ML20205S123
| ML20205S123 | |
| Person / Time | |
|---|---|
| Issue date: | 12/21/1998 |
| From: | Merrifield J NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20205S086 | List: |
| References | |
| RULE-PRM-50-63, RULE-PRM-50-63A SECY-98-264-C, NUDOCS 9904260094 | |
| Download: ML20205S123 (2) | |
Text
c o.
l NOTATION VOTE RESPONSE SHEET TO:
John C. Hoyle, Secretary FROM:
COMMISSIONER MERRIFIELD
SUBJECT:
SECY-98-264 - PROPOSED AMENDMENTS TO 10 CFR l
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 l
Approved Disapproved Abstain Not Participating COMMENTS:
See attached coments.
2-8 DATE Entered on "AS" Yes X No E **IonI$ E $**
CORRESPONDENCE PDR
4 COMMENTS OF COMMISSIONER MERRIFIELD ON SECY-98-264 I approve publication of the proposed rule in the Federal Register for a 90-day comment period as edited by Commissioner Dieus. In doing so, I am not endorsing the related draft policy issued l
earlier by the Commission on the use of Potassium lodide (KI). Had I been appointed at the time of its issuance, I would have objected to portions of it.
Specifically, I would not have agreed to the federal govemment funding a supply of potassium iodide (Kl) for "any State, or in some cases, local government, that selects the use of Kl as a supplemental protection measure for the general public." i believe that the country needs useful, robust, pre-positioned stockpiles of Kl. But, I question whether the present policy, including the plan for funding, achieves this result. It contemplates funding a stockpile for any state that desires to have one and does not provide funding for federal regional stockpiles for use by the general public. Consequently, under the present plan there is no contingency in place to make Kl available to states which do not have a stockpile, but who elect at the last minute to use Ki in the event of a radiological emergency, or for use in other unforseen circumstances.
Alternatively, it does not put a cap on the amount of Kl that the country will accumulate as whole, albeit stored at the state level. The policy does not, for example, provide an incentive for a state to minimize stockpiling and expenses by sharing its Kl reserves with neighboring states.
To me this is not the most efficient or effective use of our limited resources.
Faced with the difficult decision of how to achieve an effective national Kl policy without jeopardizing our ability to meet our other regulatory goals, I believe that the NRC as a federal agency should concentrate our efforts on pre-positioning Kl at several appropriately located regional centers under the control of the Federal Emergency Management Agency (FEMA).
The goal of the regional centers would be to ensure that Kl is accessible in the event that state stockpiles are inadequate or if some other unforeseen co,ntingency requires its use. Ultimately, I am convinced that the decision regarding whether a state should stockpile Kl, including the details of how to fund it, should be left to the states.
I recognize that the Commission is now in a very difficult and I believe unfortunate position with respect to funding because of its previous commitment to pay for state stockpiles.
Nevertheless, because i believe that the decision to fund the state stockpiles will not produce the most effective or robust national Kl policy, I believe we should revise it. I plan to issue a memorandum to my fellow Commissioners to initiate a change to the draft policy consistent with these comments.
I agree with Commissioner Dieus that a change to the proposed rule is necessary to prevent a backfit issue. Because the proposed rule requires licensees, states and local govemments to consider Kl as part of the emergency planning process, at a minimum, licensees will have to implement measures to document their compliance. Additionally, licensees may be required, in coordination with State or local govemments, to develop analyses related to Kl use to adequately consider the matter. I believe that Commissioner Dicus' suggested edit to the proposed final rule, which encourages consideration rather than requires it, potentially alleviates this problem.
5JL f.fC
/
'q UNITED STATES y
NUCLEAR REGULATORY COMMISSION
,g n
j u s m a n. e : : m s-coo' 3
% ~~ g i April 22, 1999 OF FIC E OF T'* E SECRETARY MEMORANDUM TO:
Commissioner Merrifield FROM:
Annette Vietti-Cook, Secretary
/M-M
SUBJECT:
COMJSM-98-002 - FUNDING FOR POTASSIUM IODIDE STOCKPILES This memorandum is to inform you that the Commission has concurred in your proposal for the staff to withdraw the draft Federal Register Notice provided to FEMA and work with FEMA to determine whether it is feasible for the federal government to fund and maintain regional Ki stockpiles to be used in the event of a severe nuclear power plant accident if requested by State and local officials. The attached SRM provides further details and staff direction on this issue.
This completes action on COMJSM-98-002.
Attachment:
As stated cc:
Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan EDO j
OGC i
M k
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1 s
[pn sicy#'o, UNITED STATES f
NUCLEAR REGULATORY COMMISSION g..
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,/
'v OFFICE Of TME April 22, 1999 SECRETARY MEMORANDUM TO:
William D. Travers Executive Director for Operations FROM:
Annette Vietti-Cook, Secretary
SUBJECT:
STAFF REQUIREMENTS - SECY-98-264 - PROPOSED AMENDMENTS TO 10 CFR 50.47; GRANTING PETITIONS FOR RULEMAKING (PRM 50-63 AND 50-63A) RELATING TO A REEVAL'UATION OF POLICY ON THE USE OF POTASSIUM IODIDE (KI) AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT and COMJSM-98-002 - FUNDING FOR POTASSIUM IODIDE STOCKPILES The Commission has approved issuance of the proposed rule for commer.ts subject to the foWowing comment and attached changes to the Federal Reaister Notice (FRN). The FRN should be revised and returned to SECY for signidore and publication.
~
(EDO)
(SECY Suspense:
5/31/99) g)
The staff should amend the draft Federal Register Notice on the federal Ki policy provided to FEMA to conform to this SRM, particularly with respect to the Commission's decision not to fund State stockpiles.
(EDO)
(SECY Suspense:
5/31/99)
The staff should work witn FEMA to establish and maintain regional Kl stockpiles to be used in the event of a severe nuclear power plant accident. The Commission supports the position that the federal govemment should fund the purchase of Kl for federal stockpiles at appropriately I
located regional centers. The Commission supports NRC funding of the initial purchase and resupply of Kl to the extent that this cannot be covered by FEMA under its initiatives, and to the extent that tnere is no Economy Act constraint on FEMA's receiving money from the NRC for this purpose.
if FEMA decides after working with the States to develop any formal funding request to i
Congress for a program of federaEy funded grants for State Kl stockpiles, the NRC should assist FEMA in developing its funding request.
The section entitled
- Analysis of Issues raised by Public Comments
- represents technical I
responses to questions and statements and does not represent policy decisions by the Commission. Therefore, the statements that are curre9tly attributed to the Commission in this
)'
section should be changed to indicate that tbs respoa es are those of the NitC staff.
i lN^303Yo ~7 f/ '
I 0
'(
On page 17, after the last sentence, insert 'The Commission has considered the KI policy question on numerous occasions since 1984. The voting history of the Commission shows that reaching consensus en this policy question has been an elusive goal. An important reason for this historical lack of consensus is that this policy question is not a clear cut one. Individual Commissioners, past and present, have differed in their views with respect to the relative importance to be given to factors bearing on the Kl issue. These honest clifferences have led to divided Commission views on how to resolve the policy question. The Commission is agreed that its historical datficulty to reach consensus on the KI policy question underscores the reality that this policy question is not a simple one, is.not one that is easily resolved and, as a result, has been the subject of protracted deliberation. With that relevant background, following are the Commission's views on specific issues raised by the Petition.'
The FRN should include reference to the fact that the staff is developing a final version of the NUREG related to Kl and the ass ~ociated development of an information document for State and local decision makers. On page 4, at the end of the sepond full paragraph, add a new sentence:
NRC staff is preparing a technical report and an information brochure to enable State and local decision makers to make an informed decision in this matter.
Attachment:
As stated cc:
Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield OGC CIO CFO-OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
'l
(
Changes to the Federal Register Notice
'1.
On page 1, paragraph 2, sentence 2 should be revised to read 'The proposed rule would amend the current regulations to require lnd;;;;; that consideration shall be given to including potassium iodide (KI), ;;;ng e.4h ;h;' dag end ;;;;uetion, as a ;upp'; ment;l protective measure for the general publio that would supplement sheltering and evacuation. Ki would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant.
2.
The FRN currently states incorrectly that the Commission granted two petitions (PRM 50-63 and 50-63A). PRM 50-63 was replaced by PRM 50-63A which the Commic: ion has granted..Therefore, the FRN should be revised to clarify this fact. On page 2, caragraph 1 under Supplementary Information, revise to read "By undertaking this rulemaking, the Commission, while not adopting the exact language suggested by the petitioner, is proposing to grant a petition for rulemaking (PRM 50-63A) submitted by Mr. Peter Crane on November 11,1997. That petition is a revision of a petition (PRM 50-63) that he submitted on September 9,1995.
3.
On page 3, line 5, ins u
- a new sentence after ' conditions' as follows: When the Commission amer s emergency planning regulations on November 3,1980, it r:sted that 'any dir
,unding of State or local govemments solely for emergency preparedness purgses by the Federal govemment would come through FEMA.' Begin the next sentence with 'In its decision on June 30,1997, the Commission...' In lines 5 and 6, delete ' consistent with the Commission's decision on June 30,1997,'.
4.
On page 3, line 7 and 8, replace the sentence 'The NRC staff will.. Kl is established.'
with 'The Commission ha determined that notwithstanding the June 30,1997 intention that "most likely the NRC" would fund the purchase of State stockpiles of KI, the NRC budget has continued to decrease and offers little margin for the Commission to divert resources to new initiatives. Historically, funding for State and local emergency response planning has been the responsioility of those govemments usually working with licensees. The Commission notes that the Petitioner has not requested the Federal funding of stockpiles of Kl.' Start the next sentence as follows: 'In the attemative, the NRC will....' On page 3, line 9, delete 'also'. In lines 9 and 10, replace ' procedures to enable t!.s national' with robust, pre-positioned regional' and add an 's' to ' stockpile 3'.
In line 10, delete 'for terrorist activities'. In line 11, replace ' national
- with ' regional'.
5.
On page 4, first full paragraph, sentence 1, insert 'NRC staffs' before ' proposed'.
6.
. On page 4, second full paragraph, line 1, insert ' portion of the' before ' petition'. In line 2, replace 'by directing' with 'regarding'.
7.
On page 6, last line, replace 'in favor of with 'which favored'.
8.
On page 15, at end of second full paragraph insert: However, FEMA recently reported that the federal stockpiles of KI are few and stocked only for first responders to terrorist action. As things stand now, needs of members of the public for Kl on an ad hoc basis would have to be supplied from other sources. As stated above, the Com nission intends to work with FEMA to assure that sto# piles contain adequate supplies of Kl.
l
I g
i 9.
On page 17, before the Analysis of issues raised by P'ublic Comments insert a new paragraph as follows: On November 5.1997, the Commission held a public meeting with its staff, FEMA representatives, and the author of the 1995 rulemaking petition to consider the petition and proposed changes to the Federal policy on the use of Kl. In part as a result of the meeting, the petitioner amended his petition to ask for a rule that would require that consideration would be given in the formulation of emergency plans to the use of Kl as a supplement to evacuation or sheltering, and on June 26,1998, the Conimission granted the amended petition. and directed the NRC staff to initiate the requested rulemaking, The Commissioners also decided that the FRPCC Federal Reaister notice on Federal Kl policy should include a statement to the effect that the State and local decision makers, provided with proper information, may find that the use of KI as a protective supplement is reasonable and prudent for specific local conditions.
On September 30,1998, the Commission approved a draft Federal Reaister notice and directed that it be sent to the FRPCC.
10.
On page 21, first full paragraph, line 1, insert ' thyroid' after ' excess'.
11.
On page 22, second full paragraph, line 1. correct spelling of ' measures'.
12.
On page 23, paragraph 2, add a footnote at end of.second sentence, to read 'A
- medically significant" reaction was one for which the person suffering the reaction consulted a physician more than once. Nauman and Wolff, "lodide Prophylaxis in Poland After the Chernobyl Reactor Accident: Benefits and Risks," The American Joumal of Medicine, Vol. 94, May 1993, p.530. About.02% of the population that received Kl had " medically significant" adverse reactions to Kl. Id. However, "[i}t should be pointed out that control values for these side effects in a population r.ot receiving Kl are not available." Id.' That is, it is not known what the incidence of such reactions would be in a population under similar stress, but not receiving KI, and thus it is not known to what extent these adverse reactions were the result of Kl.
13.
On page 24, under Conclusions from Polish Experience, line 1, insert 'In Poland' before
'(1)'. In line 2, delete 'in Poland'.
14.
On page 25, first full paragraph, line 1, insert 'In contrast to the Chemobyl experience, before 'in the event'. In lines 2 and 3, remove the parentheses. In line 3 replace 'that would' with 'all of which'. In line 3, replace ' risk to' with ' risk of exposure of'. Also in line 3, insert 'to all radionuclides' after 'public'. In line 4, add 'or especially sheltering' after
' evacuation', and replace 'further' with 'resulting from exposure to one important group of radionuclides, the radioiodines.' That is why current NRC guidance discusses Kl for plant personnel, emergency workers, and institutionalized persons unlikely to be evacuated promptly.
'15.
On page 25, delete the start of the second full paragraph (One public commenter...) to the start of issue 3 on the next page. Replace it with 'In this light, the Commission agrees that the use'of KI may be determined by State and local emergency response pir Nrs to be a useful supplementary protective measure
- 16.
t.. page 26, line 7 from the bottom, correct spelling of *noduies.
l
w, 17.
On page 27, under Commission Response. line 4, insert 'such as by making it available' after 'available'. In line 9. replace 'Other approaches' with 'Another approach' and replace 'could' with 'is to'.
18.
On page 28, paragraph 1, replace with "The commenter is correct, in that it was difficult to obtain Kl after the Three Mile Island accident. That is one reason why the Commission believes that planners should consider stockpiling KI, and why the Commission supports Federal stockpiles, so that States that have chosen not to stockpile K1 could have access, albeit ad hoc and delayed, to an adequate supply in a radiological emergency at a nuclear power plant. As noted elsewhere in this notice, the Commission will work with other agencies to assure that there are Fede:'el regional stockpiles that contain adequate supplies of Kl. b;;;;;r, ;;h th; ;m :cd I;derel
- kp;b ef Kl for ;r; erst even
- ;
- nd th;.;llFagne;; cf th; I;d r;l 0;;;mmeni to prevZe ; ;;;;kp;b ef Kl fer ;ny 00;;; the d;;Me; ;; u;; ;; ;; ; ;uppbinent;l pre
- ;;tiv; m;;;ur; fer the gencr;l put'b, Moreover, the general availability of K1 is greater now than at the time of the TMI accdont, partly because of the FDA's approval of Kl as an over the counter drug. Some States have elected to incorporate Kl into the emergency response plans and have obtained adequate supplies for this purpose. The Commission is not aware of any factors that would constrain the availability of Kl for stockpiling purposes. The Commission believes that an adequate supply of KI could be obtained.
19.
On page 32, line 7, replace the 'of' after ' State' with 'or'.
20.
On page 32, line 2 from the bottom, replace
- NRC staff' with ' Commission'.
21.
On page 33, line 1, replace ' considers' with ' believes'. Delete the second full paragraph under the Commission Resoonse.
22.
On page 33, replace the Commission Decision with the following: 'KI is a reasonable, prudent, and inexpensive supplement to evacuation and sheltering for specific local conditions. Therefore, the Commission's guidance on emergency planning has long taken Kl into consideration (NUREG-0654/ FEMA-REP-1, Rev.1, p. 63, items e. and f.).
However, since the last revision of that guidance, there has been experience with the mass distribution of Kl during a radiological emergency, and though the record on that distribution is not complete, the indications thus far are that mass distribution is effective in preventing thyroid cancer and causes remarkably few threatening side effects.
Moreover, many nations in Europe and elsewhere, nations gs different in their circumstances, politics, and regulatory structures as France, Canada, and Japan, have stockpiled Kl and planned for its use. So have some U.S. States. The World Health Orgart.ation and the Intemational Atomic Energy Agency recommend its use.
Therefore, it' i ' jer the achieve greater assurance that Kl will receive due attention by planners, it seems reasonable to take a small further step and, continuing to recognize the authority of the States in mrtters of emergency planning, explicitly require that planners consider the use of Kl.
The proposed rule change should not be taken to imply that the NRC believes that the present generation of nuclear power plants is any less safe than previously thought. On the contrary, present indications are tnat nuclear power plant safety has impraved since
the current emergency planning requirements were put in place after the Three Mile Island accident.
The use of potassium iodide is intended to supplement, not to replace, other protective measures. This rule change thus represents no alteration in the NRC's view that the primary and most desirable protective action in a radiological emergency is evacuation of the population before any exposure to radiation occurs, whenever that is feasible.
(Evacuation protects the whole body, whereas potassium iodide protects only a single gland, the thyroid.) De9ending on the circumstances, Kl may offer additional protection if used in conjunction with evacuation and/or sheltering.
The NRC recognizes that the decision to stockpile Kl presents issues of how best to position and distribute the medicine, to ensure, e.g., th'at optimal distribution takes place in an emergency, with first priority given to protecting children; that persons with known allergies to iodine not take it; that members of the public understand that Kl is not a substitute for measures that protect the whole body; etc. To date, these issues have been addressed in different ways in the numerous countries that currently stockpile Kl.
The NRC is working with States and localities to develop guidance on these and other points relating to the use of Kl. The NRC believes that these implementation issues can be solved, given the level of expertise in the relevant Federal and State agencies, and the experience of numerous nations that have built Kl into their emergency plans.
It is expected that States will inform FEMA and the NRC of the results of their consideration of whether to opt for stockpiling. This will enable the Federal government to engage in better contirigency planning for States that decide against stockpiling Kl.'
j 23.
On page 34, first full paragraph, line 3, insert 'in part and denied in part' after ' granted'.
24.
On page 34, under Commission Conclusions..., line 1, replace ' agrees with many of' with ', having reviewed' In line 2, replace the period with a comma and delete 'The Commission'. In item A., line 1, insert 'when determined by State and local emergency response planners and' after 'Kl,'.
25.
On page 34, line 7, replace 'noted' with ' finds' and replace ' consistent with the Commission's' with 'notwithstanding its'.. In line 7, delete '(most likely the NRC)'. in line 8, replace 'will' with 'is not prepared to'. In line 9, replace 'The' with 1n the altemative, the' and replace 'also directr d' with 'is directing'. In line 10, replace ' procedures to enable the national' with ' robust, prepositioned regional'. In line 12, replace 'the national' with ' regional'.
26.
On page 36, in item E. line1, insert 'Although the cost of KI tablets has doubled,' before
'the Commission
- and insert ', and other nations' experience,' after ' estimate'. In line 2, insert 'relatively' after 'is' At the end of item E., add the following new sentence:
'However, the overall cost is minimal when placed in the context of emergency planning and should not be a deterrent to stocxpiling Kl for use by the general public should State and local decision makers determine that the prophylactic use of Kl as a supplement to evacuation and sheltering is appropriate.' in item F., line 1, replace 'NBC modicinal' with
' robust, regional' and replace ' provide' with 'be t.stablished'. Replace lines 2 and 3 with
'to enable use by States that have not established local stockpiles and wish to make use
,.++
i of KI in the event of a severe nuclear power plant accident.
27.
On page 36, revise paragraph F to read "The Commission b;';a;; will work to assure that med;;;n;l regional Federal stockpiles should will provide ;;;urene; to St;ta and le;;' ;;;;;mment; that ; Smlted reder;l ;;;;4;lc of Kl ;; ;v;lleblc, if n=ded. enough Kl to enable use by States that have not established local stockpiles and wish to make use of KI in the event of a severe nuclear power plant accident.
28.
On page 36, replace ' Commission aooroval to fund Kl' with ' Commission decisir>n to fund 11!'
29.
On page 36, in the last paragraph, replace the last 2 sentences with: 'At that time it was believed that the NRC was the likely Federal agency to fund the stockpiling. Historically, funding for State and local; emergency response planning has been the responsibility of those govemments usually working with licensees and, absent Congressional funding specifically for this purpose, NRO is not prepared to fund stockpiling of Kl.
30.
On page 38, paragraph 2 from the bottom, line 1, replace ' directed' with disagreed with' and replace 'in SRM 98-061 to grant' with ' recommendation to deny'.
31.
On page 39, item II., line 2, replace 'SRM 98-06' with 'SRM 98-061'. In item IV., line 1, add an 's' to ' petition 3' and replace ' require' with 'take'.
32.
On page 41, paragraph 2 from the bottom, lines 1 and 2, replace ' grant the petition for rulemaking PRM-50-63A by revising' with ' revise'.
33.
On page 42, second full paragraph, line 1, insert "that" after 'Given'.
34.
On page 42, prior to the last paragraph, insert a new paragraph as fc'iows: 'The
~ Commission notes that when it amended its emergency planning regulations on November 3,1980, the regulatory standards for emergency planning were a restatement of basic joint NRC-FEMA guidance to licensees and to State and local govemments incorporated in NUREG-0654; FEMA-REP-1, " Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in Support of Nuclear Power Plants for interim Use and Comment." This guidance was cited in the regulation and speaks to radioprotective drugs including their use by the general public including quantities, storage and rneans of distribution and State and local plans for decision making with respect to their use. The Commission removed the citations of the guidance i
from the regulation in 1987 but the guidance has continued in use for planning purposes and by the Federal agencies for evaluating emergency plans. As a result, it is believed that all of the affected States have at some point considered the use of Kl. Some States have made the decision to stockpile Kl. Thus, in practical terms, the projected costs will i
occur only in those States that have not elected to stockpile Kl and choose stockpiling in light of the Chernobyl accident, recent international practice, and.ne NRC requirement to consider the use of Kl.
35.
On page 48, line 1, replace 'have' with 'has'.
.