Shellfish Safety Act of 1993

Summary: Shellfish Safety Act of 1993 - Mandates the establishment of a National Shellfish Safety Program, including the issuance of guidelines for:  (1) shellfish growers, harvesters, and shippers and their vessels; (2) water quality of shellfish growing and harvesting areas; (3) monitoring the movement of domestic and imported shellfish in interstate commerce; and (4) monitoring and controlling biotoxins and contaminants. 
Provides for State programs, including monitoring, classifying, and closing growing and harvesting areas and certification of shippers. 
Authorizes a memorandum of understanding with any country with a program at least equivalent to the Program providing for specified matters, including requiring the country to certify shippers and make available a list of waters classified as meeting requirements at least equivalent to the Program. 
Deems adulterated, for purposes of the Federal Food, Drug, and Cosmetic Act, shellfish:  (1) grown or harvested in a country without such a memorandum; (2) grown or harvested in a State without an approved program; (3) harvested from waters not classified as meeting the requirements of the program or otherwise deemed unsuitable for harvesting; or (4) shipped by an uncertified shipper. 
Directs the Secretary of Commerce to evaluate the potential for removing conditions and prohibitions on growing and harvesting areas. 
Authorizes cooperative agreements with States for restoration of such areas.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Shellfish Safety Act of 1993''.

SEC. 2. PURPOSES.

    The purposes of this Act are to--
            (1) protect against the hazards to human health associated 
        with the consumption of shellfish; and
            (2) ensure the public confidence in the wholesomeness and 
        labeling of shellfish products consumed in the United States.

SEC. 3. NATIONAL SHELLFISH SAFETY PROGRAM.

    (a) Establishment.--Not later than 9 months after the date of the 
enactment of this Act, the Secretary, in consultation with the 
Secretary of Commerce, other appropriate Federal agencies and the 
Conference shall establish a National Shellfish Safety Program to carry 
out the purposes of this Act.
    (b) Guidelines.--The National Shellfish Safety Program established 
under subsection (a) shall include the issuance of guidelines for--
            (1) shellfish growers, shellfish harvesters, shellfish 
        shippers, and their vessels;
            (2) water quality of shellfish growing and harvesting 
        areas;
            (3) monitoring the movement of domestic and imported 
        shellfish in interstate commerce;
            (4) monitoring and controlling biotoxins and other 
        naturally occurring pathogens and bacterial, viral, and 
        chemical contaminants in shellfish; and
            (5) such other matters as are necessary to carry out the 
        purposes of this Act.
    (c) Existing Guidelines.--The Program shall be consistent with 
guidelines adopted by the Conference pursuant to the Memorandum of 
Understanding between the Conference and the Food and Drug 
Administration, dated March 14, 1984.
    (d) Review and Revision.--The Secretary, in consultation with the 
Conference, shall periodically review and revise the Program to ensure 
that the program continues to carry out the purposes of this Act.

SEC. 4. DOMESTIC SHELLFISH SAFETY.

    (a) State Shellfish Safety Programs.--Each shellfish producing 
State shall submit to the Secretary, within 6 months after the 
establishment of the Program and annually thereafter--
            (1) a proposed State shellfish safety program to--
                    (A) manage its shellfish safety program consistent 
                with the Program;
                    (B) monitor and classify shellfish growing and 
                harvest areas in the State consistent with the Program;
                    (C) establish procedures for the closure and 
                reopening of shellfish growing and harvest areas in the 
                State that do not meet the standards of the Program;
                    (D) certify those shellfish shippers in the State 
                that comply with the requirements of the Program; and
                    (E) provide adequate monitoring and enforcement to 
                ensure that standards and procedures established under 
                the Program are met.
    (b) Certified Shellfish Shippers List.--Each State shall submit to 
the Secretary each month, a list of those shellfish shippers that are 
certified by the State as meeting the requirements of the Program.
    (c) Classified Waters List.--Each shellfish producing State shall 
submit to the Secretary each month, a list of those shellfish 
harvesting and growing waters that are classified by the State as 
meeting the requirements of the Program.

SEC. 5. IMPORTED SHELLFISH SAFETY.

    (a) Memorandum of Understanding.--After the date of the 
establishment of the Program, the Secretary may enter into a memorandum 
of understanding with any foreign country which the Secretary 
determines has a shellfish safety program that is at least equivalent 
to the Program.
    (b) Contents.--A memorandum of understanding entered into by the 
Secretary under this section shall--
            (1) provide for such verification activities by the 
        Secretary as the Secretary considers appropriate to determine 
        that the shellfish safety program of the foreign country is at 
        least equivalent to the Program; and
            (2) require the foreign country to--
                    (A) manage its shellfish safety program under 
                standards and procedures that are at least equivalent 
                to the Program;
                    (B) certify to the Secretary those shellfish 
                shippers located in the foreign country that comply 
                with the Program; and
                    (C) maintain and make available to the Secretary a 
                list of those shellfish harvesting and growing waters 
                of the foreign country that are classified by the 
                foreign country as meeting requirements at least 
                equivalent to the Program.

SEC. 6. PUBLICATION OF LISTS.

    The Secretary shall, within 60 days after the establishment of the 
Program--
            (1) establish, maintain, publish, and distribute monthly a 
        list of those shellfish shippers that are certified by a State 
        or a foreign country as meeting the requirements of the 
        Program; and
            (2) establish, maintain, publish, and distribute monthly a 
        list of those shellfish harvesting and growing waters that are 
        classified by States and foreign countries as meeting the 
        requirements of the Program.

SEC. 7. DELISTING OF CERTIFIED SHIPPERS.

    After consultation with the appropriate State or foreign shellfish 
control agency and the Conference, the Secretary may remove a shellfish 
shipper from the list under section 6(1) if the Secretary determines 
that--
            (1) the shipper is not in compliance with the standards and 
        procedures established under the Program that are applicable to 
        the shipper; and
            (2) the State or foreign country which certified that 
        shipper under section 4(b) or 5(b)(2)(A), respectively, has not 
        taken appropriate action with respect to that noncompliance.

SEC. 8. CERTAIN SHELLFISH DEEMED UNFIT FOR HUMAN CONSUMPTION.

    Shellfish is deemed to be adulterated for purposes of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) if--
            (1) it is grown or harvested in a foreign country that has 
        not entered into a memorandum of understanding with the 
        Secretary in accordance with section 5 within 6 months after 
        the date of the enactment of the Program;
            (2) it is grown or harvested in a State that does not have 
        State shellfish safety program that is approved by the 
        Secretary under section 4;
            (3) it is harvested from waters that--
                    (A) have not been classified by a State or a 
                foreign country as meeting the requirements of the 
                Program; or
                    (B) are otherwise deemed by the Secretary to be 
                unsuitable for harvesting; or
            (4) it is shipped by a shellfish shipper not on the list 
        published by the Secretary under section 6(1).

SEC. 9. ASSISTANCE FOR STATE SHELLFISH SAFETY PROGRAMS.

    The Secretary may enter into cooperative agreements with States for 
developing, implementing, and maintaining State shellfish safety 
programs in accordance with the Program.

SEC. 10. RESTORATION OF SHELLFISH GROWING AND HARVEST WATERS.

    (a) Evaluation.--The Secretary of Commerce shall, in cooperation 
with the Administrator of the Environmental Protection Agency and the 
States--
            (1) establish and maintain a list of those State shellfish 
        growing and harvesting areas where shellfish harvesting is 
        conditional or prohibited;
            (2) determine the causes of those conditions and 
        prohibitions; and
            (3) evaluate the potential for removing those conditions 
        and prohibitions.
    (b) Cooperative Agreements.--The Secretary of Commerce may enter 
into cooperative agreements with States for developing and implementing 
restoration programs for shellfish growing and harvesting areas listed 
under subsection (a)(1).

SEC. 11. DEFINITIONS.

    For the purpose of this Act, the term--
            (1) ``Conference'' means the Interstate Shellfish 
        Sanitation Conference;
            (2) ``Program'' means the National Shellfish Safety Program 
        established under section 3;
            (3) ``Secretary'' means the Secretary of Health and Human 
        Services;
            (4) ``shellfish''--
                    (A) means any species of molluscan bivalves;
                    (B) includes oysters, clams, mussels, and scallops 
                (except scallop abductor muscles); and
                    (C) includes any such species that is shucked, in 
                the shell, fresh, frozen, canned, cooked, thermally 
                processed, or breaded;
            (5) ``State'' means any of the several States, the District 
        of Columbia, the Commonwealth of Puerto Rico, the Commonwealth 
        of the Northern Mariana Islands, American Samoa, Guam, the 
        Virgin Islands, and any other territory of possession of the 
        United States; and
            (6) ``shellfish shipper'' means any person that shucks, 
        packs, repacks, ships, or processes (including cooking, 
        canning, freezing, depurating, breading, thermal processing, or 
        other handling) shellfish in interstate commerce.