[Federal Register Volume 67, Number 7 (Thursday, January 10, 2002)]
[Notices]
[Pages 1355-1357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-637]


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FEDERAL EMERGENCY MANAGEMENT AGENCY


Federal Policy on Use of Potassium Iodide (KI)

AGENCY: Federal Emergency Management Agency (FEMA).

ACTION: Notice of revised Federal policy.

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SUMMARY: The Federal Radiological Preparedness Coordinating Committee 
(FRPCC) has revised the 1985 Federal policy regarding the use of 
potassium iodide (KI) as a thyroidal blocking agent by emergency 
workers, institutionalized persons and the general public in the 
vicinity of nuclear power plants. This policy is for use by State \1\ 
and local

[[Page 1356]]

agencies responsible for radiological emergency planning and 
preparedness in the unlikely event of a major radiological emergency at 
a commercial nuclear power plant.
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    \1\ Consistent with FEMA initiative 4.0-4.4, Include Native 
American Tribal Nations in the REP Preparedness Process, references 
to State governments include Tribal governments.
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    The Federal position is that KI should be stockpiled and 
distributed to emergency workers and institutionalized persons for 
radiological emergencies at a nuclear power plant and its use should be 
considered for the general public within the 10-mile emergency planning 
zone (EPZ) of a nuclear power plant. However, the decision on whether 
to use KI for the general public is left to the discretion of States 
and, in some cases, local governments.

EFFECTIVE DATE: The modifications to this policy are effective January 
10, 2002.

FOR FURTHER INFORMATION CONTACT: Russell Salter, Chair, Federal 
Radiological Preparedness Coordinating Committee; (202) 646-3030; 
[email protected]. 

SUPPLEMENTARY INFORMATION:

Background

    This revised Federal policy on the use of potassium iodide as a 
thyroidal blocking agent for the general public in the vicinity of 
nuclear power plant 10-mile emergency planning zones is part of a 
Federal interagency effort coordinated by FEMA for the FRPCC. FEMA 
chairs the FRPCC and assumes the responsibility for this publication. 
The FRPCC is an interagency organization, with membership from 17 
Federal agencies, established to coordinate all Federal 
responsibilities for assisting State and local governments in emergency 
planning and preparedness for peacetime nuclear emergencies.
    The issue is addressed in terms of two components of the population 
that might require or desire potassium iodide use: (a) Emergency 
workers and institutionalized individuals, and (b) general population. 
With respect to emergency workers and institutionalized individuals, 
the Nuclear Regulatory Commission (NRC) 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-l, Rev.1. The 
NUREG and FEMA guidance recommends the stockpiling and distribution of 
KI to emergency workers and to institutionalized individuals for 
thyroidal blocking during emergencies. The guidance provides 
information regarding protective actions to be taken in the event of an 
incident at a commercial nuclear power plant. NUREG 0654 and the 1985 
FRPCC KI policy recommend thyroidal blocking for emergency workers and 
institutionalized individuals because they are thought to be more 
likely than other members of the public to be exposed to the 
radioiodine in an airborne radioactive release.
    The decision for using KI as a protective measure for the general 
public is left to the discretion of States, or in some cases, local 
governments, since these entities are ultimately responsible for the 
protection of their citizens. The policy guidance in this Federal 
Register notice is intended for State and local governments that, 
within the limits of their authority, should consider these 
recommendations in the review of their emergency plans and in 
determining appropriate actions to protect the general public. In 
making a decision whether to stockpile KI, the States should be aware 
that the Federal government believes that the use of KI is a reasonable 
and prudent measure as a supplemental protective action for the public.
    Revision of the policy to include members of the public reflects 
lessons learned from the Chernobyl Nuclear Power Plant accident of 
1986, both about the consequences of an accident and about the safety 
and efficacy of KI. The Chernobyl accident demonstrated that thyroid 
cancer can indeed be a major result of a large reactor accident. Based 
on the experiences from Chernobyl, young children are at greatest risk 
of thyroid cancer from radioactive iodine exposure. Moreover, although 
the Food and Drug Administration (FDA) declared KI ``safe and 
effective'' as long ago as 1978, the drug had never been deployed on a 
large scale until Chernobyl. The experience of Polish health 
authorities during the accident has provided confirmation that large-
scale deployment of KI is safe.\2\ The Chernobyl experiences also led 
to wide-scale changes in international practice, specifically 1989 
World Health Organization recommendations (updated in 1995 and 1999) 
and 1996 and 1997 International Atomic Energy Agency standards and 
guidance, which have led to the use of KI as a supplementary protective 
measure in much of Europe, as well as in Canada and Japan.
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    \2\ Nauman, J., and Wolff, J., Iodide Prophylaxis in Poland 
After the Chernobyl Reactor Accident: Benefits and Risks, American 
Journal of Medicine, Vol. 94, p. 524, May 1993.
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    The NRC published changes to its emergency planning regulations at 
66 FR 5441-5443, January 19, 2001. For States within the 10-mile 
planning zone of a nuclear power plant(s), the NRC believes that the 
use of KI is a reasonable and prudent measure as a supplement to 
sheltering and evacuation and in response to specific local conditions. 
The NRC requires consideration in the formulation of emergency plans as 
to whether to include the use of KI as a supplemental protective 
measure.
    The FDA has evaluated the medical and radiological risks of 
administering KI for emergency conditions, has concluded that it is 
safe and effective, and has approved over-the-counter sale of the drug 
for this purpose. FDA has concluded that ``* * * the effectiveness of 
KI as a specific blocker of thyroid radioiodine uptake is well-
established as are the doses necessary for blockage. As such, it is 
reasonable to conclude that KI will likewise be effective in reducing 
the risk of thyroid cancer in individuals or populations at risk for 
inhalation or ingestion of radioiodines.'' Since the FDA 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 
immediately available. The FDA guidance is the definitive Federal 
guidance on medical aspects of KI prophylaxis.

Considerations

    In making a decision whether to stockpile KI, States should be 
aware that the Federal government believes that the use of KI is a 
reasonable and prudent measure as a supplemental protective action for 
the public.
    While there may be logistical difficulties in providing KI to the 
general public, any distribution scheme should take care to ensure that 
KI distribution does not impede or delay orderly evacuation. There also 
may be a few medical side effects in pre-distributing the drug to 
potentially affected individuals or in distributing the drug to the 
general public in a radiological emergency. Although the post-Chernobyl 
data from Poland revealed few serious medical side effects associated 
with this drug, this possibility cannot be discounted, especially in 
certain groups of people. For example, people who are allergic to 
iodine should not take KI.
    Other considerations 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

[[Page 1357]]

include: (a) Whether KI should be distributed to the population before 
an accident occurs or as soon as possible after an accident occurs; (b) 
whether the risks of exposure to radioactivity will be lower if the 
evacuation of the general population is initiated--with or without the 
use of KI--or if the general population is sheltered and the 
administration of KI initiated; (c) how KI will be distributed during 
the emergency; (d) if KI is pre-distributed, what assumptions should be 
made about its actual availability and use in the event of an incident; 
(e) what medical assistance will be available for the individuals who 
may have some adverse reaction to KI; (f) how medical authorities will 
advise the population to take KI and under what circumstances this 
advice will be given, i.e., methods for public education, information 
and instruction; and (g) how the authorities will provide KI to 
transient populations.
    In addition, there are some site-specific considerations to 
evaluate. Any decision by State and local authorities to use KI 
following a specific emergency should be based on the site environment 
and conditions for the specific operating commercial nuclear power 
plant and would include detailed plans for distribution, administration 
and medical assistance.

Revised Policy

    In most cases, evacuation and in-place sheltering are considered 
adequate and effective protective actions for the general public in the 
event of a radiological emergency at a commercial nuclear facility. 
However, the inclusion of KI as a supplemental protective measure is 
beneficial in certain circumstances. 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 that 
protect the total body of the individual from radioactivity. Both in-
place sheltering and precautionary 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.
    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, when appropriate, local authorities on a site-specific 
basis. Thus, the decision on use of KI by the general public during an 
actual emergency is the responsibility of these authorities.
    In summary, the Federal position is that KI should be stockpiled 
and distributed to emergency workers and institutionalized persons for 
radiological emergencies at a nuclear power plant, and its use should 
be considered for the general public within the 10-mile EPZ of a 
nuclear power plant. However, the decision on whether to use KI for the 
general public is left to the discretion of States and, in some cases, 
local governments.
    This revised policy should not be taken to imply that the present 
generation of U.S. nuclear power plants is any less safe than 
previously thought. On the contrary, present indications are that 
nuclear power plant safety has steadily improved.

References

    The following references are intended to assist State and local 
authorities in decisions related to use of KI:

    1. Nuclear Regulatory Commission, final rule, Consideration of 
Potassium Iodide in Emergency Plans, 66 FR 5427, January 19, 2001.
    2. World Health Organization, Guidelines for Iodine Prophylaxis 
Following Nuclear Accidents, 1999. Http://www.who.int/environmental 
information/Information_resources/documents/Iodine/guide.pdf.
    3. National Council on Radiation Protection and Measures (NCRP) 
Protection of the Thyroid Gland in the Event of Releases of 
Radioiodine. NCRP Report No. 55, August 1, 1977.
    4. Food and Drug Administration (Health and Human Services), 
Potassium Iodide as a Thyroid-Blocking Agent in a Radiation 
Emergency, 43 FR 58798, December 15, 1978.
    5. Food and Drug Administration, Notice, Guidance on Use of 
Potassium Iodide as a Thyroid Blocking Agent in Radiation 
Emergencies; Availability, 66 FR 64046, December 11, 2001.
    6. Report of the President's Commission on the Accident at Three 
Mile Island, National Technical Information Service, Springfield, VA 
22161.
    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. Nauman, J., and Wolff, J., Iodide Prophylaxis in Poland After 
the Chernobyl Reactor Accident: Benefits and Risks, American Journal 
of Medicine, Vol. 94, p. 524, May 1993.
    9. International Atomic Energy Agency, International Basic 
Safety Standards for Protection Against Ionizing Radiation and for 
Safety of Radiation Sources. Safety Series No. 115, 1996.

    Dated: January 2, 2002.
Joe M. Allbaugh,
Director.
[FR Doc. 02-637 Filed 1-9-02; 8:45 am]
BILLING CODE 6718-02-P