I 

108TH CONGRESS 

2D SESSION H. R. 4169 

To amend the Federal Food, Drug, and Cosmetic Act to reduce human 

exposure to mercury through vaccines. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 2, 2004 

Mr. WELDON of Florida (for himself and Mrs. MALONEY) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

reduce human exposure to mercury through vaccines. 

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 ‘‘Mercury-Free Vaccines 

5 Act of 2004’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

8 (1) In July 1999, the Public Health Service 

9 and the American Academy of Pediatrics issued a 

10 joint statement, which was later endorsed by the 
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1 American Academy of Family Physicians, pro2 claiming: ‘‘[The] Public Health Service, the Amer3 ican Academy of Pediatrics, and vaccine manufac4 turers agree that thimerosal-containing vaccines 

5 should be removed as soon as possible. Similar con6 clusions were reached this year in a meeting at7 tended by European regulatory agencies, the Euro8 pean vaccine manufacturers, and the US FDA which 

9 examined the use of thimerosal-containing vaccines 

10 produced or sold in European countries.’’. 

11 (2) In July 2000, the Public Health Service, 

12 the Advisory Commission on Immunization Prac13 tices, the American Academy of Pediatrics, and the 

14 American Academy of Family Physicians issued a 

15 joint statement, providing: ‘‘The AAFP, [the] AAP, 

16 and the PHS in consultation with the ACIP reaffirm 

17 the goal set in July 1999 to remove or greatly re18 duce thimerosal from vaccines as soon as possible 

19 for the following reasons: 1) the removal or substan20 tial reduction of thimerosal from vaccines is feasible, 

21 2) the progress in removal which has been made to 

22 date is substantial, 3) the discussions between the 

23 Food and Drug Administration and the vaccine 

24 manufacturers in removing thimerosal are ongoing, 

25 and 4) the public concern about the use of mercury 
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1 of any sort remains high. Based on information from 

2 the FDA and manufacturers, the PHS projects that 

3 the United States will complete its transition to a 

4 secure routine pediatric vaccine supply free of thi5 merosal as a preservative (i.e. at least two vaccine 

6 products each for Hep B, Hib, and DTaP) by the 

7 first quarter of 2001.’’. 

8 (3) The Institute of Medicine’s Immunization 

9 Review Committee concluded that significant reasons 

10 existed for continued public health attention to con11 cerns about thimerosal exposure and 

12 neurodevelopmental disorders and recommended the 

13 removal of thimerosal from vaccines administered to 

14 children and pregnant women. 

15 (4) Federal regulatory agencies and manufac16 turers have taken positive steps to remove thimer17 osal from some medical products, most notably rou18 tinely administered childhood vaccines. 

19 (5) Considerable progress has been made in re20 ducing mercury exposures from childhood vaccines, 

21 yet 5 years after the July 1999 statement, thimer22 osal remains in several nonroutinely administered 

23 childhood vaccines. 

24 (6) There is no law or regulation to prohibit the 

25 reintroduction of thimerosal into any products from 
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1 which it has been removed, leaving open the possi2 bility that it may be reintroduced at some point in 

3 the future. 

4 (7) The Environmental Protection Agency has 

5 estimated that as many as 1 in 6 infants are born 

6 with a blood mercury level that exceeds the Agency’s 

7 safety threshold. 

8 (8) Cumulative exposures to mercury, a 

9 neurotoxin, are known to cause harm, particularly in 

10 young children and pregnant women. 

11 (9) Taking steps to reduce mercury exposures 

12 through vaccines is an important way to reduce di13 rect exposures to mercury and mercury compounds. 

14 SEC. 3. BANNED MERCURY-CONTAINING VACCINES. 

15 (a) PROHIBITION.—Section 501 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 

17 adding at the end the following: 

18 ‘‘(h) If it is a banned mercury-containing vaccine 

19 under section 351B of the Public Health Service Act.’’. 

20 (b) AMENDMENT TO PHSA.—Title III of the Public 

21 Health Service Act (42 U.S.C. 241 et seq.) is amended 

22 by inserting after section 351A the following: 

23 ‘‘SEC. 351B. BANNED MERCURY-CONTAINING VACCINES. 

24 ‘‘(a) IN GENERAL.—For purposes of section 501(h) 

25 of the Federal Food, Drug, and Cosmetic Act, and subject 
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1 to subsection (b), a vaccine is a banned mercury-con2 taining vaccine under this section if— 

3 ‘‘(1) 1 dose of the vaccine contains 1 or more 

4 micrograms of mercury in any form; or 

5 ‘‘(2) the vaccine contains any quantity of thi6 merosal and is listed in the current version of the 

7 recommended childhood and adolescent immuniza8 tion schedule of the Centers for Disease Control and 

9 Prevention. 

10 ‘‘(b) PUBLIC HEALTH EMERGENCY EXCEPTION.— 

11 ‘‘(1) EXCEPTION.—Subsection (h) of section 

12 501 of the Federal Food, Drug, and Cosmetic Act 

13 shall not apply to a vaccine during the effective pe14 riod of a declaration issued by the Secretary for 

15 such vaccine under this section. 

16 ‘‘(2) DECLARATION.—The Secretary may issue 

17 a declaration concluding that an actual or potential 

18 bioterrorist incident or other actual or potential pub19 lic health emergency makes advisable the adminis20 tration of a vaccine described in subsection (a) not21 withstanding the mercury or thimerosal content of 

22 such vaccine. 

23 ‘‘(3) LIMITATION.—The Secretary— 
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1 ‘‘(A) shall specify in any declaration under 

2 this section the beginning and ending dates of 

3 the effective period of the declaration; and 

4 ‘‘(B) may not specify any such effective pe5 riod that exceeds 12 months. 

6 ‘‘(4) RENEWALS.—At the end of the effective 

7 period of any declaration under this section, the Sec8 retary, subject to paragraph (3), may issue another 

9 declaration for the same incident or public health 

10 emergency. 

11 ‘‘(5) PUBLICATION.—The Secretary shall 

12 promptly publish each declaration under this section 

13 in the Federal Register. 

14 ‘‘(c) EFFECTIVE DATES.— 

15 ‘‘(1) MERCURY-CONTAINING VACCINES.—In the 

16 case of a vaccine described in subsection (a)(1), the 

17 amendments made by this section apply only to vac18 cines introduced, or delivered for introduction, into 

19 interstate commerce on or after the following: 

20 ‘‘(A) July 1, 2004, if the vaccine is an in21 fluenza vaccine. 

22 ‘‘(B) January 1, 2005, if the vaccine 

23 (other than an influenza vaccine) is listed in the 

24 January–June 2004 version of the rec25 ommended childhood and adolescent immuniza-
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1 tion schedule of the Centers for Disease Control 

2 and Prevention. 

3 ‘‘(C) January 1, 2006, in the case of any 

4 vaccine not described in subparagraph (A) or 

5 (B). 

6 ‘‘(2) THIMEROSAL-CONTAINING VACCINES.—In 

7 the case of a vaccine that is not described in sub8 section (a)(1), but is described in subsection (a)(2), 

9 the amendments made by this section apply only to 

10 vaccines introduced, or delivered for introduction, 

11 into interstate commerce on or after January 1, 

12 2007.’’. 

13 SEC. 4. INFORMATION ON THIMEROSAL CONTENT. 

14 Section 2126 of the Public Health Service Act (42 

15 U.S.C. 300aa–26) is amended by adding at the end the 

16 following: 

17 ‘‘(e) THIMEROSAL CONTENT.—Not later than 2 

18 months after the date of the enactment of this subsection, 

19 the Secretary shall revise the vaccine information mate20 rials developed and disseminated under this section to en21 sure that, in the case of any vaccine described in sub22 section (a) that contains thimerosal, the materials in23 clude— 

24 ‘‘(1) a statement indicating the presence of thi25 merosal in the vaccine; 
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1 ‘‘(2) information on the availability of any thi2 merosal-free or thimerosal-reduced alternative vac3 cine and instructions on how to obtain such alter4 native vaccine; and 

5 ‘‘(3) a recommendation against administration 

6 of any thimerosal-containing vaccine to a pregnant 

7 woman.’’. 

8 SEC. 5. SENSE OF CONGRESS. 

9 It is the sense of the Congress that the Director of 

10 the Centers for Disease Control and Prevention should in11 clude, in any information disseminated by the Centers to 

12 the public or to health care providers relating to the ad13 ministration of vaccines, a recommendation against ad14 ministration of any thimerosal-containing vaccine to a 

15 pregnant woman. 

16 SEC. 6. REPORT TO CONGRESS. 

17 Not later than 1 year after the date of the enactment 

18 of this Act, and annually thereafter, the Commissioner of 

19 Food and Drugs shall submit a report to the Congress 

20 annually on the progress of the Commissioner in removing 

21 mercury from vaccines. 

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