WPC v T_oj(ŕqE!˽;۲3d˗<*G4L;)n/5{ \li&ph%E;$# UN %Q 0(Ww@4 0D faf0a2F 1eNUB 1m 0cbRUH _ e hk h3 3 3 3 3 3 3 B  0R*| 0BHP LaserJet IIIHPPCL5MS,,,,,,,,0 (  Z 6Times New Roman RegularX($ I{C #, 3|x  )  XXEnvironmentalLaboratoryAdvisoryBoard@ddd  1  of EndDoc9  ՈP P P (#July28,1997(3$ !  EndDocTABLE ATABLE B$35;AGMSY_11.1.1.1.1.1.1.1.\  `*Times New RomanTT#3e37=CIQYag1.a.i.(1)(a)(i)1)a)(;3$23e  0  .3  0  )7 ' ELAB Summary , MOURRAIN#AZ0Arial Narrow RegularHUg        <@TABLE A  6      h@   @i@   @   @   s@  s@   s@  @ y@   `@   @   s@   @i@   @   @   @@   @   @TABLE B  d>:$"Small Circle  0  1, 2, 3,Level 1Level 2Level 3Level 4Level 5B?8V21, 2, 3,Numbers"1  ."0  !  ݛ_   *XXA XX*SummaryoftheMeetingofthe  EnvironmentalLaboratoryAdvisoryBoardJuly28,1997   BTheEnvironmentalLaboratoryAdvisoryBoard(ELAB)metattheWyndhamAnatoleHotelinDallas,TXonJuly28,1997.ThemeetingwasledbyELABCoChairsDr.WilsonHersheyandMs.RamonaTrovato. INTRODUCTION  8   Dr.HersheyopenedthemeetingwithanintroductionofattendingELABmembersaswellasthoseofanaudienceofapproximately80.Heoutlinedtheagenda,notingitsprovisionforpubliccomments,aswellastheOpenForumscheduledfor5pm,immediatelyfollowingtheELABmeeting.Ms.TrovatoreviewedEPAscommitmenttoseveralinnovativeprograms,includingNELAC,asdocumentedinthememoofJune11,1997,fromMr.FredHansen,EPADeputyAdministrator.Shenotedthat:a)0  EPAProgramOfficeplansareduebySeptember1997,forfullyimplementing  p PerformanceBasedMeasurementSystemsintheAgencybySeptember1998, (#(# b)0  AStrategicMonitoringPanelhasbeenestablished,andH(#(# c)0  NELACstandardswillbeimplementedacrosstheAgency,andspecificfundingprovisions 4 havebeenmadeforNELAC. (#(# М NELACSTANDARDS   Dr.HersheyannouncedthatgeneralcommentsontheproposedNELACstandardswouldbeentertainedduringthemeeting. CONSTITUTIONANDBYLAWS  X  Ms.JeanneMourrain,DesignatedFederalOfficerforELAB,andDirectorofNELAC,notedthattheEPAOfficeofGeneralCounselrestrictsEPAstaffparticipationonBoardstothosehavingnofiducuaryresponsibilities.Hence,allsuchreferences(e.g.,finances,fee)willbedeletedfromtheConstitutionandBylaws.Thesereferencesarecontainedprimarilyinseveralreservedsections. CHAPTERONE:PROGRAMPOLICYANDSTRUCTURE  &"% TheonlycommentreferredtotheissuerelatingtoGoodLaboratoryPracticesandtheirrelationshiptotheNELACStandards.Dr.HersheyindicatedthatthisspecificissuewouldbeaddressedaspartofthereportbytheELABsubcommitteeonGLPs. CHAPTERTWO:PROFICIENCYTESTING T,'+  ConcernwasexpressedoverimplementationrelatedissuesonthetimelyavailabilityofPT ,.|)- samplesduringstartupoftheNationalEnvironmentalLaboratoryAccreditationProgram(NELAP).ItwasnotedthataMemorandumofUnderstandingaswellasanInteragencyAgreementisinpreparationtoformalizethenecessaryarrangementsandincludesfundingϜarrangements.ConcernwasalsoexpressedregardingpreparationsandcommittmentsfortheNELACProficiencyTestingOversightBody(PTOB).ItwasnotedthatEPAwillcontinuetheircurrentperformanceevaluationsampleprograminsupportoftheSafeDrinkingWaterActandtheCleanWaterActthroughtheendof1998afterwhichtheNationalInstituteofStandardsandTechnology(NIST)isscheduledtoaccreditprivatesectorproficiencytestingproducers.StandardshavenotyetbeenestablishedforthePTOB,sincethereisnoprecedentforitsrolesandresponsibilitiesasanaccreditorofPTproviders.Inthiscontext,itwasnotedthatsincetheEPA/NISTrelationshipisnew,EPAwantsvotingontheAppendicespostponedforoneyeartoallowNISTtomorefullyparticipateindevelopmentofthisStandardandensureanorderlytransitiontothenewsystem. ELABPTSubcommitteeReport    Atthispoint,Dr.HersheycalledonMs.MarleneMooreandMr.ThomasCoyner,cochairsoftheELABPTsubcommitteefortheirreport.Ms.MoorenotedthatthissubcommitteehasreviewedChapter2,includingitsfourappendices,indetail.Thesubcommitteebelievesthattheproposedstandardsprovideawellwritten,soundapproachforinitiatingaPTprogram.SincetheNELACStandardsareanongoing,improvingdocument,thecommitteestronglyrecommendsadoptionofthechapterandappendicesnow.Mr.Coynernotedthatthissubcommitteeprovidedanindependentreviewofthechapter,andfoundittobetechnicallysound.Followinganoverviewofthereportofthesubcommittee,andgeneraldiscussionofthefivefindings,thefollowingrecommendationswereadopted: 0  Recommendation1: (#(# 8  ELABrecommendsthatEPAprepareaworkingsetofPTsampledesigncriteriawhichmeetProgramOfficerequirementstobeusedbytheProficiencyTestingOversightBody(PTOB)toinclude,ataminimum,concentration,interferences,media.(Passedunanimously).     0  Recommendation2: $X"(#(# 8  ELABrecommendsthatNELAC/NIST/EPAdevelopaprotocolwhichcanbeusedbythePTOB,throughreviewandanalysisofdata,toassureprogramequivalenceamongPTproviders.(SeeattachedpaperbyDanTholenforstartingpoint.)ELABfurtherrecommendsthatthisprotocolbefinalizedassoonaspossibletoensuretheintegrityofthisprogram.(Passedunanimously)    ItwasnotedthatChapter2,AppendixA,specifies continuousmonitoringbythePTOBofPTproviderswithoutindicatinghowthiscouldbeimplemented.ItwasalsonotedthatanimportantissueishowthevariabilityattributabletoonePTproviderwillbedistinguishedfromothersourcesofvariabilitysuchasthemethodorsample.ItwasnotedthatinaPTsystemhavingmultiplePTproviders,selection/approvalrequiresmorethansimplya systeminplaceandthat ,.|)- thePTOBmustbeprovidedaneffectiveprotocolforimplementingthisessentialrequirement. 0  Recommendation3: (#(# 8  ELABrecommendsthattheperiodicPTstudiesoccuratfixedtimesthroughouttheyear.ELABfurtherrecommendsthatinitialandremedialPTsamplesmaybeobtainedoutsidethisschedule.(Passedunanimously)     0  Recommendation4 $ t(#(# 8  A.0`   ELABrecommendsthatthelongrangegoalofNELACbetodevelopa  ` consistentapproachtobothscopeofaccreditationandPTprogramsampledesign,whichrecognizestheneedsofthelaboratories,theprimaryaccreditingauthorities,andtheAgency,particularlywithregardtoperformancebasedmethods,similartechnologies,andanalyticalcapabilities.(Passedunanimously) ` `  8  B.0`   ELABrecommendsthatthePTOB,duringimplementationofthePT   program,requirethateachPTproviderrecordandreportPTresultstoboththeaccreditingauthorityandthePTOBonamethodbasis,bymatrixandanalyte.(Passedunanimously). ` `  8  C.0`   ELABrecommendsthatataskgroupmonitortheimpacton H implementationofthediscrepancybetweenPTprogramdesignandthescopeofaccreditation.(Passedunanimously) . p` `   Itwasnotedthatthesubcommitteeaddressedthedifferencesbetweenaprogram/matrix/analyte L systemandaprogram/method/analytesystem,withthelatterpreferred.Itwasalsonotedthatthereisarationaleforbothapproaches,dependingononesperspective,sincesomeprogramsfocusonanalyteswithinacommonmatrix(e.g.,drinkingwater)whileothersfocusonananalyteacrossmatrices(e.g.,leadindrinkingwaterandsurfacewipes).Otherconsiderationsincludethefactthatsomesmalllabsuseonlyonemethodforaparticularanalyte,andthatdefinitionofthetermmatrixneedsclarificationduringNELACimplementation. 0  &  Recommendation5 \ (#(# 8  ELABrecommendsthatthereisconsistencybetweenNELACStandardsandtheEPAsPTExternalizationprogram.(Passedunanimously)    '\  0  Recommendation6  $\"(#(# 8  ELABrecommendsthattheproposedPTstandards(includingtheAppendices)beadoptedaspresented.(6yes,1abstain,1no).    Dr.Hersheythankedthesubcommitteeandcommendedthemfortheirexcellentefforts. CHAPTERFIVE:QUALITYSYSTEMS  )$( Ms.SilkyLabie,ChairoftheQualitySystemsCommittee,reviewedprogressonthischapteroftheStandardssincelastyearsvotinginwhich6portionswerenotadopted.Therebeingnodiscussiononthischapter,theBoardrecessedforlunch. 0.)- Ї GLPSUBCOMMITTEEREPORT   Mr.WynnJohnandDr.DavidDullpresentedtheworkofthissubcommittee.Mr.JohnindicatedthathisdiscussionwouldfocusoninformationthatthesubcommitteehaddevelopedsubsequenttoitsreporttotheBoardinFebruary,1997.HenotedthattherehadbeenthreetaskteamswithTeams1&2essentiallyhavingcompletedtheirworkforthatpreviousreport.Team3sent900surveysandreceived51responsesaddressingQAcosts,R&DCosts,Industrysector,Number/typeofstudiesconducted.Itwasnotedthatperceptionsdifferedbyrespondents,andthatQAwasgenerallyabudgeteditemandgenerallyknown;GLPactivitiesandexpensesarenotwellcharacterized,andappeartobeinterpreteddifferentlybydifferentrespondents.Estimatesforexpendituresindicatethatcurrentcostsarenottrivial,yetmaybeoverlooked.Theensuingdiscussionincludedthefollowing:preferenceforarulemakingapproachratherthantheconsensusbuildingapproachusedbyNELAC,theuseofEPAsRegulatoryNegotiation(RegNeg)approachtorulemaking,possibleneedforaccreditationtosatisfyinternationaloperations,andtheneedtoreconciletheGLPprogramsofEPAandFDA. 0  Recommendation7 \(#(# 8  ELABrecommendsthattheGLPdecisionsandtheNELAPtimelinebedecoupled.    8  ELABfurtherrecommendsthattheGLPsubcommitteereporttotheELABattheInterimMeetingwiththreeoptionsincludinga)statusquo;b)Options1+3+5;andc)labaccreditation.    8  ELABfurtherrecommendsthatISOGuide25beexplicitlyconsideredtounderstandthevalueitofferstotheGLPprocess.    8  ELABfurtherrecommendsthattheNELACprocessbeevaluatedtoidentifythevalueadded,ifany.EPAwillprovidelanguagetoclarifythattheNELACConstitutionandBylawsreflectthatdecisionmakingandimplementationoftheGLPProgramwillcontinueasanexclusivelyfederalprogram.    0  ThegoalofthisactivityistoprovideinformationtoOECAandOPPTSmanagementforadecisionregardingthedirectionoftheGLPprogram.(Passedunanimously) (#(# ELABwillforwardthefindingsoftheGLPsubcommitteetoEPAmanagement.Asnotedabove,threeoptionsappeartoemergefromthiseffort:0  a)0` (#(#statusquo,#l!` (#` (# 0  b)0` (#(#augmentationofreportingandfunding(combinationofOptions1,3,and5ofthe $X" subcommitteesreport),and ` (#` (# 0  c)0` (#(#laboratoryaccreditation.%0!$` (#` (#  ELABPBMSSUBCOMMITTEEREPORT  (#' Dr.KathyHilligpresentedthereportofthissubcommittee,notingthatthefirsttworecommendationshavebeenapprovedbythisBoardinJanuary1997.Followingbriefdiscussion,andrewording,thefollowingrecommendationswereapproved:XkAXXX   ,.|)- 0  Recommendation8 (#(# 8  ELABrecommendsthatbeforeEPApromulgatesaregulation,itmustdemonstrateanddocumentthatMQOsareachievableusingavailablemeasurementtechnology.#XkAXXXkAA/#(Passedunanimously)XkAXXXkAt    0  Recommendation9 L (#(# 8  ELABrecommendsthatEPAdemonstratethatanyneworrevisedregulatorymeasurementrequirementsareachievableonsamplesthatrepresentthesamelevelofanalyticalchallengeasthematrixforwhichtheregulationisintended.(Ideally,thiswouldbesamplesoftheactualmatrixtobemonitored,asdefinedbytheregulation.)#XkAXXXkA0#(Passedunanimously)XkAXXXkA 8    C  $#CK+ 4 <DL!XXA XK 0  Recommendation10  (#(# 8  ELABrecommendsthatEPAconsiderthefollowingremainingimportantunresolvedissues:#XkAXXXkA2#(Passedunanimously)XkAXXXkA    #XkAXXXkAZ4#XkAXXXkA0  !:  0` (#(#  PBMeasurementSystemvs.PBMethod!:4  p` (#` (#   !:  0 `   ?+ 4 <DL!X?ӜSamplematrix!:5  \` (#` (# М  !:  0 `   ݜMethodValidation!:f6  H` (#` (# М  !:  0 `   ݜMethodCompliance!:6  4` (#` (# М  !:  0 `   ݜInterlaboratoryComparability!:7   p` (#` (# М  !:  0 `   ݜCost!:.8   \` (#` (# М  !:  0 `   ݜLaboratoryClientRelationship!:8  H` (#` (# #XkAXXXkA4#Dr.Hersheythankedthesubcommitteeforcompletingitscharge,anddeclareditdisbanded. NELACTRANSITIONADHOCCOMMITTEEREPORT   Dr.CharlesHartwig,NELACChair,andMs.CarolBattertonNELACChairElectpresentedthisreport.Dr.HartwigindicatedhiswishtocommunicatetotheBoardtheplanningbeingdonebyNELACasitanticipatespassageoftheStandards.Ms.Battertonindicatedthatthetwomajorissuesforseenrelatedto:0  1.0` (#(#Capacityofthefirststate(s)approvedasaccreditingauthoritiestoaccomodateall D! laboratoriesthatmightapplyforaccreditation,and ` (#` (# 0  2.0` (#(#Unfaircompetitiveadvantageforlaboratorieswhichwereaccreditedbeforeother #l! applicants. ` (#` (# ShethenreviewedtheanticipatedtimelineintheCommitteesreport,notingthatall50States,theDistrictofColumbia,and3territoriesresponded.Forty(40)statesindicatedtheirplanstoapplyforrecognitionasNELACAccreditingAuthorities.ShealsonotedaJune1,1998targetforissuanceofapprovalofallAccreditingAuthoritiesthatsubmitanapplicationbeforetheendof191997.FollowingdiscussionthefollowingrecommendationsfromtheCommitteesreportwereadoptedbythisBoard: 0  Recommendation11 T,'+(#(# 8  ELABrecommendsthattheinitialapprovalofaccreditingauthoritiesshouldoccursimultaneously.XkAXXXkAԀ#XkAXXXkA?#(Passedunanimously)XkAXXXkA,.|)-   #XkAXXXkA?# 0  Recommendation12 (#(# 8  ELABrecommendsthatthefirstroundofNELACaccreditationoflaboratoriesby%  accreditingauthoritiesshouldalsooccursimultaneously.XkAXXXkAԀ#XkAXXXkANA#(Passedunanimously)XkAXXXkAt   #XkAXXXkAA# 0  Recommendation13 L (#(# 8  ELABrecommendsthatpriortothedesignationofapprovedproficiencytest(PT)sampleprovidersasrequiredbyChapter2,accreditedlabsshouldbeallowedtocontinueusingexistingPTsampleproviders.However,intheinterim,frequencyofPTsampleanalysisasrequiredbyChapter2mustbemet.XkAXXXkAԀ#XkAXXXkAC#(Passed  L  unanimously)XkAXXXkA 8    #XkAXXXkAC#ItwasnotedthatStatesupplementalrequirementsmayposepracticalproblemswithimplementationoftheNELACStandards.Theyinclude:#8V  #8VD"1  ."0    ReportinglimitsandDL#8VDD݌ (#(# Ќ  #8V  #8VE"2  ."0    Samplefrequencyandacceptancecriteria#8VEE݌ (#(# Ќ  #8V  #8VF"3  ."0    Methodforagivenparameter.#8VFF݌p(#(# Ќ  #8V  #8VfG"4  ."0    Samplepreservation#8VfGG݌\(#(# Ќ  #8V  #8V4H"5  ."0    Extractionmethod#8V4HOH݌H(#(# Ќ  #8V  #8VI"6  ."0    Levelandnumberofcalibrationstandards#8VII݌4(#(# Ќ  #8V  #8VI"7  ."0    Calculationprocedures#8VII݌ p(#(# Ќ  #8V  #8VJ"8  ."0    ConcentrationlevelofQCspikes#8VJJ݌ \(#(# Ќ  #8V  #8VK"9  ." 0    Contentsofdatareports.#8VKK݌H(#(# Ќ  Subsequently,theissueofconflictofinterestandtherelationshipsofprivatesectorandpublicsectorlaboratorieswasdiscussed,leadingtothefollowingrecommendation: 0  Recommendation14: (#(# 8  ELABrecommendsthatChapter6befurtherdefinedregardingAccreditingAuthorityrecognitionofStatestoaddresstheconflictofinterestbetweenpublicandprivatesectorlabs,withrespecttoaStatelaboratoryconductingroutineenvironmentaltestinganalyses.FurtherdefinitionwillincludethespecificguidancetoavoidconflictofinterestforanabovestatedAccreditingAuthority.(Passedwith8infavor,oneopposed)    Inaddition,theconflictofinterestissueamongStatelaboratorieswasdiscussedandthefollowingrecommendationwasmade:0  Recommendation15 '#&(#(# 0  ELABrecommendsthattheissueofprimacyStatelaboratoriesinaccreditingnonprimacyStatelaboratoriesbereferredtotheAccreditingAuthorityCommitteeforfurtherconsideration. (#(#  OTHERISSUES  T,'+ Dr.HersheyaskedforadditionalissuesofconcerntotheBoard.Itwasnotedthatthelimitation ,.|)- forassessmentteamcompositiontoStateandfederalemployees(Chapter6)isclearlyaddressedindocumentsfromtheOfficeofFederalProcurementPolicy,asnotedintheJuly24,1997memostatingEMMCrecommendationstoNELAC.Dr.HersheythenreferredtheBoardtotheJuly21,1997letterfromAIHAregardingthirdpartysubcommitteereestablishment.ItwassuggestedthatassessorbodiescometotheThirdNELACInterimMeetingpreparedtomakepresentationtothisBoard..Dr.Hersheythenaskediftherewereanyfurtherdiscussion.ConsideringtheBoardssupportforNELACandtheproposedStandards,thefollowingrecommendationwaspresentedforvote: 0  Recommendation16 $ (#(# 8  ELABstronglyrecommendsavoteforadoptionoftheStandardswithmodificationsasspecifiedandpassedbyELABmotionsonJuly28,1997.XkAXXXkA   #XkAXXXkAT#(Passedwith8infavor,oneopposed)XkAXXXkA    #XkAXXXkA_U#Astheresultofadditionaldiscussion,thefollowingrecommendationwaspresentedforvote: 0  Recommendation17: H(#(# 8  ELABrecommendsthatEPAProgramOfficesbecomemoreactiveinNELACandpromulgateregulationsthatareconsistentwiththeNELACstandardsasappropriate.XkAXXXkAԀ#XkAXXXkA W#(Passedunanimously) \   Ms.MourrainremindedtheallpresentthatshehasreceivedsomenominationsforreplacementsforELAB,andencouragedalltousethenominationformintheirpackettonominateothers,orthemselves.   hX_@$ ActionItems ?(#AttachmentA h *w ddd Xdd Xdd X(#(#w,dd ,dd +   0 Action '," 'Completedby ," Ms.TrovatowillscheduleateleconferencefortheBoardinearlyOctobertodiscussGLPissues      BoardmembersandothersareencouragedtosubmitELABnominationstoMs.Mourrainattheearliestpossibledate.  l       CurrentBoardmembersarerequestedtocontactMs.MourraintoindicatetheircontinuedinterestinservingonthisBoard.   p      Dr.HersheyandMs.TrovatowilltransmittherecommendationsofthisBoardtotheEMMCPolicyCommittee.Council.  D    X  Dr.VerstuyftwillpresenttheELABrecommendationsduringtheNELACOpeningPlenarySession  H JulyJuly%  28,1997 \    d @ZZ' Members ?(#AttachmentB h   *f dddd dd (#(#f,` dd ,` dd , dd +  $ D $Name '@" 'Representing '@" ''dX^XX'ContactInformation +!@"  $+XXkAYWilsonHershey,  CoChair  @ ACIL   T:0  717/6562300 "" F:0  717/6560450@ "" E:0  jwhershey@lancasterlabs.com -#h "" $ $-RamonaTrovato,CoChair  $  USEPA  d T:0  202/2607778d"" F:0  202/2604103$"" E:0  trovato.ramona@epamail.epa.gov -#|"" $ $-MiltonBush(absent)   8  TheMCompanies   x T:0  703/5339539 x"" F:0  703/5331612 8 "" E:0  bushrunner@aol.com -#` "" $ $-LindaChristenson  \  IAETL  \  T:0  703/7392188\ "" F:0  703/7392556 "" E:0  -# t "" $ $-AnnMarieGebhart(absent)  0 NSFInternational  p  T:0  313/7695351p "" F:0  313/76901090!"" E:0  -#X""" $ $-JohnHenshaw  T# SocietyforQualityAssurance  T$ T:0  314/6948830T%"" F:0  314/6945500&"" E:0  jlhens@ccmail.monsanto.com -#l'"" $ $-KathyHillig  h( ChemicalManufacturersAssociation  (* T:0  313/2466334h+"" F:0  313/2465226(,"" E:0  hilligk@np01.southgate.basf P- corp.com -#."" $ $-BillKavanagh   / A2LA   0 T:0  410/6716756 1"" F:0  410/6716720d2"" E:0  william.g.kavanagh@cpmx.saic.co $3 m -#L4"" $ $-CynthiaLee(absent)  6 SmallLaboratories  H7 T:0  502/5746000H8"" F:0  502/57456079"" E:0  apcd@iglou.com -#`:"" $ $-JeanneMourrainDesignatedFederalOfficer  < USEPA  \= T:0  919/5411120\>"" F:0  919/5414101?"" E:0  mourrain.jeanne@epamail.epa.go D@ v -#A"" $ $-MilagrosSimmons(absent)   XC UniversityofMichigan,SchoolofPublicHealth   XE T:0  313/7641817 F"" F:0  713/7649424 XG"" E:0  -#! H"" $ $-MichaelSmolen(absent)  <#!J WorldWildlifeFederation  |"!K T:0  202/8618354|"!L"" F:0  202/5300743<#!M"" E:0  smolen@wwfus.org -##"N"" $ $-EvelynTorres  $#O FairfaxCountyWaterAuthority  %P$Q T:0  703/4045049$#R"" F:0  703/4045076%P$S"" E:0  71134.3534@compuserve.com -#x&%T"" $ $-AlVerstuyft  t' &U AmericanPetroleumInstitute  t' &V T:0  510/2421792t' &W"" F:0  510/24253204(&X"" E:0  awve@chevron.com -#('Y"" $ $-FriedaWhite  )(Z NavajoTribalUtilityAuthority  )([ T:0  520/7295721)(\"" F:0  520/7292135*H)]"" E:0  -#p+*^"" $ $-LuisZamora  l,+_ TaosPuebloEnvironmentalOffice  ,-+a T:0  505/7514601l,+b"" F:0  505/7584604,-+c"" E:0   -#-,d"" $ $-GeneTatsch SupportContractor   ResearchTriangleInstitute   $ T:0  919/5416930 $"" F:0  919/5417386"" E:0  cet@rti.org#Y$_##XkAX_#)"" $  )