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.
FDA is reopening the comment period with respect to the proposed compliance dates for the pre-harvest agricultural water provisions until September 19, 2022. Comments should be submitted to docket FDA-2021-N-0471 on Regulations.gov.