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 En-
ergy 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Fresh Produce Safety Act’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
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—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. 
SEC. 2. FINDINGS. 
Congress finds that— 
(1) consumption of fresh fruits and vegetables 
can promote health and prevent disease, and should 
be encouraged; 
(2) an estimated 76,000,000 cases of foodborne 
disease occur each year in the United States, caus-
ing about 325,000 hospitalizations and 5,000 deaths 
annually, according to the Centers for Disease Con-
trol and Prevention (referred to in this section as 
the ‘‘CDC’’); 
(3) data reported to the CDC indicate that out-
breaks of foodborne illness in the United States as-
sociated with fruits and vegetables have increased in 
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absolute numbers and as a proportion of all reported 
foodborne outbreaks; 
(4) illnesses caused by E. coli O157: H7, Sal-
monella spp., and norovirus have been traced to a 
wide variety of produce, including lettuce, salads, 
melons, sprouts, tomatoes, and many fruit- and veg-
etable-containing dishes; 
(5) outbreaks of food-borne illness associated 
with produce in the United States have been docu-
mented from both imported produce and domesti-
cally grown produce; 
(6) large scale processing of produce can easily 
spread pathogens into minimally processed food and 
a single outbreak can affect hundreds of people; 
(7) persons who process produce for human 
consumption have the responsibility to prevent or 
minimize food safety hazards related to their prod-
ucts; 
(8) rising consumer demand for minimally proc-
essed produce, the growing market for various kinds 
of domestic and imported minimally processed 
produce, and the increasing variety of processing 
techniques for produce, are causing newly recognized 
or unpredicted safety hazards; and 
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(9) risk-based sanitation practices, and com-
modity-specific good agricultural and manufacturing 
practices, tailored to the hazards and the level of 
risk that a specific food product presents, should be 
applied to the processing of produce to minimize 
these hazards. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) CONTAMINANT.—The term ‘‘contaminant’’ 
includes a bacterium, chemical, natural or manufac-
tured toxin, virus, parasite, physical hazard, or other 
human pathogen that, when in food, can cause 
human illness, injury, or death. 
(2) MINIMALLY PROCESS.— 
(A) IN GENERAL.—The term ‘‘minimally 
process’’ means— 
(i) to carry out the commercial prepa-
ration or manufacture of produce, includ-
ing— 
(I) the peeling, coring, stemming, 
trimming, mashing, or shredding of 
produce; 
(II) the cutting of produce after 
harvesting; 
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(III) the preparation of fresh 
produce so to as to appear ready for 
consumption without further washing 
or preparation; and 
(IV) the mixing or blending of 
minimally processed produce with 
other produce; and 
(ii) does not include carrying out the 
harvesting, washing (except as provided in 
clause (i)(III)), waxing, packing, or sort-
ing, of a raw agricultural commodity. 
(B) EXCEPTION.—The term ‘‘minimally 
process’’ shall not apply to a raw agricultural 
commodity that is stemmed but not subject to 
further commercial preparation. 
(3) PROCESSOR
OF
PRODUCE.—The term 
‘‘processor of produce’’ means a person that mini-
mally processes produce. 
(4) PRODUCE.— 
(A) IN
GENERAL.—The term ‘‘produce’’ 
means any perishable agricultural commodity, 
as defined in section 1(b) of the Perishable Ag-
ricultural Commodities Act, 1930 (7 U.S.C. 
499a(b)). 
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(B) INCLUSIONS.—The term ‘‘produce’’ in-
cludes a mixture of— 
(i) a commodity described in subpara-
graph (A); and 
(ii) any other food, as defined in sec-
tion 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321). 
(C) EXCLUSIONS.—The term ‘‘produce’’ 
does not include— 
(i) other food in the mixture described 
in subparagraph (B)(ii); and 
(ii) an article used for food or drink 
for animals, or an article used for a com-
ponent of such an article. 
(5) RAW
AGRICULTURAL
COMMODITY.—The 
term ‘‘raw agricultural commodity’’ means a perish-
able agricultural commodity, as defined in section 
1(b) of the Perishable Agricultural Commodities Act, 
1930 (7 U.S.C. 499a(b)) that is a raw agricultural 
commodity, as defined in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321). 
(6) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
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TITLE I—FOOD SAFETY 
ACTIVITIES 
SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM. 
(a) IN GENERAL.— 
(1) NATIONAL PROGRAM.—The Secretary shall 
administer a national program for the purpose of 
protecting human health by ensuring that— 
(A) there are effective programs in place to 
assure the safety of produce minimally proc-
essed in the United States; and 
(B) producers of raw agricultural commod-
ities have effective programs in place to assure 
the safety of those commodities produced in the 
United States. 
(2) BASIS FOR PROGRAM.—The program shall 
take into consideration the distinctive characteristics 
of minimal processing of produce and the differing 
practices and levels of risk associated with the pro-
duction of different raw agricultural commodities. 
(b) PROGRAM ELEMENTS.—The program shall pro-
vide for implementation of the authorities described in— 
(1) sections 402A, 402B, 704A, and 704B of 
the Federal Food, Drug, and Cosmetic Act, as 
added by subtitles A and B; and 
(2) title II. 
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Subtitle A—Minimally Processed 
Produce 
SEC. 111. GOOD MANUFACTURING PRACTICES. 
(a) IN GENERAL.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 402 (21 U.S.C. 342) the following: 
‘‘SEC. 
402A. 
GOOD 
MANUFACTURING 
PRACTICES 
FOR 
PRODUCE. 
‘‘(a) GOOD MANUFACTURING PRACTICE REGULA-
TIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this section, the Secretary 
shall by regulation establish standards for good 
manufacturing practices for the minimal processing 
of produce. 
‘‘(2) CONTENT.—The regulations issued under 
paragraph (1) shall include the following require-
ments: 
‘‘(A) SANITATION.—Processors of produce 
shall— 
‘‘(i) establish mandatory sanitation 
standard operating procedures, including 
cleaning procedures for equipment, storage 
areas, air systems, and water storage 
areas; 
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‘‘(ii) design processing facilities to fa-
cilitate maintenance and good sanitation 
practices so that contamination may be 
controlled throughout receiving, cooling, 
processing, packing, and storage oper-
ations; and 
‘‘(iii) ensure— 
‘‘(I) controlled access to the facil-
ity and to processing areas; 
‘‘(II) adequate space for oper-
ations; 
‘‘(III) adequate drainage of proc-
essing and wash water; 
‘‘(IV) food contact surfaces that 
are easy to clean and maintain; 
‘‘(V) that areas and structures 
designed to protect the product and 
equipment from contamination; and 
‘‘(VI) that sanitation standards 
established in clause (i) are adhered 
to in the transportation of minimally 
processed produce to the extent prac-
ticable. 
‘‘(B) WATER.— 
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‘‘(i) 
IN
GENERAL.—Processors 
of 
produce shall ensure that— 
‘‘(I) the water supply used in 
food processing plants is suitable for 
its intended use; 
‘‘(II) facilities have an environ-
mental monitoring program that in-
cludes sampling for pathogens to de-
tect areas of harborage and to verify 
the effectiveness of cleaning and sani-
tizing programs in preventing cross- 
contamination; and 
‘‘(III) each sanitizer used for 
washing vegetables is appropriate for 
its intended use. 
‘‘(ii) 
SAMPLING
PROGRAMS
FOR 
WATER.—If the Secretary determines that 
effective sampling programs can be devel-
oped, processors of produce shall ensure 
that the water used for washing produce is 
monitored for the presence of pathogens at 
a rate adequate to ensure highly contami-
nated batches are identified and elimi-
nated. 
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‘‘(C) ADDITIONAL REQUIREMENTS.—Other 
requirements as determined appropriate by the 
Secretary. 
‘‘(3) RISK ASSESSMENT.—The standards estab-
lished under paragraph (1) shall be based on risk as-
sessment tools and metrics developed by the Food 
and Drug Administration in consultation with the 
Department of Agriculture and processors of 
produce. The risk assessments shall include— 
‘‘(A) identification of existing and potential 
hazards at facilities; 
‘‘(B) evaluation of human health risks 
posed by hazards identified in subparagraph 
(A); and 
‘‘(C) proposed controls to minimize haz-
ards based on subparagraph (B). 
‘‘(4) RISK
CLASSIFICATION.—The Secretary 
shall classify facilities as high-, medium-, or low-risk 
according to the risk assessments in paragraph (3), 
and by considering the hazards associated with the 
type of produce being minimally processed at a facil-
ity, the facility’s history of compliance and food safe-
ty problems, and such other factors as the Secretary 
may determine to be appropriate. Such risk classi-
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fication shall determine the specific standards and 
controls required at each facility. 
‘‘(5) SCIENCE-BASED STANDARDS.—The stand-
ards established under paragraph (1) shall— 
‘‘(A) reflect the best available science; and 
‘‘(B) be subject to change through regula-
tions promulgated by the Secretary as new sci-
entific evidence on risk becomes available. 
‘‘(b) IMPLEMENTATION PLAN FOR PROCESSORS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this section, the Sec-
retary shall require every processor of produce to 
have a written plan detailing the controls utilized the 
processor of produce. 
‘‘(2) CONTENT.—A plan under paragraph (1) 
shall— 
‘‘(A) address good manufacturing stand-
ards set forth by the Secretary; 
‘‘(B) require recordkeeping to monitor 
compliance; 
‘‘(C) require the sampling of products and 
process to be tested, at a frequency and in a 
manner commensurate with the risk presented 
by the facility and produce processed, as deter-
mined in subsection (a)(3), if the Secretary 
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deems this appropriate, and sufficient to ensure 
that the standards or process controls are effec-
tive on an on-going basis and that regulatory 
standards are met; and 
‘‘(D) provide access to the Food and Drug 
Administration to records maintained by the fa-
cility pursuant to section 414. 
‘‘(3) SPECIFIC CONTROLS.—In addition to com-
plying with standards established under section 
402A(a)(1), the Secretary may require processors to 
adopt specific process controls identified in section 
402A(a)(3), if the process controls are needed to en-
sure the protection of the public health. 
‘‘(4) TIERED
IMPLEMENTATION.—The Sec-
retary shall require such a plan for high-risk facili-
ties first, and then for medium-risk facilities, and 
then for low-risk facilities, as classified under sub-
section (a)(4). 
‘‘(c) EXCEPTIONS.—In issuing regulations under sub-
section (a), the Secretary may modify the good manufac-
turing process regulations if the Secretary determines, for 
good cause shown and stated together with the regula-
tions, that for a specific product— 
‘‘(1) a modification of such provisions would be 
more effective to prevent the contamination of, or 
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promote the sanitation of, minimally processed 
produce; or 
‘‘(2) the application of a portion of such provi-
sions would not result in the prevention of contami-
nation of, or promotion of sanitation of, minimally 
processed produce. 
‘‘(d) EFFECTIVE DATE.—The regulations promul-
gated under subsection (a) shall take effect 2 years after 
the date of enactment of this section. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) 
CONTAMINANT; 
MINIMALLY
PROCESS; 
PRODUCE.—The terms ‘contaminant’, ‘minimally 
process’, and ‘produce’ have the meanings given 
those terms in section 3 of the Fresh Produce Safety 
Act. 
‘‘(2) FACILITY.—The term ‘facility’ includes 
any factory, warehouse, or establishment, in which 
produce is minimally processed. 
‘‘(3) GOOD MANUFACTURING PRACTICE REGU-
LATIONS.—The term ‘good manufacturing practice 
regulations’ means the good manufacturing practice 
regulations for manufacturing, packing, or holding 
food, issued under sections 402, 701, and 704 of 
this Act and under section 361 of the Public Health 
Service Act (42 U.S.C. 264).’’. 
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(b) VIOLATION.—Section 402 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342) is amended by 
adding at the end the following: 
‘‘(j) It is an article of produce processed in violation 
of section 402A.’’. 
SEC. 112. INSPECTIONS OF PROCESSORS. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 704 (21 U.S.C. 374) the following: 
‘‘SEC. 704A. INSPECTIONS OF PROCESSORS. 
‘‘(a) NATURE OF INSPECTIONS.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
for unannounced inspections of processing facilities 
to determine if produce processed in the facilities is 
in compliance with the requirements of this Act that 
relate to produce. 
‘‘(2) SCHEDULE.—The Secretary shall establish 
a schedule for the unannounced inspections, which 
shall provide for— 
‘‘(A) inspections at least once per growing 
season for facilities classified as high-risk under 
section 402A(a)(4); and 
‘‘(B) less frequent inspections, as deter-
mined by the Secretary, for facilities classified 
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as medium- or low-risk facilities under section 
402A(a)(4). 
‘‘(3) EXAMINATION
OF
CLASSIFICATIONS.— 
Each such inspection of a facility shall include an 
examination of whether the facility is appropriately 
classified under section 402A(a)(4). 
‘‘(b) CONDUCT OF INSPECTIONS.— 
‘‘(1) SCOPE.—An inspection under subsection 
(a) of any facility described in subsection (a) shall 
extend to all things in the facility, any required 
records, processes, controls, and premises that bear 
on whether minimally processed produce is in com-
pliance with the requirements of this Act that relate 
to produce. Access to records may include the copy-
ing of the records. 
‘‘(2) AUTHORITIES.—In conducting such an in-
spection, an officer or employee duly designated by 
the Secretary shall have the same authorities and 
duties as the officer or employee would have under 
subsection (a)(1), (c), or (d) of section 704 to in-
spect facilities in which food is minimally processed. 
‘‘(3) REPORT.—Not later than 48 hours after 
completion of the inspection, the officer or employee 
making the inspection shall give to the owner, oper-
ator, or agent in charge a written report setting 
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forth any conditions or practices observed that indi-
cate that any produce from the facility is in violation 
of the requirements of this Act that relate to 
produce. 
‘‘(c) PRODUCT DETENTION AND CONDEMNATION.— 
‘‘(1) IN
GENERAL.—If, during an inspection 
conducted under this section, an officer or employee 
making the inspection determines that minimally 
processed produce is in violation of the requirements 
of this Act that relate to produce, the officer or em-
ployee may order the produce segregated, im-
pounded, and if objection is not made no later than 
48 hours after the issuance of the impoundment 
order, condemned. If objection is made during such 
48-hour period, minimally processed produce that is 
perishable may be processed to the extent necessary 
to prevent spoilage, and the Secretary shall expedi-
tiously commence a hearing within 24 hours after 
the objection regarding the determination and any 
action required for compliance with the requirements 
of this Act that relate to produce. The decision of 
the Secretary following the hearing shall be consid-
ered to be a final agency action. 
‘‘(2) RELEASE.—If the Secretary determines 
that, through relabeling or other action, the produce 
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can be brought into compliance with the require-
ments of this Act that relate to produce, the produce 
may be released following a determination by the 
Secretary that the relabeling or other action as spec-
ified by the Secretary has been performed. 
‘‘(3) DESTRUCTION.—Any minimally processed 
produce condemned under paragraph (1)— 
‘‘(A) in a case in which no objection is 
made under paragraph (1); 
‘‘(B) after the hearing and any judicial re-
view; or 
‘‘(C) after failure of the owner, operator, 
or agent to perform relabeling or other action 
described in paragraph (2), 
shall be destroyed under supervision of the Sec-
retary. 
‘‘(d) MAINTENANCE OF RECORDS.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent in charge of each facility shall maintain such 
records as the Secretary may prescribe. The records 
shall be maintained for a reasonable period of time 
as determined by the Secretary. The records shall 
include information concerning— 
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‘‘(A)(i) the origin, receipt, delivery, sale, 
movement, holding, and disposition of produce 
minimally processed at the facility; 
‘‘(ii) 
the 
minimal 
processing 
of 
the 
produce; and 
‘‘(iii) other matters reasonably related to 
whether produce minimally processed at the fa-
cility may be in violation of the requirements of 
this Act that relate to produce; and 
‘‘(B)(i) the origin, receipt, delivery, sale, 
movement, holding, and disposition of ingredi-
ents used in the produce minimally processed at 
the facility, including sufficient information to 
permit lot identification to facilitate traceback 
of produce found to be in violation of the re-
quirements of this Act that relate to produce, 
or to be causing human illness or injury; 
‘‘(ii) the identity and amount of ingredi-
ents used in the produce; 
‘‘(iii) the results of laboratory, sanitation, 
or other quality control tests performed on the 
produce or in the facility; and 
‘‘(iv) consumer complaints concerning the 
safety of the produce or the packaging of the 
produce. 
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‘‘(2) AVAILABILITY OF RECORDS.—The owner, 
operator, or agent shall— 
‘‘(A) make available, during an inspection 
conducted under subsection (a), the records de-
scribed in paragraph (1)(A); and 
‘‘(B) at the request of the Secretary, if the 
officer or employee finds as a result of the in-
spection that produce from the facility is associ-
ated with foodborne disease or poses an immi-
nent health hazard, make available for inspec-
tion the records described in paragraph (1)(B). 
‘‘(3) REQUIRED DISCLOSURE.—The owner, op-
erator, or agent in charge of a facility shall have an 
affirmative obligation to take corrective action, in-
cluding ensuring the product is not introduced into 
commerce, as approved by the Commissioner of 
Food and Drugs or the Secretary, if the results of 
testing or sampling of produce, equipment, or mate-
rial in contact with produce are positive for any con-
taminant, in accordance with section 414. The 
owner, operator, or agent in charge of a facility shall 
have an affirmative obligation to disclose to the 
Commissioner of Food and Drugs or the Secretary 
if the results of testing finds a positive test result 
and the product is in commerce. 
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‘‘(e) DEFINITIONS.— 
‘‘(1) FACILITY.—The term ‘facility’ includes 
any factory, warehouse, or establishment, in which 
produce is minimally processed. 
‘‘(2) MINIMALLY
PROCESS; 
PRODUCE.—The 
terms ‘minimally process’ and ‘produce’ have the 
meanings given those terms in section 3 of the 
Fresh Produce Safety Act.’’. 
(b) REMEDIES.— 
(1) IN GENERAL.—Paragraphs (f) and (n) of 
section 301, and section 304(g)(1), of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331, 
334(g)(1)) are amended by striking ‘‘section 704’’ 
and inserting ‘‘section 704 or 704A’’. 
(2) PROHIBITED DISCLOSURES.—Section 301(j) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 331(j)) is amended by striking ‘‘704,’’ and 
inserting ‘‘704, 704A,’’. 
(c) CONFORMING AMENDMENT.—Section 742(a)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379l(a)(2)) is amended by striking ‘‘section 704’’ and in-
serting ‘‘section 704 or 704A’’. 
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Subtitle B—Raw Agricultural 
Commodities 
SEC. 121. GOOD AGRICULTURAL PRACTICES. 
(a) IN GENERAL.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 111(a), 
is further amended by inserting after section 402A the fol-
lowing: 
‘‘SEC. 402B. GOOD AGRICULTURAL PRACTICES FOR RAW 
AGRICULTURAL COMMODITIES. 
‘‘(a) GOOD
AGRICULTURAL
PRACTICE
REGULA-
TIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this section, the Secretary, 
in consultation with the Secretary of Agriculture, 
shall by regulation establish general standards for 
good agricultural practices for the production of raw 
agricultural commodities, in order to minimize the 
violations of this Act and maximize the safety of 
those commodities. 
‘‘(2) CONTENTS.—The regulations issued under 
paragraph (1) shall include the following require-
ments: 
‘‘(A) MANURE.—Growers of a raw agri-
culture commodity shall— 
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‘‘(i) manage the application of manure 
to ensure that it does not contribute to the 
contamination of crops, including limita-
tions on the crops where and when manure 
may be applied; and 
‘‘(ii) monitor and maintain records re-
lating to use of manure in composting in-
tended for use on food crops to ensure ef-
fective controls are used to destroy patho-
gens. 
‘‘(B) ANIMALS, 
DOMESTIC
AND
WILD-
LIFE.—Growers of a raw agricultural com-
modity shall ensure that domestic animals 
should be excluded, to the extent reasonably 
practicable, from fields and orchards during the 
growing and harvesting season, and growing 
areas should have wildlife deterrents. 
‘‘(C) WATER.—Growers of a raw agricul-
tural commodity shall ensure that the water 
supply used for irrigation and for washing is 
suitable for its intended use and that ground 
water is regularly monitored for the presence of 
pathogens at a rate adequate to ensure that 
contaminated water is identified and diverted 
from use on food crops. 
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‘‘(D) 
ENVIRONMENTAL
CONDITIONS.— 
Growers of a raw agricultural commodity shall 
consider the unique environmental conditions 
that might increase the likelihood of crop con-
tamination, including flooding, runoff, drought, 
and other conditions and develop safety plans to 
ensure contaminated crops are not distributed. 
‘‘(E) ADDITIONAL REQUIREMENTS.—Other 
requirements as determined appropriate by the 
Secretary. 
‘‘(3) RISK ASSESSMENT.—The standards estab-
lished under paragraph (1) shall be based on risk as-
sessment tools and metrics developed by the Food 
and Drug Administration in consultation with the 
Department of Agriculture and growers of produce. 
The risk assessments shall include— 
‘‘(A) identification of existing and potential 
hazards at facilities; 
‘‘(B) evaluation of human health risks 
posed by hazards identified in subparagraph 
(A); and 
‘‘(C) proposed controls to minimize haz-
ards based on subparagraph (B). 
‘‘(4) RISK
CLASSIFICATION.—The Secretary 
shall classify facilities as high-, medium-, or low-risk 
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according to the risk assessments in paragraph (3), 
and by considering the hazards associated with the 
type of produce being grown at a facility, the facili-
ty’s history of compliance and food safety problems, 
and such other factors as the Secretary may deter-
mine to be appropriate. Such risk classification shall 
determine the specific standards and controls re-
quired at each facility. 
‘‘(5) SCIENCE-BASED STANDARDS.—The stand-
ards established under paragraph (1) shall— 
‘‘(A) reflect the best available science; and 
‘‘(B) be subject to change as new scientific 
evidence on risk becomes available. 
‘‘(b) IMPLEMENTATION PLAN.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this section, the Sec-
retary shall require growers of a raw agricultural 
commodity to have a written plan detailing the con-
trols utilized by the grower that limit the presence 
and growth of contaminants. 
‘‘(2) CONTENT.—A plan under paragraph (1) 
shall— 
‘‘(A) address standards for good agricul-
tural practices developed under subsection (a); 
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‘‘(B) require recordkeeping to monitor 
compliance; 
‘‘(C) require sampling of product to be 
tested at a frequency and in a manner commen-
surate with the risk presented by the facility 
and produce grown as determined in subsection 
(a)(3), if the Secretary deems this appropriate, 
and sufficient to ensure that the standards or 
process controls are effective on an on-going 
basis and that regulatory standards are met; 
and 
‘‘(D) provide access to the Food and Drug 
Administration to records maintained by the fa-
cility. 
‘‘(3) SPECIFIC CONTROLS.—The Secretary may 
require growers of a raw agricultural commodity to 
adopt as part of a plan under paragraph (1) specific 
process controls, if the process controls are needed 
to ensure the protection of the public health. 
‘‘(4) TIERED
IMPLEMENTATION.—The Sec-
retary shall require such a plan for high-risk facili-
ties first, and then for medium-risk facilities, and 
then for low-risk facilities, as classified under sub-
section (a)(4). 
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‘‘(c) EFFECTIVE DATE.—The regulations described 
in subsection (a) shall take effect 2 years after the date 
of enactment of this section. 
‘‘(d) DEFINITIONS.—In this section: 
‘‘(1) FACILITY.—The term ‘facility’ means a 
farm or other facility of a grower of a raw agricul-
tural commodity. 
‘‘(2) RAW
AGRICULTURAL
COMMODITY.—The 
term ‘raw agricultural commodity’ means a perish-
able agricultural commodity, as defined in section 
1(b) of the Perishable Agricultural Commodities Act, 
1930 (7 U.S.C. 499a(b)) that is a raw agricultural 
commodity, as defined in section 201.’’. 
(b) VIOLATION.—Section 402(j) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 111(b), is 
amended by inserting before the period the following: ‘‘or 
a raw agricultural commodity produced in violation of sec-
tion 402B’’. 
SEC. 122. INSPECTIONS OF FACILITIES. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act, as amended by section 112(a), 
is further amended by inserting after section 704A the fol-
lowing: 
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‘‘SEC. 704B. INSPECTIONS OF FACILITIES. 
‘‘(a) NATURE OF INSPECTIONS.—Officers and em-
ployees duly designated by the Secretary shall have the 
authority to inspect appropriate facilities (as defined in 
section 402B) to determine compliance with the standards 
described in section 402B. 
‘‘(b) REGULATIONS.—Not later than 2 years after 
the date of enactment of this section, the Secretary, in 
consultation with the Secretary of Agriculture, shall by 
regulation issue procedures for conducting the inspections. 
‘‘(c) EFFECTIVE DATE.—Subsection (a) and the reg-
ulations promulgated under subsection (b) shall take effect 
3 years after the date of enactment of this section.’’. 
(b) REMEDIES.— 
(1) IN GENERAL.—Paragraphs (f) and (n) of 
section 301, and section 304(g)(1), of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)), 
as amended in section 112(b), are further amended 
by striking ‘‘or 704A’’ and inserting ‘‘, 704A, or 
704B’’. 
(2) PROHIBITED DISCLOSURES.—Section 301(j) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 333(j)), as amended in section 112(b), is fur-
ther amended by inserting ‘‘704B,’’ after ‘‘704A,’’. 
(c) CONFORMING AMENDMENT.—Section 742(a)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
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379l(a)(2)), as amended in section 112(c), is further 
amended by striking ‘‘or 704A’’ and inserting ‘‘, 704A, 
or 704B’’. 
TITLE II—RESEARCH AND 
EDUCATION 
SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM. 
(a) COOPERATION WITH THE CENTERS FOR DISEASE 
CONTROL AND PREVENTION.—The Commissioner of Food 
and Drugs, in cooperation with the Secretary of Agri-
culture, the Director of the Centers for Disease Control 
and Prevention, and the Administrator of the Environ-
mental Protection Agency, shall establish and maintain an 
active surveillance system, for surveillance of a representa-
tive proportion of the population of the United States, to 
assess more accurately the frequency and sources of 
human illness in the United States associated with the 
consumption of fresh produce. 
(b) PUBLIC HEALTH SAMPLING.— 
(1) GUIDELINES.—Not later than 3 years after 
the date of enactment of this Act, the Commissioner 
of Food and Drugs, in cooperation with the Sec-
retary of Agriculture, the Director of the Centers for 
Disease Control and Prevention, and the Adminis-
trator of the Environmental Protection Agency, shall 
establish guidelines for a sampling system under 
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which the Commissioner and the Secretary of Agri-
culture shall collect and analyze samples of fresh 
produce, both minimally processed and unprocessed, 
to assist the Commissioner in carrying out this Act 
and the requirements of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) that relate 
to produce, and to assess more accurately the na-
ture, frequency of occurrence, and amounts of con-
taminants in the produce. 
(2) MONITORING AND OTHER INFORMATION.— 
In carrying out the sampling system, the Commis-
sioner of Food and Drugs and the Secretary of Agri-
culture shall provide for— 
(A) statistically valid monitoring, including 
the conduct of market-basket studies, on the 
nature, frequency of occurrence, and amounts 
of contaminants in produce available to con-
sumers; and 
(B) at the request of the Commissioner, 
the collection and analysis of such other infor-
mation, including analysis of information from 
monitoring and verification samples, as the 
Commissioner determines may be useful in as-
sessing the occurrence of contaminants in 
produce. 
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(3) PROCESS
VERIFICATION
STANDARD.—The 
Commissioner of Food and Drugs and the Secretary 
of Agriculture shall conduct sampling to identify— 
(A) a contaminant, or other substance, 
that is commonly found on minimally processed 
produce and, when present at low levels, accu-
rately indicates that the produce has been ap-
propriately processed, with adequate sanitation; 
and 
(B) a standard for the level of that sub-
stance that indicates that the produce has been 
minimally processed as described in subpara-
graph (A). 
SEC. 202. PUBLIC EDUCATION SYSTEM. 
The Commissioner of Food and Drugs and the Sec-
retary of Agriculture, in cooperation with private and pub-
lic organizations, including the State cooperative extension 
services and appropriate State entities, shall design and 
implement a national public education program on food 
safety relating to produce. In carrying out the program, 
the Commissioner shall— 
(1) provide information to the public regarding 
Federal standards and good agricultural and manu-
facturing practice requirements relating to food safe-
ty and promote public awareness, understanding, 
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and acceptance of the standards and requirements; 
and 
(2) provide such other information or advice to 
persons that work with the growing and minimal 
processing of produce, the food service and retail in-
dustry, consumers, and other persons as the Com-
missioner determines will promote the purposes of 
this Act. 
SEC. 203. RESEARCH. 
(a) IN GENERAL.—The Secretary of Agriculture, in 
consultation with the Commissioner of Food and Drugs, 
shall conduct research to assist in the implementation of 
this Act and the requirements of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) that relate to 
produce, including studies relating to— 
(1) improving sanitation and food safety prac-
tices in the minimal processing of produce; 
(2) developing improved techniques for the 
monitoring of produce and inspection of produce; 
(3) developing efficient, rapid, and sensitive 
methods for determining and detecting the presence 
of contaminants in produce; 
(4) determining the sources of contamination of 
produce, including contamination from growing, har-
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vesting, and minimal processing produce and post- 
processing contamination of produce; 
(5) developing consumption data with respect to 
produce (including minimally processed produce); 
and 
(6) mitigation strategies to aid produce proc-
essors and produce growers in deciding what actions 
to take when contamination is found. 
(b) CONTRACT AUTHORITY.—The Secretary of Agri-
culture is authorized to enter into contracts and agree-
ments with States, institutions of higher education, other 
government agencies, and other persons to carry out the 
activities described in this section. 
TITLE III—IMPORTED PRODUCE 
AND OTHER PROVISIONS 
SEC. 301. IMPORTED PRODUCE. 
(a) EQUIVALENCY PROCEDURES.—Not later than 1 
year after the date of enactment of this Act, the Secretary, 
in consultation with the Secretary of Agriculture, shall by 
regulation establish procedures for equivalency with for-
eign countries that intend to export raw agricultural com-
modities and minimally processed produce to the United 
States. 
(b) CONTENT.—The Secretary, in consultation with 
the Secretary of Agriculture, shall establish procedures to 
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require that imported raw agricultural commodities and 
minimally processed produce meet the criteria established 
in this Act (and the amendments made by this Act). 
SEC. 302. AUTHORIZATION OF APPROPRIATIONS. 
There are authorized to be appropriated such sums 
as may be necessary to carry out this Act (and the amend-
ments made by this Act) for each fiscal year. 
Æ 
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