The U.S. Food and Drug Administration (FDA) on Oct. 19 issued a pair of guidance documents intended for facilities that may be subject to its Preventive Controls for Animal Food Rule or the Preventive Controls for Human Food Rule.
One of the guidance documents – Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals – is designed to assist animal food establishments in determining if they are subject to the current good manufacturing practice (CGMP) requirements in the Preventive Controls for Animal Food Rule. The 51-page guidance document also provides explanation and recommendations for meeting the CGMP requirements.
The final version of the CGMP guidance replaces a draft document previously issued by the agency in August 2016 to address the same topics. Among the significant differences between the draft document and FDA’s final guidance is information related to:
- Undesirable Microorganisms: FDA highlights in the final guidance that there may be significant differences in how the CGMPs are implemented in facilities where “undesirable microorganisms” are a food safety concern for the type of animal food produced compared to facilities producing an animal food that is not as likely to be affected by undesirable microorganisms. Accordingly, the final guidance provides additional explanation and examples for facilities to implement the CGMPs based on their unique facility and type of animal food.
- CGMP Training and Qualification Requirements: The final guidance provides additional information and clarifies FDA’s expectations related to required training of individuals and records that are to be established and maintained to document the training.
- CGMP Self-Assessment Tool: The final guidance includes a self-assessment tool that animal food facilities may use to evaluate their compliance with the CGMP requirements. The tool groups and describes the CGMP requirements in a way that may be useful when conducting a walk-through review of a facility. Within the guidance, FDA emphasizes animal food facilities are not required to use the tool and that any results from its use are not subject to FDA requirements for recordkeeping, submission to FDA, or disclosure to third parties or the public.
The second FDA document – Application of the ‘Solely Engaged’ Exemptions in Parts 117 and 507 – is a draft guidance that discusses the applicability of the “solely engaged” exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food Rules.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. The draft guidance also explains that the “solely engaged” exemptions do not apply when a facility is also conducting certain other activities.
In general, FDA’s draft guidance states that the “solely engaged” exemptions provided within the rules apply when the entire facility is only engaged in specified food-related activities for which a “solely engaged” exemption exists. Those exempted activities generally are confined to the storage or transportation of raw agricultural commodities (other than fruits and vegetables). More specifically, FDA states that a facility can be exempt from both CGMP and preventive controls requirements – for part 117 or part 507 (or both parts) of its regulations – so long as it is engaged in any combination of activities that are exempt from CGMP and preventive controls requirements, and not engaged in activities that would be subject to those requirements. Significantly, FDA states that if any part of a facility is engaged in an activity subject to CGMPs or preventive controls requirements (such as manufacturing and processing activities), then the entire facility is subject to the CGMP requirements, the preventive controls requirements, or both.
Importantly, the FDA draft guidance states that a facility consisting of both a grain elevator that stores raw agricultural commodities for animal food use and a feed mill that manufactures animal food is not “solely engaged” in activities exempt from either its CGMP or preventive control requirements. “Therefore, the facility is subject to the CGMP and preventive controls requirements….,” the draft guidance states. Since a grain elevator and feed mill owned by the same company and located on the same general premises often may be combined under a single FDA facility registration number, FDA’s guidance is problematic because the grain elevator under these circumstances would not be exempt from the CGMP and preventive control requirements of the animal food rule. Using the same logic, FDA would not consider a grain elevator storing raw agricultural commodities to be exempt from CGMPs or preventive controls under the human food rule if it is under the same facility registration number as a processing plant or flour mill.
FDA has provided a 180-day public comment period for its draft “solely engaged” guidance, and NGFA will be submitting comments.