the stability of 130 mg Kl tablets that may be of interest to the Commission in its deliberations of the stockpiling petition. Several months ago I received an open carton of (originally) 100 vials of Thyro-Block Tablets (Potassium Iodide Tablets, USP, Lot T242N, Exp. November 89). The carton had been shipped from Wallace Laboratories, Division of Carter-Wallace, Inc, Cranbury , New Jersey to Dr. Bernard Shleien , Nuclear-Lectern Association , Olney , MD by UPS on October 28, 1986. The carton had been stored under ambient condition in his home, not under controlled room temperature conditions (15° - 30°C) as required by US Pharmacopeia General Notices for storage of drug products by pharmaceutical manufacturers and distributors. Recalling that one of arguments against stockpiling Kl tablets has been a concern about their long term stability and expiration dating and in the interest of public health, I requested the USP Drug Research and Testing Laboratory to analyze samples from the carton according to the tests and assays specified in the USP monograph for Potassium Iodide Tablets. Copies of the laboratory reports are appended to this letter (names of laboratory staff have been redacted) . You will note that approximately 11 years after their manufacture and eight years after their expiry date, the tablets assayed at 99 .1% of the labeled content of potassium iodide. In addition , the tablets passed the iodine and potassium identification , uniformity of dosage units and dissolution tests. Fm - 5 1998 Acknowtedged by card ........................~*-*.**-"-"** 12601 Twinbrook Parkway, Rockville. MD 20852 (301) 881 -0666

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U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAR= OFACE OF THE SECRETARY OF THE COMMISSION Document Statlstta Postmark Date - ..&&.J~ r..-&..ia..-- - - Copies Recelv8d _ _ _ _ _ __ I

The United States Pharmacopeial Convention, Inc. The Honorable Shirley Ann Jackson January 30, 1998 Page 2 I have long suspected that 14 tablets of Kl stored in a tightly closed, brown glass vial with cotton packing would be potent for a period substantially longer than the expiry date. My assumption has proven to be correct and, even if left in the same uncontrolled environment, these tablets may have remained potent and in conformance with USP monograph requirements much longer. The point of this statement, therefore is that stability of Kl tablets does not appear to be significant factor in the economics of stockpiling Kl tablets for thyroid blocking in nuclear emergencies. Stockpiles of such tablets maintained under controlled room conditions in secure storage sites from which they could be airlifted to anyplace in the United States in hours should last many years and prove to be a cost effective safety measure. Under Section 502g of the Federal Food Drug and Cosmetic Act, USP specifications for packaging and labeling are enforceable by the Food and Drug Administration. If we can be of service by devising. suitable packaging and labeling requirements, we would be happy to explore this matter with the NRC and the FDA. I hope this information will prove helpful to NRC's reaching a decision on this vexing issue. would be pleased to respond to any questions regarding the information I have provided. Sincerely y o u r s , ~ Jerome A. Halp,erin Executive Vice President-CEO cc: Peter G. Crane, Office of General Counsel John C. Hoyle, Secretary L. Joseph Callan, Executive Director for Operations Solomon Sobel, M.D., Director, Division of Metabolic and Endocrine Drug Products, HFD-150, FDA

DRUG RESEARCH AND TESTING LABORATORY CONFIDENTIAL PROJECT REPORT December 29 , 1997

Subject:

Expired Potassium Iodide Tablets Project No.: 97-167 Chemists: Project leader: Reviewer: Requester: Mr. J. Halperin Objective: To determine whether the expired potassium iodide tablets pass the USP Potassium Iodide Tablets Assay test. SUMN1ARY The 130-mg potassium iodide tablets that expired in November 1989 passed the USP Potassium Iodide Tablets Assay test. The tablets assayed at 99.1 +/- 0.3% (mean+/- RSD , n = 3) of the labeled amount of potassium iodide, which is \vell within the rubric range of 92.5 to 107.5% required by the monograph. BACKGROUND We were requested by Mr. Halperin to determine whether the expired potassium iodide tablets would pass the USP Potassium Iodide Tablets Assay test. We received 6 bottles of Thyro-Block' potassium iodide tablets from Mr. Halperin. Each bottle contained 14 tablets; the tablets were labeled as 130-mg potassium iodide tablets . All six bottles had the same lot number and expiration date of Nov. 89. According to Mr. Halperin, these tablets had been stored in a basement of a house. RESULTS AND DISCUSSION We determined the potassium iodide (KI) content of the tablets using the official titrimetric assay procedure (USP Potassium Iodide Tablets Assay, USP 13, 1265). This procedure was official when the tablets expired and had been the official method for assaying

2 potassium iodide tablets in September 1982 when it first appeared in the USP .'G'( Supple men! 3. page 584. Physical appearance. The expired tablets were about 5.8 mm in diameter and 3.2 mm thick. They were white with light brown spots. No physical damage to the tablets was observed. Filter interference challenge. To filter the sample extracts as required by the official method, we used Whatman #1 paper. This filter showed no interference to the assay results. With the first 20 mL of filtrate discarded, the mean of the assay results (n = 3) of the filtered and unfiltered sample extracts were not significantly different from each other at the 95% confidence level. Titrimetric assay. \Ve performed the titration as directed in the monograph except that we scaled down the sample size due to the limited amount of sample available. The expired tablets passed the USP Potassium Iodide Tablets Assay test. The tablets assayed at 99.1 +/- 0.3% {_mean+/- RSD, n = 3) of the labeled amount of potassium iodide per tablet (Table I). The result was within the rubric range of 92 ..5 to 107.5% required by the monograph for tablets that contain less than 300 mg of KI per tablet. A representative potentiometric curve for the potassium iodide assay is shown in Figure 1. EXPERIMENTAL Chemicals: Potassium iodide tablets, lot# T242N, expired Nov . 89, Thyro-Block 7 M 130-mg tablets; silver nitrate, Fisher; sodium chloride, NIST Standard Reference :Vfaterial 919a (dried at 110° for 2 h); nitric acid, trace metal grade, Fisher; glacial acetic acid. ACS Plus. Fisher; methanol, high purity solvent, Burdick and Jackson: ethyl alcohol (190-proof, USP), Quantum Chemical Corporation; Milli-Q~ water. Equipment: A radiometer Titralab 31 Titration System consisting of a silver billet indicator electrode, a double-junction calomel reference electrode (the outside filled with 10% potassium nitrate, the inside filled with saturated potassium chloride), VIT 90 Video .Monitor, ABU 93 Triburette, SAM 90 Sample Station, and Epson LX 300 printer; Lab-Line~ Instruments, Inc. orbit shaking water bath model 3545; International Equipment Company IEC HNS-II centrifuge model 120; Buchner funnel; Whatman filter paper# I (medium fast).

3 Solutions. Silver Nitrate VS, Tenth-Normal (0.1 N), was prepared by dissolving 8.76 g of silver nitrate in 500 mL of :\t1illi-Q!> water. The solution was standardized with sodium chloride immediately before use: observed silver normality= 0.1034 +/- 0.0004, n = 3. Procedure for titrimetric assay Preparation of tablet extracts. 20 tablets were randomly selected from three bottles and individually weighed. The tablets were reduced to powder using a mortar and pestle. A 0.62-g portion of the powder was transferred to a I 00-mL volumetric flask, and a 40-mL portion of water was added. The volumetric flask was placed on an orbital shaker for 20 minutes and then brought to volume with water. The extract was filtered through filter paper using a Buchner funnel; the first 20 rriL of filtrate was discarded. The filtration was rapid, and the filtrate was clear. The filtrate was set aside until needed for the titration. Two more 0.62-g portions of the powdered tablets were weighed out and carried through the above procedure. Titration. 25.0 mL of the filtrate, 6.25 mL of alcohol, and 0.25 mL of 1 N nitric acid were added to a 100-mL beaker and mixed. This solution was then titrated with Silver Nitrate VS, Tenth-Normal (0.1 .V) to a potentiometric end-point. Blanks. A blank \Vas prepared exactly like the samples, except that no powder from the tablets was added. Three aliquots from this blank were titrated. Procedure for jilter interference study The procedure for this study was the same as that of the titrimetric assay described above except that we prepared both unfiltered and filtered extracts for comparison. A 200-mL tablet extract was prepared by weighing out a 1.26-g portion of the tablet powder. The extract was then divided into two 100-mL portions: one would be filtered; the other would be centrifuged. The first portion was filtered through filter paper as described above. The second portion was transferred into two 50-mL centrifuge tubes and placed on a centrifuge for 20 minutes at 2000 rpm. The solids settled at the bottom of the tubes. The supernatant liquid was decanted off with a pipette and was set aside until needed for the titration. The unfiltered and filtered extracts were each titrated in triplicate. Blank determination was also performed for any necessary correction.

Table 1. Titrimetric Assay of the Expired Potassium Iodide Tablets Sample wt Titrant used 1 Blank Net titrant mmol mg Kl found mg ofKI 4 Percentage 5 mg mL mL mL found 2 .m same Ie wt3 eer tablet of label claim 636.8 7.1766 0.000 7.1766 0.7421 123.2 129.3 99.4 628.3 7.0439 0.000 7.0439 0.7283 120.9 128.6 98.9 623.5 6.9940 0 000 6 99.:10 0.7232 120.1 128.7 99.0 Mean 99.1 SD 0.3 RSD 0.3 Pooled RSD 0.3 Pooled SD 0.3 1 Silver nitrate solution (N = 0 I 034) 2 ml tit rant used x Normality of titrant 3 mmol found x mwt of KI (mwt = 166) 4 [(mg KI found in sample wt)(tablet ave. wt)(dilution factor)]/[(sample wt)] where: tablet ave. wt= 167.1 mg, dilution factor= 4. \!OO)(mg of KI per table)/(130 mg, the label claim)

Figure 1. Representative potentiometric titration curve for potassium iodide tablets assay. mV 500.0 0.0 ______,,__,__..------ ..,/

           \------~-----

- 500.0 10.0 ml o.o 5.0

DRUG RESEARCH AND TESTING LABORATORY PROJECT REPORT January 29, 1998

Subject:

Expired Potassium Iodide Chemists: Project No.: 97-167A Requester: Mr. J. A. Halperin Project Leader: Reviewer: Objective: To determine whether the same expired potassium iodide tablets that passed the Assay would pass the remaining tests required in the USP Potassium Iodide Tablets monograph.

SUMMARY

The expired 130-mg potassium iodide tablets that passed the USP Potassium Iodide Tablets Assay (DRTL Project No. 97-167) passed the dissolution, uniformity of dosage units, and identification tests. These are the remaining tests required by the Potassium Iodide Tablets monograph ( USP 2 3, 1265). For dissolution, each set of six

- tablets tested passed Stage 1 testing according to the acceptance table in General Chapter
  <711>. The percentage of potassium iodide released for individual dosage units tested ranged from 94% to 102% of the label claim (required: (Q) = not less than 75%). The expired tablets responded to the Iodide and Potassium Identification <191> tests. They met the Weight Variation requirements specified in the Uniformity of dosage units
  <905>.

BACKGROUND We were asked by Mr. Halperin to determine whether the same expired 130-mg potassium iodide tablets that passed the Assay (91.1 % +/- 0.3% of the label claim, reported in DRTL Project No. 97-167) would pass the remaining tests L

2 1 required in the USP Potassium Iodide Tablets monograph. We received an addition of 9 bottles of potassium iodide tablets from Mr. Halperin. These tablets had the same lot number, expiration date, and storage conditions as those previously received for the assay work. RESULTS AND DISCUSSION Physical appearance. The tablets were similar to those previously received for the assay work. They were about 5.8 mm in diameter and 3.2 mm thick. The tablets were white with light brown spots. No physical damage to the tablets was observed. Filtering interference challenge .. To filter dissolution sample solutions as required by the official method, we used Millex-HV 0.45-µm syringe filter. This filter showed no interference to the UV analysis of potassium iodide. With the first 5 mL of filtrate discarded, the mean of the UV absorbances (n = 3) of the filtered and unfiltered sample solutions were not significantly different from each other at the 95% confidence level. Dissolution. The dissolution tests were performed according to Potassium Iodide Tablets Dissolution (USP 23, 1265) and General Chapter <711> Dissolution (USP 23, 1791). USP Apparatus 2 was operated at 50 rpm, and the test time was 15 minutes. Deaerated water was used as Dissolution medium. Two sets of six tablets were tested to ensure consistency of the results. Six tablets were randomly selected for each set. The dissolution results of the expired tablets are shown in Table I. Each run passed Stage 1 testing according to the acceptance table in General Chapter <711>. The percentage of potassium iodide released for individual dosage units tested ranged from 94% to 102% of the label claim (required: (Q) = not less than 75%). The mean percentage (+/- one standard deviation) of potassium iodide released was 98.9 +/- 2.6% for the first run and 98.9 +/- 1.4% for the second run. 1 Potassium Iodide Tablets monograph was proposed for omission from USP 24-NF 19 (PF, 23, 4641)

3 Identification tests for potassium and iodide. We performed the iodide and potassium identification tests as directed in General Chapter <191> Identification tests (USP 23, 1722). Iodide identification. The tablets responded to the iodide identification tests. Reaction with chlorine TS. When a few drops of chlorine TS was added to a small test tube containing about 1 mL of filtered solution of potassium iodide powdered tablets, the solution turned yellowish red due to iodine generated. The presence of iodine was confirmed as it colored a starch TS blue. When a mixture of a filtered solution of powdered tablets and a few drops of chlorine TS was shaken with chloroform, the latter was colored violet. Reaction with silver nitrate TS. When a 1-mL aliquot of silver nitrate TS was added to a small test tube containing 1 mL of filtered solution* of powdered tablets, a yeUow, curdy precipitate was formed. This precipitate was insoluble in nitric acid and in 6 N ammonium hydroxide. Potassium identification. The expired tablets responded to the potassium identification tests. Reaction with a nonluminousflame. When a small portion of powdered tablets was placed directly in a nonluminous flame, it imparted a violet color to the flame as it was viewed through a cobalt glass. Reaction to sodium bitartrate TS. When a few drops of sodium bitartrate TS was added to a small test tube containing about 2 mL of filtered solution of powdered tablets, a white crystalline precipitate was slowly formed with an aid of a glass rod rubbing inside the test tube. The precipitate was soluble in 6 N ammonium hydroxide, 1 N sodium hydroxide, and 1 N sodium carbonate. Uniformity of Dosage units. [Note-This test was done concurrently with the Assay in DRTL Project No. 97-167. However, we did not report it because it was not requested]. The expired tablets met the Weight Variation requirements specified in General Chapter <905> Uniformity of Dosage Units ( USP 23, 1838). The amount of potassium iodide in each of the first two sets of 10 tablets that were used for the Assay ranged from 96% to 103% of the label claim (required: 85.0% to 115.0%) (Table II).

4 The amount of potassium iodide in each of the third set of 10 tablets that was used for Assay filter interference study ranged from 95% to 102% of the label claim. An analysis of variance (ANOV A) showed that weight variation of the tablets in one set was not significantly different from that of the tablets in the other sets. Thus, the 30 tablets randomly taken belong to the same population (batch). The relative standard deviations of the assay value were 2.2, 2.0, and 2.3% for sets #1, #2, and #3, respectively ( required: less than or equal to 6.0%). EXPERJMENTAL Chemicals: Potassium iodide tablets, Thyro-BlockTM (130 mg/tab, 14 tabs/bottle, - Lot# T242N, expiration date of November 89, 9 bottles, received for additional testing); potassium iodide, VWR; chloroform, Burdick & Jackson; starch soluble, Aldrich; nitric acid, Fisher Scientific, silver nitrate, Fisher Scientific; ammonium hydroxide, Fisher Scientific; sodium bitartrate, Aldrich; red mercuric iodide, Fisher Scientific; potassium permenganate, Baker; hydrochloric acid, Fisher Scientific, Milli-Q water. Dissolution Equipment: VanKel VK7000 dissolution tester; USP Apparatus 2; 1000-mL glass dissolution vessels; Millipore 0.45-µm HVLP membrane filter; Millex-HV 0.45-µm syringe filter, Perkin Elmer Lambda 6 UV -VIS spectrophotometer; quartz 1-cm UV cells; B-D multi-fit 30-cc glass syringe with luer lock tip; stainless steel bent cannulas with luer lock fittings. Calibration of Dissolution tester. The dissolution tester was calibrated just prior to this work. All calibration results were within the Certified Suitability Ranges for USP Salicylic Acid Tablets (Dissolution calibrator, non-disintegrating) RS, Lot N and USP Prednisone Tablets (Dissolution calibrator, disintegrating) Lot L. Fresh bottles of calibrator tablets were obtained from Distribution and used for the calibration tests. Dissolution conditions: USP Apparatus 2 (Paddle) operated at 50 rpm, 900 mL, 37° +/- 0.5°, 15-minute test time. The UV absorbances of the Standard solution and the Test solutions were measured at maximum 226 nm against a blank (Dissolution medium).

5 Solutions Dissolution medium. Milli-Q water was heated to 45° and then was degassed by vacuum filtration through a Millipore HVLP 0.45-µm membrane filter. The filtrate was further degassed under vacuum for an additional 5 minutes without stirring. The medium was gravimetrically transferred to the individual dissolution vessels. Standard solution. An accurately weighed 2.2-mg portion of potassium iodide was transferred to a 200-mL volumetric flask and diluted to volume with Dissolution medium. Test solution. Fifteen minutes into the test a 30-mL aliquot of the dissolution solution was withdrawn from each vessel. Each aliquot was filtered through a Millex-HV 0.45-µm syringe filter into a glass beaker. The first 5 mL of the filtrate was discarded, and the remainder of the filtrate was cooled to ambient temperature. Filtered and unfiltered solutions. A 168-mg portion of the potassium iodide powdered tablets (equivalent to the average weight of a tablet) was transferred to a 1000-mL bottle. A 100-mL portion of water (37°) was added to the bottle and mixed. The bottle was placed on an orbital shaker at 37° for 20 minutes and then brought to a final volume of 900 mL. The extract was brought to about 37° prior to filtering. Filtered solution was prepared by passing about 20 mL portion of the extract through a Millex-HV 0.45-µm syringe filt;;r \vith the first 5 mL of the filtrate discarded. The remainder of the filtrate was cooled to ambient temperature. Unfiltered solution was prepared by centrifuging a 20-mL portion of the extract at 2000 rpm for 5 minutes. The supernatant liquid was decanted off with a pipette and set aside for UV analysis. The unfiltered and filtered solutions were diluted (7 in 100) and analyzed by UV. Identification Equipment. A Bunsen burner to provide nonluminous flame, cobalt glass (Turner Associates). Preparation ofpotassium iodide powdered tablets. l 0 tablets were randomly selected from a composite of 42 tablets (tablets from three bottles combined) and individually weighed. The tablets were reduced to powder using a mortar and pestle.

6 Solutions. Filtered solution ofpotassium iodide powdered tablets. A 167-mg portion of the potassium iodide powdered tablets was transferred to a 25-mL test tube. A 10-mL aliquot of water was added, and the test tube was vortexed for 2 minutes. The extract was filtered through a Whatman # 1 filter paper. Silver nitrate TS. A 175-mg portion of silver nitrate was transferred to a 10-mL volumetric flask and diluted to volume with water. Chlorine TS. A 0.5-g portion of potassium permanganate was transferred to a 100-mL round bottom flask containing about 3 mL of water and mixed to dissolve. A 2.5-mL aliquot of hydrochloric acid was added to the flask. The chlorine gas generated from the reaction was bubbled through a 10-mL water in a 25-mL test tube for 15 min. Starch TS. A 1-g portion of starch soluble and a 10-mg portion of red mercuric iodide were transferred to a 400-mL beaker. About 3 mL of water was added and mixed. In a separate 400-mL beaker, a 200-mL aliquot of water was added and brought to boiling. The boiling water was transferred to the starch containing beaker and boiled for one minute with continuous stirring. The solution was cooled to ambient temperature, and its clear portion was used for the iodide identification test. Sodium bitartrate TS. A 1-g portion of sodium bitartrate was transferred to a 10-mL volumetric flask and diluted to volume with water.

Table I. Dissolution Results of the Expired 130-mg Potassium Iodide Tablets in Deaerated Water. Conditions: 900 mL, USP Aparatus 2, 50 rpm, 15-min test time Percentage of the Labeled Amount Released* Run No. Vessel Position Mean SD 1 2 3 4 5 6 1 100.3 101.6 94.1 98.1 99.9 99.1 98.9 2.6 2 99.0 100.3 99.9 99.3 97.8 96.7 98.9 1.4

• Required: (Q) = not less than 75%

Table II. Uniformity of Dosage Units (Weight Variation) in Three Sets of 10 Dosage Units of the Expired 130-mg Potassium Iodide Tablets. Set# la 2a 30 0 0 0 Tablet Mass Percentage Mass Percentage Mass Percentage

      #         (mg)     of label claim   (mg)    of label claim     (mg)      of label claim 1        168.7          100.0       167.7        99.6          172.8          102.2 2        161.8          95.9        160.9        95.5          169.7          100.3

• 3 4

5 6 7 165.4 166.0 169.9 164.0 164.7 98.0 98.4 100.7 97.2 97.6 172.4 166.8 170.4 167.2 162.3 102.4 99.0 101.2 99.3 96.4 161.2 167.6 169.2 171.8 170.3 95.3 99.1 100.0 101.6 100.7 8 173.6 102.9 167.6 99.5 164.2 97.1 9 172.0 101.9 167.2 99.3 163.4 96.6 10 166.5 98.6 166.5 98.9 166.0 98.1 C Mean 167.3 99.1 166.9 99.1 167.6 99.1 Stdev 3.7 2.2 3.4 2.0 3.8 2.3 3/4RSDe 2.2 2.2 2.0 2.0 2.3 2.3 a Sets #1 and #2 were randomly selected from a composite of 42 tablets (three bottles) and used in Assay test (DRTL Project #97-167) b Set #3 was randomly selected from a composite of 42 tablets (three bottles) and used in Assay filter interference study ( DRTL Project #97-167) c Analysis of variance (ANOV A) showed that the dosage units from three sets belong to the same population. d Calculated based on the Assay value= 99.1%; required range: 85.0% to 115.0% e Required: less than or equal to 6.0%

DOCKETED 4809 Drummond Avenue USNRC Chevy Chase, MD 20815 January 31, 1998 "98 FEB -4 P3 :46 Mr. John C. Hoyle, Secretary Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63/63A DOCKET NUMBER FEll I N RULE PRM 5o-~34

Dear Mr. Hoyle:

( {p()..F{<./pt,o3 ~) First of all, lest there be any misunderstanding, this letter constitutes a comment, to be included as such in the rulemaking record and promptly posted on the NRC's rulemaking website along with all other comments. As always, this is written at home, on my own time, in my capacity as a private citizen, not in my capacity as an employee of NRC. On December 7, 1997, almost exactly eight weeks ago, I wrote to you enclosing two recent documents pertaining to my KI petition. One was a statement made to officials in New York State, and the other was addressed to officials in Ohio. In my letter, I said: "I would like these to be considered as additional comments on the petition and the amendment to the petition filed by me on November 12, 1997." On January 8, 1998, I wrote to you again. I asked that the comment period be extended, and again asked that all documents in the PRM-50-63/63A docket file be posted on the NRC's rulemaking website. Indeed, one of the reasons for requesting the extension of time was the failure to post the relevant documents. Apart from being advised that the Commission had extended the comment period by 30 days, I have had no written reply to either letter. As far as I know, the documents I sent to the NRC on December 7 have not been treated as comments, as I requested, nor has my letter of January 8 has been posted on the rulemaking site. Now the second comment period is almost half over, and much of the relevant documentation is still unavailable to the general public, which has no reason to know that it even exists. Today, anyone who is interested in the KI issue can contact the NRC rulemaking website and read, for example, the January 9, 1998, comments of the State of Illinois, in which they assail me for having "chosen to blatantly misrepresent the established facts regarding the risk of thyroid cancer resulting from radioactive iodine exposure" in "statements made to officials in Ohio and New York, among others." (Illinois, not having learned the age-old lesson that when you find yourself in a hole, the first thing to do is to stop digging, also declares that it "stands firmly behind its contention that hundreds of thousands of people live normal, healthy lives without functioning thyroid glands." 1) 1 Illinois is apparently offended with me because I have focused on a comment made by an Illinois official, Roy Wight, at a June 27, 1996, meeting at FEMA. Mr. Wight, explaining his state's reasons for believing KI to be unnecessary, said, "Loss of the thyroid is not life-threatening." Curiously enough, in a separate statement submitted on the same occasion, Ms. Sandra Threatt, representing the state of South Carolina, used the identical words: "Loss of the thyroid is not life-threatening." Unless Acknowledged by card .. F'EB - 5 1998

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2 Thus the NRC staff finds it appropriate to post Illinois's attacks on my submissions to the states of New York and Ohio, but refuses either to post the submissions that are being attacked or send me an explanation of why it will not do so. 2 Has anyone in the staff asked the Office of General Counsel whether this approach is legally sound? Has anyone asked John Cordes, the NRC Solicitor, how he would propose to defend such selective posting of comments under questioning from judges of the Court of Appeals? Has anyone asked the Office of Public Affairs or the Office of Congressional Affairs how the public, the press, or the Congress might view these procedures? I try to keep my patience and a degree of perspective, realizing that the system of electronic posting is new and that all of us are fallible, but there are times when I feel like asking Casey Stengel's question: "Can't nobody here play this here game?" In a system grounded in the rule of law, where agency action is subject to review by the Courts of Appeals, the staff does not have unfettered discretion to pick and choose the matters it wants to think about, nor can it be capricious or biased in what it chooses to let the public see. If the staff is seen to be manipulating public information, keeping embarrassing material out of public view, it will only make things worse -- not just for itself, but also for the Commission, which is answerable for the staffs actions. In making these comments and asking these questions, I am not suggesting that the Office of the Secretary is responsible for the procedural decisions that are being made at NRC. Rather, this rulemaking petition is in the bailiwick of the NRC staff; I write to you because as Secretary, you are the contact point for communications to the docket. I would now like to offer my thoughts on the comments of the Nuclear Energy Institute (NEI) and Illinois. NEI would seem to have special reason to be careful at this point in what it says about KI. In 1994, its President earned a sharp rebuke from Deputy Executive Director for Operations James Milhoan over a "White Paper" on KI, submitted to the NRC, in which the views of Dr. David V. Becker of the American Thyroid Association were represented in a manner, Mr. Milhoan observed, "completely contrary" to his this was purest coincidence, I would, if I were Illinois, be directing my anger at whoever furnished this piece of misinformation to Mr. Wight and Ms. Threatt, not at me .. Later in this letter, I will deal in greater detail with the substance of Illinois's comments. 2 I can well understand why the NRC staff might wish to keep my comments off the Internet, because they include matters that the staff has no wish to deal with. For example, for eight years, first in my 1989 differing professional opinion and then in my 1995 petition for rulemaking, I have said repeatedly that the existing U.S. policy on KI was grounded in misinformation provided to the Commission and the public by the NRC staff. One would think that the staff could not possibly have prepared an analysis of my petition for rulemaking without addressing that assertion one way or another -- conceding the point if it was true, and refuting it if it was false. But SECY-97-245, which purported to be an analysis of the petition and the comments, had not a word to say on the subject of the alleged misinformation, and when Commissioner McGaffigan asked a question in the Commission meeting on November 5, the one staff member willing to venture a response could say only, "I have no answer." For an administrative agency that supposedly has been studying my submissions for eight years, that is the equivalent of a plea ofnolo contendere.

3 actual position. (See letter of June I, 1994, cited in my original petition at p. 20.) In 1996, at a meeting on KI held at FEMA, Alan Nelson of NEI was more circumspect. If faced with a difficult question, he did not answer untruthfully; rather, he spoke in generalities, not necessarily responsive to the question. Consider the following question and answer about evacuation, reproduced verbatim (with only punctuation corrected) from the FEMA transcript, in which Mr. Nelson manages to speak for several minutes without ever using the word "evacuation" or addressing the question posed: MR. CRANE: It is a question for Alan, which is: It seems to me, if ever we've got an event in which KI is needed, there are going to be a lot of people reading the transcript of this meeting. So I think it's good to be clear about one point. I understand what you're basically saying is, "We don't need this because evacuation works and evacuation is better." And what I would like to know is: Are you telling us on behalf of the industry that for every credible accident, complete evacuation of the affected population, apart from shut-ins and prisoners, is not only feasible but can be guaranteed? MR. A. NELSON: I'm not sure it's my place to make that statement. The states and locals are prepared to implement plans based on recommendations and data that they have as precursors to events, precautionary measures that they take early on. It's not as simple as: Can you do these things as a guarantee of a lot of things? As we have improved our emergency preparedness activities, emergency response data system is available, states are monitoring utilities, the NRC has their operations center and regional operation center to monitor the nuclear power plants. Safety systems have been improved, in spite of some of the points that were mentioned, where reactor operations and containment can be observed. Meteorological data, dose assessments are taking place at the same time. Confirmation of protective actions early on may be implemented. I think that we have improved our emergency plans to a point long after TMI. The same Kemeny position that was established back in 1979-1980, if evaluated today, one would see that there has been a great deal of improvement in emergency preparedness. I think that the adequacy of the public can be protected. And I think that the programs that we have seen in the state and local exercises and real events have borne that out. Mr. Nelson thus demonstrates how a sensible lobbyist earns his keep: you avoid saying things that can come back to bite you. But now, in 1998, NEI has gone back to being careless or worse with the facts. Consider the following paragraph, which begins NEl's "Review of U.S. Policy on KI" in its January 9, 1998, comments filed with the NRC:

        "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

4 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 [sic] reaffirmed its position of not advocating widespread stockpiling and distribution of KI for the general public. [Emphasis added.] In June 1997, Commissioners voted (3-2) to support FRPCC's recommendation." Anyone reading this paragraph would understand it to mean that the KI subcommittee had voted to maintain the existing policy on KI. That, however, is flatly untrue. In fact, the recommendation of the ad hoc subcommittee on KI of the Federal Radiological Preparedness Coordinating Committee (issued in October 1996, not 1995), was for a change in Federal policy, by which the Federal Government would make KI available at no cost to any state that requested it. The full FRPCC then backed the subcommittee. This new policy is described, for example, in a March 5, 1997, letter to me from Kay C. Goss, FEMA's Associate Director for Preparedness, Training and Exercises, who wrote:

          "Since the FRPCC unanimously approved the report and Recommendations of the Ad Hoc Subcommittee on Potassium Iodide on October 24, 1996, the two agencies most directly involved, the Nuclear Regulatory Commission (NRC) and FEMA, have been arranging the administrative details to support the new Federal policy of offering to fund a KI stockpile for those States who hereafter decide to include its use as a protective measure for the general public. As soon as these details are completed, FEMA will publish a Federal Register notice promulgating the new Federal policy. "3 What can be in it for NEI to distort the facts in this way? As long as I am involved in the KI issue, I will be correcting misrepresentations of this kind, so it is hard to see what NEI can hope to gain. Even if the NRC staff continues to refuse to post the letters I send to the docket, the op-ed columns of the newspapers remain open to me, and the newspapers so far seem to be willing to print the articles I write.

(For the record, I do not accept payment for newspaper columns I write on the subject of KI.) So how can NEI's Orwellian rewriting of history hope to succeed? I intend to bring this matter to Ms. Goss's attention, with the suggestion that FEMA may wish, for the sake of its own reputation, to correct the record. I am sure that FEMA does not want to be viewed as having acted cavalierly on the issue of protecting America's children, or as having dragged its feet. On the latter point, I have no doubt that FEMA remembers that one of the recommendations of the KI subcommittee, in October 1996, was that NRC proceed expeditiously to act on my petition. It was another year before the staff sent the Commission its analysis of the petition. Let me turn now to the Illinois Department of Nuclear Safety and its views on the significance of losing 3 Ms. Goss added that the Ad Hoc Subcommittee's report had not included a recommendation for a Federal stockpile of KI, and that the plenary FRPCC had not amended that recommendation.

5 one's thyroid to radiation-caused illness. The most recent projection of the American Cancer Society, as a telephone call will confirm, is that about 16,000 Americans will be diagnosed with thyroid cancer annually, and about 1200 will die of the disease. Thus although the loss of the thyroid is not usually life-threatening in itself (though I learned from the physicians at the December 1997 meeting of the New York State Radiological Advisory Committee that it can indeed be life-threatening in children), the cancer that causes the loss of the thyroid is fatal in a small but significant percentage of cases, and has serious impacts on the quality of life in a much larger percentage. (By the same token, loss of a breast is not in itself life-threatening, but the cancer that causes you to lose a breast can kill you.) At the June 1996 meeting at FEMA, Dr. Jacob Robbins, an eminent thyroid cancer specialist at NIH, had this to say when asked to comment on Mr. Wight's statement and on the actual consequences of the disease: That is sort of hard to answer, but if you think of cancers in general, if you were going to have a cancer, it wouldn't be bad to have a thyroid cancer. The mortality is low. And even in the children, whom we've heard have very aggressively growing thyroid cancers, the mortality is a few percent. But we have to remember that the children that were exposed who haven't had cancer yet are not free of the risk of getting cancer. So when they become adults, they can still get thyroid cancer. And then the risk gets higher, perhaps ten percent. We heard the number before. So there is a risk of mortality. So for the individual who has the disease, mortality risk is low. It's treatable. But the treatment requires not only an immediate operation but lifetime surveillance, medication, the possibility that they will require radioactive iodine therapy repeatedly. It's a significant medical illness. It's not a trivial illness. I think that's all that we need to say about it. There is no need for the Commission to decide whether or not the Illinois Department of Nuclear Safety is "ignorant" when it comes to the significance of thyroid disease. That question is unimportant. What~ important is whether thyroid disease is worth preventing, and on that score, I suggest that the Commission would be well advised to listen to physicians for medical judgments. The American Thyroid Association's unanimous position is a matter of record, and Dr. Robbins, quoted above, is a Scientist Emeritus at the National Institutes of Health, and a world-renowned expert on thyroid cancer. Illinois's comments are noteworthy for the demand that "rulemaking on this petition should exclude any reference to the Statement of Considerations" that I proposed in my November 12 filing. What is so wrong with the Statement of Considerations, other than that it lays out facts that are known to public health authorities around the world, and suggests that states consider these facts in deciding whether to adopt KI stockpiling? Illinois does not say. The state's objection seems to be that if the facts are laid out

6 as I present them, the rule change might as well be compulsory, since it will be difficult for states to reject the recommendation that stockpiling KI is reasonable and prudent. That certainly was my hope, as I made clear in the meeting. But where does the Illinois Department of Nuclear Safety get the idea that it can, with no more showing than it has made, make the Statement of Considerations disappear from the rulemaking? Finally, to those commenters who have written to the NRC to say that the original petition was preferable to the amended petition, I cannot disagree. I proposed the amendment because I thought the original petition was unlikely to secure the votes needed for passage. Having made that decision, I will not be heard to complain if the Commission approves the amended petition and the Statement of Considerations. Rather, I will consider it a very positive outcome, even if -- as I made clear in my statement to the Ohio Department of Health -- it is not the ideal solution. Finally, I would encourage anyone interested in the subject of KI to contact the Internet site ofElectricite de France, the utility which supplies, from nuclear plants, 80% of France's electricity. The site is:

   "www.edf.fr/html/en/mag/iode/serve.htm." The topics covered include: "What iodine is, its usefulness for health, its relationship with the thyroid, thyroid diseases, thyroid cancer, the threat to the thyroid in case of a nuclear accident, young people affected first, what iodine tablets contain, when the tablets must be taken, effective protection, safe absorption, why distribution today." The contrast between the openness and responsibility of the French nuclear industry and the approach of its American counterpart could not be greater.

Sincerely, Peter G. Crane Attachment A: Statement to New York State Radiological Health Committee, Nov. 21, 1997 Attachment B: Fax to Roger Suppes, Ohio Department of Health, Dec. 11, 1997 cc: Kay C. Goss, FEMA ATTACHMENT A STATEMENT OF PETER CRANE

7 submitted to the New York State Radiological Health Advisory Committee Meeting on Potassium Iodide (KI) November 21, 1997 I appreciate the opportunity to submit a statement to this Committee's meeting on the radiation antidote potassium iodide (KI). I do so in my private capacity, as an interested citizen, not in my official capacity as Counsel for Special Projects at the U.S. Nuclear Regulatory Commission. I do not speak for the NRC or the U.S. Government. This Committee recognizes, as the letter announcing the meeting made clear, that the threshold question about KI is medical: whether it is desirable as a public health matter to have KI on hand. Put another way, do the health benefits of the drug outweigh the health risks associated with its use? Only if the answer to that medical question is "yes" is it necessary to go on to address the logistical issues of where it should be stockpiled and how it should be distributed. 4 Current Federal policy on KI uses strong words -- "not worthwhile" -- to discourage stockpiling and use of the drug. That policy was put in place in July 1985,just months before the Chernobyl accident. Since that time, we have a wealth of new information that illuminates both the effects of a major nuclear accident on human health, especially the health of children; and the safety and efficacy of KI in such an accident. Nevertheless, the opponents of KI continue to assert that there is "no new information" or "no new data" that would challenge the 1985 policy. The physicians here today will have addressed the upsurge of childhood thyroid cancer in Belarus, Russia, and Ukraine since 1991; the Polish experience with KI following the Chernobyl accident in 1986; and the implications of those developments for the United States. I am not a physician, and would not presume to offer any medical advice to a committee of health experts except what comes from my own experience as a patient. My patient's-eye view is that thyroid cancer, notwithstanding that it is usually curable, can be a very nasty disease. Fatality rates are not the only measure of whether an illness is serious and worth preventing. You also have to look at the impacts on the quality of life. By that standard, thyroid cancer is significant both for the patient and the family, especially when it recurs. The process of treating it can be an ordeal, in part because of the need to take the patient off medication and induce weeks of hypothyroidism, which means being exhausted, weak, and cold. Moreover, any cancer is frightening, and that takes an emotional toll as well. There are, of course, many kinds of cancer (and many other diseases as well) that are statistically more dangerous than thyroid cancer, and that impose much greater burdens on the average patient. But that is irrelevant. The question is whether this disease is sufficiently dangerous and burdensome to be worth preventing, if prevention can be achieved with a dime's worth of medication. I would answer that question "yes," and so would my family. 4 This point may seem obvious, but for years, opponents of KI stockpiling, putting the cart before the horse, have argued that the logistical problems of getting KI to people in an emergency would be so insuperable that the decision should be made against stockpiling without ever reaching the question of the likely medical benefits of using the drug.

8 You may be asking why anyone should feel it necessary to belabor the point that thyroid cancer is a serious, non-trivial illness. The answer is that too many states -- states where decisions on radiation protection are made by bureaucrats without the benefit of medical expertise -- seem not to know that. Just last year, for example, the Federal Emergency Management Agency held a meeting on KI at which the representative of a state with a population of about 12 million offered why one reason why his state saw no need to stockpile. "Loss of the thyroid," he said, "is not life-threatening." Try telling that to Senator Tom Harkin of Iowa, who lost a brother to thyroid cancer last year. In a narrow, technical sense, however, the state official I quoted was correct. Loss of the thyroid is not life-threatening in itself. Neither is loss of a breast, for that matter. But the cancer that causes you to lose your thyroid or your breast can take your life, and it is a grave disservice to the public to imply otherwise. If many states are ill-informed about thyroid cancer and other radiogenic thyroid diseases, it is in large part because the Federal Government has done such a poor job, over the past 15 years, of giving them the information they need. In my petition for rulemaking and elsewhere, I have described how the current Federal policy on KI was grounded in misinformation provided to the NRC Commissioners and the public some 14 years ago. But all that is history. At this point, I would like to look forward, not back, and rather than concentrate on the errors of the 1980's, make sure that the Government does the right thing today. The first thing the Government must do is to learn to speak clearly and straightforwardly on the KI issue. That means calling things by their right name, not using euphemisms or generalities that obscure from the states and the public the information they need. For example, on July 1 of this year, the NRC announced that the Commissioners had decided to support a proposed new policy that would make supplies of KI available, paid for by the Federal Government, to any state that asked for it. That was major progress. Unfortunately, however, the press release on the NRC's decision never used the word "cancer" to explain what KI does, but instead referred in general terms to "thyroid diseases." To announce the availability of KI without mentioning cancer is like announcing the availability of Sabin vaccine without using the word "polio." If you want states and the public to become aware of a public health issue and do something about it, you have to be a lot more direct than that. The proposed new federal policy has yet to be put in place. A number of federal agencies are involved in the decision, not just NRC. Assuming they can arrive at a decision, a Federal Register notice will be issued, sooner or later. But the process is painfully slow. It has been more than a year since an interagency committee, the Federal Radiological Preparedness Coordinating Committee, voted to recommend that the Federal Government buy KI for those states that wanted it, and almost five months since the NRC Commissioners voted to endorse that recommendation. To date, however, no Federal Register notice has been published, the public and the states have received next to no information about these votes from the Federal Government, and officially, the status quo remains unchanged. For the present, therefore, the official U.S. Government policy on KI is still the one adopted in

9 1985, nine months before Chernobyl. Its use of the words "not worthwhile" with regard to KI is based upon what purports to be a cost-benefit analysis. This analysis measures the cost of KI against the cost of curing "thyroid nodules," and concludes that instead of spending money on prevention -- cheap as prevention would be -- it would be even cheaper for society to put its resources into curing the thyroid disease if and when it occurs. Let me interject at this point what I mean by prevention being cheap. The NRC staff calculated in 1994 that stockpiles sufficient for the vicinity of all nuclear plants would cost a total of $100,000 to at most a few hundred thousand dollars. That is for the whole country. The NRC staff also calculated that at that rate -- about $1100 for the average plant -- it would be cheaper to buy stockpiles than go on studying whether to do so. Isn't that the definition of a "no-brainer"? Only in Washington would we spend more money studying whether a medicine to protect our children is worth buying than the medicine itself would cost. To return to the cost-benefit approach underlying the current policy, because it is based exclusively on economics, mechanistically balancing dollars for KI pills against dollars for medical bills, it does not take into account the possibility that people might have reasons other than saving money for preventing cases of disease. The policy takes the old adage about an ounce of prevention being worth a pound of cure and turns it upside down. Eleven years after Chernobyl, it reflects little credit on our Government that this approach, of treating the disease after the fact rather than spending a tiny sum on prevention, should still be the basis of our policy for dealing with radiation-caused thyroid cancer. The result is that today, children in other countries, from Japan to Poland and from Canada to Switzerland, have a protection that American children don't have. In the United States, unbelievable as it sounds, we have KI to protect the sharks at Sea World but not the children who come to see them. 5 All over the world, countries know that if you are serious about being prepared to protect the public in nuclear emergencies, you should have three arrows in your quiver. Those are: (1) evacuation, which is the ideal solution -- when it is feasible; (2) sheltering, which means taking cover; and (3) potassium iodide. Having all three options gives you the flexibility to choose among them, or use them in combination, depending on the particular circumstances. If you can evacuate the entire population before the radioactivity arrives, and don't need to use Kl, so much the better. But in the real world, bad weather, congested roads, or changing winds can make a full evacuation impossible. In that case, it's better to be safe than sorry. The French, Germans, Swedes, Slovaks, Austrians, Russians, Japanese, Canadians, and many more, all know this, and they stockpile KI. It's cheap enough, at about 10 cents per person protected, that the Poles keep 90 million doses on hand. 5 The 8-year-old daughter of Charles Pond, the director of Tennessee's program, having somehow learned that sharks in captivity require KI for their health, persuaded her father that as the state's KI reaches the end of its shelf life (5 years), it should be donated to Sea World, where it is added to the sharks' water. See her father's statement at p. 57 of the transcript of the public meeting on KI held at FEMA on June 27, 1996. Young Ms. Pond's accomplishment was written up in the "Kids Did It!" section of a recent issue of the children's magazine, "National Geographic World".

10 Let me emphasize that I am not an alarmist about nuclear power, any more than are Senators Joseph Lieberman and Alan Simpson, who wrote to the NRC in 1994 to urge it to embrace KI stockpiling. I think that a major release is unlikely, because, generally speaking, our plants are well built and well run. But we have emergency planning because we know that accidents can happen, and that their consequences can be serious. If we are going to have emergency planning at all, it might as well be done right. I have often compared KI to the lifejackets on a ferryboat. Ferryboat accidents are very rare, and if one does occur, it is better to be evacuated in a lifeboat than to jump into the sea in a lifejacket. But in the real world, the unexpected happens, so we have lifeboats and lifejackets. We know that there is no inconsistency between the two: there is nothing about having lifejackets as a backup protection that could interfere with evacuation by lifeboat. So we don't do fancy cost-benefit analyses, we don't study the issue for 15 years, we just do it, because it would be reckless and irresponsible not to. Last December, when the Maine Advisory Commission on Radiation voted unanimously to support stockpiling, one of its members explained his vote in these words: "Ten years from now, if we have a release, I would rather say that we erred on the side of conservatism, knowing what we know." I think he hit the nail on the head. If the case for KI is as compelling as I have suggested, the question may be asked, what are the arguments against it? The arguments one hears against KI fall into two classes. First, there are those that are just plain invalid -- factually incorrect. The second are the objections that although they may be factually correct -- for example, that evacuation is generally the best option -- are still not a good reason to be without KI stockpiles. I will start with the wholly specious arguments, which number six.

1. "There is no new data challenging existing policy."

I have dealt with that above.

2. "Loss of the thyroid is not life-threatening."

This issue also I have dealt with above. Thyroid cancer can be life-threatening, and Chernobyl-related disease has already claimed a few lives among children in the former Soviet Union. But even if it were true that thyroid cancer is never fatal, who says a disease has to be life-threatening to be worth preventing? That's not the standard we use when we have our kids immunized against mumps, measles, and chicken pox.

3. "KI is not cost-effective."

KI is an insurance policy -- backup protection in case of certain events that are unlikely but have serious consequences when they do occur. Is it "cost-effective"? The problem with framing the issue that way is that if by "cost-effective" you mean "likely to pay for itself over time," no insurance policy meets that test. The insurance companies would all be bankrupt if they didn't take in more from the average buyer than they pay out. Rational people, when deciding whether insurance is worthwhile, don't ask whether it is sure to pay for itself, but whether it provides valuable protection at a reasonable cost.

II Stockpiling of KI meets that test. I should add that in 1992, the NRC commissioned a revised cost-benefit analysis. Whereas the old analysis had found an extremely high ratio of costs to benefits, the new study found that the costs and benefits were very close -- about 2 to 1 -- for the population within a 5-mile radius of reactors. Moreover, there is an error band of plus or minus two orders of magnitude when you are talking about the probability of severe accidents. Thus by the NRC's own calculations, KI might actually be cost-effective by a factor of 50 for close-in populations. 6

4. "KI could complicate evacuation."

You sometimes hear the argument that KI will diminish safety in an emergency, because people will ignore evacuation orders and go looking for KI instead. That's very farfetched. In fact, if you wanted to encourage evacuation, you might want to tell people over radio and television that when they get to the evacuation center, they will be checked out medically and given a medicine, potassium iodide, that will help protect them against radiation. And you add that this drug will not be available locally. So KI should not be a hindrance to an orderly evacuation; it might even be an incentive.

5. "KI carries a risk of serious side effects."

The best data on side effects comes from the Polish experience after Chernobyl, which is documented in a medical journal article co-written by Dr. Janusz Nauman, a Polish health official, and Dr. Jan Wolff, an NIH scientist. The Poles gave out 18 million doses. Two people were hospitalized, briefly. Both of them had known iodine allergies and took the drug in spite of being warned not to. Our own FDA says the benefit outweighs the side effects. The doctors of the American Thyroid Association were well aware of the side effects issue when they unanimously endorsed stockpiling in November 1996. In addition, an NRC staff document issued in 1995 7 cites a study which looked for adverse reactions in people who took cough and cold medications containing the drug. It reported that "for the most current data involving 38 million equivalent doses of KI consumed, there were no reports of adverse reactions." [Emphasis in the original.]

6. "KI could increase a state's risk ofliability."

Distribution of KI would take place only after an advisory from the federal government that it 6 Sometimes, even today, the opponents of KI will assert that there has been "no new information significantly challenging the basis of the 1985 policy," or similar words. What that means, when parsed out, seems to be this: that the cost-benefit analysis of the 1980's showed KI to be non-cost-effective; that the reanalysis still showed KI to be non-cost-effective (though by a much narrower margin); and that accordingly, there has been no change. This kind of verbal sleight-of-hand creates the false impression that the Government has not learned anything casting doubt on the basis of the 1985 policy. 7 Nuclear Regulatory Commission: An Analysis of Potassium Iodide (KI) 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.

12 was appropriate. In that situation, with a state following federal directives and doing the best it could under emergency conditions, who would find a state liable? If I were a state, I would be much more worried about the consequences of not having a KI stockpile, given all that is known about the drug's value. If ever there were an accident, and it turned out a state had no KI to give out because it had taken its medical advice from lobbyists instead of doctors, that would be the time to worry about liability. The following are eight arguments that are factually accurate, wholly or in part, but still are not persuasive reasons to forgo stockpiling.

7. "Evacuation is preferable."

The most common argument against KI is also the most meritless: that evacuation is better, so we don't need KI and shouldn't even have it around as a precaution. The problem is that evacuation isn't always feasible. The NRC and FEMA have never claimed it was. KI is backup protection -- Plan B -- for those situations where evacuation cannot be completed in time to avoid a substantial radiation dose to the thyroid -- for example, because of adverse weather conditions, blocked roads, or widely dispersed radioactivity. Also, people may be exposed to radiation while they are evacuating -- automobiles don't afford much protection. Moreover, it is not an either/or proposition. You don't choose between backing evacuation and backing stockpiling of KI; you do both. The question is whether you have three weapons in your arsenal

 -- evacuation, sheltering, and KI -- or only two, in a situation when the third weapon costs only a pittance.

8. "Big accidents are unlikely."

It is true that big accidents are unlikely. Generally speaking, a combination of good design, good operation, and good regulation makes American nuclear reactors quite safe. But there is a big difference between saying that accidents are unlikely and saying that they cannot happen. If we could be sure that accidents would not happen, then all emergency planning -- sirens, drills, and the like -- could go out the window. The cost of KI is a drop in the bucket by comparison to what is already spent on emergency preparedness. The reason we have sirens and drills and the rest is that we know that accidents can happen. (So can acts of terrorism.) If we accept the idea that emergency preparedness makes sense, then our preparedness ought to be first-rate, not second-rate.

9. "KI protects only one organ, whereas evacuation protects the whole body."

This is true, but nevertheless is not a valid reason to forgo stockpiling of KI. Evacuation is certainly the preferred protective action, when it is feasible, and when it can be accomplished in such a way as to avoid any exposure to radiation. But this may not always be the case. The Manual of Protective Action Guides and Protective Actions for Nuclear Incidents, EPA-400-R-92-001, published by the Environmental Protection Agency in May, 1992, makes clear that evacuation may be constrained by weather, floods, and road conditions. Moreover, there may be a danger to the public during an evacuation, since automobiles offer little shelter (about 10% protection). Thus although potassium iodide protects only the thyroid gland, it can, when used in conjunction with sheltering, make evacuation

13 unnecessary, thereby averting the risk of radiation exposure during evacuation. The EPA Manual thus makes plain that choosing evacuation over sheltering during a radiological emergency does not mean zero radiation risk to the evacuees; on the contrary, it may sometimes mean higher radiation doses to the public, with pregnant mothers and their children at greatest risk of all. On this last point, the Manual explains that the particular dangerto the unborn child is a risk of serious mental retardation so high, especially when the exposure occurs between the 8th and 15th week of gestation, that "induced abortion" may be indicated for any expectant mother who receives more than a relatively small dose of radiation (10 roentgen). 8 Furthermore, the Manual makes clear that in a major accident, the dose to the thyroid may well determine whether the EPA Protective Action Guidelines are reached, and officials therefore have no choice but to evacuate. If people can be provided with KI while they shelter, and their thyroid dose thereby minimized, evacuation may be unnecessary, and the whole body dose that they would receive - during evacuation can be averted. Thus while it is true that KI protects only the thyroid, having the KI option may make it possible to avert the whole-body doses that would be received during evacuation. All the above makes plain how desirable it is for decisionmakers to have the option of giving out KI. Without stockpiles, this option as a practical matter does not exist.

10. "Public confidence in the technology could be affected."

That is a quotation from an industry "White Paper" on KI that was sent to the Nuclear Regulatory Commission in 1993. The same argument could be made to assert that we shouldn't have containments or emergency core cooling systems at nuclear plants, since both of those structures might remind people that accidents can happen. You don't hear the ferryboat operators complaining that having lifejackets on board will diminish confidence in ferryboat technology. Ifl were the industry, I would be embracing KI, and making the point that even though it is very unlikely that it would ever be needed, the industry is committed to ensuring that Americans are protected to the highest standard in the world.

11. "The logistics of distribution need more study."

The opponents of KI stockpiling sometimes try to change the subject from whether KI is a valuable protective measure (an argument they know they will lose) to the logistics of delivering the drug in an emergency. The idea is to make the delivery of KI sound just impossibly complicated, so as to put off, preferably forever, the question of whether it makes sense to have the drug at all. This is the cart-before-the-horse argument I referred to earlier. Those arguments were made at the June 1996 meeting at FEMA, and answered by Dr. Jacob Robbins of the National Institutes of Health, speaking for the American Thyroid Association. He observed that there were two issues: whether to stockpile Kl, and 8 See pages B-11, B-18. To avoid misunderstanding, let me stress that EPA is not recommending abortion for pregnant women exposed to these levels of radiation, it is just reporting what the extensive journal literature on the subject says.

14 how to deliver it to people in an emergency. He said:

         "You're sort of asking the question: Which should come first? If you remember back to the Three Mile Island incident, there was no stockpile. It was requested. With a great deal of difficulty, in a rather inadequate way, it was finally made available. And it was ready to be used but with a delay. I think we have to think of both aspects. And what the American Thyroid Association has said is, create the _stockpiles, have them available, and then have expert groups developing the mechanisms of how to distribute this in time of need."

12. "The states don't want it."

This is an argument you hear again and again at the federal level. The Federal Government has been giving the states inaccurate and incomplete information about KI for 15 years, and it is small wonder that many states therefore believe that KI is undesirable. Once states begin to get full and up-to-date information about KI, their attitude toward stockpiling is likely to change, as Maine's did. Nevertheless, you still find some in the Federal Government touting surveys that were conducted several years ago, before most states had even begun to focus on the KI issue, for the proposition that there is no point in offering the drug to the states because they would not accept it if it were offered.

13. "People can buy it for themselves."

The argument can be made that people are free to buy the drug for themselves, and that the states and the Federal Government should not be involved. First, the drug is unlikely to be available locally. Second, people will know to buy the drug only if the authorities accept the obligation of informing them. It would probably be cheaper to buy a stockpile than to take on the task of telling people that they should consider buying it. Third, in an emergency, some people -- such as schoolchildren -- will not be at home. Fourth, do you really want to say that for the people who didn't have the foresight or money to buy the drug, it's their tough luck? To leave it up to individuals would be like telling ferryboat passengers that they are free to bring their own lifejackets. It's simpler, fairer, and better health policy to stockpile KI and bring it out for the entire affected population in time of need.

14. "Because the Federal Government has recently decided to stockpile KI in 27 cities for acts of nuclear terrorism, states and localities can rely on the Government's stockpiles in an emergency, and need not consider stockpiling in the vicinity of nuclear plants."

The shift in U.S. policy by which KI will be stockpiled for terrorist events is a good thing, insofar as it represents a recognition that KI is valuable in radiological emergencies. If it is valuable for emergencies caused by acts of terrorism, then it is also valuable for emergencies caused by accidents. But these terrorism stockpiles are likely to be very limited in size -- a few thousand pills -- and in any case, we are talking about a medicine whose value is entirely dependent on time. Administering the drug before the exposure to radiation is better than after, one hour after is better than two hours after, and so on. Thus it makes sense to have the drug close at hand, and to have plans in place for its use, for if there

15 is one thing we know about emergencies, it is that planning is always preferable to improvised, ad hoc responses. In conclusion, Americans have a right, where nuclear hazards are involved, to expect their Government to ensure both that they are protected adequately and that they are given accurate and complete information. In the case of potassium iodide, the Government has so far done neither. As a result, though American children should enjoy radiation protection second to none, today they do not. I hope the day will soon come that the Federal Government meets its responsibilities both to protect and to inform the public, where radiation and thyroid cancer are concerned. Until that day comes, states must rely on their own expertise, and on the expertise of those whom they consult, and decide for themselves how best to protect their citizens, especially the youngest ones. Attachments: Letter from Senators Joseph I. Lieberman and Alan K. Simpson, April 20, 1994 Letter from Dr. Jacob Robbins, July 8, 1996 ATTACHMENT B December 11, 1997 Mr. Roger L. Suppes, Chief Bureau of Radiation Protection Ohio Department of Health 246 N. High Street Columbus, Ohio 43266-0118

Dear Mr. Suppes:

I apologize that this filing is a few days past the December 8 date you specified. I had an incorrect fax number for you, and therefore my filing went astray when I sent it to you last Sunday, December 7. When I learned today of my error, I decided to make a few corrections and additions before submitting the filing today. Thank you for the opportunity to comment on the summary, prepared by the Ohio Commission on Dispute Resolution and Conflict Management, of the concerns and issues raised by participants in the meeting on potassium iodide (KI) conducted in Painesville on October 28. I would also to reiterate my thanks to you and Mr. Lucia for inviting me to take part in the meeting. The meeting, I thought, was a fine example of democracy

16 in action: a state and a local government, responding to citizen concerns by asking questions, giving the interested public an opportunity to be heard, and conducting its business in the open . As in the past, in providing these comments I am writing in my personal capacity, not as an employee of the NRC, and this is written at home, on my own time. First, I would like to inform you of some developments since the Painesville meeting, and then I will offer comments on the summary of the concerns and clarifications offered by the participants in the meeting. A. Recent Developments I. NRC Staff Admits to "Misinforming" the Commission about KI On November 5, 1997, the Nuclear Regulatory Commission held a public meeting on potassium iodide -- the first such meeting in 14 years -- at which it received presentations from the Federal Emergency Management Agency (FEMA), the NRC *technical staff, and me. 9 Among other things, the meeting was notable for the admission by the NRC staff that it had "misinformed" the Commission when it reported, in a June 1997 memorandum, SECY-97-124, that when the issue of KI was before an interagency group (the Federal Radiological Preparedness Coordinating Committee) in 1995, FEMA was the agency that opposed any change in the existing federal KI policy. In fact, said an NRC staff official, it was the NRC, not FEMA, that had opposed such a change. The NRC staff official stated that he had learned of this through a letter sent by me a few days earlier to the Federal Emergency Management Agency. 10 The NRC staff did not explain, at the November 5 meeting, why it had misinformed the Commission; it is noteworthy that it did not claim that the error was inadvertent. Moreover, when a Commissioner asked about the assertion in my petition for rulemaking that existing policy was based on misinformation provided to the Commission and the public in the 1980's, the only staff member willing to admit to long familiarity with the KI issue said that he "had no answer." 11 The tape of the October 28 meeting in Painesville shows the NRC staff representative making the identical statement which the NRC staff admitted was "misinformation" only a week and a day later. Thus to the extent that one of my major themes at the Painesville meeting was that the Federal Government has for many years been giving inaccurate and incomplete information to the states, the NRC staff seems to have demonstrated the 9 The transcript of that meeting is available through the NRC's website (www.nrc.gov). 10 The context suggests that FEMA was unwilling to allow the NRC staff to shift to FEMA the responsibility for having opposed a change in existing KI policy in 1995. 11 It is somewhat extraordinary that at this late date, the NRC staff should have no answer to the question of whether the staff misinformed the Commission and the public about KI in the 1980's. This charge was a central element of my Differing Professional Opinion on KI, which the NRC staff first received in 1989 and spent the next four or five years evaluating. Attached to that document were extensive sections of the transcript of a November 22, 1983, Commission meeting in which, I claimed, the misinformation was provided. I made the same charge of misinformation in my 1995 petition for rulemaking, again with full documentation and lengthy quotations from the transcript of the November 1983 meeting. I also made this charge in my statements to a public meeting on Kl held by FEMA in June 1996 and to a December 1996 meeting of the Maine Radiological Advisory Committee. At each step, the NRC staff was fully aware of the charges I was making against it, because it received copies of my statements.

17 validity of my contention in the Painesville meeting itself.

2. Filing of Amended Petition At the Commission meeting on November 5, I was asked by Chairman Jackson exactly what it was that I wanted. I replied that I would be satisfied with a rule change under which the NRC would "require that consideration of potassium iodide be given in the formulation of emergency plans," but "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., evacuation, sheltering, and KI) and requiring their consideration.

I was therefore asked to submit an amendment to my petition reflecting this approach, by which states would be required to consider, but not necessarily to adopt, KI stockpiling. I did so by a filing of November 12, 1997. In filing this amended proposal, I was changing only the bottom line of my 1995 petition -- and that only slightly - - but was not withdrawing the original petition or any of the arguments made in it for a change in policy. Thus any inference that I have retracted the 1995 petition would be erroneous. Rather, in the hope of a sound and expeditious (if less than ideal) resolution of a difficult and divisive issue, I was offering a compromise on the bottom line of the rule change that would result from granting the petition. 12 I was also asked to provide a suggested markup of the draft Federal Register notice proposed by the staff in SECY-97-124. 13 In providing this as part of my November 12 filing, I offered some overview comments: [T]he staff's draft Federal Register notice, both in the selection of the facts it chooses to report and in its overall tone, ... is heavily slanted against KI. I would therefore be remiss if I did not candidly advise the Commission that the draft Federal Register notice, if issued in its present form, is likely to bring nothing but opprobrium to the NRC and to FEMA. In large measure, the notice's failings speak for themselves. What is one to say about a notice that does not get around until page 8 to mentioning 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? 12 So limited a change would mean no legal necessity for a new round of public comment on the amendment to the petition; instead, the agency could proceed directly to rulemaking. I understand, however, that the NRC has decided to publish a notice of the receipt of the amended petition, and to allow public comment. On the one hand, this means further delay, but on the other, it is an opportunity for further participation by the interested public. 13 The document prepared by the Ohio Commission on Dispute Resolution & Conflict Management, and dated November 3, 1997, states in part, "Federal Register Notice has been issued -- contains current policy -- standing offer for NRC to fund ." While the attendees at the Painesville meeting might well have received this impression, in fact no Federal Register notice has been issued. All that has been issued to date is the NRC's July I, 1997, press release.

18 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 taking place now in the former Soviet Union? This is the way to court not merely criticism, but also ridicule and contempt. The NRC staff has not yet replied to my filing of November 12.

3. Meeting of New York State Radiological Health Advisory Committee On November 21, 1997, the New York State Radiological Health Advisory Committee met in Albany to consider the issue of KI stockpiling. The eight members of the panel were unanimous in support of having KI available for use in radiological emergencies. It deferred until a later date the logistical questions of how best to go about ensuring the availability of the drug. This recommendation will be passed on to the director of the New York Department of Health.

- I think it is accurate to say that the members of the Committee were puzzled that the issue of KI was even controversial, and they asked what the arguments were against it. I quoted to them the comment of an Illinois state official, Mr. Roy Wight, that "loss of the thyroid is not life-threatening 14," and at least several of the Committee members were -- so it seemed to me -- appalled at the degree of ignorance revealed by this comment. One member volunteered that he had a patient with thyroid cancer whom he considered terminal, and another said that in a child, even the surgery can be life-threatening. Another pointed out that thyroid surgery can also affect the parathyroids, which control the body's use of calcium. The same day as the Albany meeting, an article in "USA Today" reported that Illinois has decided against KI stockpiling. I think it deeply regrettable that this decision was apparently made on the basis of woeful ignorance of the medical issues involved -- an ignorance which the NRC staff has done nothing to correct. (An NRC staff member was present at the 1996 FEMA meeting at which the Illinois state official made his comment, and said not a word to suggest that the official's grasp of the medical ramifications of thyroid cancer was deficient.) Again, as I stressed at the Painesville meeting, if states are ill-informed about KI and thyroid disease, the blame lies much less on the states than on the Federal Government, for its failure over 15 years to provide the states with accurate and complete information. I am sure that the Illinois state official means the best according to his lights for the almost 12 million citizens of his state, but he has helped make Illinois a byword for ignorance and closemindedness when it comes to protecting the thyroids of our children from cancer. I hope and trust, therefore, that Ohio will follow the example of Maine and New York, not of Illinois. No one who reads this should imagine that I lack respect for the role of the states in decisions on emergency planning. On the contrary, the more I have seen (so far, in Maine, Ohio, and New York) of the responsiveness of the states to public concerns, of their willingness to confront issues, and of the timeliness with which they act, the more they show to advantage when compared with the Federal Government. It is because I am deeply 14 This appeared in Mr. Wight's statement to the June 1996 meeting on KI held at FEMA. Curiously, the identical words --

     "loss of the thyroid is not life-threatening" -- appeared in the written statement of the South Carolina representative, Ms. Sandra Threatt. This raises the question whether they had been misinformed by the same source, and if so, by whom.

19 impressed by states' willingness to act responsibly and expeditiously when presented with accurate information that I feel so keenly the Federal Government's irresponsibility in failing to provide the states with accurate and complete information on Kl. I am aware that there are some supporters of the 1985 policy who claim that because when states were surveyed several years ago 15 , most opposed any change in the current policy, respect for the states requires the Federal Government to keep the present policy unchanged. This argument, I believe, is patronizing toward the states, and in fact insults both their intelligence and their sense of responsibility toward their citizens. Reduced to its essentials, this argument assumes that states would rather have their children continue to receive second-class protection against nuclear emergencies than have to acknowledge that their existing policy is erroneous -- even though the Federal Government was to blame for the error, not the states themselves. I do not believe that that is how America's states make decisions affecting the health of their children. If states are given accurate information and an appropriate recommendation, their concern will be to do the right thing for their citizens now, rather than worrying about what someone with incomplete information might have said in response to a survey years ago. I can well understand why some federal bureaucrats would resist an open and truthful exposition of the KI issue; among other things, it would reveal the inaccuracy and incompleteness of the information provided by the federal bureaucracy in the past 15 years. In my view, it is not respect for the states, but rather the ultimate disrespect for them, to pretend that a deficient health and safety policy needs to be kept in place because the states would not want to hear that the existing policy is erroneous. B. Response to Concerns and Clarifications

1. NRC "Clarifications/Concerns" I will deal briefly with some of the points attributed to the NRC.

a. It is true that under existing policy, distribution of KI is a state and local decision, and that states have had the opportunity to stockpile and distribute it if they so choose. It is also true, however, that federal policy, adopted in 1985, has tended strongly to discourage states from doing so, by using strong language --

"not worthwhile" -- with respect to KI.

b. As noted above, no Federal Register policy announcing the new policy has been issued.

c. As to whether the NRC (or the NRC staff) is or has been "anti-KI," I think I have said enough above.

d. On the point that "KI is site specific and only protects thyroid," this is true but beside the point.

First, KI is not proposed as an alternative to those measures that protect the whole body, but as a complement to them. Moreover, there are circumstances in which KI can indirectly result in reducing whole body doses, even though the medicine itself protects only the thyroid gland. Although this sounds paradoxical, it is not. Kl, by keeping radiation dose to the thyroid below the protective action guidelines at which evacuation is required, may make sheltering a viable option when it otherwise would not be. This in turn means averting the whole-15 Poll results often depend heavily on the way the question is framed.

20 body doses that might be received during evacuation, if the plume ofradioactivity arrives before evacuation is complete. (Automobiles provide very limited protection against airborne fallout.) Whole-body doses are particularly dangerous to children in utero, especially during weeks 8 to 15 of pregnancy. 16

e. On the need of the state to deal with the FEMA local office, it is noteworthy that when asked by an NRC Commissioner at the November 5 meeting about the provisions made to move Kl from terrorism stockpiles to nuclear power plant sites in the event of an accident, a FEMA official indicated that no consideration had yet been given to this issue. This seems to highlight the importance of having Kl on hand locally if its distribution is to be a realistic possibility in the event of an accident.

2. Comments and Concerns of Other Participants

a. Liability seems to be a concern on the minds of many commenters. The short answer is the one offered by Connie Kline at the meeting: that states and localities should be more concerned about the lawsuits that would result from their failure to have stockpiled Kl in an emergency than from anything that could go wrong from Kl use during an accident. We know from the Polish experience during Chernobyl that wide-scale use of Kl is safe. We know from the Soviet experience during Chernobyl that without Kl, the result can be large numbers of aggressive thyroid cancers among children.

There is not and cannot be any guarantee that in an accident, it will be possible to get Kl to everyone, even if planning is good and everything goes according to plan. It is in the nature of emergencies that the unexpected can and does occur. In such a case, it is possible that some people whom the Kl did not reach would feel aggrieved. However, if there is no Kl at all, then it can be guaranteed that no one will get the medicine, and that all of them -- with good reason -- will then feel aggrieved, especially the parents of small children. A state that has done its best -- and that includes reasonable measures to screen out persons with known iodine allergies -- should have nothing to fear on liability grounds from having stockpiled Kl. In any case, it would not be used (under the Federal Radiological Preparedness Response Plan) until the Federal Government had advised its use was warranted in the particular accident situation. Moreover, the drug was ruled "safe and effective" for use in radiological emergencies as long ago as 1978. Liability, in short, is a bogeyman. States should not allow it to frighten them away from a reasonable, conservative safety measure widely used throughout the developed world.

b. Dr. Haler of the Ohio Department of Health raised concerns about whether there are elements in the population that might lack sufficient sophistication to use Kl safely. Whether or not her premise is valid, this is not a reason to defer a decision on whether it makes medical sense to have the Kl option in an emergency.

Rather, the issue of how best to present Kl to members of the public, like the issues surrounding distribution, is a question of implementation. As the New York State Radiological Health Committee observed, the first question is whether the drug is desirable medically, and only if that question is answered in the affirmative is it 16 In this last regard, at the meeting in Albany I mentioned that a 1992 EPA report cites studies in the medical literature indicating that at whole-body doses greater than 10 rads, therapeutic abortion may be called for. Dr. David Becker of the American Thyroid Association commented that this overstates the risk to the fetus. During Chernobyl, he said, there were many unnecessary therapeutic abortions, in part because of erroneous advice coming from the West.

21 necessary to reach the questions of implementation. To worry about details of distribution before a decision on whether the drug makes sense from a medical standpoint would be to put the cart before the horse. The first step is to make the decision to stockpile. This will assure that the medicine exists in sufficient quantity, sufficiently close to the people who may need it in an emergency. Meanwhile, federal, state, and local government officials can be addressing the question of what is the most effective way of getting this medicine to the affected population in an actual emergency.

c. On the issue of whether there is "new data," it is important to cut through the fog of artfully worded and bewildering statements from the NRC staff. The NRC staff has been assuring the world for so long that there is "no new information" on KI that this point needs to be nailed down. First, is there new information since l 985 on the health impacts of a major nuclear accident? Yes, in the areas of former Soviet Union affected by fallout from Chernobyl we are seeing childhood thyroid cancer in greater numbers, and appearing sooner, than had previously been expected. Second, is there new information since 1985 on the safety and efficacy of.KI? Yes, we have seen the Polish data on the use of.KI during Chernobyl (18 million people received the drug), and there is also information on consumption of KI as an ingredient of over-the-counter cough and cold medications: 38 million equivalent doses of KI without a single adverse reaction reported, according to a 1995 NRC staff document.

What, then, does the NRC staff mean when it talks about "no new information that seriously challenges the basis of the 1985 policy"? Apparently, it means that the 1985 policy was based on a cost-benefit analysis that showed KI not to be cost-effective, and that no one has since demonstrated that KI is cost-effective. This leaves out two important considerations: (1) a reanalysis of costs and benefits in 1992 indicated that costs and benefits of KI were far closer than previously calculated, and for the closest-in populations were nearly equal; (2) the discussion of a change in KI policy in recent years has focused not on cost-benefit analysis but on prudency, so that it is irrelevant whether new information challenges the basis of the policy. The fact is that a great deal of new information has come to light in the last several years that seriously challenges the soundness of the policy, whether or not it challenges the basis of the policy -- whatever that means. In matters affecting health and safety, words should be used to illuminate issues, not to obscure them. To create the impression that no new information bearing on the vaiue and safety of KI has accrued since 1985 -- the year before Chernobyl -- is to do a grave disservice to the public. Sincerely, Peter G. Crane

Attachment:

Draft regulatory language and Statement of Considerations, from amended petition submitted to the NRC on November 12, 1997

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DOCKETED USNRC RD 2, Box 132 Clearville, PA 15535 "00 FEB _ A :S] January 28, 1998  ;;,g 4 9 Mr . John C. Hoyle USNRC Washington, DC 20555- 0001 Attn : Rulemakings and Adjudications Staff DOCKET NUMBER Re: PRM-50-63 PETITION RULE PRM 5D*'-3,4

Dear Mr Hoyle:

( ~:J.F~t,&-03i) We urge you to modify regulation 10CFR50.47(b)(l0) in order to expand the availability of potassium iodide for use by the general public in case of a nuclear exposure. This seems like a very small thing to do for a very great benefit . Thank you very much.

                            ",ac..,

Karl Novak

                        ...         .., RR2 Box 132
                         *,,.,.-."' Clearville, PA 15535-9404 F!B

• 5 1998 Ac ow1edged by card ...............,-.....--.

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                                                                        '98 FEB -3 A10 :53 January 30, 1998 Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 DOCKET NUMBER Attention: Rulemakings and Adjudications Staff TITION RULE PAM 5 o- b 3 A Mr. John C. Hoyle, Secretary                                         ( Co :1- Fl< folo D38)

U.S. Nuclear Regulatory Commission Washington, D.C. 20555 - Re: PRM-50-63

Dear Mr. Hoyle:

I would like the NRC to decide favorably the petition by NRC attorney Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations. Potassium Iodide has been proven effective if it taken in a timely manner; therefore, stockpiling is a sensible answer in the event of another nuclear accident. The President's Commission on the Three Mile Island Accident recommends stockpiling. The American Thyroid Association also recommends stockpiling. The reluctance of the nuclear industry to provide stockpiling is puzzling. A pill that costs 10 cents can prevent the uptake of radioactive iodine to our thyroids. Arguments that people will be evacuated in a timely manner are strictly conjecture. The NRC can't dictate that an accident won't happen during a snowstorm or that some evacuees will be traveling with the radioactive wind. Sincerely, Paula Ford 998 Acknowledged by card ...*:.:~....:........~

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Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 oocKETED USHRC Re: PRM-50-63 Mr. Hoyle, "98 FEB -3 A10 :50 I would like the NRC to decide favorably the petition by NRC attorney Peter Crane for the stockpiling of Potassium Iodide {Kl). Emergency OFF\Ci:.. () , SE . . J responders have a stockpile available for themselves. Citizens should be RULB,\J... "I .,.__,, ,.:: ./\CF &Jle to use Potassium Iodide also. Many other nations already stockpile Kl ADJUDICA nc s v ,.... W 1d the US should have no less protection than ottier nations. Potassium Iodide has been proven effective if it taken in a timely manner, therefore stockpiling is a sensible answer in the event of another nuclear accident. The President's Commission on the Three Mile Island Accident 0Ul;KET UM cR recommends stockpiling. The American Thyroid Association also recommends PETfflON RULE PAM 5o-&,3tf stockpiling. The reluctance of the nuclear industry to provide stockpiling is puzzling. A 10 cents pill can prevent the *uptake of radioactive iodine ([p:JFR ~'1038') to our thyroids.

• Arguments that people will be evacuated in a timely manner are strictly conjecture. The NRC can't dictate that an accident won't happen during a snowstorm or that some evacuees will be traveling with t he radioactive wind.

Signed, NAME ' °DRESS

                 ~'-             I.

Dan Bolef

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                          * . Box 134 Irwin, PA 15642 Acknowfedged by card FEB - 5 998 H

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DO KET NUMBER 1 A 5o-C:,3A DOCKETED USNRC ( {p;). Fl<. fp!P038) To: Secretary, U.S. NRC, Washington, DC 20555-0001, ATTENTION: Rulemakings'98 FEB -3 A10 :51 and Adjudications Staff OFFIC,t O. S!:. iJ. ;R 1 From: Alice Hirt, Bd member of DON'T WASTE MICHIGAN, on behalf of DON'TRULF_ I:., <; , .*,D WASTE MICHIGAN* 6677 Summit View, Holland, MI 49423- Phone 616-335-3405 ADJUD*~t- T1C' *J TAFF Re: Peter Crane's Amended Petition for Rulemaking, Docket No. PRM-50-63A Date: 1/14/98 DON'T WASTE MICHIGAN, a statewide .e nvironmental citizen's group, stands in support of the US NRC Petition for Rulemaking regarding the stockpiling of Potassium Iodide (KI) for protection of the thyroid gland during a nuclear accident. The President's Commission on the Accident at Three Mile Island(the Kemeny Commission) recommended the stockpiling of KI. Most industrialized countries now protect their citizens with stockpiles of KI for use by the general public. The American Thyroid Association and the World Health Organization both encourage the stockpiling of KI for use by the general public. The 1986 accident at Chernobyl clearly demonstrates the necessity of having KI readily available in the case of a radiological emergency. If taken in time, KI can prevent the uptake of radioactive iodine by the thyroid thus preventing the occurrence of thyroid cancer. DON'T WASTE MICHIGAN supports the stockpiling and availability of KI for the general public in the event of a nuclear accident and favors the prophylactic use of KI as a mandatory emergency planning requirement. We encourage the NRC to disregard any influence by the nuclear industry not to require the stockpiling of KI because of industry's fear that the stockpiling of KI might give the public the idea that a nuclear accident could actually occur and therefore cause the public to oppose the use of nuclear power. The mandate of the NRC is to protect the health and safety of the general public and the stockpiling and availability of KI in case of a nuclear accident is clearly indicated as an important part of any protection plan. Sincerely, Don't Waste Michigan-Alice Hirt, Bd. Member 8

• 5 1998 Acknowl ged by

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                                                                              '98 JAN 29 P2 :20 Carol Jahnkow Executive Director Peace Resource Center of San Diego                             ooCKEl NUMB~           5t l3A-5717 Lindo Paseo San Diego, CA 92115 pET\TI     CL   ~ -

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Dear Ms. Jahnkow:

Thank you for your letter of January 15, 1998, commenting on the amended rulemaking petition of Mr. Peter Crane (PRM-50-63A). In your letter, you also requested a thirty (30) day extension of the comment period. In response to requests which arrived earlier than yours, the comment period was extended. The period has been extended by the Commission to February 17, 1998. A copy of the Federal Register notice on the extension is enclosed . Sincerely, Emile L. Julian Assistant for Rulemakings and Adjudications

Enclosure:

As stated

3052 Federal llegister / Vol. 63, No. 13 / Wednesday, Jlihuaij";_'.i~:*1~98. hProposed* Rules million pounds of cherries would not be Paperwork Reduction ,.,., List.of.~ubjecta in 7 CTR Part 930 removed from the domestic market this season, depressing grower returns for all In compliance with Office of ,* :jl ., *:Marketing agreements, Reporting and cherries. The marketing order was Management and Budget (0MB) , , . t>. record.keeping requirements, Tart regulations (5 CFR part 1320) which cheert.n:* , *'

• designed to increase grower returns by stabilizing supplies with demand as implement the Paperwork Reduction . For the reasons set forth in the well as stabilizing prices and creating a Act of 1995 (Pub. L 104-13), the p1'NDlhle, 7'CFR part 930 is proposed to more orderly and predictable marketing information collection and be amended as follows:

environment. Expanding markets and recordkeeping requirements have been PART 830-TART CHERRIES GROWN developing new products is key to previously approved by 0MB and the

• IN THE STATES OF MICHIGAN, NEW meeting this marketing order's goals. assigned 0MB Number 0581--0177. ** YORK, PENNSYLVANIA, OREGON, Not granting exemptions and There are some reporting, UTAH, WASHINGTON, ANO diversion credit for exports to countries recordkeeping and other compliance WISCONSIN other than Canada, Mexico, and Japan requirements under the marketing order.

was also discussed at Board meetings. 1. The authority citation for 7 CFR The reporting and recordkeeping However, the Board expressed that this part 930 continues to read as follows: recommendation is very important to burdens are necessary for complianoe purposes and for developing statistical A"lllllerilf- 7 U.S.C. 601-674. aeating stable condition; in the export marketplace this season and would data for maintenance of the program. 2. A new Subpart.:_suf plementary encourage future market growth. The The forms related to handler diversion Regulations consisting o § 930.250 is Board further stated that such action and handlers meeting restricted adaed to read as follows: will improve returns to growers because peiatntage obligations (i.e., inventory Note: Thia subpart will consist of handling of the tremendous growth in the export Reaerve Summary, Cherries .Acquired regulations which will not appear in the market this season. Exemptions and From Producen, Handler Reserve Plan annual Code of Federal Regulations. diversion crep.it have been addressed in and Final Pack Report, and Inventory Location Report) have received approval Subpar1 Supplementary Aegu_latlons other rulemaking actions. As mentioned earlier, USDA's by 0MB. The forms require information t 930.250 Flnal frN and ratrtc:tN "Guidelines for Fruit, Vegetable, and which is readily available from handler percentagea for the 1197-48 crop~- Specialty Crop Marketing Orders" records and which can be provided The final percentages for tart cherries specify that 110 percent of recent years' without data processing equipment or handled by handlers in volume sales should be made available to trained statistical staff. It was regulated districts during the crop year primary markets each season before anticipated that as inany as 45 handlers ~nning on July 1, 1997, which shall recommendations for volume 1'911Wation might be regulated if volume regulations be free and restricted, respectively, are are approved. The quantity avaifable are established. Many reports are designated as follows: Free percentage, under this rule is 110 percent of the submitted a single time each season, 55 percent and restricted percentage, 45 quantity shipped in the prior three while some. are submitted more percent. Restricted percentage years. frequently. In addition, the bulk of the obligations must be satisfied on or The free and restricted percentages information handJ.er.s must report is before the effective date of this rule. A proposed to be established by this rule obtained during the normal course of grace period of 30 days will be allowed release the optimum supply and apply their business opentions. It would take for handlers to segregate and uniformly to all regulated handlers ha handlers approximately 15 minutes per appropriately document any tonnage the industry, regardless of size. There report to complete for a total of 60 they wish to place in the inventory are no known additional costs incurred minutes per handler and approximately reserve and to assemble any applicable by small handlers that are not incurred diversion certificates. by large handlers. The stabilizing effects 2,700 minutes annually for the estimated 45 handlers. As with other, Dated: January 15, 1998. of the percentages impact all handlers positively by helping them maintain similar marbling order programs, RobertC.Keeaay, and expand markets, despite seasonal reports and forms are periodically Deputy Administrator, Fruit and Ve,etable Programs. supply fluctuations. Likewise, price studied to reduce or eliminate duplicate stability positively impacts all information collection burdens by [FR Doc. 98-1429 Filed 1-2~8; 8:45 am) producers by allowing them to better industry and public sector agencies. IIIU.Na CODE MtlMl-f" anticipate the revenues their tart This proposed rule does not change cherries will generate. those requirements. USDA has not identified any relevant A 15-day comment period is provided NUCLEAR REGULATORY Federal rules that duplicate, overlap, or to allow interested persons to respond COMMISSION conflict with this proposed regulation. to this proposal. Fifteen days is deemed 10 CFR Part 50 While the level of benefits of this appropriate because this rule needs to rulemaking are difficult to quantify, the be in place as soon as possible since [Docket No. P R ~ A ) stabilizing effects of the volume handlers are currently marketing 1997-regulations impact both small and large Peter G. Crane; Recefpt of an Amended 98 crop tart cherries and this action Petltlnn for Rulemaklng, Extension of handlers positively by helping them should be taken promptly to achieve the maintain markets even though tart Comment Period intended purpose of making the cherry supplies fluctuate widely from AGENCY: Nuclear Regulatory optimum supply quantity computed by season to season. Commission. the Board available to handlers. All Interested persons are invited to written comments timely received will ACTION: Amended petition for submit information on the regulatory be considered before a final rulemaking: extension of comment and informational impacts of this action period. on small businesses. determination is made on this matter.

t Federal Register / Vol. 63, No. 13 / Wednesday, January 21 , 1998 / Proposed Rules 3053 SlMIIARY: On December 17, 1997 (62 FR T. Lesar, Office of Administration, U.S. Forrestal Building, Room lE-190, 1000 66038), the Nuclear Regulatory Nuclear Regulatory Commission, Independence Avenue, SW. Commission published a notice of Washington, D.C. 20555--0001, Washington, DC 20585, (202) 586-7574, receipt of an amended petition for telephone: 301-415-7163 or Tc,ll Free: between the hours of 9:00 a.m. and 4:00 rulemaking filed by Peter G. Crane and 1--<100-368-5642, E-mail: MTI.@nrc.gov. p.m., Monday through Friday. except requested public comment on the For the Nuclear Regulatory Commission. Federal holidays. amended petition. In the amended Dated at Rockville, Maryland, this 14th day FOR FURTHER INFORMATION CONTACT: t j petition for rulemaking, the petitioner of January, 1998. Kathi Epping, U.S. Department of j, seeks to amend NRC's emergency Annette Vietti-Cook, Energy. Office of Energy Efficiency and planning regulations to require Renewable Energy, EE-43 , 1000 Acting Secretary of the Commission. consideration of sheltering. evacuation, Independence Avenue, SW, and the prophylactic use of potassium [FR Doc. 98-1379 Filed 1-20-98; 8:45 am] Washington, DC 20585--0121, (202) 586-iodide for the general public in BIWNO COOE 75~1-f' 7425, email: Kathi.Epping@hq.doe.gov, developing a range of emergency or Edward Levy. Esq., U.S. Department planning protective actions. In addition, of Energy, Office of General Counsel. the petitioner has filed supplemental DEPARTMENT OF ENERGY GC-72, 1000 Independence Avenue, information in support of his amended SW, Washington. DC 20585, (202) 586-petition which is available in the NRC Office of Energy Efficiency and 9507, email: Edward.Levy@hq.doe.gov. Public Document Room. The comment Renewable Energy SUPPLEMENTARY INFORMATION: On period on the amended petition was to October 22 , 1997, the Secretary 10 CFR Part 430 have expired on January 16, 1998. In determined, based on the best response to several requests. the NRC Energy Efficiency Test Procedures for information currently available, that has decided to extend the comment Distribution Transformers energy conservation standards for period for this action . electric distribution transformers are

The comment period bas been [Docket Number EE-OET~7~) technologically feasible, economically ded and now expires on February RIN 1904-AA85 justified, and would result in a 1 . 1998. Comments received after this significant energy savings. This date will be considered if it is practical AGENCY: Office of Energy Efficiency and determination initiated the process of to do so, but assurance of consideration Renewable Energy, Department of establishing, by notice and comment cannot be given except to those Energy. rulemaking, test procedures and energy comments received on or before this ACTION: Notice of public workshop. conservation standards for this product.

date. The Department of Energy is drafting

  ~ESSES: Submit comments to:

SUMMARY

The Department of Energy a proposed rule to implement the Secretary, U.S. Nuclear Regulatory (DOE) will hold an informal public provisions of the Energy Policy and Commission, Washington, D.C. 20555- workshop to discuss issues and gather Conservatioo Act, 42 U.S.C. 6317, for 0001. Attention : Rulemakings and information related to test procedures test procedures for distribution Adjudications Staff. for electric distribution transformers. transformers. However, several issues Deliver comments to 11555 Rockville All persons are hereby given notice of have been raised. The purpose of the Pike. Rockville, Maryland, between 7:30 the opportunity to attend this p1.;blic public workshop is to discuss the a.m. and 4:15 p.m. on Federal workdays. workshop and to submit written following issues for developing the You may also provide comments via comments. notice of proposed rulemaking:

the NRC's interactive rulemaking DATES: The public workshop will be a. Adoption of national and website through the NRC home page held on Tuesday, February 10, 1998, international consensus standards in the (http: / /www.nrc.gov) . This site provides from 9 a.m. to 4 p.m. test procedures for determining energy the availability to upload comments as ADDRESSES: The workshop will be held efficiency of distribution transformers; As (any format). if your web browser at the U.S. Department of Energy, b. Burden imposed on industry, especially on manufacturers, by Wpports that function. For information Forrestal Building. Room lE-245, 1000 about the interactive rulemaking Independence Avenue, SW, additional testing and data processing; website, contact Ms. Carol Gallagher, c. The definition of "basic model" for Washington, DC 20585. 301-415-5905; E-mail CAG@nrc.gov. distribution transformers; Written comments are welcome, d. Sampling plan for units to be For a copy of the amended petition, especially following the workshop. write: 'Rules and Directives Branch, tested; Please submit 10 copies (no faxes) to: e. Selection of a measure of energy Division of Administrative Services, Ms. Kathi Epping, U.S. Department of consumption for distribution Office of Administration, U.S. Nuclear Energy, Office of Energy Efficiency and transformers; Regulatory Commission, Washington, Renewable Energy, "Energy f. Selecting reference temperatures-D.C. 20555--0001. A copy of the Conservation Program for *Consumer the reference temperatures in the amended petition and other Products: Test Procedures for consensus standards lack uniformity; documentation filed by the petitioner Distribution Transformers, Docket No. g; Requirement for applying are also available for public inspection, EE-DET-97-550," EE-43, 1000 corrections to measurement data of both and copying for a fee, in the NRC Public Independence Avenue, SW, liquid-immersed and dry-types of Document Room, 2120 L Street NW Washington, DC 20585-0121. transformers; and (Lower Level), Washington, D.C. Telephone: (202) 586-7425; Telefax: h . Requirement for quality assurance FOR FURTHER INFORMATION C,,ONTACT: (202) 586-4617. in testing. Michael Jamgochian, Office of Nuclear Copies of the transcript of the public The Department has prepared a paper Regulatory Research , U.S. Nuclear workshop, public comments received, entitled "Issues Paper for the Regulatory Commission, Washington, and this notice may be read (or copied) Distribution Transformers Test D.C. 20555--0001, telephone: 301-415- at the Freedom of Information Reading Procedures Workshop on February 10, fi534. E-mail: MTJ1@nrc.gov; or Michael Room, U.S. Department of Energy. 1998" that explains and discusses these

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i:,. c:O The Honorable Shirley Ann Jackson (~ -

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Washington, D.C. 20555 \._ l. - f, -.J i, -i :*.-; N

Dear Dr. Jackson:

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• w I am writing to commend your agency for proposing to modify its approach to stockpiling potassium iodide (KI) as a protective measure for the general public in case of a severe nuclear reactor accident. However, I am concerned that the proposed rule does not go far enough. Senator Alan Simpson and I wrote to the NRC about this matter on April 20, 1994.

I applaud the NRC's proposal to federally fund the purchase of KI for any state requesting it. However, I believe that the record ~upports going fwther, as advocated by Commissioners Diaz and McGaffigan: stockpiling KI should be mandatory. As you know, it is well-established scientifically that KI is extremely effective in preventing the uptake of radioactive iodine by the thyroid. If taken in the proper dose prior to exposure to radioactive iodine, KI can completely block the uptake of the radioactive iodine. The distribution of KI to the general population in the event of a nuclear emergency is a widely accepted protective measure. The World Health Organization has recommended its use for people living near a nuclear power plant if radiation levels are expected to exceed a predetermined dose. A number of foreign governments -- the United Kingdom, the Czech Republic, Switzerland, Canadian provinces with nuclear power plants, and the former Soviet Union -- stockpile KI for distribution to and use by the general public in the event of a nuclear emergency. Several states include the use of KI in their emergency planning. Acknowledged by card .....Ff8 ~...--.. 1998 "M'\"*.,.,.,. ,..,. . ... ~

U.S. NUCLEAR REGULATORY CO ISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statis11cs Postmark Date ...J.~~~5:4:....,r.::.~ ~ ~.:. rl"'~

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l ~.L...)d.l~J..:>o:i r J. J AN 27 '98 15:45 FR L., Thank you for your consideration of this matter. I request that these comments be I,' ( included in the record of the rulemaking consistent with applicable legal standards. I a S~l~ I. Lieberman cc: Commissioner Greta J. Dicus Commissioner Edward McGaffigan, Jr. Commissioner Nils J. Diaz

                                                                                               ** TOTAL PAGE.03 **

JJPS Commitment. lnntWatlan. El1ef11Y. James M. Levine TEL (602)393-5300 Mail Station 7602 Palo Verde Nuclear Senior Vice President FAX (602)393-6077 P.O. Box 52034 Generating Station Nuclear Phoenix, AZ 85072-2034 102-04062-JMUGAM January 17, 1998 Secretary U.S. Nuclear Regulatory Commission ATTN: Rulemaking and Adjudications Staff

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N Docket Nos. STN 50-528/529/530 ~ ' ::.' N Response to Request for Comment on Potassium Iodide (Kl) Rulemaking Petition Filed by Mr. Peter G. Crane In the December 17, 1997 Federal Register (62FR66038), the NRC requested public comment on an amended petition for rulemaking filed by Mr. Peter G. Crane. The amended petition for rulemaking requests that the NRC amend their emergency planning regulations to require consideration of the prophylactic use of potassium iodide (Kl) for the general public in developing a range of emergency planning protective actions. Palo Verde has reviewed the petition for rulemaking in conjunction with Arizona State and local government response agency decision-makers (Arizona Division of Emergency Management). Based on this review, Palo Verde supports the position of Arizona State and local government that additional rulemaking regarding the distribution of Kl to the general public is neither necessary nor desirable, and strongly urges that this petition be denied. Emergency preparedness for Palo Verde is built on the premise of evacuation. Given the low population in the 10-mile Emergency Planning Zone (EPZ) and the relative ease of evacuation, it is felt that evacuation provides the most timely and comprehensive protection for the general public. If, for some reason, state and local government determine that it is appropriate to distribute Kl to the general public, guidance is already available to achieve this end. Additional regulatory requirements are not needed and would not likely contribute to the overall effectiveness of the emergency preparedness program. State and local government response agencies also expressed concerns with FEB - 19 Ackno eoged by rd ... ., ,., . ..,.""'JA~~"y,;*,rr,"'rt'lffl

            ... AH REGULATORY COMMISSIO r v~tMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Docwnent Statistics Pu.. mark Date - -1.;:;;....--1-- -- - - -

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U.S. Nuclear Regulatory Commission ATTN: Rulemaking and Adjudications Staff Response to Request for Comment on Potassium Iodide (Kl) Rulemaking Filed by Mr. Peter G. Crane Page2 regard to additional costs for Kl purchase, inventory, verification, plan and procedure changes, and training. In addition, they were concerned about creating new areas for evaluation exposure during drills and exercises, and about whether or not medical evidence as to the benefits of Kl (based on when and how distributed) supports a requirement that is this prescriptive. In summary, Palo Verde urges the NRC to deny the proposed amended petition and to retain the current policy as providing adequate protection of the public health and safety. Sincerely, JML/GAM/rlh cc: E. W. Merschoff J. W. Clifford J. M. Moorman K. E. Perkins

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON , D.C. 20555-0001 DOCKETED January 28, 1998 USNRC

                                                                                  '98 JAN 28 Pl2 :16 DOCKET NUMBER P    1  10 RULE PRM 5o -&3A Ms. Elaine Ethridge 15 E. Kirby

((pg.fl< /pft,03~) Apt. 830 Detroit, MI 48202

Dear Ms. Ethridge:

Thank you for your letter of January 13, 1998, commenting on the amended rulemaking - petition of Mr. Peter Crane (PRM-50-63A). In your letter, you also requested a thirty (30) day extension of the comment period. In response to requests which arrived earlier than yours, the comment period was extended. The period has been extended by the Commission to February 17, 1998. A copy of the Federal Register notice on the extension is enclosed. Sincerely, Emile L. Julian Assistant for Rulemakings and Adjudications

Enclosure:

As stated

3052 Federal Register / Vol. 63, No. 13 I Wednesday, Jahuary 21; 1998 / Proposed Rules .*, million pounds of cherries would not be Paperwork Reduction List of Subjects in 7 CFR Part 930 removed from the domestic market this Marketing agreements, Reporting and season, depressing grower returns for all In compliance with Office of Management and Budget (0MB) recordkeeping requirements, Tart cherries. The marketing order was cheeries.

• designed to increase grower returns by regulations (5 CFR part 1320) which implement the Paperwork Reduction For the reasons set forth in the stabilizing supplies with demand as preamble, 7 CFR part 930 is proposed to well as stabilizing prices and creating a Act of 1995 (Pub. L. 104-13). the information collection and be amended as follows:

more orderly and predictable marketing environment. Expanding markets and recordkeeping requirements have been PART 930-TART CHERRIES GROWN developing new products is key to previously approved by 0MB and the IN THE STATES OF MICHIGAN, NEW meeting this marketing order's goals. assigned 0MB Number 0581-0177. YORK, PENNSYLVANIA, OREGON, Not granting exemptions and There are some reporting, UTAH, WASHINGTON, ANO diversion credit for exports to countries recordkeeping and other compliance wtSCONSIN other than Canada, Mexico, and Japan requirements under the marketing order. was also discussed at Board meetings. 1. The authority citation for 7 CFR The reporting and recordkeeping part 930 continues to read as follows : However, the Board expressed that this burdens are necessary for compliance recommendation is very lmportant to Authority: 7 U.S.C. 601-674 . creating stable conditions in the export purposes and for developing statistical data for maintenance of the program. 2. A new Subpart.:__supplementary marketplace this season and would The forms related to handler diversion Regulations consisting of§ 930.250 is encourage future market growth. The Board further stated that such action and handlers meeting restricted added to read as follows: will improve returns to growers because percentage obligations (i.e., Inventory Note: This subpart will consist of handling of the tremendous growth in the export Reserve Summary, Cherries Acquired regulations which will not appear in the market this season. Exemptions and From Producers, Handler Reserve Plan annual Code of Federal Regulations. diversion cre.d it have been addressed in and Final Pack Report, and Inventory Subpart-Supplementary Regu_latlons other rulemaking actions. Location Report) have received approval As mentioned earlier, USDA's by 0MB. The forms require information S930.250 Anal free and restricted "Guidelines for Fruit, Vegetable, and which is readily available from handler percentages for the 1997--98 crop year. Specialty Crop Marketing Orders" records and which can be provided The final percentages for tart cherries specify that 110 percent of recent years' without data processing equipment or handled by handlers in volume sales should be made available to trained statistical staff. It was regulated districts during the crop year primary markets each season before anticipated that as many as 45 handlers beginning on July 1, 1997, which shall recommendations for volume regulation might be regulated if volume regulations be free and restricted, respectively, are a:e approved . The quantity available are established. Many reports are designated as follows : Free percentage, under this rule is 110 percent of the submitted a single time each season, 55 percent and restricted percentage, 45 quantity shipped in the prior three while some are submitted more percent. Restricted percentage years. frequently . ln addition, the bulk of the obligations must be satisfied on or The free and restricted percentages information handlers must report is before the effective date of this rule. A proposed to be established by this rule obtained during the normal course of grace period of 30 days will be allowed release the optimum supply and apply their business operations. It would take for handlers to segregate and uniformly to all regulated handlers in handlers approximately 15 minutes per appropriately document any tonnage the industry, regardless of size. There report to complete for a total of 60 they wish to place in the inventory are no known additional costs incurred minutes per handler and approximately reserve and to assemble any applicable by small handlers that are not incurred 2,700 minutes annually for the diversion certificates. by large handlers. The stabilizing effects Dated: January 15 , 1998. of the percentages impact all handlers estimated 45 handlers. As with other, similar marketing order programs, Robert C. Keeney, positively by helping them maintain Deputy Administrotor, Fruit and Vegetable and expand markets, despite seasonal reports and forms are periodically studied to reduce or eliminate duplicate Programs. supply fluctuations. Likewise, price information collection burdens by [FR Doc. 98-1429 Filed 1-20-98; 8:45 amJ stability positively impacts all producers by allowing them to better industry and public sector agencies. BILLING CODE 3410-42..P anticipate the revenues their tart This proposed rule does not change cherries will generate. those requirements. USDA has not identified any relevant NUCLEAR REGULA TORY A 15-day comment period is provided Federal rules that duplicate, overlap, or COMMISSION to allow interested persons to respond conflict with this proposed regulation. to this proposal. Fifteen days is deemed 10 CFR Part 50 While the level of benefits of this appropriate because this rule needs to rulemaking are difficult to quantify, the be in place as soon as possible since [Docket No. PRM-o0-63AJ stabilizing effects of the volume handlers are currently marketing 1997-regulations impact both small and large Peter G. Crane; Receipt of an Amended 98 crop tart cherries and this action Petition for Rulemaklng, Extension of handlers positively by helping them should be taken promptly to achieve the maintain markets even though tart Comment Period intended purpose of making the cherry supplies fluctuate widely from optimum supply quantity computed by AGENCY: Nuclear Regulatory season to season. the Board available to handlers. All Commission. Interested persons are invited to written comments timely received will ACTION: Amended petition for submit information on the regulatory rulemaking: extension of comment and informational impacts of this action be considered before a final determination is made on this matter. period. on small businesses.

Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Proposed Rules 3053 Sl.lal,\RY: On December 17, 1997 (62 FR T. Lesar, Office of Administration, U.S. Forrestal Building, Room 1E-190 , 1000 66038). the Nuclear Regulatory Nuclear Regulatory Commission, Independence Avenue , SW, Commission published a notice of Washington, D.C. 20555-0001, Washington, DC 20585, (202) 586-75 74, receipt of an amended petition for telephone: 301--415-7163 or Toll Free: between the hours of 9:00 a.m. and 4:00 rulemak.ing filed by Peter G. Crane and 1-600-368-5642, E-mail: MTL@nrc.gov. p.m., Monday through Friday, except requested public comment on the For the Nuclear Regulatory Commission. Federal holidays. amended petition. In the amended Dated at Rockville, Maryland, this 14th day FOR FURTHER INFORMATION CONTACT: petition for rulemaking, the petitioner of January, 1998. Kathi Epping, U.S. Department of seeks to amend NRC's emergency Annette Vietti-Cook, Energy, Office of Energy Efficiency and planning regulations to require Renewable Energy, EE--43 , 1000 Acting Secretary of the Commission. consideration of sheltering, evacuation, Independence Avenue, SW, and the prophylactic use of potassium (FR Doc. 98-1379 Filed 1-20--98; 8:45 am} Washington, DC 20585-0121, (202) 586-iodide for the general public in BIWNO COOE 759G-Q1-P 7425, email: Kathi.Epping@hq.doe.gov, developing a range of emergency or Edward Levy, Esq., U.S. Department planning protective actions. In addition, of Energy, Office of General Counsel. the petitioner has filed supplemental DEPARTMENT OF ENERGY GC-72, 1000 Independence Avenue, information in support of his amended SW, Washington, DC 20585, (202) 586-petition which is available in the NRC Office of Energy Efficiency and 9507, email: Edward.Levy@hq.doe.gov. Public Document Room. The comment Renewable Energy SUPPLEMENTARY INFORMATION: On period on the amended petition was to October 22, 1997, the Secretary 10 CFR Part 430 have expired on January 16, 1998. In determined, based on the best response to several requests, the NRC has decided to extend the comment d for this action. Energy Efficiency Test Procedures for Distribution Transformers information currently available, that energy conservation standards for electric distribution transfonners are E  : The comment period has been ded and now expires on February 17, 1998. Comments received after this [Docket Number EE-OET ~7-650] RIN 1904-AA85 AGENCY: Office of Energy Efficiency and technologically feasible, economically justified, and would result in a significant energy savings. This date will be considered if it is practical determination initiated the process of to do so, but assurance of consideration Renewable Energy, Department of establishing, by notice and comment cannot be given except to those Energy. rulemaking, test procedures and energy comments received on or before this ACTION: Notice of public workshop. conservation standards for this product. date. The Department of Energy is drafting A.DORESSES: Submit comments to :

SUMMARY

The Department of Energy a proposed rule to implement the Secretary, U.S . Nuclear Regulatory (DOE) will hold an informal public provisions of the Energy Policy and Commission, Washington, D.C. 20555- workshop to discuss issues and gather Conservation Act, 42 U.S.C. 6317, for 0001 , Attention: Rulemakings and information related to test procedures test procedures for distribution Adjudications Staff. for electric distribution transformers. transformers. However, several issues Deliver comments to 11555 Rockville All persons are hereby given notice of have been raised. The purpose of the Pike, Rockville, Maryland, between 7:30 the opportunity to attend this public public workshop is to discuss the a.m. and 4:15 p.m. on Federal workdays. workshop and to submit written following issues for developing the You may also provide comments via comments. notice of proposed rulemaking:

the NRC's interactive rulemaking DATES: The public workshop will be a. Adoption of national and website through the NRC home page held on Tuesday, February 10, 1998, international consensus standards in the (http :/ /www.nrc.gov) . This site provides from 9 a.m. to 4 p.m. test procedures for determining energy t availability to upload comments as s (any format). if your web browser pports that function. For information about the interactive rulemaking website, contact Ms. Carol Gallagher, ADDRESSES: The workshop will be held at the U.S. Department of Energy, Forrestal Building, Room lE-245, 1000 Independence Avenue, SW, efficiency of distribution transformers ;

b. Burden imposed on industry, especially on manufacturers , by additional testing and data processing;

c. The definition of " basic model" for Washington, DC 20585.

301--415-5905; E-mail CAG@nrc.gov. distribution transformers: Written comments are welcome, d. Sampling plan for units to be For a copy of the amended petition, especially following the workshop. write :*Rules and Directives Branch, tested; Please submit 10 copies (no faxes) to: e. Selection of a measure of energy Division of Administrative Services, Ms. Kathi Epping, U.S. Department of consumption for distribution Office of Administration, U.S. Nuclear Energy, Office of Energy Efficiency and transformers: Regulatory Commission, Washington, Renewable Energy, "Energy f. Selecting reference temperatures-D.C. 20555-0001. A copy of the Conservation Program for *Consumer the reference temperatures in the amended petition and other Products: Test Procedures for consensus standards lack uniformity; documentation filed by the petitioner Distribution Transformers, Docket No. g: Requirement for applying are also available for public inspection, EE-DET-97-550," EE-43, 1000 corrections to measurement data of both and copying for a fee , in the NRC Public Independence Avenue, SW, liquid-immersed and dry-types of Document Room, 2120 L Street NW Washington, DC 20585-0121. transformers; and (Lower Level). Washington, D.C. Telephone; (202) 586-7425; Telefax: h . Requirement for quality assurance FOR FURTHER INFORMATION CONTACT: (202) 586-4617. in testing. Michael Jamgochian , Office of Nuclear Copies of the transcript of the public The Department has prepared a paper Regulatory Research, U.S. Nuclear workshop, public comments received, entitled "Issues Paper for the Regulatory Commission, Washington, and this notice may be read (or copied) Distribution Transformers Test D.C. 20555-0001, telephone: 301--415- at the Freedom of Information Reading Procedures Workshop on February 10, 6534. E-mail: MTJ1@nrc.gov; or Michael Room, U.S. Department of Energy, 1998" that explains and discusses these

UNIVERSITY OF CALIFORNIA, SAN DIEGO UCSD DOCKETED BERKELEY

• DAVIS
• IRVINE
• LOS ANGELES
• RIVERSIDE
• SAN JJ~ afu FRANCISCO SANTA BARBARA
• SANTA CRUZ

                                                  '98 JAN 28 P3 :06 DEPARTMENT OF FAMILY & PREVENTIVE MEDICINE                                                         9500 GILMAN DRIVE SCHOOL OF MEDICINE                                                                                 LA JOLLA, CALIFORNIA 92093-062t MAILCODEm (:> (, l-8                           OFFIC t: . ,j* ~E-' q : . *-Hr Secretary                                         RULE \l !..:<il :. . J , ...,,.U January 21, 1998 ADJUOICAr!O 'S .::AFF U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 DOCKET NUMBER PETITION RULE PAM 50-f.o3I\

ATTENTION: Rulemakings and Adjudications Staff ( 1p;;, Fl<.t,i,03'if) @ Re: PRM-5 0-63 I am a physician, on the faculty of a medical school, with primary concerns with the health of families and the role environmental factors play in reproductive outcomes and the growth and development of infants and children . Recent studies have revealed an epidemic of thyroid cancers in children in the Chernobyl region, several years post- meltdown. Experimental studies in animals and clinical studies in Poland where over 10 million children and 7 million adults were administered potassium iodide (post Chernobyl ) provide convincing evidence of the efficacy and safety of community -wide administration of this material. I urge the NRC to modify its regulation, 10 CFR Part 50 to specify that states and licensees include the provision of potassium iodide as a thyroid protecting drug for the general public. I believe this should be implemented on a federal level with uniformity of policy for all the states. The Kemeny Commission Report on the Three Mile Island reactor release recommended that in addition to the original principles of safe siting and design/engineering features, potassium iodide be made available to optomize the protection of public health and safety. So many years have passed, and this recommendation has gone unheeded. I appreciate that the administration of potassium iodide is not a panacea. It will not protect against many of the other radioactive isotopes- cesium 137, strontium 90, plutonium, etc., that could be released, with associated risk of increased leukemia, lung, breast and bone cancer, many years later. But we can do something about protecting against thyroid cancer. And we know that the very young are the most vulnerable. Our best protection is to minimize opportunities for exposure to radioactive materials. In San Diego we have concerns, not only with the San Onofre Nuclear Power Plant in the northern part of our county, but the homeporting of three nulcear powered aircraft carriers right in San Diego Bay. It hardly seems like safe siting to place these nulcear power generators right in the center of California's second largest city, so close to our urban center with its commercial and government offices, and dense inner city neighborhoods. This area also includes our major tourist areas ( the Gas Lamp district, Point Loma and Coronado), and the city's transportation hub- (major airport, Amtrack station and bus and trolley terminals). We know very little about the design and engineering features of our "nuclear" aircraft carriers- because their containment vessels and size are shrouded in scecrecy- justified by the Navy as a "national defense" issue. F'EB.-..... Acknowledged by card ......... - 5,e,,., 1998..., , nee

U. r1 HEGULATORY COMMISSION AU MAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETAR OF THE COMMISSION Document Statistics qg, ark Date _ _/ /....;;_3_,_/__ ____ _ Received ___ /_ _ _ opies Re 1al Distri .

As a physician concerned with protecting the public's health, I urge you to make Potassium Iodide available to all communities around the United States where the potential of radioactive releases exists. Ruth M. Heifetz, M.0., M.P.H. Senior Lecturer Occupaitonal and Environmental Health

1/23/98 Dear Sirs; I live near to Crystal River Unit 3, an aging nuclear plant which is now in its third consecutive 6-month term on the NRC's Watch List. The plant has been shut down for "repairs" since September of 1996. Because of the apparent difficulty in making the plant and its people's performance meet minimum standards, I consider it to be paramount that the emergency plan for CR3 include MANDATORY stockpiling of Kl for distributiion to the general public in the event of a severe accident. respectfully, Gunnar M. Erickson gunnar@fiber-net.com DOCKET UMBER J PR 5o-G,3A ( (G~Ff<. ~lP03'8) (Retrieved from interactive rulemaking website on 01/23/98 -- ATB) Commenter: Gunnar M. Erickson 7010 W. Village Drive Homosassa, FL 34446-2155 8 Acknowledged by card ....... * - 5 1998

I U.S NUCLEAh REGULATORY CO MISSI RUL£MAKING ADJUDICATI SSTAF OFAC O THE SECRETi RY OF THE COMMISSIO Oocum8l1t Sta PonnarkDafl; ~~~ ~ ~ D>'l ,p///9i' Ad(l'I Sr ~/ I - - / -;:>z,e/

"!e{l)S           -

January 26, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher RES. ORA

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment letter related to the Amended - Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 23. 1998. The commenter's name is Gunnar M. Erickson, 7010 W. Village Drive, Homosassa. FL 34446-2155. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

In response to the amended petition for rulemaking - Use of Kl in Emergency Planning, I submit the following comments:

1. Like many other people, I take certain medications to control my blood pressure.

One is a powerful diuretic. Another is potassium chloride - to replenish the potassium leached by the diuretic. On the KCI bottle is a warning not to use salt substitutes containing potassium. If I should avoid salt-substitutes containing potassium, should I take potassium iodide? I asked my doctor. He was unfamiliar with the emergency use of potassium iodide and I couldn't tell him the amount of potassium in the pills.

2. What is needed is information to the medical community, especially cardiologists, and advice from them to you on administering potassium iodide - with appropriate precautions.

3. The NRC should not be agreeing to provide or administer a potentially lethal drug to

- the general populace without sound medical advice, if at all. (Retrieved from interactive rulemaking website on 01/20/98 -- ATB) DUli p PR 5o-'73/t ( (,~ F/2. t,t,03 ~) c._

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• Commenter:

Mary S. Wegner 12205 Bond Street Wheaton, MD 20902 Acknowledged by can1 *--~~---:-~.--.-~:~

U.S. NUCLEAR REGULATORY CO MISSION RULEMAKINGS &ADJUDICATI S STAFF OFRCE OF THE SECRETARY Of THE COMMISSI Doclln8l1 Stati&tic:S PostmlBlk Da'8 ...!.!

                ~ ~~..../12!!.~   ~~ /)'n ,?to/9r

January 21 . 1998 NOTE TO: Emile Julian FROM:

~*G:~~:::::g and ~rvi:es B ;an;~ ~

RES. ORA (ftt1"V ~O

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment letter related to the Amended Petition on Potassium Iodide (PRM-50-63) . This letter was received via the rulemaking website on January 20. 1998. The commenter's name is Mary S. Wegner. 12205 Bond Street. Wheaton. MD 20902. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records .

Attachment:

As stated cc w/o attachment: M. Jamgochian.

Station Support Department PECO NUCLEAR PECO Eneryy Comp;rny 965 Chestertirook Boulevard A Unit of PECO Energy '98 JP,N 26 p 5  :~~re PA 19087 569 1 OI r Af January 15, 1998 Mr. John C. Hoyle D CKET NUMBE:H Secretary of the Commission PETITION RULE PRM 5 o-G.3 A U.S. Nuclear Regulatory Commission Attn: Rulemakings and Adjudications Staff ( I, ~F~ Ii, (,038) Washington , DC 20555-0001

Subject:

Comments Concerning Amended Petition for Rulemaking filed by Peter G. Crane (62FR66038)

Dear Mr. Hoyle:

This letter is being submitted in response to the NRC's request for comments concerning an amended petition for rulemaking which was filed by Mr. Peter G. Crane and published in the Federal Register (i.e. , 62FR66038, dated December 17, 1997). The proposed petition recommends that the NRC amend its emergency planning regulations to include a requirement to consider the prophylactic use of potassium iodide (Kl) for the general public as one of the emergency planning protective actions. PECO Energy appreciates the opportunity to comment on this petition for rulemaking. PECO Energy recommends that the NRG deny this petition. Emergency response programs that are currently in place for nuclear power plants are developed around evacuation, since it provides an effective method for reducing radiation dose. This petition does not demonstrate that stockpiling or predistribution of potassium iodide will add significant public health and safety benefit to the emergency preparedness process currently in place around commercial nuclear power plants. Implementation of the proposed petition would burden the states with unnecessary requirements to reconsider their emergency plans . PECO Energy believes that the current guidance for emergency planning provides the appropriate mechanism for those state and local governments wishing to make Kl available to residents/transients in the immediate vicinity of a commercial nuclear power plant, and therefore, additional rulemaking is unwarranted. Additionally, in 1995, the Federal Radiological Emergency Preparedness Coordinating Committee reaffirmed an earlier position not to advocate widespread stockpiling and distribution of Kl for the general public. A survey at that time indicated that a substantial majority of the responding states opposed the creation of a stockpile of Kl. In June of 1997, the NRC Commissioners voted to support the committee's recommendations. Furthermore, PECO Energy fully supports the Nuclear Energy lnstitute's (NEl's) position and comments concerning this amended petition for rulemaking . FEB - 5 1998 Acknowledged by card ................,.....s,,,,,,,,,w

U.S. NUCLEAR REGUI.ATORY SSIOH AULEMAKINGS &ADJUOICATK.ffi STAFF OFRCE OF THE SECRETARY Of THE COMMISSION OoUnn8tatllllcPf Po5'malk Data - . :':~_,:.w:.,. "-'L-- - - CopieS Racalwad--- - -- - Add' ~ S _ ~ z <<A S . I DistribUtlon~ 17:)S_ r J J ~ J j)~: ~

                                     ~

January 15, 1998 Page2 If you have any questions, please do not hesitate to contact us. Very truly yours, /J. a. #vM~,'r . G. A. Hunger, Jr. Director - Licensing

DOCKETED 1005 Clearview Drive USNRC Middletown, PA 17057 January 17, 1998 "98 JAN 22 PS :28 Office of the Secretary DOCKE N Bl: U.S.N.R.C. p o LE PR 5o-<,,3A-Washington, D.C. 20555 ( ~~ F~ "t,038')

Dear United States Nuclear Regulatory Commission,

Living in the shadows of Three Mile Island I dream of the time citizens know we have a safe secure energy future. I am a wife and mother trying to respond to an accident, and keep my heart and head together. I know the accident happened March 28, 1979, however, the concerns still linger. I found this nuclear power technology to be science without humanity. I think you will find these facts rather staggering: democracy was denied, legal decisions didn't address human needs, and an independent in-depth health study tracking low level radiation affects on humans was lost. How is it possible for all these things to occur? Is power, money and denial justifying GPU Energy and nuclear power? It disturbed me to learn: our American companies are going to sell nuclear power plants to China, GPU can sell TMI, and a foreign company could buy it. TMI and other nuclear plants continue to store spent fuel rods on sight. Where is the safely monitored nuclear waste sight? Why aren't the human concerns for health and safety, truth and justice answered? I remember the "official report" of the TMI Unit 2 accident was based on the core temperature reaching about 2,300 degrees. Viewing the core rubble years later and learning the temperature had reached some where near 5,100 degrees made me wonder, couldn't 2,800 degrees change the quantity, quality, and character of radioactive isotopes? What did the TMI accident and the Cherbynobal disaster teach us? The complexities of this issue are overwhelming and the time needed takes away from my family. It is not an easy subject to talk about. I am sharing and ask for your help to uphold human dignity, respect for life and our environment. My gratitude and support for the petition for rulemaking before the Nuclear Regulatory Commission. Making K 1 part of the nuclear emergency planning to protect the health of American citizens, especially the children, is a welcomed initiative for human dignity. Thank you for your consideration. I would appreciate a written response regarding how you intend to address this matter. Mrs. Linda Braasch F'El3 - 3 1998 Acknowledged by card .....................__

U.S. NUCLEAR REGULATORY ISSI RULEMAKINGS&ADJUDICATIONSSTAFF OFRCE OF THE SECRETARY OF THE COMMISSION Docllnent Statistics Postmark Date ___.,,,__--1--.........- - - - Copies Recalved _ _ _ _ __ _ Add'I Copies Reproduced ---'..,___ __ Spectal Distribution_ Q ~ ~ ~ , ? 1>_.i_,_::E_~)

25343 Maplebrooke Dr. p 50- ~3A- Southfield, MI 48034 Jan. 15, 1998 ( il~ FfJ.i1,0~8) Secretary, U.S. Nuclear Regulatory Comm. ~ Washington, DC 20555-0001. 0 c:... c::O

                                                                 ~     (/)('")

Gentlemen; :z:~

                                                     /     r    ~      :::ofTl ram   writing in response to ~our request for*                     ("")-,

rr, comments on Docket No. PRM-50-63A, the request PY -0

                                                                \J'l CJ Peter G. Crane for amendment of Petition PRM-~~6_3 .            N
                                                    .,.,   ~    \0 I support the amendment, believing that it could expedite setting the rule for provision of stockpiles of potassium iodide for emergency use .

Potassium iodide has been proven to be effective in protecting against thyroid cancer and other ill-nesses in case of a nuclear accident. Ideally, such stockpiling woul.d be a mandatory protective measure. Please consider favorably the original. petition with or without the amendment. The aging of our nu-clear facilities suggests greater probability o! accidents, and the safety of the public should out-weigh any considerations of damaging the image of the: nuclear industry. Sincerely,

                                   ~-~'tZ1.>.J.J Edi th B. Phill.i-p-;  -r-FEB - 3 1998 ca

U.S. ,,.~,_,...." EG RUILEMAKIN & F OF THE CONIMISlSION

DOCKET NUMBER DOCKETED PETlTIO A LE PR 5o--'7 3A USNRC (~iFl<lll'1o3<il) (o'2S, -:1) cA.) I ~ C,{-{Ltr

                                       '96 JAN 21 P1 :41 Q:3 es '+ianPsrtAJ;>

"9£.le UPR._ ~w.t~~ (b-nm1~ ,. ;:__ ~ Rio Le-DO, DI/ 43fu~ AULt. .*~ I D -r,.. l .... /J..t/ q h ADJUDlCA I I ), ~; ' AFF c.J,--...- . "'t" 1S R0: '"boc/4-r 100. PR.rn ~0-b"3>-A-

U.S. NUCL

• RREGULATORY COMMIS I RULE ~ ' S JU CATIONS STAFF OF ECRETARY

                   ~l5SION

J ~ P. O'HANLON Innsbrook Jechnical Center Senior Wee President 5000 Dominion Boulevard Glen Allen, Vflginia 23060

                                                                                 ~273*3551 DOCKE f tu USNRC January 12, 1998 D (., t.

PETITJ A PRM 5o-<o3A

                                                                   '98 JAN 21 I      :51 Secretary                                 (<,~Fl!. lo"1038        QFFIC' *

• VIRGINIA POWER U.S. Nuclear Regulatory Commission ~ AUL_ '. I 1 Washington, DC 20555-0001 ~ ADJUO '\JP Serial N"d.1§7-240 MWH/RO Attn: Rulemakings and Adjudication Staff Request for Comments: re: Amended Petition for Rulemaking Filed by Mr. Peter G. Crane This letter provides Virginia Power's comments regarding the amended petition for rulemaking filed by Mr. Peter G. Crane [i.e, Federal Register/ December 17, 1997, Vol. 62, No. 242, p. 66038). The petitioner has requested that the Nuclear Regulatory Commission (NRC) amend its regulations concerning emergency planning corrective actions to require explicit consideration of 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 explicit consideration of the option to use potassium iodide is included in emergency planning.

Virginia Power disagrees with the petitioner, and respectfully recommends that the NRC deny the petition. We believe that a federal requirement to require explicit consideration of the prophylactic use of Kl will not significantly increase the level of protection of the public's health and safety which is currently provided through existing regulation . Our reasons for recommending that the NRC deny the petition are as follows:

1. 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.

2. 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.

Acknowledged by F'EB .. 3 19

RYCOMMISS CATIO STAFF ECRETARY

Secretary January 12, 1998 Page 3. The current "Federal Policy on Distribution of Potassium Iodide for Use as a Thyroidal Blocking Agent" provides sufficient guidance to state and local governments. This policy recognizes 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.

4. The Commonwealth of Virginia Radiological Emergency Response Plan (COVRERP) contains specific provisions regarding the procurement, storage, and use of Kl. The Kl options have been specifically considered by the Commonwealth and are addressed by the COVRERP. The COVRERP stipulates that:

• (a) Kl tablets be available for local and State emergency workers, (b) The responsibility for the care of institutionalized persons includes the utilization of Kl, and (c) Supplies of Kl are not available for the general public.

The Commonwealth of 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. In summary, Virginia Power recommends that the NRC deny the proposed amended petition and that the NRC retain the current policy which provides adequate protection of public health and safety. In addition, Virginia Power fully endorses the comments sent separately to the NRC by the Nuclear Energy Institute. We appreciate the opportunity to provide comments on this petition for rulemaking. Should you have any questions, please contact me. Very truly yours, James P. O'Hanlon

Secretary January 12, 1998 Page cc: Mr. Arthur S. Warren Chief, Radiological Emergency Response Planning Branch 10501 Trade Court Richmond, Virginia 23236-3713 Mr. Les Foldesi Bureau of Radiological Health Room 240 1500 East Main Street Richmond, Virginia 23219

• Mr. Alan Nelson, Senior Project Manager Nuclear Energy Institute 1776 I Street N.W., Suite 400 Washington, DC 20006-3708

Detroit Edison Fermi 2 6400 North Dixie Hwy Newport, Michigan 48166 (313) 586-5300 DOCKETED USHRC ~f Nuclear Generation

                                                           '98 JAN 20 PS :42 OFFIC      ,*_.

RULE. "I ~.I ,! .. .....,' ADJUD'.~ '., Ir' ., . ! F OCKET BER January 16, 1998 PETI 10 RU PRM 50-b3A NRC-98-0030 ( {p;).ff<IJ,t,D38) Secretary U. S. Nuclear Regulatory Commission Attn.: Rulemakings and Adjudications Staff Washington, D. C. 20555-0001

References:

1) Fermi 2 NRC Docket No. 50-341 NRC License No. NPF-43

2) 10 CFR SO Peter G. Crane; Receipt of an Amended Petition for Rulemaking, 62 FR 6603 8, dated December 17, 1997.

Subject:

Detroit Edison's comments on Peter G. Crane's Amended Petition for Rulemaking, 62 FR 6603 8, dated December 17, 1997 Detroit Edison has reviewed the proposed petition and conferred with the Michigan State Police Emergency Management Division on the subject. The amended petition recommends that the planning standard for protective actions require explicit consideration of the prophylactic use of potassium iodide (KI) for the general public. Detroit Edison strongly urges the NRC to deny the petition. KI 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 action to protect the public in an accident involving these releases. Additionally, the pre-distribution of KI to the public might create a false sense of security and undermine the effectiveness of an evacuation order, and could also pose a health risk to those who are allergic to potassium. FEB - 3 1998 Acknowf edQed by card ............ ,,. t * --

ON FF

NRC-98-0030 Page2 We appreciate the opportunity to comment on the proposed petition. If you have any questions, please contact Mr. Kevin Morris at (734) 586-4327. Sincerely, O~i~;-rn

                                               /4~rman K. Peterson Director - Nuclear Licensing cc: A. B. Beach B. L. Burgess G. A. Harris A. J. Kugler

D KEf NUMBER PETI ION PRM 60-IP3/r DOCKETED TO: U.S.NRC (fG:).f~~lt,031) u~~mc FROM: GARY W. McNUTT MISSOURI DEPARTMENT OF HEALTH '98 JAN 20 P5 :24

SUBJECT:

KI DISTRIBUTION FED. REG. 66038 - DECEMBER 17, 1997 OFFIC, *-,, . ~_.: __, 1 . *,. q RULE. ,I', \,i I ,  ; /- ) ADJUD:SA - CI\. ' A :F IT IS THE POLICY OF THE DEPARTMENT OF HEALTH THAT KI NOT BE STOCKPILED FOR DISTRIBUTION TO THE GENERAL PUBLIC. IT IS OUR OPINION THAT EVACUATION IS MORE FEASIBLE AND PRACTICABLE. STOCKPILING OF KI HAS LOGISTICAL PROBLEMS WHICH WE FEEL RENDERS THIS IDEA IMPRACTICABLE AND UNMANAGEABLE. WE URGE THE NRC TO DENY THE PETITION FILED BY MR. PETER CRANE. WE APPRECIATE THIS OPPORTUNITY TO COMMENT ON THE AMENDED PETITION. (retrieved from interactive ru1emaking website -- ATB) Commenter: Gary W. McNutt Missouri Department of Health P.O. Box 570 Jefferson City, MO 65102

                                                                                       -3      ~  a card ........................_,........

Ackrl wt ced

. NUCLEAR REGULATORY COMMISSIO ULEMAKI 1GS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION slmalkD * ~ .e..,.._ ~~ tm 1/20/q I' pies Rece* __ - - ~- - - - - d'I Cooies Reprod 1rAd _ _,___ __ ~ t,ft,,

              . __cc,.._ _ _

January 20. 1998 NOTE TO: Emile Juli an Chief. Docketing and Services Branch FROM : Carol Gallagher RES. ORA

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment letter related to the Amended Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 16, 1998. The commenter's name is Gary W. McNutt. Missouri Department of Health. P.O. Box 570. Jefferson City, MO 65102 . Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records. Attachment : As stated cc w/o attachment: M. Jamgochian

ENVIRONMENTAL ~EALTH COALITION 1717 Kettn~r Boulevard, Suite l 00

• Sao Diego, CA 92101 * (619) 23:{300\i E:1':-fiD (6 I 9) 232-3670 e-mail: ehcoalition@igc.apc.org
• Web address: http://www.envircu\ Q health .org "98 JAN 20 PS :21 Board of Directors OFFl(L ' -. *:_- . \ . I ~H Beatriz Barraza.Rap~. President RULt: .Ii.. 1 .l _, i_:J:J Coh1borati'tlo SABER 1r- t,T\r*, ....; ..., 1, ::i, F Sfiaron Kalemkiarian, Vice President ADJUD _;r'.i ..._,

Project Heartbeat,.San Diego January 16, 1998 County Bar Association DOCKET NUMBER Tony Pettina, MA, Treasurer S.D. Community College District Mr. John C. Hoyle PETITION R E PAM 5D-'=,3A Richard Juarez, Secretary Secretary, U.S. Nuclear Regulatory Commission M.A.A.C. Project Washington D.C. 20555-0001 ( {p'J.f~{p(,03'if) Jose Bravo Southwest Network for En'tltron-mentll and Economic Justice Scott Chatfiel'd ATTN: Rulemakings and Adjudications Staff Eagle 94.1*FM Ac Cummings

Dear Mr. Hoyle:

.athan Cummings Foundation Felicia Eaves Girl Scouts. San Diego-Imperial Council Environmental Health Coalition (EHC) is a San Diego-based private Paula Forbis non-profit environmental justice organization that works to reduce illness EHC Staff Representative caused by toxic chemicals in the. home, workplace, and environment. Elizabeth Gill Margaret Godshalk Please consider our situation. San Diego Bay is already a homeport for a-; National School District many* as 15 nuclear submarines and soon may be the homeport for up to Ruth Heifetz UCSD School of Medicine four nuclear powered aircraft carriers (two nuclear reactors each on-board) Jose Lamont Jones and transient carriers. This intense concentration of nuclear reactors is C.H.U.M., UCSD School of Medicine located within one mile and upwind of downtown San Diego. The Lyn Lacye residential City of Coronado is located directly adjacent to the nuclear Project Wildlife Dan McKiman, Ph.D. carrier homeport and includes radioactive waste storage and nuclear repair UCSD School of Medicine facilities. Coronado is essentially an isfand and, in the event of an Mark Mandel emergency,.would be virtually impossible to evacuate. The risk of a aashi Company . .Palomino release from these multiple nuclear sources so close to millions of people Community Organizer is a significant threat to our health and well-being. Because all of these Jay Powell Michael Shames nuclear power sources are regulated under the Naval Nuclear Propulsion Utility Consumers Action Network Office, the public is denied full information about their operations and Norma suµivan San Diego Audubon Society releases. Afti/i11tio11s m>tedfi;,-_ ide,11/fici1tim1 purposn ,111/y EHC supports the stockpiling of potassium iodide (KI) as a minimal Executive Director protective measure so that our residents have some protection in the event Diane Takvorian

• of a release of radiation, provided the public is even notified. We ask you to ensure that Emergency Planning Zones around Naval nuclear reactors Mission Statement are established and disclosed -to the public and that KI is distributed to Environmental Health Coalition is residents in those areas. We further encouraged you to require that dedicated to the prevention and disclosure laws that apply to commercial reactors are also should applied cleanup of toxic pollution threatening our health, our communities, and the to Naval nuciear reactors so that neigh~ors of Naval reactors do not suffer em*ironrnent. We promote environ- less protection than neighbors of commercial reactors.

mental justice. monitor government aml industry actions that cause pollution, educate communities about Releases of radiation from Naval nuclear sources is not hypothetical, it has toxic hazards and toxics use reduction, and empower the public to join our c::mse . FEB - 3 1998 Printed on towly chlorino free paper Acknowledged by card ..................,.......,,.,.."...,.... with aovhaoed inks... - - . . ,

U.S. NUCLEAR REGULArDRY COMMISSIO RUL s.

                    !CATI I :rAfF
                    *cRETAR ISSION Po~ ark Oat:   ~  LL en '(.?.o    '18' Copies Recei      J_____

Add'I Cnpies Re Spe ial istn * ,--

happened. The neighbors of such accidents should be notified and provided with protection to the extent possible. KI is one measure of that protection. Thank you for the opportunity to comment on this issue. ura Hunter, Director Clean Bay Campaign

R REGULATORYCOM 11S810 S ADJUDICATIONS STAF,- T ESECRETARY

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North DOCKETED North Atlantic Energy Service Corporation Atlantic us~rnc P.O. Box 300 Seabrook, NH 03874 (603) 474-9521

                                      '98 JAN 20 P5 :42                The Northeast Utilities System DOCKET NUMBER PETITION RULE PAM 5o-~ 3A-                                               January 15, 1998 (c,, Ff<l,l., 03ff)                                                  NYN-98006 AR# 98000240 Secretary Rulemakings and Adjudications Staff U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Seabrook Station Comments on Amended Petition For Rulemaking [Docket No. PRM-50-63A]

North Atlantic Energy Service Corporation (North Atlantic), managing agent for the Joint Owners of Seabrook Station Nuclear Power Plant, supports the Nuclear Energy Institute's (NEI) 1 2 comments on the Peter G. Crane amended petition for rulemaking . North Atlantic joins NEI in opposing the amended petition. North Atlantic staff members have discussed the amended petition with emergency management officials of New Hampshire and Massachusetts (the two states in the 10-mile emergency planning zone for Seabrook Station). North Atlantic and they agree that the existing federal policy on use of potassium iodide, that has been in place since 1985 and was recently re-affirmed by the Federal Radiological Preparedness Coordinating Committee in 1995, is adequate and should be maintained. The proposed change to 10 CFR 50.47(b)(l0) should be denied. North Atlantic appreciates the opportunity to comment on the amended petition. If you should have any questions on North Atlantic's comments, please contact Mr. Donald R. Tailleart, Emergency Preparedness Manager, at (603)773-7359. Very truly yours, NORTH ATLANTIC ENERGY SERVICE CORP. ed C. Feigenbaum Executive Vice Preside Chief Nuclear Officer Acknowfedged by card .*~ - 3 1998 1 Letter from Alan P. Nelson, Nuclear Energy Institute, to John C. Hoyle, U.S. Nuclear Regulatory Commission, dated December 22, 1997. 2 Peter C. Crane Amended Petition for Rulemaking [Docket No. PRM-50-63A].

U.S. NUCLEAR REGULATORY CON,. t~j-1iv* R LEMA INGS & ADJUDICATIO ~ TAH OFFI EOF THE SECRET'. . ' THE C M ISSION eot 8. * 'sties L l<o/'18_ _ Copie "ce'ved _ _....,I'--+ _ _ __ A d' Cop.OS Reproduced - -- ~ - - ct~ 'j>-j,?ciftt* ",

U.S. Nuclear Regulatory Commission NYN-98006/Page 2 cc: W. P. Fogg, Director Office of Emergency Management State Office Park South 107 Pleasant Street Concord, NH 03301 P. G. LaPorte, Director Massachusetts Emergency Management Agency PO Box 1496 400 Worcester Road Framingham, MA 01701

E.b ~:r; i\la ....i:rsmrP Project,

.\n 1./J/S()\ l\li./1\ . \//()\ \/. C"' " I' ' ""
                                                                                           '98 JAN 20 A11 :15 January 15, 1998 Secretary, U.S. Nuclear Regulatory Commission Attn: Rulemaking and Adjudications Staff Washington, D. C. 20555-001 DOCKET NUMBER

Subject:

Southern California Edison (SCE) PETITION RULE PAM 50 - 3A Comments on Amended Petition for Rulemaking ( ~ ~ PR t.,t,o3i Filed by Mr. Peter G. Crane (62 Federal Register 66038 - December 17, 1997) Gentlemen: The subject Federal Register notice requested comments on an amended petition for rulemaking regarding the planning standard for the NRC s emergency 1 planning regulations. The amended petition, if adopted by rulemaking, would require states to document why they choose not to distribute potassium iodide (KI) to the public. SCE has reviewed the amended petition and discussed this matter with the State of California Office of Emergency Services and Department of Health Services. This letter provides our comments on the amended petition. We believe the rulemaking requested in the amended petition would add no benefit to existing emergency plans or an increase in the public health and safety. However, it does add the burden of additional documentation associated with reconsidering existing plans which have provided reasonable assurance for the protection of public health and safety for many years and are considered to be based on the best technical information. In addition, we believe that stockpiling or predistribution of potassium iodide (KI) 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 California's 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 KI is present when predistributed to the general public, and incidents of misadministration have been informally reported at industry meetings by states which predistribute KI to the public. Sun Onufrc Nucb11* Cc*11c-ra ting Station P. 0. l\u, 12~ Sa n Clc*mc*ntc*. C:\ ll 2L>7 -t-OI 2ts 7 l -t -3b~- HLJ2 F,tX 7 1-t- )0~-7575 Acknowledged by card ...f!~...~..~.. J2~8,v-.,

U.S. NUCLEAR REGULATORY CO .,~;__ 10 1 LEMAKINGS& ADJUDICATIC S STAFF OFFICE OF THE SECRETARY F THE COMMISSION nt Strlti ti~ Postman< Date _Jf~ 4£A,~ ~ ,j:;,o /9K Coples Reooived _ _____.~- -- Add'I Co les Reproduc JO~ ~, Distribution

.di.~         , ~ - --~...-- - --

Secretary, U. S. Nuclear Regulatory Commission The Federal policy, published in 1985, does not recommend requiring that KI be stockpiled or predistributed to the general public. This position is based on the best technical information which indicates that prompt evacuation and in-place sheltering are the preferred protective actions for the general public. In 1997, the NRC revised its position to fund the purchase of KI for states at their request. In this revision, the NRC did not revise or invalidate the technical basis of the existing position. The basis for the revision was the recognition that since the state and local governments bear ultimate responsibility for protection of their citizens, NRC would allow the decision for local stockpiling and use to be made at the local level. The State of California Emergency Plans also includes a policy on potassium iodide. This policy does not recommend predistribution of KI to the general public. The amended petition does not provide any new information or justification for the additional burden of requiring states to reconsider their emergency plans. Given the demonstrated strength of current emergency preparedness programs, we urge the NRC to retain the current policy and request that the NRC deny the amended petition. Should you have any questions, please contact me at 714-368-7492. V cc: E. W. Merschoff, Regional Administrator, NRC Region IV K. E. Perkins, Jr., Director, Walnut Creek Field Office, NRC Region IV M. K. Webb, NRC Project Manager, San Onofre Unit 1 M. B. Fields, NRC Project Manager, San Onofre Units 2 and 3 Louis Carson, Regional Project Inspector, San Onofre Unit 1 J. A. Sloan, NRC Senior Resident Inspector, San Onofre Units 2 & 3

s. s. Bajwa, Section Chief, Decommissioning Section

BRUCE SMITH, MEMBER HOUSE POST OFFICE BOX 202020 MAIN CAPITOL BUILDING HARRISBURG, PENNSYLVANIA 17120-2020 COMMITTEES

                                                                                                  ~#-DFISHERIES, DOCK      C. M'AJ:~TY CHAIRMAN DISTRICT OFFICE:

540-B INDUSTRIAL DRIVE us NA~ CULTURE AND RURAL AFFAIRS LEWISBERRY, PENNSYLVANIA 17339

                                                                                    '98 JAN     'fflNr~PA~PUBLJCAN TELEPHONE:

LEWISBERRY: (717) 938-4988 J-/ouse of !Rt,presentatives '-4::AVciJS ~IRMAN YORK: 1-800-283-1708 COMMONWEALTH OF PENNSYLVANIA HARRISBURG: (717) 783-8783 HARRISBURG  :< 1 -:Jir

                                                                                                         ,...,hJD s-AFF DOCKET NUMBER Secretary, U. S. Nuclear Regulatory                                          PETITION RULE PAM 50-ft;3A Commission, Washington, DC 20555-0001 (re~ Fl< t,t,038)

Attention: Ru1emaking3 and Adjudications Staff. e Mr. John C. Hoyle, Secretary U. S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63

Dear Mr. Hoyle:

I strongly support the Nuclear Regulatory Commission stockpiling of Potassium Iodide to protect the health of the people during a nuclear accident. This issue is particularly important to me because I personally testified before the President's Commission on the Three Mile Island Accident. You are obviously aware that the Nuclear Regulatory Commission promised to stockpile Potassium Iodide after conducting the hearings on the Three Mile Island accident. As a member of the Pennsylvania House of Representatives, I willingly volunteer to work with other legislators and the administration to encourage Pennsylvania to develop a model program for stockpiling and/or distribution of the tablets. ' In the Central Pennsylvania area surrounding Three Mile Island, residents are acutely aware of the possibility of an accident at a nuclear power plant. These residents and my constituents are also aware of the promises made by the Nuclear Regulatory Commission after their visit to our area. During my eighteen years in the Legislature, I have learned that the most important responsibility of government is to keep its promises to the people. I firmly believe that the Nuclear Regulatory Commission should keep its promise to the people of Central Pennsylvania and pass the proposed rule. Sincerely, (ljfl),Vc..--11/ Bruce Smith Acknowledged by card ...f.!:i~~ J . . Ji~

U.S. NUCLEA~ REGULATORY COMMISSION

         ..MAKINGS & ADJUDICATIONS STAFF FFICEor T' ,:- C"'.CPi::TARY OF THE COMM 1SSrON Oocoo *~        ,ti~ti" Poamark Date _           ' / 1'-1 / q '8' __ _

Coples Received __ I_ u - - - Atid'I Coples Rep~rc ""'~ ial Dlstribuuo, ~ ,- ~ ~ -.1-

    ~           - . ___ ~I          l~S- ~

DOCKETED us~rnc IIID Tennessee Valley Authority, 1101 Market Street, Chattanooga, Tennessee 37402-2801

                                                                                       '98 JAN 20 A11 :15 January 14, 1998 00 l<ET NU~, ER P 1TION RUL. - *. ', i O.-.lP3 If

( (p:J. FR. bl, o 3 8) U.S. Nuclear Regulatory Commission ATTN: Rulemakings and Adjudications Staff Washington, D.C. 20555-0001 Gentlemen: NUCLEAR REGULATORY COMMISSION (NRC) - REQUEST FOR PUBLIC COMMENTS ON AMENDED PETITION FOR RULEMAKING FOR 10 CFR 50.47, "EMERGENCY PLANS" (62 FR 66038) The Tennessee Valley Authority has reviewed the amended petition for rulemaking filed by Peter G. Crane and continues to support denial of the petition. This position is based on nearly two decades of experience with the inclusion of potassium iodide in the Radiological Emergency Plans for the states of Tennessee and Alabama. Existing guidance on storage and use of potassium iodide provides state and local governments with sufficient information to protect the health and safety of the general public. The proposed rule revisions requiring documentation of the rationale for decisions would add an unnecessary burden on the states with no gain to public health. Furthermore, the requirements would provide an additional barrier to future changes.

                                                                                                         - 3 1998 Printed on recycled paper Acknowledged by card ..- *.- ---"""'

            ... JJt REGULATORY COMMISSION
       ..,A!<I GS& A... *uc:"z'"I'" ' .:', SSTAFF OFRCEOFT,~- S                  .uY OFTHE C,.); . . : N

. oS1m&rk Date * ~.,__g_____ Copies Recaivoo ___ I _ _ _ _ Add'I Copies Reproduced_ _ _ _ . _ Soecial Dlstribution_h _ , ~ ~ - I- - - - """"----

U.S. Nuclear Regulatory Commission Page 2 January 14, 1998 We appreciate the opportunity to respond to the proposed rulemaking. If you would like to discuss our comments further, please contact Everett Whitaker at (423) 751-6369 or email ewwhitaker@tva.gov. Sincerely, ?:!r-!j.~~- Manager Nuclear Licensing cc: U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C. 20555

DOCKET NUMBER DOCKETED PETITION RULE PAM 5 o-- '13 A US NR C January 13, 1998 ( (Q,:;. FR. ii,t,038)

                                                                  '98 JAN 20 Al 1 :15 COMMENTS    OF OHIO CITIZENS FOR RESPONSIBLE ENERGY o ~ ~ .--- ("~CRE _"). _.

ON PRM-50-63A (62 FR 66038, DEC. 17, 1997) Ru,*E**!-;:, L.. I 1

                                                                                *1,'*;-__ *- *,,\o.l,d
                                                                                 ,   ._.,.   , -.. \ ;

ADJUD11_*;-;r1c ~-: -;-,~FF Mr. Peter Crane has amended his petition for rulemaking such that 10 CFR 50.47(b) (10) would require consideration of the use of KI as a thyroid blocking agent. OCRE believes that the benefits of KI are sufficiently compelling that its inclusion in emergency planning should be mandated. OCRE is concerned that the states, which are responsible for emergency preparedness, have shown excessive hostility to KI. Indeed, the nine states which submitted comments on Mr. Crane's original petition were all opposed to it, often using remarkably similar arguments against the use of KI. It is unlikely that states with such deep-seated opposition to KI would become recep-tive to its use. The facts favoring the stockpiling of KI are quite clear and convincing: Radioactive iodine, which can be released in a nuclear reactor accident, concentrates in the thyroid gland, and can cause thy-roid cancer and other thyroid disorders. KI, if taken in time, can prevent the uptake of radioactive iodine by the thyroid gland. The President's Commission on the Accident at Three Mile Island (the Kerneny Commission) recommended the stockpiling of KL After the Chernobyl accident in 1986, KI was used successfully in Poland, with very few side effects, thereby preventing the high rates of childhood thyroid cancer now being observed in the former Soviet Union, where the distribution of KI was inadequate and untimely. l FEB - 3 1998 Acknowledged b card .................,.-trUl!JJJJ

 .S. NUCLEAR REGULATORY COMMISSION Hlll.EMAKINGS & ADJUDIC JIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postnark Date      I 1'I }'I i Coples Received _ __ _ _ __

Add'I Copies Reproduced - ::i:.-- - - ~ ? al Distribution ~?:HJ, * . . , _,

~<&,         n~s **

The U.S. Food and Drug Administration has declared KI to be "safe and effective" for use as a thyroid blocking agent, and it is available as a non-prescription, over-the-counter drug. The American Thyroid Association and the World Health Organiza-tion both encourage the stockpiling of KI for use by the general public in a radiological emergency. Most industrialized countries, including France, Germany, Bela-rus, Russia, Switzerland, Austria, the Czech Republic, ,Japan, Great Britain. Sweden. and Slovakia, now protect their citizens with stockpiles of KI. The United States has debated this issue long enough. It is time for this country, which should be the world leader in public health policies, to join the rest of the civilized world in protecting the public from radiation-induced thyroid disease with a stockpile of KI. Its use in radiological emergency planning should be mandated. Sincerely, Susan L. Hiatt Director, OCRE 8275 Munson Road Mentor, OH 44060-2406 440-255-3158 email: susan.hiatt@hamradio.org 2

~    Duke                                                                   Duke Power Company A Duk, Energy Company r-Power. .                                          DOCKETED                 EC07H
   .A Dulu E1tt1f:f Company us~mc                   526 South Church Street P.O. Box 1006 Charlotte, NC 28201-1006 M. S. Tuckman Executive Vice President                   '98 JAN 20 A9 :43            (704) 382-2200 OFFICE Nuclear Generation                                                      (704) 382-4360 FAX January 5, 1998 DOCKET NUMBER Secretary U. S. Nuclear Regulatory Commission                              P TfO RULE PAM 5o- 63 4 Washington, DC 20555-0001                                            ( f.,;21-'ie (,,t,038) ~
                                                                                                                  ~

Attn.: Rulemakings and Adjudications Staff

Subject:

Amended Petition for Rulemaking Filed by Mr. Peter G. Crane (62 FR 66038, December 17, 1997) Docket Number PRM-50-63A Duke Power Company wishes to offer the following comments on the amended petition for rulemaking filed by Mr. Peter G. Crane (62 FR 66038, December 17, 1997). Consideration of 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. The current "Federal Policy on Distribution of Potassium Iodide for Use as a Thyroidal Blocking Agent" provides sufficient 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. Duke Energy believes that state and local authorities should be left free to determine whether stockpiling is needed for a particular site. Yours truly, JfJf\~~ M. S. Tuckman MST/EMK/emk F'EB - j 1998 Acknowledged by card ........,,..""". t,*.-.,.....,.,., .*~

U.S. NUCLEAR REGULATORY MfSSI RUlEMAKINGS &ADJUDICATIONS STAFF OFRCE Of THE SECRETARY OF THE COMMISSION Doalnent S1atlstJcs _ _ _t r _ Ji~"-. -_-: - Ree&lllad ~ ~~~  :,-=-~

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~eL,b, ~ 1/.!;"7~

bee: L. A. Keller

s. R. Christopher J. s. Mooneyhan M. D. Thorne E. M. Kuhr D. Crisp (NC-DEM)

J. James (NC-DRP) R. w. Duggleby (SC-EPD)

s. J. Threatt (SC-DHEC)

A. P. Nelson (NEI) ELL NEP File # 430

DOCKETED USNRC

                                                             '98 JAN 20 A9 :43 117 Market St.

New Cumberland, PA 17070 rNO 15 January 1998 0~'AFF DOCKET NUMBER Office of the Secretary USNRC Fil I N RULE PRM 5o-,3t1 Washington, D.C. 20555 ( (e)'2FRG,"o3rj

DearSir,

Living the immediate evacuation area of Three Mile Island, I feel compeled to write in support of the petion being heard at the current time requiring the stockpiling of potassium iodide as a prophylactic against thyroid cancer that will occur as the result of releasing radioactive iodine into the atmosphere during a nuclear accident. Having little confidence in the veracity or accuracy of data coming from the NRC I have taken it upon mysepf to seek out and store my own supply of KI for myself, friends and family. Potassium iodide is a very modest investment to protect us the tax payer ( the Golden Calf) AND may even help to build confidence in the safety of nuclear technology . It would also show the industry is taking all responsible me-asures to diminish risks. I believe that radiation protection for American Children should be top pri-ority. I also believe that the NRC should keep the promises made at the time of the Thr ee Mile Island "incident" ... making KI a mandatory part of nuclear emergency planning. Sincerely Yours, 1 /Jr ~ ~ Barbara Stephens m ___ Acknowledged by card ......... - J 1998 _..

U.S. NUCLEAR REGULATORY COMMISSIO RULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Oocwnent Statistics

• DOCKETED USNRC

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U. . UCLEAR REGULAli RULEMAKINGS &ADJ OFRCEOFTHE OFTHE Postmark Date - ~:.lo,,J,...,.......___ Cop1 A d'I

DOCKETED USNRC "98 JAN 20 A9 :26 Log # TXX-98011 File # 10185 1UELECTR/C" January 16. 1998 DOC ET NUMBER PEllTION RULE PAM 5 O* /, 3 A Mr. John C. Hoyle ( <, ':J F~ t,C,03 8' Secretary U. S. Nuclear Regulatory Commission Washington, DC 20555 ATTENTION: Docketing and Services Branch

SUBJECT:

COMANCHE PEAK STEAM ELECTRIC STATION (CPSES) DOCKET NOS. 50-445 AND 50-446 COMMENTS ON AMENDED PETITION FOR RULEMAKING FILED BY PETER G. CRANE REF: 62 FR 66038 - December 17, 1997

Dear Mr. Hoyle:

TU Electric recommends that the NRC deny the amended petition filed by Mr. Peter G. Crane that requests the NRC amend its regulations concerning emergency planning to require consideration of sheltering, evacuation. and the prophylactic use of potassium iodide (KI) for the general public in developing a range of emergency planning protective actions. TU Electric also endorses the detailed comments being provided by the Nuclear Energy Institute (NE!) on the subject Federal Register Notice. With respect to consideration of the use of KI, the current federal policy, formulated by the Federal Radiological Preparedness Coordinating Committee (15 federal agencies) in 1985 regarding stockpiling and distributing KI 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 KI. TU Electric's recommendation to deny Mr. Crane's petition is not based on concern for KI's initial and periodic replacement costs. Potassium iodine is relatively inexpensive at approximately a dollar per a bottle of fourteen 130 mg tablets. Our recommendation to deny Mr. Crane's recommendation to make potassium iodide available to the public is based primarily on our belief that the most effective protective measure for the public would be their evacuation. On the basis of EPA-400, "Manual of Protective Action Guides and Protective Actions for Nuclear Incidents". evacuation should take place when the projected dose (whole body and organ

                                                                                       ~B - 3 1998 P. 0. Box 1002 Glen Rose Texas 76043 Acknowledged by card...................... . .....

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS &ADJUDICATIONS STAFI= OFACE OF THE SECRETARY OF THE COMMISSION Document Statistics

TXX-98011 Page 2 of 2 or TEDE and CEDE) would exceed one (1) rem. The same document recommends ingestion of stable iodine only if the projected dose (CEDE) would exceed 25 rem and would require the approval of the state medical official. The State of Texas currently does not recommend the use of KI by members of the general public, and Texas neither supplies nor will administer KI to members of the general public. Instead, the Texas Department of Health recommends that persons in areas affected by an accidental release of radioactive materials follow the advice of local officials and evacuate or seek shelter when instructed to do so. TU Electric recommends that the NRC consider the following: o Mr. Crane's advocacy of the consideration of potassium iodide predistribution is likely to be perceived by the public as an all-purpose means for self protection for all physical and chemical forms of radionuclides. The public may believe that the first choice for self protection for any projected radionuclide exposure is taking potassium iodide, which may lead to a false sense of security. o To be an effective thyroid blocking agent, KI (non-radioactive iodide tablet) should be taken prior to inhaling radioactive iodine. It is unlikely, regardless of the extent of predistributed KI within the plume exposure pathway, that determining the need for and distributing KI to the individuals will occur in time to be effective. The present regulations and the current federal and state guidance adequately address the concern and considerations for protection of the public. Sincerely, (!!!_ £ ~ C. L. Terry By:i(.?t\~~~ Regulatory Affairs Manager CLW/clw c - Mr. Alan Nelson, NE!

~ ENTERGY DOCKETED USN C Entergy Operations, I n c . @ PO Box 31995 Jackson. MS 39286-1995 Tel 601 368 5760 Fax 601 368 5768

                                                                                                              ')

c,s / Ci Jerrold G. Dewease "98 JAN 20 A9 :26 Vice Presirlent Opera1 1011s Suppor* January 14, 1998 DOCKET NUMBER Mr. John C. Hoyle PETITION RULE PAM 5 O* '13 A-Secretary, U.S. Nuclear Regulatory Commission ( <, 'J-FR <,,t., 03~ Washington, D.C. 20555-0001 ATTN: Docketing and Service Branch

Subject:

Petition For Rulemaking Filed By Mr. Peter G. Crane (60 Federal Register 58256 - November 27, 1995) CNRO-98/00001

Dear Mr. Hoyle:

On February 12, 1996, Entergy Operations, Inc. (Entergy) provided comments to the NRC staff concerning the Petition For Rulemaking filed by Peter G. Crane. Since the time Entergy provided these comments, there have been additional activities on this issue. Entergy Operations has reviewed public records associated with these additional activities and continues to have the following comments: We believe the current "Federal Policy on Distribution of Potassium Iodide for Use as Thyroidal Blocking Agent" provides the state and local agencies with sufficient guidance and direction to adequately determine the need for and use of potassium iodide. The current policy ensures that these agencies "consider" the use of potassium iodide during the development of emergency plans that initiate actions to protect the public. In addition, Entergy beiieves that evacuation and sheiiering are piefem:d alternat;ves for most situations because they provide protection for the whole body and avoid risk of misapplication of potassium iodide. Entergy strongly urges the NRC to deny the revised petition and believes that the stockpiling or predistribution of potassium iodide to the general public during an emergency will not add any significant public health and safety benefit. We believe the current policy provides adequate opportunity for the use of potassium iodide, however, we believe that the responsible state and local agencies should be free to decide whether stockpiling or predistribution makes sense based on their particular nuclear sites.

                                                                                          *m - j 998 Acknowledged by card ........._._. ___ .,.,...

U.S. NUCLEAR REGULATORY COM ISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

Petition For Rulemaking Filed By Mr. Peter G. Crane January 14, 1998 CNRO-98/00001 Page 2 of 2 If there are any questions regarding these comments, please contact David Robertson at (601) 368-5343. Very truly yours,

  ~9+f JGD/SJB/DAR/tls cc:             Mr.

J~D Chandu P. Patel Mr. Jack N. Donohew Mr. C. M. Dugger (W-GSB-300) Mr. J. J. Hagan (G-ESC3-VPO) Mr. C. R. Hutchinson (N-GSB) Mr. George Kalman Mr. J. R. McGaha (R-GSB-40) Mr. David L. Wigginton Mr. J. W. Yelverton (M-ECH-65)

DOCKETED Ernest Goitein USNRC 167 Almendral Avenue Atherton, CA 9402 7 '98 JAN 20 A9 :01 650 369 6690 January 12, 1998 Mr. John c. Hoyle Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 DO ATTENTION: Docketing and Services Branch P 50-t,3A (fp~/:~ (,t,038)

SUBJECT:

Petition for Rulemaking Filed by Mr. Peter G. Crane (60 Fed. Reg. 58256- November 27, 1995) Request for Comments

Dear Mr. Hoyle,

The proposed petition to amend the emergency planning standard in 10CFR 50.4 7 to store KI should be approved by the NRC. My own experience in trying to obtain information from FEMA about KI, indicates the need for such stockpiling. The people contacted at FEMA never heard of KI, did not call back with information, and in general were "out to lunch". Many months later I received information about dosage, etc. People involved in public disasters such as earthquakes, landslides, hurricanes have had similar poor experiences when relying on FEMA. I wish to qualify that not all experiences were bad, just some. In the event of an accident, either a transportation spill or a power plant release, very little time is available to prevent uptake of radioactive iodine by the human body. I therefore do not understand why there is even a question about stockpiling KI in local jurisdictions. I understand that European countries (France, Holland, Germany) stockpile KI. Why not here? The confusion and lack of information after the TMI accident should be enough evidence to convince the NRC to adopt the petition filed by Peter Crane. KI should be stockpiled! It is obviously a public health benefit. Thank you for your consideration. 8

U. UCLEAR REGUlATORYCDIMISSION RULEMAKINGS &ADJUDlrAIONS OFFlCEOFTiiESECRETAIW OFTHE COMMISSION Pos~mark Date - ~.:-!.,j6-.l=lr . - - - Cop*es eceived _ __,__ _ __ sA 'J'I Copies

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DOCKETED USNRC 15 E. Kirby, Apt. 830 Detroit, Ml 48202 January 13, 1998

                               '98 JAN 20 AB :56 Rules and Directives Branch Division of Administrative seQfff; *, *~1. ;:::. ,. /.: f -,. iY      CKE NUMtil:R Office of Administration      AOJU0;~~-"~11;.*~*

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                                                   ~-1~0 U.S. Nuclear Regulatory Commission *vA , IC '-1'.., :;i :AFF O      U c f_ 5o-~3A Washington, DC 20555                                                  ("' a /:I< '"o~s)

Dear Sir or Madam:

re: Docket No. PRM-50-63A I am writing to comment on the above indicated Amendment. To begin with, may I respectfully request that the time allowed for comments be extended an additional thirty days. I received my copy of the Amendment on January 10th and already knew that comments were to be submitted within 30 days after publication in the Federal Register. I learned today that publication occurred on December 17th and therefore comments were to be received by January 16th. There is not a sufficient amount of time for this very important issue and those of us who are concerned simply deserve more time. I have read the original petition in which it was stated clearly that stock-piling of potassium iodide by the various states would be mandatory if the terms of the petition were accepted. I feel that the compromise offered in the proposed amendment would take the strength out of the original proposal and I am therefore opposed to the amendment. I believe strongly that in order for KI to do its job, it must be at hand and used in a timely fashion. Regional storage facilities should be considered.

                                                                                     \

I would like to commend the NRC on the steps that have been taken to make KI available in the event of a terroristattack at a nuclear power plant. But we have learned from Three Mile Island and Chernobyl that all precautions s should be used. Evacuation, sheltering and KI are all logical, desireable protective measures and are not mutually exclusive. If KI is useful in the event of terrorist activity, can we not accept the fact that it can be useful in the event of an accident? Thank you for your kind attention to this matter. Elaine Ethridge FEB - 3 1998 Acknowledged by card ...........--_,..,,~

lJ. UCLEAR REGULATORY C(ljiUB,ICW RULEMAKINGS & ADJUDICATIONS OFFICE OF THE SECAETAR\f OF THE ISSKlt OOCt1118ntStalltlcl

Z KRIPKE M.D .* M.P .H.

                    '                     8437 Sugarman Drive, La Jolla, CA 92037-2226 (619) 453-6427, fax 453-4433 email 103163.311 O@compuserve.com January 11, 1998 Mr. John C. Hoyle, Secretary US Nuclear Regulatory Commission Washington, D.C. 20555 DOCKET      Mt::U:.                    e:i:o~

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Dear Mr. Hoyle,

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                                                                               ,:,_. ."                 ex, As a physician concerned about the aftermath of a nuclear melij~                             at JA nearby San Onofre Nuclear Power Plant and the possibility of nuclear emergency caused by the Navy's proposed Mixed Waste facility and plans to homeport nuclear carriers in San Diego, I write in support of PRM-50-63. Potassium Iodide should be stockpiled and kept ready for immediate use in this at-risk geographic area to prevent malignant changes to the thyroid gland, particularly in children. Although immediate administration of KI would not mitigate many or even most of the dangers of nuclear mishap, it is an inexpensive and safe measure that certainly should be implemented in this region. In fact, given the proof that we have long had of the efficacity of this measure, such a program is long overdue.

Information about this program needs to be more widely disseminated so that more communities and health care workers can join in the discussion, so I would also call for an extension of the deadline for comments to be received on the subject. Sincerely, Z DRESCHER KRIPKE, M.D. 8437 Sugarman Drive La Jolla, CA 92037-2226 AcknoWledaed by ca rte - 3 1998

u. l'OU...'LC ...., REGULATORY SSI RU' E AKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COM ISSION DocwnentStatlsb P wnark Date I I ~ C:, 8 Copies Received _ _...;.1_ _ _~ -

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DOCKETED Peace Resource Center of San Diego USNRC 5717 Lindo Paseo

                                                                     °98 JAN 16 P3 :13 San Diego, CA 92115 619-265-0730 January 15, 1998                                       0   i< TN MBER PETI 10 AUL         RM so.. ~ 3 A

(,:},FR r,t,o38) Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63

Dear Mr. Hoyle,

My organization supports Mr. Peter Crane's petition to include the use of potassium iodide (KI) as one action to be considered in the event of a - nuclear reactor accident. While we applaud the NRC's decision to endorse the Federal Radiological Preparedness Coordinating Committee's (FRPCC) recommended policy to federally fund the purchase of potassium iodide for states who request it, we believe that it is important that thete be a uniform Federal policy on KI. Only two states currently include the use of potassium iodide in their emergency planning for reactor accidents. Adopting Mr. Crane's petition would ensure that all states address the use of KI as one of their protective measures. The decision of whether or not to stockpile KI should not be dealt with on a state-by-state basis. It is extremely important for public safety that KI be stockpiled near all reactors. The Kemeny Commission Report on the Three Mile Island reactor accident was highly critical of the failure to stockpile KI and recommended that an adequate supply of KI should be available regionally for distribution FEB - 3 1998 Acknowledged by card ...*-**- , ,1

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to the general population and workers affected by a radiological emergency. The decisionmakers in the TMI accident did not act fast enough to protect the public. We need to put what was learned from that tragedy to use. As an organization representing a community that is slated to become the Navy's new "nuclear magnet" through the increased homeporting of nuclear-powered vessels and expanded nuclear maintenance and waste operations. this issue is of great importance to us. While stockpiling and administration of KI in our community will not protect us or mitigate most of the dangers to which we might be exposed in the event of a nuclear reactor accident in our harbor. we believe that our community, and especially its children. should at least be provided the minimum protection to their thyroid afforded by the timely administration of KI. In addition to supporting Mr. Crane's petition, we request that the deadline for comments be extended 30 days. We only become aware of this proposed change in NRC regulations during the past week and believe that many others in our community would be interested in commenting if time permitted. Sincerely, (Retrieved from interactive rulemaking website -- ATB) Carol Jahnkow Executive Director

January 16. 1998 NOTE TO: Emile Julian Chief. Docketing and Services Branch Carol Gallagher Iv ll FROM: RES. ORA ~ r ~. 0 ~

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment letter related to the Amended Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 16. 1998. The commenter's name is Carol Jahnkow. Peace Resource Center of San Diego, 5717 Lindo Paseo. San Diego, CA 92115. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

Lewis Sumner Southern Nuclear Vice President Operating Company, Inc. Hatch Project Support 40 Inverness Parkway Post Office Box 1295 DOCKETED Birmingham, Alabama 35201 IJSNRC Tel 205 992.7279 1(6 J l, I :i:t'1 Fax 205.992.0341

                                                              *9s    JAN Zf P~                      ._

SOUTHERN <<"-, COMPANY January 15, 1998 Docket Nos. 50-321 50-348 50-424 HL-5554 50-366 50-364 50-425 LCV-1151 Mr. John C. Hoyle Secretary of the Commission U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 ATTENTION: Rulemakings and Adjudications Staff Amended Petition for Rulemaking Filed by Mr. Peter G. Crane (62 Federal Register 66038 dated December 17, 1997) Docket Number PRM-50-63A

Dear Mr. Hoyle:

On December 17, 1997, the Nuclear Regulatory Commission (NRC) published in the Federal Register an Amended Petition for Rulemaking Filed by Mr. Peter G. Crane (62 Fed. Reg. 66038). The proposed petition recommends that the emergency planning standard for protective actions be changed to require explicit consideration of the prophylactic use of potassium iodide (Kl) for the general public. We have reviewed the proposed petition, and in accordance with the request for comments, Southern Nuclear Operating Company is in total agreement with the Nuclear Energy Institute comments which have been provided to the NRC. Should you have questions, please advise. Respectfully submitted,

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H. L. Sumner, Jr. HLS/NMM (distribution - see next page) L___

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U.S. Nuclear Regulatory Commission Page2 cc: Southern Nuclear Operating Company Mr. D. N. Morey, Vice President, Plant Farley Mr. C. K. McCoy, Vice President, Plant Vogtle Mr. J.B. Beasley, General Manager - Plant Vogtle Mr. R. D. Hill, General Manager - Plant Farley Mr. P.H. Wells, General Manager - Plant Hatch U.S. Nuclear Regulatory Commission, Washington, DC Mr. J. I. Zimmerman, Licensing Project Manager - Farley Mr. N. B. Le, Licensing Project Manager -Hatch Mr. D. H. Jaffe, Senior Project Manager - Vogtle U. S. Nuclear Regulatory Commission, Region II Mr. L. A Reyes, Regional Administrator Mr. T. M. Ross, Senior Resident Inspector - Farley Mr. B. L. Holbrook, Senior Resident Inspector - Hatch Mr. J. Zeiler, Senior Resident Inspector - Vogtle HL-5554 LCV-1151

CP&L Carolina Power & Light Company PO Box 1551 411 Fayetteville Street Mall Raleigh NC 27 602 January 14, 1998 Secretary U.S . Nuclear Regulatory Commission ET ER Washington, DC 20555-0001 P RULE PA 5 o-i3A ( <, :J. F~ f, i,03 8) Attn.: Rulemakings and Adjudications Staff

Subject:

Amended Petition for Rulemaking filed by Mr. Peter G. Crane (62 Fed. Reg. 6603 8 - December 17, 1997) Docket Number PRM-50-63A

Dear Sir or Madam:

The following comments are made by Carolina Power & Light in regard to the amended petition for rulemaking filed by Mr. Peter G. Crane (62 Fed. Reg. 66038 - December 17, 1997). Consideration of the prophylactic use of potassium iodide as a protective action for the general public will not 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. The current "Federal Policy on Distribution of Potassium Iodide for Use as a Thyroidal Blocking Agent", dated 1985, provides sufficient guidance to state and local governments. It recommends the stockpiling or distribution of potassium iodide during emergencies for emergency workers and institutional persons, but does not recommend that pre-distribution or stockpiling be required for the general public. State and local authorities should be allowed to determine whether stockpiling is needed for a particular plant. incerely,

                                         . "- 6      ~

Donna B. Alexander

                                                           \ )(t i~ l ,__ _

Manager - Performance Evaluation & Regulatory Affairs DSL Acknowt qed y

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PE&RAS-98-003 Page 2 be: Ms. Cynthia Cashwell Mr. Harold Chernoff Mr. Warren Dorman Mr. Johnny Eads Mr. Glenn Johnson Mr. Scott McCain Mr. Phil Opsal X-X-0724

January 15, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher RES, ORA ~ ~-d A. O ~AY\v

SUBJECT:

DOCKETING OF COMMENT ON AMENDED PETITION Attached for docketing is a comment letter related to the Amended - Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 14, 1998. The commenter's name is Donna B. Alexander, Carolina Power &Light Company, 412 Wilmington Street (OHS-7), Raleigh, NC 27601. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated - cc w/o attachment: M. Jamgochian

DOC u NUCLEAR REGULATORY COMMISSION "98 JAN 15 A8 :28 10 CFR Part 50 [ Docket No. PRM-50-63A] OFF!, ; .: ,- 1~ Sr RUL ::-).11*\1,: 1

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AOJlJ_ IC> v~-- :*-;..F F Peter G. Crane; Receipt of an Amended Petition for Rulemaking, Extension of Comment Period AGENCY: Nuclear Regulatory Commission. 5o-~3A ( (p~F~ [q lPO 3 s>) ACTION: Amended petition for rulemaking: Extension of comment period.

SUMMARY

On December 17, 1997 (62 FR 66038), the Nuclear Regulatory Commission published a notice of receipt of an amended petition for rulemaking filed by Peter G. Crane and requested public comment on the amended petition. In the amended petition for rulemaking, the petitioner seeks to amend NRC's emergency planning regulations to require consideration of sheltering, evacuation, and the prophylactic use of potassium iodide for the general public in developing a range of emergency planning protective actions. In addition, the petitioner has filed supplemental information in support of his amended petition which is available in the NRC Public Document Room. The comment period on the amended petition was to have expired on January 16, 1998. In response to several requests, the NRC has decided to extend the comment period for this action.

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2 DATES: The comment period has been extended and now expires on February 17, 1998. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except to those comments received on or before this date. ADDRESSES: Submit comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001; Attention: Rulemakings and Adjudications Staff. Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays. You may also provide comments via the NRC's interactive rulemaking website through the NRC home page (http://www.nrc.gov). This site provides the availability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking website, contact Ms. Carol Gallagher, 301-415-5905; E-mail CAG@nrc.gov. For a copy of the amended petition, write: Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001. A copy of the amended petition and other documentation filed by the petitioner are also available for public inspection, and copying for a fee, in the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, D.C. FOR FURTHER INFORMATION CONTACT: Michael Jamgochian, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, O.C. 20555-0001, telephone: 301-415-6534, E-mail: MTJ1@nrc.gov; or Michael T. Lesar, Office of

3 Administration, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001, telephone: 301-415-7163 or Toll Free: 1-800-368-5642, E-mail: MTL@nrc.gov. Dated at Rockville, Maryland, this 14th day of January, 1998. For the Nuclear Regulatory Commission. ( / ' ~-\ j ~ - ,4 ._ ~

                                                                            /l_   /

Annette Vietti-Cook, Acting Secretary of the Commission.

DOCKET DOCKETED USNRC 50-G, 3 A ( ~~ F,_ (,(g03g) "98 JAN 15 P3 :Ql Marvin I. Lewis 3133 Fairfield St Phila., PA 19136 (215) 676 1291 Secretary USNR('. Wa.~l1ington, 0. C. 20555 Dear Secretary~ Please accept this as my comments on the petition of Peter G. Crane. I agree with Mr. Crane. I agree that potassium iodide should be part of an emergency plan. I agree that 'the ship belongs to the Captain, the lifeboats belong to the crew.' TI1e nuke belongs to the licensee, the emergency plan belongs to the evacuees. We demand our right to safety. (signed)

                                                                                 ...)

12/27/97 Filename: Crane Acknowledged by B - 3 i99!

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DOCKET NUMBER PETITION RULE PAM SO-" 31\ ( ~~Fl<..fl(,D38) DOCKETED USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 A11 :26 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations. ~ _..L-.. <;\ ('\9-\..\ eo~:::.-e \)o..,\ \'Y ~~rul Lee.. (. . Sw<XnL. (j.~

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DOCKET NU 8 PETITION RULE PRM 50"1l DOCKETED ( /p~FI< "'-038) USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001

                                                                     '98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations.
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DOCKET NUMBER P O RULE PR 5D*b5A DOCKETED ( '1~F~ Ct,4,038 US RC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 '98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations. F_:~.:!. .~:.98 Acknowledged by caro .... a

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DOCKET NUMBER PETITION RULE PRM 5D*b3,A ( (,'J. F/J.. lPt,o~s) DOCKETED USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff OFF-IC~ C>F SE<:H - f-l

• RUL d.,,.,. \G. NO Mr. John C. Hoyle, Secretary ADJUDI "'/J. , tO 18 , TAFF U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations.

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DOCKET NUMBER ETITION RULE PRM 5t>-t:>3A DOCKETED ( <,~ F~ <.,,t,o 3 'i) USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff OF. I c: 0 RU EM~: Mr. John C. Hoyle, Secretary AOJUD1',A U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations. Acknowtooaed by ca:d .....~

• 3 1998

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DOCKET NUMBER P TIO RULE PRM 51)--b~A DOCKETED ( ~~ Fl<(,'1038) USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (Kl). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations. fl rk (()I/ !11.1

                                               ~;n 5:-.....--r; ... I.Ju, l:j, L ,. rt,,~:,/. ~ / f )- t ?-tZ>3 Acknowledged by cam --~-:1 1998

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                                            '1?. F~t,(,031)                  USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-000 l                                  "98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations.
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DOCKET NUMBER PETITION RULE PAM 5D-'13A DOCKETED ( t,:;.F~r, ~ 8) US RC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 Al 1 :2 6 Attention: Rulemakings and Adjudications Staff OFFICE o:- SF"'fi'- R RUL,-1\,1.t,K , ' r t 'i..) Mr. John C. Hoyle, Secretary ADJUDI'. (IC' S , TAFF U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (Kl). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other  ;' J.rJ?.0 p nations. l ~7 :::ic{I 'p --;;

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DOCKET NUMBER i:-r!TION RULE PR S o-'7~/f DOCKETED ( '4~FI( r,1,033) USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 All :26 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (KI). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations. q~ Jf)J- CA r ('I Ef f-1 IR f1 £. e ~t,/£.slc>I/} ..Sf e e /_ -/-o ~ PA- I7 II 3 - ,;? :z....3 ~ AeknowfP.Claed by cam ** :=~. .:3 1

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U.S. NUCLEAR REGULATORY CO MISS! RULEMAKINGS &ADJUDICATIONS STA F OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics

DOCKET NUMBER P O RU E PR 50*'-3A DOCKETED { tpr;. FR r,, 03 8) USNRC Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 "98 JAN 15 All :26 Attention: Rulemak:ings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, I would like the NRC to decide favorably the petition by Peter Crane for the stockpiling of Potassium Iodide (Kl). Emergency responders have a stockpile available for themselves. Citizens should be able to use Potassium Iodide also. Many other nations already stockpile KI and the US should have no less protection than other nations.

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Comn10nwc*alth EJison Com pam* 1400 Opus Placl' Downn~ C r nH". IL (,051 'i-'i-r I I DOCKETED USNR C January 8, 1998

                                           *9a JAN 15 A11 :27                   ComEd oFncc     o:    SF'.J1 1: ,).PY DOCKET N M ER Mr. John C . Hoyle                         RULErvl.-'. J.'-'./' ;..*-Tl Secretary                               ADJUDl'~,L\; /CHS \.,Ii\FF            PETITION RULE PRM 5DA'73A U.S. Nuclear Regulatory Commission                                                ((,~FR t.,t,D3~)

Washington, D.C. 20555-0001 ATTENTION: Docketing and Services Branch

SUBJECT:

Amended Petition for Rulemaking Filed by Mr. PeterG. Crare (62 Fed. Reg . 66038- Dtumrer 17, 1997) Request for Comments

Dear Mr. Hoyle:

ComEd provides this letter to strongly endorse the positions taken by the Nuclear Energy Institute on behalf of the nuclear industry and the Illinois Department of Nuclear Safety on behalf of the citizens of Illinois. We have reviewed the proposed petition to amend the emergency planning standard in 10 CFR 50.47, "Peter G. Crane, Receipt of Amended Petition for Rulemaking," (62 Fed. Reg. 66038 - December 17, 1997). The proposed petition recommends that the planning standard for protective actions require explicit consideration of the prophylactic use of potassium iodide (Kl) for the general public . There is nothing contained in the amended position that differs significantly from his initial position or that should cause the NRC to come to a different conclusion than that reached in response to that initial position. Mr. Crane has provided no resolution to the problems identified by several states in their response to that initial petiiion. The existing positions ailows the affected States the ability to stockpiie and use KI for the general public if they (the State) determines it to be an effective activity in the overall plan using evacuation as the cornerstone to maximize protection. Following the accident at Chernobyl, U.S. policy on stockpiling and distribution of KI underwent exhaustive review . The conclusions of the staff were that the current policy is sound; and federal guidance should be developed for states that include KI in their planning basis. That has been done under the existing position. Please direct any questions pertaining to these comments to Ms. Irene Johnson at (630)663-2095. Senior Vice President FEB

• 3 1998 Acknowledged by card ................,..u.....- -

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The Seacoast Anti-Pollution League@ Founded 1969 SAPL 93 H I G H S T R E E T / P. 0. B O X 1136 P O R T S M O U T H , N H 03802 JAN 1 3 1998 603-431-S089 AlllEIWI*-, ADJUOICA'JDalDIFP 1/13/98 SECY,_

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V Secretary DOCKE NUMBER U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 PETI 10 RULE PRM 5D-L,J I, Attention: Rulemakings and Adjudications Staff ( c, 2f~ "" o3B) Re: Seacoast Anti-Pollution League ' s comment on Docket No. PRM-50-63A, the amended petition for rulemaking filed by Mr. Peter G. Crane on 11/12/97

Dear Mr. Secretary:

The Seacoast Anti-Pollution League is disappointed that the petitioner, Mr. Peter G. Crane, has retreated from language, proposed for 10 CFR 50.47(b)(10) in his initial request for rulemaking, which required that prophylactic use of iodide be included in the range of protective actions developed for emergency workers and the public. SAPL takes the position that predistribution of potassium iodide (KI) to the general public should be a required protective action for emergency plans for commercial nuclear reactors, and not just an item for "consideration". Although KI does not protect the public from radionuclides other than the iodine isotopes that are released in nuclear accidents and is certainly no "magic bullet" for that reason, experts in thyroid medicine seem to be in virtually unanimous concurrence that providing KI to the public in a timely manner after the onset of a nuclear accident could significantly reduce the incidence of thyroid cancers and other thyroid disorders. Since the early health effects that manifest after a nuclear accident include a preponderance of thyroid maladies, the administration of KI could very obviously have a beneficial impact in reducing some of the burden of human suffering that would result from a nuclear accident. There is no excuse for failing to provide this protection. SAPL would call attention to the fact that the siting of the Seabrook Station Nuclear Plant is such that, during the summer tourist season especially, it can be predicted that evacuees will be forced to wait in traffic queues for great lengths of time. Estimates by reputable experts are that lengths of time to evacuate the Emergency Planning Zone could exceed eight and even more hours. If KI predistribution were

SAPL Comment on Docket No. PRM-50-63A, p. 2 accomplished and accompanied by a thorough and vigorous program of public education, one might reasonably expect that many instances of cancer, hypothyroidism and other thyroid disorders might be avoided if the public had the KI on hand for use early in such an accident scenario. SAPL has heard that a "states rights" argument has been advanced against requiring states to stockpile KI. If NRC takes that position, that will revive the question of whether states have the right to block or rescind the licensing of nuclear plants when they find the state of radiological emergency response planning fails to provide "adequate" public protection as 10 CFR 50.47(a)(1) requires. It may be recalled that the Commonwealth of Massachusetts opposed the licensing of Seabrook Station Nuclear Power Plant on those grounds among others. SAPL is of the opinion that progress on this matter of KI distribution to the general public has been stalled for long enough by bureaucratic quibbling. It is time to move forward to provide the protection in this country that citizens in other nations in the developed world are provided by their governments. Respectfully submitted, Jane Doughty

DOCKETE D Mr. John C. Hoyle, Secretary USNRC U.S. Nuclear Regulatory Commission Washington, D.C. 20555

                                                                                       '98 JAN 13 A9 :27 Attention: Rulemakings and Adjudications Staff Mr Hoyle Re: PRM-50-63                                                OFFICb      f1f,    ,S~Qf~L-. '.~RY RULt:1" ***.i -J1 *i* *,,, 1*1,i0 L,
   *       ,                                                                        Af).!l 1r, ( \'ii( iv<:; -~TAFF Please extend by 30 days the comment period for Peter Crane's petition for stockpHih'g-P'o"r'as'Smm rdclide:*.J The NRC Press Release No. 97-102 (Tuesday, July, 1, 1997) was misleading so that it appeared the NRC had reversed its long standing position on stockpiling and that it was a "done deal." The Press Release should have clarified that the NRC had not created a new regulation and that public comment would be called for during a period of Petition for Rulemaking.

We have only discovered the petition and its deadline last week (January 5, 1998).

• Scott D. Portzline Three Mile Island Alert The first paragraph of the NRC Press Release is listed below:

NRC REVISES POSITION ON USE OF POTASSIUM IODIDE IN CASE OF ACCIDENT AT NUCLEAR POWER PLANT The Nuclear Regulatory Commission has decided to modify its position regarding the use of potassium iodide as a protective measure for the general public in case of a severe nuclear reactor accident. The agency has decided to endorse the Federal Radiological Preparedness Coordinating Committee's (FRPCC) recommended policy to federally fund the purchase of potassium iodide for states at their request, and the NRC will provide the funding.

*Retrieved from rulemaking website -- ATB

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January 12. 1998 NOTE TO: Emile Julian Chief. Docketing and Services Branch FROM: Carol Gallagher RES. ORA

SUBJECT:

DOCKETING OF COMMENT ON REVISED PETITION (PRM-50-63) Attached for docketing is a comment letter related to the Revised Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 12. 1998. The commenter's name is Scott Portzline. Three Mile Island Alert. 315 Peffer Street. Harrisburg. PA 17102. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

DOCKET ED 1/9/98 DOCKET NUMBER US RC Three Mile Island Alert PETITION RULE PR 50-'13 A Harrisburg, PA ( <,, ~ ~~ IA,03i) *gs JAN 13 A9 :26 Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 Attention: Rulemakings and Adjudications Staff Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Re: PRM-50-63 Mr. Hoyle, If there is any populace in this great country who understand the need for "Defense in Depth," it is the people of Three Mile Island.

1. While the reactor conditions were such that the "defense in depth" was overcome and evacuation should have been ordered as prescribed by pre-determined criteria, the NRC Commissioners hesitated; hesitated for three days. Fuel was melting and evacuation plans were pushed aside.

2. When releases were already drifting over populated areas, no governmental body or agency was willing to order an evacuation requiring people into the open air.

3. While the NRC Commissioners understood that a precautionary evacuation was warranted because of the levels of radioactivity in the releases, they received a phone call from the Governor of Pennsylvania and did not mention what they had just admitted to themselves literally only a minute earlier.

4. Initially, the Commissioners could not even admit that a release had taken place.

Instead they took the time to debate the exact wording to be used in a press release to conceal the radioactive release. The media was left to wonder how radioactivity was being measured miles away from the reactor The following is written directly to the NRC Commissioners: FEB - 3 998 Ac nowledged by cam ...........................,_

       'I U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETAR OF THE COMMISSION Docllnent Statistics Postmmk 0a1eH&DIO(JI.~ *         ,fy-__j},,,..£~ .,,, ,/tz/9?

For a lesson in "evacuation decision making," read the transcripts of the Commissioners discussions during the accident. After reading it you will understand the enormous pressure of the biggest decision you could ever make as a Commissioner. You will understand the hesitation that interferes with the proper guidelines and even the mandated responsibilities and regulations. You will understand that the hypothetical accident and responses which you are taking into account regarding this rule, will all be overshadowed by the far-reaching impact of ordering an evacuation; overshadowed by the time of day, whether in the middle of the night or during the morning rush hour when many folks will choke the roads even further by turning around to go home before evacuating, or by a snowstorm, or by debris on the roads from a hurricane or tornado which may have triggered the accident, or even an earthquake triggered accident making evacuation a nightmare. It will all be overshadowed by the fear and uncertainty that is thrust upon a population by ordering a massive evacuation; some will die from a heart attack triggered by the stress of evacuating, or die in automobile accidents. It will all become clouded by the conflicting and confusing information coming directly from plant telemetry or from the release and dose measurements and projections which will change sometimes hourly. It will be eclipsed by conflicting advice and misunderstandings of who is responsible for what. It will be diminished by doubts about "over-reacting" or by having too much optimism for regaining control of a damaged reactor. It will be forgotten by the efforts to put the best face on a harrowing situation which is attracting unwanted publicity and the demand for accident mitigation and clear answers from the media, governments and the people. In the meantime, citizens could be using Potassium Iodide to protect their thyroid glands as will the emergency responders who will be out in the open -- just like citizens will be in the open if they evacuate whether by order or by self-determination from prior experience. Emergency responders already have a stockpile of KI for themselves. Don't you understand that we want something we can do to better our situation while you hesitate? Potassium Iodide is stockpiled in other countries and our "defense in depth" should not be less than any other country's protection. Federal emergency responders may decide to send KI to the accident scene as it progresses. Our shipment finally was railroaded into Harrisburg several days late. It was too late to use with any effectiveness and was therefore never distributed. Stockpiling KI resolves the problem. If any Commissioner cannot see the clear logic presented by the facts of what really happens during an accident and therefore the benefits of Potassium Iodide stockpiling, then it is painfully obvious that his or her decision making is already compromised because he or she is convinced that the existing "Defense in Depth" will go as planned

and that the contingency plans will be activated at the optimum time, with reasonable efficiency on a nice sunny day. Facing and making the dreaded decision to evacuate, with all of its ramifications, will require much more nerve than the valiancy or sensibility of funding the stockpiling of a 10 cents pill. Put the decision and ability to protect our thyroids into our own hands. You will be too busy examining and debating the critical data and events at that time. That is what you will be doing. That is what reasonable people expect of thoughtful and careful leaders. This letter is very "frank" because we are people, not a hypothetical population in a hypothetical accident scenario. (Retrieved from rulemaking website -- ATB) Scott D. Portzline Three Mile Island Alert

January 12. 1998 NOTE TO: Emile Juli an Chief. Docketing and Services Branch FROM: Carol Gallagher ~ ,,  ;{. 0 f)AA~ RES . ORA ~ / ~ ~rf .

SUBJECT:

DOCKETING OF COMMENT ON REVISED PETITION (PRM-50-63) Attached for docketing is a comment letter related to the Revised Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 9. 1998. The commenter's name is Scott Portzline. Three Mile Island Alert. 315 Peffer Street. Harrisburg, PA 17102. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

DOCKET NUMBER (j) Mr. John C. Hoyle, Secretary PETITION RULE PAM 5D-h3A DOCKETE D ( (p ~ ~~(,(p()3 i) USNRC U.S. Nuclear Regulatory Commission Washington, D.C. 20555

                                                                                  '98 JAN 13 A9 :27 Attention: Rulemakings and Adjudications Staff Re: PRM-50-63 Mr. Hoyle, Please allow the stockpiling of Potassium Iodide (KI) for protection of the thyroid gland during a nuclear accident. The cost of a KI pill is only 10 cents. Many other nations stockpile KI. Our protection should be e no less than that of other nations. The NRC will fund the stockpiling and thereby making it free to your local or state government.

I also request that the NRC extend the deadline for comments by 30 days. (Retrieved from rulemaking website -- ATB) Ellen Thomas, Director PROPOSITION ONE COMMITTEE PO Box 27217, Washington DC 20038 202-462-0757 I fax 202-462-0757 prop l@prop1 .org I http://propl.org 8 3 1998 a Acknowtedged by card ............*.* ...... ,:-.*.--n-:...,.r-

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January 12. 1998 NOTE TO: Emile Julian Chief. Docketing and Services Branch FROM: Carol Gallagher RES. ORA

SUBJECT:

DOCKETING OF COMMENT ON REVISED PETITION (PRM-50-63) Attached for docketing is a comment letter related to the Revised Petition on Potassium Iodide (PRM-50-63) . This letter was received via the rulemaking website on January 11. 1998 . The commenter's name is Ellen Thomas. Director. Proposition One Committee. P.O. Box 27217. Washington. D.C. 20038 . Note that this is the same comment letter I sent to you earlier today that I received via e-mail. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records .

Attachment:

As stated cc w/o attachment : M. Jamgochian

1997 1998 DOCKETED US RC President Paul]. Davis, M.D. Albany Medical Center "98 JAN 12 P2 :56 President Elect Orlo H . Clark, M.D. San Francisco, California January 9, 1998 Treasurer Manfred Blum, M.D. New York, New York Mr. John C. Hoyle, Secretary DOCKET NUMBER U.S. Nuclear Regulartory Commission PETITIO RULE PAM 50-lo3A Secretary Martin I. Surks, M.D. Washington, D.C. 20555 ( (,~ F~~t,0 39) American Thyroid Association, Inc. Montefiore Medical Center

Dear Mr. Hoyle:

111 East 210th Street Bronx, New York 10467 A .. . . The American Thyroid Association (ATA) has been concerned ~ dm101strator: Diane P. Miller Project Manager: Jennifer L. Miller ab out t h e issue

• of KI avai*1ab"l" f 1 1ty or many years an d has end orse d t h e Telephone: 718 882-6047 proposal for stockpiling. We have noted the amended petition for Fax:

Email: admin@thyroid.org 718 882-6085 ru1e m aking f"1ledby p eter G . C rane. Treasurer Elect David S. Cooper, M.D. It is first necessary to say that the 30-day period allowed for public Baltimore, Maryland comment is insufficient, all the more so because it came during the Secretary Elect holiday season. While the ATA's position on potassium iodide was Paul W. Ladenson, M.D. ratified unanimously at the organization's annual meeting, we believe Baltimore, Maryland that many physicians may wish to write individual letters to the Directors NRC as well. Having taken so many years to come to grips with the E. Chester Ridgway, M.D . potassium iodide issue--the ATA has been writing to the NRC on Denver, Colorado this subject for almost ten years -- the NRC hopefully can afford the Xl'o!Ig~ng H . Dillmann, M.D . an Diego, California interested public an additional 30 days in which to comment. Carole A. Spencer, Ph.D. Los Angeies, California The ATA reiteratc:s its previous comments to the NRC on the Terry F. Davies, M.D. potassium iodide issue; the arguments in favor of KI were aptly New Yo rk, New York summarized by Dr.Jacob Robbins, writing on behalf of the ATA to Ian D. Hay, M.0., Ph.D. the Federal Emergency Management Agency on July 8, 1996: Rochester, Minnesota Peter A. Singer, M.D. 1. The Chernobyl experience has shown us that thyroid Los Angeles, California cancer is indeed a major result of a large reactor accident, even when Michael D. Brennan, M.D. Rochester, Minnesota evacuation is carried out. Kenneth D. Burman, M.D. Washington, DC 2. The post-Chernobyl Polish experience has shown us that large scale deployment of KI is safe. Michael M. Kaplan, M.D . West Bloomfield, Michigan JAN 2 9 19

U.S. NUCLEAR REGULATORY ISSION RULEMAKINGS & ADJUOfCATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Ooclln8nt Statistics Postmark Date I q q Ss" Copies Received _ _ _, _ __ Add'I Copies Reproduced _ _._ _ _ SptlC!alDisd>Utlon /."".  !-

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3. The Three Mile Island experience has shown us that it is not easy to obtain an adequate supply of KI in an emergency.

4. The shelf life of properly packaged KI is extremely long.

5. The advantage of having a supply on hand for immediate use far outweighs its moderate cost.

6. The problems attendant on predistribution are immaterial for the matter of creating a stockpile; e 7. No one questions the ability of KI to protect the thyroid from radioiodine.

8. Even though KI administration before any exposure is ideal, the Chernobyl experience also has shown us that the exposure can continue for days; institution of KI blockade at any time in this period is beneficial.

With respect to Mr. Crane's amendment to his petition, the ATA continues to believe that it is essential that, one way or another, KI be available to protect the public, especially children, in the event of a nuclear accident or act of radiological terrorism. Mandatory inclusion of KI in emergency planning as proposed in Mr. Crane's original petition, is the surest way to accomplish this, and remains the ATA's preference. Under the amended petition, the Federal Government would couple an offer of free KI with a strongly worded recommendation to states that stockpiling of this medicine is both reasonable and prudent. We hope that Mr. Crane is correct in believing that states would not lightly reject this advice. The amended petition, while less than ideal in the view of the AT A, would nevertheless represent a significant improvement over current federal policy. Finally, the NRC should be aware that its position on the KI issue is drawing critical attention both internationally and at home. In international meetings on thyroid issues and on the medical effects of Chernobyl, speakers have commented on the fact that the United States, virtually alone among developed nations, has failed to apply the principal health lesson learned from Chernobyl. Domestically, medical advisory committees in Maine and New York State have voted unanimously in favor of KI stockpiling. In both cases, the states have had to act on their own, obtaining the relevant information themselves. So far, the Federal Government, while asserting that the decision on KI is within the discretion of the states, has signally failed to give the states the information they need for a reasoned, informed decision.

Martin I Surks, M.D. Secretary, The American Thyroid Association cc: Paul J. Davis, M.D., President David V. Becker, M.D. John T. Dunn, M.D.

Jim Edgar Thomas W. Ortciger Governor Director DOCKET NUMB PETITION RULE PRM 5o-, :3 A January 8, 1998 ( {,:l, f/(.t,~03B)

                                                                                                ~

c::, c... c:O Mr. John C. Hoyle, Secretary  ::!30 z: (/')("') U.S. Nuclear Regulatory Commission z~ N ;of"Tl Washington, DC 20555-0001 ("') rr,

                                                                                                -0                CJ N

Attention: Rulemakings and Adjudications Staff Ut VI

Dear Mr. Hoyle:

RE: NRC Docket No. PRM-50-63A Peter G. Crane; Amended Petition for Rulemaking Regarding the Use of Potassium Iodide (KI) Regarding the Amended Petition for Rulemaking submitted by Mr. Peter G. Crane, Docket No. PRM-50-63A, the Illinois Department of Nuclear Safety offers the following comments: I. The Department's position is that the intent of the amended petition does not significantly alter Mr. Crane's original position, and the amended petition should be denied.

2. The proposed rewording of 10 CFR Sec. 50.47(b)(I0), as suggested in Mr.

Crane's amended petition, does not materially alter the rule, and thus is unnecessary.

a. Under the existing language of Sec. 50.47(b)(10) and other established federal planning guidance, the states have already "considered" the prophylactic use of KI for the general public, resulting in the written state policies currently in effect in plans approved under 44CFR350.

@ recyclable JAN 2 9 1998 Acknowledged card ......................

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Mr. John C. Hoyle Page 2 January 8, 1998

b. Under existing guidance, states are free to reconsider their positions on KI stockpiling at will and to alter those policies in whatever fashion is determined to provide the best and most effective protection for the health and safety of their citizens. Further intrusion by the federal government in that process is unwarranted.

3. Mr. Crane's amended petition includes a proposed Statement of Considerations that he asks the Commission to adopt as a policy statement along with the proposed rewording of Sec. 50.47. Clearly the intent is to have the Commission go on record as adopting the petitioner's argument for requiring the establishment of KI stockpiles for use by the general public during a fixed facility accident.

This is contrary to the position taken by the Commission on June 30, 1997. Rulemaking on this petition should exclude any reference to the Statement of Considerations. States that desire to avail themselves of the Commission's June 30, 1997, offer to fund KI stockpiles should be free to do so without the requirement to address new government regulatory requirements.

4. The petitioner's amended filing offers no concrete solutions to the problems identified by the states and other organizations who originally opposed the KI stockpiling with respect to the considerable logistical obstacles to the practical and efficient distribution of the drug during an emergency situation.

Instead, the petitioner suggests that the NRC, FEMA, and the FRPCC will develop guidance on how to address these problems after the fact. It should be noted for the record that the federal government's KI stockpiles established for "nuclear, biological and chemical (NBC)" terrorism incidents also lack an established distribution mechanism that would ensure disbursement of KI to the general public in a timely manner.

5. It also has come to the Department's attention that the petitioner, in attempting to gamer support for his cause, has taken out of context certain statements regarding the position assumed by this agency in response to his original filing. In statements made to officials in Ohio and New York, among others, Mr. Crane has attacked what he describes as Illinois' ignorance about the medical efficacy of KI and the effects of radioactive iodine on the thyroid.

Mr. John C. Hoyle Page 3 January 8, 1998 For the record, the State of Illinois has made no formal determination regarding the future use of a KI stockpile for the general public, and stands firmly behind its contention that hundreds of thousands of people live normal, healthy lives without functioning thyroid glands. Moreover, this agency regrets that Mr. Crane has chosen to blatantly misrepresent the established facts regarding the risk of thyroid cancer resulting from radioactive iodine exposure. I trust that his representations will be viewed in the appropriate scientific perspective by the Commission. The continuing debate over the prudent use of KI has served no useful purpose other than to unduly undermine the effectiveness of nearly two decades of sound radiological emergency planning and preparedness. The public has, and will continue to be, protected from the potentially harmful effects of radiation exposure during a fixed facility accident based on the integrated emergency response plans and procedures already in place and proven. There is no evidence that KI stockpiling in the context of the proposal put forth by Mr. Crane offers a significant enhancement to that protective capability. IDNS therefore recommends that the petition be denied. We appreciate the opportunity to comment on this important issue. If you have any questions or concerns regarding our comments, please call me at (217) 785-9868. Director TWO/mes

NUCLEAR ENERGY INSTITUTE

                                                                     '98 JAN 12 AlO :44 Lynnette Hendricks DIRE CTOR.

PLANT SUPPORT NUCLE AR GENERA TION January 9, 1998 DOCKET NUMBER PETITION RULE PAM 50-"3A-( (p :J.. ,=~ {,IJ, o 3 8') Mr. John C. Hoyle Secretary U .S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 ATTENTION: Docketing and Services Branch

SUBJECT:

Amended Petition for Rulemaking Filed by Mr.PeterG.Crane (62 Fed. Reg. 66038- Derember17, 1997) Request for Comments

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEI) 1 submits these comments on behalf of the nuclear energy industry. We have reviewed the proposed petition to amend the emergency planning standard in 10 CFR 50.47, "Peter G. Crane, Receipt of Amended Petition for Rulemaking," (62 Fed. Reg. 66038 - December 17, 1997). 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 petitioner 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 1 N E ! i s the orga ni zation r e spnnsihl e fr,r estahlishin g u n ifie d nuclear indu stry poli cy on matte rn affe cti ng th e nuclear e nergy indus try, including r egul a tory aspects of ge neric oper ation a l and techni cal issues. NE l's m e mhers includ e a ll utilities lice nse d t o ope r ate comme r ci a l nuclear prowe r pl a nts in th e Un ite d States, nuclear plant design ers, major architect/e ngineering fir ms, fu e l fahri cati on facili t ies, mate ri a ls lico n ~ees , and oth er orga ni zation:=. and i ndividuals in volved in th e nu clear e nergy i:-.su o. These comme nts al so r e fl ect t echnical input and suppor t from the f<:l ectri c Po wer Res e a rch Ins titu te. Acknowtedged by c a r d ~ f

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Mr. John C. Hoyle January 9, 1998 Page 2 available for states and local governments that wish to make KI available to the general public if they feel it is appropriate. Following the accident at Chernobyl, U.S. policy on stockpiling and distribution of KI underwent exhaustive review. The conclusions of the staff were that the current policy is sound; and federal guidance should be developed for states that include KI in their planning basis. The attached paper reviews key points relevant to those determinations. The paper demonstrates the unnecessary burden associated with new requirements for states to explicitly reconsider their plans cannot be justified by benefits derived. We appreciate the opportunity to comment on the Amended Petition for Rulemaking filed by Mr. Peter G. Crane. 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) 73~110 or by e-mail apn@nei.org. Sincerely, Lynnette Hendricks LH/APN/tnb Enclosure

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 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 ofless benefit in the U.S. due to the additional protective features (defense in depth) in our preparedness programs. The industry agrees with the staffs assessment in SECY 245 . We strongly

• endorse NRC Option 2. Under this option the petition would be denied. Guidance would be developed in coordination with the States and other Federal agencies to address planning for KI distribution for those States that include KI in their planning basis . This is consistent with the FRPCC policy.

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 PETITION RULE PRM 50-Co3,1 ~ ( f, 2 F~ ,,03 8) \,;;:,I I COALITION FOR THE MANDATORY STOCKPILINC OF Kl - MA. I The Citizens Awareness Network

• Clean water Action
• Don't waste Massachusetts * .---,,-~

Massachusetts Citizens for Safe Energy

• Citizens Radlologlcal Monitoring Networ Duxbury Nuclear Advisory committee Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

                                                                                                          --=.

Attention: Rulemakings and Adjudications Staff JAN - 9 1998

• 91iSfZIM"60 January 9, 1998 F . .'

                                                                                                                          /IW RE: Comments Regarding Docket No. PRM-50-63A Amended Petition for Rulemaking by Peter Crane to: Amend NRC 's Emergency Planning Regulatz                  *t0 Require Consideration ofSheltering, Evacuation, and the Prophylactic Use ofPotassium Iodide f or the General Public in Developing a Range ofEmergency Planning Protective Actions - emphasis added.

These comments are being presented on behalf of state-wide Massachusetts organizations concerned with nuclear safety collectively totaling many thousands of our citizens [The Citizens Awareness Network, Clean Water Action, Don 't Waste Massachusetts, and Massachusetts Citizens for Safe Energy]; and a town appointed committee within Pilgrim NPS's Emergency Planning Zone - the Duxbury Nuclear Advisory Committee. We feel that the NRC should require the federal purchase, stockpiling and use of potassium iodide [KI] for the general public in a radiological emergency involving a commercial nuclear power plant. The current proposal is a step in the right direction by having the NRC pay for KI for states that request it; however, it falls short by not making KI mandatory. The NRC has long been criticized as an agency that consistently makes any Ten Commandments into the "Three Wishes." Unfortunately, this rulemaking is one more example -- with KI being the Third Wish." It should be a commandment. KI protects the thyroid gland, which is highly sensitive to radiation, from the radioactive iodine that would be released in nuclear accidents. KI saturates the thyroid gland with iodine in a harmless form. In so doing, it prevents any inhaled or ingested radioactive iodine from lodging in the now-filled thyroid gland, where it could lead to thyroid cancer, disease or to other illness. KI has a long shelflife, causes negligible side effects and is currently being stockpiled by the Federal Radiological Preparedness Coordinating Committee [FRPCC] to be made available to states in the event of terrorist attacks. To the thyroid, radioactive iodine is equally harmful irrespective of it's source. Our reasons for wanting potassium iodide are as follows.

• Many Massachusetts' citizens live within the EPZ's of nuclear power plants. The Pilgrim Nuclear Power Plant is in the southeastern part of the state; Yankee Atomic NPS and Vermont Yankee NPS are in the northwestern part of the state; and Seabrook NPS is in the northeastern part of the state. Also, we are downwind from reactors in Connecticut and from others throughout New England and the nation. Massachusetts' citizens are all potentially at risk - each and every one ofus.
• Accidents do happen -Titanic, Challenger, Chernobyl, TMI and the near accident at Dresden in 1994.
• Today the risk of an accident is greater due to: unanticipated premature aging of reactor components; the economics of utility restructuring; the documented history ofNRC's laxness of oversight and their unwillingness to force licensees to adhere to their licensing requirements~ and the 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.
• Radioactive iodine will be released in a nuclear reactor accident.

Acknowledged oy ca,a JAN 2 9 1998

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• Radioactive iodine is absorbed by the thyroid with the potential of causing thyroid disease, cancer and growth disorders.
• KI is a proven thyroid blocking agent and is stockpiled around reactors throughout most of the developed world.
• KI is an inexpensive drug.
• KI can prevent disease and human misery in the event of an accident.

Our reasons for wanting the NRC to require potassium iodide to be made available are as follows.

• The NRC has the ability to make KI mandatory. We have heard talk and excuses about "states rights."

We are aware that a war has already been fought, long ago - the Civil War.

• Effluent pathways know no state borders.
• The likelihood that without a federal mandate for stockpiling KI, the nuclear industry will simply shift its fight against the policy to the state and local levels.

Summary We request that the United States join the rest of the developed world and require stockpiling potassium iodide around nuclear reactors to protect our citizens in the event of an accident. There is a long history of support in the United states for stockpiling Kl. For example, support has come from: President Carter's Kemeny Commission following TMI; the American Thyroid Association, since 1989; the International Atomic Energy Agency, 1994; and from the FDA, NRC and FEMA until nuclear industry trade groups squawked too loudly. Please do not cave-in to industry trade groups once again by passing the buck to the states and hiding behind the veil of"states rights." The Civil War has been fought, that battle was won. Accidents do happen and their consequences know no state borders. The American public is at greater risk today for an accident than at any other time in our history. Our reactors are older and they have aged more rapidly than expected. Electric utility restructuring is underway letting competition set prices - another experiment. We know you can not have both safe and cheap nuclear power. Also, we know there is an inevitable lag between the time current NRC rules and policies are readjusted to fit the new and varying electric deregulation state laws - fine tuning and many readjustments will be required. If ever there were a time for added precaution, it is now. KI is safe, cheap and effective in preventing human suffering and disease. The government's job is to protect all of it's citizens. By refusing to mandate stockpiling KI, we are put at risk- unnecessarily. Respectfully submitted, Mary Elizabeth Lampert 148 Washington Street Duxbury Massachusetts 02332 Tel: 617-934-0389 Fax 617-934-5579

617 934-5579 P.01 Jan-09-98 02:3BP lampert Coalition for the Mandatory Stockpiling of Kl FAX 148 Washington Street Duxbury, MA 02332 Date 1/9/98 Number of pages including cover sheet 3 To: Secretary, U.S. N.R.C. From: Mary Elizabeth Lampert Phone Phone (617) 934-0389 Fax Phone (301) 415-1672 Fax Phone . (617) 934-5579 CC : I REMARKS: Urgent For your review Reply ASAP Please comment Comments of the Coalition For The Mandatory Stockpiling Of Kl - MA on Peter Crane's Petition, Docket Number PRM-50-63A - Please time stamp the front page of our comment and fax back to M. Lampert at 617-934-5579

To: Secretary, U.S. NRC, Washington, DC 20555-0001, ATTENTION: Rulemakings and Adjudications Staff DOCKETED r";') From: Connie Kline, 38531 Dodds Landing Dr., Willoughby Hills, OH 44094 USNRC \..::!;/ Phone & Fax 440-946-9012 Re: Peter Crane's Amended Petition for Rulemaking , Docket No. PRM-50-63ge JAN _ P : Date: 1/4/98 9 4 33 As past Chairperson of the Ohio Sierra Club Nuclear Committee and a~1fi~f;p~r,t}l;)irecfci>r of ,:tt,e four-county Ohio Concerned Citizens Network and Co-Director of Ohio C~~ , ,Q!t'i~eris--AgainsL a Radioactive Environment), my comments represent thousands of Ohio citizens. '* * * - J t-Let me preface my comments by saying that I have the utmost respect and admiration for Mr. Crane. I do not think anyone can doubt his sincere desire to bring closure and resolution to an unnecessarily long-standing issue. However, I am worried and concerned that after so many years of misinformation and negative propaganda surrounding Kl, if given a choice, states may not adequately protect their citizens. Therefore, I consider it imperative that stockpiling and availability of potassium iodide for the general public in the event of a reactor accident be required under NRC regulations as part of emergency planning, as a complement to and in coi ij'unction with sheltering and evacuation. The prophylactic use of Kl for the general public should be a mandatory emergency -anning requirement and should not be merely an optional consideration. The NRC took a wonderful step in the right direction with the 6/30/97 announcement that it will fund state purchase of Kl to protect the general public around reactors. The next logical step is to make Kl a mandated part of emergency planning. As you may know, the Ohio Department of Health hosted a comprehensive 10/28/97 meeting on the issue of Kl at the suggestion of the Lake County Department of Health, which supports stockpiling Kl because the Perry nuclear power plant is located in Lake County. The only real concern expressed by those representing county Emergency Management Agencies was the logistics of providing Kl. It is essential that the appropriate federal agencies provide assistance in these matters. Though written with Kl as an optional state decision, Mr. Crane's Statement of Considerations, which accompanies his amended petition, includes important reassurances that states and localities will have the necessary federal assistance and guidance in implementing, what I believe -o o must be a mandatory, Kl plan: - ~ g The NRC recognizes that the decision to stockpile Kl presents issues of how best  :; 6 E to position and distribute the medicine, to ensure e.g., that optimal distribution ~ z z takes place in an emergency ... The NRC intends to work with states and localities  ::: ~ ~ to develop guidance on these and other points relating to the use of Kl ... It is o Fri ~ expected that FEMA or the FRPCC will provide guidance ... and technical assistance ~ ~ :o to states... \.:,;, i:

                                                                                                                  ~

Mr. Crane's Statement of Consideration deals with one other point on which I would like to ~ comment: \A.l

                ... (a state) would still have access ... to the various stockpiles of Kl 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 pre-planning is more effective than ad-hoc responses to emergencies ... the NRC believes that it is reasonable and prudent to maintain stockpiles in the vicinity of nuclear reactors ... According to the NRC's presentation at the above-referenced 10/28/97 meeting, the Department of Defense's NBC "goal is to help prepare 120 cities over 3 years, 27 cities in FY 97, as time/resources permit." The only Ohio city included in the present NBC plan is Columbus, the state's capital. Columbus is 200 miles from Ohio's two nuclear power plants. According to the NRC, Cleveland, Ohio Acknowledged by card JAN 2 9 1998

.S NUCLEAR REGULATORY ISS RULEMAKINGS &ADJUDICATIONS STAFF OFRCE OF THE SECRETARY OF THE COMMISSION Ooctln8ffl Statistts ostmark Date ' 5' 'if opies Recelvad _ _ _.;... /_ _ __ dd'I Copies Reproduced-- ---- p8Cldl D1stnbution ;f°a k_t.s~r, '??>4--"R ~ m:°:' hi~

Kline Docket NO. PRM-50-63A will probably be one of the 120 cities eventually included in the NBC program. Cleveland, which is in Cuyahoga County, is 30 miles from Lake County's Perry reactor and 90 miles from Ottawa County's Davis Besse reactor. In the event of a reactor radiological emergency, it will be necessary for Lake and Ottawa Counties to have their own, immediately-accessible supplies of Kl. Furthermore, in a 12/11 /97 response to an Ohio Department of Health request for additional information, Mr. Crane wrote:

               ... it is noteworthy that when asked by an NRG Commissioner at the 11/5/97 meeting about the provisions made to move Kl from terrorism stockpiles to nuclear power plant sites in the event of an accident, a FEMA official indicated that no consideration had been given to this issue. This seems to highlight the importance of having Kl on hand locally if its distribution is to be a realistic possibility in the event of an accident.

It is a well-known fact that to be effective, Kl needs to be taken before or immediately after exposure to radioactive iodine and continued for 10-14 days. When used in this manner, Kl will prevent the thyroid gland from absorbing 90% or more of radioiodine. This effectiveness decreases to less than 50% if the administration of Kl is delayed for 4 hours after exposure to radioiodine. 9 In his 12/11/97 reply to the Ohio Department of Health, Mr. Crane makes another interesting observation: Kl, by keeping radiation dose to the thyroid below the protective action guidelines at which evacuation is required, may make sheltering a viable option when it otherwise would not be. This in turn means averting whole body doses that might be received during evacuation, if the plume of radioactivity arrives before evacuation is complete. (Automobiles provide very limited protection against airborne fallout.) I base my assertion that Kl should be a mandatory part of emergency planning on the following briefly summarized background information:

1. Nearly all nations with nuclear power protect their citizens by having Kl readily available and the Agistics of distribution do not seem to pose any significant problems.

~- The International Atomic Energy Agency, FEMA, The President's Commission on the Accident at Three Mile Island, the World Health Organization, the American Thyroid Association and others recommend stockpiling Kl.

3. 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% of all Polish children where 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.

4. Kl is very inexpensive insurance in the event of a reactor accident. In its 1994 recommendation to stockpile Kl, the NRG technical staff estimated that a supply sufficient to protect the population nearest to all U.S. nuclear plants would cost at most 11 a few hundred thousand dollars total", or ten cents per year per person protected. At the 10/28/97 meeting referenced above, the NRC representatives acknowledged that Kl is so inexpensive that cost is not an issue.

5. Kl has been declared "safe and effective" by the U.S. Food and Drug Administration and is approved for sale as an over-the-counter, nonprescription drug. As noted above, during the Chernobyl accident, 18 million people in Poland received Kl withot adverse affect. According to NUREG-1250, Report on the Nuclear Accident at the Chernobyl Nuclear Power Station (pp. 7-8 and 7-9) and Nuclear Safety (Vol. 29, No. 3, p. 261 ), 11 No serious side effects (from) Kl use (were)

Kline Docket No. PRM-50-63A reported" out of millions of Kl recipients. Kl is the chief component in salt substitutes and is an ingredient in over-the-counter cough and cold medications. According to a 1995 NRG staff document, 38 million equivalent doses of Kl were consumed without a single adverse reaction reported . Attached , are two related enclosures:

1. My 3/12/96 comments regarding PRM-50-63 which were in response to comments made by the Ohio Department of Health.

2. My 11 /29/97 comments requested by the Ohio Department of Health in response to the 10/28/97 Kl meeting they sponsored.

SIERRA CLUB Connie Kline 38531 Dodds Landing Dr. Willoughby Hills, OH 44094 Phone & Fax 216-946-9012 March 12, 1996 Roger Suppes, Chief Bureau of Radiation Protection Ohio Dept. of Health RE: 2/8/96 comments in opposition to NRC PRM 50-63, filed by Peter Crane to amend emergency preparedness standards in 10CFR50.47 to make potassium iodide (Kl) available to the public in the event of a nuclear power plant accident.

Dear Mr. Suppes:

We are very disturbed by your comments on beha!f of the state of Ohio in opposition to PRM 50-63 and find them devoid of factual substance and common sense. - . On what do you base the term "population mobility" and how do you define it? Are there statistics to show that the population around reactors (specifically Perry and Davis Besse) is particularly transient? Have overall population figures fluctuated drastically in the last five to ten years? And even if people move in and out affected areas, stockpiling Kl so it is available, no matter the size or makeup of the residents, makes absolute sense.

2. Again, you provide no statistics regarding stable population figures around Perry and Davis Besse.

Accessibility and central distribution of Kl at evacuation sites, drug stores etc., instead of predistribution, eliminates any concern over "vacationers taking their Kl with them, (requiring) endless replacement at endless expense to society." Clearly, the costs to society from nuclear power (high electric rates, radioactive waste, frequent shut downs and repairs), even without accidents, are so staggering that any expense associated with Kl pales in comparison. Kl is so inexpensive anyway that cost arguments are meaningless.

3. Evacuation may not even be possible or feasible under certain circumstances such as inclement

.eather. Further, evacuation and availability of Kl are not mutually exclusive - one reinforces the other. Evacuation planning should not preclude the added protection of Kl. Human nature dictates that people will avail themselves of multiple barriers of protection. . Availability of Kl would in no way "reduce the likelihood of people evacuating or adhering to reentry or food restrictions during recovery." Evacuation is a far more daunting, much more monumental undertaking than providing for the avai lability of Kl.

4. 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? That's like saying, "Don't ever make flu vaccine available because there are so many strains and they can mutate from year to year."

Again, for a variety of reasons, evacuation of the general public (not just immobilized, institutionalized populations) may be impossible. Everyone deserves accessibility to Kl.

5. 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 possible risk.

Enc., cc: John Hoyle Secretary of the U.S. NRC

To: Roger Suppes, Chief of Radiation Protection, Ohio Department of Health From: Connie Kline, 38531 Dodds Landing Dr., Willoughby Hills, OH 44094 Phone & Fax - 440-946-9012, Dedicated Fax - 216-663-4177 Date: 11 /29/97 Re: 11 /20/97 letter about Potassium Iodide Thank you again for organizing the 10/28/97 meeting on Kl and for this opportunity to clarify and elaborate on issues raised at the meeting. I hope that the comments received will be shared with the other meeting participants. I also hope that Peter Crane's 10/1 /97 Congressional testimony before the Senate Labor, Health, Human Services and Education Subcommittee was distributed to the meeting participants. And finally, I hope that in addition to ongoing written correspondence, there will be one or more follow-up meetings after the Health Department issues recommendations to foster the valuable face-to-face discussion and public comment that was afforded at the October 28th meeting. Regarding comments attributed to me under "Concerns of Participants":

1. "If there is a serious accident, what about liability?" I was responding to a comment made, believe, by Jim Greer of the Ottawa County EMA who was concerned about county or state liability if Kl was distributed to the public. I was trying to convey the following:

- A. The public would only be advised to take Kl following a Federal government determination that an emergency warranted such a recommendation. B. Ongoing, thorough public education would already have apprised the public of potassium iodide's safety, but alerted those allergic to iodine (seafood etc.) that Kl can cause an adverse reaction. C. I was emphasizing that given the safety and efficacy of Kl, states and counties should be much more concerned about liability if they FAIL TO HAVE Kl READILY AVAILABLE.

2. "Needs more specifics regarding evacuation centers' access (procedures)" To paraphrase what I said, "While I think that developing procedures for Kl distribution are essential, this is by no means an insurmountable task and is actually far less complex and far less theoretical than evacuation planning; some of the state's best radiological emergency planners are right in this meeting room."

I'd like to add that I'm attempting to research how several states and European nations handle* - Kl stockpiling and distribution. I would hope that other meeting participants, particularly the Ohio Department of Health, are doing the same. *

3. "It is the job of the Ohio Health Dept. to make Kl information available to the pubic (sic). Kl won't deter evacuation." These comments were made in response to Dr. Virginia Haller, M.D. of the Ohio Dept. of Health who lamented the supposedly impossible task of informing the public, especially poor people, about Kl.

A. The State and local health departments would undertake the same kinds of public education as is done for flu shots and childhood immunizations, food safety and prevention of food-borne illnesses, and the recent outbreaks of Pulmonary Hemosiderosis caused by the fungus Stachybotyrs atra. In these and other instances, the electronic and print media provide valuable.assistance in conveying information to the public.

8. Several individuals at the 10/28 meeting referred to Part V "Potassium Iodide as a Thyroid Blocking Agent", pi3.ges 36-41 of the April 1989 Citizens Advisory Council on Nuclear Safety Recommendations on Improving Nuclear Power Safety in Ohio which contains sample text (copy enclosed) for public education material that could easily be expanded and updated into a public information fact sheet or brochure. I would be happy to assist in preparing public information material.

Kline 11 /19/97 C. Dr. Haller suggested that people purchase Kl at a local drugstore. A while back, several people surveyed all of the major drugstore chains and most of the smaller independent drugstores in the EPZ surrounding the Perry plant, and not one of them stocked Kl or had any plans to do so. In short, Kl is just not available. Furthermore, as Dr. Haller pointed out, the public needs to be informed and educated about Kl. And why should people have to pay to purchase Kl when the NRC is willing to provide it free-of-charge? D. In countering Dr. Haller, I read from March 12, 1996 comments I made in response to those submitted by the Ohio Department of Health regarding Peter Crane's NRC Petition for Rulemaking on Kl. A copy of my comments is included with particular emphasis on # 3 and 4 which deal with evacuation. I

                                                                                            . I I

I

04/20/1995 18:24 3015553998 PETER/BEATRICE CRANE PAGE 01 Peter G. Crane/ 4809 Drummond Avenue/ ChW'/ Chase, MD 20815 / 301-656-3998 DOCKET NUMBER PETITION RULE PRM 50-~3A ( (,~~~~t,o 39) January 8, 1998

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I

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DOCKETED Mr. John C. Hoyle, Secretary JAN - 8 1998 Nuclear Regulatory Commlss1on nul.EMAKINGSANO Washington.:.1=. D. c .. ~0~~5 ADJUDICtaUJLVS Qf#.FF

                                                                   -.::... - ______ -~ -
                                                               -'_-: ~~, _---,-;ke: ---.PRM-S0-63A

Dear Mr. Hoyle:

I am pleased that the Commission has decided to take public comment on my amended petition for rulemaking regarding the stockpiling of potassium iodide for radiological emergency planning. Although this comment period was legally unnecessary, it 1s an useful opportunity to present the issue to the public anew and receive input from it -- 1f it is done right. Unfortunately, however, the Commission has so far squandered this opportunity. First, despite repeated suggestions from me, the NRC staff has failed to issue any press release or other public announcement that might alert the public. Anyone who contacts the NRC's website and cl1cks the "What's New icon will find not a word about the potassium iodide issue, although there is a profusion of press releases on matters seemingly of much less public concern. Second, the comment period is short. While I am as eager as anyone for an expeditious resolution of the KI issue, a 30-day comment period, when coupled with the absence of an announcement, is too brtef. The NRC staff, which took five years to proc:::ess my differing professional opinion on KI, and two years to prepare a Comm1ss1on paper on my petition for rulernaking, should not begrudge the public an additional 30 days. Third, scheduling the comment period over the holiday season meant that many of the people who might be expected to be concerned about the KI issue were not in their offices. Fourth, I have repeatedly requested that all the documents in the PRM-50-63 docket be placed on the NRC's website. The NRC staff has not done this, nor have my requests even been acknowledged. A number of extremely pertinent documents were placed on the docket in 1997, but aa far as any member of the public would know, the last entry to the docket was made early in 1996. If the answer to this criticism is that the staff members responsible for adding documents to the website were on leave for the holidays, and have not had time to supplement the 11st of documents, this only confirms the validity .of the points made earlier. Put this all together, and the inadequacy of the present comm.en~ period is apparent. =_Tbe unfortunate result isJt:,At _ cYtllC! __will conclude that the NRC was del1bera~tryU1g,:~minimtz_e -p_4!>lic cornltl~"':8Q,that the only comments

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r U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS &ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Oocllnent Statistics Posm1a1k 0ete , f t If7) -r. le~ ~ Copies Recalwd _ _..:.. /_ _ _ Add'l Coplae Reproduced _ _,___ _ Special DlslrbJtion \1(;. m!Jo.. c.b/~,., I - Lesac, ?'1>~ 1 x,:zu_

2 received would be those from the nuclear industry and its allies. I do not make that charge myself -- I tend to believe that bureaucratic mishandling is more often due to thoughtlessness or inattention than to deliberate design -- but others doubtless will. I therefore renew my request that a press release be issued, and that all documents in the PRM-50-63/63A docket file be placed on the website. Further, I request that the comment period be extended by 30 days. Incidentally, persons interested in the KI issue will find an excellent discussion at the website of the French nuclear utility, Electricite de France. (A search for "iodine tablets" will quickly yield this site.) If a French utility can treat the public like adults, and talk about ways of reducing the risk of thyroid cancer in the event of nuclear accidents, one would think that American utilities could do the same. Whatever the French are doing seems to be working, in terms of broad public acceptance of nuclear power and the achievement of a thriving nuclear industry. In France today, nuclear power accounts for more than three-quarters of all electricity generated. One can only wonder what might have happened to the nuclear option in the United States if the American nuclear industry had shown anything like the degree of enlightenment and sophistication demonstrated by the French. I would ask that copies of this letter be circulated to the Commissioners, the Executive Director for Operations, and the Director of the Office of Public Affairs. Thank you. Sincerely, Peter G. Crane

DOCKET NUMBER PETITION RULE PAM So -G:. 3 ,4 DOCKETED 0 December 20, 1997 ( &, :l.. ~~ &,l,o3B) USNR C 304 Manor Drive Sautee, GA 30571 "97 DEC 31 A9 :55 Secretary, U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Attention: Rulemaking and Adjudications Staff After following U.S. nuclear policy for a number of years and attending numerous PEISs, I am taking this opportunity to support the petition by Mr. Peter G. Crane to provide stocks of potassium iodide for the purpose of public protection. This has been long overdue. We know that potassium iodide which is cheap and safe

• when used properly could protect the general population in the event of a nuclear accident. Not to see that it is available to those who want it borders on the criminal.

Sincerely, Joc,W 0 Joan 0. King JAN 2 9 1998 Acknowledged by ....... A 1 fl! .....

U.S. NUCLEAR REBULATORY CXltMISSION IUEMAKINGS &ADJllllC.VDe STAFF OFFICE OFllfE SECRETARY OF THE COMMISSION Docllnent Slatlallcl Poatmark 0a1a };)1,~ Copies Recalvad _ _ _ _ _ __

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DOCKETED From: Peter Crane < pgcrane@erols.com > USNRC To: TWD 1. TWPS(NRCWEB) Date: 12/17/97 7:01am

Subject:

Potassium iodide issue "97 DEC 19 A8 :28 First, although I am an NRC employee, this message is written from home, in my private capacity, on my own time. I currently have pending before the agency a petition for rulemaking relating to potassium iodide, or KI. The docket number is PRM-50-63. Last week, I was sent a notice saying that the Federal Register would publish a notice of an amendment to my petition submitted on November 12. There will be a 30-day comment period. The Federal Register notice invites people to write to the NRC to DOCKET NUMBER obtain copies of the original petition. By the time anyone writes to the NRC and gets a response, the comment period will probably be over. PETITION RULE PRM 50-- 03,4 (What's more, the comment period straddles the holiday season.) The ( (p :2 Ft<. (pt,o3&) notice also does not make clear the gist of my argument -- namely, that data from Chernobyl provides important new information both on the safety and efficacy of KI and on the consequences (large numbers of aggressive childhood cancers, appearing early) of being without it in an accident -- apparently on the theory that these points were already made in my original 1995 petition. All of this makes it critically important that members of the public who contact the NRC to try to find out about the KI issue be able to do so without undue difficulty. At this point, the NRC website is extremely difficult to negotiate, where the subject is a pending petition for rulemaking. The NRC's November 5 meeting is in one category (archived meetings); looking under "rulemakings" will get you nowhere; and you would have to know to look in "Fedworld" to find some -- but by no means all -- of the documents in the PRM-50-63 docket file. What is badly needed, therefore, is a news release, with hypertext links to the original petition, the amended petition, the November 5 meeting transcript, and the full docket file of PRM-50-63. (As noted, many documents in the docket file have yet to be made electronically available.) The KI issue has been afflicted from the start by an insufficiency of accurate and complete information from the Federal Government. For example, as I mentioned at the Nov. 5 meeting, the NRC's press release of July 1, 1997, did not mention that prevention of cancer is the primary reason for using this medicine. In writing this message, therefore, I am trying to get the situation fixed BEFORE it is too late to do any good; I do not want to have to complain after the fact that the NRC failed to give the public usable information. I have sent copies of this message to Commissioners' assistants for the Chairman, Commissioner Diaz, and Commissioner McGaffigan. I would have sent it to Brad Jones if I had remembered his initials. If you would not mind, please forward this to Brad. Thank you. CC: WND1.WNPl(JRG,MLO,RKD,HLT),WNDl.WNP2(JCH,JFC),GATE ...

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document StatlsUcs Postmar1<Date Z-m~ (}')") 1~ /te/e,1 ~ ~ If~ Copies Received _ _ _1  ;.....-,_ _ __ Add'I Copies Reproduced _ 4_,______ Special Distribution .;Ta ro&_ 11c. 6,* "- ~ J.e.sar '?J>R 1?1 "DS '

Peter G. Crane/ 4809 Drummond A venue / Chevy Chase, MD 20815 I 301-656-3998 oocKEIEO USNRC December 12, 1997 "97 OEC l2 ~9 :55 UUChf NlJMBE Mr. John C. Hoyle, Secretary PETITION RULE PAM 50.e,3 _* OF S':'"'o~ '.' RY Nuclear Regulatory Commission Washington, D. C. 20555 ( (,:J.F~ ~ '-0 3 g>) O FJ~Scl1vt\K\I~(~~ tHPcF ADJUDICA, (> ~s v11"\1 Re: PRM-50-63 uJv f UMBE PETITION RULE PRM 50- " 3

Dear Mr. Hoyle:

( fl, o F ~ 5"'8' ..25&, ) On December 7, 1997, I submitted two documents for inclusion in the docket of my petition for rulemaking. One of them was a filing that I submitted to the Ohio Department of Health over the weekend. Unfortunately, I had an incorrect fax number for the official to whom the filing was addressed, as I learned yesterday. Accordingly, I resubmitted the document, but before doing so, made some corrections and additions. I would therefore like to ask you to discard my submission of December 7 and replace it with this one. Enclosed, therefore, for inclusion of the docket on my petition for rulemaking, are two documents. The first is a statement that I submitted to the New York State Radiological Health Committee on November 21 , 1997. The second is a response, dated December 11, 1997, to a request from Mr. Roger Suppes, Chief of the Bureau of Radiation Protection in the Ohio Department of Health, for feedback on issues and concerns identified by participants in a meeting on KI that was held in Painesville , Ohio, on October 28, 1997. I would like these to be considered as additional comments on the petition and the amendment to the petition filed by me on November 12, 1997. As in the past , these were prepared at home, on my own time, using my own materials, etc. - Thank you. Sincerely,

                                             ~~~£--_;

Attachments: Statement to New York State, Nov. 21, 1997 Submission to Ohio Health Dept., Dec. 11, 1997

U.S. NUCLEAR REGULATORY COMMISSION RULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Docwnent Statistics Postmartc Date _ _ _,_ _ _ __ Coples Received _ _...,,_ _ _ __ Add~ Reproduced__._ _ __ Sp~~~~~£;:;; ID.s r~

Peter G. Crane/ 4809 Drummond Avenue/ Chevy Chase, MD 20815 / 301-656-3998 FAX FOR: ROGER SUPPES OHIO DEPT. OF HEALTH 614-466-0381 FROM: PETER C RANE 301-656-3998 ( telephone ) December 11, 1997 Mr. Roger L. Suppes, Chief Bureau of Radiation Protection Ohio Department of Health 246 N. High Street Columbus, Ohio 43266-0118

Dear Mr. Suppes:

I apologize that this filing is a few days past the December 8 date you specified. I had an incorrect fax number for you, and therefore my filing went astray when I sent it to you last Sunday, December 7. When I learned today of my error, I decided to make a few corrections and additions before submitting the filing today. Thank you for the opportunity to comment on the summary, prepared by the Ohio Commission on Dispute Resolution and Conflict Management, of the concerns and issues raised by participants in the meeting on potassium iodide ( KI) conducted in Painesville on October 28. I would also to reiterate my thanks to you and Mr. Lucia for inviting me to take part in the meeting. The meeting, I thought, was a fine example of democracy in action: a state and a local government, responding to citizen concerns by asking questions, giving the interested public an opportunity to be heard, and conducting its business in the open. As in the past, in providing these comments I am writing in my personal capacity, not as an employee of the NRC, and this is written at home, on my own time. First, I would like to inform you of some developments since the Painesville meeting, and then I will offer comments on the summary of the concerns and clarifications offered by the participants in the meeting. A. Recent Developments

2

1. NRC Staff Admits to "Misinforming" the Commission about KI On November 5, 1997, the Nuclear Regulatory Commission held a public meeting on potassium iodide -- the first such meeting in 14 years -- at which it received presentations from the Federal Emergency Management Agency ( FEMA), the NRC

• technical staff, and me. 1 Among other things, the meeting was notable for the admission by the NRC staff that it had 11 misinformed 11 the Commission when it reported, in a June 1997 memorandum, SECY-97-124, that when the issue of KI was before an interagency group ( the Federal Radiological Preparedness Coordinating Committee) in 1995, FEMA was the agency that opposed any change in the existing federal KI policy. In fact, said an NR C staff official, it was the NR C, not FEMA, that had opposed such a change. The NRC staff official stated that he had learned of this through a letter sent by me a few days earlier to the Federal Emergency Management Agency. 2 The NRC staff did not explain, at the November 5 meeting, why it had misinformed the Commission; it is noteworthy that it did not claim that the error was inadvertent. Moreover, when a Commissioner asked about the assertion in my petition for rulemaking that existing policy was based on misinformation provided to the Commission and the public in the 1980's, the only staff member willing to admit to long familiarity with the KI issue said that he "had no answer. 113 The tape of the October 28 meeting in Painesville shows the NRC staff representative making the identical statement which the NRC staff admitted was "misinformation" only a week and a day later. Thus to the extent that one of my major themes at the Painesville meeting was that the Federal Government has for many years been giving 1

The transcript of that meeting is available through the NRC's website (www.nrc.gov). 2 The context suggests that FEMA was unwilling to allow the NRC staff to shift to FEMA the responsibility for having opposed a change in existing KI policy in 1995 . 3 It is somewhat extraordinary that at this late date, the NRC staff should have no answer to the question of whether the staff misinformed the Commission and the public about KI in the 1980's. This charge was a central element of my Differing Professional Opinion on KI, which the NRC staff first received in 1989 and spent the next four or five years evaluating. Attached to that document were extensive sections of the transcript of a November 22, 1983, Commission meeting in which, I claimed, the misinformation was F~ovided. I made the same charge of misinformation in my 1995 petition for rulejnaking, again with full documentation and lengthy quotations from the trBJ)Script of the November 1983 meeting. I also made this charge in my stateme~t:s to a public meeting on KI held by FEMA in June 1996 and to a December 1999 rqeeting of the Maine Radiological Advisory Committee. At each step, the NRC staff was fully aware of the charges I was making against it, because it received copies of my statements.

3 inaccurate and incomplete information to the states, the NRC staff seems to have demonstrated the validity of my contention in the Painesville meeting itself.

2. Filing of Amended Petition At the Commission meeting on November 5, I was asked by Chairman Jackson exactly what it was that I wanted. I replied that I would be satisfied with a rule change under which the NRC would "require that consideration of potassium iodide be given in the formulation of emergency plans, 11 but "would not ram potassium iodide down the throat of a state that emphatically rejected it. 11 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., evacuation, sheltering, and KI) and requiring their consideration.

I was therefore asked to submit an amendment to my petition reflecting this approach, by which states would be required to consider, but not necessarily to adopt, KI stockpiling. I did so by a filing of November 12, 1997. In filing this amended proposal, I was changing only the bottom line of my 1995 petition -- and that only slightly -- but was not withdrawing the original petition or any of the arguments made in it for a change in policy. Thus any inference that I have retracted the 1995 petition would be erroneous. Rather, in the hope of a sound and expeditious (if less than ideal) resolution of a difficult and divisive issue, I was offering a compromise on the bottom line of the rule change that would result from granting the petition. 4 I was also asked to provide a suggested markup of the draft Federal Register notice proposed by the staff in SECY-97-124. 5 In providing this as part of my November 12 filing, I offered some overview comments: [T]he staff's draft Federal Register notice, both in the selection of the facts it chooses to report and in its overall tone, . . . is heavily slanted against KI. 4 So limited a change would mean no legal necessity for a new round of public comment on the amendment to the petition; instead, the agency could proceed directly to rulemaking. I understand, however, that the NRC has decided to publish a notice of the receipt of the amended petition, and to allow public comment. On the one hand, this means further delay, but on the other, it is an opportunity for further participation by the interested public. 5 The document prepared by the Ohio Commission on Dispute Resolution & Conflict Management, and dated November 3, 1997, states in part, 11 Federal Register Notice has been issued -- contains current policy -- standing offer for NRC to fund." While the attendees at the Painesville meeting might well have received this impression, in fact no Federal Register notice has been issued. All that has been issued to date is the NRC's July 1, 1997, press release.

4 I would therefore be remiss if I did not candidly advise the Commission that the draft Federal Register notice, if issued in its present form, is likely to bring nothing but opprobrium to the NRC and to FEMA. In large measure, the notice's failings speak for themselves. What is one to say about a notice that does not get around until page 8 to mentioning 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 taking place now in the former Soviet Union? This is the way to court not merely criticism, but also ridicule and contempt. The NRC staff has not yet replied to my filing of November 12.

3. Meeting of New York State Radiological Health Advisory Committee On November 21, 1997, the New York State Radiological Health Advisory Committee met in Albany to consider the issue of KI stockpiling. The eight members of the panel were unanimous in support of having KI available for use in radiological emergencies. It deferred until a later date the logistical questions of how best to go about ensuring the availability of the drug. This recommendation will be passed on to the director of the New York Department of Health.

I think it is accurate to say that the members of the Committee were puzzled that the issue of KI was even controversial, and they asked what the arguments were against it. I quoted to them the comment of an Illinois state official, Mr. Roy Wight, that "loss of the thyroid is not life-threatening 6 , " and at least several of the Committee members were -- so it seemed to me -- appalled at the degree of ignorance revealed by this comment. One member volunteered that he had a patient with thyroid cancer whom he considered terminal, and another said that in a child, even the surgery can be life-threatening. Another pointed out that thyroid surgery can also affect the parathyroids, which control the body's use of calcium. 6 This appeared in Mr. Wight's statement to the June 1996 meeting on KI held at FEMA. Curiously, the identical words -- "loss of the thyroid is not life-threatening" -- appeared in the written statement of the South Carolina representative, Ms. Sandra Threatt. This raises the question whether they had been misinformed by the same source, and if so, by whom.

5 The same day as the Albany meeting, an article in "USA Today" reported that Illinois has decided against KI stockpiling. I think it deeply regrettable that this decision was apparently made on the basis of woeful ignorance of the medical issues involved -- an ignorance which the NRC staff has done nothing to correct. (An NRC staff member was present at the 1996 FEMA meeting at which the Illinois state official made his comment, and said not a word to suggest that the official's grasp of the medical ramifications of thyroid cancer was deficient.) Again, as I stressed at the Painesville meeting, if states are ill-informed about KI and thyroid disease, the blame lies much less on the states than on the Federal Government, for its failure over 15 years to provide the states with accurate and complete information. I am sure that the Illinois state official means the best according to his lights for the almost 12 million citizens of his state, but he has helped make Illinois a byword for ignorance and closemindedness when it comes to protecting the thyroids of our children from cancer. I hope and trust, therefore, that Ohio will follow the example of Maine and New York, not of Illinois. No one who reads this should imagine that I lack respect for the role of the states in decisions on emergency planning. On the contrary, the more I have seen (so far, in Maine, Ohio, and New York) of the responsiveness of the states to public concerns, of their willingness to confront issues, and of the timeliness with which they act, the more they show to advantage when compared with the Federal Government. It is because I am deeply impressed by states' willingness to act responsibly and expeditiously when presented with accurate information that I feel so keenly the Federal Government's irresponsibility in failing to provide the states with accurate and complete information on KI. I am aware that there are some supporters of the 1985 policy who claim that because when states were surveyed several years ago7 , most opposed any change in the current policy, respect for the states requires the Federal Government to keep the present policy unchanged. This argument, I believe, is patronizing toward the states, and in fact insults both their intelligence and their sense of responsibility toward their citizens. Reduced to its essentials, this argument assumes that states would rather have their children continue to receive second-class protection against nuclear emergencies than have to acknowledge that their existing policy is erroneous -- even though the Federal Government was to blame for the error, not the states themselves. I do not believe that that is how America's states make decisions affecting the health of their children. If states are given accurate information and an appropriate recommendation, their concern will be to do the right thing for their citizens now, rather than worrying about what someone with incomplete information might have said in response to a survey years ago. I can well understand why some federal bureaucrats would resist an open and truthful exposition of the KI issue; among other things, it would reveal the inaccuracy and incompleteness of the information provided by the federal 7 Poll results often depend heavily on the way the question is framed.

6 bureaucracy in the past 15 years. In my view, it is not respect for the states, but rather the ultimate disrespect for them, to pretend that a deficient health and safety policy needs to be kept in place because the states would not want to hear that the existing policy is erroneous. B. Response to Concerns and Clarifications

1. NRC "Clarifications/Concerns" I will deal briefly with some of the points attributed to the NRC.

a. It is true that under existing policy, distribution of KI is a state and local decision, and that states have had the opportunity to stockpile and distribute it if they so choose. It is also true, however, that federal policy, adopted in 1985, has tended strongly to discourage states from doing so, by using strong language --

" not worthwhile" -- with respect to KI.

b. As noted above, no Federal Register policy announcing the new policy has been issued.

c. As to whether the NRC (or the NRC staff) is or has been "anti-KI," I think I have said enough above.

d. On the point that "KI is site specific and only protects thyroid," this is true but beside the point. First, KI is not proposed as an alternative to those measures that protect the whole body, but as a complement to them. Moreover, there are circumstances in which KI can indirectly result in reducing whole body doses, even though the medicine itself protects only the thyroid gland. Although this sounds paradoxical, it is not. KI, by keeping radiation dose to the thyroid below the protective action guidelines at which evacuation is required, may make sheltering a viable option when it otherwise would not be. This in turn means averting the whole-body doses that might be received during evacuation, if the plume of radioactivity arrives before evacuation is complete. (Automobiles provide very limited protection against airborne fallout.) Whole-body doses are particularly dangerous to children in utero, especially during weeks 8 to 15 of pregnancy. 8

e. On the need of the state to deal with the FEMA local office, it is noteworthy that when asked by an NRC Commissioner at the November 5 meeting about the provisions made to move KI from terrorism stockpiles to nuclear power plant sites in 8

In this last regard, at the meeting in Albany I mentioned that a 1992 EPA report cites studies in the medical literature indicating that at whole-body doses greater than 10 rads, therapeutic abortion may be called for. Dr. David Becker of the American Thyroid Association commented that this overstates the risk to the fetus. During Chernobyl, he said, there were many unnecessary therapeutic abortions, in part because of erroneous advice corning from the West.

7 the event of an accident, a FEMA official indicated that no consideration had yet been given to this issue. This seems to highlight the importance of having KI on hand locally if its distribution is to be a realistic possibility in the event of an accident.

2. Comments and Concerns of Other Participants

a. Liability seems to be a concern on the minds of many commenters. The short answer is the one offered by Connie Kline at the meeting: that states and localities should be more concerned about the lawsuits that would result from their failure to have stockpiled KI in an emergency than from anything that could go wrong from KI use during an accident. We know from the Polish experience during Chernobyl that wide-scale use of KI is safe. We know from the Soviet experience during Chernobyl that without KI, the result can be large numbers of aggressive thyroid cancers among children.

- There is not and cannot be any guarantee that in an accident, it will be possible to get KI to everyone, even if planning is good and everything goes according to plan. It is in the nature of emergencies that the unexpected can and does occur. In such a case, it is possible that some people whom the KI did not reach would feel aggrieved. However, if there is no KI at all, then it can be guaranteed that no one will get the medicine, and that all of them -- with good reason -- will then feel aggrieved, especially the parents of small children. A state that has done its best -- and that includes reasonable measures to screen out persons with known iodine allergies -- should have nothing to fear on liability grounds from having stockpiled KI. In any case, it would not be used ( under the Federal Radiological Preparedness Response Plan) until the Federal Government had advised its use was warranted in the particular accident situation. Moreover, the drug was ruled "safe and effective" for use in radiological emergencies as long ago as 1978. Liability, in short, is a bogeyman. States should not allow it to frighten them away from a reasonable, conservative safety measure widely used throughout the developed world.

b. Dr. Haler of the Ohio Department of Health raised concerns about whether there are elements in the population that might lack sufficient sophistication to use KI safely. Whether or not her premise is valid, this is not a reason to defer a decision on whether it makes medical sense to have the KI option in an emergency.

Rather, the issue of how best to present KI to members of the public, like the issues surrounding distribution, is a question of implementation. As the New York State Radiological Health Committee observed, the first question is whether the drug is desirable medically, and only if that question is answered in the affirmative is it necessary to reach the questions of implementation. To worry about details of distribution before a decision on whether the drug makes

8 sense from a medical standpoint would be to put the cart before the horse. The first step is to make the decision to stockpile. This will assure that the medicine exists in sufficient quantity, sufficiently close to the people who may need it in an emergency. Meanwhile, federal, state, and local government officials can be addressing the question of what is the most effective way of getting this medicine to the affected population in an actual emergency.

c. On the issue of whether there is "new data," it is important to cut through the fog of artfully worded and bewildering statements from the NRC staff. The NRC staff has been assuring the world for so long that there is "no new information" on KI that this point needs to be nailed down. First, is there new information since 1985 on the health impacts of a major nuclear accident'? Yes, in the areas of former Soviet Union affected by fallout from Chernobyl we are seeing childhood thyroid cancer in greater numbers, and appearing sooner, than had previously been expected. Second, is there new information since 1985 on the safety and efficacy of KI? Yes, we have seen the Polish data on the use of KI during Chernobyl (18 million people received the drug), and there is also information on consumption of KI as an ingredient of over-the-counter cough and cold medications: 38 million equivalent doses of KI without a single adverse reaction reported, according to a 1995 NRC staff document.

What, then, does the NRC staff mean when it talks about "no new information that seriously challenges the basis of the 1985 policy"? Apparently, it means that the 1985 policy was based on a cost-benefit analysis that showed KI not to be cost-effective, and that no one has since demonstrated that KI is cost-effective. This leaves out two important considerations: ( 1) a reanalysis of costs and benefits in 1992 indicated that costs and benefits of KI were far closer than previously calculated, and for the closest-in populations were nearly equal; (2) the discussion of a change in KI policy in recent years has focused not on cost-benefit analysis but on prudency, so that it is irrelevant whether new information challenges the basis of the policy. The fact is that a great deal of new information has come to light in the last several years that seriously challenges the soundness of the policy, whether or not it challenges the basis of the policy -- whatever that means. In matters affecting health and safety, words should be used to illuminate issues, not to obscure them. To create the impression that no new information bearing on the value and safety of KI has accrued since 1985 -- the year before Chernobyl -- is to do a grave disservice to the public. Sincerely, Ltfi:Z~

Attachment:

Draft regulatory language and Statement of Considerations, from amended petition submitted to the NRC on November 12, 1997

9 PROPOSED RULE CHANGE 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 this 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 ingestion exposure pathway EPZ appropriate to the locale have been developed.

10 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 been developed" for protecting the public in the unlikely event of a radiological emergency. As amended, the regulation will spell out that in developing emergency plans, states must consider the following: evacuation, sheltering, and the use of radioprotective drugs (i.e., 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's thyroid glands are particularly sensitive to these effects. Since the efficacy of KI in protecting the thyroid depends on timing (i.e., 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 plants 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 primarily 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 Administration declared KI "safe and effective" as long ago as 1978, the drug had never been deployed on 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 reassurance 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. According to the World Health Organization, children are even less likely than adults to experience allergic reactions to KI. The NRC therefore recommends that states make KI stockpiling one of their tools to prepare for the unlikely event of a major nuclear 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 "range of protective actions" mandated by the NRC's emergency planning rules. The NRC has previously decided (on June 30, 1997) 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 rule 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 complement, not to replace, other protective measures. This rule change thus represents no alteration in the NRC's

11 view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs, when that is feasible. ( Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid.) Depending on the circumstances, KI may offer additional protection if used in conjunction with evacuation and/or sheltering. The approach taken in this rule change is consistent with International Basic Safety Standards issued by the International Atomic Energy Agency, et al.; 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 specializing in thyroid disease. Stockpiling 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 pre-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 to stockpile KI presents issues of how best to position and distribute the medicine, to ensure, ~ , 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 KI 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 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 in 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 stockpiling, 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.

STATEMENT OF PETER CRANE submitted to the New York State Radiological Health Advisory Committee Meeting on Potassium Iodide (KI) November 21, 1997 I appreciate the opportunity to submit a statement to this Committee's meeting on the radiation antidote potassium iodide (KI) . I do so in my private capacity, as an interested citizen, not in my official capacity as Counsel for Special Projects at the U.S. Nuclear Regulatory Commission. I do not speak for the NRC or the U.S. Government. This Committee recognizes, as the letter announcing the meeting made clear, that the threshold question about KI is medical: whether it is desirable as a public health matter to have KI on hand. Put another way, do the health benefits of the drug outweigh the health risks associated with its use? Only if the answer to that medical question is "yes" is it necessary to go on to address the logistical issues of where it should be stockpiled and how it should be distributed. 1 Current Federal policy on KI uses strong words -- "not worthwhile" -- to discourage stockpiling and use of the drug. That policy was put in place in July 1985, just months before the Chernobyl accident. Since that time, we have a wealth of new information that illuminates both the effects of a major nuclear accident on human health, especially the health of children) and the safety and efficacy of KI in such an accident. Nevertheless, the opponents of KI continue to assert that there is "no new information" or "no new data" that would challenge the 1985 policy. The physicians here today will have addressed the upsurge of childhood thyroid cancer in Belarus, Russia, and Ukraine since 1991; the Polish experience with KI following the Chernobyl accident in 1986; and the implications of those developments for the United States. I am not a physician, and would not presume to offer any medical advice to a committee of health experts except what comes from my own experience as a patient. My patient's-eye view is that thyroid cancer, notwithstanding that it is usually curable, can be a very nasty disease. Fatality rates are not the only measure of whether an illness is serious and worth preventing. You also have to look at the impacts on the quality of life. By that standard, thyroid cancer is significant both for the patient and the family, especially when it recurs. The process of treating it can be an ordeal, in part because of the need to take the patient off medication and induce weeks of hypothyroidism, which means being exhausted, weak, and cold. Moreover, any cancer is frightening, and 1 This point may seem obvious, but for years, opponents of KI stockpiling, putting the cart before the horse, have argued that the logistical problems of getting KI to people in an emergency would be so insuperable that the decision should be made against stockpiling without ever reaching the question of the likely medical benefits of using the drug.

2 that takes an emotional toll as well. There are, of course, many kinds of cancer ( and many other diseases as well) that are statistically more dangerous than thyroid cancer, and that impose much greater burdens on the average patient. But that is irrelevant. The question is whether this disease is sufficiently dangerous and burdensome to be worth preventing, if prevention can be achieved with a dime's worth of medication. I would answer that question "yes," and so would my family. You may be asking why anyone should feel it necessary to belabor the point that thyroid cancer is a serious, non-trivial illness. The answer is that too many states -- states where decisions on radiation protection are made by bureaucrats without the benefit of medical expertise -- seem not to know that. Just last year, for example, the Federal Emergency Management Agency held a meeting on KI at which the representative of a state with a population of about 12 million offered ~ one reason why his state saw no need to stockpile. "Loss of the thyroid," he said, "is not life-threatening." Try telling that to Senator Tom Harkin of Iowa, who lost a brother to thyroid cancer last year. In a narrow, technical sense, however, the state official I quoted was correct. Loss of the thyroid is not life-threatening in itself. Neither is loss of a breast, for that matter. But the cancer that causes you to lose your thyroid or your breast can take your life, and it is a grave disservice to the public to imply otherwise. If many states are ill-informed about thyroid cancer and other radiogenic thyroid diseases, it is in large part because the Federal Government has done such a poor job, over the past 15 years, of giving them the information they need. In my petition for rulemaking and elsewhere, I have described how the current Federal policy on KI was grounded in misinformation provided to the NR C Commissioners and the public some 14 years ago. But all that is history. At this point, I would like to look forward, not back, and rather than concentrate on the errors of the 1980's, make sure that the Government does the right thing today. The first thing the Government must do is to learn to speak clearly and straightforwardly on the KI issue. That means calling things by their right name, not using euphemisms or generalities that obscure from the states and the public the information they need . For example, on July 1 of this year, the NRC announced that the Commissioners had decided to support a proposed new policy that would make supplies of KI available, paid for by the Federal Government, to any state that asked for it. That was major progress. Unfortunately, however, the press release on the NRC's decision never used the word "cancer" to explain what KI does, but instead referred in general terms to "thyroid diseases." To announce the availability of KI without mentioning cancer is like announcing the

3 availability of Sabin vaccine without using the word "polio. " If you want states and the public to become aware of a public health issue and do something about it, you have to be a lot more direct than that. The proposed new federal policy has yet to be put in place. A number of federal agencies are involved in the decision, not just NRC. Assuming they can arrive at a decision, a Federal Register notice will be issued, sooner or later. But the process is painfully slow. It has been more than a year since an interagency committee, the Federal Radiological Preparedness Coordinating Committee, voted to recommend that the Federal Government buy KI for those states that wanted it, and almost five months since the NRC Commissioners voted to endorse that recommendation. To date, however, no Federal Register notice has been published, the public and the states have received next to no information about these votes from the Federal Government, and officially, the status quo remains unchanged. - For the present, therefore, the official U.S. Government policy on KI is still the one adopted in 1985, nine months before Chernobyl. Its use of the words "not worthwhile" with regard to KI is based upon what purports to be a cost-benefit analysis. This analysis measures the cost of KI against the cost of curing "thyroid nodules," and concludes that instead of spending money on prevention -- cheap as prevention would be -- it would be even cheaper for society to put its resources into curing the thyroid disease if and when it occurs. Let me interject at this point what I mean by prevention being cheap. The NRC staff calculated in 1994 that stockpiles sufficient for the vicinity of all nuclear plants would cost a total of $100,000 to at most a few hundred thousand dollars. That is for the whole country. The NRC staff also calculated that at that rate -- about $1100 for the average plant -- it would be cheaper to buy

• stockpiles than go on studying whether to do so. Isn't that the definition of a "no-brainer"? Only in Washington would we spend more money studying whether a medicine to protect our children is worth buying than the medicine itself would cost.

To return to the cost-benefit approach underlying the current policy, because it is based exclusively on economics, mechanistically balancing dollars for KI pills against dollars for medical bills, it does not take into account the possibility that people might have reasons other than saving money for preventing cases of disease. The policy takes the old adage about an ounce of prevention being worth a pound of cure and turns it upside down. Eleven years after Chernobyl, it reflects little credit on our Government that this approach, of treating the disease after the fact rather than spending a tiny sum on prevention, should still be the basis of our policy for dealing with radiation-caused thyroid cancer. The result is that today, children in other countries, from Japan to Poland and from Canada to Switzerland, have a protection that American children don't have. In the United States, unbelievable as it sounds, we have KI to protect the sharks at Sea World but

4 not the children who come to see them. 2 All over the world, countries know that if you are serious about being prepared to protect the public in nuclear emergencies, you should have three arrows in your quiver. Those are: ( 1) evacuation, which is the ideal solution -- when it is feasible; ( 2) sheltering, which means taking cover; and ( 3) potassium iodide. Having all three options gives you the flexibility to choose among them, or use them in combination, depending on the particular circumstances. If you can evacuate the entire population before the radioactivity arrives, and don't need to use KI, so much the better. But in the real world, bad weather, congested roads, or changing winds can make a full evacuation impossible. In that case, it's better to be safe than sorry. The French, Germans, Swedes, Slovaks, Austrians, Russians, Japanese, Canadians, and many more, all know this, and they stockpile KI. It's cheap enough, at about 10 cents per pers on protected, tha t the Poles keep 90 million doses on hand. Let me emphasize that I am not an alarmist about nuclear power, any more than are Senators Joseph Lieberman and Alan Simpson, who wrote to the NRC in 1994 to urge it to embrace KI stockpiling. I think that a major release is unlikely, because, generally speaking, our plants are well built and well run. But we have emergency planning because we know that accidents can happen, and that their consequences can be serious. If we are going to have emergency planning at all, it might as well be done right. I have often compared KI to the lifejackets on a ferryboat. Ferryboat accidents are very rare, and if one does occur, it is better to be evacuated in a lifeboat than to jump into the sea in a lifejacket. But in the real world, the unexpected happens, so we have lifeboats and lifejackets. We know that there is no inconsistency between the two: there is nothing about having lifejackets as a backup protection that could interfere with evacuation by lifeboat. So we don't do fancy cost-benefit analyses, we don't study the issue for 15 years, we just do it, because it would be reckless and irresponsible not to. Last December, when the Maine Advisory Commission on Radiation voted unanimously to support stockpiling, one of its members explained his vote in these words: "Ten years from now, if we have a release, I would rather say that we erred on the side of conservatism, knowing what we know." I think he 2 The 8-year-old daughter of Charles Pond, the director of Tennessee's program, having somehow learned that sharks in captivity require KI for their health, persuaded her father that as the state's KI reaches the end of its shelf life ( 5 years) , it should be donated to Sea World, where it is added to the sharks' water. See her father's statement at p. 57 of the transcript of the public meeting on KI held at FEMA on June 27, 1996. Young Ms. Pond's accomplishment was written up in the "Kids Did It!" section of a recent issue of the children's magazine, "National Geographic World".

5 hit the nail on the head. If the case for KI is as compelling as I have suggested, the question may be asked, what are the arguments against it? The arguments one hears against KI fall into two classes. First, there are those that are just plain invalid -- factually incorrect. The second are the objections that although they may be factually correct -- for example, that evacuation is generally the best option -- are still not a good reason to be without KI stockpiles. I will start with the wholly specious arguments, which number six.

1. "There is no new data challenging existing policy."

I have dealt with that above.

2. "Loss of the thyroid is not life-threatening."

This issue also I have dealt with above. Thyroid cancer can be life-threatening, and Chernobyl-related disease has already claimed a few lives among children in the former Soviet Union. But even if it were true that thyroid cancer is never fatal, who says a disease has to be life-threatening to be worth preventing'? That's not the standard we use when we have our kids immunized against mumps, measles, and chicken pox.

3. 11 KI is not cost-effective."

KI is an insurance policy -- backup protection in case of certain events that are unlikely but have serious consequences when they do occur. Is it "cost-effective"'? The problem with framing the issue that way is that if by "cost-effective" you mean "likely to pay for itself over time, no insurance 11 policy meets that test. The insurance companies would all be bankrupt if they didn't take in more from the average buyer than they pay out. Rational people, when deciding whether insurance is worthwhile, don't ask whether it is sure to pay for itself, but whether it provides valuable protection at a reasonable cost. Stockpiling of KI meets that test. I should add that in 1992, the NRC commissioned a revised cost-benefit analysis. Whereas the old analysis had found an extremely high ratio of costs to benefits, the new study found that the costs and benefits were very close -- about 2 to 1 -- for the population within a 5-mile radius of reactors. Moreover, there is an error band of plus or minus two orders of magnitude when you are talking about the probability of severe accidents. Thus by the NRC's own calculations, KI might actually be cost-effective by a factor of 50 for close-in populations. 3 3 Sometimes, even today, the opponents of KI will assert that there has been "no new information significantly challenging the basis of the 1985 policy," or similar words. What that means, when parsed out, seems to be this: that the cost-benefit analysis of the 1980's showed KI to be non-cost-effective; that

6

4. "KI could complicate evacuation."

You sometimes hear the argument that KI will diminish safety in an emergency, because people will ignore evacuation orders and go looking for KI instead. That's very farfetched. In fact, if you wanted to encourage evacuation, you might want to tell people over radio and television that when they get to the evacuation center, they will be checked out medically and given a medicine, potassium iodide, that will help protect them against radiation. And you add that this drug will not be available locally. So KI should not be a hindrance to an orderly evacuation; it might even be an incentive.

5. "KI carries a risk of serious side effects."

The best data on side effects comes from the Polish experience after Chernobyl, which is documented in a medical journal article co-written by Dr. Janusz Nauman, a Polish health official, and Dr. Jan Wolff, an NIH scientist. The Poles gave out 18 million doses. Two people were hospitalized, briefly. Both of them had known iodine allergies and took the drug in spite of being warned not to. Our own FDA says the benefit outweighs the side effects. The doctors of the American Thyroid Association were well aware of the side effects issue when they unanimously endorsed stockpiling in November 1996. In addition, an NR C staff document issued in 1995 4 cites a study which looked for adverse reactions in people who took cough and cold medications containing the drug. It reported that "for the most current data involving 38 million equivalent doses of KI consumed, there were no reports of adverse reactions." [Emphasis in the original.]

6. "KI could increase a state's risk of liability."

Distribution of KI would take place only after an advisory from the federal government that it was appropriate. In that situation, with a state following federal directives and doing the best it could under emergency conditions, who would find a state liable? If I were a state, I would be much more worried about the consequences of not having a KI stockpile, given all that is known about the drug's value. If ever there were an accident, and it turned out a state had no KI to give out because it had taken its medical advice the reanalysis still showed KI to be non-cost-effective ( though by a much narrower margin); and that accordingly, there has been no change. This kind of verbal sleight-of-hand creates the false impression that the Government has not learned anything casting doubt on the basis of the 1985 policy. 4 Nuclear Regulatory Commission: An Analysis of Potassium Iodide (KI) 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.

7 from lobbyists instead of doctors, that would be the time to worry about liability. The following are eight arguments that are factually accurate, wholly or in part, but still are not persuasive reasons to forgo stockpiling.

7. "Evacuation is preferable."

The most common argument against KI is also the most meritless: that evacuation is better, so we don't need KI and shouldn't even have it around as a precaution. The problem is that evacuation isn't always feasible. The NRC and FEMA have never claimed it was. KI is backup protection -- Plan B -- for those situations where evacuation cannot be completed in time to avoid a substantial radiation dose to the thyroid -- for example, because of adverse weather conditions, blocked roads, or widely dispersed radioactivity. Also, people may be exposed to radiation while they are evacuating -- automobiles don't afford much protection. Moreover, it is not an either/or proposition. You don't choose between backing evacuation and backing stockpiling of KI; you do both. The question is whether you have three weapons in your arsenal -- evacuation, sheltering, and KI -- or only two, in a situation when the third weapon costs only a pittance.

8. 11 Big accidents are unlikely. 11 It is true that big accidents are unlikely. Generally speaking, a combination of good design, good operation, and good regulation makes American nuclear reactors quite safe. But there is a big difference between saying that accidents are unlikely and saying that they cannot happen. If we could be sure that accidents would not happen, then all emergency planning --

sirens1 drills 1 and the like -- could go out the window. The cost of KI is a drop in the bucket by comparison to what is already spent on emergency preparedness. The reason we have sirens and drills and the rest is that we know that accidents can happen. (So can acts of terrorism.) If we accept the idea that emergency preparedness makes sense, then our preparedness ought to be first-rate, not second-rate.

9. "KI protects only one organ, whereas evacuation protects the whole body."

This is true, but nevertheless is not a valid reason to forgo stockpiling of KI. Evacuation is certainly the preferred protective action, when it is feasible, and when it can be accomplished in such a way as to avoid any exposure to radiation. But this may not always be the case. The Manual of Protective Action Guides and Protective Actions for Nuclear Incidents, EPA-400-R-92-001, published by the Environmental Protection Agency in May, 1992, makes clear that evacuation may be constrained by weather, floods, and road conditions. Moreover, there may be a danger to the public during an evacuation, since automobiles offer little shelter ( about 10% protection). Thus

8 although potassium iodide protects only the thyroid gland, it can, when used in conjunction with sheltering, make evacuation unnecessary, thereby averting the risk of radiation exposure during evacuation. The EPA Manual thus makes plain that choosing evacuation over sheltering during a radiological emergency does not mean zero radiation risk to the evacuees; on the contrary, it may sometimes mean higher radiation doses to the public, with pregnant mothers and their children at greatest risk of all. On this last point, the Manual explains that the particular danger to the unborn child is a risk of serious mental retardation so high, especially when the exposure occurs between the 8th and 15th week of gestation, that "induced abortion" may be indicated for any expectant mother who receives more than a relatively small dose of radiation ( 10 roentgen). 5 Furthermore, the Manual makes clear that in a major accident, the dose to the thyroid may well determine whether the EPA Protective Action Guidelines A are reached, and officials therefore have no choice but to evacuate. If people W can be provided with KI while they shelter, and their thyroid dose thereby minimized, evacuation may be unnecessary, and the whole body dose that they would receive during evacuation can be averted. Thus while it is true that KI protects only the thyroid, having the KI option may make it possible to avert the whole-body doses that would be received during evacuation. All the above makes plain how desirable it is for decisionmakers to have the option of giving out KI. Without stockpiles, this option as a practical matter does not exist.

10. "Public confidence in the technology could be affected."

That is a quotation from an industry "White Paper" on KI that was sent to the Nuclear Regulatory Commission in 1993. The same argument could be made A to assert that we shouldn't have containments or emergency core cooling W systems at nuclear plants, since both of those structures might remind people that accidents can happen . You don't hear the ferryboat operators complaining that having lifejackets on board will diminish confidence in ferryboat technology. If I were the industry, I would be embracing KI, and making the point that even though it is very unlikely that it would ever be needed, the industry is committed to ensuring that Americans are protected to the highest standard in the world.

11. "The logistics of distribution need more study."

The opponents of KI stockpiling sometimes try to change the subject from s See pages B-11, B-18. To avoid misunderstanding, let me stress that EPA is not recommending abortion for pregnant women exposed to these levels of radiation, it is just reporting what the extensive journal literature on the subject says.

I. 9 I , whether KI is a valuable protective measure ( an argument they know they will lose) to the logistics of delivering the drug in an emergency. The idea is to make the delivery of KI sound just impossibly complicated, so as to put off, preferably forever, the question of whether it makes sense to have the drug at all. This is the cart-before-the-horse argument I referred to earlier. Those arguments were made at the June 1996 meeting at FEMA, and answered by Dr. Jacob Robbins of the National Institutes of Health, speaking for the American Thyroid Association. He observed that there were two issues: whether to stockpile KI, and how to deliver it to people in an emergency. He said:

          "You're sort of asking the question: Which should come first? If you remember back to the Three Mile Island incident, there was no stockpile. It was requested. With a great deal of difficulty, in a rather inadequate way, it was finally made available. And it was ready to be used but with a delay. I think we have to think of both aspects. And what the American Thyroid Association has said is, create the stockpiles, have them available, and then have expert groups developing the mechanisms of how to distribute this in time of need. "

12. "The states don't want it."

This is an argument you hear again and again at the federal level. The Federal Government has been giving the states inaccurate and incomplete information about KI for 15 years, and it is small wonder that many states therefore believe that KI is undesirable. Once states begin to get full and up-to-date information about KI, their attitude toward stockpiling is likely to change, as Maine's did. Nevertheless, you still find some in the Federal Government touting surveys that were conducted several years ago, before most states had even begun to focus on the KI issue, for the proposition that there is no point in offering the drug to the states because they would not accept it if it were offered.

13. "People can buy it for themselves."

The argument can be made that people are free to buy the drug for themselves, and that the states and the Federal Government should not be involved. First, the drug is unlikely to be available locally. Second, people will know to buy the drug only if the authorities accept the obligation of informing them. It would probably be cheaper to buy a stockpile than to take on the task of telling people that they should consider buying it. Third, in an emergency, some people -- such as schoolchildren -- will not be at home. Fourth, do you really want to say that for the people who didn't have the foresight or money to buy the drug, it's their tough luck? To leave it up to individuals would be like telling ferryboat passengers that they are free to bring their own lifejackets. It's simpler, fairer, and better health policy to stockpile KI and bring it out for the entire affected population in time of need.

10

14. "Because the Federal Government has recently decided to stockpile KI in 27 cities for acts of nuclear terrorism, states and localities can rely on the Government's stockpiles in an emergency, and need not consider stockpiling in the vicinity of nuclear plants."

The shift in U.S. policy by which KI will be stockpiled for terrorist events is a good thing, insofar as it represents a recognition that KI is valuable in radiological emergencies. If it is valuable for emergencies caused by acts of terrorism, then it is also valuable for emergencies caused by accidents. But these terrorism stockpiles are likely to be very limited in size - - a few thousand pills -- and in any case, we are talking about a medicine whose value is entirely dependent on time. Administering the drug before the exposure to radiation is better than after, one hour after is better than two hours after, and so on. Thus it makes sense to have the drug close at hand, and to have plans in place for its use, for if there is one thing we know about a emergencies, it is that planning is always preferable to improvised, ad hoc W' responses. In conclusion, Americans have a right, where nuclear hazards are involved, to expect their Government to ensure both that they are protected adequately and that they are given accurate and complete information. In the case of potassium iodide, the Government has so far done neither. As a result, though American children should enjoy radiation protection second to none, today they do not. I hope the day will soon come that the Federal Government meets its responsibilities both to protect and to inform the public, where radiation and thyroid cancer are concerned. Until that day comes, states must rely on their A own expertise, and on the expertise of those whom they consult, and decide for W themselves how best to protect their citizens, especially the youngest ones. Attachments: Letter from Senators Joseph I. Lieberman and Alan K. Simpson, April 20, 1994 Letter from Dr. Jacob Robbins, July 8, 1996

tinittll ~tat~ __ .... ~matt WdNICTa 9C - tN I H April 20, 1914 The Honorable Ivan Selin Cb&irman u.s. Nuclear aequlatory C011'1nia1ion waahinqton, DC 20555

Dear Chairman Selin:

• we are writing to urge the Nuclear Requlatory C0111ni11ion (NRC) to reviae it* currant policy reQar41nq the availabilitY and Yte of potassium io~ide (Xl) in the event of an amer9ency at*

nuclear power plant. The NRC'I current policy is that atate and local qovernmant1 should consider atockpilinq KI for amer9ancy uaa by emar9eney workers and institutionalize~ persons, but not for the general public. This policy was established in the early 1980 1 1. Since that time, however, new information has ariaen and additional experience has been 9ained on the coats and benefit* of the prophylactic use of XI by the general population. we believe that this new info:r"TMtion and axpari*nca r~iraa a new approach to thia issue.

  . I~ 1s we11*estab11sheo 1cient1r1ca11y that KI 11 extremely effective in preventinq the uptake of radioactive iodine by the thyroid. If taken in the proper doae prior to axpo1ure to radioactive iodine, XI can completely block the uptake of the radioactive iodine.
        ~he di1tribution of ~I to the qeneral population in tha event of a nuclear emergency i1 a widely accepte4 protective
  -**ur*. The world Nealth Or~aniaation ha* raCU111nan4ad ita u**

for people livinq near* nuclear power plant if ra41at1cm levels are expected to exceed a predetermine4 doae. A n\.llftber of foreiqn 9overnmenta**inclu4in; tbe united kin;dcn, the Csech **Public. lwit&erlan4, C.na41an provinces vith nuclear power plant , and th* former loviat Union**atoclcpil* KI for 4iatribution to and u1e by the 9aneral public in the avant of a nuclear mer9ency. %n

 ~the u.s ** three atatea**Alabama, TeMe11ee, and Arisona**have plans to distribute or already bave diatributed KI to people living near one or more nuclear power plant* within thoae 1tate1

• A recent co1t*ben1tit 1tudy of thia i11ua conduct~ for the IIRC indicate* that the co1t1 of atockpiliDIJ u for people wb0 live within five mil** of a nuclear power plant are aini.11&1**

approximately ten cent* per per10n per year. ftli1 **n1 a t)'Pie&l population of 10,000 people ~ivin9 wi~in five lli1e1 of that for

• nucl ...r power plant, it lf0u14 coat approxinately ,1,000 to 11&ke KI available fc;>r 411tribution. Tbe llllC taff project that th*

coat of *~ockpil.1119 sx for everyone 1D the oo,m~ry w1Ch1n CS.ve miles of a nuclear power plant would be on the order of everal bundrad tbouaand dollar par yaar. 'J'hil 11 only* mall fraction of the expanae1 already 1pent on mnerveney plaMin;. Altha IDtC staff ii.1 noted , *[cJ01t1 in thi* ran;* preaent no 1iqnificant

   ~arrier ~o *tockpi1inq and are probably 1*** than t.h* oo*~ of ~h*

continued tu4iaa.* lcme concern bas been axpreaaecl t.bat P\,\blic *~~c.\.ion OD the u1e of KI may result in a potentially ai;nificant naqative public perception. However, no evidence baa been provided that any of the exi&ting policies in other nation* or in tbe atat** that

• provide for the use of XI by the ;eneral population haa caused .,

any undue panic or apprahanaion to th* oanaral publi~ . Moreover, the federa l qovernment has a moral reeponsibility to provide the pu.blic with complete and accurate infonn&tion re9ardinq the ri1k1 from federally -licen*ed activitie1 and way in which may be reduced .

                                                                 ~ho** ri  k*

ID sum, therefore, XI can ~e an extremely effective countermeasure to prevent damage to the thyroid in the event of a radiolooical amer;ency . It can also be made available for the qeneral population living near a nuclear power plant for Ai~iraal costs . The NRC should revise its policy to provide thia additional potential protective mQaGure for nuclear amarqency planni ng . we thank you for your time and con i~*r*~ion.

            ~-----                    linoerely,      U--
                                  **=
                                                ~~n Al~s~n            ;,,_.                J ~ h I, Li~erman aankin; N1nor1ty Nemtiar Subcommittee on Clean Air

• sw:>eOllll\ittae on Clean Air anc .Nuclear aequlation an4 11\.lclear aequlat1on

DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service National Institute of Diabetes National Institutes of Health and Digestive and Kidney Diseases Bethesda, Maryland 20892 Genetics and Biochemistry Branch Bldg 10 Room 8N315 10 CENTER DR MSC 1766 BJ:THFSDA, MD 20892-1766 301-496-5761 FAX 301-402-0387 8 July 1996 William F. McNutt, Chairman Federal Radiological Coordinating Committee Ad Hoc Committee on Potassium Iodide Federal Emergency Management Agency Washington, D.C. 20472

Dear Mr. McNutt,

I very much appreciated the opportunity to participate in the 27 June meeting to consider stockpiling KI. I want to thank you for conducting an interesting and well run meeting, and also to reinforce my Wish that those of us who recommended stockpiling convinced your committee that this is long overdue. The reasons are clear enough:

1. The Chernobyl experience has shown us that thyroid cancer is indeed a major result of a large reactor accident, even when evacuation is carried out;

2. The Polish experience has shown us that large scale deployment of KI is safe;

3. The Three Mile Island experience has shown us that it is not easy to obtain a good supply of KI in an emergency;

4. The shelf life of properly packaged KI is extremely long; S. The advantage of having a supply on hand for immediate use far outweighs its moderate cost;

6. The problems attendant on predistribution are immaterial for the matter of creating a stockpile;

7. No one questions the ability of KI to protect the thyroid from exposure _t9 radio iodine. .. .

8~ -~~:thqugh Kl~dministration before any exposure is ideal, the ChemoJ:?yl experience _also has shown us that the*exposure can . * *

• continue for days; institution of KI blockade at any time in this period is beneficial.

I sincerely hope that the subcommittee has been convinced by these arguments, and that the full committee will now devote its effort to creating one or more stockpiles and to developing the methodology for rapidly distributing the KI to a region where an accident is immin~t or has already taken place. I should add that the forgoing presents my personal opinion. I represent myself and the American Thyroid Association in this matter, but not the Public Health Service. Sincerely yours, d-~ Jacob Robbins, M.D. Scientist Emeritus

DUCKET NlJ PETITION RULE PR 5 o .. t:, 3 A-( t.,~ Fl< (,f,038) NUCLEAR REGULATORY COMMISSldN DEC 11 P2 :Q9 10 CFR Part 50 [Docket No. PRM-50-63A] Peter G. Crane; Receipt of an Amended Petition for Rulemaking AGENCY: Nuclear Regulatory Commission.

• ACTION: Amended petition for rulemaking: Notice of receipt.

SUMMARY

The Nuclear Regulatory Commission (NRC) has received and requests public comment on an amended petition for rulema:<ing filed by Mr. Peter G. Crane.

The amended petition has been docketed by the Commission and has been assigned Docket No. PRM-50-63A. The petitioner states, in this amendment to the earlier petition, that the rulemaking he seeks is to amend NRC's emergency planning regulations to require consideration of sheltering, evacuation, and the prophylactic use of potassium iodide for the general public in developing a range of emergency planning protective actions.

                                         ~ /~/ l9'/3 DATE: Submit comments by (30 days after pt:1elieetion in the FedeFOI Registe~.

Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except to those comments received on or before this date. ADDRESSES: Submit comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff.

Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm on Federal workdays. You may also provide comments via the NRC's interactive rulemaking website through the NRC home page (http://www.nrc.gov). This site provides the availability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking website, contact Ms. Carol Gallagher, 301-415-5905; e-mail: CAG@nrc.gov. For a copy of the petition, write: Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission,

• Washington, DC 20555. A copy of the petition is also available for public inspection, and copying for a fee, in the NRC Public Document Room, 2120 L Street, NW (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Michael Jamgochian, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone: 301-415-6534, e-mail: MTJ1@nrc.gov; or Michael T. Lesar, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone: 301-415-7163 or Toll Free: 1-800-368-5642, e-mail: MTL@nrc.gov. SUPPLEMENTARY INFORMATION:

Background

The NRC received a petition for rulemaking dated September 9, 1995, submitted by Mr. Peter G. Crane on his own behalf. The petition was docketed as PRM-50-63 on September 12, 1995. The notice of receipt of this petition was published on 2

I I I

• November 27, 1995 (60 FR 58256). On November 12, 1997, the NRC received an amendment to this petition submitted by Mr. Crane in response to the Commission's invitation at a public meeting held on November 5, 1997, at which the petitioner spoke.

The amended petition was assigned docket number PRM-50-63A. The amended petition revises the original petition by requesting that the NRC add one sentence to the planning standard in 10 CFR 50.47(b)(10) that refers to considering evacuation, sheltering, and the prophylactic use of potassium iodide for the general population in developing a range of emergency planning protective actions. In particular, as proposed, 10 CFR 50.47 (b)(10) would include the use of potassium iodide (Kl) as one action to be considered in emergency situations under onsite and offsite emergency plans. Potassium Iodide The petitioner states that Kl protects the thyroid gland, which is highly sensitive to radiation, from the radioactive iodide that could be released in extremely serious nuclear accidents; that by saturating the gland with iodide in a harmless form, Kl can prevent inhaled or ingested radioactive iodide from lodging in the thyroid gland, where it could lead to thyroid cancer or other illnesses; and that Kl itself has a long shelf life-at least five years--and causes negligible side effects. The petitioner further states that, in addition to preventing deaths from thyroid cancer, Kl prevents radiation-caused illnesses. The petitioner states that thyroid cancer, curable in 90-95 percent of cases, generally means surgery, radiation 3

treatment, and a lifetime of medication and monitoring. The petitioner asserts that the changes in medication that go with periodic scans put many patients on a physiological and psychological roller coaster. The petitioner also states 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 Proposed Amendment The peti~ioner initially requested that 10 CFR 50.47 be amended by revising paragraph (b)(10) to read as follows: §50.47 Emergency plans. (b) * * * (10) A range of protective actions, including sheltering, evacuation, and prophylactic use of iodide, 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 amended petition, the paragraph, as revised, would read as follows: §50.47 Emergency plans. (b) * *

• 4

(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 . As part of the amended petition, the petitioner also attached a proposed Statement of Considerations and, as invited by the Commission, a draft mark-up of a document from the Federal Emergency Management Agency entitled "Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent." Dated at Rockville, Maryland, this// (hday of December, 1997. For the Nuclear Regulatory Commission. n . Hoyle, ecretary of the Commission. 5

Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, MD 20815 I 301-656-3998 DOCKETED USNRC December 7, 1997 "97 0£C -8 P3 :49 DOCKET NL Mr. John C. Hoyle, Secretary LE PRM '50<11~ . _ ... Nucl~ar Regulatory Commission PETITION u Washmgton, D.C. 20555 ("1~F~~~03fJ

                                                  )       OFH _:~ l. i~rc?t ADRULt_,. _,_,_-.r.,,~.---,; /*., -JJ.)
                                                                                                   -

• r I

JUDI'. *\1

                                                                       '- l-1. j*
                                                                                          ,r.:(.~

TAFF COCKc. T Nu1vw1:M Re: PRM-50-63 PETITION RULE PRM 5o~(,,3

Dear Mr. Hoyle:

( <,oFl<.58~5to) Enclosed, for inclusion of the docket on my petition for rulemaking, are two documents. The first is a statement that I submitted to the New York State Radiological Health Committee on November 15, 1997. The second is a response to a request from Mr. Roger Suppes, Chief of the Bureau of Radiation Protection in the Ohio Department of Health, for feedback on issues and concerns identified by participants in a meeting on KI that was held in Painesville, Ohio, on October 28, 1997. I would like these to be considered as additional comments on the petition and the amendment to the petition filed by me on November 12, 1997. As in the past, these were prepared at home, on my own time, using my own materials, etc. Thank you. Sincerely,

U.S. NUClEAR REGULATORY COMM 1'.' '~ RlJlEMAKINGS &ADJUDICATIONS :::* OP=ICE OF THE SECRET.t-RY OF THE COMMISSION OocWn8ffl Statistics p~Tk OatJ. /d/'i'/,'1 _, 1/4,,M.f ~/,*.;eret/ bf /J~fer CY1.ne Coples RecQ!vad - - - ' - - - - - Ad(i*1copies Reproduced ---'5 ___ Specii\1Oismbtrlinr 1t.tm~o chi o.o_,.. Les~'") G~llttdbet:'.":- ---*-

STATEMENT OF PETER CRANE submitted to the New York State Radiological Health Advisory Committee Meeting on Potassium Iodide (KI) November 21, 1997 I appreciate the opportunity to submit a statement to this Committee's meeting on the radiation antidote potassium iodide (KI) . I do so in my private capacity, as an interested citizen, no_t in my official capacity as Counsel for Special Projects at the U.S. Nuclear Regulatory Commission. I do not speak for the NRC or the U.S. Government. This Committee recognizes I as the letter announcing the meeting made clear, that the threshold question about KI is medical: whether it is desirable as a public health matter to have KI on hand. Put another way, do the health benefits of the drug outweigh the health risks associated with its use'? Only if the answer to that medical question is "yes" is it necessary to go on to address the logistical issues of where it should be. stockpiled and how it should be distributed. 1 Current Federal policy on KI uses strong words -- "not worthwhile" -- to discourage stockpiling and use of the drug. That policy was put in place in July 1985, just months before the Chernobyl accident. Since that time, we have a wealth of new information that illuminates both the effects of a major nuclear accident on human health, especially the_ health of childrenJ and the safety and efficacy of KI in such an accident. Nevertheless I the opponents of KI continue

• to assert that there is "no new information" *or "no new data" that would challenge the 1985 policy.

The physicians here today will hav.e addressed the upsurge of childhood thyroid cancer in Belarus 1 Russia, and Ukraine since 1991; the Polish experience with KI following the Chernobyl accident in 1986; and the implications of those developments for the United States. I am not a physician, and would not presume to offer any medical advice to a committee of health experts except what comes from my own experience as a patient. My patient's-eye view is that thyroid cancer, notwithstanding that it is usually curable, can be a very nasty disease. Fatality rates are not the only measure of whether an illness is serious and worth preventing. You also have to look at the impacts on the quality of life. By that standard, thyroid cancer is significant both for the patient and the family, especially when it recurs. The process of treating it can be an ordeal, in part because of the need to take the patient off medication and induce weeks of hypothyroidism, which means being exhausted, weak, and cold. Moreover, any cancer is frightening, and This point may seerri obvious, but for years, opponents of KI stockpiling, putting the cart before the horse, have argued that the logistical problems of getting KI to people in an emergency would be so insuperable that the decision should be made against stockpiling without ever reaching the question of the likely medical benefits of using the drug.

2 that takes an emotional toll as well. There are, of course, many kinds of cancer ( and many other diseases as well) that are statistically more dangerous than thyroid cancer, and that impose much greater burdens on the average patient. But that is irrelevant. The question is whether this disease is sufficiently dangerous and burdensome to be worth preventing, if prevention can be achieved with a dime's worth of medication. I would answer that question "yes, 11 and so would my family. You may be asking why anyone should feel it necessary to belabor the point that thyroid cancer is a serious, non-trivial illness. The answe:r is that . too many states -- states where decisions on radiation protection are made by bureaucrats without the benefit of medical expertise -- seem not to know that. Just' last year, for example, the Federal Emergency Management Agency held a meeting on KI at which the representative of a state with a population of about 12 million offered ~ one .reason why his state saw no need to stockpile.

 "Loss of the thyroid, 11 he said, "is not life-threatening. 11 Try telling that to Senator Tom Harkin of Iowa, who lost a brother to thyroid cancer last year.

In a narrow, technical sense, however, the state official I quoted was correct. Loss of the thyroid is not life-threatening in itself. Neither is loss of a breast, for that matter. But the cancer that causes you to lose your thyroid or your breast can take your life, and it is a grave disservice to the public to imply otperwise,. .. If many states are ill-informed about thyroid cancer and other radiogenic thyroid *diseases, it is in large part because the Federal Government has done such a poor job, over the past 15 years, of giving them the information they need. In my petition for rulemaking and elsewhere, I have described how the current Federal policy on KI was grounded in misinformation provided to the NR C Commissioners and the public some 14 years ago. But all that is history. At this point, I would like to look forward, not back, and rather than concentrate on the errors of the 1980's, make sure that the Government does the right thing today. The-first thing the Government must do is to learn to speak clearly and straightforwardly on the KI issue. That means calling things by their right name, not using euphemisms or generalities that obscure from the states and the public the information they need. - For example, on July 1 of this year, the NRC announced that the CorQmis~ioners had decided to support a p_roP.osed :oew _9-oJJcy tha;t would make supplies of KI availabie, paid for by the *Federal Government; to any state that asked for it. That was major progress. Unfortunately, however, the press release on the NRC's decision never used the word "cancer" to explain what KI does, but instead referred in general terms to "thyroid diseases. 11 To announce the availability of KI without mentioning cancer is like announcing the

3 availability of Sabin vaccine without using the word "polio." If you want states and the public to become aware of a public health issue and do something about it, you have to be a lot more direct than that. The proposed new federal policy has yet to be put in place. A number of federal agencies are involved in the decision, not just NRC. Assuming they can arrive at a decision, a Federal Register notice will be issued, sooner or* later. But the process is painfully slow. It has been more than a year since an interagency committee, the Federal Radiological Preparedness Coordinating Committee, voted to recommend that the Federal Government buy KI for those states that wanted it, and almost five months since the NRC Commissioners voted to endorse that rE:!co:mmendation. To date, however, no Federal Register notice has been published, the public and the states have received next to no information about these votes from the Federal Government, and officially, the status quo remains unchanged. For the present, therefore, the official U.S. Government policy on KI is still the one adopted in 1985, nine months before Chernobyl. Its use of the words "not worthwhile" with regard to KI is based upon what purports to be a cost-benefit analysis. This analysis measures the cost of KI against the cost of curing "thyroid nodules," and concludes that instead of spending money on prevention -- cheap as prevention would be -- it would be even cheaper for society to put its resources into curing the thyroid disease if and when it occurs. Let me, interject at this point what Lsmean b¥ prevention being cheap. The NR C staff calculated in 1994 that stockpiles sufficient for the vicinity of all nuclear plants would cost a total of $100,000 to at most a few hundred thousand dollars. That is for the whole country. The NR C staff also calculated that at that rate -- about $1100 for the average plant -- it would be cheaper to buy stockpiles than go on studying whether to do so. Isn't that the definition of a "no-brainer"? Only in Washington would we spend more money studying whether a medicine to protect our children is worth buying than the medicine itself would cost. To return to the cost-benefit approach underlying the current policy, because it is based exclusively on economics, mechanistically balancing dollars for KI pills against dollars for medical bills, it does not take into account the possibility that people might have reasons other than saving money for preventing cases of disease. The policy takes the old adage about an ounce of prevention being worth a pound of cure and turns it upside down. Eleven years after Chernobyl, it reflects little credit on our Government , ,1 that this approach, of treating the diseas~. after the fact rather. tq.an, spending a tiny sum on prevention, should still be the basis of our policy for dealing with radiation-caused thyroid cancer. The result is that today, children in other countries, from Japan to Poland and from Canada to Switzerland, have a protection that American children don't have. In the United States, unbelievable as it sounds, we have KI to protect the sharks at Sea World but

4 not the children who come to see them. 2 All over the world, countries know that if you are serious about being prepared to protect the public in nuclear emergencies, you should have three arrows in your quiver. Those are: (1) evacuation, which is the ideal solution -- when it is feasible; (2) sheltering, which means taking cover; and ( 3) potassium iodide. Having all three options gives you the flexibility to choose among them, or use them in combination, depending on the particular circumstances. If you can evacuate the entire population before the radioactivity arrives, and don't need to use KI, so much the better. But in the real world, bad weather, congested roads, or changing winds can make a full evacuation impossible. In that case, it's better to be safe than sorry. The French, Germans, Swedes, Slovaks, Austrians, Russians, Japanese, Canadians, and many more, all know this~ and they stockpile KI. It's cheap enough, at about 10 cents per person protected, that the Poles keep 90 million doses on hand. Let me emphasize that I am not an alarmist about nuclear power, any more than are Senators Joseph LiebermaB and Alan Simpson, who wrote to the NRC in 1994 to urge it* to embrace KI stockpiling. I think that a major release is unlikely, because, generally speaking, our plants are well built and well run. But we have emergency planning because we know that accidents can happen, j and that their consequences can be seriou,s. If we ar_e going to have emergency

           .I         ),*      *   -.

• fG.:-.-*. .... * ,,

planning at all, it might as well be done right. I have often compared KI to the lifejackets on a ferryboat. Ferryboat accidents are very rare, and if one does occur, it is better to be evacuated in a lifeboat than to jump into the sea in a lifejacket. But in the real world, the unexpected happens, so we have lifeboats and lifejackets. We know that there is no inconsistency between the two: there is nothing about having lifejackets as a backup protection that could interfere with evacuation by lifeboat. So we don't do fancy cost-benefit analyses, we don't study the issue for 15 years, we just do it, because it would be reckless and irresponsible not to. Last December,. when the Maine Advisory Commission on Radiation voted unanimously to support stockpiling, one of its members explained his vote in these words: "Ten years from now, if we have a release, I would rather say that we erred on the side of conservatism, knowing what we know." I think he 2 The 8-year-old daughter of Charles Pond, the director of Tennessee's program, having 1-* -~ somehow learned that sharks

                                                     ~-

in Icaptivity require;;. KIL for- their health, persuaded her father that as the state's KI reaches the end of its shelf life (5 years), it should be donated to Sea World, where it is added to the sharks' water. See her father's statement at p. 57 of the transcript of the public meeting on KI held at FEMA on June 27, 1996. Young Ms. Pond's accomplishment was written up in the "Kids Did It l" section of a recent issue of the children's magazine, "National Geographic World".

                                            .5 hit the nail on the head.

If the case for KI is as compelling as I have suggested, the question may be asked, what are the arguments against it? The arguments one hears against KI fall into two classes. First, there are those that are just plain invalid -- factually incorrect. The second are the objections that although they may be factually correct -- for example, that evacuation is generally the best option -- are still not a good reason to be without KI stockpiles. I will start with the wholly specious arguments, which number six.

1. "There is no new data challenging existing policy."

I have dealt with that above.

• 2. "Loss of the thyroid is not life-threatening."

This issue also I have dealt with above. Thyroid cancer can be life-threatening, and Chernobyl-related disease has already claimed a few lives among children in the former Soviet Union. But even if it were true that thyroid cancer is never fatal, who says a disease has to be life-threatening to be worth preventing? That's not the standard we use when we have our kids immunized against mumps, measles, and chicken pox.

3. 11 KI is not cost-effective."

KI is an insurance policy -- backup protection in case of certain events that are unlikely but have serious consequences when they do occur. Is it "cost-effective"? The problem with framing the issue that way is that if by "cost-effective" you mean "likely to pay for itself over time," no insurance policy meets that test. The insurance companies would all be bankrupt if they didn't take in more from the average buyer than they pay out. Rational people, when deciding whether insurance is worthwhile, don't ask whether it is sure to pay for itself, but whether it provides valuable protection at a reasonable cost. Stockpiling of KI meets that test. I should add that in 1992, the NRC commissioned a revised cost-benefit analysis. Whereas the old analysis had found an extremely high ratio of costs to benefits, the new study found that the costs and benefits were very close -- about 2 to 1 -- for the population within a 5-mile radius of reactors. Moreover, there is an error band of plus or minus two orders of magnitude when you are talking about the probability of severe accidents. Thus by the NRC's own calculations, KI might actually be cost-effective by a factor of 50 for close-in

                                                                               ~

3 populations . 1 ,~* 3 Sometimes, even today, the opponents of KI will assert that there has been "no new information significantly challenging the basis of the 1985 policy," or similar words. What that means, when parsed out, seems to be this: that the cost-benefit analysis of the 1980's showed KI to be non-cost-effective; that

6

4. "KI could complicate evacuation."

You sometimes hear the argument that KI will diminish safety in an emergency, because people will ignore evacuation orders and go looking for KI instead. That's very farfetched. In fact, if you wanted to encourage evacuation, you might want to tell people over radio and television that when they get to the evacuation center, they will be checked out medically and given a medicine, potassium iodide, that will help protect them against radiation,. And you add that this drug will not be available locally. So KI should not be a hindrance to an orderly evacuation; it might even be an incentive.

5. "KI carries a risk of serious side. effects;"

The best data on side effects comes from the Polish experience after Chernobyl, which is documented in a medical journal article co-written by Dr. Janusz Nauman, a Polish health official, and Dr. Jan Wolff, an NIH scientist. The Poles gave out 18 million doses. Two people were hospitalized, briefly. Both of them had known iodine allergies and took the drug in spite of being warned not to. Our own FDA says the benefit outweighs the side effects. The doctors of the American Thyroid Association were well aware of the side effects issue when they unanimously endorsed stockpiling in November 1996. In addition, an NRC staff document issued in 19954 cites a study which looked for adverse reactions in people who took cough and cold medications containing the drug. It reported that. "for the most current data, involving 38 million equivalent doses of KI consumed, there were no reports of adverse reactions." [Emphasis in the original. ]

6. "KI could increase a state's risk of liability."

Distribution of KI would take place only after an advisory from the federal government that it was appropriate. In that situation, with a state following federal directives and doing the best it could under emergency conditions, who would find a state liable? If I were a state, I would be much more worried about the consequences of not having a KI stockpile, given all that is known about the drug's value. If ever there were an accident, and it turned out a state had no KI to give out because it had taken its medical advice the reanalysis still showed KI to be non-cost-effective ( though by a much narrower margin); and that accordingly, there has been no change. This kind. of verbal sleight-of-hand creates the false impression that the Government has not learned a~ything, casting doubt on:. the basis of the 1985 policy. 4 Nuclear Regulatory Commission: An Analysis of Potassium Iodide ( KI) 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.

7 from lobbyists instead of doctors, that would be the time to worry about

        ~ability.

The following are eight arguments that are factually accurate, wholly or in part, but still are not persuasive reasons to forgo stockpiling.

7. "Evacuation is preferable."

The most common argument against KI is also. the most meritless: that evacuation is better, so we don't need KI and shouldn't even have it around as a precaution. The problem is that evacuation isn't always feasible. The NRC and FEMA have never claimed it was. KI is backup protection -- Plan B -- for those situations where evacuation cannot be completed in time to avoid a substantial radiation dose to the thyroid -- for example, because of adverse ,"".")s, weather conditions, blocked roads, or widely dispersed radioactivity. Also,

 '. i people may be exposed to radiation while they are evacuating -- automobiles don't afford much protection.

Moreover, it is not an either/or proposition. You don't choose between backing evacuation and backing stockpiling of KI; you do both. The question is whether you have three weapons in your arsenal -- evacuation, shelteringi and KI -- or only two, in a situation when the third weapon costs only a pittance.

8. "Big accidents are unlikely. 11 It is true that big accidents are unlikely. Generally speaking, a combination of good design, good operation, and good regulation makes American nuclear reactors quite safe. But there is a big difference between saying that accidents are unlikely and saying that they cannot happen. If we could be sure that accidents would not happen, then all emergency planning --

sirens, drills, and the like -- could go out the window. The cost of KI is a drop in the bucket by comparison to what is already spent on emergency preparedness. The reason we have sirens and drills and the rest is that we know that accidents can happen. ( So can acts of terrorism. ) If we accept the idea that emergency preparedness makes sense, then our preparedness ought to be first-rate, not second-rate.

9. 11 KI protects only one organ. whereas evacuation protects the whole body."

This is true, but nevertheless is not a valid reason to forgo stockpiling of KI. Evacuation is certainly the preferred protective action, when it is feasible, and when it can be accomplished in such a way as to avoid any exposure to radiation. But this may not ~ways be .the. G~.e. The Manual of Protective Action Guides and Protective Actions for Nuclear Incidents, EPA-400-R-92-001, published by the Environmental Protection Agency in May, 1992, makes clear that evacuation may be constrained by weather, floods, and road conditions. Moreover, there may be a danger to the public during an evacuation, since automobiles offer little shelter ( about 10% protection) \. Thus

8 although potassium iodide protects only the thyroid gland, it can r when used in conjunction with sheltering, make evacuation unnecessary, thereby averting the risk of radiation exposure during evacuation. The EPA Manual thus makes plain that choosing evacuation over sheltering during a radiological emergency does not mean zero radiation risk to the evacuees; on the contrary, it may sometimes mean higher radiation doses to the public, with pregnant mothers and their children at greatest risk of all. On this last point, the Manual explains that the particular danger to the unborn child is a risk of serious mental retardation so high, especially when the exposure occurs between the 8th and 15th week of gestation, that "induced abortion" may be indicated for any expectant mother who receives more than a relatively small dose of radiation (10 roentgen). 5 Furthermore, the Manual makes clear that in a major accident, the dose to the thyroid may well determine whether the EPA Protective Action Guidelines are reached, and officials therefore have no choice but to evacuate. If people . can be provided with KI while they shelter, and their thyroid dose thereby minimized, evacuation may be unnecessary, and the whole body dose that they would receive during evacuation can be averted. Thus while it is true that KI protects only the thyroid, having tn.e KI option may make it possible to avert the whole-body doses that would be received during evacuation. All the above makes plain how desirable it is for decisionmakers to have the option of giving out KI. Without stockpiles, this option as a .practical matter does not exil?:t.

10. "Public confidence in the technology could be affected."

That is a quotation from an industry "White Paper" on KI that was sent to the Nuclear Regulatory Commission in 1993. The same argument could be made to assert that we shouldn't have containments or emergency core cooling systems at nuclear plants, since both of those structures might remind people that accidents can happen . You don't hear the ferryboat operators complaining that having lifejackets on board will diminish confidence in ferryboat technology. If I were the industry, I would be embracing KI, and making the point that even though it is very unlikely that it would ever be needed, the industry is committed to ensuring that Americans are protected to the highest standard in the world.

11. "The logistics of distribution need more study."

    - . T--b,e opponents of KI ;:;tockpiling sqf)"letimes try to change the subject from 5

See pages B-11, B-18. To avoid misunderstanding, let me stress that EPA is not recommending abortion for pregnant women exposed to these levels of radiation, it is just reporting what the extensive journal literature on the subject says.

9 whether KI is a valuable protective measure ( an argument they know they will lose) to the logistics of delivering the drug in an emergency. The idea is to make the delivery of KI sound just impossibly complicated, so as to put off, preferably forever, the question of whether it makes sense to have the drug at all. This is the cart-before-the-horse argument I referred to earlier. Those arguments were made at the June 1996 meeting at FEMA, and answered by Dr. Jacob Robbins of the National Institutes of Health, speaking for the American Thyroid Association. He observed that there were two issues: whether to stockpile KI, and how to deliver it to people in an emergency. He said:

             "You're sort of asking the question: Which should come first'? If you remember back to the Three Mile Island incident, there was no stockpile. It was requested. With a great deal of difficulty, in a rather inadequate way, it* was finally made available. And it was
           . ready to be used but with a delay. I think we have to think of both aspects. And what the American Thyroid Association has said is, create the stockpiles, have them available, and then have expert groups developing the mechanisms of how to distribute this in time of need. 11

12. "The states don't want it. "

This is an argument you hear ag~n and again at the federal level. The Federal Government has been giving the states inaccurate and incomplete information about KI for 15 years, and it is small wonder that many states

   ;the:r:efore b~lieve that KI is undesirable. ,pnce st.ates, begin to get full and up-to-date information about KI, their attitude toward stockpiling is likely to change, as Maine's did. Nevertheless, you still find some in the Federal Government touting surveys that were conducted several years ago, before most states had even begun to focus on the KI issue, for the proposition that there is no point in offering the drug to the states because they would not accept it if it were offered.

13. "People can buy it for themselves."

The argument can be made that. people are free to buy the drug for themselves, and that the states and the Federal Government should not be involved. First, the drug is unlikely to be available locally. Second, people will know to buy the drug only if the authorities accept the obligation of informing them. It would probably be cheaper to buy a stockpile than to take on the task of telling people that they should consider buying it. Third, in an emergency, some people -- such as schoolchildren -- will not be at home. Fourth, do you really want to say that for the people who didn't have the

 , foresight <:>r,. mo11~y to buy the drug, it's their to~gh luck? .      ;,

To leave it up to individuals would be like telling ferryboat passengers that they are free to bring their own lifejackets. It's simpler, fairer, and better health policy to stockpile KI and bring it out for the entire affected population in time of need.

10

14. "Because the Federal Government has recently decided to stockpile KI in 27 cities for acts of nuclear terrorism, states and localities can rely on the Government's stockpiles in an emergency, and need not consider stockpiling in the vicinity of nuclear plants. "

              .J The shift in U.S. policy by which KI will be stockpiled for terrorist events is a good thing, insofar as it represents a recognition that KI is valuable in radiological emergencies. If it is valuable for emergencies caused by acts of terrorism, then it is also valuable for emergencies caused by accidents. But these terrorism stockpiles are likely to be very limited in size -
- a few thousand pills -- and in any case, we are talking about a medicine whose value is ep.tirely dependent on time. Administering the drug before the exposure to radiation is better than after, one hour after is better than two hours after, and so on. Thus it makes sense to have the drug close at hand, and to have plans in place for its use, for if there is one thing we know about emerge:r:icies, it is that planning is always preferable to improvised, ad hoc responses.

In conclusion, Americans have a right, where nuclear hazards are involved, to expect their Government to ensure both that they are protected adequately and that they are given accurate and complete information. In the case of potassium iodide, the Government has so far done neither. As a result, ,.though Ame,rican children should enjoy r5\.diation .protection second to none, today they do not.

• I hope the day will soon come that the Federal Government meets its responsibilities both to protect and to inform _the public, where radiation and thyroid cancer are concerned. Until that day comes, states must rely on their own expertise, and on the expertise of those whom they consult, and decide for themselves how best to protect their citizens, especially the youngest ones.

Attachments: Letter from Senators Joseph I. Lieberman and Alan K. Simpson, April 20, 1994 Letter from Dr. Jacob Robbins, July 8, 1996

t\nittll ~tat~ ~mate April 20, 1914

     ~he Honorable Yvan Selin Cb.airman U.S. Nuclear Requlatory CClllmia1i0n waahinqton, DC    aosss

Dear Chairman Selin:

we are writing to urge the Nuclear Regulatory CClrlni11ion (NR.C) to reviae ite current Policy reoar41nq the ava11~1l1tY and u1e of potassium iodide (KI) in the event ot an amer;ency at a nuclear power plant. The NRC'e current policy is that 1tate ano local qovernmant should consider atockpilinq KI for amer9ancy uaa by mnar9ency worters and institutionalized persons, but not tof the ;eneral public. This policy was .established in the early 1980'1. Since that time, however, new information has ari1en and addition&l experience has been qained on the costs and benefits of the ,~- prophylactic use of KI by the qaneral'"popul&tion. tte believe that thia new information and axparienca req\,lira1 a new approach to this issue. *

     .      I~ 18 well*establ1Shea ICient1!1CallY thlt XI 11 extremely effective in preventin; the upta~e of radioactive iodine by the thyroid. If taken in the proper dose prior to ~*ure to radioactive iodine, XI can completely block the uptake of the radioactive iodine.

The diatribution of KI to the oeneral population in th* event cf a nuclear amergency i1 a widelv accepte4 protective

     -**ur*. The Worl4 Nealth 0r9anization ha* r*canwn*nded it* u**

for people livinq near a.nuclear power plant if radiation levels are,expected to exceed a predetermined doae. A number of forai9n 90vernment***inclu4in; tb* united kin;dom, the Czech **Public, lwit&erland, Cenadian provinces vith nuclear power plant , and th* fo%1Dar loviat Union***tockpil* XI for 4i1tribution tc and us* by the 9aneral public in the avant of a nuclear amarvancy. xn

    ~the o.s., three 1tates**Alabama, TeMe11ee, and Arisona**bave plans to diatribu~e or already 1have diatributed KZ t.o people 1

living near one ot more nuclear power plant, within thoae 1tates

• A recent co1t*benatit 1tudy cf thia i11ue conduct~ for the HRC indicates that the coat of atockpilioq u for people Who live within five mil** of a nuclear power plant are ainimal**

approximately ten cents per peraon par yu.r. !'hi* **M a typie&l population of 10,000 people livin9 wit.h1n five ai1e1 of that for

• nuclur power plant, it lf0ul4 coat approxillately ,1,000 ~ aaJte ltI available for 4i1tribution. Tbe IIRC ataff project* that th*

coat of *tockp1l1D; E:t for everyone 1n ~* ooun~zy wiUlS.D Ci.Ye miles of a nuclear power plant would be on th* ord*r of **varal hundred thousand dollar per year. Thi* 11 only* aull fraction of the axpenaes already 1pent on mnerqeney plaMinq. Al the IDlC staff has noted, *(cJ01t1 in thi1 ranqe pre1ent no 1iqnificant barrier ~o *tockpi1ift9 and &r* probably 1*** Ulan~* ao*~ of ~h* continued tudia.* lane concern bas been axpreaaecl t.bat snmlic *~uc.Lion OD the u1e of KI may result in a potentially aiqnificant neqativ* public parc*ption. However, no evidence has bean provided that any of the existing policies in other nations or in tbe atat** that

• provide for the use of XI by the ;eneral population has caused any undue panic or apprahan&~on to the qanaral public. Moreover.

the federal qovermnent has a moral responsibility to provide the public with ccmpleta and acc:urat* information regarding the ri1k1 from federally-licensed activities and may be reduced. way in which tho

• ri ka In sum, therefore, XI can be an extremely effective countermeasure to prevent damage to the thyroid in the event of a radioloqical emer;ency. It can also be made available for the 9eneral population living near a nuclear power plant. for minimal

 .. cost,s. * -The NRC should revise ci"t.s pol'icy to' provide this additional potential prctectivc m~acure for nuclear amar9ency pla.nning.

we thank you for your time and consideration.

             /:);2----                    s.1.ncerely,     U------

Al~~n ~ ll&nkin9 N1nor1tY Member

                                   **-               ~~h
                                                     ~~n    I. L.l.el>eman Subccmmi ttee on Clean Air

• SubcOftll\itt** on Clean Air and Nuclear aequlation an4 Huclear aequlation

DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Service National Institute of Diabetes National Institutes of Health and Digestive and Kidney Diseases Bethesda, Maryland 20892 Genetics and Biochemistry Branch Bldg 10 Room 8N315 10 CENTER DR MSC 1766 BETHFSDA, 1'.ID 20892-1766 301-496-5761 FAX 301-402-0387 8 July 1996 William F. McNutt, Chairman Federal Radiological Coorclinatin*g Committee Ad Hoc Committee on Potassium Iodide Federal Emergency Management Agency . Washington, D.C. 20472

Dear Mr. McNutt,

I very much appreciated the opportunity to participate in the 27 June meeting to consider stockpiling KI. I want to thank you for conducting an. inte:i-esting and well run meeting, and also to reinforce my Wish that those of us who recommended stockpiling convinced your committee that this is long overdue. The reasons are clear enough:

1. The Chernobyl experience has shown us that thyroid cancer is indeed a major result of a large reactor accident, even when evacuation is carried out;

2. The Polish experience has shown us that large scale deployment of KI is safe;

3. The Three Mile Island experience has shown us that it is not easy to obtain a good supply of KI in an emergency;

4. The shelf life of properly packaged KI is extremely long; S. The advantage of having a supply on hand for immediate use far outweighs its moderate cost;

6. The problems attendant on predistribution are immaterial for the matter of creating a stockpile;

7. No one questions the ability of KI to protect the thyroid from exposure to. radio iodine. .. . . . . ** ,

8~.~~'.t#9~gh KI ~~stration befo;t;~ aµy exposure is ideal, the. Che:rzi91?yl experience _also has shown us that the* exposure can . ,

continue for days; institution of KI blockade at any time in this period is beneficial. I sincerely hope that the subcommittee has been convinced by these arguments, and that the full committee will now devote its effort to creating one or more stockpiles and to developing the methodology for rapidly distributing the KI to a region where an accident is immin~t or has already taken place. I should add that the forgoing presents my personal opinion. I represent myself and the American Thyroid Association in this matter, but not the Public Health Service. Sincerely yours,

• c J l -

Jacob Robbins, M.D.

                            ~

Scientist Emeritus

Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, MD 20815 I 301-656-3998 FAX FOR: ROGER SUPPES OHIO DEPT. OF HEALTH 614-466-0831 FROM: PETER CRANE 301-656-3998 (telephone) -~ December 6, 1997 /~:.~;,/ Mr. Roger L. Suppes, Chief Bureau of Radiation Protection Ohio Department of Health 246 N. High Street Columbus, Ohio 43266-0118

Dear Mr. Suppes:

Thank you for, the opportunity to comment on the summary,* *prepared by the Ohio Commission on Dispute Resolution and Conflict Management, of the concerns and issues raised by participants in the meeting on potassium iodide ( KI) conducted in Painesville on October 28. I would also to reiterate my thanks to you and Mr. Lucia for inviting me to take part in the meeting. The meeting, I thought, was a fine example of democracy in action: a state and a local government, responding to citizen concerns by asking questions,. giving the interested public an opportunity to be heard, and conducting its business in the open. As in the past, in providing these comments I am writing in my personal capacity, not as an employee of the NRC, and this is written at home, on my own time. First, I would like to inform you of some developments since the Painesville meeting, and then I will offer comments on the summary of the concerns and clarifications offered by thia participants in the meeting. A. Recent Developments t I . ,, if' *I' 1 .. NRC Staff Admits to "Misinforming" the Commission about KI On November 5, 1997, the Nuclear Regulatory Commission held a public meeting on potassium iodide -- the first such meeting in 14 years -- at which it received presentations from the Federal Emergency Management Agency (FEMA), the NRC

2

      *technical staff, and me. 1 Among other things, the meeting was notable for the admission by the NRC staff that it had "misinformed" the Commission when it reported, in a June 1997 memorandum, SECY-97-124, that when the i~sue of KI was before an interagency group ( the Federal Radiological Preparedness Coordinating Committee) in 1995, FEMA was the agency that opposed any change in the existing federal KI policy. In fact, said an NRC staff official, it was the NRC, not FEMA, that had opposed such a change. The NRC staff official stated that he had learned of this through a letter sent by me a few days earlier to the Federal Emergency Management Agency. 2 The NRC staff did not explain, at the November 5 meeting, why it had mtsinformed the Commission; it is noteworthy that it did not claim that the error was inadvertent. Moreover, when a Commissioner asked about the assertion in my petition for rulemaking that existing policy was based on misinformation provided to the Commission and the public in the 1980's, the only staff member willing to admit

• to long familiarity with the KI issue said that he "had no answer. 113 The tape of the October 28 meeting in Painesville shows the NRC staff representative making the identical statement which the NRC staff admitted was "misinformation" only a week and a day later. Thus to the extent that one of my major themes at the Painesville meeting was that the Federal Government has for many years been giving inaccurate and incomplete information to the states, the NRC staff seems to have demonstrated the validity of my contention in the Painesville meeting itself.

2. Filing of Amended Petition F'4' 1

The transcript of that meeting is available through the NRC's website (www.nrc.gov). 2 The context suggests that FEMA was unwilling to allow the NRC staff to shift to FEMA the responsibility for having opposed a change in existing KI policy in 1995 . 3 It is somewhat extraordinary that at this late date, the NRC staff should have no answer to the question of whether the staff misinformed the Commission and the public about KI in the 1980's. This charge was a central element of my Differing Professional Opinion on KI, which the NRC staff first received in 1989 and spent the next four or five years evaluating. Attached to that document were extensive sections of the transcript of a November 22, 1983, Commission meeting in which, I claimed, the misinformation was provided. I made the same charge of misinformation in my 1995 petition for rulemaking, again with full documentation and len_gthy quotations fro,m th.e tran,sc;:::ipt-;_,of the November 1983 meeting. I also made this charge in my statements to a public meeting on KI held by FEMA in June 1996 and to a December 1996 meeting of the Maine Radiological Advisory Committee. At each step, the NRC staff was fully aware of the charges I was making against it, because it received copies of my statements.

3 At the Commission meeting on November 5, I was asked by Chairman Jackson exactly what it was that I wanted. I replied that I would be satisfied with a rule change under which the NRC would "require that consideration of potassium iodide be given in the formulation of emergency plans," but "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., evacuation, sheltering, and KI) and requiring their consideration. I was therefore asked to submit an amendment to my petition reflecting this approach, by which states would be required to consider, but not necessarily to adopt, KI stockpiling. I did so by a filing of November 12, 1997. In filing this amended proposal, I was changing only the bottom line of my 1995 petition -- and that only slightly -- but was not withdrawing the original petition or any of the arguments made in it for a change in policy. Thus any inference that I have retracted the 1995 petition would be erroneous. Rather, in the hope of a sound and expeditious (if less than ideal) resolution of a difficult and divisive issue, I was offering a compromise on the bottom line of the rule change that would result from granting the petition. 4

• I was also asked to provide a suggested markup of the draft Federal Register notice proposed by the staff in SECY-97-124. 5 In providing this as part of my November 12 filing, I offered some overview comments:

[T]he staff's draft Federal Registe;: notice:~ both in the selection of the facts it chooses to report and in its overall tone, ... is heavily slanted against KI. I would therefore be remiss if I did not candidly advise the i Commission that the draft Federal Register notice, if issued in its present form, is likely to bring nothing but opprobrium to the NRC and to FEMA. In large measure, the notice's failings speak for themselves. What is one to say about a notice that does not get around until page 8 to mentioning 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 4

              ,So limited a change would mean no need for a new round of public comment on the amendment to the petition; instead, the agency could proceed directly to rulemaking.

r*

• I' *,'P' . r.;-* I *  :$

5 The document prepared by the Ohio Commission on Dispute Resolution & Conflict Management, and dated November 3, 1997, states in part, "Federal Register Notice has been issued ~- contains current policy -- standing offer for NRC to fund." While the attendees at the Painesville meeting might well have received this impression, in fact no Federal Register notice has been issued. All that has been issued to date is the NRC's July 1, 1997, press release.

4 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 taking place now in the former Soviet Union? This is the way to court not merely criticism, but also ridicule and contempt. The NRC staff has not yet replied to my filing of November 12. ~ 3. Meeting of New York State Radiological Health Advisory Committee

• On November 15, 1997, the New York State Radiological Health Advisory Committee met in Albany to consider the issue of KI stockpiling. The eight members of the panel were unanimous in support of having KI available for use in radiological emergencies. It deferred until a later date the logistical questions of how best to go about ensuring the availability of the drug. This recommendation will be passed on to the director of the New York Department of Health.

I think it is accurate to say that the members of the Committee were puzzled that the

 -~ issue 9t Kl;, was ev:en controversial, and.,~hey as~ed whaJ the argum~nts were against it. I quoted to them the comment of an* Illinois state official that "loss of the thyroid is not life-threatening6 , " and at least several of the Committee members were -- so it seemed to me -- appalled at the depth of ignorance revealed by this comment. One member volunteered that he had a patient with thyroid cancer whom he considered terminal, and another said that in a child, even: the surgery can be life-threatening.

Another pointed out that thyroid surgery can also affect the parathyroids, which control the body's use of calcium. The same day as the Albany meeting, an article in "USA Today" reported that Illinois has decided against KI stockpiling. I think it deeply regrettable that this decision was apparently made on the basis of woeful ignorance of the medical issues involved -- an ignorance which the NRC staff has done nothing to correct. (An NRC staff member was present at the 1996 FEMA meeting at which the Illinois state official made his comment, and said not a word to suggest that the official's grasp of the medical ramifications of thyroid cancer was deficient.) Again, as I stressed at the Painesville meeting, if states are ill-informed about KI and thyroid disease, the blame lies much less on the states than on the Federal Government, for its failure

                             -;;=              r::__,   **!    11          l

• 6 Curiously, the identical words -- "loss of the thyroid is not life-threatening" -- appeared in the written statements of Illinois and South Carolina. This raises the question whether their misinformation came from the same source, and if so, from whom.

5 over 15 years to provide the states with accurate and complete information. I am sure that the Illinois state official means the best according to his lights for the almost 12 million citizens of his state, but he has helped make Illinois a byword for ignorance and closemindedness when it comes to protecting the thyroids of our children from cancer. I* hope and trust, therefore, that Ohio will follow the example of Maine and New York, not of Illinois. B. Response to Concerns and Clarifications 11

1. NRC Clarifications/Concerns11 I will deal briefly with some of the points attributed to the NRC.

a. It is true that under existing policy, distribution of KI is a state and local decision, and that states have had the opportunity to stockpile and distribute it if they so choose. It is also true, however, that federal policy, adopted in 1985, has tended strongly to discourage states from doing so, by using strong language --

11 not worthwhile" -- with respect to KI.

b. As noted above, no Federal Register policy announcing the new policy has been issued.

c. As to whether the NRC (or the NRC staff) is or has been "anti-KI," I think I have said enough above. ,

d. On the point that "KI is site specific and only protects thyroid, 11 this is true but beside the point. First, KI is not proposed as an alternative to those measures that protect the whole body, but as a complement to them. Moreover, there are circumstances in which KI can indirectly result in reducing whole body doses, even though the medicine itself protects only the thyroid gland. Although this sounds paradoxical, it is not. KI, by keeping radiation dose to the thyroid below the protective action guidelines at which evacuation is required, may make sheltering a viable option when it otherwise would not be. This in turn means averting the whole-body doses that might be received during evacuation, if the plume of radioactivity arrives before evacuation is complete. (Automobiles provide very limited protection against airborne fallout.) Whole-body doses are particularly dangerous to children in utero, especially during weeks 8 to 15 of pregnancy.

e. On the need of the state to deal with the FEMA local office, it is noteworthy that when asked by an NRC Commissioner at the November 5 meeting about the provisions made to move KI from terrorism stockpiles to nuclear power plant sites in w the event of an accident, a FEMA official indicated that *no consideration had yet been given to this issue. This seems to highlight the importance of having KI on hand locally if its distribution is to be a realistic possibility in the event of an accident.

6

2. Comments and Concerns of Other Participants

a. Liability seems to be a concern on the minds of many commenters. The short answer is the one offered by Connie Kline at the meeting: that states and localities should be more concerned about the lawsuits that would result from their failure to have stockpiled KI in an emergency than from anything that could go wrong fro1'1 KI use during an accident. We know from the Polish experience during Chernobyl that wide-scale use of KI is safe. We know from the Soviet experience during Chernobyl that without KI, the result can be large numbers of aggressive thyroid cancers among children.

• There is not and cannot be any guarantee that in an accident, it will be possible to get KI to everyone, even if planning is good and everything goes according to plan.

It is in the nature of emergencies that the unexpected can and does occur. In such a case, it is possible that some people whom the KI did not reach would feel aggrieved. However, if there* is no KI at all, then it can be guaranteed that no one will get the medicine, and that all of them -- with good reason -- will then feel aggrieved, especially the parents .of small children. A state that has done its best -- and that includes reasonable measures to screen out persons with known iodine allergies -- should have nothing to fear on liability grounds from having stockpiled KI. In any case, it would not be used ( under the Federal Radiological Preparedness Response Plan) until the Federal Government had advised its use was warranted in the particular accident situation. Moreover, the drug was ruled "safe and effective" for use in radiological emergencies as long ago I., , t , '!;;p 1#-. ' * ~ as 1978. Liability, in short, is a bogeyman. States should not allow it to frighten them away (:-*-.,\ from a reasonable, conservative safety measure widely used throughout the ' ~,.,._.; ) developed world.

b. Dr. Haler of the Ohio Department of Health raised concerns about whether there are elements in the population that might lack sufficient sophistication to use KI safely. Whether or not her premise is valid, this is not a reason to defer a decision on whether it makes medical sense to have the KI option in an emergency.

Rather, the issue of how best to present KI to members of the public, like the issues surrounding distribution, is a question of implementation. As the New York State Radiological Health Committee observed, the first question is whether the drug is desirable medically, and only if that question is answered in the affirmative is it necessary to reach the questions of implementation. To worry about details of distribution before a dedsion on whether the drug makes

       . r sense from a medichl standpoint would be tel put the cart before the horse. "The first step is to make the decision to stockpile. This will assure that the medicine exists in sufficient quantity, sufficiently close to the people who may need it in an emergency. Meanwhile, federal, state, and local government officials can be addressing the question of what is the most effective way of getting this medicine to

7 the affected population in an actual emergency.

c. On the issue of whether there is 11 new data," it is important to cut through the fog of artfully worded and bewildering statements from the NRC staff. The NRC staff has been assuring the world for so long that there is "no new information" on KI that this point needs to be nailed down. First, is there new information since 1985 on the health impacts of a major nuclear accident'? Yes, in the areas of former Soviet Union affect~d by fallout from Chernobyl we are seeing childhood thyroid cancer in greater numbers, and appearing sooner, than had previously been expected. Second, is there new information since 1985 on the safety and efficacy *Of KI'? Yes, we have seen the Polish data on the use of KI during Chernobyl (18 million people rece~ved the drug) , and there is also information on consumption of KI as an ingredient of over-the-counter cough and cold medications: 38 million equivalent doses of KI without a single adverse reaction reported, according to a -

1995 NRC staff document. What, then, does the NRC staff mean when it talks about "no new information .that seriously challenges the basis of the 1985 policy"'? Apparently, it means that the 1985 policy was based on a cost-benefit analysis that showed KI not to be cost-effective, and that no one has since demonstrated that KI is cost-effective. This leaves out two important considerations: (1) a reanalysis of costs and benefits in 1992 indicated that costs and benefits of KI were far closer than previously

     . calculated, and for the closest-in populations were nearly equal; (2) the discussion of a change in KI policy in recent years has focused not on cost-benefit analysis but d*,

on prudency, so that it is irrelevant whether

               ,., **      I                      r:::...--

new information challenges the basis of

                                                               *:ll*   .,       .  ,,        - -

the policy.* The fact is that a great deal of new information has come to light in the last several years that seriously challenges the soundness of the policy, whether or not it challenges the basis of the policy -- whatever that means. In matters affecting health and safety, words should be used to illuminate issues, not to obscure them. To create the impression that no new information bearing on the value and safety of KI has accrued since 1985 -- the year before Chernobyl -- is to do a grave disservice to the public. Sincerely, ik).~ Peter G. Crane

   " Attach.merit: Draft regulatory ianguaget*and Statement bf Considerations,* from ,*

amended petition submitted to the Nuclear Regulatory Commission on November 12, 1997

8 PROPOSED RULE CHANGE 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)(l0) 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 this 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 ingestion exposure pathway EPZ appropriate to the locale have been developed.

9 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 been developed" for protecting the public in the unlikely event of a radiological emergency. As amended, the regulation will spell out that in developing emergency plans, states must consider the following: evacuation, sheltering, and the use of radioprotective drugs (i.e., 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's thyroid glands are particularly sensitive to these effects. Since the efficacy of KI in protecting the thyroid depends on timing (i.e., 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 plants 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 primarily 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 r~~ult of a large reactor accident. Moreove,;i:-, altho~gh the .Food and Drug Administration declared KI "safe and effective" as long ago as 1978, the drug had never been deployed on 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 reassurance 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. According to the World Health Organization, children are even less likely than adults to experience allergic reactions to KI . The NRC therefore recommends that states make KI stockpiling one of their tools to prepare for the unlikely event of a major nuclear 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 "range of protective actions" mandated by the NRC's emergency planning rules. The NRC has previously decided (on June 30, 1997) to support a change in federal policy by which supplies of Kl will be made available, paid for by the Federal G6vernment, to states thae request it. Thl rule ctlange proposed in *this n6tice 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 complement, not to replace, other protective measures. This rule change thus represents no alteration in the NRC's

10 view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs, when that is feasible. (Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid.) Depending on the circumstances, KI may offer additional protection if used in conjunction with evacuation and/or sheltering. The approach taken in this rule change is consistent with International Basic Safety Standards issued by the International Atomic Energy Agency, et al.; 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 specializing in thyroid disease. Stockpiling 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 pre-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 r~asonable and prudent to maintain sto£kp~les in the vicinity of nuclear reactors and to include provisions for their distribution in emergency plans. The NRC recognizes that the decision to stockpile KI presents issues of how best to position and distribute the medicine, to ensure, ~ , 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 KI 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 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 in 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 stockpiling, 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- asl1stance 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.

Peter G. Crane/ 4809 Drummond Avenue/ Chevy Chase, MD 20815 / 301-656-3998 DOCKETED US . C November 12, 1997 DOCKET NUMBER Mr. John C. Hoyle, Secretary PETITION RULE PRM ,o-'13A "97 NOV 13 AlO :10 U.S. Nuclear Regulatory Commission 3 Washington, D. C. 20555 ( <PtF~t-t,0 S) OFFIC£ OF ECRf I fY RULctv*.,.~:<J"- *.-; ,\i D Re: Amendment to Petition for rulemaking (PRM-50-63) AOJUDICA !Cr *s STAFF

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, Peter G. Crane

Attachment:

corrected page 3

U.S. NUCLEAR REGULATORY CO flJLEMAKINGS &ADJUDICATIONS F OFRCE OF THE SECRETARY OF THE COMMISSION Document Stati tics Postmark Date _ _.....7_ __ CopiesRecelvoo _ _/_ __ Add'I . Reproduced _L.-----,-- Speclal Oistrlbution____:= ~ ~ c. = I, i'"-n1 _1 ~S_!A r --'-=~l...1...,1,~-

r 3 A KI rulemaking along the lines I am proposing would be a minor, not a major rulemaking. 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 required. I was also asked to provide for the record the citation to an Environmental 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." This letter and its attachment are in the rulemaking docket as comment no. 5, docketed November 13, 1995. Finally, I was asked to provide a suggested markup 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 appended Federal Register notice. 1 Neither the vote sheet of Chairman Jac~son nor that of 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's vote for Option 2 should be regarded as a vote for the Federal Register notice as drafted by the NRC staff, and my criticisms of the notice are directed at the NRC staff, not at the Commission. The NRC staff has already acknowledged, at the November 5 Commission 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 contains 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. 11

Peter G. Crane I 4809 Drummond Avenue I Chevy Chase, MD 20815 I 301-656-3998 == OOCKL1EO USNRC November 11, 1997 Mr. John C. Hoyle, Secretary "97 NOV 12 P4 :17 U.S. Nuclear Regulatory Commission Washington, D. C. 20555 OFFICE. ni--* '* 0E,* *,r.,* -.RY 1f"\ Ru LU:'.J,<li\Jt; Jl

                                                                                                        /~*~o Re: Amendment to Petition for rulemaking (PRM-~~~ ICti. , IOi S t. TAFF
         =-=..::.........=..=====--=='-=--===-=..;=-=--=-======-,--=--=-==-==---.a=;-,... cTNuM

Dear Mr. Hoyle:

PETITION RULE PR 5 o

• G,3 A

( &:J. h'< l,,t,03g-) 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 "require that consideration of potassium iodide be given in the formulation of emergency plans," but "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. , evacuation, sheltering, and KI) and requiring their consideration. In the meeting, I sometimes referred to the "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 would 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 proposing 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

U.S. NUCLEAR REGULATORY COMMISSION AULEMAKINGS & ADJUDICATIONS STAFF OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date _ _? _ _ _ _ __ C ~Received _ _ _, _ _ _ __ Add'I . Reproduced _ 'f ,.__~-- SnAC1al Disr1bution ~~ oc/2ioo.; Lesa r~ '71:> f4 _ _7s__1.IX$

2 on November 5 1 is an indication that I take this amendment of my petition very seriously I without game-playing. I would like as much as anyone to see this protracted process brought to closure, with broad consensus acceptance. Accordingly I I have tried to produce a solution that satisfies the NRC's obligations to protect and inform the public I that does not encroach unnecessarily on state prerogatives, and that enables the Commission 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 Commission, 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 I such as those I referred to in the November 5 meeting I I have omitted these historical matters from the proposed Statement of Considerations that I am offering today. This reflects a conscious decision to look forward, not to the past, in the recognition that for a health and safety agency I the central question must always be: What makes sense today, in light of what we know now? I believe that if the approach I am proposing is accepted I it would be viewed as so patently reasonable that if challenged legally I 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 memorable words of the late Judge Harold Leventhal 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 Commission should of course rely on the General Counsel and the Solicitor for advice. A rulemaking of this kind need not consume significant resources. Though it was suggested at the November 5 Commission meeting that a rulemaking would take two additional years (i.e. 1 for a total of more than four years since the filing of the petition) 1 this seems exaggerated. It is a matter of public record, for example, that the Commission's last major emergency planning rulemaking I the "realism" rule of 1987 1 did 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 Commission was prepared in which the issues and comments were analyzed and discussed in detail, with the arguments on both sides fairly presented. A Commission briefing was also held at which the merits of the competing arguments were discussed at length. In the end, the analysis 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 rulemaking along the lines I am proposing would be a minor, not a major rulemaking. 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 required. I was also asked to provide for the record the citation to an Environmental 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 attachment are in the rulemaking docket as comment no. 5, docketed November 13, 1995. Finally, I was asked to provide a suggested markup of the draft Federal Register notice proposed to the Commission in SECY 124. First, I would like to put the notice in context. SECY-97-124 asked for Commission approval of an approach, not of the appended 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 . Nor did the Commission's Staff Requirements Memorandum of June 30, 1997. Thus I do not think that the Commission's vote for Option 2 should be regarded as a vote for the Federal Register notice as drafted by the NRC staff, and my criticisms of the notice are directed at the NRC staff, not at the Commission. The NRC staff has already acknowledged, at the November 5 Commission meeting, that SECY 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: 11 Attachment 1 contains 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. 11

.. ,l., c'

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 remiss if I did not candidly advise the Commission that the draft Federal Register notice, if issued in its present form, is likely to bring nothing but opprobrium to the NRC and to FEMA. In large measure, the notice's failings speak for themselves. What is one to say about a notice that does not get around until page 8 to mentioning 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 taking 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 of context. For example, I think it is unwise for the NRC 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 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 untrue. Rather, the sentence seems to mean that the 1985 policy was based on a 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.

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 bearing 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, 11 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 Special 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 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 this 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 ingestion 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 been developed" for protecting the public in the unlikely event of a radiological emergency. As amended, the regulation will spell out that in developing emergency plans, states must consider the following: evacuation, sheltering, and the use of radioprotective drugs (i.e., 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's thyroid glands are particularly sensitive to these effects. Since the efficacy of KI in protecting the thyroid depends on timing (i.e., 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 plants 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 primarily 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 Administration declared KI "safe and effective" as long ago as 1978, the drug had never been deployed on 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 reassurance 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. According to the World Health Organization, children are even less likely than adults to experience allergic reactions to KI. The NRC therefore recommends that states make KI stockpiling one of their tools to prepare for the unlikely event of a major nuclear 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 "range of protective actions" mandated by the NRC's emergency planning rules. The NRC has previously decided (on June 30, 1997) 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 rule 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 complement, 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, when that is feasible. ( Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid. ) Depending on the circumstances, KI may offer additional protection if used in

9 conjunction with evacuation and/or sheltering. The approach taken in this rule change is consistent with International Basic Safety Standards issued by the International Atomic Energy Agency, et al. ; 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 specializing in thyroid disease. Stockpiling 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 pre-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 to stockpile KI presents issues of how best to position and distribute the medicine, to ensure, ~ , 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 KI is not a substitute for measures that protect

10 the whole body; etc. To date, these issues have been addressed in different ways in the numerous countries 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 in 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 stockpiling, 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.

Billing Code 671 8-06-P April 16, 1997 FEDERAL EMERGENCY MANAGEMENT AGENCY DRAFT Federal PoOcy on Distribution of Pota11lum Iodide Around Nuclear Power Sites for UH a a Thyroidal Blocking Agent AGENCY: Federal Emergency Management Agency. Pro -fec.tr'o 1-t 1 ., f"-4t.e:l I ~( ~ e.-( I' ACTION: Issuance of Federal Policy on Potassium Iodide A (t",S~vtc1.*, s. 9

SUMMARY

The Federal Radiological Preparedness Coordinating Committae (FRPCC) la issuing this revised Federal policy concerning the purchase, stockpiling, and use of -fk~ drwj

                                    .                    , to pr-ctt..cr                   jl4~

potassium iodide_ (Kl) as a prophylaxia~fer the thyroid,_in the unlikely event of a major radiological emergency at a commercial nuclear power plant. Taken in time, Kl blocks the Nvtvtt -H,, rv,/4 <::.1..1ur 4.1.::f ofli<,r.

• thyroid's uptake of airborne radioactive Iodine, and thus could hel E81tue~thyroid diseases

 \. ,~ft.,i1o.ll'f i'l l~dt\rt.M,                                                      .

caused by such exposure>)-1;:t__Ct:lvt ffe.e~f~ Co~pl~.1,,,ti,,rt of!,u* frofc.ctJ w . c:f ctio11s~

                         .                          f"                       ~J      evc,cua~l°"f         avi,I        IH-pl*ce. .sl,~/nr,~,)                                   I.(~

ttlmui.i provic\e$ fo protect- tt-,c j~vttra,.( f"'~ I"? Ci rad,ofe>j,'c.ed C.u.rf(-11 __:~---- * [ ~ Federal policy(is hat Kl should be SlOCkpiled and distrib~ed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of / tor -f1.t t t., tfA.l p1..1. l.i It, . . tl VCt i'l411 ~/, ' [publi~protective actions for severe 1ccident1 at commercial nuclear facilities, the~stJ

                                                                                                             .                                       -ti-te. "~ s l-technical information indicates that evacuation and in-place sheltering provide jdequatti]                                                                          ..
                  ..._bt.UWS' _f.,ic. ro'ttc..t"' 1'u., wl,olt. loOCl-1

• l<I p,.ov,cl~S q,(.:( 1 hc'4~l p,of<d10H fpr Oltt nt.:l11).1l011*Jtl\S1-fl"' /

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protection for the general public) Hunev,r. the State (or in some cases, the local t11~ro/1l., io'1nt

                                          .                             </1    ':                                                                                1.tScd i" government) is ultimately responsible for the protection of its citizens. Therefore, the                                                            !~;i~~:~~;..,
                                                                                                                                                                  ..... ~/o.r             i
                                                                                                                                                                         !SLtc li'"tri.., .

decision for local stockpiling and use of Kl as a protective measure for the general public is 1 left to the discretion of State ( or, in some cases, local government.)

• ATTACHM ENT 1 (ei41(f'jlVIC't Be./ic.C/, *f1J i'1ed ;</ stockp,/,..,j. '~ Cl t<:'Ci.SOv((tLle avi4 prL,( clev{t "' i'IS(( r~ I fL 1t Fttifra I Gi?//{,lf #Ifni w, f / pt( rc t,()!, ( .s'-1"/J J, C'!: ol /<; /

for -ft,o5( .sfa1cs {or iii so11u ca;;u, f;)t4f B"-'U*t ..,,,.,rs) tl,c..r- efut ro u.-iak t<:t f'1"r r:,F ~.,~,,. emer5e,1t'f pltUis,

2 It is recognized that the State (or in some cases, the local government), within the limits of its authority, can take measures beyond those &commended oi}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 the option tlJ use Kl if they 10 elcc1., the Feaeral government is prepared to provide funding for the purchase of a supply of Kl. Any State (or in some cases, local govemment) which selects the use of Kl as a protectJve measure for the general public may 10 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 emergencies 1

• To that end, and as an added assurance for radiological emergencies in which the location and timing of an emergency are unpredictable and for

                                                                                                             /1 ,t,i I+"'

which, unlike licensed nuclear power plants, there is little planning possible,

• stockpile: of art 1..__ a..t ~ 111twd,tr f 1.-t,J a,'"0 ..,._.,._J. ftt(,. IJ.S, .r Kl ,. being established by the Federal government ~ Federal stockpile" will be available to any State for any type of radiological emergency, at any time.

1 1n response to new thruta, the Federal government broadened the scope of emergency response preparedness to Include terrorism Involving nuclaar, biological, ind chemical agema. M a result, and In support of State and local governments, new r*ourcea were Identified to be nHded in response to such events: About two dozen Metropolitan Medical Strike Teems (MMST) are being established for reaponae to such evema. Medical auppliu, including Kl, are being 1tockpiltd nationally for the use by MMST1 in thrH locations: East coat. Central, and Wut coat. The quantity of aupplln stockpiled UHi a planning buia 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 30258). The principal difference between this revised policy and the 1985 version are the addition of the offer of I

                                                                                               )

the Federal Government to purchase a supply of Kl for States at a State's request"ene the ~ ~ablishment of a Federal stockpil~ 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 (202 648-4183. Q.\l\t\ 111.t.- e~rt,*c.i-r rt,Oj111 it101-1 ~~ -ffu. F°u'tf'M 3ol)lv>1A.w.,cet.CtJ reJ\tc,t~ I"1 ff~ offt-. to r<<rt: WtSe i' (, ft.tet-t" iit-t'.s :

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 ~          tllt~           t vil.t41'1~       prof-ic..t,*,,1-1 of tfi<_ pu.b(ic

4

Background

This policy on use of Kl as a thyroidal blocking agent is the result of a Federal interagency effort coordinated by FEMA for the FRPCC. On March 1 1, 1982, FEMA issued II final regulation in the FederaJ Register (47 fB 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 tum delegated to the Food and Drug Administration (FDA) was providing guidance to State and local governments on the use of radioprotective sub_ stances and prophylactic use 9 of drugs (e.g., Kl) to reduce radiation doses to 1pecific organs including dosage and projected radiatic,n exposures at which such drugs should be used. In the June 29, 1982 Federal Regjster (47 .EB 28158), FDA published reco~mendations for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health officials should con3ider the use of KJ.- The Federal policy on stockpiling and distribution of Kl was published in the July 24, 1985 Federal Regjster (50 fB 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 lodide.@n 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.]

r {!__o~p.£NT: IT rs ft STR..IJNi:>E" ltPPIU)/tClt 7D Hf~Te>ll.Y Tf{tlT FIAJJ:>S THc FrZPcc vorc {,,) oa. TH MFJ..JTiO A..)J~b To me pu£>(1(_ Bvr A)() T CHE llJJOS yi.., -me Fl!.P~c... ])ET£t2-~1 1NIITto1J AJIJS /JDT Pr;8'-1SHe1J 8C.ltvSf: FEMft- e£,tt..(2Eb Tl-lltT IT HAb dCl.N 8/lSEb 0/J JA)(.Ol-1()(.£TC-JNF°Dtltf-(1tT1 oN. 1/fc.)S 11115 S(Pr£1VCc Mt}y lCffl T/.lc l<.Cri0,£,1' l'}!;,~A.-', l

                                                                         /.JOT*. LJt{.~ No }J~IJ INFoflMIIT10JJ, **

.. . 1H P~/lASc- 11 w1,11ov, CH.A~61Nh iH~ L-***-FEbfiZAL.- PoLtC'(" CAIJ Elt5tt.'r' t.elfb ro e..o,.; F1.J5, o A>

• 6 On April 3, 1996, in connection.with a September 9, 1995 Petition for Rulemaking submitted to the Nuclear ~egulatory Commission (NRC) on this issue, the FRPCC 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~o new information that seriously challenges the bases for the 1985 recommendations concerning public use of Kl for radiological emergenc:H at nuclear power plants. However, several_recommendations were made to the FRPCC. The Subcommittee's three recommendations were: 1) without

                             *                 :fl1a:t i +- i .s

• changi~~-~~~.!!~eral P°.licy~y interceding ~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 ls 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.

lvOiF: r /CECD&,;1z.f 'Tlf-~T 17-11$ f5 lvl/ltT THC Su6(0IJ.J-(ITTF~ s~r"b. THC

• fR.o8LE"M. IS 11-i!tT iHE' KE'-1 PHr'lf-iSt /$ 11 T Ht:: tf)5E5. Foe. Tf-+f: /C,g~

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                                                                                     .       C l-4 /'l.AJ08 'IL? ' 1

8 The full FRPCC endorsed the subcommittee's recommendations with some modifications. Policy on Distribution of Kl Around Nuclear Power Sites for UH aa a Thyroidal Blocking Agent The purpose of this document is to provide Federal policy and guidance with regard to distribution of Kl, and lts usage as a thyroid blocking agent, around operating nuclear pt1wer 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. a.Ir! P'°"'l\C':S Cu f'rt"'t-

         ,:,. Federal policy j4 that Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of for t~1, t..t(nJ. pl.(1,,11,t                                               ave.i'/,ib.lc.
         ~Ylalie pr~tective actio!'ls or severe accidents at commercial nuclear facilities, the NSt fttt ~est technical information indicates that evacuation and in-place sheltering provide a~equete
        *----*----***-*--- .. ___ _ _                        qf--

protection for the general publi~ Howeve,, ~e 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.) btta.use -fttt'f pi*~~tc': -f{tt tJul.t &~((, /(f . prov0-<£- Mdit,*t,t,4'. i~ri>:Cct104 (O(' 0\\(.. <,4tti4.1t 01.1- seu~,ii~. l'Ht;4 L, -ft.,tl H- '1 rp,'(\) w4Lvt U5t>A I'-,

                                                       .....      I 1

t.e"'j'-lv1.e,.'t;~"' wifl.t fv(\(~-<.41101-, cud,(or 5~cl_1tr,"i,j,

7 It Is recognized that the State (or in some cases, the local government), within the limita of its authority, can take measures beyond thosef.ecommended o~required,._* The availability of Kl as a protective measure for the general public supplements other options for public offic;a1s 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 govemmen,~ 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 wicler*range of radiological emergencies2

• To that end, and s an added assurance, for radiological emergencies in which the location and timing of an emergency are unpredictable and for w,..uc

h , unl'k 1* d I I e 1cense nuc ear power p ants, I th ere .** ,.ittIe pIann1ng . poss,'ble,li~lifol 1, .. *1 s f JI 1toc.....,1 e" o dt'ct '-~t.-~-!'-~~-~!:'__ oL_s-,*tt.6 ttrc:>1tvi,.. 'f1,,.t. u. s-, "Tl.\uc. s Kl Jal-being established by the Federal govemmen~ This Federal stockpile"-will be available to any State for any type of radiological emergency, at any time.

The bases for these recommendations are given below. 2 tn rNponse to new threats, the Federal government broadaned tt,e scope of emergency response preparednesa to include terrorism, involving nuclear, biological, and chemical agents.Ma rNult. and in auppori of State and local governments, new resourcq were identified to be needed In response to such events. About two dozen Metropolitan Medical Strike Teams (MMSTI are being utablished for response to such events. Medical suppliN, including Kl, are being stockpiled nationally for the use by MMSTs In three locations: Eeat coeat, Central, and West coat. The quantity of supplies stockpiled uses I 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 operating commercial nuclear power plants in NUREG-0654/FEMA-REP-1, Revision 1, in 1980. This guidance recommends the stockpiling and distribution of KJ during emergencies to emergency workers and to institutionalized individuals. Thyroid blocking f Qr emergency workers and institutionalized Individuals was recommended bec1u11 these individuals are more likely to be exposed to radioiodine 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 11te is relatively ,mall and requires a limited supply of KJ 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 e,o,,o.i.~fJf~LJ.- actions. It is well-recognized that the inclusion of Kl as a protective measure, in addition -fi.~*oF to evacuation and sheltering, is benefici~I ~~l_y in v,~_ry--~~!""O~!_~_i_r~~mstances. The use of KJ is not without controversy. On the one hand, Kl has been shown to be an effective C"-HU(; a .... A. '1'1po-+t.!Jro,~i$"4'1 drug for protecting the thyroid from1thyroid nodule~ er ""°"fused by the uptake of radioicdine, especially in children fifteen years of age or younger. On the other hand, 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

9 by itself for protecting individuals from the radioactivity in *an ai_rbome 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 KJ 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, acciJent-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

                                                                                .                  1'"ff,S government Into the emergency plans will not be subject to Federal evaluation. This is          ~ CAµ-,

based on the recognition that the use of Kl by the State for the general public is a ec- {ottC.lf; supplemental protective measure, and on the Federal government's determination that the ~cc

                                                                                                ]>6l:..,,ss,l\r' existing emergency planning and preparedness guidance for nuclear power plants is                I tJ ,JOtJ S
                                                                                               µtf:r,tJf,.

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-ttie-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 aradiological emergency are outweighed by the risks of radioiodine Induced thyroid nodules or cancer at a projected

10

                                                                                                                       ~ ~
                                                                                                                       ~ C:
                                                                                                                   ~q ~

dase to the thyroid gland of 25 rem or greater. Since FDA has authorized the

                                                   ~                                                              ~~ ~

nonprescription sale of Kl, it is available to individuals who, baaed on their own personal k .

                                                                                                                  ~~~

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

                                                                                                                       '4.><
                                                                                                                           ~
                                                                                                                    ~~ . ~
                                                                                                                   "- \    a..:.

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

                                                                                                                   ~t
                                                                                                                   ~ ~ ~
                                                                                                                           ~

decisions related to the use of Kl. ~ \..

                                                                                                                   "-~     Q
                                                                                                                  ~~ ~
                                                                                                                   ..j
                                                                                                                        ~ \II Conclusion
                                                                                                                  ~~~

1~~ K~l 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 Kt for the general ~~ -:1: ~

                                                                                                                           ~

public in the ~~;~;~, a radiological emergency at a commercial nuclear plant. The policy is ~ ~ ::t~

                                                                                                                        ~

that Kl should be stockpiled and distributed to emergency workers and institutionalized ~"'(.("'

                                                                                                                  ~ '-u ~

persons during radiological emergencies, but leaves the decision for the stockpiling, ~\~~

                                                                                                                       'l.l 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 Kt 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 stockpning, distribution and use by any State or local wou (...j) government into the emergency plans will riot be subject to Federal evaluation. This is Dct Eit based on the recognition that the use of Kl by the State for the general public ia a PfrV' C.t,1r,t1 supplemental protective measure, and on the Federal government's determi~ation that the

11 existing emergency planning and preparedness guidance for nuclear power planta is effective and adequate to protect the public health and safety. J Those States or local governments which opt to include Kl for the general population will be responsible for the maintenanci, distribution, and any subsequent costs or legal liabilities associated with this program. As an added assurance, for a broader range of radiological er,,ergencies 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

  ,.        National Council on Radiation Protection and Meas~res (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 fB 58798, December 16, 1978.

12

3. Halperin, J. A., B. Shleien, S. E. Kahana, and J. M. Bilstad; *eackground Material for the Development of the Food and Drug Administrition's Recommendations on Thyroid Blocking with Potassium Iodide,* FDA 81-8158, U.S. Department of Health and Human Services (March 1981 ).

4. Food and Drug Administration; Potassium Iodide as a Thyroid-Blocking Ag~nt in a Radiation Emergency: Final Recommer:dations on Use (Notice of Availability) '!7 fB 28158, June 29, 1982).

e 5. Food and Drug Administration; Potassium Iodide as I Thyroid-Blocking Agent in 1 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 and Human Services.

e. NuclHr Regulatory Commi11ion; Examination of th* UH of Pota11lum Iodide (Kl) H 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-631 o, February 1995). Prepared by S. Cohen and Associates, Inc. and Scientech, Inc. for the NRC.

gy JJot.,,j, ,rt,s SHouL.1;; e~ 12-i~;..ieDGb As ]),sc12Eu1Tw. PrT 1/-fC 1Jt{2..Y Lt~, IT HAS Bce.P 5v1P£1L:S£'tl!:~ By

 ,He /2.c,t 1Jft c,~, s I t0 1Ju12 tG ( c 12.. - (;s ,o ( r ,cM 7)

• 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 l~ide After I Severe Accident at a Nuclear Power Plant (ScCY-94-087, March 29, 1994).

Signed:

• 0. Megs Hepler, Ill Chair Federal Radiological Preparedness Coordinating Committee

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- ~ .¥ United States Nuclear Regulatory Commission Office of Public Affairs Washington, DC 20555 Phone 301-415-8200 Fax 301-415-2234 Internet:opa@nrc.gov No. 98-12 NRC SEEKS COMMENT ON PETITION FOR RULEMAKING CONCERNING USE OF THYROID-PROTECTING DRUG IN EMERGENCY RESPONSE The Nuclear Regulatory Commission is seeking public comment on a petition for rulemaking which asks that the NRC modify its regulation, 10 CFR 50.47 (b) (10), to require that nuclear power plant emergency plans consider the inclusion of the use of potassium iodide, a thyroid-protecting drug, for the general public. The deadline for comments is February 17. Current Federal policy, published July 24, 1985, calls for potassium iodide to be stockpiled for distribution during emergencies to emergency workers and institutionalized persons. If taken in time, the substance blocks most of the thyroid gland's uptake of radioactive iodine. It could thus help reduce the risk of thyroid cancer and other diseases that might otherwise be caused by exposure to radioactive iodine which could be dispersed in a severe nuclear accident. The Commission last year voted to approve a proposed revision to the current Federal policy which would offer to provide funding for states which want to stockpile potassium iodide for use by the general public in the event of a nuclear power plant emergency. The rulemaking petition now pending before the Commission calls for a change in NRC regulations to specify that states and licensees consider the use of potassium iodide, as well as evacuation and sheltering, in the preparation of nuclear power plant emergency plans.

The petition was filed by Peter G. Crane, an NRC staff attorney who took the action as a private citizen. The original January 16 deadline for comments has been extended by 30 days to allow sufficient time for public comment. Persons wishing copies of the petition may write: Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy of the petition and other related documents are also available at the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, DC. The petition also may be accessed on the Internet at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=KI_PETITION. Comments should be mailed to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments also may be delivered to 11555 Rockville Pike, Rockville, MD, between 7:30 a.

m. and 4:15 p. m. on Federal workdays. They also may be provided through the NRC's interactive rulemaking website, which may be reached via the Internet at http://www.nrc.gov by looking for rulemaking under the heading "Public Participation and School Programs."

NUCLEAR R~~~~L!~~~~ BY.__,. 1i_o_;.~_() __ ____,,.,,.k.,. WASHINGTON, D.C. 20555 COMEXM-97-00S October 16 . 1997 MEMORANDUM TO : Cha i rman Jackson Conmissioner Dicus Conmissioner Diaz FROM : Edward McGaffigan. Jr . SUBJECT : REQUEST FOR BRIEFING ON NEW FEDERAL POLICY ON THE USE OF POTASSIUM IODIDE In SECY-97 -124: PROPOSED FEDERAL POLICY REGARDING USE OF POTASSIUM IODIDE AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT . the staff described va ri ous options for a Conmission policy on the use of potassium iodide (KI) after an accident at an NRC l icensed nuclear power plant . and recoomended that the Conmission either (1) revise the current pol icy and make KI available to the States. or (2) endorse the reconvnendations of the Federal Radiological Preparedness Coordinati ng Conmittee (FRPCC ) wherein the Federal government would stockpile KI around the country for use in nuclear. biological and chemical events and would fund the initial procurement of KI for any State or local government which selects the use of KI as a protective measure for the general public. The staff also provided a first draft Federal Register Notice (FRN) to be published by the Federal Emergency Management Agency (FEMA) that would describe the change in Federal policy reco1T111ended by the FRPCC . A majority of the Conmission approved option (2) -- endorse the FRPCC reconmended change in KI policy -- and directed the staff to advise the COOJnission as to how the staff will inform NRC licensees of the need to discuss the new KI policy with State and local governments. In a letter dated July 29. 1997. the NRC staff informed the Chairman of the FRPCC that the Conmission had endorsed the FRPCC rec01T111endations on a revised KI policy and proposed to schedule a special FRPCC meeting to discuss the status of the proposed Federal policy, to approve the formation of a working group to finalize the draft policy , to develop a procedure for handling funding requests from the States. and to develop the criteria for determining

2 eligibility of funding requests. [and] to request that HHS review the product warning for KI and ensure that it is suitable for use by the public during major radiological emergencies . In August. FEMA provided its revised draft FRN and policy statement to the staff for further NRC review. 1 From my review of these documents. I reached several conclusions about the current state of development of the general Federal policy on KI that the Commission has endorsed -- (1) Although the FRPCC-recommended policy was generally described in SECY-97-124. there appear to be many important details of the policy (e .g .. criteria for determining funding eligibility: apparent remaining questions about what the public should be told about the suitability of KI for unrestricted public use: number and location of the stockpile centers) that remain to be worked out . (2) Much remains to be done to implement the policy (e.g .. State and local governments must decide on whether and how they will use the Federal offer; NRC licensees must consult with State and local governments on the governments' KI policy in light of the new Federal policy ; NRC and FEMA may have to modify their own emergency response procedures to accommodate the new policy and the States' approaches under the new policy 2 ) . 1 The Commission did not comment on the draft FRN/policy statement that was appended to SECY-97-124. Pursuant to a request from my office, the staff provided FEMA's revised draft of the notice and policy statement to the Commission in an attachment to a memo from the OEDO, dated September 12, 1997. 2 In August, I served as the Headquarters Executive Team Director in an emergency preparedness exercise for Calloway. During the exercise, I raised a question as to how the new Federal policy on KI would impact our procedures in an emergency response. The Headquarters response staff indicated that, because of the new Federal policy, the NRC/FEMA response teams likely would need to consult with the State on the State's intent with regard to the distribution and use of KI for the general public, even in those situations in which the States had previously eschewed the use of KI. In addition, arrangements would need to be made to transport stocks of KI to the general location of the emergency in the event that the State determines, despite its previous position, that it should distribute KI to the general public. In that exercise, the State of Missouri was asked whether it wished to take advantage of the Washington, D.C. KI stockpile; the State declined the offer.

3 (3) The latest draft FRN/policy statement contains errors and misleading statements 3 and is not balanced in its treatment of the costs and benefits of KI . 4 The draft policy statement needs to be corrected. 5 Accordingly. I felt that the Commission could benefit from more information on the details of the new KI policy (and the Federal government's plan for implementation) that the Commission has adopted. and I requested a public 3 In two places, the draft policy statement indicates that the "incorporation of a program for KI stockpiling, distribution and use by any State or local government into the emergency plans will not be subject to Federal evaluation." (See draft FRN at pp.10) 12.) This statement is simply wrong. If a State or local government adopts a policy of predistribution and general public use of KI for a radiological emergency and incorporates this policy as a new protective action in offsite emergency plans, 10 CFR 50.54(q) and Appendix E will require that the NRC eventually evaluate such a change (either for prior approval if the change decreases the effectiveness of the plan or as part of the required full participation exercise of the offsite plans). I would note that this error in the draft policy statement was carried over to a draft speech that the Chairman's Office proposed for presentation at the Annual Meeting of the Organization of Agreement States on October 16, 1997. Obviously, the lack of complete development and understanding of the impacts of the new Federal policy will lead to such problems. 4 The draft policy statement highlights the fact that KI is not currently required for the general public (p.6), that evacuation and sheltering are the preferred protective actions (pp.7, 9), that KI has limited benefits (pp.9, 10), and that the use of KI is controversial and may entail medical side effects (p.9). With all of this emphasis on the negative, the draft statement fails to reflect the fact that KI can be of substantial benefit as a supplemental protective action taken at the time of evacuation or in-place sheltering, as several nations and at least two States have decided, and the fact that KI has been approved by the FDA as an over-the-counter drug, and the fact that the American Thyroid Association has endorsed KI stockpiling and distribution. In its present form, the draft FRN raises a question as to why the Federal government would even consider changing its KI policy. 5 In my view, the description of the new Federal policy that is provided to the public itself involves policy issues that should be of interest to the Commission. The staff must agree since staff personnel indicated, at the Commission Technical Assistants' briefing on October 1, 1997, that the staff would forward the final draft policy statement "to the Commission for final comment/approval. (A copy of the staff's briefing outline is attached.)

4 Commission briefing on that policy. on the final version of the FRN that will describe that policy. and on the related petition for rulemaking filed by Peter Crane . In asking for this briefing , I did not intend to imply that the Commission should reconsider its decision on SECY 124. Instead. I am simply asking for more details on (a) the new policy. (b) how the new policy might affect NRC emergency preparedness requirements and oversight processes. and. (c) the status of Federal agency actions to implement the new policy. Such detailed information is likely to be of assistance in the Commission's deliberations on the petition for rulemaking filed by Peter Crane . At least I believe that it will be of significant assistance to me . Consequent:y. I renew my request for a public Commission briefing on the new Federal KI policy. the status of its implementation. and the potential effects of that policy on NRC emergency preparedness requirements. Since there is an obvious nexus between these matters and the Peter Crane petition. I continue to believe that this briefing should also cover the staff ' s proposed response to the Crane petition. I also renew my request that the Commission review and comment on the staff's final draft FRN . SECY. please track .

Attachment:

as stated cc : SECY OGC OEDO

Commissioners' Assistants Briefing on 10/1 /97 regarding Staff Activities Regarding Kl Policy

• SECY-97-124 submitted June 16, 1997
• Commission voted to approve Option 2
• SRM issued June 30, 1997
• Staff officially notified FEMA on July 29, 1997 (via letter from FJC to Megs Hepler) of Commission decision with a copy of draft proposed Federal policy (i.e., the draft proposed FRN) included in the SECY-97-124
• FJC received from FEMA, via fax, a preliminary draft FRN on August 14, 1997. A copy was of this fax was requested by and delivered to the EDO's office. On August 18, 1997, EDO reminded the staff that it must ensure Kl FRN is fully consistent with SRM
• On August 26, 1997 NRR and AEOD staff discussed with FEMA the apparent differences in the FEMA's version and that which the Commission approved as part of Option 2
• On August 28, 1997, also in response to the June 30, 1997 SRM, staff described to the Commission its plan to inform NRC licensees of the need to discuss revised Federal policy on Kl with State and local governments
• On September 3, 1997 DEDR requested and received from the staff a description of the nature of the staff's August 26 comments to FEMA
• Staff meeting with FEMA scheduled for September 17 to work on the FRN was put on hold until the Commissioners' Assistants have been briefed
• On Sept 26, 1997, staff prepared a written update of staff ac!;vities to Commissioners' Assistants via EDO (presently in concurrence)
• Next step: Reschedule meeting with FEMA to achieve consensus on FRN content
• When the content of the draft FRN is acceptable to NRC staff, it will be forwarded to the Commission for final commenUapproval
• At the next FRPCC meeting (tentatively scheduled for October 9, 1997) the Federal agencies will be briefed on status of the FRN among other agenda items. The vote will be scheduled for a later date
• FEMA will publish the final version of FRN

From: Peter Crane < pgcrane@erols.com > To: TWD2.TWP9(MTJ1) Date: 2/18/98 7:47am

Subject:

Keeping Kl Petition and Comments on the Website I hope and trust that no one will have the idea that as soon as Feb. 17 is past, the Kl petition and the comments can be removed from the rulemaking website. That would be a serious mistake for several reasons, including:

1. The website serves a public information function, apart from being an avenue for filing comments;

2. The Federal Register notice said that the NRC would accept comments after Feb. 17 if it was feasible to do so, and it would be hard to argue that accepting late-filed comments would be infeasible;

3. We have seen once before that when documents disappear from the Internet, it just increases the burden on SECY to find, duplicate, and mail documents to persons who request them;

4. Removing the information from the Internet will undoubtedly be seen by some as an effort to keep the issue from public view; and

5. If the argument is made that the NRC will save money by removing the information from the Internet, it may sound hollow coming from a staff that has spent millions of dollars trying to justify why spending a few hundred thousand dollars on Kl would be a waste of money.

CC: WNDl. WNPl(HLn, WND 1. WNP2(JCH)

C 3052 Federal Register / Vol.. 63, No. 13 / Wednesday, Jahu~*zt 1998. /-:Proposed, Rules million pounds of cherries would not be Paperwork I.eduction  ;*i'.,., , 11 List-o~ ~objects in 7 CFR Part 930 removed from the domestic market this ,; *:Marketing *-ments, Reporting and season, depressing grower returns for all In compliance with Office of ,. -er-- cherries. The marketing order was Management and Budget (0MB) -. ,* .J recori:lkeeping requirements, Tart

• cheerieii ,:*

designed to increase grower returns by regulations (5 CFR part 1320) which , stabilizing supplies with demand as implement the Paperwork Reduction . Fol'tbe 1"888ons set forth in the well as stabilizing prices and creating a Act of 1995 (Pub. L 104-13), the p.,..m~le, 7'CFR part 930 is proposed to more orderly and predictable marketing information collection and be amended u follows: environment. Expanding markets and recordkeeping requirements have been PART 830-TART CHERRIES GROWN developing new products is key to previously approved by 0MB and the

• IN THE STATES OF MICHIGAN, NEW meeting this marketing order's goals. usigned 0MB Number 0581--0177. ' y ~ PENNSYLVANIA, OREGON, Not granting exemptions and There are some reporting, UTAH, WASHINGTON, ANO diversion credit for exports to countries recordkeeping and other compliance WISCONSIN other than Canada, Mexico, and Japan requirements under the marketing order.

was also discussed at Board meetings. 1. The authority citation for 7 CFR The reporting and recordkeeping part 930 continues to read as follows: However, the Board expressed that this burden, are necessary for compliance recommendation is very important to A ~ 7 U.S.C. 601--674. purposes and for developing statistical creating stable conditiorui in the export marketplaot this season and would data for maintenance of the program. 2. A new Subpart~urplementary The forma related to handler diversion Regulations conaisting.o § 930.250 is encourage future market growth. The and handlers meeting restricted added to read as follows: Board further stated that such action will improve returns to growers because percentage obligations (i.e., Inventory Now. Thia subpart will consist of handling of the tremendous growth in the export Reserve Summary, Cherries Acquired reswations which will not appear In the market this season. Exemptions and From Producers, Handler Reserve Plan annual Code of Federal Regulations. diversion ~ t have been addressed in and Final Pack Report, and Inventory other rulemaking actions. Location Report) haw received approval Subpar"'...--Suppl,Mlentary Regu_latlona As mentioned earlier, USDA'a by 0MB. The forms require information f '30.250 Fina! fl'M and restricted "Guidelines for Fruit, Vegetable, and which is readily available from handler percentagea tor the 1N7--M crop year. Specialty Crop Marketing Orders" records and which can be provided The final percentages for tart cherries specify that 110 percent of recent years' without data processing equipment or handled by handlers in volume sales should be made available to trained statistical staff. It was regulated districts during the crop year primary markets each season before anticipated that as inany as 45 handlers beginning on July 1, 1997, which shall recommendations for volume f8RU}ation might be regulated if volume regulations be free and restricted, respectively, are are approved. The quantity avaifable are established. Many reports are designated as follows: Free percentage, under this rule is 110 percent of the submitted a single time each season, 55 percent and restricted percentage, 45 quantity shipped in the prior three while some. are submitted more percent. Restricted percentage years. frequently. In addition, the bulk of the obligations must be satisfied on or The free and restricted percentages information bandlei:s must report is before the effective date of this rule. A proposed to be established by this rule obtained during the normal course of grace period of 30 days will be allowed release the optimum supply and apply their business operations. It would take for handlers to segregate and uniformly to all regulated handlers in handlers approximately 15 minutes per appropriately document any tonnage the industry, regardless of size. There report to complete for a total of 60 they wish to place in the inventory are no known additional costs incurred minutes per handler and approximately reserve and to assemble any applicable by small handlers that are not incurred 2,700 minutes annually for the diversion certificates. by large handlers. The stabilizing effects Dated: January 15, 1998. estimated 45 handlers. As with other, of the percentages impact all handlers ll.obertC.Keenay, positively by helping them maintain similar marketing order programs, reports and formure periodically Deputy Administrator, Fruit and Ve,etable and expand markets, despite seasonal supply fluctuations. Likewise, price studied to reduce or eliminate duplicate Programs. information collection burdens by (FR Doc. 98-1429 Filed 1-2G-98; 8:45 am) stability positively impacts all producers by allowing them to better industry and public sector agencies. IIIUJNQ 000E M1o-Ol-4" anticipate the revenues their tart This proposed rule does not change cherries will generate. those requirements. USDA has not identified any relevant A 15-day comment period is provided NUCLEAR REGULATORY Federal rules that duplicate, overlap, or to allow interested persons to respond COMMISSION conflict with this proposed regulation. to this proposal. Fifteen days is deemed 10 CFR Part 50 While the level of benefits of this appropriate because this rule needs to rulemaking are difficult to quantify, the be in place as soon as possible since [Docket No. PRM-60-e3A] stabilizing effects of the volume handlers are currently marketing 1997-regulations impact both small and large Peter G. Crane; Receipt of an Amended 98 crop tart cherries and this action Petition *ror Rulemaklng, Extension of handlers positively by helping them should be taken promptly to achieve the maintain markets even though tart Comment Period intended purpose of making the cherry supplies fluctuate widely from optimum supply quantity computed by AGENCY: Nuclear Regulatory season to season. the Board available to handlers. All Commission. Interested persons are invited to written comments timely received will ACTION: Amended petition for submit information on the regulatory rulemalcing: extension of comment and informational impacts of this action be considered before a final determination is made on this matter. period. on small businesses.

Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Proposed Rules 3053

~RY:       On December 17 , 1997 (62 FR   T. Lesar. Office of Administration, U.S.      Forrestal Building, Room lE-190, 1000 66038). the Nuclear Regulatory            Nuclear Regulatory Commission,                Independence Avenue, SW, Commission published a notice of          Washington, D.C. 20555--0001 ,                Washington, DC 20585 , (202) 586-7574, receipt of an amended petition for        telephone: 301-415-7163 or Toll Free:         between the hours of 9:00 a.m. and 4:00 rulemak.ing filed by Peter G. Crane and   1-800-36~5642, E-mail: MTL@nn::.gov.          p.m., Monday through Friday, except requested public comment on the             For the Nuclear Regulatory Commission.      Federal holidays.

amended petition . In the amended Dated at Rockville, Maryland, this 14th day FOR FURTHER INFORMATION CONTACT: petition for rulemaking. the petitioner of January. 1998. Kathi Epping, U.S. Department of seeks to amend NRC 's emergency Annette Vietti-Cook, Energy, Office of Energy Efficiency and planning regulations to require Renewable Energy , EE-43 , 1000 Acting Secretary of the Commission . consideration of sheltering, evacuation, Independence Avenue, SW, and the prophylactic use of potassium [FR Doc. 98-1379 Filed 1-20-98; 8:45 am} Washington, DC 20585--0121, (202) 586-iodide for the general public in BILUNO COOE 75~1~ 7425, email: Kathi.Epping@hq.doe.gov, 1 developing a range of emergency or Edward Levy, Esq., U.S. Department  ;* planning protective actions. In addition , of Energy , Office of General Counsel. the petitioner has filed supplemental DEPARTMENT OF ENERGY GC-72, 1000 Independence Avenue, information in support of his amended SW, Washington, DC 20585, (202) 586-petition which is available in the NRC Office of Energy Efficiency and 9507, email: Edward.Levy@hq.doe.gov . Public Document Room. The comment Renewable Energy SUPPLEMENTARY INFORMATION: On period on the amended petition was to October 22, 1997, the Secretary 10 CFR Part 430 have expired on January 16, 1998. In determined, based on the best response to several requests, the NRC Energy Efficiency Test Procedures for information currently available, that has decided to extend the comment Distribution Transformers energy conservation standards for period for this action . electric distribution transformers are DATES: The comment period has been [Docket Number EE-OET--47-MO] technologically feasible, economically extended and now expires on February RIN 1904-AA85 justified, and would result in a 17, 1998. Comments received after this significant energy savings. This date will be considered if it is practical AGENCY: Office of Energy Efficiency and determination initiated the process of to do so. but assurance of consideration Renewable Energy, Department of establishing, by notice and comment cannot be given except to those Energy. rulemaking, test procedures and energy comments received on or before this ACTION: Notice of public workshop. conservation standards for this product. date . The Department of Energy is drafting ADDRESSES: Submit comments to:

SUMMARY

The Department of Energy a proposed rule to implement the Secretary, U.S. Nuclear Regulatory (DOE) will hold an informal public provisions of the Energy Policy and Commission. Washingto.n, D.C. 20555.- workshop to discuss issues and gather Conservation Act, 42 U.S.C. 6317, for 0001, Attention: Rulemakings and information related to test procedures test procedures for distribution Adjudications Staff. for electric distribution transformers. transformers. However, several issues Deliver comments to 11555 Rockville All persons are hereby given notice of have been raised. The purpose of the Pike. Rockville, Maryland, between 7:30 the opportunity to attend this public public workshop is to discuss the a.m. and 4:15 p.m . on Federal workdays. workshop and to submit written following issues for developing the You may also provide comments via comments. notice of proposed rulemaking:

the NRC's interactive rulemaking DATES: The public workshop will be a. Adoption of national and website through the NRC home page held on Tuesday, February 10, 1998, international consensus standards in the (http:/lwww.nrc.gov). This site provides from 9 a.m. to 4 p.m. test procedures for determining energy the availability to upload comments as ADDRESSES: The workshop will be held efficiency of distribution transformers; files (any format), if your web browser at the U.S. Department of Energy, b. Burden imposed on industry, supports that function . For information Forrestal Building, Room lE-245, 1000 especially on manufacturers, by about the interactive rulemaking Independence Avenue, SW, additionaJ testing and data processing; website, contact Ms. Carol Gallagher, c. The definition of "basic model" for Washington, DC 20585. 301-415-5905; E-mail CAG@nn::.gov. distribution transformers; Written comments are welcome, d. Sampling plan for units to be For a copy of the amended petition, especially following the workshop. wri.te: *Rules and Directives Branch, tested; Please submit 10 copies (no faxes) to: e. Selection of a measure of energy Division of Administrative Services, Ms. Kathi Epping, U.S. Department of consumption for distribution Office of Administration, U.S. Nuclear Energy, Office of Energy Efficiency and transformers; Regulatory Commission, Washington, Renewable Energy, "Energy f. Selecting reference temperatures-D.C. 20555-0001. A copy of the Conservation Program for*Consumer the reference temperatures in the amended petition and other Products: Test Procedures for consensus standards lack uniformity; documentation filed by the petitioner Distribution Transformers, Docket No. g; Requirement for applying are also available for public inspection, EE-DET-97-550," EE-43, 1000 corrections to measurement data of both and copying for a fee, in the NRC Public Independence Avenue, SW, liquid-immersed and dry-types of Document Room, 2120 L Street NW Washington, DC 20585--0121. transformers; and (Lower Level), Washington, D.C. Telephone: (202) 586-7425; Telefax: h. Requirement for quality assurance FOR FURTHER INFORMATION CONTACT: (202) 586-4617 . in testing. Michael Jamgochian , Office of Nuclear Copies of the transcript of the public The Department has prepared a paper Regulatory Research , U.S. Nuclear workshop, public comments received, entitled "Issues Paper for the Regulatory Commission, Washington, and this notice may be read (or copied) Distribution Transformers Test D.C. 20555-0001, telephone: 301-415- at the Freedom of Information Reading Procedures Workshop on February 10, fi 534. E-mail: MTJ1@nrc.gov; or Michael Room, U.S. Department of Energy, 1998" that explains and discusses these

, It CR: 98-025 CR: 98-025 COMMISSION CORRESPONDENCE Correspondence Response Sheet Date: February 26, 1998 To: Commissioner Dicus Commissioner Diaz Commissioner McGaffigan From: John C. Hoyle, Secretary

Subject:

Letter to Senator Joseph I. Lieberman concerns the stockpiling and availability of potassium iodide for the general public ACTION: Please comment/concur and respond to the Office of the Secretary by: Time: 9:30 p.m. Day: Tuesday Date: March 3, 1998 Comment:

Contact:

Michael Jamgochian, EDOIRES 415-6534 Entered in Vote Tracking System: OYes CNo

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 The Honorable Joseph I. Lieberman United States Senate Washington, D.C. 20510

Dear Senator Lieberman:

Thank you for your January 27, 1998, letter which urged the Commission to revise its current policy regarding the availability of potassium iodide (Kl) for use by the general public in the event of an emergency at a nuclear power plant. As you requested, your letter has been included in the record of the rulemaking. We have also posted it on the Nuclear Regulatory Commission (NRC) Web Page which includes the comments from the public received on the petition. As a result of the petitioner revising his petition, the Commission published a request for public comments in the Federal Register on December 17, 1997 (62 FR 66038). The comment period was extended until February 17, 1998 by a Federal Register notice published on January 21, 1998 (63 FR 3052). We anticipate publishing a revised policy regarding the stockpiling and availability of potassium iodide for the general public in April 1998. For your information, I am enclosing a copy of the January 16, 1998, press release that the NRC issued on this matter. The Commission appreciates your interest in this matter. Sincerely, Shirley Ann Jackson

Enclosure:

As stated

i United States Nuclear Regulatory Commission Office of Public Affairs Washington, DC 20555 Phone 301-415-8200 Fax 301-415-2234 Internet:opa@nrc.gov No. 98-12 January 16, 1998 NRC SEEKS COMMENT ON PETITION FOR RULEMAKING CONCERNING USE OF THYROID-PROTECTING DRUG IN EMERGENCY RESPONSE The Nuclear Regulatory Commission is seeking public comment on a petition for rulemaking which asks that the NRC modify its regulation, 10 CFR 50.47 (b) (10), to require that nuclear power plant emergency plans consider the inclusion of the use of potassium iodide, a thyroid-protecting drug, for the general public. The deadline for comments is February 17. Current Federal policy, published July 24, 1985, calls for potassium iodide to be stockpiled for distribution during emergencies to emergency workers and institutionalized persons. If taken in time, the substance blocks most of the thyroid gland's uptake of radioactive iodine. It could thus help reduce the risk of thyroid cancer and other diseases that might otherwise be caused by exposure to radioactive iodine which could be dispersed in a severe nuclear accident. The Commission last year voted to approve a proposed revision to the current Federal policy which would offer to provide funding for states which want to stockpile potassium iodide for use by the general public in the event of a nuclear power plant emergency. The rulemaking petition now pending before the Commission calls for a change in NRC regulations to specify that states and licensees consider the use of potassium iodide, as well as evacuation and sheltering, in the preparation of nuclear power plant emergency plans. The petition was filed by Peter G. Crane, an NRC staff attorney who took the action as a private citizen. The original January 16 deadline for comments has been extended by 30 days to allow sufficient time for public comment. Persons wishing copies of the petition may write: Rules and Directives Branch, Division

J of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy of the petition and other related documents are also available at the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, DC. The petition also may be accessed on the Internet at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=KI_PETITION. Comments should be mailed to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulernakings and Adjudications Staff. Comments also may be delivered to 11555 Rockville Pike, Rockville, MD, between 7:30 a.

m. and 4:15 p. m. on Federal workdays. They also may be provided through the NRC's interactive rulemaking website, which may be reached via the Internet at http://www.nrc.gov by looking for rulemaking under the heading "Public Participation and School Programs.*

JOSEf'.H I. LIEBERMAN SE""'TE Ona BUII.DINC: COHNeDT1CVT WAS><lff(;TON, DC JOS 10 (202l2l~1 COMMITTEES: STATEOfflCE, ARMED SERVICES ONE STATI STIIUT

                                            <iinitfd ~tatrs ~rnatl~

HIVIJl~MENT AND PUBI.IC WORICS 1 en, Fi.oo~ HAIITF()jlD, CT 0&103 GOVERNMENTAL Al'FAIIIS ~ SMALL 8USINESS Tou.F~££: 1 ~ WASHINGTON, DC 20510-0703 INT8'ffET-S$! an:itor_11eo.rman@lietlennan,,eruo1e.9ov O,OM£1'Aot: hnpJJWww .sen.inc:.;ovJ-*;*-maov January 27, 1998 The Honorable Shirley Ann Jackson Chairman The Nuclear Regulatory Commission Washingtt,n, D.C. 20555

Dear Dr. Jackson:

I am writing to com.mend your agency for proposing to modify its approach to stockpiling potassium iodide (KI) as a protective measure for the general public in case of a severe nuclear reactor accident. However, I am concerned that the proposed rule does not go far enough. Senator Alan Simpson and I wrote to the NRC about this matter on April 20, 1994. I applaud the NRC' s proposal to federally fund the purchase of KI for any state requesting it. However, I believe that the record supports going further, as advocated by Commissioners Diaz and McGaffigan: stockpiling KI should be mandatory. As you know, it is well-established scientifically that Kl is extremely effective in preventing the uptake of radioactive iodine by the thyroid. If taken in the proper dose prior to exposure to radioactive iodine, KI can completely block the uptake of the radioactive iodine. The distribution of KI to the general population in the event of a nuclear emergency is a widely accepted protective measure. The World Health Organization has recommended its use for people living near a nuclear power plant if radiation levels are expected to exceed a predetermined dose. A number of foreign governments - the United Kingdom, the Czech Republic, Switzerland, Canadian provinces with nuclear power plants, and the former Soviet Union - stockpile KI for distribution to and use by the general public in the event of a nuclear emergency. Several states include the use of KI in their emergency planning.

• Thank you for your consideration of this matter. I request that these comments be included in the record of the roJemaking consistent with applicable legal standards.

S~I~

                                            ~ I. Liebennan cc:     Commissioner Greta J. Dicus Commissioner Edward McGaffigan, Jr.

Commissioner Nils J. Diaz

                                                                                 ** TOTAL PAGE.03 **

CR: 98-025 COMMISSION CORRESPONDENCE Conespondence Response Sheet Date: February 19, 1998 Chairman Jackson . ) '* \ *. '. From: John;C. Hoy!e, Secretary S~bj11et: Letter t,f $enator Joseph J.,Lieberman concerns the stockpiling and availability of potassium iodide for the _general P'!blic

*.. *-.-.. 1:*,..::**. '~. *-.'.*' . *. *s,i-'},'.:~,~,';/~' \I *   '   *'     .. *.  ' * * * * ' .  -* ,:**!:"*~*-* *.:

ACTION::?t1fo'i-'1tiitii11Review and Co,riment Prior to Circulation to *

. . . :<:' .*. ; -')(thtf Commissioners. Yo~r'                                                   response must            be received
                                              ~by the Office of the Secretary by:

Time: 1:30 p.rn. Day: *Tuesday Date: February 24, 1998 Comment:

Contact:

Michael Jamgochian, EDOIRES 415-6534

CR: 98-025 CR: 98-025 COMMISSION CORRESPONDENCE Correspondence Response Sheet Date: February 19, 1998 To: OGC OCA From: John C. Hoyle, Secretary

Subject:

Letter to Senator Joseph I. Lieberman concerns the stockpiling and availability of potassium iodide for the general public ACTION: For Initial Review and Comment Prior to Circulation to the Commissioners. Your response must be received by the Office of the Secretary by: Time: c.o.s. Day: Friday Date: February 20, 1998 Comment:

Contact:

Michael Jamgochian, EDD/RES 415-6534

The Honorable Joseph I. Lieberman, Chairman Subcommittee on Clean Air and Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairman:

Thank you for your January 27, 1998, letter which urged the Commission to revise its current policy regarding the availability of potassium iodide (Kl) for use by the general public in the event of an emergency at a nuclear power plant. As you requested, your letter has been included in the record of the rulemaking. We have also posted it on the Nuclear Regulatory Commission (NRC) Web Page which includes the comments from the public received on the petition. As a result of the petitioner revising his petition, the Commission published a request for public comments in the federal Regjster on December 17, 1997 (62 FR 66038). The comment period was extended until February 17, 1998 by a federal Register notice published on January 21, 1998 (63 FR 3052). We anticipate publishing a revised policy regarding the stockpiling and availability of potassium iodide for the general public in April 1998. For your information, I am enclosing a copy of the January 16, 1998, press release that the NRC issued on this matter. The Commission appreciates your interest in this matter. Sincerely, Shirley Ann Jackson

Enclosure:

As stated Distribution: C. Trottier R/F J. Blaha Central Files S. Bums F. Costanzi S. Collins, NRR L. Riani T. Martin, AEOD J. Callan, EDO R. Bangart, SP A. Thadani K. Cyr, OGC H. Thompson P.Norry A. Summerour, RES 980032 M. Bridgers, GT-980054, CRC:98-0072 DOCUMENT NAME: g:\jamgochi\gt980054.wp *See previous concurrence To receive a copy of this document. indicate in the box *c* =copy without attachment/enclosure, "B" =copy with attachment/enclosure, "N" =No copy OFFICE: DRA/RPHEB I DRA/RPHEB I Tech Editor I D/ORA/RES I dxi) NAME: MJamQochian;nb* CTrottier" ABeranek* JMurphy* ~ DATE: 2/3198 2/3 /98 2/3/98 2/6/98 i,f5', OFFICE: D/RES* I OCA I OGC I DEDE I Chairman NAME: MKnapp/Morris DRathbun STreby* AThadani SAJackson DATE: 2/ 10 /98 2/ /98 2/10/98 2//t98 2J 198 OFFICIAL RECORD COPY RES FILE CODE NO.: _

United States Nuclear Regulatory Commission Office of Public Affairs Washington, DC 20555 Phone 301-415-8200 Fax 301-415-2234 Internet:opa@nrc.gov No. 98-12 January 16, 1998 NRC SEEKS COMMENT ON PETITION FOR RULEMAKING CONCERNING USE OF THYROID-PROTECTING DRUG IN EMERGENCY RESPONSE The Nuclear Regulatory Commission is seeking public comment on a petition for rulemaking which asks that the NRC modify its regulation, 10 CFR 50.47 (b) (10), to require that nuclear power plant emergency plans consider the inclusion of the use of potassium iodide, a thyroid-protecting drug, for the general public. The deadline for comments is February 17. Current Federal policy, published July 24, 1985, calls for potassium iodide to be stockpiled for distribution during emergencies to emergency workers and institutionalized persons. If taken in time, the substance blocks most of the thyroid gland's uptake of radioactive iodine. It could thus help reduce the risk of thyroid cancer and other diseases that might otherwise be caused by exposure to radioactive iodine which could be dispersed in a severe nuclear accident. The Commission last year voted to approve a proposed revision to the current Federal policy which would offer to provide funding for states which want to stockpile potassium iodide for use by ~he general public in the event of a nuclear power plant emergency. The rulemaking petition now pending before the Commission calls for a change in NRC regulations to specify that states and licensees consider the use of potassium iodide, as well as evacuation and sheltering, in the preparation of nuclear power plant emergency plans. The petition was filed by Peter G. Crane, an NRC staff attorney who took the action as a private citizen. The original January 16 deadline for comments has been extended by 30 days to allow sufficient time for public comment. Persons wishing copies of the petition may write: Rules and Directives Branch, Division

of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A copy of the petition and other related documents are also available at the NRC Public Document Room, 2120 L Street NW (Lower Level), Washington, DC. The petition also may be accessed on the Internet at http://ruleforum.llnl.gov/cgi-bin/rulemake?source=KI_PETITION. Comments should be mailed to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. Comments also may be delivered to 11555 Rockville Pike, Rockville, MD, between 7:30 a. rn. and 4:15 p. m. on Federal workdays. They also may be provided through the NRC's interactive rulemaking website, which may be reached via the Internet at http://www.nrc.gov by looking for rulernaking under the heading "Public Participation and School Programs.n

JCSE~H I. LIEBERMAN SE"ATt O"'c:E BUILDl"C:

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                                                                                                           *NTO~-ss, ttMtor_lleDermar,@lieoerman,,en.,ic.gov hnpJ/WWoN .Mnate-90\IJ-1;er:,e,,.,,,n1 January 27, 1998 The Honorable Shirley Ann Jackson Chairman The Nuclear Regulatory Commission Washington, D.C. 20555

Dear Dr. Jackson:

I am writing to commend your agency for proposing t,o modify its approach t,o stockpiling potassium iodide (KI) as a protective measure for the general public in case of a severe nuclear reactor accident. However, I am concerned that the proposed rule does not go far enough. Senaror Alan Simpson and I wrote to the NRC about this matter on April 20, 1994. I applaud the NRC' s proposal to federally fund the purchase of Kl for any state requesting it. However, I believe that the record supports going further, as advocated by Commissioners Diaz and McGaffigan: stockpiling KI should be mandatory. As you know, it is well-established scientifically that KI is extremely effective in preventing the uptake of radioactive iodine by the thyroid. If taken in the proper dose prior to exposure to radioactive iodine, Kl can completely block the uptake of the radioactive iodine. The distribution of KI to the general population in the event of a nuclear emergei:.~y is a widely accepted protective measure. The World Health Organization has recommended its use for people living near a nuclear power plant if radiation levels are expected to exceed a predetermined dose. A number of foreign governments -- the United Kingdom, the Czech Republic, Switzerland, Canadian provinces with nuclear power plants, and the former Soviet Union - stockpile Kl for distribution to and use by the general public in the event of a nuclear emergency. Several states include the use of KI in their emergency planning.

• Thank you for your consideration of this matter. I request that these comments be included in the record of the rulemaking consistent with applicable legal standards.

S~l~ a I. Liebennan cc: Commissioner Greta J. Dicus Commissioner Edward McGaffigan, Jr. Commissioner Nils J. Diaz

                                                                               ** TOTAL PAGE.03 **

From: Carol Gallagher

• To:

Date: CAT1, FAC, JAM1, MTJ1, WND1.WNP2.ELJ 12/18/97 10:23am

Subject:

NRC website and potassium iodide -Forwarded I received this e-mail message from Peter Crane this morning, and wanted to inform all interested parties. Carol

From: Peter Crane <pgcrane@erols.com>

• To:

Date: TWD2. TWP9(CAG) 12/18/97 7:13am

Subject:

NRC website and potassium iodide Yesterday, the Federal Register published a notice that the NRC is allowing a 30-day public comment period in which people can comment on an amended rulemaking petition submitted by me on November 12. 30 days is not a lot of time, especially over the holidays, so it will be an uphill effort to get people to focus on this. Accordingly, it is all the more important that the information be readily accessible to people who contact the NRC website. Unfortunately, the NRC website is all but impenetrable to anyone looking for information on potassium iodide. There is no news release that might tell people where to look. The various elements of the record are scattered around the site in various categories: the original petition under "Fedworld", some (but not all) the comments on it in several different files, also under "Fedworld"; the transcript of the November 5 Commission meeting in another place; and so on. This is not the way to encourage or to permit meaningful public participation on this issue. At this rate, the opponents of Kl, with the means of communication available to industry trade associations, are likely to have a monopoly on the comment process. The Federal Register notice could have told people where to find this material on the website but failed to do so. Something needs to be done to fix this and fix it quickly.

January 12, 1998 NOTE TO: Emile Julian Chief, Docketing and Services Branch FROM: Carol Gallagher ;1 " A. 01A A ~ RES, ORA ~ /~-,* .

SUBJECT:

DOCKETING OF COMMENT ON REVISED PETITION (PRM-50-63) Attached for docketing is a comment letter related to the Revised Petition on Potassium Iodide (PRM-50-63). This letter was received via the rulemaking website on January 9. 1998. The commenter's name is Scott Portzline. Three Mile Island Alert, 315 Peffer Street, Harrisburg, PA 17102. Please send a copy of the docketed comment to Michael Jamgochian (mail stop T9-C-24) for his records.

Attachment:

As stated cc w/o attachment: M. Jamgochian

From: Frank Costanzi To: MRK Date: 1/27/98 9:12am

Subject:

Kl Petition Mal As you are aware, last Friday Peter Crane contacted Mike Jamgocian, the RES project manager handling Mr. Crane's petition, asking why all the comment letters that had been written on his revised petition had not been posted on the rulemaking web site. Mike responded by providing the comment letters he had received from SECY to Carol Gallagher, the RES individual who maintains the rulemaking web site. Ms. Gallagher receives copies of docketed comment letters from SECY directly, which she then optically scans, converts to WordPerfect and HTML texts, and uploads onto the web site. Comments that have been submitted electronically on the site she posts herself and makes a hard copy that she then sends to SECY for docketing. Because of a breakdown in communications the written comments were not provided to Carol for uploading. Upon learning of this situation Carol came in over the weekend and scanned the letters, and as of yesterday they had been all uploaded onto the web site supplementing the letters received electronically. As of 1/21/98 there are 48 comment letters received from the public posted on the site, and two from Agreement States. To avoid reoccurrences of the ki nd of breakdown in communications, we will prepare a memorandum reminding all parties involved in the process to strive for more timely incorporation of written comments on the electronic bulletin board. Nick

From: Malcolm Knapp To: TWP9.MTJ1, WNDl.WNPI.ACT, WNDl.WNPl.BWJ, WNDl.WNPl... Date: 1/29/98 6:29pm

Subject:

Posting of materials on Kl petition Last Saturday, Peter E-mailed you his concerns regarding posting Kl comments on NRC's web site. (Copy below). The attached informally documents RES activities so far related to his concerns.

 > > > Peter Crane <pgcrane@erols.com> 01/24/98 08:33am > > >

Recently, OPA issued a press release announcing the extension of time for comment on the KI petition. The press release was informative and to the point, with a hypertext link to the Internet rulemaking site -- just what was needed. Unfortunately, the problems with the rulemaking site themselves have yet to be corrected. In describing these problems, I'm not suggesting that any particular individuals are falling short, but rather that the system is not functioning as it should. I'm well aware that the system is a new one, and that bugs are to be expected. That seems to me all the more reason that I should speak up, so that problems can be identified and corrected. The principal problem is that comments are not appearing on the site in a timely way. My understanding is that between 40 to 50 comments have been received; only 8 had been posted, as of this morning. The January 9, 1998, letter of the American Thyroid Association was only two or three pages long, but it captured the essence of the arguments for granting the petition. Here it is January 24 and the letter has yet to show up on the rulemaking site. How long can it reasonably take? I realize that comments submitted electronically can probably be posted more quickly, but in an era in which hard copies can be run through a scanner and turned into electronic files in a matter of seconds, it shouldn't take weeks. Having an electronic website is a great innovation, with tremendous potential to open up the rulemaking process to public view. But having voluntarily undertaken this initiative, the agency is obligated to do it competently, and that means devoting adequate resources. At present, members of the public have no reason to suspect that only one in five or one in six comments has been posted; they will naturally assume that everything relevant is there. The agency is thus setting itself up for yet another request for an extension of the comment period, when it should be doing what it can to allow the issue to be resolved and put behind it. I hope as much as anyone that this matter does not wind up in court, but if it does -- other participants could seek review, even if I don't -- what is the NRC Solicitor supposed to say if a judge asks him why Carolina Power and Light's criticism of the KI petition was posted within 24 hours, while the American Thyroid Association's letter of support for the petition remained unpasted two weeks after it was sent? I don't myself think that anything sinister was going on, but consider how it might look to an outside observer, who must decide whether the agency is being manipulative or merely inefficient. (It was more than a week ago, I believe, that I sent an e-mail pointing out the delay in posting the ATA's letter, and comparing it with the speed in posting CP&L's.) The responsibility for handling this rulemaking rests with the Office of Research and its Director. When comments are being posted at the rate of fewer than one per day, it suggests that something is seriously amiss. Do more people need to be assigned to the job? Then assign them. Do the staffers need scanners and not have them? Then make sure they get them. Are incoming letters not being copied, with copies routed ASAP to the people responsible for getting them posted on the website? Then change the procedures to make sure that copies are

made and forwarded. But for pity's sake do SOMETHING, because the Office's continued inaction, and its lack of response when problems are pointed out, are turning this process, I regret to say, into a shambles.

From: Peter Crane < pgcrane@erols.com > To: TWD2. TWPO(MRK) Date: 1/30/98 3: 16pm

Subject:

Posting of Documents -- KI Petition Mal -- Some eight weeks ago, I sent a letter to the docket enclosing two statements in which I have addressed the KI issue. One was made to officials in New York, the other to a meeting called by the State of Ohio. Three weeks ago, I renewed that request. What has happened? Nothing. Today, people who contact the NRC rulemaking website can read the comments of the Illinois Department of Nuclear Safety, denouncing what I said to Ohio and New York State, but cannot read what I actually said, because the staff will not post those documents . Nor will the staff post the letter in which I requested an extension of the comment period (although other such letters were posted) and commented on the process. I realize that the whole concept of electronic posting is a new system. The staff took steps a few days ago to post the backlog of comments, and that considerable effort is appreciated. But this is a different issue -- whether the Office of Research has the discretion to post some comments and not others. I have tried to be reasonably patient, but I am not going to allow the clock to run out on the comment period -- a second time -- while my comments and only mine are kept from public view. I have filed an electronic comment today, attaching the Ohio and New York statements, and I expect it to be posted promptly . (A copy is attached.) I would also like the staff either to post the other relevant documents, including the January 8 letter asking for an extension, or else give me a written explanation of why it refuses to do so. I am sure the recipients of this message are tired of reading my complaints about the staffs handling of the KI matter, but they cannot be half so tired as I am of having to write them. Hard as this may be to believe, I would much rather be praising the staff than criticizing it. Can't these procedural matters be handled in an even-handed, transparent, professional manner so that we can get on with resolving the issue on the merits, once and for all, and then move on to other things? For the record, I'm on annual leave today, and this is written from home.

                                 -- Peter CC:                     WNDl.WNPl(LJCl,HLT,ACT,JRG,MLO,BWJ,KDSl,RKD) ,TWD2 ....

From: Malcolm Knapp To: GATED.nrcsmtp("pgcrane@erols.com") Date: 1/31/98 2: l 7pm

Subject:

Posting of Documents -- KI Petition -Reply Peter - Last night my staff and I reviewed your E-Mail below. My staff worked today to post the documents you attached and referred to. They believe they have now posted all the documents. I would appreciate it if you would check the WEB site and advise me if we missed any documents or if we posted any incorrectly. Thank you Mal Knapp

> > > Peter Crane <pgcrane@erols.com> 01/30/98 03:16pm > > >

Mal -- Some eight weeks ago, I sent a letter to the docket enclosing two statements in which I have addressed the KI issue. One was made to officials in New York, the other to a meeting called by the State of Ohio. Three weeks ago, I renewed that request. What has happened? Nothing. Today, people who contact the NRC rulemaking website can read the comments of the Illinois Department of Nuclear Safety, denouncing what I said to Ohio and New York State, but cannot read what I actually said, because the staff will not post those documents. Nor will the staff post the letter in which I requested an extension of the comment period (although other such letters were posted) and commented on the process. I realize that the whole concept of electronic posting is a new system. The staff took steps a few days ago to post the backlog of comments, and that considerable effort is appreciated. But this is a different issue -- whether the Office of Research has the discretion to post some comments and not others. I have tried to be reasonably patient, but I am not going to allow the clock to run out on the comment period -- a second time -- while my comments and only mine are kept from public view. I have filed an electronic comment today, attaching the Ohio and New York statements, and I expect it to be posted promptly. (A copy is attached.) I would also like the staff either to post the other relevant documents, including the January 8 letter asking for an extension, or else give me a written explanation of why it refuses to do so. I am sure the recipients of this message are tired of reading my complaints about the staffs handling of the KI matter, but they cannot be half so tired as I am of having to write them. Hard as this may be to believe, I would much rather be praising the staff than criticizing it. Can't these procedural matters be handled in an even-handed, transparent, professional manner so that we can get on with resolving the issue on the merits, once and for all, and then move on to other things? For the record, I'm on annual leave today, and this is written from home.

                                 -- Peter CC:                     TWD2 .TWP9(MTJ1), WNDl.WNPl(ACT, BWJ, HLT, JRG, KDS ...

From: John Hoyle To: ELJ,ATBI Date: 2/4/98 11:37am

Subject:

Posting of materials on KI petition -Forwarded Emile/ Adria, I'm sending several e-mails concerning the KI rulemaking which were logged in my absence. The first is attached here. Please come down and fill me in on the current situation - number of comments, extent of backlog, if any, etc. John

From: Peter Crane < pgcrane@erols.com > To: TWD2.TWP0(MRK),WND1.WNP1(HLT,ACT,LJC1,JRG,MLO,RKD, ... Date: 1/24/98 8:33am

Subject:

Posting of materials on KI petition Recently, OPA issued a press release announcing the extension of time for comment on the KI petition. The press release was informative and to the point, with a hypertext link to the Internet rulemaking site -- just what was needed. Unfortunately, the problems with the rulemaking site themselves have yet to be corrected. In describing these problems, I'm not suggesting that any particular individuals are falling short, but rather that the system is not functioning as it should. I'm well aware that the system is a new one, and that bugs are to be expected. That seems to me all the more reason that I should speak up, so that problems can be identified and corrected. The principal problem is that comments are not appearing on the site in a timely way. My understanding is that between 40 to 50 comments have been received; only 8 had been posted, as of this morning. The January 9, 1998, letter of the American Thyroid Association was only two or three pages long, but it captured the essence of the arguments for granting the petition. Here it is January 24 and the letter has yet to show up on the rulemaking site. How long can it reasonably take? I realize that comments submitted electronically can probably be posted more quickly, but in an era in which hard copies can be run through a scanner and turned into electronic files in a matter of seconds, it shouldn't take weeks. Having an electronic website is a great innovation, with tremendous potential to open up the rulemaking process to public view. But having voluntarily undertaken this initiative, the agency is obligated to do it competently, and that means devoting adequate resources. At present, members of the public have no reason to suspect that only one in five or one in six comments has been posted; they will naturally assume that everything relevant is there. The agency is thus setting itself up for yet another request for an extension of the comment period, when it should be doing what it can to allow the issue to be resolved and put behind it. I hope as much as anyone that this matter does not wind up in court, but if it does -- other participants could seek review, even if I don't -- what is the NRC Solicitor supposed to say if a judge asks him why Carolina Power and Light's criticism of the KI petition was posted within 24 hours, while the American Thyroid Association's letter of support for the petition remained unpasted two weeks after it was sent? I don't myself think that anything sinister was going on, but consider how it might look to an outside observer, who must decide whether the agency is being manipulative or merely inefficient. (It was more than a week ago, I believe, that I sent an e-mail pointing out the delay in posting the ATA's letter, and comparing it with the speed in posting CP&L's.) The responsibility for handling this rulemaking rests with the Office of Research and its Director. When comments are being posted at the rate of fewer than one per day, it suggests that something is seriously amiss. Do more people need to be assigned to the job? Then assign them. Do the staffers need scanners and not have them? Then make sure they get them. Are incoming letters not being copied, with copies routed ASAP to the people responsible for getting them posted on the website? Then change the procedures to make sure that copies are made and forwarded. But for pity's sake do SOMETHING, because the Office's continued inaction, and its lack of response when problems are pointed out, are turning this process, I regret to say, into a shambles.

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555 FACSIMILE NUMBER: (301) 415-1101 VERIFICATION NUMBER: (301) 415-1966 OFFICE OF THE SECRETARY RULEMAKING§ AND ADJUJDICATION§ STAFF FACSIMILE TRANS MITTAL DATE: JANUARY 12, 1998 To: M. LAMBERT ORGANIZATION: COALITION FOR THE MANDATORY STOCKPILING OF Kl PHONE NUMBER: (617) 934-0389 FAX NUMBER: (617) 934-5579 FROM: ADRIA T. BYRDSONG PHONE NUMBER: (301) 415-1675 COMMENTS: ATTACHED IS A COPY OF THE COMMENT YOU SUBMITTED. IT WAS TIME STAMPED ON JANUARY 9, 1998 AT 5:20 P.M. NUMBER OF PAGES J_ PLUS COVER SHEET 2.._

- P. 1

                     * *

• COMMUNICATION RESULT REPORT C JAN.12.1998 9:23AM) * *
• TTI FILE MODE OPTION ADDRESS (GROUP) RESULT PAGE 252 MEMORY TX 916179345579 OK P. 2/2 REASON FOR ERROR E-1) HANG UP OR LINE FAIL E-2) BUSY E-3) NO ANSWER E-4) NO FACSIMILE CONNECTION UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINOTON, DC 20555 FACSIMILE NUMBER: (301) 415-1101 VERIFICATION NUMBER: (301) 415-1966 OFFICE OF THE SECRETARY RULEMAIONGS A.ND ADJUDICATIONS STAFF FACSIMILE TRANSM!TTAL DATE: JANUARY 12, 1998 To: M. LAMBERT ORGANIZATION: COALITION FOR THE MANDATORY STOCKPILING OF Kl PHONE NUMBER: (617) 934-0389 FAX NUMBER: (617) 934-5579}}