FDA Releases Draft Guidance on Human Food By-Products For Use As Animal Food

Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry No. 239, “Human Food By-Products for Use as Animal Food” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance describes the regulatory requirements — including the provisions of FDA’s new food safety rule for animal food in 21 C.F.R. part 507 — that apply to human food by-products intended for use as animal food. Part 507, which applies to animal food establishments required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FDCA), contains current good manufacturing practices (CGMPs) and requirements for hazard analysis and risk-based preventive controls for animal food. As discussed below, certain human food by-products intended for use as animal food are exempt from the requirements of part 507, except for limited CGMPs relating to holding and distribution. This alert highlights key aspects of the draft guidance and discusses points of interest to industry stakeholders.