FDA releases two FSMA draft guidance documents

By Evin Bachelor, Law Fellow, and Ellen Essman, Sr. Research Associate, Ohio State University

The Food and Drug Administration recently released draft guidance documents explaining how to follow rules under the Food Safety Modernization Act (FSMA). One document, titled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce,” provides guidance on how to follow the Preventive Controls Rule under FSMA.

“Fresh-cut produce,” is defined as “any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field without additional processing.” The guidance would affect manufacturers, processors, packers, and holders of fresh-cut produce. The document covers current good manufacturing practices, as well as “new requirements for hazard analysis and risk-based preventive controls.” The draft guidance document, in addition to information on how to submit a comment on the guidance, is available here.

The second draft guidance document is titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry.” This document provides guidance on how to follow FSMA’s Produce Safety Rule. The guidance would affect produce farms. The guidance covers personnel qualifications and training, health and hygiene practices, biological soil amendments, contamination from domesticated and wild animals, suggestions for practices during the growing, harvesting, packing, and holding of produce, sanitation of equipment, recordkeeping on produce farms, and other topics. According to a press release about the two guidance documents, FDA will be holding a series of four public meetings at various places around the U.S. to discuss the second draft guidance document with those affected. FDA will be announcing the details about the meetings in the Federal Register soon.

It is important to remember that these are draft guidance documents. Furthermore, guidance documents are just that—guidance. In other words, the documents are there as suggestions on how to follow rules, and “do not establish legally enforceable responsibilities.”

This is an excerpt from “The Ag Law Harvest” the Ohio Agricultural Law Blog at ohioaglaw.wordpress.com.

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