In December 2021, FDA published a notice of proposed rulemaking to amend the agricultural water provisions of the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (i.e., the “Produce Safety Rule”). The proposed revisions were in response to stakeholder concerns that the pre-harvest agricultural water provisions were too complex and prescriptive. As we have previously blogged, the proposed amendment would replace the detailed pre-harvest agricultural testing requirements in the Produce Safety Rule with provisions that allow for a systems-based agricultural water assessment that are designed to be more feasible to implement and adaptable to future advancements.

FDA has now announced a supplemental notice of proposed rulemaking in which it is requesting comment on only the compliance dates for the proposed pre-harvest agricultural water provisions for covered produce other than sprouts. The proposed compliance dates would allow time for covered farms to prepare for compliance and for other stakeholders, including state regulators, to develop education, outreaching, training, and other tools to facilitate understanding and compliance. The proposed compliance dates are as follows:

• 2 years and 9 months after the effective date of a final rule for very small businesses, defined in 21 CFR 112.3 to mean “a farm that is subject to any of the requirements of this part [the Produce Safety Rule] and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $250,000.”

• 1 year and 9 months after the effective date of a final rule for small businesses, defined in 21 CFR 112.3 to mean “a farm that is subject to any of the requirements of this part and, on a rolling basis, the average annual monetary value of produce (as defined in this section) the farm sold during the previous 3-year period is no more than $500,000; and the farm is not a very small business as defined in this section.”

• 9 months after the effective date of a final rule for all other businesses.

In addition, although no changes to the harvest and post-harvest requirements have been proposed, to allow for adequate preparations, FDA also announced that it intends to continue to exercise enforcement discretion for the harvest and post-harvest agricultural water provisions for covered produce other than sprouts until the following dates:

• January 26, 2025 for very small businesses.

• January 26, 2024 for small businesses.

• January 26, 2023 for all other businesses.

Comments to the proposed compliance dates can be submitted until September 19, 2022