Current GMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
FDA Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act was passed by Congress on December 21, 2010 and signed by the President in early January 2011.
The FDA Food Safety Modernization A has been described as a significant step in the evolution of the U.S. food law. The intent of the legislation is to advance a pro-active approach to concerns about food safety, rather than a reactive approach after a problem arises. The legislation advances the concept that food law should be based on science, and that food businesses and government agencies aggressively pursue reducing the risk of unsafe food.
Since then a number of guidelines and rules have been issued.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.