As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance with the animal food CGMP requirements. Very small businesses must comply by September 17, 2018.  As of September 18, 2017, large animal food producers were also required to comply with the preventive controls provisions mandated by FSMA.

Today, the FDA released two guidance documents intended for facilities that may be subject to the Preventive Controls for Animal Food rule or the Preventive Controls for Human Food rule. The first guidance document, entitled “Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals,” will assist animal food facilities that are subject to the Current Good Manufacturing Practice (CGMP) requirements for animal food at 21 CFR Part 507 Subpart B.  The guidance document further elaborates on the following:  (1) applicability of the animal food CGMPs especially with regard to facilities that handle human and animal food, (2) training and qualification requirements, (3) recordkeeping requirements; and (4) further discussion of the specific animal food CGMPs. Appendix B of the guidance document is a Self-Assessment Tool,  that facilities may use to evaluate their compliance with the animal food CGMP requirements.

The second guidance document, entitled “Application of the ‘Solely Engaged’ Exemptions in Parts 117 and 507,” addresses the applicability of the “solely engaged” exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. In particular, it explains when facilities are exempt from CGMP or preventive controls requirements because they are “solely engaged” in certain activities. The document also explains the circumstances under which the “solely engaged” exemptions do not apply (i.e., when a facility is also conducting certain other activities).  The “Solely engaged” draft guidance is open for a 180-day public comment period.