Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on advancing new tools and science for implementing agricultural water requirements for produce safety

As FDA finalizes previously proposed extensions to compliance dates for agricultural water requirements, the agency is providing an update on how it is using the additional time to ensure the feasibility of federal requirements and incorporate lessons learned from recent romaine lettuce outbreaks.

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U.S. Food and Drug Administration

Mar 15, 2019, 11:21 ET

SILVER SPRING, Md., March 15, 2019 /PRNewswire/ -- A critical component to growing, harvesting, packing and holding of fruits and vegetables for human consumption involves the use of agricultural water—water that's likely to come into contact with produce or food contact surfaces. This can include water used to grow crops, to clean harvested crops, and water sprayed on harvested produce in order to prevent dehydration. Because water can carry pathogens that can potentially contaminate crops, agricultural water is a known on-farm route of produce contamination. It can be a potential source of contamination as well as a means by which contamination can spread.

Farmers may have numerous water sources available to them, including ground water sources like wells, and different surface water sources like ponds, rivers, creeks and canals. There are also upstream land and water uses that are beyond the control of growers that may impact agricultural water. The food safety landscape is shifting, in part, through our work to change the prevention paradigm with the implementation of preventative measures as part of the landmark FDA Food Safety Modernization Act (FSMA), and new tools we now have that enable us to further bolster the nation's food safety system. The diversity of how farmers source water used in the growing, harvesting, and packing and holding of produce can contribute to the challenges in implementing measures to efficiently mitigate potential risks.

An important part of FSMA's Produce Safety Rule includes agricultural water requirements for produce subject to the rule. These requirements are critical because we know safe produce and safe agricultural water go hand in hand. The Produce Safety Rule for the first time set forth science-based standards for the safe growing, harvesting, packing and holding of fruits and vegetables. Over the last three years, as we've worked closely with farmers to implement this rule, we've identified areas of the rule's agricultural water requirements that may need refinement or explanation to ensure they are protective of public health. We need to ensure that standards are strong enough to protect public health, but practical enough to be effectively implemented on farms. To fully achieve these goals, we've previously outlined in detail, in a proposed rule, why additional time is needed.

In September 2017, we proposed to delay the compliance dates for the rule's agricultural water requirements. Today, we're re-affirming our commitment to stick to that revised schedule and providing an update on our progress toward this goal. Specifically, we're announcing a final rule to formally extend compliance dates for the rule's agricultural water requirements for large farms to January 2022, small farms to January 2023, and very small farms to January 2024. This extension period is applicable to all produce subject to the Produce Safety Rule's requirements, other than for sprouts, which were required to meet compliance dates that have passed. The final rule's compliance date extensions have been previously announced in the proposed rule. The dates have not changed, and we are committed to this schedule, and making sure no further extensions are needed. The extension is designed to provide additional time to ensure the FDA applies the best thinking to clarify standards for pre-harvest microbial water quality and to continue working closely with produce farmers on sensible approaches to protect consumers. While the produce industry has adopted many measures to promote the safety of agricultural water, we want to make sure that federal requirements reflect the most modern, robust, and practical measures.

The final rule, "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E," finalizes the compliance date extensions related to agricultural water, but produce remains subject to all the other requirements in the rule, as well as the adulteration provisions of the Federal Food, Drug and Cosmetic Act. We continue to work with stakeholders on the agricultural water requirements, and efforts to make sure that water is suitable for its intended use, and that farms continue using good agricultural practices to maintain and protect the quality of their water sources, and ensure that the food they produce is not adulterated under the FD&C Act.

We know that fresh produce is an important part of an overall healthy diet and the vast majority of fresh produce we eat is safe. Unfortunately, foodborne illnesses and outbreaks are still being linked to fresh produce. This includes romaine lettuce.

We recently issued an environmental assessment following our investigation into a spring 2018 multi-state outbreak of E. coli O157:H7 infections linked to romaine lettuce from the Yuma growing region. Our environmental assessment noted that this outbreak most likely occurred from water used on multiple farms from a contaminated irrigation canal. A separate investigation was launched following a different outbreak announced last fall linked to romaine lettuce grown in certain California counties. Our investigation report on last fall's outbreak outlined how the strain of E. coli O157:H7 associated with this outbreak was found in the sediment of one farm's water reservoir, suggesting the pathogen may have lingered in the environment or was repeatedly introduced into the environment.

The additional time provided by the extension of the compliance dates for the agricultural water requirements will allow the FDA and the produce industry to apply lessons learned from these recent outbreaks and adopt the best thinking as we continue to build upon our nation's food safety practices. Our ultimate goal is to better protect fresh produce from contamination.

The two, recent outbreaks involving romaine lettuce also highlight the differences in the production of just one type of a subset of produce. We know that the produce farming community is diverse, as are farming practices across our country and around the world. We've learned about some of the unique challenges farmers face in implementing these new FSMA requirements. That's why it's so important to make sure that our agricultural water standards work across the variety of farms, commodities and regions.

To accomplish this important goal, the agency will incorporate the lessons we've learned from consulting with experts in produce safety, water systems, and water microbiology, from both the public and private sectors on the very latest scientific developments and what we've learned from the recent outbreaks. We'll also incorporate the information we've learned from visiting farms throughout the country and our dialogue with our state and regional contacts to solidify our steps related to agricultural water.

Our primary goal is the protection of public health, including protection of consumers. This is at the heart of our mission. Ultimately, we'll implement requirements that are modern, efficient, rigorous, and achievable. We remain firmly committed to science-based requirements directed to agricultural water to minimize the risk to public health. We look forward to continued engagement with stakeholders in the coming months as we further consider the path forward on agricultural water. The FDA, our state and international regulatory partners and the produce industry all have shared food safety goals. We'll continue working collaboratively to enhance the safety of the produce Americans enjoy.

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.

Media Inquiries: Lindsay Haake, 301-796-3007, [email protected]
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SOURCE U.S. Food and Drug Administration