The U.S. Food and Drug Administration (FDA) has issued a supplemental notice of proposed rulemaking that extends the compliance dates for pre-harvest agricultural water provisions as outlined in the recent 2021 Agricultural Water Proposed Rule. The proposed rule, if finalized, will require farms to conduct annual, systems-based agricultural water assessments to determine the necessary measures to minimize potential risks associated with pre-harvest agricultural water. 

FDA is now proposing extended compliance dates for the proposed pre-harvest requirements and is also providing clarifying information about the enforcement discretion policy for the harvest and post-harvest agricultural water requirements. The supplemental rulemaking proposes to establish the following compliance dates for the pre-harvest agricultural water requirements for covered produce other than sprouts:

• Two years and nine months after the effective date of a final rule for very small businesses
• One year and nine months after the effective date of a final rule for small businesses
• Nine months after the effective date of a final rule for all other businesses.

The 2021 pre-harvest agricultural water proposed rule did not set forth substantive changes to the harvest and post-harvest agricultural water requirements in the Produce Safety Rule; however, FDA recognizes that prior to the proposal, stakeholders did not have clarity on whether FDA might propose changes to the harvest and post-harvest agricultural water requirements. In addition, FDA recognizes that adequate training and technical assistance are needed to fully recognize the benefits of the harvest and post-harvest requirements. Therefore, the agency intends to continue enforcement discretion for the harvest and post-harvest agricultural water requirements of the Produce Safety Rule until the following dates:

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

FDA states that it will employ an “educate before and while we regulate” approach to implementing the harvest and post-harvest requirements. For the first year of compliance, FDA intends to work closely with state, regulatory, and industry partners to advance training, technical assistance, educational visits, and on-farm readiness reviews to prepare growers and state regulators for implementing the provisions prior to initiating routine inspections to verify compliance.