Mercury-Free Vaccines Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to deem a banned mercury-containing vaccine to be adulterated. Amends the Public Health Service Act to deem a vaccine to be a banned mercury-containing vaccine if: (1) one dose of the vaccine contains 1 or more micrograms of mercury in any form; or (2) the vaccine contains any thimerosal and is listed in the current version of the recommended childhood and adolescent immunization schedule of the Centers for Disease Control and Prevention (CDC).
Allows the Secretary of Health and Human Services to declare that an actual or potential bioterrorist incident or other public health emergency makes the administration of such vaccines advisable for a specified period.
Specifies different effective dates of the provisions of this Act for particular vaccines.
Requires the Secretary to revise the vaccine information included with thimerosal-containing vaccines to include: (1) a statement that indicates the presence of thimerosal in the vaccine; (2) information on the availability of any thimerosal-free or thimerosal-reduced alternative vaccine and instructions on how to obtain such an alternative vaccine; and (3) a recommendation against administration of any thimerosal-containing vaccine to a pregnant woman.
Expresses the sense of Congress that the CDC should disseminate, with any vaccine-related information, a recommendation against administration of any thimerosal-containing vaccine to a pregnant woman.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4169 Introduced in House (IH)]
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.
Be it enacted by the Senate and House of Representatives 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 2004''.
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, proclaiming: ``[The] Public Health Service, the
American Academy of Pediatrics, and vaccine manufacturers agree
that thimerosal-containing vaccines should be removed as soon
as possible. Similar conclusions were reached this year in a
meeting attended by European regulatory agencies, the European
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 Practices, 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 reduce thimerosal from vaccines
as soon as possible for the following reasons: 1) the removal
or substantial 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 thimerosal 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 concerns 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 manufacturers have
taken positive steps to remove thimerosal from some medical
products, most notably routinely administered childhood
vaccines.
(5) Considerable progress has been made in reducing mercury
exposures from childhood vaccines, yet 5 years after the July
1999 statement, thimerosal remains in several nonroutinely
administered childhood 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 possibility that it may be
reintroduced at some point in the future.
(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 direct 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:
``(h) 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(h) of the Federal
Food, Drug, and Cosmetic Act, and subject to subsection (b), a vaccine
is a banned mercury-containing vaccine under this section if--
``(1) 1 dose of the vaccine contains 1 or more micrograms
of mercury in any form; or
``(2) the vaccine contains any quantity of thimerosal and
is listed in the current version of the recommended childhood
and adolescent immunization schedule of the Centers for Disease
Control and Prevention.
``(b) Public Health Emergency Exception.--
``(1) Exception.--Subsection (h) of section 501 of the
Federal Food, Drug, and Cosmetic Act shall not apply to a
vaccine during the effective period of a declaration issued by
the Secretary for such vaccine under this section.
``(2) Declaration.--The Secretary may issue a declaration
concluding that an actual or potential bioterrorist incident or
other actual or potential public health emergency makes
advisable the administration of a vaccine described in
subsection (a) notwithstanding the mercury or thimerosal
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 period
that exceeds 12 months.
``(4) Renewals.--At the end of the effective period of any
declaration under this section, the Secretary, 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.--
``(1) Mercury-containing vaccines.--In the case of a
vaccine described in subsection (a)(1), the amendments made by
this section apply only to vaccines introduced, or delivered
for introduction, into interstate commerce on or after the
following:
``(A) July 1, 2004, if the vaccine is an influenza
vaccine.
``(B) January 1, 2005, if the vaccine (other than
an influenza vaccine) is listed in the January-June
2004 version of the recommended childhood and
adolescent immunization schedule of the Centers for
Disease Control and Prevention.
``(C) January 1, 2006, in the case of any vaccine
not described in subparagraph (A) or (B).
``(2) Thimerosal-containing vaccines.--In the case of a
vaccine that is not described in subsection (a)(1), but is
described in subsection (a)(2), the amendments made by this
section apply only to vaccines introduced, or delivered for
introduction, into interstate commerce on or after January 1,
2007.''.
SEC. 4. INFORMATION ON THIMEROSAL 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) Thimerosal Content.--Not later than 2 months after the date
of the enactment of this subsection, the Secretary shall revise the
vaccine information materials developed and disseminated under this
section to ensure that, in the case of any vaccine described in
subsection (a) that contains thimerosal, the materials include--
``(1) a statement indicating the presence of thimerosal in
the vaccine;
``(2) information on the availability of any thimerosal-
free or thimerosal-reduced alternative vaccine and instructions
on how to obtain such alternative vaccine; and
``(3) a recommendation against administration of any
thimerosal-containing vaccine to a pregnant woman.''.
SEC. 5. SENSE OF CONGRESS.
It is the sense of the Congress that the Director of the Centers
for Disease Control and Prevention should include, in any information
disseminated by the Centers to the public or to health care providers
relating to the administration of vaccines, a recommendation against
administration of any thimerosal-containing vaccine to a pregnant
woman.
SEC. 6. 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.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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