Manufacturers - 1
"operating" process in which retort operators are instructed to use retort temperatures and/or processing times slightly in excess of those specified in the scheduled process as a safety factor to compensate for minor fluctuations in temperature or time to assure that the minimum times and temperature in the scheduled process are always met. 'Operating processes' do not constitute a modification to the regularly scheduled process and therefore do not need to be filed.
Use of the On-Line LACF Computer File - The LACF on-line system is an interactive data base developed for FDA Headquarters and Field personnel in need of information concerning firm registration and process filing. The system allows information retrieval from the LACF Firm Registration File and the LACF Process File thereby ensuring quick and easy responses to questions from investigators, import operations personnel, as well as importers and their brokers.
The system is maintained by the Division of Information Resources Management in the Center for Food Safety and Applied Nutrition. Access to the system is through the Time Sharing Option (TSO) on the Parklawn Computer Center. A TSO ID and password are required to access TSO and the LACF On-Line Computer File. TSO ID, system security clearance, and a system users guide may all be obtained by contacting CFSAN, Division of Information Resources Management, HFS-676.
Investigators should utilize the On-line LACF computer file to familiarize themselves with a firm's products, processing systems and scheduled processes prior to performing an LACF or acidified food inspection. It should also be used to determine if an imported LACF or acidified product is from a registered firm and is covered by a filed process.
[21 CFR 108.35(c)(3) and 108.25(c)(3)]
These sections require all LACF and acidified food processors to comply with the mandatory requirements of 21 CFR 113 and 114, including registration of processing plants, filing of scheduled processes, control of critical factors and adherence to the filed processes. Note: FDA's request and examination of such information does not constitute approval of the information by the FDA. Information concerning processes and other data so furnished are regarded as trade secrets.
[21CFR113.83 and 113.89]
A processing authority is a person who has expert knowledge of thermal processing requirements for low-acid foods packaged in hermetically sealed containers, or has expert knowledge in the acidification and processing of acidified foods. Knowledge can be obtained by education or experience or both. Expert implies experience, knowledge and achievement as well as recognition as an authority on a subject, usually by one's peers. Anyone who is establishing scheduled processes must have adequate facilities for making the appropriate determinations (21 CFR 113.83). Anyone who is evaluating processes which are less than the scheduled process must utilize procedures recognized by competent processing authorities as being adequate to detect any potential hazard to public health (21 CFR 113.89).
Some have asked FDA if a certain individual can be approved as a processing authority. FDA has no specific statutory authority to require that processors obtain our prior approval before engaging the services of an individual or an organization to act as a processing authority. FDA does not intend to institute such approval procedures, nor to generate a list of competent processing authorities. The regulations are intended to govern the end product of a processing authority's work rather than that person's qualifications. However, if CFSAN (HFS-617-Division of HACCP, Regulatory Food Processing and Technology Branch) is unfamiliar with the person/establishment they may need to review their qualifications, and the procedures and methods utilized to evaluate the adequacy of the final work product.
There are certain groups and individuals, such as trade associations, equipment manufacturers, food consulting firms, food container manufacturers, academic institutions, professors, and firms with a thermal process expert on their staff. FDA often has knowledge of the qualifications of their personnel for establishing processes and for conducting evaluations in accordance with procedures recognized by competent processing authorities as being adequate to detect any potential public health hazard; and they are routinely engaged in such activities. Even though they may be recognized by their peers as being processing authorities, this does not prevent the agency from performing inquiries.
What are the responsibilities of the processing authority? First a processing authority must establish thermal processes (21 CFR 113.83).