I 
109TH CONGRESS 
1ST SESSION 
H. R. 881
To amend the Federal Food, Drug, and Cosmetic Act to reduce human 
exposure to mercury through vaccines. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 17, 2005
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.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Mercury-Free Vaccines 
Act of 2005’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
(1) In July 1999, the Public Health Service 
and the American Academy of Pediatrics issued a 
joint statement, which was later endorsed by the
American Academy of Family Physicians, pro-
claiming: ‘‘[The] Public Health Service, the Amer-
ican Academy of Pediatrics, and vaccine manufac-
turers agree that thimerosal-containing vaccines 
should be removed as soon as possible. Similar con-
clusions were reached this year in a meeting at-
tended by European regulatory agencies, the Euro-
pean vaccine manufacturers, and the US FDA which 
examined the use of thimerosal-containing vaccines 
produced or sold in European countries.’’. 
(2) In July 2000, the Public Health Service, 
the Advisory Commission on Immunization Prac-
tices, the American Academy of Pediatrics, and the 
American Academy of Family Physicians issued a 
joint statement, providing: ‘‘The AAFP, [the] AAP, 
and the PHS in consultation with the ACIP reaffirm 
the goal set in July 1999 to remove or greatly re-
duce thimerosal from vaccines as soon as possible 
for the following reasons: 1) the removal or substan-
tial reduction of thimerosal from vaccines is feasible, 
2) the progress in removal which has been made to 
date is substantial, 3) the discussions between the 
Food and Drug Administration and the vaccine 
manufacturers in removing thimerosal are ongoing, 
and 4) the public concern about the use of mercury
of any sort remains high. Based on information from 
the FDA and manufacturers, the PHS projects that 
the United States will complete its transition to a 
secure routine pediatric vaccine supply free of thi-
merosal as a preservative (i.e. at least two vaccine 
products each for Hep B, Hib, and DTaP) by the 
first quarter of 2001.’’. 
(3) The Institute of Medicine’s Immunization 
Review Committee concluded that significant reasons 
existed for continued public health attention to con-
cerns 
about 
thimerosal 
exposure 
and 
neurodevelopmental disorders and recommended the 
removal of thimerosal from vaccines administered to 
children and pregnant women. 
(4) Federal regulatory agencies and manufac-
turers have taken positive steps to remove thimer-
osal from some medical products, most notably rou-
tinely administered childhood vaccines. 
(5) Considerable progress has been made in re-
ducing mercury exposures from childhood vaccines, 
yet 5 years after the July 1999 statement, thimer-
osal remains in several nonroutinely administered 
childhood vaccines and many pediatric and adult in-
fluenza vaccines.
(6) There is no law or regulation to prohibit the 
reintroduction of thimerosal into any products from 
which it has been removed, leaving open the possi-
bility that it may be reintroduced at some point in 
the future in new vaccines or vaccines from which it 
has already been removed. 
(7) The Environmental Protection Agency has 
estimated that as many as 1 in 6 infants are born 
with a blood mercury level that exceeds the Agency’s 
safety threshold. 
(8) Cumulative exposures to mercury, a 
neurotoxin, are known to cause harm, particularly in 
young children and pregnant women. 
(9) Taking steps to reduce mercury exposures 
through vaccines is an important way to reduce di-
rect exposures to mercury and mercury compounds. 
SEC. 3. BANNED MERCURY-CONTAINING VACCINES. 
(a) PROHIBITION.—Section 501 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
adding at the end the following: 
‘‘(j) If it is a banned mercury-containing vaccine 
under section 351B of the Public Health Service Act.’’. 
(b) AMENDMENT TO PHSA.—Title III of the Public 
Health Service Act (42 U.S.C. 241 et seq.) is amended 
by inserting after section 351A the following:
‘‘SEC. 351B. BANNED MERCURY-CONTAINING VACCINES. 
‘‘(a) IN GENERAL.—For purposes of section 501(j) 
of the Federal Food, Drug, and Cosmetic Act, and subject 
to subsection (b), a vaccine is a banned mercury-con-
taining vaccine under this section if 1 dose of the vaccine 
contains 1 or more micrograms of mercury in any form. 
‘‘(b) PUBLIC HEALTH EMERGENCY EXCEPTION.—
‘‘(1) EXCEPTION.—Subsection (j) of section 
501 of the Federal Food, Drug, and Cosmetic Act 
shall not apply to a vaccine during the effective pe-
riod of a declaration issued by the Secretary for 
such vaccine under this subsection. 
‘‘(2) DECLARATION.—The Secretary may issue 
a declaration concluding that an actual or potential 
bioterrorist incident or other actual or potential pub-
lic health emergency makes advisable the adminis-
tration of a vaccine described in subsection (a) not-
withstanding the mercury content of such vaccine. 
‘‘(3) LIMITATION.—The Secretary—
‘‘(A) shall specify in any declaration under 
this section the beginning and ending dates of 
the effective period of the declaration; and 
‘‘(B) may not specify any such effective pe-
riod that exceeds 12 months. 
‘‘(4) RENEWALS.—At the end of the effective 
period of any declaration under this section, the Sec-
retary, subject to paragraph (3), may issue another 
declaration for the same incident or public health 
emergency. 
‘‘(5) 
PUBLICATION.—The 
Secretary 
shall 
promptly publish each declaration under this section 
in the Federal Register. 
‘‘(c) EFFECTIVE DATES.—This section applies only 
to the introduction, or delivery for introduction, of a 
banned mercury-containing vaccine into interstate com-
merce on or after the earlier of the following: 
‘‘(1) July 1, 2006, if the vaccine is listed in the 
January–June 2005 version of the recommended 
childhood and adolescent immunization schedule of 
the Centers for Disease Control and Prevention 
(other than an influenza vaccine). 
‘‘(2) January 1, 2009.’’. 
SEC. 4. RESTRICTIONS ON ADMINISTRATION OF MERCURY-
CONTAINING INFLUENZA VACCINES TO CHIL-
DREN AND PREGNANT WOMEN. 
(a) APPLICATION.—This section applies only to a vac-
cine that—
(1) is a banned mercury-containing vaccine (as 
that term is defined in section 351B(a) of the Public 
Health Service Act (as amended by section 3)); 
(2) is an influenza vaccine; and
(3) is manufactured for use in the 2006–2007 
influenza season or any subsequent period. 
(b) RESTRICTIONS ON ADMINISTRATION OF VACCINE 
TO CHILDREN.—Any approval by the Secretary of Health 
and Human Services of a biologics license under section 
351 of the Public Health Service Act (42 U.S.C. 262) for 
any vaccine described in subsection (a) shall provide that 
such vaccine is being approved as a biological product sub-
ject to subpart H of part 314 of title 21, Code of Federal 
Regulations (or any successor regulations). Under such 
subpart H, the Secretary shall establish the following re-
strictions on the distribution of the vaccine: 
(1) Effective July 1, 2006, the vaccine shall not 
be administered to any child under the age of 3 
years old. 
(2) Effective July 1, 2006, if the vaccine con-
tains thimerosal, the vaccine shall not be adminis-
tered to any pregnant woman. 
(3) Effective July 1, 2007, the vaccine shall not 
be administered to any child under the age of 6 
years old. 
(c) TRANSITIONAL PROVISION.—In the case of a bio-
logics license under section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262) that was approved before the date
of the enactment of this Act for a vaccine described in 
subsection (a)—
(1) at the request of the holder of the license, 
the Secretary shall modify the license to include the 
restrictions described in subsection (b); or 
(2) if the holder of the license fails to submit 
such a request, the Secretary shall revoke the license 
as applied to vaccines manufactured for use in the 
2006–2007 influenza season or any subsequent pe-
riod. 
(d) PUBLIC HEALTH EMERGENCY EXCEPTION.—
This section shall not apply to a vaccine during the effec-
tive period of a declaration issued by the Secretary for 
such vaccine under section 351B(b) of the Public Health 
Service Act (as amended by section 3). 
SEC. 5. INFORMATION ON MERCURY CONTENT. 
Section 2126 of the Public Health Service Act (42 
U.S.C. 300aa–26) is amended by adding at the end the 
following: 
‘‘(e) MERCURY CONTENT.—Not later than 2 months 
after the date of the enactment of this subsection, the Sec-
retary shall revise the vaccine information materials devel-
oped and disseminated under this section to ensure that, 
in the case of any vaccine described in subsection (a) that 
contains mercury, the materials include—
‘‘(1) a statement indicating the presence of 
mercury in the vaccine; 
‘‘(2) information on the availability of any mer-
cury-free or mercury-reduced alternative vaccine and 
instructions on how to obtain such alternative vac-
cine; and 
‘‘(3) a recommendation against administration 
of any mercury-containing vaccine to a pregnant 
woman.’’. 
SEC. 6. SENSE OF CONGRESS. 
It is the sense of the Congress that the Director of 
the Centers for Disease Control and Prevention should in-
clude, in any information disseminated by the Centers to 
the public or to health care providers relating to the ad-
ministration of vaccines, a recommendation against ad-
ministration of any thimerosal-containing vaccine to a 
pregnant woman. 
SEC. 7. REPORT TO CONGRESS. 
Not later than 1 year after the date of the enactment 
of this Act, and annually thereafter, the Commissioner of 
Food and Drugs shall submit a report to the Congress 
annually on the progress of the Commissioner in removing 
mercury from vaccines.
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