This proposed rule would establish regulations for domestic and foreign facilities regarding the manufacturing, processing, packing, or holding of animal food in two ways. First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. Second, it would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food.
In general, with some exceptions the new preventive control provisions would apply to animal food facilities that are required to register with FDA under FDA’s current food facility registration regulations. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions.
Preliminary Regulatory Impact Analysis
Federal Register: 78 FR 64735, October 29, 2013