FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond to food safety problems and foodborne illness outbreaks. FSMA provides FDA with new enforcement authorities such as mandatory recall authority and the authority to suspend a food facility’s registration, gives FDA the ability to hold imported foods to the same standards as domestic foods, and places a number of new food safety obligations on food manufacturers, farms, handlers, and other entities involved in the food supply chain.

Congress established specific implementation dates in the legislation. Some of the provisions went into effect quickly, but others required FDA to promulgate regulations. Notably, in 2013, FDA issued four key proposed rules governing: (1) “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”; (2) “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food”; (3) “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”; and (4) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.” The comment periods for these original proposed rules closed in late 2013 and early 2014.