FDA Acidified Foods What is Happening?

Why is it Happening?•Recent outbreaks involving fresh (apple and orange juice),minimally processed and low-moisture foods have placedspotlight on the whole industry•Discovery of acid-tolerant pathogens (E. coli 0157 H:7,Listeriai monocytogenes, Sl Salmonella ll enterica)•Significant recalls in low-acid, shelf-stable products resultingfrom plant operations mistakesFDA Draft Guidance forIndustry: Acidified FoodsWhat does it mean to discover thatyour product is an “acidified food”,and is covered by 21 CFR part 114?2

21 CFR Parts 108 and114Eleven Compliance Activities• Plant registration.• Process filing.• Personnel training• Equipment andprocedures.• Product preparation.• Establishingscheduled processes.• Processes andcontrols.• Process deviations.• Filling and sealingoperations.• Record keeping andstorage.• Recall planning.How is it happening?•FDA has stepped up in-depth scrutiny of all newprocess filings•FDA is assisted by state public health agencies, whoare sending inspectors to visit all food processingestablishments within their state.•Example: p Florida Department of Agriculture & ConsumerServices (FDACS)•Supermarkets•Retail Food Establishments•Food Manufacturing and Storage Facilities3

What do they look for?•Investigators identify and visit food processingestablishments manufacturing shelf-stable foodsand beverages, and ask to see copies of theirprocess filings submitted to FDA•If the processor has submitted no filings theinvestigator will ask to see letter from a processauthority.What is a “Process Authority”?“An individual or group expert in thedevelopment, implementation, andevaluation of thermal and/or asepticprocesses for shelf-stable foods”.**Institute for Thermal Processing Specialists (IFTPS)4

What is an “Acidified Food”?Low-acid food with water activitygreater than 0.85 to which acidingredients are added resultingin equilibrium finished productpH less than 4.6.What might bean “Acidified Food”?Food containing both acid food(s)and low-acid food(s) may or maynot be considered an acidified food.5

Acid Foods Containing“Small Amount” of Low-acid Foods.Weight of low-acid ingredients must be less than 10%of weight of low-acid plus acid ingredients.Low-acid < 0.10 (Low-acid + Acid)ANDNo significant shift in pH between predominant acidingredients and finished product equilibrium.Significant pH ShiftPredominant Acid IngredientspHMaximum Shift in pHBt Between Acid AidIngredientsand Final ProductAbove 4.2Not an Acid Food, and must beconsidered “Acidified Food”4.2 0.23.8 – 4.2 0.3Below 3.8 0.46

What should we do about it?1. Determine which, if any, of your productscould be considered “Acidified Foods”.2. Register with the FDA all processingestablishments in which acidified foods aremade, and file processes for each product.3. Document rationale with process authority forall products not considered acidified foods.What about cold-fill?7

Excerpt from Typical FDA LetterTherefore, we request that filers of cold fill processes providescientific support (challenge study) for their cold fillprocess which establishes that if pathogens are present,they are destroyed and if so, how long it takes for a fivelogreduction of such microorganisms, and at whattemperature the product must be held for this reduction totake place.The pathogens customarily examined include the acid-tolerantE. Coli Ol57:H7, Salmonella, and Listeria Monocytogenes.Journal of Food Protection. Vol. 70, No. I l, 2007, Pages 2638-2641Research NoteDetermination of 5-Log Reduction Times forFood Pathogens inAcidified Cucumbers duringStorage at 10 and 25 CFRED BREIDT, JR.,* JANET HAYES, and ROGER F, McFEETERSUSDA/ARS and North Carolina Agricultural Research Service.North Carolina State University, Raleigh, NC 27695-7624, USA• MS 07-100: Received 2l February 2007/Accepted 13 Junce20078

Determination of 5-Log Reduction Times for Food PathogensinAcidified Cucumbers during Storage at 10 and 20C• “FRED BREIDT, JR.,* JANET HAYES, and ROGER F, McFEETERS• We have shown that manufacturers ofacidified foods with pH at or below3.3, with acetic acid as the primaryacidulent, can therefore safely producethose products without heat treatment.”Cold Fill at 10 C9

Cold Fill at 25 CChallenge Study ProtocolsYou can also refer to:“NACMCF Challenge Study Protocols"published in Journal of FoodProtection,Vol. 73, No. 1, 2010.Please bear in mind that these guidelines andprotocols have not been developed by FDA andthat the FDA requirements are not solely based onand/or not limited to these protocols.10

What does this mean toDressings and Sauces Industry• Assume more foods will be classified acidified• Assure safety and stability of acidified products• Rely on solid science• Obtain results from challenge studies on cold-filled products with pH > 3.33• Rely on proper implementation, execution anddocumentation of food processing activities• Understand guidance is not yet finalized11