The U.S. FDA requires that scheduled processes for low-acid and acidified foods must be established by an organization or person qualified as a "Process Authority." A Process Authority must have expert scientific knowledge of thermal processing requirements for low-acid foods and/or processing requirements for acidified foods acquired through appropriate education, training, and experience. The processes are based on scientifically obtained data relating to heat or acid resistance of public health and spoilage bacteria and/or upon data pertaining to heat penetration in canned foods.
The type, range, and combination of variations encountered in commercial production must be adequately provided for in establishing the scheduled process. Critical factors, e.g. maximum equilibrium pH, minimum headspace, consistency, maximum fill-in or drained weight, water activity, etc. that may affect the scheduled process and the attainment of commercial sterility must be specified in the scheduled process. Acceptable scientific methods of establishing heat sterilization processes must include, when necessary, but may 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. 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.
U.S. FDA regulations prohibit marketing shelf-stable acidified and low-acid foods unless the manufacturer's processes were established by a qualified Process Authority. Products which do not satisfy this requirement may be seized by U.S. FDA or refused entry for imports. Marketing such products is a prohibited act which can result in criminal and civil penalties, including imprisonment, fines, injunctions, and seizures.
Registrar Corp does not act as a Process Authority, but can often suggest a competent Process Authority in your region. For assistance, please contact us