If you are a facility that produces animal food or supplies by-products for use as animal food – large, small, or very small – this coming Monday (Sept. 17) is a critical day for you. While it is a compliance date for small and very small businesses, large businesses should take note that it brings with it the first year in which FDA will begin routine regulatory inspections against the Preventive Controls for Animal Foods (PCAF) rule.
Thus: Small businesses are to be in full compliance with the rule by Monday; very small businesses are to be in compliance with the CGMPs of the rule.
For both, FDA will be focusing on continuing to increase the level of oversight of CGMPs with more routine inspections. Large businesses were to be in compliance with the rule this time last year.
FDA will be conducting both CGMP and preventive controls inspections. Because the rule brings new requirements for animal food facilities, FDA delayed the start of routine PCAF regulatory inspections of large facilities last year “to allow them time to develop, implement, and then fine tune their food safety plans,” according to the Conversation with Jenny Murphy, the consumer safety officer at FDA’s Center for Veterinary Medicine. For the same reason, FDA does not intend to conduct PCAF regulatory inspections of small businesses until the fall of 2019 and very small businesses until the fall of 2020. This same timeline also impacts food importers who must comply with the Foreign Supply Verification Programs (FSVP) rule, as FDA also intends to delay routine inspections of animal food importers. Although animal food regulation is not new, the preventive controls and CGMP requirement are, so, in response to industry request, FDA staggered compliance for the two sections, enabling facilities to first on CGMPs which “are a helpful foundation to have in place before you establish preventive controls,” Murphy said. As was the case with the Preventive Controls for Human Foods rule, this does not mean that companies won’t be held accountable for food safety practices during the interim. If FDA determines that there is a food safety issue, it “will use the tools available to us to keep that food out of the marketplace” – including the increased authorities the agency received under FSMA, such as mandatory recall and suspension of facility registration to block a facility’s ability to distribute food. Murphy also clarified FDA’s intentions in delaying regulatory inspections. That is: the agency may conduct preventive controls inspections at facilities that are small businesses, but it is delaying routine regulatory inspections, which “are mostly considered surveillance type inspections.” So, when FDA needs to conduct an inspection to further investigate a food safety issue, it will consider it “for-cause,” which, in all likelihood, would include a preventive controls inspection. Examples would include: the facility has a history of violative samples (product or environmental); its food is subject to a recall; it has made a reportable food registry report involving a potential hazard; significant observations were made during a previous inspection; and/or it is subject to enforcement actions taken by FDA or its state regulatory partners. By-Product Production One of the questions we often get from clients that make human food is how the PCAF impacts them. Facilities that produce human food but supply by-products for use as animal food may or may not be subject to the PCAF rule, based on the following: If the by-product is not further processed after it has been separated from the human food and the facility is complying with CGMPS and other applicable FDA requirements for their human food, then the manufacturer is only subject to limited requirements to protect the by-product during holding and distribution. If the facility is only doing certain manufacturing and processing activities performed on the by-products to facilitate transportation and storage after the by-product has been separated from the human food, then it is not subject to PCAF rule unless the activities are performed to prevent or significantly minimize animal food hazards, or they introduce hazards. However, CGMPs must be followed for the manufacturing and processing activities performed on the by-products after separation from the human food. If the facility is performing more complex manufacturing and processing activities on the by-product (such as pelleting) after the by-product has been separated from the human food
then it is subject to both the CGMP and PC requirements, but it can choose to follow either the requirements in the PCHF or PCAF rule for the processing and manufacturing of the by-product. To assist the industry in compliance, FDA has published PCAF final guidance on compliance with CGMPs and the small entity compliance guide; and draft guidance on the hazard analysis and preventive control requirements, the supply-chain program, and the use of human-food byproducts as animal food. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.AchesonGroup.com