FDA Regulations

The FDA's general regulatory requirements for foods ("Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food") are found in Title 21 of the Code of Federal Regulations (CFR) Part 110. Requirements for "Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers" are found in 21 CFR 113, and requirements for "Acidified Foods" in 21 CFR 114. Foods that have a water activity of 0.85 or less and those that are refrigerated or frozen are exempt from the low-acid and acidified food regulations, as are carbonated and alcoholic beverages, jams, jellies, preserves, dressings, and condiments. The FDA has recently mandated Hazard Analysis and Critical Control Point (HACCP) regulations for seafood and seafood products (21 CFR 123), although canned foods complying with 21 CFR 113 or 114 do not have to include critical control points for microbiological hazards. In addition, 21 CFR 108 describes the emergency permit system that can be imposed on processors who fail to comply with the regulations.

The regulations in 21 CFR 113 define low-acid foods and commercial sterility. They specify the proper design, controls, and instrumentation for all the common retorting systems and the practices necessary in the operation of these systems to ensure safety. The regulations require that records be kept of all coding, processing, and container closure inspections and that these be reviewed prior to shipment of product. The regulations also describe the actions to take when a process deviation has occurred. They require that the heat process be designed by qualified persons having expert knowledge of thermal processing requirements (processing authority). The term processing authority is not explicitly defined in the regulations, there are no specific criteria for qualifications, nor does FDA (or USDA) maintain a list of processing authorities. However, certain organizations, such as the National Food Processors Association (NFPA), are widely recognized by government agencies and the food industry as having the experience and expertise to serve in this capacity (11). Some food processing firms have individuals on staff who can serve as the processing authority, and a number of consultants are recognized as processing authorities. Another requirement is that all thermal processing operations be conducted under the supervision of an individual who has satisfactorily completed an FDA-approved course of instruction; these Better Process Control Schools, sponsored jointly by the FDA, the Food Processors Institute (FPI) (12), and key universities, are held around the country every year. Occasionally such courses are given to specific companies or overseas.

The regulations in 21 CFR 114 define acidified foods and describe procedures for acidification (described in the next section). The regulations require that the process be established by a processing authority, and they define the procedures to be followed in the event of a deviation from the scheduled process or the pH exceeds 4.6. They describe the methods to determine pH or acidity for acidified foods and the records that must be kept. Supervisors with responsibility for pH control and other critical factors must receive instruction through an FDA-approved course.

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