The U.S. Food and Drug Administration published a proposed rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts.

The proposal would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule.

Farms would be required to conduct annual systems-based agricultural water assessments to determine and guide appropriate measures to minimize potential risks associated with pre-harvest agricultural water.

The assessment would include an evaluation of the water system, agricultural water use practices, crop characteristics other relevant factors, such as the results of optional testing.

In 2015, the FDA published the final Produce Safety Rule, establishing science- and risk-based standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption.

During outreach, the FDA heard from a variety of stakeholders that certain pre-harvest microbial quality criteria and testing requirements were too difficult to understand, interpret, and implement.

After additional stakeholder engagement on these agricultural water requirements, the FDA extended the compliance dates for the agricultural water requirements for covered produce.

The proposal announced today would replace the pre-harvest microbial water quality criteria and testing requirements with requirements for a systems-based pre-harvest agricultural water assessment for covered produce.

The requirements described in this proposal are intended to be workable across produce farms of all sizes, both domestic and foreign, recognizing the wide variety of water systems, uses, and practices.

They also are designed to be adaptable to future advancements in agricultural water quality science and technology.

If finalized, farms covered by the Produce Safety Rule would be required to conduct an assessment of their pre-harvest agricultural water annually, and whenever a significant change occurs, to identify any conditions likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.

Based on their assessments, farms would then determine whether corrective or mitigation measures are needed to reduce the potential for contamination.

The proposal also includes expedited mitigation measures that would be required for specific types of hazards related to certain activities associated with adjacent and nearby lands.

The FDA intends to hold two virtual public meetings to discuss the proposal and hear feedback.

Importantly, the FDA intends to work closely with state partners to implement these changes, if finalized.