In the weeks since the Food and Drug Administration (FDA) issued two proposed regulations to implement the Food Safety and Modernization Act (FMSA), the agency has reported ten food recall notices, eight of them for undeclared ingredients and two for pathogenic contamination by either Shiga-Toxin producing E. coli or Listeria monocytogenes. The ongoing recalls illustrate the importance of the FDA and other agencies in ensuring the safety of the US food supply.

In our previous column we looked at the proposed rule (Standards for the growing, harvesting, packing, and holding of produce for human consumption) that primarily involves the farm-level production of fruits and vegetables. This column is focused on the other proposed rule, which amends FDA’s “regulation for Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human food (GCMPs) to modernize it and add requirements for domestic and foreign facilities that are required to register” with the FDA.

Under this regulation, covered facilities must “establish and implement hazard analysis and risk-based preventative controls for human food” that are similar to the hazard analysis and critical control points (HACCP) rules that are in effect for meat slaughter and processing plants whose activities are regulated by the USDA’s Food Safety and Inspection Service (FSIS).

In the past, FSIS was criticized for being slow to implement traceback to the source of E. coli—the packing facility—when contamination was found at a downstream processing firm that did not slaughter animals. In response to outbreaks of foodborne illness and pressure from food safety advocates, the USDA has since instituted traceback procedures.

The FDA specifically writes that “depending on the circumstances…[a] multidisciplinary investigation…[of an outbreak of foodborne illnesses] may involve a traceback investigation (i.e., an investigation to determine and document the production chain and the source(s) of contaminated or potentially contaminated food); a traceforward operation (i.e., an operation to determine the distribution of contaminated or potentially contaminated food); regulatory inspections; and, in some cases, root cause investigations (to try and determine the specific causes of contamination and contributing factors).”