EAS Consulting Group aids food professionals, pharma companies, cosmetics firms and other manufacturers in sorting the tangles associated with regulatory changes. Staffers (many former FDA compliance officials themselves) offer advice on how to understand such shifts, often confusing, to ensure existing products and future launches are in line with all necessary regulations.
One such regulatory change is the recently issued FDA CFSAN non-binding draft guidance on Food Facility Registration and New Electronic and Paper Forms, pertaining to Low-Acid and Acidified Canned Foods. David Park, senior consultant with EAS, discussed the guidance with FPD, including notable changes and what food manufacturers need to do to ready themselves.
FPD: What are some of the most notable aspects about this particular guidance?
David Park: In presenting its rationale for the Draft Guidance, FDA envisions having canning facilities file more comprehensive scheduled process information than currently accepted. This involves the use of using individually-customized canning system forms for low-acid and acidified foods packaged in hermetically-sealed containers.
Additional information entries will be filed using newly-designed electronic and paper forms in order to better focus upon specific canning system-related preventive controls of both facility and FDA interest.
Individually-customized FDA preservation system forms are, actually, not new. A number of years ago, FDA had exclusively used paper forms to capture facility scheduled process information for separate canning systems.
These paper forms separately addressed acidified foods, batch retorting systems, continuous container handling retorting systems, hydrostatic retorting systems and aseptic sterilization systems. These forms were used prior to the introduction of electronic forms which took full advantage of industry and government internet access.
When electronic filing was introduced, these individual process system forms were consolidated into one menu-driven form to accommodate the various commercial preservation and sterilization systems available in the industry. FDA clearly envisions the re-introduce both separate paper and electronic forms that will be individually custom-matched to each of these identified preservation systems.
Currently, Form FDA 2541a (food canning establishment process filing for all methods except aseptic) or Form FDA 2541c (food canning establishment process filing for aseptic systems) in both electronic and paper format. FDA intends to update the regulation to specify new forms. In addition, those forms currently drafted in the new FDA Guidance are more detailed in technical content required to complete the submissions.
Are there any areas of this draft guidance that food producers/packagers should pay special attention to?
First, read the entire Draft Guidance and understand what changes may be later implemented by FDA and how they may affect your management of facility registrations and scheduled process filings. Submit your own facility comments by March 17, 2014 regarding suggestions, issues and concerns that you may have to this FDA Draft Guidance Document, as announced in the Federal Register on January, 14, 2014.
Carefully review the Appendicies to the Draft Document and study the extent of the additional content entries on the individual filing forms designated for various products and preservation systems.
Note the types of facility or vendor documents, including documents such as process authority letters, packaging supplier documents, and other process-supporting documents including microbiological challenge studies, where applicable and upon FDA request, to be attached to the newly formatted scheduled process filing form submissions.
Watch for any new upcoming FDA Federal Register announcements regarding the Draft Guidance, any extension of public comment periods and then respond within the designated timelines specified.
Are there any provisions in the draft that seem especially positive, or problematic?
On the positive side: After many years, FDA has taken steps to further modernize and integrate the canning facility registration and scheduled process filing form procedures including those required under Section 415 of the Bioterrorism Act of 2002. FDA is backing the development of “smart forms” along with providing additional canning facility account management flexibility.
Lastly, FDA appears to be very willing to collaborate with a canning facility in a pre-review of technical data involving new processing systems and new equipment in advance of an official facility scheduled process filing. This should further assist the process of canning industry technology innovation and help streamline FDA new process and equipment acceptance.
Aspects that are potentially problematic: Domestic and foreign canning facilities should review the type of detailed documentation examples in the sample process filing form Appedicies before the end of the comment period. The examples provided by FDA in the Draft Guidance give a glimpse of what may be additional scientifically-derived documentation that may be FDA-required to support current and future facility scheduled process filings.
To best prepare for these types of uncertainties, some low-acid and acidified food canning facilities may need to consider conducting additional process validation testing where technical gaps may still exist. These considerations to factor in may include product and packaging microbiological challenge studies which may not only be costly, but also, time consuming to complete.
It is important to prepare now for what may later may be further FDA-requested scientific evidence to support either current Submission Identifiers (SID’s) and / or future scheduled process filings.
What are your final thoughts on this draft guidance?
Overall, what FDA has initially disclosed in this new LACF / AF Draft Guidance should be a further step in the right direction for simplifying current procedures used for domestic and foreign food canning facility registration and process filing compliance as set forth in 21 CFR Part 108 and other related FDA food facility statutes and regulations.