II

106TH CONGRESS

1ST SESSION S. 1126

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 26, 1999

Ms. MIKULSKI (for herself, Mr. KENNEDY, and Mr. DURBIN) 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 of 1999’’.
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1 TITLE I—IMPROVEMENTS TO

2 THE FOOD SAFETY IMPORT

3 SYSTEM

4 SEC. 101. EQUIVALENCE AUTHORITY TO PROTECT THE

5 PUBLIC HEALTH FROM CONTAMINATED IM6 PORTED FOODS.

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 food

16 offered for import into the United States shall be prepared

17 (including produced), packed, and held under a system or

18 conditions, or subject to measures, that meet the require19 ments of this Act or that have been determined by the

20 Secretary to be equivalent to a system, conditions, or

21 measures for such food in the United States and to achieve

22 the level of public health protection for such food pre23 pared, packed, and held in the United States. Consistent

24 with section 492 of the Trade Agreements Act of 1979

25 (19 U.S.C. 2578a), the Secretary shall make, where ap-
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1 propriate, equivalence determinations described in that

2 section relating to sanitary or phytosanitary measures (in3 cluding systems and conditions) that apply to the prepara4 tion, packing, and holding of food offered for import into

5 the United States.

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

7 shall conduct systematic evaluations of the systems, condi8 tions, and measures in foreign countries that apply to the

9 preparation, packing, and holding of food offered for im10 port into the United States.

11 ‘‘(3) The Secretary shall develop a plan for the imple12 mentation of the authority under this subsection within

13 2 years after the date of enactment of the Imported Food

14 Safety Improvement Act of 1999. In developing the plan,

15 the Secretary shall provide an opportunity for, and take

16 into consideration, public comment on a proposed plan.’’.

17 (b) GENERAL AUTHORITY.—Section 801 of the Fed18 eral Food, Drug, and Cosmetic Act (21 U.S.C. 381), as

19 amended in subsection (a), is further amended by insert20 ing after subsection (d) the following:

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

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

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

24 the Secretary of Health and Human Services makes and

25 publishes—
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1 ‘‘(i) a written determination that the food—

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

3 separate outbreaks of foodborne disease or has

4 been repeatedly determined by the Secretary to

5 be adulterated within the meaning of section

6 402;

7 ‘‘(II) presents a reasonable probability of

8 causing significant adverse health consequences

9 or death; and

10 ‘‘(III) is likely, without systemic interven11 tion or changes, to cause disease or be adulter12 ated again; or

13 ‘‘(ii) an emergency written determination that

14 the food has been strongly associated with a single

15 outbreak of foodborne disease that has caused seri16 ous adverse health consequences or death.

17 ‘‘(B)(i) The Secretary shall make a determination de18 scribed in subparagraph (A) with respect to—

19 ‘‘(I) a food from a specific producer, manufac20 turer, or shipper; or

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

22 country;

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

24 ‘‘(ii) Only the food from the specific producer, manu25 facturer, shipper, growing area, or country for which the
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1 Secretary makes the determination shall be subject to de2 nial of entry under this subsection.

3 ‘‘(C) The denial of entry of any food under this para4 graph shall be done in a manner consistent with bilateral,

5 regional, and multilateral trade agreements and the rights

6 and obligations of the United States under the agree7 ments.

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

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

10 written comments, on a proposed determination, made by

11 any party affected by the proposed determination and any

12 remedial actions taken to address the findings made in

13 the proposed determination. In making the written deter14 mination, the Secretary may modify or rescind the pro15 posed determination in accordance with such comments.

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

17 emergency written determination under subparagraph

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

19 determination.

20 ‘‘(II) Within 30 days after the issuance of the emer21 gency determination, the Secretary shall consider written

22 comments on the determination that are made by a party

23 described in clause (i) and received within the 30-day pe24 riod. The Secretary may affirm, modify, or rescind the
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1 emergency determination in accordance with the com2 ments.

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

4 effect—

5 ‘‘(aa) for the 30-day period; or

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

7 determination, until the Secretary rescinds the de8 termination.

9 ‘‘(2)(A) The food initially denied entry under para10 graph (1) may be imported into the United States if the

11 Secretary finds that—

12 ‘‘(i) the written determination made under

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

14 of the food; or

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

16 the producer, manufacturer, shipper, specific grow17 ing area, or country for which the Secretary made

18 the written determination under paragraph (1) ad19 dresses the determination.

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

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

22 the date of the submission of the evidence.

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

24 ‘‘(I) lifting the denial of entry of the food; or
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1 ‘‘(II) continuing to deny entry of the food while

2 requesting additional information or specific reme3 dial action from the producer, manufacturer, ship4 per, specific growing area, or country.

5 ‘‘(iii) If the Secretary does not take action on evi6 dence submitted under subparagraph (A)(ii) within 90

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

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

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

10 United States.

11 ‘‘(3) The Secretary shall by regulation establish cri12 teria and procedures for the system described in para13 graph (1). The Secretary may by regulation modify those

14 criteria and procedures, as the Secretary determines ap15 propriate.’’.

16 (c) TECHNICAL AND CONFORMING AMENDMENTS.—

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

18 Act (42 U.S.C. 262(h)) is amended by striking ‘‘sec19 tion 801(e)(1) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 381(e))’’ and inserting ‘‘sec21 tion 801(g)(1) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 381(g)(1))’’.

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

24 Cosmetic Act (21 U.S.C. 331) is amended—
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1 (A) in paragraph (t), by striking ‘‘section

2 801(d)(1)’’ and inserting ‘‘section 801(f)(1)’’;

3 and

4 (B) in paragraph (w)—

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

6 and 801(d)(3)(B)’’ and inserting ‘‘sub7 paragraphs (A) and (B) of section

8 801(f)(3)’’;

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

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

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

12 and

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

14 inserting ‘‘section 801(g)’’.

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

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

17 amended by striking ‘‘section 801(d)(1)’’ and insert18 ing ‘‘section 801(f)(1)’’.

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

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

21 amended—

22 (A) by striking ‘‘section 801(e)(1)’’ and in23 serting ‘‘section 801(g)(1)’’; and
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1 (B) except as provided in subparagraph

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

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

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

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

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

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

8 inserting ‘‘subsection (b) or subsection

9 (e)(2)(A) (in the case of a food described in

10 that subsection)’’;

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

12 as redesignated in subsection (a), by striking

13 ‘‘section 801(e) or 802’’ and inserting ‘‘sub14 section (g), section 802,’’; and

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

16 redesignated in subsection (a), by striking ‘‘sub17 section (e)’’ and inserting ‘‘subsection (g)’’.

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

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

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

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

22 801(g)(2)’’;

23 (B) in subsection (f)(3), by striking ‘‘sec24 tion 801(e)(1)’’ and inserting ‘‘section

25 801(g)(1)’’; and
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1 (C) in subsection (i), by striking ‘‘section

2 801(e)(1)’’ and inserting ‘‘section 801(g)(1)’’.

3 SEC. 102. PROHIBITION AGAINST THE DISTRIBUTION OF

4 CERTAIN FOOD.

5 (a) ADULTERATED FOODS.—Section 402 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 342) is

7 amended by adding at the end the following:

8 ‘‘(h)(1) If—

9 ‘‘(A) it is a food being imported or offered for

10 import into the United States;

11 ‘‘(B) the food has been designated by the Sec12 retary for sampling, examination, or review for the

13 purpose of determining whether the food is in com14 pliance with this Act;

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

16 801(a)(2)(B), that the food not be distributed until

17 the Secretary authorizes the distribution of the food;

18 and

19 ‘‘(D) the food is distributed before the Sec20 retary authorizes the distribution.

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

22 with respect to food, means—

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

24 offering the food for sale, or delivering the food for
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1 the purpose of selling the food or offering the food

2 for sale; or

3 ‘‘(B) delivered contrary to any bond require4 ment.’’.

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

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

7 amended—

8 (1) in the third sentence, by redesignating para9 graphs (1) through (3) as subparagraphs (A)

10 through (C), respectively;

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

12 The’’;

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

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

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

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

17 Secretary’’ and inserting the following:

18 ‘‘(2)(A) The Secretary’’; and

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

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

21 may require that a food being imported or offered for im22 port into the United States not be distributed until the

23 Secretary authorizes distribution of the food.’’.
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1 SEC. 103. REQUIREMENT OF SECURE STORAGE OF CERTAIN

2 IMPORTED FOOD.

3 (a) ADULTERATED FOODS.—Section 402 of the Fed4 eral Food, Drug, and Cosmetic Act, as amended in section

5 102(a), is further amended by adding at the end the fol6 lowing:

7 ‘‘(i) If—

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

9 import into the United States;

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

11 801(a)(2)(C), that the food be held in a secure stor12 age facility until the Secretary authorizes distribu13 tion of the food; and

14 ‘‘(3) the food is not held in a secure storage fa15 cility as described in section 801(a)(2)(C) until the

16 Secretary authorizes the distribution.’’.

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

19 102(b), is further amended by adding at the end the fol20 lowing:

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

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

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

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

25 facility until the Secretary authorizes distribution of the
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1 food, if the Secretary makes the determination that the

2 food is—

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

4 the United States by a person described in clause

5 (ii); or

6 ‘‘(II) owned by or consigned to a person de7 scribed in clause (ii).

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

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

10 the Secretary of the Treasury has assessed liquidated

11 damages not less than twice under subsection (b) for fail12 ure to redeliver, at the request of the Secretary of the

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

14 SEC. 104. REQUIREMENT OF ADMINISTRATIVE DESTRUC15 TION OF CERTAIN IMPORTED FOOD.

16 (a) ADULTERATED FOODS.—Section 402 of the Fed17 eral Food, Drug, and Cosmetic Act, as amended in section

18 103(a), is further amended by adding at the end the fol19 lowing:

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

21 section 801, if—

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

23 import into the United States;
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1 ‘‘(2) the food presents a reasonable probability

2 of causing significant adverse health consequences or

3 death;

4 ‘‘(3) the Secretary, after the food has been re5 fused admission under section 801(a), requires

6 under section 801(a)(2)(D) that the food be de7 stroyed; and

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

9 comply with that destruction requirement.’’.

10 (b) REQUIREMENT.—Section 801(a)(2) of the Fed11 eral Food, Drug, and Cosmetic Act, as amended in section

12 103(b), is further amended by adding at the end the fol13 lowing:

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

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

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

17 United States that presents a reasonable probability of

18 causing significant adverse health consequences or

19 death.’’.

20 SEC. 105. PROHIBITION AGAINST PORT SHOPPING.

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

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

23 adding at the end the following:

24 ‘‘(k) If it is an article of food being imported or of25 fered for import into the United States, and the article
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1 of food previously has been refused admission under sec2 tion 801(a), unless the person reoffering the article affirm3 atively establishes, at the expense of the owner or con4 signee of the article, that the article complies with the ap5 plicable requirements of this Act, as determined by the

6 Secretary.’’.

7 SEC. 106. PROHIBITION OF IMPORTS BY DEBARRED PER8 SONS.

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

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

11 adding at the end the following:

12 ‘‘(l) If it is a food being imported or offered for im13 port into the United States by a person debarred under

14 section 306(b)(4).’’.

15 SEC. 107. AUTHORITY TO MARK REFUSED ARTICLES.

16 (a) MISBRANDED FOODS.—Section 403 of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 343) is

18 amended by adding at the end the following:

19 ‘‘(t) If—

20 ‘‘(1) it has been refused admission under sec21 tion 801(a);

22 ‘‘(2) the food has not been required to be de23 stroyed under subparagraph (A) or (B) of section

24 801(a)(2); and
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1 ‘‘(3) the packaging of the food does not bear a

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

3 (b) REQUIREMENT.—Section 801(a)(2) of the Fed4 eral Food, Drug, and Cosmetic Act, as amended in section

5 104(b), is further amended by adding at the end the fol6 lowing:

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

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

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

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

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

12 that—

13 ‘‘(i) clearly and conspicuously bears the fol14 lowing statement: ‘United States: Refused Entry.’;

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

16 is brought into compliance with this Act; and

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

18 owner or consignee of the food.’’.

19 SEC. 108. EXPORT OF REFUSED ARTICLES.

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

21 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as des22 ignated in section 102(b), is amended by striking ‘‘ninety

23 days’’ and inserting ‘‘30 days’’.
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1 SEC. 109. COLLECTION AND ANALYSIS OF SAMPLES OF

2 FOOD IMPORTS.

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

4 Act (21 U.S.C. 381), as amended in section 101(a), is fur5 ther amended by adding at the end the following:

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

7 as necessary to govern the collection and analysis by enti8 ties other than the Food and Drug Administration of sam9 ples of food imported or offered for import into the United

10 States to ensure the integrity of the samples collected and

11 the validity of the analytical results.’’.

12 TITLE II—ENFORCEMENT AND

13 PENALTIES FOR IMPORTING

14 CONTAMINATED FOOD

15 SEC. 201. ENHANCED BONDING REQUIREMENTS FOR PRIOR

16 INVOLVEMENT IN IMPORTING ADULTERATED

17 OR MISBRANDED FOOD.

18 Section 801(b) of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 381(b)) is amended—

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

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

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

23 through the Commissioner of Customs, shall issue regula24 tions that establish a rate for a bond required to be exe25 cuted under paragraph (1) for an article of food if an
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1 owner, consignee, or importer of the food has committed

2 a covered violation.

3 ‘‘(B) The regulations shall require the owner or con4 signee to execute such a bond—

5 ‘‘(i) at twice the usual rate; or

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

7 committed more than 1 covered violation, at a rate

8 that increases with the number of covered violations

9 committed, as determined in accordance with a slid10 ing scale established in the regulations.

11 ‘‘(C) In this paragraph:

12 ‘‘(i) The term ‘committed’ means been con13 victed of, or found liable for, a violation by an ap14 propriate court or administrative officer.

15 ‘‘(ii) The term ‘covered violation’ means a viola16 tion relating to—

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

18 the United States—

19 ‘‘(aa) an article of food during a pe20 riod of debarment under section 306(b)(4);

21 ‘‘(bb) an article of food that is adul22 terated within the meaning of paragraph

23 (h), (i), (j), (k), or (l) of section 402; or
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1 ‘‘(cc) an article of food that is mis2 branded within the meaning of section

3 403(t); or

4 ‘‘(II) making a false or misleading state5 ment in conduct relating to the import or offer6 ing for import of a food into the United States.

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

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

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

10 has not committed a covered violation.’’.

11 SEC. 202. DEBARMENT OF REPEAT OFFENDERS AND SERI12 OUS OFFENDERS.

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

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

15 amended—

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

17 by striking ‘‘IN GENERAL.—’’ and inserting ‘‘DE18 BARMENT FOR VIOLATIONS RELATING TO DRUGS.—’’;

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

20 by striking ‘‘PERSONS SUBJECT TO PERMISSIVE DE21 BARMENT.—’’ and inserting ‘‘PERSONS SUBJECT TO

22 PERMISSIVE DEBARMENT FOR VIOLATIONS RELAT23 ING TO DRUGS.—’’;

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

25 by striking ‘‘STAY OF CERTAIN ORDERS.—’’ and in-
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1 serting ‘‘STAY OF CERTAIN ORDERS RELATING TO

2 DEBARMENT FOR VIOLATIONS RELATING TO

3 DRUGS.—’’; and

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

5 ‘‘(4) DEBARMENT FOR VIOLATIONS RELATING

6 TO FOOD IMPORTS.—

7 ‘‘(A) IN GENERAL.—The Secretary may

8 debar a person from importing a food or offer9 ing a food for import into the United States,

10 if—

11 ‘‘(i) the Secretary finds that the per12 son has been convicted for conduct that is

13 a felony under Federal law and relates to

14 the importation or offering for importation

15 of any food into the United States; or

16 ‘‘(ii) the Secretary makes a written

17 determination that the person has repeat18 edly or deliberately imported or offered for

19 import into the United States a food adul20 terated within the meaning of paragraph

21 (h), (i), (j), or (k) of section 402, or mis22 branded within the meaning of section

23 403(t).

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

25 under subparagraph (A), the Secretary shall
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1 provide notice of the debarment to the Sec2 retary of the Treasury, who shall deny entry of

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

4 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

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

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

7 amended—

8 (A) in subsection (c)—

9 (i) in paragraph (1)—

10 (I) in subparagraph (B), by

11 striking ‘‘, and’’ at the end and in12 serting a comma;

13 (II) by redesignating subpara14 graph (C) as subparagraph (D); and

15 (III) by inserting after subpara16 graph (B) the following:

17 ‘‘(C) shall, during the period of a debar18 ment under subsection (b)(4), prohibit the

19 debarred person from importing a food or offer20 ing a food for import into the United States,

21 and’’;

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

23 after clause (iii) the following:
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1 ‘‘(iv) The period of debarment of any

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

3 less than 1 year.’’; and

4 (iii) in paragraph (3)—

5 (I) in subparagraph (C)—

6 (aa) by striking ‘‘suspect

7 drugs’’ and inserting ‘‘suspect

8 drugs or food’’; and

9 (bb) by striking ‘‘fraudu10 lently obtained’’ and inserting

11 ‘‘fraudulently obtained or on food

12 wrongfully imported into the

13 United States’’; and

14 (II) in subparagraph (E), by in15 serting ‘‘in the case of a debarment

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

17 (B) in subsection (d)—

18 (i) in paragraph (3)—

19 (I) in subparagraph (A)—

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

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

22 paragraph (2)(A) or (4) of sub23 section (b)’’; and

24 (bb) in clause (ii)(II), by in25 serting ‘‘in the case of a debar-
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1 ment relating to a drug,’’ after

2 ‘‘(II)’’; and

3 (II) in subparagraph (B)—

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

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

6 subsection (b)(2)(B)’’ and insert7 ing ‘‘, clause (i), (ii), (iii), or (iv)

8 of subsection (b)(2)(B), or sub9 section (b)(4)’’; and

10 (bb) in clause (ii), by strik11 ing ‘‘subsection (b)(2)(B)’’ and

12 inserting ‘‘paragraph (2)(B) or

13 (4) of subsection (b)’’; and

14 (ii) in paragraph (4)—

15 (I) in subparagraph (A), by strik16 ing ‘‘(a)(2)’’ and inserting ‘‘(a)(2) or

17 (b)(4)’’;

18 (II) in subparagraph (B)—

19 (aa) in clause (ii), by strik20 ing ‘‘involving the development or

21 approval of any drug subject to

22 section 505’’ and inserting ‘‘in23 volving, as appropriate, the devel24 opment or approval of any drug
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1 subject to section 505 or the im2 portation of any food’’; and

3 (bb) in clause (iv), by strik4 ing ‘‘drug’’ each place it appears

5 and inserting ‘‘drug or food’’;

6 and

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

8 matter following clause (ii), by insert9 ing ‘‘, in the case of a debarment re10 lating to a drug,’’ before ‘‘protects’’;

11 and

12 (C) in subsection (l)(2), in the second sen13 tence, by striking ‘‘(b)(2)(B)’’ and inserting

14 ‘‘(b)(2)(B), subsection (b)(4),’’.

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

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

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

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

19 306(b)(4))’’.

20 SEC. 203. INCREASED ENFORCEMENT TO IMPROVE THE

21 SAFETY OF IMPORTED FOOD.

22 Subchapter A of chapter VII of the Federal Food,

23 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend24 ed by adding at the end the following:
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1 ‘‘SEC. 712. POSITIONS TO IMPROVE THE SAFETY OF IM2 PORTED FOOD.

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 food through the creation of additional employ8 ment positions for laboratory, inspection, and compliance

9 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) SECRETARY.—The term ‘Secretary’ means

26 the Secretary of Health and Human Services, acting
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1 through the Director of the Centers for Disease

2 Control and Prevention.

3 ‘‘SEC. 252. PUBLIC HEALTH SURVEILLANCE ENHANCE4 MENT.

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

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

7 agreements with, and provide technical assistance to

8 eligible agencies to enable the agencies to enhance

9 their capacity to carry out activities relating to sur10 veillance and prevention of foodborne pathogen-re11 lated disease, particularly pathogen-related disease

12 associated with imported food, as described in sub13 section (b)(1); and

14 ‘‘(2) carry out the activities described in sub15 section (b)(2).

16 ‘‘(b) USE OF ASSISTANCE.—

17 ‘‘(1) AGENCIES.—An eligible agency that re18 ceives assistance under subsection (a) shall use the

19 assistance to enhance the capacity of the agency—

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

21 threats of foodborne pathogen-related disease,

22 particularly pathogen-related disease associated

23 with imported food; and
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1 ‘‘(B) to conduct additional surveillance and

2 studies to address prevention and control of the

3 disease.

4 ‘‘(2) CENTERS FOR DISEASE CONTROL AND

5 PREVENTION.—The Secretary may use not more

6 than 30 percent of the funds appropriated to carry

7 out this section—

8 ‘‘(A) to assist an agency described in para9 graph (1) in enhancing the capacity described

10 in paragraph (1) by providing standards, tech11 nologies, information, materials, and other re12 sources; and

13 ‘‘(B) to enhance national surveillance sys14 tems, including the ability of domestic and

15 international agencies and entities to respond to

16 food safety issues associated with imported food

17 that are identified through such systems.

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

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

20 State or local health department.

21 ‘‘(d) APPLICATION.—To be eligible to receive assist22 ance under subsection (a)(1), an agency shall submit an

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

24 and containing such information as the Secretary may re25 quire.
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1 ‘‘(e) 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. 253. PATHOGEN DETECTION RESEARCH AND DEVEL6 OPMENT.

7 ‘‘(a) IN GENERAL.—The Secretary may conduct ap8 plied research, directly or by grant or contract, to develop

9 new or improved methods for detecting and subtyping

10 emerging foodborne pathogens in human specimens, food,

11 and relevant environmental samples. The Secretary may

12 use funds appropriated to carry out this section to support

13 applied research by State health departments or institu14 tions of higher education.

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

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

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

18 in such manner, and containing such information as the

19 Secretary may require.

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

21 are authorized to be appropriated to carry out this section

22 such sums as may be necessary for fiscal years 2000

23 through 2002.
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1 ‘‘SEC. 254. TRAINING, EDUCATION, AND PUBLIC INFORMA2 TION.

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

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

5 eligible entities, to support training activities and

6 other collaborative activities with the entities to in7 form health professionals about foodborne disease,

8 including strengthening training networks serving

9 State, local, and private entities; and

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

11 out by the Centers for Disease Control and Preven12 tion to provide information to the public on

13 foodborne disease.

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

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

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

17 carrying out clinical laboratory training programs, a

18 school of public health, another institution of higher edu19 cation, a professional organization, or an international or20 ganization.

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

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

3 agencies, international organizations, and other interested

4 parties.

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

6 are authorized to be appropriated to carry out this section

7 such sums as may be necessary for fiscal years 2000

8 through 2002.

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

10 TECHNICAL ASSISTANCE.

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

12 by agreement, provide training and technical assistance to

13 agencies and entities in foreign countries, to strengthen

14 the foodborne disease surveillance and investigation capac15 ities of the agencies and entities, including establishing or

16 expanding activities or programs such as the Field Epide17 miology and Training Program of the Centers for Disease

18 Control and Prevention.

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

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

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

22 and containing such information as the Secretary may re23 quire.

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

25 are authorized to be appropriated to carry out this section
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1 such sums as may be necessary for fiscal years 2000

2 through 2002.

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

4 FUNDS.

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

6 assistance under section 252, 253, 254, or 255, the Sec7 retary may, subject to subsection (b), provide supplies,

8 equipment, and services for the purpose of aiding the re9 cipient in carrying out the section involved and, for such

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

11 employee of the Department of Health and Human Serv12 ices. Such detail shall be without interruption or loss of

13 civil service status or privilege.

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

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

16 Secretary shall reduce the amount of payments under the

17 section involved by an amount equal to the cost of detail18 ing the officer or employee and the fair market value of

19 the supplies, equipment, or services provided by the Sec20 retary. The Secretary shall, for the payment of expenses

21 incurred in complying with such a request, expend the

22 amounts withheld.’’.

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