II

106TH CONGRESS

1ST SESSION S. 1123

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

of imported food, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MAY 25, 1999

Ms. COLLINS (for herself, Mr. FRIST, Mr. ABRAHAM, Ms. SNOWE, Mr. JEFFORDS, and Mr. COVERDELL) introduced the following bill; which was

read twice and referred to the Committee on Agriculture, Nutrition, and

Forestry

A BILL

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

improve the safety of imported food, 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 Food Safety

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

2 THE FOOD SAFETY IMPORT

3 SYSTEM

4 SEC. 101. AUTHORITY TO PROTECT THE PUBLIC HEALTH

5 FROM CONTAMINATED IMPORTED FOODS.

6 (a) GENERAL AUTHORITY.—Section 801 of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381) is

8 amended—

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

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

11 (2) by inserting after subsection (c) the fol12 lowing:

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

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

15 of any food offered for import into the United States if

16 the Secretary of Health and Human Services makes and

17 publishes—

18 ‘‘(i) a written determination that the food—

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

20 separate outbreaks of foodborne disease or has

21 been repeatedly determined by the Secretary to

22 be adulterated within the meaning of section

23 402;
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1 ‘‘(II) presents a reasonable probability of

2 causing serious adverse health consequences or

3 death; and

4 ‘‘(III) is likely, without systemic interven5 tion or changes, to cause disease or be adulter6 ated again; or

7 ‘‘(ii) an emergency written determination that

8 the food has been strongly associated with a single

9 outbreak of foodborne disease that has caused seri10 ous adverse health consequences or death.

11 ‘‘(B)(i) The Secretary shall make a determination de12 scribed in subparagraph (A) with respect to—

13 ‘‘(I) a food from a specific producer, manufac14 turer, or transporter; or

15 ‘‘(II) a food from a specific growing area or

16 country;

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

18 ‘‘(ii) Only the food from the specific producer, manu19 facturer, transporter, growing area, or country for which

20 the Secretary makes the determination shall be subject to

21 denial of entry under this subsection.

22 ‘‘(C) The denial of entry of any food under this para23 graph shall be done in a manner consistent with bilateral,

24 regional, and multilateral trade agreements and the rights
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1 and obligations of the United States under the agree2 ments.

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

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

5 written comments, on a proposed determination, made by

6 any party affected by the proposed determination and any

7 remedial actions taken to address the findings made in

8 the proposed determination. In making the written deter9 mination, the Secretary may modify or rescind the pro10 posed determination in accordance with such comments.

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

12 emergency written determination under subparagraph

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

14 determination.

15 ‘‘(II) Within 30 days after the issuance of the emer16 gency determination, the Secretary shall consider written

17 comments on the determination that are made by a party

18 described in clause (i) and received within the 30-day pe19 riod. The Secretary may affirm, modify, or rescind the

20 emergency determination in accordance with the com21 ments.

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

23 effect—

24 ‘‘(aa) for the 30-day period; or
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1 ‘‘(bb) if the Secretary affirms or modifies the

2 determination, until the Secretary rescinds the de3 termination.

4 ‘‘(2)(A) The food initially denied entry under para5 graph (1) may be imported into the United States if the

6 Secretary finds that—

7 ‘‘(i) the written determination made under

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

9 of the food; or

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

11 the producer, manufacturer, transporter, specific

12 growing area, or country for which the Secretary

13 made the written determination under paragraph (1)

14 addresses the determination.

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

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

17 the date of the submission of the evidence.

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

19 ‘‘(I) lifting the denial of entry of the food; or

20 ‘‘(II) continuing to deny entry of the food while

21 requesting additional information or specific reme22 dial action from the producer, manufacturer, trans23 porter, specific growing area, or country.

24 ‘‘(iii) If the Secretary does not take action on evi25 dence submitted under subparagraph (A)(ii) within 90
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1 days after the date of submission, effective on the 91st

2 day after the date of submission, the food initially denied

3 entry under paragraph (1) may be imported into the

4 United States.

5 ‘‘(3) The Secretary shall by regulation establish cri6 teria and procedures for the system described in para7 graph (1). The Secretary may by regulation modify those

8 criteria and procedures, as the Secretary determines ap9 propriate.’’.

10 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

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

12 Act (42 U.S.C. 262(h)) is amended by striking ‘‘sec13 tion 801(e)(1) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 381(e))’’ and inserting ‘‘sec15 tion 801(f)(1) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 381(f)(1))’’.

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

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

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

20 801(d)(1)’’ and inserting ‘‘section 801(e)(1)’’;

21 and

22 (B) in paragraph (w)—

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

24 and 801(d)(3)(B)’’ and inserting ‘‘sub-
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1 paragraphs (A) and (B) of section

2 801(e)(3)’’;

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

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

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

6 and

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

8 inserting ‘‘section 801(f)’’.

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

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

11 amended by striking ‘‘section 801(d)(1)’’ and insert12 ing ‘‘section 801(e)(1)’’.

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

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

15 amended—

16 (A) by striking ‘‘section 801(e)(1)’’ and in17 serting ‘‘section 801(f)(1)’’; and

18 (B) except as provided in subparagraph

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

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

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

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

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

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

25 inserting ‘‘subsection (b) or subsection
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1 (d)(2)(A) (in the case of a food described in

2 that subsection)’’;

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

4 as redesignated in subsection (a), by striking

5 ‘‘section 801(e) or 802’’ and inserting ‘‘sub6 section (f), section 802,’’; and

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

8 redesignated in subsection (a), by striking ‘‘sub9 section (e)’’ and inserting ‘‘subsection (f)’’.

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

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

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

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

14 801(f)(2)’’;

15 (B) in subsection (f)(3), by striking ‘‘sec16 tion 801(e)(1)’’ and inserting ‘‘section

17 801(f)(1)’’; and

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

19 801(e)(1)’’ and inserting ‘‘section 801(f)(1)’’.

20 SEC. 102. PROHIBITION AGAINST THE DISTRIBUTION OF

21 CERTAIN FOOD.

22 (a) ADULTERATED FOODS.—Section 402 of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 342) is

24 amended by adding at the end the following:

25 ‘‘(h)(1) If—
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1 ‘‘(A) it is a food being imported or offered for

2 import into the United States;

3 ‘‘(B) the food has been designated by the Sec4 retary for sampling, examination, or review for the

5 purpose of determining whether the food is in com6 pliance with this Act;

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

8 801(a)(2)(B), that the food not be distributed until

9 the Secretary authorizes the distribution of the food;

10 and

11 ‘‘(D) the food is distributed before the Sec12 retary authorizes the distribution.

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

14 with respect to food, means—

15 ‘‘(A) moved for the purpose of selling the food,

16 offering the food for sale, or delivering the food for

17 the purpose of selling the food or offering the food

18 for sale; or

19 ‘‘(B) delivered contrary to any bond require20 ment.’’.

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

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

23 amended—
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1 (1) in the third sentence, by redesignating para2 graphs (1) through (3) as subparagraphs (A)

3 through (C), respectively;

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

5 The’’;

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

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

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

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

10 Secretary’’ and inserting the following:

11 ‘‘(2)(A) The Secretary’’; and

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

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

14 may require that a food being imported or offered for im15 port into the United States not be distributed until the

16 Secretary authorizes distribution of the food.’’.

17 SEC. 103. REQUIREMENT OF SECURE STORAGE OF CERTAIN

18 IMPORTED FOOD.

19 (a) ADULTERATED FOODS.—Section 402 of the Fed20 eral Food, Drug, and Cosmetic Act, as amended in section

21 102(a), is further amended by adding at the end the fol22 lowing:

23 ‘‘(i) If—

24 ‘‘(1) it is a food being imported or offered for

25 import into the United States;
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1 ‘‘(2) the Secretary requires, under section

2 801(a)(2)(C), that the food be held in a secure stor3 age facility until the Secretary authorizes distribu4 tion of the food; and

5 ‘‘(3) the food is not held in a secure storage fa6 cility as described in section 801(a)(2)(C) until the

7 Secretary authorizes the distribution.’’.

8 (b) REQUIREMENT.—Section 801(a)(2) of the Fed9 eral Food, Drug, and Cosmetic Act, as amended in section

10 102(b), is further amended by adding at the end the fol11 lowing:

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

13 may require that a food that is being imported or offered

14 for import into the United States be held, at the expense

15 of the owner or consignee of the food, in a secure storage

16 facility until the Secretary authorizes distribution of the

17 food, if the Secretary makes the determination that the

18 food is—

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

20 the United States by a person described in clause

21 (ii); or

22 ‘‘(II) owned by or consigned to a person de23 scribed in clause (ii).

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

25 subclause (I) or (II) of clause (i) is a person against whom
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1 the Secretary of the Treasury has assessed liquidated

2 damages not less than twice under subsection (b) for fail3 ure to redeliver, at the request of the Secretary of the

4 Treasury, food subject to a bond under subsection (b).’’.

5 SEC. 104. REQUIREMENT OF ADMINISTRATIVE DESTRUC6 TION OF CERTAIN IMPORTED FOOD.

7 (a) ADULTERATED FOODS.—Section 402 of the Fed8 eral Food, Drug, and Cosmetic Act, as amended in section

9 103(a), is further amended by adding at the end the fol10 lowing:

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

12 section 801, if—

13 ‘‘(1) it is a food being imported or offered for

14 import into the United States;

15 ‘‘(2) the food poses a strong likelihood of caus16 ing serious adverse health consequences or death;

17 ‘‘(3) the Secretary, after the food has been re18 fused admission under section 801(a), requires

19 under section 801(a)(2)(D) that the food be de20 stroyed; and

21 ‘‘(4) the owner or consignee of the food fails to

22 comply with that destruction requirement.’’.

23 (b) REQUIREMENT.—Section 801(a)(2) of the Fed24 eral Food, Drug, and Cosmetic Act, as amended in section
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1 103(b), is further amended by adding at the end the fol2 lowing:

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

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

5 consignee, of food imported or offered for import into the

6 United States that poses a strong likelihood of causing

7 serious adverse health consequences or death.’’.

8 SEC. 105. PROHIBITION AGAINST PORT SHOPPING.

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

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

11 adding at the end the following:

12 ‘‘(k) If it is an article of food being imported or of13 fered for import into the United States, and the article

14 of food previously has been refused admission under sec15 tion 801(a), unless the person reoffering the article affirm16 atively establishes, at the expense of the owner or con17 signee of the article, that the article complies with the ap18 plicable requirements of this Act, as determined by the

19 Secretary.’’.

20 SEC. 106. PROHIBITION OF IMPORTS BY DEBARRED PER21 SONS.

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

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

24 adding at the end the following:
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1 ‘‘(l) If it is a food being imported or offered for im2 port into the United States by a person debarred under

3 section 306(b)(4).’’.

4 SEC. 107. AUTHORITY TO MARK REFUSED ARTICLES.

5 (a) MISBRANDED FOODS.—Section 403 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) is

7 amended by adding at the end the following:

8 ‘‘(t) If—

9 ‘‘(1) it has been refused admission under sec10 tion 801(a);

11 ‘‘(2) the food has not been required to be de12 stroyed under subparagraph (A) or (B) of section

13 801(a)(2); and

14 ‘‘(3) the packaging of the food does not bear a

15 label or labeling described in section 801(a)(2)(E).’’.

16 (b) REQUIREMENT.—Section 801(a)(2) of the Fed17 eral Food, Drug, and Cosmetic Act, as amended in section

18 104(b), is further amended by adding at the end the fol19 lowing:

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

21 may require the owner or consignee of food that has been

22 refused admission under paragraph (1), and has not been

23 required to be destroyed under subparagraph (A) or (B),

24 to affix to the packaging of the food a label or labeling

25 that—
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1 ‘‘(i) clearly and conspicuously bears the fol2 lowing statement: ‘United States: Refused Entry.’;

3 ‘‘(ii) is affixed to the packaging until the food

4 is brought into compliance with this Act; and

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

6 owner or consignee of the food.’’.

7 SEC. 108. EXPORT OF REFUSED ARTICLES.

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

9 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as des10 ignated in section 102(b), is amended by striking ‘‘ninety

11 days’’ and inserting ‘‘30 days’’.

12 SEC. 109. COLLECTION AND ANALYSIS OF SAMPLES OF

13 FOOD IMPORTS.

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

15 Act (21 U.S.C. 381), as amended in section 101(a), is fur16 ther amended by adding at the end the following:

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

18 as necessary to govern the collection and analysis by enti19 ties other than the Food and Drug Administration of sam20 ples of food imported or offered for import into the United

21 States to ensure the integrity of the samples collected and

22 the validity of the analytical results.’’.
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1 TITLE II—ENFORCEMENT AND

2 PENALTIES FOR IMPORTING

3 CONTAMINATED FOOD

4 SEC. 201. ENHANCED BONDING REQUIREMENTS FOR PRIOR

5 INVOLVEMENT IN IMPORTING ADULTERATED

6 OR MISBRANDED FOOD.

7 Section 801(b) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 381(b)) is amended—

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

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

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

12 through the Commissioner of Customs, shall issue regula13 tions that establish a rate for a bond required to be exe14 cuted under paragraph (1) for an article of food if an

15 owner, consignee, or importer of the food has committed

16 a covered violation.

17 ‘‘(B) The regulations shall require the owner or con18 signee to execute such a bond—

19 ‘‘(i) at twice the usual rate; or

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

21 committed more than 1 covered violation, at a rate

22 that increases with the number of covered violations

23 committed, as determined in accordance with a slid24 ing scale established in the regulations.

25 ‘‘(C) In this paragraph:
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1 ‘‘(i) The term ‘committed’ means been con2 victed of, or found liable for, a violation by an ap3 propriate court or administrative officer.

4 ‘‘(ii) The term ‘covered violation’ means a viola5 tion relating to—

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

7 the United States—

8 ‘‘(aa) an article of food during a pe9 riod of debarment under section 306(b)(4);

10 ‘‘(bb) an article of food that is adul11 terated within the meaning of paragraph

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

13 ‘‘(cc) an article of food that is mis14 branded within the meaning of section

15 403(t); or

16 ‘‘(II) making a false or misleading state17 ment in conduct relating to the import or offer18 ing for import of a food into the United States.

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

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

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

22 has not committed a covered violation.’’.
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1 SEC. 202. DEBARMENT OF REPEAT OFFENDERS AND SERI2 OUS OFFENDERS.

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

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

5 amended—

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

7 by striking ‘‘IN GENERAL.—’’ and inserting ‘‘DE8 BARMENT FOR VIOLATIONS RELATING TO DRUGS.—’’;

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

10 by striking ‘‘PERSONS SUBJECT TO PERMISSIVE DE11 BARMENT.—’’ and inserting ‘‘PERSONS SUBJECT TO

12 PERMISSIVE DEBARMENT FOR VIOLATIONS RELAT13 ING TO DRUGS.—’’;

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

15 by striking ‘‘STAY OF CERTAIN ORDERS.—’’ and in16 serting ‘‘STAY OF CERTAIN ORDERS RELATING TO

17 DEBARMENT FOR VIOLATIONS RELATING TO

18 DRUGS.—’’; and

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

20 ‘‘(4) DEBARMENT FOR VIOLATIONS RELATING

21 TO FOOD IMPORTS.—

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

23 debar a person from importing a food or offer24 ing a food for import into the United States,

25 if—
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1 ‘‘(i) the Secretary finds that the per2 son has been convicted for conduct that is

3 a felony under Federal law and relates to

4 the importation or offering for importation

5 of any food into the United States; or

6 ‘‘(ii) the Secretary makes a written

7 determination that the person has repeat8 edly or deliberately imported or offered for

9 import into the United States a food adul10 terated within the meaning of paragraph

11 (h), (i), (j), or (k) of section 402, or mis12 branded within the meaning of section

13 403(t).

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

15 under subparagraph (A), the Secretary shall

16 provide notice of the debarment to the Sec17 retary of the Treasury, who shall deny entry of

18 food offered for import by the person.’’.

19 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

20 (1) IN GENERAL.—Section 306 of the Federal

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

22 amended—

23 (A) in subsection (c)—

24 (i) in paragraph (1)—
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1 (I) in subparagraph (B), by

2 striking ‘‘, and’’ at the end and in3 serting a comma;

4 (II) by redesignating subpara5 graph (C) as subparagraph (D); and

6 (III) by inserting after subpara7 graph (B) the following:

8 ‘‘(C) shall, during the period of a debar9 ment under subsection (b)(4), prohibit the

10 debarred person from importing a food or offer11 ing a food for import into the United States,

12 and’’;

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

14 after clause (iii) the following:

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

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

17 less than 1 year.’’; and

18 (iii) in paragraph (3)—

19 (I) in subparagraph (C)—

20 (aa) by striking ‘‘suspect

21 drugs’’ and inserting ‘‘suspect

22 drugs or food’’; and

23 (bb) by striking ‘‘fraudu24 lently obtained’’ and inserting

25 ‘‘fraudulently obtained or on food
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1 wrongfully imported into the

2 United States’’; and

3 (II) in subparagraph (E), by in4 serting ‘‘in the case of a debarment

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

6 (B) in subsection (d)—

7 (i) in paragraph (3)—

8 (I) in subparagraph (A)—

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

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

11 paragraph (2)(A) or (4) of sub12 section (b)’’; and

13 (bb) in clause (ii)(II), by in14 serting ‘‘in the case of a debar15 ment relating to a drug,’’ after

16 ‘‘(II)’’; and

17 (II) in subparagraph (B)—

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

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

20 subsection (b)(2)(B)’’ and insert21 ing ‘‘, clause (i), (ii), (iii), or (iv)

22 of subsection (b)(2)(B), or sub23 section (b)(4)’’; and

24 (bb) in clause (ii), by strik25 ing ‘‘subsection (b)(2)(B)’’ and
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1 inserting ‘‘paragraph (2)(B) or

2 (4) of subsection (b)’’; and

3 (ii) in paragraph (4)—

4 (I) in subparagraph (A), by strik5 ing ‘‘(a)(2)’’ and inserting ‘‘(a)(2) or

6 (b)(4)’’;

7 (II) in subparagraph (B)—

8 (aa) in clause (ii), by strik9 ing ‘‘involving the development or

10 approval of any drug subject to

11 section 505’’ and inserting ‘‘in12 volving, as appropriate, the devel13 opment or approval of any drug

14 subject to section 505 or the im15 portation of any food’’; and

16 (bb) in clause (iv), by strik17 ing ‘‘drug’’ each place it appears

18 and inserting ‘‘drug or food’’;

19 and

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

21 matter following clause (ii), by insert22 ing ‘‘, in the case of a debarment re23 lating to a drug,’’ before ‘‘protects’’;

24 and
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1 (C) in subsection (l)(2), in the second sen2 tence, by striking ‘‘(b)(2)(B)’’ and inserting

3 ‘‘(b)(2)(B), subsection (b)(4),’’.

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

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

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

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

8 306(b)(4))’’.

9 SEC. 203. INCREASED ENFORCEMENT TO IMPROVE THE

10 SAFETY OF IMPORTED FOOD.

11 Subchapter A of chapter VII of the Federal Food,

12 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend13 ed by adding at the end the following:

14 ‘‘SEC. 712. POSITIONS TO IMPROVE THE SAFETY OF IM15 PORTED FOOD.

16 ‘‘There is authorized to be appropriated such sums

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

18 2002 to enable the Commissioner, in carrying out chapters

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

20 imported food through the creation of additional employ21 ment positions for laboratory, inspection, and compliance

22 personnel.’’.
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1 TITLE III—IMPROVEMENTS TO

2 PUBLIC HEALTH INFRA3 STRUCTURE AND AWARENESS

4 SEC. 301. IMPROVEMENTS.

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

6 202 et seq.) is amended by adding at the end the fol7 lowing:

8 ‘‘PART C—PUBLIC HEALTH INFRASTRUCTURE

9 AND AWARENESS

10 ‘‘SEC. 251. DEFINITIONS.

11 ‘‘In this part:

12 ‘‘(1) INSTITUTION OF HIGHER EDUCATION.—

13 The term ‘institution of higher education’ has the

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

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

16 ‘‘(2) SECRETARY.—The term ‘Secretary’ means

17 the Secretary of Health and Human Services, acting

18 through the Director of the Centers for Disease

19 Control and Prevention.

20 ‘‘SEC. 252. PUBLIC HEALTH SURVEILLANCE ENHANCE21 MENT.

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

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

24 agreements with, and provide technical assistance to

25 eligible agencies to enable the agencies to enhance
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1 their capacity to carry out activities relating to sur2 veillance and prevention of foodborne pathogen-re3 lated disease, particularly pathogen-related disease

4 associated with imported food, as described in sub5 section (b)(1); and

6 ‘‘(2) carry out the activities described in sub7 section (b)(2).

8 ‘‘(b) USE OF ASSISTANCE.—

9 ‘‘(1) AGENCIES.—An eligible agency that re10 ceives assistance under subsection (a) shall use the

11 assistance to enhance the capacity of the agency—

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

13 threats of foodborne pathogen-related disease,

14 particularly pathogen-related disease associated

15 with imported food; and

16 ‘‘(B) to conduct additional surveillance and

17 studies to address prevention and control of the

18 disease.

19 ‘‘(2) CENTERS FOR DISEASE CONTROL AND

20 PREVENTION.—The Secretary may use not more

21 than 30 percent of the funds appropriated to carry

22 out this section—

23 ‘‘(A) to assist an agency described in para24 graph (1) in enhancing the capacity described

25 in paragraph (1) by providing standards, tech-
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1 nologies, information, materials, and other re2 sources; and

3 ‘‘(B) to enhance national surveillance sys4 tems, including the ability of domestic and

5 international agencies and entities to respond to

6 food safety issues associated with imported food

7 that are identified through such systems.

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

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

10 State or local health department.

11 ‘‘(d) APPLICATION.—To be eligible to receive assist12 ance under subsection (a)(1), an agency shall submit an

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

14 and containing such information as the Secretary may re15 quire.

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

17 are authorized to be appropriated to carry out this section

18 such sums as may be necessary for fiscal years 2000

19 through 2002.

20 ‘‘SEC. 253. PATHOGEN DETECTION RESEARCH AND DEVEL21 OPMENT.

22 ‘‘(a) IN GENERAL.—The Secretary may conduct ap23 plied research, directly or by grant or contract, to develop

24 new or improved methods for detecting and subtyping

25 emerging foodborne pathogens in human specimens, food,
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1 and relevant environmental samples. The Secretary may

2 use funds appropriated to carry out this section to support

3 applied research by State health departments or institu4 tions of higher education.

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

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

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

8 in such manner, and containing such information as the

9 Secretary may require.

10 ‘‘(c) 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. 254. TRAINING, EDUCATION, AND PUBLIC INFORMA15 TION.

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

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

18 eligible entities, to support training activities and

19 other collaborative activities with the entities to in20 form health professionals about foodborne disease,

21 including strengthening training networks serving

22 State, local, and private entities; and

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

24 out by the Centers for Disease Control and Preven-
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1 tion to provide information to the public on

2 foodborne disease.

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

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

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

6 carrying out clinical laboratory training programs, a

7 school of public health, another institution of higher edu8 cation, a professional organization, or an international or9 ganization.

10 ‘‘(c) APPLICATION.—To be eligible to receive a grant

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

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

13 in such manner, and containing such information as the

14 Secretary may require.

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

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

17 agencies, international organizations, and other interested

18 parties.

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

20 are authorized to be appropriated to carry out this section

21 such sums as may be necessary for fiscal years 2000

22 through 2002.
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1 ‘‘SEC. 255. INTERNATIONAL PUBLIC HEALTH TRAINING AND

2 TECHNICAL ASSISTANCE.

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

4 by agreement, provide training and technical assistance to

5 agencies and entities in foreign countries, to strengthen

6 the foodborne disease surveillance and investigation capac7 ities of the agencies and entities, including establishing or

8 expanding activities or programs such as the Field Epide9 miology and Training Program of the Centers for Disease

10 Control and Prevention.

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

12 agreement under subsection (a), an entity shall submit an

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

14 and containing such information as the Secretary may re15 quire.

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

17 are authorized to be appropriated to carry out this section

18 such sums as may be necessary for fiscal years 2000

19 through 2002.

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

21 FUNDS.

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

23 assistance under section 252, 253, 254, or 255, the Sec24 retary may, subject to subsection (b), provide supplies,

25 equipment, and services for the purpose of aiding the re26 cipient in carrying out the section involved and, for such
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1 purpose, may detail to the grant recipient any officer or

2 employee of the Department of Health and Human Serv3 ices. Such detail shall be without interruption or loss of

4 civil service status or privilege.

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

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

7 Secretary shall reduce the amount of payments under the

8 section involved by an amount equal to the cost of detail9 ing the officer or employee and the fair market value of

10 the supplies, equipment, or services provided by the Sec11 retary. The Secretary shall, for the payment of expenses

12 incurred in complying with such a request, expend the

13 amounts withheld.’’.

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