FDA Announces Proposed Changes to Agricultural Water Requirements Under the Food Safety Modernization Act

December 9, 2021

On December 2, 2021 the U.S. Food and Drug Administration (FDA) released a proposed rule aimed at enhancing the safety of agricultural water used on covered produce (other than sprouts). The proposed rule is the agency’s latest step in implementing the Food Safety Modernization Act (FSMA), signed into law in 2011 by President Obama. In recent years, there have been a series of very public outbreaks of foodborne illnesses, some of which were linked to contamination in pre-harvest agricultural water. In response, the FDA’s proposed rule makes several key changes to how growers evaluate agricultural water.

The proposed rule comes in response to extensive stakeholder feedback, which criticized the existing -harvest microbial quality criteria and testing requirements imposed by the Produce Safety Rule (PSR) as overly complicated and unworkable. Under the proposed rule, covered farms (other than sprouts farms) must conduct an annual systems-based pre-harvest agricultural water assessment to identify possible conditions likely to introduce hazards into, or onto, covered produce or food contact surfaces. That assessment would include an evaluation of the farm’s water system, agricultural water practices, environmental conditions, crop characteristics, and other relevant factors. A complete list of factors to consider as part of the agricultural water assessment can be found here.

Farms would then be required to consider corrective or mitigation measures in response to risks identified in the assessment. The proposed rule provides more flexibility than the current PSR, including a suite of mitigation measures to select from in response to pre-harvest agricultural water assessments. Some hazards, particularly those identified as known routes of contamination for food-borne illness outbreaks (such as animal activity, manure applications, or untreated or improperly treated human waste), would trigger expedited mediation.

The proposed rule also provides a route for exemptions from the pre-harvest agricultural water assessment requirement. If growers can demonstrate that their pre-harvest agricultural water for covered produce is treated in accordance with the standards outlined in the PSR or meets certain water quality and treatment standards applicable to harvest and post-harvest agricultural water, then they do not need to prepare an assessment. Likewise, farms that receive water from a public water system or that are otherwise already compliant with the PSR’s requirements would be exempt from the assessment.

The FDA is seeking comments on the proposed rule, which is intended to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices, while also being adaptable to future advancements in agricultural water quality science. Online comments can be submitted to docket FDA-2021-N-0471 on Regulations.gov until April 5, 2022. The FDA also plans on holding two virtual public meetings that have yet to be scheduled.

Dale Stern is a partner and co-chair of the Downey Brand food & agriculture practice and serves as general counsel to many food industry trade associations and agricultural operations.

Rebecca Smith is a partner in the Downey Brand water law practice, representing clients on water, agricultural, and food production issues across the state.

Breana Inoshita is an associate in the firm’s natural resources practice group and represents clients in CEQA/NEPA, Land Use, Air Quality & Climate Change, and Regulatory Law & Business Permitting.