PSR.15 What is the current status of the PSR agricultural water requirements?

Agricultural water can be a major conduit of pathogens that can contaminate produce. The feedback that the FDA has received is that some of the agricultural water standards in the Produce Safety Rule may be too complex to understand, translate, and implement for some covered farms. These factors can be important to achieving high rates of compliance. In December 2021, the FDA published a proposed rule that would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts. The proposal would replace the pre-harvest microbial water quality criteria and testing requirements in subpart E of the Produce Safety Rule with requirements to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water. The comment period closed on April 5, 2022 and the agency is evaluating feedback. On July 19, 2022, FDA reopened the comment period only with respect to the compliance dates for the proposed pre-harvest agricultural water provisions for covered produce other than sprouts.

More information on this proposal can be found: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-agricultural-water

COMPLIANCE WITH CURRENT AGRICULTURAL WATER REQUIREMENTS

PSR.16 While FDA is undertaking rulemaking to revise the pre-harvest agricultural water provisions in the produce safety regulation for covered produce other than sprouts, are non-sprout farms expected to comply with the current agricultural water requirements? 

In March 2019, the FDA issued a final rule extending, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health. See 84 FR 9706 (March 18, 2019).

In December 2021, FDA published a proposed rule to revise the pre-harvest agricultural water requirements for covered produce other than sprouts. In July 2022 FDA published a supplemental notice of proposed rulemaking (SNPRM) proposing compliance dates for those pre-harvest agricultural water provisions and specifying the duration of the period during which we intend to exercise enforcement discretion for the harvest and post-harvest agricultural water requirements for covered produce other than sprouts

The proposed compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts are:

• 2 years and 9 months after the effective date of a final rule for very small businesses.
• 1 year and 9 months after the effective date of a final rule for small businesses; and
• 9 months after the effective date of a final rule for all other businesses

The SNPRM also clarified that we intend to exercise enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety regulation until the following dates:

• January 26, 2025, for very small businesses.
• January 26, 2024, for small businesses; and
• January 26, 2023, for all other businesses.

While these rulemakings are underway, FDA encourages non-sprout covered produce farms to continue to use good agricultural practices to maintain and protect the quality of their water sources. (See, e.g., FDA’s “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.”)