Working Group Chair Presentation Book

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Item
Line
Numbers(If
Applicable)
Comment ProposedChange(s) Response
1 139(table
2)
Chocolateisanimportantmatrixforpeanut,hazelnutandmilk. chocolateisaknownproblemthantheapplicabilityshouldclearly
statethatchocolateisnotpossibletomeasureusingthevalidated
method.
Nochange. Chocolateisanoptionalmatrixtobetestedfor
candidatemethodthatclaimtoworkinchocolate.
2 56Ͳ65 Shouldtheprecisiondataobtainedoverthewholeanalyticalrange?Numberoflevels? Describethevalidationofprecisioninamoreprecisewaye.g.include
numberoflevelsandreplicates
Additionalreference toAppendixDandFareadded
3 116(table
1)
BydefinitiontheanalyticalrangecanonlystartwithanLoQ.MDLonlygivesayesorno. Nochangerecommended. Thecommentistruebutthereis
notanyprohibitionagainsttheLOQ=MDL.
4
Aftervalidation,LCͲMS/MSmethodswillbeusedforcomparisonwithELISAresults.Ancommercial
ELISAis(often)calibratedtothewholeallergenicfoodwhileLCͲMS
comparabilityestablishedviareferencematerials?(again:traceabilityofLCͲMS/MStotheseRMsis
mandatory!)
DiscusstraceabilityandcomparabilitytoELISAresults(note:thisSMPR
discussapossiblereferencemethodforcGMPcompliance!)
Nochange. TheworkinggroupdidnotagreetotieLCͲMS/MS
resultstoELISAresults.
5 96 NISTSRM2387isnotpurepeanutbutamixtureofroastedpeanut,sugar,partiallyhydrogenated
vegetablesoilsandsalt.SeeNISTcertificate:proteincontentisgivenbutnotpeanutcontent.
DiscusssuitabilityofthisSRMintheworkinggroupandgiveconversion
factor
Nochange. That’swillbeleftuptothemethodedeveloper.
6 92 NISTSRM1549issupersededbyNIST1549a DeleteNISTSRM1549 Agree.ReplaceNISTSRM1549wuth1549a.
7 85
NIST8445isawholeeggpowderwithagivenproteincontent.Howshouldamethoddeveloper
traceittowholeeggwithoutconversionfactor?
Discusstraceabilityintheworkinggroupanddiscussaconversion
factor
WorkingGroupagreedthatallresultstobe"reportedasppm
ofthetargetallergeninfoodcommodity".
8 67 Recovery:Whatkindofsamplesisrequired?Spikedorincurred?ForELISAincurredispreferred. WeshouldfollowtheguidelineforELISAwhichpreferincurred
AddareferencetoAppendixM: ValidationProceduresfor
QuantitativeFoodAllergenELISAMethods. AppendixMdoes
mandatetheuseofincurredsamples. AOACpolicyallowsfor
bothkindsofsamples. Methoddeveloperdiscretion.
9 67
Recovery:Howshouldamethoddeveloperdeterminethisparameter?Byspikingwithreference
materialsorpeptidesoradifferentmaterial.Oneshouldrememberthatitisnotallowedtousea
referencematerialforcalibrationANDspiking!Ifpeptidesareusedforcalibration,howwas
traceabilityestablished?
Discussintheworkinggroupandremembertosolvethetraceability
problem
Nochangerecommended. Methoddevelopmentissuenot
SMPRissue.
10 62
Sincereproducibilitydeterminationisonlypossiblebyacollaborativestudy,anintraͲlaboratory
reproducibilityshouldbedefinedtoeasesingleͲlabvalidationsatthebeginning
Inlcudeanewclauseafterrepeatabilityanddescribethevalidationto
bedone Nochange. AllpreviousSMPRsusedRSDRandRSDr.
AOAC SPSFAM ALLERGENS DRAFT SMPR Ͳ COMMENTS on ALLERGENS SMPR FINAL
7
11 50
MDL:Howshouldamethoddeveloperestimatethisparameter?Byusingblankmatricesorblank
matricesspikedwithreferencematerials/peptides?Howmanyreplicates?Wehaveveryclear
guidelinesforallergendeterminationbyELISAͲwhynotfor“ReferencemethodsforcGMP
compliance”?
DiscussintheworkinggroupmaybefollowELISAguidelines
ReferencetoAppendixM: ValidationProceduresfor
QuantitativeFoodAllergenELISAMethodsaddedtoSMPR.
SMPRwillalsorefertoFDAand/orEPAdefinitionforMDL.
12 46
LoQ:Howshouldamethoddeveloperdetermineorevenestimatethisparameter?Byusing
referencematerialsorpeptidesolutionsorblankmatricesorblankmatricesspikedwithreference
materials/peptides?Howmanyreplicates?Wehaveveryclearguidelinesforallergen
determinationbyELISAͲwhynotfor“ReferencemethodsforcGMPcompliance”?
DiscussintheworkinggroupmaybefollowELISAguidelines ReferencetoAppendixM: ValidationProceduresfor
QuantitativeFoodAllergenELISAMethodsaddedtoSMPR.
13 46Ͳ69 LoQ,MDL,recoveryandprecisiondataneedtobedeterminedforeveryclaimedmatrix includeasentenceforeachparameterthatexplainstheparameterͲ
specificvalidation
Line108ofversion revised torecommend"LOQ,MDL,recovery
andprecision"dataforeveryclaimedmatrix.
14 116(table
1)
BytakingthelatestpublishedVITALreferencedosesC18(FoodChem.Toxicol.63:9Ͳ17,2014)itis
obviousthattheMDLs/LoQsintable1arenotsufficientwhenafoodisanalyzedthatisconsumed
inaservicesizeofmorethan50g. LowerMDL/LoQappropriatelytothefollowingtable.Note:C19
Hazelnut:Referencedoseasprotein:0.1mg;Referencedoseasallergenicfood:0.64mg;
Minimumconcentrationtobequantifiedwhenconsuming50gfood:12.8mg/kgandfor200g3.2
mg/kg.
Milk:Referencedoseasprotein:0.1mg;Referencedoseasallergenicfood:3.03mg;Minimum
concentrationtobequantifiedwhenconsuming50gfood:60.6mg/kgandfor200g15.2mg/kg.
Peanut:Referencedoseasprotein:0.2mg;Referencedoseasallergenicfood:0.8mg;Minimum
concentrationtobequantifiedwhenconsuming50gfood:16mg/kgandfor200g4mg/kg.
Wholeegg:Referencedoseasprotein:0.03mg;Referencedoseasallergenicfood:0.25mg;
Minimumconcentrationtobequantifiedwhenconsuming50gfood:4.8mg/kgandfor200g1.2
mg/kg.
ChangeMDLs/LoQintable1accordingtotheVITALvaluesand
calculationsgivenundercomments.Discussintheworkinggroup
Nochange. WorkingGroupdiscussedon3/3/2016.Thereare
multipleVITALswithdifferentmaximumpermissiable
concentrations. TheWorkingGroupconsensusisthatnoneof
theVITALsareinternationalconcensusnstandards,anddeclined
toresettheLOQsorMDLs basedonVITALmaximum
permissiableconcentrations.
15
Howshouldamethoddeveloperprovethattheselectedpeptidesarenot“too”specifice.g.a
theopposite,iftheselectedpeptidesarenotspecificenough,nearbotanicalrelativesaredetected
whicharemaybenotallergenicorregulated(seeprunusmahalebexample).
Atminimumachapterdescribingtheknownspecificities/selectivities
shouldbeprovided.(Note:Unknownoccurrenceofpeptidesthatare
notfromaallergenicsourcewillalwaysoccurinthefuture,seealso
prunusmahaleb)
Nochange. Theworkinggroupdidnotagree.
16 Whataretheminimumperformancecriteriaforpeptideselection? Includecriteriaforpeptideselectionorgivereference Nochange. Theworkinggroupdidnotagree.
17
VITALvaluesarebasedonamountofproteinperservicesize.Therefore,thedefinitionofthefood
allergensas“foodcommodities”withoutmentioningtheproteincontentwillestablishanonͲ
comparabilitybetweenresultsobtainedbyanLCͲMS/MSmethodandVITALvalues.
Includesomeguidancefortheuserorletthemethoddeveloper
describehiswayofestablishingtraceabilitytoVITALvalues
Nochange. WorkingGroupdiscussedon3/3/2016.Thereare
multipleVITALswithdifferentmaximumpermissiable
concentrations. TheWorkingGroupconsensusisthatnoneof
theVITALsareinternationalconcensusnstandards,anddeclined
toresettheLOQsorMDLs basedonVITALmaximum
permissiableconcentrations. ANDE25
18 9
collaborativetest:ItshouldbecriticallycheckedifAppendixDissufficientinthecasewhereLESS
than8participants(and/orLCͲMS/MSmachines)areavailable.Isthisstillcollaborativeor
forbiddenatall?
discussintheworkinggroup Nochange. AOACpolicynotaworkinggroupdecision.
19 3 Thetitleisunclear changeto“…selectedfoodallergens” Changetitleto“…selectedfoodallergens."
20 9
Thismeansamethodcomparisonbetweentheoriginalmethod(checkedbyanERP)andthis
methodtransferredtoanotherlab.Arethereanyguidelinesforthiscase?Whatistheminimum
requirednumberofmeasurementstobesurethatbothmethodsarecomparable?
Includeminimumrequirementsforverification
Nochange. Methodcomparisionisnotaverification
requirement.
8