The Food and Drug Administration recently announced it will delay the date for certain routine regulatory inspections of large animal food facilities until next year.
The agency said it won’t make those inspections until the fall of 2018. The inspections cover preventive controls and Foreign Supplier Verification Program (FSVP) compliance that is required by the Food Safety Modernization Act (FSMA) and the FDA’s final rule on Preventive Controls for Animal Food.
The FDA recently indicated the inspection delay was to allow the industry more time to obtain technical assistance, as well as to understand and comply with the requirements. The deadline for large animal food companies to comply with the Hazard Analysis and Risk-Based Preventive Controls (HARPC) is September 18. Small businesses face a September 17, 2018, deadline and “qualified facilities” have until September 17, 2019, for compliance. The agency is delaying inspections aimed at enforcing the HARPC requirements.
It is important to remember, however, that large animal food companies have been required to comply with Current Good Manufacturing Practices (cGMP) since September 2016. Large animal food companies have more than 500 full-time equivalent employees. The same cGMP requirements take effect September 18 for small animal food companies – fewer than 500 full-time equivalent employees. Preventive controls requirements for small animal food companies are not effective until September 2018. The FDA is not delaying cGMP inspections, only the HARPC inspections.
While aspects of animal feed manufacturing have been regulated in the past, the cGMP and preventive controls requirements are new. The cGMP requirements relate to good manufacturing basics, such as cleaning and pest control. The preventive controls rule will require the adoption of a food safety plan addressing biological, chemical and physical hazards for food that could present a public health concern. Large feed manufactures may anticipate inquiries about their food safety plan status and contents if a cGMP inspection identifies concerns.
Please contact me or any of the attorneys in Barley Snyder’s Food & Agribusiness Industry Group if you have questions about the effect of these rules and announcements on your business.