I 

110TH CONGRESS 

2D SESSION H. R. 5620 

To establish a program to assure the safety of fresh produce intended for 

human consumption, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 13, 2008 

Mr. BRALEY of Iowa (for himself, Mr. COHEN, Mr. FILNER, and Mr. PAYNE) 

introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, 

for a period to be subsequently determined by the Speaker, in each case 

for consideration of such provisions as fall within the jurisdiction of the 

committee concerned 

A BILL 

To establish a program to assure the safety of fresh 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 ‘‘Fresh Produce 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. 


hsrobinson on PROD1PC76 with BILLS
2 

•HR 5620 IH

TITLE I—FOOD SAFETY ACTIVITIES 

Sec. 101. Administration of national program. 

Subtitle A—Minimally Processed Produce 

Sec. 111. Good manufacturing practices. 

Sec. 112. Inspections of processors. 

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 system. 

Sec. 203. Research. 

TITLE III—IMPORTED PRODUCE AND OTHER PROVISIONS 

Sec. 301. Imported produce. 

Sec. 302. Authorization of appropriations. 

1 SEC. 2. FINDINGS. 

2 Congress finds that— 

3 (1) consumption of fresh fruits and vegetables 

4 can promote health and prevent disease, and should 

5 be encouraged; 

6 (2) an estimated 76,000,000 cases of foodborne 

7 disease occur each year in the United States, caus8 ing about 325,000 hospitalizations and 5,000 deaths 

9 annually, according to the Centers for Disease Con10 trol and Prevention (referred to in this section as 

11 the ‘‘CDC’’); 

12 (3) data reported to the CDC indicate that out13 breaks of foodborne illness in the United States as14 sociated with fruits and vegetables have increased in 


hsrobinson on PROD1PC76 with BILLS
3 

•HR 5620 IH

1 absolute numbers and as a proportion of all reported 

2 foodborne outbreaks; 

3 (4) illnesses caused by E. coli O157: H7, Sal4 monella spp., and norovirus have been traced to a 

5 wide variety of produce, including lettuce, salads, 

6 melons, sprouts, tomatoes, and many fruit- and veg7 etable-containing dishes; 

8 (5) outbreaks of food-borne illness associated 

9 with produce in the United States have been docu10 mented from both imported produce and domesti11 cally grown produce; 

12 (6) large scale processing of produce can easily 

13 spread pathogens into minimally processed food and 

14 a single outbreak can affect hundreds of people; 

15 (7) persons who process produce for human 

16 consumption have the responsibility to prevent or 

17 minimize food safety hazards related to their prod18 ucts; 

19 (8) rising consumer demand for minimally proc20 essed produce, the growing market for various kinds 

21 of domestic and imported minimally processed 

22 produce, and the increasing variety of processing 

23 techniques for produce, are causing newly recognized 

24 or unpredicted safety hazards; and 


hsrobinson on PROD1PC76 with BILLS
4 

•HR 5620 IH

1 (9) risk-based sanitation practices, and com2 modity-specific good agricultural and manufacturing 

3 practices, tailored to the hazards and the level of 

4 risk that a specific food product presents, should be 

5 applied to the processing of produce to minimize 

6 these hazards. 

7 SEC. 3. DEFINITIONS. 

8 In this Act: 

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

10 includes a bacterium, chemical, natural or manufac11 tured toxin, virus, parasite, physical hazard, or other 

12 human pathogen that, when in food, can cause 

13 human illness, injury, or death. 

14 (2) MINIMALLY PROCESS.— 

15 (A) IN GENERAL.—The term ‘‘minimally 

16 process’’ means— 

17 (i) to carry out the commercial prepa18 ration or manufacture of produce, includ19 ing— 

20 (I) the peeling, coring, stemming, 

21 trimming, mashing, or shredding of 

22 produce; 

23 (II) the cutting of produce after 

24 harvesting; 


hsrobinson on PROD1PC76 with BILLS
5 

•HR 5620 IH

1 (III) the preparation of fresh 

2 produce so to as to appear ready for 

3 consumption without further washing 

4 or preparation; and 

5 (IV) the mixing or blending of 

6 minimally processed produce with 

7 other produce; and 

8 (ii) does not include carrying out the 

9 harvesting, washing (except as provided in 

10 clause (i)(III)), waxing, packing, or sort11 ing, of a raw agricultural commodity. 

12 (B) EXCEPTION.—The term ‘‘minimally 

13 process’’ shall not apply to a raw agricultural 

14 commodity that is stemmed but not subject to 

15 further commercial preparation. 

16 (3) PROCESSOR OF PRODUCE.—The term 

17 ‘‘processor of produce’’ means a person that mini18 mally processes produce. 

19 (4) PRODUCE.— 

20 (A) IN GENERAL.—The term ‘‘produce’’ 

21 means any perishable agricultural commodity, 

22 as defined in section 1(b) of the Perishable Ag23 ricultural Commodities Act, 1930 (7 U.S.C. 

24 499a(b)). 


hsrobinson on PROD1PC76 with BILLS
6 

•HR 5620 IH

1 (B) INCLUSIONS.—The term ‘‘produce’’ in2 cludes a mixture of— 

3 (i) a commodity described in subpara4 graph (A); and 

5 (ii) any other food, as defined in sec6 tion 201 of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 321). 

8 (C) EXCLUSIONS.—The term ‘‘produce’’ 

9 does not include— 

10 (i) other food in the mixture described 

11 in subparagraph (B)(ii); and 

12 (ii) an article used for food or drink 

13 for animals, or an article used for a com14 ponent of such an article. 

15 (5) RAW AGRICULTURAL COMMODITY.—The 

16 term ‘‘raw agricultural commodity’’ means a perish17 able agricultural commodity, as defined in section 

18 1(b) of the Perishable Agricultural Commodities Act, 

19 1930 (7 U.S.C. 499a(b)) that is a raw agricultural 

20 commodity, as defined in section 201 of the Federal 

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

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

23 the Secretary of Health and Human Services. 


hsrobinson on PROD1PC76 with BILLS
7 

•HR 5620 IH

1 TITLE I—FOOD SAFETY 

2 ACTIVITIES 

3 SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM. 

4 (a) IN GENERAL.— 

5 (1) NATIONAL PROGRAM.—The Secretary shall 

6 administer a national program for the purpose of 

7 protecting human health by ensuring that— 

8 (A) there are effective programs in place to 

9 assure the safety of produce minimally proc10 essed in the United States; and 

11 (B) producers of raw agricultural commod12 ities have effective programs in place to assure 

13 the safety of those commodities produced in the 

14 United States. 

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

16 take into consideration the distinctive characteristics 

17 of minimal processing of produce and the differing 

18 practices and levels of risk associated with the pro19 duction of different raw agricultural commodities. 

20 (b) PROGRAM ELEMENTS.—The program shall pro21 vide for implementation of the authorities described in— 

22 (1) sections 402A, 402B, 704A, and 704B of 

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

24 added by subtitles A and B; and 

25 (2) title II. 


hsrobinson on PROD1PC76 with BILLS
8 

•HR 5620 IH

1 Subtitle A—Minimally Processed 

2 Produce 

3 SEC. 111. GOOD MANUFACTURING PRACTICES. 

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

5 Drug, and Cosmetic Act is amended by inserting after sec6 tion 402 (21 U.S.C. 342) the following: 

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

8 PRODUCE. 

9 ‘‘(a) GOOD MANUFACTURING PRACTICE REGULA10 TIONS.— 

11 ‘‘(1) IN GENERAL.—Not later than 1 year after 

12 the date of enactment of this section, the Secretary 

13 shall by regulation establish standards for good 

14 manufacturing practices for the minimal processing 

15 of produce. 

16 ‘‘(2) CONTENT.—The regulations issued under 

17 paragraph (1) shall include the following require18 ments: 

19 ‘‘(A) SANITATION.—Processors of produce 

20 shall— 

21 ‘‘(i) establish mandatory sanitation 

22 standard operating procedures, including 

23 cleaning procedures for equipment, storage 

24 areas, air systems, and water storage 

25 areas; 


hsrobinson on PROD1PC76 with BILLS
9 

•HR 5620 IH

1 ‘‘(ii) design processing facilities to fa2 cilitate maintenance and good sanitation 

3 practices so that contamination may be 

4 controlled throughout receiving, cooling, 

5 processing, packing, and storage oper6 ations; and 

7 ‘‘(iii) ensure— 

8 ‘‘(I) controlled access to the facil9 ity and to processing areas; 

10 ‘‘(II) adequate space for oper11 ations; 

12 ‘‘(III) adequate drainage of proc13 essing and wash water; 

14 ‘‘(IV) food contact surfaces that 

15 are easy to clean and maintain; 

16 ‘‘(V) that areas and structures 

17 designed to protect the product and 

18 equipment from contamination; and 

19 ‘‘(VI) that sanitation standards 

20 established in clause (i) are adhered 

21 to in the transportation of minimally 

22 processed produce to the extent prac23 ticable. 

24 ‘‘(B) WATER.— 


hsrobinson on PROD1PC76 with BILLS
10 

•HR 5620 IH

1 ‘‘(i) IN GENERAL.—Processors of 

2 produce shall ensure that— 

3 ‘‘(I) the water supply used in 

4 food processing plants is suitable for 

5 its intended use; 

6 ‘‘(II) facilities have an environ7 mental monitoring program that in8 cludes sampling for pathogens to de9 tect areas of harborage and to verify 

10 the effectiveness of cleaning and sani11 tizing programs in preventing cross12 contamination; and 

13 ‘‘(III) each sanitizer used for 

14 washing vegetables is appropriate for 

15 its intended use. 

16 ‘‘(ii) SAMPLING PROGRAMS FOR

17 WATER.—If the Secretary determines that 

18 effective sampling programs can be devel19 oped, processors of produce shall ensure 

20 that the water used for washing produce is 

21 monitored for the presence of pathogens at 

22 a rate adequate to ensure highly contami23 nated batches are identified and elimi24 nated. 


hsrobinson on PROD1PC76 with BILLS
11 

•HR 5620 IH

1 ‘‘(C) ADDITIONAL REQUIREMENTS.—Other 

2 requirements as determined appropriate by the 

3 Secretary. 

4 ‘‘(3) RISK ASSESSMENT.—The standards estab5 lished under paragraph (1) shall be based on risk as6 sessment tools and metrics developed by the Food 

7 and Drug Administration in consultation with the 

8 Department of Agriculture and processors of 

9 produce. The risk assessments shall include— 

10 ‘‘(A) identification of existing and potential 

11 hazards at facilities; 

12 ‘‘(B) evaluation of human health risks 

13 posed by hazards identified in subparagraph 

14 (A); and 

15 ‘‘(C) proposed controls to minimize haz16 ards based on subparagraph (B). 

17 ‘‘(4) RISK CLASSIFICATION.—The Secretary 

18 shall classify facilities as high-, medium-, or low-risk 

19 according to the risk assessments in paragraph (3), 

20 and by considering the hazards associated with the 

21 type of produce being minimally processed at a facil22 ity, the facility’s history of compliance and food safe23 ty problems, and such other factors as the Secretary 

24 may determine to be appropriate. Such risk classiVerDate Aug 31 2005 21:57 Mar 14, 2008 Jkt 069200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5620.IH H5620

hsrobinson on PROD1PC76 with BILLS
12 

•HR 5620 IH

1 fication shall determine the specific standards and 

2 controls required at each facility. 

3 ‘‘(5) SCIENCE-BASED STANDARDS.—The stand4 ards established under paragraph (1) shall— 

5 ‘‘(A) reflect the best available science; and 

6 ‘‘(B) be subject to change through regula7 tions promulgated by the Secretary as new sci8 entific evidence on risk becomes available. 

9 ‘‘(b) IMPLEMENTATION PLAN FOR PROCESSORS.— 

10 ‘‘(1) IN GENERAL.—Not later than 2 years 

11 after the date of enactment of this section, the Sec12 retary shall require every processor of produce to 

13 have a written plan detailing the controls utilized the 

14 processor of produce. 

15 ‘‘(2) CONTENT.—A plan under paragraph (1) 

16 shall— 

17 ‘‘(A) address good manufacturing stand18 ards set forth by the Secretary; 

19 ‘‘(B) require recordkeeping to monitor 

20 compliance; 

21 ‘‘(C) require the sampling of products and 

22 process to be tested, at a frequency and in a 

23 manner commensurate with the risk presented 

24 by the facility and produce processed, as deter25 mined in subsection (a)(3), if the Secretary 


hsrobinson on PROD1PC76 with BILLS
13 

•HR 5620 IH

1 deems this appropriate, and sufficient to ensure 

2 that the standards or process controls are effec3 tive on an on-going basis and that regulatory 

4 standards are met; and 

5 ‘‘(D) provide access to the Food and Drug 

6 Administration to records maintained by the fa7 cility pursuant to section 414. 

8 ‘‘(3) SPECIFIC CONTROLS.—In addition to com9 plying with standards established under section 

10 402A(a)(1), the Secretary may require processors to 

11 adopt specific process controls identified in section 

12 402A(a)(3), if the process controls are needed to en13 sure the protection of the public health. 

14 ‘‘(4) TIERED IMPLEMENTATION.—The Sec15 retary shall require such a plan for high-risk facili16 ties first, and then for medium-risk facilities, and 

17 then for low-risk facilities, as classified under sub18 section (a)(4). 

19 ‘‘(c) EXCEPTIONS.—In issuing regulations under sub20 section (a), the Secretary may modify the good manufac21 turing process regulations if the Secretary determines, for 

22 good cause shown and stated together with the regula23 tions, that for a specific product— 

24 ‘‘(1) a modification of such provisions would be 

25 more effective to prevent the contamination of, or 


hsrobinson on PROD1PC76 with BILLS
14 

•HR 5620 IH

1 promote the sanitation of, minimally processed 

2 produce; or 

3 ‘‘(2) the application of a portion of such provi4 sions would not result in the prevention of contami5 nation of, or promotion of sanitation of, minimally 

6 processed produce. 

7 ‘‘(d) EFFECTIVE DATE.—The regulations promul8 gated under subsection (a) shall take effect 2 years after 

9 the date of enactment of this section. 

10 ‘‘(e) DEFINITIONS.—In this section: 

11 ‘‘(1) CONTAMINANT; MINIMALLY PROCESS; 

12 PRODUCE.—The terms ‘contaminant’, ‘minimally 

13 process’, and ‘produce’ have the meanings given 

14 those terms in section 3 of the Fresh Produce Safety 

15 Act. 

16 ‘‘(2) FACILITY.—The term ‘facility’ includes 

17 any factory, warehouse, or establishment, in which 

18 produce is minimally processed. 

19 ‘‘(3) GOOD MANUFACTURING PRACTICE REGU20 LATIONS.—The term ‘good manufacturing practice 

21 regulations’ means the good manufacturing practice 

22 regulations for manufacturing, packing, or holding 

23 food, issued under sections 402, 701, and 704 of 

24 this Act and under section 361 of the Public Health 

25 Service Act (42 U.S.C. 264).’’. 


hsrobinson on PROD1PC76 with BILLS
15 

•HR 5620 IH

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

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

3 adding at the end the following: 

4 ‘‘(j) It is an article of produce processed in violation 

5 of section 402A.’’. 

6 SEC. 112. INSPECTIONS OF PROCESSORS. 

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

8 Drug, and Cosmetic Act is amended by inserting after sec9 tion 704 (21 U.S.C. 374) the following: 

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

11 ‘‘(a) NATURE OF INSPECTIONS.— 

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

13 for unannounced inspections of processing facilities 

14 to determine if produce processed in the facilities is 

15 in compliance with the requirements of this Act that 

16 relate to produce. 

17 ‘‘(2) SCHEDULE.—The Secretary shall establish 

18 a schedule for the unannounced inspections, which 

19 shall provide for— 

20 ‘‘(A) inspections at least once per growing 

21 season for facilities classified as high-risk under 

22 section 402A(a)(4); and 

23 ‘‘(B) less frequent inspections, as deter24 mined by the Secretary, for facilities classified 


hsrobinson on PROD1PC76 with BILLS
16 

•HR 5620 IH

1 as medium- or low-risk facilities under section 

2 402A(a)(4). 

3 ‘‘(3) EXAMINATION OF CLASSIFICATIONS.— 

4 Each such inspection of a facility shall include an 

5 examination of whether the facility is appropriately 

6 classified under section 402A(a)(4). 

7 ‘‘(b) CONDUCT OF INSPECTIONS.— 

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

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

10 extend to all things in the facility, any required 

11 records, processes, controls, and premises that bear 

12 on whether minimally processed produce is in com13 pliance with the requirements of this Act that relate 

14 to produce. Access to records may include the copy15 ing of the records. 

16 ‘‘(2) AUTHORITIES.—In conducting such an in17 spection, an officer or employee duly designated by 

18 the Secretary shall have the same authorities and 

19 duties as the officer or employee would have under 

20 subsection (a)(1), (c), or (d) of section 704 to in21 spect facilities in which food is minimally processed. 

22 ‘‘(3) REPORT.—Not later than 48 hours after 

23 completion of the inspection, the officer or employee 

24 making the inspection shall give to the owner, oper25 ator, or agent in charge a written report setting 


hsrobinson on PROD1PC76 with BILLS
17 

•HR 5620 IH

1 forth any conditions or practices observed that indi2 cate that any produce from the facility is in violation 

3 of the requirements of this Act that relate to 

4 produce. 

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

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

7 conducted under this section, an officer or employee 

8 making the inspection determines that minimally 

9 processed produce is in violation of the requirements 

10 of this Act that relate to produce, the officer or em11 ployee may order the produce segregated, im12 pounded, and if objection is not made no later than 

13 48 hours after the issuance of the impoundment 

14 order, condemned. If objection is made during such 

15 48-hour period, minimally processed produce that is 

16 perishable may be processed to the extent necessary 

17 to prevent spoilage, and the Secretary shall expedi18 tiously commence a hearing within 24 hours after 

19 the objection regarding the determination and any 

20 action required for compliance with the requirements 

21 of this Act that relate to produce. The decision of 

22 the Secretary following the hearing shall be consid23 ered to be a final agency action. 

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

25 that, through relabeling or other action, the produce 


hsrobinson on PROD1PC76 with BILLS
18 

•HR 5620 IH

1 can be brought into compliance with the require2 ments of this Act that relate to produce, the produce 

3 may be released following a determination by the 

4 Secretary that the relabeling or other action as spec5 ified by the Secretary has been performed. 

6 ‘‘(3) DESTRUCTION.—Any minimally processed 

7 produce condemned under paragraph (1)— 

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

9 made under paragraph (1); 

10 ‘‘(B) after the hearing and any judicial re11 view; or 

12 ‘‘(C) after failure of the owner, operator, 

13 or agent to perform relabeling or other action 

14 described in paragraph (2), 

15 shall be destroyed under supervision of the Sec16 retary. 

17 ‘‘(d) MAINTENANCE OF RECORDS.— 

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

19 agent in charge of each facility shall maintain such 

20 records as the Secretary may prescribe. The records 

21 shall be maintained for a reasonable period of time 

22 as determined by the Secretary. The records shall 

23 include information concerning— 


hsrobinson on PROD1PC76 with BILLS
19 

•HR 5620 IH

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

2 movement, holding, and disposition of produce 

3 minimally processed at the facility; 

4 ‘‘(ii) the minimal processing of the 

5 produce; and 

6 ‘‘(iii) other matters reasonably related to 

7 whether produce minimally processed at the fa8 cility may be in violation of the requirements of 

9 this Act that relate to produce; and 

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

11 movement, holding, and disposition of ingredi12 ents used in the produce minimally processed at 

13 the facility, including sufficient information to 

14 permit lot identification to facilitate traceback 

15 of produce found to be in violation of the re16 quirements of this Act that relate to produce, 

17 or to be causing human illness or injury; 

18 ‘‘(ii) the identity and amount of ingredi19 ents used in the produce; 

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

21 or other quality control tests performed on the 

22 produce or in the facility; and 

23 ‘‘(iv) consumer complaints concerning the 

24 safety of the produce or the packaging of the 

25 produce. 


hsrobinson on PROD1PC76 with BILLS
20 

•HR 5620 IH

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

2 operator, or agent shall— 

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

4 conducted under subsection (a), the records de5 scribed in paragraph (1)(A); and 

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

7 officer or employee finds as a result of the in8 spection that produce from the facility is associ9 ated with foodborne disease or poses an immi10 nent health hazard, make available for inspec11 tion the records described in paragraph (1)(B). 

12 ‘‘(3) REQUIRED DISCLOSURE.—The owner, op13 erator, or agent in charge of a facility shall have an 

14 affirmative obligation to take corrective action, in15 cluding ensuring the product is not introduced into 

16 commerce, as approved by the Commissioner of 

17 Food and Drugs or the Secretary, if the results of 

18 testing or sampling of produce, equipment, or mate19 rial in contact with produce are positive for any con20 taminant, in accordance with section 414. The 

21 owner, operator, or agent in charge of a facility shall 

22 have an affirmative obligation to disclose to the 

23 Commissioner of Food and Drugs or the Secretary 

24 if the results of testing finds a positive test result 

25 and the product is in commerce. 


hsrobinson on PROD1PC76 with BILLS
21 

•HR 5620 IH

1 ‘‘(e) DEFINITIONS.— 

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

3 any factory, warehouse, or establishment, in which 

4 produce is minimally processed. 

5 ‘‘(2) MINIMALLY PROCESS; PRODUCE.—The 

6 terms ‘minimally process’ and ‘produce’ have the 

7 meanings given those terms in section 3 of the 

8 Fresh Produce Safety Act.’’. 

9 (b) REMEDIES.— 

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

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

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

13 334(g)(1)) are amended by striking ‘‘section 704’’ 

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

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

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

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

18 inserting ‘‘704, 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)) is amended by striking ‘‘section 704’’ and in22 serting ‘‘section 704 or 704A’’. 


hsrobinson on PROD1PC76 with BILLS
22 

•HR 5620 IH

1 Subtitle B—Raw Agricultural 

2 Commodities 

3 SEC. 121. GOOD AGRICULTURAL PRACTICES. 

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

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

6 is further amended by inserting after section 402A the fol7 lowing: 

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

9 AGRICULTURAL COMMODITIES. 

10 ‘‘(a) GOOD AGRICULTURAL PRACTICE REGULA11 TIONS.— 

12 ‘‘(1) IN GENERAL.—Not later than 1 year after 

13 the date of enactment of this section, the Secretary, 

14 in consultation with the Secretary of Agriculture, 

15 shall by regulation establish general standards for 

16 good agricultural practices for the production of raw 

17 agricultural commodities, in order to minimize the 

18 violations of this Act and maximize the safety of 

19 those commodities. 

20 ‘‘(2) CONTENTS.—The regulations issued under 

21 paragraph (1) shall include the following require22 ments: 

23 ‘‘(A) MANURE.—Growers of a raw agri24 culture commodity shall— 


hsrobinson on PROD1PC76 with BILLS
23 

•HR 5620 IH

1 ‘‘(i) manage the application of manure 

2 to ensure that it does not contribute to the 

3 contamination of crops, including limita4 tions on the crops where and when manure 

5 may be applied; and 

6 ‘‘(ii) monitor and maintain records re7 lating to use of manure in composting in8 tended for use on food crops to ensure ef9 fective controls are used to destroy patho10 gens. 

11 ‘‘(B) ANIMALS, DOMESTIC AND WILD12 LIFE.—Growers of a raw agricultural com13 modity shall ensure that domestic animals 

14 should be excluded, to the extent reasonably 

15 practicable, from fields and orchards during the 

16 growing and harvesting season, and growing 

17 areas should have wildlife deterrents. 

18 ‘‘(C) WATER.—Growers of a raw agricul19 tural commodity shall ensure that the water 

20 supply used for irrigation and for washing is 

21 suitable for its intended use and that ground 

22 water is regularly monitored for the presence of 

23 pathogens at a rate adequate to ensure that 

24 contaminated water is identified and diverted 

25 from use on food crops. 


hsrobinson on PROD1PC76 with BILLS
24 

•HR 5620 IH

1 ‘‘(D) ENVIRONMENTAL CONDITIONS.— 

2 Growers of a raw agricultural commodity shall 

3 consider the unique environmental conditions 

4 that might increase the likelihood of crop con5 tamination, including flooding, runoff, drought, 

6 and other conditions and develop safety plans to 

7 ensure contaminated crops are not distributed. 

8 ‘‘(E) ADDITIONAL REQUIREMENTS.—Other 

9 requirements as determined appropriate by the 

10 Secretary. 

11 ‘‘(3) RISK ASSESSMENT.—The standards estab12 lished under paragraph (1) shall be based on risk as13 sessment tools and metrics developed by the Food 

14 and Drug Administration in consultation with the 

15 Department of Agriculture and growers of produce. 

16 The risk assessments shall include— 

17 ‘‘(A) identification of existing and potential 

18 hazards at facilities; 

19 ‘‘(B) evaluation of human health risks 

20 posed by hazards identified in subparagraph 

21 (A); and 

22 ‘‘(C) proposed controls to minimize haz23 ards based on subparagraph (B). 

24 ‘‘(4) RISK CLASSIFICATION.—The Secretary 

25 shall classify facilities as high-, medium-, or low-risk 


hsrobinson on PROD1PC76 with BILLS
25 

•HR 5620 IH

1 according to the risk assessments in paragraph (3), 

2 and by considering the hazards associated with the 

3 type of produce being grown at a facility, the facili4 ty’s history of compliance and food safety problems, 

5 and such other factors as the Secretary may deter6 mine to be appropriate. Such risk classification shall 

7 determine the specific standards and controls re8 quired at each facility. 

9 ‘‘(5) SCIENCE-BASED STANDARDS.—The stand10 ards established under paragraph (1) shall— 

11 ‘‘(A) reflect the best available science; and 

12 ‘‘(B) be subject to change as new scientific 

13 evidence on risk becomes available. 

14 ‘‘(b) IMPLEMENTATION PLAN.— 

15 ‘‘(1) IN GENERAL.—Not later than 2 years 

16 after the date of enactment of this section, the Sec17 retary shall require growers of a raw agricultural 

18 commodity to have a written plan detailing the con19 trols utilized by the grower that limit the presence 

20 and growth of contaminants. 

21 ‘‘(2) CONTENT.—A plan under paragraph (1) 

22 shall— 

23 ‘‘(A) address standards for good agricul24 tural practices developed under subsection (a); 


hsrobinson on PROD1PC76 with BILLS
26 

•HR 5620 IH

1 ‘‘(B) require recordkeeping to monitor 

2 compliance; 

3 ‘‘(C) require sampling of product to be 

4 tested at a frequency and in a manner commen5 surate with the risk presented by the facility 

6 and produce grown as determined in subsection 

7 (a)(3), if the Secretary deems this appropriate, 

8 and sufficient to ensure that the standards or 

9 process controls are effective on an on-going 

10 basis and that regulatory standards are met; 

11 and 

12 ‘‘(D) provide access to the Food and Drug 

13 Administration to records maintained by the fa14 cility. 

15 ‘‘(3) SPECIFIC CONTROLS.—The Secretary may 

16 require growers of a raw agricultural commodity to 

17 adopt as part of a plan under paragraph (1) specific 

18 process controls, if the process controls are needed 

19 to ensure the protection of the public health. 

20 ‘‘(4) TIERED IMPLEMENTATION.—The Sec21 retary shall require such a plan for high-risk facili22 ties first, and then for medium-risk facilities, and 

23 then for low-risk facilities, as classified under sub24 section (a)(4). 


hsrobinson on PROD1PC76 with BILLS
27 

•HR 5620 IH

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

2 in subsection (a) shall take effect 2 years after the date 

3 of enactment of this section. 

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

5 ‘‘(1) FACILITY.—The term ‘facility’ means a 

6 farm or other facility of a grower of a raw agricul7 tural commodity. 

8 ‘‘(2) RAW AGRICULTURAL COMMODITY.—The 

9 term ‘raw agricultural commodity’ means a perish10 able agricultural commodity, as defined in section 

11 1(b) of the Perishable Agricultural Commodities Act, 

12 1930 (7 U.S.C. 499a(b)) that is a raw agricultural 

13 commodity, as defined in section 201.’’. 

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

15 Drug, and Cosmetic Act, as added by section 111(b), is 

16 amended by inserting before the period the following: ‘‘or 

17 a raw agricultural commodity produced in violation of sec18 tion 402B’’. 

19 SEC. 122. INSPECTIONS OF FACILITIES. 

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

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

22 is further amended by inserting after section 704A the fol23 lowing: 


hsrobinson on PROD1PC76 with BILLS
28 

•HR 5620 IH

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

2 ‘‘(a) NATURE OF INSPECTIONS.—Officers and em3 ployees duly designated by the Secretary shall have the 

4 authority to inspect appropriate facilities (as defined in 

5 section 402B) to determine compliance with the standards 

6 described in section 402B. 

7 ‘‘(b) REGULATIONS.—Not later than 2 years after 

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

9 consultation with the Secretary of Agriculture, shall by 

10 regulation issue procedures for conducting the inspections. 

11 ‘‘(c) EFFECTIVE DATE.—Subsection (a) and the reg12 ulations promulgated under subsection (b) shall take effect 

13 3 years after the date of enactment of this section.’’. 

14 (b) REMEDIES.— 

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

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

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

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

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

20 704B’’. 

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

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

23 U.S.C. 333(j)), as amended in section 112(b), is fur24 ther amended by inserting ‘‘704B,’’ after ‘‘704A,’’. 

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

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


hsrobinson on PROD1PC76 with BILLS
29 

•HR 5620 IH

1 379l(a)(2)), as amended in section 112(c), is further 

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

3 or 704B’’. 

4 TITLE II—RESEARCH AND 

5 EDUCATION 

6 SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM. 

7 (a) COOPERATION WITH THE CENTERS FOR DISEASE

8 CONTROL AND PREVENTION.—The Commissioner of Food 

9 and Drugs, in cooperation with the Secretary of Agri10 culture, the Director of the Centers for Disease Control 

11 and Prevention, and the Administrator of the Environ12 mental Protection Agency, shall establish and maintain an 

13 active surveillance system, for surveillance of a representa14 tive proportion of the population of the United States, to 

15 assess more accurately the frequency and sources of 

16 human illness in the United States associated with the 

17 consumption of fresh produce. 

18 (b) PUBLIC HEALTH SAMPLING.— 

19 (1) GUIDELINES.—Not later than 3 years after 

20 the date of enactment of this Act, the Commissioner 

21 of Food and Drugs, in cooperation with the Sec22 retary of Agriculture, the Director of the Centers for 

23 Disease Control and Prevention, and the Adminis24 trator of the Environmental Protection Agency, shall 

25 establish guidelines for a sampling system under 


hsrobinson on PROD1PC76 with BILLS
30 

•HR 5620 IH

1 which the Commissioner and the Secretary of Agri2 culture shall collect and analyze samples of fresh 

3 produce, both minimally processed and unprocessed, 

4 to assist the Commissioner in carrying out this Act 

5 and the requirements of the Federal Food, Drug, 

6 and Cosmetic Act (21 U.S.C. 301 et seq.) that relate 

7 to produce, and to assess more accurately the na8 ture, frequency of occurrence, and amounts of con9 taminants in the produce. 

10 (2) MONITORING AND OTHER INFORMATION.— 

11 In carrying out the sampling system, the Commis12 sioner of Food and Drugs and the Secretary of Agri13 culture shall provide for— 

14 (A) statistically valid monitoring, including 

15 the conduct of market-basket studies, on the 

16 nature, frequency of occurrence, and amounts 

17 of contaminants in produce available to con18 sumers; and 

19 (B) at the request of the Commissioner, 

20 the collection and analysis of such other infor21 mation, including analysis of information from 

22 monitoring and verification samples, as the 

23 Commissioner determines may be useful in as24 sessing the occurrence of contaminants in 

25 produce. 


hsrobinson on PROD1PC76 with BILLS
31 

•HR 5620 IH

1 (3) PROCESS VERIFICATION STANDARD.—The 

2 Commissioner of Food and Drugs and the Secretary 

3 of Agriculture shall conduct sampling to identify— 

4 (A) a contaminant, or other substance, 

5 that is commonly found on minimally processed 

6 produce and, when present at low levels, accu7 rately indicates that the produce has been ap8 propriately processed, with adequate sanitation; 

9 and 

10 (B) a standard for the level of that sub11 stance that indicates that the produce has been 

12 minimally processed as described in subpara13 graph (A). 

14 SEC. 202. PUBLIC EDUCATION SYSTEM. 

15 The Commissioner of Food and Drugs and the Sec16 retary of Agriculture, in cooperation with private and pub17 lic organizations, including the State cooperative extension 

18 services and appropriate State entities, shall design and 

19 implement a national public education program on food 

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

21 the Commissioner shall— 

22 (1) provide information to the public regarding 

23 Federal standards and good agricultural and manu24 facturing practice requirements relating to food safe25 ty and promote public awareness, understanding, 


hsrobinson on PROD1PC76 with BILLS
32 

•HR 5620 IH

1 and acceptance of the standards and requirements; 

2 and 

3 (2) provide such other information or advice to 

4 persons that work with the growing and minimal 

5 processing of produce, the food service and retail in6 dustry, consumers, and other persons as the Com7 missioner determines will promote the purposes of 

8 this Act. 

9 SEC. 203. RESEARCH. 

10 (a) IN GENERAL.—The Secretary of Agriculture, in 

11 consultation with the Commissioner of Food and Drugs, 

12 shall conduct research to assist in the implementation of 

13 this Act and the requirements of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 301 et seq.) that relate to 

15 produce, including studies relating to— 

16 (1) improving sanitation and food safety prac17 tices in the minimal processing of produce; 

18 (2) developing improved techniques for the 

19 monitoring of produce and inspection of produce; 

20 (3) developing efficient, rapid, and sensitive 

21 methods for determining and detecting the presence 

22 of contaminants in produce; 

23 (4) determining the sources of contamination of 

24 produce, including contamination from growing, harVerDate Aug 31 2005 21:57 Mar 14, 2008 Jkt 069200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\H5620.IH H5620

hsrobinson on PROD1PC76 with BILLS
33 

•HR 5620 IH

1 vesting, and minimal processing produce and post2 processing contamination of produce; 

3 (5) developing consumption data with respect to 

4 produce (including minimally processed produce); 

5 and 

6 (6) mitigation strategies to aid produce proc7 essors and produce growers in deciding what actions 

8 to take when contamination is found. 

9 (b) CONTRACT AUTHORITY.—The Secretary of Agri10 culture is authorized to enter into contracts and agree11 ments with States, institutions of higher education, other 

12 government agencies, and other persons to carry out the 

13 activities described in this section. 

14 TITLE III—IMPORTED PRODUCE 

15 AND OTHER PROVISIONS 

16 SEC. 301. IMPORTED PRODUCE. 

17 (a) EQUIVALENCY PROCEDURES.—Not later than 1 

18 year after the date of enactment of this Act, the Secretary, 

19 in consultation with the Secretary of Agriculture, shall by 

20 regulation establish procedures for equivalency with for21 eign countries that intend to export raw agricultural com22 modities and minimally processed produce to the United 

23 States. 

24 (b) CONTENT.—The Secretary, in consultation with 

25 the Secretary of Agriculture, shall establish procedures to 


hsrobinson on PROD1PC76 with BILLS
34 

•HR 5620 IH

1 require that imported raw agricultural commodities and 

2 minimally processed produce meet the criteria established 

3 in this Act (and the amendments made by this Act). 

4 SEC. 302. AUTHORIZATION OF APPROPRIATIONS. 

5 There are authorized to be appropriated such sums 

6 as may be necessary to carry out this Act (and the amend7 ments made by this Act) for each fiscal year. 

Æ 


hsrobinson on PROD1PC76 with BILLS