• FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA).
  • The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 FR 55907). In January 2018, FDA published a Draft Guidance to explain the Agency’s current thinking on how to comply with certain HARPC requirements. Then on October 19, 2018, FDA released another draft guidance related to this rule. The “Guide to Minimize Food Safety Hazards of Fresh-cut Produce” is specifically for fresh-cut produce processors and explains how they can comply with the CGMP and HARPC requirements imposed by the Preventive Controls Rule. The draft guidance defines “fresh-cut produce” as “any fruits or vegetables or combination thereof that has been physically altered (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking).” When finalized, this draft guidance will replace the 2008 guidance, “Guide to Minimize Microbial Food Hazards of Fresh-cut Fruits and Vegetables.”
  • The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353). The second draft guidance document published by FDA on October 19, 2018, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” relates to this rule. The draft guidance reflects the flexibility that was built into the Produce Safety Rule to accommodate practices that vary by region and commodity, explained FDA Commissioner Scott Gottlieb, M.D. in a Statement on the new draft guidance documents. (FDA may issue additional draft guidance on the Produce Safety Rule to address agricultural water in the future. As we previously reported on this blog, FDA published a proposed rule in September 2017 seeking to extend the compliance dates for the agricultural water standards set forth in the Produce Safety Rule.)
  • Comments on these draft guidance documents need to be submitted by April 22, 2019, to be considered by FDA before it begins work on the final versions of these guidance documents. We will continue to monitor and report on developments related to these rules and other FSMA developments.