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.

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)''.

Summary: Seafood Safety Enforcement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to refuse admission to seafood that either appears to contain impermissible substances or originates from a country identified as a likely source of articles subject to refusal of admission Permits entry upon submission of acceptable evidence to the contrary. Directs the Secretary of Health and Human Services to issue guidance when an exporter or country appears to be a source of articles subject to refused admission based on specified criteria, including the detection of substances by other importing countries. Requires the Secretary to notify the appropriate congressional committees: (1) of all countries and exporters for which guidance was issued. And (2) before issuing a tolerance for any substance considered impermissible .