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HomeU.S. FDA Food RegulationsU.S. FDA FCE-SID › Process Authority Assistance

Process Authority Assistance

The U.S. FDA requires that scheduled processes for low-acid and acidified foods must be established by person qualified as a "Process Authority." A Process Authority must have expert knowledge of thermal processing requirements for low-acid foods acquired through appropriate education, training, and experience.

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 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.

If you need a Process Authority

As a Process Authority, Registrar Corp provides assistance with food canning processes, including:
  • Expert knowledge in thermal processes and science based methods of establishing thermal processes (including determination of F-value, Death Rate (z), Thermal Process Lethality, etc);
  • Scheduled process establishment, including heat penetration and distribution test reports and data, and microbiological data when appropriate, plus establishment of required record-keeping processes; and
  • Flexibility to provide different combinations of variations when the scheduled process is established and evaluations of deviations.
If you manufacture shelf-stable foods in sealed containers and do not have a qualified Process Authority, click below for assistance:

Process Authority Assistance >>

U.S. FDA Regulations:

U.S. FDA FCE/SID: 21 C.F.R. sections 108, 109, 113, 114

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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