FDA expands its support for states to implement FSMA Produce Safety Rule

Jul 13 2018

The U.S. Food and Drug Administration today announced new cooperative agreements with Hawaii, Kentucky and Mississippi, as well as renewed agreements with 43 other states, in support of efforts to implement the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

"Providing Americans with confidence in the safety of their fruits and vegetables is a major priority for the FDA, and states are a critical partner in implementing the Produce Safety Rule requirements that are designed to achieve these goals," said FDA Commissioner Scott Gottlieb, M.D. "Preventing contamination of produce consumed by Americans every day is a key part of the FDA's mission to protect and promote the public health. To support our partners in this important work, the FDA is providing the funding to help states implement produce safety standards in their farming communities. Congress recognized the need for funding to build an integrated food safety system, and we're pleased to be able to continue providing this assistance to our partners for a third year in a row."

The cooperative agreements announced today are a key part of implementing a modern produce safety system and developing and providing education, outreach and technical assistance to farmers who sell or import their products in the U.S. For growers of covered produce other than sprouts, the first major compliance date for large farms was in January 2018, except for the agricultural water requirements that are being re-examined. For the remainder of 2018, the FDA intends to support farmers through training and providing guidance on the rule's requirements in collaboration with the states and other partners. With routine inspections under the Produce Safety Rule set to begin in 2019, it is important to have as many state partners as possible participate in cooperative agreements with the FDA. In the future, states will use much of the cooperative agreement funding to conduct produce inspections.

Under the cooperative agreements' inspection component, the FDA anticipates that most inspections will be conducted by state partners. In addition, cooperative agreement funds are used for the state partners to conduct self-assessments to evaluate existing regulatory resources and food/produce safety programs and to determine infrastructure needs.

The recipients of the cooperative agreements are also developing inventories of farms covered by the Produce Safety Rule to target outreach, education and inspection activities. Recipients can use the funds to recruit personnel; evaluate educational needs and implement educational systems to create outreach programs to the farming community; deliver produce safety grower training; and conduct On-Farm Readiness Reviews (OFRRs). The OFRRs are a voluntary program to allow farmers to learn about the Produce Safety Rule and determine the level of preparedness of their farm for the rule's requirements.

The availability of funding to establish the cooperative agreement program was first announced in March 2016. Bids were open to all states and U.S. territories. The FDA announced the first cooperative agreements with 42 states in September 2016, and the second-year agreements, which included 43 states, were announced in July 2017. Today, the FDA is announcing $32.5 million in funding for the 46 states participating in the cooperative agreements.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.