ML20237E258

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Responds to Requesting NRC Review & Provide Comments on Draft Policy Ki.Nrc Comments on Draft Ki Policy Followed by Brief Chronology of Federal policy-making & Funding Process
ML20237E258
Person / Time
Issue date: 08/14/1998
From: Congel F
NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To: Suppes R
OHIO, STATE OF
References
NUDOCS 9808310066
Download: ML20237E258 (3)


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NUCLEAR REGULATORY COMMISSION T

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August 14,1998 Mr. Roger L Suppes, Chief Bureau of Radiation Protection 35 E. Chestnut Street-7th Floor Columbus, OH 43266

Dear Mr. Suppes:

This is in response to your letter dated June 8,1998, requesting that we review and provide comments on your draft policy on potassium lodide (Kl). You also referred to the Federal process for funding the purchase of KI at the request of a State. Our comments on your draft Kl policy are followed by a brief chronology of the Federal policy-making and funding process.

Your draft KI policy was reviewed in the context of the staffs technical assessment entitled

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" Assessment of the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents" (Draft NUREG-1633, enclosed), which has been published for comment.

Determining the adequacy of your offsite plans is the responsibility of the Federal Emergency Management Agency (FEMA). It is important to note that the Federal Radiological Preparedness Coordinating Committee (FRPCC) is charged with issuing Federal Kl policy.

Since the final revision to the 1985 policy has not yet been developed, our comments are subject to change. However, we fully expect that the decision regarding the use of KI as a supplemental protective action will remain with the States. This State decision authority is consistent with the 1985 Federal policy, with the FRPCC Kl Subcommittee's recommendations, i

and with recent Commission decisions on Kl (Staff Requirements Memoranda dated June 30, l

1997, and June 26,1998).

l Conceming your draft Ki policy, we believe that the important concepts are captured. Your draft

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policy appropriate!y acknowledges that for events that could lead to severe core damage, j

evacuation is and will remain the primary protective action for the general public. We also note that your draft policy includes caveats and caution statements highlighting the limitations of Kl and the risks associated with the mass administration of this drug. As part of our effort to seek comments on the draft NUREG-1633, we have requested that the Food and Drug Administration

-(FDA) take this opportunity to address some of the more specific medicalissues associated with the use of Kl (letter enclosed). Your draft policy states that if taken in time, stable lodine blocks the thyroid gland uptake of radiciodine. As noted in section Ill. D of the draft NUFIG-1633 (page 7), perfect (total) blocking of the thyroid is not possible; timely administration of stable l

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'The FDA comments and those of other commenters will be considered in the final b ' q, { @ /* W version of NUREG-1633.

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R.L.Suppes iodine may block up to 95% of the thyroid uptake of inhaled radiciodines and has no impact on the external radiation dose to the thyroid, in the following section, the process of Federal Kl policy-making and funding the purchase of Ki will be briefly described. The staff receives its direction formally from the Commission via Staff Requirements Memoranda (SRM). On June 26,1998, the Commission issued an SRM directing the staff, among other things, to revise the draft Federal Register Notice (FRN! defining the new Federal Kl policy and proceed with rule-making in accordance with its prescribed schedule (SRM enclosed). The two actions that are relevant to Federal K! policy and KI funding are as follows:

1) Draft Federal Reaister Notice (FRN) July 15,1998. By way of background, the Commission issued its June 30,1997 SRM informing the staff that it had endorsed the FRPCC recommendations to offer Federal funding for the purchase of Kl for States upon their request.

On July 29,1997 the NRC submitted to FEMA a revised FRN incorporating the Commission decision of June 30,1997. Following staff interactions with FEMA, on July 29,1997, the staff provided to the Commission for its review FEMA's final draft FRN and stated that it found the final draft FRN to be consistent with the Commission decision. On November 5,1997, the Commission conducted a public meeting on the KI issues. Presentations were made by the petitioner, FEMA, and the NRC staff. As a result of that meeting the petitioner modified his petition to request that 50.47(b)(10) be revised to read:

"A range of protective actions have been developed for the plume exposure EPZ for emergency workers and the public. In developing this range of actions, consideration has been given to evacuation, sheltering, and the prophylactic use of potassium lodide (KI), as appropriate. Guidelines for the choice of protective actions during an emergency, consistent with Federal guidelines, are developed and in place, and protective actions for the ingestion exposure pathway EPZ appropriate to the locale have been developed." (FR Doc. 97-32879 filed 12/6/97)

On November 12,1997, the petitioner filed his modified petition (PRM-50-63A). On November 25,1997, the Commission indicated that it would temporarily defer action with respect to the i

resolution of the Kl petition (PRM 50-63) and the draft FRN pending an evaluation of the f

modified petition by the NRC staff. Essentially, the petitioner no longer petitioned to " require" that the States include Kl as a protective action for the general public, rather petitioned that States " consider" Kl as a supplement, as appropriate.

I in its June 26,1998 SRM, the Commission directed the staff to include in the FRN a statement to the effect that State and local decision makerc, provided with proper information, may find that the use of Kl as a protective supplement is rr:asonable and prudent for specific local conditions.

The staff submitted the revised draft FRN to the Commission for approval in accordance with the Oommission direction and schedule. We are currently waiting for the Commission's response.

When a final version is approved by the Commission, the staff will present the revision to the FRPCC for review and acceptance. When FRPCC finalizes its position, FEMA will publish the new Federal policy in the Federal Register which will supersede the 1985 Federal policy. This new policy will articulate the Federal position to fund the purchase of KI, upon State request.

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R.L.Suppes I hope this brief description helps you' understand the processes involved in the development of a revised Federal policy and the Federal funding process. I would like to assure you that the NRC, together with other Federal agencies such as the FDA, EPA, and FEMA, will continue to support the States in planning for and implementation of public protective actions.

Sincerely, Origle!signedbyFmnk,l. Conger

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Frank J. Congel, Director i

incident Response Division Office for Analysis and Evaluation l

of Operational Data

Enclosures:

1.

Draft NUREG-1633, " Assessment of the Use of Potassium lodide (KI) as a Public Protective Action During Severe Reactor Accidents" 2.

Letter to M. A. Friedman, FDA, from F J. Congel, NRC, dated July 29, 1998 3.

SRM dated June 26,1998 Distribution: (W/O Enclosures)

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