ML20205R913
| ML20205R913 | |
| Person / Time | |
|---|---|
| Issue date: | 12/29/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| SECY-98-264-C, NUDOCS 9904260008 | |
| Download: ML20205R913 (13) | |
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, 'FROM CHilRNAH JACKSON 12.29.1998 20:36 P.12
! t NOTATION VOTE RESPONSE SHEET
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RELEASED TO THE PDR .
TO:
John C. Hoyle, Secretary "/
FROM:
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CHAIRMAN JACKSON
SUBJECT:
SECY-98 264 - PROPOSED AMENDMENTS TO 60.47; GRANTING OF PETITIONS FOR RULEMAKIN 80-63 AND 60-63A) RELATING TO A REEVALU POLICY ON THE USE OF POTASSIUM IODI SEVERE ACCIDENT AT A NUCLEAR POWER PLA Approved __xjn partOlsapproved. yin part Abstain Not Participating _ _
COMMENTS:
see attached comments.
These coments also apply to COMJSM-98-002. ;
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Shirley Ann Jackson SIGNATURE t>lmist DATE 020031 Entsred on "AS" Yesl No 9904260000 901229 ORREW ND E PDR
FROM CHAIRMAN JAcr50H 12.29.1998 20s37 P.13 04ld Chairman Jackson's Comments on SECY 98 264 and COMJg1DA0 .
Commission provided to the staff relative ng eto the d (PRM 50-63A). Regarding the recommendations by Commissioners Dlcu change the proposed rule to prevent a backfit issue, the proposed rule on States and the licensees consider the use of Kl. This rule only represen parties to consider the use of Kl as part of their emergency plans, a considera parties have already performod in the past, and does not require the part Therefore, I do not agree that a backfit analysis is necessary. As such, t .
to the proposed rule in Commissioner Dieus' vote is unnecessary. There a o
re' solution of the issues listed below, I approve the pub As presented the proposed Federal Register Notice contains several min errors that need to be corrected.
i The FRN currently states incorrectly that the Commission granted two petition
) (PRM S0-63 and 50-63A). In fact, the Commission did not grant PRM granted PRM 50-63A in part. Therefore, the FRN should be revised to clarify th The portlen of the FRN which presents the petitioner's discussion of the basis petition contains some statements that draw conclusions and makes stateme
, NRC and FEMA Internal deelstons and actions. To issue end balance the Information provided, the staff should provide a brief h perspective of the Commission's actions with respect to this issue.
The section entitled
- Analysis of lasues raised by Public Comments
- repre responses to questions and statefnents and does not represent policy decisions
, Commission. Therefore, the statements that are currently attributed to the Com in this section should be changed to Indloate that the responses are those of t staff.
With respect to Kl purchases for the States, the NRC should not be the discussed in the Statement of Consideration in the FRN on Emergency under the section on Funding, the Commisston stated that "any direct funding of St ,
local governments so!aly foremergency preparedness purposes by the Federal government would come through FEMA." Because the Federal Emergency Mana Agency (FEMA)is the lead Federal Agency for offsite planning and preparednes the progenitor of the concept of funding such stockpiles in its draft FEMA FRN FE appropriate agency to seek such an appropriation. Therefore, i do not approve th However, I believe that the NRC should assist FEM request for such a program of federaty funded grants for State K1 stockpiles.
Notwlthstanding my position on tho NRC providing funding for the purchase of KI f in COMJM 98 002, that the NRC should provide fstockpiles, I agr unding for Kl stockpiles at appropriately
'FROM. CHAIRMAN J4 K50H 12.29.1998 20 37 P.14 3 ;;3,*a*aa'~ - in. n,,,,,w^<atn.~ .nna ,,,,,, ,,,; 4>f e 1
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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,.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 l
be examined at the Commission's Public Document Room at 2120 L Street NW (Lower Level),
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Washington, DC.
You may also provide comment 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 l 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: , t
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By undertaking this rulemaking, the Commission is proposing to grant-twe petit rulemaking (PRM 55tT3 and 50-63A) from Mr. Peter Crane submitted on September 9,1995, and November 11,1997.
Considering a:1 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
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l l first sentence: "In developing this range of actions, e
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 l
policy relating to the use of Ki for the general public. pen 0^ bbb On June 26,1998 (SRM 98-061), the Commission decided to grant the petition for e- y ch %
rulemaking PRM-50-63A by uJccMg the requested amendment to 10 CFR 50.47(b)(10). The l 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 t
use of Kl as a protective supplement is reasonable and prudent for specific local conditions.
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Petitioner's Basts for Requesting Potassium lodide l
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The petitioner stated that potassium iodide (KI) protects the thyroid gland, which is l l
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, KI prevents l any inhaled or ingested radioactive iodine from lodging in the thyroid gland, where it could lead 4
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 )
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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 N
The Petitioner's Discussion of the Potassium lodide Policy 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 general public as part of State emergency response plans. i I
According to the petitioner, the three agencies most concerned, the FDA, the NRC, and 1 the Federal Emergency Management Agency (FEMA), favored the stockpiling of KI for the next several years. The petitioner stated that the Atomic Industrial Forum, a nuclear industry trade association, declared itself against the stockpiling of K1 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 1 proposing that the Commission agree with a draft interagency policy statement supporting Kl I
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 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 KI 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 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 h
of the Kerneny Commission's recommendationb favorW stockpiling Kl. According to the
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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
\ 'y,e 1 cancer cases have been detected since the accident. All of these cases were registered after j
! l the end of the latent period for radiation-induced thyroid cancer. Taking into account the l i
spontaneous rate of this disease in this age group and the number of evacuated persons, all of L ]
1 these cases are considered accident-induced. -
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The total number of excess 6n s 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.8 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 ionizing 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.
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the commission recommended intervention levels for taking protective actions on the morning
( of April 29 (day 4).7 l
On April 29, Poland's Minister of Health gave orders to prepare and distribute Kl to the
- 11 provinces most affected. Kl 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. d'p/O The Commission then instituted the following additional protectiveacass,8
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Feeding of cows on pastures or with fresh fodder was banned countrywide until May 15,1986.
Fresh milk with radioactivity concentration above 1,M0 Bq/L was banned for 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 Kl to more than 90 percent of the children under l
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 Kl prophylaxis p was not repeated. In the second phase of the response, powdered milk was made available to
'd 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 af ter the initial exposure to fallout from the continuing fire at the Chernobyl plant."
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" Stockpiling or predistribution of patassium 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 since it protects against exposure to all radionuclides, not just iodine. In addition, the potential for misadministration of Ki is present when predistributed to the general public, O
and incidents of misadministration have been informally reported at industry meetings by states which predistributed Ki to the public."
Commission Response The Commission agrees that it is the State's prerogative to decide to include stockpiling or predistribution of Kl as a protective action for the general public. The FDA concluded i
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 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 takir.g 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.
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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.
l However, it would appear that a Commission decision to require State and local emergency planning officials to consider stockpiling Ki for public distribution should be subject to the " discretionary function" exception to the Federal Tort Claims Act,28 USC l 2671, et seq.," which protects the Federal Government from liability. The question of whether a State Nlocality 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 I
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 upca 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 discretion involved be abused.
i 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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- fo kq Comrnission Response W
l,y The Commission considers that State and local decision makers, provided wi information, may find that the use of Kl as a protective supplement to evacuation an sheltering is reasonable and prudent for specific local conditions.
The 1998 proposed Federal Policy on use of Ki as an emergency preparedness measure for commercial nuclear power plant cecidents is being developed by the F7PCC. 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 emer 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 KI as a protective measure for the general publ:c 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 KI 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 e,Jpply 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 26,1938, the Commission decided to grant etition for rulemaking ^ '
Accordingly, tha NRC staff was directed to proceed with rulemaking to change 10 CFR
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! 50.47(b)(10) by inserting the following sentence, af ter the first sentence: "In developing this l I !
range of actions, consideration has been given to evacuation, sheltering, and, as a supplement !
i p to these, the prophylactic use of potassium iodide (KI), as appropriate." In addition, the 1l 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 l
supplement is reasonable and prudent for specific local conditions. The Commission also l 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 KI 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 enable the national stockpiles to be effectively l 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 rule is 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 KI, it 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 and 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 use of
- 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 4
- endorsed the Federal offer to fund the purchase of Kl for States at their request and endorsed I 1 Federal Radiological Preparedness Coordinating Committee (FRPCC) recognition of the availability to State and local governments of the Federal stockpiling of Kl.
I 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.
s @d i Given the Commission considered the options and directed the staff to grant the petition, the only alternatives considered here are the Commission approved option and the baseline, no-action alternative.
The proposed rulemaking does not " require" anything of licens,aes, 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 5
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