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[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 2692 Introduced in Senate (IS)]

106th CONGRESS
  2d Session
                                S. 2692

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety 
             of imported products, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                 June 7 (legislative day, June 6), 2000

Ms. Mikulski (for herself, Mr. Kennedy, and Mr. Durbin) 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 improve the safety 
             of imported products, 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 ``Imported Products Safety Improvement 
and Disease Prevention Act of 2000''.

       TITLE I--IMPROVEMENTS TO THE PRODUCT SAFETY IMPORT SYSTEM

SEC. 101. EQUIVALENCE AUTHORITY TO PROTECT THE PUBLIC HEALTH FROM 
              CONTAMINATED IMPORTED PRODUCTS.

    (a) Equivalence Determinations, and Measures, Systems, and 
Conditions To Achieve Public Health Protection.--Section 801 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended--
            (1) by redesignating subsections (d), (e), and (f) as 
        subsections (f), (g), and (h), respectively; and
            (2) by inserting after subsection (c) the following:
    ``(d)(1) Subject to paragraphs (2) and (3), any covered product 
offered for import into the United States shall be prepared (including 
produced), packed, and held under a system or conditions, or subject to 
measures, that meet the requirements of this Act or that have been 
determined by the Secretary to be equivalent to a system, conditions, 
or measures for such covered product in the United States and to 
achieve the level of public health protection for such covered product 
prepared, packed, and held in the United States. Consistent with 
section 492 of the Trade Agreements Act of 1979 (19 U.S.C. 2578a), the 
Secretary shall make, where appropriate, equivalence determinations 
described in that section relating to sanitary or phytosanitary 
measures (including systems and conditions) that apply to the 
preparation, packing, and holding of covered products offered for 
import into the United States.
    ``(2) In carrying out this subsection, the Secretary shall conduct 
systematic evaluations of the systems, conditions, and measures in 
foreign countries that apply to the preparation, packing, and holding 
of covered products offered for import into the United States.
    ``(3) The Secretary shall develop a plan for the implementation of 
the authority under this subsection within 2 years after the date of 
enactment of the Imported Products Safety Improvement and Disease 
Prevention Act of 2000. In developing the plan, the Secretary shall 
provide an opportunity for, and take into consideration, public comment 
on a proposed plan.''.
    (b) General Authority.--Section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381), as amended in subsection (a), is further 
amended by inserting after subsection (d) the following:
    ``(e)(1)(A) The Secretary shall establish a system, for use by the 
Secretary of the Treasury, to deny the entry of any covered product 
offered for import into the United States if the Secretary of Health 
and Human Services makes and publishes--
            ``(i) a written determination that the covered product--
                    ``(I) has been associated with repeated and 
                separate outbreaks of disease borne in a covered 
                product or has been repeatedly determined by the 
                Secretary to be adulterated within the meaning of 
                section 402;
                    ``(II) presents a reasonable probability of causing 
                significant adverse health consequences or death; and
                    ``(III) is likely, without systemic intervention or 
                changes, to cause disease or be adulterated again; or
            ``(ii) an emergency written determination that the covered 
        product has been strongly associated with a single outbreak of 
        disease borne in a covered product that has caused serious 
        adverse health consequences or death.
    ``(B)(i) The Secretary shall make a determination described in 
subparagraph (A) with respect to--
            ``(I) a covered product from a specific producer, 
        manufacturer, or shipper; or
            ``(II) a covered product from a specific growing area or 
        country;
that meets the criteria described in subparagraph (A).
    ``(ii) Only the covered product from the specific producer, 
manufacturer, shipper, growing area, or country for which the Secretary 
makes the determination shall be subject to denial of entry under this 
subsection.
    ``(C) The denial of entry of any covered product under this 
paragraph shall be done in a manner consistent with bilateral, 
regional, and multilateral trade agreements and the rights and 
obligations of the United States under the agreements.
    ``(D)(i) Before making any written determination under subparagraph 
(A)(i), the Secretary shall consider written comments, on a proposed 
determination, made by any party affected by the proposed determination 
and any remedial actions taken to address the findings made in the 
proposed determination. In making the written determination, the 
Secretary may modify or rescind the proposed determination in 
accordance with such comments.
    ``(ii)(I) The Secretary may immediately issue an emergency written 
determination under subparagraph (A)(ii) without first considering 
comments on a proposed determination.
    ``(II) Within 30 days after the issuance of the emergency 
determination, the Secretary shall consider written comments on the 
determination that are made by a party described in clause (i) and 
received within the 30-day period. The Secretary may affirm, modify, or 
rescind the emergency determination in accordance with the comments.
    ``(III) The emergency determination shall be in effect--
            ``(aa) for the 30-day period; or
            ``(bb) if the Secretary affirms or modifies the 
        determination, until the Secretary rescinds the determination.
    ``(2)(A) The covered product initially denied entry under paragraph 
(1) may be imported into the United States if the Secretary finds 
that--
            ``(i) the written determination made under paragraph (1) no 
        longer justifies the denial of entry of the covered product; or
            ``(ii) evidence of remedial action submitted from the 
        producer, manufacturer, shipper, specific growing area, or 
        country for which the Secretary made the written determination 
        under paragraph (1) addresses the determination.
    ``(B)(i) The Secretary shall take action on evidence submitted 
under subparagraph (A)(ii) within 90 days after the date of the 
submission of the evidence.
    ``(ii) The Secretary's action may include--
            ``(I) lifting the denial of entry of the covered product; 
        or
            ``(II) continuing to deny entry of the covered product 
        while requesting additional information or specific remedial 
        action from the producer, manufacturer, shipper, specific 
        growing area, or country.
    ``(iii) If the Secretary does not take action on evidence submitted 
under subparagraph (A)(ii) within 90 days after the date of submission, 
effective on the 91st day after the date of submission, the covered 
product initially denied entry under paragraph (1) may be imported into 
the United States.
    ``(3) The Secretary shall by regulation establish criteria and 
procedures for the system described in paragraph (1). The Secretary may 
by regulation modify those criteria and procedures, as the Secretary 
determines appropriate.''.
    (c) Technical and Conforming Amendments.--
            (1) Section 351(h) of the Public Health Service Act (42 
        U.S.C. 262(h)) is amended by striking ``section 801(e)(1) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e))'' 
        and inserting ``section 801(g)(1) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 381(g)(1))''.
            (2) Section 301 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 331) is amended--
                    (A) in paragraph (t), by striking ``section 
                801(d)(1)'' and inserting ``section 801(f)(1)''; and
                    (B) in paragraph (w)--
                            (i) by striking ``sections 801(d)(3)(A) and 
                        801(d)(3)(B)'' and inserting ``subparagraphs 
                        (A) and (B) of section 801(f)(3)'';
                            (ii) except as provided in clause (i), by 
                        striking ``section 801(d)(3)'' each place it 
                        appears and inserting ``section 801(f)(3)''; 
                        and
                            (iii) by striking ``section 801(e)'' and 
                        inserting ``section 801(g)''.
            (3) Section 303(b)(1)(A) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 333(b)(1)(A)) is amended by striking 
        ``section 801(d)(1)'' and inserting ``section 801(f)(1)''.
            (4) Section 304(d)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 334(d)(1)) is amended--
                    (A) by striking ``section 801(e)(1)'' and inserting 
                ``section 801(g)(1)''; and
                    (B) except as provided in subparagraph (A), by 
                striking ``section 801(e)'' each place it appears and 
                inserting ``section 801(g)''.
            (5) Section 801 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 381) is amended--
                    (A) in subsection (a), in the third sentence, by 
                striking ``subsection (b) of this section'' and 
                inserting ``subsection (b) or subsection (e)(2)(A) (in 
                the case of a covered product described in that 
                subsection)'';
                    (B) in paragraph (3)(A) of subsection (f), as 
                redesignated in subsection (a), by striking ``section 
                801(e) or 802'' and inserting ``subsection (g), section 
                802,''; and
                    (C) in paragraph (1) of subsection (h), as 
                redesignated in subsection (a), by striking 
                ``subsection (e)'' and inserting ``subsection (g)''.
            (6) Section 802 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 382) is amended--
                    (A) in subsection (a)(2)(C), by striking ``section 
                801(e)(2)'' and inserting ``section 801(g)(2)'';
                    (B) in subsection (f)(3), by striking ``section 
                801(e)(1)'' and inserting ``section 801(g)(1)''; and
                    (C) in subsection (i), by striking ``section 
                801(e)(1)'' and inserting ``section 801(g)(1)''.

SEC. 102. PROHIBITION AGAINST THE DISTRIBUTION OF CERTAIN PRODUCTS.

    (a) Adulterated Products.--Section 402 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the 
following:
    ``(h)(1) If--
            ``(A) it is a covered product being imported or offered for 
        import into the United States;
            ``(B) the covered product has been designated by the 
        Secretary for sampling, examination, or review for the purpose 
        of determining whether the covered product is in compliance 
        with this Act;
            ``(C) the Secretary requires, under section 801(a)(2)(B), 
        that the covered product not be distributed until the Secretary 
        authorizes the distribution of the covered product; and
            ``(D) the covered product is distributed before the 
        Secretary authorizes the distribution.
    ``(2) In this paragraph, the term `distributed', used with respect 
to a covered product, means--
            ``(A) moved for the purpose of selling the covered product, 
        offering the covered product for sale, or delivering the 
        covered product for the purpose of selling the covered product 
or offering the covered product for sale; or
            ``(B) delivered contrary to any bond requirement.''.
    (b) Prohibition.--Section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended--
            (1) in the third sentence, by redesignating paragraphs (1) 
        through (3) as subparagraphs (A) through (C), respectively;
            (2) by striking ``(a) The'' and inserting ``(a)(1) The'';
            (3) in the last sentence, by striking ``Clause (2)'' and 
        inserting ``Subparagraph (B)'';
            (4) by moving the fourth sentence to the end;
            (5) in the sentence so moved, by striking ``The Secretary'' 
        and inserting the following:
    ``(2)(A) The Secretary''; and
            (6) by adding at the end the following:
    ``(B) The Secretary of Health and Human Services may require that a 
covered product being imported or offered for import into the United 
States not be distributed until the Secretary authorizes distribution 
of the covered product.''.

SEC. 103. REQUIREMENT OF SECURE STORAGE OF CERTAIN IMPORTED PRODUCTS.

    (a) Adulterated Products.--Section 402 of the Federal Food, Drug, 
and Cosmetic Act, as amended in section 102(a), is further amended by 
adding at the end the following:
    ``(i) If--
            ``(1) it is a covered product being imported or offered for 
        import into the United States;
            ``(2) the Secretary requires, under section 801(a)(2)(C), 
        that the covered product be held in a secure storage facility 
        until the Secretary authorizes distribution of the covered 
        product; and
            ``(3) the covered product is not held in a secure storage 
        facility as described in section 801(a)(2)(C) until the 
        Secretary authorizes the distribution.''.
    (b) Requirement.--Section 801(a)(2) of the Federal Food, Drug, and 
Cosmetic Act, as amended in section 102(b), is further amended by 
adding at the end the following:
    ``(C)(i) The Secretary of Health and Human Services may require 
that a covered product that is being imported or offered for import 
into the United States be held, at the expense of the owner or 
consignee of the covered product, in a secure storage facility until 
the Secretary authorizes distribution of the covered product, if the 
Secretary makes the determination that the covered product is--
            ``(I) being imported or offered for import into the United 
        States by a person described in clause (ii); or
            ``(II) owned by or consigned to a person described in 
        clause (ii).
    ``(ii) An importer, owner, or consignee referred to in subclause 
(I) or (II) of clause (i) is a person against whom the Secretary of the 
Treasury has assessed liquidated damages not less than twice under 
subsection (b) for failure to redeliver, at the request of the 
Secretary of the Treasury, a covered product subject to a bond under 
subsection (b).''.

SEC. 104. REQUIREMENT OF ADMINISTRATIVE DESTRUCTION OF CERTAIN IMPORTED 
              PRODUCTS.

    (a) Adulterated Products.--Section 402 of the Federal Food, Drug, 
and Cosmetic Act, as amended in section 103(a), is further amended by 
adding at the end the following:
    ``(j) Notwithstanding subsections (a)(2)(A) and (b) of section 801, 
if--
            ``(1) it is a covered product being imported or offered for 
        import into the United States;
            ``(2) the covered product presents a reasonable probability 
        of causing significant adverse health consequences or death;
            ``(3) the Secretary, after the covered product has been 
        refused admission under section 801(a), requires under section 
        801(a)(2)(D) that the covered product be destroyed; and
            ``(4) the owner or consignee of the covered product fails 
        to comply with that destruction requirement.''.
    (b) Requirement.--Section 801(a)(2) of the Federal Food, Drug, and 
Cosmetic Act, as amended in section 103(b), is further amended by 
adding at the end the following:
    ``(D) The Secretary of Health and Human Services may require 
destruction, at the expense of the owner or consignee, of a covered 
product imported or offered for import into the United States that 
presents a reasonable probability of causing significant adverse health 
consequences or death.''.

SEC. 105. PROHIBITION AGAINST PORT SHOPPING.

    Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended 
in section 104(a), is further amended by adding at the end the 
following:
    ``(k) If it is a covered product being imported or offered for 
import into the United States, and the covered product previously has 
been refused admission under section 801(a), unless the person 
reoffering the article affirmatively establishes, at the expense of the 
owner or consignee of the article, that the article complies with the 
applicable requirements of this Act, as determined by the Secretary.''.

SEC. 106. PROHIBITION OF IMPORTS BY DEBARRED PERSONS.

    Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended 
in section 105, is further amended by adding at the end the following:
    ``(l) If it is a covered product being imported or offered for 
import into the United States by a person debarred under section 
306(b)(4).''.

SEC. 107. AUTHORITY TO MARK REFUSED ARTICLES.

    (a) Misbranded Products.--Section 403 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(t) If--
            ``(1) it has been refused admission under section 801(a);
            ``(2) the covered product has not been required to be 
        destroyed under subparagraph (A) or (B) of section 801(a)(2); 
        and
            ``(3) the packaging of the covered product does not bear a 
        label or labeling described in section 801(a)(2)(E).''.
    (b) Requirement.--Section 801(a)(2) of the Federal Food, Drug, and 
Cosmetic Act, as amended in section 104(b), is further amended by 
adding at the end the following:
    ``(E) The Secretary of Health and Human Services may require the 
owner or consignee of a covered product that has been refused admission 
under paragraph (1), and has not been required to be destroyed under 
subparagraph (A) or (B), to affix to the packaging of the covered 
product a label or labeling that--
            ``(i) clearly and conspicuously bears the following 
        statement: `United States: Refused Entry.';
            ``(ii) is affixed to the packaging until the covered 
        product is brought into compliance with this Act; and
            ``(iii) has been provided at the expense of the owner or 
        consignee of the covered product.''.

SEC. 108. EXPORT OF REFUSED ARTICLES.

    Paragraph (2)(A) of section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)), as designated in section 102(b), is 
amended by striking ``ninety days'' and inserting ``30 days''.

SEC. 109. COLLECTION AND ANALYSIS OF SAMPLES OF PRODUCT IMPORTS.

    Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381), as amended in section 101(a), is further amended by adding at the 
end the following:
    ``(i) The Secretary may issue regulations or guidance as necessary 
to govern the collection and analysis by entities other than the Food 
and Drug Administration of samples of a covered product imported or 
offered for import into the United States to ensure the integrity of 
the samples collected and the validity of the analytical results.''.

SEC. 110. DEFINITION.

    Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321) is amended by adding at the end the following:
    ``(kk) The term `covered product' means an article that is 
described in subparagraph (1), (2), or (3) of paragraph (f) and that is 
not a dietary supplement. The term shall not include an article to the 
extent that the Secretary of Agriculture exercises inspection authority 
over the article at the time of import into the United States.''.

TITLE II--ENFORCEMENT AND PENALTIES FOR IMPORTING CONTAMINATED PRODUCTS

SEC. 201. ENHANCED BONDING REQUIREMENTS FOR PRIOR INVOLVEMENT IN 
              IMPORTING ADULTERATED OR MISBRANDED PRODUCTS.

    Section 801(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(b)) is amended--
            (1) by inserting ``(1)'' after ``(b)''; and
            (2) by adding at the end the following:
    ``(2)(A) The Secretary of the Treasury, acting through the 
Commissioner of Customs, shall issue regulations that establish a rate 
for a bond required to be executed under paragraph (1) for a covered 
product if an owner, consignee, or importer of the covered product has 
committed a covered violation.
    ``(B) The regulations shall require the owner or consignee to 
execute such a bond--
            ``(i) at twice the usual rate; or
            ``(ii) if the owner, consignee, or importer has committed 
        more than 1 covered violation, at a rate that increases with 
        the number of covered violations committed, as determined in 
        accordance with a sliding scale established in the regulations.
    ``(C) In this paragraph:
            ``(i) The term `committed' means been convicted of, or 
        found liable for, a violation by an appropriate court or 
        administrative officer.
            ``(ii) The term `covered violation' means a violation 
        relating to--
                    ``(I) importing or offering for import into the 
                United States--
                            ``(aa) a covered product during a period of 
                        debarment under section 306(b)(4);
                            ``(bb) a covered product that is 
                        adulterated within the meaning of paragraph 
                        (h), (i), (j), (k), or (l) of section 402; or
                            ``(cc) a covered product that is misbranded 
                        within the meaning of section 403(t); or
                    ``(II) making a false or misleading statement in 
                conduct relating to the import or offering for import 
                of a covered product into the United States.
            ``(iii) The term `usual rate', used with respect to a bond, 
        means the rate that would be required under paragraph (1) for 
        the bond by a person who has not committed a covered 
        violation.''.

SEC. 202. DEBARMENT OF REPEAT OFFENDERS AND SERIOUS OFFENDERS.

    (a) In General.--Section 306(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 335a(b)) is amended--
            (1) in paragraph (1), in the paragraph heading, by striking 
        ``In general.--'' and inserting 
        ``Debarmentforviolationsrelatingtodrugs.--'';
            (2) in paragraph (2), in the paragraph heading, by striking 
        ``Persons subject to permissive debarment.--'' and inserting 
        ``Persons subject to permissive debarment for violations 
        relating to drugs.--'';
            (3) in paragraph (3), in the paragraph heading, by striking 
        ``Stay of certain orders.--'' and inserting ``Stay of certain 
        orders relating to debarment for violations relating to 
        drugs.--''; and
            (4) by adding at the end the following:
            ``(4) Debarment for violations relating to product 
        imports.--
                    ``(A) In general.--The Secretary may debar a person 
                from importing a covered product or offering a covered 
                product for import into the United States, if--
                            ``(i) the Secretary finds that the person 
                        has been convicted for conduct that is a felony 
                        under Federal law and relates to the 
                        importation or offering for importation of any 
                        covered product into the United States; or
                            ``(ii) the Secretary makes a written 
                        determination that the person has repeatedly or 
                        deliberately imported or offered for import 
                        into the United States a covered product 
                        adulterated within the meaning of paragraph 
                        (h), (i), (j), or (k) of section 402, or 
                        misbranded within the meaning of section 
                        403(t).
                    ``(B) Impact.--On debarring a person under 
                subparagraph (A), the Secretary shall provide notice of 
the debarment to the Secretary of the Treasury, who shall deny entry of 
a covered product offered for import by the person.''.
    (b) Technical and Conforming Amendments.--
            (1) In general.--Section 306 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 335a) is amended--
                    (A) in subsection (c)--
                            (i) in paragraph (1)--
                                    (I) in subparagraph (B), by 
                                striking ``, and'' at the end and 
                                inserting a comma;
                                    (II) by redesignating subparagraph 
                                (C) as subparagraph (D); and
                                    (III) by inserting after 
                                subparagraph (B) the following:
                    ``(C) shall, during the period of a debarment under 
                subsection (b)(4), prohibit the debarred person from 
                importing a covered product or offering a covered 
                product for import into the United States, and'';
                            (ii) in paragraph (2)(A), by inserting 
                        after clause (iii) the following:
                            ``(iv) The period of debarment of any 
                        person under subsection (b)(4) shall be not 
                        less than 1 year.''; and
                            (iii) in paragraph (3)--
                                    (I) in subparagraph (C)--
                                            (aa) by striking ``suspect 
                                        drugs'' and inserting ``suspect 
                                        drugs or covered products''; 
                                        and
                                            (bb) by striking 
                                        ``fraudulently obtained'' and 
                                        inserting ``fraudulently 
                                        obtained or on a covered 
                                        product wrongfully imported 
                                        into the United States''; and
                                    (II) in subparagraph (E), by 
                                inserting ``in the case of a debarment 
                                relating to a drug,'' after ``(E)'';
                    (B) in subsection (d)--
                            (i) in paragraph (3)--
                                    (I) in subparagraph (A)--
                                            (aa) in clause (i), by 
                                        striking ``or (b)(2)(A)'' and 
                                        inserting ``or paragraph (2)(A) 
                                        or (4) of subsection (b)''; and
                                            (bb) in clause (ii)(II), by 
                                        inserting ``in the case of a 
                                        debarment relating to a drug,'' 
                                        after ``(II)''; and
                                    (II) in subparagraph (B)--
                                            (aa) in clause (i), by 
                                        striking ``or clause (i), (ii), 
                                        (iii) or (iv) of subsection 
                                        (b)(2)(B)'' and inserting ``, 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subsection (b)(2)(B), 
                                        or subsection (b)(4)''; and
                                            (bb) in clause (ii), by 
                                        striking ``subsection 
                                        (b)(2)(B)'' and inserting 
                                        ``paragraph (2)(B) or (4) of 
                                        subsection (b)''; and
                            (ii) in paragraph (4)--
                                    (I) in subparagraph (A), by 
                                striking ``(a)(2)'' and inserting 
                                ``(a)(2) or (b)(4)'';
                                    (II) in subparagraph (B)--
                                            (aa) in clause (ii), by 
                                        striking ``involving the 
                                        development or approval of any 
                                        drug subject to section 505'' 
                                        and inserting ``involving, as 
                                        appropriate, the development or 
                                        approval of any drug subject to 
                                        section 505 or the importation 
                                        of any covered product''; and
                                            (bb) in clause (iv), by 
                                        striking ``drug'' each place it 
                                        appears and inserting ``drug or 
                                        covered product''; and
                                    (III) in subparagraph (D), in the 
                                matter following clause (ii), by 
                                inserting ``, in the case of a 
                                debarment relating to a drug,'' before 
                                ``protects''; and
                    (C) in subsection (l)(2), in the second sentence, 
                by striking ``(b)(2)(B)'' and inserting ``(b)(2)(B), 
                subsection (b)(4),''.
            (2) Civil penalties.--Paragraphs (6) and (7) of section 
        307(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        335b(a)) are amended by striking ``306'' and inserting ``306 
        (except section 306(b)(4))''.

SEC. 203. INCREASED ENFORCEMENT TO IMPROVE THE SAFETY OF IMPORTED 
              PRODUCTS.

    Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.) is amended by adding at the end the 
following:

``SEC. 712. POSITIONS TO IMPROVE THE SAFETY OF IMPORTED PRODUCTS.

    ``There is authorized to be appropriated such sums as may be 
necessary for each of fiscal years 2001 through 2003 to enable the 
Commissioner, in carrying out chapters IV and VIII, to decrease the 
health risks associated with imported covered products through the 
creation of additional employment positions for laboratory, inspection, 
and compliance personnel.''.

 TITLE III--IMPROVEMENTS TO PUBLIC HEALTH INFRASTRUCTURE AND AWARENESS

SEC. 301. IMPROVEMENTS.

    Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) 
is amended by adding at the end the following:

          ``PART C--PUBLIC HEALTH INFRASTRUCTURE AND AWARENESS

``SEC. 251. DEFINITIONS.

    ``In this part:
            ``(1) Covered product.--The term `covered product' has the 
        meaning given the term in section 201 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 321).
            ``(2) Institution of higher education.--The term 
        `institution of higher education' has the meaning given the 
        term in section 101(a) of the Higher Education Act of 1965 (20 
        U.S.C. 1001(a)).
            ``(3) Secretary.--The term `Secretary' means the Secretary 
        of Health and Human Services, acting through the Director of 
the Centers for Disease Control and Prevention.

``SEC. 252. PUBLIC HEALTH SURVEILLANCE ENHANCEMENT.

    ``(a) In General.--The Secretary may--
            ``(1) make grants to, enter into cooperative agreements 
        with, and provide technical assistance to eligible agencies to 
        enable the agencies to enhance their capacity to carry out 
        activities relating to surveillance and prevention of pathogen-
        related disease borne in a covered product, particularly 
        pathogen-related disease associated with imported covered 
        products, as described in subsection (b)(1); and
            ``(2) carry out the activities described in subsection 
        (b)(2).
    ``(b) Use of Assistance.--
            ``(1) Agencies.--An eligible agency that receives 
        assistance under subsection (a) shall use the assistance to 
        enhance the capacity of the agency--
                    ``(A) to identify, investigate, and contain threats 
                of pathogen-related disease borne in a covered product, 
                particularly pathogen-related disease associated with 
                imported covered products; and
                    ``(B) to conduct additional surveillance and 
                studies to address prevention and control of the 
                disease.
            ``(2) Centers for disease control and prevention.--The 
        Secretary may use not more than 30 percent of the funds 
        appropriated to carry out this section--
                    ``(A) to assist an agency described in paragraph 
                (1) in enhancing the capacity described in paragraph 
                (1) by providing standards, technologies, information, 
                materials, and other resources; and
                    ``(B) to enhance national surveillance systems, 
                including the ability of domestic and international 
                agencies and entities to respond to product safety 
                issues associated with imported covered products that 
                are identified through such systems.
    ``(c) Eligible Agencies.--To be eligible to receive assistance 
under subsection (a)(1), an agency shall be a State or local health 
department.
    ``(d) Application.--To be eligible to receive assistance under 
subsection (a)(1), an agency shall submit an application to the 
Secretary at such time, in such manner, and containing such information 
as the Secretary may require.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal years 2001 through 2003.

``SEC. 253. PATHOGEN DETECTION RESEARCH AND DEVELOPMENT.

    ``(a) In General.--The Secretary may conduct applied research, 
directly or by grant or contract, to develop new or improved methods 
for detecting and subtyping emerging pathogens (borne in covered 
products) in human specimens, covered products, and relevant 
environmental samples. The Secretary may use funds appropriated to 
carry out this section to support applied research by State health 
departments or institutions of higher education.
    ``(b) Application.--To be eligible to receive a grant or enter into 
a contract under subsection (a), an entity shall submit an application 
to the Secretary at such time, in such manner, and containing such 
information as the Secretary may require.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal years 2001 through 2003.

``SEC. 254. TRAINING, EDUCATION, AND PUBLIC INFORMATION.

    ``(a) In General.--The Secretary may--
            ``(1) make grants and enter into contracts with eligible 
        entities, to support training activities and other 
        collaborative activities with the entities to inform health 
        professionals about disease borne in covered products, 
        including strengthening training networks serving State, local, 
        and private entities; and
            ``(2) increase and improve the activities carried out by 
        the Centers for Disease Control and Prevention to provide 
        information to the public on disease borne in covered products.
    ``(b) Eligible Entities.--To be eligible to receive a grant or 
enter into a contract under subsection (a), an entity shall be a 
medical school, a nursing school, an entity carrying out clinical 
laboratory training programs, a school of public health, another 
institution of higher education, a professional organization, or an 
international organization.
    ``(c) Application.--To be eligible to receive a grant or enter into 
a contract under subsection (a), an entity shall submit an application 
to the Secretary at such time, in such manner, and containing such 
information as the Secretary may require.
    ``(d) Consultation.--In carrying out this section, the Secretary 
shall consult with Federal, State, and local agencies, international 
organizations, and other interested parties.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal years 2001 through 2003.

``SEC. 255. INTERNATIONAL PUBLIC HEALTH TRAINING AND TECHNICAL 
              ASSISTANCE.

    ``(a) In General.--The Secretary shall, directly or by agreement, 
provide training and technical assistance to agencies and entities in 
foreign countries, to strengthen the surveillance and investigation 
capacities of the agencies and entities relating to disease borne in 
covered products, including establishing or expanding activities or 
programs such as the Field Epidemiology and Training Program of the 
Centers for Disease Control and Prevention.
    ``(b) Application.--To be eligible to enter into an agreement under 
subsection (a), an entity shall submit an application to the Secretary 
at such time, in such manner, and containing such information as the 
Secretary may require.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for fiscal years 2001 through 2003.

``SEC. 256. SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.

    ``(a) In General.--On the request of a recipient of assistance 
under section 252, 253, 254, or 255, the Secretary may, subject to 
subsection (b), provide supplies, equipment, and services for the 
purpose of aiding the recipient in carrying out the section involved 
and, for such purpose, may detail to the grant recipient any officer or 
employee of the Department of Health and Human Services. Such detail 
shall be without interruption or loss of civil service status or 
privilege.
    ``(b) Corresponding Reduction in Payments.--With respect to a 
request described in subsection (a), the Secretary shall reduce the 
amount of payments under the section involved by an amount equal to the 
cost of detailing the officer or employee and the fair market value of 
the supplies, equipment, or services provided by the Secretary. The 
Secretary shall, for the payment of expenses incurred in complying with 
such a request, expend the amounts withheld.''.
                                 <all>
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