On January 4, 2013, two years to the day after President Obama signed the Food Safety Modernization Act into law the U.S. Food and Drug Administration (FDA) issued two proposed regulations they said will “help prevent foodborne illness.” According to the U.S. Centers for Disease Control and Prevention (CDC), “roughly one in six Americans gets sick…,128,000 are hospitalized, and 3,000 die of foodborne diseases” http://www.cdc.gov/foodborneburden/.

In recent years, major outbreaks of foodborne illness have included products from spinach and melons, to peanut butter and ground beef. About 80 percent of food products fall under the aegis of the FDA while the remaining—most meat, poultry, and processed egg products—are the responsibility of the U.S. Department of Agriculture, Food Safety and Inspection Service. Food safety for fish is the responsibility of the FDA. In addition, responsibility for restaurant food safety falls to state and local health departments.

The FMSA framework for food safety included human food, produce safety, imports, and animal food. The first two of these are the subjects of the January 4 proposed regulations. Together these two proposed rules run to more than 1,250 typed pages. Both proposed rules are subject to a 120-day comment period after which the FDA will take the comments into consideration in preparation of the final rule. Proposed rules for imports and animal food will be forthcoming.

The first of these proposed rules, titled, Current good manufacturing practice and hazard analysis and risk-based preventative controls for human food,” would “revise FDA’s current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food in…fundamental ways.”

The proposed rule “would add new preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA). In general, with some exceptions the new preventive controls provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations.