One of the most significant and powerful statements in all of the United States collection of food regulations may be found in 21 CFR Part 113: “Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.” The regulation clearly states that processes must be established by a “competent process authority.” The regulation also includes the following definition:
Scheduled process means the process selected by the processor as adequate under the conditions of manufacture for a given product to achieve commercial sterility. This process may be in excess of that necessary to ensure destruction of microorganisms of public health significance, and shall be at least equivalent to the process established by a competent processing authority to achieve commercial sterility.