[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 555 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                 S. 555

   To amend the Federal Food, Drug, and Cosmetic Act to require the 
Secretary of Health and Human Services to establish a tolerance for the 
     presence of methylmercury in seafood, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 15, 2001

 Mr. Leahy (for himself and Mr. Harkin) 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 require the 
Secretary of Health and Human Services to establish a tolerance for the 
     presence of methylmercury in seafood, and for other purposes.

    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-Safe Seafood Act of 2001''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) mercury pollution from coal-fired power plants, waste 
        incinerators, and other anthropogenic sources continues to 
        contaminate inland waterways and territorial waters of the 
        United States;
            (2) mercury accumulates in fish as methylmercury and is 
        passed on to humans that eat those fish;
            (3) methylmercury is a potent neurotoxin that, even in 
        small quantities--
                    (A) can cause serious damage to the human central 
                nervous system and adverse effects on many other 
                systems in the human body;
                    (B) is especially harmful to pregnant women and 
                young children; and
                    (C) puts an estimated 60,000 newborns at risk for 
                adverse neurodevelopmental effects each year in the 
                United States from in utero exposure;
            (4) certain commercial seafood species can have dangerously 
        high levels of methylmercury, as evidenced by Food and Drug 
        Administration data acquired in the 1990's, up to the time that 
        the agency discontinued domestic sampling in 1998;
            (5) the Food and Drug Administration's long-standing action 
        level of 1.0 parts per million for methylmercury in fish--
                    (A) is out of date; and
                    (B) according to scientific evidence, does not 
                adequately protect pregnant women and young children;
            (6) the comprehensive Mercury Study Report to Congress 
        issued by the Environmental Protection Agency in December 1997 
        recommended a methylmercury consumption limit of 0.1 micrograms 
        per kilogram of body weight per day, which is 5 times lower 
        than the Food and Drug Administration's current action level;
            (7) the report entitled ``Toxicological Effects of 
        Methylmercury'', issued by the National Academy of Sciences in 
        July 2000, confirmed that the Environmental Protection Agency's 
        limit is ``scientifically justifiable for the protection of 
        public health'';
            (8) the report entitled ``Food Safety: Federal Oversight of 
        Seafood Does Not Sufficiently Protect Consumers'', issued by 
        the General Accounting Office in February 2001, highlights the 
        inadequacies of Food and Drug Administration guidance regarding 
        methylmercury in commercial seafood;
            (9) many States have been forced to issue mercury 
        advisories for inland waterways and health warnings regarding 
        the fish that may be caught in those waterways; and
            (10) some States have also issued mercury advisories for 
        commercial seafood.

SEC. 3. TOLERANCE FOR METHYLMERCURY IN SEAFOOD.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended--
            (1) in section 402(a)(2), by inserting after ``section 512; 
        or'' the following: ``(D) if it is seafood that bears or 
        contains methylmercury that is unsafe within the meaning of 
        section 406A(a); or''; and
            (2) by inserting after section 406 the following:

``SEC. 406A. TOLERANCE FOR METHYLMERCURY IN SEAFOOD.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this section, the Secretary shall by regulation establish 
a tolerance for the presence of methylmercury in seafood.
    ``(b) Requirements.--The tolerance established under subsection (a) 
shall--
            ``(1) be based on a scientific analysis of the health risks 
        attributable to methylmercury; and
            ``(2) be set at a level for which the Secretary determines 
        that there is a reasonable certainty that no harm will result 
        from aggregate exposure to methylmercury in seafood, including 
all anticipated dietary exposures for which there is reliable 
information.
    ``(c) Seafood Deemed Unsafe.--Any seafood bearing or containing 
methylmercury shall be deemed to be unsafe for purposes of section 
402(a)(2)(D) unless the quantity of methylmercury is within the limits 
of the tolerance.
    ``(d) Pregnant Women, Infants, and Children.--In establishing or 
modifying the tolerance under subsection (a), the Secretary shall 
ensure that there is a reasonable certainty that no harm will result to 
pregnant women, infants, and children from aggregate exposure to 
methylmercury.
    ``(e) Sampling System.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of this section, the Secretary, after consultation 
        with the Secretary of Agriculture, shall establish a system for 
        the collection and analysis of samples of seafood to determine 
        the extent of compliance with the tolerance under subsection 
        (a).
            ``(2) Monitoring.--The sampling system shall provide 
        statistically valid monitoring (including market-basket 
        studies) with respect to compliance with the tolerance.
            ``(3) Avoidance of duplication of effort.--To the extent 
        practicable, the sampling system shall be consistent with, and 
        shall be coordinated with, other seafood sampling systems that 
        are in use, so as to avoid duplication of effort.
    ``(f) Public Education and Advisory System.--
            ``(1) Public education.--The Secretary, in cooperation with 
        private and public organizations (including cooperative 
        extension services and appropriate State entities) shall design 
        and implement a national public education program regarding the 
        presence of methylmercury in seafood.
            ``(2) Features.--The program shall provide--
                    ``(A) information to the public regarding--
                            ``(i) Federal standards and good practice 
                        requirements; and
                            ``(ii) promotion of public awareness, 
                        understanding, and acceptance of the standards 
                        and requirements;
                    ``(B) information to health professionals so that 
                health professionals may improve diagnosis and 
                treatment of mercury-related illness and advise 
                individuals whose health conditions place those 
                individuals at particular risk; and
                    ``(C) such other information or advice to consumers 
                and other persons as the Secretary determines will 
                promote the purposes of this section.
            ``(3) Health advisories.--The Secretary, in consultation 
        with the Secretary of Agriculture and the Administrator of the 
        Environmental Protection Agency, shall work with the States and 
        other appropriate entities to--
                    ``(A) develop and distribute regional and national 
                advisories concerning the presence of methylmercury in 
                seafood;
                    ``(B) develop standardized formats for written and 
                broadcast advisories regarding methylmercury in 
                seafood; and
                    ``(C) incorporate State and local advisories into 
                the national public education program under paragraph 
                (1).''.

SEC. 4. CONSIDERATION OF REPORT OF NATIONAL ACADEMY OF SCIENCES.

    In carrying out section 406A(a) of the Federal Food, Drug, and 
Cosmetic Act (as added by section 3), the Secretary of Health and Human 
Services, acting through the Commissioner of Food and Drugs, shall 
consider the findings of the National Academy of Sciences regarding the 
Environmental Protection Agency's recommended level for methylmercury 
exposure and the presence of methylmercury in seafood, as such findings 
are described in the report issued by the National Academy of Sciences 
in July 2000.

SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

    (a) Sampling.--There is authorized to be appropriated to carry out 
sampling under section 406A(e) of the Federal Food, Drug, and Cosmetic 
Act (as added by section 3) $500,000 for each of fiscal years 2002 
through 2011.
    (b) Public Education and Advisory System.--There is authorized to 
be appropriated to develop and implement the public education and 
advisory system under section 406A(f) of the Federal Food, Drug, and 
Cosmetic Act (as added by section 3) $500,000 for each of fiscal years 
2002 through 2011.
    (c) State Support.--
            (1) In general.--There is authorized to be appropriated to 
        support efforts of the States to sample noncommercial fish and 
        inland waterways for mercury and to produce State-specific 
        health advisories related to mercury $2,000,000 for each of 
        fiscal years 2002 through 2011.
            (2) Equitable distribution.--The Administrator of the 
        Environmental Protection Agency shall distribute amounts made 
        available under paragraph (1) equitably among the States 
        through programs in existence on the date of enactment of this 
        Act.

SEC. 6. REPORT.

    (a) In General.--Not later than 180 days after the date of 
enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall submit to 
Congress a report on the progress of the Secretary in establishing the 
tolerance required by section 406A of the Federal Food, Drug, and 
Cosmetic Act (as added by section 3).
    (b) Contents.--The report shall include a description of the 
research that has been conducted or reviewed with respect to the 
tolerance.
                                 <all>