II

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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Imported Products

5 Safety Improvement and Disease Prevention Act of

6 2000’’.
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1 TITLE I—IMPROVEMENTS TO

2 THE PRODUCT SAFETY IM3 PORT SYSTEM

4 SEC. 101. EQUIVALENCE AUTHORITY TO PROTECT THE

5 PUBLIC HEALTH FROM CONTAMINATED IM6 PORTED PRODUCTS.

7 (a) EQUIVALENCE DETERMINATIONS, AND MEAS8 URES, SYSTEMS, AND CONDITIONS TO ACHIEVE PUBLIC

9 HEALTH PROTECTION.—Section 801 of the Federal Food,

10 Drug, and Cosmetic Act (21 U.S.C. 381) is amended—

11 (1) by redesignating subsections (d), (e), and

12 (f) as subsections (f), (g), and (h), respectively; and

13 (2) by inserting after subsection (c) the fol14 lowing:

15 ‘‘(d)(1) Subject to paragraphs (2) and (3), any cov16 ered product offered for import into the United States

17 shall be prepared (including produced), packed, and held

18 under a system or conditions, or subject to measures, that

19 meet the requirements of this Act or that have been deter20 mined by the Secretary to be equivalent to a system, con21 ditions, or measures for such covered product in the

22 United States and to achieve the level of public health pro23 tection for such covered product prepared, packed, and

24 held in the United States. Consistent with section 492 of

25 the Trade Agreements Act of 1979 (19 U.S.C. 2578a),
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1 the Secretary shall make, where appropriate, equivalence

2 determinations described in that section relating to sani3 tary or phytosanitary measures (including systems and

4 conditions) that apply to the preparation, packing, and

5 holding of covered products offered for import into the

6 United States.

7 ‘‘(2) In carrying out this subsection, the Secretary

8 shall conduct systematic evaluations of the systems, condi9 tions, and measures in foreign countries that apply to the

10 preparation, packing, and holding of covered products of11 fered for import into the United States.

12 ‘‘(3) The Secretary shall develop a plan for the imple13 mentation of the authority under this subsection within

14 2 years after the date of enactment of the Imported Prod15 ucts Safety Improvement and Disease Prevention Act of

16 2000. In developing the plan, the Secretary shall provide

17 an opportunity for, and take into consideration, public

18 comment on a proposed plan.’’.

19 (b) GENERAL AUTHORITY.—Section 801 of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381), as

21 amended in subsection (a), is further amended by insert22 ing after subsection (d) the following:

23 ‘‘(e)(1)(A) The Secretary shall establish a system, for

24 use by the Secretary of the Treasury, to deny the entry

25 of any covered product offered for import into the United
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1 States if the Secretary of Health and Human Services

2 makes and publishes—

3 ‘‘(i) a written determination that the covered

4 product—

5 ‘‘(I) has been associated with repeated and

6 separate outbreaks of disease borne in a cov7 ered product or has been repeatedly determined

8 by the Secretary to be adulterated within the

9 meaning of section 402;

10 ‘‘(II) presents a reasonable probability of

11 causing significant adverse health consequences

12 or death; and

13 ‘‘(III) is likely, without systemic interven14 tion or changes, to cause disease or be adulter15 ated again; or

16 ‘‘(ii) an emergency written determination that

17 the covered product has been strongly associated

18 with a single outbreak of disease borne in a covered

19 product that has caused serious adverse health con20 sequences or death.

21 ‘‘(B)(i) The Secretary shall make a determination de22 scribed in subparagraph (A) with respect to—

23 ‘‘(I) a covered product from a specific producer,

24 manufacturer, or shipper; or
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1 ‘‘(II) a covered product from a specific growing

2 area or country;

3 that meets the criteria described in subparagraph (A).

4 ‘‘(ii) Only the covered product from the specific pro5 ducer, manufacturer, shipper, growing area, or country for

6 which the Secretary makes the determination shall be sub7 ject to denial of entry under this subsection.

8 ‘‘(C) The denial of entry of any covered product

9 under this paragraph shall be done in a manner consistent

10 with bilateral, regional, and multilateral trade agreements

11 and the rights and obligations of the United States under

12 the agreements.

13 ‘‘(D)(i) Before making any written determination

14 under subparagraph (A)(i), the Secretary shall consider

15 written comments, on a proposed determination, made by

16 any party affected by the proposed determination and any

17 remedial actions taken to address the findings made in

18 the proposed determination. In making the written deter19 mination, the Secretary may modify or rescind the pro20 posed determination in accordance with such comments.

21 ‘‘(ii)(I) The Secretary may immediately issue an

22 emergency written determination under subparagraph

23 (A)(ii) without first considering comments on a proposed

24 determination.
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1 ‘‘(II) Within 30 days after the issuance of the emer2 gency determination, the Secretary shall consider written

3 comments on the determination that are made by a party

4 described in clause (i) and received within the 30-day pe5 riod. The Secretary may affirm, modify, or rescind the

6 emergency determination in accordance with the com7 ments.

8 ‘‘(III) The emergency determination shall be in

9 effect—

10 ‘‘(aa) for the 30-day period; or

11 ‘‘(bb) if the Secretary affirms or modifies the

12 determination, until the Secretary rescinds the de13 termination.

14 ‘‘(2)(A) The covered product initially denied entry

15 under paragraph (1) may be imported into the United

16 States if the Secretary finds that—

17 ‘‘(i) the written determination made under

18 paragraph (1) no longer justifies the denial of entry

19 of the covered product; or

20 ‘‘(ii) evidence of remedial action submitted from

21 the producer, manufacturer, shipper, specific grow22 ing area, or country for which the Secretary made

23 the written determination under paragraph (1) ad24 dresses the determination.
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1 ‘‘(B)(i) The Secretary shall take action on evidence

2 submitted under subparagraph (A)(ii) within 90 days after

3 the date of the submission of the evidence.

4 ‘‘(ii) The Secretary’s action may include—

5 ‘‘(I) lifting the denial of entry of the covered

6 product; or

7 ‘‘(II) continuing to deny entry of the covered

8 product while requesting additional information or

9 specific remedial action from the producer, manufac10 turer, shipper, specific growing area, or country.

11 ‘‘(iii) If the Secretary does not take action on evi12 dence submitted under subparagraph (A)(ii) within 90

13 days after the date of submission, effective on the 91st

14 day after the date of submission, the covered product ini15 tially denied entry under paragraph (1) may be imported

16 into the United States.

17 ‘‘(3) The Secretary shall by regulation establish cri18 teria and procedures for the system described in para19 graph (1). The Secretary may by regulation modify those

20 criteria and procedures, as the Secretary determines ap21 propriate.’’.

22 (c) TECHNICAL AND CONFORMING AMENDMENTS.—

23 (1) Section 351(h) of the Public Health Service

24 Act (42 U.S.C. 262(h)) is amended by striking ‘‘sec25 tion 801(e)(1) of the Federal Food, Drug, and Cos-
8

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1 metic Act (21 U.S.C. 381(e))’’ and inserting ‘‘sec2 tion 801(g)(1) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 381(g)(1))’’.

4 (2) Section 301 of the Federal Food, Drug, and

5 Cosmetic Act (21 U.S.C. 331) is amended—

6 (A) in paragraph (t), by striking ‘‘section

7 801(d)(1)’’ and inserting ‘‘section 801(f)(1)’’;

8 and

9 (B) in paragraph (w)—

10 (i) by striking ‘‘sections 801(d)(3)(A)

11 and 801(d)(3)(B)’’ and inserting ‘‘sub12 paragraphs (A) and (B) of section

13 801(f)(3)’’;

14 (ii) except as provided in clause (i), by

15 striking ‘‘section 801(d)(3)’’ each place it

16 appears and inserting ‘‘section 801(f)(3)’’;

17 and

18 (iii) by striking ‘‘section 801(e)’’ and

19 inserting ‘‘section 801(g)’’.

20 (3) Section 303(b)(1)(A) of the Federal Food,

21 Drug, and Cosmetic Act (21 U.S.C. 333(b)(1)(A)) is

22 amended by striking ‘‘section 801(d)(1)’’ and insert23 ing ‘‘section 801(f)(1)’’.
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1 (4) Section 304(d)(1) of the Federal Food,

2 Drug, and Cosmetic Act (21 U.S.C. 334(d)(1)) is

3 amended—

4 (A) by striking ‘‘section 801(e)(1)’’ and in5 serting ‘‘section 801(g)(1)’’; and

6 (B) except as provided in subparagraph

7 (A), by striking ‘‘section 801(e)’’ each place it

8 appears and inserting ‘‘section 801(g)’’.

9 (5) Section 801 of the Federal Food, Drug, and

10 Cosmetic Act (21 U.S.C. 381) is amended—

11 (A) in subsection (a), in the third sentence,

12 by striking ‘‘subsection (b) of this section’’ and

13 inserting ‘‘subsection (b) or subsection

14 (e)(2)(A) (in the case of a covered product de15 scribed in that subsection)’’;

16 (B) in paragraph (3)(A) of subsection (f),

17 as redesignated in subsection (a), by striking

18 ‘‘section 801(e) or 802’’ and inserting ‘‘sub19 section (g), section 802,’’; and

20 (C) in paragraph (1) of subsection (h), as

21 redesignated in subsection (a), by striking ‘‘sub22 section (e)’’ and inserting ‘‘subsection (g)’’.

23 (6) Section 802 of the Federal Food, Drug, and

24 Cosmetic Act (21 U.S.C. 382) is amended—
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1 (A) in subsection (a)(2)(C), by striking

2 ‘‘section 801(e)(2)’’ and inserting ‘‘section

3 801(g)(2)’’;

4 (B) in subsection (f)(3), by striking ‘‘sec5 tion 801(e)(1)’’ and inserting ‘‘section

6 801(g)(1)’’; and

7 (C) in subsection (i), by striking ‘‘section

8 801(e)(1)’’ and inserting ‘‘section 801(g)(1)’’.

9 SEC. 102. PROHIBITION AGAINST THE DISTRIBUTION OF

10 CERTAIN PRODUCTS.

11 (a) ADULTERATED PRODUCTS.—Section 402 of the

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342)

13 is amended by adding at the end the following:

14 ‘‘(h)(1) If—

15 ‘‘(A) it is a covered product being imported or

16 offered for import into the United States;

17 ‘‘(B) the covered product has been designated

18 by the Secretary for sampling, examination, or re19 view for the purpose of determining whether the cov20 ered product is in compliance with this Act;

21 ‘‘(C) the Secretary requires, under section

22 801(a)(2)(B), that the covered product not be dis23 tributed until the Secretary authorizes the distribu24 tion of the covered product; and
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1 ‘‘(D) the covered product is distributed before

2 the Secretary authorizes the distribution.

3 ‘‘(2) In this paragraph, the term ‘distributed’, used

4 with respect to a covered product, means—

5 ‘‘(A) moved for the purpose of selling the cov6 ered product, offering the covered product for sale,

7 or delivering the covered product for the purpose of

8 selling the covered product or offering the covered

9 product for sale; or

10 ‘‘(B) delivered contrary to any bond require11 ment.’’.

12 (b) PROHIBITION.—Section 801(a) of the Federal

13 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is

14 amended—

15 (1) in the third sentence, by redesignating para16 graphs (1) through (3) as subparagraphs (A)

17 through (C), respectively;

18 (2) by striking ‘‘(a) The’’ and inserting ‘‘(a)(1)

19 The’’;

20 (3) in the last sentence, by striking ‘‘Clause

21 (2)’’ and inserting ‘‘Subparagraph (B)’’;

22 (4) by moving the fourth sentence to the end;

23 (5) in the sentence so moved, by striking ‘‘The

24 Secretary’’ and inserting the following:

25 ‘‘(2)(A) The Secretary’’; and
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1 (6) by adding at the end the following:

2 ‘‘(B) The Secretary of Health and Human Services

3 may require that a covered product being imported or of4 fered for import into the United States not be distributed

5 until the Secretary authorizes distribution of the covered

6 product.’’.

7 SEC. 103. REQUIREMENT OF SECURE STORAGE OF CERTAIN

8 IMPORTED PRODUCTS.

9 (a) ADULTERATED PRODUCTS.—Section 402 of the

10 Federal Food, Drug, and Cosmetic Act, as amended in

11 section 102(a), is further amended by adding at the end

12 the following:

13 ‘‘(i) If—

14 ‘‘(1) it is a covered product being imported or

15 offered for import into the United States;

16 ‘‘(2) the Secretary requires, under section

17 801(a)(2)(C), that the covered product be held in a

18 secure storage facility until the Secretary authorizes

19 distribution of the covered product; and

20 ‘‘(3) the covered product is not held in a secure

21 storage facility as described in section 801(a)(2)(C)

22 until the Secretary authorizes the distribution.’’.

23 (b) REQUIREMENT.—Section 801(a)(2) of the Fed24 eral Food, Drug, and Cosmetic Act, as amended in section
13

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1 102(b), is further amended by adding at the end the fol2 lowing:

3 ‘‘(C)(i) The Secretary of Health and Human Services

4 may require that a covered product that is being imported

5 or offered for import into the United States be held, at

6 the expense of the owner or consignee of the covered prod7 uct, in a secure storage facility until the Secretary author8 izes distribution of the covered product, if the Secretary

9 makes the determination that the covered product is—

10 ‘‘(I) being imported or offered for import into

11 the United States by a person described in clause

12 (ii); or

13 ‘‘(II) owned by or consigned to a person de14 scribed in clause (ii).

15 ‘‘(ii) An importer, owner, or consignee referred to in

16 subclause (I) or (II) of clause (i) is a person against whom

17 the Secretary of the Treasury has assessed liquidated

18 damages not less than twice under subsection (b) for fail19 ure to redeliver, at the request of the Secretary of the

20 Treasury, a covered product subject to a bond under sub21 section (b).’’.

22 SEC. 104. REQUIREMENT OF ADMINISTRATIVE DESTRUC23 TION OF CERTAIN IMPORTED PRODUCTS.

24 (a) ADULTERATED PRODUCTS.—Section 402 of the

25 Federal Food, Drug, and Cosmetic Act, as amended in
14

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1 section 103(a), is further amended by adding at the end

2 the following:

3 ‘‘(j) Notwithstanding subsections (a)(2)(A) and (b) of

4 section 801, if—

5 ‘‘(1) it is a covered product being imported or

6 offered for import into the United States;

7 ‘‘(2) the covered product presents a reasonable

8 probability of causing significant adverse health con9 sequences or death;

10 ‘‘(3) the Secretary, after the covered product

11 has been refused admission under section 801(a), re12 quires under section 801(a)(2)(D) that the covered

13 product be destroyed; and

14 ‘‘(4) the owner or consignee of the covered

15 product fails to comply with that destruction re16 quirement.’’.

17 (b) REQUIREMENT.—Section 801(a)(2) of the Fed18 eral Food, Drug, and Cosmetic Act, as amended in section

19 103(b), is further amended by adding at the end the fol20 lowing:

21 ‘‘(D) The Secretary of Health and Human Services

22 may require destruction, at the expense of the owner or

23 consignee, of a covered product imported or offered for

24 import into the United States that presents a reasonable
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1 probability of causing significant adverse health con2 sequences or death.’’.

3 SEC. 105. PROHIBITION AGAINST PORT SHOPPING.

4 Section 402 of the Federal Food, Drug, and Cosmetic

5 Act, as amended in section 104(a), is further amended by

6 adding at the end the following:

7 ‘‘(k) If it is a covered product being imported or of8 fered for import into the United States, and the covered

9 product previously has been refused admission under sec10 tion 801(a), unless the person reoffering the article affirm11 atively establishes, at the expense of the owner or con12 signee of the article, that the article complies with the ap13 plicable requirements of this Act, as determined by the

14 Secretary.’’.

15 SEC. 106. PROHIBITION OF IMPORTS BY DEBARRED PER16 SONS.

17 Section 402 of the Federal Food, Drug, and Cosmetic

18 Act, as amended in section 105, is further amended by

19 adding at the end the following:

20 ‘‘(l) If it is a covered product being imported or of21 fered for import into the United States by a person

22 debarred under section 306(b)(4).’’.
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1 SEC. 107. AUTHORITY TO MARK REFUSED ARTICLES.

2 (a) MISBRANDED PRODUCTS.—Section 403 of the

3 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343)

4 is amended by adding at the end the following:

5 ‘‘(t) If—

6 ‘‘(1) it has been refused admission under sec7 tion 801(a);

8 ‘‘(2) the covered product has not been required

9 to be destroyed under subparagraph (A) or (B) of

10 section 801(a)(2); and

11 ‘‘(3) the packaging of the covered product does

12 not bear a label or labeling described in section

13 801(a)(2)(E).’’.

14 (b) REQUIREMENT.—Section 801(a)(2) of the Fed15 eral Food, Drug, and Cosmetic Act, as amended in section

16 104(b), is further amended by adding at the end the fol17 lowing:

18 ‘‘(E) The Secretary of Health and Human Services

19 may require the owner or consignee of a covered product

20 that has been refused admission under paragraph (1), and

21 has not been required to be destroyed under subparagraph

22 (A) or (B), to affix to the packaging of the covered prod23 uct a label or labeling that—

24 ‘‘(i) clearly and conspicuously bears the fol25 lowing statement: ‘United States: Refused Entry.’;
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1 ‘‘(ii) is affixed to the packaging until the cov2 ered product is brought into compliance with this

3 Act; and

4 ‘‘(iii) has been provided at the expense of the

5 owner or consignee of the covered product.’’.

6 SEC. 108. EXPORT OF REFUSED ARTICLES.

7 Paragraph (2)(A) of section 801(a) of the Federal

8 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as des9 ignated in section 102(b), is amended by striking ‘‘ninety

10 days’’ and inserting ‘‘30 days’’.

11 SEC. 109. COLLECTION AND ANALYSIS OF SAMPLES OF

12 PRODUCT IMPORTS.

13 Section 801 of the Federal Food, Drug, and Cosmetic

14 Act (21 U.S.C. 381), as amended in section 101(a), is fur15 ther amended by adding at the end the following:

16 ‘‘(i) The Secretary may issue regulations or guidance

17 as necessary to govern the collection and analysis by enti18 ties other than the Food and Drug Administration of sam19 ples of a covered product imported or offered for import

20 into the United States to ensure the integrity of the sam21 ples collected and the validity of the analytical results.’’.

22 SEC. 110. DEFINITION.

23 Section 201 of the Federal Food, Drug, and Cosmetic

24 Act (21 U.S.C. 321) is amended by adding at the end the

25 following:
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1 ‘‘(kk) The term ‘covered product’ means an article

2 that is described in subparagraph (1), (2), or (3) of para3 graph (f) and that is not a dietary supplement. The term

4 shall not include an article to the extent that the Secretary

5 of Agriculture exercises inspection authority over the arti6 cle at the time of import into the United States.’’.

7 TITLE II—ENFORCEMENT AND

8 PENALTIES FOR IMPORTING

9 CONTAMINATED PRODUCTS

10 SEC. 201. ENHANCED BONDING REQUIREMENTS FOR PRIOR

11 INVOLVEMENT IN IMPORTING ADULTERATED

12 OR MISBRANDED PRODUCTS.

13 Section 801(b) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 381(b)) is amended—

15 (1) by inserting ‘‘(1)’’ after ‘‘(b)’’; and

16 (2) by adding at the end the following:

17 ‘‘(2)(A) The Secretary of the Treasury, acting

18 through the Commissioner of Customs, shall issue regula19 tions that establish a rate for a bond required to be exe20 cuted under paragraph (1) for a covered product if an

21 owner, consignee, or importer of the covered product has

22 committed a covered violation.

23 ‘‘(B) The regulations shall require the owner or con24 signee to execute such a bond—

25 ‘‘(i) at twice the usual rate; or
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1 ‘‘(ii) if the owner, consignee, or importer has

2 committed more than 1 covered violation, at a rate

3 that increases with the number of covered violations

4 committed, as determined in accordance with a slid5 ing scale established in the regulations.

6 ‘‘(C) In this paragraph:

7 ‘‘(i) The term ‘committed’ means been con8 victed of, or found liable for, a violation by an ap9 propriate court or administrative officer.

10 ‘‘(ii) The term ‘covered violation’ means a viola11 tion relating to—

12 ‘‘(I) importing or offering for import into

13 the United States—

14 ‘‘(aa) a covered product during a pe15 riod of debarment under section 306(b)(4);

16 ‘‘(bb) a covered product that is adul17 terated within the meaning of paragraph

18 (h), (i), (j), (k), or (l) of section 402; or

19 ‘‘(cc) a covered product that is mis20 branded within the meaning of section

21 403(t); or

22 ‘‘(II) making a false or misleading state23 ment in conduct relating to the import or offer24 ing for import of a covered product into the

25 United States.
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1 ‘‘(iii) The term ‘usual rate’, used with respect

2 to a bond, means the rate that would be required

3 under paragraph (1) for the bond by a person who

4 has not committed a covered violation.’’.

5 SEC. 202. DEBARMENT OF REPEAT OFFENDERS AND SERI6 OUS OFFENDERS.

7 (a) IN GENERAL.—Section 306(b) of the Federal

8 Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is

9 amended—

10 (1) in paragraph (1), in the paragraph heading,

11 by striking ‘‘IN GENERAL.—’’ and inserting ‘‘DE12 BARMENT FOR VIOLATIONS RELATING TO DRUGS.—’’;

13 (2) in paragraph (2), in the paragraph heading,

14 by striking ‘‘PERSONS SUBJECT TO PERMISSIVE DE15 BARMENT.—’’ and inserting ‘‘PERSONS SUBJECT TO

16 PERMISSIVE DEBARMENT FOR VIOLATIONS RELAT17 ING TO DRUGS.—’’;

18 (3) in paragraph (3), in the paragraph heading,

19 by striking ‘‘STAY OF CERTAIN ORDERS.—’’ and in20 serting ‘‘STAY OF CERTAIN ORDERS RELATING TO

21 DEBARMENT FOR VIOLATIONS RELATING TO

22 DRUGS.—’’; and

23 (4) by adding at the end the following:

24 ‘‘(4) DEBARMENT FOR VIOLATIONS RELATING

25 TO PRODUCT IMPORTS.—
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1 ‘‘(A) IN GENERAL.—The Secretary may

2 debar a person from importing a covered prod3 uct or offering a covered product for import

4 into the United States, if—

5 ‘‘(i) the Secretary finds that the per6 son has been convicted for conduct that is

7 a felony under Federal law and relates to

8 the importation or offering for importation

9 of any covered product into the United

10 States; or

11 ‘‘(ii) the Secretary makes a written

12 determination that the person has repeat13 edly or deliberately imported or offered for

14 import into the United States a covered

15 product adulterated within the meaning of

16 paragraph (h), (i), (j), or (k) of section

17 402, or misbranded within the meaning of

18 section 403(t).

19 ‘‘(B) IMPACT.—On debarring a person

20 under subparagraph (A), the Secretary shall

21 provide notice of the debarment to the Sec22 retary of the Treasury, who shall deny entry of

23 a covered product offered for import by the per24 son.’’.

25 (b) TECHNICAL AND CONFORMING AMENDMENTS.—
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1 (1) IN GENERAL.—Section 306 of the Federal

2 Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is

3 amended—

4 (A) in subsection (c)—

5 (i) in paragraph (1)—

6 (I) in subparagraph (B), by

7 striking ‘‘, and’’ at the end and in8 serting a comma;

9 (II) by redesignating subpara10 graph (C) as subparagraph (D); and

11 (III) by inserting after subpara12 graph (B) the following:

13 ‘‘(C) shall, during the period of a debar14 ment under subsection (b)(4), prohibit the

15 debarred person from importing a covered prod16 uct or offering a covered product for import

17 into the United States, and’’;

18 (ii) in paragraph (2)(A), by inserting

19 after clause (iii) the following:

20 ‘‘(iv) The period of debarment of any

21 person under subsection (b)(4) shall be not

22 less than 1 year.’’; and

23 (iii) in paragraph (3)—

24 (I) in subparagraph (C)—
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1 (aa) by striking ‘‘suspect

2 drugs’’ and inserting ‘‘suspect

3 drugs or covered products’’; and

4 (bb) by striking ‘‘fraudu5 lently obtained’’ and inserting

6 ‘‘fraudulently obtained or on a

7 covered product wrongfully im8 ported into the United States’’;

9 and

10 (II) in subparagraph (E), by in11 serting ‘‘in the case of a debarment

12 relating to a drug,’’ after ‘‘(E)’’;

13 (B) in subsection (d)—

14 (i) in paragraph (3)—

15 (I) in subparagraph (A)—

16 (aa) in clause (i), by striking

17 ‘‘or (b)(2)(A)’’ and inserting ‘‘or

18 paragraph (2)(A) or (4) of sub19 section (b)’’; and

20 (bb) in clause (ii)(II), by in21 serting ‘‘in the case of a debar22 ment relating to a drug,’’ after

23 ‘‘(II)’’; and

24 (II) in subparagraph (B)—
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1 (aa) in clause (i), by striking

2 ‘‘or clause (i), (ii), (iii) or (iv) of

3 subsection (b)(2)(B)’’ and insert4 ing ‘‘, clause (i), (ii), (iii), or (iv)

5 of subsection (b)(2)(B), or sub6 section (b)(4)’’; and

7 (bb) in clause (ii), by strik8 ing ‘‘subsection (b)(2)(B)’’ and

9 inserting ‘‘paragraph (2)(B) or

10 (4) of subsection (b)’’; and

11 (ii) in paragraph (4)—

12 (I) in subparagraph (A), by strik13 ing ‘‘(a)(2)’’ and inserting ‘‘(a)(2) or

14 (b)(4)’’;

15 (II) in subparagraph (B)—

16 (aa) in clause (ii), by strik17 ing ‘‘involving the development or

18 approval of any drug subject to

19 section 505’’ and inserting ‘‘in20 volving, as appropriate, the devel21 opment or approval of any drug

22 subject to section 505 or the im23 portation of any covered prod24 uct’’; and
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1 (bb) in clause (iv), by strik2 ing ‘‘drug’’ each place it appears

3 and inserting ‘‘drug or covered

4 product’’; and

5 (III) in subparagraph (D), in the

6 matter following clause (ii), by insert7 ing ‘‘, in the case of a debarment re8 lating to a drug,’’ before ‘‘protects’’;

9 and

10 (C) in subsection (l)(2), in the second sen11 tence, by striking ‘‘(b)(2)(B)’’ and inserting

12 ‘‘(b)(2)(B), subsection (b)(4),’’.

13 (2) CIVIL PENALTIES.—Paragraphs (6) and (7)

14 of section 307(a) of the Federal Food, Drug, and

15 Cosmetic Act (21 U.S.C. 335b(a)) are amended by

16 striking ‘‘306’’ and inserting ‘‘306 (except section

17 306(b)(4))’’.

18 SEC. 203. INCREASED ENFORCEMENT TO IMPROVE THE

19 SAFETY OF IMPORTED PRODUCTS.

20 Subchapter A of chapter VII of the Federal Food,

21 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend22 ed by adding at the end the following:
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1 ‘‘SEC. 712. POSITIONS TO IMPROVE THE SAFETY OF IM2 PORTED PRODUCTS.

3 ‘‘There is authorized to be appropriated such sums

4 as may be necessary for each of fiscal years 2001 through

5 2003 to enable the Commissioner, in carrying out chapters

6 IV and VIII, to decrease the health risks associated with

7 imported covered products through the creation of addi8 tional employment positions for laboratory, inspection,

9 and compliance personnel.’’.

10 TITLE III—IMPROVEMENTS TO

11 PUBLIC HEALTH INFRA12 STRUCTURE AND AWARENESS

13 SEC. 301. IMPROVEMENTS.

14 Title II of the Public Health Service Act (42 U.S.C.

15 202 et seq.) is amended by adding at the end the fol16 lowing:

17 ‘‘PART C—PUBLIC HEALTH INFRASTRUCTURE

18 AND AWARENESS

19 ‘‘SEC. 251. DEFINITIONS.

20 ‘‘In this part:

21 ‘‘(1) COVERED PRODUCT.—The term ‘covered

22 product’ has the meaning given the term in section

23 201 of the Federal Food, Drug, and Cosmetic Act

24 (21 U.S.C. 321).

25 ‘‘(2) INSTITUTION OF HIGHER EDUCATION.—

26 The term ‘institution of higher education’ has the
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1 meaning given the term in section 101(a) of the

2 Higher Education Act of 1965 (20 U.S.C. 1001(a)).

3 ‘‘(3) SECRETARY.—The term ‘Secretary’ means

4 the Secretary of Health and Human Services, acting

5 through the Director of the Centers for Disease

6 Control and Prevention.

7 ‘‘SEC. 252. PUBLIC HEALTH SURVEILLANCE ENHANCE8 MENT.

9 ‘‘(a) IN GENERAL.—The Secretary may—

10 ‘‘(1) make grants to, enter into cooperative

11 agreements with, and provide technical assistance to

12 eligible agencies to enable the agencies to enhance

13 their capacity to carry out activities relating to sur14 veillance and prevention of pathogen-related disease

15 borne in a covered product, particularly pathogen-re16 lated disease associated with imported covered prod17 ucts, as described in subsection (b)(1); and

18 ‘‘(2) carry out the activities described in sub19 section (b)(2).

20 ‘‘(b) USE OF ASSISTANCE.—

21 ‘‘(1) AGENCIES.—An eligible agency that re22 ceives assistance under subsection (a) shall use the

23 assistance to enhance the capacity of the agency—

24 ‘‘(A) to identify, investigate, and contain

25 threats of pathogen-related disease borne in a
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1 covered product, particularly pathogen-related

2 disease associated with imported covered prod3 ucts; and

4 ‘‘(B) to conduct additional surveillance and

5 studies to address prevention and control of the

6 disease.

7 ‘‘(2) CENTERS FOR DISEASE CONTROL AND

8 PREVENTION.—The Secretary may use not more

9 than 30 percent of the funds appropriated to carry

10 out this section—

11 ‘‘(A) to assist an agency described in para12 graph (1) in enhancing the capacity described

13 in paragraph (1) by providing standards, tech14 nologies, information, materials, and other re15 sources; and

16 ‘‘(B) to enhance national surveillance sys17 tems, including the ability of domestic and

18 international agencies and entities to respond to

19 product safety issues associated with imported

20 covered products that are identified through

21 such systems.

22 ‘‘(c) ELIGIBLE AGENCIES.—To be eligible to receive

23 assistance under subsection (a)(1), an agency shall be a

24 State or local health department.
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1 ‘‘(d) APPLICATION.—To be eligible to receive assist2 ance under subsection (a)(1), an agency shall submit an

3 application to the Secretary at such time, in such manner,

4 and containing such information as the Secretary may re5 quire.

6 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

7 are authorized to be appropriated to carry out this section

8 such sums as may be necessary for fiscal years 2001

9 through 2003.

10 ‘‘SEC. 253. PATHOGEN DETECTION RESEARCH AND DEVEL11 OPMENT.

12 ‘‘(a) IN GENERAL.—The Secretary may conduct ap13 plied research, directly or by grant or contract, to develop

14 new or improved methods for detecting and subtyping

15 emerging pathogens (borne in covered products) in human

16 specimens, covered products, and relevant environmental

17 samples. The Secretary may use funds appropriated to

18 carry out this section to support applied research by State

19 health departments or institutions of higher education.

20 ‘‘(b) APPLICATION.—To be eligible to receive a grant

21 or enter into a contract under subsection (a), an entity

22 shall submit an application to the Secretary at such time,

23 in such manner, and containing such information as the

24 Secretary may require.
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1 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

2 are authorized to be appropriated to carry out this section

3 such sums as may be necessary for fiscal years 2001

4 through 2003.

5 ‘‘SEC. 254. TRAINING, EDUCATION, AND PUBLIC INFORMA6 TION.

7 ‘‘(a) IN GENERAL.—The Secretary may—

8 ‘‘(1) make grants and enter into contracts with

9 eligible entities, to support training activities and

10 other collaborative activities with the entities to in11 form health professionals about disease borne in cov12 ered products, including strengthening training net13 works serving State, local, and private entities; and

14 ‘‘(2) increase and improve the activities carried

15 out by the Centers for Disease Control and Preven16 tion to provide information to the public on disease

17 borne in covered products.

18 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive

19 a grant or enter into a contract under subsection (a), an

20 entity shall be a medical school, a nursing school, an entity

21 carrying out clinical laboratory training programs, a

22 school of public health, another institution of higher edu23 cation, a professional organization, or an international or24 ganization.
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1 ‘‘(c) APPLICATION.—To be eligible to receive a grant

2 or enter into a contract under subsection (a), an entity

3 shall submit an application to the Secretary at such time,

4 in such manner, and containing such information as the

5 Secretary may require.

6 ‘‘(d) CONSULTATION.—In carrying out this section,

7 the Secretary shall consult with Federal, State, and local

8 agencies, international organizations, and other interested

9 parties.

10 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

11 are authorized to be appropriated to carry out this section

12 such sums as may be necessary for fiscal years 2001

13 through 2003.

14 ‘‘SEC. 255. INTERNATIONAL PUBLIC HEALTH TRAINING AND

15 TECHNICAL ASSISTANCE.

16 ‘‘(a) IN GENERAL.—The Secretary shall, directly or

17 by agreement, provide training and technical assistance to

18 agencies and entities in foreign countries, to strengthen

19 the surveillance and investigation capacities of the agen20 cies and entities relating to disease borne in covered prod21 ucts, including establishing or expanding activities or pro22 grams such as the Field Epidemiology and Training Pro23 gram of the Centers for Disease Control and Prevention.

24 ‘‘(b) APPLICATION.—To be eligible to enter into an

25 agreement under subsection (a), an entity shall submit an
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1 application to the Secretary at such time, in such manner,

2 and containing such information as the Secretary may re3 quire.

4 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

5 are authorized to be appropriated to carry out this section

6 such sums as may be necessary for fiscal years 2001

7 through 2003.

8 ‘‘SEC. 256. SUPPLIES AND SERVICES IN LIEU OF GRANT

9 FUNDS.

10 ‘‘(a) IN GENERAL.—On the request of a recipient of

11 assistance under section 252, 253, 254, or 255, the Sec12 retary may, subject to subsection (b), provide supplies,

13 equipment, and services for the purpose of aiding the re14 cipient in carrying out the section involved and, for such

15 purpose, may detail to the grant recipient any officer or

16 employee of the Department of Health and Human Serv17 ices. Such detail shall be without interruption or loss of

18 civil service status or privilege.

19 ‘‘(b) CORRESPONDING REDUCTION IN PAYMENTS.—

20 With respect to a request described in subsection (a), the

21 Secretary shall reduce the amount of payments under the

22 section involved by an amount equal to the cost of detail23 ing the officer or employee and the fair market value of

24 the supplies, equipment, or services provided by the Sec25 retary. The Secretary shall, for the payment of expenses
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1 incurred in complying with such a request, expend the

2 amounts withheld.’’.

Æ