Produce Safety Act of 2007 - Section by Section

This section by section analysis of the bill provided by Sen. Tom Harkin's office:

Fresh Produce Safety Act of 2007

Section 1: Short title and table of contents

Section 2: Findings
Provides background on the importance of promoting the consumption of fresh fruits and vegetables, and how a greater assurance of food safety in produce is needed to continue to call on Americans to eat produce. Recognizes the need for a risk-based food safety framework for fresh produce.

Section 3: Definitions
Provides definitions for terms used throughout the bill, such as the terms contaminant, minimally process (fresh-cut), processor of produce (only includes those who minimally process produce), produce, and Secretary. Specifically, minimally process includes what consumers and industry know as “fresh-cut.”

Title I – Food Safety Activities

Section 101: Administration of national program
Establishes a national program to assure the safety of fresh, raw produce, both unprocessed and minimally processed. The program will take into consideration differences in practices and levels of risk associated with the production and minimal processing of produce.

Subtitle A – Minimally Processed Produce

Section 111: Good manufacturing practices
Requires the secretary to establish good manufacturing standards through rulemaking for good manufacturing practices for the minimal processing of produce. The standards will include sanitation standard operating procedures, water standards and water sampling programs, and other requirements as determined by the Secretary. The standards established will reflect the best available science and will be based on risk assessment tools and metrics developed by FDA, in consultation with USDA, and the processors of produce. As new scientific evidence on risk becomes available, the Secretary is authorized to change standards through rulemaking.

The Secretary of Health and Human Services will classify facilities as high-, medium-, or low-risk according to risk assessments, and these will determine what specific standards and controls each facility will have in place.

Every processor of produce as defined in the Act will have a written plan detailing the controls used to limit the presence and growth of contaminants, which will address the good manufacturing standards set by the Secretary, require recordkeeping to monitor compliance, and require sampling of products, if appropriate and sufficient to ensure that the standards are effective. Processors will provide access of these records to FDA. The written plan requirement will be implemented by tiers, from high- to low-risk facilities, with low-risk facilities being the last to implement such a plan.

An article of produce processed in violation of this section is prohibited under the Federal Food, Drug, and Cosmetic Act.

Section 112: Inspections of processors

Requires the Secretary of Health and Human Services to inspect facilities that minimally process produce to monitor compliance with requirements of this Act. Inspections will be at least once per growing season for high-risk facilities, and less frequently for medium- and low-risk facilities as deemed by the Secretary. Each inspection will include an evaluation of whether the facility is appropriately classified by risk. Within 48 hours of the inspection, the owner or operator of the facility will receive a report setting forth any conditions of practices observed that indicate any violations of this Act.

If during the inspection, the inspector determines that the produce is in violation of this Act, the inspector may order the produce segregated, impounded, and if no objection is made within 48 hours, condemned. If an objection is made, the Secretary shall hold a hearing within 24 hours after the objection. The Secretary will determine the fate of the produce after the hearing, which may include a release of the produce after corrective action is taken, or destruction of the produce if no corrective action is taken.

The processor must maintain records as prescribed by the Secretary. The records must include origin, receipt, delivery, sale, movement, holding, and disposition of produce minimally processed at the facility, other information to facilitate traceback of produce, and other matters reasonably related to whether the food product produced at the facility may be in violation of this Act. These records must be made available during an inspection.

If testing finds a positive test result the processor must ensure that corrective action is taken, including ensuring the product is not introduced into commerce. If the product is in commerce, the processor must disclose the results to the Secretary or FDA, and.

Subtitle B – Raw Agricultural Commodities

Section 121: Good agricultural practices

Requires the secretary to establish general standards through rulemaking for good agricultural practices for the production of raw agricultural commodities. The standards will include manure application management, the exclusion of domestic animals to the extent reasonable practicable during the growing and harvesting season, water standards and ground water monitoring, consideration for environmental conditions such as flooding and runoff, and other requirements as determined by the Secretary. The standards established will reflect the best available science and will be based on risk assessment tools and metrics developed by FDA, in consultation with USDA, and the processors of produce. As new scientific evidence on risk becomes available, the Secretary is authorized to change standards through rulemaking.

The Secretary of Health and Human Services will classify facilities as high-, medium-, or low-risk according to risk assessments, and these will determine what specific standards and controls each facility will have in place.

Every grower of produce will have a written plan detailing the controls used to limit the presence and growth of contaminants, which will address the good agricultural practices set by the Secretary, require recordkeeping to monitor compliance, and require sampling of products, if appropriate and sufficient to ensure that the standards are effective. Processors will provide access of these records to FDA. The written plan requirement will be implemented by tiers, from high- to low-risk facilities, with low-risk facilities being the last to implement such a plan.

An article of produce processed in violation of this section is prohibited under the Federal Food, Drug, and Cosmetic Act.

Section 122: Inspections of facilities

Requires the Secretary of Health and Human Services to promulgate regulations to establish procedures for the inspection of facilities that grow raw agricultural commodities to monitor compliance with requirements of this Act.

Title II – Research and Education

Section 201: Public health assessment system

Establishes an active surveillance system to assess more accurately the frequency and sources of human illness in the United States associated with the consumption of fresh produce. The surveillance system will be established and maintained by FDA, CDC, and EPA. The surveillance system will include collection and analyses of samples of fresh produce, both minimally processed and unprocessed, to assess more accurately the nature, frequency of occurrence, and amounts of contaminants in fresh produce. For minimally processed product, the sampling and testing will also be used to identify a contaminant or other substance commonly found on minimally processed produce that, when present at low levels, accurately indicates the produce has been appropriately process with adequate sanitation.

Section 202: Public education system

Establishes a FDA-USDA national public education program on food safety related to produce. The program will provide public information on federal standards and good manufacturing and good agricultural practices relating to food safety. The program will provide this and other information or advice to persons that work with minimally processed produce, the food service and retail industry, and consumers.

Section 203: Research

Authorizes the Secretary of Agriculture, in consultation with FDA, to conduct research on improving food safety in produce.

Title III – Imported Produce and other provisions

Section 301: Imported produce

Requires the Secretary of Health and Human Services, in consultation with USDA, to promulgate regulations for equivalency with foreign countries that export fresh produce to the United States. As part of the regulations, the Secretaries will establish procedures to require that imported fresh produce meets the criteria established in this Act.

Section 302: Authorization of appropriations

Authorized appropriations for the implementation and conduct of activities in this Act.

Fresh Produce Safety Act of 2007

The Fresh Produce Safety Act of 2007 will be introduced by Senator Harkin. With the rising number of food-borne illness outbreaks associated with fresh produce, and with the promotion of fruits and vegetables as a healthful addition to the American diet, there is a need for a national food safety framework for all fresh produce. This legislation:
Establishes a national program to assure the safety of fresh, raw produce, both unprocessed and minimally processed (including fresh-cut).
Requires FDA to promulgate rule-making to set mandatory good agricultural and good manufacturing practices tailored to the risks of specific commodities.
Requires FDA to conduct risk assessments of growers and processors to determine the specific standards and controls that each facility should have in place
Requires inspections of growers and minimal processors (fresh-cut) of fresh produce
Establishes a public health assessment system to assess more accurately the frequency and sources of human illness in the United States associated with the consumption of fresh produce.
Establishes a joint FDA-USDA national public education program on food safety related to produce that will provide public information on federal standards to persons that work with minimally processed (fresh-cut) produce, the food service and retail industry, and consumers.
Establishes a research program at USDA to improve food safety in fresh produce.
Requires regulations for equivalency with foreign countries that export fresh produce to the United States to ensure that imported fresh produce meets the criteria established in this Act.