II

106TH CONGRESS

2D SESSION S. 2480

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety

of perishable products whose import is regulated by the Commissioner

of Food and Drugs, and for other purposes.

IN THE SENATE OF THE UNITED STATES

APRIL 27, 2000

Ms. COLLINS (for herself, Mr. FRIST, Mr. ABRAHAM, Ms. SNOWE, and Mr.

JEFFORDS) 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 perishable products whose import

is regulated by the Commissioner of Food and Drugs,

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 Perishable

5 Product Safety Improvement Act’’.
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1 TITLE I—IMPROVEMENTS TO

2 THE SAFETY SYSTEM FOR IM3 PORTED PERISHABLE PROD4 UCTS

5 SEC. 101. AUTHORITY TO PROTECT THE PUBLIC HEALTH

6 FROM CONTAMINATED IMPORTED PERISH7 ABLE PRODUCTS.

8 (a) GENERAL AUTHORITY.—Section 801 of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) is

10 amended—

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

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

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

15 ‘‘(d)(1)(A) The Secretary shall establish a system, for

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

17 of any perishable product offered for import into the

18 United States if the Secretary of Health and Human Serv19 ices makes and publishes—

20 ‘‘(i) a written determination that the perishable

21 product—

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

23 separate outbreaks of disease borne in a perish24 able product or has been repeatedly determined
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1 by the Secretary to be adulterated within the

2 meaning of section 402;

3 ‘‘(II) presents a reasonable probability of

4 causing serious adverse health consequences or

5 death; and

6 ‘‘(III) is likely, without systemic interven7 tion or changes, to cause disease or be adulter8 ated again; or

9 ‘‘(ii) an emergency written determination that

10 the perishable product has been strongly associated

11 with a single outbreak of disease borne in a perish12 able product that has caused serious adverse health

13 consequences or death.

14 ‘‘(B)(i) The Secretary shall make a determination de15 scribed in subparagraph (A) with respect to—

16 ‘‘(I) a perishable product from a specific pro17 ducer, manufacturer, or transporter; or

18 ‘‘(II) a perishable product from a specific grow19 ing area or country;

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

21 ‘‘(ii) Only the perishable product from the specific

22 producer, manufacturer, transporter, growing area, or

23 country for which the Secretary makes the determination

24 shall be subject to denial of entry under this subsection.
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1 ‘‘(C) The denial of entry of any perishable product

2 under this paragraph shall be done in a manner consistent

3 with bilateral, regional, and multilateral trade agreements

4 and the rights and obligations of the United States under

5 the agreements.

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

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

8 written comments, on a proposed determination, made by

9 any party affected by the proposed determination and any

10 remedial actions taken to address the findings made in

11 the proposed determination. In making the written deter12 mination, the Secretary may modify or rescind the pro13 posed determination in accordance with such comments.

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

15 emergency written determination under subparagraph

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

17 determination.

18 ‘‘(II) Within 30 days after the issuance of the emer19 gency determination, the Secretary shall consider written

20 comments on the determination that are made by a party

21 described in clause (i) and received within the 30-day pe22 riod. The Secretary may affirm, modify, or rescind the

23 emergency determination in accordance with the com24 ments.
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1 ‘‘(III) The emergency determination shall be in

2 effect—

3 ‘‘(aa) for the 30-day period; or

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

5 determination, until the Secretary rescinds the de6 termination.

7 ‘‘(2)(A) The perishable product initially denied entry

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

9 States if the Secretary finds that—

10 ‘‘(i) the written determination made under

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

12 of the perishable product; or

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

14 the producer, manufacturer, transporter, specific

15 growing area, or country for which the Secretary

16 made the written determination under paragraph (1)

17 addresses the determination.

18 ‘‘(B)(i) The Secretary shall take action on evidence

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

20 the date of the submission of the evidence.

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

22 ‘‘(I) lifting the denial of entry of the perishable

23 product; or

24 ‘‘(II) continuing to deny entry of the perishable

25 product while requesting additional information or
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1 specific remedial action from the producer, manufac2 turer, transporter, specific growing area, or country.

3 ‘‘(iii) If the Secretary does not take action on evi4 dence submitted under subparagraph (A)(ii) within 90

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

6 day after the date of submission, the perishable product

7 initially denied entry under paragraph (1) may be im8 ported into the United States.

9 ‘‘(3) The Secretary shall by regulation establish cri10 teria and procedures for the system described in para11 graph (1). The Secretary may by regulation modify those

12 criteria and procedures, as the Secretary determines ap13 propriate.’’.

14 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

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

16 Act (42 U.S.C. 262(h)) is amended by striking ‘‘sec17 tion 801(e)(1) of the Federal Food, Drug, and Cos18 metic Act (21 U.S.C. 381(e))’’ and inserting ‘‘sec19 tion 801(f)(1) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 381(f)(1))’’.

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

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

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

24 801(d)(1)’’ and inserting ‘‘section 801(e)(1)’’;

25 and
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1 (B) in paragraph (w)—

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

3 and 801(d)(3)(B)’’ and inserting ‘‘sub4 paragraphs (A) and (B) of section

5 801(e)(3)’’;

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

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

8 appears and inserting ‘‘section 801(e)(3)’’;

9 and

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

11 inserting ‘‘section 801(f)’’.

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

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

14 amended by striking ‘‘section 801(d)(1)’’ and insert15 ing ‘‘section 801(e)(1)’’.

16 (4) Section 304(d)(1) of the Federal Food,

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

18 amended—

19 (A) by striking ‘‘section 801(e)(1)’’ and in20 serting ‘‘section 801(f)(1)’’; and

21 (B) except as provided in subparagraph

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

23 appears and inserting ‘‘section 801(f)’’.

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

25 Cosmetic Act (21 U.S.C. 381) is amended—
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1 (A) in subsection (a), in the third sentence,

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

3 inserting ‘‘subsection (b) or subsection

4 (d)(2)(A) (in the case of a perishable product

5 described in that subsection)’’;

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

7 as redesignated in subsection (a), by striking

8 ‘‘section 801(e) or 802’’ and inserting ‘‘sub9 section (f), section 802,’’; and

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

11 redesignated in subsection (a), by striking ‘‘sub12 section (e)’’ and inserting ‘‘subsection (f)’’.

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

14 Cosmetic Act (21 U.S.C. 382) is amended—

15 (A) in subsection (a)(2)(C), by striking

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

17 801(f)(2)’’;

18 (B) in subsection (f)(3), by striking ‘‘sec19 tion 801(e)(1)’’ and inserting ‘‘section

20 801(f)(1)’’; and

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

22 801(e)(1)’’ and inserting ‘‘section 801(f)(1)’’.
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1 SEC. 102. PROHIBITION AGAINST THE DISTRIBUTION OF

2 CERTAIN PERISHABLE PRODUCTS.

3 (a) ADULTERATED PERISHABLE PRODUCTS.—Sec4 tion 402 of the Federal Food, Drug, and Cosmetic Act

5 (21 U.S.C. 342) is amended by adding at the end the fol6 lowing:

7 ‘‘(h)(1) If—

8 ‘‘(A) it is a perishable product being imported

9 or offered for import into the United States;

10 ‘‘(B) the perishable product has been des11 ignated by the Secretary for sampling, examination,

12 or review for the purpose of determining whether the

13 perishable product is in compliance with this Act;

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

15 801(a)(2)(B), that the perishable product not be dis16 tributed until the Secretary authorizes the distribu17 tion of the perishable product; and

18 ‘‘(D) the perishable product is distributed be19 fore the Secretary authorizes the distribution.

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

21 with respect to a perishable product, means—

22 ‘‘(A) moved for the purpose of selling the per23 ishable product, offering the product for sale, or de24 livering the product for the purpose of selling the

25 product or offering the product for sale; or
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1 ‘‘(B) delivered contrary to any bond require2 ment.’’.

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

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

5 amended—

6 (1) in the third sentence, by redesignating para7 graphs (1) through (3) as subparagraphs (A)

8 through (C), respectively;

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

10 The’’;

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

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

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

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

15 Secretary’’ and inserting the following:

16 ‘‘(2)(A) The Secretary’’; and

17 (6) by adding at the end the following:

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

19 may require that a perishable product being imported or

20 offered for import into the United States not be distrib21 uted until the Secretary authorizes distribution of the per22 ishable product.’’.
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1 SEC. 103. REQUIREMENT OF SECURE STORAGE OF CERTAIN

2 IMPORTED PERISHABLE PRODUCTS.

3 (a) ADULTERATED PERISHABLE PRODUCTS.—Sec4 tion 402 of the Federal Food, Drug, and Cosmetic Act,

5 as amended in section 102(a), is further amended by add6 ing at the end the following:

7 ‘‘(i) If—

8 ‘‘(1) it is a perishable product being imported

9 or offered for import into the United States;

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

11 801(a)(2)(C), that the perishable product be held in

12 a secure storage facility until the Secretary author13 izes distribution of the perishable product; and

14 ‘‘(3) the perishable product is not held in a se15 cure storage facility as described in section

16 801(a)(2)(C) until the Secretary authorizes the dis17 tribution.’’.

18 (b) REQUIREMENT.—Section 801(a)(2) of the Fed19 eral Food, Drug, and Cosmetic Act, as amended in section

20 102(b), is further amended by adding at the end the fol21 lowing:

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

23 may require that a perishable product that is being im24 ported or offered for import into the United States be

25 held, at the expense of the owner or consignee of the per26 ishable product, in a secure storage facility until the Sec-
12

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1 retary authorizes distribution of the perishable product,

2 if the Secretary makes the determination that the perish3 able product is—

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

5 the United States by a person described in clause

6 (ii); or

7 ‘‘(II) owned by or consigned to a person de8 scribed in clause (ii).

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

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

11 the Secretary of the Treasury has assessed liquidated

12 damages not less than twice under subsection (b) for fail13 ure to redeliver, at the request of the Secretary of the

14 Treasury, a perishable product subject to a bond under

15 subsection (b).’’.

16 SEC. 104. REQUIREMENT OF ADMINISTRATIVE DESTRUC17 TION OF CERTAIN PERISHABLE PRODUCTS.

18 (a) ADULTERATED PERISHABLE PRODUCTS.—Sec19 tion 402 of the Federal Food, Drug, and Cosmetic Act,

20 as amended in section 103(a), is further amended by add21 ing at the end the following:

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

23 section 801, if—

24 ‘‘(1) it is a perishable product being imported

25 or offered for import into the United States;
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1 ‘‘(2) the perishable product poses a strong like2 lihood of causing serious adverse health con3 sequences or death;

4 ‘‘(3) the Secretary, after the perishable product

5 has been refused admission under section 801(a), re6 quires under section 801(a)(2)(D) that the perish7 able product be destroyed; and

8 ‘‘(4) the owner or consignee of the perishable

9 product fails to comply with that destruction re10 quirement.’’.

11 (b) REQUIREMENT.—Section 801(a)(2) of the Fed12 eral Food, Drug, and Cosmetic Act, as amended in section

13 103(b), is further amended by adding at the end the fol14 lowing:

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

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

17 consignee, of a perishable product imported or offered for

18 import into the United States that poses a strong likeli19 hood of causing serious adverse health consequences or

20 death.’’.

21 SEC. 105. PROHIBITION AGAINST PORT SHOPPING.

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

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

24 adding at the end the following:
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1 ‘‘(k) If it is an article that is a perishable product

2 being imported or offered for import into the United

3 States, and the article previously has been refused admis4 sion under section 801(a), unless the person reoffering the

5 article affirmatively establishes, at the expense of the

6 owner or consignee of the article, that the article complies

7 with the applicable requirements of this Act, as deter8 mined by the Secretary.’’.

9 SEC. 106. PROHIBITION OF IMPORTS BY DEBARRED

10 PERSONS.

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

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

13 adding at the end the following:

14 ‘‘(l) If it is a perishable product being imported or

15 offered for import into the United States by a person

16 debarred under section 306(b)(4).’’.

17 SEC. 107. AUTHORITY TO MARK REFUSED ARTICLES.

18 (a) MISBRANDED PERISHABLE PRODUCTS.—Section

19 403 of the Federal Food, Drug, and Cosmetic Act (21

20 U.S.C. 343) is amended by adding at the end the fol21 lowing:

22 ‘‘(t) If—

23 ‘‘(1) it has been refused admission under sec24 tion 801(a);
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1 ‘‘(2) the perishable product has not been re2 quired to be destroyed under subparagraph (A) or

3 (B) of section 801(a)(2); and

4 ‘‘(3) the packaging of the perishable product

5 does not bear a label or labeling described in section

6 801(a)(2)(E).’’.

7 (b) REQUIREMENT.—Section 801(a)(2) of the Fed8 eral Food, Drug, and Cosmetic Act, as amended in section

9 104(b), is further amended by adding at the end the fol10 lowing:

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

12 may require the owner or consignee of a perishable prod13 uct that has been refused admission under paragraph (1),

14 and has not been required to be destroyed under subpara15 graph (A) or (B), to affix to the packaging of the perish16 able product a label or labeling that—

17 ‘‘(i) clearly and conspicuously bears the fol18 lowing statement: ‘United States: Refused Entry.’;

19 ‘‘(ii) is affixed to the packaging until the per20 ishable product is brought into compliance with this

21 Act; and

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

23 owner or consignee of the perishable product.’’.
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1 SEC. 108. EXPORT OF REFUSED ARTICLES.

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

3 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as des4 ignated in section 102(b), is amended by striking ‘‘ninety

5 days’’ and inserting ‘‘30 days’’.

6 SEC. 109. COLLECTION AND ANALYSIS OF SAMPLES OF

7 CERTAIN IMPORTS.

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

9 Act (21 U.S.C. 381), as amended in section 101(a), is fur10 ther amended by adding at the end the following:

11 ‘‘(h) The Secretary may issue regulations or guidance

12 as necessary to govern the collection and analysis by enti13 ties other than the Food and Drug Administration of sam14 ples of perishable products imported or offered for import

15 into the United States to ensure the integrity of the sam16 ples collected and the validity of the analytical results.’’.

17 SEC. 110. DEFINITION.

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

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

20 following:

21 ‘‘(kk) The term ‘perishable product’ means an article

22 that is described in subparagraph (1), (2), or (3) of para23 graph (f) and that is not a dietary supplement. The term

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

25 of Agriculture exercises inspection authority over the arti26 cle at the time of import into the United States.’’.
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1 TITLE II—ENFORCEMENT AND

2 PENALTIES FOR IMPORTING

3 CONTAMINATED PERISHABLE

4 PRODUCTS

5 SEC. 201. ENHANCED BONDING REQUIREMENTS FOR PRIOR

6 INVOLVEMENT IN IMPORTING ADULTERATED

7 OR MISBRANDED PERISHABLE PRODUCTS.

8 Section 801(b) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 381(b)) is amended—

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

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

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

13 through the Commissioner of Customs, shall issue regula14 tions that establish a rate for a bond required to be exe15 cuted under paragraph (1) for an article that is a perish16 able product if an owner, consignee, or importer of the

17 article has committed a covered violation.

18 ‘‘(B) The regulations shall require the owner or con19 signee to execute such a bond—

20 ‘‘(i) at twice the usual rate; or

21 ‘‘(ii) if the owner, consignee, or importer has

22 committed more than 1 covered violation, at a rate

23 that increases with the number of covered violations

24 committed, as determined in accordance with a slid25 ing scale established in the regulations.
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1 ‘‘(C) In this paragraph:

2 ‘‘(i) The term ‘committed’ means been con3 victed of, or found liable for, a violation by an ap4 propriate court or administrative officer.

5 ‘‘(ii) The term ‘covered violation’ means a viola6 tion relating to—

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

8 the United States—

9 ‘‘(aa) an article that is a perishable

10 product during a period of debarment

11 under section 306(b)(4);

12 ‘‘(bb) an article that is a perishable

13 product and that is adulterated within the

14 meaning of paragraph (h), (i), (j), (k), or

15 (l) of section 402; or

16 ‘‘(cc) an article that is a perishable

17 product and that is misbranded within the

18 meaning of section 403(t); or

19 ‘‘(II) making a false or misleading state20 ment in conduct relating to the import or offer21 ing for import of a perishable product into the

22 United States.

23 ‘‘(iii) The term ‘usual rate’, used with respect

24 to a bond, means the rate that would be required
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1 under paragraph (1) for the bond by a person who

2 has not committed a covered violation.’’.

3 SEC. 202. DEBARMENT OF REPEAT OFFENDERS AND SERI4 OUS OFFENDERS.

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

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

7 amended—

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

9 by striking ‘‘IN GENERAL.—’’ and inserting ‘‘DE10 BARMENT FOR VIOLATIONS RELATING TO DRUGS.—’’;

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

12 by striking ‘‘PERSONS SUBJECT TO PERMISSIVE DE13 BARMENT.—’’ and inserting ‘‘PERSONS SUBJECT TO

14 PERMISSIVE DEBARMENT FOR VIOLATIONS RELAT15 ING TO DRUGS.—’’;

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

17 by striking ‘‘STAY OF CERTAIN ORDERS.—’’ and in18 serting ‘‘STAY OF CERTAIN ORDERS RELATING TO

19 DEBARMENT FOR VIOLATIONS RELATING TO

20 DRUGS.—’’; and

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

22 ‘‘(4) DEBARMENT FOR VIOLATIONS RELATING

23 TO IMPORTS OF PERISHABLE PRODUCTS.—

24 ‘‘(A) IN GENERAL.—The Secretary may

25 debar a person from importing a perishable
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1 product or offering a perishable product for im2 port into the United States, if—

3 ‘‘(i) the Secretary finds that the per4 son has been convicted for conduct that is

5 a felony under Federal law and relates to

6 the importation or offering for importation

7 of any perishable product into the United

8 States; or

9 ‘‘(ii) the Secretary makes a written

10 determination that the person has repeat11 edly or deliberately imported or offered for

12 import into the United States a perishable

13 product adulterated within the meaning of

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

15 402, or misbranded within the meaning of

16 section 403(t).

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

18 under subparagraph (A), the Secretary shall

19 provide notice of the debarment to the Sec20 retary of the Treasury, who shall deny entry of

21 a perishable product offered for import by the

22 person.’’.

23 (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 perishable

16 product or offering a perishable product for im17 port 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 perishable products’’;

4 and

5 (bb) by striking ‘‘fraudu6 lently obtained’’ and inserting

7 ‘‘fraudulently obtained or on a

8 perishable product wrongfully im9 ported into the United States’’;

10 and

11 (II) in subparagraph (E), by in12 serting ‘‘in the case of a debarment

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

14 (B) in subsection (d)—

15 (i) in paragraph (3)—

16 (I) in subparagraph (A)—

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

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

19 paragraph (2)(A) or (4) of sub20 section (b)’’; and

21 (bb) in clause (ii)(II), by in22 serting ‘‘in the case of a debar23 ment relating to a drug,’’ after

24 ‘‘(II)’’; and

25 (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 perishable 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 perishable

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 PERISHABLE

20 PRODUCTS.

21 Subchapter A of chapter VII of the Federal Food,

22 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend23 ed by adding at the end the following:
25

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1 ‘‘SEC. 712. POSITIONS TO IMPROVE THE SAFETY OF IM2 PORTED PERISHABLE PRODUCTS.

3 ‘‘There is authorized to be appropriated such sums

4 as may be necessary for each of fiscal years 2000 through

5 2002 to enable the Commissioner, in carrying out chapters

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

7 imported perishable 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) INSTITUTION OF HIGHER EDUCATION.—

22 The term ‘institution of higher education’ has the

23 meaning given the term in section 101(a) of the

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

25 ‘‘(2) PERISHABLE PRODUCT.—The term ‘per26 ishable product’ has the meaning given the term in
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1 section 201 of the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 321).

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 perishable product, particularly pathogen16 related disease associated with imported perishable

17 products, 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 perishable product, particularly pathogen-re2 lated disease associated with imported perish3 able products; 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 safety issues associated with imported perish20 able products that are identified through such

21 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 2000

9 through 2002.

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 perishable products) in

16 human specimens, perishable products, and relevant envi17 ronmental samples. The Secretary may use funds appro18 priated to carry out this section to support applied re19 search by State health departments or institutions of high20 er education.

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

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

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

24 in such manner, and containing such information as the

25 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 2000

4 through 2002.

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 per12 ishable products, including strengthening training

13 networks serving State, local, and private entities;

14 and

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

16 out by the Centers for Disease Control and Preven17 tion to provide information to the public on disease

18 borne in perishable products.

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

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

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

22 carrying out clinical laboratory training programs, a

23 school of public health, another institution of higher edu24 cation, a professional organization, or an international or25 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 2000

13 through 2002.

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 perishable

21 products, including establishing or expanding activities or

22 programs such as the Field Epidemiology and Training

23 Program of the Centers for Disease Control and Preven24 tion.
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1 ‘‘(b) APPLICATION.—To be eligible to enter into an

2 agreement under subsection (a), an entity 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 ‘‘(c) 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 2000

9 through 2002.

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

11 FUNDS.

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

13 assistance under section 252, 253, 254, or 255, the Sec14 retary may, subject to subsection (b), provide supplies,

15 equipment, and services for the purpose of aiding the re16 cipient in carrying out the section involved and, for such

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

18 employee of the Department of Health and Human Serv19 ices. Such detail shall be without interruption or loss of

20 civil service status or privilege.

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

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

23 Secretary shall reduce the amount of payments under the

24 section involved by an amount equal to the cost of detail25 ing the officer or employee and the fair market value of
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1 the supplies, equipment, or services provided by the Sec2 retary. The Secretary shall, for the payment of expenses

3 incurred in complying with such a request, expend the

4 amounts withheld.’’.

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