Proposed Changes to FSMA’s Produce Safety Rule

The U.S. Food and Drug Administration (FDA) is proposing changes to the Produce Safety Rule provision of the Food Safety Modernization Act (FSMA). Proposed changes pertain to certain criteria for agricultural water. FDA has indicated that the proposal is in response to stakeholder feedback, addressing concerns about the complexity of the ag water requirements.

“The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA,” FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said in a press release. “If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Specifically, the changes address subpart E of the Produce Safety Rule. Adjustments would be made to certain pre-harvest agricultural water requirements. Proposed changes include a requirement for farms to manage their ag water quality based on the results of an adaptable comprehensive systems assessment. An annual assessment of pre-harvest water risks would need to be performed, which includes an evaluation of an operations water system, water use practices, crop characteristics, and other relevant factors. Farming operations would also need to implement expedited mitigation efforts to address risks associated with certain activities conducted on adjacent lands. Certain testing requirements for pre-harvest ag water would be removed and replaced with the newly proposed protocols.

Current requirements of the Produce Safety Rule will still come into effect in January 2022; however, enforcement discretion will be exercised. The proposed rule has a comment period of 120 days. FDA will be hosting two virtual public meetings to go over the proposal and gather stakeholder input.