U.S. Congress - Text of H.R.5620 as Introduced in House Fresh Produce Safety Act
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Donate NowH.R.5620 - Fresh Produce Safety Act
To establish a program to assure the safety of fresh produce intended for human consumption, and for other purposes.
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HR 5620 IHCommentsClose CommentsPermalink
To establish a program to assure the safety of fresh produce intended for human consumption, and for other purposes.CommentsClose CommentsPermalink
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 concernedCommentsClose CommentsPermalink
To establish a program to assure the safety of fresh produce intended for human consumption, and for other purposes.CommentsClose CommentsPermalink
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the `Fresh Produce Safety Act'.CommentsClose CommentsPermalink
(b) Table of Contents- The table of contents for this Act is as follows:CommentsClose CommentsPermalink
Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink
Sec. 2. Findings.CommentsClose CommentsPermalink
Sec. 3. Definitions.CommentsClose CommentsPermalink
TITLE I--FOOD SAFETY ACTIVITIES
Sec. 101. Administration of national program.CommentsClose CommentsPermalink
Subtitle A--Minimally Processed Produce
Sec. 111. Good manufacturing practices.CommentsClose CommentsPermalink
Sec. 112. Inspections of processors.CommentsClose CommentsPermalink
Subtitle B--Raw Agricultural Commodities
Sec. 121. Good agricultural practices.CommentsClose CommentsPermalink
Sec. 122. Inspections of facilities.CommentsClose CommentsPermalink
TITLE II--RESEARCH AND EDUCATION
Sec. 201. Public health assessment system.CommentsClose CommentsPermalink
Sec. 202. Public education system.CommentsClose CommentsPermalink
Sec. 203. Research.CommentsClose CommentsPermalink
TITLE III--IMPORTED PRODUCE AND OTHER PROVISIONS
Sec. 301. Imported produce.CommentsClose CommentsPermalink
Sec. 302. Authorization of appropriations.CommentsClose CommentsPermalink
SEC. 2. FINDINGS.
Congress finds that--CommentsClose CommentsPermalink
(1) consumption of fresh fruits and vegetables can promote health and prevent disease, and should be encouraged;CommentsClose CommentsPermalink
(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');CommentsClose CommentsPermalink
(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;CommentsClose CommentsPermalink
(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;CommentsClose CommentsPermalink
(5) outbreaks of food-borne illness associated with produce in the United States have been documented from both imported produce and domestically grown produce;CommentsClose CommentsPermalink
(6) large scale processing of produce can easily spread pathogens into minimally processed food and a single outbreak can affect hundreds of people;CommentsClose CommentsPermalink
(7) persons who process produce for human consumption have the responsibility to prevent or minimize food safety hazards related to their products;CommentsClose CommentsPermalink
(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; andCommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
SEC. 3. DEFINITIONS.
In this Act:CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(2) MINIMALLY PROCESS-CommentsClose CommentsPermalink
(A) IN GENERAL- The term `minimally process' means--CommentsClose CommentsPermalink
(i) to carry out the commercial preparation or manufacture of produce, including--CommentsClose CommentsPermalink
(I) the peeling, coring, stemming, trimming, mashing, or shredding of produce;CommentsClose CommentsPermalink
(II) the cutting of produce after harvesting;CommentsClose CommentsPermalink
(III) the preparation of fresh produce so to as to appear ready for consumption without further washing or preparation; andCommentsClose CommentsPermalink
(IV) the mixing or blending of minimally processed produce with other produce; andCommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(B) EXCEPTION- The term `minimally process' shall not apply to a raw agricultural commodity that is stemmed but not subject to further commercial preparation.CommentsClose CommentsPermalink
(3) PROCESSOR OF PRODUCE- The term `processor of produce' means a person that minimally processes produce.CommentsClose CommentsPermalink
(4) PRODUCE-CommentsClose CommentsPermalink
(A) IN GENERAL- The term `produce' means any perishable agricultural commodity, as defined in section 1(b) of the Perishable Agricultural Commodities Act, 1930 (
(B) INCLUSIONS- The term `produce' includes a mixture of--CommentsClose CommentsPermalink
(i) a commodity described in subparagraph (A); andCommentsClose CommentsPermalink
(ii) any other food, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (
(C) EXCLUSIONS- The term `produce' does not include--CommentsClose CommentsPermalink
(i) other food in the mixture described in subparagraph (B)(ii); andCommentsClose CommentsPermalink
(ii) an article used for food or drink for animals, or an article used for a component of such an article.CommentsClose CommentsPermalink
(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 (
(6) SECRETARY- The term `Secretary' means the Secretary of Health and Human Services.CommentsClose CommentsPermalink
TITLE I--FOOD SAFETY ACTIVITIES
SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.
(a) In General-CommentsClose CommentsPermalink
(1) NATIONAL PROGRAM- The Secretary shall administer a national program for the purpose of protecting human health by ensuring that--CommentsClose CommentsPermalink
(A) there are effective programs in place to assure the safety of produce minimally processed in the United States; andCommentsClose CommentsPermalink
(B) producers of raw agricultural commodities have effective programs in place to assure the safety of those commodities produced in the United States.CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(b) Program Elements- The program shall provide for implementation of the authorities described in--CommentsClose CommentsPermalink
(1) sections 402A, 402B, 704A, and 704B of the Federal Food, Drug, and Cosmetic Act, as added by subtitles A and B; andCommentsClose CommentsPermalink
(2) title II.CommentsClose CommentsPermalink
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 (
`SEC. 402A. GOOD MANUFACTURING PRACTICES FOR PRODUCE.
`(a) Good Manufacturing Practice Regulations-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(2) CONTENT- The regulations issued under paragraph (1) shall include the following requirements:CommentsClose CommentsPermalink
`(A) SANITATION- Processors of produce shall--CommentsClose CommentsPermalink
`(i) establish mandatory sanitation standard operating procedures, including cleaning procedures for equipment, storage areas, air systems, and water storage areas;CommentsClose CommentsPermalink
`(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; andCommentsClose CommentsPermalink
`(iii) ensure--CommentsClose CommentsPermalink
`(I) controlled access to the facility and to processing areas;CommentsClose CommentsPermalink
`(II) adequate space for operations;CommentsClose CommentsPermalink
`(III) adequate drainage of processing and wash water;CommentsClose CommentsPermalink
`(IV) food contact surfaces that are easy to clean and maintain;CommentsClose CommentsPermalink
`(V) that areas and structures designed to protect the product and equipment from contamination; andCommentsClose CommentsPermalink
`(VI) that sanitation standards established in clause (i) are adhered to in the transportation of minimally processed produce to the extent practicable.CommentsClose CommentsPermalink
`(B) WATER-CommentsClose CommentsPermalink
`(i) IN GENERAL- Processors of produce shall ensure that--CommentsClose CommentsPermalink
`(I) the water supply used in food processing plants is suitable for its intended use;CommentsClose CommentsPermalink
`(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; andCommentsClose CommentsPermalink
`(III) each sanitizer used for washing vegetables is appropriate for its intended use.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(C) ADDITIONAL REQUIREMENTS- Other requirements as determined appropriate by the Secretary.CommentsClose CommentsPermalink
`(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--CommentsClose CommentsPermalink
`(A) identification of existing and potential hazards at facilities;CommentsClose CommentsPermalink
`(B) evaluation of human health risks posed by hazards identified in subparagraph (A); andCommentsClose CommentsPermalink
`(C) proposed controls to minimize hazards based on subparagraph (B).CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(5) SCIENCE-BASED STANDARDS- The standards established under paragraph (1) shall--CommentsClose CommentsPermalink
`(A) reflect the best available science; andCommentsClose CommentsPermalink
`(B) be subject to change through regulations promulgated by the Secretary as new scientific evidence on risk becomes available.CommentsClose CommentsPermalink
`(b) Implementation Plan for Processors-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(2) CONTENT- A plan under paragraph (1) shall--CommentsClose CommentsPermalink
`(A) address good manufacturing standards set forth by the Secretary;CommentsClose CommentsPermalink
`(B) require recordkeeping to monitor compliance;CommentsClose CommentsPermalink
`(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; andCommentsClose CommentsPermalink
`(D) provide access to the Food and Drug Administration to records maintained by the facility pursuant to section 414.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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).CommentsClose CommentsPermalink
`(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--CommentsClose CommentsPermalink
`(1) a modification of such provisions would be more effective to prevent the contamination of, or promote the sanitation of, minimally processed produce; orCommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(d) Effective Date- The regulations promulgated under subsection (a) shall take effect 2 years after the date of enactment of this section.CommentsClose CommentsPermalink
`(e) Definitions- In this section:CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(2) FACILITY- The term `facility' includes any factory, warehouse, or establishment, in which produce is minimally processed.CommentsClose CommentsPermalink
`(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 (
(b) Violation- Section 402 of the Federal Food, Drug, and Cosmetic Act (
`(j) It is an article of produce processed in violation of section 402A.'.CommentsClose CommentsPermalink
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 (
`SEC. 704A. INSPECTIONS OF PROCESSORS.
`(a) Nature of Inspections-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(2) SCHEDULE- The Secretary shall establish a schedule for the unannounced inspections, which shall provide for--CommentsClose CommentsPermalink
`(A) inspections at least once per growing season for facilities classified as high-risk under section 402A(a)(4); andCommentsClose CommentsPermalink
`(B) less frequent inspections, as determined by the Secretary, for facilities classified as medium- or low-risk facilities under section 402A(a)(4).CommentsClose CommentsPermalink
`(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).CommentsClose CommentsPermalink
`(b) Conduct of Inspections-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(c) Product Detention and Condemnation-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(3) DESTRUCTION- Any minimally processed produce condemned under paragraph (1)--CommentsClose CommentsPermalink
`(A) in a case in which no objection is made under paragraph (1);CommentsClose CommentsPermalink
`(B) after the hearing and any judicial review; orCommentsClose CommentsPermalink
`(C) after failure of the owner, operator, or agent to perform relabeling or other action described in paragraph (2),CommentsClose CommentsPermalink
shall be destroyed under supervision of the Secretary.CommentsClose CommentsPermalink
`(d) Maintenance of Records-CommentsClose CommentsPermalink
`(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--CommentsClose CommentsPermalink
`(A)(i) the origin, receipt, delivery, sale, movement, holding, and disposition of produce minimally processed at the facility;CommentsClose CommentsPermalink
`(ii) the minimal processing of the produce; andCommentsClose CommentsPermalink
`(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; andCommentsClose CommentsPermalink
`(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;CommentsClose CommentsPermalink
`(ii) the identity and amount of ingredients used in the produce;CommentsClose CommentsPermalink
`(iii) the results of laboratory, sanitation, or other quality control tests performed on the produce or in the facility; andCommentsClose CommentsPermalink
`(iv) consumer complaints concerning the safety of the produce or the packaging of the produce.CommentsClose CommentsPermalink
`(2) AVAILABILITY OF RECORDS- The owner, operator, or agent shall--CommentsClose CommentsPermalink
`(A) make available, during an inspection conducted under subsection (a), the records described in paragraph (1)(A); andCommentsClose CommentsPermalink
`(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).CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(e) Definitions-CommentsClose CommentsPermalink
`(1) FACILITY- The term `facility' includes any factory, warehouse, or establishment, in which produce is minimally processed.CommentsClose CommentsPermalink
`(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.'.CommentsClose CommentsPermalink
(b) Remedies-CommentsClose CommentsPermalink
(1) IN GENERAL- Paragraphs (f) and (n) of section 301, and section 304(g)(1), of the Federal Food, Drug, and Cosmetic Act (
(2) PROHIBITED DISCLOSURES- Section 301(j) of the Federal Food, Drug, and Cosmetic Act (
(c) Conforming Amendment- Section 742(a)(2) of the Federal Food, Drug, and Cosmetic Act (
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:CommentsClose CommentsPermalink
`SEC. 402B. GOOD AGRICULTURAL PRACTICES FOR RAW AGRICULTURAL COMMODITIES.
`(a) Good Agricultural Practice Regulations-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(2) CONTENTS- The regulations issued under paragraph (1) shall include the following requirements:CommentsClose CommentsPermalink
`(A) MANURE- Growers of a raw agriculture commodity shall--CommentsClose CommentsPermalink
`(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; andCommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(E) ADDITIONAL REQUIREMENTS- Other requirements as determined appropriate by the Secretary.CommentsClose CommentsPermalink
`(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--CommentsClose CommentsPermalink
`(A) identification of existing and potential hazards at facilities;CommentsClose CommentsPermalink
`(B) evaluation of human health risks posed by hazards identified in subparagraph (A); andCommentsClose CommentsPermalink
`(C) proposed controls to minimize hazards based on subparagraph (B).CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(5) SCIENCE-BASED STANDARDS- The standards established under paragraph (1) shall--CommentsClose CommentsPermalink
`(A) reflect the best available science; andCommentsClose CommentsPermalink
`(B) be subject to change as new scientific evidence on risk becomes available.CommentsClose CommentsPermalink
`(b) Implementation Plan-CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(2) CONTENT- A plan under paragraph (1) shall--CommentsClose CommentsPermalink
`(A) address standards for good agricultural practices developed under subsection (a);CommentsClose CommentsPermalink
`(B) require recordkeeping to monitor compliance;CommentsClose CommentsPermalink
`(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; andCommentsClose CommentsPermalink
`(D) provide access to the Food and Drug Administration to records maintained by the facility.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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).CommentsClose CommentsPermalink
`(c) Effective Date- The regulations described in subsection (a) shall take effect 2 years after the date of enactment of this section.CommentsClose CommentsPermalink
`(d) Definitions- In this section:CommentsClose CommentsPermalink
`(1) FACILITY- The term `facility' means a farm or other facility of a grower of a raw agricultural commodity.CommentsClose CommentsPermalink
`(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 (
(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'.CommentsClose CommentsPermalink
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:CommentsClose CommentsPermalink
`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.CommentsClose CommentsPermalink
`(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.CommentsClose CommentsPermalink
`(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.'.CommentsClose CommentsPermalink
(b) Remedies-CommentsClose CommentsPermalink
(1) IN GENERAL- Paragraphs (f) and (n) of section 301, and section 304(g)(1), of the Federal Food, Drug, and Cosmetic Act (
(2) PROHIBITED DISCLOSURES- Section 301(j) of the Federal Food, Drug, and Cosmetic Act (
(c) Conforming Amendment- Section 742(a)(2) of the Federal Food, Drug, and Cosmetic Act (
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.CommentsClose CommentsPermalink
(b) Public Health Sampling-CommentsClose CommentsPermalink
(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 (
(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--CommentsClose CommentsPermalink
(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; andCommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
(3) PROCESS VERIFICATION STANDARD- The Commissioner of Food and Drugs and the Secretary of Agriculture shall conduct sampling to identify--CommentsClose CommentsPermalink
(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; andCommentsClose CommentsPermalink
(B) a standard for the level of that substance that indicates that the produce has been minimally processed as described in subparagraph (A).CommentsClose CommentsPermalink
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--CommentsClose CommentsPermalink
(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; andCommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
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 (
(1) improving sanitation and food safety practices in the minimal processing of produce;CommentsClose CommentsPermalink
(2) developing improved techniques for the monitoring of produce and inspection of produce;CommentsClose CommentsPermalink
(3) developing efficient, rapid, and sensitive methods for determining and detecting the presence of contaminants in produce;CommentsClose CommentsPermalink
(4) determining the sources of contamination of produce, including contamination from growing, harvesting, and minimal processing produce and post-processing contamination of produce;CommentsClose CommentsPermalink
(5) developing consumption data with respect to produce (including minimally processed produce); andCommentsClose CommentsPermalink
(6) mitigation strategies to aid produce processors and produce growers in deciding what actions to take when contamination is found.CommentsClose CommentsPermalink
(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.CommentsClose CommentsPermalink
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.CommentsClose CommentsPermalink
(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).CommentsClose CommentsPermalink
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.CommentsClose CommentsPermalink
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