On January 4, 2011, the Food Safety Modernization Act was signed into law, giving the U.S. Food and Drug Administration (FDA) power to require sweeping changes to how companies tied to the United States food supply think about and act with regard to food safety. Regulations established under this law will impose significant new requirements on producers and handlers of human and animal food and food components to take steps to identify and diminish threats to food safety.

Yesterday, FDA announced the publication of two important and hotly anticipated final rules in implementation of the Food Safety and Modernization Act (FSMA):

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; and
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.

Thursday, September 17 is the official publication date for the rules; however, prepublication versions of the text are available now.

The agency was under a court order to publish these two rules by August 30, so this announcement does not come as a surprise. Venable will be reviewing and analyzing the rules over the next few days, after which we will be available to answer your questions and provide a more detailed summary of the rules' key provisions.