[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Notices]
[Pages 5840-5842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1769]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Notice of Decision Under Section 127(f) of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Office of Science and Technology Policy, Executive Office of 
the President.

ACTION: Notice of Decision to Waive Requirements of Sections 127(a) and 
(d) of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002. Notice of Availability of Associated OSTP 
Director's Decision Memorandum and Interagency Technical Evaluation 
Report.

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SUMMARY: Notice is hereby given of the determination, under Section 
127(f) of the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Act), to waive the requirements of Section 
127(a) and (d) of the Act. Notice is also given that the Associated 
Decision Memorandum and an interagency technical analysis report are 
available on the Office of Science and Technology Policy (OSTP) Web 
site at http://www.ostp.gov/KI.
    Section 127(a) of the Act directed the President to establish a 
Potassium Iodide (KI) distribution program, under which State and local 
governments could receive KI tablets for distribution to the population 
in the 20 mile radius surrounding nuclear power plants (NPPs). The 
Nuclear Regulatory Commission (NRC) already has such a program for the 
10 mile emergency planning zones surrounding NPPs, so Section 127(a) 
effectively extended that program to the 10-20 mile range.
    Through Section 127(f), Congress authorized the President to waive 
this distribution requirement if there exists ``an alternative and more 
effective prophylaxis or preventive measures for adverse thyroid 
conditions that may result from the release of radionuclides from 
nuclear power plants.''
    On July 3, 2007, the President delegated the Section 127(f) waiver 
authority to the Director of the Office of Science and Technology 
Policy.
    On July 30, 2007, to help inform his decision, the OSTP Director 
requested the Federal Radiological Policy Coordinating Committee 
(FRPCC) to provide a technical evaluation of the issues surrounding 
Section 127. The FRPCC is an interagency organization, with membership 
from 17 Federal agencies, established to coordinate Federal 
responsibilities for assisting State and local governments in emergency 
planning and preparedness for peacetime nuclear emergencies. The FRPCC 
transmitted its final technical evaluation paper to the OSTP Director 
on October 23, 2007.
    On January 22, 2008, the OSTP Director executed his final decision 
pursuant to the Section 127(f) delegation. The complete Decision 
Memorandum, as well as the FRPCC technical information paper, is 
available on the OSTP Web site at http://www.ostp.gov/KI.
    The OSTP Director's determination waived Section 127(f) because a 
more effective preventive measure does exist for the extended zone 
covered by the Act, namely avoidance of exposure altogether through 
evacuation of the potentially affected population and interdiction of 
contaminated food. Analysis of radiological release events that could 
lead to adverse thyroid conditions beyond the current 10 mile zone 
shows that limiting or avoiding exposure to radiation through these 
mechanisms is practical and much more effective than the administration 
of KI in the proposed extended zone.

DATES: The Decision Memorandum was executed on January 22, 2008. 
Associated documents will be available on the OSTP Web site on January 
31, 2008.

ADDRESSES: Questions concerning this Notice should be sent to OSTP by 
e-mail at [email protected] or by Fax at 202-456-6027.

Background

    Section 127(a) of the Act directs the President to establish a KI 
distribution program as discussed above. Section 127(b) of the Act 
calls for State and local authorities to submit their KI stockpile 
plans to the President. Section 127(c) requires the President to issue 
guidelines for the stockpiling of KI tablets. Section 127(d) requires 
the Federal government to undertake efforts to make states and 
localities aware of the availability of KI under 127(a). Section 127(e) 
requires the President to

[[Page 5841]]

submit a progress report to Congress no later than 6 months after the 
guidelines under (c) are issued, and requires the President to request 
the National Academies of Science to conduct a study to determine the 
most effective and safe way to distribute and administer KI on a mass 
scale.
    In Section 127(f), Congress authorized the President to waive the 
requirements of Sections 127(a) and (d) if there exists ``an 
alternative and more effective prophylaxis or preventive measures for 
adverse thyroid conditions that may result from the release of 
radionuclides from nuclear power plants.''
    On July 3, 2007, the President delegated the authority to make a 
determination whether to invoke Section 127(f) to the Director of the 
Office of Science and Technology Policy, and the authority to implement 
the remaining subsections of Section 127 to the Nuclear Regulatory 
Commission (NRC), which established and implements the existing 10 mile 
KI distribution program.
    On July 30, 2007, the OSTP Director requested the FRPCC to provide 
a technical evaluation of the issues surrounding Section 127(f). The 
FRPCC is an interagency organization, with membership from 17 Federal 
agencies, established to coordinate Federal responsibilities for 
assisting State and local governments in emergency planning and 
preparedness for peacetime nuclear emergencies. Member agencies include 
the NRC, the Federal Emergency Response Agency (FEMA), the Department 
of Health and Human Services (HHS), the Food and Drug Administration 
(FDA), the Environmental Protection Agency, and others. The OSTP 
Director asked the FRPCC to provide him with technical background 
information only; the FRPCC was not asked to provide any findings or 
recommendations concerning the invocation of Section 127(f). The FRPCC 
asked their Potassium Iodide Working Group to conduct the work of 
drafting this document.
    As part of this process, OSTP specifically requested that agencies 
with expertise in topical subjects in the technical evaluation take the 
lead on the subjects of their particular expertise--to be responsible 
for carefully reviewing and approving the information presented. For 
example, FDA was asked to take the lead on the sections dealing with 
the effects of Potassium Iodide, HHS was asked to take the lead on the 
sections dealing with the health effects of radiation including 
radioiodine, and FEMA was asked to take the lead on the sections 
dealing with evacuations, etc. In addition, each agency had the 
opportunity to review and approve the entire document, both at the 
working group and full FRPCC levels. If irreconcilable disputes existed 
between the various Federal agencies while drafting the document, OSTP 
requested that this information, along with the reasons why, be 
presented to the OSTP Director as well.
    The FRPCC transmitted its final technical evaluation paper to the 
OSTP Director on October 23, 2007.
    On January 22, 2008, the OSTP Director executed his decision on the 
127(f) delegation. The analysis underlying the decision to invoke the 
Section 127(f) waiver is presented in a Decision Memorandum. The 
complete Decision Memorandum, as well as the supporting interagency 
FRPCC technical information paper, is available on the OSTP Web site at 
http://www.ostp.gov/KI.
    To provide additional background on the basis for the decision in 
this Notice, the ``Decision Summary'' section of the Decision 
Memorandum is presented in full below:

Decision Summary

    On July 3, 2007, the President delegated to me his authority to 
invoke, if appropriate, the waiver provision in the Potassium Iodide 
(KI) distribution program enacted through Section 127 of the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(the Act).\1\ In that Section of the Act, Congress authorized the 
President to waive the program if he determines that there exists ``an 
alternative and more effective prophylaxis or preventive measures for 
adverse thyroid conditions that may result from the release of 
radionuclides from nuclear power plants.'' Under the Act, the Federal 
government would provide KI to be distributed by state and local 
governments to populations living in a zone extending an additional 10 
miles beyond the existing 10 mile emergency planning zone near nuclear 
power plants (NPPs), in which a KI distribution program already exists. 
The Background section below describes the process I used to make the 
necessary determination.
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    \1\ Pub. L. 107-188, 42 U.S.C. 300hh-12 (Notes).
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    After a thorough review of the technical issues, and as explained 
in detail below, I have decided to invoke the Section 127(f) waiver. I 
have determined that a more effective preventive measure does exist for 
the extended zone covered by the Act, namely avoidance of exposure 
altogether through evacuation of the potentially affected population 
and interdiction of contaminated food. Analysis of radiological release 
events that could lead to adverse thyroid conditions beyond the current 
10 mile zone shows that such limiting or avoiding exposure to radiation 
through these mechanisms is practical and much more effective than the 
administration of KI in the proposed extended zone.
    Key facts leading to this conclusion are the existence of Federal 
support for KI distribution programs within 10 miles of an NPP, the 
long advance warning available to potentially affected populations 
given the type of event that could possibly lead to actionable 
radionuclide concentrations beyond 10 miles, and the existence of 
tested operational plans for effectively interdicting contaminated 
agricultural products in this extended zone.
    For the types of nuclear reactors in use within the United States, 
there are very few accident scenarios that produce such effects. These 
very severe events have been well-analyzed, and none lead to the rapid 
appearance of thyroid-threatening radioiodines beyond 10 miles. 
Experience with major evacuations (approximately one every three weeks 
in the U.S.), and detailed analysis for a typical nuclear power plant 
(NPP), show that populations in the extended zone likely to be affected 
by such an event can be evacuated in time to avoid adverse thyroid 
conditions. Moreover, KI is only effective in decreasing thyroid 
exposure to radioactive isotopes of iodine, and the events in question 
would produce health effects from radionuclides other than the isotopes 
of iodine. Evacuation and interdiction of contaminated food products 
are the preferred actions to prevent exposures to these other 
radionuclides, and will have to be taken in response to such an event 
in any case.
    While the Section 127(f) authority delegated to me primarily 
concerns distribution of KI beyond the current 10 mile Nuclear 
Regulatory Commission (NRC) program, the review brought to my attention 
weaknesses in the implementation of existing programs within 10 miles 
that deserve attention. States distribute KI currently provided by the 
NRC in diverse programs with disparate characteristics, suggesting that 
many are not based on best practices for prevention of adverse thyroid 
conditions. Accordingly, while not a pre-condition of my decision to 
invoke the Section 127(f) waiver, I strongly recommend that the NRC, in 
conjunction with the Federal Emergency Management Agency (FEMA), the 
Department of Health and Human

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Services (HHS), State and local health authorities and relevant public 
and private sector stakeholders develop and promulgate ``best 
practice'' guidelines for the existing state-level KI distribution 
programs within the 10 mile emergency planning zones.

Stanley S. Sokul,
Chief of Staff and General Counsel, Office of Science and Technology 
Policy.
[FR Doc. E8-1769 Filed 1-30-08; 8:45 am]
BILLING CODE 3170-W8-P