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InterstateShellfishSanitationConference(ISSC)ReducedOxygenPackaging(ROP)WorkshopReport

November1‐2,2016–Atlanta,GA

I. Purpose

In 2015, theUS Food&DrugAdministration(FDA) submitted Proposal 15‐208 tothe ISSC Biennial Conference addressing reduced oxygen packaging (ROP) ofshucked shellfish. The 2015 ISSC Voting Delegates referred the proposal tocommitteetobegindiscussionsoftheappropriatenessofincorporatingC.botulinumcontrolsintotheNSSP.TheISSCheldaReducedOxygenPackagingWorkshopinAtlanta,GA.Thepurposeofthis meeting was to discuss the need for requirements to address the risk of C.botulinum associated in reduced oxygen packages in the National ShellfishSanitation Program (NSSP). C. botulinum produces the most potent neurotoxinknown. To date, there are no reported cases of botulism associated withconsumptionofshuckedshellfish,however,researchindicatesthatC.botulinumcanpotentially grow in oysters. Many participants in the ISSC question the need toincludeC.botulinumcontrolsintheNSSP.Therearemanypackagingtypesusedinthe shellfish industry that have not been evaluated to determine their anaerobicpotentialandtheircapacitytoallowC.botulinumgrowth.ThismeetingbroughttogetherexpertpanelistsonC.botulinum,shellfishpackagingandshellfishshipping.TheISSCReducedOxygenPackagingCommitteeparticipatedinthemeetinganddevelopedrecommendationsforConferenceaction.

II. Introduction

AReducedOxygenEnvironmentinShuckedShellfishContainersIn a 1981, as a result of research published on the risks of vacuum (VAC) andmodified atmosphere packaging (MAP) of raw fish products, NMFS issued amoratorium on the use of VAC / MAP for refrigerated fresh fish. In 1985, theNational Research Council of the National Academy of Sciences recommendedthat studies were needed on the potential hazard of non‐proteolytic C. botulinumtoxin production in vacuum and modified atmosphere fresh fish. They wereconcerned that the non‐ proteolytic strains of C. botulinum commonly associatedwith seafood products could grow and produce toxin at refrigerationtemperatures with no visible signs of growth to alert the consumer. They statedthat“This practiceisnotrecommendeduntilsafetyisvalidated.”

TheNationalAdvisoryCommittee forMicrobiologicalCriteria forFoods(NACMCF)reviewed the topic in 1991 and determined that refrigeration below 3.3°C (38°F)

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was the only control for the growth of non‐ proteolytic C. botulinum in raw fishthat is vacuum or modified atmosphere packaged. The NACMCF recommendedthatunrestricteduseofVAC/MAPshouldnotbepermitted.TheystatedthatVAC/ MAP would be permitted for raw fishery products when: (1) products werepackaged under an established HACCP plan, (2) detectable spoilage and rejectionby the consumer precedes the possibility of toxin production, ( 3 ) h igh qualityraw fish is used, ( 4 ) p ackaged product is stored below 38°F (3.3°C), and (5)p roduct is adequately labeled for storage temperature, shelf life, and cookingrequirements.

To address the need to demonstrate that detectable spoilage and rejection by theconsumer precedes the possibility of toxin production, several studies wereinitiated by the FDA. In salmon packaged under modified atmosphere, toxinproduction coincided with spoilage under moderate temperature abuse at 8°C(46.5°F). Temperatures below 4°C (39.2°F) were needed to prevent toxinformation. Similar studies were done in other seafood including cod, tilapia, andcatfish.

Anumberofconditionscanresultinthecreationofareducedoxygenenvironmentinpackagedfishandfisheryproducts.Theyinclude:

Vacuum, modified, or controlled atmosphere packaging. These packagingmethodsgenerallydirectlyreducetheamountofoxygeninthepackage;

Packaginginhermeticallysealedcontainers(e.g.,double‐seamedcans,glassjarswithsealedlids,andheat‐sealedplasticcontainers),orpackingindeepcontainersfromwhichtheairisexpressed(e.g.,caviarinlargecontainers),or packing in oil. These and similar processing and packaging techniquesprevent the entry of oxygen into the container. Any oxygenpresent at thetime of packaging (including oxygen that may be added during modifiedatmospherepackaging)mayberapidlydepletedby theactivityofspoilagebacteria,resultingintheformationofareducedoxygenenvironment

III. RelevancetoMolluscanShellfish

The Fish and Fishery ProductsHazards and Controls Guidancewas issued by theFDAtoassistprocessorsinidentifyinghazardsassociatedwiththeirproducts.Thisdocument addresses both species‐specific hazards and process‐related hazards.Under process‐ related hazards, page 73 indicates that raw oysters, clams andmusselshaveaC.botulinumhazardwhenpackedinreducedoxygenpackages.

IV. FormatandMeetingObjectives

Prior to the ROP Workshop, the ISSC solicited ROP related questions from themembership. 40questionswerereceivedandreviewedfortheexpertpaneliststo

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address. Each question was assigned to a panelist to answer. Other panelists,membersoftheReducedOxygenPackagingCommitteeandattendeesweregivenanopportunitytocommentandaskquestionsrelatedtoeachresponseoftheassignedpanelist.

V. ExpertPanelists

The ISSC invited several panelists with expertise in the use of reduced oxygenpackagingandthescientificaspectsthatpertaintobothreducedoxygenpackagingandC.botulinum.Thepanelistsarelistedbelow.A. MaryLosikoff

Senior Regulatory Microbiologist, the FDA Center for Food Safety and AppliedNutrition,OfficeofFoodSafety,DivisionofSeafoodSafety,SeafoodProcessingandTechnologyPolicyBranch

B. PatBarker

RexRefrigeratedExpressLLCC. YoonSong

FDAOfficeofFoodSafetyProcessEngineeringBranch D. MikeDoyle

University of GeorgiaE. GuySkinner

FDA Center for Food Safety and Applied Nutrition Division of FoodProcessingScienceandTechnology

F. MelissaAbbott

FDA Center for Food Safety and Applied Nutrition, Office of Food Safety, Division of Food Safety, Shellfish and Aquaculture Policy Branch

G. RobBartholomew

BerryPlastics/RFCContainerCo./ChemStretch/SpecialtyIndustriesH. KeithJackson

PerformanceFoodGroupI. PaulDiStefano

FDA Center for Food Safety and Applied Nutrition, Office of Food Safety, Division of Seafood Safety, Shellfish and Aquaculture Policy Branch

J. A.J.Erskine Aquaculture Manager and Field Scientist with Bevans Oyster Company,

CowartSeafoodCorp.

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K. AustinDocter

Director of Processing, Retail and Restaurants at Taylor Shellfish Farms L. JoeGoetz C&SWholesaleGrocersInc.

M. RogerPeel

Georgia Department of Agriculture

VI. Questions Answered by Panelists

A. Policy Related

1. DisappointedthattheFDAhasoptedtofocusonC.botulinumwhenthere areotherhighprioritypublichealthissuesthatareactuallycausing illnesses (Vibrio, Norovirus). Could the FDA provide arationale?

PaulDiStefano‐ThetheFDArecognizesthatepidemiologicalrecordsofC.botulinumillnessesdonotexistrelatedtotheconsumptionofoysters,however, the science shows that C. botulinum is reasonably likely tooccur.TheFDAwantstoseetheriskaddressedbeforeadeathorseriousillnessoccurs.theFDAwantstoworkwiththestatesthroughtheNSSPtoestablisheffectivecontrols.In determining reasonably likely to occur, the FDA uses illness data,scientific reports or other information that provides the basis toconclude that there is a reasonable possibility that a hazard exist.NACMCFandNWDT,theNationalAcademyofScienceshave indicatedthat theuseofROP inpackaging raw seafood isahazarddue to thepotential for growth of non‐proteolytic C. botulinum at refrigerationtemperatures.It is the process of placing the product in ROP that is primarilyresponsibleforcreatingthehazard.

2. Whilewe knowC.botulinumis a hazard,why is there not a history ofillness?

MaryLosikoff ‐TheFDAbelievesthiscouldbeattributedtodifficultiesindiagnosinglessseriouscasesaswellasmis‐diagnosisofmoreseriouscases.

3. Whyareweregulatingaquestionthat’snotanissue?

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SeeQuestion1

4. CantheFDAidentifytheagencypriorityamongtheissuesofC.botulinum,Vibrio, and Viruses and communicate how they are demonstrating thisprioritizationthroughexpendedresources?

Paul DiStefano ‐ The FDA has not prioritized food borne illnessesassociated with consumption of shellfish. All illnesses need to beaddressed.C. botulinum has always posed a risk. It has just recentlybecomeafocusoftheFDA.

5. Providejustificationmorethan“thiscouldhappen”.MaryLosikoff‐ThescienceshowsitispossibleforC.botulinumtogrowin an anaerobic environment and that environment exists in reducedoxygenpackaging.

6. WhattypesofscientificevidencewouldtheFDAbewillingtoconsiderinevaluatingtheactualneedforROP?Studies to identify substance inhibitors thatdonotallowgrowthofC.botulinuminananaerobicenvironment.Studieswouldhavetobedoneoneverytypeofoysterstomakesurethestudyremainstrueinall.Mary Losikoff – The FDA follows the advice of theNational AdvisoryCommittee on Microbiological Criteria for Foods (NACMCF), whichrecommendsthattheunrestricteduseofvacuum/modifiedatmospherepackagingor,collectively,reducedoxygenpackaging(ROP)technologyforrefrigeratedraw fisheryproductsnotbepermitted.TheuseofROPtechnologymay be permitted onlywhen it is assured that detectablespoilageandrejectionbytheconsumerprecedesthepossibilityoftoxinproduction. Research should be conducted to define the minimumconditions for control, incorporating reasonable limits for inoculationsize, storage temperatures, and stochastic (predictive) modelingtechniques.NACMCFprovidesprocedures for inoculatedpackstudies inthereporttitled“VacuumorModifiedAtmospherePackagingforRefrigeratedRawFishery Products” adopted March 20, 1992 and “Parameters forDeterminingInoculatedPack/ChallengeStudyProtocol”adoptedMarch20,2009.

7. Isthereanopportunityforaminorchange?

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Mary Losikoff ‐ The proposed controls are the only known controlsavailabletoaddressC .botulinuminROP. Iceasanalternativetotherefrigerationrequirementcouldbeused.CommentsbytheISSCsuggestthatpackagingtypescouldchangeandthiswouldleadtoasignificantcostinresearchanddevelopment.Allknownalternativecontrolswouldnotbeconsideredaminorchange.TheFDAdoesnotplantochangeitspolicy.Severalworkshopparticipantsindicatedthatuseoficewouldbecostlyand the research and development cost of changing packaging typescouldbecostprohibitive.

8. Can the FDA determine an estimated risk level associated with C.botulinum,similartotherisk?MaryLosikoff‐Thereisnodatatoestimatetherisklevel.TheavailablestudyshowsthatC.botulinumcangrowinshellfishpackages,butdoesnotprovideanestimatesrisk.Whatstudy?

9. Does theFDAhavedataabout illnessesrelated tooysterproductionthathasnotbeenshared?GuySkinner–TheFDAhasprovidedallavailableillnessdata.

B. ScienceRelated

10. Provide evidence thatprovesC.botulinum can grow in apackageofshuckedoysters.Not aware of studies specific to oysters. Challenge studies wereconductedonmussels.MikeDoylesuggestedachallengestudyshouldbeconducted.

11. WhatisthetimingofC.botulinumformationaftertheproductfallsoutoftemp?Thehigherthetemperature,thefasterthetoxinsareproduced.

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Skinner‐LarkinCurve

12. WilltheproductactuallyspoilbeforeC.botulinumformation?

Couldexpirationdatebeusedasacontrol?MaryLosikoff‐Ifdatacouldbedevelopedtoshowthis,theFDAwouldconsider. Expirationdatehasnotbeenusedascontrol inother foodsandexpirationdatesforoystershavenotbeenestablished. Withotherfood, sometimes yes, sometimes no. Determining timing of spoilagewouldbedifficult.Based on consumer behavior studies relative to consumer reaction toexpiration date, the FDA has no reason to believe consumers wouldreacttoTTIdifferentlythanexpirationdate.IfthereisscientificevidencetosupportthatspoilageoccurspriortothegrowthofC.botulinumandanexpirationdateon thecontainercouldindicateadatepriortothegrowth,thisoptioncouldbeexplored.Thisisnotsomethingthathasbeendonebeforesoitwouldneedanindepthstudy.

13. CurrentNSSP storage and shipping conveyance requirements are atorbelow45°F.Is45°FadequatetoaddresstheC.botulinumhazard?GuySkinner ‐Studies inpublished literaturesuggestthatC.botulinumcangrowattemperaturesabove38°F.

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14. IdentifyotheralternativesforC.botulinumcontrol.

a. Can the FDA and or the committee explore validation fortheories thatsuggestpHandpackagingplayarolein reducingthethreatofC.botulinum?Ifsubstancesareaddedtheshellfishmaynolongerbeconsidereda fresh product and would be regulated under the SeafoodHACCPRegulation.Studieswouldneedtobeconducted.

b. Might washing product in ozonized water, which mightincreaseoxygencontent(creatinganaerobiccondition),abovewhereC.botulinumcould surviveprovide any reduction ofC.botulinum?MikeDoyle‐StudieswouldneedtobeconductedtodetermineifozonizedwaterwouldpreventananaerobicenvironmentGuySkinner–Ozoneisconsideredahumanhealthhazard.

c. Does salinity or salt impact growth? If salt is shown to be aninhibitor, what might the necessary salt level be? In otherwords, a more thorough investigation of alternate controlsratherthanjustcontainertypes.

Studieswouldneedtobeconducted.

JonBell–Ozonizedwater in theprocesscould increase rateofspoilage but would have little impact on eliminating ananaerobicenvironmentinthepackage.MikeDoyle–Theruleofthumbis5%saltservesasaninhibitorforC.botulinum. 2.5% saltcombinationwithother substancessuch as ascorbic acid could be an effective inhibitor for C.botulinumGuySkinner–TheFDAwouldneedtoseeaninoculationstudyMikeDoyle–Respondedtothefollowingquestions;What temperature isnecessary tokillC.botulinum?Sporesarekilledat100°C.Toxincanbeinactivatedat180°Ffor5minutesorboiling.

C. PackagingRelated

15. Needtoknowthepackingtypesthatwouldbeaffected.

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Yoon Song ‐ The screw cap containers andmetal pop lid containersalmost definitely pose anROP concern. It is possible that all of thepackagingtypescouldposeanROPconcern.TheOxygenTransmissionRateofeach containerneeds tobedeterminedbeforea finaldecisioncanbemadeastowhichcontainersmayposeaROPconcern.

16. Existing containers that are not a ROP concern pose significantproblemsfortheindustry.Pleaseexplainwhy.

AustinDocter/AJErskine ‐Many shuckingoperationshave found thattheexistingpackagesthatareleastlikelytoposeaROPconcerncreateshipping challenges due to package leakage from lids not staying inplace.Theleakageproblemiscompoundedinairshipments.Shuckingoperations are also using seals for tamper proofing in response tocustomerpreference.Usingtamperproofingdoesnotsolvetheleakageproblem.UsingtheexistingpackagesthatareleastlikelytoposeaROPconcern would not be a viable option for shucking operations. Theindustryhasattemptedtouse filmsealswithcontainersthathave lidswhichallowoxygentransfer.Thefilmswithmicroscopicholesleakandbulge.

17. What is the criterion applied to exempt some containers but notothers?

YoonSong‐TheoxygentransmissionrateofthecontainerdeterminesifthepackagingisROP.

18. TherearepresentlynoventedcontainersavailabletoaddresstheROPconcern. What containers/packaging alternatives are available toaddresstheconcern?Yoon Song/Austin Docter ‐ A microporous membrane that haspermeabilityaswellasbeingwaterproofedhasbeendeveloped.Similarmaterials have been tested but tiny amounts of pressure can causeleakage.

19. IsitpossibletoaddressROPwithcontainerscurrentlyonthemarket?

Seequestions16,17&18.

20. Could existing packages be modified to address C. botulinumconcerns?

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Testing of current packagingmust be conducted before this questioncanbeanswered.

D. Compliance&LogisticsChallenges

21. What would be the compliance options for meeting shipping andreceivingrequirementsassociatedwithreducedoxygenpackaging?

JoeGoetz – Currently, the FDA’s suggested compliance options are to

keeptheentiresupplychainbelow38°Fwithmechanicalrefrigerationorbycompletelysubmergingtheproductiniceandensuringthateachindividual container has a time temperature indicator to ensure thatnoneoftheproducthasbeenexposedtotemperaturesabove38°F.

22. Whatarethechallengescreatedbyrequiringstorageat38°F?

AJ Erskine/Austin Docter/Keith Jackson/Joe Goetz/Roger Peel/BruceFlippens/DebraScovilleSome processors would have to reconfigure their freezers or installadditionalicemachineswhichcouldbecostprohibitive.Thiswouldnotbe an issue at the retail level asmost retailers already have coolerscapableofmaintaining38°F.Many companies have differentials in cooler temperatures, often asmuchasfour(4)degrees. Arequirementof38°Fcouldresult in lowertemperaturesthatcouldresultintheformationofice.Dealingwithiceinacoolerwouldbeproblematic. Wholesalerspresentlyhavecoolersthat aremaintained at 38°F and a requirement of 38°F would not affect wholesalers very much. Large retailers would not be affected by a requirement of 38°F. Smaller retailers could be affected. Some retailers place retail packages in cases surrounded in ice. The use of ice requires disposal of water, which can be problematic.

23. Whatarethechallengescreatedbyrequiringshuckedshellfishtobeshippedat38°F?

PatBarker–Trucksarecapableofmaintaining38°F.Whenrejectionis

extremely costly, ice is used. The weight of ice increases cost ofshipments. Icecancauseboxestogetwetandruintheintegrityofthebox. TTR placement in the truck is critical. If individual TTIs werereceived,receivingcustomerswouldwanttoopeneverybox.LackofunderstandingregardinguseofTTRs.

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Every shipment normally has its own TTR monitoring trucktemperature.Trucksnowhavetechnologyavailabletotracktemperatefromremotelocations.Atsomepointtherewillbeaneedtoaddresscorrectiveactions.

24. Confusionassociatedwithdifferentrefrigerationrequirements:

i. NSSP‐45°Fii. NSSP‐Vibrioshellstockinternaltemprequirement50°Fiii. FoodCodeforpotentiallyhazardousfoods‐41°Fiv. ROP‐38°FTherefrigeration temperatures listedaboverepresentdifferent foodsafetyrequirements.Dothesedifferentrequirementscreateconfusionforwholesalers,retailers,orconsumers?Wholesalers and retailers already cope with different refrigerationrequirements. There is no way to ensure temperature safety forindividualconsumers.Keith Jackson–There is confusionbecausemostworkersusuallyonlyhave a high school education and do not understand differenttemperatures for different products. They often have to make splitseconddecisionsregardingreceiptorrejection.Confusion at retail especiallywhen reduced oxygen package productsareinvolved.Requirements do not exist at retail to ensure that temperature ischecked at receipt. Most illnesses occur at home and at restaurants.Inspectors conduct most education. It is not likely these retailinspectors in non‐producing states can educate retailers abouttemperaturecontrolsforshellfish.

25. Would<38°Frequireseparatecoolersforshuckedshellfish? AJErskine/AustinDocter/KeithJackson/JoeGoetz

Producerlevel:Yesforsome.Noforsome.Somecouldadjustexistingcoolers.Wholesalelevel:Notaproblem.

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Retaillevel:Largecould. SmallermayneedadditionalcoolerorwouldchoosetonothandleROPproducts.

26. a) What is the ability for retail establishments to maintain

multiple temperatures with their cases, i.e. oysters, at 38°Fwhenotheritemsareheldatothertemperatures?

Noadditionalcomments.Seequestion24.

b) Willretailersbewillingtochangeinfrastructure? Seequestion25.

27. Cold chain temps are typically > 38°F. What challenges would thiscreate?

Seequestions24and25.28. Trucking companies won’t run mixed load trailers at 38°F just to

accommodateshuckedshellfish.Howdotruckingcompaniesaddressshippingproductswithdifferenttemperaturerequirements?

Trucking companies can run mixed load trailers. They ship at the

lowesttemperaturerequiredfortheproductsbeingshipped.

PatBarker –Trucking companieswill inform shipper of temperaturethetruckisrunningat.Willrunmixedloads.Temperaturenormallyrunsabout34°F‐36°F.If temperature gets below freezing, live productmortality can occur.Seecommentsassociatedwithiceinquestion23.

29. How will the consumer respond when the temperature device

immediatelychangescolorafterleavingthedelicase?

HowshouldconsumerrespondtoTTIchanges?MaryLosikoff–ConsumershouldnotpurchaseproductifTTIindicatestemperatureabuse.IfTTIindicatedchangeafterpurchase,consumershoulddiscard.

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Retail inspectorswerenotawareTTIs can changewhileproduct is ingrocerycartbeforecheckout.

What products currently require individual TTI? The FDA indicatedmost other seafoodprocessorshave changed packaging toavoidROPcontrols.MaryLosikoff–Imports.IfTTIrequirementwasadoptedbytheISSC,theFDAwouldworkwithConferenceofFoodProtectiontoeducateconsumers.Industry expressed concern that shucked shellfish may be the onlydomesticproductwhichwouldberequiredtouseindividualTTIsanditappearsthatconsumersdonotknowhowtorespondtoTTIchanges.***Ken will get statement from retail how they communicate toconsumers.

30. Would adequate icing be an acceptable alternative to a conveyancemaintainedat45°F?

MaryLosikoff‐Yes,as longas theproduct iscompletely submerged in

iceforthedurationofshipment.

PatBarker‐questionedwhatdoessubmergeinicemean.Submergediniceandcoveredinicemightbeinterpreteddifferently.

E. CostRelated

31. Whatisthecostassociatedwithchangingpackaging?

Rob Bartholomew ‐ Reduced oxygen packaging could affect volumepurchasingprices.Toknowthecostassociatedwithpackagingchanges,currentpackagingmustbetestedtobeclassifiedasROPornon‐ROP.Ifacceptable filmcouldbe identified, therewouldbeacostassociatedwithapplyingthefilm.Newpackagingcouldaffectshelflife.

32. What is the cost associatedwithmeeting lower temperature critical

limitsforshuckedmeats?

Costwouldvaryandcouldincludenewcoolers,newicemachines,timetemperatureindicators,etc.

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KeithJackson–RejectioncostJoeGoetz–NoadditionalcostatwholesalePatBarker –Additionalcostof transportationat lower temperaturesoruseoficeRogerPeel–Smallerretailermayneednewcooler Disposingofice LargerfirmsnoadditionalcostDebraScoville–ShouldnotresultinadditionalcostatretailBruceFlippens–Disposalofwaterfromicemelt SmallerretailerswillnothandleproductAJErskine–Smallerprocessorsmaynotbeabletopasstheaddedcosttoretailerinthepresentcompetitivefoodmarket

33. Whatisthecostofnewstoragethatwouldbecompliant?

AJ Erskine/Austin Docter/Keith Jackson/Joe Goetz/Roger Peel/BruceFlippens/DebraScovilleCostwouldvaryandcouldincludenewcoolers,newicemachines,timetemperatureindicators,etc.

34. Ifwehadtoputtemperaturetrackeroneverycontainer,whatwould

thatcost?

JoeGoetz‐Mostfirmswouldpay$1.00foreachTTI.Smallerfirmscouldpayasmuchas $2.50 ‐ $5.00 each.Bulk purchases couldbemade toreducecosts.10,000‐20,000unitswouldbearound$0.50each.AustinDocter‐500,000unitscouldbeaslowas$0.38each.ThereisashelflifefortheTTI.Thiswouldlimitvolumepurchasing.AustinDocter–Wouldadd$500,000to$700,000toTaylorShellfish’scost.In addition to the cost of the TTI, there is also cost associatedwithadded staff time forattaching theTTI to thepackage. TTI’smustbestoredinaspecificwayandtheydohaveashelflife.ThefailurerateisalsoaconcernwithTTIs.

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AustinDocter–TTI’sarenotcommonplace in themarketandoneofthesmallestfoodindustriesintheUSshouldnotbethe“guineapig.”MaryLosikoff–TheFDAaskedforTTIcostinformation.AustinDocter–TTItechnologyisnotasreliableasitisthoughttobe.ErinButler – Cost ofmodifyingHACCP plans andHACCPmonitoring.TTImust be stored at 27°F. Could require additional equipment forstorage.Miranda Ries – May have to be attached in cooler. Could requiremodificationofcoolertoaccommodateworkingspace.PatBarker–Difficulttopasscostontoretailersbecauseofimportsandcompetitivepricing.

35. Whatisthebenefitofthatcostespeciallyifnotresultinginsignificantbenefit?

Paul DiStefano ‐ From the perspective of the FDA, spores are in theproductsocontrolsareneeded. Accordingtoscience,thebenefit isnogrowthofC.botulinumthusavoidingtheriskofillnessthatcouldcausedeathorhavelifelongconsequencesforpatients. Preventingan illnesswouldreducemedicalcostsassociatedwithillnessandpreventthelossofhumanlife,whichhasestablishedmonetaryvalue.The shelf life of shucked product is long enough to allow for C.botulinumgrowth.PatBarker–ShouldgowithBMPsinsteadofrequirements.JoeGoetz–Whatisthemortalityrateofillnessinvolvingshellfish?GuySkinner–Maybeaslowas15%.Paul DiStefano – Suggested the FDA would considermodification toproposal15‐208.MirandaRies– Industry isawareof illnessassociatedwithVvandVpandunderstandsthepurposeofadditionalcontrols. TheindustrydoesnotfeelROPcontrolsarenecessarywithoutanillnessburden.

F. Other

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36. Existing data about ROP and seafood lumps shellfish into a generalfishcategory,canthisbechangedsothatshellfishdataisseparate?

Mary Losikoff ‐ There has been no recorded cases of C. botulinum inoysterssothereisnoshellfishdatathatcanbeseparatedout.MobileBaystudyshowsC.botulinumwasisolatedfromshellfishMusseldata–showsC.botulinumpresentinshellfishTherewasaC.botulinumcaseassociatedwithfrozenscallopsinFrancein1998.MikeDoyle–referenced2researchpapersScallopindustrymaybeusingTTIsonpaintcans.

37. Request that the Committee engagewith representatives from boththe retail and shipping sectors and encourage their participation inthesediscussions.

Retailandshippingsectorsparticipatedinthismeeting.

G. SuggestedResearchThe following is a list of research needs. The ISSC has some funding,however,itwilltakemuchmoremoneytoconductthesestudies.

38. NeedvalidatedstudiestodeterminetheimpactsofProposal15‐208.

Studies should outline shipping options and provide guidance forcompliancewithregulations.

MaryLosikoff‐Notsureoftheintentofthisquestion.

39. Request proposal from the FDA for funding necessary to complete

scientificinformationandabetterunderstandingofhowC.botulinumgrowswithinshuckedoysters.

MikeDoyle–C.botulinumresearchiscostly.The FDA was not able to respond but indicated ISSC could make arequestforfundstoconductstudy.

40. Request scientific experiments – perhaps inoculate oysters and put

themindifferentpackagestoseehowtheyrespond.

GuySkinner–Wouldneedtoaddressworstcasescenario.Mayneedtoaddressgeographicaldifferences.

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MikeDoyle–DetermineifthereareinhibitorsthatcouldinhibitgrowthwithoutchangingproductAJ Erskine – Are there currently inhibitors that explainwhy illnesseshavenotoccurred?

41. Isanyoneawareofanystudiesthatmayofferalternatives?JonBell– If traditional containersare consideredROPand theyhavebeenusedforalongtimewithoutillness,istheresomewaytousethatassomebaseline?MikeDoyle–ShellfishdeterminationisimportantAJErskine–Whatcompetitivebacteriaexistinthecontainer?Industry Question ‐What are other countries doing to address ROPconcerns?

VII. ReducedOxygenPackagingCommitteeAction

TheReducedOxygenPackagingCommitteedevelopedthefollowingrecommendations:1.TheExecutiveBoardidentifyfundingforstudiestodeterminethefollowing:

a.Arethereinhibitorsthatmaybepresentoradded?b. Arethepresentshuckingandpackingpracticesprovidingcontrolsthatcanexplain why there are no reported cases of illness associated with C.botulinum?

c.DeterminetheeffectthatnormalproductdeteriorationhasonPH.DetermineifPHreachesalevelthatprohibitsC.botulinumgrowth.

d.DetermineifareducedshelflifeoffersapotentialC.botulinumcontrol.e.ConductastudyofcompetitivebacteriaanditseffectonC.botulinumgrowth.

2. The ISSC Executive Board requested that the FDA conduct a cost analysis of theimpactofProposal15‐208.

3.TheISSCExecutiveBoardrequestedthattheFDAdeterminehowpackagingchangeswouldaffectexports.

4. The ISSC Executive Board requested that the FDA consult with other countries todeterminewhattheyaredoingtoaddressC.botulinuminshuckedshellfish.

5. The ISSC Executive Board requested that the FDA provide the rationale for theAgency’s determination that C. botulinum is reasonably likely to cause illnessassociatedwithconsumptionofshuckedshellfish.