For immediate release:

Today, the United States Food and Drug Administration released a proposed rule which aims to improve product safety. He proposes to require farms to conduct comprehensive assessments that would help them identify and mitigate the dangers of water used to grow produce. This is the latest step in the agency’s implementation of the Food Safety Modernization Act (FSMA) of the FDA, and it proposes to replace some of the existing requirements for agricultural water in the Produce the safety rule (PSR).

“There have been far too many outbreaks of foodborne illness likely related to pre-harvest agricultural water in recent years, including water from land near production farms. As the federal government agency charged with protecting public health, the FDA is committed to implementing modern and effective scientific measures designed to prevent these epidemics from occurring in the future, ”said Frank Yiannas, Commissioner FDA Assistant for Food Policy and Response. “The proposed rule is the latest step taken by the FDA to continue working on the implementation of key FSMA provisions. If finalized, we are confident that this proposal would lead to fewer product-related epidemics in the United States, protecting public health and saving lives. This proposed rule is a monumental step toward improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA is eager to engage with stakeholders on the proposed changes.

The proposed rule, if finalized, would change some pre-harvest agricultural water requirements for products and farms subject to ESP, other than germination operations. Key provisions of the proposed rule include:

  • A requirement for farms to manage the quality of their agricultural water based on the results of a comprehensive systems assessment (“agricultural water assessment”) that is adaptable to the wide variety of sources and uses of water and future scientific advancements.
  • An annual assessment by farms of their agricultural water before harvest to identify conditions that may introduce hazards in or on covered produce or food contact surfaces. Based on these assessments, farms would then determine whether corrective or mitigation actions are reasonably necessary to reduce the potential for contamination. The assessment would include an assessment of the farm’s water supply system, agricultural water use practices, crop characteristics, environmental conditions, and other relevant factors, such as outcomes. any tests performed to inform the assessment.
  • A requirement that farms implement accelerated mitigation measures for hazards associated with certain activities associated with adjacent and neighboring lands, in order to protect the quality of water used on products. This is included as a result of several recent investigations of product outbreaks that have revealed potential routes of contamination, including activities and conditions, such as animal grazing and the presence of livestock and wildlife on the site. land adjacent to or near production farms or their water sources.
  • Removing some testing requirements for pre-harvest agricultural water and replacing them with the agricultural water ratings identified above. The proposed revisions are intended to address stakeholder concerns regarding the complexity and practical challenges of implementation while protecting public health.

The FDA intends to continue to work closely with stakeholders and our state and tribal partners to provide the necessary training, technical assistance, education, and awareness. The agency will hold two virtual public meetings to discuss the proposal and hear comments, and more details will be announced in an upcoming Federal Register notice. In addition, the agency is also developing an online tool to help producers understand agricultural water ratings.

Recognizing that the current agricultural water compliance dates for products covered other than sprouts under the ESP are expected to begin in January 2022, the agency intends to exercise its enforcement discretion for these requirements by agricultural water requirements while continuing another proposed rule to extend the compliance dates for all agricultural water requirements in the PSR for those covered commodities. Further information on the proposed extension of the compliance date will be announced in an upcoming Federal Register notice.

Today’s proposal is one of the remaining essential elements of the work towards the implementation of the FSMA. The FDA has taken many important steps to meet the food safety goals envisioned by Congress when the FSMA was established in 2011, such as implementing Seven Ground Rules. The FDA has also developed several action plans to address specific food safety issues and has built on the foundations of the FSMA through the New Era of Smarter Food Safety initiative.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.