Food Regulations: A Changed Industry
By Rick Falkenberg Ph.D.
As a certified process authority, I am often asked what a process authority is and what their responsibilities are. The answers to these questions give us a better understanding of the process authority's essential role in the food processing industry.
In the "old days" (before 1971) it was easy to get a process for thermally processed foods. The processor simply contacted a container supplier, equipment manufacturer or the National Canners Association (subsequently called National Food Processors Association now known as the NPA) to secure this information.
That all changed in the summer of 1971 as a result of two incidents of contamination of commercially canned soups with Clostridium botulinum. In January 1973 the Food and Drug Administration (FDA) issued Title 21 Code of Federal Regulations Part 128B entitled "Thermally-Processed Low-Acid Foods Packaged in Hermetically Sealed Containers" (since recodified as Part 113). Additionally, a second regulation was promulgated and designated as 21 CFR Part 90 (since recodified as Part 108b). Part 128b went into effect in March 1973 and Part 90 (the Emergency Permit Control) in April 1974. These two regulations changed the regulatory scrutiny of the commercial canning industry forever.
Today, it isn't as easy to establish a process as it was prior to the regulations. Advances in food processing technology have created an array of process control choices for the manufacturer. The regulations cover the important foundation aspects of canning operations including process establishment, process delivery equipment, process deviation handling, record keeping, and container integrity. The FDA and U.S. Department of Agriculture (USDA) have, throughout their regulations, made references to "competent processing authorities". Part 113.83 of 21 CFR refers to "establishing scheduled processes" and states:
"Scheduled processes for low-acid foods shall be established by qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations. The type, range, and combination of variations encountered in commercial production shall be adequately provided for in establishing the scheduled process. Critical factors, e.g. minimum headspace, consistency, maximum fill-in or drained weight, water activity (aw) , etc. that may affect the scheduled process, shall be specified in the scheduled process. Acceptable scientific methods of establishing heat sterilization processes shall include, when necessary, but shall not be limited to, microbial thermal death time data, and inoculated packs. Calculation shall be performed according to procedures recognized by competent processing authorities. If incubation tests are necessary for process confirmation, they shall include containers from test trials and from actual commercial production runs during the periods of instituting the process. The incubation tests for confirmation of the scheduled processes should include the containers from the test trials and a number of containers from each of the four or more actual commercial production runs. The number of containers from actual commercial production runs should be determined on the basis of recognized scientific methods to be of a size sufficient to ensure the adequacy of the process. Complete records covering all aspects of the establishment of the process and associated incubation tests shall be prepared and shall be permanently retained by the person or organization making the determination."
This section of the regulation mandates that scheduled processes for low-acid foods be established by qualified persons: having expert knowledge in the heat sterilization of low-acid canned foods. Having facilities, instrumentation, and equipment adequate to determine the heat processing requirements of the food product. Adequately providing for the type, range, and combination of variations encountered in commercial production when the scheduled process is established. Using acceptable scientific methods of establishing heat sterilization processes including the use of appropriate F and z values and/or the development of bacterial spore thermal-death-time data. Maintaining records which cover all aspects of the process.
While this general description covers how a process will be established, it does not speak directly to of who process authorities are or how one qualifies to be a process authority. In Part 113.89 "Deviation in processing, venting, or control of critical factors" the regulation states:
". . .such evaluation shall be made by a competent processing authority and shall be in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential hazard to the public health."