FDA Announces New Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water

FDA News Release

• For Immediate Release: July 30, 2020

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Today, the U.S. Food and Drug Administration announced a new protocol for the development and registration of antimicrobial treatments for preharvest agricultural water, such as the water used in farm irrigation systems. The protocol was developed through a collaboration with the U.S. Environmental Protection Agency. Companies can now use data developed under this protocol to support the EPA registration of products that can treat agricultural water against foodborne bacteria, which could provide farmers with a useful tool to help protect the safety of produce intended for consumers, like romaine lettuce and other leafy greens.

The announcement was made during a webinar on the FDA’s 2020 Leafy Green STEC Action Plan.

“This new protocol is a huge milestone for produce safety and for the Leafy Green Action Plan released by the FDA earlier this year. Working together, the FDA and EPA have supported the development of this protocol that may ultimately help farmers address contamination issues in their water sources and protect consumers from foodborne illness,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. “We must all work together to help ensure the safety of produce to consumers across the country. We will continue to work with our partners in industry, government and academia on this and other longer-term studies on the ecology of human pathogens in specific growing regions, and new efforts as part of the New Era of Smarter Food Safety Initiative.”

“Thanks to the strong partnership between EPA and the FDA, we can now unleash the innovation needed to develop treatment products for the agricultural water used to irrigate our nation’s leafy greens,” said Alexandra Dapolito Dunn, assistant administrator of EPA's Office of Chemical Safety and Pollution Prevention. “We look forward to working with pesticide product manufacturers, innovators, and farmers on this important development that will help protect public health and our environment.”

EPA’s approval of this protocol allows for companies to develop data on the effectiveness of their products in inactivating foodborne bacteria, such as E. coli or Salmonella, in preharvest agricultural water. Companies may use the data developed to support registration of new treatment products, or amendments to current products’ labels, for use against microbial contamination in preharvest agricultural water.

Recent outbreaks of foodborne illness associated with the consumption of romaine lettuce and other leafy greens have highlighted the need for a viable option for treating agricultural water against foodborne pathogens. While farmers are not required to treat their agricultural water, these treatments could be a valuable tool to help farmers protect the safety of their produce. There currently are no registered antimicrobial treatment products that are authorized for use on agricultural fields, or for treatment of irrigation water systems or ponds. This protocol is an important step toward addressing this lack of available treatments for preharvest agricultural water.

Teams of FDA experts have been working collaboratively with partners in the public and private sectors to help protect agricultural water from the many ways it can be contaminated in the environment or from unsanitary practices on a farm. This effort has included hundreds of farm visits over the past few years. In addition, the FDA intends to release a proposed rule in late 2020, to revise certain agricultural water requirements in the Produce Safety Rule and to address practical implementation challenges while protecting public health. The development and approval of this treatment protocol is one of several steps the agency has taken or intends to take to help improve produce safety, such as through the Leafy Green Action Plan and through the New Era of Smarter Food Safety initiative.

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.