Here are the key points raised/outcomes:

• Michael Mignogna, the supervisor of the LACF office, said requiring process filings for stuffed olives was not a change in FDA policy; it was a change in enforcement. (To us, that seemed like semantics.)
• Fermented olives do not require a process filing but proving the exemption to the individual port inspectors may be required with a flow chart of the fermentation process and resultant pH levels. Mignogna said that while in the food industry he voluntarily registered product that was exempt. It appeared he was suggesting those who hermetically seal containers file a process and list the critical control points.
• FDA said if the stuffings in question were sold by themselves, they would require process filings. Therefore, when the stuffings are added to another product a process filing is required.
• FDA is reviewing several products with regard to their treatment under the acidified food regulations, though they wouldn’t name those products.
• An FDA compliance policy guide will be issued shortly that will address many acidified foods issues. FDA lawyers are reviewing the document. Dr. Beru said although he expects the guide to be published shortly, he doesn’t feel comfortable giving a timeframe because the length of time for legal reviews varies greatly depending on the complexity of what’s being reviewed and the workload of the attorneys reviewing the document.
• Mr. Mignogna and Ms. Brecher said a process has to be filed for either the finished product or the stuffing. Import documents should list one or the other, not both. In bulk shipments, for example, an import could be made declaring the olives as fermented and listing the SID of the stuffing manufacturer.
• Online filing is much more efficient and much quicker. On both the paper and online forms, cold fill and hold can be checked in the thermal processing section. It’s one of the 18 options listed. If a method is used but not listed, FDA can easily add that method to the form.
• When a compliance officer is seeking more information about whether a food falls under the acidified food regulations, importers and exporters should immediately provide a process follow chart. That should answer those questions.
• We said we were concerned about length of time it will take FDA to review the process filings, particularly in light of the fact that so many olive processors and/or stuffing processors will be submitting filings. Ms. Brecher said the turn-around time has improved a great deal; some are completed within a week. She said they temporarily will try to expedite the filings of olives and olive stuffings and said filers should send an e-mail to her (Susan.brecher@fda.hhs.gov) after they file so she can monitor the filings and get them through as soon as possible. Mr. Mignogna can be reached via e-mail at Michael.Mignogna@fda.hhs.gov.