FDA to Improve how Food Processors Submit Information to FDA – New Approach to Reduce Errors and Improve Public Health Protection
September 17, 2013
The Food and Drug Administration is seeking to make it easier for manufacturers of acidified and low-acid canned foods (LACF) to submit information about their manufacturing processes to FDA and to improve the accuracy of the information they provide. FDA is doing this by modernizing both the paper and electronic process filing forms that acidified and low-acid canned food manufacturers are required to file with the agency under 21 CFR 108.25(c)(2) and 21 CFR 108.35(c)(2).
As part of this modernization, FDA will stop using Form 2541a and Form 2541c to collect information from manufacturers and will begin using forms that are specific to the different industry manufacturing processes. In the future, acidified and low-acid canned food manufacturers will be able to submit one or more of the process filing forms listed below, depending on the processing methods they use.
- 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 will be easier to use and reduce any confusion about the type of information FDA needs from a manufacturer to evaluate the adequacy of its processes. This, in turn, will enable FDA to better ensure the safety of acidified and low-acid canned foods.
The new forms will be available in paper and electronic format. The electronic forms will mirror the paper forms.
Before FDA begins using the new forms, stakeholders will have two opportunities to comment on them. First, stakeholders will have an opportunity to comment on specific topics relevant to the collection of information in the forms and the Paperwork Reduction Act. Second, at a future date, stakeholders will have an opportunity to comment more broadly on the content of the forms and how the forms will be integrated into the process for submitting information about their manufacturing processes as required by 21 CFR 108.25 and 21 CFR 108.35, when FDA publishes related draft guidance.
The opportunity to comment on specific topics relevant to the Paperwork Reduction Act will begin in the next few days. In the near future, FDA expects to issue a Federal Register notice announcing the availability for public comment of a draft guidance that provides general information about how to submit information about manufacturing processes as required by 21 CFR 108.25 and 21 CFR 108.35.
Manufacturers should continue using the Forms 2541a and 2541c until the new forms are finalized and formally adopted.