```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1422 Introduced in Senate (IS)]

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.

    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 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, 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 and many pediatric and adult 
        influenza 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 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 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:
    ``(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-containing 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 period 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 public health emergency makes 
        advisable the administration of a vaccine described in 
        subsection (a) notwithstanding 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 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.--This section applies only to the 
introduction, or delivery for introduction, of a banned mercury-
containing vaccine into interstate commerce 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 CHILDREN AND PREGNANT WOMEN.

    (a) Application.--This section applies only to a vaccine 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 subject 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 restrictions 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 contains 
        thimerosal, the vaccine shall not be administered 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 biologics license 
under section 351 of the Public Health Service 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 period.
    (d) Public Health Emergency Exception.--This section shall not 
apply to a vaccine during the effective 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 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 mercury, the materials include--
            ``(1) a statement indicating the presence of mercury in the 
        vaccine;
            ``(2) information on the availability of any mercury-free 
        or mercury-reduced alternative vaccine and instructions on how 
        to obtain such alternative vaccine; 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 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. 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.
                                 <all>
```