[Federal Register Volume 70, Number 166 (Monday, August 29, 2005)]
[Notices]
[Pages 51065-51069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Federal Guidelines for Requesting, Stockpiling, Distributing 
Potassium Iodide (KI) From the Strategic National Stockpile (SNS)

AGENCY: Office of Public Health Emergency Preparedness (OPHEP), HHS.
SUMMARY: In accordance with the provisions of Section 127 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002, 
Public Law 107-188, (the Bioterrorism Act), this document provides 
guidelines for State, local, and tribal governments, for the expanded 
distribution, stockpiling, and utilization of KI in the event of a 
radioactive iodine release from a commercial nuclear power plant 
incident. This program would extend coverage from the current ten mile 
radius up to twenty miles from a commercial nuclear power plant. This 
document is being published in the Federal Register to permit public 
input on this expanded coverage from a wider

[[Page 51066]]

range of interested entities than was accomplished with a previous 
draft. Respondents are also invited to include comments as to whether 
or not employing measures of prophylaxis other than KI or continuing 
reliance upon established preventive measures without expanding the 
area of KI coverage would render the deployment of this expanded KI 
distribution unnecessary. Further background follows later in these 
draft guidelines.
    If individuals inhale or ingest radioactive iodine, administration 
of KI, when given prior to or within several hours after exposure, can 
reduce the risk of thyroid cancer among certain categories of persons. 
KI does not provide protection from external exposure or contamination 
with radioactive iodine nor does it provide general protection from 
other sources of ionizing radiation. The primary protective actions are 
evacuation of the area near the source of the plume, external 
decontamination of individuals affected, and preventing potentially 
contaminated food and milk from reaching consumers. Because radioactive 
iodine exposure at distances beyond 10 miles is likely to be due to 
contamination of the food and water supply, avoiding the consumption of 
food or water is expected to be the most effective protective measure 
for persons in this zone.
    The Federal Government, through the Nuclear Regulatory Commission, 
presently makes KI available to States upon their request for 
distribution to or stockpiling for individuals within 10 miles of a 
commercial nuclear power plant.

FOR FURTHER INFORMATION CONTACT: Office of Mass Casualty Planning, 
Office of Public Health Emergency Preparedness, U.S. Department of 
Health and Human Services, 200 Independence Avenue SW., Room 638G, 
Washington, DC 20201, Tel: 202-260-1198.

Background

Bioterrorism Act

    Section 127 of the Bioterrorism Act established new Federal 
requirements for the distribution and use of KI within 20 miles of 
commercial nuclear power plants. It requires that KI tablets be made 
available through the Strategic National Stockpile (SNS) to State and 
local governments for stockpiling and distribution, as appropriate, to 
public facilities, such as schools and hospitals, in quantities 
sufficient to provide adequate protection for the population within 20 
miles of a commercial nuclear power plant.
    In addition, Section 127 requires:
     Development of guidelines by the U.S. Government for 
stockpiling, distribution and utilization of KI. State, local, and 
tribal governments requesting KI under this program are required to 
submit plans for local stockpiling, distribution, and utilization of KI 
accompanied by certification that sufficient quantities of KI have not 
already been provided by the U.S. Government.
     Submission of a Report to Congress six months after 
publication of guidelines on measures taken to implement the Act, 
including whether KI has been made available.
     A National Academy of Sciences (NAS) study on the most 
effective and safe way to distribute and administer KI.
    The Department of Health and Human Services (HHS) funded the NAS KI 
study and in December 2003 the NAS released ``Distribution and 
Administration of Potassium Iodide in the Event of a Nuclear 
Incident.'' Although the Homeland Security Act of 2002, Public Law 107-
296, established joint management of the Strategic National Stockpile 
(SNS) by the Department of Homeland Security (DHS) and the Department 
of Health and Human Services (HHS), the SNS was officially transferred 
back to HHS under the Project BioShield Act of 2004, Public Law 108-
276. This transfer became effective on August 13, 2004.

Potassium Iodide

    KI is the chemical symbol for the chemical compound potassium 
iodide. It is a salt, similar to table salt and, in fact, KI is the 
ingredient that is routinely added to table salt, sodium chloride 
(NaCl), to make it ``iodized salt.''
    Iodine is a necessary element for the formation of thyroid hormone, 
and in order to accomplish this, KI is `taken up' by the thyroid gland 
and used in hormone synthesis. If KI is administered as a 
countermeasure just before or within 4 hours following exposure to 
inhaled or ingested radioactive iodine, it will saturate receptor 
capability within the thyroid gland so that radioactive iodine does not 
become concentrated within the thyroid, thereby minimizing its exposure 
to ionizing radiation. Significant internal exposures to radioactive 
iodine can increase the risk of thyroid diseases, notably thyroid 
cancers.
    The use of KI has been recognized by the World Health Organization, 
the U.S. Food and Drug Administration and the National Academy of 
Sciences as a safe and effective thyroid prophylaxis in the event of a 
significant release of radioactive iodine from a nuclear power plant. 
However, KI offers protection for only one radiation-sensitive organ, 
the thyroid, under conditions of inhalation or ingestion of radioactive 
iodine. It does not protect against external irradiation of the 
thyroid, as might happen if one is exposed to external iodine in a 
radioactive cloud as opposed to iodine that is inhaled or ingested. It 
is not a panacea for protection from radiation injury.
    The health effect risks to the thyroid gland depend upon many 
factors, including: (1) The radiation dose to the thyroid, including 
time (hours/days/weeks/months) required to deliver the dose); (2) the 
age of the person at the time of exposure and; (3) whether or not the 
individual is deficient in dietary iodine intake.
    A review by The National Academy of Sciences (NAS) of experience 
with thyroid cancer in populations exposed to the consequences of 
nuclear events shows that:
     Exposure to external radiation or internal radiation from 
radioactive iodine is linked to a dose-dependent increase in thyroid-
cancer incidence.
     Young children are by far the most sensitive to the 
carcinogenic effect of radiation on the thyroid, especially after 
exposure to radioactive iodine in fallout.
     The risk of thyroid cancer in adults exposed to 
radioactive iodine in fallout is low for adults over 40 years of age.

Radiological Emergency Preparedness Program (REPP)

    The REPP, a program managed by the Nuclear and Chemical Hazards 
Branch within DHS, is designed to assure that off-site response 
organizations are capable of protecting the public in the event of an 
incident at a commercial nuclear power plant. The primary actions for 
protecting the public include evacuation and, as indicated, sheltering. 
Off-site response organizations base their initial protective action 
decisions on plant conditions, so that the people closest to the 
facility are evacuated before significant releases of radioactive 
materials occur. This ensures maximum protection of the population 
closest to the facility. The use of KI as a supplemental action to 
evacuation and sheltering is also sometimes recommended to protect the 
public. However, the use of KI should not be adopted as an alternative 
for the implementation of an effective evacuation strategy. Additional 
protective actions include decontamination of individuals that have 
external contamination and preventing potentially contaminated food and 
milk from being ingested by

[[Page 51067]]

consumers. Because radioactive iodine exposure at distances beyond 10 
miles is likely to be due to contamination of the food and water 
supply, avoiding the consumption of contaminated food or water is the 
most effective countermeasure at this distance.

Emergency Planning Zones

    To permit protective measures to be taken effectively, the Nuclear 
Regulatory Commission (NRC) established two Emergency Planning Zones 
(EPZ) around each commercial nuclear power plant. The zone within 10 
miles (16 km) of the plant is designated the plume EPZ and the region 
within 50 miles (80 km) from the plant the ingestion EPZ. Current 
analyses indicate that in the event of a power plant accident, direct 
exposure to the plume poses the greatest threat for persons near the 
plant, and people who had not evacuated would be exposed to radiation 
from the airborne radioactive material, material deposited on the 
ground or other surfaces, and materials taken into the body by 
inhalation. Within the plume EPZ, circumstances may result in levels, 
which, if delivered in a short period of time, may be high enough to 
produce acute radiation effects in exposed people. Farther from the 
power plant, the predominant exposure threat would come from 
radioactive materials taken into the body, primarily by the consumption 
of contaminated foods, milk, and water. The planned protective measures 
differ in the two zones, however there is flexibility in the emergency 
plans, and protective measures will be adapted to the circumstances at 
the time of the incident.
    The NAS report, Chapter 5, PROTECTIVE MEASURES, page 81, states: 
``Exposure to radioactive iodine is possible through the ingestion 
pathway, so it is important that plans address this situation. 
Monitoring of the environment and food products controls this route of 
exposure. Removing contaminated products from the market and isolating 
contaminated products until the radioactive iodine decays to safe 
levels are the most effective way to eliminate radiation exposure and 
damage to the thyroid. That also eliminates the need for the use of KI 
by the general public as a protective action [in the ingestion zone].''
     The 10 mile Emergency Planning Zone (Plume EPZ)
    The 10 mile EPZ predetermined protective actions include 
sheltering, decontamination, evacuation, and the use of KI as a 
supplement to sheltering and evacuation, where appropriate.
     The 50 mile Emergency Planning Zone (Ingestion EPZ)
    In the area beyond 10 miles and out to approximately 50 miles, the 
primary exposure to radioactive materials is from ingestion and the 
protective actions for this exposure area include a ban on consumption 
of contaminated food, milk, and water.
    The 10-mile EPZ has been reviewed and accepted by the EPA, NRC, and 
FEMA as the appropriate EPZ size for commercial nuclear power plant 
licensees to use in developing emergency plans in cooperation with 
State and local governments. It is not within the scope of these 
guidelines to question the appropriateness of the 10-mile EPZ under NRC 
regulations, and nuclear power plant licensees will not be expected to 
modify their emergency plans.

Chernobyl

    A great deal has been learned since the accident at Chernobyl. We 
believe that design and safety features of U.S. nuclear power plants 
plus our emphasis on planning through the REPP make it unlikely that a 
similar scenario could occur on U.S. soil. Persons have tried to 
extrapolate a Chernobyl experience to the U.S. However, according to 
the NAS, ``although the qualitative results after Chernobyl are 
valuable, the quantitative results cannot be transposed to the United 
States situation without many caveats.''

Terrorism and Nuclear Power Plants

    The rigid design features of U.S. nuclear power plants coupled with 
heightened security measures at these facilities would present 
significant challenges to terrorists who would seek to cause 
radioiodine to be released from one of our power plants as the result 
of an attack. As the National Academy of Sciences concluded, ``The 
terrorism threat does not appear to add significantly to the risk, 
because of the existing mechanisms and procedures.''

Roles and Responsibilities

    In order to facilitate implementation of the requirements of 
Section 127 and ensure coordination with the existing REPP 
requirements, the roles and responsibilities of HHS, DHS, and State, 
local, and tribal governments are set forth below.

A. HHS

    Within HHS, the Office of Public Health Emergency Preparedness 
(OPHEP) will be responsible for implementing the requirements of 
Section 127. OPHEP will:
    1. Review and approve in writing all requests for KI;
    2. Develop the procedures and mechanisms for distribution of KI to 
State, local, or tribal governments;
    3. Provide subject matter expertise on KI and other technical 
support to State, local, and tribal governments, as requested;
    4. Provide the initial approved quantity of KI and ensure 
sufficient supplies are available to replace used or expiring stocks; 
and
    5. Submit Reports to Congress, as required in Section 127, for the 
following:
     Measures taken by the Federal Government to implement 
Section 127
     Whether KI has been made available to State, local, and 
tribal governments under Section 127 or other programs;
     The extent to which State, local, and tribal governments 
have made KI available to their populations;
     The findings of the NAS study.

B. DHS

    Although Section 127 does not establish direct implementing 
requirements for the DHS, DHS will maintain its current activities in 
support of the NRC's current KI program.

C. NRC

    Although Section 127 does not establish direct implementing 
requirements for the NRC, the NRC will maintain its current program for 
KI distribution and will approve all requests for the initial supply of 
KI within the 10 mile EPZ, consistent with NRC regulations, after DHS 
has reviewed the requests for completeness and appropriateness.

D. State Governments Will

    1. Decide whether to add KI as a protective measure to their 
emergency plans. See the NAS Study for examples of distribution 
options;
    2. Submit KI applications to the HHS' Office of Public Health 
Emergency Preparedness; such applications will include a plan for 
stockpiling and for distribution and use of KI in the event of a 
nuclear incident;
    3. Certify that the State has not already received sufficient 
quantities of KI from the Federal Government, (See Section 
127(b)(1)(B));
    4. Consider FDA's Guidance, ``Potassium Iodide as a Thyroid 
Blocking Agent in Radiation Emergencies'' in preparing emergency KI 
dosing plans;

E. Local Governments Will

    1. Decide whether to add KI as a protective measure in their 
emergency

[[Page 51068]]

plans. We recommend that local governments review Appendix D of the NAS 
Study prior to making a decision on the use of KI;
    2. Petition the State in which they are located to modify its plan 
to address their population (not to exceed a 20-mile radius from the 
plant);
    3. Submit their plans for stockpiling, distribution, and using KI 
to the State for approval and certification that the plan is ``not 
inconsistent'' with the State emergency plan;
    4. Consider FDA's Guidance, ``Potassium Iodide as a Thyroid 
Blocking Agent in Radiation Emergencies'' in preparing emergency KI 
dosing plans;
    5. Submit KI requests to the HHS Office of Public Health Emergency 
Preparedness, such applications will include a plan for stockpiling KI 
and for distribution and use of KI in the event of a nuclear incident.

    Note: State approval and certification must be obtained before 
HHS will accept a KI request from a local government for review and 
approval.

F. Tribal Governments

    1. Decide whether to add KI as a protective measure in their 
emergency plans. We recommend that tribal governments review Appendix D 
of the NAS Study prior to making a decision on the use of KI;
    2. Petition the state in which they are located to modify its plan 
to address their population (not to exceed a 20-mile radius from the 
plant);
    3. Consider FDA's Guidance, ``Potassium Iodide as a Thyroid 
Blocking Agent in Radiation Emergencies'' in preparing emergency KI 
dosing plans;
    4. Submit a KI request to the HHS' Office of Public Health 
Emergency Preparedness.

Stockpiling, Distribution, Public Education

A. Considerations for KI Utilization

    Numerous issues must be considered when making the decision whether 
to utilize KI as a protective action. These issues include, but are not 
limited to, the following:
     How will incorporation of KI as a protective measure 
impact existing emergency plans, procedures, and operations?
     What is the benefit to public health and safety from 
incorporating KI into emergency response plans?
     Who will be responsible for the KI program? Is there an 
existing program that can take on this responsibility or must a new one 
be created?
     Who has the authority to make the recommendation that KI 
be taken? If the State government is not participating in the program, 
does the local government have the authority to recommend that KI be 
taken?
     How will KI be stockpiled and distributed?
     How will incident-specific emergency and environmental 
conditions be included in the decision to use KI?
     How will the public be notified during an incident when to 
take KI? Is there a communication system available to notify the public 
of a nuclear incident?
     How will KI be provided to transient populations?
     What medical assistance will be available for the 
individual who experiences an adverse medical reaction following KI 
administration?
     How will medical authorities advise the population to take 
KI, and under what circumstances will this advice be given, i.e., 
methods for public education, information, and instruction?
     What is the cost-benefit of the program? Are there better 
uses of the funding and resources that would result in a greater 
reduction in risk?
     What is the liability associated with establishing a KI 
program?
     What procedures will be used to monitor the expiration of 
KI stocks and request KI replacement from the stockpile?
     If KI is stockpiled under controlled conditions, will they 
pursue shelf-life extension pursuant to the Food and Drug 
Administration's guidance? (See Reference O below.)

B. Stockpiling and Distribution

    The NAS's report on KI distribution reviewed KI distribution 
programs in various countries as well as within the United States. An 
extensive discussion on these programs can be found in Chapter 6, 
EXISTING DISTRIBUTION PLANS FOR POTASSIUM IODIDE. It is important to 
note that the report did not identify a preferred method of mass 
distribution of KI to the public. The report recognized that local 
conditions surrounding the commercial power plants and existing 
emergency plans vary between the countries surveyed as well as between 
the States. The report recognized that the most successful KI plan will 
take into consideration existing State/local emergency planning as well 
as specific characteristics of the location and population around the 
commercial nuclear power plants. A method for evaluation of KI 
distribution plans was developed and published in Appendix D to the KI 
distribution report. It is recommended that the NAS's Report on KI 
distribution be reviewed by State, local, and tribal governments for 
insights in development and implementation of KI plans and programs.

C. Public Education

    Public education is a key component to the success of a KI program. 
It is important that members of the public have a basic knowledge about 
the use and side effects of KI, are aware that KI protects only the 
thyroid from internal exposure to radioactive iodine, and understand 
that it is to be taken only at the direction of authorized officials. 
Several methods have been used by States with existing KI programs. 
These include: Letters to physicians and residents, in-home visits by 
public health officials, newspaper ads, distribution through 
pharmacies, press releases and a press conference, a cable television 
program, KI distribution or ``pick-up'' days, and commercial nuclear 
power plant public education materials. An expanded discussion of 
various public education methods is included in chapter 6 of the NAS KI 
Report.

Health and Human Services KI Distribution Program

    A. Requests for KI should be submitted to the:
Office of Mass Casualty Planning, Office of Public Health Emergency 
Preparedness, U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Room 638G, Washington, DC 20201, Tel: 202-260-
1198.
    B. State Government KI requests must:
     Certify that the State has not already received sufficient 
quantities of KI from the Federal Government;
     Specify the quantity and formulation of KI needed and 
describe the calculation used to make this determination;
     Identify the location of the commercial nuclear power 
plant within the State or within a 20-mile border strip inside an 
adjacent State; and contain the State's and Tribal Government's plans 
and procedures for stockpiling, distributing, and administering KI.
    These plans must:
     Identify the office with the authority to recommend the 
use of KI by the general public;
     Identify the organization(s) responsible for implementing 
the KI use decision;
     Identify the single recipient responsible for receiving 
the KI; provide

[[Page 51069]]

a recipient address for the shipment of KI;
     Specify the decision-making criteria for KI 
administration;
     Specify the criteria for issuing KI to the public 
(location, special need);
     Specify the method for making KI available to the public; 
pre-distribution or stockpiling;
     Specify the method for ensuring the supply of KI is 
sufficient for the targeted population, including the estimated 
transient/seasonal population that may be advised to take KI;
     If pre-distributing KI, specify the procedure for the 
public or special population groups to obtain KI;
     Specify the procedure for storing, monitoring, 
safeguarding, dispensing (to include, if applicable, tracking who 
received the drug, when, in what quantity, and maintenance of waivers 
from liability), and disposing of KI stocks;
     Identify the method for alerting and notifying the general 
public of the recommendation to take KI;
     Specify how the plan is integrated into existing emergency 
response plans; and
     Specify quantities of KI (tablets and pediatric liquid 
oral formulation) that will be requested.

C. Local Governments

    KI requests from local governments must certify that:
     The State in which the local government is located does 
not have a DHS-approved KI distribution plan that includes KI as a 
protective measure for populations, or a DHS approved plan that does 
not address populations located beyond 10 miles from the commercial 
nuclear power plant;
     The local government has petitioned the State in which it 
is located to modify the State plan to address populations within 20 
miles of a commercial nuclear power plant, and 60 days have elapsed 
without the State modifying the plan to accommodate the request;
     The local government KI plans have been approved by the 
State and certified to be `not inconsistent' with the State emergency 
plan; and
     The local government has reached an agreement with the 
State that the State will serve as the single point of contact for 
receipt of KI shipments from the stockpile and will then redistribute 
the KI to the approved governments.

Funding and Resource Requirements

    State, local, and tribal governments are responsible for obtaining 
the funding and resources necessary to request and implement the KI 
program within their respective jurisdictions, should they decide to 
request KI. Only the provision of KI tablets/liquid will be funded 
through HHS.

    Dated: August 24, 2005.
Robert G. Claypool,
Deputy Assistant Secretary, Office of Public Health Emergency 
Preparedness, Department of Health and Human Services.

References

A. NUREG-0654/DHS-REP-1, Criteria for Preparation and Evaluation of 
Radiological Emergency Response Plans and Preparedness in Support of 
Nuclear Power Plants, March 1987.
B. NUREG-0396/EPA 520/1-78-016, Planning Basis for the Development 
of State and Local Government Radiological Emergency Response Plans 
in Support of Light Water Nuclear Power Plants, December 1978.
C. National Academy of Sciences (NAS) Study, Distribution and 
Administration of Potassium Iodide in the Event of a Nuclear 
Incident, January 2004.
D. Federal Emergency Management Agency, Notice of revised Federal 
policy, Federal Policy on Use of Potassium Iodide (KI), 67 FR 1355, 
January 10, 2002.
E. Nuclear Regulatory Commission, Final rule, Consideration of 
Potassium Iodide in Emergency Plans, 66 FR, 5427, January 19, 2001.
F. World Health Organization, Guidelines for Iodine Prophylaxis 
Following Nuclear Accidents, 1999. http://www.who.int/environmentalinformation/Information_resources/documents/Iodine/guide.pdf.
G. 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.
H. Food and Drug Administration (Department of Health and Human 
Services), Potassium Iodide as a Thyroid-Blocking Agent in Radiation 
Emergencies; 66 FR 64046, December 11, 2001. http://www.fda.gov/cder/guidance/4825fnl.htm.
I. Report of the President's Commission on the Accident at Three 
Mile Island.
J. Federal Emergency Management Agency, Federal Policy on 
Distribution of Potassium Iodide Around Nuclear Power Sites for Use 
as a Thyroidal Blocking Agency, 50 FR, 30258, July 24, 1985.
K. 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.
L. International Atomic Energy Agency, International Basic Safety 
Standards for Protection Against Ionizing Radiation and for Safety 
of Radiation Sources. Safety Series No. 115, 1996.
M. Food and Drug Administration (Department of Health and Human 
Services) Guidance for Industry KI in Radiation Emergencies--
Questions and Answers, http://www.fda.gov/cder/guidance/5386fnl.htm.
N. Food and Drug Administration (Department of Health and Human 
Services) Frequently Asked Questions on Potassium Iodide (KI). 
http://www.fda.gov/cder/drugprepare/KI_Q&A.htm.
O. Food and Drug Administration (Department of Health and Human 
Services) Guidance for Federal Agencies and State and Local 
Governments: Potassium Iodide Tablets: Shelf Life Extension. http://www.fda.gov/cder/guidance/5666fnl.pdf.
P. National Council on Radiation Protection and Measures (NCRP) 
Report 138, Management of Terrorist Events Involving Radioactive 
Materials.

[FR Doc. 05-17223 Filed 8-25-05; 2:41 pm]
BILLING CODE 4150-37-P