The purpose of proposed SEC 507.10(b) is to make clear that although a facility solely engaged in the storage of unexposed packaged animal food is exempt from subpart C, such a facility is subject to modified requirements that would be established in proposed SEC 507.48. These requirements would apply to the storage of unexposed refrigerated packaged TCS animal food. The Agency explains the basis for those proposed requirements in section X.I.
IX. Proposed Subpart B--Current Good Manufacturing Practice
A. Animal Food and Current Good Manufacturing Practices (CGMPs)
The preventive controls system will result in controls that are specific to each facility based on the hazards it identifies and the controls it determines are necessary to control such hazards. Although FDA has had general baseline controls that apply to most establishment manufacturing, processing, packing, and holding human food in its current good manufacturing regulations under part 110, FDA has not had such baseline controls for facilities manufacturing, processing, packing, and holding animal food. The animal food industry, as well as governmental entities and international bodies, have recognized the need for basic safety and sanitation measures that apply across the board to facilities handling animal food. The AAFCO passed its "Model Good Manufacturing Practice Regulations for Feed and Feed Ingredients" in August 2009 and published them in 2010 in the AAFCO Official Publication (Ref. 42). AAFCO is a voluntary membership association of State and Federal Agencies charged with the regulation, sale, and distribution of animal feeds. The goal of AAFCO is to provide a mechanism for developing and implementing uniform and equitable laws, regulations, standards, definitions, and enforcement policies for regulating the manufacture, labeling, distribution, and sale of animal feeds. AAFCO's Model CGMPs stipulate basic requirements for the production of safe animal food, and cover the following areas: Personnel; establishments, including construction, design, and grounds; maintenance and housekeeping, including pest control; equipment, including construction and design; receiving and storage for further manufacture; manufacturing; labeling; storage of finished feed and/or feed ingredients; inspection, sampling, and testing of incoming and finished feed and/or feed ingredients for adulterants; transportation of feed and/or feed ingredients; and voluntary recall/withdrawal. AAFCO is not an enforcement agency, however in States that adopt the model CGMPs into their State animal feed regulations, failure of an animal food facility to adhere to these CGMPs would be grounds for enforcement action by the state.
The Codex Animal Production and Health Manual of Good Practices for the Feed Industry is a collaborative effort between the Food and Agriculture Organization (FAO) of the United Nations, and the International Feed Industry Federation, with significant contributions from members of a number of national feed industry trade associations, members of individual companies within the feed industry, and animal feed experts from universities. The good manufacturing practices (GMPs) described in Section 3 (Ref. 43) of the manual are practices and procedures intended to ensure the safety and suitability of animal food throughout the feed chain, and provide for such practices and procedures to be implemented in the following areas: Buildings and facilities; location of feed establishment; design and layout; internal structure and fittings; water supply; cleaning facilities; air quality, temperature and ventilation; lighting; equipment; personal hygiene; cleaning; maintenance; pest control; waste; drains; storage; transport; and training.