I 

108TH CONGRESS 

2D SESSION H. R. 5000 

To require the Secretaries of Health and Human Services, Defense, and 

Homeland Security to carry out activities toward bringing to market 

effective medical countermeasures to radiation from a nuclear or radiological attack. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 22, 2004 

Mr. WELDON of Pennsylvania (for himself and Mr. ISSA) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Armed Services and Select 

Homeland Security, for a period to be subsequently determined by the 

Speaker, in each case for consideration of such provisions as fall within 

the jurisdiction of the committee concerned 

A BILL 

To require the Secretaries of Health and Human Services, 

Defense, and Homeland Security to carry out activities 

toward bringing to market effective medical countermeasures to radiation from a nuclear or radiological attack. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Radioprotectant Pro5 curement Act of 2004’’. 
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1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) The threat of a radiological or nuclear at4 tack on the American people is one of the greatest 

5 potential threats now faced by the United States, 

6 considering the potential number of deaths, injuries, 

7 illnesses and economic devastation such an attack on 

8 American civilians or military personnel could have. 

9 (2) There are at least 30,000 known nuclear 

10 weapons deployed around the world today and the 

11 proliferation of nuclear weapons technology con12 tinues to pose an enormous threat to the United 

13 States, its people, and its interests and allies around 

14 the world. 

15 (3) Even a crude radiological weapon, using 

16 conventional explosives combined with widely avail17 able radiological materials, could cause death, radi18 ation sickness, and widespread panic and economic 

19 hardship if detonated in an urban center of the 

20 United States, and such an attack would dramati21 cally strain our public health resources. 

22 (4) Numerous government and private studies, 

23 including the findings of several leading medical 

24 journals, have concluded that a nuclear weapon deto25 nated in a large urban center would cause wide26 spread death, sickness, and physical and economic 
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1 damage. For example, in February 2002, the British 

2 Medical Journal estimated that a 12.5 kiloton nu3 clear bomb (approximately the size of the bomb used 

4 at Hiroshima), if detonated in New York City, would 

5 cause 50,000 immediate deaths, 200,000 short-term 

6 deaths from high-exposure radiation injury, and 

7 700,000 cases of radiation sickness. 

8 (5) There are 103 nuclear power plants in the 

9 United States, each with the potential to expose area 

10 residents to high levels of radiation in the event of 

11 a successful attack. 

12 (6) For potentially stockpiled radioprotectants 

13 to be most effective, they must be administered soon 

14 after exposure to radiation, so the procurement of a 

15 radioprotectant must be large enough and located in 

16 enough regions of the country to facilitate the rapid 

17 treatment of the hundreds of thousands and poten18 tially millions of Americans who would be exposed to 

19 radiation, as well as the many ‘‘worried well’’ who 

20 will flood emergency rooms should a nuclear or radi21 ological attack or large accident occur. 

22 (7) Considering the need to rapidly administer 

23 a radioprotectant, Federal procurement of an effec24 tive radioprotectant should be comparable to stock-
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1 piles of other drugs designed to counter the effects 

2 of chemical or biological agents. 

3 (8) Current treatment options for acute radi4 ation exposure are wholly inadequate, with potas5 sium iodide being the only widely stockpiled counter6 measure currently available. This treatment protects 

7 against the long-term risk of thyroid cancer, and 

8 does nothing to counteract short-term radiation sick9 ness and possible death within the first 30 days of 

10 exposure. 

11 (9) Effective medical countermeasures to both 

12 acute and long-term exposure of radiation are pres13 ently in development at the Armed Forces 

14 Radiobiology Research Institute (AFRRI) and 

15 among pharmaceutical companies, including at least 

16 one compound that has demonstrated efficacy in 

17 preventing radiation sickness and death caused by 

18 the destruction of bone marrow from acute radiation 

19 exposure. 

20 (10) While the Departments of Health and 

21 Human Services, Homeland Security, and Defense 

22 are appropriately dedicating substantial resources to 

23 the development and procurement of counter24 measures to biological threats, including smallpox 

25 and anthrax vaccines, few resources to date have 
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1 been dedicated to bring to market and procure an 

2 effective, whole-body radioprotectant. 

3 (11) In enacting the Homeland Security Act of 

4 2002, it was and is the intent of Congress that the 

5 development and procurement of radiological and 

6 nuclear countermeasures be given full and appro7 priate consideration and dedication of resources. 

8 SEC. 3. AMENDMENT TO THE HOMELAND SECURITY ACT OF 

9 2002. 

10 Section 304 of the Homeland Security Act of 2002 

11 (6 U.S.C. 184; Public Law 107–296) is amended by add12 ing at the end the following subsection: 

13 ‘‘(d) DEVELOPMENT AND PROCUREMENT OF RADI14 ATION MEDICAL COUNTERMEASURES.—For the purpose 

15 of rapidly developing, bringing to market, and procuring 

16 whole-body radioprotectants, the Secretaries of Health 

17 and Human Services, Homeland Security, and Defense 

18 shall utilize and expend such funds as may be necessary, 

19 including funds appropriated by Congress, and not other20 wise prohibited from being used for such purpose, under 

21 the appropriations headings ‘Public Health Programs’, 

22 ‘Strategic National Stockpile’, ‘Nuclear and Radiological 

23 Countermeasures’, ‘Biodefense Countermeasures’, ‘Re24 search, Development, Acquisition and Operations’, ‘Bio25 logical Countermeasures’, and ‘Chem-Bio Defense Initia-
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1 tive’, as well as relevant departmental and subagency oper2 ations budgets, subject to the appropriations Act in3 volved.’’. 

4 SEC. 4. REPORT REGARDING EFFECTIVE 

5 RADIOPROTECTANTS; DEVELOPMENT AND 

6 PROCUREMENT. 

7 (a) REPORT.—Not later than 120 days after the date 

8 of the enactment of this Act, the Secretary of Homeland 

9 Security (referred to in this section as the ‘‘Secretary’’) 

10 shall, in consultation with the Secretary of Health and 

11 Human Services and the Secretary of Defense, submit to 

12 the Congress a report providing a determination by the 

13 Secretary of— 

14 (1) the extent to which there is a threat of a 

15 nuclear or radiological attack against the United 

16 States; and 

17 (2) the availability of effective radioprotectant 

18 medical countermeasures against the threat. 

19 (b) DEVELOPMENT AND PROCUREMENT.— 

20 (1) IN GENERAL.—If in carrying out subsection 

21 (a) the Secretary determines that one or more effec22 tive radioprotectants are currently available, or may 

23 become available within a reasonable amount of 

24 time, then not later than 90 days after the submis25 sion of the report under such subsection, the Sec-
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1 retary shall enter into one or more agreements with 

2 one or more private companies for the development 

3 and procurement of one or more effective, safe, sta4 ble, and low-cost radioprotectants, subject to the 

5 availability of funds under an appropriations Act. 

6 (2) ADEQUATE PROTECTION.—An agreement 

7 under paragraph (1) shall provide for the procure8 ment and stockpiling of enough dose regimens of the 

9 radioprotectants involved to provide for adequate 

10 protection of the people of the United States, includ11 ing adequate response to a multi-location attack sce12 nario, if in carrying out subsection (a) the Secretary 

13 determines that such a scenario is plausible. 

14 (3) CERTAIN AUTHORITIES.— 

15 (A) DEVELOPMENT.—With respect to an 

16 agreement under paragraph (1) that provides 

17 funds for the development of a radioprotectant, 

18 the Secretary may use the same authorities as 

19 are described in subsections (b) through (e) of 

20 section 319F–1 of the Public Health Service 

21 Act. 

22 (B) PROCUREMENT.—With respect to an 

23 agreement under paragraph (1) that provides 

24 funds for the procurement of a radioprotectant, 

25 the Secretary may use the same authorities as 
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1 are described in section 319F–2(c)(7) of the 

2 Public Health Service Act. 

3 (C) CONDITIONS.—An agreement under 

4 paragraph (1) may contain such reasonable 

5 conditions in addition to the conditions required 

6 in paragraph (2) as the Secretary determines to 

7 be appropriate, including— 

8 (i) the condition that the final pro9 curement be contingent upon approval of 

10 the radioprotectants by the Food and Drug 

11 Administration, subject to section 564 of 

12 the Federal Food, Drug, and Cosmetic 

13 Act; and 

14 (ii) the condition that the company or 

15 companies that produce such 

16 radioprotectants may be required to as17 sume the development costs of improve18 ments to the radioprotectants. 

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