II

106TH CONGRESS

1ST SESSION S. 823

To establish a program to assure the safety of processed produce intended

for human consumption, and for other purposes.

IN THE SENATE OF THE UNITED STATES

APRIL 15, 1999

Mr. HARKIN (for himself and Mr. DURBIN) introduced the following bill;

which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To establish a program to assure the safety of processed

produce intended for human consumption, 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; TABLE OF CONTENTS.

4 (a) SHORT TITLE.—This Act may be cited as the

5 ‘‘Fruit and Vegetable Safety Act’’.

6 (b) TABLE OF CONTENTS.—The table of contents for

7 this Act is as follows:

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

Sec. 3. Definitions.
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TITLE I—FOOD SAFETY ACTIVITIES

Sec. 101. Administration of national program.

Subtitle A—Processed Produce

Sec. 111. Good manufacturing practices.

Sec. 112. Inspections of processors.

Sec. 113. State and Federal cooperation.

Subtitle B—Raw Agricultural Commodities

Sec. 121. Good agricultural practices.

Sec. 122. Inspections of facilities.

TITLE II—RESEARCH AND EDUCATION

Sec. 201. Public health assessment system.

Sec. 202. Public education and advisory system.

Sec. 203. Research.

TITLE III—IMPORTED FOOD

Sec. 301. Criteria for deeming imported food adulterated.

1 SEC. 2. FINDINGS.

2 Congress finds that—

3 (1) persons who process produce for human

4 consumption have the responsibility to prevent or

5 minimize food safety hazards related to their prod6 ucts;

7 (2) consumption of fresh fruits and vegetables

8 can promote health and prevent disease, and should

9 be encouraged;

10 (3) rising consumer demand for processed

11 produce, the growing market for various kinds of do12 mestic and imported processed produce, and the in13 creasing variety of processing techniques for

14 produce, are causing newly recognized or

15 unpredicted safety hazards; and
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1 (4) uniform sanitation practices, applied to

2 processing of produce, will minimize these hazards.

3 SEC. 3. DEFINITIONS.

4 In this Act:

5 (1) CONTAMINANT.—The term ‘‘contaminant’’

6 includes a bacterium, a chemical contaminant, a nat7 ural toxin, a virus, a parasite, a physical hazard, or

8 other substance, that when found on or in produce

9 can cause human illness or injury.

10 (2) PROCESS.—The term ‘‘process’’—

11 (A) means to carry out the commercial

12 preparation or manufacture of produce,

13 including—

14 (i) the freezing, dehydration, salting,

15 sprouting, peeling, coring, stemming, trim16 ming, fermentation, mashing, or shredding

17 of produce;

18 (ii) the cutting of produce after har19 vesting;

20 (iii) the final washing of produce that

21 will be presented for sale so as appear to

22 the average consumer to be ready for con23 sumption without further washing or prep24 aration; and
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1 (iv) the mixing or blending of produce

2 with other produce; and

3 (B) does not include carrying out the har4 vesting, washing (except as provided in sub5 paragraph (A)(iii)), waxing, packing, or sorting,

6 of a raw agricultural commodity.

7 (3) PRODUCE.—The term ‘‘produce’’—

8 (A) means any perishable agricultural com9 modity, as defined in section 1(b) of the Perish10 able Agricultural Commodities Act, 1930 (7

11 U.S.C. 499a(b));

12 (B)(i) includes, except as provided in

13 clause (ii), a mixture of—

14 (I) a commodity described in subpara15 graph (A); and

16 (II) any other food, as defined in sec17 tion 201 of the Federal Food, Drug, and

18 Cosmetic Act (21 U.S.C. 321); and

19 (ii) does not include the other food in the

20 mixture described in clause (i)(II); and

21 (C) does not include an article used for

22 food or drink for animals, or an article used for

23 a component of such an article.

24 (4) RAW AGRICULTURAL COMMODITY.—The

25 term ‘‘raw agricultural commodity’’ means a perish-
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1 able agricultural commodity, as defined in section

2 1(b) of the Perishable Agricultural Commodities Act,

3 1930 (7 U.S.C. 499a(b)) that is a raw agricultural

4 commodity, as defined in section 201 of the Federal

5 Food, Drug, and Cosmetic Act (21 U.S.C. 321).

6 (5) SECRETARY.—The term ‘‘Secretary’’ means

7 the Secretary of Health and Human Services.

8 TITLE I—FOOD SAFETY

9 ACTIVITIES

10 SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.

11 (a) IN GENERAL.—

12 (1) NATIONAL PROGRAM.—The Secretary shall

13 administer a national program for the purpose of

14 protecting human health by ensuring that—

15 (i) the produce processing industry has ef16 fective programs in place to assure the safety of

17 produce processed in the United States; and

18 (ii) producers of raw agricultural commod19 ities have effective programs in place to assure

20 the safety of those commodities produced in the

21 United States.

22 (2) BASIS FOR PROGRAM.—The program shall

23 take into consideration the distinctive characteristics

24 of produce processing and the production of raw ag25 ricultural commodities.
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1 (b) PROGRAM ELEMENTS.—The program shall pro2 vide for implementation of the authorities described in—

3 (1) sections 402A, 402B, 407A, and 407B of

4 the Federal Food, Drug, and Cosmetic Act, as

5 added in subtitles A and B;

6 (2) section 113; and

7 (3) title II.

8 Subtitle A—Processed Produce

9 SEC. 111. GOOD MANUFACTURING PRACTICES.

10 (a) IN GENERAL.—Chapter IV of the Federal Food,

11 Drug, and Cosmetic Act is amended by inserting after sec12 tion 402 (21 U.S.C. 342) the following:

13 ‘‘SEC. 402A. GOOD MANUFACTURING PRACTICES FOR

14 PRODUCE.

15 ‘‘(a) GOOD MANUFACTURING PRACTICE REGULA16 TIONS.—Not later than 1 year after the date of enactment

17 of this section, the Secretary shall by regulation issue

18 standards for good manufacturing practices for the proc19 essing of produce.

20 ‘‘(b) APPLICATION.—

21 ‘‘(1) IN GENERAL.—The regulations issued

22 under subsection (a) shall be the same as the provi23 sions of the good manufacturing practice regulations

24 that apply to the processing of food (notwith25 standing any exclusions in Federal law relating to
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1 establishments engaged solely in the harvesting,

2 storage, or distribution of raw agricultural commod3 ities), except as provided in paragraph (2).

4 ‘‘(2) EXCEPTIONS.—In issuing regulations

5 under subsection (a), the Secretary may modify the

6 provisions described in paragraph (1) if the Sec7 retary determines, for good cause shown and stated

8 together with the regulations, that—

9 ‘‘(A) a modification of such provisions

10 would be more effective to prevent the contami11 nation of, or promote the sanitation of, proc12 essed produce; or

13 ‘‘(B) the application of a portion of such

14 provisions would not result in the prevention of

15 contamination of, or promotion of sanitation of,

16 processed produce.

17 ‘‘(c) EFFECTIVE DATE.—The regulations described

18 in subsection (a) take effect 2 years after the date of en19 actment of this section.

20 ‘‘(d) DEFINITIONS.—In this section:

21 ‘‘(1) CONTAMINANT; PROCESS; PRODUCE.—The

22 terms ‘contaminant’, ‘process’, and ‘produce’ have

23 the meanings given the terms in section 3 of the

24 Fruit and Vegetable Safety Act.
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1 ‘‘(2) GOOD MANUFACTURING PRACTICE REGU2 LATIONS.—The term ‘good manufacturing practice

3 regulations’ means the good manufacturing practice

4 regulations for manufacturing, packing, or holding

5 food, issued under sections 402, 701, and 704 and

6 under section 361 of the Public Health Service Act

7 (42 U.S.C. 264).’’.

8 (b) VIOLATION.—Section 402 of the Federal Food,

9 Drug, and Cosmetic Act (21 U.S.C. 342) is amended by

10 adding at the end the following:

11 ‘‘(h) It is an article of produce processed in violation

12 of section 402A.’’.

13 SEC. 112. INSPECTIONS OF PROCESSORS.

14 (a) IN GENERAL.—Chapter VII of the Federal Food,

15 Drug, and Cosmetic Act is amended by inserting after sec16 tion 704 (21 U.S.C. 374) the following:

17 ‘‘SEC. 704A. INSPECTIONS OF PROCESSORS.

18 ‘‘(a) NATURE OF INSPECTIONS.—

19 ‘‘(1) IN GENERAL.—The Secretary shall provide

20 for unannounced inspections of processing facilities

21 to determine if produce processed in the facilities is

22 in compliance with the requirements of this Act that

23 relate to produce.

24 ‘‘(2) SCHEDULE.—
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1 ‘‘(A) IN GENERAL.—The Secretary shall

2 establish a schedule for the unannounced in3 spections, which shall provide for—

4 ‘‘(i) annual inspections for the facili5 ties, except as provided in clause (ii); and

6 ‘‘(ii) less frequent inspections for fa7 cilities classified as low-risk facilities under

8 subparagraph (B).

9 ‘‘(B) LOW-RISK FACILITIES.—The Sec10 retary may classify processing facilities as low11 risk facilities. In making the classification, the

12 Secretary shall classify facilities by considering

13 the hazards associated with the type of produce

14 being processed at a facility, the facility’s his15 tory of compliance and food safety problems,

16 and such other factors as the Secretary may de17 termine to be appropriate.

18 ‘‘(3) EXAMINATION OF CLASSIFICATIONS.—

19 Each such inspection of a facility shall include an

20 examination of whether the facility is appropriately

21 classified under paragraph (2).

22 ‘‘(b) CONDUCT OF INSPECTIONS.—

23 ‘‘(1) SCOPE.—An inspection under subsection

24 (a) of any facility described in subsection (a) shall

25 extend to all things in the facility (including records
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1 required to be maintained under subsection

2 (d)(1)(A)), processes, controls, and premises) that

3 bear on whether processed produce is in compliance

4 with the requirements of this Act that relate to

5 produce. Access to records may include the copying

6 of the records.

7 ‘‘(2) AUTHORITIES.—In conducting such an in8 spection, an officer or employee duly designated by

9 the Secretary shall have the same authorities and

10 duties as the officer or employee would have under

11 subsection (a)(1), (c), or (d) of section 704 to in12 spect establishments in which food is processed.

13 ‘‘(3) REPORT.—Immediately after completion of

14 the inspection, the officer or employee making the

15 inspection shall give to the owner, operator, or agent

16 in charge a written report setting forth any condi17 tions or practices observed that indicate that any

18 produce from the facility is in violation of the re19 quirements of this Act that relate to produce.

20 ‘‘(c) PRODUCT DETENTION AND CONDEMNATION.—

21 ‘‘(1) IN GENERAL.—If, during an inspection

22 conducted under this section, an officer or employee

23 making the inspection determines that processed

24 produce is in violation of the requirements of this

25 Act that relate to produce, the officer or employee
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1 may order the produce segregated, impounded, and

2 if objection is not made within 48 hours after the

3 issuance of the impoundment order, condemned. If

4 objection is made within that 48 hours, processed

5 produce that is perishable may be processed to the

6 extent necessary to prevent spoilage, and the Sec7 retary shall expeditiously commence a hearing re8 garding the determination and any action required

9 for compliance with the requirements of this Act

10 that relate to produce. The decision of the Secretary

11 following the hearing shall be considered to be a

12 final agency action.

13 ‘‘(2) RELEASE.—If the Secretary determines

14 that, through relabeling or other action, the produce

15 can be brought into compliance with the require16 ments of this Act that relate to produce, the produce

17 may be released following a determination by the

18 Secretary that the relabeling or other action as spec19 ified by the Secretary has been performed.

20 ‘‘(3) DESTRUCTION.—Any processed produce

21 condemned under paragraph (1)—

22 ‘‘(A) in a case in which no objection is

23 made under paragraph (1);

24 ‘‘(B) after the hearing and any judicial re25 view; or
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1 ‘‘(C) after failure of the owner, operator,

2 or agent to perform relabeling or other action

3 described in paragraph (2);

4 shall be destroyed under supervision of the Sec5 retary.

6 ‘‘(d) MAINTENANCE OF RECORDS.—

7 ‘‘(1) IN GENERAL.—The owner, operator, or

8 agent in charge of each processing facility shall

9 maintain such records as the Secretary may pre10 scribe. The records shall be maintained for a reason11 able period of time as determined by the Secretary.

12 The records shall include information concerning—

13 ‘‘(A)(i) the origin, receipt, delivery, sale,

14 movement, holding, and disposition of produce

15 processed at the facility;

16 ‘‘(ii) the processing of the produce; and

17 ‘‘(iii) other matters reasonably related to

18 whether produce processed at the facility may

19 be in violation of the requirements of this Act

20 that relate to produce; and

21 ‘‘(B)(i) the origin, receipt, delivery, sale,

22 movement, holding, and disposition of ingredi23 ents used in the produce processed at the facil24 ity, including sufficient information to permit

25 lot identification to facilitate traceback of
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1 produce found to be adulterated under the re2 quirements of this Act that relate to produce,

3 or to be causing human illness or injury;

4 ‘‘(ii) the identity and amount of ingredi5 ents used in the produce;

6 ‘‘(iii) the results of laboratory, sanitation,

7 or other quality control tests performed on the

8 produce or in the facility; and

9 ‘‘(iv) consumer complaints concerning the

10 produce or the packaging of the produce.

11 ‘‘(2) AVAILABILITY OF RECORDS.—The owner,

12 operator, or agent shall—

13 ‘‘(A) make available, during an inspection

14 conducted under subsection (a), the records de15 scribed in paragraph (1)(A); and

16 ‘‘(B) at the request of the Secretary, if the

17 officer or employee finds as a result of the in18 spection that produce from the facility is associ19 ated with foodborne disease or poses an immi20 nent health hazard, make available for inspec21 tion the records described in paragraph (1)(B).

22 ‘‘(e) DEFINITIONS.—

23 ‘‘(1) FACILITY.—The term ‘facility’ includes

24 any factory, warehouse, or establishment, in which

25 produce is processed.
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1 ‘‘(2) PROCESS; PRODUCE.—The terms ‘process’

2 and ‘produce’ have the meanings given the terms in

3 section 3 of the Fruit and Vegetable Safety Act.’’.

4 (b) REMEDIES.—

5 (1) IN GENERAL.—Paragraphs (f) and (n) of

6 section 301, and section 304(g)(1), of the Federal

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331,

8 334(g)(1)) are amended by striking ‘‘section 704’’

9 and inserting ‘‘section 704 or 704A’’.

10 (2) PROHIBITED DISCLOSURES.—Section 301(j)

11 of the Federal Food, Drug, and Cosmetic Act (21

12 U.S.C. 331(j)) is amended by striking ‘‘704,’’ and

13 inserting ‘‘704, 704A,’’.

14 (c) CONFORMING AMENDMENT.—Section 742(a)(2)

15 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

16 379l(a)(2)) is amended by striking ‘‘section 704’’ and in17 serting ‘‘section 704 or 704A’’.

18 SEC. 113. STATE AND FEDERAL COOPERATION.

19 (a) IN GENERAL.—The Secretary shall work with the

20 States in undertaking activities and programs that con21 tribute to the national program established under section

22 111 so that State food safety programs involving the safe23 ty of processed produce and the national program function

24 in a coordinated and cost-effective manner. With the as-
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1 sistance provided under subsection (b), the Secretary shall

2 encourage States to—

3 (1) establish, continue, or strengthen State food

4 safety programs, especially with respect to the regu5 lation of retail commercial food establishments; and

6 (2) establish procedures and requirements for

7 ensuring that processed produce under the jurisdic8 tion of the State food safety programs is not unsafe

9 for human consumption.

10 (b) ASSISTANCE.—The Secretary may provide to a

11 State, for planning, developing, and implementing such a

12 food safety program—

13 (1) advisory assistance;

14 (2) technical assistance, training, and labora15 tory assistance (including necessary materials and

16 equipment); and

17 (3) financial and other assistance.

18 (c) SERVICE AGREEMENTS.—The Secretary may,

19 under an agreement entered into with a Federal, State,

20 or local agency, use, on a reimbursable basis or otherwise,

21 the personnel, services, and facilities of the agency to carry

22 out the responsibilities of the agency under this Act. The

23 agreement shall provide that any compliance records, no24 tices, or reports that are recorded or issued in connection

25 with activities under the agreement, and are in the posses-
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1 sion of the agency that entered into the agreement shall

2 be made available in accordance with section 552 of title

3 5, United States Code. An agreement entered into with

4 a State agency under this subsection may provide for

5 training of State employees.

6 Subtitle B—Raw Agricultural

7 Commodities

8 SEC. 121. GOOD AGRICULTURAL PRACTICES.

9 (a) IN GENERAL.—Chapter IV of the Federal Food,

10 Drug, and Cosmetic Act, as amended by section 111(a),

11 is further amended by inserting after section 402A the fol12 lowing:

13 ‘‘SEC. 402B. GOOD AGRICULTURAL PRACTICES FOR RAW

14 AGRICULTURAL COMMODITIES.

15 ‘‘(a) GOOD AGRICULTURAL PRACTICE REGULA16 TIONS.—Not later than 2 years after the date of enact17 ment of this section, the Secretary, in consultation with

18 the Secretary of Agriculture, shall by regulation issue

19 standards for good agricultural practices for the produc20 tion of raw agricultural commodities, in order to minimize

21 the adulteration and maximize the safety of those com22 modities.

23 ‘‘(b) IMPLEMENTATION PLAN.—Not later than 3

24 years after the date of enactment of this section, the Sec25 retary, in consultation with the Secretary of Agriculture,
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1 shall issue and carry out an implementation plan for the

2 implementation of the standards.

3 ‘‘(c) EFFECTIVE DATE.—The regulations described

4 in subsection (a) take effect 3 years after the date of en5 actment of this section.

6 ‘‘(d) DEFINITION.—The term ‘raw agricultural com7 modity’ means a perishable agricultural commodity, as de8 fined in section 1(b) of the Perishable Agricultural Com9 modities Act, 1930 (7 U.S.C. 499a(b)) that is a raw agri10 cultural commodity, as defined in section 201.’’.

11 (b) VIOLATION.—Section 402(h) of the Federal

12 Food, Drug, and Cosmetic Act, as added by section

13 111(b), is amended by inserting before the period the fol14 lowing: ‘‘or a raw agricultural commodity produced in vio15 lation of section 402B’’.

16 SEC. 122. INSPECTIONS OF FACILITIES.

17 (a) IN GENERAL.—Chapter VII of the Federal Food,

18 Drug, and Cosmetic Act, as amended by section 112(a),

19 is further amended by inserting after section 704A the fol20 lowing:

21 ‘‘SEC. 704B. INSPECTIONS OF FACILITIES.

22 ‘‘(a) NATURE OF INSPECTIONS.—Officers and em23 ployees duly designated by the Secretary shall have the

24 authority to inspect appropriate facilities to determine

25 compliance with the standards described in section 402B.
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1 ‘‘(b) REGULATIONS.—Not later than 2 years after

2 the date of enactment of this section, the Secretary, in

3 consultation with the Secretary of Agriculture, shall by

4 regulation issue procedures for conducting the inspections.

5 ‘‘(c) EFFECTIVE DATE.—Subsection (a) and the reg6 ulations described in subsection (b) take effect 3 years

7 after the date of enactment of this section.’’.

8 (b) REMEDIES.—

9 (1) IN GENERAL.—Paragraphs (f) and (n) of

10 section 301, and section 304(g)(1), of the Federal

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)),

12 as amended in section 112(b), are further amended

13 by striking ‘‘or 704A’’ and inserting ‘‘, 704A, or

14 704B’’.

15 (2) PROHIBITED DISCLOSURES.—Section 301(j)

16 of the Federal Food, Drug, and Cosmetic Act (21

17 U.S.C. 333(j)), as amended in section 112(b), is fur18 ther amended by inserting ‘‘704B,’’ after ‘‘704A,’’.

19 (c) CONFORMING AMENDMENT.—Section 742(a)(2)

20 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

21 379l(a)(2)), as amended in section 112(c), is further

22 amended by striking ‘‘or 704A’’ and inserting ‘‘, 704A,

23 or 704B’’.
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1 TITLE II—RESEARCH AND

2 EDUCATION

3 SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM.

4 (a) COOPERATION WITH THE CENTERS FOR DISEASE

5 CONTROL AND PREVENTION.—The Commissioner of Food

6 and Drugs, in cooperation with the Secretary of Agri7 culture, the Director of the Centers for Disease Control

8 and Prevention, and the Administrator of the Environ9 mental Protection Agency, shall establish and maintain an

10 active surveillance system, for surveillance of a representa11 tive proportion of the population of the United States, to

12 assess more accurately the frequency and sources of

13 human illness in the United States associated with the

14 consumption of produce.

15 (b) PUBLIC HEALTH SAMPLING.—

16 (1) GUIDELINES.—Not later than 12 months

17 after the date of enactment of this Act, the Commis18 sioner of Food and Drugs, in cooperation with the

19 Secretary of Agriculture, the Director of the Centers

20 for Disease Control and Prevention, and the Admin21 istrator of the Environmental Protection Agency,

22 shall establish guidelines for a sampling system

23 under which the Commissioner and the Secretary of

24 Agriculture shall collect and analyze samples of

25 produce to assist the Commissioner in carrying out
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1 this Act and the requirements of the Federal Food,

2 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)

3 that relate to produce, and to assess more accurately

4 the nature, frequency of occurrence, and amounts of

5 contaminants in the produce.

6 (2) MONITORING AND OTHER INFORMATION.—

7 In carrying out the sampling system, the Commis8 sioner of Food and Drugs and the Secretary of Agri9 culture shall provide for—

10 (A) statistically valid monitoring, including

11 the conduct of market-basket studies, on the

12 nature, frequency of occurrence, and amounts

13 of contaminants in produce available to con14 sumers; and

15 (B) at the request of the Commissioner,

16 the collection and analysis of such other infor17 mation, including analysis of information from

18 monitoring and verification samples, as the

19 Commissioner determines may be useful in as20 sessing the occurrence of contaminants in

21 produce.

22 (3) PROCESS VERIFICATION STANDARD.—The

23 Commissioner of Food and Drugs and the Secretary

24 of Agriculture shall conduct sampling to identify—
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1 (A) a contaminant, or other substance,

2 that is commonly found on processed produce

3 and, when present at low levels, accurately indi4 cates that the produce has been appropriately

5 processed, with adequate sanitation; and

6 (B) a standard for the level of that sub7 stance that indicates that the produce has been

8 processed as described in subparagraph (A).

9 SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM.

10 (a) PUBLIC EDUCATION.—The Commissioner of

11 Food and Drugs, in cooperation with private and public

12 organizations, including the State cooperative extension

13 services and appropriate State entities, shall design and

14 implement a national public education program on food

15 safety relating to produce. In carrying out the program,

16 the Commissioner shall—

17 (1) provide information to the public regarding

18 Federal standards and good manufacturing practice

19 requirements relating to food safety and promote

20 public awareness, understanding, and acceptance of

21 the standards and requirements; and

22 (2) provide such other information or advice to

23 the produce processing industry, the food service and

24 retail industry, consumers, and other persons as the
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1 Commissioner determines will promote the purposes

2 of this Act.

3 (b) HEALTH ADVISORIES.—The Commissioner of

4 Food and Drugs, in cooperation with the Secretary of Ag5 riculture, the Director of the Centers for Disease Control

6 and Prevention, the Administrator of the Environmental

7 Protection Agency, States, and other appropriate entities,

8 shall—

9 (1) develop and distribute regional and national

10 advisories concerning food safety relating to

11 produce;

12 (2) develop standardized formats for written

13 and broadcast advisories concerning food safety re14 lating to produce; and

15 (3) incorporate State and local advisories, at

16 the election of the States and local entities, con17 cerning food safety relating to produce into the na18 tional public education program required under sub19 section (a).

20 SEC. 203. RESEARCH.

21 (a) IN GENERAL.—The Commissioner of Food and

22 Drugs shall conduct research to assist in the implementa23 tion of this Act and the requirements of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) that re25 late to produce, including studies relating to—
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1 (1) improving sanitation and food safety prac2 tices in the processing of produce;

3 (2) developing improved techniques for the

4 monitoring of produce and inspection of produce;

5 (3) developing efficient, rapid, and sensitive

6 methods for determining and detecting the presence

7 of contaminants in produce;

8 (4) determining the sources of contamination of

9 produce, including contamination from growing, har10 vesting, and processing produce and post-processing

11 contamination of produce; and

12 (5) developing consumption data with respect to

13 produce (including processed produce).

14 (b) CONTRACT AUTHORITY.—The Commissioner of

15 Food and Drugs is authorized to enter into contracts and

16 agreements with States, institutions of higher education,

17 other government agencies, and other persons to carry out

18 the activities described in this section.

19 TITLE III—IMPORTED FOOD

20 SEC. 301. CRITERIA FOR DEEMING IMPORTED FOOD ADUL21 TERATED.

22 (a) AMENDMENT TO THE FEDERAL FOOD, DRUG,

23 AND COSMETIC ACT.—Section 402 of the Federal Food,

24 Drug, and Cosmetic Act (21 U.S.C. 342), as amended by
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1 sections 111(b) and 121(b), is further amended by adding

2 at the end the following:

3 ‘‘(i) If it is food consisting of processed produce or

4 a raw agricultural commodity (as defined in section 402A

5 or 402B) that is offered for import into the United States

6 and that has not been prepared, packed, and held under

7 a system or conditions, or subject to measures, that meet

8 the requirements of this Act (including sections 402A and

9 402B), or that otherwise achieve the level of protection

10 required, as determined by the Secretary, for such food

11 prepared, packed, or held in the United States. In deter12 mining whether a system, conditions, or measures meet

13 the requirements of this Act or otherwise achieve the level

14 of protection required, the Secretary may consider whether

15 an officer or employee duly designated by the Secretary

16 has requested, and has been refused, access to the estab17 lishment or location where such food was prepared,

18 packed, or held for the purpose of inspection (including

19 sample collection), including inspection under subsection

20 (a)(1), (b), or (d) of section 704A or section 704B, test21 ing, or other relevant procedures, at a reasonable time and

22 in a reasonable manner, and may deny the importation

23 of such food from such establishment or location on the

24 basis of such refusal and other relevant factors.’’.
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1 (b) IMPLEMENTATION OF AUTHORITY; PLAN.—The

2 Secretary of Health and Human Services shall develop a

3 plan for the initial implementation of the authority under

4 section 402(i) of the Federal Food, Drug, and Cosmetic

5 Act, as added by subsection (a), and shall carry out the

6 authority of such section consistent with such plan.

Æ