A draft guidance document, recently published by FDA for public comment, describes changes being contemplated for the procedures that manufacturers of acidified foods and low-acid canned foods prospectively will use to submit information about the processes they use to ensure that the foods they produce are safe for consumers. The draft guidance addresses:
- Administrative procedures for submitting registration and process filing information required under 21 C.F.R. §§ 108.25(c) and 108.35(c);
- Administrative procedures for voluntary registration and processing filing for certain foods that are not subject to registration and filing requirements under these regulations; and
- A voluntary process whereby, upon request, FDA would review data and other information that support the establishment of a scheduled process for a new processing method or new equipment.
As part of this planned modernization, FDA would stop using Form FDA 2541a and Form FDA 2541c to collect processing information from manufacturers, and begin using forms that are specific to different industry manufacturing processes. In the future, acidified and low-acid canned food manufacturers likely will be able to submit one or more of the process filing forms listed below, depending on the processing methods being used:
- Form 2541d – Food Process Filing for Low-Acid Retorted Method
- Form 2541e – Food Process Filing for Acidified Method
- Form 2541f – Food Process Filing for Water Activity/Formulation Control Method
- Form 2541g – Food Process Filing for Low-Acid Aseptic Systems
The new forms would be available in paper and electronic (which mirror the paper) formats. The new forms are intended to be easier to use and to reduce confusion about the type of information FDA needs from a manufacturer to evaluate the adequacy of its processes. This, in turn, reportedly would enable FDA to better ensure the safety of acidified and low-acid canned foods.
Before FDA begins using the new forms, stakeholders reportedly will have two opportunities to comment on them.
- First, on specific topics relevant to the collection of information in the forms; and
- Second, at a future date, more broadly on the content of the forms and how the forms would best be integrated into the process for submitting information about subject manufacturing processes, as required by 21 C.F.R. § 108.25 and 108.35.
Until the information in the draft guidance is finalized and the new forms are made available for use officially, manufacturers of acidified and low-acid canned foods must continue to submit establishment registrations and process filings using the procedures, forms, and guidance that are currently in effect.
