ML20199L767

Forwards Copy of Amended Petition for Rulemaking (PRM-50-63A),requesting That NRC Amend 10CFR50 Regulation Governing Emergency Planning.Petition Filed by Pg Crane.Fr Notice Containing Addl Info Re Petition Also Encl

ML20199L767
Person / Time
Issue date:	12/16/1997
From:	Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA)
To:	Inhofe J, Schaefer D HOUSE OF REP., SENATE, ENVIRONMENT & PUBLIC WORKS
References
RULE-PRM-50-63A CCS, NUDOCS 9802100023
Download: ML20199L767 (2)

Text

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December 16, 1991 The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power i

Committee on Commerce United States House of R=-;-i:::1^2;x Washington, DC 20515

Dear Mr. Chairman,

Enclosed for your information is a copy of no am...ded petition for rulemak (PRM 50-63A) requesting that the Nuclear Regulatory C.'ammission (NRC) e W

10 CFR Part 50. The petition was filed by Mr. Peter G. Crane.

The petition requests that the NRC amend its regulWions goveming emergency planning to requira consideration of sheltering, evacuation, and the prophylactic use of potassium lodide for tha general public in developing a range of emergency planning protective actions.

Also enclosed is a copy of the Federal Register notice that contains additional' information conoeming the petition. The notice will be puolished requesting comment for a 304ay period.

Sincerely, I

h[

Dennis K. Rathbun, Director Of5ce of Congressional Affairs-

Enclosures:

1. PRM-50 63A

2. Federal Register notice oc: Representative Ralph Hall 50-63A PDR

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l December 16, 1997 The Honorable James M. Inhofe, Chairman

, Subcommittee on Clear. Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510

Dear Mr. Chairman:

Enclosed for your information is a copy of an amended petition for rulemaking (PRM 5043A) requesting that the Nuclear Regulatory Commission (NRC) amend 10 CFR Part 50. The petition was filed by Mr. Peter G. Crane.

The petition requests that the NRC amend its regulations goveming emergency planning to require consideration of sheltering, evacuation, and the prophylactic use of potassium iodide for the general public in developing a range of emergency planning 1

protective actions.

Also enclosed is a copy of the Federal Register notice that contains additional information concoming the petition. The notice will be published requesting comment for a 30-day period.

l Sincerely, 4

M0 (

Dennis K. Rathbun, Director Office of Congressional Affairs L

Enclosures:

- 1. PRM 5043A

2. Federal Register notice i

oc: Senator Bob Graham 4

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. Peter G. Crce / 4809 Dnomm:nd Avenre / Chny Ch.ne, MD 2080 / 3016$g.399g vucntitv USNRC November 11, 1997 N D 12

'17 Mr. John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission OTF.C s c:

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Washington, D.C. 20555 RUL i

NF knendment to Petition for rulemakina (PRM bdf Ret

Dear Mr. Hoyle:

At the Commission meeting on potassium iodide held on November 5.1997, Chairman Jackson asked me whether I could submit, within the week, language reflecting the modified position that I outlined during the meecing. 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 I made clear that I was asking for two things:

a emphatically rejected it."

statement clearly recommending stockpiling of XI 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 adc rdd 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

( At one point, Commissioner D!.az observed, and I agreed, that I such a rule."

was proposing that the Commission, in a "public statement or a rule," express In short, there may have the belief that stockpiling was a prudent measure.)

been ambiguity as to whether I was seeking two separate documents -- a rule change and a plicy statement explaining it -- or just one, a rule change with Plainly, the policy stated and explained in the statemr4 of considerations.

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 L

the Commission's interest in resolving the K! issue in an efficient and timely way.

In the attached proposal, which represents an amendment to my petition, l

the Commission's expression of policy therefore would take place in the context I trust that no of the rule change, i.e., in the statement of considerations.

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 The fact that this think you can possibly get, as a prelude to bargaining.

Mgt proposal does not do that, but instead is squarely in W 9-

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on November 5, is an indication that I take this amendment of my petation very seriously, without game-playing. I would like as mue' as anyone to see this protracted process brought to closure, with broad consensus acceptan'ce.

Accordingly, I have tried to produce a solution that satisfies the NRC's obligations to !,rotect and inform the public, 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 draf t Statement of Considerations to present the K1 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 of ten, in past submissionr discussed troubling past events, such as those ! referred to in the November 5 meeting, I have omitted these historical matters from the proposed Statement of Considerations that I am oliering 'oday. This reflects a conscious decision to look forward, not to the past, in the recognition that for a health and safety agency, the central question must always be: What makes sense today, in light of what we know now?

I believe that if the approach I an. proposing is accepted, it would be viewed as so patently reasonable that if challenged legally, it would be sustained by any reviewing court, whether the challenge came from those whoIn thought it went too far or from those who thought it did not go far enough.

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 r.ot good law." On issues of litigation risk, however, the Commission should of course rely on the General Counsel and the Solicitor for advice.

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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., for a total of more than four It is a matter years since the filing of the petition), this seems exaggerated.

of public record, for example, that the Commission's last major emergency planning rulemaking, the " realism" rule of 1987, did not require any two years, though it involved many extremely complicated issues and elicited more thanIn 38,000 comments (including many duplicates), all of which had to be read.

that casa, a 66-page memorandum to the Commission was prepared in which the issue 9 and comments were analyzed and discussed in detail, with the arguments on both sides fairly presented. A Commission briefing was also held at which In the end, the merits of the competing arguments were discussed at length.

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 --

The entire process, from proposed rule to final decided to seek judicial review.

rule, took 9 months.

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3 A K! rulemaking along the hnes 1 am proposing would be a minor, not a major rulemaking. It would involve fewer issues and, to judge from trie 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 K!

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 blanual 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 draf t 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.' 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-97-124 misinformed the Commission as to one element of the procedural history of the K1 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

' All that SECY-97-124 had to say about the draf t notice was the following,

" Attachment I contains a proposed Federal policy on KI that reflects at p.10:l It incorporates changes recommended by the the key elements of tMa option.

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."

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. draf t 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 remtsa if I did not candidly advise the Commission that the draf t 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 faihngs 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 K17 What is one to say about a purported history of the K! issue that describes how the FRPCC almost reaffirmed the 1985 K!

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

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public learn all about petty bureaucratic maneuverings that occurred in 1994 and 1995, b'Jt 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 mere 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 une, "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.' 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 caDed upon to explain this sentence, and it turned out to mean what I suggest it seems to mean, would

' 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" pobey. 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,poucy showed an extremely high ratio of costs to benefits.

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they feel comfortable that the notice Sad done a good job of informing the pubile? Or would the sentence seem, on examination, to be a cleverly, worded way of disguising the fut that an enormous amount of new information bearing on the value of K1 has emerged since 19857 1 believe that Government agencies should be careful to speak so clearly and forthrightly on issues like these that they never leave themselves open to the charge, just or unjust, of having used words artfully to create a misleading impression.

At one point, I have included the words " reasonable and prudent," on the assumption that the Commission would not be proposing to offer K1 to states and localities, and the Government would not be stockpiling KI now, if I

stockpiling of K1 were not regarded as a reasonable and prudent measure.

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 It was written on Special Projects in the NRC's Office of the General Counsel.

my own time, at home, using my own computer and materials, and relying on information available to the public in the NRC's Public nocument Room.

Sincerely, (fd4ta_

Peter G. Crane -

Attachments: Draf t rule change with Statement of Considerations Markup of draft Federal Register notice from SECY-97-124 cc: Chairman Jackson Commissioner Dieus Commissioner Diaz Commisstoner McGaffigan Executive Director for Operations General Counsel Director, Federal Emergency Management Agency

6 PROFOSED RULE CHANGE For the reasons set forth in the Statement of Considerations, the NRC is

. proposing to change the planning standard in 10 CFR 550.47(b)(10) by adding i

one sentence, as indicated by underlining:

(10) A range of protective actions have been developed l

for the plume exposure EPZ for emergency workers and

- the public. In developina this ranae of actions.

l ggnsideration has been alven to evacuation, shelterim and the crochvlactic use of notassium iodide (KI). as approortate. 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.

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7 STATEMENT OF CONSIDEhATIONS The Nuclear Regulatory Commission is proposing to amend its emergency planning rules, codified at 10 CFR 550.47(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 (W, 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 K! in protecting the thyroid depends on timing (R, administering it either before or within a few hours af ter the exposure to radioactive iodine),

the NRC believes that stockpiling of K1 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 vafety has improved since the current emergency planning requirements were put in place af ter 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 K1 " safe and offective" as long ago as 1973, the drug had never been deployed on a large scale until Chernobyl. The expeNence 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 of fsite releases of radioactivity. While NHC strongly encourages the stockpiling

- of K1 by the states, it does not mandate it under this rule change.- The rule change requires only that states consider K! stockpiling in developing the

" range of protective Mons" 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 thyrold. )

Depending on the circumstances, KI may offer additional protection if used in

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conjunction with e"acuation and/or sheltering.

The approach taken in this rule change is consistent with Interriational Basic Safety Standards issued by the International Atomic Energy Agency, 31 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: Alabart.a, 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" (nu:: lear, 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 recognizek that the decision to stockpile K1 presents issues of how best to position and distribute the medicine, to ensure, gA, 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 Tof the public understand that El is not a substitute for measures that protect a

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c 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 s,tates 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 e.tpertise in the relevant federal and state agencies.

It is expected that FEMA or the FRPCC will p o /tde 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 possib!e to states which desire it, as well as to provide any further assistance that may be called for, and it will also Miow the Government to engage in better contingency planning for states that decide against stockpiling KI.

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SUMMARY

The Federal Redlelogleal Preparedness Coordneting Committee (PRPCC) le Issuing this revised Federal polley conoeming the purchase, stosketing, and use of '&

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potessium lodido (KI) es a prophylaxis {for the thyroid in the unBkely event of a mehr radiological emergency et e commercial nut. lear power plant. Taken in time,10 blocks the t A/vw.H *froid ca cer n.v cre,,,

iedwoo thyroid doesses thyreld's uptake of enrbome radioactive ledine, and thus seuld

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and Insthutionellaed persone during radiological emergenoles, in devoleping the range of ga,la M Jer %e4(*tratpubtic

[pubne] protective actione}er severe econdents et eT.T ;.:d nuoleer'festities, theb j

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left to the discretion of State ( or, in some esses, local govemment.)

ATTACHMENT 1 1ssas tc t stoc kp,I. g o's c; rensosrQte s,g twe ency. Eclie v,~,g i

f t e fen,a s hee,,,,,e.,7 w,H pte rcko s e.ny ker J r< t pr estr oun ce.rs< re,

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It is recognized that the State (or in some cases, the local government), within the limits of A

its authority, con take measures beyond those [ecommended o]r required [The avai 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 went to usurp the State prerogative to incorporate the use of Kl as e protective measure for the general public.

Therefore, to ensure that States have the option to use KI if they so elect, the Feoeral govemment is prepared to provide funding for the purchase of a supply of Kl. Any State (or in some cases, local govemmentl which selects the use of Kl es a protectJve measure for the general public may so notify FEMA and may request funding for the purpose of purchasing a supply of Kl.

In addition, the Federal government is also required to prepare for a wider range of radiological emergencies'. To that end, and as an added assurance for radiological emergencies in which the location and timing of an emergency are unpredictable and for l.

M which, unlike licensed nuclear power plants, there is little planning possible,y stock r.st asymye of Was creu.J tks QTL aa pg Ki ) being established by the Federal government) his Federal stockpile,will be availab to any State for any type of radiological emergency, et any time.

'M response to new throots. 9ts Federal govemment broseyed the scope of emereeney reopense preparedness te Inofude terrottom involving nuclear, hieloeical, and chemici seente. As a re State and local govemmente, new resources were identified to be reeded h toepente to such evente. N deren Metropoliten Medical Strike Tooms (MMST) are beine estebushed for response to such events Esoteoest.

suopf ee. 6ncluding Kl. are beine stockeaed nationally for the use by MM of two doyo.

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3 The posey herein incorporates changes recommended by the FRPCC's Subcommhtee on Peteesium lodido, and supersedes the 1985 Federal relicy (505 3025s). The prinolpel stforence between this revloed policy and the 1985 version we the addhion of the offer of

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the Federal Govemment to purchase a supply of Kl for States et a State's request,end the m

establishmer.: ef a Federal stockpilej, The Fedwei Emere ney Menneement Aeoney (FEMA) sheirs the FRPCC, thereby assuming the responalbility for this publiestion.

For Further Information Centest Wluiem F. McNutt, senior Poucy Advisor, Room 834, Federal Emergency Management Agency, 500 C Street, SW., Weehineton, DC 20472, (202) 646 2857; facsimile (202 646 415 3.

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Background

This policy on use of Kl as a thyroidal blocking agent is the resuh of a Federal interogency effort coordinated by FEMA for the FRPCC. On March 11,1982, FEMA issued a final l

regulation in the federal Realstar 147 310758), which delineated agency roles and responsib5 hies for radiological incident emergency response planning (44 CPR 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 substances and prophylactic use of drugs (e.g., KI) to reduce redietlen doses to specific organo including dosage and projected radiation exposures et which such drugs should be used, in the June 29,1982 federal Manistar (47 3 28158), PDA published recorrmondetione for State and local agencies regarding the projected radiation dose to the thyiDid gland at which State and local health officials should consider the use of Kl ' The Federal policy on stockpiling and distribution of Kl was published in the July 24,1985 Fedgral Realstar (50 S 30268). On September 11,198g, the American Thyroid Association requested FEMA, as Chair of the FRPCC, to reexamine the 1985 policy and to revish the issue of stockpiling and distribution of Ki for use by the general public. In response, the FRPCC established an Ad Hoc Subcommittee on Potassium lodido, hn December 5,1994, the FRPCC edopted the report and recommendations of the Ad Hoc Subcommhtee on Potassium lodido, which reaffirmed the Federal poshion as expressed in the 1985 poBoy.)

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On April 3,1996,in connection whh a September 9,1995 Pet} tion for Rulemaking submhted to the Nuclear Regulatory Commission (NRC) on this leeue, the FRPCC established a new Subcommittee on Potassium lodide to review current infomation. Th Subcommittee conducted a public meeting on June 27,1996. Based on the information collected, the Subcommittee concluded that there was no new information that seriously challenges the bases for the 1985 recommendations concoming public use of KJ for radiological emergenc!ss et nuclear power plants. However, several recommendations were made to the FRPCC. The Subcommittee's three recommendetJons were: 1) whhout Aa+ lt I.s changing the Federal policyhy interceding 13the State's prerogative to make hs own decisions on whether or not to use KI, the Federal government (NRC, or through FEMA) should fund the purchese of a stockpile for any State that, hereinafter, decides to incorporate Kl as protective measure for the general publici 2) The Subcommittee belirwes the language in the 1985 policy should be softened to be more flexible and balanced. For exemple, the problem many intervonors observe in the Federal policy is irt the helicized irtetement "The Federal position with...potessium iodide for use t:y the general public is that h should not be required.' h would not be as negative if the last phress were reworded to state 'it rpotassium lodido for use by the general public)is not required, but may be selected as a protective measure et the option of the State or, in some cases, lo l

governments.' and 3) The subcommittee recommends that local jurisdictJone who wish to incorporate Kl as a protective action for the general public should consult whh the State to I

~

l determine if such errengements are appropriate, if local governments have the authortty or secure the approval to incorporate K1 as a protective measure for the general public, they would nrad to Alude such a measure in their emergency plans.

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nri r acowat nrst roc w unr rac cvuowunce wz. ruc-k Mod LO\\ Is THAT TM KEY PkthSE IS "Tht it%CC F02 Tk t 19tC TilC PreftetSE " u r) DEQ (2 C CO W IAEUL,hTi k!JC " ~ ~

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e The full FRPCC endorsed the subcommittee's recommendations wkh some modtfications, i

Policy on Distribution of Ki Around Nuclear Power Shes for Use as a Thyroidal Blocking i

Agent The purpose of this document is to provide Federal policy and guldence whh regard to distribution of KI, and 'ts usujo es a thyroid blocking egent, around operating nuclear power generstlng facilhies. The issue has been addressed in terms of two components of the population that might require or desire Kl uset (1) Emergency workers and institutionellaed individuals close to the nuclear power plant site, and (2) the nearby gene el population. This guldence 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.

alre f p n +6ts,

94 Federal policy 4that K1 should be stockpiled and distributed to emergency workere and insthutionalized persons during radiological emergencies, in developing the rence of Joe Al<< grs'rnd pu e n,,;s te,

.public protective actions]for severe accidents et commerciel nuclear facilitsee, the best Mc 6tsr technical information Indicates that evacuation and in-place sheltering provide edegeste

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[ _ protection for the general public}However, the State (or in some ceaes, the local government) is ultimately responsible for the protection of its citizens. Therefore, the deciolon for local stockpiling and use of Ki es a protective measure for the general public is left to the discretion of State ( or, in some cases, local govemment.)

hfh h

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uuA in b ou rnMlon-ceu,%e cry,. n n y eoM, wiu

(%" hub on wiR twnhttdeeni c,.. ; / p r ne tte r,'.g.

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Lq 4 Rhal(o* ofed-7 n is r.cognis.d that the state (or in some cas.s. th. ioesi gov.cnm.no, whhin the iimke of he autherfty, con take measures beyond those(ocommended o]r required [The availabilhy of K1 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 K1 es a protective action for the general public. The FRPCC does not went to usurp the State prerogative to incorporate the use of K1 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 govemment is prepared to provide funding for the purchese of a supply of Kl. Any State (or in some cases, local government) which selects the use of Kl as b protective measure for the general public may so notify FEMA, and may request funding for the purpose of purchasing a supply of Kl.

In addhion, the Federal government is also required to prepare for a wider range of radiological emergencies'. To that end, and as en added assurance, for radiological emergencies in which the location and timing of en emergency are unpredictable and for liitoted which, unlike lit.ensed nuclear power plants, there is little planning possible,Jr stockp Q t i..".t-bfr. 01 3 *tL5 d roud fks v. r. The st.

K1 %being established by the Federal govemmery This Federal stockpile,will g

to any State for any type of radiological emergency, et any time.

The bases for these recommendations are given below.

m response to new throots the Pedwel sovemment breedened tie esepe of emereeney roepense J

s preparedness to include torferiam,invWng nuclear, bieleelcel, and ehemical agente. Ao e resuK, and in suppor of State end lacel govemmente, new resources were identified to be needed in reopense to such events. About two dozen Metropolitan Medical strne Teeme (MMST) are Wing established for response to eveh evente. M suppces,ine#wding Kl. are being stockplied notionally for the use by MMSTe in three locotions: East s Conval, and West seest. The evenety of supplieis stockpiled vees e plenning basis of of two days.

l'.

8 The NRC and FEMA issued guidance to State end local authertties as well as licensees,0f oporsting commercial nuclest power plants in NUREG 0654/ FEMA tWP.1, Revision 1, in l

1980. This guidance recommends the stockpiling and distnbution of K1 dW omergencies to emergency workers and to institutionalised indviduals. Thyroid blocking for emergency workers and insthutionallred individuals was recommended because these Indviduals are more likely to be exposed to radiolodine in an airbome radioactive release then other members of the public, in addition, the number of emergency workers and instJtutionellaed Individuals potentially effected at any she is relatively email and requires a 1

limhed supply cf Kl that can be readily distributed.

For the general public, in the event of a radiological emergency at a commercial nuclear f acility, evacuation and in place sheltering are considered edequas and effective protective AkCM actions, it is well recognized that the inclusion of Kl as a protective measure,in addition to evacuation and sheltering, is beneficial only in very remote circumstances. The use of g, P.

Kl is not without controversy. On the one hand, Kl has been shown to be en effetas 44 No.3re,4,sm n

ca.tegg drug for protecting the thyroid f thyroid noduleep xx used by the uptake of radiolodine, especially in children fifteen years of age of younger. On the other hand, Wp there are logistical difficuttles, and potential medical side _ effects es;ociated_with the drug,

.4 5

Also, Ki in distributing the drug to the general public in a radiological emergency.

r r76 effectively reduces the radiation exposure of on',y the thyroid gland from ingested or M

puTI#g(, inhaled radiolodines. While this kt an important contribution to the hostth a

/

.' 5hr(

NI individuel, h is not as offective as measures which ptotect the total body. Both in-place g$ sheltering and precautionary evacuations can reduce the exposure to the thyroi A-pA g total body, it is very important to remember that the use of Kl is not en effect 6

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by heeN for protecting individuals from the radioactivity in'en airbome reisese resulting from a nuclear power plant occident end, therefore, should only be considered in cor$ unction with sheltering, evecustion, or other protective methods. Therefore, while the use of Kl can provide additional protection in certain circumstances, the assessment of the effectiveness of Kl and other protective actions and their implementation indicates that the deelslon 'o use Ki land /or other protective actions) should be made by the States and, N appropriate, loaal authorhies on a she specific, ecclJent opecNic basis.

Those States of local governments which opt to include K1 for the genersi population will be responsible for the maintenance, distribution, and any subsequent costs associated with this program, i

The incorporation of a program for Ki stockpiling, distribution and use by any State or local TH85 government into the mergency plans will not be subject to Federal evolustion. This is klgggy N

based on the recognition that the use of K1 bt the State for the general public is a

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supplemental protective measure, and on the Federal govemment's determination that the 6CCed

' go existing omergency planning and preparedness guidance for nuclear power plants is g ood 6 MOfd b -

effective and adequate to protect the public health and safety.

The FDA has evolusted the medical and radiological risks of administering K1 for emergency conditions and bec :oncluded that h is safe and effective and has approved over the-counter sale of the drug for this purpose. FDA guidance states that risks from the short term use of relatively low doses of K1 for thyroidal blocking in a radiological emergency are outweighed by the risks of radiolodine induced thyroid nodules or cancer et a projected

~

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j io w8 1

44

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dose to the thyroid gland of 25 rem or grooter Since FDA has autherised the 4QW 7

g6e

.%vn t%i sale of KI, it is ovellable to individuals who, beood en their own persensi y4@

i tu a analyele, shoose to have the drug immediateh eveBoble.

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Attached is e Ilot of ten refwencee intended to seeist State and local autherhise in g g

v a.

declelJns related to the use of Kl.

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The FMpCC did not find any new informaten that would require e change in the beels of b 0, 9

a 4Nk l

the existing Federal policy concoming the stockpile or pre distribution of K1 for the general N%

public in the even[of a radiological emergency at a co W

the, Ki.ouid be etockpiiod and distributed io eme,gency woriere and inethutionsiired NWT persons during radiological emergencies, but leavec the declaien for the stockpilng, k distribution, and use of KI for the general public to the discretion of State, and in some casse, local govemments. Any State or local govemment that selects the use of K1 se e

• protecthe measure for the general public may so notify PSMA and may request funding fo

+

the purpose of purchasing en adequate supply.

' e incorporation of a program for K! steekpliing, distribution and une by any State or local Th 6 %(

Sevemment into the emergewy plane' will tot be outdoet to Federal evolustion. This is

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wud ened on the recognition that the use of Kl by the State for the general public la e U

b supplemental protective meneure, and on the Federal govemment's determination that T

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11 esdoting erNeeney planning and preparedness guidance for nuoloar power plants is i

.ff tl.e aa.de

. to ote.t

,ubsc,.a,th eu f.,y.,i These States or local govemments which opt to include Kl for the general popuistion wR he re++r'M: for the maintenance, distribution, and any subsequent oosts or P,1,1 Retetles esecolated with this program.

As an added assurance, for a broader range of radiological ornergencies in which the l

loostion and timing of an emergency are unpredictable and for which, unlike scensed l

nuclear power plants, there is little planning possible, e stockpile of K! will be established by the Federal government. Such a stockpile would cons:st of individual Kl caches et VA j

hosphals in m4)or metropolitan centers across the country. This supply would te evellable to any State ur local government for any type of radiological emergency,

d t

References National Council on Radiation Protection and Measures (NCRP), ' Protection of the s

1.

Thyroid Oland in the Event of Releases of Radiolodine," NCRP Report No. 55,

. August 1,1977.

i i.

l Food and Drug Administration (HHS), Potassium lodido as a Thyroid Slocking Agent 2.

in a Radiation Emergency,43 EB 58798, December 15,1978.

e 4

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..w,-,

-,...n, -,.

wn n.,...-.

.,.r..

..v--

,,,--rv..r,

t 12 3.

Helperin, J. A., s. Shielen, s. E. Kahane, and J. M. Bi6sted; 'Beckground Material fo' the Development of the Food and Drug Administration's Recommendatione on Thyroid Blocking with Potassium lodide,' PDA 514158, U.S. Department of Hoehh and Human Services (March 1981).

4.

Food and Drug Administration; Potasolum lodido se a Thyr #Blocidng Agent in s Redist en Emergency; Pinal Recommendstione on use (Notice of Avsilability) 473 8

28158, June 29,1982).

5.

Food and Drug Administration; Poteesium lodido se e Thyroid Blocking Agent in a Medletion Emergency: Recommendatione on Use. (April 1992). Prepared by the Bureau of Radiological Heshh and Burosu of Druge, Food and Drug Administration, Department of Heshh and Human Servloos.

I.

Nuclear Regulatory Commlesion; Examinetlen of the Use of Petesolum ledido (Kil es G

an Emergency Protc%e Measure for Nuclear Reactor Acoldente (NUMEG/CR 1433,

,y March 1990). Propered by Sandle National Laboratories for the NRC.

v Nuclear Regulatory Commisalon; An Anew of Potasolum ledido (KI) Prophylaxie 7.

l for the General Pub 5c in the Event of a Nuclear Acoldent (NUREG/CR4310, Pobruary 1995). Prepared by S. Cohen and Associates, Inc. and Solentech, Inc. for the NRC.

l l

8Y AJod,

Gi5 SHouth ($r /Lt 4 AEDED AS 31sCGCDf7ED.

. A7 mc vtM L EMG lT Hr%

BCEA> Gipu_Stu h SY TWC llCr)lJA WSI S IM MVt2 CC, {C 2 ~ le 310 ( [ TCM *)) s I

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y.

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I a., ~

's 13 8..

Nu lear Regulatory Commlasler 3 Redvolustion of Policy Regarding Use of Potassium ledido After a bever. Azcident et a Nuclear Power Plant (SECY 93 318, November 23,1993).

9.

Nuclear Regulate / Commiselon; Addendum to SECY 93 318, Re4velustion of Policy Regarding Use of Potass'.m lodide After a Severe Accident et a Nucieer Power Plant (SIC %94 087, March 29, i tM).

Signed:

O. Megs Hopler, lil Chair Federal Radiologicat rieparedness coordinating committee E

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' Peter G. Crane / 4809 Drummond Avenue / Chevy Chase, MD 20813 / 301656 3998 00CKETED USNRC November 12, 1997 W @ 13 #0:10 Mr. John C. Hoyle, Secresary U.S. Nuclear Regulatory Commission

_]

Washington, D.C. 20555 OFF la : c c -

Ru 2.

• IMF Re: Amendment to Petition for rulemakino (PRM-50-63)

Dear Mr. Hoyle:

On rereading my filing of earlier today (dated November 11), I find a minor editing error (two references instead of one to the Commission's SRM of June E

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 documer.t is unchanged.

Thank you.

Sincerely, Peter G. Crane i

Attachment:

corrected psge 3 X

^k c-

3 o

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 desens, 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 lesa 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 Manud of Protective Ac+4+m Guides and Protective Actions for Nuclog incidents, EPA-400-R-92-001, published by EPA in May,1992. - On November 11, 1995, I wrote to you, as Secretary of the Commissson, that at the time I filed n.y 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-97-114. 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.' Neither the vote sheet of Chairman Jackson nor that of Commissioner Dieus, who voted for Option 2, ref" M specifically to the draft Federal Register notice in Attachment 1.

Nor dL..e 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 1

vote for the Federal-Register notice as drafted by the NRC staff, and my i

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 seme lack of perspective (to use the mildest term possible) that was responsible for that misstatement can be seen in the staff's t

' All that SECY-97-124 had to say about the draft notice was the fobowing, 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."

[7590-01-P)

NUCLEAR REGULATORY COMMISSION 10 CFR Part 50

[ Docket No. PRM-50-63A)

Peter G. Crane; Receipt c,f an Amended Petition for Rulemaking I

AGENCY: Nuclear Regulatory Commission.

ACTION: ' Amended pe*!* ion for rulemaking: Notice of receipt.

SUMMARY

The Nuclear Regulatory Commission (NRC) has received and requests public comment on an amended petition for rulemaking filed by Mr. Peter G. Crane.

The amended petition has been docketed by the Commission and has been assigned Docket No. PRM-U 63A. - The petitioner states, in this amendment to the earlier petition, that the rulemaking he see' s is to emend NRC's emergency planning regulations to require consideration of sheltering, evacuation, and the prophylactic use of potassium iodide for the ge..ael public in developing a range of emergency planning protective actions.

DATE: Submit comments by (30 days after publication in the Federal Register).

Comments received after this date veill 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.

egA

.g ( (

• l

m Deliver comme,1ts 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 Cirectives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC.20555. A copy of the pet l tion is also available for public inspection, and copying for a fea, 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 notw ceceipt of this petition was published on 2

1

t 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-50-6?a.

,,4 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 (KI) as one action to be considered in emergency situations under onsite and offsite emergency

plans, i

A Potassium lodide The petitioner states that Ki protects the thyroid gland, which is highly sensitive to radiaticn, from the radioactive iodide that could be released in extremely serious nuclear accidents; that by saturating the gland with iodide in a harmless form, Ki can prevent inhaled or ingested rad!oactive iodide from lodging in the thyroid gland, where it could lead to thyroid cancer or other illnesses; and that KI itself has a long shelf life-at

. least five years-and causes negligible side effects.

The petitioner further states that, in addition to preventing osaths from thyroid cancer, Kl prevents radiation-caused illnesses. The F.etitioner states that thyroid cancer, curable in 90-95 perr9nt 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 i

The petitioner initially requested that 10 CFR 50.47 be amended by revising paragraph (b)(10) to read as followc:

@50.47 Emer0ency 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:

650.47 Emergency plans.

(b) 4 aa

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y i.,,.

(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.

As part of the amended petition, the petitioner also attached a proposed Statement of Considerations and, as ir:vited by the Commission, a draft mark-up of a document from the Federal Emergency Management Agency entitled " Federal Policy

- on Distribution of Potassium lodide Around Nuclear Power Sites for Use as a Thyroidal ~

Blocking Agent."

Dated at Rockville, Maryland, this /[

day of December,1997.

-l For ths Nuclear Regulatory Commission.

John C. Hoyle, Secretary of ths Commission.

5 I

CONGRESSIONAL CD ENG S151EM DOCUMENT PREPARATION CRECKLIST This check list is to be submitted with each document (or group of Qs/As) sentfor processing into the CG.

l. BRIEF DESCRIPTION OF DOCUMENT (5)_

A c0

2. TYPE OF DOCUMENT X l.ORRESPONDENG RE4 RINGS (Qc!As) 3, DOCUMENT CONTROL _ SENSITIVE (NRC ONLY) X NON-SENSITIVE y

CONGkESSIONAL COMMITIEE AND SUBCOMMITTEE ((f applicable) 4 Congressional Commissee Subconunittee

5. SUBJECT CODES (A)

(B)

(C)

6. SOURG OFDOCUMENTS (A) 5520 (DOCUMENT NAME

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SCIN (C)

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-(D)

OTHER

7. SYSTgy'll90 DATA OC4 SENTDOCUbiENT TO CCS LPG DATES (A) X/

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(F)

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,m COMMENTS:

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RELEASE TD PDR l

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