October 5, 2015
The Food and Drug Administration (FDA) has completed its review of public comments received on drafts of new process filing forms that acidified and low-acid canned food manufacturers will be required to file with the agency under 21 CFR 108.25(c)(2) and 21 CFR 108.35(c)(2). FDA has made changes to the draft forms and instructions where appropriate, and has made the revised forms and instructions available to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act (PRA).
FDA has retained much of the information that was in the version of the forms that FDA made available for public comment, but has also revised the forms in several places to make the forms easier to use and more accurate. FDA’s revisions to the new forms mark the culmination of the agency’s process of modernizing the 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).
Acidified and low-acid canned food manufacturers will now be able to submit one or more of the process filing forms listed below, depending on the processing methods they use.
- Form FDA 2541d – Food Process Filing for Low-Acid Retorted Method
- Form FDA 2541e – Food Process Filing for Acidified Method
- Form FDA 2541f – Food Process Filing for Water Activity/Formulation Control Method
- Form FDA 2541g – Food Process Filing for Low-Acid Aseptic Systems
The new forms will replace the agency’s old process filing forms, Forms FDA 2541a and 2541c. Like the old forms, the new forms are available in paper and electronic format. The electronic forms mirror the paper forms. The new forms are 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 are currently available on FDA’s website for manufacturers to use. The old forms are also still available, but will be eliminated once FDA completes the process of amending its regulations in 21 CFR part 108 to remove references to the old forms.
Stakeholders and other members of the public have had three opportunities to comment on the forms. The first opportunity to comment was in connection to specific topics relevant to the collection of information in the forms and the PRA, and was announced in the Federal Register when FDA published a request for comments in accordance with the PRA on September 18, 2013 (78 FR 57391). FDA subsequently extended the comment period for an additional 90 days on November 18, 2013 (78 FR 69095).
The second opportunity to comment was an opportunity to comment more broadly on the content of the forms and how the forms would be integrated into the process for submitting information about their manufacturing processes as required by 21 CFR 108.25 and 21 CFR 108.35. That opportunity was announced when FDA published a related draft guidance and issued a notice announcing the availability of the draft guidance in the Federal Register on January 14, 2014 (79 FR 2448). The third opportunity was on August 14, 2014 (79 FR 47642) when interested parties could submit comments directly to OMB.
For More Information
- Code of Federal Regulations Title 21, Sec. 108.25(c)(2)
- Code of Federal Regulations Title 21, Sec. 108.35(c)(2)