December 2, 2021

FDA Proposes Changes to the Produce Safety Rule Agricultural Water Requirements

Today, December 2, 2021, the U.S. Food and Drug Administration (FDA) published a proposed rule to subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule, adjusting the requirements of agricultural water for fresh produce operations subject to this regulation. According to FDA, these proposed requirements are intended to address stakeholder concerns about the complexity and practical implementation of certain pre-harvest agricultural water requirements in the Produce Safety Rule while continuing to protect public health.

If finalized, these proposed requirements would:

  • replace the current pre-harvest microbial quality criteria and testing requirements within the Produce Safety Rule
  • require farms to annually conduct assessments of pre-harvest agricultural water
    •  if a significant change is detected, it would require farms take action by identifying any conditions likely to introduce hazards into or onto produce or food contact surfaces
  • expedite mitigation measures that would be required for specific types of hazards related to certain activities associated with adjacent and nearby lands

Click here to read additional provisions of the proposed rule. The FDA intends to hold two virtual public meetings to discuss the proposal and hear feedback. The agency is also developing an online tool to help farms evaluate potential risks posed by their water sources and determine potential management options. If the proposal is finalized, the agency plans to work closely with other organizations, entities and educators to provide the training necessary to implement these changes.

The FDA recognizes that the current agricultural water compliance dates are set to begin in January 2022 and intends to exercise enforcement discretion for the agricultural water requirements for fresh produce operations subject to this regulation (other than sprouts). They propose extending the compliance dates for all subpart E provisions applicable to such produce, with the goal of completing the compliance date rulemaking as quickly as possible. More information on the proposed compliance dates will be announced in a forthcoming notice in the Federal Register.

Click here to view the FDA Constituent Update.

Click here to view the FDA Press Release.

Western Growers Science will be submitting comments to the agency and encourages interested members to engage in this process and/or submit individual comments. If you are interested in joining a working group to develop comments, need support to develop your own comments or have any questions or concerns regarding this proposed rule, please feel free to reach out the Western Growers Science team at [email protected].