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Historically, the Food Safety and Inspection Services (FSIS), a branch of the United States Department of Agriculture (USDA), required meat and poultry facilities to use only nonfood compounds and proprietary substances that had been approved under the USDA authorization program. This requirement, written into the U.S. Food Code, was based on the recognized public health benefits of the authorization, carried over into many other product applications (including retail operations).
The process of product evaluation was based upon formulation and label review only, and generally did not include testing. Upon determination of compliance, the USDA issued a letter of authorization. This authorization ensured FSIS inspectors would approve a product's use within meat and poultry operations. Manufacturers and formulators therefore secured letters of authorization before marketing their products for food-related applications.
Two Federal Register notices, published August 25, 1997 and the final on February 13, 1998, announced the end of the USDA authorization program.
The FSIS significantly altered their approach to facility inspections, eliminating the need for USDA product evaluation. FSIS moved away from prescriptive regulation to performance-based reviews. This new approach was driven by the established system of Hazard Analysis and Critical Control Point (HACCP) facility operation.
Under HACCP, all meat and poultry establishments must identify and manage critical control points for food processing. Control points are defined as those where chemical, physical, and microbial contamination may occur. Once these points are identified, the processor must reduce contamination risk and maintain documentation describing the corrective actions taken. For nonfood compounds and proprietary substances, the facility operators must select the appropriate product to not only meet their operational needs, but also their HACCP requirements.