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SB\  `&Times New RomanS77(X75+ ` hp x 5  &  d d5)1dxd'dxd<:zTop of For79(X7    5+ ` hp x 5?C%2A`Arial?  SB\  `&Times New RomanS77(X75+ ` hp x 5  5)2dxd0KS.SampleKA<6X9`(Courier NewKSB\  `&Times New RomanS0.Strong 8dl6TypewriterKA<6X9`(Courier NewKSB\  `&Times New RomanS42Variable: 8HTML MarkupB      2 0CommentB   35;AGMSY_11.1.1.1.1.1.1.1.<6X9`(Courier New\  `&Times New Roman%2A`Arial3#37=CIQYag1.a.i.(1)(a)(i)1)a)Di)8s \8:i+003|xU !USUS.,  _   EAXX STATEMENTOFWORK #X<X EAI#Ԁ  (fromcurrentcontractEP-W-04-019forinformationpurposesonly) : =A.BACKGROUND  Sections4,5,6,8,and21oftheToxicSubstancesControlAct(_TSCA_)requireEPAtoscreen   andevaluatedatasubmittedbyindustry,theInteragencyTestingCommittee(ITC),petitioners, r  and/orotherinterestedpartiesforthepurposeofassessingpotentialhealthandenvironmental ^  hazardsandrisksofchemicalsandbiotechnologyproducts,whichmustoftenbecompleted J   withinashorttime. 6  UndertheHighProductionVolumeChemicalsProgramEPAreviewstechnicalreportsprepared ^  bygovernmentortheprivatesectorwhichprovidedatacharacterizingpotentialtoxicityandto J  assessrisksassociatedwithvariouschemicalsubstances.EPAcommentsonthescientific 6  adequacyofthedata,andthereportasawholeidentifiesdatagapsandresearchneedsthat " impactdeterminationsofpotentialtoxicityandrisk,andmakesthesereportsavailabletothe  publicand/orgenerateshazard/risksummariesandassessmentsforactionstakenbyEPAonthe  chemicalorbiologicalsubstance.  Intheperformanceofthesevarioustasksunder_TSCA_Ԁandsimilaractivitiesundersuchother n statutesastheAsbestosHazardandEmergencyResponseAct(_AHERA_),Emergency Z PreparednessCommunityRight-to-KnowAct(EPCRA),SafeDrinkingwaterAct,Department F ofHomelandSecurityact,CleanAirActAmendments,andsuchExecutiveOrdersas#12898on 2 EnvironmentalJustice,EPAcoordinatesitsactionswiththerequirementsoftheFederal n Insecticide,Fungicide,andRodenticideAct(FIFRA)asimplementedinthevariouspesticide  Z programs. F Moreover,undertheDesignfortheEnvironment(DfE),UseCluster,PollutionPrevention(PP),  andGreenChemistryinitiativesofOPPT,EPAconductscomparativeriskevaluationsof   environmentalchemicalstoidentifysafersubstitutes.Otherinitiativesduringthistermof   contractmayinclude,butwillnotbelimitedto:(1)ToxicsReleaseInventory(TRI),(2) ! Persistent_Bioaccumulative_ԀToxicPollutants(PBTs),(3)HighProductionVolumeChemicals ~"  (_HPV_),andTesting,(4)VoluntaryChildrensChemicalExposureProgram(_VCCEP_). j#! Analysesandassessmentsofhazardandriskmustfrequentlybeconductedunderseveretimeand B% # scopeconstraintsimposedunder_TSCA_ԀSection5(premanufacturenotification)orbecauseof .&~!$ court-imposeddeadlinesunderSections4(testing),6(control)and21(petitions).Draftsof 'j"% completedanalysesandriskassessmentsorreviewsmayrequireoutsidereviewbyscientistsin (V#& designateddisciplinespriortodeliverytoEPA.Completedassessmentsandreviewsmustadhere (B$' torelevantAgencyguidelines.Whennecessary,theymustbelegallydefensibleandmustbeable ).%( tosupportregulatoryactionsbyEPAandtheOfficeofPollutionPreventionandToxics(OPPT) *&) inparticular.Thisdiverseevaluation,analysis,reviewandcomment(intheformofseparate +'* memorandaordocumentsections)iscollatedintopackagesthatsupportregulatorydecisions. ,'+ Thetimetableforassemblingtheseassessmentpackagesusuallyrequirescoordination, -(, adjustmentsandchangesacrossthesections,and,ineffect,requirestheContractortobeon  callforrapidturnaroundofsmall-scaletasks.  EPAmusthaveaccesstothehighestqualitypersonnel,technicalexpertise,andscientific  methodologiestoassistinorconductroutine,peakworkload,andshort-turnaroundscientificand t technicalanalysissupporting_TSCA_ԀandotheractswhichTSCAmaysupport.Thisaccesshelps ` _OPPT_Ԁsustainitsregulatorydecisionswhenreviewedbythepublic,environmentalgroups,other L  executiveagencies,Congress,orthecourts. 8  B.PURPOSE  ` Tomeetthesechallenges,thiscontractwillprovidesupportforthehazardevaluation,risk  8  screeningandassessmentfunctionsofOPPT. $  Thepurposeofthiscontractis:   1)tosupportassessment,throughcompilationandevaluationofdata,ofchemicals,and   biotechnologyproductsexaminedby_OPPT_.Assessmentsrangefromscreeninglevelevaluations p thattypicallyusereadilyavailabledatatomoredetailedevaluationsthatassessandintegrate \ hazard,doseresponse,exposure,andpotentialriskstohealthandtheenvironment.These H activitiesalsocanincludepreparationofreports,identificationoftestingneedsforchemicalsand 4 biotechnologyproducts,developmentandevaluationoftestprotocols,andsupportfor  p extensivedataexamination.  \ 2)toimprovethequalityandconsistencyofEPA'ssciencebyprovidingtimelyexpertreview, 4 andassistinthepreparationof(1)Specificandgenerichazard,doseresponse,andrisk   assessmentdocumentsincludingthosedealingwithcomparativerisk;(2)Testguidelinesand   standardsfordevelopingadequatetestdatatocharacterizethehealthandenvironmentaleffects  ofchemicalsandbiotechnologyproducts;and(3)analysesofscientificissuesdealingwith  hazard,risk,andcomparativeriskthatariseinthecourseofassessmentsandAgencyregulatory  decisionmaking. l 3)toprovideautomaticdataprocessingsupportandinformationmanagementsupporttoorganize D! andtracksubmitteddataand_OPPT_Ԁevaluationsofthesedata;toprovideexpertiseinsoftware 0"  systemsforthecreationandmaintenanceofdatabases;andtoprovidepresentationmaterialsfor #l! completedassessments,expertreviews,anddatabases. $X" 4)theContractorwillcomplywithallapplicablerequirementsoftheEPAOrder2100ascalled %0!$ forunderSection508oftheRehabilitationAct. &"% C.STAFFING )$( Thecontractorshallbeabletoperformallofthetaskssetforthbelow.Thecontractorshall h+&* provideastableteamofprofessionallevelscientistsandmanagementandsupportstaffto T,'+ performchemicalandbiotechnologicalassessmentandrelatedWorkAssignments.Asrequested, @-(, thecontractorshallprovidetheexpertiseofprominentnationallyrecognizedexpertscientists  particularlyknowledgeableinselectedchemicalsorbiologicalorganisms,disciplines,andareas  identifiedbyWorkAssignments.Thecontractorshallmanageandsupporttheseexpertssothat  theperformanceofWorkAssignmentsoccursintimelyandcoordinatedfashion. t Thecontractorshallprovideexpertiseinthefollowingareas: L  Biochemistry $ t _Biostatistics_  ` Biotechnology/GeneticEngineering  L  ChemicalFate  8  Chemistry $  ClinicalMicrobiology   MicrobialSystematics   ComputerSystems   GeneralToxicology   Acute,_Subchronic_,ChronicToxicology p DevelopmentalToxicology \ GeneticToxicology H _Immunotoxicology_ 4 _Neuro_/BehavioralToxicology  p Oncology  \ ReproductiveToxicology H GeneticConstructAssessment 4 Ecology   Aquatic_Ecotoxicology_   MicrobialEcology  PlantEcology  Terrestrial_Ecotoxicology_  Economics l EnvironmentalRiskAssessmentMethodologies X  Epidemiology D! ExposureAssessment-forChemicalsandBiotechnologyProducts. 0"  HealthRiskAssessmentMethodologies #l! Metabolism/_Pharmacokinetics_ $X" PhysicochemicalProperties $D # PlantGenetics %0!$ PlantPathology &"% Structure-ActivityRelationships '#& TechnicalDataManagement (#' InformationManagement )$( FieldDataAnalysis |*%) MolecularBiology h+&* IndustrialMicrobiology/FermentationTechnology T,'+  @-(, D.TASKS  PerformanceofworkunderthecontractshallbeinitiatedbyWorkAssignmentsissuedbythe  ContractingOfficer.WorkAssignmentswillbewithinthescopeofworkstatedinthecontract, t andwillprovideinstructionsdefiningtheproblem,availableEPAinformation,sourcestobe ` investigated,themannerofevaluationandassessment,andtheoutputs.TheContractorshall L  supplythenecessarylabor,materials,andoff-sitefacilitiesrequiredforperformanceofeach 8  individualWorkAssignment.Becausetimelinessandefficientuseofresourcesareoftheutmost $ t importance,contractorsmayattimesberequiredtoworkonsiteatEPAHeadquartersandother  ` government-providedlocations.Inadditiontobeingscientificallysound,thereportsmustadhere  L  toAgencycriteriaforpubliccommunications,beingclear,concise,transparentandreasonable.  8  Thecontractorshallperformthefollowingtasksasrequiredbyspecificworkassignments: $  1(a).Screening   Screeningisconductedonchemicalandbiotechnologyproductdatareceivedby_OPPT_.The   contractorshallperformscreeninglevelassessments.Additionalworkmayincludetriageof p submittedstudiesandanalysesusingstructure-activityrelationships.Trackingofthesescreening \ activitiesshallalsobemaintained.Screeningencompassesreviewsatlimitedlevelsofeffort H fromlimited,generallyreadilyavailable,informationwithoutextensiveresearchorevaluation. 4 1(b).AssessmentsforChemicalsandBiotechnologyProducts  \ Thecontractorshallpreparehealthandenvironmentalhazardandriskassessmentsfor_OPPT_. 4 Analysesmayinvolvethefollowingactivities:summaryofdata;literatureanddatareview;   evaluationincludingvalidationandanalysisofdata;determinationofsufficiencyofdatafor   hazardassessment;identificationofdatagaps;anddeterminationofeffectsofconcern.As  specifiedbyworkassignment,thecontractorshallpreparestatisticalanalyses,includingbutnot  limitedto"no-observed(-adverse)-effect-levels"(NO(A)_ELs_),anddose-responsecurves.  Measuresofvirulenceandgeneticconstructpersistencemayberequestedforbiotechnology l products.Thecontractormayberequiredtoprovidecomputer-assistedaggregationandanalysis X  ofscientificandtechnicaldatausingstatisticalanddeterministicmodelsandothersoftwaretools D! availabletothe_OPPT_.Wheresubmitteddataarelimited(forexampleasinSection5 0"  _Premanufacture_ԀNotices),theContractormayberequiredtoperformstructure-activityanalyses #l! withrespecttotoxicologicallyimportantmoietiesandstructuralanaloguesandbiotechnology $X" products. $D # TheContractorshallbeabletomaintain,developormodifystatisticalproceduresand &"% methodologiestocompile,validateandanalyzehealthandenvironmentaleffectsresearchdata '#& arisingfromepidemiologicstudies,plant,andanimalbioassays,andtoxicitytestsand (#' structure-activitydata..Thismayinvolvethepreparation,modification,and/ortestingof )$( statisticalanalysismethodsandprocessingandcomputationprograms.TheContractorshallbe |*%) abletoadjustorfine-tunestatisticalpackagestobetteradaptthemtoContractorusefor_OPPT_ h+&* needs.InadditiontofacilityintheAgencysBenchmarkDoseSoftwareand_Catreg_,the T,'+ ContractormustbeabletoprograminC++,VSFortran,Pascal,andS,tocompileandlink-edit @-(, suchprogramsastheJCLorasimilarproduct,andalsotousestatisticalpackagesincluding  S+andR,andtheStatisticalAnalysisSystem(SAS)(residentonmainframeandonpersonal  computer),witheachastheymayaidinthecompletionofEPA-requiredanalysis,review,or  assessmentoftoxicologicorepidemiologicdataorstudies.Theabilityshouldextendtouseof t statisticalgraphingpackagessuchas_SASGRAPH_Ԁand_SYSGRAPH_Ԁandobject-oriented ` languageswhichmaybeusedtopresentvariouspostulateddose-responserelationshipsovera L  rangeofdoseorexposurelevels.Inaddition,theContractormayberequiredtocreatenew 8  statisticalalgorithmstoaidinanalysisandassessment.Analyses,assessmentsandreviews $ t carriedoutunderallthestatutoryrequirementsmayneedtosupportEPAregulatoryactions;  ` consequently,theymustbeaccompaniedbyfulldocumentation(hardcopyandonelectronic  L  media;specificstobegiveninworkassignments)ofanymethodologyused.  8  Thecontractor'sreviewershallbeavailabletodiscusstheresultsofanyreviewandoffer   clarification,ifneeded.Thesediscussionswillbeviateleconferenceand/orfacetofacemeetings   withEPAscientists.   2.ScientificIssueResolution p Thecontractorshallprovidethesupportrequiredtoaddressscienceissues,comparativerisk H issues,and/orothersciencequestionsofimportancetoEPAforEPA'sdevelopmentofscience 4 policydeterminationsandstatutorydecisionmaking.Foreachissue,orsetofquestions,  p identifiedinWorkAssignments,thecontractorshallhavescientistswithexpertknowledgeofthe  \ subjectpreparereportsthatsubstantivelydiscusstheissueorquestions,presentingthevarious H optionsforresolutionandbasingtheoptionsonthepublishedscientificliterature;andthese 4 scientistsshallattendaround-tablediscussionwithEPAscientistsatEPAHeadquartersfor   furtherinformationexchangeandconsensusbuilding.   3.ReviewPanels/Workgroups/Workshops/Symposia  Thecontractorshallorganize,prepare,conduct,presentreports,participateinand/ordocument l theproceedingsofScientificReviewPanels,Workgroups,Workshops,orSymposiaconvened X  to:l)reviewhealthandenvironmentaldatatodeterminethecurrentstateofknowledgeof D! adversehealthandenvironmentaleffects;2)reviewstate-of-the-arttestmethodsinparticular 0"  healthandenvironmentalareas;3)performrelatedinformation-sharingtasksonhealthand #l! environmentaleffectstopicsofinteresttoEPA.Thiseffortshallincludebothadministrative $X" supporttasks(whichareintegraltotheplanning,coordinationandconductofscientific $D # meetings)andtechnicalorscientificsupportforthepreparationofreportsandissuepapers,as %0!$ wellasacquisitionofcitedkeyreferencesandtranslations.Thecontractorshallprovide &"% administrativesupportonlyfortasksthatalsorequiretechnicalscientificsupportunderthis '#& contract.Supportthatisnottechnicalinnatureincludesacquisitionofmeetingfacilities,advance (#' andonsiteregistration,non-technicalnotetaking,courtreporterservices,and/oracquisitionof )$( non-technicalmeetingfacilitation.ThecontractorshallassistEPAinconductingvariousforms |*%) ofAgencyPeerReviewofscientificpapersanddocuments. h+&* 4.TestGuidelines/Standards @-(, ЇThecontractorshallprovidesupportinpreparinghealthandenvironmentaltestguidelinesand  standardsin_OPPT_Ԁstandardguidelineformat(seeOTSManualforPreparingDocuments,  AttachmentI)andsupportdocumentsthatincludetherationalefortestingproceduresand  conditionsfortests.Thisworkmayincludereviewingexistingguidelinesandevaluating t scientificdataconcerningthechoiceoftestparameters(includingsamplesizestoachievedesired ` specifications),developingandvalidatingnewtestmethods,andformattingandtranscribing L  guidelinesbasedondecisionsmadebyEPA.Aqualityassuranceprojectplanwillbe 8  requiredwhenthetaskistodeveloporvalidatenewtestmethods. $ t 5.(a)AutomatedDataProcessing(ADP)and(b)InformationManagementSupport(IMS)  L  Thecontractorshallprovidetechnicalinformationmanagementsupportforintranetandinternet $  informationsystemdevelopment.Informationsystemsmayrequirethecapturingandprocessing   ofexternalandinternaldatasourcesusingimagingtechnology,trackinginformation(both   externalandinternal)withinasystem,capturinginternalwordprocessingdataand/orother   electronicgenerateddataaswellasexternalelectronicdata,archivingdata,andpossibly   disseminatingthisinformationviatheinternet,EPA'sHomeWebPage,oraDivisionHome p page.ThecontractorshallprovidetechnicalprocessingsupportandbasicADPsupportto \ complementin-houseresources.Technicalprocessingsupportshallincludebutnotbelimitedto H theinitialreviewofsubmissions,preparationofdataentryforms,anddataentryfollowing 4 accompanyingQualityControl(Q/C)procedures;internaltransmittals;preparationandmailing  p ofacknowledgmentlettersto_submitters_;preparationofsubmissionabstractsanddata  \ summaries;documentimagingsupporttoEPAsystems;andmaintenanceoffileintegrity.ADP H supportincludesthedesign,developmentandmaintenanceofexistingchemicalassessment 4 technicalsupportsystems,suchassmall-scalecomputersystemsandofficeautomationsystems   withintheconstraintsofOfficeofInformationResourcesManagement(_OIRM_)policyand   contracts.Developmentofsuchsystemsshallbeprecededbyafeasibilitystudyandrequirements  analysis.  TheContractorshallprovidesupportthatincludes,butisnotlimitedto,thefollowing: l maintainingexistinganddevelopingnewinformationexchangesystems;developing X  management-eventtrackingsystems;developingreportingformsfullycontainedincomputer D! media;evaluatinghardware/software/peripheralcombinationsfordocumenttracking,reviewand 0"  dissemination.Contractormustbeknowledgeableintheconstructionofdatabasesusedfor #l! chemicalandbiotechnologyproducts.Thisincludesfamiliaritywithdataformatscommonly $X" usedfordatabasesrelevanttotheseproducts.Contractorsshalldevelopandmaintaindatabases $D # usingsuchsoftwareproductsas:ISIS/Base,LotusApproach,LotusNotes,andotherstandard %0!$ softwareaswellasprovidefordatamaintainedin_Genbank_Ԁand_RKC_Ԁformatsusedforbiological &"% products. '#& OtherSupport )$( Thecontractorshallaidindefiningliteratureandchemicalstructuresearchstrategiesand h+&* performingsuchsearches.Thesecapabilitieswillberequiredonlytosupplement,onanas T,'+ neededbasis,thestandard_OPPT_Ԁsearchcapabilities. @-(, ЇAsrequestedinspecificworkassignments,thecontractorshallprovidesupplementalreferences  andtranslationacquisition,fromaforeignlanguagetoEnglish,whenessentialreferencesarenot  availablewithinthetimelimitsofaspecificassignmentthrough_OPPT_'sstandardreferenceand  translationacquisitionsources. t Asrequestedinspecificworkassignments,thecontractorshallprovidepresentationmaterialsof L  completedassessments,expertreviews,_SARs_,databases,resolutionsofscientificissues,and 8  testguidelines/protocols.Presentationmaterialsshallinclude,butnotbelimitedtoPowerPoint $ t presentations,35-mmslides,overheads,camera-ready_graphs_Ԁandfigures,Posters,andcoversfor  ` EPApublications.