As written, the CGMP and hazard analysis and risk-based preventive control requirements of the Preventive Controls for Animal Food rule apply to manufacturing/processing activities, including those performed to facilitate storage and transportation, unless an exemption applies. In draft guidance #239 Human Food By-Products for Use as Animal Food, we identified several manufacturing/processing activities for which there would only be limited CGMP requirements related to holding and distribution, including passive dewatering, as well as holding by-products at a particular temperature to facilitate transportation (e.g., keeping something in liquid or solid state).
Several sectors of the food industry have expressed concern about having to meet preventive controls requirements for certain other activities performed on their human food by-product and have asked that FDA consider streamlining the requirements for other activities that are also commonly performed to facilitate the storage and transportation of their by-products, including commingling ingredients, evaporating, chopping, mechanical mixing, pressing, trimming and washing.
The agency takes these concerns seriously and understands the practical value of these activities in preparing human food by-products for storage and transportation. As we implement FSMA requirements, we recognize the need to balance how these requirements impact current industry practices and the need to protect human and animal health. We are committed to working with industry to address these concerns, and are considering approaches that balance practical and public health considerations.
As we consider these approaches, the industry should be aware that in August 2017, we announced that we would not be conducting routine regulatory inspections of compliance with the animal food preventive controls requirements until the fall of 2018. This delay in routine regulatory inspections includes inspection of human food by-products that are further processed and required to comply with the animal food preventive control requirements.
