The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PCAF or the rule) (80 FR 56173). 

The regulation creates new current good manufacturing practice (CGMP) requirements for animal food facilities. In addition, it creates new requirements for certain animal food facilities to establish and implement risk-based preventive controls. The regulations are found at Title 21 of the Code of Federal Regulations part 507 (21 CFR part 507).

FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. Law 104-121). The intent of this guide is to inform domestic and foreign animal food facilities about the PCAF regulations and enable them to better understand the requirements of the rule. It contains important information that may affect your facility.

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