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June 22, 2018

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FDA Publishes Proposed Rule Seeking to Extend Compliance Dates for Agricultural Water Standards

  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the U.S. Food and Drug Administration (FDA) announced that it was exploring ways to simplify the agricultural water standards established by FSMA’s Produce Safety Rule in light of feedback from stakeholders that some of the requirements were too complex to understand and implement. Earlier this summer, FDA announced its intention to extend the compliance dates for agricultural water requirements in the Produce Safety Rule (other than for sprouts).

  • Today FDA issued a proposed rule (82 FR 42963) that, if finalized, would extend the compliance dates for the agricultural water requirements by an additional two to four years (for produce other than sprouts). The proposed extension will give the Agency time to take another look at the water standards to ensure that they are feasible for farmers in all regions of the country, while protecting public health. The new agricultural water compliance date the FDA is proposing for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively.

  • The Agency notes that the proposed extension would also simplify the compliance framework to give all of the water requirements a four-year delay compared to farms’ primary compliance dates. The produce rule currently includes a delay of two years in the compliance dates for certain agricultural water requirements, but for others there is no delay.  The FDA indicates that it does not intend to take action to enforce the agricultural water requirements for produce other than sprouts while the rulemaking to extend the compliance dates is underway. Sprouts remain subject to applicable agricultural water requirements in the final rule and their original compliance dates due to their unique vulnerability to contamination.

  • The publication of the proposed rule comes on the heels of a speech by FDA Commissioner Scott Gottlieb to the annual conference of the National Association of State Departments of Agriculture (NASDA), yesterday, outlining a number of immediate next steps in a comprehensive approach to ensuring successful implementation of the Produce Safety Rule.  Gottlieb noted that these steps included measures the Agency will be taking in such areas as compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.

  • FDA will be accepting comments on the proposed rule for the next 60 days (i.e., through November 13, 2017).

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...