S 2077
110th CONGRESS
1st Session
S. 2077
To establish a program to assure the safety of fresh produce
intended for human consumption, and for other purposes.
IN THE SENATE OF THE UNITED STATES
September 20, 2007
Mr. HARKIN (for himself, Mr. KOHL, 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 fresh produce
intended for human consumption, and for other purposes.
Be it enacted by the Senate and House of Representatives 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.
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.
TITLE III--IMPORTED PRODUCE AND OTHER PROVISIONS
Sec. 301. Imported produce.
Sec. 302. Authorization of appropriations.
SEC. 2. FINDINGS.
(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, causing about 325,000 hospitalizations
and 5,000 deaths annually, according to the Centers for Disease Control
and Prevention (referred to in this section as the `CDC');
(3) data reported to the CDC indicate that outbreaks of foodborne
illness in the United States associated with fruits and vegetables
have increased in absolute numbers and as a proportion of all reported
foodborne outbreaks;
(4) illnesses caused by E. coli O157: H7, Salmonella spp., and norovirus
have been traced to a wide variety of produce, including lettuce,
salads, melons, sprouts, tomatoes, and many fruit- and vegetable-containing
dishes;
(5) outbreaks of food-borne illness associated with produce in the
United States have been documented from both imported produce and
domestically 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 products;
(8) rising consumer demand for minimally processed 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
(9) risk-based sanitation practices, and commodity-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.
(1) CONTAMINANT- The term `contaminant' includes a bacterium, chemical,
natural or manufactured toxin, virus, parasite, physical hazard, or
other human pathogen that, when in food, can cause human illness,
injury, or death.
(A) IN GENERAL- The term `minimally process' means--
(i) to carry out the commercial preparation or manufacture of
produce, including--
(I) the peeling, coring, stemming, trimming, mashing, or shredding
of produce;
(II) the cutting of produce after harvesting;
(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 sorting,
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 minimally processes produce.
(A) IN GENERAL- The term `produce' means any perishable agricultural
commodity, as defined in section 1(b) of the Perishable Agricultural
Commodities Act, 1930 (7 U.S.C. 499a(b)).
(B) INCLUSIONS- The term `produce' includes a mixture of--
(i) a commodity described in subparagraph (A); and
(ii) any other food, as defined in section 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 component of such an article.
(5) RAW AGRICULTURAL COMMODITY- The term `raw agricultural commodity'
means a perishable 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.
TITLE I--FOOD SAFETY ACTIVITIES
SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.
(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 processed in the United States; and
(B) producers of raw agricultural commodities 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 production
of different raw agricultural commodities.
(b) Program Elements- The program shall provide 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
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 section 402 (21 U.S.C. 342) the following:
`SEC. 402A. GOOD MANUFACTURING PRACTICES FOR PRODUCE.
`(a) Good Manufacturing Practice Regulations-
`(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 requirements:
`(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;
`(ii) design processing facilities to facilitate maintenance and
good sanitation practices so that contamination may be controlled
throughout receiving, cooling, processing, packing, and storage
operations; and
`(I) controlled access to the facility and to processing areas;
`(II) adequate space for operations;
`(III) adequate drainage of processing 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 practicable.
`(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 environmental monitoring program that
includes sampling for pathogens to detect areas of harborage
and to verify the effectiveness of cleaning and sanitizing 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 developed, 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 contaminated batches are identified and eliminated.
`(C) ADDITIONAL REQUIREMENTS- Other requirements as determined appropriate
by the Secretary.
`(3) RISK ASSESSMENT- The standards established under paragraph (1)
shall be based on risk assessment 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 hazards 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 facility, the facility's
history of compliance and food safety problems, and such other factors
as the Secretary may determine to be appropriate. Such risk classification
shall determine the specific standards and controls required at each
facility.
`(5) SCIENCE-BASED STANDARDS- The standards established under paragraph
(1) shall--
`(A) reflect the best available science; and
`(B) be subject to change through regulations promulgated by the
Secretary as new scientific 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 Secretary 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 standards 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 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 facility pursuant to section 414.
`(3) SPECIFIC CONTROLS- In addition to complying 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 ensure the protection of the
public health.
`(4) TIERED IMPLEMENTATION- The Secretary shall require such a plan
for high-risk facilities first, and then for medium-risk facilities,
and then for low-risk facilities, as classified under subsection (a)(4).
`(c) Exceptions- In issuing regulations under subsection (a), the Secretary
may modify the good manufacturing process regulations if the Secretary
determines, for good cause shown and stated together with the regulations,
that for a specific product--
`(1) a modification of such provisions would be more effective to
prevent the contamination of, or promote the sanitation of, minimally
processed produce; or
`(2) the application of a portion of such provisions would not result
in the prevention of contamination of, or promotion of sanitation
of, minimally processed produce.
`(d) Effective Date- The regulations promulgated 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 REGULATIONS- 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).'.
(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 section 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 determined by the Secretary,
for facilities classified 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 compliance with the requirements
of this Act that relate to produce. Access to records may include
the copying of the records.
`(2) AUTHORITIES- In conducting such an inspection, 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 inspect 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,
operator, or agent in charge a written report setting forth any conditions
or practices observed that indicate 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 employee may order the produce
segregated, impounded, 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 expeditiously 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 considered to be a final agency action.
`(2) RELEASE- If the Secretary determines that, through relabeling
or other action, the produce can be brought into compliance with the
requirements 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 specified 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 review; 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 Secretary.
`(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--
`(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 facility 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 ingredients 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 requirements of this Act that relate to produce,
or to be causing human illness or injury;
`(ii) the identity and amount of ingredients 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.
`(2) AVAILABILITY OF RECORDS- The owner, operator, or agent shall--
`(A) make available, during an inspection conducted under subsection
(a), the records described in paragraph (1)(A); and
`(B) at the request of the Secretary, if the officer or employee
finds as a result of the inspection that produce from the facility
is associated with foodborne disease or poses an imminent health
hazard, make available for inspection the records described in paragraph
(1)(B).
`(3) REQUIRED DISCLOSURE- The owner, operator, or agent in charge
of a facility shall have an affirmative obligation to take corrective
action, including 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 material
in contact with produce are positive for any contaminant, 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.
`(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.'.
(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 inserting `section 704 or 704A'.
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 following:
`SEC. 402B. GOOD AGRICULTURAL PRACTICES FOR RAW AGRICULTURAL COMMODITIES.
`(a) Good Agricultural Practice Regulations-
`(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 requirements:
`(A) MANURE- Growers of a raw agriculture commodity shall--
`(i) manage the application of manure to ensure that it does not
contribute to the contamination of crops, including limitations
on the crops where and when manure may be applied; and
`(ii) monitor and maintain records relating to use of manure in
composting intended for use on food crops to ensure effective
controls are used to destroy pathogens.
`(B) ANIMALS, DOMESTIC AND WILDLIFE- Growers of a raw agricultural
commodity 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 agricultural 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.
`(D) ENVIRONMENTAL CONDITIONS- Growers of a raw agricultural commodity
shall consider the unique environmental conditions that might increase
the likelihood of crop contamination, 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 established under paragraph (1)
shall be based on risk assessment 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 hazards 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 grown at a facility, the facility's history
of compliance and food safety problems, and such other factors as
the Secretary may determine to be appropriate. Such risk classification
shall determine the specific standards and controls required at each
facility.
`(5) SCIENCE-BASED STANDARDS- The standards 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 Secretary shall require growers of a raw agricultural
commodity to have a written plan detailing the controls 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 agricultural practices developed
under subsection (a);
`(B) require recordkeeping to monitor compliance;
`(C) require sampling of product to be tested at a frequency and
in a manner commensurate 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 facility.
`(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 Secretary shall require such a plan
for high-risk facilities first, and then for medium-risk facilities,
and then for low-risk facilities, as classified under subsection (a)(4).
`(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 agricultural commodity.
`(2) RAW AGRICULTURAL COMMODITY- The term `raw agricultural commodity'
means a perishable 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 section 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 following:
`SEC. 704B. INSPECTIONS OF FACILITIES.
`(a) Nature of Inspections- Officers and employees 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 regulations promulgated
under subsection (b) shall take effect 3 years after the date of enactment
of this section.'.
(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 further 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. 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 Agriculture, the Director of the Centers for Disease Control and
Prevention, and the Administrator of the Environmental Protection Agency,
shall establish and maintain an active surveillance system, for surveillance
of a representative 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 Secretary of Agriculture, the Director of the Centers for Disease
Control and Prevention, and the Administrator of the Environmental
Protection Agency, shall establish guidelines for a sampling system
under which the Commissioner and the Secretary of Agriculture 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 nature, frequency of occurrence, and amounts of contaminants in
the produce.
(2) MONITORING AND OTHER INFORMATION- In carrying out the sampling
system, the Commissioner of Food and Drugs and the Secretary of Agriculture
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 consumers; and
(B) at the request of the Commissioner, the collection and analysis
of such other information, including analysis of information from
monitoring and verification samples, as the Commissioner determines
may be useful in assessing the occurrence of contaminants in produce.
(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, accurately
indicates that the produce has been appropriately processed, with
adequate sanitation; and
(B) a standard for the level of that substance that indicates that
the produce has been minimally processed as described in subparagraph
(A).
SEC. 202. PUBLIC EDUCATION SYSTEM.
The Commissioner of Food and Drugs and the Secretary of Agriculture,
in cooperation with private and public 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 manufacturing practice requirements relating
to food safety and promote public awareness, understanding, 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 industry, consumers, and other persons as the Commissioner
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 practices 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, harvesting, 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 processors and produce growers
in deciding what actions to take when contamination is found.
(b) Contract Authority- The Secretary of Agriculture is authorized to
enter into contracts and agreements 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 foreign countries that intend to export raw agricultural commodities
and minimally processed produce to the United States.
(b) Content- The Secretary, in consultation with the Secretary of Agriculture,
shall establish procedures to 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 amendments made by this Act) for each
fiscal year.
