ML20154C473
| ML20154C473 | |
| Person / Time | |
|---|---|
| Issue date: | 07/13/1998 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Diaz N, Shirley Ann Jackson, Mcgaffigan E, The Chairman NRC COMMISSION (OCM) |
| References | |
| NUDOCS 9810060281 | |
| Download: ML20154C473 (11) | |
Text
\\
11EQUEST RERY 97 MhiM#
fparq...
o
g UNITED STATES S
NUCLEAR REGULATORY COMMISSION coMSECY-98-016 5
j W AsHINGTON, D.C. 2055W l
'\\
/
July 13, 1998 RELEASED TO THE PDR
$ /0 / W W$ u9 m - MEMORANDUM TO: Chairman Jackson Commissioner Diaz Commissioner McGaffigan g fC k Wh A FROM: L.' Joseph Callan f Executive Director for erations SUBJECT. EEDERAL REGISTER NOTICE ON POTASSIUM IODIDE In response to the SRM dated June 26,1998, the staff modified the Federal Emergency l Management Agency's (FEMA's) proposed draft Federal Reaister Notice (FRN) to include a j statement to the effect that State and local decision makers, provided with proper information, may find that the use of potassium iodide (KI) as a protective supplement is reasonable and prudent for specific local conditions. Attached is the modified FRN for Commission review prior to release to other Federal agencies that are members of the Federal Radiological Preparedness Coordinating Committee (FRPCC). The added sentence is highlighted in bold print on Page 5 of the FRN. The staff has made no revisions to the FRN, except to add the statement directed by the Commission and to correct wording where there was an obvious grammatical or syntax problem. By way of background, on, October 23,1997, the start provided to the Commission FEMA's final draft FRN entitled, " Federal Policy on the Use of Potassium lodide as an Emergency Preparedness Measure for Commercial Nuclear Power Plant Accidents" (COMSECY-97-028). In that submittal, the staff stated that it found FEMA's draft FRN consistent with the Commission policy outlined in the SRM dated June 30,1997. The Commission directed the staff to schedule a public Commission briefing on KI issues; this briefing occurred on November 5,1997. In the l SRM dated November 25,1997, the Commission informed the staff that it would temporarily defer action on FEMA's draft FRN pending resolution of the petition for rulemaking relating to the use of KI, PRM 50-63 (SECY-97-245). The draft FRN presented in COMSECY 97-028 was modified and is attached to this paper. l l} CONTACT; Frank J. Congel, AEOD 415-7476 'o3 9310060281 900713 p p / _. O-(10 l fed p7 k-; PDR ORG NE ED PDR 7 C,3-F.-1le p+sa wa
l' l-2- l Upon Commission approval, the staff will provide a copy of this revised draft FRN to FEMA for G;t.tribution to FRPCC member agencies for their review. The staff has also requested FEMA to reconvene the FRPCC to address the proposed revisions to the FRN. The FRPCC's final FRN will be provided to the Commission if it differs from the version approved by the Commission. SECY please track. 1
Attachment:
As stated cc: SECY OPA RES I OSP NRR NMSS OCA OGC ACRS 1 I f L A: 4 9 4 i 6 e , ~. g
1 \\ ~ DRAFT l The Staff's revision to FEMA'S FINAL DRAFT FRN (highlighted on page 5) Billing Code 6718-06-P FEDERAL EMERGENCY MANAGEMENT AGENCY Federal Policy on Use of Potassium lodide as an Emergency Preparedness Measure for Commercial Nuclear Power Plant Accidents AGENCY: Federal Emergency Management Agency. ACTION: Issuance of Federal Policy on Potassium Iodide.
SUMMARY
The Federal Radiological Preparedness Coordinating Committee (FRPCC) is issuing this revised Federal policy in connection with the purchase, stockpiling and use of potassium iodide (KI), as a prophylaxis for the thyroid in the event of a major radiological emergency at a commercial nuclear power plant. The policy herein, which was endorsed by both the FRPCC and the Nuclear Regulatory Commission -(NRC), incorporates changes recommended by the FRPCC's Ad Hoc Subcommittee on Potassium Iodide, and supersedes the 1985 Federal policy. The Federal Emergency Management Agency (FEMA) chairs the FRPCC, thereby assuming the responsibility for this publication. FOR FURTHER INFORMATION CONTACT: William F. McNutt, Senior Policy Advisor, room 634, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2857; facsimile (202) 646-4183. SUPPLEMENTARY INFORMATION
Background
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 deliner.ted agency roles and responsibilities for radiological incident emergency response planning (44 CFR 351). One of the responsibilities assignt. co the Department of Healt
- 1d Human Services (HHS) and in turn delegated to the Food (
' ) rug Administration (FDA) was providing guidance to. .;s and local Governments on the use of radioprotective substances and prophylactic use of drugs (e.g., potassium iodide) including dosage and projected 1 ATTACHMENT
l-radiation exposures at which such drugs shculd be used to l reduce radiation doses to specific organs. In the June 29, 1932, Federal Register 47 FR 28258 the Food l and Drug Administration publiched recommendations for State l and local agencies regarding the projected radiation dose to l the thyroid gland at which State and local health officia2s l should consider the'use of KI. The Federal policy on stockpiling and distributing KI was published in the July 24, 1985, Federal Register, 50 FR 30258. This policy recommended stockpiling or distribution of KI during emergencies for l emergency workers and institutionalized persons, but did not l 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 l policy and to revisit the issue of stockpiling and l distributing KI for use by the general public. In response, the FRPCC established an Ad Hoc Subcommittee on Potassium Iodide. On December 5, 1994, the FRPCC adopted the report and recommendations of t he Ad Hoc Subcommittee on Potassium Iodide, which reaffirmed the Federal position as expressed in l the 1985 policy. l On April 3, 1996, in connection with a September 9,
- 1995, Petition for Rulemaking submitted to the NRC on this issue, l
the FRPCC established a new Ad Hoc Subcommittee on Potassium j Iodide to review current information. The Subcommittee l conducted a public meeting on June 27, 1956. Based on the L information collected, the Subcommittee concluded that there was no new information that seriously challenged the bases for the 1985 recommendations concerning public use of KI for radiological emergencies at commercial nuclear power plants. L However, three recommendations were made to the FRPCC by the {- Subcommittee: (1) without changing the Federal policy by r interceding in the State's prerogative to make its own i L decisions en 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; l (2) the Subcommittee believed the language in the 1985 policy should be softened to be more flexible and balanced. For 2 ATTAOHMENT 1 =-
l 1 - [ example, the problem many intervenors observe in the Federal j policy'is in the italicized statement, "The Federal position with... potassium iodide for use by the general public is that l fit should not [be] required." It would not be as negative if the last_ phrase were reworded to. state "it [ potassium iodide for use by she gen;ral public]-is not required, but_may-be , selected'as & protective measure at the option of the-State or, in some cases, local governments"; and (3) The Subcommittee recommends that local jurisdictions who wish to -consider the option.of incorporating the use of KI in their protective _ measures consult with-the State to determine if such arrangements are appropriate. If local governments have the authority-or secure the approval _to incorporate KI as a protective measure for the general public, they would need to ' include such a measure in their eniergency plans. l l In addition'to-the FRPCt Tctions, the Federal government has i 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 j
national stockpiles located in the east, central and western L areas of the United States. These stockpiles would be available on an'ad hoc basis, in the event of an accident at a commercial nuclear power plant, f l l On. October 24, 1996, the full FRPCC endorsed the Subcommittee's. recommendations with some minor moalfications. On June 30, 1997. the NRC [ComT.iccion] approved the staff recommendation to endorse the FRPCC position and to recognize the availability to State and local governments of the Federal l stockpile of KI in connection with preparedness for acts of I' terrorism. The commissicners also asked that licensed nuclear power plant operators discuss this revised Federal policy on KI with their counterparts in State and local agencies. Policy on Use of Potassium Iodide as an Emergency Preparedness [ Measure for Commercial' Nuclear Power Plant Accidents The purpose of this document is to provide Federal policy and guidance with regard to distribution of KI and its use as a thyroidal blocking agent in response to commercial nuclear 1 3 ATTACHMENT j.- ,. ~,,,..
power plant accidents. The issue has been addressed in terms of two components of the population within the 10-mile Emergency Planning Zone that might require or desire KI use: (1) emergency workers and institutionalized individuals, and (2) nearby general populations. This guidance is intended for those State and local governments who, within the limits of their authority, should consider these recommendations in the development of emergency plans and in determining appropriate actions to protect the general public. i The Federal policy is that KI should be stockpiled and distributed to emergency workers and institutionalized persons during radiological emergencies, but leaves the decieion for stockpiling and use of KI for the general public to the discretion of State and, in some cases, local governments. It is recognized that options on the distribution and use of KI for the general public rest with the States, and hence, State and local governments, within the limits of their authority, can take supplemental measures beyond those recommended or required nationall) 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 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, except for the decision making process on its use. The State and local government may also contact FEMA when the shelf life of the drug has expired and the supply needs to be replenished. Policy Considerations The NEC and FEMA have issued guidance to State and local authorities as well as to licensees of operating commercial nuclear power plants in NUREG-0654/ FEMA-REP-1,Rev.1, recommending the stockpiling and distribution of KI for 4 ATTACHMENT
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 foi emergency workers and institutionalized individuals was recommended because these individuals are more likely to be exposed to the radioiodine in an airborne radioactive release than other members of the public. In addition, the number of emergency workers and institutionalized individuals potentially affected at any site is relatively small and requires a limited supply of KI that can be readily distributed. KI can be an effective and safe drug for protecting the thyroid from the uptake of radiciodine, particularly I-121, especially for children 15 years of age or younger, on the j other hand, the logistical difficulties in distributing the j drug to the general public in a radiological emergency, in addition to the use of evacuation as the primary and preferred protective action,_may dissuade some States and jurisdictions from its use. While the use of KI can clearly provide additional protection in certain circumstances, the assessment of the effectiveness of KI and other protective actions and their implementation indicates that the decision to use KI (or other protective actions) should be made by the States and, if appropriate, local autnorities on a site-specific basis. It is recognized that State or local decision makers, provided with proper information, may find that the use of KI as a protective supplement is reasonable and prudent for specific local conditions. It is also recognized that the exercise of options to distribute and use KI for thyroidal blocking to protect the public health and safety resides with the State and, in some cases, local health authorities. Therefore, the decision on use of KI by the general public during an actual emergency is the responsibility of these authorities. It should be noted that the timely use of KI effectively reduces the radiation exposure of only the thyroid gland. While this is an important contribution to the health and safety of the individual, it is not as effective as measures which protect the total body of the individual from radioactivity. Both in-place sheltering and precautionary 5 ATTACHMENT
~ ~ evacuations can reduce the exposure to the thyroid and total body. The use of KI for thyroidal blocking is not an effective means by'itself for protecting individuals from the radioactivity in an airborne release resulting from a nuclear power plant accident, and therefore, should only be considered in conjunction with sheltering or evacuation or a combination thereof. The Food and Drug Administration has evaluated the medical and radiological risks of administering KI for emergency conditions and has concluded that it is safe and effective and has approved over-the-counter sale of the drug for this purpose. Food and Drug Administration guidance states that risks from the short term use of relatively low doses of fee KI for thyroidal blocking in a radiological emergency are outweighed by the risks of radiciodine induced thyroid nodules or cancer at a project (ed] dose to the thyroid gland of 25 rem or greater. Since the Food and' Drug Administration has authorized the nonprescription sale of KI, it may be available to individuals who, based on their own personal analysis, choose to have the drug immediate]y available. Other considerat ons and problems to be evaluated by the State and local authorities in deciding whether to institute a program for the use of KI by the general public include: (1) Whether the KI should be distributed to the population before an accident occurs or as soon as possible after an accident occurs; (2) whether ".he risks of exposure to radioactivity will be lower if the evacuation of the ger.eral population is initiated 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 actus.1 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 advise will be given, i.e., methods for public education, infermation and instruction; and (7) how the authorities will provide KI to transient populations. 6 ATTACHMENT
i l \\ 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 Federal 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 come cases, local governments. Any Scate or local government that selects the use of KI as a protective measure for the general public may so notify the appropriate FEMA Regional Director, and may request funding for the purpose of purchasing a supply. 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 should also be noted that medical supplies, including KI, will be stockpiled in 27 metropolitan areas and in three national stockpiles across the country in support of State and local government response to emergencies caused by acts of terrorism involving nuclear, chemical and biological agents. For radiological emergencies resulting from any cause, including accidents at commercial nuclear power plants, this additional stockpile can be acquired ad hoc by State or local government officials if they determine its use would be beneficial. The f llowing references are intended to assist State and local authorities in decisions related to use of KI: 1. National Council on Radiation Protection and Measures (NCRP) Protection of the Thyroid Gland in the Event of Releases of Radiciodine. NCRP Report No. 55, August 1, 1977. 7 ATTACHMENT
l 2. Food and Drug Administration (HHS), Potassium Iodide as a L Thyroid-Blocking Agent in a Radiation Emergency, 43 FR 58798, December 15, 1978.
- 3. 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.
- Shleien, S.E.
Kahans, and J.M.
- Bilstad, Background Material for the Development of the Food and Drug Administration's Recommendations on Thyroid Blocking with Potassium Iodide. (FDA 81-8158, U.S.
Dept. of Health and Human Serrices (March 1981). 5. Food and Drug Administration, Potassium Iodide as a Thyroid-Blocking Agent in a Radiation Emergency: Recommendations on Use. (April 1981) Prepared by the Bureau of Radiological Health and Bureau of Drugs, Food and Drug Administration, Department of Health and Human Services. 6. 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).
- 7. Federal Emergency Management Agency, Federal Policy on Distribution of Potassium Iodide Around Nuclear Power Sites for Use as a Thyroidal Blocking Agent, 50 FR 30258, July 24, 1985.
- 8. Nuclear Regulatory Commission, Re-Evaluation of Policy Regarding Use of Potassium Iodide After a Severe Accident at-a Nuclear Power Plant (SECY-93-318, November 23, 1993).
- 9. Nuclear Regulatory Ccmmission, Supplemental Information Regarding the Cost-Benefit of KI Prophylaxis, February 1994, Prepared by S.
Cohen and Associates, inc., for the NRC.
- 10. 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).
8 ATTACHMENT
- 11. Federal Radiological Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Subcommittee Report and Recommendations, September 15, 1994,
- 12. Nuclear Regulatory Commission, An Analysis of Potassium Iodide (KI) Prophylaxis for the General Public in the Event of a Nuclear Accident (NUREG/CR-6310, February 1995). Prepared by S.
Cohen and Associates, Inc., and Scientech, Inc., for the NRC.
- 13. Federal Radiological Emergency Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Public
'"ee tings : 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.
- 14. Federal Radiological Preparedness Coordinating Committee, Ad Hoc Subcommittee on Potassium Iodide, Subcommittee Report and Recommendations, October 3, 1996.
- 15. Nuclear RecJulatory Commission, Proposed Federal Policy Regarding Use Potassium Iodide -Ster a Severe Accident at a Nuclear Power Plant (SECY-97.
June 16, 1997). i Dated. O. Megs Hepler, 111 Chair Federal Radiological Preparedness Coordinating Committee DRAFT l 9 ATTACHMENT}}