August 8, 2013
Authored by: Brandon Neuschafer
FDA announced today that it is extending by sixty days the deadline for commenting on the proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and the proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. The new deadline for comments is November 15, 2013, and FDA has indicated that this will be the last extension of time.
The two draft rules were originally proposed in January of 2013 to implement provisions of the Food Safety Modernization Act. The proposed Human Food rule will, among other things, require hazard analysis and critical control points (HACCP) plans for domestic and foreign facilities that manufacture, process, pack or hold human food. The proposed Produce Safety Standards are prevention-based standards that require those growing, harvesting, packing or holding produce on foreign or domestic farms to undertake a science-based risk analysis of potential routes for microbial contamination, and devise and implement measures to minimize the risk of microbial contamination. Each of the rules will be phased in over a period of years, with timelines generally depending on the size of the company involved.
The FDA pages linked above contain a significant amount of guidance on the proposed rules. We strongly encourage potentially-impacted companies to study the proposed rule and submit comments to the FDA.