The FDA is proposing a revision to Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule that would change the pre-harvest agricultural water requirements for covered produce (other than sprouts). The requirements in this proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule with requirements for systems-based pre-harvest agricultural water assessments. These assessments would be used to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces, and to determine whether corrective or mitigation measures are needed to minimize the risks associated with pre-harvest agricultural water.
These proposed requirements are intended to address stakeholder concerns about the complexity and practical implementation of certain pre-harvest agricultural water requirements in the Produce Safety Rule while continuing to protect public health. The requirements also are designed to be adaptable to future advancements in agricultural water quality science.
We are not proposing to change the requirements for harvest and post-harvest uses of agricultural water, or the agricultural water requirements for sprouts. Sprouts are subject to specific pre-harvest agricultural water requirements, and the compliance dates for those sprouts requirements have passed.
1. Agricultural Water Assessment
Agricultural Water Assessment Fact Sheet
The proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule for covered produce (other than sprouts) with requirements for systems-based pre-harvest agricultural water assessments to be used for hazard identification and risk management decision-making (see the webpage for the final Produce Safety Rule for a description of the requirements as currently written). Under the proposed requirements, covered farms would be required to conduct pre-harvest agricultural water assessments once annually, and whenever a change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto produce or food contact surfaces. As part of their pre-harvest agricultural water assessments, these farms would be required to evaluate certain factors (listed in the link above) that could impact produce safety.