ML20205S668
| ML20205S668 | |
| Person / Time | |
|---|---|
| Issue date: | 11/10/1998 |
| From: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| RULE-PRM-50-63, RULE-PRM-50-63A SECY-98-264, SECY-98-264-01, SECY-98-264-1, SECY-98-264-R, NUDOCS 9904260296 | |
| Download: ML20205S668 (118) | |
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POLICY ISSUE 1
November 10.1998 (Notation Vote)
SECY-98-264 FOR: The Commissioners FROM: William D. Travers Executive Director for Operations
SUBJECT:
PROPOSED AMENDMENTS TO 10 CFR 50.47; GRANTING OF PETITIONS FOR RULEMAKING (PRM 50-63 AND 50-63A) RELATING TO A REEVALUATION OF POLICY ON THE USE OF POTASSIUM IODIDE (KI)
AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT PURPOSE:
To obtain Commission approval to publish a proposed rule in the Federal Reaister for a 90-day public comment period, that would grant petitions for rulemaking (PRM 50-63 and 50-63A).
These petitions requested changing the NRC policy on the use of potassium iodide (Kl) as a radioprotective agent for the general public in the event of a severe reactor accident.
BACKGROUND:
On September 9,1995, a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. ,j
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In SECY-97-245, dated October 23,1997, the staff presented three options to the Commission for resolving PRM 50-63.
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98-264 R PDR CONTACT:
Mike Jamgochian, NRR/DRPM/PGEB ,
(301) 415-3224 ; ) / g,.y 230103 I
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The Commissioners On November 5,1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resolving the petition for rulemaking. During the meeting, the Commission invited the petitioner to submit a modification to his petition in order to address the views he discussed during the meeting.
On November 11,1997, the petitioner submitted a revision to his petition, PRM 50-63A (Enclosure 1). The petitioner made two requests:
A statement be made clearly recommending stockpiling of Kl as a " reasonable and prudent" measure, and A proposed rule change to 10 CFR 50.47(b)(10), which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (Kl), as appropriate."
The petitioner also provided a marked-up version of the proposed Federal Radiological Preparedness Coordinating Committee (FRPCC) Federal Reaister notice concerning a revision to the Federal policy relating to the use of Kl for the general public.
On June 26,1998, the Commission directed the staff in SRM 98-061 (Enclosure 2) to grant the petition for rulemaking PRM 50-63A by revising 10 CFR 50.47(b)(10).
PUBLIC COMMENT ON THE AMENDED PETITION:
On November 27,1995 (60 FR 58256), a Notice of Receipt of the Petition for Rulemaking was published in the Federal Recister requesting public comment. A total of 63 comment letters were received, of which 20 utilities,9 State governmental agencies,2 utility interest organizations,1 letter signed by 12 health physicists,2 State universities and 1 member of the public were against the granting of the petition for rulemaking. Those letters in favor of granting the petition came from 5 environmental groups,22 members of the public (including 1 from the petitioner), and the American Thyroid Association.
On December 17,1997 (62 FR 66038), the Commission published a request for public comment on the amended petition in the Federal Reaister. In response to several requests, the comment period was extended until February 17,1998, by a Federal Reaister notice published on January 21,1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 utilities,3 State government agencies,1 utility interest association, and 1 member of the public were against granting the petition for rulemaking. The letters in favor of granting the petition came from 8 public interest groups,46 members of the public (including 1 from the petitioner),
3 physicians,2 U.S. Senators, and 1 State Representative. A detailed analysis of the issues raised by the public comments along with the Commission response to those issues is in the proposed Federal Register Notice (Enclosure 3).
The Commissioners DISCUSSION: l in the revised petition (PRM 50-63A) dated November 11,1997 the petitioner requested that consideration be given to including Kl as a protective measure for the general public. This is a change from the original petition in which the petitioner requested that the regulations be i amended to require einergency plans to include Ki as a protective measure. In both the original and the amended petitions, the proposed rule language lists sheltering and evacuation as protective measures along with Kl. The planning standard (10 CFR 50.47(b)(10)) currently does not identify any specific protective actions, but indicates that a range of protective actions should be developed for the plume exposure pathways zone (EPZ) for emergency workers and the public, and included in emergency response plans. Additionally, the petitioner requested that a statement be made clearly recommending stockpiling of Kl as a reasonable and prudent protective measure.
On June 26,1998, the Commission voted 3 to 1 to grant the petition for rulemaking.
Accordingly, the staff was directed to proceed with rulemaking to change 10 CFR 50.47(b)(10) by inserting the following sentence, or similar words, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate." In addition, the statement of considerations for the proposed rule should include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of KI as a protective supplement is reasonable and prudent for specific local conditions. The Commission also noted that, consistent with the Commission's decision on June 30,1997, the Federal government (most likely NRC) is prepared to fund the purchase of a stockpile of Kl for the States, upon request. The NRC staff also was directed to work with other relevant agencies to ensure that there are established procedures to enable the national stockpile, for response to terrorism, to be effectively and timely used by States that have not established local stockpiles and wish to make use of the national stockpiles in the event of a severe nuclear power plant accident.
The attached Federal Reaister notice implements the Commission's decision by publishing the proposed amendment to 10 CFR 50.47(b)(10) for a 90-day public comment period.
RESOURCES:
Approximately one FTE is budgeted to resolve this petition by conducting a rulemaking in accordance with the Commission 6 won. The cost of purchasing Ki was discussed in SECY 97-124 (Enclosure 4) with tw astimates ranging from $48K to $1.3M. The staff has recently found these estimates to be overly conservative by approximately a factor of 2.5 due to the increased costs of purchasing the Kl tablets. Therefore, the revised estimate range is
$117K to $3.25M depending on the number of States that request funding. These resources are not currently budgeted and would have to be reprogrammed from existing agency programs or carryover. A more detailed cost and funding analysis will be provided prior to the final rulemaking. Additionally, prior to FEMA going forward with the issuance of the FRPCC Federal Kl policy, a letter from the NRC committing the above funds will be necessary.
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The Commissioners COORDINATION:
' The Office of the Chief Financial Officer has reviewed this Commission paper for resource implications and has no objections. The CRGR has reviewed this Commission paper but does not agree with the staff's no backfit analysis (see Enclosure 6). The Office of the Chief Information Officer has reviewed this Commission paper for information technology impacts and compliance with the Paperwork Reduction Act and concurs in it. The Office of the General Counsel has no legal objection.
RECOMMENDATION:
That the Commission:
- 1. Acorove publication of the proposed rule in the Federal Reaister.
- 2. N_gle:
- a. The proposed rule change would be published in the Federal Reaister for a 90-day public comment period,
- b. Appropriate Congressional committees will be notified.
- c. The Office of Public Affairs draft public announcement is attached (Enclosure 5).
- d. The evaluation of a need for a backfit analysis was prepared by OGC. The EDO accepts OGC's position that this rule change does not constitute a backfit under 10 CFR 50.109; therefore, a backfit analysis is not required.
- e. FEMA has been provided with an advance copy of this rulemaking package.
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William D. T avers Executive Director for Operations Attachments:
- 1. Revised Petition for Rulemaking (PRM 50-63A)
- 2. SRM 98-061, dated June 26,1998
- 3. Proposed Federal Register Notice ,
- 4. SECY 97-124
- 5. Draft Public Announcement
- 6. CRGR comment letter dtd. October 23,1998
r Commissioners' completed vote sheets / comments should be provided directly to the Office of the Secretary by COB Friday, November 27, 1998.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT November 19, 1998, with an information copy to the Office of the secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners OGC OCAA OIG OPA OCA CIO CFO EDO REGIONS SECY l
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l Peter G. Crane / 4809 Drummond Avenue / Chezy Chase, MD 20815 / 30].656 3998
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vuLntitu UShRC November 11, 1997 l Mr'. John C. Hoyle, Secretary T E' 12 P4 :17 U.S. Nuclear Regulatory Commission l Washington, D.C. 20555 OFF . .
RJL Re: Amendment to Petition for rulemakina (PRM- h *
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Dear Mr. Hoyle:
At the Commission meeting on potassium iodide held on November 5,1997, Chairman Jackson asked me whether I could submit, within the week, language reflecting the modified position that I outlined during the meeting. Attached to this letter is a draft of a proposed rule change, accompanied by a statement of l 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 l plans," but "would not ram potassium iodide down the throat of a state that {
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emphatically rejected it." I made clear that I was asking for two things:
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. , evac"Ation, 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 niay 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 Plainly, the policy stated and explained in the statement of considerations.
latter makes more sense (in any event, to propose a rule change, the NRC wou2d have to offer its reasons for doing so) and seems most consistent with the Commission's interest in resolving the K1 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 propesing 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 HAM [ I
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I on November 5, is an indication that I take this amendment of my pet 2 tion very f t
seriously, without game-playing. I would like as much as anyone to see this protracted process brought to closure, with broad consensus acceptance.
Accordingly, I have tried to produce a solution that satisfies the NRC's obligations to protect 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 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, such as those I referred to in the November 5 meeting, I have omitted these historical matters from the proposed Statement of Considerations that I am offenng today. This reflects a conscious decision to look forward, not to the past, in the recognition that for a health and safety agency, the central question must always be: What makes sense today, in light of what we know now?
I believe that if the approach I am proposing is accepted, it would be viewed as so patently reasonable that if challenged legally, it would be sustained by any reviewing court, whether the challenge came from those who thought it went too far or from those who thought it did not go far enough. In the 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., for a total of more than four years since the filing of the petition), this seems exaggerated. It is a matter of public record, for example, that the 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 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.
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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 Ins 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 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 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
' All that SECY-97-124 had to say about the draft notice was the following, at p.10: " Attachment I 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."
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 cne 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 ton 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 inte pret it to mean that there is no new information bearing significantly on tne 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 called upon to explain this l sentence, and it turned out to mean what I suggest it seems to mean, would I
' 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.
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5 they feel comfortable that the notice had done a good job of informing the public? Or would the sentence seem, on exanunation, 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," 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. l 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 I
cc: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan Executive Director for Operations General Counsel l 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 550.47(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 developino th.s rance of actions, consideration has been oiven to evacuation, shelterino, and the prophylactic use of potassium iodide ( KI), as appropriate. Guidelines for the choice of protective actions dunng 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, i
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7 STATEMENT OF CONSIDERATIONS 1
The Nuclear Regulatory Commission is proposing to amend its emergency I planning rules, codified at 10 CFR 550.47(b)(10), to clarify the requirement i 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 l 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 I efficacy of KI in protecting the thyroid depends on timing (i.e., administering it either before er 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 19%, 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 1973, 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 ;onsider 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 supphes of KI will be made available, paid for by te 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
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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 spe<-imliving 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 distribilte the medicine, to ensure, LL., 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
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the whole body; etc. To date, these issues have been addressed in different i
- i. ways in the numerous countries that currently stockpile KI. The NRC intends l-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 sr.ites 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.
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BlBing Code 6718 06 P Apr816,1997 FEDERAL EMERGENCY MANAGEMENT AGENCY DRAFT Federal Poucy on Distribudon of Potaselum lodde Around Nuclear Power Sitas for Use as a Thyroidal Blocking Agent AGENCY: Federal Emergency Managament A0ency.
y it Prokat<'ou k swise4 L w , h socaJ j ACTION: lasuance of Federal Policy on Potassium lodid]e ggeacce
SUMMARY
- The Federal Piediological Preparedness Coordinating Committee (FRPCCI is issuing this revised Federal policy concoming the purchase, stockpRing, and use of & druj
, +o Prettd $in4 potassium iodide (KI) as a prophylaxis {for the thyroid in the unlikely event of a major radiological emergency at a commercial nuclear powe* plant. Taken in time, K1 blocks the t pr<ve q + neved ca nt a sa e-he,,
thyroid's uptake of airborne radioactive iodine, and thus could esNiese thyroid diseases tewesM, a ca..th caused by such axposure f
- k"8b W ld*ddfa8in.h pin g e vacua to m o ce .s/"f'#'
he /tt ro *ns,4usas
- '#'f 6 grp proosces, fo protect ~ the geners4 publ*'e en 4 FAdoolo3.M s
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% Federal policy (is]gthat K1 should be sakp8ed and distributed to emergency wo s
and institutionalized persons during radiological emergencies. In developing the range of Jer %e 4carrat public , .
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[public] protective action}s or severe accidents at commercial nuclear facRities, thelesQ
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technical information indicates that evacuation and in place aholtoring provide jdequat( l 64causs Au pr.Nr 4 uA.te %. k# pr..,.o,s a b..,d pr.tc.t... s r ew ma,ati .susih I prot.cdon fw the genwel pub 5Q he State (or in some cases, the local r5 .1.
M.*E,K govemment) is ultimately responsible for the protection of its citizens. Therefore, my/ I decision for local stockpiling and use of KI as a protective measure for the general pub 6c is left to the discretion of State ( or, in some cases, local govemment.)
ATTACHMENT 1 (McGency Belie si.',,g .it,a s ici stoc kp. t.q. is a reanic< sie a na rg dg4 pe r s.ss, eg, , fine Fenta t 6 svens , stent tv, !I pst rcks s e npp /,*cc c/ rc t or ttcse rf a1cs (or e., $ vert CG >a, l3 c4 I josw =seteert ) thW eIK' W "40I Ns.d I /
- W e f tseeor enor!$r*'ty f son
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@ k Mud dovaswed.
It is recognized that the State (or in some cases, the local government), within the limits of its authority, can take measures beyond those {ecommended o3 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 K1 as a protective action for the general public. The FRPCC does not want to usurp the State prerogative to incorporate the use of KI as a protective measure for the general public.
Therefore, to ensure that States have the option to use Ki if they so elect, the Feceral 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 K1 as a protective messure 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 4
radiological emergencies'. To that end, and as an added assurance for radiological emergencies in which the location and timin0 of an emergency are unpredictable and for
- f. e H which, unlike licensed nuclear power plants, there is little planning possible,,a stockpile'of
,, a ~m ,o , ~ ,,em r.
K1 Jg being established by the Federal government) This Federal stockpile [will be available to any State for any type of radiological emergency, et any time.
'In response to new threats, the Federal sovemment broadened the scope of emergency resporww preparedness to incdude temmam involving nuclear, biological, and chemical agents. As e result, and in support of State and local govemments, new resources were identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMST) are being established for response to such events Medical supplies, including K!. are being stockpiled nationally for the use by MMSTs in three locsoons: East coast.
Central, and West coast. The quanoty of supplies stockpiled uses a planning basis of loo,oco people for a period of two days.
i
i
.. , .- , i 3
The policy herein incorporates changes recommended by the FRPCC's Subcommittee on Potassium lodide, and supersedes the 1985 Federal policy (50 EB 30258). The principal difference between this revised policy and the 1985 version are the addstion of the offer of i
the Federal Government to purchase a supply of KI for States at a State's request3end the
' , . -. m establishment of a Federal stockpile,' The Federal Emergency Management Agency (FEMA) i chairs the FRPCC, thereby assuming the responsibility for this publication. !
/
For Further information
Contact:
Wdliam F. McNutt, Senior Policy Advisor, Roorn 634, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646 2857; facsimile (202 646-4183.
ua u egen rec, son 9 u rac<a y-r, cdicctek in & ofrec 4. gucc6se th he tw.s kicdichtc can compk+ed e%er profedst measures M Ntr ty hduct,, protcciton of f$ f 41slic e
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4
Background
This policy on use of Ki as a thyroidal blocking agent is the result of a Federal interagency effort coordinated by FEMA for the FRPCC. On March 11,1982, FEMA issued s final regulation in the Federal Reatster (47 310758), 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 substances and prophylactic use of drugs fe.g., KI) to reduce radiation doses to specific organs including dosage and projected radiation exposures at which such drugs should be used.
In the June 2g,1982 Federal Reaister (47 3 28158), FDA published recommendstions for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health officials should consider the use of Kl. The Federal policy on stockpiling and distribution of Kl was published in the July 24,1985 Federal Reaister (50 .
S 30258). On September 11,198g, the American Thyroid Association requested FEMA, as Chair of the FRPCC, to reexamine the 1985 policy and to revisit the issue of stockpiling and dist:ibution of K1 for use by the general public. In response, the FRPCC sstablished an Ad Hoc Subcommittee on Potassium lodido.hn December 5,1994, the FRPCC adopted the report and recommendations of the Ad Hoc Subcommittee on Potassium lodido, which reaffirmed the Federal position as expressed in the 1985 pohey. j 8
ADMMEAIT:
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On April 3,1996,in connection with a September 9,1995 Petition for Rulemaking I
submitted to the Nuclear Regulatory Commission (NRC) on this issue, the FRPCC l established a new Subcommittee on Potassium lodide to review current information. The Subcommittee conducted a public meeting on June 27, igg 6. Based on the information I
collected, the Subcommittee concluded that there was no new information that seriously challenges the bases for the 1985 recommendations concoming public use of K1 for Rf l r radiological emergenc!ss at nuclear power plants. However, several recommendations were made to the FRPCC. The Subcommittee's three recommendations were: 1) without At it i.s changing the Federal policyhy interceding i]the State's prerogative to make its own decisions on whether or not to use K!, 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 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 intervonors observe in the Federal policy is in the italicized statement 'The Federal position with... potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were rewordc:1 to state "it fpotassium 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 junsdictions who wish to incorporate KI as a protective action for the general public should consult with the State to determine if such arrangements are appropriate. If local governments have tre authonty 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.
\
A/0TE: .i ,eECK UIEE TWAT fc 15 lu%T THc couomorrcc ar.u. Tuc-flotLW is THAT TM KEY PMhSE 15 " T Hb th5(S Foe Tk C l%C (2 6 Co M Mcu t4T; d4C " - f . E' . ; C o$ r- 6 C AJr F e r TAC PN2 rife "UO AJE W I u Fort M WTs od " Is LMs Lv 7 ytsa co- y C o u TEkT. T T Ltlts T W l
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8 The full FRPCC endorsed the subcommittee's recommendations with some modifiestions.
Policy on Distribution of Ki Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent The purpose of this iLw is to provide Federal policy arid guidance with regard to distribution of KI, and its usage as a thyroid blocking agent, around operating nuclear power generating facilities. The issue has been addressed in terms of two components of I
the population that might require or desire KI use: (1) Emergency workers and l insatutionalized individuals close to the nuclear power plant site, and (2) the nearby general population. This guidance is for those State and local govemments who, within the limits of their authonty, need to consider these recommendations in the development of emergency plans and in determining appropriate actions to protect the general public.
g GIf& P'*N% ,
'p( Federal policy j( that K: should be stockpiled and distrbuted to emergency workers
. n ,
and institutionalized persores during radiological emergencies. In developing the range of ,
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.public protective actionspx severe accidents at commercial nuclear faciDties, the best '
%e kew technical information indicates that evacustion and in-piece sheltering provide adegumes
-=
9-
- f. ..-protection for the general public}However, the State (or in some cases, the local govemment) is ultimately responsible for the protection of its citizens. Therefore, the decision for local stockpiling and use of KI as a protective measure for the general public is left to the discretion of State ( or, irt some cases, locali gr.c.cr.r 7 )
betAuSe ,C fimbs Addifnand protcctro'u foter ilte idhde b I" for one. rndid'ow-stacitue orgAu, ne f by esiA 3 Wbca U S* ^
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ft is recognized that the State (or in some cases, the local govemment), within the limits of its authority, can take measures beyond thosehcommended c3regured[The availability of K! as a protective measure for the general public supplements other options for public officials responsibis for protective action decisions. A few States have indeed incbded K1 1
)
as a protective action for the general public. The FRPCC does not want to usurp the State !
I 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 govemment. is prepared to provide funding for the purchase of a supply of KI. 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 govemment is also required to prepare for a wider range of radiological emergencies8 . To that end, and as an added assurance, for radiological emergencies in which the location and timing of an emergency are unpredictable and for lituttd which, unlike licensed nuclear power plants, there is little planning possible,Jr stockpile of g wAt* A M~b_e.L_0f3.tl4 Atput A 1kt. U. C. Thest.
KI Kbeing established by the Federal govemmery This Federal stockpile,wul be available to any State for any type of radiological emergency, at any time.
The bases for these recommendations are given below.
sin roepense to new threses, the Federal govemment breedened the esepe of emereeney reopenas
_ 4 r to insiuele terronem, involving nuelser, beiseical, and ehemical egenes. As a residt, and in support of state and iscal sevemmema, new resources were leanimod is be needed in response to such events. About two dozen Metropeuten Medical strike Teams (MMsT) are being established for reseense se such events. Medoel supp6es, including KI, are being stockpiled nationally for the use by MMSTs in three locations: East enest, Central, and West seest. The quenoty of supplies stockpiled uses a plantene beeis of 100,000 people for a period of two eleys.
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 Kl during emergencies to emergency workers and to institutionalized individuals. Thyroid blocking for emergency workers and institutionalized individuals was recommended because 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 site is relatively small and requires a limited supply of K1 that can be readily distnbuted.
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 gkEs actions. It is well-recognized that the inclusion of Kl as a protective measure, in addition g , P. to evacuation and sheltering, is beneficial only in very remote circumstances. The use of Kl is not without controversy. On the one hand, K1 has been shown to be an effective c aaceq a3L kgpes yro. A.sm caused by the uptake of drug for protecting the thyroid fr% thyroid nodules,; =
radioiodine, especially in children fifteen years of age or younger. On the other hand, DV there are logistical difficulties, and potential medical side effects associated with the drug, l p5C68lf in distributing the drug to the general public in a radiosogical emergency. Also, K1
(
ff6 effectively reduces the radiation exposure of only the thyroid gland from ingested or J W Q4 inhaled radiciodines. While this in an important contribution to the health end safety of the (g4t#
sSnX fi[ individual, it is not as effective as measures which protect the total body. Both in-place
. Cf g-
) 4- p shottoring and precautionary evacuations can reduce the exposure to the thyroid add the gh g total body. It is very important to remember that the use of KI is not an effective means 6 ftlA d&N g(rih U ( GJ h h
' w$ ps.g.(tgmw\ q L su L 'a
9 by itself for protecting individuals from the radioactrvity in an airbome rvosse resulung from a nuclear power plant accident and, therefore, should only be considered in conjunction with sheltering, evacuanon, or other protective methods. Therefore, wtvie the use of KI can provide additional protecten in certain circumstances, the asasssment of the effectiveness of KI 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-specif*m, accalent-specific basis.
Those States or local govemments which opt to include Kl for the general population will be responsible for the maintenance, distributior. . and any subsequent costs associated with this program, e
The incorporation cf a program for K1 stockpiling, distributen and use by any state or local
! TMa govemment into the emergency plans will not be subject to Federal evaluation. This is kgf based on the recognition that the use of K1 by the State for the general public is a N (odU h supplemental protective measure, and on the Federal govemment's cletermination that the 66C pwd existing emergency planning and preparedness guidance for nuclear power plants is g ood 6 effective and adequate to protect the public heshh and safety. MO The FDA has evaluated the medical and radiological risks of administanng K1 for emergency conditions and has concluded that it is safe and effective and has approved over the-counter sale of the drug for this purpose. FDA guidance states that riska from the short term use of relatively low doses of K1 for thyroidal blocking in a radiological emergency are outweighed by the risks of radioiodine induced thyroid nodules or cancer at a projected
bW 10 e$
4.
'q4 g dose to the thyroid gland of 25 rem or greater. Since FDA has authorized the
@ 4WM nonpresenption sale of K1, it is available to individuals who, based on their own personal (A@ to 2 analysis, choose to have the drug immediately available. Qg' 2
u43 vo C
C Attached is a list of ten references intended to assist State and local authorities in gh3 o9:E.
decisbns related to the use of Kl. -
2u VT o QkQ 3 J D
" $4x 1 M d' k k R*% s i The FRPCC did not find any new information that would require a change in the basis of g j hJ ^$
the existing Federal policy concoming the stockpile or pre-distnbution of KI for the general grp kb !
public in the event of a radiological emergency at a commercial nuclear plant. The policy is M y i
- t- I that K! should be stockpiled and distributed to emergency workers and institutionalized N
[ I persons during radiological emergencies, but leaves the decision for the stockpiling, k {W 4 distnbution, and use of K1 for the general public to the discretion of State, and in some cases, local govr,mments. Any State or local govemment that selects the use of Kl as a -
protective measure for the general public may so notify FEMA and may request funding for the purpose of purchasing an adequate supply.
The inceipe..Gon of a program for Kl stockpiling, disvibution and use by any State or local ved LD govemment into the emergency plans wig set be subject to Federal evolus6on. This is (-- $6C 68 based on the recognition that the use of Ki by the State for the general public is a g60'J ogn ced supplemental protective measure, and on the Federal government's determiraten that the l
I
11 existing emergency planning and preparedness guidance for nuclear power plants is effective and adequate to protect the public health and safety. I Those States or local govemments which opt to include KI for the general population will be responsible for the maintenance, distribution, and any subsequent costs or legal liabilities associated with this program.
As an added assurance, for a broader range of radiological emergencies in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of Kl will be established by the Federal government. Such a stockpile would consist of individual K1 caches at VA hospitals in major metropokten centers across the country. This supply would be available to any State or local government for any type of radiological emergency.
References
- 1. National Council on Radiation Protection and Measures (NCRP), " Protection of the Thyroid Gland in the Event of Releases of Radiciodine," NCRP Report No. 55, August 1,1977.
- 2. Food and Drug Administration (HHS), Potassium lodide as a Thyroid-Blocking Agent in a Radiation Emergency,43 EB 58798, December 15,1978.
)
12
- 3. Halperin, J. A., 8. Shicien, S. E. Kahans, and J. M. Bilstad: " Background Material for the Development of the Food and Drug Administration's Recommendations on Thyroid Blocking with Potassium lodide," FDA 81-8158, U.S. Department of Health and Human Services (March 1981).
- 4. Food and Drug Administration; Potassium lodsde as a Thyroid Blocking Agent in a Radiation Emergency: Final Recommendations on Use (Notice of Availability) 47 fB 28158, June 29,1982).
l 1
- 5. Food and Drug Administration; Potassium lodide as a Thyroid-Biocking Agent in a Radiation Emergency: Recommendations on Use. (Apr01992). Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Admirustration, i Department of Health and Human Services.
b.6 Nuclear Regulatory Commission: Examination of the Use of Potassium lod 6de (KI) es an Emergency Protective Measure for Nuclear Reactor Accidents (NUREG/CR-1433,
.y March 1990). Prepared by Sandia National Laboratories for the NRC.
v i
- 7. Nuclear Reguistory Commission; An Analysis of Potassium lodido (KI) Mvh I 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. >
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13 8.. Nuclear Regulatory Commission; Re-Evaluation of Policy Regarding Use of Potassium lodide 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 lodido After a Severe Accident at a Nuclear i Power Pfant (SiECY-94 087, March 29,1994).
Signed:
l C. Megs Hepler, Ill l Chair Federal Radiological Preparedness Coordinating Commhtee i T UOU @ SUGEST Ab.D/Ng 7W $2p(sgating gcFestem
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. Peter G. Crane / 4809 Drummond Avenue / Chen Chase, MD 20215 / 301656 3999 00CKETED U54o,C i
November 12, 1997 Mr. John C. Hoyle, Secretary 77 NCV 13 A10:10 i ,
U.S. Nuclear Regulatory Commission Washington, D.C. 20555 OFj , r Mt
&"es I.. .,l .
-n Re: Amendment to Petition for rulemakina (PRM-50-63) -
Dear Mr. Hoyle:
On rereading my filing of earlier today (dated November 11), I find a minor editing error (two references instead of one to the Commission's SRM of June 30, 1997) in the third paragraph of the third page. Would you be so kind as to replace the third page with the attached correction? Otherwise the document is unchanged.
Thank you.
Sincerely, Dr' /
L I% LAAh'-
Peter G. Crane
Attachment:
corrected page 3 l
I t
l
- o. .. -
.IN RESPONSE, PLEASE REFER TO M971105A November 25, 1997 MEMORANDUM TO: L. Joseph Callan Executive Director for Operations FROM: John C. Hoyle /s/
SUBJECT:
BRIEFING ON PROPOSED RESOLUTION TO A PETITION FOR RULEMAKING RELATING TO USE OF POTASSIUM IODIDE (KI) FOLLOWING SEVERE ACCIDENT AT A NUCLEAR POWER PLANT, 9:35 A.M. WEDNESDAY, NOVEMBER 5, 1997, COMMISSIONERS CONFERENCE ROOM, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)
The Commission was briefed by representatives of the Federal Emergency Management Agency; by Mr. Peter Crane, author of a petition for rulemaking (PRM-50-63) on the use of potassium iodide (KI); and by the NRC staff regarding issues associated with a proposed change to the Federal policy on the use of KI as a protective measure for the general public following severe accidents.
The Commission indicated that it would temporarily defer action with respect to resolution of PRM 50-63 (SECY 97-245) and the draft Federal Register Notice on Federal KI Policy (COMSECY-97-028 pending submission by the petitioner of a revision to his petition reflecting the petitioner's comments at the meeting and the staff's subsequent evaluation of the impact of the revised petition on its recommendations as reflected in SECY 97-245.
(EDO) (SECY Suspense: 12/12/97)
-cc: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OIG Office Directors, Regions, ACRS, ACNW, ASLBP (by E-Mail)
, e Action: Collins, NRR/ Martin, AE
. /'pD Cico UNITED STATES CyS: Callan
!' 'k NUCLEAR REGULATORY COMMISSION Thompson f I wAssiscioN. o.c. 20sss Thadani i 'f Norry
]
/ Blaha j June 26, 1998 Bangart, SP -
OFFICE OF THE . Knapp NMSS w rrs S7 0on3 aghss Shelton, CIO tJamgochian, NF congel, AE00 MEMORANDUM TO: L. Joseph Callan Trottier, RES Ex ti Dire orforOperations FROM: J .
b--
yle ecretary
SUBJECT:
AFF REQUIREMENTS - SECY-97-245 and SECY-98-061 -
STAFF OPTIONS FOR RESOLVING A PETITION FOR RULEMAKING (PRM-50-63 AND 50-63A) RELATING TO A RE-EVALUATION OF THE POLICY REGARDING THE USE OF POTASSIUM IODIDE (KI) BY THE GENERAL PUBLIC AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT and COMSECY-97-028 - FEDERAL REGISTER NOTICE ON POTASSIUM IODIDE The Commission has disapproved the staffs recommendation to deny the petition for rulemaking and approved Option 1. As such, the staff should proceed with rulemaking to change 10 CFR 50.47(b)(10) by inserting the following sentence, or similar words, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, l sheltering, and, as a supplement to these, the prophylactic use of potassium *odide (KI), as appropriate." In addition, the Federal Reaister notice and the statements of considerations for j the proposed and final rules should be modified to include a statement to the effect that State l and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. The Federal Reaister notice should be reviewed by the Commission before the notice is given to the other relevant agencies for their review. The Commission notes that, consistent with the Commission's decision on the June 30,1997, SRM, the Federal governmer.t (most likely NRC) is prepared to fund the purchase of a stockpile of KI for the States upon request. The NRC staff should work with other relevant agencies to ensure that there are established procedures to enable the national stockpile to be effectively and timely used by states that have not established local stockpiles and wish to make use of the national stockpiles in the event of a severe nuclear power plant accident.
To assist the State and local decision makers, the staff should submit its paper, " Assessment of SECY NOTE: This SRM, SECY 98-061, SECY 97-245, COMSECY-97-028, and the Commission Voting Record for SECY 98-061 containing the vote sheets of all Commissioners will be made publicly available 5 working days from the date of this SRM.
BNct 2.
the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents," for public comment. Staff is encouraged to submit the assessment in whole, or in part, to peer reviewed joumals for publication.
Following receipt and evaluation of the public comments, the staff should revise the paper, as appropriate, subject to Commission review. Using this as a basis, the staff should complete and issue a user-friendly information brochure containing the essential data and analyses in the technical assessment attached to SECY 98-61 to assist State and local planners in reaching an informed decision as to whether Kl is an appropriate protective supplement.
(EDO)-(SECY Suspense: Draft Federal Reaister Notice W1W98- 7/8/98 9700193 "
(NRR/AEOD) Notice of proposed rulemaking 10/29/98 10/22/98 "
Issuance of final assessment report 10/29/98 10/22/98 Issuance of brochure no later than final rule) cc: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OlG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
i I
1
[7590-01-P]
a NUCLEAR REGULATORY COMMISSION i
10 CFR Part 50 RIN: 3150-AG11 Consideration of Potassium lodide in i
Emergency Plans AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing an amendment to its emergency planning regulations governing the domestic licensing of production and utilization facilities. The proposed rule would amend the current regulations to indicate that consideration shall be given to including potassium iodide (KI), along with sheltering and evacuation, as a supplemental protective measure for the general public. The proposed rule responds to l petitions for rulemaking submitted by Mr. Peter G. Crane concerning the use of Kl in emergency plans.
EFFECTIVE DATES: The comment period expires 90 days after publication in the Federal Reaister. Comments received after this date will be considered if practical to do so, but only those comments received on or before this date can be assured of consideration.
CNcaskAt 3
i
[7590-01-P]
ADDRESSES: Comments may be sent to the Secretary of the Commission, Attention:
Rulemaking and Adjudications Staff, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or may be hand-delivered to One White Flint North,11555 Rockville Pike, Rockville, MD '
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments received may be examined at the Commission's Public Document Room at 2120 L Street NW (Lower Level),
Washington, DC.
You may also provide commant via the NRC's interactive rulemaking web site on the NRC home page (http://www.nrc. gov). This site provides the availability to upload comments as files in any format that the NRC web browser supports. For information about the interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-6215; e-mail CAG @ nrc. gov.
FOR FURTHER INFORMATION CONTACT: Michael T. Jamgochian, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
Telephone: (301) 415-3224. Internet: MTJ1 @NRC. GOV.
SUPPLEMENTARY INFORMATION: l By undertaking this rulemaking, the Commission is proposing to grant two petitions for rulemaking (PRM-50-63 and 50-63A) from Mr. Peter Crane submitted on September 9,1995, l and November 11,1997.
Considering all public comments received, the information available in the literature, 20 years of experience gained in evaluating licensee emergency preparedness plans, and the arguments presented by the petitioner, the Commission has decided to grant the petition for rulemaking and to proceed with rulemaking to amend 10 CFR 50.47(b)(10) by inserting the following sentence, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate." In addition, the preamble for this proposed rule includes a statement to the effect that State and local decision makers, provided with proper information, may find that the use of K1 as a protective supplement is reasonable and prudent for specific local conditions. The Commission also noted that, consistent with the Commission's decision on June 30,1997, the Federal government (most likely the NRC) is prepared to fund the purchase of a stockpile of Kl for the States, upon request. The NRC staff will work to ensure that the process for States to obtain funding for Ki is established. The NRC staff will also work with other relevant agencies to ensure that there are established procedures to enable the national stockpile of KI, for terrorist activities, to be effectively and timely used by states that have not established local stockpiles and wish to make use of the nationa! stockpiles in the event of a severe nuclear power plant accident.
On November 27,1995 (60 FR 58256), the Nuclear Regulatory Commission (NRC) published a Notice of Receipt of a petition for rulemaking (PRM-50-63) filed by Mr. Peter G.
Crane on his own behalf. The petitioner requested that the NRC amend its regulations concerning emergency planning to include a requirement that emergency planning protective actions include the prophylactic use of potassium iodide (Kl), which the petitioner notes prevents thyroid cancer after nuclear accidents.
On November 11,1997, the petitioner submitted a revision to his original petition (PRM-50-63A). The NRC published a Notice of Receipt of the amended petition on December 17, 1997 (62 FR 66038). In the amended petition, the petitioner requested that:
A statement (be made) clearly recommending stockpiling of Kl as a " reasonable and prudent' measure, and; A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the 1
I
first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (KI), as appropriate."
The petitioner also provided a marked-up version of the proposed Federal Radiological
. Preparedness Coordinating Committee (FRPCC) Federal Register notice concerning Federal policy relating to the use of Ki for the general public.
On June 26,1998 (SRM 98-061), the Commission decided to grant the petition for rulemaking PRM-50-63A by directing the requested amendment to 10 CFR 50.47(b)(10). The Commission also directed that the preamble for the proposed rule include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions.
Petitioner's Basis for Requesting Potassium lodide The petitioner stated that potassium iodide (KI) protects the thyroid gland, which is highly sensitive to radiation from the radioactive iodine that would be released in extremely serious nuclear accidents. By saturating the gland with iodine in a harmless form, Kl prevents any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead i to thyroid cancer or other illnesses. The petitioner stated that the drug itself has a long shelf-life, at least 5 years, and causes negligible side effects.
The petitioner further stated that, in addition to preventing deaths from thyroid cancer, Kl prevents radiation-caused illnesses. The petitioner notes that thyroid cancer generally means surgery, radiation treatment, and a lifetime of medication and monitoring. The petitioner asserted that the changes in medication that go with periodic scans put many patients on a physiological and psychological roller coaster. The petitioner stated that hypothyroidism can 4
cause permanent retardation in children and, if undiagnosed, can condemn adults to a lifetime of fatigue, weakness, and chills.
The Petitioner's Discussion of the Threo Mile Island Accident (TMI)
The petitioner noted that in December 1978, the Food and Drug Administration (FDA) announced that it had determined that Kl was safe and effective for thyroid protection in nuclear j I
accidents. The petitioner stated that the issue attracted little attention, that the NRC and the
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Federal Government as a whole took no public position on the drug, and that three months after the FDA announcement, on March 28,1979, the TMI accident began to unfold. The petitioner stated that Federal and State officials, searching for supplies of Kl in case it should be needed, discovered that none was to be had and that a supply had to be manufactured, literally overnight. The petitioner indicated that at 3:00 a.m. on Saturday, March 31,1979, an FDA official arranged with the Mallinckrodt Chemical Company for the immediate production of 250,000 doses of Kl.
The petitioner also discussed the Report of the President's Commission on the Accident at Three Mile Island (the Kemeny Commission report), issued in October 1979, and stated that the report was strongly critical of the failure to stockpile Kl. The petitioner noted that among the Kemeny Commission's major recommendations was that an adequate supply of the radiation i protective agent, Ki for human use, should be available regionally for distribution to the general j population and workers affected by a radiological emergency.
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The Petitioner's Discussion of the Potassium lodide Policy i
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The petitioner stated that in NUREG-0632, "NRC Views and Analysis of the Recommendations of the President's Commission on the Accident at TMI," issued in November 1979, the NRC agreed with the findings of the Kemeny Commission and planned to require nuclear power plant licensees to have adequate supplies of Kl available for nuclear power plant workers and the i
general public as part of State emergency response plans.
According to the petitioner, the three agencies most concerned, the FDA, the NRC, and the Federal Emergency Management Agency (FEMA), favored the stockpiling of Kl for the next ;
several years. The petitioner stated that the Atomic Industrial Forum, a nuclear industry trade association, declared itself against the stockpiling of Kl in May 1982.
The petitioner indicated that the NRC staff was strongly in favor of Kl stockpiling as late as September 27,1982, when the NRC staff submitted a memorandum to the Commissioners proposing that the Commission agree with a draft interagency policy statement supporting Kl 1
stockpiling. The petitioner further stated that on October 15,1982, less than 3 weeks after j sending the draft policy statement to the Commission for approval, the NRC staff sent a supplementary memorandum withdrawing the memorandum of September 27. The later-memorandum informed the Commissioners that NRC's Office of Nuclear Regulatory Research (RES) could, by January 1,1983, produce a paper showing that Kl was significantly less cost -
beneficial than previously assumed. The NRC staff proposed sending this document to the FDA and FEMA with the recommendation not to stockpile and distribute Kl. The petitioner l indicated that the NRC staff briefed the Commission in November 1983 on the NRC staff's proposal to take a strong position against Kl. A policy statement was later issued that disposed of the Kemeny Commission's recommendation in favor of stockpiling Kl. According to the petitioner, only a year later, the Chernobyl accident would give tangible proof of the value of the drug in radiological emergencies.
The Petitioner's Discussion of the Effectn of Chernobyl The petitioner stated that during the Chernobyl accident of 1986, the damaged reactor spewed radioactive iodine over a wide area of what was then the Soviet Union and Poland. The petitioner further stated that in Russia, the Ukraine, and Belarus, where the distribution of KI j
i was inadequate and untimety, the population in these countries is now experiencing extraordinarily high levels of childhood thyroid cancer. However, in Poland, where Kl was 4
admir.istered to 97 percent of the nation's children, there has been no similar increase in thyroid 1
cancer. The petitioner noted that Poland is a proof-positive example of the benefits of a j well-prepared Kl program.
The petitioner stated that the U.S. Government is spending money to study radiation-caused thyroid cancer in the Ukraine and Belarus, and the Department of Energy (DOE) announced a $15 million,15-year program that will follow 70,000 children in the Ukraine, to understand the thyroid cancer risk of exposure to radioiodine. The petitioner further stated that the U.S. Government has spent generously to bring Ukrainian doctors to the United States for training in thyroid surgery because mishandled operations can result in damaged nerves l and larynxes, rendering patients permanently mute.
The petitioner discussed post-Chernobyl developments on Kl policy. He stated that the Chernobyl accident demonstrated that Ki worked and that countries that failed to stockpile and distribute it are experiencing serious public health problems.
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The Petitioner's Discussion of the NRC's Reconsideistion of Potassium lodide 1
I The petitioner notes that in June 1989, the NRC reconsidered the Kl issue after the 1 petitioner filed a differing professional opinion urging a change in policy. On November 27, 1989, the American Thyroid Association wrote to the NRC urging Kl stockpiling on a nationwide basis and, in 1990, the NRC announced that it was reconsidering the existing Federal puiicy. In April 1992, a contractor under the sponsorship of the NRC Office of Nuclear Regulatory Research issued a report that included a revised cost-benefit analysis of the use of Kl. The petitioner described the report as concluding that stockpiling Kl continued to be not cost-effective, but that the difference between costs and benefits was narrower than had been calculated by the NRC staff in the early 1980s. The petitioner further indicated that, in December 1993, an industry trade group, the Nuclear Utility Management and Resources Council, sent a report entitled " Review of Federal Policy on Use of Potassium lodide," to the Commission arguing against any change in current Kl policy.
The petitioner noted that, in March 1994, the NRC staff declared its support for Kl stockpiling. However, the NRC staff proposal for a change in policy was not adopted, the Commissioners having voted 2 to 2 on the staff's proposal in May 1994. (Under Commission procedures, a tie vote means that a proposal fails.)
The Petitioner's Discussion of Additional Suppor1 for Granting the Petition for Rulemaking The petitioner described a September 1994, FEMA publication proposing a " Federal Radiological Emergency Response Plan" that envisioned the use of Kl during radiological emergencies. Under the plan, the NRC would be the lead Federal agency during emergencies
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at nuclear power plants and would advise State and local governments whether or not to distribute Ki (based on advice received from an interagency panel). The States and localities would then administer the KI, if necessary.
The petitioner also indicated that the Board of Governors of the International Atomic Energy Agency, with U.S. Govemment support, adopted new International Basic Safety Standards in 1994. The petitioner stated that these standards represented the consensus of the world's experts on radiation safety and the standards provide, among other things, that intervention levels of immediate protective actions, including sheltering, evacuation, and iodine prophylaxis, shall be specified in emergency plans. Thus, the petitioner stated, the international radiation protection community, like the Kemeny Commission in 1979 and the short-lived draft Federal policy statement of 1982, recognized that effective preparedness for radiological emergencies means having three actions to consider [ evacuation, sheltering and iodine prophylaxis].
The Petitioner's Discussion of the Merits of the Petition for Rulemaking The petitioner believes the NRC should implement the recommendation of the Kemeny Commission and that the United States should maintain the option of using the drug Kl for public thyroid protection during nuclear accidents. The petitioner requested that the Commission definitively review and decide on the issue rather than simply having the NRC staff decide not to propose it to the Commission.
The petitioner stated that evacuation is not necessarily the protective measure of choice in every emergency, and even when it is the preferred option, it is not always feasible. The Kemeny Commission report explained that d:.;erent types of accidents, and the particular circumstances presented, may call for different protective measures. The petitioner notes that
maintaining a Kl option ensures that responsible authorities have the option of additional protection at their disposal.
The petitioner indicated that NRC has made it clear that a finding of adequate emergency planning does not translate into a guarantee that the entire affected public can be evacuated, but that evacuation is generally feasible.
The petitioner believes that sometimes, either by choice or necessity, authorities may decide to shelter people or tell them to remain indoors rather than evacuate them. The petitioner points out that it may be desirable to administer Kl any time people are sheltered or told to stay indoors, when evacuation routes would take people through areas of radiological contamination, and when there has been a large airborne release of radioactive iodine to the atmosphere.
The petitioner believes that the decision on stockpiling Kl should turn on whether, given the enormous consequences of being without it in a major accident, the drug is a prudent measure; not on whether it will necessarily pay for itself over time. The petitioner further believes that Ki represents a kind of catastrophic-coverage insurance policy offering protection l
for events which, while they occur only rarely, have such enormous consequences that it is sensible to take special precautions.
The petitioner stated that the estimates of Kl's cost-effectiveness depend on estimates that are no more than informed guesses about the probability of severe accidents and that the NRC's cost-benefit analysis of the early 1980s was based on the assumption that a severe accident with a major release of radioactivity could occur in this country oniv once every 1 or 2 thousand years.
The petitioner believes that if it were really true that serious accidents with a release of radioactivity were so unlikely, there would be good reason not only to reject stockpiling of Kl but also to dispense with all emergency planning. The petitioner also stated that if K1 is not
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a
l cost-effective, then the rest of nuclear emergency planning is probably not cost-effective either.
l The petitioner believes that cost benefit analysis is a technique that should be applied 1
with good sense, especially where public health measures are concerned. According to the l
petitioner, the cost-benefit analysis of Kl proceeded from the assumption that there was no difference in desirability between prevention of radiation-caused thyroid disease and cure.
Thus, the only factor to be considered in evaluating Kl was the cost. The petitioner also believes that the U.S. Government determined that instead of spending money to prevent radiation-caused thyroid disease, society should spend its money treating the disease if and when it occurs.
The petitioner believes that the existing policy on Kl was defective from the start because it was based, in part, on inaccurate information provided to the NRC Commissioners.
He stated that the information provided to the NRC Commissioners seriously understated the l
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c significance of radiation-caused thyroid disease and thereby understated to an equal degree I the value of Kl.
The petitioner also believes that it was not clear that the Commission had any idea of the real nature of post-accident thyroid disease at the time it adopted an anti-Kl position.
The petitioner stated that existing policy left the judgment on stockpiling Kl to the States.
The petitioner asserts that this policy also ensures that the States uo not have an adequate basis for making informed decisions. He believes that the Federal Government, and NRC in particular, has failed to provide the States with sound technical advice on the subject. The petitioner also believes that without accurate and current information on Kl--including the Chemobyl experience and the consensus of international experts--States cannot make an informed judgment.
The petitioner believes that no State or local official or member of the public could imagine that in a real emergency, there would be no KI to administer. The petitioner raised the question: If Kl stockpiling is not worthwhile, why is the administration of the drug one of the protective measures identified in the 1994 Federal Emergency Response Plan? He also asked why, if Kl is worthwhile, as the plan implies, something is not being done to make sure that it is available.
The petitioner believes that the Federal Government should either change the 1985 '
policy and make the use of Kl a viable option in a real emergency, or it should explain why the United States has decided that Kl will not be an option.
The Petitioner's Proposed Amendment to the NRC Regulations in the original petition (PRM-50-63) that was submitted on September 9,1995, the petitioner requested that 10 CFR Part 50 be amended to include !angence t 'oen from FEMA's Federal Radiological Emergency Response Plan of September 1994, and recommended the following revision to the regulations.
The petitioner proposed that Section 50.47(b)(10) be amended to read as follows: I I
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(10) A range of protective actions includina shelterino, I evacuation and orochvlactic use of iodine have been j developed for the plume exposure pathway EPZ (emergency j planning zone) for emergency workers and the public.
Guidelines for the choice of protective actions dunng an l
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emergency, consistent with Federal guidelines are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale hsve been developed.
1 In the revised petition (PRM-50-63A) that was submitted on November 11,1997, the i
petitioner requested that 10 CFR 50.47(b) be revised to read:
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(10)' A range of protective action have been developed for the plume exposure EPZ for emergency workers and the public. In develooina this ranae of actions. consideration has been oiven to evacuation. shelterina. and the prochviactic use of Dotassium iodide (Kl). as aooropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidelines, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed.
The petitioner believes that if this revised change is adopted, the plan wif. become an accurate description of emergency preparedness for radiological emergencies; the l
recommendation of the Kemeny Commission will at last be implemented; and the United States will be in compliance with the intemational Basic Safety Standards.
The petitioner suggested that the NRC, either on its own or jointly with other agencies, issue a policy statement declaring that K1 stockpiling is a reasonable and prudent measure that is necessary to ensure that the drug will be available in the event of a major accident. The
. . 1 petitioner believes that this statement would clarify that Kl can be used in conjunction with evacuation and sheltering to maximize protection to the public. )
The petitioner also believes that the policy statement would show the willingness of the NRC to provide a stockpile of the drug to States and localities upon request, and would support l
the Kemeny Commission's recommendation to create regional stockpiles of the drug as a backup for emergencies.
Discussion I
Stockoile of Medicinal Suoolies for Nuclear. Bioloaical. and Chemical Aaents (1995)
In June 1995, the President issued Presidential Decision Directive 39 (PDD-39) on U.S.
Policy on Counter Terrorism. The PDD-39 directed Federal agencies to take a number of measures to reduce vulnerability to terrorism, to deter and respond to such acts, and to strengthen capabilities to prevent and manage the consequences of terrorist use of nuclear, biological, and chemical (NBC) weapons, including weapons of mass destruction. The PDD-39 assigned to FEMA the task of ensuring that the Federal Response Plan (FRP) was adequate to respond to the consequences of terrorism.
FEMA, in coordination with the Catastrophic Disaster Response Group (CDRG)',
developed a draft report to the President entitled,"An Assessment of Federal Consequence Management Capabilities for Response to Nuclear, Biological or Chemical (NBC) Terrorism,"
dated June 12,1996. The report recommended, among other things, that the Federal j
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Govemment purchase and stockpile thyroid blocking agents (Kl) for the general public that
'The CDRG is the headquarters senior-level coordinating group which addressees policy issues regarding the Federal Response Plan (FRP). The CDRG is enaired by FEMA and comprises representatives of Federal departments and agencies with responsibilities under the FRP. The NRC is represented by the incident Response Division Director, AEOD.
e l'
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could be used in the event of a nuclear terrorist event. The NRC was a member of the Core Group which generated the recommendations and was instrumental in adding Kl to the list of medical supplies to be stockpiled nationally.
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l The Core Group concluded that as the result of recent events, significant threats over )
the past few years, and the increased availability and proliferation of NBC materials, there is an j increasing concern for the potential of terrorist incidents, NBC events, the report continued, l
may occur as a local event with potentially profound national implications. In responding to these events, the first responders must be able to provide critical resources to the victims. '
l These include, but are not limited to, chemical nerve antidotes, vaccines for anthrax, and antibiotics. The Core Group identified the need to purchase and preposition stockpiles of adequate medical supplies at the Federal, State, and local level. While Kl was not considered as vital as chemical nerve antidotes and vaccines, the NRC staff was successful in getting Kl l included with other medical supplies for NBC events because of the unusual characteristics of l
l these events.
Because of the special characteristics of NBC events, the Core Group recommended a.
t broader range of protective actions. The NRC concurred in the findings of the report in a letter l .
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dated September 25,1996, from the Director of NRC's Office of Analysis and Evaluation of Operational Data to FEMA's Director. The report was subsequently presented to the President in February 1997, and approved for distribution in May 1997.
FRPCC Subcommittee on KI (1996L Atong with petitioning the NRC, Mr. Crane also requested that FEMA review his petition and reconsider the Federal policy. In early 1996, the FRPCC convened an Ad-Hoc Subcommittee on Potassium lodide to request and review new information on this matter from !
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interested parties. The subcommittee conducted a public meeting on June 27,1996. The subcommittee evaluated all comments from the June 27 public meeting and made the following recommendation regarding the Federal Kl policy:
- 1. Without changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether to use Kl, the Federal Government (NRC, or through FEMA) should fund the purchase of a stockpile for a State that decides to incorporate K1 as a protective measure for the general public;
- 2. The Subcommittee believes the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many intervenors observe with the Federal policy is the italicized statement "The Federal position with... potassium iodide for use by the general public is that it should not be ;
required." It would not be as negative if the last phrase were reworded to state "it (potassium iodide for use by the general public) is not required, but may be selected as a protective measure at the option of the State or, in 1
some cases, local governments." l
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- 3. The subcommittee recommends that local jurisdictions '
that wish to incorporate KI as a protective action for the l
- , .. I general public should consult with the State to determine if these arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need 1o include this measure in their emergency plans.
Analysis of lasues Raised by Public Comments On November 27,1995 (60 FR 58256), a Notice of Receipt of the Petition for Rulemaking was published in the Federal Reaister requesting public comment. A total of 63 comment letters were received, of which 20 utilities, 9 State governmental agencies,2 utility interest organizations,1 letter signed by 12 health physicists,2 State universities and 1 member of the public were against the granting of the petition for rulemaking. Those letters in favor of granting the petition came from 5 environmental groups,22 members of the public (including 1 from the petitioner), and the American Thyroid Association.
On December 17,1997 (62 FR 66038), the Commission published a request for public comment on the revised petition in the Federal Register. In response to several requests, the comment period was extended until February 17,1998, by a Federal Register notice published on January 21,1998 (63 FR 3052). A total of 82 comment letters were received, of which 13 utilities,3 State governmental agencies,1 utility interest association, and 1 member of the public were against granting the petition for rulemaking. The letters in favor of granting the petition came from 8 public interest groups,46 members of the public (including 1 from the petitioner),3 physicians,2 U.S. Senators, and 1 State Representative. The following issues were raised by the public commenters with an accompanying Commission response:
Issue 1
- Nearly all nations with nuclear power protect their citizens by having Kl readily available and the logistics of distribution do not seem to pose any significant problems. Would implementing a policy of using Kl for the general public be so difficult?
Commission Resoonse At the November 5,1997, Commission meeting', senior NRC staff members told the Commission: "We recognize that there are difficulties in distribution, but they are not insurmountable. If a decision is made by the State to do it [ stockpile and/or predistribute -
Kl] we can figure out a way to do it. It is the Commission's perception that if the State -
decides to include Kl as a supplemental protective measure for the general public, one possible method of implementation could be that the State could make Kl readily available where other over-the-counter drugs can be purchased. The public could be informed of the drug's availability through the yearly emergency preparedness information brochure that is mailed out to all residents throughout the 10 mile EPZ. It would then be up to individual members of the public to obtain and store this supply of KI, which should then be available for use in the event of an emergency. The administration of the Kl could be at the direction of the State Medical Officer.
Issue 2 it is " factual that the 1986 Chernobyl accident clearly demonstrated the benefit of having Kl readily available, in Poland, where authorities expediently administered 18 million a ____ -__
doses of KI,97 percent of all Polish children were protected from thyroid disease. In contrast, there are soaring rates of childhood thyroid cancer,200 times pre-Chernobyl levels, in the former Soviet republics of Russia, Belarus, and the Ukraine because very little Kl was administered, too long after exposure."
Commission Resoonse The Chernobyl reactor (a RBMK-1000 design) is located in the Ukraine close to Belarus.
The accident occurred at 01:23 on Saturday,26 April 1986, when explosions destroyed the reactor core and reactor building. The explosions sent debris from the core flying into the air and exposed the reactor core to the atmosphere. The heavier debris from the plume was deposited close to the site. In general, the initial release is thought to have risen to over 1 km in altitude, thereby resulting in much lower doses close to the site than those expected from a ground level release. The major release lasted 10 days, during which most of the noble gases and more than 40 percent of the iodines are estimated to have been released. The varying meteorological conditions, release rates, and release heights resulted in very complex dose and ground deposition patterns.
It is often assumed that ingestion was the major source of thyroid dosc early in the accident. However, the contribution of inhalation cannot be assessed because air sampling was not effectively conducted early in the accident. As of 1996, except for thyroid cancer, there has been no confirmed increase in the rates of other cancers, including leukemia, among the first responders, liquidators,2 or the public, that have been attributed to release from the accident.
Belarus Experience. With the Chernobyl plant located only 4 miles (7 km) away, Belarus was heavily impacted by the accident. This impact was heightened by the fact that protective actions were not implemented in Belarus during the first six days after the accident.
Several authors have stated that Kl was distributed to the population in Belarus during the first week following the accident. However, there is no confirmed published data on the dosage, coverage, or other details concerning the implementation of the thyroid blocking in Belarus.d in addition, cows typically grazed in Belarus at the time of year when the accident occurred, and yet no efforts were taken to restrict the consumption of contaminated milk for the first 10 days following the accident.
On May 2 (day 7 following the accident) the decision was made to evacuate the areas of Belarus and Ukraine within 18 miles (30 km) of the plant (30 km zone). The evacuation was completed on May 5,1986.
Since 1990, a rapid increase has been observed in the incidence in thyroid cancer among Belarus children who were O to 14 years old at the time of the accident. Before the accident, the rate of thyroid cancer among this cohort was about 0.4 per 100,000; by 1996, this 8 '
Liquidators are a large number (about 200,000) of workers and military personnel who performed cleanup, construction of the sarcophagus, and other operations in the contaminated zones following the accident.
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' Personal communication, E. Buglova M.D., Head Laboratory of Radiation Hygiene and l Risk Analysis, Ministry of Health, Republic of Belarus, December 1997.
" Thyroid Cancer in Children Living Near Chernobyl, Expert Panel Report on the Consequences of the Chemobyl Accident"- Williams D. et al., K.H. ECSL-EAEC, Report EUR 15248 EN, Brussels-Luxembourg,1993, p.108.
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rate had risen to 3.9 per 100,000.58 This included approximately 3,000 children, O to 18 years old, that were evacuated from the 30-km zone within Belarus. Among this group, four thyroid cancer cases have been detected since the accident. All of these cases were registered after the end of the latent period for radiation-induced thyroid cancer. Taking into account the spontaneous rate of this disease in this age group and the number of evacuated persons, all of these cases are considered accident-induced.
The total number of excess cancers in Belarus children is currently about 750, and is estimated to reach a maximum of more than 3500 over the lifetime of this cohort.8^* The vast majority of the thyroid cancers were diagnosed among those living more than 50 km (31 miles) from the site.
The increase in the rate of thyroid cancers in Belarus is concentrated among those who were youngest at the time of the accident. Fortunately, these cancers respond favorably to early treatment; to date, two or three of the Belarus children diagnosed with thyroid cancer have died as a result of that disease.'
Poland Experience. Poland detected increased levels of airborne radioactive contamination on the night of April 27,1986 (day 2). Although there was no official notification of the accident by the USSR, it was assumed, on the basis of Tass News Agency reports, that the increase were attributable to the accident at Chernobyl. On April 28 (day 3), the country formed a governmental commission to recommend protective actions. Among these actions, 5E. Buglova et al., " Thyroid Cancer in Belarus After the Chernobyl Accident; incidence, Prognosis, Risk Assessment." Low Doses of lonizing Radiation: Biological Effects and Regulator Control, Spain, November 1997, Contributed Paper, pp. 280-284.
'" Thyroid Cancer Incidence Rate in the Republic of Belarus." Okeanov A. et al.,
Radiation and Risk Bulletin of National Radio-Epidemiological Registry, Obninsk.,1995, Issue 6,pp.236,239.
the commission recommenced intervention levels for taking protective actions on the morning of April 29 (day 4).7 On April 29, Poland's Minister of Health gave orders to prepare and distribute KI to the 11 provinces most affected. Ki was to be made available through hospitals, public health centers, schools, and kindergartens. The country used its mass media to announce the protective action and to appeal for volunteers to assist in the nationwide distribution.
The Commission then instituted the following additional protective meases:8 Feeding of cows on pastures or with fresh fodder was banned countrywide until May 15,1986.
Fresh milk with radioactivity concentration above 1,000 Bq/L was banned for consumption by children and pregnant or lactating women.
Al! children under the age of 4 were given powdered milk through numerous distribution centers.
Children and pregnant or lactating women were advised to eat a minimum of fresh leafy vegetables (until May 16,1986).
The distribution of Ki was initiated on April 29 (day 4) and was virtually completed by May 2 (day 7). This included the distribution of Kl to more than 90 percent of the children under the age of 16 and about a quarter of the adults. A total of 10.5 million doses of Kl were given to children and 7 million doses were given to adults. Multiple doses, although not recommended, were taken in a number of cases. Because of diminishing air contamination, the Ki prophylaxis was not repeated. In the second phase of the response, powdered milk was made available to all children less than 4 years of age. This program effectively started on May 3 (day 8).
l 1
It is estimated that approximately a 40-45 percent reduction in thyroid burden was I
achieved by thyroid blocking and milk restrictions in the 11 provinces treated.7 Had the Russian authorities given prompt warning, the 24- or 48-hour gain in time might have improved the f
effectiveness of their response.
There were no reported serious adverse reactions except for two adults with known iodide sensitivity. About 36,000 medically significant reactions were also reported (mostly nausea). Because of the low lodine concentrations in Poland it is doubtful that epidemiological studies could detect excess cancers resulting from intake of radioiodine.a International Practices - During this assessment, the NRC staff examined the current ,
policies and practices regarding the use of thyroid blocking during Nuclear Power Plant i
l accidents for a number of countries. The NRC staff accomplished this task primarily through personal communication with colleagues in each country. In general, the countries either are following or intend to implement systems that are consistent with the guidance promulgated by the World Health Organization (WHO) Specifically, the WHO recommends predistribution of stable lodine close to the site and stockpiles further from the site. These stocks should be strategically stored at points such as schools, hospitals, pharmacies, fire stations, or police stations, thereby allowbg prompt distribution. A further description of the WHO guidance is provided below, followed by a discussion of the guidance promulgated by lAEA and a comparison between U.S. and international practice.
7 The implementation of Short-term Countermeasures After a Nuclear Accident, Proceeding of an NEA Workshop Stockholm," Sweden,1-3 June 1994, OECD 1995.
' Manual on Public Health Actions in Radiation Emergencies, WHO, European Center of Environmental and Health, Rome Division,1995.
World Health Organization (WHO) Guidance. The main points of the WHO Guidelines'* regarding the use of stable iodine are as follows:
Near field: Stable iodine should be available for immediate distribution to all groups if the predicted thyroid dose is likely to exceed national reference levels. Close to nuclear installations iodine tablets should be stored or predistributed to facilitate prompt utilization.
Far field: Stable iodine should be available for distribution to pregnant women, neonates, infants, and children if the predicted dose is likely to exceed reference levels.
Conclusion from Polish Experience. (1) Small amounts of radioactive iodine were deposited in Poland as a result of the Chernobyl accident, (2) no protective actions were taken for the first 2 days of the accident, and (3) protective actions (except sheltering or evacuation) were taken after the first 2 days of the accident. Because of the low iodine concentrations in Poland and the protective actions implemented, Poland has not detected excess cancers resulting from intake of radioiodines.
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Overall Chernobyl Conclusion. The World Health Organization, almost every industrial country in the world with nuclear power plants, and the American Thyroid Association, believe that the low lodine concentrations, the banning of the consumption of fresh milk and the di.stribution and administration of 90 million doses of Kl contributed to the observed lack of
' International Basic Safety Standards for Protection Against lonizing Radiation and for Safety of Radiation Sources, Safety Series No.115, IAEA,1996.
"" Method for the Development of Emergency Response Preparedness for Nuclear or (
Radiological Accident," Tecdoc-953, IAEA, July 1997. 'I increase of childhood thyroid cancers in Poland. Most industrial nations with nuclear power plants have decided to stockpile Ki around nuclear power for use by the general public.
In the event of an accident in the United States, our emergency planning calls for protective actions, (sheltering, evacuation, and removal of contaminated food from consumption) that would significantly reduce the risk to the public. Making Kl available to the public for use during evacuation could, under certain conditions, reduce the risk further.
One public commenter articulated the conclusion of the Chernobyl experience by stating:
"Early arguments against the stockpiling of Kl for use in such an event have focused on the issues of possible toxicity from widespread use of potassium iodide, the difficult logistics of early distribution of Kl and the question of cost / benefit ratio. Although all of those arguments have some cogency, the recent Chernobyl experience has nullified their pertinence. To date, over 1200 children in the Chernobyl area have developed papillary thyroid cancer requiring major medical intervention. Although the certainty of the fallout initiation of these cancers cannot be fully confirmed until current dose assessment studies are completed, the remarkable coincidence and extraordinarily high incidence of this rare tumor in the Chernobyl area is convincing enough to require some action."
"The concern about significant toxicity from potassium iodide in emergency blocking doses has been made moot by the extensive Polish experience where 18 million individuals received prophylactic potassium iodide with overall toxicity of .2 percent (mostly nausea) but with only a fraction of 1 percent having serious side-effects.
Current packaging of Ki in Europe has appeared to resolve the problems about shelf life and the blister packing that is used in Sweden is 'certainly effective and inexpensive.
There are admittedly problems in effective and complete rapid early distribution and certainly in 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 serious disrupting effect upon the life of the individual and such effect cannot be minimized."
"The simplicity of having available a simple, inexpensive agent that can greatly lower the likelihood of this disease occurring is a fact that cannot be overlooked. Indeed, Kl will not decrease whole body radiation and evacuation clearly is an optimal initial response to an accident, but it is not always 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 percent
l j
l 1
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."
lasue 3
" 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 commercial nuclear power plants. Our emergency plans focus on evacuation as the key protective action to prevent exposure j since it protects against exposure to all radionuclides, not just iodine. In addition, the potential for misadministration of Kl is present when predistributed to the general public, {
and incidents of misadministration have been informally reported at industry meetings by states which predistributed Kl to the public."
Commission Resoonse l
The Commission agrees that it is the State's prerogative to decide to include stockpiling or predistribution of Ki as a protective action for the general public. The FDA concluded that risks from short term use of relatively low doses of Kl are out weighed by the I i
radiologically induced thyroid modules or cancers at a projected dose to the thyroid gland of 25 rem or greater. In so doing, the FDA approved Kl as an over-the-counter drug. The American Thyroid Association fully endorses the use of Kl and, as previously discussed, there were only 2 significant adverse reactions and 36,000 medically significant reactions (nausea) in 90 million doses of Kl after the Chernobyl accident.
The taking of Kl should require precautions similar to those associated with any other over-the counter drug, and, of course, the packaging instructions should be followed.
I . .
I l
issue 4
" Evacuation is more feasible and practicable. Stockpiling of Kl has logistical problems which we feel renders this idea impracticable and unmanageable."
l Commission Resoonse:
The Commission agrees that evacuation is usually Measible and practicable" and is most effective protective action. If the State decides to include Kl as a supplemental protective measure for the general public, one possible method of implementation could be that the State could make Kl readily available where other over-the-counter drugs can be purchased. The public could be informed of the drug's availability through the yearly emerg6ncy preparedness information brochure that is mailed out to all residents throughout the 10 mile EPZ. Individual members of the public would be responsible for obtaining and storing this supply of KI, which could then be availab!e for use in the event of an emergency. Other approaches to predistribution could include stockpiling at reception centers for distribution during an evacuation. Other countries have found ways to effectively distribute Kl when needed and the distribution issue is certainly not unsurmountable. The administration of the Kl should be at the direction of the State Medical Officer.
Issue 5 The Three Mile Island experience has shown us that it is not easy to obtain an adequate supply of Kl in an emergency. <
l 27-i
Commission Resoonse:
The commenter is correct, in that it was difficult to obtain Kl after the Three Island accident. However, with the limited Federal stockpile of Kl for terrorist events and the willingness of the Federal Government to provide a stockpile of Kl for any State that decides to use it as a supplemental protective measure for the general public, the Commission believes that an adequate supply of Kl could be obtained.
Issue 6 Even though Kl administration before any exposure is ideal, the Chernobyl experience also has shown that the exposure can continue for days. Is the institution of Kl blockade at any time in this period beneficial?
Commission Resoonse The administration of Kl is most effective if done before or immediately after (within 2 to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />) a release. Nonetheless, during a chronic exposure of several days, the administration of KI any time during the exposure period may block some uptake of radioactive lodine. However, the benefit diminishes quickly over time and may be very small if administered late. If a release is expected to continue for several days, the NRC anticipates that the public would be evacuated or other protective action would be taken, depending on the level of release. Kl could nevertheless serve as a useful supplemental and complement to these primary protective actions.
n i
Issue 7 KI is an effective thyroid blocking agent only when administered immediately before or l 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.
L l
l l Commission Resoonse l
The Commission disagrees with this position. If a State chooses to include Kl as an additional protective measure, it is anticipated that the State could make Kl readily available to the public where other over-the-counter medicines are available or by other distribution means and that the public be made aware of its (the KI) availability, not at the time of an emergency, but Kl could be made available year round.
Issue 8 One of the major impediments to duribution of Kl to school children is coordination and administration of the program, e.g., the actual decision making process to administer Kl or evacuate, parental approval and recordkeeping, identification and documenting allergic reactions, and the availability of a qualified medical professional to administer the potassium iodide.
Commission Resoonse The Commission disagrees. Upon declaration of a general emergency there should be NO decision "to administer Kl or evacuate." The preferred protective action for the close-in population should be evacuation. The administration of Kl should be treated in the same fashion as any other over-the-counter medication that enight be given to children while away from home, after observing the instructions provided with the Kl packaging. Prior parental approval to administer Kl in the event of an emergency can and should be addressed in the planning process for any State that decides to use Kl.
The individual State may provide the appropriate guidance and establish a system for obtaining parental approval before the taking of other protective actions that are currently being followed in the EPZ around nuclear power plants.
Issup 9 Does the post-Chernobyl Polish experience show that large-scale deployment of Kl is safe?
Commission Resoonse Approximately 18 million doses of Kl were distributed primarily, but not exclusively, to children. The bulk of the distribution took about three days. There were no reported serious adverse reactions except for two adults with known iodide sensitivity. The rate of serious side effects (10'7)is consistent with the frequency seen during routine use of Kl for medical treatment of respiratory disease. The incidence of medically significant, but not serious, reactions to this single dose of Kl was also very low (0.2 percent). In addition, no detectable long-term disturbance in children's thyroid function was detected as of 1989. Additionally, the FDA has approved Ki for over-the-counter distribution.
The Commission, therefore, agrees that the post-Chernobyl experience has shown that large-scale deployment of Kl is relatively safe.
Issue 10 l
t Several comments raised the question of liability: "Is the NRC prepared to address the number of legal implications should a member of t'he general public be given Kl at their i directive or recommendation and the individual have an extreme allergic reaction, possibly death?; ""The Federal Register Notice does not address legal issues for states who decide to adopt Kl and states who do not decide to adopt or administer Kl to the public."; "The issue of legalliability should not be dismissed lightly. If the NRC decides to require stockpiling of Ki for the general public, has NRC considered what liability may arise from any adverse health effects? No initiative such as this should be undertaken i
without resolution of this issue."; "Who would assume liability if the Kl was used prior to the Governor ordering its use?"
Commission Resoonse:
i The comments focus principally on concems that State and local governments involved in distribution and administration of Kl may be liable in tort if an individual receiving the !
Kl has a significant adverse medical reaction to the Kl. To the extent that commenters
- are raising the potential for federal government liability for the promulgation of this proposed rule, the NRC believes that whether the Commission may be subject to tort liability through the implementation of a KI program depends upon a number of factors.
However, it would appear that a Commission decision to require State and local emergency planning officials to consider stockpiling Kl for public distribution should be subject to the " discretionary. function" exception to the Federal Tort Claims Act,28 USC 2671, et seq.," which protects the Federal Government from liability. The question of whether a State of locality might be liable for involvement with administration of K1 to the general public can only be answered by reference to the laws and precedents of particular States. The NRC presumes that this would be part of the " consideration" that States and localities will undertake if this rule is promulgated. The NRC has not undertaken this analysis.
Issue 11 Does the NRC staff consider stockpiling and using Kl as a reasonable and prudent protective measure for the general public?
"This exception from waiver of sovereign immunity provides that:
Any claims based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or
. perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the diceretion involved be abused.
28 USC 2680(a). United States v. Varig Airlines,467 U.S. 797,808 (1984); Berkovitz v.
United States,486 U.S. 531 (1988).
Commission Resoonse The Commission considers that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement to evacuation and sheltering is reasonable and prudent for specific local conditions.
The 1998 proposed Federal Policy on use of Kl as an emergency preparedness measure for commercial nuclear power plant accidents is being developed by the FRPCC. FEMA plans to publish this policy in the Federal Register in early 1999, nonetheless, it currently is proposed to state that:
The revised Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons for radiological emergencies, but leaves the decision on whether to stockpile, distribute and use Kl for the general public to the discretion of State and, in some cases, local governments. Any State or local government that selects the use of Kl as a protective measure for the general public may so notify the appropriate FEMA Regional Director, and may request funding for the purpose of purchasing a supply. The Federal offer to fund purchases of Kl for the States represents an explicit recognition that this medicine can, under certain conditions, supplement other protection measures and thereby enhance protection of the public. State and local governments that opt to include Kl as a protective measure for the general public will be responsible for preparing guidelines for its stockpiling, maintenance, distribution and use. State and local governments may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished. It should also be noted that medical supplies, including KI, will be stockpiled in 27 metropolitan areas and in three national stockpiles across the country in support of State and local government response to emergencies caused by acts of terrorism involving nuclear, chemical and biological agents. For radiological emergencies resulting from any cause, including accidents at commercial nuclear power plants, this additional stockpile can be acquired ad hoc by State or local government officials if they determine its use would be beneficial.
Commission Decision On June 26,1998, the Commission decided to grant the petition for rulemaking.
Accordingly, the NRC staff was directed to proceed with rulemaking to change 10 CFR l
l 1
1
50.47(b)(10) by inserting the following sentence, after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium iodide (KI), as appropriate." In addition, the preamble for the proposed rule was to include a statement to the effect that State and local decision makers, provided with proper information, may find that the use of Kl as a protective supplement is reasonable and prudent for specific local conditions. The Commission also noted that, consistent with the Commission's decision on June 30,1997, the Federal government (most likely the NRC) will fund the purchase of a stockpile of Kl for the States upon request. The Commission also diruded the NRC staff to work with other relevant agencies to ensure that there are established procedures to enable the national stockpiles to be effectively and timely used by States that have not established local stockpiles and wish to make use of the national stockpiles in the event of a severe nuclear power plant accident.
The Commission decision is implemented by publication of this proposed rule that would change 10 CFR 50.47(b)(10) with a 90-day public comment period. If the proposed ruk, is adopted in final form, the petition would be granted 6nd NRC action would be completed on PRM 50-63 and PRM 50-63A.
Commission Conclusions or Issues Raised by the Petitioner and Public Commenters t
The Commission agrees with many of the issues raised by the petitioner and the public l
commenters. The commission has reached the following conclusions: i A. The Commission agrees that Kl, if adrainistered in a timely fashion, could protect the thyroid gland from exposure to radioiodines inhaled or ingested following a major radiological accident. This is the basis for stockpiling it and distributing it to emergency workers and institutionalized persons during radiological emergencies. The petitioner believes that the 34 -
distribution of Kl was inadequate and untimely in the Ukraine and Belarus after the Chernobyl accident in 1986 and that this accounts for the increased incidence of thyroid cancer in these areas. He also argues that distribution of Kl in Poland was timely and effective and that no similar increase in the incidence of thyroid cancer was seen. The Commission considered all of the above information in deciding to grant the petitioner's requested actions.
B. The Kemeny Commission criticized the failure to stockpile Kl and recommended that regional stockpiles be established. The Kemeny Commission's report recognized that evacuation was not invariably the preferred response to an emergency and that even when evacuation was desirable, it might not be feasible. The Commission believes that prompt evacuation and/or sheltering are the generally preferred protective measures for severe reactor accidents. In developing the range of public protective actions for severe accidents at commercial nuclear power plants, evacuation and in-place sheltering provide adequate protection for the general public. The Commission believes that Kl for the general public should not replace evacuation and sheltering, but supplement them.
C. The Federal Radiological Emergency Response Plan (FRERP) is the plan that would be used by the Fedeial Government to support State and local officials in responding to any peacetime radiological emergency. Such emergencies range from transportation accidents involving redioactive materials to terrorist events involving nuclear materials. The FRERP includes a range of protective actions commensurate with the risks associated with the range of emergencies for the general public and emergency workers. These protective actions include evacuation, sheltering, and the prophylactic use of stable iodine. With respect to protective actions for nuclear power plants, the NRC and FEMA have issued Draft Supplement 3 to NUREG-0654/ FEMA-REP-1, Rev.1, to provide updated guidance for the development of protective action recommendations for severe reactor accidents. This l
O
document emphasizes that prompt evacuation is the preferred protective action for actual or projected severe core damage accidents.
D. The Commission recognizes that in 1994 the Board of Governors of the IAEA adopted new International Basic Safety Standards. With respect to emergency planning, these standards provide, among other things, " intervention levels for immediate protective action, including sheltering, evacuation, and iodine prophylaxis." It is important to note that each country bases its response plans on local and regional characteristics. For example, Italy and France, using the same intemational standards and guidelines, implement them differently, E. The Commission agrees with the NRC staff estimate that the purchase of Kl tablets is inexpensive. KI-related costs increase when the cost of maintenance, distribution, and public education are considered.
- F. The Commission believes that NBC medicinal stockpiles should provide assurance to States and local governments that a limited Federal stockpile of Ki is available, if needed.
Commission aooroval to fund Kl:
On June 30,1997, the Commission voted to approve the NRC staff recommendation to endorse the FRPCC recommendations for the Federal Government to fund the purchase of potassium iodide (KI) for States at their request and endorsed the FRPCC recognition of the availability of the Federal stockpile of Kl to State and local governments for purposes of mitigating the consequences of terrorist use of nuclear, biological, or chemical (NBC) weapons. '
Under this endorsement, the Federal Government would fund the purchase of Kl, and State and local governments would be responsible for maintenance, distribution, and subsequent costs. As part of their emergency response planning, NRC licensees should discuss this matter y eth State and local governments that make decisions on protective measures in planning for responses to emergencies.
36 -
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Findings Metric Policy On October 7,1992, the Commission published its final Policy Statement on Metrication.
According to that policy, after January 7,1993, all new regulations and major amendments to existing regulations were to be presented in dual units. The amendment to the regulations contains no units.
ENVIRONMENTAL ASSESSMENT AND FINDING OF NO SIGNIFICANT IMPACT FOR GRANTING THE PETITION FOR RULEMAKING RELATING TO THE USE OF POTASSIUM IODIDE (KI)
- 1. Introduction On September 9,1995, a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl.
In SECY 97-245, dated October 23,1997, the staff provided three options for the Commission's consideration in order to resolve PRM 50-63.
On November 5,1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resolving the petition for rulemaking. During the meeting, the Commission invited the petitioners to submit a modification to his petition in order to address views he discussed during the meeting.
On November 11,1997, the petitioner submitted a revision to his petition PRM 50-63A, which requested two things:
- 1. A statement clearly recommending stockpiling of KI as a " reasonable and prudent" measure, and
- 2. A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (KI), as appropriate."
On June 26,1998, the Commission directed the staff in SRM 98-061 to grant the petition for rulemaking PRM 50-63A by revising 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in response to this directive.
Alternatives were essentially considered in previous documents. In SECY-97-124 (June 16,1997), on the " Proposed Federal Policy Regarding Use of Potassium lodide after a Severe Accident at a Nuclear Power Plant." The staff identified three options, one of which contained three sub-options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (KI) as a protective measure for the general public during severe reactor accidents. Next, in an SRM dated June 30,1997, the Commission approved an option that endorsed the Federal offer to fund the purchase of Kl for States at their request and endorsed Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local governments of the Federal stockpiling of Kl.
38 -
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ll. Need for Action l
in SECY-97-245, the staff proposed options for resolving the referenced petition for rulemaking. In SRM 98-06, the Commission directed the staff to proceed with the rulemaking.
Ill. EnvironmentalImpact of the Proposed Action The environmentalimpacts of the proposed action and its alternative are considered negligible by the NRC staff. Given the proposed action would only add the sentence:"In developing th:s range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium ic. tide (Kl), as appropriate." The staff is not aware of any environmental impact as a result of this proposed action.
IV. Alternative to the Proposed Action The alternative to the proposed action at this time is to deny the petition and require no action with respect to the use of Kl by the public. Should this no-action alternative be pursued, the staff is not aware of any resulting environmental impact.
V. Agencies and Persons Consulted Cognizant personnel from the Federal Emergency Management Agency were consulted, i
as was the petitioner, as part of this rulemaking activity, s
VI. Finding of No Significant Impact:: Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the amendments are not a major Federal action significantly affecting the quality of human environment, and therefore, an environmental impact statement is not required. This amendment will require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl. This action will not have a significant impact upon the environment.
Paperwork Reduction Act Statement This proposal rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995 (44 U.S.C 3501 et seq.). Existing requirements were approved by the Office of Management and Budget (OBM) approval numbers 3150-0009 and 3150-0011.
Public Protection Notification w
if an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
Regulatory Analysis of the Proposed Rulemaking Granting Petitions for Rulemaking (PRM 50-63 AND 50-63A) Relating to the Use of Potassium lodide (KI)
On September 9,1995, a petition for rulemaking (PRM 50-63) was filed with the NRC by Mr. Peter Crane. The petitioner requested that the NRC amend its emergency planning regulations to require that emergency plans specify a range of protective actions to include sheltering, evacuation, and the prophylactic use of Kl.
In SECY 97-245, dated October 23,1997, the staff provided three options for the Commission's consideration in order to resolve PRM 50-63.
On November 5,1997, the Commission was briefed by the NRC staff, the Federal Emergency Management Agency (FEMA), and the petitioner regarding the options available for resolving the petition for rulemaking. During the meeting, the Commission invited the petitioners to submit a modification to his petition in order to address views he discussed during the meeting.
On November 11,1997, the petitioner submitted a revision to his petition PRM 50-63A, which requested two things:
{
A statement clearly recommending stockpiling of Kl as a " reasonable and prudent"
' measure, and i
A proposed rule change to 10 CFR 50.47(b)(10) which would be accomplished by ]
inserting the following sentence after the first sentence: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic us of potassium iodide (KI), as appropriate."
On June 26,1998, the Commission directed the staff in SRM 98-061 to grant the petition for rulemaking PRM 50-63A by revising 10 CFR Part 50.47 (b)(10). This proposed rulemaking is in response to this directive.
Altematives were essentially considered in previous documents. In SECY-97-124 (June 16,1997), on the " Proposed Federal Policy Regarding Use of Potassium lodide after a Severe Accident at a Nuclear Power Plant." The staff identified three options, one of which contained three sub-options, concerning a proposed change in the Federal policy regarding the use of potassium iodide (KI) as a protective measure for the general public during severe reactor accidents. Next, in an SRM dated June 30,1997, the Commission approved an option that endorsed the Federal offer to fund the purchase of Kl for States at their request and endorsed Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local governments of the Federal stockpiling of Kl.
In SECY 97-245, the staff proposed options for resolving the referenced petition for rulemaking. In SRM 98-03, the Commission directed the staff to proceed with the rulemaking.
Given the Commission considered the options and directed the staff to grant the petition, the only attematives considered here are the Commission approved option and the baseline, no-action alternative.
The proposed rulemaking does not " require" anything of licensees, but States are to have shown " consideration" of the use of Ki along with evacuation and sheltering as protective actions. It is estimated that 30 States will need to make this consideration. Further, the staff estimates that the labor needed by the States could range from a staff-week, to a half staff-year. The latter being the case if a State decided to hold hearings on the issue.
If one assumes an average hourly salary of $70 (this estimate includes benefits, pro-rated secretarial and managerial assistance, but not overhead), the range of estimates would be from $2800 to $63,000. Again using a base of 30 States, the range is from $84,000 to $1.9 million.
It is difficult to estimate the benefit of a State's consideration to stockpile Kl. However, we believe the benefit of such an action by the States is summed up by the petitioner who stated that the decision to stockpile Kl should turn on whether, given the enormous consequences of being without Ki in a major accident, the drug is a prudent measure; not on whether it will necessarily pay for itself over time. As the petitioner further noted, Kl represents
l I
a kind of catastrophic-coverage insurance policy offering protection for events which, while they -
l occur only rarely, can have such enormous consequences that it is sensible to take special precautions, especially where, as here, the cost of such additional precautions is relatively low.
As stated above, this analysis focuses on the rule being proposed as the result of a petition. Also, since the Commission has directed the staff to pursue the FRPCC results with respect to Kl and has directed the staff to pursue the rulemaking, the regulatory analysis presented here is for the edification of the decision makers so they can make an informed decision on the proposed rule.
The above constitutes the regulatory snalysis for this action.
Regulatory Flexibility Certification in accordance with the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Commission hereby certifies that this rule, if adopted, will not have a significant economic impact on a substantial number of small entities. This proposed rule would affect only the licensees of nuclear power plants. These licensees, do not fall within the scope of the definition 1
of "small entities" set forth in the Regulatory Flexibility Act. 5 U.S.C. 601, or the size standards i
adopted by the NRC (10 CFR 2.810).
Backfit Analysis The definition of backfit, as set forth in 10 CFR 50.109(a)(1), is clearly directed at I obligations imposed upon licensees (and applicants) and'their facilities and procedures.
Section 50.109(a)(1) defines a backfit as:
. . . the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility, any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previously applicable staff position . . . .
Section 50.109 is replete with referenco to " facilities" and " licensees," which in their totality make clear that the rule is intended to apply to actions taken with respect to nuclear power plant licensees and the facilities they operate. See Section 50.109(a)(7),"If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written licensee commitments . . . then ordinarily the applicant or licensee is free to choose the way that best suits its purposes [ emphasis added]." This focus on i
licensees and their facilities is further confirmed by the Statement of Considerationn j l
accompanying the backfit rule, 53 FR 20603 (June 6,1988), where the Commission stated l that backfitting "means measures which are intended to improve the safety of nuclear power reactors . . . ." 53 FR at 20604. The nine factors to be considered under 10 CFR 50.109(c) further make clear that the rule is aimed at requirements on licensees and facilities. These include:"(2) General description of the activity that would be required by the licensee or acolicant in order to complete the backfit; . . . (5) Installation and continuing costs associated
)
with the backfit, including the cost of facility downtime or the cost of construction delay; [and] (6)
The potential safety impact of changes in plant or operational complexity. . . . [ emphasis added)"
The proposed rule imposes no new requirements on licensees, nor does it alter l procedures at nuclear facilities. Rather, it is directed to States or local governments -- the entities with the authority to determine the appropriateness of the use of Kl for their citizens --
calling upon the governments to tonsider" Kl as one of the elements of their offsite emergency planning. Even as to states or local governments, it imposes no binding requirement to alter plans and procedures. Furthermore, the basic standard that emergency planning must include consideration of a range of protective actions, is already set forth in the existing wording of section 50.47(b)(10). On this basis, the proposed rule in reality does not impose new i
requirements on anyone. On a consideration of all of the above factors, no backfit is involved l
and no backfit analysis is required.
Commission precedent also makes clear that the proposed rule change does not constitute a backfit. The Commission's position was stated explicitly in 1987, when the last major change took place in emergency planning regulations. 52 FR 42078 (Nov. 3,1987). The Commission's final notice of rulemaking on this rule involving the " Evaluation of the Adequacy of Off-Site Emergency Planning for Nuclear Power Plants at the Operating License Review Stage Where State and Local Governments Decline to Participate in Off-Site Emergency Planning" stated that the emergency planning rule change in question "does not impose any new requirements on production or utilization facilities; it only provides an alternative method to l
1 meet the Commission's emergency planning regulations. The amendment therefore is not a backfit under 10 CFR 50.109 and a backfit analysis is not required." 52 FR at 42084. Likewise, when the Commission altered its emergency planning requirements in 1987 to change the timing requirements for full participation emergency exercises (a change that, as a practical matter, could be expected to result in licensees' modifying emergency preparedness-related procedures to accommodate exercise frequency changes), it stated: "The fins' rule does not modify or add to systems, structures, components or design of a facility; the design approval or 2
manufacturing license for a facility; or the procedures or organization required to design, construct, or operate a facility. Accordingly, no backfit analysis pursuant to 10 CFR 50.109 is
l i
l required for this final rule." 52 FR 16828 (May 6,1987). The instant proposed emergency )
I planning rule change is of a similar nature and similarly does not involve a backfit. l i
lt has been argued by at least one commenter on the petition for rulemaking that, although licensees are not directly burdened by the proposed rule, they would be indirectly burdened because they would feel called upon to explain the new policy to their customers. By
{
l this logic, almost any Commission action that led an NRC licensee to issue a press release
]
could be considered a backfit. Such a position would represent unsound law and policy. Here, the burden of public information on licensees or applicants, if any, appears de minimis. It I plainly does not rise to the level of the type of concrete burden contempleted by the Commission when ;t onacted the backfit rule. It might also be argued that, if a State or local government were to decide to stockpile and use KI for the general public, it would undertake interactions with the affected licensee to ccordinate offsite emergency planning. Although this could reruit in some voluntary action by the licensee to coordinate its planning, the proposed rule itself does not impose any requirement or burden on the licensee. Accordingly, the Commission concludes that the proposed rule, if adopted, would not impose any backfits as defined in 10 CFR 50.109.
List of Subjects 10 CFR Part 50 Antitrust, Classified information, Criminal penalties, Fire protection, Intergovemmental relations, Nuclear power plants and reactors, Radiation protection, Reactor siting criteria, i
Reporting and recordkeeping requirements.
For the reasons set out in the preamble and under the authority of the Atomic Energy l l
Act for 1954, as amended, the Energy Reorganization Act of 1974, as amended, the Nr" >nal 6 i Environmental Policy Act of 1969, as amended, and 5 U.S.C. 553, che NRC is proposing to adopt the following amendment to 10 CFR Part 50.
1 l
PART 50--DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES l
l
- 1. The authority citation for 10 CFR Part 50 continues to read as follows:
Authority: Secs.102,103,104,105,161,182,183,186,189,68 Stat. 936,938,948, 4
953,954,955,956, as amended, sec. 234,83 Stat. 444, as amended (42 U.S.C. 2132,2133, 2134,2135,2201,2232,2233,2239,2282); secs. 201, as amended,202,206,88 State.
1242, as amended 1244,1246, (42 U.S.C. 5841, 5842, 5846).
Section 50.7 also issued under Pub. L.95-601, sec.10,92 Stat. 2951, as amended by Pub. L. 102 - 486, sec. 2902,106 Stat. 3123, (42 U.S.C. 5851). Sections 50.10 also issued under secs. 101,185,68 State. 936,955, as amended (42 U.S.C. 2131,2235); sec. 102, Pub. L. 91 - 190,83 Stat. 853 (42 U.S.C. 4332). Section 50.13,50.54(dd), and 50.103 also issued under sec.108,68 Stat. 939, as amended (42 U.S.C. 2138). Sections 50.23, 50.35,50.55, and 50.56 also issued under sec.185,68 Stat. 955 (42 U.S.C. 2235). Sections 50.33a,50.55a and Appendix Q also issued under sec.102, Pub. L.91-190,83 Stat. 853 (42 U.S.C. 4332). Sections 50.34 and 50.54 also issued under Pub. L.97-415,96 Stat. 2073 (42 U.S.C. 2239). Section 50.78 also issued under sec.122,68 Stat. 939 (42 U.S.C. 2152).
Sections 50.80,50.81 also issued under sec.184,68 Stat. 954, as amended (42 U.S.C.
2234). Appendix F also issued under sec.187,68 Stat. 955 (42 U.S.C. 2237).
- 2. In 9 50.47, paragraph (b)(10) is resised to read as follows:
9 50.47 Emergency plans.
l -
-(b)
(10) A range of protective actions have been developed for the plume exposure pathway EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and, as a supplement to these, the prophylactic use of potassium lodide (KI), as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidance, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed.
Dated at Rockville, Maryland, this day of .1998.
For the Nuclear Regulatory Commission.
John C. Hoyle Secretary of the Commission s c l
l June 16, 1997 SECY-97-124 E9.B: The Commissioners FROM: L. Joseph Callan Executive Director for Operations
SUBJECT:
PROPOSED FEDERAL POLICY REGARDING USE OF POTASSIUM IODIDE AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT PURPOSE:
To provide the Commission with options concerning a proposed change in the Federal policy regarding the use of potassium iodide (KI) as a protective measure for the general public during severe reactor accidents.
SUMMARY
As part of the Federal effort to reevaluate the Federal policy on Ki based on a reque::t by a petitioner, the Federal Radiological Preparedness Coordinating Committee (FRPCC) adopted
- recommendations that would result in a revised Federal policy statement. NRC staff has participated in the FRPCC activities and has worked closely with the Federal Emergency Management Agency (FEMA) in this area. l There are three options that can be taken with regard to the FRPCC recommendations:
(1) recommend no change in the existing Federal policy, (2) recommend the adoption of the FRPCC recommendations, with the added recognition of recent developments regarding medicinal stockpiles for nuclear, biological, and chemical events, or (3) recommend modifications to the FRPCC recommendations.
l CONTACT: Frank J. Congel, AEOD NOTE: TO BE MADE PUBLICLY AVAILABLE WHEBN (301)415 7476 THE FINAL SRM IS MADE AVAILABLE i
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The Commission l The staff recommends either option 2 or option 3(b). In light of the fact that this is a national policy issue, Commission guidance is requested.
BACKGROUND:
Federal Policy on Kl (1985)
The current Federal guidance to State and local governments on the distribution of KI was promulgated in 1985 by FEMA in its capacity as Chair of the FRPCC (50 ER 30285) and as the Federal agency charged with establishing policy and providing leadership via the FRPCC s (44 CFR 351 Subpart C). The FRPCC was established in accordance with 44 CFR Part I 351 to coordinate all Federal responsibilities for assisting State and local governments in emergency planning and preparedne=s for peacetime radiological emergencies.
Federal agencies which participate in the FRPCC are: Federal Emergency Management Agency (FEMA), Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA), Department of Health and Human Services (HHS), Department of Energy (DOE),
Department of Transportation (DOT), Department of Agriculture (USDA), Department of Defense (DOD), Department of Commerce (DOC), Department of Interior (DOI), Department of State (DOS), Department of Veterans Affairs (DVA), General Services Administration (GSA), National Communication System (NCS), and National Aeronautics and Space Administration (NASA).
The 1985 Federal policy recommends the stockpiling or distribution of Kl during emergencies for emergency workers and institutionalized persons, but does not recommend requiring pre-distribution or stockpiling for the general public. It recognizes, however, that options on the distribution and use of Kl rest with the States. Hence, the policy statement permits State and local governments, within the limits of their authority, to take measures beyond those recommended or required nationally.
DPO (1989) in 1989, Peter G. Crane, a member of the NRC staff, filed a Differing Professional Opinion (DPO) which alleged that there were deficiencies in the original cost-benefit analysis (NUREG/CR-1433) provided to the FRPCC by the NRC. The DPO suggested that the staff discussion at a November 1983 Commission briefing on Kl might have left Commissioners and members of the public with insufficient understanding of the adverse consequences (thyroid disease) that the use of Kl could avert. The DPO also suggested that the cost-benefit analysis, by simply balancing the dollar costs of a Kl program against the dollar costs of treating radiation-caused thyroid illness, did not adequately consider the non-monetary costs of an illness.
In SECY-91-321, the DPO panel developed a simplified analysis of the value and impact of the K1 policy, including revisions to several factors used in NUREG/CR-1433. The panel concluded that no change in the Federal policy was warranted. However, in order to consider all of the issues raised by the DPO and incorporate new data, the Office of
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The Commission Nuclear Regulatory Research performed a detailed update of the NRC's Kl policy basis, taking into account both qualitative and quantitative factors.
The staff presented its recommendation to resolve the DPO in SECY-93-318 (November 23,1993) and SECY-94-087 (March 29,1994). The staff recommended that the NRC, in coordination with HHS and FEMA, revise current Federal Kl policy as a matter of prudency to make KI available to the States. The Commission's vote on the above staff recommendation was split 2 to 2 (SRM dated May 6,1994). Thus, the policy remained unchanged.
American Thyroid Association's Reanest and Establishment of Kl Subcommittee (1989)
In September 1989, the American Thyroid Association (ATA) submitted a letter to the Chairman of the FRPCC requesting that the Committee reconsider the issues involved in stockpiling Kl. The ATA proposed that:
"As best as can be determined at this time, no substantial stockpile of potassium iodide is available for public use.
Despite the unlikely event of an emergency requiring its use, the ATA believes that the option of potassium iodide distribution should be available for consideration to those responsible for public health measures. To this end, the ATA believes that it would be prudent to have available at central locations a suitable stockpile of KI for possible distribution should its use be contemplated."
In response, the FRPCC established an Ad Hoc Subcommittee on Potassium lodide and asked the HHS to review the medical and clinical status of the use of Kl. In an initial response, HHS reviewed the then current scientific literature on K! and its use as a blocking agent. HHS reported to the FRPCC in February 1990 that no new scientific data had been found that would affect the basis for tne 1985 guidance to refrain from stockpiling or predistributing Ki for the public. To ensure a more comprehensive review, HHS also decided to solicit new data, scientific opinions, and reports on the experience of States concerning KI use and distribution.
HHS convened a meeting of experts on July 24,1990 in Atlanta, Georgia.
Representatives of the State and Federal agencies responsible for medical research, drug regulation, and radiological emergency response, representatives of medical associations, and nationally recognized experts in the fields of endocrinology and nuclear medicine attended. Daniel A. Hoffman, Ph.D, M.H.P., Assistant Director f~ Science, Center for Environmental Health and injury Control, Centers for Disease Control chaired the meeting.
Following the experts' meeting, HHS made the following recommendations to the FRPCC in October 1990:
The Commission 1. The 1985 FRPCC guidance need not be changed at this time since no compelling evidence to support a modification was presented.
- 2. Existing stores of Ki should be inventoried. The FDA would determine the locations and size of Kl supplies by identifying large customers of Kl manufacturers'. The FRPCC should request that the Conference of Radiation Control Program Directors identify appreciable supplies of Kl within the States by surveying State Radiation Control Programs.
- 3. The FRPCC should establish a working group to address the issue of stockpiling.
Group objectives should be to:
e Review and catalog type, location, and expiration of existing suitable supplies of Kl.
e Review and determine feasibility of specific stockpiling recommendations i made by meeting participants. I e Make final recommendations to FRPCC on U.S. Government Kl stockpiling policy.
The FRPCC Subcommittee on Ki followed up on these recommendations. L i
An Analysis of Kl for the General PM in the Event of a Nuclear Accident Under the sponsorship of NRC's Office of Nuclear Regulatory Research, S. Cohen & ,
Associates completed a report entitled, "An Analysis of Potassium lodide (KI) Prophylaxis l for the General Public in the Event of a Nuclear Accident" in April 1992. The analysis was updated and published in February 1995 (NUREG/CR-6310).
The analysis, whose central objective was to conduct a cost-benefit analysis of Kl, assigned monetary values to thyroid health effects. The report addressed not only the scientific aspects of the use of Kl but also the economic costs and benefits to society.
The. report indicated that a fair evaluation of K1 cannot be limited to an assessment of the cost-benefit ratios, but must include a thorough understanding of how these ratios were derived.
I
' According to FEMA, the FDA inquiry conducted in late 1996 showed that Carter Wallace, one of the largest manufacturers of KI, had an inventory of 70 cases of Kl. Each case contains 1000 bottles. Each bottle contains 14 tablets, a 14-day supply. According to this inquiry, Carter Wallace can manufacture 40-50 cases a day if necessary Roxanne, another manufacturer of KI, has an unknown inventory of liquid Klin 30 mi bottles.
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The analysis utilized the technicalinsights from both the National Academy of Sciences,
)
BEIR V Committee (NAS 1990) and the National Council on Radiation Protection and Measurements (NCRP 1987) regarding iodine and thyroid dosimetry.
The analysis also addressed the effectiveness of Kl. According to the analysis, given the rapid uptake of iodine (radioactive or stable), there is a limited benefit of Kl administration following exposure to radioiodines. For Kl to serve as an efficient blocking agent, the report continued, it must be administered in sufficient quantities before or concurrently with radioiodine exposure.
This report estimated the cost / benefit ratio of stockpiling Kl prophylaxis as a function of estimated population within radial distances from a plant. The results M this analysis showed that the cost-benefit ratio ranged from 2.222 for populations within 5 miles to 81.8 for populations within 50 miles. This means that for the O- to 5-mile population cell,
$2.22 would be spent for stockpiling Kl in order to avoid the economic equivalent cost of
$1.00. For the O- to 50 mile population cell, $81.8 would be spent to avoid the economic i
equivalent of $1.00. The cost-benefit ratios for population cells increased nearly exponentially with distance. l j
As basis for the cost benefit analysis, the authors used four accident categories postulated for the Surry nuclear power plant as described in NUREG-1150. The analysis used the accident consequence code to calculate the thyroid doce to individuals as a function of age, gender, and distance. For the worst case that us analyzed, the whole body doses close to the plant at the plume centerline were high t. tikely to be fatal 3 Doses !
decrease with distance and away from the plume centerline. Within 5 miles, where the cost-benefit ratio for stockpiling Kl was estimated to be 2.22, the whole body doses may still exceed thresholds for early health effects
- for which administration of Kl is ineffective. !
It was precisely such insights that led to the NRC's recommendation for prompt evacuation of areas close to the plant and five miles downwind as the preferred protective action. ,
This guidance is contained in NUREG-0654 Rev.1 Supp. 3 entitled Criteria for Protective '
Action Recommendations for Severe Accidents published in July 1996.
State Survey (19941 in June 1993, the April 1992 report was provided to the representatives of FEMA and HHS who co-chaired the FRPCC Potassium lodide Subcommittee. The subcommittee reported on the NRC-sponsored analysis at a meeting of the FRPCC in September 1993. It recommended initiating two studies to secure State input on implementation strategies for providing Kl to the public: t1) request the Conference of Radiation Control Program
'In SECY-94-o87, the staff applied correction factort, to tne cost. benefit ratios and produced a modified ratio of 11 instead of 2.2.
' Assuming no protective actions, such as evacuation or sheltering.
The health effects include nausea, f atigue, vomiting, epilation, diarrhea, and hemorrhage.
The Commission .
Directors (CRCPD) to survey those States with nuclear power plants for opinions regarding Federal purchase and stockpiling of Kl and regarding the feasibility of States providing Ki to the public under emergency conditions and (2) request the International Atomic Energy Agency to provide information on existing plans and procedures from member nations related to the storage, distribution, and dosage of Kl. The latter study, which involved the IAEA, was never conducted. The first study, which consisted of a survey of States in connection with a Federal purchase and stockpiling of Kl, was completed in mid-1994. All 32 States with nuclear power plants responded, as well as 11 States without plants. In general, the responses were as follows:
X.M .N_lg I
Does your Ftste favor a Federal Kl Stockpile?
- States with nuclear power plants 7 25 j l
- States without nuclear power plants J _8_
Total 10 33 The primary reason given by States for not supporting Federal purchase and stockpiling of KI was that the State policy did not include Kl as a protective measure for the general public. The State use of Kl was specified only for emergency workers. Many States emphasized that the distribution of Ki to the general public would be difficult in the event of a radiological emergency. The difficulty stems from logistical challenges presented for timely distribution of Kl to permanent and non-permanent populations and the liabilities associated with the misuse of Kl.
Of the 10 States that supported the Federal purchase and stockpiling of KI, one State preferred one centrally located national stockpile, four preferred Federal regional stockpiles, and five preferred a stockpile within their State.
l In early 1995, the FRPCC subcommittee was prepared to recommend that:
- 1. The FRPCC Federal Policy on Distribution of Potassium lodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent (50 FR 30258), should not be changed.
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- 2. The Federal government should not purchase and stockpile Kl for use by the public.
The basis for these recommendations were:
- 1. The results of the State survey,
- 2. The 1992 NRC cost benefit study,
- 3. The lack of new data challenging the 1985 guidance on Ki stockpiling,
- 4. The lack of justification that the subcommittee could find for a Federal stockpile, and
The Commission .
5.
The lack of support for such an initiative by the States and the primary Federal regulatory agency (FEMA).
However, FEMA did not issue the results of these findings because of a petition for reconsideration.
Petition for P= dam =kina (19951 On September 9,1995, Mr. Crane, who filed the DPO, filed a petition for rulemaking (PRM-50-63) with the NRC as a private citizen. He requested that the NRC amend its emergency planning regulations to require that emergency planning protective actions include sheltering, evacuation, and the prophylactic use of Kl. The request would amend one of the 16 planning standards in 10 CFR 50.47, which licensees' and offsite agencies' emergency plans are required to meet, in order to assure that the option of using K1 is included in emergency plans.
The staff's resolution of the petition is currently under consideration. The implications of the policy options on the petition are discussed later.
Stocknile of "MLW Se==as for NeWr . Blatoona=L and Chen:M A=.6 (1007,1 in June 1995, the White House issued Presidential Decision Directive 39 (PDD-39) on US Policy on Counterterrorism. The PDD-39 directed the Federal agencies to take a numbcr of measures to reduce vulnerability to terrorism, to deter and respond to such acts, and to strengthen capabilities to prevent and manage the consequences of terrorist use of nuclear, biological, and chemical (NBC) weapons including weapons of mass destruction. The PDD-39 assigned to FEMA the task of ensuring that the Federal Response Plan (FRP) was adequate to respond to the consequences of terrorism.
FEMA, in coordination with the Catastrophic Disaster Response Group (CDRG)", developed a draft report to the President entitled, "An Assessment of Federal Consequence Management Capabmties for Response to Nuclear, Biological or Chemical (NBC) Terrorism,"
dated June 12,1996. The report recommended, among other things, that the Federal government purchase and stockpile thyroid blocking agents (KI) for the general public that could be used in the event of a nuclear terrorist event. The NRC was a member of the Core Group which generated the recommendations and was instrumental in adding Kl to the list of medicinal supplies to be stockpiled nationally.
5 The CDRG is the headquarters-senior-level coordinating group which addressees policy issues regarding the Federal Response Plan (FRP). The CDRG is chaired by FEMA and comprises representatives of Federal departments and agencies with responsibilities under the FRP. The NRC is represented by the incident Response Division Director, i
l
The Commission The Core Group concluded that as the result nf recent events, significant threats over the past few years, and the increased availability and proliferation of nuclear, biological, or chemical materials, there is an increasing concern for the potential of terrorist incidents.
NBC events, the report continued, may occur as a local event with potentially profound national implications. In responding to these events, the first responders must be able to provide critical resources to the victims. These include, but are not limited to, chemical nerve antidotes, vaccines for anthrax, and r.ntibiotics'. It was therefore determined that there is a need to purchase and preposition stockpiles of adequate medical supplies at the Federal, State, and locallevel. While Kl was not considered as vital as chemical nerve antidotes and vaccines, the NRC staff was successful in getting Kiincluded with other medicinal supplies for NBC events because of the unusual characteristics of these events:
- 1. NBC events are unpredictable with many unquantifiable parameters. In contrast to nuclear power plant accidents, NBC events can occur in major metropolitan areas.
The group postulated NBC scenarios for which evacuation and sheltering were not effective or even possible.
- 2. NBC events can have consequences ranging from low to disastrous. Some may not escalate beyond the threat stage while others may occur without a threat stage with devastating consequences, with everything in between.
- 3. Even with the significant amount of planning at the Federal, State, and local level, NBC events still have potential for mass casualties.
Because of the special characteristics of NBC events, the Core Group recommended a broader range of protective actions. The NRC concurred in the findings of the report by letter from AEOD Director to FEMA Director dated September 25,1996. The report was subsequently presented to the President in February 1997 and approved for distribution in May 1997.
The staff believes that such a stockpile of Kl substantially addresses the issue raised by the American Thyroid Association.
FRPCC Subcommittee on Kl (19961 in parallel with petitioning the NRC, Mr. Crane also requested that FEMA review his petition and reconsider tM Federal policy. In early 1996 the FRPCC convened an Ad-Hoc Subcommittee on Potassium lodide to request and review new information on this matter from interested parties. The subcommittee conducted a public meeting on June 27,1996.
The subcommittee evaluated all comments from the June 27 public meeting and concluded in its report to the FRPCC that "while the viewpoints presented at the public meeting were
'Some of these medicines can save hves only when administered urgently. The timely distribution remains an issue.
The Commission -9 compelling, the 1996 Subcommittee on Potassium lodide heard no new information that seriously challenges the bases for the 1985 recommendation concerning public use of Kl'" .
However, the Subcommittee made the following recommendation regarding the Federal Kl policy:
1.
Without changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether to use KI, the Federal govemment (NRC, or through FEMA) should fund the purchase of a stockpile for a State that decides to
. incorporate Kl as a protective measure for the general public;
- 2. The Subcommittee believes the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many intervenors observe with the Federal policy is the italicized statement "The Federal position with... potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were reworded to state "it
[ potassium iodide for use by the general public) is not required, but may be selected i
as a protective measure at the option of the State or, in some cases, local governments."
- 3. The subcommittee recommends that local jurisdictions who wish to incorporate Kl as a protective action for the general public should consult with the State to determine if such arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include such a measure in their emergency plans.
Pror,osed Federal Poliev on Kl (199))
The full FRPCC endorsed the subcommittee's recommendations with some modifications and plans to publish a revised Federal policy statement on distribution of Kl. Because of the NRC's interest and recognized expertise in emergency planning around nuclear power plants, NRC staff agreed to work closely with FEMA te propose language that would integrate the FRPCC subcommittee's recommendations, the FRPCC's endorsement, and the recent developments in the areas regarding preparedness for terrorism.
FRPCC and Intermoency Ae=~=.r._.s Under 44 CFR 351, the FRPCC is the Federal coordinating body responsible for assisting ,
FEMA in providing policy direction for the program of Federal assistance to State and local governments in their radiological emergency planning and preparedness activities. FEMA, se chair of the FRPCC, establishes policy and issues guidance to State and local governments. The FRPCC member agencies jointly review and evaluate the status of emergency planning periodically. Part 351.21 (f) requires the NRC to assist FEMA in developing and promulgating guidance to State and local governments for the preparation of radiological emergency plans. Part 351.21 (i) requires the NRC to provide representation to and support for the FRPCC. The NRC has fully participated in FRPCC activities. Because of its specialinterest in emergency planning for nuclear power plants, )
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The Commission .
the NRC staff worked closely with FEMA and other Federal agencies in developing the proposed Kl policy. The staff recognized the importance of working closely with health agencies such as HHS and DVA regarding the use of Kl by the general public. Throughout this process, the staff worked collegially with other key Federal agencies to ensure a broader consensus on the Federal policy.
The NRC's representative to the FRPCC has agreed to propose language that integrates what was already recommended and endorsed by various Federal committees and working groups. By virtue of its regulatory functions, the NRC staff had to consider some additional fine points. For example, the NRC staff considered the licensing implications of the proposed Kl policy, the need for additional guidance to the licensees or States, and the potential impact on FEMA's responsibilities in offsite emergency planning.
If accepted by the FRPCC, the proposed policy will be noticed in the federalRegister.
Since FEMA chairs the FRPCC, it assumes the responsibility for this publication.
Options Option 1. Recommend no change in existing policy.
This option would result in continuation of the present policy, i.e., stockpiling Kl for use by emergency workers and institutionalized persons but predistribution or stockpiling of K1 for use by the general public should not be required.
'This option would require that NRC staff request that the FRPCC reconsider its current recommendations and not consider the existing Federal stockpile for NBC events. The staff does not believe that other key Federal agencies on the FRPCC would be receptive to this option because of the activities that have taken place since 1985.
This option does not updata the current policy to reflect the recent developments. The staff believes that the time is appropriate to update the present policy. A Federal stockpile of KI, among other medicinal supplies, already was available for the Olympics and the national political conventions. There is a new national impetus for expanding the Federal preparedness to include medicinal supplies for NBC events. While the FRPCC determined that there is no new information that seriously challenges the basis of the current policy regarding reactor accidents, it did recommend that the Federal government fund the purchase of KI for any State upon their request and soften the language in the present policy.
Option 2. Recommend the adoption of the FRPCC recommendations recognizing the recent developments in preparation for NBC events.
This is one of the options favorcd by the staff. As pointed out in option 1, the staff believes that the present policy should be updated. Attachment 1 contains a proposed Federal policy on K1 that reflects the key elements of this option. It incorporates changes recommended by the FRPCC's Subcommittee on Potassium lodide, acknowledges the
The Commission .
developments in the area of NBC events regarding K! but does not alter the current emergency planning requirements. The principal differences between option 2 and the 1985 version are the addition of the willingness of the Federal Government to purchase a supply of Kl for States at their request, and the establishment of a Federal stockpile.
The highlights of option 2 proposed policy are as follows:
e Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, in developing the range of public protective actions for savore accidents at commercial nuclear facilities, the best technical information indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, the State (or in some cases, the local government) is ultimately responsible for the protection of its citizens.
Therefore, the decision for local stockpiling and use of Kl as a protective measure for the general public is left to the discretion of the State or, in some cases, the local government, e
The Federal government will establish funding for the purchase of a supply of Kl. It is recognized that the State or the local government, within the limits of their authority, can take measures beyond those recommended or required. The availability of Kl as a protective measure for the general public supplements other options for public officials responsible for protective action decisions. A few States have indeed included Kl as a protective action for the general public. The FRPCC does not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public. Therefore, to ensure that States have available to them the option to use Kl if they so elect, the Federal government will be prepared to pravide funding for the purchase of a supply of Kl. Any State or local government which selects the use of Kl as a protective measure for the general public may notify FEMA and request funding for the purpose of purchasing a supply of Kl. Guidance would have to be developed in this area jointly with FEMA.
e A stockpile of KI is being established by the Federal government. The Federal govemment is required to prepare for a wider range of radiological emergencies 7.
To that end, and as an added assurance for radiological emergencies in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of K1 is being established by the Federal government. This Federal stockpile will be available to any State for any type of radiological emergency at any time.
'in response to new threats, the Federal government broadened the scope of ernergency response I preparedness to include terrorism involving nuclear, biological, and chemical agents. As a result, and in support of State and local governments, new resources were identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMST) are being established for response to such events.
Medical supplies, including KI, are being stockpiled nationally for the use by MMSTs in three locations: East coast (Washington, DC), Central (Denver), and West coast (Los Angeles). The quantity of supplies stockpiled uses a planning basis of 100,000 people for a period of two days.
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e 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.
e The incorporation of a program for Kl stockpiling, distribution, and use by any State or local government into the emergency plans will not be subject to Federal evaluation. This is based on the recognition that the use of Kl by the State for the general public is a supplemental protective measure, and that the existing
. emergency planning and preparedness guidance for nuclear power plants are effective and adequate to protect the public health and safety.
Analysis of Option 2 Proposed Policy To ensure that the Kl policy adheres to the principles of good public policy, NRC staff f identified key factors that should be taken into account:
i
- 1. The preeminent role of State and local governments in the protection of offsite public health and safety;
- 2. The application of good science to the development of any new guidance regarding Kl;
- 3. The value added of any new guidance in the context of existing planned protective measures;
- 4. The recognition that Kl is not without side effects which have been discussed at length throughout the past years. Before the NRC actually participates in the purchase and supply of KI, it will prepare through consultation with HHS, a suitable product warning to be used by the State and local governments. .
- 5. The implementation challenges of any new guidance.
The NRC staff considered these factors in developing the proposed Federal policy on KI.
Furthermore the staff believes that the proposed policy does the following:
- 1. Integrates the subcommittee's recommendations with the recent developments in the area of preparedness for NBC events, namely the establishment of neional medicinal stockpiles, including Kl;
- 2. Recognizes the central role of State and local governments in protecting public health and safety, and honors the State's prerogative to determine whether it wishes to add Kl as a supplemental protective measure for the general public;
- 3. Does not encumber the States and local governments who choose to retain their existing plans if they believe that the implementation of a Kl program may reduce
[. i The Commission the effectiveness of implementing prompt evacuation as a preferred protective action for the general public;
- 4. Provides added assurance to those States and local governments that a Federal stockpile of Kl is available, should it be needed;
- 5. Is consistent with the recently published draft guidance (NUREG-0654 FEMA-REP-1 Rev.1 Supplement 3) by NRC and FEMA on " Criteria for Protective Action Recommendation for Severe Accidents;"
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- 6. Does not result in a rule change which is a two-year process and may require a backfit analysis;
- 7. Maintains the foundation of offsite emergency planning by confirming that the existing guidance and requirements are adequate.
The proposed policy is also strengthened by the already existing stockpile of Kl that was available for the Olympics and the national political conventions. The staff believes that given these stockpiles, unlike the TMI experience, Kl could be made available in a more timely manner if needed in the future.
This option has some fiscal implications for the NRC associated with its offer to purchase
.Kl for any State that requests it.
Fiscal implications of Proposed Kl Policy The cption 2 proposed Federal policy ent tins an offer by the Federal government (most likely the NRC) to fund the purchase of a supply of Kl for any State that chooses to add Kl to its opt;ons of protective actions in response to an emergency at a NRC licensed nuclear ,
power plant. To fulfill this proposed obligation, staff's estimate of the range of NRC costs I is given in three scenarios in Attachment 2. Currently, resources are not budgeted for the purchase of Kl and funds would have to be reprogrammed should a State (or States) rgquest funding through FEMA.
The coct estimate does not include the administrative costs associated with the Kl purchase. The more likely scenario is that several sites may request funding each year for a few years. In that case, the estimate is about $50,000 each year for a period of three y ars and repeated every seven years, thereafter.
Option 3. Recommend modifications to the FRPCC recommendations.
There are a number of possible modifications to the FRPCC recommendations that can be r: commended. The staff has prepared a limited number of cases to scope the wide range cf possibilities, a) Endorse FRPCC recommendations without the offer to fund the purchase of Kl.
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There are already two States which have Kl for the general public under the current policy. The staff is not aware of any cases where funding to purchase a supply of KI is the obstacle for adding Kl as a protective measure for the general public. The staff believes that the costs associated with a Kl program couH be significant when activities such as public education and the' logistics associated with the distribution are added to the cost to purchase Kl supplies. The FRPCC's offer to fund the purchase of Klis intended to demonstrate a good faith effort on behalf of the Federal government to assure that if any State wishes to add this supplemental measure, there is no implicit discouragement from the Federal government.
If this option is selected, the staff would have to request that the FRPCC reconsider its recommendation regarding Federal funding for the purchase of Kl.
b) Recommend that the staff, in coordination with HHS and FEMA, revise current Federal KI policy to make Kl available to the States.
This was recommended by the staff in SECY-94-087. The revised policy would state that:
Kl will be purchased by the Federal government (most likely by the NRC) and made available through FEMA to the States.
While the NRC encourages the stockpiling of KI, the decision to stockpile, distribute, and use Kl would be the responsibility of the individual States. At the option of the State, procedures incorporating the use of Klin State emergency plans would be developed with the assistance af FEMA. The details regarding this option would be developed and coordinated through the FRPCC.
This option contains some of the essential elements of option 2 and is the other option favored by the staff. For example: (1) it is a State option to determine whether it wishes to include K1 in its plans, and (2) the Federal government (most likely the NRC) will purchase Kl for the States. This option could have fiscalimplications up to scenario 3 in option 2. The principal difference with option 2 is that in this option the Federal government openly encourages the stockpile of Kl by States for prudency.
The States may perceive the NRC encouragement to stockpile KI by the States as going beyond what is necessary. This is based on the statements presented by States' representatives at the public meeting conducted by the subcommittee on Kiin 1996. Not only were they not ccnvinced that there is a benefit to a Kl stockpile, but believed that it may hamper the implementation of prompt evacuation which is the preferred protective measure, indeed, it was after these testimonies and a careful examination of issues and information presented to the subcommittee, that FRPCC recommended a position that reflected a more subtle encouragement (as reflected in option 2).
- k k s
The Commission .
SECY-94-087 was silent on cases where States did not opt to haw a local stockpile of Kl.
In today's environment, those States could rely on the NBC stockpile to use Kl on an ad hg.g basis if needed.
This option was favored by the staff in 1994 and, in recognition of the NBC development, remains one of the two recommended options today, c) Direct the staff to effect a rule that requires KI as a protective measure for the general public.
This option is based on the presumption that stockpiling Kl for limited populations located close to operating nuclear power plants, if not cost-beneficial, is, nonetheless, prudent.
The option would require that emergency plans be revised to include a Kl distribution system for the public and the criteria for its administration in an accident.
This option would be at odds with the FRPCC recommendations and according to the polls, the States would not view this option favorably. The FRPCC recommendations were, in part, based on the notion that the State or local governments are ultimately responsible for the decisions regarding protective actions and their implementation. To have a national
, stockpile of KI allows the States to use KI on an ad hoc basis if needed.
This option would also have wide-spread implications for emergency planning. It would require the States and local governments to make significant changes to their plans and procedures in order to ensure that Kl can be distributed to the public (permanent and transient populations) in a timely manner, preferably without reducing the effectiveness of prompt evacuation if necessary, it would require that Federal agencies develop additional guidance for FEMA evaluation of the changed plans. The NRC and staff would have to revise the existing Federal guidance on protective actions for severe accidents, such as Supplement 3 to NUREG-0654. ' The State and local officials would have to conduct public training for public une of Kl. Public health officials and school officials would neeo specific instructions for dispensing Kl to the general public and school children.
- For the purpose of placing this option in perspective using the two States which currently stockpile KI for the general public, the staff contacted officials from Alabama and Tennessee. In each case, Kl supplies would be made available at reception centers following an accident. Under the direction of the Health Officer, Kl tablets would be Edministered to members of the public reporting to these centers. Neither State has a planned distribution system to provide Kl to the members of the public in case evacuation would not be feasible. Under these circumstances, Kl would be distributed on an ad-hoc basis, i
The Commission In short, this option has the potential to undo the web of emergency planning withcut any significant added benefit.
Imolications of Ootions on the Petition for Rulemakina l l
Before discussing the implications of the options on the Petition for Rulemaking, the contributions of Mr. Peter Crene of the NRC, the petitioner, should be recognized for their ,
value in illuminating all aspects of this issue. He has persevered, over many years and in j the face of technical disagreement on intangible issues, in Peeping this important issue '
before the agency and without his efforts even the policy changes recommended in this paper would not likely have been made.
l Option 1: No change to existing policy.
j If this option were approved, then the petition would be denied. The staff could still grant part of the petition by referencing the NBC developments which will result in a Federal stockpile.
Option 2: Endorse FRPCC recommendations recognizing the recent developments in preparation for NBC events.
If the proposed Federal policy is accepted, there will be no rule change to amend 10 CFR 50.47 to require that Ki be included in the emergency plans. Thus, the petition would be denied. However, the staff believes that the Federal offer to fund the purchase of Kl for the States at their request and the Federal stockpile of K1 for NBC events
- substantially addresses the fundamental concerns behind the petition, without requiring changes in State and local emergency plans.
There are currently two States which stockpile or distribute K1 for the general public around nuclear power plants. More States may choose to add Kl to their protective actions for the general public.
Option 3 (a): Endorse option 2 with no funding.
The petition would be denied. The Federal stockpile for NBC events partly addresses the fundamental concerns behind the petition.
Option 3 (b): In coordination with HHS and FEMA, revise current policy to make Kl available to the States.
'As pointoa out in the proposed Federal policy, the Federal stockpile of Ki will be available to any State for any type of radiological emergency.
L .y .. .
The Commission .
The petition would be denied. The availability of Kl would substantially address the fundamental concerns behind the petition.
Option 3 (c): Effect a rule change.
This option would grant the petition by directing the staff to make the requested rule change.
Coordination
~
The Office of the General Counsel has reviewed this paper and has no legal objection. The
' Office of the Chief Financial Officer has no objection to the resource estimates contained in this paper.
RECOMMENDATION:
The staff requests that the Commission approve either option 2 or option 3(b).
L. J eph Callan Executive Director for Operations Attachments:
- 1. Proposed Federal Policy on Kl
- 2. Estimation of Cost Commissioners' comments or consent shculd be provided directly to the Office of the Secretary by COB Wednesday, July 2, 1997.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT June 25, 1997, with an information copy to the Office of the Secretary. If the paper is of such a nature that it requires additional review and comment, the Commissioners and the Secretariat shoudl be apprised of when comments may be expected.
DISTRIBUTION:
Commissioners CIO OGC CFO OCAA EDO OIG REGIONS OPA SECY 0CA ACRS
e Billing Code 6718-06-P April 16,1997
~
FEDERAL EMERGENCY MANAGEMENT AGENCY DRAFT Federal Policy on Distribution of Potassium lodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent AGENCY: Federal Emergency Management Agency.
ACTION: 1ssuance of Federal Policy on Potassium lodide.
SUMMARY
- The Federal Radiological Preparedness Coordinating Committee (FRPCC) is issuing this revised Federal policy concerning the purchase, stockpiling, and use of potassium iodide (Kl) as a prophylaxis for the thyroid in the unlikely event of a major radiological emergency at a commercial nuclear power plant. Taken in time, Kl blocks the thyroid's uptake of airborne radioactive iodine, and thus could help reduce thyroid diseases caused by such exposure.
The Federal policy is that Ki should be stockpiled and distributed to emergency workers tnd institutionalized persons during radiological emergencies, in developing the range of public protective actions for severe accidents at; commercial nuclear facilities, the best technicalinformation indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, the State (or in some cases, the local government) is ultimately responsible for the protection of its citizens. Therefore, the decision for local stockpiling and use of KI as a protective measure for the general public is I:;ft to the discretion of State ( or, in some cases, local government.)
ATTACHMENT 1
i
{
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 recommended or required. The availability of Kl as a protective measure for the general public supplements other options for puolic officials responsible for protective action decisions. A few States have indeed included Kl as a protective action for the general public. The FRPCC doer, not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public.
Therefore, to ensure that States have the option to use Kl if they so elect, the Federal government is prepared to provide funding for the purchase of a supply of Kl. Any State (or in some cases, local government) which selects the use of Kl as a protective measure for the general public may so notify FEMA, and may request funding for the purpose of purchasing a supply of Kl.
In addition, the Federal government is also required to prepare f ar 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 which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of K1 is being established by the Federal government. This Federal stockpile will be available to any Stete for any type of radiological emergency, at any time.
'In response to new threats, the Federal government broadened the scope of emergency response l
preparedness to include terrorism involving nuclear, biological, and chemical agents. As a result, and in support of l State and local governments, new resources were identified to be needed in response to such events. About two l dozen Metropolitan Medical Strike Teams (MMST) are being established for response to such events. Medical supplies, including KI, are being stockpiled nationally for the use by MMSTs in three locations: East coast, Central, and West coast. The quantity of supplies stockpiled uses a planning basis of loo,ooo people for a penod of two days.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ----------J
3 The policy herein incorporates changes recommended by the FRPCC's Subcommittee on Potassium lodide, and supersedes the 1985 Federal policy (50 EB 30258). The principal difference between this revised policy and the 1985 version are the addition of the offer of the Federal Government to purchase a supply of Kl for States at a State's request and the catablishment of a Federal stockpile. The Federal Emergency Management Agency (FEMA) chairs the FRPCC, thereby assuming the responsibility for this publication.
For Further information
Contact:
William F. McNutt, Senior Policy Advisor, Room 634, F deral Emergency Management Agency,500 C Street, SW., Washington, DC 20472, (202) 646-2857; facsimile (202 646-4183.
p . .
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 11,1982, FEMA issued a final regulation in the Federal Reaister (47 810758), which delineated agency roles and responsibilities for radiological incident emergency response planning (44 CFR 351). One of the responsibilities assigned to the Department of Health and Human Services (HHS) and in turn delegated to the Food and Drug Administration (FDA) was providing guidance to State and local governments on the use of radioprotective substances and prophylactic use of drugs (e.g., KI) to reduce indiation doses to specific organs including dosage and projected radiation exposures at which such drugs should be used.
In the June 29,1982 Federal Reaister (47 8 28158), FDA published recommendations for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health officials should consider the use of Kl. The Federal policy on stockpiling and distribution of Ki was published in the July 24,1985 Federal Reaister (50 B 30258). On September 11,1989, the American Thyroid Association requested FEMA, as Chair of the FRPCC, to reexamir.s the 1985 policy and to revisit 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 lodide. On December 5,1994, the FRPCC adopted the report and recommendations of the Ad Hoc Subcommittee on Potassium lodide, which reaffirmed the Federal position as expressed in the 1985 policy.
5 On April 3,1996,in connection with a September 9,1995 Petition for Rulemaking submitted to the Nuclear R<agulatory Commission (NRC) on this issue, the FRPCC established a new Subcommittee on Potassium lodide to review current information. The Subcommittee conducted a public meeting on June 27,1996. Based on the information collected, the Subcommittee concluded that there was no new information that seriously challenges the bases for the 1985 recommendations concerning public use of Kl for-radiological emergencies at nuclear power plants. However, several recommendations were I
made to the FRPCC. The Subcommittee's three recommendations were: 1) without i
}
changing the Federal policy by interceding in the State's prerogative to make its own decisions on whether or not to use Kl, the Federal government (NRC, or through FEMA) should fund the purchase of a stockpile for any State that, hereinafter, decides to incorporate KI as protective measure for the general public; 2) The Subcommittee believes the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many intervenors observe in the Federal policy is in the italicized statement "The Federal position with... potassium iodide for use by the general public is that it should not be required." It would not be as negative if the last phrase were reworded to state "it [ potassium iodide for use by the general public) is not required, but may be selected as a protective measure at the option of the State or, in some cases, local governments." and 3) The subcommittee recommends that local jurisdictions who wish to incorporate Kl as a protective action for the general public should consult with the State to determine if such arrangements are appropriate. If local governments have the authorky 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.
1 6
The full FRPCC endorsed the subcommittee's recommendations with some modifications.
Policy on Distribution of Kl Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent The purpose of this document is to provide Federal policy and guidance with regard to distribution of KI, and its usage as a thyroid blocking agent, around operating nuclear power generating facilities. The issue has been addressed in terms of two components of the population that might require or desire Kl use: (1) Emergency workers and institutionalized individuals close to the nuclear power plant site, and (2) the nearby general population. This guidance is for those State and local governments who, within the limits of their authority, need to consider these recommendations in the development of emergency plans and in determining appropriate actions to protect the general public.
The Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear facilities, the best technical information indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, the State (or in some cases, the local government) is ultimately responsible for the protection of its citizens. Therefore, the decision for local stockpiling and use of Kl as a protective measure for the general public is left to the discretion of State ( or, in some cases, local government.)
_r.
7 it is recognized that the State (or in some cases, the local government), within the limits of its authority, can take measures beyond those recommended or required. The availability of Kl as a protective measure for the general public supplements other options for public officir:Is 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 govemment is prepared to provide funding for the purchase of a supply of Kl. Any State (or in some cases, local government) which selects the use of Kl as a protective measure for the general public may so notify FEMA, and may request funding for the purpose of purchasing a supply of Kl.
In addition, the Federal government is also required to prepare for a wider range of 2
radiological emergencies . To that end, and as an added assurance, for radiological smergencies in which the location and timing of an eme gency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of 1
Kl is being established by the Federal government. This Federal stockpile will be available to any State for any type of radiological emergency, at any time.
The bases for these recommendations are given below.
- in response to new threats, the Federal government broadened the scope of emergency response preparedness to include terrorism, involving nuclear, biological, and chemical agents. As a result, and in support af State and local governments, new resources were identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMST) are being established for response to such events. Medical supplies, including KI, are being stockpiled nationally for the use by MMSTs in three locations: East coast, Central, of two days.and West coast. The quantity of supplies stockpiled uses a planning basis of loo,ooo people for a period
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 KI during emergencies to emergency workers and to institutionalized individuals. Thyroid blocking for emergency workers and institutionalized individuals was recommended becaure these individuals are more likely to tie exposed to radiciodine in an airborne radioactive release than other members of the public. In addition, the number of emergency wuikers and institutionalized individuals potentially affected at any site is relatively small and requires a limited supply of Kl that can be readily distributed.
For the general public, in the event of a radiological emergency at a commercial nuclear I
facility, evacuation and in-place sheltering are considered adequate and effective protective !
actions. It is well-recognized that the inclusion of Kl as a protective measure, in addition to evacuation and sheltering, is beneficial only in very remote circumstances. The use of Kl is not without controversy. On the one hand, Kl has been shown to be an effective drug for protecting the thyroid from thyroid nodules or cancer caused by the uptake of radioiodine, especially in children fifteen years of age or younger. On the other hand, there are logistical difficulties, and potential medical side effects associated with the drug, in distributing the drug to the general public in a radiological emergency. Also, Kl
)
I effectively reduces the radiation exposure of only the thyroid gland from ingested or inhaled radioiodines. While this in an important contribution to the health and safety of the individual, it is not as effective as measures which protect the total body. Both in-place i
sheltering and precautionary evacuations can reduce the exposure to the thyroid and the total body. It_is very important to remember that the use of Kl is not an effective means j
,a . .
9 by itself for protecting individuals from the radioactivity in an airborne release resulting from a nuclear power plant accident and, therefore, should only be considered in conjunction with sheltering, evacuation, or other protective methods. Therefore, while the use of Kl can provide additional protection in certain circumstances, the assessment of the sffectiveness of KI and other protective actions and their implementation indicates that the decision to use Ki (and/or other protective actions) should be made by the States and, if appropriate, local authorities on a site-specific, accident-specific basis.
Those States or local governments which opt to include Kl for the general population will be responsible for the maintenance, distribution, and any subsequent costs associated with this program.
The incorporation of a program for KI stockpiling, distribution and use by any State or local government into the emergency plans will not be subject to Federal evaluation. This is based on the recognition tht the use of Kl by the State for the general public is a supplemental protective measure, and on the Federal government's determination that the existing emergency planning and preparedness guidance for nuclear power plants is sffective and adequate to protect the public health and safety.
The FDA has evaluated the medical and radiological risks of administering Ki for emergency ccnditions and has concluded that it is safe and effective and has approved over-the-c:unter sale of the drug for this purpose. FDA guidance states that risks from the short 12rm use of relatively low doses of K1 for thyroidal blocking in a radiological emergency are cutweighed by the risks of radioiodine induced thyroid nodules or cancer at a projected i
10 dose to the ' thyroid gland of 25 rem or greater. Since FDA has authorized the nonorescription sale of KI, it is available to individuals who, based on their own personal analysis, choose to have the drug immediately available.
Attached is a list of ten references intended to assist State and local authorities in decisions related to the use of Kl.
Conclusion The FRPCC did not find any new information that would require a change in the basis of the existing Federal policy concerning the stockpile or pre-distribution of Kl for the general public in the event of a radiological emergency at a commercial nuclear plant. The policy is that Ki should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, but leaves the decision for the stockpiling, distribution, and use of Kl for the general public to the discretion of State, and in some cases, local governments. Any State or local government that selects the use of Ki as a protective measure for the general public may so notify FEMA and may request funding for the purpose of purchasing an adequate supply.
The incorporation of a program for Kl stockpiling, distribution and use by any State or local government into the emergency plans will not be subject to Federal evaluation. This is based on the recognition that the use of Kl by the State for the general public is a supplemental protective measure, and on the Federal government's determination that the
11 existing emergency planning and preparedness guidance for nuclear power plants is effective and adequate to protect the public health and safety.
l l
~
Those States or local governments which opt to include Ki for the general population will l
be responsible for the maintenance, distribution, and any subsequent costs or legal liabilities associated with this program.
I As an added assurance, for a broader range of radiological emergencies in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of Ki will be established by the Federal government. Such a stockpile would consist of individual K1 caches at VA hospitals in m.sior metropolitan centers across the country. This supply would be available to any State or local government for any type of radiological emergency.
4 References 1.
National Council on Radiation Protection and Measures (NCRP), " Protection of the Thyroid Gland in the Event of Releases of Radioiodine," NCRP Report No. 55, August 1,1977.
2.
Food and Drug Administration (HHS), Potassium lodide as a Thyroid-Blocking Agent in a Radiation Emergency,43 fB 58798, December 15,1978.
I
12 !
- 3. Halperin, J. A., 8. Shleien, S. E. Kahans, and J. M. Bilstad: " Background Material l
for the Development of the Food and Drug Administration's Recommendations on Thyroid Bbcking with Potassium lodide," FDA 81-8158, U.S. Department of Health and Human Services (March 1981).
- 4. Food and Drug Administration; Potassium lodide as a Thyroid-Blocking Agent in a Radiation Emergency: Final Recommendations on Use (Notice of Availability) 47 FB 28158, June 29,1982). j i
l
- 5. !
Food and Drug Administration; Potassium lodide as a Thyroid-Blocking Agent in a '
Radiation Emergency: Recommendations on Use. (April 1992). Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Administration, Department of Health and Human Services.
- 6. Nuclear Regulatory Commission; Examination of the Use of Potassium lodide (KI) as >
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 lodide (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.
4 13 8.
Nucte' ar Regulatory Commission; Re-Evaluation of Policy Regarding Use of Potassium lodide 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 lodide After a Severe Accident at a Nuclear Power Plant (SECY-94-087, March 29,1994).
Signed:
O. Megs Hepler, lil '
Chair Federal Radiological Preparedness Coordinating Committee i
l l
_. s Estimation of the Cost to Purchase K1 for the States in Using Three Scenarios
.The option 2 proposed Federal policy contains an offer by the Federal government (most likely the NRC) to fund the purchase of a supply of Kl for any State that chooses to add Kl to its options of protective actions in response to an emergency at a NRC licensed nuclear power plant. Current'ly, resources are not budgeted for the purchase of Kl and funds would have to be reprogrammed should a State (or States) request funding through FEMA.
To fulfill this proposed obligation, staff's estimate of the range of NRC costs is given below:
No. of Cost Cost Cost in Sites Cost in Cost in in k$ k$/yr k$/yr Added No. of k$/yr k$/yr Year Year Year Each Year Years Year 1-3 Year 4-5 8 9-10 11-12 Scenario 18 3 3 48 48 48 Scenado 2 10 5 160 160 160 160 160 Scenario 3 70 1 1,120 1,120 Table: Cost of KI purchase in $1000 for three scenarios 1 1
The cost estimate does not include the administrative costs associated with the Kl purchase. Although the cost / benefit ratio to purchase Kl for the population in the 10-mile Emergency Planning Zone (EPZ) may be excessive for most sites, the NRC staff used the 10-mile EPZ population as the basis for cost estimation. The cost range is from
$48,000/ year for the first three years and repurchased every seven years, to a maximum of $1,280,000 the first year and repurchased every seven years. The higher estimate assumes all sites would request funding for the purchase of Kl in the first year, which staff believes is highly unlikely. The more likely scenario is that several sites may request funding each year for a few years. In that case, the estimate is about $50,000 each year for a period of three years and repeated every seven years, tnereafter.
Three scenarios were used to estimate the cost to purchase Kl for the States who request such funding. The first is based on the assumption that one State per year (with three sites) requests funding for a period of three years. The second scenario assumes three States per year (with a total of 10 sites) request funding for a period of five years. The third scenario assumes every State with a nuclear power plant requests funding the first year.
ATTACHMENT 2 The three scenarios are described in Attachment 2.
s .
2 The staff assumed the entire 10-mile EPZ population in the cost estimation. Although the Kl package contains an insert instructing the user to take one tablet a day for 10 days unless directed otherwise by State or local public health officials, the cost estimation was based on a two-day supply.
Our estimate of the range of costs are as follows:
I Scenario 1 !
One State (with three sites) per year requests funding for a period of three years.
Number of sites added per year, S: 3 Average number of people per site (within 10-mile EPZ), P: 80,000 l Average number of Kl tablets / person, T: 2 Average cost /Ki tablet, c: $0.10 Average shelf life of KI, L: 7 years The start up cost would be: C = S *P'T *c = 3
- 80,000'2 'O.1 = $48,000/ year, or
$146,000 over three years.
Scenario 1 1998 1999 2000 No. of Sites Added 3 3 3 Cost
($1000) 48 48 48 The replacement cost would be the same plus inflation, every seven years.
Scenario 2 Three States per year (containing a total of 10 sites) request funding for a period of five years.
Number of sites added per year, S: 10 Average number of people per site (within 10-mile EFZ), P: 80,000 Average number of Kl tablets / person, T: 2 Average cost /Kl tablet, c: $0.10 Average shelf life of KI, L: 7 years
. v '
1 3
i The start-up cost would be: C = S*P*T*c = 10
- 80,000 ' 2 '0.1 = $160,000/ year, or
$800,000 for five years. i Scenario 2 1998 1999 2000 2001 2002 No. of Sites 1 Added 10 10 10 10 10 Cost i
($1000) 160 160 160 160 160 The replacement cost would be the same plus inflation, every seven years.
Scenario 3 Number of sites, S: 70 Average number of people per site (within 10-mile EPZ), P: 80,000 Average number of Kl tablets / person, T: 2 Average cost /KI tablet, c: $0.10 Average shelf life of KI, L: 7 years If every State with a nuclear power plant site requested funding in the first year, the start-up cost would be: C = S'P'T*c = 70
- 80,000' 2 '0.1 = $ 1,120,000 Scenario 3 1998 i No. of Sites 70 Cost ($1000) 1,120 The replacement cost would be $1,120,000, plus inflation, every seven years.
l
f ' Papulation Data within the Nuclear Powsr Plant Emergsncy Planning Zonas blTE ' PERMANENT TRANSIEN ' Total 0-2 MILES 0-5 MILES 0-10 MILE 0-10 MILE 0-10 miles ARKANSAS .
853 7,320 25,394 6,000 31,394 1 BEAVER VALLEY 3,676 16,658 142,268 3,400 145,668 2 BELLEFONTE 309 4,696 25,050 2,437 27,487 3 BIG ROCK POINT 269 4,368 9,274 9,274 4 BRAIDWOOD 3,545 11,490 26,015 8,105 34,120 5 BROWNS FERRY 148 2,414 27,678 19,600 47,278 6 BRUNSWICK 711 4,373 10,583 21,000 31,583 7 BYRON 371 7,140 21,393 43,762 65,155 8 CALLAWAY 82 632 5,759 4,545 10,304 9 CALVERT CLIFFS 241 3,501' 19,972 1,150 21,122 10 CATAWBA 340 1,058 81,423 46,879 128,302 11 CLINTON 48 918 12,666 28,472 41,138 12 COMANCHE PEAK 29 2,684 10,731 8,918 19,649 13 COOPER STATION 40 830 5,417 3,000 8,417 14 CRYSTAL RIVER 0 825 13,595 1,010 14,605 15 DC COOK 723 12,364 53,755 16,089 69,844 ~ 16 DAVIS BESSE 1,030 2,572 16.427 16,427 17 DIABLO CANYON 10 57 18,099 53,700 71,799 18 DRESDEN 613 7,498 39,289 5,900 45,189 19 DUANE ARNOLD 235 3,821 79,323 79,323 20 FARLEY 27 1,577 10,681 1,420 12,101 21 FERMI. .
3,004 13,460 71,517 71,517 22 FITZPATRICK 242 3,909 35,155 20,790 55,945 23 FORT CALHOUN 207 7,666 15,254 871 16,125 24 GINNA 930 9,979 39,162 5,863 45,025 25 GRAND GULF 180 2,025 7,255 2,873 10,128 26 HADDAM NECK 2,345 12,129 74,080 29,415 103,495 27 HARRIS - 110 1,545 15,795 11,000 26,795 28 HATCH '107 894 5,312 150 5,462 29 HOPE CREEK 0 1,209 22,556 5,539 28,095 30 INDIAN POINT 15,165 74,755 240,455 92,852 333,307 31 KEWAUNEE 163 1,600 11,086 11,086 32 LASALLE 130 1,145 13,913 3.130 17,043 33 LIMERICK 4,349 100,364 164,870 23,165 188,035 34 MAINE YANKEE 372 2,001 28,730 42,338 71,068 35 MCGUIRE 420 4,189 46,233 31,178 77,411 36 MILLSTONE 5,176 48,648 110,166 83,129 193,295 37 MONTICELLO 279 7,611 20,153 20,153 38 NINE MILE POINT 242 3,909 35,155 20,790 55,945 39 NORTH ANNA 225 1,639 8,688 1,166 9,854 40 OCONEE ". 401 4,670 50,841 20,000 70,841 41 OYSTER CREEK 4,700 14,950 71,440 73,676 145,116 42 PALISADES 959 5,203 32,773 32,773 43 PALO VERDE 10 205 761 4,000 4.761 44 PEACH BOTTOM 512 '6,153 28,647 9,858 38,505 45 PERRY 1,882 17,238 71,902 53,271 125,173 46
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N51NT BEACH 239 1,356 2blbb4 1,3bb 32[1b4 48 P,RAIRIE ISLAND 290 4,228 21,462 21,462 49 QUAD CITIES .224 5,740 36,445 12,035 48,480 50 RIVERBEND 601 4,053 22,872 13,700 36,572 51 ROBINSON . 1,164 10,435 26,908 5,000 31,908 52 ST LUCIE 210 9,417 94,854 40,000 134,854 53 i SALEM 0 1,209 22,556 5,539 28,095 54 SAN ONOFRE 3,650 28,450 57,150 25,900 83,050 55 SEABROOK 6,040 32,060 100,720 116,988 217,708 56 SEQUOYAH 890 7,503 38,972 24,000 62,972 57 SOUTH TEXAS 4 268 2,550 4,622 7,172 58 SUMMER 220 1,883 8,869 2,000 10,869 59 SURRY 49 1,399 73,411 63,755 137,166 60 SUSQUEHANNA 1,177 13,317 51,232 3,720 54,952 61 THREE MILE ISLAND 2,331 27,466 161,509 6,335 167,644 62 TURKEY POINT 0 30 92,664 4,500 97,164 63 VERMONT YANKEE 2,086 9,231 31,909 3,544 35,453 64 VOGTLE 517 1,133 2,669 200 ?,869 65 WATERFORD 914 13,756 60,009 7,000 67,009 66 WATTS BAls 209 2,696 13,916 8,000 21,916 67 WOLF CREEK 24 3,698 5,520 1,100 6,620 68 WNP-2 0 80 1,338 11,824 13,162 69 ZION 12,981 59,247 245,006 65,750 310,756 70 SUM 90,946 697,696 3,111,627 1,320,238 4,431,865 Thiss are estimates of 1982 population which were developed by NRC staff Transient population estimates were based on information obtained from FSARs, E Plans, NUREG/CR -1856 (1981) and on licensee estimates. Transient population data are considered to include a large degree of ' uncertainty
/ AvsrLge population per site 63,312 Ava pop / site assuming 20% increas 75,975
, -ee en . seem
e .
1 June 26. 1997 i SECY-97-124A fQll:. The Comissioners '
f20ti:. L. Joseph Callan /s/
Executive Director for Operations SUBJFCT-ADDITIONAL INFORMATION REGARDING THE FEDERAL POLICY ON POTASSIUM IODIDE PURPOSE-The purpose of this transmittal is to inform the Commission of additional information announced on June 25. 1997, by the Department of Health and Human Services (HHS) regarding the number of Metropolitan Medical Strike Teams (MMST) and their individual medicinal supplies. At the Federal Radiological Preparedness Coordinating Committee (FRPCC) meeting i held June 25, the HHS representative reported that there will be 26 MMSTs r.ationwide, each with a full cache of medical supplies. including KI. This is in addition to the nationally stocksled medical supplies in three locations nationwide which the staff reported in SECY l 97-1R (footnote 7 on page 11).
i The increased number of medicinal stockpiles would markedly improve the availability of and access to KI by States or local governments should it become necessary. In addition, the HHS representative reported that the East Coast location for one of the three national stockpiles is now Winston Salem, NC instead of Washington, DC. According to the HHS representative, two of the HMSTs are already in place (Atlanta, GA and Washington, DC). The remaining 24 MMSTs are in the process of being established..
L. Joseph Callan Executive Director for Operations
Contact:
Frank J. Congel. AE0D (301) 415-7476
G:\dpr\KIRULE.WPDOctober 5, 1998 3:09 PM VLD FINAL VERSION SENT TO: MIKE JAMGOCHIAN NRR/DRPM/PGEB READY FOR USE D R JL FT I
(POTASSIUM IODIDE RULE CHANGE /FOR BBCY PAPER)
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NRC PROPOSES REVISIONS TO ITS REGULATIONS ON USE OF POTASSIUM IODIDE IN RNERGENCY RESPONSE The Nuclear Regulatory Commission is proposing to revise a section of its emergency preparedness regulations to include the possible use of potassium iodide as a supplemental protection for the public in case of a severe nuclear power plant accident.
Potassium iodide, if taken in time, blocks the thyroid gland's uptake of radioactive iodine and thus could help prevent ;
thyroid cancers and other diseases that might otherwise be caused l
, by exposure to airborne radioactive iodine that could be i l
dispersed in a nuclear accident. Nuclear power plant emergency plans already provide for distribution of the drug to emergency workers and certain specialized populations, such as hospital patients.
The proposed rule change would add potassium iodide to the j range of protective actions which must be considered in nuclear '
power plant emergency plans. It would accomplish this by adding this sentence to Part 50. 4 7 (b) (10) of Title 10, Code of Federal Regulations: "In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium iodide (KI) as appropriate."
t l
'NRC is moving to amend this regulation as the result of an action it took in July, when it granted a rulemaking petition t
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i'
~ -
( filed by Peter G. Crane, an NRC staff attorney who acted as a private citizen. The NRC staff also is preparing guidance that will be distributed to local and state authorities to assist them in determining whether stockpiling KI is a "reaconable and prudent" measure.
The proposed rule will be published for public comment in an i upcoming edition of the Federal Recister. It also will be l available on the NRC Hcmepage at: www.nrc.cov/NRC/ru]e.html.
1 Comments should be filed within 90 days after publication.
They should be sent to: Secretary, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001. ATTN: Rulemakings and Adjudications Staff. Comments may also be filed electronically as described in the Federal Recister notice.
1 i
,' 1 m. l 0o09 .
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UNITED STATES NUCLEAR REGULATORY COMMISSION !
WASHINGTON, D.C. 20$65 0001
\y# October 23, 1998 l
MEMORANDUM TO: William D. Travers Executive Director for Operations FROM: Thomas T. Martin, Chairman M Committee to Review Generic Requirements-
SUBJECT:
PROPOSED AMENDMENTS TO 10 CFR 50.47 - RULE CHANGE RELATED TO THE USE OF POTASSIUM IODIDE FOR GENERAL PUBLIC l I
The Committee to Review Generic Requirements (CRGR) met on Tuesday, October 13,1998, !
from 9:00 a.m. to 3:30 p.m. to hold the Committee's 329th meeting. Mr. Joseph A. Murphy presided as Acting Chairman. At this meeting, the staff presented for CRGR review and endorsement the proposed rule relating to use of potassium lodide (Kl) by the general pubite.
Please note that at the time of the CRGR review, this proposed action did not have OGC and other office concurrences as required by the CRGR Charter. However, to support the staff's schedule commitments, the Committee agreed to review this rulemaking with the understanding that the staff would submit to the Committee the revised proposal clearly indicating the changes made in response to office (including OGC) concurrences, concurrences with comments, and !
Indicate any non-concurrences.
Subsequently, the CRGR membership (as configured on the day of the meeting on October 13th) met again to discuss the backfit issue. Mr. Francis Cameron (OGC) was present at this-meeting. Pending issuance of the final minutes of the meeting, the purpose of this memorandum is to raise to your attention the Committee's backfit-related concerns and other comments and recommendations:
- 1. As proposed, this rule appears to be a backfit. The CRGR recommends that an appropriate backfit analysis should be performed in accordance with the provisions of 10 CFR 50.109.
- 2. The staff should clarify the issue of resources as to who will bear the cost of Kl stockpiling, distribution and subsequent replenishment.
- 3. Finally, the Committee indicated that it would have no other objections to the staff proceeding with the issuance of this rulemaking for public comment if the comments provided by various offices during the concurrence process are appropriately addressed.
As always, I am available to discuss this matter further, cc: F. Miraglia J. Murphy D. Dambly B. Sheron J. Dyer C. Rossi M. Knapp 1 Euc um M L I
i