Manufacturers - 1
PROCESS FILING REQUIREMENTS
[21CFR 108.35(c)(2) and 108.25(c)(2)]
Low-acid canned food processors are required to provide the Food and Drug Administration information as to the scheduled processes including, but not limited to: processing method, type of retort or other thermal processing equipment employed, minimum initial temperature, times and temperatures of processing, sterilizing value (F0, -or other equivalent scientific evidence of process adequacy), critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such LACF and acidified food in each container size; not later than 60 days after registration, and prior to the packing of a new product.
Acidified food processors are required to provide to the FDA information on the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels; and source and date of the establishment of the process for each acidified food in each container size.
Submission for scheduled process filing for LACF and acidified foods is accomplished using Form FDA 2451a for all processing methods except aseptic processing and packaging. Scheduled processes for aseptic processing and packaging systems are filed using Form FDA 2541c and a separate supplement. Aseptically processed and packaged acidified foods are filed using form FDA2541a.
A separate process filing form for each product must be completed and submitted to FDA. This includes a separate form for: 1) each product form or style (whole, diced, French style, strained, solid-pack, syrup strength category, cream style, mature, cured, dry pack, vacuum pack, etc.) which receives a different scheduled process; 2) each different packing medium (e.g., water, oil, sauce, etc.) when the characteristics of the packing medium effect heat transfer, 3) each processing method (still, agitating, hydrostatic, etc.) 4) each type of container in which the product is packed (i.e., metal cans, glass, etc.), even though all other information is the same, and 5) each scheduled process source when all scheduled processes listed were not established jointly. However, products packed in water, brine, and sweetened brine may be filed on the same form as long as the scheduled processes are exactly the same.
A separate form is not required for each different brand name of a product if the scheduled process for the brands is exactly the same. In addition, multiple container sizes for a product should be listed on the same form, as long as the container type, packing medium, and other such information not related to container size is identical.
NOTE: Failure to file scheduled processes is a FDA 483 item.
For further information on the filing of scheduled process information, refer to Section III of the booklet Instructions for Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods.
Prior to beginning an inspection, Investigators should acquaint themselves with the firm's filed scheduled processes, particularly the product style or form, packing medium, processing method, container type, times and temperatures, and any other critical control factors. The Investigator should confirm in his initial conversations with the firm that the scheduled processes are still in use and have not been replaced or changed since they were filed. Note: the LACF regulations [108.35(c)(2)(ii)] require that when a packer intentionally makes a change in a previously filed scheduled process by reducing the initial temperature or retort temperature, reducing the time of processing, or changing the product formulation, the container, or any other condition basic to the adequacy of the scheduled process; the packer shall prior to using such changed processes, yconfirm with a processing authority the adequacy of the process. Such confirmation may be obtained by telephone, telegram, or other media, but must be promptly recorded, verified in writing by the authority, and contained in the packer's files for review by the FDA. Within 30 days after first use, the packer is required to submit to FDA a complete description of the modifications made and utilized, together with a copy of the file record showing prior confirmation of the safety of the changed processes.
Any intentional change of a previously filed scheduled process or modification thereof in which the change consists solely of a higher initial temperature, a higher retort temperature, or a longer processing time, shall not be considered a change subject to the above notification requirement. However, if this kind of modification is thereafter to be regularly scheduled, the modified process shall be promptly filed as a scheduled process, accompanied by full information on the specified forms.
When new owners have acquired a firm they must refile the processing forms unless the previous owners, or their process authorities, have supplied a letter stating that the data used to establish the processes used by the previous owner has been transferred to the new owners.
Operating Processes - Many packers employ an