ML20132D163

Responds to 841115 Request Re Proposed Draft Federal Policy Statement on Distribution & Use of Potassium Iodide. Commission Approved 850326 Version.Encl Draft Should Be Distributed to State & Local Govts

ML20132D163
Person / Time
Issue date:	06/24/1985
From:	Jordan E NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:	Krimm R Federal Emergency Management Agency
Shared Package
ML20132D166	List: ML20132D163 ML20133E605 ML20133E620
References
NUDOCS 8507050455
Download: ML20132D163 (9)

Text

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5 soc uy'o, UNITED STATES

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g NUCLEAR REGULATORY COMMISSION

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J WASHINGTON, D. C. 20555

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JUN 2 41985 MEMORANDUM FOR:

Richard W. Krimm, Chairman Federal Radiological Preparedness Coordinating Comittee Federal Emergency Management Agency FR0 :.

Edward L. Jordan, Director Division of Emergency Preparedness and Engineering Response Office of Inspection and Enforcement

SUBJECT:

DRAFT FEDERAL POLICY STATEMENT ON THE DISTRIBUTION AND USE OF POTASSIUM IODIDE This responds to your request of November 15, 1984 regarding the proposed draft i:ederal policy statement on the distribution and use of potassium iodide.

The Comission has reviewed the draft policy statement that was distributed to the FRPCC on March 26, 1985 and finds that it is consistent with its views and opinions on this protective action. Accordingly, the NRC agrees with the accept-ability of the draft policy statement and concurs with its distribution to state and local governments as Federal guidance with the minor editorial changes

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annotated on the enclosed copy.

tdwa d

.J an Director Divisi of Emergency Preparedness and gineering Response Office of Inspection and Enforcement

Enclosure:

Draft Federal Policy Statement cc:

See page 2 O}D5O/E5

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JUN 2 41985 Richard W. Krimm cc:

W. J. Dircks, ED0 J. M. Taylor, IE R. H. Vollmer, IE J. G. Partlow, IE B. -K. Grimes. IE

' S. A. Schwartz, IE "D

B. Matthews, IE K. E. Perkins, IE C. R. Van Niel, IE F. Kantor, IE E. F. Williams, IE d

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i Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Acency he purpose of this document is to provide Federal policy and guidance with regard

o distribution of potassium iodide (KI) and its usage as a thyroid blocking agent tround operating nuclear power sites. The issue has been addressed in terms of two

mponents of the population that might require or ~ desire potassium iodide use:

(1)

Energency workers and institutionalized individuals, and (2) general population.

nis guidance is advisory to State and local governments who, within the limits of neir authority, should consider these recommendations in the development of emergency

ans and in determining appropriate actions to protect the general public.

In

} ': =ary, the policy recommends the stockpiling or distribution of KI during emergencies or emergency workers and institutionalized persons, but does not recommend requiring

redistribution or stockpiling for the general public.

The bases for these ecc=mendations are given below.

It is recognized, however, that options on the

-istribution and use of KI rests with the States, and hence, the policy statement

'.ermits State and local governments, within the limits of their authority, to take

>.easures beyond those recommended or required nationally.

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The U.S. Nuclear Regulatory Commission (NRC) and the Federal Emergency Management Agency (FEM.A) have already issued cuidance to State and local authorities as well

• s licensees of operating commercial nuclear power plants in NUREG-0654/ FEMA-REP-1, v.1, recomending the stockoiling and distribution during emergencies of KI

.or thyroical blocking _to emeroency workers and to institutionalized individuals.

That reconnendation is endorsed as an available protective action in the event of i

an incident at a nuclear power plant. Thyroid blocking for emergency workers and insticutionalized inpididuals was recoarnended because:

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(i) These individuals would be more likely to be exposed to the radiciodine in an airborne radioactive release from the plant in the event of an accident; (2) The number of individuals involved at any site is relatively small and requires a limited supply of KI that can be readily distributed; (3) The storage, distribution, and administration of KI can be readily controlled;

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(4) The known sensitivity to potassium iodide of this limited number of

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individuals can be reviewed; and, (5) These individuals can be readily monitored for adverse side effects by

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medical personnel.

1 ne Federal cosition with regard to the predistribution or stockoiling of cotassium ocion f or use by the oeneral public is that it should not be recuired.

While valid ircoments may be made for the use of KI, the preponderance of information indicates a nationwide requirement for the predistribution or stockpiling for use by the t.al public would not be worthwhile.

This is based on the ability to evacuate the neral population and the cost effectiveness of a nationwide program which has been

.alyzed by the NRC and DOE National 1.aboratories (NUREG/CR-1433y)4

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While X

ne use of KI can clearly provide additional pretection in certain circumstances, the Lssessment of the effectiveness of KI. and other protective actions and their implemen-

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. important to stress that the use of potassium iodide in a radiation emergency

s not a panacea in that it does not block the uptake of other radionuclides and

ces not protect against external radiation.

Furthermore, its use needs to be balanced tgainst the cost and effectiveness of other protective measures such as theltering j

.nd evacuation.

This recommendation is made in full recognition of the potential

.ositive effects of the drug, action by the FDA pennitting KI over-the-counter sales.

nd the authority of State and local health officials to elect to distribute and use

.ae drug based on the specific needs of individual sites.

he use of KI is effective as a thyroidal blocking agent in reducing accumulation ry tha thyroid. gland of radiciodine which has entered the body through inhalation or

'ngestion.. Radiciodine accumulation in the thyroid can be reduced to less than 10 cercent of what it would be without a blocking agent by a daily oral intake of (130

illigrams for adults, 65 milligrams for infants) KI providing administration is

tarted before or immediately after the exposure to the radioiodine, and treatment

entinues for at least 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> beyond the time of the last exposure.

This

ffectiveness decreases to less than 50 percent blocking of the radiciodine uptak'e, if administration of the KI is delayed until 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after an acute ingestion or inhalation.

is recognized that the ootions on distribution and use of KI for thyroidal

_ locking to protect the public health and safety resides with the State and in

r cases, local health authorities.

Therefore, with the exception of Feder

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y and utility personnel, the decision for use of KI during an actual. emergency

, una general public is the responsibility of these authorities.

In deciding whether

o distribute and use KI for the general population, these authorities must consider

. number of factors.

ne of the considerations in deciding whether to implement the distribution and use

f KI for the general population is that KI blocking effectively reduces the rad.iation exposure of only the thyroid gland.

While this is an important contribution to the

ealth and safety of the individual, it is not nearly as effective as measures which

rctect the total. body of the individual from radioactivity.

Both in-place sheltering 2nd precautionary evacuatiions can reduce the exposure to the thyroid and total body.

Fhe 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 power plant accident and, therefore, should only be considered in conjunction with sheltering, evacuation, or other protective methods.

he Food and Drug Administration (FDA) has evaluated the medical and radiological risks of administering KI for thyroidal blocking under these emergency conditions and has concluded that it is safe and effective and has approved over-the-counter sale of she drug for this purpose.

FDA guidance states that risks from the short term use of aelatively low doses of KI for thyroidal blocking in a radiation emergency are betweighed by the risks of radioiodine induced thyroid nodules or cancer at a projected po' to the thyroid gland of 25 rem or greater.

Since FDA has authorized.the non-br 1ption sale of KI, it is leoally available to individuals who, based on' their

<n personal analysis, choose to have the di uo immediately available.

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! considerations and problems to be evaluated by the State and local authorities

.:ciding whether to institute this program include:

(1) Whether the KI should be 4

Stributed to the population before an accident occurs or as soon as possible after

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, accident occurs; (2) whether the risks of exposure to radioactivity kl.11 be lower 1 the evacuation of the general population is initiated or if the general population i

sheltered and the administration of KI initiated; (3) how the KI will be distributed

ring the emergency; (4) what medical assistance will be available to assist the

,dividuals who may have some adverse reaction to XI; (5) how medical authorities ill advise the population to take KI and under what circumstances this advice will 4

2 given; (6) if KI is predistributed, what assumptions should be made about its

' :tual availability and use in the event of an incident.

(7) how the authorities ill provide KI to transient populations; and (8) whether use of other respiratory

! rctection-(e.g., dust masks, or breathing through wet towels) may be equally effective,

.:pecially in conjunction with sheltering.

1 a sumary, the use of KI to prevent radiciodine from accumulating in the thyroid l ;and can be an effective ancillary protective action during a nuclear power plant

cident.

However, many factors make stockpiling and/or pre-distribution to the

eneral public questionable.

Whether KI should be stockpiled and distributed to the

! eneral public around a particular site depends on local conditions.

Additionally icisions on its use or the use of altertiative protective measures during an emerge,ncy spends on accident and environmental conditions that may prevail at the time.

Any 3

j 2:ision by State and local authorities to use KI should be based on the conditions ite environment for the specific operating commercial nuclear power plant and 1

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.d include detailed plans for distribution, administration, and medical assistance.

e following references are intended to assist State and local ~ authorities in cisions related to use of KI.

s 1.

National Council on Radiation Protection and Measures (NCRP), Protection of i

the Thyroid Gland in the Event of Releases of Radioiodine.

NCRP-Report No. 55,

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August' 1, 1977.

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l 2.

Food and Drug Administration (HEW), Potassium Iodide as a Thyroid-Blocking Agent in a -Radiation Emergency. 43 FR 58798, December 15, 1978.-

3.

Halperin, J. A., B. Shleien, S. E. Kahana,' and J. M. Bilstad, Background Material for the Development of the Food and Drug Administration's Recomendations on Thyroid-Blocking with Potassium Iodide, F,DA 81-8158, U.S. Dept. of Health i

and Human Services (March 1981).

^

i 4

Food and Drug Administration, Potassium Iodide as a Thyroid-Blocking Agent in -

a Radiation Emergency:

Final Recommendations on Use.

(Notice of Availability) 47 FR 28158, June 29,1982.,

i 5.

Food and Drug Administration, Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency:

Recomendations on Use.

(April 1982) Prepared by the Bureau of Radiolooical Health and Bureau of Druas. Food and Druo Administration, Department of Health and Human Services.

6.

Nucle _ar Reculatory Commission. Examination of the Use of Potassium Iodide (KI) b As an Emergency Protective Measure for Nuclear Reactor Accidents)(March 1980).

F Prepared by Sandia National 1.aboratories for the NRC.

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.u 4-25GlTA Federal Register / Vol lio. No.119 /. Thursday. June 20, 1985 / Notices 4

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that day.New applicatinct involving be considered by the Commission in

[ Docket No.fD-2181-0001 y

this project site to the extentprosided determining the appropriate action to be for under 18 CFR Part 4. may be Ed on taken,but will not serve to mar gg

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the next business day.

protestants parties to the prawdms-june 13.1985.

Kenneth F. Plumb...., _

Any persoe wishing to become a party

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Seen tory.

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must h a motion to irttervene. Copies V rgil C. Summer (applicantJ Ed an 4'

Take notice that on May IL 1935.

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[FR Doc. 85-14M6 Filed 6-19-45[8:45 arn[

of thisfilmgare on h with the sumo cood orn.ons

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Commission and are available for public application pursuant to Section,305(b) of h the FederalPower Act to hold the

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inspection.

following positions:

IDocket No.RP&5-162-ooc 1 Kenneth F.Plumh-Directcr. South Carolina Elect-ic & Gas Southern Natural Gas Co.t Proposed Company Changes in FERC Gas Tariff 85-14st7 nied 6-19-45:8:45 amt Chief Executive Officer. Sout}. Carohna J

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Electric & Gas Company I""* 1N3-Chairman of Board. South C;rolina y

i Take notice that Southern Natural Electric & Gas Company

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Gas Company (Southeralon June 12, (Docket No. RP85-156-0011 Director, South Carolina Generating t'

1965. tendered for f2ing the folfowing Company, Inc 5

revised tariffsheets to its FERCCas Toriff. Sixth Revised Voluma No.1:

Valero interstate Transmission Co.t Chairman. South Carolina Generating First Revised Sheet No.40)

Corrected F!Iing Company

• Inc.

I Fourth Revised Sheel No. 41 Any person desmng to be heard or to Origina! Sheet No. 41A -

June 14.1985.

protest said filing should & a motion to The proposed eFective date of the Take notice that on June 12,1985, intervene or protest with the Federaf sheets is july 15.1985.

Valero interstate Transmission Energy Regulatory Commission.825 Southem's present Section 13 of the Company (Vitco) tendered for filing the North Capitol Street, NE., Washington, qi GeneralTerms and Omations provides following substitute tariff sheets D.C. 20426, m accordance with rules 211

(

- previ filing of Ma 31*

2H Me Omns&n s Ned a

that a purchaser may,within any I2 month period, decrease its enntract 1

f et h.

Im Practice and Procedure (18 CFR 385.211 j

385.214). All such motions or protests demand at any delivery point.if that FERC Gas Tadff.Odginal Vnfuma No.1 should be filed on or before June 24, purchaser or another purcf aser or other.

purchasers increase their contract Substitute 8th Remed' Sheet No.14 1985. Protests will be considered by the demands at other delivery points in total supersedng7th Revised SheetNo.14 Commission in determining the amount equal to the decrease.'provided appropriate action to be taken, but wdi tha t the increase ~d contract demand can FERC Gas Tariff. Original Volurna No. 2 not sem to make protestants parties to the proceeding. Anyperson wishing to be delivered without investment in new Substitute 2nd RevisedSheet No.6 become a party must & a motion to - * ' )

e, facifities (except minor ineasurement or

, delivery facilities) bySouthem. As strperseding 1st Revised Sheet No.6 intervene. Copies of this filing are ort Ble i

proposed. revised Section 13 of the Vitco's filing of May 31.1985 for the with the Commission and are available General Terms and Conditions would purpose ofreinstahgiWse tadff f r public inspection.

allow each of Southerrfs resale rates did not conectly re!Iect gas costs customers, subject to Southem's ability c,,g,.g ygg., pgggg, Secretary.'

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to deliver the gas, an opportunity to June 1,1985.

[FR Doc. 85-14849 Died 6-19-85; 8A5 aml I

receive a pro rata share of the contract Any person desm _,ng to be heard a to,,,,,,,,,,--

demand made available when one of protest said firing should file a motion to Southem's resalc *m requests a intervene er a protest with the Federal reduction in its total conteact demand in Energy Rep!atory Ccmmission.825 FEDr*.A!. EMERGENCY S

0 an amount greater than 1.000 Mcf. In North Capitol Street. NE. Washington, fJANAGEMENT AGENCY

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- addition. all customers desiring to D.C. 20428. in accordance with Rufes 211 increa se their total contract dema nds and 214 of the Commissien's Rules of Federal Policy on Distr!bution of would be entitled. subject to the abihty of Soutnern to dehver the gas. to receive Practice and Procedure (18 CFR 385.211, Potassium lodide Arcund Nucicar 5 Mcias a adninumshare of the '

uM4). All such motzons or protests Power sites for Use as a Thyroidal contract demand made a v=LMe should be Gled on or beforeJune 21.

Blocking Agent Copies of t!ds fihngleste been served 1985. Protests will be considered by the A AcENcy: Federal Emergency 1

Commission hr determining the and interested state pubac serviceupon Southern's jurisdichn==1 customers appropriate action to be take Management Agency.

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AcTsopr:Notire ofIssuance of Federa!

not serve to make p:utestants parties to Policy.

, commissions.

Any person destrmg to be heard orto the proceeding. Anyperson wishing to l

protest said f>Iing shock! & a motion to become a party most Ste a motion to SUMMARv:*Ibe Federal Radiologics!

9' intemne a protest wi e Federal intervene. Copies of this filing are on fife Preparedness Coordinating Committee Energy C--

.azs North Capitel with the Commission and are avaifable (FRPCC)is publishing this notice to h{

Street NE., Washmgtaus. D.C. 2042fi. ht g t Pu

..C m8Pectm.n.

provideguidance to State and tocal accordance with Rules 211 and 214 of agencies respcasih for radictogical the Commission's Rafes af Practice and K

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emergency planning and preparedness i

Procedure (18 CFR 385.211.385.214) All S'C*'ry-regstding the d.s+ribufion of potassium such motions or prc0ests should be filed (FR Doc.as-1484aRichts4a45 am[

iodide for ese as a thyroidal biceking on or before june 22.1985. Protests wtl1 agent by the general p olicin the erum.c cocc mw-u vicinity of nur. fear powerplants. The o

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-, l'eder:1 Regi:ter'/ Ycl. 50.'No. '119 / Thursday June 20. 1985 / Notic s h25625 v deral Emergency Management

. The. guidance published here contains Based on the evaluations by the agency (FEhiA) chairs the FRPCC.

the rationale on the use of potassium Regional Director and the review by the e

.hereby assuming the responsibility for, iodide for emergency workers and FEMA Headquarters staff. I find and Institutionalized individuals. It also determine that, subject to the condition this publication.

incorporates the considerations that stated below, the State and local plans FOR F1JRTHER INFORM ATION CONTACT:

should be made in deciding to and preparedness for the Kewaunee and Ger rd W. Smith. Technological implement the distribution and use of Pcint Beach Nuclear Power Plants are H::ards Division. Office of Natural and potassium lodide for the general adequate to protect the health and,,ty safety of the public living in the vicmi T4chnological Hazards Programs. State population.The decisions on cnd Local Programs and Support, distribution and use of potassium iodide of the plants.These offsite plans and Federal Emergency Management f r thyroidalblocking to protect the preparedness are assessed as adequate Ag:ncy 500 C Street SW., Washington, public health and safety resides with the in that they provide reasonable D C 2047 W 4 2 9.

State and. in some cases. local health assurance that appropriate protective SUPPLEMENTARY INFORM ATION:

authorities. it suggests that any decision actions can be taken offsite in the event by State andlocal authorities to use of a radiological emergency and are

-Background potassium lodide should be based on the capable of being implemented.The site environment and conditions at the condition for the above approvals is that This guidance on distribution of time of an emergency for the specific the adequacy of the public alert and potassium iodide as a thyroidal blocking operating commercial nuclear power notification system already installed j

cgent to ihe general public la the plant and should include detailed plans and operational must be verified as vicinity of nuclear power plants is part for distribution administration, and meeting the standards set forth in of a Federalinteragency effort coordinated by the Federal Emergency medical assistance.,

Appendix 3 of the Nuclear Regulatory The Federal position with regard to Commission (NRC)/ FEMA criteria of M:nagement Agency (FEMA) for the tl e predistribution or stockpiling of NUREG-0654/ FEMA-REP-1. Revision 1 Federal Radiological Preparedness potassium iodide for use by the general and FEMA-43. " Standard Guide for the Coordinating Committee (FRPCC).

public is that it should not be required.

Evaluation of Alert and Notification FEMA issued a final regulation in the Richard W. Annun.

Systems for Nuclear Power Plants."

F1deral Register of March 11,1982. (47 FR 10758), which refleeted governmental Chairman.FedemIRodiological FEMA will continue to review the Paporedness Coodinating Committee.

status of offsite plans and preparedness reorganizations and reassigned agency IFR Doc. 85-14810 Filed 6-19-85: 8.45 am) associated with the Kewaunee and Po. int responsibilites for radiological incident Beach Nuclear Power Plants in siwwa coot arts-os-as Emergency response planning. A accordance with I 350.13 of the FEMA responsibility assigned to the Department of Health and Human (Docket No. FEMA-REP-5-Wi-2 and FEMA-For further details with respect to th.is Services (HHS) and in tum delegate to REP-5-Wl-31 action, refer to Docket Files FEMA-the Food and Drug Administration

• (FDA)is the responsibility to provide Th'e Wisconsin riadiological REP-WI-2 and FEMA-REP-5-WI-3 maintained by the Regional Director, guidance to State and local governments Emergency Response Plans Site-.

en the use of radioprotective substances ' Specific for the Kewaunee and Point FEMA Region V. Federal Center, Battle and prohylactic use of drugs (e.g.

Beach Nuclear Power Plants Creek. Michigan 49016.

g Dated: June 14.1985.

potassium iodide) to reduce radiation Certification of FEMA Findings dose to specific organs including dosage ACji and projected radiation exposures at Agency.

which such dnigs should be used.

In accor 'ance with the Federal samuel W. Speck.

In the Federal Register of June 29.1982 Emergency Management Agency Associate Director, State'endl.oco/Pmgrams (FEMA) rule 44 CFR Part 350 the State. andSupport.

(47 FR 28158). IT)A published recomraendations for State and local of Wisconsin submitted its plans

[FR Doc. 85-148o9 Filed 6.-19-85; 8.45 ami cgencies regarding the projected relating to the Kewaunee and Point

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radiation dose to the thyroid gland at Beach Nuclear Power Plants to the which State and local health officials Director of FEMA Region V on April 6.

should consider the use of potassium 1981, for FEMA review and approval.

FEDERAL RESERVE SYSTEM

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iodide.The recommendations stated On August 30.19M. the Regional First Railroad & Banking Company of that: (1) Potassium iodide be used during Director forwarded his evaluations to Georgia and First Financial radiation emergencies by people who the Associate Director for State and Management Corp.; Acquisition of I

cre likely to receive more than 10 to 20 Local Programs and Support in Compariy Engaged in Permissible r:ds to the thyroid. (2) The drug at the accordance with i 350.11 of the FEMA Nonbanking Activities recommended doses could block at least rule. Included in the evaluations are g

90 percent of radiciodine absorption if reviews of the State and local plans The organization listed in this notice

% 1hc first dose is given shortly before or around the Kewaunee and Point Beach has applied under i 225.23 (a)(2) or (f) of immediately after exposure to facilities and evaluations of the joint the Board's Regulation Y (12 CFR 225.23 radiciodine.The drug could still block 50 exercises conducted on January 21.1981.

(a)(2) or (f)) for the Board's approval J

l percent of radioiodine uptake if the first March 9.1982. November 1.1983, and under section 4(c)(8) of the Bank l

dose is administered within 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> june 19.1984,in accordance with I 350.9 Holding Company Act (12 U.S.C.

4,,

after exposure.(3) State and local of the FEMA rule. A report of the public 1843(c)[8)) and i 225.21(a) of Regulation C (ficials should establish a system for,. meeting held on january 22.1981 to Y (12 CFR 225.21(a)) to acquire or informing the public how to~use discuss the site-specific aspects of the control voting securities or assets of a l

potassium Iodide, how to report side State and local plans in accordance with company engaged in a nonbanking cffects of the drug. and how to get

$ 350.10 of the FEMA rule was also activity that is listed in 6 225.25 of g

I treatment for any adverse reactions.

Included.

Regulation Y es closely related to i

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j 30250 Fcdcrn! Register / Vo!. 50. No.142 / Mg

'.7 [aly M 1935 / Notices

' FEDERAL EMERGENCY on the use of radioprotect:ve 56stancc6 gis en below. It is recognized, however, MANAGEMEfiT AGENCY and prophylactic use of drugs (r.r..

that options on the distribution and use potassium iodide) to reduce radiation of K1 rests with the States, and hence.

Federal Policy on Distribution of dose to specific organs including dosage the policy statement permita State and Potassiumlodide Around Nuclear and projected radiation exposures at local governments, within the limits of Power S:tes for Use as a Thyroidal which such drugs should be used.

their authority, to take measures beyond Blocking Agent in the Federal Register of June 29,1982 those recommended or required (n FR 28158), FDA published nationally.

AGENCY: Federal Emergency recommendations for State and local The U.S. NuclearRegulatory Management Agency.

agencies regarding the projected Commission (NRC)and the Federal Actoc Notice of Issuance of Federal radiation dose to the thyroid gland at EmergencyAfanagementAgency Policy-correction.

which State and local health officials (FEMA)have cheadyissuedguidance EUWHaRY:The Federal Radiological should consider the use of potassium to State and local authorities as well as lodide.

licensees of operating commercial Preparedness Coordinating Committee The guidance published here contains nuclear power plants in NUREG-0654/

(FRPCC)is publishing this notice to the rationale on the use of potassium FEMA-REP-1. Rev.1, recommending the provide guidance to State and local agencies responsible for radiolo'gical iodide for emergency workers and stocApiling and distribution during institutionalized individuals. It also emergencies of K1 for thyroidal blocking emergency planning and preparedness incorporates the considerations that to emergency worAers and to regarding the distribution of potassium should be made in deciding to institutionalizedindividuals. net iodide for use as a thyroidal blocking implement the distribution and use of

, recommendation is endorsed as an agent by the general public in the potassium iodide for the general available protective action in the event vicinity of nuclear power plants. The Federal Emergency Management population.De decisions on of an incident at a nuclear power plant.

distribution and use of potassium iodide %yroid blocking for amergency workers Agency (FDfA) chairs the FRPCC, thereby assuming the responsibility for for thyroidal blocking to protect the and institutionalized individuals was public health and safety resides with the recommended because:

this publication.

In FR Doc.85-14810 beginning on page. State and,in some cases, local health (1)These individuals would be more 25624 in the issue of Thursday June 20, authorities. it suggests that any decision likely to be exposed to the radiolodine 1985, the statement of Federal Policy by State and local authorities to use in an airborne radioactive release from was inadvertently not included.The Potassium iodids should be based on the the plant in the event of an accident; site environment and conditions at the (2)The number ofindividuals complete policy is stated herein. In addition, a portion of the Supplementary time of an emergency for um specTic involved at any site is relatively small Information has been deleted because it CPerstmg emamercial nuclear power and requires a limited supply of KI that was inconsistent with previously plant and should include detailed plans - can be readily distributed; for distribution, administration, and (3) he storage, distribution, and published Food and Drug me ca ass anc administration of K1 can be readily Administration policy.

P controlled; FOR FURTHER HIFOnes AT10sl COorf aCT*

the predistnbution or stockpiling of (4)The known sensitivity to Gerard W. Smith, Technological potassium iodide for use by the general potassium lodide of this limited number Hazards Division. Office of National public is that it should not be required.

ofIndividuals can be reviewed, and and Technological Hazards Programs, State and local Programs and Support.

Policy on Distribution of Potassium (5)hese individuals can be readily Federal Emergency Manegement lodide Around Nuclear Power Sites for monitored for adverse side effects by l

Agency,500 C Street SW., Washington, Use as a%yroidal Blocking Agency medical personnel D.C. 20472 202-646-2a69.

%e purpose of this document is to

. The Federalposition with regard to the SUPPLEssEsfTARY le8FORstaT10N:

' provide Federal policy and guidance predistribution orstocApfling of with regard to distribution of potassium Potassium lodide for use by the general

• • eyI'*"0

• sodide (KI) andits usage ae a thyroid public is that it shouldnot be required.

This guidance on distribution of blocking agent around operating nuclear While valid arguments may be made for potassium iodide as a thyroidal blocking power sites.The issue has been the use of KI, the preponderance of agent to the general public in the addressed in terms of two components information Indicates that a nationwide vicinity of nuclear power plants is part of the population that might require or requirement for the predistribution or of a Federalinteragency effort desire potassium lodide use:(1)-.

stockpiling for use by the general public coordinated by the Federal Emergency Emergency workers ar.d would not be worthwhile. This is based Management Agency (FEMA) for the institutionalized individuals, and (2) on the ability to evacuate the general Federal Radiological Preparedness general population.%is guidance is

, population and the cost effectiveness of Coordinating Committee (FRPCC).

advisory to State and local governments a nationwide program which haii been FEMA issued a final regulation in the who, within the limits of their authority, analyzed by the NRC and DOE National Federal Register of March 11.1982, (47 should consider these recommendations Laboratories (NUREC/CR-1433). While FR 10758), which reflected governmental in the development of emergency plans the use of K1 can clearly provide reorganizations and reassigned agency and in determining appropriate actions additional protection in certain responsibilities for radiologicalincident to protect the general public. In circumstances,the assessment of the emergency response planning. 44 CFR summary, the policy recommends the effectiveness of K1 and other protective 351 Atesponsibility assigned to the stockpiling or distribution of K1 during actions and their implementation Department of Health and Human emergencies for emergency workers and problems indicates that the decision to Services (IDIS) and in turn delegated to institutionalized persons, but does not use Kl(and/or other protective actiors) the Food and Drug Administration recommend requiring predistribation or should be made by the States and,if (FDA) is the responsibility to provide' stockpiling for the general public.The appropriate, local authorities on a site guidance to State and local governments bases for these recommendatiens are specific basis.

c.

. l

Federal Register / Vol. 50. No.142 / Wednesd:y, July 24, 1985 / Notices 30259 It la important to streu that the use of total body. 'I he use of KI for thyroldt!

miny frctors rraks atockpihng and/or potassium iodide in a radiation blocking is not an effectiva mIans by pre-distribution to the general public

• cmergency is not a panacea in that it itself for protecting individuals from the questionable. Whether KI should be does not block the uptake of other radioactivity in an airberne release stockpiled and distributed to the general radionuclides and does not protect resulting from a nuclea'r power plant public around a particular site depends against external radiation. Furthermore, accident and, therefore, should only be on local conditions. Additionally, its use needs to be balanced against the considered in conjunction with decisions on its use or the use of cost and effectiveness of othat sheltering. evacuation, or other alternative protective measures during protective measures such as sheltering protective methods, an emergency depends on accident and and evacuation.%is recommendation is ne Food and Drug Administration environmental conditions that may made in full recognition of the potential (GA) has evaluated the medical and prevail at the time. Any decision by positive effects of the drug. action by the radiological risks of administering KI for State and local authorities to use K1 FDA permitting KI over-the-counter thyroidal blocking under the' e should be based on the conditions and s

sales, and the authority of State and emergency conditions and has site environment for the specific local health officials to elect to concluded that it is safe and effective operating commercial nuclear power distribute and use the drug based on the and has approved over.the-counter sale plant and should include detailed plans specific needs ofindividual sites.

of the drug for this purpose. FDA for distribution, administration, and I

ne use of KIis effective as a guidance states that risks from the short medical assistance.He following thyroidal blocking agent in reducing term use of relatively low doses of KI for reference are intended to assist State accumulation by the thyroid gland of thyroidal blocking in a radiation ~

and local authorities in decisions related radiolodine which has entered the body emergency are outweighed by the risks to use of KI.

through inhalation or ingestion.

of radiolodine induced thyroid nodules

1. National Council on Radiation Radioiodine accumulation in the thyroid or cancer at a projected dose to the Protection and Measures (NCRP),

can be reduced to less than to percent of thyroid gland of 25 rem or greater. Since Protection of the Hyroid G!and in the what it would be without a blocking FDA has authorized the nonprescription Event of Releases of Radioiodine. NCRP agent by a daily oralintake of(130 sale of KI,it is legally available to Report No. 55. August 1,1977.

milligrams for adults,65 milligrams for individuals who, based on their own

2. Food and Drug Administration infants) KI providing administration is personal aralysis, cisoose to have the (HEW), Potassium Iodide as a nyroid.

started before or immediately after the dmgimmediately available.

Blocking Agent in a Radiation exposure to the radiolodine, and Other considerations and problems to Emergency. 43 FR 58798, December 15, treatment continues for at least 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> be evaluated by the State and local 1978.

beyond the time of the last exposure.

authorities in deciding whether to

3. Halperin, J.A., B. Shleien, S.E.

his effectiveness decreases to less than institute this program include:(1)

Kahana, and J. M. Bilstad, Background 50 percent blocking of the radioiodine Whether the K1 should be distributed to Material for the Development of the uptake,if administration of the KIis the population before an accident occurs Food and Drug Administration *s delayed until 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> after an acute or as soon as possible after an accident Recommendations onHyroid. Blocking ingestion or inhalation.

occurs;(2) whether the risks of exposure with Potassium Iodide. FDA 81-8158, i

It is recognized that the options on to radioactivity will be lower if the U.S. Dept. of Health and llumen distribution and use of KI for thyroidal evacuation of the general population is Services (March 1981).

I blocking to protect the public health and initiated or if the general population is

4. Food and Drug Administration, safety resides with the State end in sheltered and the administration of KI Potassium Iodide as a nyroid. Blocking I

some cases. localhealth authorities.

Initiated;(3) how the KI will be Agent in a Radiation Emergency: Final I

Herefore, with the exception of Federal distributed during the emergency; (4)

Recommendations en Use. (Notice of l

agency and utility personnel, the what medical assistance will be Availability) 47 FR 28158, June 29.1982.

l decision for use of KI during an actual

-available to assist the individuals who

5. Food and Drug Administration, emergency by the general public is the may have some adverse reaction to Kl; Potassium Iodide as a nyroid. Blocking responsibility of these authorities. In (5) how medical authorities will advise Agent in a Radiation Emergency:

deciding whether to distribute and use the population to take KI and under Recommendations on Use. (April 1982)

KI for the general population, these what circumstances this advice will be Pmpared by the Bureau of Radiological.

{

cuthorities must consider a number of gisen; (6) 11 KI ie predistributed, what Health andBureau ofDrugs. Foodand factors.

assumptions should be made about its Dmg Administration. Department of One of the mnsiderations in deciding actual availability and use li the event Health andHuman Services.

whether to implement the distribution of an incident:(7) how the authorities

8. Nuclear Regulatory Commission, and use of KI for the general population will provide KI to transient populations:

Examination of the Use o' Potassium is that KI blocking effectively reduces and [8] whether use of other respiratory Iodide (KI) As an Emergency Protective the radiation exposure of only the protection (e.g., dust masks, or breathing Measure for Nuclear Reactor Accidents i

thyroid gland. While this is an important through wet towels) may be equally (NUREG/CR-1433, March 1980).

contribution to the health and safety of effective, especially in conjunction with Prepared by Sandia National the individual,it is not nearly as -

sheltering.

Laboratories for the NRC.

effective as measures which protect the in summary, the use of K1 to prevent Richard W. Krimm.

total body of the individual from radioidine from accumulating in the Chairman.FedemIRodiological radioactivity.Both in-place sheltering thyroid gland can be an effective Preparedness Coordmoting Committo.

and precautionary evacuations can ancillary protective action during a (FR Doc. 85-17171 Filed 7-2 bas: 8.45 am) reduce the exposure to the thyroid and nuclear power plant accident. Ilowever.

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