Manufacturers - 1
compliance with the requirements of each of these sections (registration, process filing, process adherence, providing information and records to FDA, notifying FDA of problems, recall procedures, attendance at an approved school and record retention).
However, §108.25(a) requires compliance only with specific sections of Part 114 while §108.35(a) requires compliance with all sections of Part 113. Section 108.35 also has one additional section [§108.35(e)], which in Part 114 is combined into §108.25(d). Sections 108.25(h) and 108.35(i) exclude products under continuous USDA inspection. Sections 108.25(i) and 108.35(j) allows us to consider that processors in states with effective regulations equivalent to Part 114 or Part 113 are in compliance with the Federal regulations. The States may register their factories with FDA and file processes for their products.
Sections 108.25(j) and 108.35(k) apply to imports. Emergency Permits are applicable only to manufacturers operating here in the United States. When investigation indicates that a foreign manufacturer of either LACF or acidified food has not registered; has not filed a scheduled process; or is not in compliance with all the mandatory provisions of 21CFR 108.25 or 108.35, and 113 or 114, then in lieu of an emergency permit, FDA will request the Secretary of the Treasury (U.S. Customs) to refuse admission (detention without sampling, i.e, automatic detention) into the United States to any such foods which may result in the distribution in interstate commerce of foods that may be injurious to health.
The emergency permit provisions are a powerful tool that the Commissioner has at his disposal to assure the public is protected from low-acid canned food, distributed in interstate commerce, which may have been inadequately or improperly manufactured or packed; and whose harmful nature cannot be adequately determined. CFSAN exercises considerable care to assure emergency permit action is taken only in instances where public health is threatened and there is documented evidence that the processor is either incapable of complying with the mandatory requirements of 21 CFR 108.35 and 113, or has no intention of complying.
ESTABLISHMENT REGISTRATION REQUIREMENTS
[21 CFR 108.35(c)(1) and 108.25(c)(1)]
Registration is required for U.S. establishments who thermally process low-acid canned food or acidified food, and foreign processors who import these products into the United States. Wholesalers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.
Commercial low-acid canned and acidified food processors in the United States must register with FDA not later than 10 days after first engaging in the manufacture, processing, or packing of acidified or low-acid canned foods. Foreign processors must register before offering any such products for import into the United States.
Registration is accomplished by completing Form FDA 2541 according to the instructions in Section II of the booklet Instructions for Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods. Process filing forms will be accepted only from registered firms. However, registration and initial process filing may be done at the same time.
If a previously registered processing plant has moved to a new location, the plant must be registered at the new location. To do so, Form FDA 2541 must be executed again, with "Change of Registration Information" checked and "Re-registration" entered on the same line. FDA will issue a new Food Canning Establishment (FCE) number and cancel the old FCE number (any process filing or attempted import using the old FCE will be refused), unless another company intends to use the old factory for the production of LACF or acidified food. If another company takes over the old factory, the FCE number would remain with that factory location. In this case, the new company should complete a Form FDA 2541 indicating 'change of name' after the 'change of registration' box and fill in the factory's current FCE number on the line provided. Both of these transactions (registration of the new factory and change of name of the old factory) should occur at the same time to avoid confusion. A letter from either party or both should be submitted with the registration forms to explain the circumstances of the situation.
Investigators should confirm a firm's registration by asking to see a copy of the Form FDA 2541 and verifying that the information contained on the form is correct. Note: the list of "low-acid or acidified foods processed at this location" may not always reflect or include all products because there is no regulatory requirement that the registration form show additions or deletions of products. However, the firm must have scheduled processes on file for each and every low-acid canned food or acidified food product it produces.