On October 19, FDA issued 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.
- “Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals – to help animal food establishments determine if they are subject to the Current Good Manufacturing Practice (CGMP) requirements in the Preventive Controls for Animal Food rule and provide explanation and recommendations for meeting the CGMP requirements. This guidance includes a self-assessment tool that facilities may use to evaluate their compliance with the CGMP requirements.
- “Application of the ‘Solely Engaged’ Exemptions in Parts 117 and 507 Draft Guidance discusses the applicability of the “solely engaged” exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. It explains when facilities are exempt from CGMP or preventive controls requirements because they are “solely engaged” in certain activities. It also explains that the “solely engaged” exemptions do not apply when a facility is also conducting certain other activities. The “solely engaged” exemptions are related to the holding or transportation of raw agricultural commodities, the storage of raw agricultural commodities (other than fruits and vegetables), the storage of unexposed packaged food, and other activities tied to the preparation of nuts and the ginning of cotton. This draft guidance is open for a 180-day public comment period.
Covered large and small businesses are now required to be in compliance with the animal food CGMP requirements. (Very small businesses have additional time to comply.) Large animal food producers are also now required to comply with the preventive controls provisions. For covered producers of human food, large and small businesses are now required to be in compliance with both human food CGMP and preventive controls provisions. (Very small businesses have additional time to comply.)
For more information about any of the FSMA rules, visit www.fda.gov/Food/GuidanceRegulation/FSMA.