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Proposed Changes to Produce Safety Rule’s Agricultural Water Requirements

  • FDA’s Produce Safety Rule (PSR), finalized in 2015 under the Food Safety Modernization Act (FSMA), established “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” including requirements applicable to agricultural water using a direct application method during growing activities (commonly referred to as ‘‘pre-harvest agricultural water’’).  As we have discussed, FDA was criticized, following foodborne illness outbreaks linked to lettuce, for extending the compliance dates for the agricultural water requirements applicable to covered produce (other than sprouts) until January 26, 2022 for the largest farms, and one or two years later for small and very small farms, respectively.

  • On December 6, 2021, FDA published a proposed rule that would replace the pre-harvest microbial water quality criteria and testing requirements of the 2015 rule, which stakeholders complained were too complex, with new rules that would require farms covered by the PSR to assess their pre-harvest agricultural water system annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces and, based on their assessments, determine whether corrective or mitigation measures are needed to reduce the potential for contamination.  The proposed rule includes:

    • New provisions requiring consideration of agricultural water sources, distribution systems, and practices, as well as adjacent and nearby land uses, and other relevant factors in conducting pre-harvest agricultural water assessments for hazard identification and risk management decision making;

    • A testing option for certain covered farms that elect to test their pre-harvest agricultural water for generic Escherichia coli (E. coli) (or other appropriate indicator organism, index organism, or analyte) to help inform their agricultural water assessments;

    • Flexible options for mitigation measures, such as, for example, using microbial die-off or removal post-harvest (i.e., between harvest and end of storage, and during activities such as commercial washing) as a mitigation measure, provided the covered farm has adequate supporting scientific data and information;

    • Expedited implementation of mitigation measures for known or reasonably foreseeable hazards related to certain adjacent and nearby land uses, such as animal grazing and the presence of livestock and wildlife; and

    • Required management review of pre-harvest agricultural water assessments.

  • Information on proposed compliance dates will be announced in a forthcoming notice.  In the meantime, FDA intends to exercise enforcement discretion for the agricultural water requirements for covered produce (other than sprouts).  Additionally, FDA is working on plans to hold two virtual public meetings to discuss the proposal and hear feedback and is developing an online tool to assist farms in evaluating potential risks posed by their water sources and in determining potential management options.  The solicitation period for comments on the proposed amendments is scheduled to close on April 5, 2022. 

© 2022 Keller and Heckman LLPNational Law Review, Volume XI, Number 340
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About this Author

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...

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