ML20059G824
| ML20059G824 | |
| Person / Time | |
|---|---|
| Issue date: | 11/23/1993 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-93-318, NUDOCS 9401250321 | |
| Download: ML20059G824 (10) | |
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POLICY ISSUE November 23. 1993 sEcy_93_318 (Notation Vote) a l
E9R:
The Commissioners L
I FROM:
James M. Taylor Executive Director for Operations
SUBJECT:
RE-EVALUATION OF POLICY REGARDINO USE OF POTASSIUM IODIDE AFTER A SEVERE ACCIDENT AT A HUCLEAR POWER PLANT I
_ PURPOSE:
To seek Comission guidance concerning a possible change in the NRC policy regardino the use of cotassium iodide (KI) as a radioprotective agent for the general public.
MBlGQ:
As pirt of the effort to resOve a Differing Professional Opinion concerning the use 6f KI, the staff recently sponsored a reanalysis of the costs and benefits 47 stockpiling potassium iodide for use by the general public, a protective measure not currently endorsed by Comission or Federal policy.
Although the reanalysis continues to show that there is insufficient benefit to justify iequiring power reactor licensees to purchase and stockpile potassium iodide, the balance between costs and benefits is much closer than when the issue was first examined in the early 1980's.
In particular, costs and benefits are almost equivalent for populations within five miles of a nuclear plant.
Results of the reanalysis differ in degree but not in substance from previous studies upon which the current policy is based. Consequently, there appears to be little quantitative evidence to support a change in Comission policy on public use of KI. However, also discussed in this paper are other, equally-important factors which suggest that the Comission may nevertheless consider such changes.
There are three options that can be taken with regard to this matter:
(1) make no change in existing NRC policy, (2) await a request from the appropriate interagency group which recomends federal policy in this area to comment on or endorse any proposed guidance before changing the current NRC policy, or (3) adopt a change in policy which would encourage the federal emergency planning authorities to acquire potassiu... iodide reserves that could N
Contact:
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be made available during a nuclear emergency. The staff is not united in its views on which is the recomended option.
In light of the fact that this is a national policy issue, and both Comission level and EDO level officas are involved. Commission guidance is requested.
RACKGROUND:
The current federal guidance to State and local agencies on the distribution of potassium iodide (Enclosure A) was promulgated in 1985 by the Federal Emergency Management Agency (FEMA) [50 FR 30285] in its capacity as Chair of the Federal Radiological Preparedness Coordinating Committee (FRPCC). As described in 44 CFR Part 351, the FRPCC was established to coordinate all Federal responsibilities for assisting State and local governments in emergency planning and preparedness for peacetime radiological emergencies.
t About 15 Federal agencies participate in the FRPCC: FEMA, NRC, EPA, DHHS, 1
DOE, DOT, USDA, D0D, DOC, DOI, DOS, DVA, GSA, NCE, and NASA. The NRC, as a FRPCC member, contributed an analysis (NUREF/CR-1433, Reference 1), which examined the costs and benefits of using potassium iodide as a radioprotective agent for the general public. The guidance stated that using KI to prevent radiciodine from accumulating in the thyroid gland could be an effective t
ancillary protective action during a nuclear power plant incident.
It further stated, however, that many factors made stockpiling or predistributing potassium iodide for the general public questionable. Therefore, the FRPCC i
recommended stockpiling or distributing potassium iodide during emergencies for emergency workers and institutionalized persons, but did not recommend requiring stockpiling or predistribution for the general public.
In 1989, a Differing Professional Opinion (DPO) was filed by a member of the OGC staff, which alleged deficiencies in the original cost-benefit analysis (NUREG/CR-1433) provided to the FRPCC by the NRC. The DP0 suggested that discussion by the staff at a November 1983 Commission briefing on KI could have left Commissioners ad members of the public with insufficient understanding of the nature of the adverse consequences (thyroid disease) that use of potassium iodide could avert. The DP0 also suggested that the cost-benefit analysis, by simply balancing the dollar costs of a KI program against the dollar costs of treating radiation-caused thyroid illness, gave inadequate consideration to the non-monetary costs of having an illness.
As reported to the Commission in SECY-91-321 (Reference 2), the DP0 panel developed a simplified analysis of the value and impact of the potassium iodide 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 take into account all of the issues raised by the DPO, and to incorporate new data currently available for several of the factors used in the analysis, the Office of Nuclear Regulatory Research was directed
-i to perform a detailed update of the NRC's potassium iodide policy basis, taking into account both qualitative and quantitative factors.
In September 1989 (Reference 3), the American Thyroid Association (ATA) submitted a letter to the Chairman of the FRPCC requesting that the committee reconsider the issues involved in stockpiling potassium iodide.
In a t
statement attached to the letter, the ATA proposed that:
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As best as can be determined at this time, no substantial stockpile of potassium iodide is available for public use. Despite the 1
unlikely event of an emergency requiring its use,'the ATA believes I
that the option of potassium iodide distribution should be available i
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 i
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possible distribution should its use be contemplated.
On the basis of the ATA letter and statement, the FRPCC asked the Department of Health and Human Services (HHS) to review the medical and clinical status of the use of potassium iodide.
In an initial response to this request, HHS reviewed current scientific literature on potassium iodide and its use as a blocking agent.
In february 1990, HHS reported to the FRPCC that no new scientific data had been found that would affect the basis for the 1985 guidance. To ensure a comprehensive review, HHS also decided to solicit, from appropriate organizations and individuals, new data, scientific opinions, and reports on the experience of States concerning potassium iodide use and.
distribution. This resulted in a meeting on issues associated with the use of potassium iodide as a radioprotective agent.
HHS convened [55 FR 25373] that meeting of experts on July 24, 1990 in Atlanta, Georgia.
In attendance were representatives of the State and federal agencies responsible for medical research, drug regulation, and radiological emergency response; representatives of medical assorbns; and nationally recognized experts in the fields of evidocr' nd nuclear medicine. The meeting was chaired by Daniel A. Hoffman,
...D., M.H.P., Assistant Director for Science, Center for Environmental Health and Injury Control, Centers for Disease Control.
Dr. David V. Becker, M.D., a signatory to the ATA petition, was the principal spokesperson for that organization at the meeting. His 1987 paper (Reference
- 4) entitled " Reactor Accidents, Public Health Strategies and Their Medical Implications," was distributed to participants.
It contains the following statements in its conclusions:
for maximum effectiveness, KI must be taken immediately before or at the time of exposure, a requirement producing major distribution 1
problems. The logistics of KI distribution are complex and seem to limit its use to special situations.
Significant side effects can occur from iodide ingestion, although they are not likely to be frequent with the KI dose proposed.
In most accident scenarios, the overall gain from K1 use seems to be marginal.
In considering KI use as a public health measure, we are confronted by the problem of establishing sound public policy in the absence of sufficient scientific information and in the face of conflicting and often unrealistic perceptions.
In October 1990, HHS reported to the FRPCC on its Atlanta meeting. The report (Reference 5) contained the following recommendations:
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4 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 has agreed to attempt to determine the locations and size of some KI supplies by identifying large customers of KI manufacturers. The FRPCC should l
request that the Conference of Radiation Control Program Directors j
attempt to identify appreciable supplies of KI within the States by surveying State Radiation Control Programs.
j 3.
The FRPCC should establish a working group of appropriate FRPCC agencies to address the issue of stockpiling. Group objectives should be to:
Review and catalog type, location, and expiration of existing suitable supplies of KI.
Review and determine feasibility of specific stockpiling recommendations made by meeting participants.
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Make final recommendations to FRPCC on U.S. Government KI stockpiling policy.
In April 1992, a report entitled "An Analysis of Potassium lodide (KI) l Prophylaxis for the Generai Public in the Event of a Nuclear' Accident" (Reference 6) was completed by S. Cohen & Associates under the sponsorship of NRC's Office of Nuclear Regulatory Research. A summary of the report is given in Reference 7, with a discussion of the various assumptions made in the analysis, including the assumption that stockpiled potassium iodide can be distributed to the population surrounding a nuclear power piant before that population is exposed to radioactive iodine.
j The reanalysis shows that the cost / benefit ratio for use of potassium iodide by the general public approaches a value of two for the small percentage of the exposed population within 5 miles of a nuclear plant. The results also show that the cost / benefit ratio remains from 50 up to 10,000 or higher Sr the exposed population further than 10 miles from a nuclear p? ant.
l In June 1993 the report was provided to representatives of FEMA and HHS, who i
co-chair the FRPCC Potassium Iodide Subcommittee. The Subcommittee reported on i
the NRC-sponsored analysis at a meeting of the FRPCC in September 1993.
It recommended initiating two studies to secure State input on implementation
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strategies for providing K1 to the public:
(1) request the Conference of Radiation Centrol Program Directors (CRCPD) to survey those States with nuclear power plants for opinions regarding Federal purchase and stockpiling of K1 and on 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 States related to KI storage, distribution, and dosage. The Subcommittee will use j
the results of the surveys and the NRC cost-benefit study and make recommendations to the FRPCC on whether the FRPCC 1985 policy statement on KI-l should be revised.
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5 DISCUSSION:
Reexamination of federal policy on the use of potassium iodide has been i
1 subject to considerable controversy, both within and outside of the NRC.
Because the reanalysis considers psychological costs, the assumptions and resulting uncertainties in the analysis have served to exacerbate rather than l
i resolve this controversy. However, there are other factors (beyond those explicitly included in the revised analysis) that may influence the Commission's decision regarding potassium iodide.
In support of a continuation of the present policy, that state and local l
governments should consider stockpiling potassium iodide for use by emergency workers and institutionalized persons but not for the general public, are the following:
Perceived Contrast in Commission Policy on Need for Protection To some members of the public, existence of a potassium iodide stockpile (like other kinds of emergency planning) may seem inconsistent with a Commission position that nuclear power plants are acceptably safe, even though the Commission requires K1 tablets for emergency workers. (On the i
other hand, the stockpile may provide reassurance to others that the l
Commission has taken appropriate measures to deal with remote contingencies).
Correct Emphasis on Protective Measures use of potassium iodide could be an effective auxiliary protective measure for the general population under some conditions, but the primary protective measure for most individuals is, and should continue to be, evacuation.
- Psychological Costs in the Regulatory Decision Making Process The current Commission policy on potassium iodide focuses on the monetary costs of illness in the recognition that non-monetary costs (discomfort, pain, anxiety, etc.) do not lend themselves to being quantified.
Inappropriate Sense of Protection In the case of predistribution, self-administration of potassium iodide may lead to an inappropriate sense of protection (e.g., "I took potassium iodide so I don't have to evacuate").
i in support of a change to the existing policy, which would encourage federal, state, and local authorities to acquire potassium iodide reserves that could be made available during or before a nuclear emergency, are the following l
considerations:
Efficacy of Potassium Iodide as Radioprotective Agent l
Based on the ability of KI under cptimal conditions to eliminate nearly l
all internal thyroid exposure (Reference 3), use of potassium iodide as.a thyrmJ-blocking agent is widely accepted.
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Low Cost of Stockpiling The absolute cost of stockpiling is very modest (5100,000 to a few
$100,000 depending on the population radius to be protected, with a yearly maintenance cost somewhere around 20% of the initial cost). Costs' a"
in this range present no significant barrier to stockpiling and are probably less than the cost of the continued studies.
Policy Applies to the Populations Closest to a Nuclear Power Plant I
The recommendation to exclude the general population from the existing potassium iodide policy is based on perceived lower risk to the general public, higher costs of stockpiling for a greater number of people, and the ability to evacuate the general public during an emergency. These considerations are less tronounced for populations closest to a nuclear power plant where the risk is highest and the number of people is relatively small.
Consistency with Some State and some Foreign Government Potassium Iodide Programs i
Several states, including Alabama and Tennessee, and a number of foreign-i governments (e.g., the Canadian provinces of New Brunswick, Ontario and Quebec, Austria, the Czech Republic, Poland, Slovakia, the former Soviet Union, and the United Kingdom) have plans.to provide potassium iodide to limited portions of the general population near nuclear power plants.
The staff's proposal would bring the. Commission into line with what has become, especially since the Chernobyl accident, generally accepted
- 3 practice in some parts of the developed world.
Expectations of the General Public There is the perception that potassium iodide should be stockpiled as a-measure consistent with general public expectation and belief that potassium iodide should and would be available if it were ever needed (or e
even thought to be needed, such as at Three Miie Island).
The Commission may consider: (1) no change in existing NRC policy, (2) await a request from the FRPCC to comment on or endorse any proposed FRPCC guidance before changing the current NRC policy, or (3) adopt a change in policy which would encourage the federal emergency planning authorities to acquire potassium iodide reserves that could be made available during a nuclear emergency.
OPTIONS:
1.
Make no change in existing NRC policy.
This option would result in continuation of the present policy that state-and local governments should consider stockpiling potassium iodide for use by emergency workers and institutionalized persons but not for the
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i general public. However, the public may consider the 1985 policy _
i contradictory because on the one hand it states that K1 can be an effective ancillary protective action during a nuclear power plant accident, and on the other hand, it does not support Federal stockpiling or predistribution of K1 so that it could be made available to provide protection to members of the public.
j 2.
Await request from FRPCC to comment on or endorse any proposed new FRPC:
guidance before changing current NRC policy.
This option is favored by the Deputy Executive Director for Nuclear Reactor Regulation, Regional Operations and Research and the Director, Office of Nuclear Reactor Regulation, and the Director, AEOD because it is consistent with the established federal process of waiting for the FRPCC to formulate federal policy that is subsequently commented on or endorsed by member agencies. It would result in continuation of the present policy until the FRPCC completes its studies, reconsiders the federal policy, and seeks the NRC's position on any proposed new FRPCC guidance. However, the current Commission policy on stockpiling potassium iodide may be an impediment to the willingness of the FRPCC to propose policy changes.
Furthermore, we are spending almost as much money continuing to study this issue as it would likely cost to establish potassium iodide stockpiles.
3.
Revise the current Commission policy now.
This option is favored by the Deputy Executive Director for Nuclear Materials Safety, Safeguards and Operations Support who has been primarily involved in attempting to reach resolution of the Differing Professional Opinion related to potassium iodide since it crossed EDO and.
Commission level offices. It would result in the approval of the following position:
Even though severe releases from potential accidents at NRC-licensed nuclear power plants are extremely unlikely, the Commission recognizes that in that unlikely event, potassium iodide could prove effective and useful under certain conditions. There also may be a benefit to the public in the immediate vicinity of the nuclear power plant in knowing that, in that unlikely event, a stockpile of potassium iodide will be available if needed.
For these reasons, the Commission supports the Federal Emergency Management Agency, which has the appropriate statutory authority for such expenditure, if it wishes to promulgate a new federal policy that' includes maintenance of a potassium iodide stockpile. This stockpile could be made quickly available to state and local governments in the onlikely event of a severe release from a nuclear power plant, or (on a strictly voluntary basis) be made available to the State emergency planning personnel for stockpiling in the local vicinity of the nuclear power plant, if they so desire.
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COORDINATION:
i The Office of the General Counsel has reviewed this paper.and has no legal l
objection.
RECOMMENDATION:
The' staff is not united in its views on the recommended optio':.
In light of
' the fact that this is a national policy issue and both Commission level and q
EDO level offices are involved, the staff requests Commission guidance on the options presented.
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J es M. Ta or xecutive irector for Operations
Enclosure:
Present NRC-Endorsed Federal Potassium Iodide Stockpiling Policy i
Commissioners' comments or consent should be provided directly to the Office of the Secretary by COB Wednesday, December 8, 1993.
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Commission Staff Office comments, if any, should be submitted to the Commissioners NLT. Wednesday, December 1, 1993, with an information copy'to the Office of the Secretary.
If the paper is of such a nature thatEit requires additional review and comment, the Commissioners and the Secretariat should be apprised of when comments may be expected.
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_EFERENCES:
R 1.
D.C. Aldrich, R.M. Blond, " Examination of t'he Use of Potassium Iodide (KI) as an Emercency Protective Measure for Nuclear Reactor Accidents,"
l Sandia National Laboratory Report NUREG/CR-1433, March 1980.
l l
-2.
J.M.- Taylor paper (SECY-91-321) for The Commissioners on "Re-Evaluation i
of Policy Regarding Use of Potassium lodide (KI) After a Severe Accident at a Nuclear Power Plant" dated October 11, 1991.
l 3.
D. Fisher, L. Wartofsky, D.S. Cooper and D. Becker (American Thyroid
_i Association) letter to R.W. Krimm (Federal Emergency Management Agency) dated September 11,1989 [see Attachment 2 of Reference _5 below).
4.
D.V. Becker, " Reactor Accidents, Public Health Strategies and Their i
Medical Implications," Journal of the American Medical Association, t
Vol. 258, pp. 649-654 (August 1987) (see Attachment 6 of Reference 5 below).
l 5
5.
J. A. Rabb (Department of Health and Human Services) letter to L. Soffer (NRC) dated October 3, 1990.
l 6.
"An Analysis of Potassium lodide (KI) Prophylaxis for the General Public
.f in the Event of a Nuclear Accident," U.S. Nuclear Regulatory Commission i
Report prepared by S. Cohen & Associates, Inc., April 1992. Available from the Office of the Secretary and _the Public Document Room.
q 7.
" Summary of Assumptions Made by and Results of the Potassium Iodide-l Stockpiling Cost-Benefit Ratio Reanalysis." Provided to J.A. Rabb (HHS) and V.L. Wingert (FEMA) by H.L. Thompson,- Jr., letter dated June 10, 1993. Available from the.0ffice of the Secretary and the Public Document.
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.t a e ENCLOSURES Predecisional t
Present NRC-Endorsed Federal Potassium Iodide Stockpiling Policy The present policy was established by the Federal Emergency Management Agency (FEMA), the chair agency of the Federal Radiological Preparedness Coordinating Committee (FRPCC), based upon the NRC-sponsored cost / benefit study l
" Examination of the Use of Potassium lodide as an Emergency Protective Measure ci for Nuclear Reactor Accidents", NUREG/CR-1433, Sandia National Laboratories,-
l Narch, 1980 (Reference 1).
The final Federal policy was published by FEMA in the Federal Register, Vol.
50, No. 142, July 24, 1985, cf. 30258, which states in part:
"In summary, the policy recommends the stockpiling or distribution of KI during emergencies for emergency workers and institutionalized persons, but does not recommend requiring predistribution or stockpiling for the general public."
Prior to its publication-in the Federal Register by FEMA, a draft of the proposed policy had been presented to the Commission for their negative consent by SECY-85-167, " Federal Policy Statement on the Distribution and Use of Potassium lodide", May 13, 1985.
In SECY-85-167, the Commission was i
informed that:
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"..The proposed Federal position with regard to the predistribution and stockpiling of K1 for use by the general public is that it should not be required. The new draft policy statement observes that iSile valid arguments may be made for the use of KI,.the l
prer aerance of information indicates that a nationwide requirement for the predistribution or stockpiling for use by the general public would not be worthwhile. The statement leaves the decision on the
-l use of K1 by the general public to the state and local authorities j
on a site specific basis...."
J By a Memorandum to William J. Dircks, EDO, from Samuel J. Chilk, Secretary, "SECY-85-167 - Federal Policy Statement on the Distribution and Use of Potassium Iodide", June 11, 1985, the staff was informed that "...the i
i Commission has not objected to your proposal to concur with the new draft Federal Policy Statement on Potassium Iodide."
As described in complete detail in SECY-85-167, the above-described approval by the Commission of the final form of the Federal potassium iodide policy (as published in the Federal Register, cf. 30258) followed a series of events
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during which the Commission had earlier stated that they favored inclusion of 4
a recommendation against requiring the distribution and use of potassium iodide by the general public. This was later changed to reflect that 'the 1
Commission favored inclusion of a statement that they believed "...this protective action is not worthwhile...." The final form of the policy, without such a statement, was approved by the Commission (as described above) following an OGC recommendation (SECY-84-161, April 17,1984) that the Commission adopt a more neutral approach to the distribution and use of potassium iodide as a protective action.
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