In December 2001, the Food and Drug Administration (FDA) issued a final Guidance on Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (PDF – 40KB).
The objective of the document is to provide guidance to other Federal agencies, including the Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC), and to state and local governments regarding the safe and effective use of potassium iodide (KI) as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment.
The adoption and implementation of the recommendations are at the discretion of the state and local governments responsible for developing regional emergency-response plans related to radiation emergencies. The recommendations in the guidance address KI dosage and the projected radiation exposure at which the drug should be used. This guidance updates FDA’s 1982 recommendations.
Click to view the updated FDA guidlines
For the document that cites these references, see the Politics Over Protection page.
REFERENCES
1 Report to the Senate by The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. Issued December 3, 2008
2 Federal Register, December 15, 1978, FDA Talk Paper, December 10, 2001.
3 Letter from Michael Leavitt to United States Nuclear Regulatory Commission, March, 27, 2006.
4 Guidelines for Iodine Prophylaxis following Nuclear Accidents, 1999. World Health Organization, Geneva.
5 United States Nuclear Regulatory Commission, Report on the Accident at the Chernobyl Nuclear Power Station. NUREG-1250, Pages 7-8,9.
6 National Preparedness for Bioterrorism and Other Public Health Emergencies 2002 (HHS) HR 3448 Sec. 127
7 National Research Council of the National Academies of Science: Distribution of Potassium Iodide in a Nuclear Accident. Jan. 2004.
8 Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in support of Nuclear Power Plants. NUREG-0654, FEMA-REP-1, Rev.1 Page 11
9 “Federal Policy on the Use of Potassium Iodide (KI),” Federal Register, Volume 67, Number 7, January 10, 2002.
10 Kathleen Sebelius letter to Congressman Bill Young dated September 29, 2009.
11 Examination of the Use of Potassium Iodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents. NUREG/CR-1433. Prepared by Sandia National Labs for the United States Nuclear Regulatory Commission. October 1980.
12 An Analysis of Potassium Iodide (KI) Prophylaxis for the General Public in the Event of a Nuclear Accident. NUREG-6310. Prepared by S. Cohen & Associates for the Office of Nuclear Regulatory Research, Reactor & Plant Safety Issues Branch, Division of Safety Issue Resolution, April 1992.
13 Guidelines for Iodine Prophylaxis following Nuclear Accidents, 1999. World Health Organization, Geneva, page 5
14 Assessment of the Use of Potassium Iodide (KI) As a Public Protective Action During Severe Reactor Accidents. US Nuclear Regulatory Commission. Draft NUREG 1633, page 15
15 IBID. page 16
16 US Nuclear Regulatory Commission, Office of Public Affairs, Backgrounder, April 2012
17 Thyroid Disease 60 Years After Hiroshima and 20 years After Chernobyl. Journal of the American Medical Association, March 1, 2006, vol. 295, No. 9
18 Radiation Effects in the Marshall Islands. Clinical Endocrinology Branch, National Institutes of Health, Bethesda, MD; Medical Department, Brookhaven National Laboratory, Upton, NY, Jacob Robbins, Lead Researcher.
19 Exposure of the American People to Iodine-131 from Nevada Nuclear-Bomb Tests. Review of the National Cancer Institute Report and Public Health Implications. Board on Radiation Effects Research Commission on Life Sciences, National Research Council, National Academy Press, Washington, D.C., 1999
20 Kemeny, John J. “Report of the President’s Commission on the Accident at Three Mile Island.” October 1979.
21 Fackler, Martin. “Japan Weighed Evacuating Tokyo in Nuclear Crisis.” NY Times, February 27, 2012.
22 Bipartisan letter signed by 30 United States Representatives to President Barak Obama dated May 9, 2011.
23 National Research Council. Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident . Washington, DC: The National Academies Press, 2004.
24 American Thyroid Association. ATA Endorses Potassium Iodide for Radiation Emergencies. July 24, 2002.
25 Letter from Richard T. Kloos, MD, Chief Operating Officer, American Thyroid Association to Dr. John Holdren, Director, Office of Science and Technology Policy, Executive Office of the President, March 30, 2011
26 Radiation Disasters and Children. American Academy of Pediatrics Committee on Environmental Health. June 2003.
27 Criteria for Preparation and Evaluation of Radiological Emergency Response Plans and Preparedness in support of Nuclear Power Plants. NUREG-0654, FEMA-REP-1, Rev.1
28 IBID, page 11
30 Assessment of the Use of Potassium Iodide (KI) As a Public Protective Action During Severe Reactor Accidents. US Nuclear Regulatory Commission. Draft NUREG 1633, page 15
31 Letter to Dr. Robert Claypool, US Dept. of Health and Human Services, November 1, 2005
32 Examination of the Use of Potassium Iodide (KI) as an Emergency Protective Measure for Nuclear Reactor Accidents. NUREG/CR-1433. Prepared by Sandia National Labs for the United States Nuclear Regulatory Commission. October 1980, page 39.
33 Decision Memorandum, Executive Office of the President, Office of Science and Technology Policy, January 22, 2008, John Marburger, Director.
34 See NUREG/CR-1433 and NUREG-6310, referenced above.
35 NRC NEWS, US Nuclear Regulatory Commission, Office of Public Affairs, March 16, 2011
36 See, for example, “White House may stop plan for anti-radiation pills”, USA Today, Oct. 23, 2007. Available at http://www.usatoday.com:80/news/nation/2007-10-22-nukepill_N.htm
38 US Nuclear Regulatory Commission, May 31, 2011, “For the Record”.
39 US Nuclear Regulatory Commission, “Planning Basis for the Development of State and Local Government Radiological Emergency Response Plans in Support of Light Water Nuclear Power Plants.” NUREG-0396, page I-2