ML20149L187

Forwards 970630 SRM Informing of Commission Approval Re Option 2 of SECY-97-124,endorsing Frpcc Recommendations on Revised Ki Policy

ML20149L187
Person / Time
Issue date:	07/29/1997
From:	Congel F NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:	Hepler O Federal Emergency Management Agency
References
SECY-97-124-C, NUDOCS 9707310177
Download: ML20149L187 (15)

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July 29, 1997

&~ iir. O. Megs Hepler, Chairman Federal Radiological Preparedness Coordinating Committee Federal Emergency Management Agency Room 508, FCP 500 C Street, SW-Washington, DC 20472

Dear Mr. Hepler:

Enclosed for your information is a copy of the Staff Requirement Memorandum issued on June 30, 1997, informing the staff that the Commission has approved Option 2 of SECY-97-124, endorsing the FRPCC recommendations on a revised KI policy. Option.2 includes the changes proposed by the FRPCC and the recognition nf the availability of medicinal supplies in support of the

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developments in the planning for nuclear, biological, and chemical (NBC) terrorist events.

The enclosed draft. proposed Federal policy on KI, which incorporates Option 2, has been revised to include a need for NRC licensees.to discuss the change in Federal policy with their counterparts in State and local agencies. Upon the publication of the revised Federal policy on KI in the Federal Reaister, the NRC will inform its licensees of this change and the need that licensees discuss the new policy with their State and local counterparts.

I am proposing that you schedule a special FRPCC meeting for.the following purposes:

to discuss the status of the proposed Federal policy to approve the formation of'a working group to finalize the draft policy, to develop a procedure for handling funding requests from  ;

States, and to develop the criteria for determining eligibility of  ;

funding requests to request that HHS review the product warning for KI and ensure that it is suitable for use.by the public during major radiological emergencies 1 am looking forward to working with you to finalize the revised Federal policy on KI.

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Enclosures:

As stated 2 Sincerely, ME , . . a ;

)g Frank J. Congel, Director Incident Response Division 97 73 g 77 9 h EMA a Office for Analysis and Evaluation PDR _ of Operational Data Distribution:

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Action: Ross, AE_00/Thadani, RES '

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/ June 30, 1997 Blaha Bangart, SP OFFICE OF THE C0llins, NRR SECRETARY COngel, AE0D ,

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MEMORANDUM TO: L. Joseph Callan Execu ive Di ector for Operations  !

L b Secretary l FROM: John- H ,

SUBJECT:

STAFF REQUIREMENTS - SECY-97-124 - PROPOSED FEDERAL POLICY REGARDING USE OF POTASSIUM IODIDE AFTER A SEVERE ACCIDENT AT A NUCLEAR POWER PLANT The Commission has approved Option 2 - endorsing the Federal i Radiological Preparedness Coordinating Committee (FRPCC) recommendations. As such, the Commission has endorsed the j Federal offer to fund the purchase of potassium iodide'(KI) for States at their request and endorsed the FRPCC recognition of the availability to State and local governments of the Federal i I

stockpiling of KI for purposes of mitigating the consequences of

' terrorist use of nuclear, biological, or chemical (NBC) weapons.

Under this option, the Federal government would provide funding for the purchase of KI and State and local governments would be responsible for maintenance, distribution, and subsequent costs. i NRC licensees should, as part of the emergency response planning, l discuss this matter with State and local governments who make decisions on protective measures as part of their planning for i responses to emergencies. The staff should inform the Commission j ac to how it will inform NRC licensees of the need to discuss KI  ;

with State and local governments.

(-EDG)- ( AE00)

(SECY Suspense: 4/29/-97) 9700g27 i 8/22/97 KI stockpiles should be available to NRC employees who are expected to perform first responder responsibilities.

The Commission's approval of Option 2 should not be viewed as a denial of, or Commission action on, the petition for rulemaking (PRM) of Peter Crane. The staff should prepare an assessment of Mr. Crane's petition and of the comments on that petition and l submit the assessment to the Commission for its consideration in 1 i

SECY NOTE: THIS SRM, SECY-97-124, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL )

COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.

n- ENCLOSURE 1 "I76 f g g

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I accordance with 10 CFR 2.802 and 2.803.

(-sse) (RES) (SECY Suspense: 4/29/37) 9700193 l 8/22/97 i

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cc: Chairman Jackson Commissioner Rogers  !

Commissioner Dicus  !

Commissioner Diaz l Commissioner McGafflgan i OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)  !

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C Billing Code 6718-06-P July 14,1997 DRAFT FEDERAL EMERGENCY MANAGEMENT AGENCY  !

Federal Policy on Distribution of Potassium lodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent I

AGENCY: Federal Emergency Management Agency.

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ACTION: Issuance of Federal Policy on Potassium lodide, j l

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SUMMARY

The Federal Radiological Preparedness Coordinating Committee (FRPCC) is j issuing this revised Federal policy concerning the purchase, stockpiling, and use of potassium iodide (KI) as a prophylaxis for the thyroid in the unlikely event of a major radiological emergency at a commercial nuclear power plant. Taken in time, Kl blocks the l thyroid's uptake of airborne radioactive iodine, and thus could help reduce thyroid diseases caused by such exposure.

The Federal policy is that KI should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear facilities, the best technical information indicates that evacuation and in-place sheltering provide adequate protection for the general public. However, 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 Kl as a protective measure for the general public is left to the discretion of State ( or, in some cases, local government.)

ENCLOSURE 2

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it is recognized that the State (or in some cases, the local government), within the limits of its authority, can take measures beyond those recommended or required. The availability of Kl as a protective measure for the general public supplements other options for public officials responsible for protective action decisions. A few States have indeed included Kl as a protective action for the general public. The FRPCC does not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public.

Therefore, to ensure that States have the option to use Ki if they so elect, 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 Kl.

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 'iming of an emergency are unpredictable and for which, unlike licensed nuclear power plants, there is little planning possible, a stockpile of Kl is being established by the Federal government. This Federal stockpile will be available to any State for any type of radiological ernergency, at any time.

'in response to new threats, the Federal government broadened the scope of emergency response preparedness to include terrorism involving nuclear, biological, and chemical agents. As a result, and in support of State and local governments, new resources were identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMST) are being established for response to such events. Medical supplies, including KI, are being stockpiled nationally Mr the use by MMSTs in three locations: East coast, Central, and West coast. The quantity of supplies stockpiled e.,es a planning basis of 100,000 people for a period of two days.

4 The policy herein incorporates changes recommended by the FRPCC's Subcommittee on Potassium lodide, and supersedes the 1985 Federal policy (50 EB 30258). The principal l differences between this revised policy and the 1985 version are the addition of the offer of the Federal Government to purchase a supp!y of Kl for States at a State's request and the establishment of a Federal stockpile. The Federal Emergency Managemenit 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., Washingto:i, DC 20472, (202) 646-2857; facsimile (202 646-4183.

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Background

h This policy on use of Kl as a thyroidal blocking agent is the result of a Federalinteragency

effort coordinated by FEMA for the FRPCC. On March 11,1982, FEMA issued a final regulation in the Federal Reaister (47 810758), which delineated agency roles and responsibilities for radiologicalincident emergency response planning (44 CFR 351). One l i of the responsibFities 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., Kl) to reduce raoiation doses to specific organs including dosage and projected rad

J_*n exposures at which such drugs should be used.

.In the June 29,1982 Federal Reaister (47 8 28158), FDA published recommendations for State and local agencies regarding the projected radiation dose to the thyroid gland at which State and local health officials should consider the use of K! The Federal policy on stockpiling and distribution of Kl was published in the July 24,1985 Federal Reaister (50 B 30258). 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 distribution of Ki for use by the general public. In response, the FRPCC established an Ad Hoc Subcommittee on Potassium lodide. On December 5,1994, the FRPCC adopted the report and recommendations of the Ad Hoc Subcommittee on Potassium lodide, 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 I

6 submitted to the Nuclear Regulatory Commission (NRC) on this issue, the FRPCC established a new Subcommittee on Potassium lodide 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 challenges the bases for the 1985 recommendations concerning public use of Kl for radiological emergencies at nuclear power plants. However, several recommendations were made to the FRPCC. The Subcommittee's three recommendations were: 1) without changing the Federal policy by interceding in the State's prerogative to make its own

, decisions on v.hether or not to use KI, the Federal government (NRC, or through FEMA) should fund the purchase of a stockpile for any State that, hereinafter, decides to incorporate Kl as protective measure for the general public; 2) The Subcommittee believes 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 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 requird out may be selected as a protective measure at the option of the State or, in some cases, local governments." and 3) The subce mmittee recom nends that local jurisdictions who wish to incorporate KI as a protective action for the general public should consult with the State to determine if such arrangements are appropriate. If local governments have the authority or secure the approval to incorporate Kl as a protective measure for the general public, they would need to include such a measure in their emergency plans.

The full FRPCC endorsed the subcommittee's recommendations with some modifications.

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i On June 30,1997, the NRC Commission approved a revised policy that endorses the FRPCC recommendations and acknowledges the availablity'to State and local governments of the Federal stockpiles of Kl for purposes of mitigating the consequences of nuclear, blalogical, and chemical terrorist events.

I Policy on Distribution of Ki Around Nuclear Power Sites for Use as a Thyroidal Blocking l l

Agent l The purpose of this document is to provide Federal policy and guidance with regard to distribution of KI, and its usage as a thyroid blocking agent, around operating nuclear i power generating facilities. The issue has been addressed in terms of two components of the population that might require or desire Kl use: (1) Emergency workers and institutionalized individuals close to the nuclear power plant site, and (2) the nearby general population. This guidance is for those State and local governments who, within the limits of their authority, need to consider these recommendations in the development of emergency plans and in determining appropriate actions to protect the general public.

The Federal policy is that Kl should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies. In developing the range of public protective actions for severe accidents at commercial nuclear f acilities, the best technical information indicates that evacuation and in-place sheltering provide adequate prote.ction for the general public. However, 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 Kl as a protective measure for the general public is left to the

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1 discretion of State ( or, in some cases, local government.)'

1 It is recognized that the State (or in some cases, the local government), within the limits of

'its authority, can take measures beyond those recommenced vi muired. The availability

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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 indeed included KI as a protective action for the general public. The FRPCC does not want to usurp the State prerogative to incorporate the use of Kl as a protective measure for the general public.

l Therefore, to ensure that States have the option to use Kl if they so elect, the Federal government is prepared to provide funding for the purchase of a supply of Kl. Any State (or in some cases, local government) which selects the use of Kl as a protective measure  !

for the general public may so notify FEMA, and may request funding for the purpose of

. purchasing a supply of Kl.

1 in addition, the Federal government is also required to prepare for a wider range of radiological emergencies2 I To that end, and as an added assurance, for radiological I 1

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, a stockpile of

1. i n response to new threats, the Federal government broadened the scope of emergency response preparedness to include terrorism, involving nuclear, biological, and chemical egents. As a result, and in ruPrort of State and local governments, new resources were identified to be needed in response to such events. About two dozen Metropolitan Medical Strike Teams (MMST) are being established for response to such events. Medical supplies, including Kl, are being stockpiled nationally for the use by MMSTs in three locations: East coast, Central, l and West coast. The quantity of supplies stockpiled uses a planning basis of 100.000 people for a period of two j days, j l

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9 Kl is being established by the Federal government. This Federal stockpile will be available I to any State for any type of radiological emergency, at any time.

The bases for these recommendations are given below.

The NRC and FEMA issued guidance to State and local authorities as well as licensees of operating commercial nuclear power plants in NUREG-0654/ FEMA-REP-1, Revision 1, in 1980. This guidance recommends the stockpiling end distribution of Kl during emergencies to emergency workers and to institutionalized individuals. Thyroid blocking for emergency workers and institutionalized individuals was recommended because these individuals are more likely to be exposed to radiciodine in an airborne radioactive release than other 4

members of the public. In addition, the number of emergency workers and institutionalized i individuals potentially affected at any site is relatively small and requires a limited supply of '

Kl that can be readily distributed.

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

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actions. It is well-recognized that the inclusion of Kl as a protective measure, in addition to evacuation and sheltering, is beneficial only in very remote circumstances. The use of Kl is not without controversy. On the one hand, Kl has been shown to be an effective drug for I

protecting the thyroid from thyroid nodules or cancer caused by the uptde of radiciodine,  ;

especially in children fifteen years of age or younger. On the other hand, there are logistical difficulties, and potential medical side effects associated with the drug, in .

I distributing the drug to the general public in a radiological emergency. Also, Kl effectively l

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10 reduces the radiation exposure of only the thyroid gland from ingested or inhaled  !

radiciodines. While this in an important contribution to the health and safety of the I individual, it is not as effective as measures which protect the total body. Both in-place l i

sheltering and precautionary evacuations can reduce the exposure to the thyroid md the i total body. It is very important to remember that the use of Kl is not an effective means by itself for protecting individuals from the radioactivity in an airborne release resulting i from a nuclear power plant accident and, therefore, should only t,e considered in conjunction with sheltering, evacuation, or other protective methods. Therefore, while the use of Kl can provide additional protection in certain circumstances, the assessment of the effectiveness of Kl and other protective actions and their implementation indicates that the decision to use Ki (and/or other protective actions) should be made by the States and, if  ;

appropriate, local authorities on a site-specific, accident-specific basis.

Those States or local governments - which opt to include Ki for the general population will be responsible for the maintenance, distribution, and any subsequent costs associated with this program.

1 The incorporation of a program for KI stockpiling, distribution and use by any State or local government into the emergency plans will not be subject to Federal evaluation. This is based on the recognition that the use of Kl by the State for the general public is a supplemental protective measure, and on the Federal government's determination that the existing emergency planning and preparedness guidance for nuclear power plants is effective and adequate to protect the public health and safety.

4 11 The FDA has evaluated the medical and radiological risks of administering Kl 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. FDA guidance states that risks from the short term use of relatively low doses of Kl 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 FDA has authorized the nonprescription sale of Kl, it is available to individuals who, based on their own personal analysis, choose to have the drug immediately available.

The NRC licenced nuclear power plant operators should discuss the revised Federal policy on K; with their counterparts in State and local agencies and ccordinate any changes to their emergency plans as a result of this policy.

Attached is a list of ten references intended to assist State and local authorities in decisions related to the use of Kl.

Conclusion The FRPCC did not find any new information that would require a change in the basis of the existing Federal policy concerning the stockpile or pet -distribution of Kl for the general public in the event of a radiological emergency at a comi : rcial nuclear plant. The policy is that K1 should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, but leaves the decision for the stockpiling, distribution, and use of Ki for the general public to the discretion of State, and in some l

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12 cases, local governments. Any State or local government that selects the use of Kl as a protective measure for the general public may so notify FEMA and may request funding for the purpose of purchasing an adequate supply.

The incorporation of a program for Ki stockpiling, distribution and use by any State or local government into the emergency plans will not be subject to Federal evaluation. This is i

based on the recognition that the use of Kl by the State for the general public is a i

supplemental protective measure, and on the Federal government's determination that the existing emergency planning and preparedness guidance for nuclear power plants is effective and adequate to protect the public health and safety.

Those States or local governments which opt to include Kl for the general population will 4

4 be responsible for the maintenance, distribution, and any subsequent costs or legal liabilities associated with this program.

As an added assurance, for a broader range of radiologice! 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, a stockpile' of Kl will be established by the Federal government. Such a stockpile would consist of individual Kl caches at VA hospitals in major metropolitan centers across the country. Thit, supply would be available to any State or local government for any type of radiological emergency. l References l

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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 lodide as a Thyroid-Blocking Agent in a Radiation Emergency, 43 8 58798, December 15,1978.

3. 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 lodide," FDA 81-8158, U.S. Department of Health and Human Services (March 1981).

4. Food and Drug Administraticn; Potassium lodide as a Thyroid-Blocking Agent in a Radiation Emergency: Final P.ecommendations on Use (Notice of Availability) 47 8 28158, June 29,1982).

5. Food and Drug Administration; Potassium lodide as a Thyroid-Blocking Agent in a Radiation Emergency: Recommendations on Use. (April 199'l). Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Administration, Department of Health and Human Services.

6. Nuclear Regulatory Commission; Examination of the Use of Potassium lodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents (NUREG/CR-1433, March 1990). Prepared by Sandia National Laboratories for the NRC.

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, 7. Nuclear Regulatory' Commission; An Analysis of Potassium lodide (KI) Prophylaxis 1 for the General Public in the Event of a Nuclear Accident (NUREG/CR-6310, i

February 1995). Prepared by S. Cohen and Associates, Inc. and Scientech, Inc. for 1

! the NRC.

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