I

106TH CONGRESS

1ST SESSION H. R. 830

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

safety of food from foreign countries.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 24, 1999

Mr. DINGELL (for himself, Mr. BROWN of Ohio, Mr. STUPAK, Mr. PALLONE,

Mr. WAXMAN, Mr. MARKEY, Mr. BOUCHER, Mr. GORDON, Mr. DEUTSCH,

Mr. RUSH, Mr. KLINK, Mr. WYNN, Mr. GREEN of Texas, Ms. MCCARTHY

of Missouri, Ms. DEGETTE, Mr. BARRETT of Wisconsin, Mrs. CAPPS, Mr.

BONIOR, and Mr. SERRANO) introduced the following bill; which was referred to the Committee on Commerce

A BILL

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

respect to the safety of food from foreign countries.

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 Act of 1999’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:
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1 (1) The Food and Drug Administration (FDA)

2 has confirmed that the number of produce-related

3 foodborne illness outbreaks in the United States has

4 increased in recent years.

5 (2) Imported food poses a special problem for

6 FDA in its efforts to guarantee the health and safe7 ty of the food American consumers eat. While FDA

8 has the ability to inspect and test food produced in

9 the United States at every stage of production, dis10 tribution, and sale, FDA may have access to im11 ported food for only a matter of hours at the inter12 national border, and it cannot trace back beyond the

13 border the origin of imported food believed to be re14 sponsible for outbreaks of foodborne illnesses.

15 (3) FDA data demonstrate that the pesticide

16 violation rate for imported food entering the United

17 States is nearly three time as great as for domesti18 cally produced food.

19 (4) FDA says its resources to deal with im20 ported food safety are limited. The General Account21 ing Office reported that between 1992 and 1997, the

22 number of imported food entries increased by more

23 than 200 percent, from 1.1 million to 2.7 million. At

24 the same time, FDA inspection of imported food has
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1 fallen from an estimated 8 percent in fiscal year

2 1992 to 1.7 percent in fiscal year 1997.

3 (5) FDA confirms that there is a critical need

4 for rapid, accurate methods to detect, identify, and

5 quantify pathogens. For example, FDA can identify

6 only about half of the approximately 400 pesticides

7 for which the Environmental Protection Agency has

8 established tolerances. In addition, FDA says its

9 method for detecting hepatitis A on shellfish is inef10 fective for strawberries, and its method for detecting

11 cyclospora on raspberries is also ineffective.

12 (6) FDA lacks statutory authority to maintain

13 physical custody of imported foods until the admissi14 bility of the food has been determined, creating a

15 critical need for pathogen detection tests that will

16 produce real-time results while imported food is still

17 before FDA inspectors at the international border.

18 SEC. 3. ADDITIONAL AUTHORITIES OF FOOD AND DRUG AD19 MINISTRATION REGARDING FOOD SAFETY.

20 (a) REQUIREMENT FOR PRIOR APPROVAL OF SEC21 RETARY FOR COMMERCIAL DISTRIBUTION AND RELATED

22 ACTIVITIES.—Section 801 of the Federal Food, Drug, and

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

24 (1) by striking ‘‘(b) Pending decision’’ and in25 serting ‘‘(b)(1) Pending decision’’, and by redesig-
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1 nating subsection (c) as paragraph (2) of subsection

2 (b); and

3 (2) by inserting after subsection (b) the follow4 ing subsection:

5 ‘‘(c)(1) Food entering the United States shall not,

6 without the prior approval of the Secretary, be—

7 ‘‘(A) transferred from the control of the person

8 who held control when the food entered the United

9 States;

10 ‘‘(B) commercially distributed within the

11 United States; or

12 ‘‘(C) removed from its intact state, with respect

13 to the manner in which the food was packed for

14 transport.

15 ‘‘(2) In determining whether to grant approval under

16 paragraph (1), the Secretary shall consider the following:

17 ‘‘(A) Whether the person or persons preparing,

18 packing, holding, manufacturing, or processing the

19 food involved cooperate with the Secretary in inspec20 tions regarding the food that are conducted by the

21 Secretary (including inspections conducted in foreign

22 countries).

23 ‘‘(B) Whether the person or persons have a his24 tory of failing to comply with applicable provisions

25 of this Act regarding food.
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1 ‘‘(C) Whether the food (as a particular type of

2 product) has such a history.

3 ‘‘(D) Whether there is such a history with re4 spect to a particular foreign country.

5 ‘‘(E) Whether the system of regulating food

6 maintained in the foreign country provides at least

7 the same level of protection as domestic laws that

8 affect the safety of the food supply.

9 ‘‘(F) Whether the foreign country permits the

10 Secretary to conduct within the country inspections

11 regarding food.

12 ‘‘(G) Such other factors as the Secretary deter13 mines to be appropriate.

14 ‘‘(3)(A) If the system of regulating food maintained

15 in a foreign country does not provide at least the same

16 level of protection as domestic laws that affect the safety

17 of the food supply, or if the foreign country does not per18 mit the Secretary to conduct within the country inspec19 tions regarding food, the Secretary shall deny approval

20 under paragraph (1) for all food prepared, packed, held,

21 manufactured, or processed in the foreign country, except

22 as provided in subparagraph (B).

23 ‘‘(B) In the case of a foreign country with respect

24 to which approval under paragraph (1) has been denied

25 under subparagraph (A), a shipment of food prepared,
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1 packed, held, manufactured, or processed in the foreign

2 country may be granted approval under such paragraph

3 if the Secretary receives proof satisfactory to the Secretary

4 that food in the shipment is not adulterated. The Sec5 retary shall require for purposes of the preceding sentence

6 that proof be presented that the shipment has been tested

7 for the presence of microbial pathogens and pesticide

8 chemicals or related residues, and for such other sub9 stances as the Secretary determines to be appropriate.

10 ‘‘(4) The Secretary shall by regulation provide for the

11 marking of any shipment of food that has been denied ap12 proval under paragraph (1) in a manner making it readily

13 apparent that the food has been refused admission into

14 the United States.

15 ‘‘(5) The Secretary shall give high priority to increas16 ing significantly, relative to fiscal year 1999, the number

17 of inspections under this section, including the testing of

18 imported food for pesticide and microbial contamination,

19 that are conducted with respect to food at ports of entry

20 into the United States.

21 ‘‘(6)(A) The Secretary shall submit to the Congress

22 periodic reports describing the activities of the Secretary

23 under this section with respect to the safety of food.

24 ‘‘(B) Each report under subparagraph (A) shall, for

25 each port of entry into the United States, specify the num-
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1 ber of inspections and tests that were conducted under

2 this section with respect to food during the preceding fis3 cal year, and the extent to which such number is an in4 crease over the number of such inspections specified for

5 such port in the preceding report under subparagraph (A).

6 ‘‘(C) Each report under subparagraph (A) shall state

7 the statistical methodologies used by the Secretary in sam8 pling food for purposes of inspections under this section,

9 including the testing of imported food for pesticide and

10 microbial contamination, and the levels of confidence asso11 ciated with the methodologies.

12 ‘‘(D) The first report under subparagraph (A) shall

13 be submitted not later than December 1, 2000, and subse14 quent reports shall be submitted annually thereafter.’’.

15 (b) CRIMINAL PENALTIES.—

16 (1) ACTING WITHOUT APPROVAL OF SEC17 RETARY.—Section 301 of the Federal Food, Drug,

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

19 adding at the end the following:

20 ‘‘(aa)(1) In the case of food, the carrying out of any

21 act in violation of section 801(c)(1).’’.

22 (2) FAILURE TO DISPOSE OF FOODS DENIED

23 ENTRY.—Section 301(aa) of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 331(aa)), as
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1 added by paragraph (1), is amended by adding at

2 the end the following:

3 ‘‘(2) The failure to comply with an order under sec4 tion 801 regarding the disposition of food that for pur5 poses of such section has been refused admission or denied

6 the approval of the Secretary.’’.

7 (3) FAILURE TO PROVIDE COUNTRY-OF-ORIGIN

8 LABELING FOR CERTAIN FOODS.—Section 403 of the

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C.

10 343) is amended by adding at the end the following:

11 ‘‘(t) If it is a food intended for human consumption,

12 it is grown, prepared, packed, manufactured, or processed

13 in a foreign country, and it fails, at the time the food is

14 offered for retail sale, to bear or be accompanied by label15 ing that identifies the country or countries in which the

16 food was grown, prepared, packed, manufactured, or proc17 essed, except that this paragraph does not apply to food

18 offered for retail sale by restaurants or other eating estab19 lishments.’’.

20 (c) CONFORMING AMENDMENT.—Section 801 of the

21 Federal Food, Drug, and Cosmetic Act, as amended by

22 subsection (a), is amended in subsection (b)(2) by striking

23 ‘‘subsection (b)’’ and inserting ‘‘paragraph (1)’’.
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1 SEC. 4. RESEARCH ON TESTING TECHNIQUES FOR USE IN

2 INSPECTIONS OF FOOD SAFETY.

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

4 Act, as amended by section 3(a), is amended in subsection

5 (c) by adding at the end the following paragraph:

6 ‘‘(7)(A) The Secretary shall (directly or through

7 grants or contracts) provide for research on the develop8 ment of tests and sampling methodologies, for use in in9 spections of food under this section—

10 ‘‘(i) whose purpose is to determine whether food

11 is adulterated by reason of being contaminated with

12 microorganisms or pesticide chemicals or related res13 idues; and

14 ‘‘(ii) whose results are available not later than

15 approximately 60 minutes after the administration

16 of the tests.

17 ‘‘(B) In providing for research under subparagraph

18 (A), the Secretary shall give priority to conducting re19 search on the development of tests that are suitable for

20 inspections of food at ports of entry into the United

21 States.

22 ‘‘(C)(i) In providing for research under subparagraph

23 (A), the Secretary shall under subparagraph (B) give pri24 ority to conducting research on the development of tests

25 for detecting the presence in food of the pathogens E. coli,

26 salmonella, cyclospora, cryptosporidium, hepatitis A, or
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1 listeria, the presence in or on food of pesticide chemicals

2 and related residues, and the presence in or on food of

3 such other pathogens or substances as the Secretary deter4 mines to be appropriate. The Secretary shall establish the

5 goal of developing, by the expiration of the three-year pe6 riod beginning on the date of the enactment of the Im7 ported Food Safety Act of 1999, tests under subparagraph

8 (A) for each of the pathogens and substances receiving

9 priority under the preceding sentence.

10 ‘‘(ii) The Secretary shall submit to the Congress peri11 odic reports describing the progress that has been made

12 toward the goal referred to in clause (i) and describing

13 plans for future research toward the goal. Each of the re14 ports shall provide an estimate by the Secretary of the

15 amount of funds needed to meet such goal, and shall pro16 vide a determination by the Secretary of whether there

17 is a need for further research under this paragraph. The

18 first such report shall be submitted not later than March

19 1, 2000, and subsequent reports shall be submitted semi20 annually after the submission of the first report until the

21 goal is met.

22 ‘‘(D) The Secretary shall carry out the program of

23 research under subparagraph (A) in consultation with the

24 Director of the Centers for Disease Control and Preven25 tion, the Director of the National Institutes of Health, and
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1 the Administrator of the Environmental Protection Agen2 cy. The Secretary shall with respect to such research co3 ordinate the activities of the Department of Health and

4 Human Services. The Secretary shall in addition consult

5 with the Secretary of Agriculture (acting through the

6 Food Safety Inspection Service of the Department of Agri7 culture) in carrying out the program.

8 ‘‘(E) Of the amounts reserved under section

9 801A(a)(2)(B)(ii) for a fiscal year for carrying out the

10 program of research under subparagraph (A), the Sec11 retary shall make available not less than 50 percent for

12 making awards of grants or contracts to private entities

13 to conduct such research.’’.

14 SEC. 5. USER FEES REGARDING INSPECTIONS OF FOOD

15 SAFETY.

16 Chapter VIII of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 381 et seq.) is amended by inserting

18 after section 801 the following section:

19 ‘‘USER FEES REGARDING FOOD SAFETY

20 ‘‘SEC. 801A. (a) IN GENERAL.—

21 ‘‘(1) ASSESSMENT.—Beginning in fiscal year

22 2000, the Secretary shall in accordance with this

23 section assess and collect fees on food imported into

24 the United States.

25 ‘‘(2) PURPOSE OF FEES.—
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1 ‘‘(A) IN GENERAL.—The purpose of fees

2 under paragraph (1) is to defray increases in

3 the costs of the resources allocated for carrying

4 out section 801 with respect to food over the

5 costs of carrying out such section with respect

6 to food in fiscal year 1999 multiplied by the ad7 justment factor. Increases referred to in the

8 preceding sentence include increases in such

9 costs for an additional number of full-time

10 equivalent positions in the Department of

11 Health and Human Services to be engaged in

12 carrying out such section.

13 ‘‘(B) ALLOCATIONS BY SECRETARY.—Of

14 the total fee revenues collected under paragraph

15 (1) for a fiscal year, the Secretary shall reserve

16 and expend amounts in accordance with the fol17 lowing:

18 ‘‘(i) The Secretary shall reserve not

19 less than 50 percent for carrying out sec20 tion 801 with respect to food, other than

21 research under subsection (c)(7) of such

22 section. In expending the amount so re23 served, the Secretary shall give priority to

24 inspections conducted at ports of entry

25 into the United States.
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1 ‘‘(ii) The Secretary shall reserve not

2 more than 50 percent for carrying out re3 search under section 801(c)(7).

4 ‘‘(3) AMOUNT OF FEE; COLLECTION.—A fee

5 under paragraph (1) shall be assessed on each line

6 item of food, as defined by the Secretary by regula7 tion. The amount of the fee shall be based on the

8 number of line items, and may not exceed $20 per

9 line item, notwithstanding subsection (b). The liabil10 ity for the fee constitutes a personal debt due to the

11 United States, and such liability accrues on the date

12 on which the Secretary approves the food under sec13 tion 801(c)(1). The Secretary may coordinate with

14 and seek the cooperation of other agencies of the

15 Federal Government regarding the collection of such

16 fees.

17 ‘‘(b) TOTAL FEE REVENUES.—The total fee revenues

18 collected under subsection (a) for a fiscal year shall be

19 the amount appropriated under subsection (f)(3).

20 ‘‘(c) ADJUSTMENTS.—

21 ‘‘(1) INFLATION ADJUSTMENT.—With respect

22 to the amount of total fee revenues referred to in

23 subsection (b), the amount authorized in subsection

24 (f)(3) for a fiscal year shall be adjusted by the Sec-
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1 retary (and as adjusted shall be published in the

2 Federal Register) to reflect the greater of—

3 ‘‘(A) the total percentage change that oc4 curred during the preceding fiscal year in the

5 Consumer Price Index for all urban consumers

6 (all items; U.S. city average); or

7 ‘‘(B) the total percentage change for such

8 fiscal year in basic pay under the General

9 Schedule in accordance with section 5332 of

10 title 5, United States Code, as adjusted by any

11 locality-based comparability payment pursuant

12 to section 5304 of such title for Federal em13 ployees stationed in the District of Columbia.

14 ‘‘(2) ANNUAL FEE ADJUSTMENT.—Not later

15 than 60 days after the end of each fiscal year begin16 ning after fiscal year 2000, the Secretary, subject to

17 not exceeding the maximum fee amount specified in

18 subsection (a)(3), shall adjust the amounts that oth19 erwise would under subsection (a) be assessed as

20 fees during the fiscal year in which the adjustment

21 occurs so that the total revenues collected in such

22 fees for such fiscal year equal the amount applicable

23 pursuant to subsection (b) for the fiscal year.

24 ‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary

25 shall grant a waiver from or a reduction of a fee assessed
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1 under subsection (a) where the Secretary finds that the

2 fee to be paid will exceed the anticipated present and fu3 ture costs incurred by the Secretary in carrying out sec4 tion 801 with respect to food (which finding may be made

5 by the Secretary using standard costs).

6 ‘‘(e) ASSESSMENT OF FEES.—

7 ‘‘(1) LIMITATION.—Fees may not be assessed

8 under subsection (a) for a fiscal year beginning after

9 fiscal year 2000 unless the amount appropriated for

10 salaries and expenses of the Food and Drug Admin11 istration for such fiscal year is equal to or greater

12 than the amount appropriated for salaries and ex13 penses of the Food and Drug Administration for fis14 cal year 2000 multiplied by the adjustment factor

15 applicable to the fiscal year involved, except that in

16 making determinations under this paragraph for the

17 fiscal years involved there shall be excluded—

18 ‘‘(A) the amounts appropriated under sub19 section (f)(3) for the fiscal years involved; and

20 ‘‘(B) the amounts appropriated under sec21 tion 736(g) for such fiscal years.

22 ‘‘(2) AUTHORITY.—If the Secretary does not

23 assess fees under subsection (a) during any portion

24 of a fiscal year because of paragraph (1) and if at

25 a later date in such fiscal year the Secretary may as-
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1 sess such fees, the Secretary may assess and collect

2 such fees, without any modification in the rate of

3 the fees, at any time in such fiscal year notwith4 standing the provisions of subsection (a)(3) relating

5 to the time at which fees are to be paid.

6 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.—

7 ‘‘(1) IN GENERAL.—Fees collected for a fiscal

8 year pursuant to subsection (a) shall be credited to

9 the appropriation account for salaries and expenses

10 of the Food and Drug Administration and shall be

11 available in accordance with appropriation Acts until

12 expended without fiscal year limitation. Such sums

13 as may be necessary may be transferred from the

14 Food and Drug Administration salaries and ex15 penses appropriation account without fiscal year lim16 itation to such appropriation account for salaries

17 and expenses with such fiscal year limitation. The

18 sums transferred shall be available solely for carry19 ing out section 801 with respect to food, and the

20 sums are subject to allocations under subsection

21 (a)(2)(B).

22 ‘‘(2) COLLECTIONS AND APPROPRIATION

23 ACTS.—The fees authorized in subsection (a)—
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1 ‘‘(A) shall be collected in each fiscal year

2 in accordance with subsections (a)(3) and (b);

3 and

4 ‘‘(B) shall only be collected and available

5 for the purpose specified in subsection (a)(2).

6 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS; AL7 LOCATIONS BY SECRETARY.—Subject to paragraph

8 (4) and subsection (c)(1), there is authorized to be

9 appropriated for fees under this section $56,000,000

10 for each of the fiscal years 2000 through 2004.

11 ‘‘(4) OFFSET.—Any amount of fees collected

12 for a fiscal year under subsection (a) that exceeds

13 the amount of fees specified in appropriation Acts

14 for such fiscal year shall be credited to the appro15 priation account of the Food and Drug Administra16 tion as provided in paragraph (1), and shall be sub17 tracted from the amount of fees that would other18 wise be authorized to be collected under this section

19 pursuant to appropriation Acts for a subsequent fis20 cal year.

21 ‘‘(g) COLLECTION OF UNPAID FEES.—In any case

22 where the Secretary does not receive payment of a fee as23 sessed under subsection (a) within 30 days after it is due,

24 such fee shall be treated as a claim of the United States
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1 Government subject to subchapter II of chapter 37 of title

2 31, United States Code.

3 ‘‘(h) CONSTRUCTION.—This section may not be con4 strued as requiring that the number of full-time equivalent

5 positions in the Department of Health and Human Serv6 ices, for officers, employers, and advisory committees not

7 engaged in carrying out section 801 with respect to food

8 be reduced to offset the number of officers, employees, and

9 advisory committees so engaged.

10 ‘‘(i) DEFINITION OF ADJUSTMENT FACTOR.—For

11 purposes of this section, the term ‘adjustment factor’ ap12 plicable to a fiscal year is the lower of—

13 ‘‘(1) the Consumer Price Index for all urban

14 consumers (all items; United States city average) for

15 April of the preceding fiscal year divided by such

16 Index for April 1999; or

17 ‘‘(2) the total of discretionary budget authority

18 provided for programs in categories other than the

19 defense category for the immediately preceding fiscal

20 year (as reported in the Office of Management and

21 Budget sequestration preview report, if available, re22 quired under section 254(c) of the Balanced Budget

23 and Emergency Deficit Control Act of 1985) divided

24 by such budget authority for fiscal year 1999 (as re25 ported in the Office of Management and Budget
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1 final sequestration report submitted after the end of

2 the 105th Congress, 2d Session).

3 The terms ‘budget authority’ and ‘category’ in subpara4 graph (B) are as defined in the Balanced Budget and

5 Emergency Deficit Control Act of 1985.’’.

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