[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2759 Introduced in Senate (IS)]
107th CONGRESS
2d Session
S. 2759
To protect the health and safety of American consumers under the
Federal Food, Drug, and Cosmetic Act from seafood contaminated by
certain substances.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 18, 2002
Mr. Hollings (for himself, Mr. Lott, and Mr. Breaux) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To protect the health and safety of American consumers under the
Federal Food, Drug, and Cosmetic Act from seafood contaminated by
certain substances.
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 ``Seafood Safety Enforcement Act''.
SEC. 2. FINDINGS
(a) Chloramphenicol, a potent antibiotic, can cause severe toxic
effects in humans, including hypo-aplastic anemia, which is usually
irreversible and fatal. The drug is administered to humans only in
life-threatening situations when less toxic drugs are not effective.
(b) Because of these human health impacts, chloramphenicol and
similar drugs are not approved for use in food-producing animals in the
United States. However, other countries have been found to use these
drugs in the aquaculture of shrimp and other seafood, including
Thailand, Vietnam, and China.
(c) The majority of shrimp consumed by the United States is
imported. The nation imports 400,000 metric tons of shrimp annually,
and the percentage of shrimp imports rises each year. Thailand and
Vietnam are the top two exporters of shrimp to the United States, and
China is the fifth largest exporter of shrimp to the United States.
(d) Upon detection of chloramphenicol in certain shipments of
seafood from China and other nations, in 2002 the European Union and
Canada severely restricted imports of shrimp and other food from these
nations.
(e) The United States Food and Drug Administration inspects only 2
percent of all seafood imports into the United States and utilizes a
testing procedure that cannot detect the presence of chloramphenicol
below 1 part per billion. The European Union and Canada use testing
protocols that can detect such substances to 0.3 parts per billion.
(f) While Food and Drug Administration import testing did not
detect chloramphenicol in shrimp imported from these nations in 2002,
independent testing performed by the state of Louisiana detected
chloramphenicol at a level of over 2 parts per billion in crawfish
imported from China.
(g) Imports of seafood from nations that utilize substances banned
in the United States pose potential threats to United States consumers.
Denial of entry to contaminated shrimp and other products to the
European Union and Canada will likely redirect imports to the United
States of contaminated products turned away from these countries.
(h) Immediate and focused actions must be taken by the Federal
government to improve enforcement of food import restrictions of
seafood imports in order to protect United States consumers and ensure
safety of the food supply.
SEC. 3. CONTAMINATED SEAFOOD.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381) is amended by--
(1) striking all of the text in the third sentence of
subsection (a) after ``section 505,'' and inserting ``or (4)
such article is seafood that appears to bear or contain one or
more substances listed in section 530.41(a) of title 21, Code
of Federal Regulations, or (5) such article is seafood
originating from an exporter or country that the Secretary has
identified in guidance as a likely source of articles subject
to refusal of admission under clause (4) of this sentence, then
such article shall be refused admission, except as provided in
subsection (c) of this section and, with respect to articles
subject to clause (5) of this sentence, except as provided in
subsection (b) of this section.'';
(2) redesignating subsections (b) through (n) as
subsections (c) through (o), respectively; and
(3) inserting after subsection (a) the following:
``(b)(1) Notwithstanding clause (5) of the third sentence in
subsection (a) of this section, the Secretary may permit individual
shipments of seafood originating in a country or from an exporter
listed in guidance to be admitted into the United States if evidence
acceptable to the Secretary is presented that the seafood in that
shipment does not bear or contain a substance listed in section
530.41(a) of title 21, Code of Federal Regulations.
``(2) The Secretary may remove a country or exporter listed in
guidance under clause (5) of the third sentence of subsection (a) of
this section only if the country or exporter has shown to the
satisfaction of the Secretary that each substance at issue is no longer
sold for use in, being used in, or being used in a manner that could
contaminate food-producing animals in the country at issue.''.
SEC. 4. GUIDANCE FOR REFUSING ENTRY OF SEAFOOD FROM A COUNTRY OR
EXPORTER.
(a) Issuance of Guidance.--Upon a determination by the Secretary of
Health and Human Services that, based on information acceptable to the
Secretary, an exporter or country appears to be a source of articles
subject to refusal under section 801(a)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(a)(4)), the Secretary shall issue
guidance described in section 801(a)(5) of that Act.
(b) Determination Criteria.--In making the determination described
in subsection (a), or any determination under section 801(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), the Secretary
may consider--
(1) the detection of substances described in section
801(a)(4) of that Act by the Secretary;
(2) the detection of such substances by a person
commissioned to carry out examinations and investigations under
section 702(a) of that Act;
(3) findings from an inspection under section 704 of that
Act;
(4) the detection by other importing countries of such
substances in shipments of seafood that originate from such
country or exporter; and
(5) other evidence or information as determined by the
Secretary.
(c) Annual Report.--The Secretary shall provide a report within 30
days after the end of each fiscal year to the Senate Committee on
Health, Education, Labor, and Pensions and the House of Representatives
Committee on Energy and Commerce setting forth the names of all
countries and exporters for which the guidance described in subsection
(a) was issued during that fiscal year.
(d) Rule of Construction.--Nothing in this Act, and no amendment
made by this Act, shall be construed to limit the existing authority of
the Secretary of Health and Human Services or the Secretary of the
Treasury to consider any information or to refuse admission of any
article under section 801(a) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381(a)).
SEC. 5. ISSUANCE OF TOLERANCES.
If, after the date of enactment of this Act, the Secretary of
Health and Human Services intends to issue a tolerance under section
512(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b))
for any of the substances listed in section 530.41(a) of title 21, Code
of Federal Regulations, then the Secretary shall notify the Senate
Committee on Health, Education, Labor, and Pensions and the House of
Representatives Committee on Energy and Commerce before issuing that
tolerance. The Secretary shall include in the notification a draft of
any changes in Federal statute law that may be necessary.
SEC. 6. CONFORMING AMENDMENTS.
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381), as amended by subsection (a), is amended by--
(1) striking ``subsection (b)'' in subsection (d), as
redesignated by section 2(2) of this Act, and inserting
``subsection (c)'';
(2) striking ``subsection (e)'' in paragraph (1) of
subsection (g), as redesignated by section 2(2) of this Act,
and inserting ``subsection (f)'';
(3) striking ``section 801(a)'' in paragraph (1)(A)(i) of
subsection (h), as redesignated by section 2(2) of this Act,
and inserting ``subsection (a) of this section'';
(4) striking ``section 801(a)'' in paragraph (1)(A)(ii) of
subsection (h), as redesignated by section 2(2) of this Act,
and inserting ``subsection (a) of this section'';
(5) striking ``section 801(d)(1);'' in paragraph
(1)(A)(iii) of subsection (h), as redesignated by section 2(2)
of this Act, and inserting ``subsection (e)(1) of this
section;''.
(6) striking ``Subsection (b)'' in paragraph (2) of
subsection (k), as redesignated by section 2(2) of this Act,
and inserting ``Subsection (c)'';
(7) striking ``Subsection (b)'' in paragraph (1) of
subsection (l), as redesignated by section 2(2) of this Act,
and inserting ``Subsection (c)'';
(8) striking ``Subsection (b)'' in subsection (m), as
redesignated by section 2(2) of this Act, and inserting
``Subsection (c)''; and
(9) striking ``Subsection (b)'' in paragraph (2)(B)(i) of
subsection (n), as redesignated by section 2(2) of this Act,
and inserting ``Subsection (c)''.
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