I
110th CONGRESS
2d Session
H. R. 5620
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.
Short title; table of contents
Short title
This Act may be cited as the Fresh Produce Safety Act
.
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.
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.
Findings
Congress finds that—
consumption of fresh fruits and vegetables can promote health and prevent disease, and should be encouraged;
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
);
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;
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;
outbreaks of food-borne illness associated with produce in the United States have been documented from both imported produce and domestically grown produce;
large scale processing of produce can easily spread pathogens into minimally processed food and a single outbreak can affect hundreds of people;
persons who process produce for human consumption have the responsibility to prevent or minimize food safety hazards related to their products;
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
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.
Definitions
In this Act:
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.
Minimally process
In general
The term minimally process means—
to carry out the commercial preparation or manufacture of produce, including—
the peeling, coring, stemming, trimming, mashing, or shredding of produce;
the cutting of produce after harvesting;
the preparation of fresh produce so to as to appear ready for consumption without further washing or preparation; and
the mixing or blending of minimally processed produce with other produce; and
does not include carrying out the harvesting, washing (except as provided in clause (i)(III)), waxing, packing, or sorting, of a raw agricultural commodity.
Exception
The term minimally process shall not apply to a raw agricultural commodity that is stemmed but not subject to further commercial preparation.
Processor of produce
The term processor of produce means a person that minimally processes produce.
Produce
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)).
Inclusions
The term produce includes a mixture of—
a commodity described in subparagraph (A); and
any other food, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
Exclusions
The term produce does not include—
other food in the mixture described in subparagraph (B)(ii); and
an article used for food or drink for animals, or an article used for a component of such an article.
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).
Secretary
The term Secretary means the Secretary of Health and Human Services.
Food safety activities
Administration of national program
In general
National program
The Secretary shall administer a national program for the purpose of protecting human health by ensuring that—
there are effective programs in place to assure the safety of produce minimally processed in the United States; and
producers of raw agricultural commodities have effective programs in place to assure the safety of those commodities produced in the United States.
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.
Program elements
The program shall provide for implementation of the authorities described in—
sections 402A, 402B, 704A, and 704B of the Federal Food, Drug, and Cosmetic Act, as added by subtitles A and B; and
title II.
Minimally processed produce
Good manufacturing practices
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:
Good manufacturing practices for produce
Good manufacturing practice regulations
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.
Content
The regulations issued under paragraph (1) shall include the following requirements:
Sanitation
Processors of produce shall—
establish mandatory sanitation standard operating procedures, including cleaning procedures for equipment, storage areas, air systems, and water storage areas;
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
ensure—
controlled access to the facility and to processing areas;
adequate space for operations;
adequate drainage of processing and wash water;
food contact surfaces that are easy to clean and maintain;
that areas and structures designed to protect the product and equipment from contamination; and
that sanitation standards established in clause (i) are adhered to in the transportation of minimally processed produce to the extent practicable.
Water
In general
Processors of produce shall ensure that—
the water supply used in food processing plants is suitable for its intended use;
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
each sanitizer used for washing vegetables is appropriate for its intended use.
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.
Additional requirements
Other requirements as determined appropriate by the Secretary.
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—
identification of existing and potential hazards at facilities;
evaluation of human health risks posed by hazards identified in subparagraph (A); and
proposed controls to minimize hazards based on subparagraph (B).
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.
Science-based standards
The standards established under paragraph (1) shall—
reflect the best available science; and
be subject to change through regulations promulgated by the Secretary as new scientific evidence on risk becomes available.
Implementation plan for processors
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.
Content
A plan under paragraph (1) shall—
address good manufacturing standards set forth by the Secretary;
require recordkeeping to monitor compliance;
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
provide access to the Food and Drug Administration to records maintained by the facility pursuant to section 414.
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.
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).
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—
a modification of such provisions would be more effective to prevent the contamination of, or promote the sanitation of, minimally processed produce; or
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.
Effective date
The regulations promulgated under subsection (a) shall take effect 2 years after the date of enactment of this section.
Definitions
In this section:
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.
Facility
The term facility includes any factory, warehouse, or establishment, in which produce is minimally processed.
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).
.
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:
It is an article of produce processed in violation of section 402A.
.
Inspections of processors
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:
Inspections of processors
Nature of inspections
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.
Schedule
The Secretary shall establish a schedule for the unannounced inspections, which shall provide for—
inspections at least once per growing season for facilities classified as high-risk under section 402A(a)(4); and
less frequent inspections, as determined by the Secretary, for facilities classified as medium- or low-risk facilities under section 402A(a)(4).
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).
Conduct of inspections
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.
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.
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.
Product detention and condemnation
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.
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.
Destruction
Any minimally processed produce condemned under paragraph (1)—
in a case in which no objection is made under paragraph (1);
after the hearing and any judicial review; or
after failure of the owner, operator, or agent to perform relabeling or other action described in paragraph (2),
Maintenance of records
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—
the origin, receipt, delivery, sale, movement, holding, and disposition of produce minimally processed at the facility;
the minimal processing of the produce; and
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
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;
the identity and amount of ingredients used in the produce;
the results of laboratory, sanitation, or other quality control tests performed on the produce or in the facility; and
consumer complaints concerning the safety of the produce or the packaging of the produce.
Availability of records
The owner, operator, or agent shall—
make available, during an inspection conducted under subsection (a), the records described in paragraph (1)(A); and
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).
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.
Definitions
Facility
The term facility includes any factory, warehouse, or establishment, in which produce is minimally processed.
Minimally process; produce
The terms minimally process and produce have the meanings given those terms in section 3 of the Fresh Produce Safety Act.
.
Remedies
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
.
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,
.
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
.
Raw agricultural commodities
Good agricultural practices
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:
Good agricultural practices for raw agricultural commodities
Good agricultural practice regulations
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.
Contents
The regulations issued under paragraph (1) shall include the following requirements:
Manure
Growers of a raw agriculture commodity shall—
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
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.
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.
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.
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.
Additional requirements
Other requirements as determined appropriate by the Secretary.
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—
identification of existing and potential hazards at facilities;
evaluation of human health risks posed by hazards identified in subparagraph (A); and
proposed controls to minimize hazards based on subparagraph (B).
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.
Science-based standards
The standards established under paragraph (1) shall—
reflect the best available science; and
be subject to change as new scientific evidence on risk becomes available.
Implementation plan
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.
Content
A plan under paragraph (1) shall—
address standards for good agricultural practices developed under subsection (a);
require recordkeeping to monitor compliance;
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
provide access to the Food and Drug Administration to records maintained by the facility.
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.
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).
Effective date
The regulations described in subsection (a) shall take effect 2 years after the date of enactment of this section.
Definitions
In this section:
Facility
The term facility means a farm or other facility of a grower of a raw agricultural commodity.
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.
.
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
.
Inspections of facilities
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:
Inspections of facilities
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.
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.
Effective date
Subsection (a) and the regulations promulgated under subsection (b) shall take effect 3 years after the date of enactment of this section.
.
Remedies
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
.
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,
.
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
.
Research and education
Public health assessment system
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.
Public health sampling
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.
Monitoring and other information
In carrying out the sampling system, the Commissioner of Food and Drugs and the Secretary of Agriculture shall provide for—
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
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.
Process verification standard
The Commissioner of Food and Drugs and the Secretary of Agriculture shall conduct sampling to identify—
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
a standard for the level of that substance that indicates that the produce has been minimally processed as described in subparagraph (A).
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—
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
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.
Research
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—
improving sanitation and food safety practices in the minimal processing of produce;
developing improved techniques for the monitoring of produce and inspection of produce;
developing efficient, rapid, and sensitive methods for determining and detecting the presence of contaminants in produce;
determining the sources of contamination of produce, including contamination from growing, harvesting, and minimal processing produce and post-processing contamination of produce;
developing consumption data with respect to produce (including minimally processed produce); and
mitigation strategies to aid produce processors and produce growers in deciding what actions to take when contamination is found.
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.
Imported produce and other provisions
Imported produce
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.
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).
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.