U.S – The Food and Drug Administration (FDA) has reminded stakeholders in the produce industry in an information sheet and constituent update that the intended enforcement discretion period for the harvest and post-harvest agricultural water requirements in the Produce Safety Rule for covered produce other than sprouts will soon come to an end.
According to the Produce Safety Rule (PSR) requirements for harvest and post-harvest agricultural water, all agricultural water must be safe and of adequate sanitary quality for its intended use.
On January 26, 2023, for all enterprises other than small and very small firms, the intended enforcement discretion period for the harvest and post-harvest agricultural water rules in the Produce Safety Rule for covered produce (other than sprouts) will come to an end.
The FDA has made a fact sheet with questions and answers on the requirements available to farmers to assist in their preparation.
The FDA published a proposed rule in December 2021 that would amend some pre-harvest agricultural water requirements for covered produce other than sprouts. This revision would be made to subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule.
Changes to the requirements for agricultural water during and after harvest were not included in the plan.
Covered farms are subject to the requirements of Subpart E if they use water during the growing, harvesting, packing, or holding of covered produce in a way that meets the definition of “agricultural water.”
The FDA then published a supplement to its initial notice of proposed rulemaking, which set end dates for the anticipated enforcement discretion for the harvest and post-harvest agricultural water standards.
The end dates in the supplemental notice of proposed rulemaking are January 26, 2025, for very small businesses, January 26, 2024, for small businesses, and January 26, 2023, for all other businesses.
The FDA intends to adopt an educational approach for these harvest and post-harvest standards once farms start implementing them, as it has done with other FSMA regulations.
While it continues the regulatory process, it still intends to use enforcement discretion for the pre-harvest agricultural water standards for covered produce other than sprouts.
The regulator will work closely with state and industry partners during the first year following the conclusion of the intended enforcement discretion period to advance training, technical assistance, educational visits, and on-farm readiness reviews to get both farmers and state regulators ready for implementing these provisions.