II 

109TH CONGRESS 

1ST SESSION S. 1422 

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

exposure to mercury through vaccines. 

IN THE SENATE OF THE UNITED STATES 

JULY 19, 2005 

Mr. HAGEL introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

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 2005’’. 

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 and many pediatric and adult in24 fluenza vaccines. 
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1 (6) There is no law or regulation to prohibit the 

2 reintroduction of thimerosal into any products from 

3 which it has been removed, leaving open the possi4 bility that it may be reintroduced at some point in 

5 the future in new vaccines or vaccines from which it 

6 has already been removed. 

7 (7) The Environmental Protection Agency has 

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

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

10 safety threshold. 

11 (8) Cumulative exposures to mercury, a 

12 neurotoxin, are known to cause harm, particularly in 

13 young children and pregnant women. 

14 (9) Taking steps to reduce mercury exposures 

15 through vaccines is an important way to reduce di16 rect exposures to mercury and mercury compounds. 

17 SEC. 3. BANNED MERCURY-CONTAINING VACCINES. 

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

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

20 adding at the end the following: 

21 ‘‘(j) If it is a banned mercury-containing vaccine 

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

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

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

25 by inserting after section 351A the following: 
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1 ‘‘SEC. 351B. BANNED MERCURY-CONTAINING VACCINES. 

2 ‘‘(a) IN GENERAL.—For purposes of section 501(j) 

3 of the Federal Food, Drug, and Cosmetic Act, and subject 

4 to subsection (b), a vaccine is a banned mercury-con5 taining vaccine under this section if 1 dose of the vaccine 

6 contains 1 or more micrograms of mercury in any form. 

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

8 ‘‘(1) EXCEPTION.—Subsection (j) of section 

9 501 of the Federal Food, Drug, and Cosmetic Act 

10 shall not apply to a vaccine during the effective pe11 riod of a declaration issued by the Secretary for 

12 such vaccine under this subsection. 

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

14 a declaration concluding that an actual or potential 

15 bioterrorist incident or other actual or potential pub16 lic health emergency makes advisable the adminis17 tration of a vaccine described in subsection (a) not18 withstanding the mercury content of such vaccine. 

19 ‘‘(3) LIMITATION.—The Secretary— 

20 ‘‘(A) shall specify in any declaration under 

21 this section the beginning and ending dates of 

22 the effective period of the declaration; and 

23 ‘‘(B) may not specify any such effective pe24 riod that exceeds 12 months. 

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

26 period of any declaration under this section, the Sec-
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1 retary, subject to paragraph (3), may issue another 

2 declaration for the same incident or public health 

3 emergency. 

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

5 promptly publish each declaration under this section 

6 in the Federal Register. 

7 ‘‘(c) EFFECTIVE DATES.—This section applies only 

8 to the introduction, or delivery for introduction, of a 

9 banned mercury-containing vaccine into interstate com10 merce on or after the earlier of the following: 

11 ‘‘(1) July 1, 2006, if the vaccine is listed in the 

12 January–June 2005 version of the recommended 

13 childhood and adolescent immunization schedule of 

14 the Centers for Disease Control and Prevention 

15 (other than an influenza vaccine). 

16 ‘‘(2) January 1, 2009.’’. 

17 SEC. 4. RESTRICTIONS ON ADMINISTRATION OF MERCURY18 CONTAINING INFLUENZA VACCINES TO CHIL19 DREN AND PREGNANT WOMEN. 

20 (a) APPLICATION.—This section applies only to a vac21 cine that— 

22 (1) is a banned mercury-containing vaccine (as 

23 that term is defined in section 351B(a) of the Public 

24 Health Service Act (as amended by section 3)); 

25 (2) is an influenza vaccine; and 
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1 (3) is manufactured for use in the 2006–2007 

2 influenza season or any subsequent period. 

3 (b) RESTRICTIONS ON ADMINISTRATION OF VACCINE

4 TO CHILDREN.—Any approval by the Secretary of Health 

5 and Human Services of a biologics license under section 

6 351 of the Public Health Service Act (42 U.S.C. 262) for 

7 any vaccine described in subsection (a) shall provide that 

8 such vaccine is being approved as a biological product sub9 ject to subpart H of part 314 of title 21, Code of Federal 

10 Regulations (or any successor regulations). Under such 

11 subpart H, the Secretary shall establish the following re12 strictions on the distribution of the vaccine: 

13 (1) Effective July 1, 2006, the vaccine shall not 

14 be administered to any child under the age of 3 

15 years old. 

16 (2) Effective July 1, 2006, if the vaccine con17 tains thimerosal, the vaccine shall not be adminis18 tered to any pregnant woman. 

19 (3) Effective July 1, 2007, the vaccine shall not 

20 be administered to any child under the age of 6 

21 years old. 

22 (c) TRANSITIONAL PROVISION.—In the case of a bio23 logics license under section 351 of the Public Health Serv24 ice Act (42 U.S.C. 262) that was approved before the date 
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1 of the enactment of this Act for a vaccine described in 

2 subsection (a)— 

3 (1) at the request of the holder of the license, 

4 the Secretary shall modify the license to include the 

5 restrictions described in subsection (b); or 

6 (2) if the holder of the license fails to submit 

7 such a request, the Secretary shall revoke the license 

8 as applied to vaccines manufactured for use in the 

9 2006–2007 influenza season or any subsequent pe10 riod. 

11 (d) PUBLIC HEALTH EMERGENCY EXCEPTION.— 

12 This section shall not apply to a vaccine during the effec13 tive period of a declaration issued by the Secretary for 

14 such vaccine under section 351B(b) of the Public Health 

15 Service Act (as amended by section 3). 

16 SEC. 5. INFORMATION ON MERCURY CONTENT. 

17 Section 2126 of the Public Health Service Act (42 

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

19 following: 

20 ‘‘(e) MERCURY CONTENT.—Not later than 2 months 

21 after the date of the enactment of this subsection, the Sec22 retary shall revise the vaccine information materials devel23 oped and disseminated under this section to ensure that, 

24 in the case of any vaccine described in subsection (a) that 

25 contains mercury, the materials include— 
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1 ‘‘(1) a statement indicating the presence of 

2 mercury in the vaccine; 

3 ‘‘(2) information on the availability of any mer4 cury-free or mercury-reduced alternative vaccine and 

5 instructions on how to obtain such alternative vac6 cine; and 

7 ‘‘(3) a recommendation against administration 

8 of any mercury-containing vaccine to a pregnant 

9 woman.’’. 

10 SEC. 6. SENSE OF CONGRESS. 

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

12 the Centers for Disease Control and Prevention should in13 clude, in any information disseminated by the Centers to 

14 the public or to health care providers relating to the ad15 ministration of vaccines, a recommendation against ad16 ministration of any thimerosal-containing vaccine to a 

17 pregnant woman. 

18 SEC. 7. REPORT TO CONGRESS. 

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

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

21 Food and Drugs shall submit a report to the Congress 

22 annually on the progress of the Commissioner in removing 

23 mercury from vaccines. 

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