- On August 14, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) finalized amendments to the rules (9 CFR 318.12 and 9 CFR 381.152) relating to the preparation and handling of “uninspected, inedible products, such as pet food” in USDA registered facilities. As described in the proposed rule from July 31, 2018, the existing rules “set forth prescriptive requirements intended to prevent the creation of insanitary conditions in official establishments, the commingling of inedible and edible meat and poultry products, and the movement of inedible meat and poultry products into commerce as human food” and that manufacture occurs “only when an FSIS inspector is on the premises” (emphasis in original).
- However, these rules predate the Hazard Analysis and Critical Control Point (HACCP) regulations at 9 CFR Part 417 and related sanitation rules at 9 CFR Part 416 and, according to USDA, they are incompatible with the flexible approach available under the HACCP regulations. Under the HACCP regulations it is the responsibility of the facility to develop and implement plans with necessary and appropriate controls for safe, unadulterated product. Specifically, HACCP requires the determination of hazards reasonably likely to occur in the production process, the institution of controls to prevent the hazards or keep them within acceptable limits, monitoring and verification that the HACCP system is working as intended, and records maintenance. Though there are required objectives and some firm requirements (like recordkeeping), the HACCP regulations provide considerable flexibility in how a firm will achieve compliance. Similarly, the sanitation rule sets forth sanitation objectives for facilities but it permits great flexibility in achieving compliance.
- Under the revised rules, facilities may produce uninspected, inedible products at any time and with the only limitations that manufacture of these products will not:
- Adulterate edible products;
- Create insanitary conditions such that edible products might become adulterated; or
- Prevent or interfere with inspection or other FSIS efforts to regulate the establishment.
Further, the handling of the products must be such that they will not accidentally be distributed as human food.
- As noted in USDA’s response to the comments, manufacture of pet food is also subject to FDA regulation, including compliance with the Hazard Analysis and Risk-Based Preventive Controls and Good Manufacturing Practices (HARPC and GMP; 21 CFR Part 507).
Keller and Heckman attorneys are available to assist interested parties in navigating compliance with USDA HACCP and FDA HARPC and GMP. For assistance, please email: firstname.lastname@example.org.