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MISCELLANEOUSITEMS 4  Dr.HilligaskedforadditionsandcorrectionstotheminutesofJanuary30,1997.TherewereϜnone.Mr.LarryLafleurwillforwardtheelectronicversionoftheminutesforpostingonEPAsϢTTN/NELACwebsite. RECOMMENDATON#3 l  TobegindiscussionitwasassertedthatEPAshouldspecifyMeasurementQualityObjectives(MQOs)ratherthanreferencemethodswhenitpromulgatesregulations.Furtherdiscussionofthisdraftrecommendationresultedinthefollowingwording:0,X,X, X08  8!! ELABrecommendsthatbeforeEPApromulgatesaregulation,itmustϜdemonstrateanddocumentthatMeasurementQualityObjectives(MQOs)areachievableusingavailablemeasurementtechnology    ̢Mr.DavidFriedmandiscussedtheEMMCsuseoftheterm PerformanceBasedMeasurementSystems(PBMS)withrespecttotheterm PerformanceBasedMethods(PBMs).HenotedthatunderPBMS,anymethod(includingEPAmethods)areacceptabletoEPAwhenitcanbedemonstratedtomeetEPAsMQOs.HenotedthatthisshouldnotbeconfusedwithPBMs,sincenoparticularmeasurementmethodisassociatedwithit.Discussionoftheterm referencemethod(thelegallyrequired rightwaytomakea ,.|)- measurement)ensued.Hence,underPBMS,areferencemethodisnotmeaningful;EPAmustsimplydemonstratethatitispossibletoachievethepromulgatedMQOs.EPAmaynotethemethodsithasfoundthatarecapableofmeetingtheMQOs,withoutstipulatingarequiredmethod.Thiswouldoccurasamatterofdocumentation,notrequiringapproval(i.e.,demonstrationofequivalencytoareferencemethod).Thepossibilitythatthemethodderivedqualityparameter,ratherthanhealthbasedorotherscientificallybasedinformation,maybethesourceoftheMQOwasacknowledged.Itwasalsoacknowledgedthatcurrentlawsandregulationsmayneedtobechangedtoallowforthisapproach. RECOMMENDATION#4 $   The demonstrationoftheachievabilityofMQOsshouldbeapplicableinthematrixofinterest,forthemeasurementmethodofinterest.Measurementinanonsimilarmatrix,includingwater,isnotseenbymembersofthesubcommitteeasavaliddemonstration.Thisisseenasamajorregulatoryimplementationissue,irrespectiveofwhethera referencesystemorPBMSisadopted.Basedonextensivediscussion,itwasagreedtorewordtherecommendationtoread:-,XX4,,X,-8  EPAmustdemonstratethatanyneworrevisedregulatorymeasurementrequirementsareachievableonsamplesthatrepresentthesamelevelofanalyticalchallengeasthematrixforwhichtheregulationisintended.(Ideally,thiswouldbesamplesoftheactualmatrixtobemonitored,asdefinedbytheregulation.)    1,X,,XX4,T1Theissueofcleardefinitionoftheterm matrixisacriticalissueinthisdiscussion.Mr.FriedmanofferedtosharewiththissubcommitteethedefinitioncurrentlybeingusedbyEPAsEnvironmentalMonitoringManagementCouncil(EMMC).TheyareprovidedasAttachmentC. ADDITIONALISSUES X   SubcommitteemembersdiscussedthecharterofthisELABsubcommittee,agreeingthatPBMSshouldbeimplemented.However,itwasacknowledgedthatthereisconcernovertheacceptanceofPBMSamongstakeholders.Itwasalsoagreedthatafocusonhowtoeffectively $X" implementPBMSmayalsoaddressmorefundamentalconcerns.Forexample,underthehighlyflexibleenvironmentenvisionedforPBMS,auditingwillneedtobecarefullyaddressed,aswillotherissues.ItwasnotedthatthissubcommitteehasbeenaskedtoaddressbothissuesforELAB.̛̜ NEXTMEETING T,'+  ThenextteleconferenceofthissubcommitteeistentativelyscheduledforThursday,April3,1997 ,.|)- 13pm.EST.Theremainderoftodaysagendawillbeaddressedatthattime.   X %  pp?(#AttachmentA  X   oUX4` <hDp Lx (#,X,o ACTIONITEMS  D  ELABPBMSubcommitteeTeleconference 0 March6,1997   *q ddd Xdd Xdd X(#(#q,d@,t@+  1"  C1 Action ؃ =*DC" C= Date D Completed  J9%0C"  CJ H9%0C"  CH LarryLaFleur willforwardminutesoftheJanuary30meetingtoGene    TatschforprocessingtopostontheTTN/NELACwebsite. =*  C C= =*  C C= C4%  C 0  CC =* 8 C C= E4% 8 C 0  CE =*4 C C=5+)  C 0   5      uUX4` <hDp Lx (#X, Xu  ؃AttachmentB  X   LISTOFPARTICIPANTS  D  ELABPBMSubcommitteeTeleconference 0 March6,1997     & &XX,& & &&*f67ddd@t@(#(#f,` td , td ," tt +  1" | z*1Name 9*^" 9Affiliation =*^" =  Telephones H9*^  * z  P HKathyHillig,Chair 'D   'BASFCorporation +x   +T:313/2466334F:313/2465226E: :+!   P   :МMikeConlon(absent) ' t  'LabStrategyGroup +  +T:703/9131314F:703/9131314E: 5& @     5DavidFriedman(invited) 'T  'ТUSEPA + 0  +T:202/2603535F:202/2604346E:Ϣfriedman.david@epamail.epa.gov 5&`    5LarryLaFleur 'P 'NCASI +P +T:541/7528801F:541/7528806̢E:llafleur@wcrcncasi.org 5&@!    5CynthiaLee(absent) '# 'AnalyticalServicesLaboratory +% +T:502/9626400F:502/9626411E: C4p(   P CJeanneMourrain,DesignatedFederalOfficer 0!,* 0USEPA,NERLResearchTrianglePark 4!P- 4T:919/5411120F:919/5414101E:Ϣmourrain.jeanne@epamail.epa.gov :+!2  P   :TonyPagliaro(absent) 'L4 'ТACIL +5 +T:202/8875872F:202/8870021E:acil@ix.netcom.com :+p8   P :JerryParr '`9 'QuanterraEnvironmentalService +,; +T:303/4216611F:303/4679136E:jerryparr@msn.com :+!>  P   :JanGeiselmanPower(absent) ' \@ 'PowerAssociatesCorp. +A +T:301/2617074F:301/2614232E: 5&!(D    5ТJerrryThoma% !  'p" E 'EnvironmentalHealthLaboratories +<# G +T:219/2334777F:219/2338207E:thoma@hastech.iag.net :+$!J   P :MimiUhlfelder(absent) '%l#L 'EALaboratories +$"M +T:301/7714920F:301/7714407E:Ϣmmu@eaeng.mhs.compuserve.com A0!((%R  P  P AGeneTatsch,SupportContractor ))'T )ResearchTriangleInstitute +)&U +T:919/5416930F:919/5417386E:cet@rti.org#& & &&Q$##X,X &&2$#1'%*X(X  P  1  +0)X  AttachmentC  X   X,XXX, @ LEVELSOFMETHODPERFORMANCEDOCUMENTATION  0  PurposeandGoals     ThepurposeofthemethodperformancedocumentationcategorizationschemeistoprovideasimplesystemfordocumentingtheamountofvalidationdataavailableonspecificEPAtestmethods.Thegoalistogivepotentialusersanindicationofhowconfidenttheycanbeinamethod'spublishedprecision,biasandmethodsensitivityvaluesandusethisinformationtohelpselectwhichEPAmethodismostsuitablefortheirneeds.  TheintentionisforthedocumentationcodestobeincludedinEPAmethodsindicessuchastheEnvironmentalMonitoringMethodsIndex(EMMI).Forexample,ananalystanalyzingasedimentsampleforpolynucleararomaticcompoundscouldlookatanindexsuchasEMMIandfindseveralpotentiallyappropriatemethods.Bylookingatthedocumentationcode,theanalystcanquicklydeterminetowhichleveltheavailablemethodshavebeenvalidatedandmoreeasilymakeadecisionaboutwhichmethodshe/hewantstouse.  Thisschemeisnotmeanttobeusedasanapprovalprocessnordoesitprescribehowtovalidateamethodforaparticularpurpose.Theonlystipulationforamethodbeingratedisthattheproceduresusedformeasuringprecision,biasandmethodsensitivitybeapprovedbytheprogramforwhichthemethodisbeingdeveloped.Proceduresformeasuringprecision,biasandmethodsensitivityarenotprovided;itisonlystipulatedthattheproceduresmustbeapprovedbytheprogram. DefinitionofLevels  P   Thesystemiscomprisedofthreelevels.Level1hastheleaststringentdocumentationrequirementsandLevel3hasthemoststringentrequirements.Thehigherthelevelthemorecompletethevalidationprocess.  Level1Validation      8   !!   DataareavailableintheEMMCdatabaseortheregulatorydocketthatdocumentstheprecision,bias,methodsensitivityanddynamicrangeofthemethodbasedonasinglelaboratoryevaluationusingatleastoneexampleofasuitablematrix. #0!$  Level2Validation `%#&    DataareavailableintheEMMCdatabaseortheregulatorydocketthatdocumentstheprecision,bias,methodsensitivityanddynamicrangeofthemethodbasedontheevaluationofatleastoneexampleofasuitablematrixbyaminimumoftwolaboratories. &  Level3Validation  *(,   DataareavailableintheEMMCdatabaseortheregulatorydocketthatdocumentssufficientinformationforamultilaboratory,multimatrixvalidationstudythatsatisfiesthemethods'*l<approvalneedsofnationalstandardsettingbodiessuchastheAssociationofOfficialAnalytical .@,0 Chemists(AOAC)ortheAmericanSocietyforTestingandMaterials(ASTM).Theseorganizationsrequirethatthevalidationdatamustincludedatafromatleastsevenlaboratoriesandthatthematerialsusedtovalidatethemethodmustincludeavarietyofsampleswhosecharacteristicsencompassthevarietyofmaterialsthatthemethodisexpectedtoencounterinroutineuse. NA  Thisclassificationschemeisnotconsideredasapplicabletoamethodofthistype.   NR 0  Nodeterminationhasbeenmadeastothelevelofdocumentationthatiscurrently x availableforthismethod.  h(#(# DefinitionofTerms  X @* Bias:    0   Thesystematicorpersistentdistortionofameasurementprocesswhichdeprivestheresult0  ofrepresentativeness(i.e.,theexpectedsamplemeasurementisdifferentthanthesample'struevalue.)Thebiasofameasurementmethodisduetothesystematicerrorinherentinthemethodandmaybedescribedasthedegreetowhichthemethodyieldsresultsthatareconsistentlydifferentfromthesample'struevalue. (#(#  DynamicRange :0  L  (# (# 0  Therangeofsampleconcentrationsoverwhichthemethodwillyielddataofacceptablequality. (#(# 0   Matrix: X (#(# 0  Aspecificsubsetofamedium(e.g.,surfacewater,drinkingwater,kaolinite)inwhichtheϢanalyteofinterestmaybecontained.Matricesmaybedefined/differentiatedbytheirbehavior:samplesofthesameorsimilarmatrixareexpectedtobehavethesameorsimilarlywithrespecttotheprocedure(s)employedonthem. (#(#  MethodSensitivity:0  (# (# 0  Thecharacterizationofamethod'sperformanceintermssuchasdetectionlimit,quantitationlimit,dynamicrange,etc.byanEPA(orothercommonlyrecognized)methodvalidationprotocol. (#(#  Precision:  ( 0  Thedegreetowhichasetofobservationsormeasurementsofthesameproperty,usuallyobtainedundersimilarconditions,conformtothemselves.Precisionisusuallyexpressedasstandarddeviation,varianceorrange,ineitherabsoluteorrelativeterms. (#(#  0   Validatedmethod:  (#(# 0  Amethodwhichhasbeendeterminedtomeetcertainperformancecriteriaforsamplingand/ormeasurementoperations. (#(#  0   Validation:  |!(#(# 0  Theprocessofsubstantiatingspecifiedperformancecriteria.Confirmationbyexaminationandprovisionofobjectiveevidencethattheparticularrequirementsforaspecificintendeduseare "X # fulfilled.(ISO8402) (#(# #X,XXX,$2#