On September 17, 2015, the FDA announced two new final rules for the Food Safety Modernization Act (“FSMA”) (Pub. L. 111-353). The two new final rules are: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food.

Covered facilities, which exclude farms, must create and implement a food safety systems that includes:

  • Hazard analysis: identification of known or reasonably foreseeable biological, chemical, and physical hazards
  • Preventive controls: measures that assure identified hazards can be minimized or prevented
  • Monitoring, verification, and corrective action plans for use of preventive controls; additionally, each animal food facility with a preventive control in place must develop a recall plan

For animal food facilities, Current Good Manufacturing Practices (“cGMP”) are being established for the first time. The animal food rule contains FDA’s baseline