ML20154C504
| ML20154C504 | |
| Person / Time | |
|---|---|
| Issue date: | 09/16/1998 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| SECY-98-061-C, SECY-98-61-C, NUDOCS 9810060292 | |
| Download: ML20154C504 (16) | |
Text
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[g uog'o UNITED STATES
, !' n NUCLEAR REGULATORY COMMISSION
{ $ WASHINGTON, D.C. 20555
%...../ .
RELEASED TO THE PDR .
COMMISSIONER *
- m a September 16, 1998 MEMORANDUM T0: John C. Hoyle. Secretary FROM: Edward McGaffigan, Jr.
SU8 JECT: COMSECY-98-016 - FEDERAL REGISTER NOTICE ON POTASSIUM IODIDE I am attaching for my colleagues' consideration a revised version of the draft Federal Reaister Notice (FRN) which I believe is more consistent with the Commission's decisions on SECY-98-061 and COMSECY-97-028. I apologize to my j colleagues and the staff for my delay in completing this revision. '
l I also note, as I said publicly on September 3. 1998 at the all employees l meeting, that I believe that the June 26, 1998 staff requirements memorandum (SRM) on SECY-98-061 and COMSECY-97-028 may not have provided sufficient !
guidance on the extent of the revisions the Commission expected in the FRN.
The simple addition of a single sentence to the FRN probably would not have i required resubmission of the FRN to the Commission. I believe that the [
requirement for resubmission implied broader changes of the sort Commissioners had discussed in their individual votes, but that was not explicit in the SRM [
and probably should have been.
L I also use this opportunity to raise another aspect of the June 26 SRM, namely the direction to release for public comment Enclosure 8 to SECY-98-061, the g/ji3 l staff paper " Assessment of the Use of Potassium Iodide (KI) as a Public Protection Action During Severe Reactor Accidents." That paper, now cited as NUREG-1633, has received severe criticism during the public comment period.
As one NRC staffer has pointed out to me, it was never intended to be !
supportive of the policy the Commission established in its June 26 SRM, but was instead a justification for the policy (not granting the revised petition for rulemaking) which the staff had advocated and the Commission rejected. As I admitted at the public meeting. I had not read Enclosure 8 in any detail when I agreed to put it out for public comment and peer review as the SRM was drafted. I made the mistake of thinking no harm could come from just putting a document out for public comment. I was wrong.
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The errors in NUREG-1633 can be corrected. But my more fundamental problem with the NUREG is that it is not the document needed by state'and local decisionmakers trying to decide whether to use KI as a supplement to evacuation and sheltering. A much better discussion is needed of how the practical problems in KI stockpiling, distribution and use are handled in the states which already use KI as a supplement and in the numerous nations who use KI as a supplement. A discussion, in some detail, of the various guidance documents of the World Health Organization and International Atomic Energy Agency, as well as our own Food and Drug Administration, would be very useful to state and local decisionmakers. What we need, in short, is a guidance document that is consistent with the policy adopted by the Commission in response to the petition for rulemaking and that fairly discusses the factors that need to be weighed in the state and local decisions. NUREG-1633 is not that document, and, to be fair to the staff, was never intended to be that document.
Therefore, I recommend that it be withdrawn (including from our web page) and substantially revised as part of the rulemaking process.
Attachment:
As stated cc: Chairman Jackson Commissioner Diaz E00 OGC OPA OCA ACRS
DRAFT
[ Commissioner McGaffigan's September 16, 1998, revision (marked in redline /strikout) of the Staf f's revision (highlighted in bold in the section, " Policy Considerations")
of FEMA'S final draft FRN, first conveyed to the Commission by the staff's October 23, 1997 memo.)
Billing Code 6718-06-P FEDERAL EMERGENCY MANAGEMENT AGENCY Revised Federal Policy on Use of Potassium Iodide forfThyroid Protection: 65 en Raergency Freperedness Meesure for in R'adiological'.EmergenciesLat Commercial Nuclear Power Plants Accidents AGENCY: Federal Emergency Management Agency.
ACTION: Issuance of Revised Federal Policy on Potassium Iodide.
SUMMARY
- The Federal Radiological Preparedness Coordinating Committee (FRPCC) is issuing this revised Federal policy in connection with the purchase, stockpiling and use of the drug potassium iodide (KI) as a prophylaxis tolprotedt for the thyroid glandifrom. thyroid cancer in tne unlikely event of a l I
at a commercial nuclear power major plant.radiological emergency'od and' Drug Admi'nistration Efound In:1978',lthe;U.S.[Fo KI'"safeLandteffective"-for?use in radiological emergencies and approved :its~ over-the'-counter; sale. Taken;inLtime,+KI blocks.:.the" thyroid's uptake of airborne' radioactive. iodine, andithusfcould help preventLthyroid cancer andTother' thyroid diseases1 caused-by:such exposure, especiallyg.in; children. It canctherefore supplement other protective actions,s-i.e.,
evacuation;andfin-place; sheltering,.usedLto} protect'the ~
general public' inca radiological 1 emergency'. Believing:that ;
prophylacticiuse ofiKI is a: reasonable and: prudent measure for specific localiconditions,-the Federal 1 government?will purchase. supplies!of KI forLthose 'tatesJ(or.in1some_
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cases, localTgovernments) that elect to make KI stockpiling, distribution,.and-use part of their. emergency plans.
CurrentTFederal policyfalready provide ~s that'KI should be stockpil'edfand' distributed to emergency. workers.and institutionalized persons during radiological emergencies. Ln I developing thel range of protective actions for'the general public :for severe accidents at commercial; nuclear' facilities, 1
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the available technical information indicates that evacuation and in-place sheltering. provide the best protection for the general public, because-they protect the whole body. KI provides additional protection for one radiation-sensitive organ, the thyroid, when used in conjunction with evacuation and/or sheltering.
The State (or in some cases, the local government) is ultimately rennonsible for theLprotection of its citizens.
Therefore, th decision for local stockpiling and use of KI as a protective t asure for the general public:is left to the discretion of State; (or in some cases, local government.)
However,. states should be aware that-the Federal government believes that?the use'of KI is a reasonable and prudent measure for specific local conditions, and that'for1 states with nuclear power plants within their borders, the NRC has initiated rulemaking that will require states to consider whether to include stockpiling, distribution,_and use of KI in their emergency. plans.
It is recognized that the_ state (or in some cases, the local government), within the limits of its authority, can take measures beyond those required by the Federal government. The availability of KI as a protective measure ~for the general public supplements other_ options for public officials responsible for' protective action decisions. A few States have long included KI as a protective action for the general public, others have recently. decided to stockpile and distribute KI, and still others are considering whether to do so. The FRPCC does not want.to deny a State the option of incorporating the use cNE KI as a protective measure for the general public. Therefore, the Federal _ government is prepared to provide' funding for the purchase of_a supply of KI. Any State (or in some-cases,_ local' government) which selects-the use of.KI as a protective measure for~the general public may so notify FEMA, and may' request funding for_the purpose of purchasing a. supply of KI.
In addition, the Federal government is also required to prepare for a wider range of radiological emergencies. To that end, and as an added assurance for radiological emergencies in which the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, limited stockpiles of KI-are being established.by the Federal government at a
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number of' sites around the U.S. These Federal stockpiles will be available on an_ad hoc basis to any State.for any type of radiological emergency, at any time. However, the stockpiles i l
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are limited and are not likely to provide enough KI for use in a major radiological emergency.
The policy herein, which was endorsed by both the FRPCC and the Commissioners of the Nuclear Regulatory Commission (NRC),
incorporates changes recommended by the FRPCC's Ad Hoc Subcommittee on Potassium Iodide, and supersedes the 1985 Federal policy (50 ER 30258). The principal differences between-this revised. policy and the 1985 version are the addition of the offer of the Federal government to purchase a supply of KI for States at a State's request; the establishment of a raderal stockpile; and the explicit recognition by the ioderal government, reflected in the offer to purchase.KI, that use of this; medicine can under certain conditions be a reasonable and prudent supplement.to other protective me'asures~and thereby enhance protection of the public. The Federal Emergency Management Agency (FEMA) chairs the FRPCC, thereby assuming the responsibility for this publication.
FOR FURTHER INFORMATION CONTACT: William F. McNutt, Senior Policy Advisor, room 634, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2857; facsimile (202) 646-4183. l l
SUPPLEMENTARY INFORMATION )
l Backaround This policy on the use of KI as a thyroidal blocking agent is ,
the result of a Federal interagency effort coordinated by the l Federal Emergency Management Agency for the Federal Radiological Preparedness Coordinating Committee. On March 11, 1982, FEMA issued a final regulation in the Federal Register (47 FR 10758), which delineated agency roles and responsibilities for radiological incident emergency response planning (44 CFR 351) . One of the responsibilities assigned to the Department of Health and Human Services (HHS) and in turn delegated to the Food and Drug Administration (FDA) was providing guidance to State and local Governments on the use of radioprotective substances and prophylactic use of drugs (e.g., potassium iodide), including dosage and projected radiation exposures at which such drugs should be used to reduce radiation doses to specific organs.
In the June 29, 1982, Federal Register, 47 FR 28158, the Food and Drug Administration published recommendations for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health officials 3 ATTACHMENT ,
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9 should consider the use of KI. The Federal policy on stockpiling and distributing KI was published in the July 24, 1985,~ Federal Register, 50 FR 30258. This policy recommended stockpiling or distribution of KI during emergencies for .
emergency workers and institutionalized persons, but,c onLeost-benefitfg~rdunds? did not recommend predistribution or stockpiling for the general public.
7 On September 11, 1989, the American Thyroid Association requested FEMA, as Chair of the FRPCC, to reexamine the 1985 policy and to revisit the issue of stockpiling and !
distributing KI for use by the general public. In response, ,
the FRPCC established an Ad Hoc Subcommittee on Potassium Iodide. On December 5, 1994, the FRPCC adopted the report and ,
recommendations of the Ad Hoc Subcommittee on Potassium Iodide,'which reaffirmed the Federal position as expressed in '
the 1985 policy.
On April 3, 1996, in connection with a September 9, 1995, petition for rulemaking submitted to the NRC on this' issue, the FRPCC established a new Ad Hoc Subcommittee on Potassium Iodide to review current information. The Subcommittee conducted a public meeting on June 27, 1996. Based on the information collected, the Subcommittee concluded that there was no new information that seriously challenged the bases
!(1 % ,jcostybenefit)' for the 1985 recommendations concerning pu**ic use of KI for radiological emergencies at commercial nuclear power plants.1 However, three recommendations were made to the FRPCC by the Subcommittee: (1) Without changing the Federal policy by interceding in that]itlis the State's prerogative to make its own decisions on whether or not to use KI, the Federal government (NRC, or through FEMA) should fund the purchase of a KI stockpile for any State that, hereafter, decides to incorporate KI as a protective measure for the general public; (2) the Subcommittee believed the language in the 1985 policy should be softened to be more flexible and balanced. For example, the problem many intervenors observe in the Federal policy is in the italicized statement, "The l Federal position with... potassium iodide for use by the !
general public is that it should not-[be] required." It would not be as negative if the last phrase were reworded to state "it'[ potassium iodide for use by the general public) is not 1 I
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% shodid %e; note'd',? howeve'r, thatO aEcost--benefittana' lysis E.h_e NRC published in:1995M(see. item 1951n the list of references at;th'efendsof this[ notice) was orders of 'magnitiude more favorable t.oatheLuse?of KIzthan,was the analysisipublished in 1985. :
4 ATTACHMENT )
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required, but may be selected as a protective measure at the option of the State or, in some cases, local governments"; and l' (3) The Subcommittee recommends that local jurisdictions who wish to consider the option of incorporating the use of KI in !
i their protective measures consult with the State to determine if such arrangements are appropriate. If local governments I have the authority or secure the approval to incorporate KI as l a protective measure for the general public, they would need to include such a measure in their emergency plans.
In addition to the FRPCC actions, the Federal government has broadened the scope of emergency preparedness to include resources to respond to terrorist acts involving nuclear, biological and chemical agents. Included among these resources are stockpiles of KI, which would be located in 27 metropolitan areas throughout the country and in three ,
national stockpiles located in the east, central and western i areas of the United States. These stockpiles would be available on an ad hoc basis, in the event of an accident at a commercial nuclear power plant. However,1the: stockpiles:are limited and"are'not likely to provide enough KI for~use in a major radiologica1' emergency.
On October 24, 1996, the full FRPCC endorsed the Subcommittee's recommendations with some minor modifications.
On June 30, 1997, the NRC (Coamission] approved the its J staff's recommendation to endorse the FRPCC position and to recognize the availability to State and local governments of the limitedEFederal stockpile of KI in connection with preparedness for acts of terrorism. The NRC Commissioners also asked that licensed nuclear power plant operators to discuss this revised Federal policy on KI with their counterparts in State and local agencies.
~
Onf'ovemberl5h 1997, thefCommiss' ion: held a publ'ic meetingtwith
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N its: staff? FEMA.-representatives,Dandithe.: author ofLthe 1995 rulemaking7 petition 1t ~o considertthe petitioniand; proposed changestto,theLFederalLpolicy on the use of-KI.; In;part.Lasia resultiofLthe meeting,-the.petitionerTamedded hisipetition, andioniJunc(26,f1998,.the Commission granteditheLamended petitioniand directeditheLNRC staff.to?initiatefrulemaking thatfw'ould; require lStatesLandflocal' governments tol consider the.use:of KIJas a' supplement;to other measures, i.a.,
evacuation'and)in-place..: sheltering,-used to.protectJthe generalipubliefin a' radiological emergency. TheLCommissioners alsofurged'that this Federal Recister notice include a
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statementitoEthe effect'that the.StateLand localidecision makers,'provided'with.properfinformation, may' find;that'the 5 ATTACHMENT
9 use of KI as a protective supplement is reasonable and prudent for specific local conditions. On September __, 1998, the Commission approved a draft Federal Recister-notice and directed that it be sent to the FRPCC.
Policy on Use of Potassium Iodide as an Emergency Preparedness Measure for Commercial Nuclear Power Plant Accidents The purpose of this document is to provide Federal policy and guidance with regard to distribution of KI and its use as a thyroidal blocking agent in response to commercial nuclear power plant accidents. The issue has been addressed in terms of two components of the population within the 10-mile Emergency Planning Zone that might require or desire KI use:
(1) emergency workers and institutionalized individuals, and (2) nearby general populations. This guidance is intended for those State and local governments who, within the limits of their authority, should consider these recommendations in the development of emergency plans and in determining appropriate actions to protect the general public.
1 In.1978, the U.S. Food and Drug Administration found KI " safe I and effective" for use in radiological emergencies.
The I current Federal policy is already provides that KI should be l stockpiled and distributed to emergency workers and I institutionalized persons during radiological emergencies, but lesves the decision for stockpiling end use of KI for the generel public to the discretion of St&te end, in some ceses, locel governments. In developing the range of protective actions for the gene'ral public for severe accidents at commercial nuclear: facilities, the available. technical information indicates that. evacuation and~in-place. sheltering provide the best protection for the' general-public, because they protect the whole body. KI provides additional protection for one radiation-sensitive organ, the thyroid, when_used in~ conjunction with_ evacuation and/or sheltering.
The State-(or in.some cases, the local' government) is ultimately responsible for the protection of its citizens.
~
Therefore, the decision for local stockpiling and:use of KI as a protective measure for the general public is left.to the discretion of State (or in some cases, l' ocal government. )
However, states-should be aware that the Federal-government believes that the usa-of KI is a reasonable and_ prudent measure for specific local conditions, and that for states with nuclear power plants within their. borders, the NRC has initiated rulemaking that will require states to consider whether to include stockpiling, distribution, and use of KI in 6 AlTACHMENT l
their emergency plans. !
It is recognized that options on the stockpiling, distribution, and use of KI for the general public rest with the States, and hence, State and local governments, within the j limits of their authority, can take supplemental measures !
beyond those reconcended or required n5tions11y by the Federal government. The availability of KI as a protective measure for the general public supplements other options for public officials responsible for protective action decisions. A few States have long included KI as a protective action for the l general public, others have recently decided to stockpile KI for possible use, and still others are considering whether to do so. The FRPCC does not want to deny a State the option to incorporate the use of KI as a protective measure for the general public. Therefore, the Federal government is prepared to provide funding for the purchase of a supply of KI.
Any State, or in some cases, local government, t selects the use of KI as a supplemental protection meast e for the general public may so notify the FEMA Regional Director from the FEMA Reg j on in which the State is located, and may request funding for the purpose of purchasing a supply. State and local governments that opt to include KI as a supplemental protective measure for the general public will be responsible for preparing guidelines for its stockpiling, maintenance, distribution and use. The snoorpor5 tion of 5 progrem for F l 5tockpiling, distribution end use by eny Stete ci 10061 government into the emergency plen5 will not be subjece 0 l Peder51 evelustion, except foi the decision meking process on its use. The State and local government may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished.
In addition, the Federal government is also required to prepare for a wider range of radiological emergencies. To that end, and as an added assurance for radiological emergencies in which.the location and timing of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, limited stockpiles of KI are being established by the Federal government at a number of sites around the U.S. These Federal stockpiles will be available on an ad hoc basis to any State for any type of radiological emergency, at any time. However, the stockpiles are limited and are not likely to provide enough KI for use by the general public in a major radiological emergency.
Policy Considerations 7 ATTACHMENT
The NRC and FEMA have issued guidance to State and local authorities as well as to licensees of operating commercial nuclear power plants in NUREG-0654/ FEMA-REP-1, Rev.1, recc.nmending the stockpiling and distribution of KI for thyroidal blocking during emergencies to emergency workers and to institutionalized individuals. That guidance is endorsed as an available protective action in the event of an incident at a commercial nuclear power plant. Thyroidal blocking for emergency workers and institutionalized individuals was recommended because these individuals are more likely to be exposed to the radiciodine in an airborne radioactive release than other members of the public. In addition, the number of emergency workers and institutionalized individuals potentially affected at any site is relatively small and requires a limited supply of KI that can be readily distributed.
The revised' policy partly reflects lessons l'arned from the e
Chernobyl disaster of 1986, both about the consequences of an accident and about the safety and efficacy of KI. The Chernoby1_ accident demonstrated that thyroid. cancer can indeed be'a major result of a large reactorLaccident. Moreover, although the Food'and Drug Administration declared KI " safe and eff2ctive" as long ago as 1978, the drug had never been deployed;on'a large scale until Chernobyl. The experience'of Polish health authorities during the-accident has provided confirmation.that_large; scale deployment..of KI is safe.
The. revised policy also~' reflects widescale' change'in international practice following the Chernobyl-disaster, specifically11989 World Health Organization recommendations (updated in-1995) and 1996 and 1997 International Atomic Energy Agency standards and guidance, which .have led to. use of KI:as a. supplementary protective measure in much of Europe, as well as in Canada and Japan.
This revised policy should not be'taken!to imply that the present generation'of-nuclear power plantslis any less safe than previously thought. On the contrary, present indications are.thatLnuclear power plant safety has substantially improved since the' current emergency planning _ requirements were put_in place after the Three Mile Island accident.
For the general public, in.the event of a radiological emergency at a commercial nuclear facility, evacuation and in-place sheltering'are considered adequate and effective protective actions in most cases. However, the inclusion of KI:as a protective measure, in addition to evacuation and 8 ATTACHMENT
sheltering, is beneficial in certain circumstances, as recognized by the World Health Organization, the International Atomic Energy Agency, and many European governments. The use of KI is not without controversy. On the one hand, KI can be an effective and safe drug for protecting the thyroid from the uptake of radiciodine, particularly I-131, especially for children 15 years of age or younger. The Food and Drug Administration has evaluated the medical and radiological risks of administering KI for emergency conditions and has concluded that it is safe and effective and has approved over-the-counter sale of the drug for this purpose. Food and Drug Administration guidance states that risks from the short term use of relatively low doses of for KI for thyroidal blocking in a radiological emergency are outweighed by the risks of radiciodine induced thyroid nodules or cancer at a projected dose to the thyroid gland of 25 rem or greater. Since the Food and Drug Administration has authorized the nonprescription sale of KI, it may be available to individuals who, based on their own personal analysis, choose to have the drug immediately available.
On the other hand, there may be logistical difficulties in predistributing the drug to potentially affected individuals, or in distributing the drug to the general public in a radiological emergencyr. Any distribution scheme should take care to ensure that orderly evacuation is not impeded or delayed by KI distribution. potentiel medicel side effects 6550ci5ted with the drug, in eddition to the use of evecuetion 55 the primery ens preferred protectivc ection, Although the post-Chernobyl data from Poland revealed few serious side effects, their possibility cannot be discounted, especially in certain groups of people. For example, people who are allergic to iodine should not take KI. Although the Federal policy is that use of KI is a reasonable and prudent supplement to evacuation or sheltering in specific local conditions, the FRPCC recognizes that the difficulties noted may dissuade some States and jurisdictions from its use.
It should be noted that the timely use of KI effectively reduces the radiation exposure of only the thyroid gland.
While this is an important contribution to the health and safety of the individual, it is not as effective as measures which protect the total body of the individual from radioactivity. Both in-place sheltering and precautionary evacuations can reduce the exposure to the thyroid and total body. The use of KI for thyroidal blocking is not an effective means by itself for protecting individuals from the radioactivity in an airborne release resulting from a nuclear 9 ATTACHMENT
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. l cheese to heve the drug immedietely eveileble.
Other considerations and problems to be evaluated by the State !'
and local authorities in deciding whether to institute a program for the use of KI by the general public include: (1) !
Whether the KI should be distributed to the population before I an accident occurs or as soon as possible after an accident occurs; (2) whether the risks of exposure to radioactivity ]
will be lower if the evacuation.of the general population is ,
initiated - mwitiforlwithouitthe use of KIl ,- or if the l
, general population is sheltered and the administration of KI ,
initiated; (3) how the KI will be distributed during the l emergency; (4) if KI is predistributed, what assumptions should be made about its actual availability and use in the event of an incident; (5) what medical assistance will be ,
available for the individuals who may have some adverse reaction to KI; (6) how medical authorities will advise the ;
. population to take KI and under what circumstances this advice will be given, i.e., methods for public education, information and instruction; and (7) how the authorities will provide KI to transient populations. )
i In addition, there are some site-specific considerations to evaluate. Whether KI should be stockpiled and distributed to the general public around a particular site may depend on local conditions. Decisions on its use and the use of l alternative protective measures during an emergency may depend i on prevailing accident and environmental conditions.
Summary In summary, the revisedfFederal policy is that KI should be stockpiled and distributed to emergency workers and
- institutionalized persons for radiological emergencies, but leaves the decision on whether to stockpile, distribute and use KI for the general public to the discretion of State and, in some cases, local governments. Any State or local government that selects the use of KI as a protective measure for the general public may so notify the appropriate FEMA Regional Director, and may request funding fo.r_.the purpose of purchasing a supply. The; government now explicitly.
recognizes,4what isipartly reflected in this; offer _to purchase Kli+that-this medicine can,-under certdin conditions, supplement.otherl protective measuresiand.thereby; enhance protectionJof;,the-public. State and local governments that opt to include KI as a protective measure for the general public will be responsible for preparing guidelines for its 11 ATTACHMENT ;
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stockpiling, maintenance, distribution and use. State and local governments may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished.
It should also be noted that medical supplies, including KI, will be stockpiled in 27 metropolitan areas and in three national stockpiles across the country in support of State and local government response to emergencies caused by acts of terrorism involving nuclear, chemical and biological agents.
For radiological emergencies resulting from any cause, including accidents at commercial nuclear power plants, this additional stockpile can be acquired ad hoc by State or local government officials if they determine its use would be beneficial.
The following references are intended to assist State and local authorities in decisions related to use of KI:
- 1. National Council on Radiation Protection and Measures (NCRP) Protection of the Thyroid Gland in the Event of Releases of Radiciodine. NCRP Report No. 55, August 1, 1977.
- 2. Food and Drug Administration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency, 43 FR 58798, December.15, 1978.
- 3. . ' Report of the President's Commission: on .the Accident at Three MilefIsland,3 1979.
- 94. Nuclear Regulatory Commission, Examination of the Use of ,
Potassium Iodide (KI) as an Emergency Protective Measure for !
Nuclear Reactor Accidents. NUREG/CR-1433, October 1980. l Prepared by Sandia National Laboratories for the NRC. )
l
- 45. Halperin, J.A., B. Shleien, S.E. Kahans, and J.M.
Bilstad, Background Material for the Development of the Food and Drug Administration's Recommendations on Thyroid Blocking with Potassium Iodide. FDA 81-8158, U.S. Dept. of Health and Human Services, March 1981. l
- 56. Food and Drug Administration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency:
Recommendations on Use. April 1981. Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Administration, Department of Health and Human Services.
- 67. Food and Drug Administration (HHS), Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency: Final Recommendations on Use. (Notice of Availability 47 FR 28158, 12 ATTACHMENT
e I
1 1
June 29, 1982.
- 48. Federal Emergency Management Agency, Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites
)
for Use as a Thyroidal Blocking Agent, 50 FR 30258, July 24, !
1985. l I
- 9. Halperin, J., Potassium Iodide as a Thyroid Blocker--Three ;
Mile Island to Today, DICP, The Annals of Pharmacotherapy, Vol l 23, May 1989.
- 10. Food and Drug Administration, Potassium Iodide as a )
Thyroid-Blocking Agent in a Radiation Emergency:
Recommendations on Use. . Prepared by the_ Bureau.of )
Radiological. Health and Bureau of Drugs, April 1992.
- 11. Environmental Protection Agency, Manual of Protective Action Guides and Protective Actions'for Nuclear Incidents.
EPA-400-R-92-001, May 1992.
- 12. Nauman, J.,-and Wolff, J., Iodide Prophylaxis in Poland After the Chernobyl Reactor Accident: Benefits and Risks, American Journal of Medicine, Vol. 94, p. 524, May, 1993.
013. Nuclear Regulatory Commission, Re-Evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at a Nuclear Power Plant. SECY-93-318, November 23, 1993.
14,. Nuclear Regulatory Commission,-Re-Evaluation of. Policy Regarding Use'of Potassium Iodide After a Severe Accident at a l Nuclear Power Plant. SECY-93-318, November 23, 1993. l 915. Nuclear Regulatory Commission, Supplemental Information Regarding the Cost-Benefit of KI Prophylaxis, February 1994. j Prepared by S. Cohen and Associates, inc., for the NRC.
te16. Nuclear Regulatory Commission, Addendum to SECY-93-318, Re-Evaluation of Policy Regarding Use of Potassium Iodide After a Sever Accident at a Nuclear Power Plant. SECY-94-087, March 29, 1994.
til7. Federal Radiological Preparedness Coordinating j Committee, Ad Hoc Subcommittee on Potassium Iodide, i Subcommittee Report and Recommendations, September 15, 1994. l
- 18. World Health Organization, Manual o't Public Health Actions in Radiation Emergencies, 1995.
ATTACHMENT I 13 1
te19. Nuclear Regulatory Commission, An Analysis of Potassium Iodide (KI) Prophylaxis for the General Public in the Event of a Nuclear Accident. NUREG/CR-6310, February 1995. Prepared by S. Cohen and Associates, Inc., and Scientech, Inc., for the NRC.
- 20. . International Atomic Energy Agency, International Basic Safety Standards for Protection Against Ionizing Radiation and forfSafety of' Radiation Sources. Safety Series No. 115, 1996.
4921. Federal Radiological Emergency Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Public Meetings: Federal Policy on the Purchase and Stockpiling of Potassium Iodide for Use by the General Public in Radiological Emergencies at Commercial Nuclear Power Plants. Transcript, June 27, 1996.
++22. Federal Radiological Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Subcommittee Report and Recommendations, October 3, 1996.
t523. Nuclear Regulatory Commission, Proposed Federal Policy Regarding Use Potassium Iodide After a Severe Accident at a Nuclear Power Plant. SECY-97-124, June 16, 1997.
24., International Atomic. Energy Agency, Method for the Development of Emergency Response Preparedness fora Nuclear.or
~
i Radiological Accident. .Tecdoc-953, July 1997. i 2 5. - International Atomic Energy Agency, Generic' Assessment l Procedures-for Determining Protective Actions.During a Reactor Accident. Tecdoc-955, August 1997.
Dated:
O. Megs Hepler, 111 Chair Federal Radiological Preparedness Coordinating Committee DRAFT 14 ATTACHMENT