ML20205S083
| ML20205S083 | |
| Person / Time | |
|---|---|
| Issue date: | 04/22/1999 |
| From: | Vietticook A NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| Shared Package | |
| ML20205S086 | List: |
| References | |
| REF-10CFR9.7, RULE-PRM-50-63, RULE-PRM-50-63A SECY-98-264-C, NUDOCS 9904260081 | |
| Download: ML20205S083 (2) | |
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UNITED STATES p
NUCLEAR REGULATORY COMM$SIONELEASED TO THE o
WASHINGTON. D.C. 20555-0001 e E
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April 22,1999 I
N A-19--t' data ini COMMISSION VOTING RECORD *""* * *" * *tials 0~
OFFICE OF THE SECRETARY DECISION ITEM:
SECY 264 TITLE:
PROPOSED AMENDMENTS TO 10 CFR 50.47; GRANTING PETITIONS FOR RULEMAKING (PRM 5043 AND 5043A)
RELATING TO A REEVALUATION OF POLICY ON THE USE l
OF POTASSIUM IODIDE (KI) AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT The Commission (with Chairman Jackson and Commissioners Dicus and Merrifield agreeing in part and disagreeing in part and Commissioners Diaz and McGaffigan agreeing) approved the subject paper as recorded in the Staff Requirements Memorandum (SRM) of April 22,1999.
This Record contains a summary of voting on this matter together with the individual vote sheets, views and comments of the Commissioners, and the SRM of April 22,1999.
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Annette Vietti-Cook Secretary of the Commission Attachments:
- 1. Voting Summary
- 2. Commissioner Vote Sheets
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- 3. Final SRM cc:
Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan Commissioner Mornfield OGC-EDO PDR DCS 9904260001 990422 PDR COPMS NRCC CORRESPONDENCE PDR a
l VOTING
SUMMARY
- SECY 264 RECORDED VOTES l
l NOT APRVD DiSAPRVD ABSTAIN PARTICIP COMMENTS DATE CHRM. JACKSON X
X X
12/29/98' COMR. DICUS X
X X
12/17/98 COMR. DIAZ X
X 12/2/98 COMR. McGAFFIGAN X X
2/22/99 COMR. MERRIFIELD X X
X 12/21/98 I
t COMMENT RESOLUTION in their vote sheets, Chairman Jackson and Commissioners Dicus and Merrifield approved the staff's recommendation in part and disapproved in part. Commissioners Diaz and McGaffigan approved the staff's recommendation. All the Commissioners provided some additional comments. Subsequently, through the SRM review process, the comments of the Commission were incorporated into the guidance to staff as reflected in the SRM issued on April 22,1999.
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FRbM CHRIRMAN JACKSON NOTATION VOTE RESPONSE SHF#T l
To:
John C. Hoyle, Secretary FROM:
CHAIRMAN JACKSON
SUBJECT:
SECY-98-264 - PROPOSED AMENDMEN 6043 AND 6043A) RELATING TO POLICY ON THE USE OF POTASSIUM SEVERE ACCIDENT AT A NUCLEAR POWE Approved _ XAn PartDlSepproved yin part Abstain Not Participating _
COMMENTS:
i See attached comments.
i These comments also apply to COMJSM-98-002.
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Shirley Ann Jackson SIGNATURE t>{nist DATE Entered on "AS" Yes __X_
No _
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'FROM CHAIRMAN JACKSON
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........v b41d Chairman Jackson's Com;..r.6 on SECY 98 284 and COMJM 9
-2 The proposed rule in the Federal Register Notles (FRN) is consis Commission provided to the staff relative to the dispositioning of e guidance that the
_(PRM 5043A). R*garding the recommendations by Comm n orRulemaking States and the licensees consider the use of K e
parties to consider the Oso of Kl as part of their emergency pla equirement for the parties have alrosdy performod in the past, and does not req e
Therefore, I do not agree that a bacidit analysis is necessar i
to the proposed rule in Commissioner Dicus' vote is unnecessary Th e revision re' solution of the issues listed below, I approve t severallasues As presented the proposed Federal Register Notice contains seve errors : hat need to be corrected.
ypographical The FRN currently states incorrectly that the Commission grante
- (PRM $0-63 and 50-63A). In fact, the Commission did not granted PRM 50-63A in part. Therefore, the FRN should be revis The portion of the FRN which presents the petitioner's discussio petition contains some statements that draw conclusions and m the NRC's actions that in certain areas appear to be speculative NRC and FEMA intomaldecialons and actions. To clastfy the NR out past issue sad balance the information provided, the staff should prov perspective of the Commission's actions with respect to this issue.
The section entitled ' Analysis of leaues raised by Public Comm responses to questions and atsternerds and does not represent po Commission. Therefore, the statements that are currently attributed in this section should be changed (Wdloste.that the responeos are n
staff.
With respect to Kl purchases for the States, the NRC should n docussed in the Statement of Consideration in the FRN on E under the section on Funding, the Commission stated that *any direct f local governments solely for m.g:ny preparedness purposes by the Fede Agency (FEMA)is the lead Federal Agency for off t
the progenitor of the concept of funding such stockples in its draft FEM o
appropriate agency to ocek such an appropriation. Therefore, I do not However, I believe that the NRC should assist request for such a program of federally funded grants for State Ki stockpiles.
Notwithstanding my position on the NRC providing funding for the purc stockpbos, I agree with the recommendation in Commissioner Merrtfle in COMJM 98 002, that the NRC should provide fund ng for Kl stockpiles at appropriately
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'FROM CHAIRMAN J A C K b'O H 12.29.1998 20:37 P.14 k
loosted regional centers under the control of FEMA to the extent constraints.
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[7590-01 ADDRESSES: Comments may be sent to the Secretary of the Commission, Attention:
Rulemaking and Adjudications Staff, U.S. Nuclear Regulatory Commission, Washington, D 20555, or may be hand-delivered to One White Flint North,11555 Rockville Pike, Rockville, M 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. Copies of comments receiv be examined at the Commission's Public Document Room at 2120 L Street NW (Lower Le Washington, DC.
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You may also provide comment via the NRC's interactive rulemaking web site on the NRC home page (http1/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:
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By undertaking this rulemaking, the Commission is proposing ~to gra rulemaking ("PN. 5$67and 50-63A) from Mr. Peter Crane submitted on September 9,1995, and November 11,1997.
Considering all public comments received, the information available in the literature, 20 years of experience gained in evaluating licensee emergency preparedness plans, and the arguments presented by the petitioner, the Commission has decided to grant the petition for rulemaking and to proceed with rulemaking to amend 10 CFR 50.47(b)(10) b/ inserting the following sentence, after the first sentence: "In developing this range of actions, consideration p pk)
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first sentence: "In developing this range of actions, I
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 Fedcral Radiological Preparedness Coordinating Committee (FRPCC) Federal Register notice concerning Federal policy relating to the use of Kl for the general public.
pe/N^ E N On June 26,1998 (SRM 98-061), th'e Commission decided to grant th petition for e-e.ga.4%
rulemaking PRM-50-63A by sectd,3 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, my find that the Il-use of Kl as a protective supplement is reasonable and prudent for specific local conoitions.
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n m Petitioner's BasYs for Requesting Potassium lodide 6
The petitioner stated that potassium iodide '(Kl) protects the thyroid gland, which is highly sensitive to radiation from the radioactive iodine that would be released in extremely serious nuclear accidents. By saturating the gland with iodine in a harmless form, Kl prevents any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead to thyroid cancer or pther illnesses. The petitioner stated that the drug itself has a long shelf-life, at least 5 years, and causes negligible side effects.
I The petitioner further stated that, in addition to preventing deaths from thyroid cancer, KI prevents radiation-caused illnesses. The petitioner notes that thyroid cancer generally means
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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
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e The Petitioner's Discussion of the Potassium lodide Policy The petitioner stated that in NUREG-0632, "NRC Views and Analysis of the Recommendatio of the President's Commission on the Accident at TMl," issued in November 1979, the NRC l
agreed with the findings of the Kemeny Commission and planned to require nuclear pow licensees to have adequate supplies of Kl available for nuclear power plant workers and the general public as part of State emergency response plans.
According to the petitioner, the three agencies most concerned, the FDA, the NRC, and the Federal Emergency Management Agency (FEMA), favored the stockpiling of Kl for the nex several years. The petitioner stated that the Atomic industrial Forum, a nuclear industry trad association, declared itself against the stockpiling of Kiin 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 K I
supplementary memorandum withdrawing the memorandum of September 27. The later stockpiling. The petitioner further stated that on October 15,1982, less than 3 weeks after sending the draft policy statement to the Commission for approval, the NRC staff sent a 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 -
5eneficial than previously assumed. The NRC staff proposed sending this docume FDA and FEMA with the recommendation not to stockpile and distribute Kl. The petitioner indicated that the NRC staff briefed the Commission in November 1983 on the NRC proposal to take a strong position against Kl. A policy statement was later issued that disposed U
of the Kemeny Commission's recommendation % favor <el stockpiling Kl. According to the
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,_ Y rate had risen to 3.9 per 100,000.58 This included approximately 3,000 children, O to 18 years g!
old, that were evacuated from the 30-km zone within Belarus. Among this group, four thyroid
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A 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 i
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 6n Belarus children is currently about 750, and is estimated to reach a maximum of more than 3500 over the lifetime of this cohort.8^5 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.'
4 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, tilat the increase were attributable to the accident at Chemobyl. On April 28 (day 3), the country formed a govemmental commission to recommand protective actions. Among these actions,
'E. 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.
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- 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. 1
the commission recommended intervention levels for taking protective actions on the m
.f of April 29 (day 4).7 0, p On April 29, Poland's Minister of Health gave orders to prepare and distribute Ki to the i
. i 11 provinces most affected. Ki was to be made available through hospitals, public health b
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.
ed rn The Commission then instituted the following additional protectiv 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 o
consumption by children and pregnant or lactating women.
All children under the age of 4 were given powdered milk through numerous distribution centers.
Children and pregnant or lactating women were advised to eat a minimum of fresh leafy vegetables (until May 16,1986).
The distribution of Kl was initiated on April 29 (day 4) and was virtually completed by May 2 (day 7). This included the distribution of Ki to more than 90 percent of the children under Ll the age of 16 and about a quarter of the adults. A total of 10.5 million doses of Kl were give children and 7 million doses were given to adults. Multiple doses, although not recommended, were taken in a number of cases. Because of diminishing air contamination, the Kl prophylaxis 4
i was not repeated. In the second phase of the response, powdered milk was made available to I
all children less than 4 years of age. This program effectively started on May 3 (day 8).
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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."
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Issue 3
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" Stockpiling or predistribution of potassium iodide (KI) as a protective action would no add any significant public health and safety benefit to the current level of protectio provided by existing emergency plans for commercial nuclear power plants. Our emergency plans focus on evacuation as the key protective action to prevent exposure since it protects against exposure to all radionuclides, not just iodine. in addition potential for misadministration of Ki is present when predistributed to the general p and incidents of misadministration have been informally reported at industry m states which predistributed Kl to the public."
Commission Resoonse The Commission agrees that it is the State's prerogative to decide to include st or predistribution of Kl as a protective action for the general public. The FDA concluded that risks from short term use of relatively low doses of Kl are out weighed by the n
radiologically induced thyroid modules or cancers at a projected dose to the thyroid
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g 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 KI and, as prev t
a discussed, there were only 2 significant adverse reactions and 36,000 medically i
significant reactions (nausea) in 90 million doses of Kl after the Chemobyl accident.
The taking of K1 should require precautions similar to those associated with any oth over-the counter drug, and, of course, the packaging instructions should be followed. !
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proposed rule, the NRC believes that whether the Commission may be subject to tort liability through the implementation of a Kl program depends upon a number of factors.
However, it would appear that a Commist!on decision to require State and local emergency planning officials to consider stockpiling K1 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 liabiity. The question of whether a State [dlocality might be liable for involvement with administration of Kl to the general public can only be answered by reference to the laws and precedents of particular States. The NRC presumes that this would be part of the " consideration" that States and localities will undertake if this rule is promulgated. The NRC has not undertaken this analysis.
Issue 11
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Does the NRC staff consider stockpiling and using Kl as a reasonable and prudent protective measure for the general public?
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"This exception from waiver of sovereign immunity provides that:
Any claims based upon an act or omission of an employee of the Govemment, exercising due care, in t.1e 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 Gover;iment, whether or not the discretion involved be abused.
28 USC 2680(a). United States v. Varig Airlines,467 U.S. 797,808 (1984); Berkovitz v.
United States,486 U.S. 531 (1988).
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Commission Resoonse sw n
The Commission considers that State and local decision make information, may find that the use of Ki as a protective supplemen
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sheltering is reasonable and prudent for specific local conditions.
i The 1998 proposed Federal Policy on use of KI as an emergency pre measure for commercial nuclear power plant accidents is being develop FRPCC. FEMA plans to publish this policy in the Federal Register in nonetheless, it currently is proposed to state that:
workers and institutional: zed persons for radiolo discretion of State and, in some cases, local gove govsmment that selects the use of Ki as a protective measure for the purpose of purchasing a supply. The Federal offer to States represents an explicit recognition that this medicine can, under certa
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conditions, supplement other protection measures and thereby enhance p the public. State and local govemments that opt to include Kl as a protec maintenance, distribution and use. State and loca
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FEMA when the shelf life of the drug has expired and the supply needs to be i replenished. It t..ould also be noted that medical supplies, including KI, will be }
in support of State and local govemment respons 1
terrorism involving nuclear, chemical and biological agents. For radiological I
plants, this additional stockpile can be acquired ad h officials if they determine its use would be beneficial.
j Commission Decision On June 26,1998, the Commission decided to grant he petition i
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Accordingly, the NRC staff was directed to proceed with rulemaking to change 10 C s
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I 50.47(b)(10) by inserting the following sentence, efter the first sentence: "In d6veloping this 1
I range of actions, consideration has been given to evacuation, sheltering, and, as a supplement i
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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 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 governmont (most likely the NRC) will fund the purchase of a stockpile of Kl for the States upon request. The Commission also directed the NRC staff to work with other relevant agencies to ensure that there are established procedures to enablo the national stockpiles to be effectively and timely used by States that have not established local stockpiles and wish to make use of I
change 10 CFR 50.47(b)(10) with a 90-day public comment period. If the proposed rule is 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 adopted in final form, the petition would be granted and NRC action would be completed on PRM 50-63 and PRM 50-63A.
Commission Conclusions or issues Raised by the Petitioner and Public Commenters The Commission agrees with many of the issues raised by the petitioner and the public commenters. The[ommission has reached the following conclusions:
A.
The Commission agrees that Kl, if administered in a timely fashion, could protect the thyroid gland from exposure to radioiodines inhaled or ingested following a major radiological accident. This is the basis for stockpiling it and distributing it to emergency workers a'nd institutionalized persons during radiological emergencies. The petitioner believes that the l
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l three sub-options, concerning a proposed change in the Federal policy regarding the I
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 govemments of the Federal stockpiling of Kl.
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 rulem fW Given [he Commission considered the options and directed the sta petition, the only attematives considered here are the Commission approved option and the baseline, no-action altemative.
The proposed rulemaking does not *requira" anything of licensees, but States are to have shown " consideration" of the use of Kl along with evacuation and sheltering as protect 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
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million.
It is difficult to estimate the benefit of a State's consideration to stockpile Kl. However,
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we believe the benefit of such an action by the States is summed up by the petitioner who stated that the decision to stockpile Ki should tum on whether, given the enormous consequences of being without Kl in a major accident, the drug is a prudent measure; not on whether it will necessarily pay for itself over time. As the petitioner further noted, Kl represents l 1