US Food and Drug Administration requirements for the processing of low-acid canned foods

Abstract

Due to concerns over the potential for contamination with Clostridium botulinum toxin, the U.S. Food and Drug Administration (USFDA) has been inspecting commercial processors of low-acid canned foods under an industry-specific regulation (21 Code of Federal Regulations Parts 108 and 113) since 1973 (amended in 1979). This regulation is designed to control four critical areas of processing: establishment of the scheduled process, delivery of the scheduled process, documentation of delivery of the scheduled process, and container integrity. It represents the first instance in U.S. government regulations of a HACCP-based rule designed to control a significant health hazard. The U.S. Department of Agriculture published its own low-acid canned food regulation (9 CFR Parts 318 and 381) for canned meat and poultry in 1986, based largely on the U.S. FDA model. Because of the similarities in the two regulations, this article will deal primarily with the requirements of the U.S. FDA in three sections: Definitions, Major Regulatory Requirements, and Critical Compliance Issues and USFDA Enforcement Policy Failure to comply with the most essential parts of the regulation can result in prohibition against shipping for domestic firms and detention without physical examination (automatic detention) for foreign processors.