I
107TH CONGRESS
2D SESSION
H. R. 3885
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 methyl mercury in seafood, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 6, 2002
Mr. PALLONE 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
require the Secretary of Health and Human Services
to establish a tolerance for the presence of methyl mer-
cury in seafood, and for other purposes.
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 ‘‘Seafood Safety and
Mercury Screening Act of 2002’’.
SEC. 2. REQUIREMENT OF ESTABLISHMENT OF TOLER-
ANCE FOR METHYL MERCURY 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)(A), by inserting ‘‘meth-
yl mercury in seafood,’’ after ‘‘food additive,’’;
(2) in section 402(a)(2), by inserting after ‘‘sec-
tion 512; or’’ the following: ‘‘(D) if it is seafood that
bears or contains methyl mercury that is unsafe
within the meaning of section 406A(a); or’’; and
(3) by inserting after section 406 the following
section:
‘‘TOLERANCE FOR METHYL MERCURY IN SEAFOOD
‘‘SEC. 406A. (a) IN GENERAL.—Not later than one
year after the date of the enactment of the Seafood Safety
and Mercury Screening Act of 2002, the Secretary shall
by regulation establish a tolerance for the presence of
methyl mercury in seafood, which shall be based on a sci-
entific analysis of the health risks attributable to such
substance. Any seafood containing methyl mercury shall
be deemed unsafe for purposes of section 402(a)(2)(D)
unless the quantity of such substance is within the limits
of the tolerance.
‘‘(b) STANDARD.—
‘‘(1) IN GENERAL.—The Secretary shall ensure
that the tolerance under subsection (a) is safe, and
shall modify or revoke the tolerance if the Secretary
determines that it is not safe.
‘‘(2) DETERMINATION OF SAFETY.—As used in
this section, the term ‘safe’, with respect to a toler-
ance for methyl mercury in seafood, means that the
Secretary has determined that there is a reasonable
certainty that no harm will result from aggregate ex-
posure to methyl mercury, including all anticipated
dietary exposures and all other exposures for which
there is reliable information.
‘‘(c) PREGNANT
WOMEN, INFANTS, AND
CHIL-
DREN.—In establishing or modifying a 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
methyl mercury.
‘‘(d) SAMPLING SYSTEM.—Not later than 18 months
after the date of the enactment of the Seafood Safety and
Mercury Screening Act of 2002, the Secretary, after con-
sultation with the Secretary of Agriculture, shall establish
a system for the ongoing collection and analysis of samples
of seafood to determine the extent of compliance with the
tolerance under subsection (a). Such system shall provide
statistically valid monitoring, including market-basket
studies, with respect to such compliance.
‘‘(e) PUBLIC EDUCATION AND ADVISORY SYSTEM.—
‘‘(1) PUBLIC
EDUCATION.—The Secretary, in
cooperation with private and public organizations,
including the cooperative extension services and ap-
propriate State entities, shall design and implement
a national public education program regarding the
presence of methyl mercury in seafood. The program
shall provide—
‘‘(A) information to the public regarding
Federal standards and good practice require-
ments and promotion of public awareness un-
derstanding and acceptance of such standards
and requirements;
‘‘(B) information to health professionals so
that they may improve diagnosis and treatment
of mercury-related illness and advise individuals
whose health conditions place them in par-
ticular risk; and
‘‘(C) such other information or advice to
consumers and other persons as the Secretary
determines will promote the purposes of this
section.
‘‘(2) 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 appro-
priate entities to—
‘‘(A) develop and distribute regional and
national advisories concerning the presence of
methyl mercury in seafood;
‘‘(B) develop standardized formats for
written and broadcast advisories regarding
methyl mercury in seafood; and
‘‘(C) incorporate State and local advisories
into the national public education program re-
quired in paragraph (1).’’.
SEC. 3. CONSIDERATION OF REPORT OF NATIONAL ACAD-
EMY OF SCIENCES.
In carrying out section 406A of the Federal Food,
Drug, and Cosmetic Act (as added by the amendment
made by section 2 of this Act), the Secretary of Health
and Human Services, acting through the Commissioner of
Food and Drugs, shall consider the findings made by the
National Academy of Sciences regarding the Environ-
mental Protection Agency’s recommended level for methyl
mercury exposure and the presence of methyl mercury in
seafood, as such findings are described in the report issued
by such Academy in July 2000.
SEC. 4. REPORT.
Not later than 180 days after the date of the enact-
ment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and
Drugs, shall submit to the Congress a report on the
progress of the Secretary in establishing the tolerance re-
quired by the amendments made by section 2. The report
shall include a description of the research that has been
conducted with respect to the tolerance.
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