ML20154A873

Staff Requirements Memo Re COMSECY-98-016, FRN on Potassium Iodide

ML20154A873
Person / Time
Issue date:	09/30/1998
From:	Hoyle J NRC OFFICE OF THE SECRETARY (SECY)
To:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
References
REF-10CFR9.7 NUDOCS 9810050029
Download: ML20154A873 (16)

Text

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k NUCLEAR REGULATORY COMMISSIpN RELEASED TOTHE PDR e

o WASHINGTON, D.C. 20555-0001 e

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. September 30, 1998 SECRETARY MEMORANDUM TO:

L. Joseph Callan Exec e Directo for Operations FROM:

John oyle' ec ry

SUBJECT:

STAFF REQUIREMENTS - COMSECY-98-016 - FEDERAL REGISTER NOTICE ON POTASSIUM IODIDE The Commission has approved the attached revision to the Federal Reaister Notice (FRN) on potassium lodide (KI). The draft FRN should be provided to FEMA for distribution to other Federal Agencies that are members of the Federal Radiological Preparedness Coordinating Committee (FRPCC) for their review.

(EDO)

(SECY Suspense:

10/2/98)

The staff should issue a Federal Reaister notice that states that, in light of the many useful public comments on draft NUREG-1633, a substantially revised document that takes those comments into account will be issued in its place, and that the draft NUREG is therefore being withdrawn (it should also be withdrawn from the NRC's Website). The reissued document should include an improved discussion of how the practical problems in KI stockpiling, distribution, and use are handled in the states which already use Kl as a supplement and in the numerous nations who use Kl as a supplement. A discussion, in some detail, of the various guidance documente of the World Health Organization and Intemational Atomic Energy Agency, as well as the U.S. Foed and Drug Administration, would be very useful to state and local decisionmakers. The guidance document should be consistent with the policy adopted by the Commission in response to the petition for rulemaking and should fairly discuss the factors that need to be weighed in the state and local decisions. The revised document should be submitted to the Commission as a SECY information paper.

(EDO)

(SECY Suspense:

Date Draft Final Rulemaking is Provided To the Coramission) f

Attachment:

R. ised FRN on potassium iodide w

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C f r1 10

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KPLM-Scx M i

9010050029 980930 PDR 10CFR PT9.7 PDR

cc:

Chairman Jackson Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)

PDR DCS

DRAFT Billing Code 6718-06-P FEDERAL EMERGENCY MANAGEMENT AGENCY Federal Policy on Use of Potassium Iodide

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_ n - Gm.-o AGENCY:

Federal Emergency Management Agency.

ACTION:

Issuance of M d$ Federal Policy on Potassium Iodide.

SUleIARY:

The Federal Radiological Preparedness Coordinating i

Committee (FRPCC) is issuing this revised Federal pol,icL ~n connection with the purchase, stockpilin and t.se of 3:$fdrug as a r

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'f{r[dsE}%EUE3diiE5f[ dis 6ffdifEfhTsif6M5"df516"di5E1 emergency; 1

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 polic

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pub 1IcQ 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, 50p C Street SW., Washington, DC 20472, (202) 646-2857; facsimile (202) 646-4183.

SUPPLEMENTARY INFORMATION Backaround This policy on the use of KI as a thyroidal blocking agent is the result of a Federal interagency effort coordinated by the 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 ATTACHMENT

i c

l should consider the use of KI.

The Federal policy on i

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 but 66hEh85m emergency workers and institutionalized persons, y

t MEfEfgfo'Q$El did not recommend predistribution or stockpiling for the general public.

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 g@eneral public.the FRPCC established M$i G E M

$n3 M fd @ an Ad Hoc In response, Subcommittee on Potassium Iodide.

On December 5, 1004, the PRECC edopted the report end recommendetions of the Ad Hoc Cubcommittee on Pete55 ids Iodide, which reeffirmed the rederel position 55 cxpressed in the 1005 policy.

On April 3, 1900, in connection with e Septeeler 0,

1000, petition for rulemeking submitteu to the NRC on this issue, the PRECC esteblished e new Ad Hoc Cubcommittee on rote 55ium Iodide to review current informetion.

The BK66fid Subcommittee conducted a public meeting on June 27, 1996.

Desed on the informetion collected, the 3dbcoamittee concluded thet there wes no new informetion thet seriously chellenged the beses for the 1005 recoseendetions concerning public use of KI for commerciel nucleer power plents.

rediologicelemher--nciesetW @ M @j three recommendations were mede i

36

!!owever Eb to the FRPCC by the Subcommittee: (1) Without changing the Federal policy by interceding in t!M@6Q 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 beliewed the language in the 1985 policy should be softened to be more flexible and balanced.

For exemple, the problem meny intervenors observe in the rederel policy is in the itelicized stetement, "The

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-vutu vuuciat guvitu to wuau not be e5 negetise if the lest phrese were reworded to 5 tete "it [pote55ium iodide for use by the generel public' is not required, but mey be selected es e protective meeeire et the option of the Otete ar, in some ceseo, locel governments", end (3) The Subcommittee recommends thet local jurisdictions who wish to consider the option of incorporating the use of KI in their protective measures 3.68_6.f8 consult with the State determine if such arrangements are appropriate andy i_,to

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10061 governinents heve the euthority or 5eonze the approvel to incorporete IG e5 e protectivo messure for the generel pu'ello, 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 areas of the United States.

These stockpiles would be available on an ad hoc basis, in the event of an accident at a flTnHIdT56 fay 55Ifio'tWiTElyTtBIIFii6Yidd$db"hif5EE511RTEE5 commercial nuclear power plant.

EwdifeW ssWEistrang$1ssgratorsatsusiisdgnEn~j~ ~lhyShj hDKiM oi use On October 24, 1996, the full FRPCC endorsed the Subcommittee's recommendations with some minor modifications.

On June 30, 1997, the NRC [Cowni35 ion] approved the $$

stafffA recommendation to endorse the FRPCC position and to recognize the availability to State and local governments of the MattA ] Federal stockpile of KI in connection with d

preparedness for acts of terrorism.

The J.RC 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.

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Policy on Use of Potassium Iodide as an Emergency Preparedness 1 ATTACHMENT

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l 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 terme of two componants 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, YFiff6H K@66ndi?I D ife 4 $ji ~ o.Eh fj "d gg d 6. fhe wn

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ploLes that KI should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, but leeves the decision for stockpiling end use of "I for the gener61 public to the discretion af Otete end, in seine ce5es,

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It is recognized that options on the sitiSd${lTnM distribution, and use of KI for the general public rest with ATTACHMENT

i the States, and hence, State and local governments, within the

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w Any State, or in some cases, local government, that selects the use of KI as a supplemental protection measure for the general public may so notify the FEMA Regional Director from the FEMA Region 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 incorparetion of & progree for KI stockpiling, distribution end u se-bymy Otete Or lacel government into the e nergency pism, will not be subject to Federel evelustien, e;& cept foi the det muon aking process On its use.

The State and local government ma) also contact FEMA i

when the shelf life of the drug has expired and the supply needs to be replenished.

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nuclear power plants in NUREG-0654/ FEMA-REP-1, Rev.1, recommending 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 otentially affected at any site is relatively small and

quires a limited supply of KI that can be readily distributed.

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and local authorities in deciding whether to institute a program for the use of KI by the general public inc'.ude: (1)

Whether the KI should be distributed to the population before l

an accident occurs or as soon as possible after an accident occurs; (2) whether the risks of exposure to radioactivity j

will be lower if the evacuation of the general population is initiated $3 Hiihifr HIThK6B31 @ yS Eo MRi M or if the general population is sheltered and the administration of KI initiated; (3) how the KI will be distributed during the 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.

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 alternative protective measures during an emergency may depend on prevailing accident and environmental conditions.

Summary In summary, the EeyfGMFederal 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 reguest funding for the rgose of purchasing a su jedeQGf6E

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pujspMh[ 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 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 ATTACHMENT

should also be noted that medical supplies, including KI, will be stockpiled in 27 metropolitan 'reas 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 Radioiodine.

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.

P

@ @2sTC# W 4 M 26n W G EM3 6 MNs 9].

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.

Prepared by Sandia National Laboratories for the NRC.

4].

Halperin, J.A.,

B.

Sh3eien, S.E. Kahans, and J.M.

Bilstad, Background Material for the Development of the Food l

and Drug Administ ation's Recommendations on Thyroid Blocking with Potassium Iodide.

FDA 81-8158, U.S.

Dept. of Health and Human Services, March 1981.

l 5$.

Food and Drug Administration (HHS), Potassium Iodide as a l

Thyroid-Blocking Agent in a Radiation Emergency:

l 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.

62.

Food and Drug Administration (HHS), Potassium Iodide as a l

Thyroid-Blocking Agent in a Radiation Emergency: Final Recommendations on Use.

(Notice of Availability 47 FR 28: 0, June 29, 1982.

4l.

Federal Emergency gement Agency, Federal Policy on Distribution of Potassium lodide Around Nuclear Power Sites

' ATTACHMENT l

4

~ _ -. _ _ -

for Use as a Thyroidal Blocking Agent, 50 FR 30258, July 24, 1985.

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Nuclear Regulatory Commission, Re-Evaluation of Policy Regarding Use of Pctassium Iodide After a Severe Accident at a Nuclear Power Plant.

SECY-93-318, November 23, 1993.

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p' 93 Nuclear Regulatory Commission, Supplemental Information Regarding the Cost-Benefit of KI Prophylaxis, February 1994.

Prepared by S. Cohen and Associates, inc., for the NRC.

TOM.

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.

itfj.

Federal Radiological Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Subcommittee Report and Recommendations, September 15, 1994.

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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 Assoc.iates, Inc., and Scientech, Inc., for the ATTACHMENT

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Federal Radiological Emergency Preparedness Coordinating Comrtttee, Ad Hoc Subcommittee on Potassium Iodide, Pu'elic M6etings: 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.

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Federal Radiological Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Subcommittee Report and Recommendations, October 3, 1996.

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Nuclear Regulatory Commission, Proposed Federal Policy Regarding Use Potassi'im Iodide Af ter a Severe Accident at a Nuclear Power Plent.

'ECY-97 -12 4, June 16, 1997.

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O. Megs Hepler, 111 Chair Federal Radiological Preparedness Coordinating Committee j

DRAFT ATTACHMENT

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