FridayJune5, 1987

Part 11

EnvironmentaiProtection Agency40 CFR Parts 707 and 766Po~yha~ogenatedDibenzo~p~D~ox~ns/Dibenzofurans;Testing and ReporthigRequfrernents;F~na~Ru~e

21412 Federal Register I Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Parts 707 and 766

[OPTS—83002C; FRL-3212—1]

Polyhalogenated Dibenzo-p~Dioxins/Dibenzofurans; Testing and ReportingRequirements

AGENCY: EnvironmentalProtectionAgency(EPA).ACTION: Final rule.

SUMMARY: This documentpromulgatesregulationsundersections4 and8 of theToxic SubstancesControlAct (TSCA).15 U.S.C. 2603 and2607 for certainchemicalswhich maybecontaminatedwith certainchlorinatedandbrominateddibenzo-p-dioxins(HDDs) anddibenzofurans(HDFs). HHDsandHDFshavebeenrecognizedashavingpotentialpublichealthandenvironmentalsignificancebecauseoftheir potentialfor industrial toxic effectat very low doses.The regulationspromulgatedunderthis documentrequireanalyticaltestingfor certainchemicalsfor HDD/HDF contamination.submissionof existing testdataoncontaminationof thesechemicalswithHDDs/HDFs,submissionof healthandsafetystudieson HDDs/HDFs,andsubmissionof worker allegationsofsignificantadversereactionsto HDDs/HDFs.A summaryof the requirementsof this ruleis setforth underSUPPLEMENTARY INFORMATION, below.DATES: In accordancewith 40 CFR 23,5.this ruleshall bepromulgatedforpurposesof judicial review at 1 p.m.easternstandardtime on June19, 1987.This rule shall be effectiveon July 6.1987.FURTHER INFORMATION CONTACT:EdwardA. Klein, Director, TSCAAssistanceOffice (TS—799),Office ofToxic Substances,EnvironmentalProtectionAgency,Rm. E—543,401 MStreetSW., Washington,DC 20460,Telephone:(202—554—1404).SUPPLEMENTARY INFORMATION: This rulerequiresmanufacturersandimportersof12 organicchemicalsto testtheirchemicalsfor thepresenceof certainchlorinatedandbrominateddibenzo-p-dioxins anddibenzofurans.This testingwill also be requiredfor 20 additionalorganicchemicalsnot currentlymanufacturedor importedin the UnitedStatesif their manufactureorimportation should resume.

Manufacturers,importers,andprocessorsof the 12 chemicalsmustalsosubmit existingtestdataoncontaminationof thesechemicalswithHDDsor HDFs, healthandsafety

studieson HDDs/HDFs,and consumeror workerallegationsof significantadversereactionsto HDDs/HDFs;thesameinformationon the20 additionalchemicalsis requiredshouldmanufactureor importationresume.

If either the testingrequiredunderthisrule, or the existing testdataoncontaminationsubmittedunderthis ruleshowthat anyof thesechemicalscontainanyHDDs/HDFsinconcentrationsabovethe LevelsofQuantitation(LOQ) designatedin thisrule, the manufacturersand/orimportersmust submit the followinginformationwith respectto thechemicals:(1) Productionvolume,process,use,exposure,anddisposaldata;(2) unpublishedhealthandsafetystudies,and(3) recordsof allegationsofsignificantadversereactions.

This rulealso requiresthesubmissionof processandreactioncondition databy importersandmanufacturersofchemicalsubstancesmadefrom any of29precursorchemicalsto determinewhetherthereis a needfor dioxin andfurantestingof thechemicalsubstancesmadefrom theseprecursorchemicals.

If testingof achemicalunderthis ruleshowsthechemicaldoesnot containHDDs/HDFs,this rule providesforterminationof exportnotificationnormallyrequiredundersection12(b) ofTSCA, 15 U.S.C.2611(b),for achemicalsubjectto section4 testrules.

I. Organization of this Final Rule

This is afinal rule issuedafterconsiderationof commentssubmittedinresponseto aproposedrule publishedinthe Federal Registerof December19,1985 (50 FR 51794), anamendmentto theproposedrulepublishedin theFederalRegisterof October23, 1986 (51 FR37612),andall relevantinformationsubmittedto or otherwiseobtainedbyEPA.

The preambleto this final rulebeginswith thehistoricalbackground(Unit II),andcontinueswith a short summaryofchangesfrom theprovisionsproposed(Unit III). Unit IV discussesfindings andconsiderationsundersection4 of TSCA;Unit V discussescostsof testingandreporting;andUnit VI discussestheavailability of testing facilitiesandpersonnelto performtheproposedtesting.Unit VII discussesEPA’srationalefor issuinginformationgatheringrulesundersection8 of TSCA.Unit VIII discussestherelationshipofthis rule to exportnotificationrequirementsundersection 12(b)ofTSCA; Unit IX discussescomplianceandenforcement;Unit X describestherulemakingrecord;andUnit XI listsreferencesusedby EPA in preparingthisrule. RequirementsEPA mustmeet

underotherauthoritiesbeforeit mayissuea rulearediscussedin Unit XII.

II. Background

A. Regulationof HDBs/HDFs

EPA haslong recognizedthepotentialpublic healthandenvironmentalsignificanceof 2,3,7,8-tetrachlorodibenzo-p-dioxin(2,3,7,8-TCDD). 2,3,7,8-TCDDexhibits delayedbiological responsein manyspeciesandis lethalat exceptionallylow dosestoaquaticorganisms,birds,andsomemammals.It hasbeenshownto becarcinogenic,teratogenic,fetotoxic, andacnegenic.In addition,2,3,7,8-TCDDhasbeenshownto adverselyaffect theimmuneresponsein mammals.EPA alsorecognizesthepotentialhealthsignificanceof avariety of tetra-throughhepta-halogenateddibenzo-p-dioxinsanddibenzofurans(HDDs andHDFs)thatarestructurallyrelatedto 2,3,7,8-TCDD in thatthey arechlorinatedorbrominatedatthe2,3,7and8 positionson themolecularstructure(Refs.5 and15). Limited in vivo andin vitro datasupportthe structure-activitybasedargumentthat laterallysubstituted2,3,7,8-HDIJ5/HDFssharequalitativetoxicity propertieswith 2,3,7,8-TCDD.Thereis alsoevidencethat2,3,7,8-TCDD, someof theotherHDDs/HDFs,andby implication the remainderof theHDDs/HDFs may be hazardous tohumanhealthandtheenvironmentatlow levels.These2,3,7,8-substitutedtetra-throughhepta-dibenzo-p-dioxinsanddibenzofurans,aswell as2,3,7,8-TCDD, are the subjectsof thisrulemaking.Hereafter,unlessotherwisestated,this documentwill referto tetra-throughhepta-chlorinatedandbrominateddioxins anddibenzofuranssubstitutedat the 2,3,7 and8 positionsas agroupby usingtheterm “HDDs/HDFs.” The 2,3,7,8-HDDs/HDFshavebeenmeasuredin anumberofcommercialchemicals(Ref. 43). EPA hasreasonto believethat theyalsoappearin a numberof othercommercialchemicalswhich arestructurallysimilarto thosein whichHDDs/HDFshavebeenmeasured,andaremanufacturedunderconditionsfavorableto HDD/HDF formation.

EPA’s NationalDioxin Strategy(Ref.32), issuedin December1983, offersacomprehensiveoverviewof EPA’s past,present,andplannedactivities in thisarea.EPA’s pastregulatoryeffortsonHDDs/HDFsfocusedon a numberofproductsandprocessesthatcouldgenerateHDDsandHDFsor couldotherwiseleadto humanorenvironmentalexposureto thesesubstances.Theseactivitieswerenoted

FederalRegister / Vol. 52, No. 108 I Friday, June 5, 1937 / Rules and Regulations 21413

in the preambleto theproposedruleunderUnit I. Sincethat time EPA hastakenthefollowing additional actions:(1) A final agreementbetweenEPA andmanufacturersof woodpreservingproductscontainingpentachiorophenol,subjectto regulationundertheFederalInsecticide,Fungicide,andRodenticideAct (FIFRA) wasreachedregardinganalysisandmaximumpermissiblelimits in pentachiorophenolfor HDDs;(2) treatmentstandardsundertheResourceConservationandRecoveryAct (RCRA) for dioxin-containinghazardouswastewereproposedJanuary14, 1986 (51 FR 1602), andpromulgatedNovember7, 1986 (51 FR 40572, 40615);(3) cancellationof the dioxin-contaminatedherbicides2,4,5-Tandsilvex werecompletedin February1985;(4) a noticeof intent to cancelmostnon-woodpreservativeregistrationsofpentachlorophenolwaspublishedonJanuary21, 1987 (52FR 2282);(5) aDioxin UpdateCommittee(Ref. 40) ofscientificexpertswasconvenedtodeterminetheir views in theareasofhumanhealtheffects, immunotoxicity,bioavailability, mechanismof actionandappropriaterisk assessmentproceduresfor 2,3,7,8-TCDD;and(6) afavorablereviewwasissuedby theScienceAdvisory Boardof theapplicationof Toxicity EquivalencyFactorsdevelopedby Drs. BarnesandBellin to estimatethetoxicity ~fcongenersofHDDs/HDFsotherthan2,3,7,8-TCDD(Ref. 35). In addition,thefollowing regulatoryactivitiesareunderwaywithin EPA to controloreliminatepotentialhumanorenvironmentalexposureto HDDs/HDFs:RCRA listing of HDDs/HDFs as “acutelyhazardous”wastes;RCRA land bandisposalrule; evaluationof wastestreamsfrom pentachlorophenolwoodtreaters;municipal wastecombustionguidelinesandevaluationof ashresiduesfrom municipal combustion;establishmentof NationalPollutantDischargeEffluent Standards(NPDES)dischargelimits, andnumerousSuperfundsitecleanupactivities,

B. Backgroundto ThisFinal Rule

On October22, 1984, theEnvironmentalDefenseFundandtheNationalWildlife Federationfiled acitizens’ petition undersection21 ofTSCA, 15 U.S.C.2620. The petition (Ref.14) requestedthat EPA commencecertainregulatoryactionsrelatedtocertainHDDsandHDFs andinitiaterelatedinvestigationsandresearch.

More specifically,thepetitionersaskedEPA to useits authorityunderTSCA to analyzeaggregatehazardspocedby multi-media releasesof thespccific HDDs/HDFssubjectto this rule

(thosesubstitutedat the 2,3,7and3positionson thebenzenerings) andtotakeactionunderTSCA to commenceanintegrated,multi-media effort toreducetherisks from thereleaseofthesechemicals.

Although thepetitionersacknowledgedthatEPA in its DioxinStrategy(Ref. 32)hasrecognizedtheneedfor amulti-media approachincleaningup contamination,they believethatEPAhasnot takensufficientactionto preventfuturecontaminationfrom thecontinuedgenerationof HDDsandHDFs ascontaminantsduring themanufactureof otherchemicalsandmaterials.The petitionersrequestedthatEPA takeanumberof specificregulatoryandinformation-gatheringstepsunderTSCA to regulatetheHDDs/HDFsgenerically,asa classofchemicals.

EPA decidedthat,in general,it woulddeny therequestto regulatethespecifiedHDDs/HDFsunderamulti-mediaTSCA approachfor two reasons:(1) TheAgencywasalreadyproceedingto gatherextensivedataandinitiateregulationunderother,more appropriatestatutes,and(2) EPA did not havethedataneededto makeafinding ofunreasonablerisk undersection6ofTSCA, theprovisionof theAct thatauthorizessubstantiveregulationofchemicals.EPA did decide.however,tograntpart of the petition andonDecember19, 1985 (50FR 51794)proposedthis rulemakingundersections4 and8of TSCA to gatheradditionalinformationon HDDs/HDFsincommercialchemicals.EPA will reviewthedatasubmittedasaresultof thisrule to decidewhetheradditionalregulatoryactionundersection8 ofTSCA is warrantedto limit or controlthe furthermanufacture,processing,distributionin commerce,and/oruseofchemicalscontaminatedwith HDDs/HDFs.

EPA received13 commentsto theproposedruleduringthe publiccommentperiod,whichclosedonFebruary18, 1986.On March4, 1986.EPA heldapublic hearinginWashington,DCwherethreeorganizationspresentedtestimony.Atranscriptof this meetingis in the publicdocketfile for this rule. EPA also heldameetingclosedto thepublic on March 4,1986,at therequestof GreatLakesChemicalCo. (GreatLakes),to receiveconfidentialbusinessinformation(tBI)from GreatLakesandto requestadditionalGBI on listedchemicalsmanufacturedby the company.Atranscriptof themeetinganda copyoflettersin whichEPA requestedspecificdataaceincludedin the rulemaking

recordfor this rule. A secondpublicmeetingwasheld April 22, 1986,inWashington,DC, at the requestof theChemicalManufacturers’Association(CMA), to allow CMA to presenttheAgencywith aproposalfor analternativeprocedurefor collectingtheneededdata.This procedureandEPA’sevaluationof it arediscussedunderUnitIV of this preamble.

As aresultof commentsmadeatthesemeetingsandotherinformationreceivedby EPA, theAgencyamendedthe proposedrule andsolicitedpublicviews anddataon whetherto collectprocessandreactionconditiondataon18 additionalbhlorinatedandbrominatedbenzenesundersection8(a)of TSCA (51 FR 37612,October23, 1986).TheAgencyreceivedfive commentstothat proposedamendmentandrespondsto thosecommentsin appropriatesectionsof this preamble.

Also in responseto comments,EPAhasamended40 CFR Part707 to providefor terminationof reportingfor exportpurposesundersection12(b)of TSCAwhentesting showsno contaminationofachemicalby HDDs/HDFsabovetheLOQs.

EPA hasconsideredall thecommentsreceivedandotherrelevantinformationobtainedby theAgency, andhasmodified otherpartsof the ruleappropriately.Thecommentsareaddressedundertheappropriatesectionsof this preamble.

EPA believesthatproduction,processing,distribution,use,anddisposalof the listed chemicalsmaypresentanunreasonablerisk of injury tohumanhealthandtheenvironmentbecauseof their potential forcontaminationby chlorinatedandbrominateddibenzo-p-dioxinsanddibenzofurans.EPA believesthesecontaminantsmaypresenta healthriskat verylow levels, down to 0.1 partperbillion (ppb)for 2,3,7,8-TCDD,the mosttoxic congener,andfor 2,3,7,8-tetrabromodibenzo-p-dioxin(TBDD),believedto be equally astoxic.Therefore,this targetlevel ofquantitationhasbeensetfor 2,3,7,8-TCDD and2,3,7,8-TBDD,with higherlevelsfor the remainingcongenersbasedon toxicity equivalentto thatof2,3,7,8-TCDD.Theselevelsaretargets,andEPA expectstesting laboratoriestomakeagood faith effort to reachthesetargets.EPA’sDirectorof theOffice ofToxic Substances(OTS)will determinewhethergoodfaith efforts aremade,advisedby apanelof expertsinanalyticalchemistryconvenedby EPA.In caseswheregood faith effortsaremade,EPA will acceptresultshigherthan the targetLOQs. EPA alsobelieves

21414 FederalRegister I Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations

that thedifferencesin cost to test forHDDs/HDFat 0.1 ppb or 10 ppb or even100 ppbarevery smallbecausethemajorpartof thecostof testing isincurredby separationof matrix andclean-upof sample,andthis costwill beapproximatelythesamefor theselevels,

Ill. Comparison of Proposedand FinalRule

A. TestingRequirementsUnderSection4

Under section4 of TSCA, explainedintheproposedruleunderUnit 11.5.,EPAproposedto requiretestingof 14currentlymanufacturedor importedchemicalsand20 chemicalsnotcurrentlymanufacturedor imported.Inthis rule, EPA is requiringtestingforl-IDD/HDF contaminationof 12 currentlymanufacturedor importedchemicals,and20 chemicalsnot currentlymanufacturedor importedif theirmanufactureor importation resumes.The two chemicalsremovedfrom thelistare24-Dichlorophenoxyaceticacidand2,4-Dichlorophenoxybutyricacid,chemicalswhichareboth pesticidesandpesticideintermediates.Contaminationof thesetwo chemicalsby HDDs/HDFswill be determinedby a DataCall-InProgramconductedunderFIFRA. The 12chemicals,which aresubjectto testingas of thepromulgationdateof this rule.arelistedbelowwith their ChemicalAbstractServices(CAS) registrynumbers.

cAS No Chemical name

79—94-7 Tehabcomobisphenol-A.118-75—2 2,3,5,6-Tetracoro-2,5-cvclohexad~ene-1.4.

dione.118-79-6 2.4.6-T~ibcomopheoaL120-83-2 2.4-Dichlorophenol.

1163-1S-~ Decabromodiphenyloxide.4192—45-2 Tetcabromobispheciol-A-bixelhoxylale

21850—44—2 Telrabrornobisphenol-A-b~s.2,3.dibrcmopropylelher.

25327-69-3 A8y1 elSe, of telrabcomObispll000l-A32534-81—9 Pentabromodiphenyloede32536—52—0 Dc,aorcmodiphenyloxide.37853-59—1 1 ,2-Bistiribromophenoxy).elhane,55205-38-4 Tehabromobisphenol-A diacrylate,

(PPAhasassumedthat achemicaliscurrentlymanufacturedif it wasmanufacturedsinceJanuary1, 1984.)

The 20 chemicals,whichwill besubjectto testingafter their manufactureor importationresumes,arelistedclaw.

CAS No. Chemical name

79-95-8 Teirachlorobisphenol.A87-10-5 3,4’,h-Tribromoxalicylanlide.57-45-0 2,4 Oichierophenol.95 77-2 3,4-Dichlorophenol.95-95-4 2.4.5-T’ichlorophenol.92-72 ~3 2,6.Ctbi4rno-4-mlrcpi4c-eol

120-36—5 2(2,4-(Dichlorophenoxy)]-prcpanoc acid320-72-9 3,5.D~chio~osalicyclicacid‘52-47—1 Tei,oreorcoca1ecl~oi

CAS No. Chemical name

Manufacturersof anylisted chemicalmayrequestanexclusionorwaiverfrom testingfor any of four reasons:(1)Detailedprocessandreactionconditiondatafor thechemicalshowtheabsenceof conditions.conduciveto HDD/HDFformation;(2) existing testdataon thechemicalmeetthetesting requirementsof this rule in termsof QualityAssurance/QualityControl (QA/QC)andbesteffort to analyzeat lowestpossibleLOQs; (3) an affirmationsignedby a responsiblecompanyofficial thatthe chemicalis producedat levelsof 100kilograms peryearor less,andis usedonly for researchanddevelopmentpurposes;and(4) themanufacturerprovidesevidencethatthechemical,dueto thecostof testing,will eitherbetakenoff themarketor will not reachthemarket,andthe chemicalcanbeshownto resultin no unreasonablerisk. Thislastexclusion/waiveris intendedtoprovide anopportunityfor EPA to grantrelieffrom testing requirementsincircumstanceswherethecost of testingwould precludeproductionof achemicalandno unreasonablerisk wouldresultifthechemicalwereproduced.Requestsfor exclusions/waiversmustbesubmittedwithin 60 daysof theeffectivedateof this rule. Personswho plan toresumemanufacture,import orprocessingof a chemiballistedfortesting mustapply for anexclusion60daysprior to actualsuchresumption.EPA will issuein theFederalRegisteranoticeof receiptof anyrequestsforexclusionunderthis rule, andanoticeofits decisionon eachsuchrequest.

Personsrequiredto testunderthisrulemust,within 60 daysof theeffectivedate,or60 daysafter they becomesubjectto therule, submit to EPA eithera letterof intent to test or anapplicationfor exemption/waiver.For chlorinatedchemicals,personswho submita noticeof intent to testmust submit to EPA,within 12 monthsof suchsubmission,chemicalmatrix-specifictestprotocolssensitiveenoughto quantitateto thetargetLOQsspecifiedin this rule, or ifoneormore of thoselevelsarenotpossiblefor agiven matrix, for thelowestpossiblelevel of quar~titationachievable.For brominatedchemicals,theprotocolsmust be submittedwithin24 monthsof submissionof the noticeof

intent to test.Shouldtesting berequiredin thefuture for a chemicalin whichboth chlorineandbromineoccur, andneitherpredominates,testing would berequiredfor bothchlorinatedandbrominatedHDDs/HDFs.Foradiscussionof requirementsfor suchprotocols,seeUnit IV.B.2. and§ § 766.10,766.12,768.14,766.16,and766.18of thisrule.

LOQs for eachcongenerhave beenadjustedbasedon toxic equivalencyto2,3,7,8-TCDD,using theToxicEquivalencyFactorsdevelopedby Drs.BarnesandBellin of EPA (Refs.4 and35). Usingverylimited data,andin theabsenceof datato thecontrary.brominatedHDDs/HDFshavebeenassumedto beas toxic astheirchlorinatedcounterparts.

Therulerequiresthat thesetargetLOQs be achievedthroughtheuseofhigh-resolutiongaschromatography(HRGC) with high resolutionmassspectraldetection(HRMS), unlessanothermethodcanbedemonstratedto reachthetargetLOQsaswell or better.

EPA will conveneapanelofanalyticalchemistsemployedby theU.S. Governmentandexpertin HDD/HDF analysisto reviewtheprotocolsandofferrecommendationswherenecessaryto ensurethatthemethodsarecapableof accuratelyandpreciselymeasuringHDDs/HUFsat thetargetedor the lowestpossiblelevels. During thisreviewprocessEPAwill takeintoaccountthepossibility that interferencesmay not allow quantitationto the levelsspecifiedand,in thosecaseswheregoodfaith efforts havebeenmadeto reachthe targetLOQ, theAgencymayagreeto ananalyticalprotocolwhichresultsin ahigherLOQ. This determinationwillbe madeby theDirectorof the Office ofToxic Substancesbasedon therecommendationof the expertpanel.

To facilitate the developmentofextraction,cleanup,andanalysisproceduresin theseprotocols,EPA willprovide aguidancedocumenttitled,‘Guidelinesfor theDeterminationof -

PolyhalogenatedDibenzo-p-dioxinsandDibenzofuransin CommercialProducts”(Ref. 24). This guidancedocumenthasbeenadjustedto allow (QA/QC) asfollows: thelevel of reproducibilityisplus!minus20 percent,recoverylevelsfor spikedinternalcalibrationstandardsare50 to 150 percent.

Within B monthsof the completionofEPAreview of the protocols,test resultsmustbe submittedto EPA.

To summarize,as aresultofconsiderationof comments,EPA madesomechangesfrom theproposal.Twochemicalsmanufacturedboth aspesticidesandas isolatedintermediates

576-24-9 2,3-Oichlorophenof.583—79—6 2,5-Oichlorophenol.609-71-9 Pentabromophenot.615-58-7 2,4-D~bromophenol.933-75-5 2,3,6-TrichloropS8nol.

1940-42—7 4.Bromo-2,5~dicl1l0rophenal.2577—72—2 3,5-Dibxomosalicylariilide.3772-94-9 Pentac

96oroplienyl aerate.

37853-61—5 Bismethylethe~ol tetrabromobisphenol-A.

‘:::‘j~~~~ahen~o.

FederalRegister / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 21415

of pesticideproducts,2,4-Dichiorophenoxyaceticacidand2.4-Dichiorophenoxybutyricacid,weredeletedfrom the list of chemicalsto betested.LOQs weremodified to takeintoaccountToxic EquivalencyFactors(TEFs)developedby EPA for thedifferent HDD/HDF congeners.Thetimeframesfor submissionof protocolsandtest resultshavebeenmodified.QA/QCrequirementshavebeenadjusted.Testing for onechemicalmanufacturedby Dow ChemicalCompany(Dow) hasbeenexcludedasaresultof commentssubmittedon theproposedrule. The ruleprovidesprocedureswherebycompaniesmaypresentto EPA information thatmayconvincetheAgencyto excludetheirchemicalsfrom testing or waive thetestingrequirements.

Finally, theregulationsunderTSCAsection12(b)havebeenamendedtoprovide terminationof reportingforexportpurposeswhendatahavebeensubmittedshowingno HDDs/HDFspresentabovethe LOQs. Thesechangesandthereasonsthereforarediscussedin theappropriateplaceslaterin thispreamble.

B. ReportingRequirementsUnderSection8

Under section8(a) of TSCA, EPA mayrequirechemicalmanufacturersandprocessorsto maintainsuchrecordsandsubmit suchreportsasthe Agencymayreasonablyrequire.EPA hasdeterminedthatcertainchemicalmanufacturersmustsubmitinformationto assisttheAgencyin evaluatingtherisk fromchemicalspotentiallycontaminatedwithHDDsIHDFs.The datarequiredto besubmittedundersection8 will beusedto completeacomprehensiveoverviewof uses,exposures,risks, andadvantagesof chemicalscontainingorpotentiallycontainingtheHDDs/HDFsso thatEPA mayassesstheneedfor andnatureof futureregulatorycontrolmeasures.

This rule requiresmanufacturers(includingimporters)andprocessorsofthe12 chemicalslistedfor testing tosubmit,90 daysafter the effective dateof this rule, anyavailabletest results,with necessaryprotocols,which showtheresultsof anyexisting testing of theirchemicalsfor concentrationsof HDDs/HDFs.Thesetestdatamay alsobeusedto supportanexclusionfrom testing.Personswho manufactureor import anyof the20 chemicalsnot currentlyinproductionmustsubmit this informationwithin 90 daysof theresumptionofmanufactureor importation.

The manufacturers,importers,andprocessorsof the12 chemicalsmustalsosubmit,undersection8(c) of TSCA,

allegationsin their possessionofsignificantadversereactionsto HDDs/HDFs and,undersection8(d)of TSCA,anyunpublishedhealthandsafetystudiestheymay haveon HDDs/HDFs.This informationmust be submittedtoEPA within 90 daysfrom the effectivedateof this rule, or 90 daysafter thepersonbeginsmanufactureor import,whicheveris later,

In addition,shouldthe testingconductedunderthis rule or theexistingtestdatasubmittedundersection8 ofTSCA showthat particularchemicalscontainHDDs/HDFsabovethedesignatedLOQs,the manufacturers(includingimporters)of thoseparticularchemicalsmustsubmit,undersection8(a), productionvolume,processandreactionconditions,exposure,useanddisposaldataasspecifiedon EPA Form7710—51.Submittersmayrequestcopiesof theform from theTSCA AssistanceOffice, or submitthedatarequiredbythe form. In addition,thesemanufacturersandimportersmustthensubmit, undersection8(c) of TSCA,recordsof allegedadversereactionstothetestedchemicals,and, undersection8(d) of TSCA, unpublishedhealthandsafetystudieson thetestedchemicals,This section8(a), (c), and(d)information mustbe submitted90 daysafter thesubmissionof apositive testresultasdefinedat § 766.3.

If testingdatafrom this ruleshowthatfor a particularchemical,somemanufacturersreportHDDs/HDFssignificantly abovethedesignatedLOQsandothersshowno contamination,EPAmayrequirethroughpublicationof anoticein theFederalRegister,thatallmanufacturersandimportersof thatchemicalsubmitprocessandreactionconditiondata.This meansthatmanufacturerswho havereportednocontaminationmayberequiredtosupplydata,

Finally, undersection8(a) of TSCA,manufacturers(exceptsmallmanufacturers)of chemicalsusinganyof certainlisted precursorchemicalsasfeedstocksor intermediatesmust submitdataon manufacturingprocessandreactionconditionsfor thechemicalstheymanufactureusing theseprecursors.Theseprecursorchemicalsarenot themselvescontaminated,butcan,duringfurtherprocessingandundercertainreactionconditions,leadtoformation of I-IDDs/HDFsin otherchemicals.ShouldEPA learnfrom thisdatagatheringprocessthatreactionconditionsfavorableto HDD/HDFformation exist,EPA mayproposeadditional chemicalsfor testing.

The originalDecember1985proposallisted 12 precursorchemicals.Afterconsideringcomments,however,EPA

amendedtheproposalandopenedacommentperiodto acceptcommentsonthe additionof 18 chlorinatedandbrominatedbenzenesto thelist ofprecursorchemicals.

Oneof these18 addedchemicals,pentachloronitrobenzene(PCNB),wasremovedfrom the list aftercommentsreceivedin responseto theproposedamendmentshowedthat this chemicalisnot currently manufacturedin the U.S.,is importedonly for useas a registeredactive ingredient(pesticideuseonly),andassuchis regulatedunderFIFRA.All detailsconcerningmanufacturingprocess,intermediates,reactionsandproductchemistryfor this chemicalhavebeensubmittedto EPA as requiredunderFIFRA’s specialDataCall-In letterof May 8, 1985.Becausethis chemicalisnot subjectto TSCA jurisdiction at thistime, it hasbeendeleted.ShouldEPAreceiveinformationindicating thatPCNBmanufactureor importationresumesfor non-pesticidalusessubjectto jurisdiction underTSCA, thischemicalmayagainbe addedto the listof precursorssubjectto the reportingrequirementsoutlined above.This finalrule thusincorporatesall 29 chemicalsinto theprecursorlist.

The completelist of the 29 precursorchemicalsappearsbelow.

CA5 No. Chemical name

85-22-3 Penfabro.’noethyfbenzene.87-61-6 1 .2,3-Thchlorobxnzeoe.87-84-3 1,2,3,4,5. Pentabromo-6~chlorocyclohexane.89-61-2 1 ,4-Oichloro-2-nilrobenzene.89-64-5 4-Chloro~2~nitrophenol.89—69-0 2,4 ,5.Trichloronitrobenzene.92-04-6 2-chloro-4-phenylphenol.94-74-6 4.Chloro-o-toloxy acetic acid.94—81-5 4.(2-i2ethyl.4.chlorophenoi0i) butryic acid.95-50-1 o-Dichlorobenzene.95-56-7 I o-Bromophenol.95—57-8 o-Ciiforophenol.95-88-5 4~Chlororesorcinol.95-94-3 1 ,2,4,5-Telrachlorobenzene.97-50-7 5~Chloro~24amethoxyaniline99—30—9 I 2,6-Dichloro-4-nitroaniline.99-54-7 1 ,2-Dichloro-4-n,loobenzene.

106-37-5 Dibromobeacene.106-46-7 p~Dichlorobenzone.108-70-3 1 ,3,5-Trichlorobenzene.108-86-1 Bromobeezene.109-90-7 Chlorobenzene.117—18—0 1,2,4,5-Txtrachlcwo-3.nilrobenZene.120—52—1 1 ,2,4.Irichlorobenzone.348-51—6 o-Chforofluorobenzene.350-30—1 3.Chloro..4.lluoroflitrobenZ$ne615—67—8 Chforohydroquinone.626-39-1 11 ,3,5.Trib,omobenzexe.827—94—1 2,6.Dibromo-4-nitroanlline.

EPA madeonly two changestoreportingrequirementsundersection8of TSCA. After consideringcomments.EPA addedthe17 chlorinatedandbrominatedhenzenesto theoriginal 12precursorchemicals.In addition,EPAdeletedanumberof reportingrequirementsfor chemicalsmanufacturedfrom the precursors.Specifically, requirementsfor all data

21416 Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations

otherthan processandreactionconditionshavebeeneliminated.Thesechangesandthereasonsthereforarediscussedin theappropriateplacesinthis preamble.

IV. Findingsand Considerations

A. FindingsUnderSection41a,.)Section4 of TSCA authorizesEPA to

require,by rule, thatchemicalmanufacturersor processorsconductteststo developdatarelevantto thedeterminationthat thechemicalsdo ordo not presentan unreasonableri.sk ofinjury to healthor the environment.EPAmustmakeanumberof findingsbeforeit mayissuea section4 rule. Undersection4(a)(1)(A),EPA mustfind thatachemicalmaypresentanunreasonablerisk of injury to healthortheenvironment,that thereareinsufficientdataandexperienceupon which theeffectsof activities involving thechemicalcan reasonablybedeterminedor predicted,andthat testingof thechemicalis necesssaryto developsuchdata.-

EPA makesfourfindingsundersection4(a)(l)(A) of TSCA with respectto the32 chemicalslistedin this finalrule. First, EPA finds thatthesechemicalsmaypresentart unreasonablerisk of injury to healthortheenvironmentbecausetheymay becontaminatedwith HDDs/HDFs,whichmay be highly toxic evenat tracelevels.Second,EPA finds that thereareinsufficientdatauponwhich theeffectsof thesechemicalson healthor theenvironmentcouldreasonablybedeterminedbecauseEPA hasverylittledataon whetherthereis anyHDD/HDF -

contaminationand,if so, thelevels ofsuchcontamination.Third, EPA findsthat analyticaltestingis necessarytotievelopdata onHDD/HDF contaminantlevelsbecausesuchtesting is the onlyway to determineconclusivelywhetherandat what levelsHDDs/HDFsarepresent.Fourth,EPA finds that thisanalyticaltesting is relevanttodeterminingwhetheractivities involvingthe 32 substancesdo or do not presentanunreasonablerisk. Further,EPA findsthat the costof testingfor thepresenceof thesecontaminantsat thelevelsproposedby EPA is reasonablegiventhepotentiallyhighly toxic natureoftheseHDDs/HDFs.

In supportof thesefindings, EPAadoptstheanalysissetforth in thepreambleto theproposedrule underUnit IV.A. andV., modifiedasdiscussedbelow.Thesemodificationsweremadeasaresultof considerationof commentsandotherrelevantinformation.Below,EPA discussesthecommentsreceivedon its proposedfindings,andthe

Agency’s response.Discussionof eachcommentalsocontainsareferencetotheperson(s)who submittedit.

1. EPA’slegalauthorityto requireanalytic testingundersection4 ofTSGA—Comment1: EPA lackslegalauthorityundersection4 of TSCA torequireanalyticaltesting for impuritiesin chemicals.Section4 doesnotexplicitly referto testingforcontamination,but ratherlimits EPAtorequiringtestingon “healthandenvironmentaleffects.” Section4(b)(2)(A) describesthe “effects” and“characteristics”for which testing ispermittedanddoesnot mentiontestsforcontamination.This position issupportedby the legislativehistory.AnearlySenateversionof TSCA (S. 776(1975))containedspecific languageallowing contaminanttesting.Thatlanguagewasleft out of the final versionof TSCA, thusindicatingthat Congressdid not intend to allow contaminanttestingundersection4. (CMA pp. 6—9;Vulcanp. 1).

Responseto Comment1: EPAdisagreeswith this narrowreadingofTSCA. EPA interpretssection4 to allowthe testingof-chemicalsto obtaindatarelevantto a determinationofunreasonablerisk. Thesedataincludethe typesof informationwhich would begeneratedby testing undertheproposedrule. EPA rejectsthe positiontakenbythesecornmenters,whichwould limitsection4 to toxicity testing,ratherthan“effects” testing.

Section4(a) providesthatEPA, aftermakingcertainfindings, mayrequiretestingof achemical~—

to developdata. . . whicharerelevantto adeterminationthat, . . [the chemical)doesordoesnot presentanunreasonablerisk ofinjury to healthor theenvironment.Section4(b)(2)(A)statesthat the effectsfor which teststandardsmay beprescribedincludea numberof specificeffects“and anyothereffectwhich maypresentan unreasonablerisk of injury tohealthorthe environment.”In addition,characteristicsfor which standardsmaybe prescribedincludespecificcharacteristicsand“any othercharacteristicwhichmay presentsucha~nunreasonable)risk.”

The potential for a chemicalto becontaminatedwith dangerousimpurities,suchas HDDs, fails withinthe “effects” or “characteristics”of thatchemicalwhichwould berelevanttowhetherthe chemicalmay presentanunreasonablerisk. Requiringanalyticaltesting of the type discussedin theproposedrule—the levelsat whichaparticulartoxic contaminant,suchasHDDs, is presentin a chemicalsubstance—isanimportantfactor in any

determinationof unreasonableriskbecauseit providesEPA withinformation fromwhichhumanandenvironmentalexposureto thecontaminantcanbe assessed.Moreover,information on the amountof thecontaminantin achemicalsubstanceallows theAgencyto betterassessthehazardof thatparticularchemicalsubstance,Finally, requiringchemicalmanufacturersto conductsuchanalyticalchemistrytestingis consistentwith the well-definedCongressionalintent in enactingTSCA that“adequatedatashould bedevelopedwith respectto the effectof chemicalsubstancesandmixtureson healthandtheenvironmentandthat the developmentof suchdatashould betheresponsibilityof thosewho manufactureandthosewhoprocesssuchchemicalsubstanceandmixtures~.j”TSCA section2(b)(1).

The fact thatsection4 doesnotspecifically mentioncontaminanttestingis not dispositive.Thetypesof testslistedin section4 areonly examples.

Finally, CMA’s referenceto S. 776doesnot supportcMA’s position. S. 776providedthat,if EPAdeterminesthat achemicalmaypresentanunreasonablerisk, theAgencyshall “prescribestandardsfor atestprotocolfor suchsubstance.”A testprotocolisspecifically definedasa methodto befollowedin teststo “determinetheeffectsof themanufacture,processing,or distributionin commerceof achemicalsubstance.”Thebill goeson tostatethat in prescribingthe protocols,EPA:

shall require that informationpertainingto allrelevantfactorswith respectto theapplicablechemicalsubstancebedeveloped.Suchfactorsinclude—

[A) theeffectsof thesubstanceonhumanhealth,andthemagnitudeof humanexposure;and,

[B) theeffectsof suchsubstanceon theenvironment,andthemagnitudeofenvironmentalexposure.

[2) Standardsfor testprotocols. . . mayrequire that testsbeperformed,inaccordancewith thoseprotocols,forcarcinogenicity,mutagenicity,teratogenicity,acutetoxicity, subacutetoxicity, chronictoxicity, cumulativeproperties,synergisticproperties.clinical effects, epidemiologicaleffects,ecologicaleffectsandothereffectsofsuchsubstancewhichmight causeunreasonablerisk to humanhealthor theenvironment.

CMA apparentlyarguesthat thelanguagereferringto the “magnitudeofexposure”wasdeletedfrom the finalversionof TSCA and,thus,supportstheposition thatCongresslimited EPA’sauthorityto “effects” testing.CMA citesrio furtherexplanationin thelegislative

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history for thedeletionof the“magnitudeof exposure”language.

EPA viewsthe legislativehistory assupportiveof its position.Both S.776andthefinal versionof TSCA indicateanintentionthat “relevant” factorsbetested.Thereis an additionalparallelbetweenthe two versions,indicatingtheyboth refer to thesametypesoftesting.S. 776refersto factorsrelevantto healtheffectsandmagnitudeofexposure;TSCA refersto factorsrelevantto “unreasonablerisk.” Plainly,unreasonablerisk includeselementsoftoxicity andexposure.

CMA’s interpretationof thelegislativehistory, regardlessof theeffect ofdeletingthe “magnitudeof exposure”language,doesnot affect this rule.Contaminanttesting,asnotedabove,is“effects” testing.

2. Commentson EPA’Sapproachtothis rule—Comment2: Beforerequiringtestingundersection4 of TSCA onHDDs/HDFs,EPA should useTSCAsection8(a) authority to collectextensiveexposuredata,specificallyinformation on production,process,use,anddisposal.Only thencanEPAdeterminewhethertheremaybe anunreasonablerisk requiringtestingundersection4(a).This approach(collecting section8(a) informationbeforeproposingsection4 testing rules)is theAgency’sstandardapproachtorespondingto recommendationsfortesting chemicalsmadeby theInteragencyTestingCommittee(ITC)undersection4(e) ofTSCA. The Agencycould usetheSNUR provisionto gatherinformationon thechemicals.(CMA atpp. 2—4; Dow at p. 2; GreatLakesat p. 2;pp. 3/4 in commentsto proposedamendmentaddingadditional precursorchemicals).

Responseto Comment2: EPAdisagreeswith this comment.Theamountof exposureinformationneededto testundersection4 ofTSCA, whichrequiresafinding that achemical“may”presentanunreasonablerisk, neednotbe asextensiveasthat neededtoregulateundersection6 of TSCA, whichrequiresafinding that achemical“will”presentanunreasonablerisk. Thecommentsconfusethetype ofinformationandlevel of detail neededtoissueasection4 testing rule withinformationneededto issuerequirementsundersection6 of TSCA.

Furthermore,whenEPA hasinformation,as it doesfor HDDs/HDFs,that a chemicalmay behighly toxic atvery low levels,the amountof exposuredataneededto makeasection4(a)finding may be evenlessdefinitive. ForHDDs/HDFsthemajoruncertaintiesaretheir presenceandlevelsofconcentrationin commercialchemicals,

If HDDs/HDFsarepresent,evenatlowlevels, the toxicity of that chemicalmaybe high basedon theimpurity.

In addition,EPA believesthat itwould becounterproductiveto obtainsection8(a) exposuredataon chemicalspotentiallycontaminatedwith HDDs/HDFs if testing showsthat thesecontaminantsarein fact not present.This would alsodelay theAgency’sability to concentrateits attentiononthosechemicalscontaminatedandtodeterminewhetherregulationto reduceexposure,is necessary.Only ifcontaminationis presentabovetheLOQswill EPA collect thedetailedprocess,reactioncondition,production,use,exposure,anddisposaldatatodeterminewhetherthe chemicaldoesinfact presentanunreasonablerisk ofharmto humanhealthortheenvironment.

Finally, EPA disagreeswith thesuggestionthat, insteadof section4testing rules,SNIJRsundersection5(a)of TSCA shouldbeusedto gatherinformation on particularusesof thechemicalssubjectto this rule. EPAbelievesthelogic behindthis commentis reversed.Doing a SNUR beforetestingthesechemicalswould only prolongtheregulatoryprocessunnecessarily.TheAgencyshouldfirst gathergeneralinformation on HDD/HDF levelsin themanufacturedchemicalandthenconsiderwhetherparticulardownstreamusesshouldbesubjectto regulatoryrequirements.At thatpoint,EPA coulddecidesuchissuesaswhetherpotentialdownstreamusesshouldbesubjecttoSNURsor whethersubstantiveregulatoryrequirementsundersection6of TSCA should bepromulgated.Further,gatheringinformationonspecificusesfirst would becounterproductive,sinceit is a-uselessexerciseto promulgatea SNUR if, infact,HDDs/HDFsarenot presentin themanufacturedchemical.Finally, a SNURcould not beusedto obtaininformationon ongoinguses.

Comment3: EPA mustestablishanexposurepatternfor eachchemicalto betested.(CMA at pp. 2 and4).

Responseto CommentS:EPA doesnotagree.As notedabove,informationrequiredto makeasection4(a)unreasonablerisk finding is not asextensiveasthatrequiredto regulateunderTSCA section6. Furthermore,undersection26 of TSCA EPA isauthorizedto takeactionunderthe Actwith respectto categoriesof chemicals.Categoriesof chemicalsincludegroupsthat aresimilar in molecularstructure,in physical,chemicalorbiologicalproperties,in modeof entranceinto thehumanbody or into the environmentorin someotherway suitablefor

classification.Thechemicalssubjecttothis rule all havethepossibilityof beingcontaminatedwith HDDs/HDFsbasedonchemicalstructure,known pathwaysto contamination,andmanufacturingconditionswhichareconduciveto theformationof HDDs/HDFs.The HDDs/HDFsarealsosuitableforcategorizationalsobecause,asdiscussedmorefully in thepreambleoftheproposedrule andelsewherein thispreamble,HDDs/HDFsarestructurallysimilar, certainof the I-IDDs/HDFsarehighly toxic evenat low exposurelevels,therearenumerousimportantphysical!chemicalsimilaritiesbetweentheHDDs/HDFsandthesephysicalsimilarities havebeenrelatedto theinductionof toxic effects.Thus,EPA isjustified in consideringthesechemicalsasa classfor section4 testing purposes.

EPA believesthereis potentialforhumanexposureto eachof the 32chemicalswhen theyaremanufactured,processed,distributedin commerce,usedor disposedof at the levelsofconcernstatedin this rule.

Comment4: In orderto setanalytictargetsfor impurity analysis(LOQs),EPA mustcollect exposuredata oneachindividual chemicalusing section8(a) ofTSCA. (CMA at pp. 3 and4; p. 4 incommentsto proposedamendmentaddingprecursors).

Responseto Comment4: EPAdisagrees.As with thecommentsdiscussedabove,this commentconfusesthedataneededto determinealevel atwhich testingwill berequiredwith the“action” level at which regulationmaybe imposedundersection6 of TSCA.The preambleto theproposedrule madethis distinction clear(50FR 51800(column2)). EPA indicatedthatanyactionlevel would bederivedfor eachindividual chemicalbasedon itscontaminationlevelsandits potentialfor exposure,andtaking into accountcostof testing andbenefitto societyresultingfrom informationgeneratedbysuchtesting.For testingpurposestheAgencychoselevelsthat couldpossiblypresentrisks of concern,usinggenericexposurescenarios,choosingtheworstcasesto ensurethat EPAhasadequatedata to evaluateanypotentialriskresultingfrom low levelsof all 7 HDDsand8 HDFsoccurringin asinglechemical.Thus, the Agencycancatchinits analyticalnetanyusethat couldpotentially causeunreasonablerisk.

Comment5: EPA hasadequateinformation underTSCA not only torequiretesting undersection4, but alsohasall dataneededto regulatethechemicalsimmediatelyundersection6,andshould do so. (EDFp. 2).

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Responseto G’omment5: EPAdisagrees.EPA lacks importantdatarequiredto makethefinding ofunreasonablerisk requiredby section6,asdetailedin its responseto the EDF/NWF Petitionat 50 FR 4426(January30,1985). EPA hasdeterminedthat it canfind that the listedchemicalsmaypresentanunreasonablerisk, asrequiredby section4 of TSCA, andthereforecangatherthedataneededtodeterminewhetherthesechemicalspresentanunreasonablerisk andwhetherregulationof thesechemicalsundersection6 of TSCA is appropriate.

Comment6: EPA hasnotdemonstratedthatreductionsbelow0.1ppbarefeasiblefor all HDDsand1.0ppbfor all HDFs.EPA only referencedDow ChemicalCompany’sstudiesof2,3,7,8-TCDDreductionsduringthemanufactureof apesticide,2,4,5-T; thesestudiesonly showreductionof onecongenerto a 10ppb level. (CMA at pp.22 and23). This comment,apparently,ismeantto supporttheposition thatEPAcannotmakeafinding ofunreasonablerisk for purposesof this rule.

Responseto Comment8: Thiscommentalsoconfusesthenatureof theTSCA section4(a) finding with theTSCA section6(a) finding. EPA canjustify testingachemicalbasedon thelimited dataindicatingthatDow wasableto reduce2,3,7,8-TCDDlevelsin itsproduct,therebyshowingthatregulationmaybefeasible(Ref. 12). EPA doesnotcommenton whethersuchinformationwould justify settingparticularcontaminantlevelsin products.

Gomment7: Therisks from exposureto contaminantsat low levelsmaybemuchlower thanpredicted,basedon thelow risk from exposureto thesubstanceitself. Reducingthelevel of impuritieswill havenegligible effectson risks fromuseof the commercialsubstance.Theunreasonablerisk determinationmustbemadeon therisk from thecommercialsubstanceasmarketed;otherdeterminationsareuselassfrom arisk reductionstandpoint.(Dow at pp. 5and6).

Responseto Comment7: Theeffectofanimpurity on risk, of course,dependson thenatureof the impurity. Thedataon contaminationof thechemicalwithHDDs/HDFs,gatheredfrom thisrulemaking,will be usedby EPA toexaminethe risk from exposureto thechemicalwhenthe Agencyconsidersregulationundersection6 of TSCA.- Comment8: EPA mustconsidertheconditionsof usefor thechemicalslistedfor testing,especiallywhen theconditionsinvolve elevatedtemperatureswhich increasethepossibility of exposureto both residualHDDs/HDFsandnewlyformedHDD8/

HDFs.Plasticsworkersarecommonlyexposedto decompositionproductsduringequipmentpluggingand/armalfunctions,andfirefightersandconsumersareexposedto suchproductsduringfire-relatedexposures.(Workers’Institute for SafetyandHealthpp. 1 and2).

Resnonseto Comment8: EPA hasconsideredworkerexposureto achemicalcontaminatedwith low levelsofHDDs/HDFsin its genericexposurescenarios,Issuesof combustionproductswhichmayposeanunreasonablerisk arenot immediatelyapplicableto a considerationof whetherto testa chemicalfor HDDs/HDFs.Ifsuchcontaminationis found,however,this issuewill be consideredin thedeterminationof unreasonableriskundersection6.

Comment9: GMA believesthatallcompaniesrequiredto testwill bewilling to do so if theprogramis areasonableone. Thekeyto CMA’sreasonableprogramis establishmentofreasonableLOQs, basedon afullexposureandrisk assessmentfor eachchemical,andon demonstratedcapabilityto analyzeHDDs/HDFsinchemicalmatrices.The companiesrequiredto testwill bewilling to beginby summer(1986)andprovideresultswithin 1 year.(Transcriptto April 22meeting,pp. 5 and6; p. 4 in commentstoproposedamendmentaddingadditionalprecursors.)CMA alsobelievesthecompanieswould bewilling to providethesection8 datarequiredto establishexposurefor eachchemicalto determineareasonableLOQ basedboth onexposureandcapability.(Transcriptatpp. 7 and8.)

Responseto Comment9: EPA’sconcernswith a voluntary testingprogramlie chiefly in the lackofenforcementpowers,andthepotentialfor lost time if ~MA andEPAcouldnotarrive at an agreementon thetestingconditions.CMA implies that theAgencymustcollect exposuredataforeachchemical,andperformariskassessmentto setanLOQ for each1-IDD/HDF for eachchemical.ThentheAgencymustfurtherreviseits LOQbasedon whathasbeendonein thepastto analyzeHDDs/HDFsincommercialchemicals.EPA rejectedthatapproachin responseto comments2 and3. However,to meetCMA’sconcernsaboutthe low level of theLOQsasproposed,EPA hasadjustedthe LOQssomewhat,basedon toxicityequivalenciesto 2,3,7,8-TCDD.Thissystemallows higherLOQs for higherhalogenatedHDDs/HDFs,which CMAhassaidwill bethe moredifficultcongenersto analyze.EPA hasalsosetthe LOQ not asan inflexible level,but

ratherasatargetto be met if possible,givena-reasonableamountof time bothfor anexperiencedanalystandforrequiredequipment.All of theseadjustmentsshouldconsiderablyreduceCMA’s concerns.

3. Commentsonproposedfindingsundersection4(a)—a.Unreasonable’risk. EPA basesits unreasonableriskdeterminationon theanalysiscontainedin the preambleto theproposedrule (50FR 51797—51800and51805—51806).Thedataandanalysisdescribedthereinwith the modificationsdiscussedbelowjustify afinding underTSCA section4(a) that thechemicalssubjectto this -

rule maypresentanunreasonablerisk,suchthat testingof thechemicalsforHDDs/HDFis requiredat theLOQsdescribedin this rule. The toxicpotentialof HDDs/HDFscarryconsiderableweight in making thisdetermination.Two of theHDDs/HDFswhichhavebeentestedforcarcinogenicityarequantitativelyestimatedto bepotentcarcinogens.Many of theremainingHDDs/HDFs.allof whicharestructurallysimilar to thetwo whichhavebeentestedin long termstudies,havebeenshownto producetoxic effectsin animalsandexhibitbiological activity in in vitro andin vivostudiesat verylow levels.TheseHDDs/HDFsmaybepresentas impuritiesi.ncertainchemicalsbaseduponreactionswhichcanreasonablybe expectedtooccurunderconditionsexpectedto existduringtheir manufacturingprocesses.Therefore,peoplemay be exposedtothesechemicalsandtheir associatedimpurities duringproduction,processing.distribution in commerce,use,anddisposalof thesechemicals,andmaytherebybeat risk of potentialadversehealtheffectsassociatedwith theseimpurities.

Thereis anindicationthatexposure-

to chemicalscontaminatedwith 2,3.7,8WTCDD at levelsas low as0.1 ppb mayposea significantrisk to workerswhomanufacturethe chemicals.Therefore,the testinglevelshavebeensetas lowasreasonablyattainable,with targetLOQsbeginningat 0.1 ppbandadjustmentsfor eachcongenerbasedonits toxicity relative to thatof 2,3,7,8-TCDD, the mosttoxic congener.EPAexpectsmanufacturersto makegoodfaith efforts to reachthe targetlevels,but will allow reportingof higher levelsif it determines,basedon review of the’protocolandtheresultsof testing underthoseprotocols,that themanufacturerhasmadeagood faith effort to measureHDDs/HDFsaslow- aspossiblein his orher chemical.An additional reasonfortargeting-0.1 ppbas theLOQ for 2,3,7,8-TCDD is’ that thespecificationof this

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LOQ asa targetat theoutsetof themethodsdevelopmentprogramfor aparticularproductcanbe factoredintotheestimatedcostsnecessaryto achievethe targetLOQ; therefore,theactualcostpersampleshouldnot besignificantly affected.If the requirementfor ahighertargetLOQ werespecifiedat theoutsetof preliminarymethoddevelopmentandthenlowered-afterinitial methoddevelopmentwerecompleted,anincreasein costofanalysispersamplewould beexpecteddueto requirementsfor total reanalysis.EPA hasfoundno reasonto alteritsdeterminationthat theoverallcostsoftesting arereasonable,SeeUnit V,below.

Elimination or preclusionfrom themarketdueto cost of testingforindividual manufacturersandindividualchemicalshasbeenconsidered,andEPA hasallowedmanufacturersto file arequestfor exclusionfrom the testingrequirementsif themanufacturercanalsoshowthat thechemicalwill notpresentan unreasonablerisk of injury tohealthorthe environment,Additionalreasonsfor which anexclusion-fromtestingmay begrant-edare: (1) Themanufacturingprocessis suchthatconditionswhich mayleadto formationof HDDs/HDFsarenot present;(2) thepre-existingtestdataareadequateunderthis rule; and(3) thechemicalisproducedin quantitiesof 100kilogramsor lessper yearandis usedfor researchanddevelopmentpurposes.Discussionof the commentson toxicity andexposureappearsbelow. Discussionofthecommentson costappearsin Unit V.

(i) Toxicity. The toxicity discussioninthepreambleto theproposedrule (50 FR51797—51798)appliesto EPA’s toxicityfinding on HDDs/HDFs.Oneisomer,2,3,7,8—TCDDhasbeenestimatedbyEPA’s CarcinogenAssessmentGroup(CAG) to bethe mostpotentof 55suspectedhumancarcinogens(50FR51798,column1). The otherHDDs/HDFssubjectto this rule appearto bequalitativelysimilar to 2,3,7,8-TCDDintheir toxic actionandappearto havestrongstructuralandchemicalreactivitiessimilar to 2,3,7,8-TCDD(50FR 51798).As discussedbelow, EPAseesno reasonto changethesebasicaspectsof its toxicity finding. However,EPA haschangedits determinationinonerespect.RatherthanconsideringallHDDs/HDFsto be as toxic as2,3,7,8-TCDD, EPA hasusedTEFsto relatethetoxicity of eachHDD/HDF to thetoxicity of 2,3,7,8-TCDD.TheseTEFshavebeendevelopedby the EPA andhavebeenfavorably reviewedby theAgency’s ScienceAdvisory Board(SAB)(Ref. 35). In addition,all comments

submittedin responseto EPA’s proposalwerefavorableto useof theTEFs.

Comment10.’ EPA hasoverestimatedthe toxic potentialof HDDs/HDFs.Thisis becauseEPA incorrectlyrelieson theincrementalcancerrisk for lifetimeexposureto 2,3,7,8-TCDDdevelopedbythe Agency’s CAG. This calculationisthat theincrementalcancerrisk is I in amillion if an individual is exposedto0.006picogramsperkilogramof bodyweight perday(pg/kg/day)basedon alinear low-dosemodel. Instead,EPAshouldbaseits determinationof potencyon aNoObservedEffectLevel (NOEL),suchasthatdevelopedin an analysisbytheCanadianMinistry of Environment(EnvironmentCanada).EnvironmentCanadarecommendsamaximumAllowable Daily Intake(ADI) for 2,3,7,8-TCDD of 10 pg/kg/day,whichis 1,000times higherthan the EPA risk level.(CMA at pp. 14 and15.) TheEnvironmentCanadaassessmentismoreappropriatebecauseit is basedonthedeterminationthat 2,3,7,8-TCDDisananimal cancerpromoterandnot acancerinitiator. Thus, thelinear no-thresholdmodelusedby EPAis notappropriate.(Dow at pp. 4.)

Responseto G’omment10: EPAdisagreesthat it hasoverestimatedcarcinogenicpotencyfor purposesofthis rule. RatherEPAhasemployedascientificallyacceptablemethodtodeterminepotency.This determinationappliedano-threshhold,linear low-dose,multi-stagemathematicalmodeltotheresultsof a2,3,7,8-TCDDfeedingstudyby Kociba 1978(seeRef. 34) thatshowedstatistically significantincidencesof tumors in the liver, lungs,hardpalate,andnasalturbinatesoffemalerats.

EPA believesthat theno-threshold,linearlow-dosemodel is appropriateforanumberof reasons.First, while thereisno conclusiveproofthat2,3,7,8-TCDDisacancerinitiator, thebiological half-lifeandprolongedretentiontime of thiscompoundin the humanbodymayresultin “promotereffect” whichis essentiallyirreversible(Ref. 26). Thus,although2,3,7,8-TCDDis not aprovencancerinitiator, the no-threshold,linear low-dosemodelis appropriatebecauseofthe plausiblemechanisticmodeloftumorigenesis,whichsuggeststhat thereis somerisk of tumorformation at anylevel of exposure.Second,for chronicexposureof 2,3,7,8-TCDD,experimentalevidencesuggestsalineardose-responserelationshipin the low doseregionfor tumorigenesisandenzymeinduction(Ref. 36). Finally, for 2,3,7,8-TCDD the mechanismsofcarcinogenesis(thebiochemicalchangesthat ultimatelyresult in the

21419

manifestationsof cancer)areunknown.SeeEPA’s HealthAssessmentDocumentfor PolychlorinatedDibenzo-p-Dioxinsat pages2 through7 (hereafter“I-lAD”) (Ref. 34); alsoseeRef. 27.Accordingto the Office of ScienceandTechnologyPolicy (OSTP), (50FR 10371;March 14, 1985), alinear low-dosemodel,suchas theoneusedby EPA, isthepreferredrisk assessmentapproachif mechanismsof carcinogenesisfor achemicalarenot known.TheEPAGuidelinesfor CarcinogenicRiskAssessment(51 FR 33861,September24,1985)agreewith theOSTP policyon thispoint.

With respectto thepromoterversusinitiator issue,EPA agreesthat allevidencepoints to the fact that2,3.7,8-TCDD, andby implication theHDDs/HDFsin this rule, arepotentcancerpromoters.However,currentEPA policyis containedin the Agency’sGuidelinesfor Risk AssessmentandtheHAD,whichconcludesthat 2,3,7,8-TCDDshould alsobetreatedasacancerinitiator aswell asapromoter, basedonaseriesof animalstudieswith 2,3,7,8-TCDD andothercompounds(Ref. 34 at11—58 and11—59).This approachisendorsedby-EPA’sSAB (Ref. 35). Whileit is true thatsomeexpertsbelievethat2,3,7,8-TCDDis only a cancerpromoter,andnot a cancerinitiator (Ref. 36). andthat someagenciesin othercountrieshaveactedon that belief, EPA has,atleastfor purposesof this testing rule,maintainedthe currentAgencypositionto treattheHDDs/HDFsascompletecarcinogens(capableof both promotionandinitiation).

In any case,thepromotervs. initiatorissuemaybe irrelevant for riskassessmentpurposes,evenif 2,3,7,8-TCDD is only apromoter.The thresholdmodelis appropriatefor apromoteriftheeffectsfromthepromoterareassumedto bereversibleif thepromoteris removed.Thus,onemayestimatealevel (referencedose)whichwould beacceptedto bewithout risk of harmfuleffectsin humansby applyinganuncertaintyfactor to athresholdorNOEL level.Becauseretentiontime andbiological half-life of 2,3,7,8-TCDDis solong (upto 8years; Ref. 26), andbecauseits “promotingaction” may not bereversible,it maynot bepossibletoestimatea ReferenceDosefor usein athresholdmodelwhich takesintoaccountthe manifestationof prolongedeffectsfrom multiple promoters/initiators.EPA believesthat thisapproachmore completelyaddressesthe questionof simultaneousexposureto multiple initiators in theenvironmentat thesametime, aswell asexposuretoaccumulativedosesof compoundswith

21420 Federal Register / Vol. 52, No. 108 I Friday. June 5, 1987 / Rules and Reguititions

long half-livesin thehumanbody, suche~2.3,7.8-TCDD.

EnvIronmentCanadabaseditsd’~termninationthat 10 pg/kg/dayis anacceptablelevel of exoosureto 2.3.7,8-TCDD in humanson thefact thatreprodectiveandcancerstudiesshowno observableeffects1n animalsatadoseof 0.001 pg/kg/day,andsetthislevel as theNOEL. TheNOEL is thelevel at which therewould ber~odifferencein risk betweenthepopulatIonsexposedto 2,3,7,8-TCDDandpopulationsnot exposed.A safetyfactorof 100 wasappliedin ordertoarrive at the 10 pg/kg/daylevel. Such ananproachdoesnot addressthequestionof simultaneousexposureto multipleinitiators in the environmentat thesametime, andexposureto accumulativerinsesof compoundswith long hall-livesin the humanbody,suchas2,3.7,8-l’CDD.

Thua,the differencebetweenthe 10pg/kg/day level adoptedbyEnvironmentCanadaandthe0.006pg/kg/day level usedby EPA reflr.ctdifferencesin viewsof themechanismof act~ooby whichthesecompoundseffect their toxicity, aswell asaitemptin,gto estimatethe effectofmultiple ox additiveinitiators. EPA’sapproachis thereforeacceptableirons aregulatorystandpoint.

Co~iunent11. EvidenceagainstEPA’sunduly high estimatesof toxic potencyfor HDDs/HDFscanbe seenin resultsfrom humanepidemiologystudies.Exposuresto 2,3,7,8-TCDDamongherbicidemanufacturingworkerswerehigh enoughto producereadilydiscerniblecancerexcessesif potencywereashigh asEPA suggests.No suchexcesseshavebeenfound. Further,ifEPA’s potencyvaiueswerecorrect,andf backgroundexposuresto HDDs/HDFs

3m) to 40 yearsagoweresimilar tocurrentbackgroundexposures,assuggestedby Czuczwa,et al. (Refs.9and10), a discernibleupwardtrend incancermortality beginning15 to 20yearsagowould havebeenobserved.This is not thecase.In both theherbicideworkerstudyandthepredictedbackgroundlevels, the numberof excesscancerdeathspredictedbyEPA exceedsthesensitivity ofmeasurementby afactorof 10.Therefore,theEPA potencyestimateisatleastten times too large.(CMA at pp.15 and16.)

Responseto Comment11: EPAdisagreesthat theresults from theepidemiologystudiescited aboveshowthatEPA’s estimateof thepotencylevelfor 2,3,7.8-TCDDis too high. EPA hasalwaysmaintainedthat the Agency’sestimateof toxic potencyfor 2.3,7,8-TCDD is in fact anupperlimit; that is,

theAgencydoesnot think that thepotencyis likely to hegreaterthanthegivenestimateand,in fact, may beless.While it maybe truethat therealpotencymaybesomethinglessthanEPA’s suggestedupperiimit, it is notclearthat thescientificdatabaseavailableat this time presentsevidencestrongenoughto supportsomeother(lower) estimate.

Further,epidemiologicstudiesareinherentlycapableof detectingonlycomparativelylargeincidencesofcancer,andconfoundingfactorssuchaslong latencyperiods,bias,andpoorexposurecharacterizationoftenaffecttheadequacyof the study.The useofdataby Czuczwa,etal. cannotbeusedto :dentifygeneralpopulationexposurelevels,becauseneitherstudywasof as:u’usticaidesignfrom which onecouldinfergeneralU.S. exposures.CzuezwastudxedtWO lakes in Michigan,LakeSiskiwit andLake Huron.Thcs~studiesof thelnke sedimentsshowthatHDLl~/I-i.DFs weredepositedin lakesedimentsbeginningaround19-10,generallyincreasingthereafter,andthat thedistributionof congener.sfoundcorrespondswith present-dayconcentrationsof congenemsassociatedwith emissionsfrom combustionof fuelandwastes.While thesestudieswerenot directly intendedto addresstheque3tionof generalenvironmentallevelsof l-IDDs/HDFs, Czucz’wanotesthat thelevelsof HDDs andHDFsin theGreatLakesBasinmaybehigherthan in otherareasof the U.S. dueto heavychemicalproductionandwasteincineration.

CommenterssuggestedacomparisonbetweengeneralbackgroundlevelsofHDDs/HDFsandcancermortalitytrends.Such acomparisonis limited dueto the inability to characterizegeneralpopulationbackgroundexposuretoHDDs!HDFs.While EPA hasno reasonto believe thatthe HDD/HDF levelsfoundby Czuczwa,et al., arerepresentativeof levelsin therestof theU.S.. theredoesappearto be a plausiblebasisfor thehypothesisthatbackgroundlevelsof HDD5/HDFsexist in thegeneralpopulation.Thesourcesof thesebackgroundlevelsarelikely to bedispersed,andcouldincludepointsources(suchassuggestedbyCzuczwa’sGreatLakesBasin dataabove) that leadto generalcontaminationof the food chain,up toandincluding mother’smilk, forexample.

If onehypothesizedthat generalpopulationexposureshavebeenincreasingin the last30 to 40 years,althoughit is not possibleto identifylevel or magnitudeof increase,onemight expectto seeincreasesin cancermortality. In reahty,however,the

incidenceof most formsof cancerisgenerdilysteadyor declining,with thenotableexceptionof lung cancer(directly attributableto cigarettesmoking).whichis on theincrease,particularly amongwomen.Without adefinitivelink betweengeneralbackgroundlevelsof HDDs/HDFsin theenvironmentaswell asin thegeneralpopulation,andthe currentincreaseordecreaseof specifictypesof cancer,theincrease(or decrease)in excesscancermortality attributableto exposuretoHDDs/HDFsin the environmentor theindividual cannotbeaccuratelypredicted.as suggestedaboveby CMA.

Examinationof total neoplasticmortality is insensitivefor this typeofecologicanalysisdueto a highbackgroundincidence,but examinationof site-specificmortality canyieidinformation.It is not unreasonabletolook at connectivetissueandsoft tissuecancermortality sincealimited amountof evIdencesuggeststhis maybeatargetsite.Fromthis ecologicexamination,an increasein connectivetissueandsoft tissuecancermortalityratesis seenfor all races(whiteandnonwhite)andsexes(male andfemale).

The epidemiologicevidencefrom bothSwedenandNewZealandregardingHDD exposurefrom contaminatedherbicidesandthe incidenceof cancerin humanshavebeensubjectedtoconsiderablescrutinydueto poorlycharacterizedexposureestimatesandotherconfoundingfactors.butemphasizesthat the epidemiologicalinferencesupportingtherelationshipbetweenhumanexposuresto phenoxyherbicidescontaminatedwith TUDOandthe occurrenceof soft tissuesarcomaremainsstrong.EPA believestheassociationreportedin the twoSwedishsoft tissuesarcomastudiesarestrongenoughto makeit unlikely thattheyhave resultedentirely fromrandomvariations,bias,or confoundingfactors.A similarview hasbeenexpressedbyDr. AaronBlair, of theNationalCancerInstitute (NC1), who after evaluatingexistinghumandata regardingdioxinandcancersummarizedthat,

Theepidemiologicevidenceregardingdioxin exposureand canceris contradictory.In fact the contradictionis striking. On onehandwe havetheScandinavianstudieswherestriking excessesoflymphoma (5-fold)andsoft tissuesarcomas(3.-5 fold) occurandon theotherhandstudiesfrom NewZealandfind norisk oronly slight risk of thesetumors.As it standsnow theepidemiologicdata arenot persuasiveregardingoneinterpretationover theother.The highrelativerisk seenin theSwedishstudies,however,cannotbe dismissed(Ref. 40).

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 21421

Regardingtheanalysisof HDDs/HDFs in adiposetissue from personsfrom theSt. Louis, Mo. area,theanalysisof 35 samples,of which8 showed -

detectableHDD/HDFlevels, is too smallasamplesizeto berepresentativeof theU.S. populationas a whole. Furthermore,thesampleswerenot takenfrom astatistically-designedstudy.Theepidemiologicstudiesarelimited in theirability to be comparedwith the animal-basedpredictionof humancancerrisk.

Theissueof determiningexposuresinepidemiologicstudiesis aperennialone,confoundedevenmoreby thepotentialfor backgroundexposureandtheexistenceof backgroundlevelsin thegeneralpopulation,asdiscussedabove.Although scientificconjectureandsubsequentrelative studies in the U.S.andelsewherehavenot yetresolvedthesediscrepancies,EPA maintains thatthis suggestivelink is indicative of theunresolvedconcernrelating2,3,7,8-TCDD exposureto cancerin humans.Until theseconcernsareresolved,EPAwill continueto interpretthesestudies -

assuggestiveevidenceof thepotentialcarcinogeniceffectof 2,3,7,8-TCDD.

Comment12: EPA has overlookedthefact thatanimal speciesvarygreatly intheir toxic responseto HDDs/HDFs.(CMA at p. 14.)

Responseto Comment12; EPA isawarethat thereis awide speciesdifferencein toxicity for HDDs/HDFs.For 2,3,7,8-TCDD,sciencehasbeenunableto determinewhy suchvariationexists,or wherehumansfit into thespectrumof othermammals.This issuewasdiscussedin anEPA SAB hearingNovember4, 1906, wheretheSAB notedthat thespeciesdifferencein toxicresponsesto different HDDs/HDFsislikely to bedueto genetic, metabolism,andabsorptionfactors.TheSABacknowledgedthe lackof datain theseareasandencouragedEPAto sponsorresearchon metabolismandoncarcinogerxicityof untestedcongeners.

in theabsenceof data,EPA cannotsaythat thehumanis moreor lesssensitivethananyotherspecies.EPA’sCarcinogenicityRisk AssessmentGuidelinesindicatethat for regulatorypurposesEPA will choosethemostsensitivespecies.For HDDs/HDFs,moreover,thecausefor concernis thatthoseHDDs/HDFswhichhavebeentestedshowtoxic responsesat verylowlevels.SeeUnit IV.A.1.a. of theproposedrule,

Comment1.3; EPAassumeswithoutverification that all HDDs/l-IDFsarecarcinogenic,althoughmosthaveneverbeentestedfor carcinogenicity.(CMA atp. 14).

Responseto £‘oznment13: Thiscommentmisinterpretsthenatureof

EPA’s decisionin this rulemaking.EPAacknowledgesthat few of theHDDs/HDFshaveactuallybeentestedforcarcinogenicity.Only 2,3,7,8-TCDDanda mixtureof 2,3,7,8-substitutedHx CDDshavebeentested,but theyarethe mostpotentanimal carcinogensevaluatedbyEPA to date.Thebasisof thetoxicological finding in this rule is thestructuralactivity relationshipsamongtheHDDs/HDFs.Experimentaldata -

haveaccumulatedwhichclearlyindicatea link betweenintracellularbiochemicalmechanismandwholeanimal toxicities from exposuretoHDDs/HDFs.Theoccurrenceof thesebiochemicalphenomenaappearto becloselyrelatedto the structureof theHDB5/HDFs; themore similar thestructureto 2,3,7,8-TCDDthe moretoxicis the compound.(Refs.3, 21, and22).Limited in vivoand in vitro data supportthe structure/activityargumentthat2,3,7,8-substitutedHDDs/HDFssharequalitativetoxicity propertieswith2,3,7,8-TCDD(see50 FR 51798).Thissimilarity of responseis notedin awiderangeof toxic endpointsincludinglimited carcinogenicityandteratogenicityresults.Thereforeit isprudentto considerthatsimilar HDDs/HDFshavesimilar toxic potentials,including carcinogenicity(Ref. 4).

Comment14: EPA incorrectlyrefersto“suggestive”epidemiologicalevidencelinking 2,3,7,8-TCDDto the occurrenceofcancer.All studiesother thanthoseof asingle investigatorhavenot found anysuchlink andthis studyhasbeensubjectedto significantcriticism. (CMAat p. 14).

Responseto Comment14: EPA doesnot meanto statethat epidemiologicalstudiesarepersuasiveregardinganyinterpretation.The epidemiologicalevidenceis contradictory.SeeResponseto Comment11 above.However, thehigh relativerisk of certainSwedishstudiesof herbicideworkerscannotbetotally dismissed.Furthermore,a recentstudyof farmersin Kansasprovidesadditional evidencethatepidemiologicalevidenceis suggestiveof apositive linkbetweenexcesscancersandexposuretoaHDD-containingherbicide(Ref. 18).

Gomment15: In setting LOQsEPAshould usetheToxic EquivalencyFactors(TEFs)developedby theAgency. (Dow at p. 6; March4, 1986,HearingTranscriptatpp. 12 and13, 20and21; CMA at pp. 39 and40).

Responseto G’omment15: EPArequestedcommenton theuseof itsTEFsin thepreambleto the proposedrule, 50 FR 51800,column2. Sincethattime theconcepthasbeenreviewedfavorablyby the Agency’sRiskAssessmentForum, the RiskAssessmentCouncil, andthe SAB (Ref.

35). Moreover,the responseboth fromcommentsandfrom the public meetingswasfavorabletowardusingTEFsto setLOQe, althoughthevariouspartiesrecommendeddifferentapproachestotheir use. CMA advocatedusing theTEFs alongwith actualexposurestoeachcongenerto developLOQs.Incontrast,theEnvironmentalDefenseFund(EDF)recommendedapplying theTEFs so that the sumof all HDD/HDFcongenersfoundin anychemicalwouldnot exceed0.1 ppb.This would involveananalysisto determinewhich -

congenerswerepresent,andanapplicationof theTEFs to determinethelevel of quantitationfor each.(March4,1986, HearingTranscriptat pp. 33 and34). This would necessitatelevelsin thepartspertrillion range,whichEPAbelievesis not generallyachievableinchemicalmatrices,basedon experiencein EPA laboratories.

SinceEPA haselectedto treatthechemicalsasa classfor purposesof thisrule, EPAhasrejectedsettingLOQ5 on achemical-by-chemicalbasis,asnotedabovein responseto comment4. Withrespectto EDF’s scheme,EPA believesthat theseLOQswouldbe too low to bereasonablyandaccuratelymeasured. -

EPA hasdecidedto use0.1-ppbasatargetlevel for 2,3,7,8-TCDD,becausetheAgency’s genericassessmentof riskshowsapotentialworst-caserisk fromdermal-exposureto workersfrom thatcorigenerpresentat that level,andhassettargetLOQ5 for all othercongenersat somelevel above0.1 ppbbecausethosecongenersare, accordingto theTEF scheme,likely to be lesstoxic than2,3,7,8-TCDD.

With regardto thebrominatedspecies,EPA hadadifferent problemsincetheTEPshavebeensetonly forchlorinatedHDDs/HDFs.Thus, EPA hadthechoice of settingtheLOQsfor thebrominatedHDDs/HDFsat the samelevel astheir chlorinatedcounterparts,basedon theassumptionthat thebrominatedcounterpartis equally toxic,or of leaving theLOQ for brominatedHDDs/HDFsat theproposedlevel of 0.1ppb. Very little datahavebeencollectedon brominatedHDDs/HDFs,but thatwhichhavebeencollectedsuggestthatbrominatedHDDs/HDFsaregenerallyastoxic as their chlorinatedanalogues(Ref. 25).

For purposesof this rule, EPA hasassumedequaltoxicity. andhasadjustedtheLOQ5 for brominatedHDDs/HDFsto matchthoseof theirchlorinatedanalogues.

The newLOQsareas follows: 0.1 ppbfor T4HDDs; 0.2 ppbfor P5HDDs,2.5 ppbfor i--Ix8HDDs; 100ppb for Hp1HDDs;1.0

21422 Federal Register / Vol. 52, No. 108 / Friday, june 5, 1987 / Rules and Regulations

ppb for ‘l’~HDFs;1.0 ppb for P5HDFs;10ppb for Hx51IDFs; 100ppbfor Hp7HDFs.

Comment16.’ EPA shouldeliminatetheheptahalogenatedcongenersfromthe testingrequirementbecausetoxicityfor thesecongenersis ordersofmagnitudeless thanthat of 2,3,7,8-TODD. (CMA at p. 42).

Responseto Comment16: EPA agreesthat its TEF schemeindicatesthat theheptahalogenatedcongenersareconsiderablylesstoxic than2,3.7,8-TCDD, but doesnot agreethat theyshouldbe droppedfrom the testingrequirement.In chemicalswhichhavebeentested,suchaspentachlorophenol,theheptachlorinateddioxins arepresentin suchlargequantitiesthat they couldpreducea toxic effect, eventhough theirindividual toxicity is manytimeslowerthanthat of 2,3,7,8-TCDD(Refs.4 and8).In addition,thehigherhalogenatedcongenershavea tendencytodehalogenatein thepresenceof light tolowerhalogenated,andmoretoxic,congeners.(April 22, 1986,HearingTranscriptat pp. 46 and47; commentssubmittedby CambridgeIsotopeLaboratories(GiL)). Thereis alsosomeevidencethathigherhalogenatedHDDs/HDFsmay havelongerhalf livesin thehumanbody, therebyenhancingtheir toxic potential (Ref. 26). For thesereasonsEPA hasnot removedtheheptohaiogenatedcongenersfrom thetestingrequirement,but hasadjustedtheLOQsbasedon theTEFs.

Comment17.’ EPA shouldnot haveexcludediodinatedandfluorinatedSum ~CS from this rule. Studiessuggestthat fluorinateddioxins areniorebiologically active thanchlorinatedorbrominatedonesandthereis thepo’mihiiity that fluorinatedcompoundscouldreplacechlorinatedorbroininatedcompounds.(March4, 1966, HearingTranscriptat p. 9; EDF at p. 5, p. 2 incommentsto proposedamendmentaddingadd~tionaiprecursors).

Responseto Comment17: EPA hasdecidednot to focus on thefluorinatedandiodinatedcompoundsin this rule.Straightsubstitutionof fluorine or iodinefor chlorineor bromineproducescompoundswith considerablydifferentphysicochemicalandbiologicalproperties,thusindicating thatfluorineandiodinatedcompoundswould not begood substitutesfor chlorinatedorbromirxatedcompoundsascommercialproducts.However, it is possiblethatfluorinatedandiodinatedcompounds(which maytheoreticallybe predisposedto IIUD/HUF contamination)may beusedto formulatecommercialchemicalproductson anincreasinglylargerscalein the future.At thepresenttinse,however,theuseof thesecompoundsinthemanufactureof commercialchemical

productsis small in comparisonto thenumberof productsusingchlorinatedorbrominatedchemicals,

Developmentof theanalyticalmethodology,includingappropriatestandards,necessaryto ensureaccuraleanalysiswith appropriateQA/QCproceduresfor theiodinatedandfluorinatedcompoundsdoesnot appearto be costeffective at this time. Thereinno indication thatany commerciallaboratoryis attemptingto makesuchstandards,andthecostof developingstandardswasoneof the majorcostsofthis final rule.

EPA may receiveinformation,eitherasa resultof thereportingrequirementsin this rule, or from informationreportedto the Agencyin responsetorequirementspromulgatedunderTSCAor otherstatutes,on theproduction,use,or disposalof theseiodinatedorfluorinatedcompounds.In theeventthisinformationindicatesthat thesechemicalsarebeingusedon anincreasinglyfrequentbasisto replacechlorine andbrominein themanufactureof chemicalsto whichpersonsmay beexposed,EPA will investigate,asit hasfor thechlorinatedandbrominatedchemicalcompoundsin this final rule,thepotential for contaminationwithHDD.s/ilDFs,thelikelihood ofsubsequenthumanexposureandthepotentialfor unreasonablerisk.

(ii) Exposure.EPAsproposedruleestimatedexposureto theHDDs/HDFssubjectto this ruleby analyzingtherisks that couldtheoreticallyoccurif thechemicalssub}ect to testing werecontaminatedwith 2.3,7,8-TODD,andbyimplication theotherHDDs/HDFs, inthe 0.1 ppbto 1.0 ppm ranges.TheAgencyappliedtheserangestorepresentativeexposurescenariosconsistingof dermalexposureto ahouseholdcleanerandto chemicalsintheworkplace.Theoreticalrisksresultingfrom the0.1 ppb and1.0 ppmcontaminationlevelsin therepresentativeexposurescenarioswexecalculatedusingLifetime AverageDailyDose(LADD) valuesin themultistagelinear low-dosemodeldiscussedabove.(See50 FR 5?793-.-51799).The risksrangedfrom a theoretical1 in 1occurrencefor occupationaldermalexposureatacontaminantlevel of Ippm to anindividual risk level ofapproximately4 in 10 million forconsumerexposureto householdcleanerscontaminatedat 0.1 ppb.

EPA acknowledgesthatmuchof theexposureanalysisin theproposalindicatedahigherrisk thanmay beexpected;however,afteranalysingthecommentsen its exposuremodeling,theAgencyhasconcludedthat, for purposesof this rule, the0.1 ppb LOQ is an

appropriatetargetlevel for testing2,3,7,8-TODD.This is basedonmodificationsto theexistingoccupationalexposurescenario,whichindicatestherecouldbe potentialrisk tochemicalworkersfrom 2,3,7,8-TCDDexposureat 0.1 ppb.The sametargetLOQ has been set for 2.3,7,8-TBDD.Annotedabove,the targetLOQs for theotherHDDs/HDFshavebeenadjustedupwardusing theTEFs.Analysisfor anyHDDs/HDFsin chemicalmatricesdownto 0.1 ppbwill be verydifficult, butespeciallydifficult for higherhalogenatedHDDs/HDFs.However, thetoxicity of the HDDs/HDFsin this casemaybeexpectedto decreasewith thedegreeof halogenation,so that useoftheTEEsadjuststheLOQsupwardforthehigherhalogenatedcongeners.EPAhasalsosettheLOQsasatarget,sincethelevelssetmaynot be achievableinsomechemicalmatrices.A review of thecostof analysison aper-samplebasisatthesetargetlevelsindicatedthat thedifferencesin costsassociatedwithanalysisat higherl~veisarenotappreciablysignificantif thetargetLOQis specifledat theoutsetin analyticalmethoddevelopment.If the targetLOQwereestablishedata higherlevel beforeallocationof resourcesfur methoddevelopment,thenloweredto a moreconservativetargetlevel, anincreaseincostper analysiswould beexpectedbecauseof reanalysisat thelower level,Theexposurescenariosshowthat therisks posedby exposureto workersatthe 1 ppm rangemay be substantial,Therefore,EPAhasdecidedthatthemodifiedoccupationaldermalexponurescenarioprovidesanadequatebasisforchoosing0.1 ppb astheappropriatetargettesting level for the tetraHDD/HDF congeners.whicharethoseofgreatestconcernto theAgency.Choosingthe 0.1 ppblevel asthelowesttestinglevel will allowEPA to evaluateanyof thepotentialrisks resultingfromlow levelsof all the HDDs/HDFsoncethe testingdataa~’esubmittedandwillallow theAgencyto catchin itsanalyticalnetanyusethatcouldpotentiallycauseunreasonablerisk,includingpossiblenewuses.

In additiun, it is betterto COCi~ZCthesecompoundsat low levelswhenthey arefirst created,ratherthanwaituntil theyhaveenteredenvironmentalpathways,suchasfood chainsandwatersupplies,andmayhavecausedwidespreadcontamination.In addition,becausethesecompoundsaredifficultto monitorat tracelevelsin theenvironmentusingstandardtechniques,theyarebestanalysedwhen theyarefirst createdin the manufacturing

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 21423

processfor laterpredictionofenvironmentalcontamination,

EPA’s responsesto commentson itsexposureanalysisarediscussedbelow.

Comment18: EPA’s consumerexposurescenariobasedon ahouseholdcleaneris not representativeof theusesof thechemicalssubjectto this rule,sincenoneof thosechemicalsareusedin suchproductsandmanyareusedalmost exclusivelyin applicationsinwhichthey areboundinto polymericmatricesandthus areunavailableforhumanexposure.In fact, thehouseholdcleanerscenariois basedon useofphenoliccompoundsin pesticides,whicharenot subjectto TSCAjurisdiction.(CMA at pp. 18 and19.)

Responseto Comment18: EPAconcludesthat thehouseholdcleanerscenariois relevantto this rulemaking.While the specificscenariousedby EPAon householdcleanersis basedon apesticideusenot subjectto regulationunderTSCA, EPA hasno indication thatthechemicalssubjectto this rulemaynot be in productsintendedfor similarusesthatmaybe subjectto TSCA. Forexample,no commentsindicatedthatparticularchemicalsarenot or couldnotbe usedfor somekind of sprayedapplicationor mightnot havesomepotentialhigh exposurepattern.Indeed,thereis someevidencethat the useofcertainchemicalsmaypossiblyresultinhigh exposurepatterns,mostnotablycompoundsusedasadditiveor blendedfire retardants,or asdyecarriersfortextile dyes.An additivefire retardantistopically appliedto thedesiredmaterials(e.g., fabric, wood,synthetics),ratherthanincorporatedinto theproductmatrixby physicalbondingorchemicalreactivity (Ref. 13).

SinceEPA hassomeindicationthatchemicalsrelatedto chemicalssubjectto this rule maybeusedin highexposuresituations,manufacturersofthechemicalssubjectto this rulehavean affirmativeduty to inform theAgencythat thechemicals,in fact, arenot usedin high exposuresituations,andcouldnot beusedin high exposuresituations.After all, manufacturersshouldhavesuchinformationin theirpossessionandin manycasesmayrepresentthe only wayin whichEPAmayobtainit. Instead,CMA, therepresentativeof the industry,onlystatesthatnoneof thechemicalsto betestedis “currently” usedin householdcleanerapplicationsandthat “many” ofthechemicalsareused“almostexclusively”in boundmatrices.(CMA at19). EPA assumesthis statementdoesnot refutethe Agency’sdeterminationthat the chemicalscouldpossiblybeusedin high exposuresituationsor thatsomearecurrentlybeingusedother

than in boundmatrices.Indeed,while aparticularmanufacturermay feelconfidentthat its currentusesareintotally boundmatrices,thesamemanufacturermaydevelopanewhighexposureusein thefutureor anothermanufacturermaybe currentlyproducingthesamechemicalfor ahighexposureuse.

Thehouseholdcleaneranalysis,therefore,whichshowsindividual risksat 4 in 10 million for the 0.1 ppb levelandindividual risks of 4 in 1 thousandatthe 1.0 ppm level, merelyindicatesthatEPA, for testingpurposes.shouldbeconcernedwith someintermediatelevel,if no otherrisk scenariowere to apply.Of courseas notedaboveandmorefullydiscussedbelow, thedermaloccupationalscenariogivesEPA reasonto believethat the 0.1 ppb level maybeof concernfor someHDDs/HDFs.

Comment19: Evenif EPA’scalculationsregardingrisk of thehouseholdcleanerscenarioarerelevantto this rule, the Agency’scalculationsareunrealistic.A realistic scenariodemonstratesthat this usewould notposeanunreasonablerisk evenif2,3,7,8-TCDDwerepresentat 1 ppm. If adisinfectantwith active ingredientspresentat0.1 percentlevelswerecontaminatedwith 1 ppm HDDs/HDFs,onceweeklyusage,evenassuming100percentabsorption,over55 yearswouldyield aLADD of 4.8x101°mg/kg/day(4.8x107~g/kg/day).This is twoordersof magnitudelessthanEPA’sLADD of 2.7x105

1.mg/kg/day.(CMA atpp. 18 and19).

Responseto Comment19.’ EPA rejectsthis comment.TheAgency’scalculationsat the1 ppm contaminationlevel arereasonable.The differencebetweenthetwo calculationsresultsfrom CMA’sassumingactive ingredientspresentat0.1 percentandEPA’s assumptionof a4.5 percentactiveingredientconcentration.EPA’s assumptioncomesfrom acommonhouseholdcleanerlabel.CMA givesno reasonfor assuminga0.1percentlevel,or why that level is moreappropriatethanEPA’S level. Theremainderof the differenceis accountedfor by EPA’s assuminga70-yearlifetimeexposureandCMA’s assuming55 yearsCMA givesno reasonwhy EPA’sassumptionis incorrect,or why EPAshould deviatefrom its usualassumption.In anyevent,thedifferencebetweenthesetwo assumptionsisnegligible for analyticalpurposes.

EPA’s individual risk analysisat1ppm concentrationin householdcleanersof 4 in 1,000, therefore,is areasonablecalculationandgivesEPAcausefor concern.

Comment20.’ A more relevantworst-caseconsumerexposurescenariowould

be the leachingof chemicalsfrom plastichandlescontainingflame retardants.This showsa negligible consumerexposure.This exposurescenario,evenwith chemicalscontaminatedwithHDDs/HDFsat 1 ppm. showsa worst-caseLADD at1.3X10’9mg/kg/day(1.3x106~.mg/kg/day).(CMA p. 20).

Responseto Comment20: EPAdisagreesthat the plastic handlescenariois theworst-caseconsumerexposurescenariothatshouldbe usedfor this rule. As notedabove,EPAbelievesthat theappropriateanalysistouseis thehouseholdcleanerscenario.Furthermore,theLADD calculatedbyCMA would still presentarisk ofconcernfor testingpurposesunderEPA’s linear low-doserisk assessmentmodel,becauseCMA’s calculatedworst-caseLADD of 1.3xltY9mg/kg/day (1.3x106~.mg/kg/day)would stillyield oncogenicrisk estimateshigherthanixi0~. This level canbeusedasatriggerfor testingpurposes,givenEPA’sotherconcernswith respectto thechemicalssubjectto this rule.

Comment21: EPA’s workerexposurescenariosareunrealistic.TheAgencyassumesthatboth handsareimmersedin the chemicaldaily, despitethe factthat in somecases,suchas 2,4-dichlorophenol,asinglesuchincidentwould causeseverethermal andchemicalburns.Similar burnswould beexpectedfor most of thechemicalsto betestedastheyarehigh-meltingsolids. Infact,usingmedicalrecordsfrom certainchemicalcompaniesshowingaverageworkerdermalexposureof less than 2cm2 skin surfaceperyear,andassumingthematerialcontains1 ppm 2,3,7,8-TCDD, the LADD would beonly8.7X10’1mg/kg/day(8.7x108~.rg/kg/day).This contrastswith EPA’s LADDof 0.1 ppbof 2.11X106 ~.mg/kg/day(or2.11Xl05~.mg/kg/dayat 1 ppm.) (CMAat pp. 20and21).

Responseto Comment21.’ EPA’sexposurescenariois not a statementbytheAgencythatworkerswould, in fact,immersetheirhandsin vats of chemicalliquids; rather,thescenariois aquantitativesurrogatefor the typesofexposuresthatmay occurin achemicalplant,usuallyasaresultof accidentalspills, resultantcleanupefforts involvingthe lackof protectiveclothing(e.g.,gloves,goggles,etc.),andinstancesofworkernegligencein handlingsmallamountsof potentiallyhazardouschemicalsubstances.Thus, EPA’s intentwasnot to suggestthatworkerexposureresultsfromtotal immersionof thehandsin chemicalliquids,but rathertoprovidea worst-caseestimatebasedonthe total unprotectedareaof thehandswhichcouldbe exposedresultingfrom

21424 FederalRegister / Vol. 52, No. 108 / Friday, june 5, 1987 / Rules and Regulations

thesetypesof spills, cleanupefforts,orimproperhandlingpractices.

In responseto commentsregardingthereasonablenessof EPA’s estimateofworkerexposure,EPA re-evaluateditsoccupationalexposureestimates.EPAcontactedrepresentativesof OSHA,NIOSH, the AmericanIndustrialHygienistsandthe AmericanCouncilofGovernmentindustrial Hygieniststosolicit dataon thereasonablenessofEPA’s exposureassumptions(Ref. 42).Although EPA’s contactswereunabletoprovide estimatesfor theentirechemicalsynthesisindustry(becauseofsubstantialdifferencesamongtheprocesses,worker activitiesandindustrialhygienepractices),they didagreethat theassumptionthata skinareaequalto both hands,exposedto achemicaleachday, is too high. Basedontheir informationEPAbelievesamorereasonableestimaterangesfrom theareaof 1 handto theareaof one-halfof1 handexposedto thechemicalsubstanceduringeachtime, or event,whenthe worker is exposed,oranestimateof 10 percentof theskin areaequivalentto 2handsexposedeachday.

To estimatethenumberof times aworkeris exposedto a chemicaleachyear,EPA usedasa surrogateanestimateof 77 as theaveragenumberofdrumming,baggingandtransferoperationsper year.Then EPAcalculatedtheLADD assumingthatbothanareaequalto one-halfof 1 handandan areaequalto 1 hand,wasexposedtothe chemicalsubstanceeachtime. TheLADD for onehalf of1 handexposed,ifthe chemicalis contaminatedat 0.1 ppbis 2 >< 10 7~mg/kg/day.The LADD for 1handexposed,lithe chemicaliscontaminatedat0.1 ppb,is 4X10-7bothLADD’s resultin a risk of 10~.litheassumptionis madethatonly 10 percentof theskin areaof aworker’s2 handswill be exposedto the chemicalsubstanceeachwork day,the LADD is2X10~,againresultingin arisk of 10~(Ref42).

Minor differencesin severalotherassumptionsaccountfor theremainingdifferencein theLADDs, but thesedifferencesareinsignificant.Forexample,EPA assumedthe liquid filmthicknesson exposedskin surfacesatl.8X103 cm; thedensity of theliquid at1.38gm/cm3,andthenumberof yearsofexposureat 70years.CMiX assumedliquid film thicknessat1.51<i0~cm, aliquid densityof 1.3 gm/cm2and55yearsfor lifetime exposure.

EPA believesthatCMA’s suggestionof an averagedermalexposureof lessthan2 cm2skin surfaceperyearisunrealisticbasedon normal chemicalmanufacturingpractices,includingaccidentalspills andresultingcleanup

efforts involving lack of protectiveclothing, andevenisolatedinstancesofworkernegligencein handlingsuchchemicalsubstances.Unlesstheeventisseriousor widespreadenoughto causeaslowdownorhalt of theproductionprocess,theeventusuallygoesunreported.The estimateof skin areaexposedduring chemicalmanufactureby thepersonnelcontactedby EPA areordersof magnitudelargerthan CMA’s 2cm2peryear (Ref. 42).

Gommerit22: Hypotheticalworkerinhalation exposuresshowextremelylow LADDs andwould not justify theLOQs in this rule. (CMA at p. 21).

Responseto Comment22: Becauseoftheverylow vaporpressureof 2,3,7,8-TCDD in its pureform (1.7x10~mm/Hg), inhalation toxicity scenarioswereincludedin asupportdocument(Ref. 43)but werenot usedto calculateexposuresfor purposesof this rule.ThesecalculationscanprovideLADDswhichmay beusefulin assessinganoverallestimateof risk whenconsideredwith risk estimatesbasedon otherroutesof exposurebut, takenalone,donot allow a meaningfulevaluationofpotentialrisk. While EPA is unabletostatewhetherrisk from inhalationexposure,alone,is significant,suchriskaddsto theAgency’sconcernwhenconsideredwith risk frompossibledermalexposure.

(iii) Exclusionsandwaivers.EPA willexcludechemicalsfrom testing baseduponsubmissionof prior testdatawhichsatisfy TSCA section4(a)(1)(a)(i)requirements,or submissionofdetailedprocessandreactionconditiondatawhich showthatconditionsknownto beconduciveto HDD/HDF formation arenot present.EPA will waivetestingrequirementsfor anychemicalproducedin quantitiesof 100kg/yearor lessforpurposesof researchanddevelopment,Whenproductionof thatchemicalexceeds100kg/year, thewaiverexpires,andtheproducerthenbecomessubjectto the testingrequirementsin this rule.EPAwill alsowaive testingrequirementsfor thosedevelopmentalchemicalsthat, dueto thecostsoftesting,eitherwill be takenoff themarketorwill not reachthemarket.WhileEPA believesthatapotentiallyhighly toxic chemicalshouldnot bemarketedif it cannotbearthe costsoftesting,the Agencywill considerawaiver to testingin appropriatecircumstances.

If amanufacturerhasadevelopmentalchemicalthat, dueto thecostsof testing,eitherwill betakenoff themarketorwill not reachthemarket,it may applyfor a waiverby submittinginformationto EPA that showssuchadversemarketeffects.EPA will evaluatethat

informationto determinewhetherthemanufacturer’sallegationsof marketeffectswill, in fact,occur. If EPA agreeswith themanufacturer,theAgencywillthenweighthepotentialrisks of thechemicalagainstthecostsof testing todeterminewhethertestingis warrantedunderthis ruleevenat thedevelopmentalstage.EPAwill grant thewaiver,with appropriateconditions,iftherisks do not outweighthecostsoftestingfor that particularchemical.Thesecriteriaaresimilar to thoseEPAemploysin evaluatingwhetherchemicalsubstancesshouldberestrictedundersection5(e)of TSCA.

EPA expectsthis waiver to beapplicableonly to chemicalsmanufacturedin amountsof nomorethan2,000to 5,000total poundsannually.Preliminaryanalysisof datasubmittedfor this rule showsthat thiswaiverwill applyto only onechemicalproducedby Arco SpecialtyProductsDivision, which wasrecentlysold toHorseheadIndustries.

b. Insufficientdata. In thepreambletotheproposedruleEPA statedthat,withtheexceptionofsomedataon 2,3,7,8-TODD andevenlessdataon severalrelatedcongeners,the Agencyhaslittleorno dataon concentrationsof HDDs/HDFsin commercialchemicalsuponwhichto basea determinationofunreasonablerisk (58FR 51800).EPAreceivedcommentsrelativeto this issueon twO chemicals,anddiscussesthosecommentsbelow. Asa resultof thedatasubmitted,theAgencyhasexcluded1gradeof decabromodiphenyloxideproducedby DOW, for whicha2-yearbioassayandan analysisfor HDDs/HDFsin thetestarticlewasdone.ForTetrabromobisphenol-A,theotherchemicalon whichcommentswerereceivedwith respectto insufficientdata,theAgencyseesno reasontochangeits determinationthat existingdatais insufficientandthustesting isnecessaryto obtain that data.

C’omment23: Existing bioassaydatap1uschemicalanalysisfor HDDs/HDFsfor decabromodiphenyloxideprovideall dataneededto showabsenceofunreasonablerisk. Acute,28-dayfeeding,mutagenicityand2-yearfeedingstudiesfoundno significantadversetoxicologiceffectsfordecabromodiphenyloxide. An analysisof thetestarticleusedin thesestudiesfor thepresenceof HDDs/HDFsrevealednonepresentat 1.0 ppb, thelowestlevel achievablein theanalysis.(CMA p. 24, Dow pp. 5-6).

Responseto C’omment23: EPA hasexaminedthedata submittedondecabromodiphenyloxidein whichtoxicologyandcarcinogenesisstudies

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wereperformedby NTP, alongwith achemicalanalysisfor thepresenceofHDDs/HDFs.The toxicologyandcarcinogenesisstudieswereperformedon both ratsandmice,at dosesof 0,25,000and50,000ppmin the diet.Resultsincludedincreasedincidencesofneoplasticnodulesof the liver in lowdosemales,andin high dosegroupsofeachsex,equivocalevidenceofcarcinogenicityfor malemiceasshownby increasedincidencesofhepatocellularadenomasor carcinomas(combined)in the low dosegroupandofthyroidglandfollicular cell adenomasorcarcinomas(combined)in both dosedgroups,andno evidenceofcarcinogenicityfor femalemice.Anaccompanyinganalysisby NTP withappropriateQA/QC andusing GC/MS,showedno HDDs/HDFsin the 2samplesanalyzedat the level of 1 ppb.While EPA doesnot necessarilyconcurwith thefact that the testsshownounreasonablerisk, the Agencydoesagreethat testingunderthis rule wouldnot be warranted,in view of theextensivebioassaydatacombinedwithexistingtestdatawith adequateQA/QC.Therefore,EPA will exemptthegradeof decabromodiphenyloxideproducedby Dow for theresearchNTPproject,providedDow cansupplyevidenceshowingwhichgradewasproducedfor the NTP project.If Dowproducesothergradesby differentprocesses,orproducesby thesameprocessa gradein whichhighertemperaturesor more alkalineconditionsoccur, thatgradewill havetobe testedunderthis rule.

Comment24: The InteragencyTestingCommittee(ITC) hasdeterminedthatTetrabromobisphenol-A(TBBPA) shouldnot be recommendedfor healtheffectstesting,andEPA hasacceptedthatrecommendation.Thus, the compound,containingwhateverHDD/HDFimpuritiesmaybe present,hasalreadybeenfoundto demonstrateabsenceofunreasonablerisk. (CMA pp. 24 and25andDow pp. 5 and6).

Responseto Comment24: EPA did notfind thatTBBPA did not presentanunreasonablerisk to humanhealthinacceptingtheITC’s recommendationtonot requirehealtheffectstesting.Adeterminationthat achemicaldoesnotpresentanunreasonablerisk can onlybemadeafterextensivetesting.Theissueof contaminationby HDDS/HDFswasnot examinedat the time TBBPAwasevaluatedasa candidatefor testingby the ITC, andtheshort-termtestswhich showedlow mammaliantoxicitywould not becapableof identifying thelatenttoxic effectscharacteristicof2,3,7,8-TCDD.However, in September

1986,apaperwaspresentedwhichshowedHDD contaminationof TBBPA(Ref. 30). Therefore,thereis a basisforrequiringtestingof TBBPA in this finalrule, andthis finding is not inconsistentwith EPA’s earlierdecisionnot toincludehealtheffectstestingof TBBPA,

c. Necessityfor testing.EPAhasdeterminedthat testingis necessarytogeneratedataon which to basetoxicityandexposure,becausesuchdataarefundamentalto theassessmentof risk,andbecausetheanalyticaldatageneratedby requiredtestingin thisfinal rule is currentlynot availableinanyaccessibleorusableformforpurposesof assessingthesepotentialrisks.No commentsotherthan thosealreadyaddressedin comments23 and24 abovewerereceivedon thenecessityfor testing.

EPA hasdecided,however,that it isnot necessaryto testunderTSCA twochemicalsoriginally proposedfortesting.Thesechemicalsare2,4-Dichlorophenoxyaceticacid(2,4-D) and2,4-Dichlorophenoxybutyricacid(2,4-DB). Bothareregisteredpesticidesaswell asisolatedintermediatesusedtoproducepesticides.Usedaspesticides,they aresubjectto testingunderFIFRA.Usedaspesticideintermediates,theyaresubjectto testingunderTSCA. Atthetime this rule wasproposed,planshadnot beencompletedto requiretestingof thesepesticidesunderFIFRA,so theywere listedin theproposedrule.EPA plansto requireunderFIFRAequivalenttestingof pesticidesforcontaminationby HDDs/HDF5.EPAbelievesthat testing thesetwochemicalsunderTSCA would beduplicativeandunnecessary,particularlysinceEPA doesnot expectthem to beusedfor non-pesticidepurposes.Accordingly, theywill not besubjectto thetesting provisionsof thisfinal rule underTSCA, but insteadaresubjectto theFIFRA DataCall-Inprogram.Theywill be subjectto thesametestingprovisionsaschemicalslistedfor testing in this final rule,including targetLOQs, thesamemethods,QA/QCprocedures,andunderthesamedeadlinesas the chemicalslistedfor testing in this final rule.

EPA hasalsoexaminedanotherchemicalthathasboth pesticideuses,aswell asnon-pesticideusessubjecttoTSCA jurisdiction, andhasdecided,similarly, that testingis not necessaryunderthis rule becausethatchemicalisbeingtestedunderDataCall-Inprovisionsof FIFRA. This chemical,pentachlorophenol,wasnot originallyproposedfor testing,but EPAsubsequentlylearnedthat it hasnon-pesticideuses.Nevertheless,EPA has

decidedthattesting underTSCA is notnecessaryfor pentachiorophenolbecausesuchtestingwould beduplicativeof the testingunderFIFRA.However,becausepentachlorophenolhasusesotherthan as apesticide,datacollectedthroughthe OPPData Call-Inwill beavailablefor OTS reviewandevaluation.

B. RequirementsUnderSection4(b)

Section4(b)of TSCA, discussedindetailin thepreambleto theproposedrule (50 FR 51797,cols. 1 and2), requiresEPA to dealwith a numberof issuesbeforepromulgatinga test rule. Section4(b)(1) setsforth threeadditional issuesto beincludedin atestrule. First, EPAmust identify thechemical substancesfor whichtestingis requiredundertherule. Second,EPA is to include“standardsfor thedevelopmentof testdata.”Third, section4(b) requiresEPAto specify theperiodwithin whichpersonsrequiredto conducttestsshallsubmitdatato EPA. In determiningthestandardsfor developmentof testdataandtheperiodfor submissionof data,EPA’s considerationsshall include therelativecostsof thevarioustestprotocolsandmethodologiesthatmaybe requiredandthereasonablyforeseeableavailability of facilities andpersonnelneededto performthe testingrequired.Section4(b)(3)(B) setsforth thecriteria for determiningwho shouldtest.

Thepreambleto theproposedrulediscussesthesection4(b) considerations(50FR 51800).Below,EPA discussesthecommentsreceivedon theseissuesandthechangestheAgencyhasmadeto itsfinal regulation.

1. Identificationof substancesto betested.EPA chosethechemicalsfortestingbasedon two broadcriteria.Somechemicalshaveactually beentestedin thepastandfoundto contain2,3,7,8-substitutedHDDs/HDFs.TheothersarechemicalswhichEPA hasgood reasonto believearecontaminatedbasedon structuralsimilaritieswith thechemicalsactuallytested,andtheuseofmanufacturingprocessconditionsbelievedto aidtheformation of dioxinsanddibenzofurans.Thus,theselistedchemicalscontaincarbonandutilizechlorinatedand/orbrominatedcompoundsin theirmanufactureandaremanufacturedundercircumstancesthatincludehigh temperatureorpressureandthepresenceof alkaline conditions,

Contaminationof thelistedchemicalsis expectedto occurduring manufacture.Thus,the focusof the testing is ondetectingcontaminationat thebeginningof the manufacturingchain to allow EPAto drawconclusionsaboutthe degreeofcontaminationduring furtherprocessing

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of the chemical.Commentson chemicalidentificationarediscussedbelow.

Comment25:Theprocessandreactionconditionsunderwhichbrominatedphenolicsareproducedmakeit unlikely that dioxins or furansofconcernwill beformed, Thesechemicalsshould be removedfrom the list ofchemicalsto be tested.(GreatLakesp.17; p. 4 in commentsto proposedamendmentaddingadditionalprecursors;Ameribromp. 2.)

Responseto G’omment25:Confidential datadetailingthemanufacturingprocessandreactionconditionsweresubmittedby thesecommenters.Thesecommentersprovideddetaileddatato substantiatetheir claimthat theprocessesunderwhich certainchemicalsareproducedaredifferentfrom thoseassumedbyEPA, andthatreactionconditionsaresuchthat HDDs/HDF5would not heexpectedto form. EPA hasaskedseveralclarifying questionsabouttheprocessandreactioncondition datasubmitted.Theresponseto thesequestionswill form thebasisfor adecisionby EPA to excludeor waive acompanyfrom testingcertainspecificchemicalsbasedon aprocessdifferentfrom thatexpectedby EPA andreactionconditionsnot expectedto form HDD5/HDFs.

Evenif theexclusionsor waiversaregranted,EPA will not removethechemicalsfrom the list, however,sinceanothermanufacturermayusetheprocessspecifiedby EPA to producethesechemicals,thusmakingproductionof HDDs/HDFslikely.

Comment26: EPA’s list of chemicalsto be testedis too narrow,andmustbebroadenedto include all chemicalslikely to becontaminatedwith HDDs/HDFs, aswere includedon thelist of 238chemicalsfrom whichEPA chosethoseto be testedunderthis rule. (EDFat p. 5;p. 2 of commentsto proposedamendmentaddingadditionalprecursors.)

Responseto Comment26: EPAdisagrees.Thelist of 238chemicalswhichwaswidely circulatedin July1985, to getearly commentfrom allsegmentsof the communitymostinvolved with HDD/HDF analysis,wascompiledfrom everyavailablereferencein whichchemicalstheorizedto containHDDs/HDFswere listed.Its purposewasasastarting point for additionalanalysis.Its circulationwasto getinputon chemicalsor classesof chemicalswhichshould or shouldn’tbeincluded,andthereasonstherefor.Thebreakdownof this list is detailedinReference43 to this rule. EPA firstlooked for chemicalswhich in thepasthavebeentestedandfoundto contain

HDDs/HDFs.Chemicalsstructurallysimilar to thesechemicals,with atheoreticalchemicalpathwayto HDD/HDF formation,andmanufacturedunderconditionslikely to produceHDDs/HDFshavebeenlistedfor testing.Fortheotherchemicals,thereis not a strongtheoreticalbasisat presentto concludethat thechemicalsarecontaminatedwith significantlevelsof HDDs/HDFs,dueto lackof anydocumentedpathwayfor L-IDD/HDF formationandlackoffavorableprocessconditions.In severalcaseschemicalswerenot listedbecausecontaminationwould occurfrom acontaminatedfeedstockchemical,whichwasalreadylisted.Therationaleis thatachemicaltestingcontaminatedwillundergofurtherinvestigation,includinginvestigationof contaminationof allchemicalsproducedfrom the knowncontaminatedchemical.Thus testingatthis time is not indicatedfor thedownstreamchemicals.Finally, thosechemicalswith usesonly aspesticideswereseparatedinto a separatelist.

Theresultof this selectionprocessisthelist of 32 chemicals.12 manufacturedand20 not currentlymanufactured,which arerequiredto be testedunderthis rule.

~‘omment27.’EPA hasomitted thehalogenatedanilinesandbenzeriesandmostdiethyl ethersfrom considerationfor testing,althoughthe publication“Dioxins” (Ref. 15) andthe supportdocument(Ref. 43) citethesechemicalsashighly likely to becontaminated.Further,it is well knownthatheatinghalogenatedbenzeneswill yield PHDDs.(WEp. 4.)

Responseto Comment27:EPAdisagreesthathalogenatedanilinesanddiethylethersshouldbe addedasaclassof compounds,Although thehalogenatedanilineswerecitedashighly likely to becontaminated(Ref.43), theformationof HDDs/HDFsduringtheirmanufactureis dependentonspecificreactioncriteria of heat,pressure,alkalinity anddurationofreactionemployedin manufacturingthechemical.In mostcasessuchconditionsarenot believedto bepresentin theirmanufacture.However,severalhalogenatedanilinesarelistedasprecursorchemicals,sincetheyarebelievedto beconduciveto theformation of HDDs/HDFs,andtheapplicationof heatduringthe synthesisof otherchemicalscouldproduceHDDs/HDFsin thoseotherchemicals.Conversely,pentachlorobenzene,whichmaybepredisposedto HDD/HDFcontaminationduringsynthesis,wouldrequiredechlorinationin anaerobicenvironmentat high temperaturestoproducechlorinateddioxinsor lumens.This combinationof reactionconditions

is unlikely undercurrentmanufacturingprocesses.

Diethyl ethersarenot discussedineitherReference43 or in thepublication“Dioxins” (Ref. 15).

As aresultof EDF’s commentsandadditionalinformationreceivedafterpublicationof theproposedrule, EPAissuedanamendmentto theproposednile (51 FR 37612;October23, 1986),proposingto add18 chlorinatedandbrominatedbeazenesto theoriginal listof 12 precursorchemicals.This ruleadds17 of thosechemicalsto thecategoryof precursorchemicalsandrequiresreportingundersection8(a)ofTSCAon chemicalsmadefrom thoseprecursors.If processandreactioncondition datasubmittedshowthatHDDs/HDFsarelikely to be formed,additionalchemicalsmay belistedfortesting;

G’omment28: EPA shouldrequiretestingof precursorchemicals.(EDF p.5.)

Responseto Comment28.’ EPAdisagrees.Theprecursorchemicalsarelistedseparatelybecausetheydo notmeetEPA’s criteria for testing,namely,the reactionconditionsneededto formHDDs/HDF5arenot present.Allpublishedresearchshowsthat heat,pressureandalkalinity, or somecombinationof theseconditions,areneededfor theformation ofHDDs/HDFs.

Thesechemicalsarelistedasprecursorsbecausetheapplicationofthelistedconditionsduritig furtherchemicalprocessingmay occur,andmayproduceHDDs/HDFsin thefinalchemicalsubstanceproduced.Reportingof processdataandreactionconditionswill help EPA determinewhetheranyofthechemicalsmanufacturedfrom theseprecursorsshouldbeproposedfortesting.

Comment29:EPA doesnot specifywhatgradeofsubstancemust be tested.(Dowp. 19.)

Responseto Gomment29:EPArequiresthat manufacturerstestchemicalswhich arelistedin this finalrulein all gradesnormallymarketedinactivecommerceonly if manufactureoccursby different processes.Ifmanufacturingoccursby thesameprocessundervariableconditions,thetestsubstancemay beasinglegrade:thegradesubjectto themost intenseheatandalkalinity for the longestduration.If thesetwo factorsdo notdiffer for thevariousgrades,the testsubstanceshould bethegradewith thehighestvolume of sales.In the testprotocol,themanufacturermust tell theAgencyhow manygradesof thechemicalareproducedanddescribethe

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reasonsfor choosingthegradeto betested,

2. Standardsfor thedevelopmentoftestdata. This termis definedundersection3(12) of TSCA andrefersto theprescriptionof the informationfor whichtestdataareto be developedandanyanalysisto be performedon suchdata.Italsoincludesthemannerin which thedataareto be developed,thespecificationof any testprotocolormethodology,andanyotherrequirementsneededto provideassuranceof the reliability andadequacyof thedata.Thesestandardsshouldbe differentiatedfrom analyticalstandards,whicharereferencechemicalmaterialsusedto calibrateandquantitatespecificsubstances.

a. Generalanalyticalmethodconsideration.The analyticalproceduresspecifiedin this final rule forthequantitativemeasurementof H]JDs/HDFsin commercialproductsinclude:(1) The quantitativeextractionorpartitioningof theanalytesfrom thecommercialproduct;(2) separationoftheHDDs/HDFsfrom interferencespresentin theextract;and(3)separation,identificationandquantitatio.nof HDD/HDF congeners,usinghigh-resolutiongaschromatography(HRGC) andhigh-resolutionmassspectrometry(HRMS) orlow-resolutionmassspectrometry(LRMS), if it canbeshownto be aseffectiveas HRMS for aparticularmatrix.

The most significantdifferencein theanalysisof HDDs/HDFsin commercialproductsin comparisonwithenvironmentalandbiological sampleswill be theextractionandcleanupprocedures.The physicalandchemicalpropertiesof environmentalandbiological matricesaretypicallydifferentenoughfrom thepropertiesoftheanalytesto allow relativeeaseofseparation.In contrast,thecommercialproducts,in most cases,may bestructurallysimilar to theanalytes,complicatingtheseparationandnecessitatingthecompleteremovalofthematrix to avoidinterferencesin thefinal determination(Ref. 24).Theanalystis thereforeconfrontedwith achoiceof two basicoptionsin achievingfinal analysis:(1) Theanalystcandevelopsamplepreparationproceduresthat effectivelyseparatethe commercialproductmatrix from theHDDs/HDFsthat allow for LRMS analysisat theLOQsdesignatedin this final rule; or (2)theanalystcanelectto preparesamplesin which somepotentialinterferenceremains,but rely on theresolvingcapabilitiesof HRMS to distinguishthedifferencefrom HDDs andHDFsand

potentialinterferenceat the LOQ. Theoption for use of LRMS is viableonly totheextentthat theanalystcandemonstratethat theLOQ specifiedinthis final rulecan be achievedusingthismethod.

b.Detectionmethod.In theproposedrule, EPA choseHRGC/HRMSastheanalyticalmethodof detection(see50FR 51801,unit IV.B.2.b.).

G’omment30.’ EPA hasfailed toconsiderthat the differencesin thenatureof halogenatedcompoundswouldpresentproblemsin loss of sampleduringthedetailedextractionandcleanupproceduresnecessarytopreparesamplesfor analysisby HRGC/MS. Dow statesthat extensiveexperienceexistswith samplesof thechlorinatedspecies,while very littlework hasbeendoneon the brominatedspecies.Dow predictsthatproblemswith chemicalreactivity andheatandlight stability will presentmajorproblemsin preparingthesebrominatedspeciesfor analysis.(Dow p. 14; CMA p.45).

Responseto Gomment30: EPAagreeswith theseobservations,and,basedpartlyon thesecomments,hasextendedthe requiredreportingdeadlineforsubmissionof studyplansfor theanalysisof totally brominatedcompoundsfor an additionalyearafterthe effective dateof this final rule. Thedeadlinefor reportingthe resultsofanalysesof thesecompoundsis within 6monthsafterEPAreview of thesestudyplans.

EPAhasextendedthesedeadlinesbecauseof the lackof experienceinanalyzingbrominatedcompoundsforHDD5/HDFsat theselow levels. Anextensionof ayear will provide time tomodify andperfectfor brominatedcompoundsthe methodsusedto analyzechlorinatedcompounds.Theadditionaltime alsoallows morefreedominschedulingavailablelaboratorycapacityto performtheseanalyses.

Comment31: Dow notedthat theHRMS recommendedfor testing wouldnot scantheatomic massunit rangebutwould usesingleion monitoring.Becauseof the differencein atomicmassbetweenchlorine andbromine,Dowasserts,manyof the instrumentsusedfor molecularions up tooctachlorodioxinsandoctachlorofuransarenot suitablefor anybrominatedmaterialsabovethetribrominatedcompounds(e.g., tetrathru hepta).Thiswill resultin thenecessityof procuringaseparateinstrumentfor detectionof thechlorinatedandbrominatedcongeners.Dow notesthat their instrument,aquadrupolemassspectrometerwithmolecularion capabilityup to 600

atomic massunits, would allow analysisup to andincluding thepentabrominatedcongeners,but would not allow similaranalysisof hexa-or heptabrominatedcongeners.(Dow p. 14).

Responseto Comment31:EPA agreesthat Dow may needaseparateinstrumentto analyzefor higherbrominatedHDDS/HDFs,but notesthatnewerquadrupoleinstrumentscapableof extendingdetectionat thehigheratomicmassunitsrequiredfor thebmominatedHDDs/HDFsareavailable(Ref. 36). EPA recognizesthat theanalysesof thesecompoundscanpossibly bestbeachievedusingmagneticsectorfocusinginstruments.This final ruledoesnot definetheresolutionmode(incrementof mass!massof interest)necessaryto completethe analysis.SinceHRMS magneticsectorinstrumentsmaybe operatedineither high or low resolutionmodes,theanalysthasthe opportunity to defineinstrumentparametersto meettherequirementsfor a specificanalysis.

This doesnot meanthatmanufacturersrequiredto analyzebrominateddioxinsandfuransmustmakelargeadditional investmentsinnewintrumentationsolelyfor thepurposeof completinganalysesfor thesechemicals.EPA expectsthat thesemanufacturerswill makearrangementsto contracttheseanalysesout or leasetime on availableinstrumentsusingtheir own analyticalsupportstaff toperformanalyses,ratherthancommitthe fundsnecessaryto purchasetheseinstruments.

c. Methodsensitivity.As EPAdiscussedin theproposedrule achiefconcernin using anyanalyticalmethodis the ability to achievethedesiredlevelof detection/quantitation.

Comment32: Thereis a definitepossibilityof decreasinganalyticsensitivity astheanalysesfor the morehighly substitutedHDDs/HDFsareattempted.Therearethreereasonsforthis predictedloss in sensitivity: (1) Theadditionalhalogenswill result in lowervolatility andthusgreatertendencyforthecompoundto eitheradsorbor findcold sitesin thecolumn, therebypreventingelution or detection;(2) themassspectrometerwill experiencealoss in sensitivityas thedegreeofhalogenationof acongenerincreases,becausethemassspectrometerdetectsmolecules,ratherthangramsofsubstance.Thus, higherhalogenatedcongeners,havingfewermoleculesthanlower halogenatedcongeners,will bemore difficult to detectandquantify (3)a considerableadditional lossinsensitivity (40to 50 percent)can beexpectedin goingfrom tetrato hepta

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halogenated congenersbecause,in thecaseof thetotra halogenatedcongeners,3 majormolecularions carryappmoxnmately38 percentof theioncurrent,while in theheptahalogenatedcongener.6majormolecularions carry23 percentof theion current.These3factorscanbe expectedto resultin aloss of 50 percentanalyticalsensitivityin going from thetetra to theheptahalogenatedcongeners.(CMA p. 28).

Responseto Comment32.’ EPA did, infact,considerthis situation,andgenerallyagreeswith this commentonthe. loss of analyticalsensitivity.I-iowever, LOQshavebeenadjustedbasedon toxicity of the congenersrelativeto the toxicity of 2,3,7,8-TODD.This adjustmenthasallowed theLOQfor theheptahalogenateddioxins to riseto 100 ppb,3 ordersof magnitudelesssensitivethanthat proposed.TheLOQfor all congenershigherthan tetrahavebeenadjustedso thatall arelesssensitivethan the 0.1 ppb and1 pphproposedfor HDDs andHDFsrespectively.TheseadjustedLOQsshouldmore than compensatefor thepredictedlOSS of analyticalsensitivityfor the higherhalogenatedcongeners,sincethelossof analyticalsensitivityfrom tetra-to heptahalogenatedis only50percent,andtheadjustedLOQsoffera level 3 ordersof magnitudehigher.

d. Quality assurance/qualitycontroltQA/QC~procedures.In theproposedrule, EPA specifiedQA/QCrequirements,including reproduceability01 :tlO percentfor at least2analysesofthe sameisotopically labeledHDDs/F-IDFs spikedto a concentrationof theLOQ, andde~erminationof the LOQ byrecoverywithin 70 to 130percentof theamountspikedfor the internalcalibrationstandardwhich hasrunthroughtheentire chemicalanalysis.Otherwisedocumentedcorrectiveactionsmusthetakenandthe samplesetmustbe rerun,

Comment33: EPA hassetQA/QCrequirementsthat arefar too stringent.Crummetet al. reportedin their reviewof ahumanadiposestudy(Ref. 7) that8of theworld’s mostexperiencedlaboratoriesin HDD/HDF analysisreportedhighly variableresults(e.g.,morethan 50 percenthigheror lowerthan backgroundandspikedlevels).Recoveryof spikedsamplesrangedfrom27 to 100percent.Crummetet al. alsofound that,althoughinterlaboratoryagreementis good for experimentalwork, manyvaluesstill differby 100percentor more,evenin matrices(tissue) that arenot nearlyso difficult toextractor cleanupaschemicalproductsamples.Experiencedlaboratories,Cmummetobserves,havenot achieved

reproduciblespikedsampleresults“within ±10percentof eachother,”andrecoveries“within 70 to 130percentoftheamountspiked,” asEPA specified,andsuchanexpectationon replicatesamplesat the1,OQ specifiedis notscientificallysound.Analytical chemistsalwaysstrive for narrow limits butrecognizethat this cannotbeachievedunlesstheyareoperatingordersofmagnitudeabovethe LOQ sincethatvalueis definedasthe limit wheretheycanfirst assigna legitimatequantitativenumberto theconcentration.Thegenerallyacceptedlower limit ofrecoveryhasbeen50 percentandchangingthis percentageof requiredrecoverycouldgreatlyincreasetheprotocoldevelopmentandtheanalysiscosts.” (Dow p. 15—20 CMA p. 30).

Responseto Comment33: EPA agreesthat thereproducibilityandrecoveryrequirementsareoverlystringentfor theLOQsspecified,and, basedon theobservationsoutlined above,will acceptanadjustmentin precisionto ±20percent,andanadjustmentin recoveryto 50 to 150 percent.The internalstandardsaddedat initial samplepreparationaresubjectedto eachphaseof extraction,separationandcleanupasexperiencedby thenativeHDDs/HDFswhich maybepresentin the sample.Thus, thefinal quantitationusingtheratio of responsesof thenativeHDD/i-IDE to the internal standardpairscompensatesfor therecoverythroughthemethod.

e. Analyticalstwoiam’ds.In specifyingi-tRGC/HRMSto performtheanalysisintheproposedrule, severalpossiblemethodsof quantitationwereexamined,basedon analyticalstandardsof 2,3,7,8-HDD/HDF conipounds~nconcentratmnssimilar to theconcentrationrangeofinterest(0.1 ppb for 2,3,7,8-HDDsand1.0pphfor 2,3.7,8-HUEs)foundin chemicalproductsto be tested.

Quantitationusinginternalstandardswasselectedasthe preferredmethodintheproposedrule, becausetheuseofinternal standardscanprovidecontinuousmonitoringof extractionefficiency andmethodprecisionin theanalysisof actualproductsamples;thustheinternal standardsmay provideinformationon matrix effects.SincetheODD andHDF compoundsof greatestconcernarethosesubstitutedat the2,3,7,8positions,EPA specifiedthatthesecompounds(isotopically labeled)be usedasreferencestandardsin theproposedrule. Theseanalyticstandardsareexpectedto be availablefrom atleastonemanufacturerat the time thisrule becomeseffective.(Seecommentsto theproposedrule submittedbyCambridgeIsotopeLaboratories).

Comment34: CMA’s reviewof theavailability of standardsrequiredindicatesonly 1 of therequired30brominatedand23 of the30 requiredchlorinatedstandardsareavailable.(CMA p. 38).

Responseto Gomment34:EPA relieson commentssubmittedby CambridgeIsotopeLaboratoriesin which itspresident,Dr. Joel Bradley,statesthatall chlorinatedandbrominatedstandardsrequiredin theproposedrulewill be availableby the time this ruie ispromulgated,with thepossibleexceptionof 1,2.3,4,6,7,8-and1,2,3,4,7.89-HpBDF.

3. Periodfor submissionof testdata.EPA proposedthatmanufacturerssubjectto the testingrequirementsofthis rulesubmitpr-3tocolsdevelopedfortheanalyticalmethodologywithin 6monthsafterpromulgationof afinalrule, andthat testresultsfor the listedchemicalsbe submittedno laterthan 1yearafterEPA reviewof protocolsforanalyticalmethodology.

Comment35.’ EPA should extendthetime for completingtheanalysesfor allchemicals,andanalysesfor brominatedcongenersshould beextendedevenmore.All previouswork hasbeendoneon chlorinatedcompounds,andeventhat is state-of-the-art.In addition, thebrominatedHDDs/HDFsareexpectedto presentadditional problemssuchaschemicalreactivityandheatandlightinstability. (CMA p. 45; Dow p. 113; Ethylp.1; Vulcanp.1; Ameribromp.1; GreatLakesp.1).

Responseto G’omment35: EPA agreesthat the time shouldbeextendedfordevelopmentof orotocols,sincemostofthemethodsdevelopmentwork will bedoneduring thatperiod. However, thetime allowedfor actualanalysis,oncethe methodhasbeendeveloped,can bedecreasedfrom 1 year to 6 months.Further,EPA agreesthat additional timeis neededto adaptanddevelopmethodsfor analysisof thebrominatedcongeners,sinceverylittle work hasbeendonein this area.Therefore,EPAhasadjustedthe schedulefordevelopmentof methodsandsubmissionof protocolsto 1 yearfor predominantlychlorinatedcompoundsand2 yearsforpredominantlybrominatedcompounds.Time for analysishasbeenadjustedto 6monthsafterEPA reviewof theprotocol.

Comment36.’ EPA should requiretiered testingwithin thetestingschemefor brominatedchemicalsso thatbrominateddiphenyl ethersaretestedbeforebrominatedphenolicsandtheirderivatives,andso thatTetrabromobisphenol-Ais testedbeforeanyof its derivatives.The rationaleforthis schemeis that the moredifficult

Federal Register / Vol. 52, No. 108 / Friday. June 5, 1987 / Rules and Regulations 21429

analyticalproblemsposedby thebrominateddiphenyl etherswillfacilitate the developmentof ananalyticalmethodfor the phenolics,andthatTetrabromobisphenol-Aas theparentcompoundshould be tested -

beforeits derivatives,sincethe oniysourceof HDDs/HDFsin thederivativeswould be from theparentcompound.(GreatLakespp. 46 thru 50).

Responseto Comment36: EPAagreeswith theexpecteddifficulty of testingdiphenylethers,sincethemoleculeis sosimilar to the HDF moleculethatseparationof thematrix will be difficult.However, thelogic of testingthemoredifficult compoundfirst seemsreversed.In anycase,thedecisionaboutwhichcompoundsto test first is aninternalmanagementdecisionto be madebyeachmanufacturerdependingen thecircumstances.EPA hasaddedanextrayearto the timetablefor testingofbromiriatedcompounds,andbelieveseachmanufacturershould determinetesting prioritieswithin that time.

EPA listed thederivativesofTetrabromobisphenol-Abecausethecontaminationis expectedto resultfrommanufacturingconditionsthesameas orsimilar to thosefor the parentcompound,not asa resultof acontaminatedfeedstock,aswould bethecaseif thecontaminationisexpectedto resultfrom theparentcompound.However,EPA will leavetesting orderor priority up to each -

manufacturer.4. Personsrequiredto test.Persons

requiredto testhasbeenfully discussedin thepreambleto theproposedruleunderUnit IV,B.4. (50 FR 51803,Dec.19,1985).EPA hasfoundthat thereisinsufficient dataandexperienceuponwhich to determineor reasonablypredict theeffectsof the manufacture,processing,distributionin commence,use,anddisposalof the chemicalssubjectto thetesting requirementsofthis rule. Therefore,in accordancewithsection4(b)(3)(B)of TSCA,manufacturersandprocessorsareresponsiblefor testing.

It is expectedthat in all casessubjectto this rule, testing will be performedbyeachof themanufacturerson themostappropriategradeof thesubstancetheyproduce,andthatpartof thecostoftesting will be passedon to theprocessorsthroughthe pricingmechanism,therebyenablingthem tosharein the costsof testing. Section4(c)of TSCA permitsa manufacturertoobtain exemptionsfrom testing if thesubstanceit producesis equivalentto atest substanceandtesting thesubstancewould result in generationof duplicativedata.A manufacturerwill not bepermittedto obtain an exemptionbased

uponanothermanufacturer’stestingunlessit candemonstratethat thesubstanceit producesis equivalenttothesubstancebeingtested.Amanufacturermustdesignatethe testsubstanceit believesis equivalentto thesubstanceit producesandsubmitdetailed,completeprocessandreactionconditiondatato substantiateits claimsof equivalence.

Processorswill be calledupontosponsortesting only if manufacturersfail to do so;however,in somecasesprocessorsmay berequiredto providereimbursementdirectly to thosesponsoringthis testing.If themanufacturerdoesnot submita letterofintent to performtesting within the45-day period, EPA will issueanoticeintheFederalRegisterto notify allprocessorsof the subjectchemical.Thenoticewill state thatEPA hasnotreceivedlettersof intent to performtestingandthat currentprocessorswillhave45 daysto submiteitheraletterofintent to performthe test or anexemptionapplicationfor suchtesting.Eachprocessorwho submitsaletterofintent to performtesting will beobligatedto submitaproposedstudyplan and,ultimately, to performtesting.If processorsarerequiredto sponsortesting. theymay applyfor exemptionsfrom testingby submittingprocessdatato demonstrateequivalence.

If no manufactureror processorsubmitsaletterof intent to performtesting,EPA will notify allmanufacturersandprocessors,either bynoticein theFederalRegisterorbyletter, thatall exemptionapplicationswill bedeniedandthat within 30 daysall manufacturersandprocessorswill bein violation of the rule until aproposedstudyplanis submittedfor requiredtesting.

5. Ghemicalscreeningmethods.In thepreambleto theproposedrule, EPAnotedthat all chemicalscreeningmethodsinvestigatedwereeitherasexpensiveas therequiredtestingorwereunreliable.EPA requestedcommentsandinformation on theavailability of ascreeningmethodwhichcouldbe usedto determinewhetherthefull-scaleanalysiswould be necessary.

Comment37: EPA shouldallow amanufacturerto test for themostlikelycongenerto form basedon predictivereactionchemistry,andif thatcongenerwasnot quantifiable,discontinuefurthertesting.Dow cited ananalyticaleffort inwhichreactionchemistrypredictedthatdichlorodioxins would predominate,andanalysisratifiedthat prediction.(Dow p. 10; April 22Transcriptpp. 86and87).

Responseto G’omment37:EPA findsthreedrawbacksto this approach.First,

thepredictedcongenermayor may notbe formedaccordingto the mostprobablereactionpathway.Forexample,in thecaseofpentachiorophenol,reactionconditionsfavorableto the formation of dioxinshould yield a predominanceofoctachlorodioxinsasreactionproducts;yeta largenumberof lower chlorinateddioxinsareroutinelyobservedaswell.Additionally, underthis scheme,asignificantlevel of acongenerdifferentfrom thatpredictedor analyzedforwould neverbemeasuredor reported.Finally, anychemicalsubjectedto thistypeof screenwould have to undergoextractionandcleanupidentical to thatrequiredfor the requiredHDDIHDFanalysis.Becauseextractionandcleanupcomprisemost of thetestingcostfor agiven sample,very littleeconomicadvantagewould be realizedby adoptingsuchascreen.

Comment38.’ EPA shouldallow ascreenfor total dioxins ata level of 0.1ppb.and, if nonewere found,thechemicalcouldbe considered“clean,”with no furtheranalysesnecessary.

Responseto Comment38: EPA findsthis approachacceptablein termsofevaluatingthechemicalfrom apotentialhealthrisk standpoint,but EPA did notproposethis screen,believingit -

unacceptableto manufacturersin degreeof difficulty andcost of the method.Asnotedabovein the Dow comment,thechemicalsubjectedto suchascreenwould necessarilyundergoextractionandcleanupproceduresidenticalto asamplepreparedfor thestandardHDD/HDF analyticalmethodsnow in use;thus EPA believesno substantialcostsavingwould berealized,andthemanufacturercould incurlargeadditional coststo testfor congenersifthescreenresultedin HDD5/HDFsabovethelevel of 0.1 ppb.

EPA hasnot founda perfectchemicalscreeningmethodwhichis acceptableboth in termsof sensitivityandcosteffectivenesswhencomparedto theanalyticalapproachoutlined in this finalrule. However,EPA will considerresultsfrom ascreenfor total HDDs/HDFsatalevel of 0.1 ppbfor HDDs/HDFs,or 0.1ppbfor HDDsand1.0 ppbfor HDFs, forwhich a protocolmust be submittedandreviewedby EPA. The screenmustbecarriedout usingacceptablemethodsasdescribedin the protocolreviewedbyEPA.

ShouldEPA identify achemicalscreeningmethodwhichit believessuitableboth in termsof sensitivityandcost,EPA mayamendthis rule to permitsubmissionof resultsfrom thatmethod.

Sincethepublicationof theproposedrule, EPA hasfurtherinvestigatedthe

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations

posstbilitv of chemicalscreensandhasidentified thefollowing chemicalscrcr’nicgmethods:

a. Derivativetesting.This methodrelieson the conversionof lowerhalogenateddioxin or furan compoundsto theoctahalogenatedconfigurationandtheanalysisfor thepresenceoftheseoctahalogenatedspecies.Atpresent,thereis disagreementamongindustry andacademiaasto theefficacyandvalidity of this methodasapredictoror screenfor highersubstitutedPHDDs/PHDFs,primarilybecauseof theunresolvedissueof yield(eg., to whatdegreethe conversionfromthe lowerhalogenatedto theoctahalogenaledconfigurationtakespiecej.At leastoneinvestigator,hutsever,hashadlimited successinconvertinglower substitutedPODstofully substitutedoctachlnminatedbtphenyl [Ref. 36).

h. Reversephasechroniatogm’o.ahywmth UV delectonA calculatedLOQ of0.167ppb hasbeenachievedon internalstandards(5ng/30g)of isotopicallylabeled2,3,7,8-TCDD(Ref. 36). EPA hasnot yetdeterminedwhetherthis methodis applicableasa chemicalscreeninIerm~ ~liabiltty or laboratoryreproducibility on a consistentbasis.

c. Sh’n-tcolumnCCwith halogendetector.The halogendetectoris a verysensitiveinstrumentwhich reliesonelectroncaptureor conductivitydetectionto calcolotetheamountofhalog’enatedspecies.Tee shortcolumnCC can be usedto separateotherinterferenceswhicharenormallynotableto be isolatedusingstandardmethodsfor sampleextractionandcleanup.However,oneinvestigatorreportedthat in usingthis methodinanalyzingpentachiorophenol,thechlortnoteddiphenyl oxidealmost neverseparated,oftengiving falsepositivesintheanalysis.

d. Total CC separationwith MSasdetector,This methodrelies on theseparationof thevariousPHDD/PJIIJFhonnologsusinggaschromatography,aftersshichmissspecirometryis usedto detectthe individual homolog.This ismadepossibleby definingthe “windowof separation”for eachhomolog.

6. Bjoor,aivticalscreeningmethods.Inthe preambleto theproposedrule, EPAnotedthat it hadinvestigatedradioimnmunoassay(Refs.1 and23);ar~lhvdrocarbonhydroxylaseIAHH)induction (Refs.6 and28): cytosolreceptorassay(Ref. 2); anearlylifestagebioassay(Ref. 17) andan in vitroker~’tintxationassay(Ref. 20). Asoutl:ned in theproposedmule, theprimary advantagesof theradiuimniunoassay,theAl-IH andthecyto~olr~~ceptorassayarerelativelylow

costandrapidity. The disadvantageofthesetechniquesin generalis that theydo not necessarilyrespondto specificisomersof HDDs and}IDFs; theyrespondto othercompoundssuchashalogenatedbiphenyls.azobenzenes,andnonhalogenatedpolynucleararomatichydrocarbons,andeachtechniqueis lesssensitivethanavailablemechanicalanalyticalmethods.The in vitro keratinizationorE.L.S. bloassaysmorerecentlyhaveprovidedpossiblymore specificity fordeterminingthepresenceof 2,3,7.8-HDDs/HDFs.Both techniqueshavebeendemonstratedto give roughlycomparableresultswith HRGC/MSanalysisof total PCDDsandPCDFsin aPCB fire soot (Ref. 116), andfly ashfroma municipal incinerator(Ref. 17).

It is important to note thateachof thebioassaytechniquesis mostsensitivetothepresenceof 2,3,7,8-TODDasopposedto otherHDDs!HDEs. it is speculatedthat therelativeresponseto otherRODsandHDFsmight be dependentonhalogensubstitutionin the2,3,7,8positionsandultimately to thetoxicpotentialof thecompound.It is alsoimportant to note that therangeofcompoundsevaluatedwith eachof thesebioassaytechniquesis somewhatlimited. EPA believesthatevaluationofcommercialproductsfor thepresenceofODDsandHDFswith anyof thesebioassaytechniquescould be avaluablescreeningtool, particularlyin termsoftime andresourcesnecessaryfor thechemicalpreparationandinstrumentalanalysesof thesechemicals.At thistime, EPA doesnot havesufficientdatato determinetheadequacyof thesebioanalyticaltechniquesandwhetherthey aresensitiveenoughto achievethelevel andspecificityof detectionnecessaryto quantitate2,3,7,8-RODs/HDFsat verylow levels. Additionally,theeconomicadvantageof thesemethodsrelies in largemeasureon thenumberof samplesrun: only in large(bulk) analyseswould significantsavingsin costbe realizedoverotherrecommendedmethodssuchasGeMS,etc. For suchbulk sampleanalyses,themethodalsomust be standardizedintermsof reproducibility andreliability;tt mustbeavailablefor routine analyseson a largescale.Thesemethods,whilecurrentlyundergoingfurtherdevelopment,arenot yet acceptableforscreeningpurposes.

‘V. EconomicAnalysisof Final Rule

.4. EstimatedGoat of TestingProgramUnderSection4(a}(1)(A)

This portion of thepreamblepresentsEPXs estimateof the total costof thisrule andreviewsthe potential

tncrketplaceeffectsidentifiedby EPA.The estimatedcostsandexpectedimpactsarediscussedin detail in theeconomicanalysispreparedin supportof this rulemaking.Muchof theinformahonreviewedin the economicanaiyCsis CBI arid is not availableforpublic review.This analysisis in therulemakingrecordfor this rule. A nun-CBI VCiClOfl of theeconomicanalysishasbeenpreparedandis availableforpublic review,Estimatedcostsandexpectedeconomicimpactsof therulemakingaresummarizedbelow.

Informationincorporatedin theeconomicanalysiswasfoundin avarietyof sources;a detailedaccountofthe specificinformationsourcesusedinthe economicanalysisis availablein thepublic record.In brief, EPA contractorsinitially providedestimatesof theproductionvolumes,process,andusesof eachchemical,aswell astheidentityof eachmanufacturingor importingfirm,Thesedatawereverified by reviewoftheavadahietechnicalliterature,andbydirectcontactbetweenEPA andrepresentativesof themanufacturingfirms. In thosecaseswhereinformationwasnot availabledirectly from industrysourcesor from theliterature,estimatesweremadefrom thebestavailableinformation.Muchof the informationsubmittedto theEPA frommanufacturerswasclaimedconfidential.

Assessmentof thepotentialforsignificantadverseeconomiceffectsonthe chemicalindustry asadirectresultof this rulewasperformedusingEPA’sstandardmethodfor measuringimpactsof TSCA section4testingrules.Theeconomicanalysisestimatesthecostsofconductingtherequiredtesting andevaluatesthepotentialfor significantadverseeconomicimpactasaresultofthesetestcostsby examiningfourmarketcharacteristicsof eachchemical:(1) Pricesensitivityof demand,(2)industrycostcharacteristics,(3)industry structure,and(4) marketexpectations.If thereis no indicationofsignificantadverseeffectfor anindividual chemical,no furthereconomicanalysisis performed;however,if apotentialfor significantadverseimpactis identified for aspecificchemical,amorecomprehensiveanddetailedanalysisisconductedwhichmorepreciselyreviewsthemagnitudeanddistributionofexpectedimpact on thatchemical.Inkeepingwith theworst-casecostmethodologyincorporatedin theeconomicanalysis,at eachpoint in theanalysiswherea wide rangeof costscanbe justified, a highestcostscenariohasbeenassumedso asnot to

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 21431

underestimatethepotentialburdenborneby thefirms subjectto testing.

Of the 32 chemicalssubjectto thistesting rule, 12 havebeenidentifiedaschemicalscurrentlybeingmanufacturedor imported.Fourteenfirms havebeenidentified asmanufacturersor importersof oneor more of thesetwelvechemicals.Becauseeachmanufacturerusesauniqueproductionprocessanduniqueequipmentandraw materialswhichcouldleadto contaminationofthechemicalby HDDs/HDFs,eachmanufacturer/importeris requiredtotest its own chemicalproduct.In total,32 uniquechemicalproductshavebeenidentifiedby EPA assubjectto thistesting rule.

The total cost for performingtherequisitetesting on the32 chemicalproductsis estimatedat $2.37million.This estimateof the total cost of thetestingprogramis composedof threeelements:developmentof analyticalmethodsfor thedeterminationof HDDsIHDFsin thesubjectchemicals,synthesisof analytic standards,andtheanalysisof each‘saniple.

1. MethodsDevelopment.Testing forthespecifiedHDD/FIDF congenersincommercialchemicalproductswillrequirethat methodologiesfor preparingandtestingsamplesbe developedforeachchemical.Testingfirms arefree tousethemostcosteffectivemethodofclean-upandanalysisthat they canidentify to meetthe testrequirementsandQA/QC requirements.EPA believesthat it is in thebestinterestof thetesting firms to coordinatetheir methoddevelopmentactivities in ordertominimize total cost.

EPA estimatesthat theupperboundcost for methodsdevelopmentfor thetesting specifiedin this ruleis $1.25million. In the economicanalysisfor theproposedrule, EPA estimatedmethodsdevelopmentcostsat$600,000.Incommentsto theproposedrule, severalcommentersquestionedthis costestimate,includingGreatLakesChemicalCompany,which claimedthattheactualmethodsdevelopmentcostswould beequivalentto 10 person-yearsof analyticchemistlaborvaluedat$125,000perperson-year.The total costfor methodsdevelopmentwould then be$1.25million. Due to the difficulty ofprojectingcostsprior to theperformanceof themethodsdevelopment,EPA hasadoptedthis estimateasareasonableupperbound.

2. Synthesisof analytical standards.To conductthesampleanalyses,anyrequisiteanalyticalstandardswhich arenot availablewill haveto bemanufactured.The acquisitioncost forcommerciallyavailablestandardsareincludedin thecostof eachsample

analysis,but costsfor synthesizingandproducingstandardsthatarenotcommerciallyavailableupon thepromulgationof therule area uniquecost of the rule. EPAestimatesthat therewill be no uniquecostfor analyticstandardmanufacturedueto this rule.

In theeconomicanalysissupportingtheproposedrule, the costfor analyticstandardswasestimatedat $182,000.This estimatewasbaseduponthemanufactureof 18 standardswhich wereunavailableat that time. In commentstotheproposedrule, onecommenter,CambridgeIsotopeLaboratories(OIL),respondedthat OIL wasin theprocessof manufacturingfor commercialsalethe 18 unavailablestandards.SubsequentcommunicationsbetweenEPA andCIL havedemonstratedto thesatisfactionof EPA that thestandardsareindeedavailableat this time.Therefore,costsfor the synthesisofanalyticalstandardsdueto this rule areestimatedat$0.

Othercommentersto theproposedrule commentedthat the costsforanalytic standardsynthesiswereunderestimatedbecauseEPA hadnottakeninto accountadditional(non2,3,7,8-substituted)standardswhichwould be requiredto conductthe sampleanalyses.EPA hasconcludedthat therewill be no additionalcostbecausetheadditional standardsarenot necessaryto conductthe sampleanalyses.

3. Sampleanalyses.The total costforsampleanalysisis estimatedatapproximately$1.12million. Eachsampleanalysisis expectedto costfrom$2,000to $5,000,andeachchemicalproductmay beanalyzedup to 7 timesfor anupperboundtesting costof$35,000perchemicalproduct.Anestimated14 manufacturerswill testanestimated32 samplesets forapproximately$1.12million,

Costsfor sampleanalysisarelowerthanthe sampleanalysiscostsestimatedin the economicanalysisfortheproposedrule. Two factorsaccountfor the reducedcostestimate.Thenumberof chemicalssubjectto testingissmaller—12commerciallyavailablechemicalsin thefinal rule asopposedtothe 14 commerciallyavailablechemicalsincludedin theproposedrule. Secondly,additionalinformation onmanufacturers/importersgatheredin theinterim following thepublicationof thepmnposedrule hasshownthat somefirms originally identifiedasmanufacturersor importersof somechemicalsarenot currentmanufacturersor tmporters.

B. Antic~aatedEconomicImpact UnderSection41a}(IXA)

A reviewof the costsallocatedtoeachmanufacturerandchemicalindicatesthat the probabilityofsignificantadverseeconomicimpact forsevenchemicalsis verylow. However,the costanalysisindicatespotential forsignificantadverseeconomicimpact forthe five remainingchemicals.The-sefivechemicalswere thereforereviewedingreaterdetail.After furtherinvestigation,EPA hasdeterminedthatthelikelihood of adverseeconomicimpactof threeof the five chemicalsislow. Eachof the five chemicalsisdiscussedbelow. Specific costsallocatedto eachchemicalandtheimpactlevel calculatedfor eachchemicalarenot reportedhere,in mostcases,becausethedatausedin the costcalculationsareCBI.

1. Tetrabromobisphenol-ADiacr,~vIate.Thecalculatedimpactlevel forTetrabromobisphenol-A(TBBPA)diacrylateindicatesthat theprobabilityof adverseeconomicimpactis veryhigh.Furtherinvestigationinto themarketcharacteristicsof this chemicalindicatesahigh likelihood that thechemicalwillbewithdrawn from themarketby itsmanufacturer,ARCO SpecialtyChemicals.ARCO did not submitcommentsto theproposedrule;however,directcontactbetweenEPAandarepresentativefrom themanufacturerverifiedthat TBBPAdiacrylateis alow volume specialtyflameretardantwhichhasbeenmanufacturedon a developmentalbasisonly. The annualizedallocatedtest costsfor TBBPA diacrylateareconfidential,but arebelievedto be higherthan themanufacturer’sannualrevenuefrom theproduct.Given thesecosts,HorseheadIndustries,whichrecentlyacquiredARCO SpecialtyChemicals,willprobablyceasemanufactureanddistribution of the chemicalif facedwiththe testingcosts.

2. 2,3,5,6-Tetrachloro-2,5-cyc!ohexadiene-1,4-diane(GhloranilJ.Theestimatedcostsallocatedto thechemicalchloranilraisetheprobabilityof adverseeconomicimpact.Furtherinvestigationof the marketcharacteristicsof chioranilindicatesthat firms importingsmall amountsofchioranil mayceaseimportation(similarly, firms whichhavein thepastimportedchioranilmay bepreventedfrom re-enteringthe market)dueto thetesting costs.Oneor morefirmsimporting chioranilin significantlyhighervolumeswill be ableto provideanynecessarysupply displacedfrom theotherfirms.

21432 FederalRegister / Vol. 52, No. 108 I Friday, June 5, 1987 / Rules and Regulations

Six firms arebelievedto be currentorrecentimportersof chloranil;however,only oneor two of the importing firmsarealsochloranil manufacturers.Theother importerspurchasetheirsupply ofchioranil directly from themanufacturingfirm(s). Due to the smallvolumesbelievedto beimportedby thenon-manufacturingfirms, theannualizedallocatedtestcostsrepresentasubstantialproportionof the revenueattributableto chioranil.Therefore,it isanticipatedthat the non-manufacturingimporterswill exit themarket(or avoidre-enteringthe market)ratherthancontributeto the testing program.Thefirm(s) which areboth manufacturersandimporterswill then provide theadditionalsupplyof chloranilandpayfor agreaterportion of the testing costs.

The importing firms whichmaybedisplacedfrom themarketareamongthe smallestfirms subjectto thisrulemaking.However, thesefirms importrelativelysmall quantitiesof chioranil,andnonearefinancially dependentupon chloranil. Withdrawingfrom themarketfor chloranil (or remainingout ofthe market)will not adverselyaffectanyof the non-manufacturingimporters.

3. Tetrabromobispherzol-A-Bis-2,3dibromopropylether,Tetrabromobisphenol-A-Bisethoxylate.arid Ally/etherof Tetrabromobisphenol-A. The estimatedtesting costsallocatedto eachof thesethreechemicalsindicatedthepossibilityof significantadverseimpact.Additional investigationinto themarketcharacteristicsof eachchemicalindicatesthat theprobabilityof significantadverseimpactis low.Much of the informationuponwhichthisconclusionis basedis CBI andisthereforenot availablefor publicreview. In general,this conclusionisbasedupon the following observations:(1) Eachof thesethreechemicalsis abrominatedflame retardant.Demandforbrominatedflame retardantshasexpandedrapidly, andmarketexpectationsfor brominatedflameretardantsareoptimistic; (2) EPAbelievesthatdemandfor eachof thesechemicalsis relatively insensitivetochangesin pricebecauseof a lack ofsubstituteswhicharecomparableintermsof priceand/orperformance;and(3) The structureof themarketsfor eachchemicalsupportstheconclusionthatthe testingcostswill not causeasignificantadverseimpact.

G. TestingCostsas a Barrier to MarketEntry

After this rule takeseffect, anyfirmwishingto initiate manufactureof anyofthe32 subjectchemicalswill incur costsfor methodsdevelopmentandsampleanalysis.Thesecostswill serveas a

barrierto entry into themarketsforthesechemicals.This effectwill be mostsignificantfor firms wishing to initiateproductionor importationof only asmall volumeof oneof the subjectchemicals.However, theregulationprovidesan opportunityfor obtainingwaiversfrom testing in certaincircumstances.

D. Costsof ReportingUnderSection8

1. Section8(a): The costsof reportingundersection8(a) areminimal. Underthe section8(a)rule, submissionof fourdifferent setsof reportsarespecified:(1)Submissionof productionprocessandreactionconditionsfor chemicalsidentified asprecursors;(2) submissionof certainexistingdatafor the 32chemicalslisted for testing in this rule;(3) productionvolume, processandreactionconditions,use,exposure,anddisposaldatafor chemicalstestingpositivefor HDDs/HDFs;and(4)processandreactionconditionsonchemicalstestingnegativefor HDDs/HDFsmay berequiredby EPA if anyothermanufacturerof thesamechemicaldiscoversHDD/HDFcontamination.

Threeuniquesetsof informationwillbesubmittedfor the fourreportingcategoriesoutlinedabove.The first setwill bereportedby firms manufacturingor importinga chemicalwhichtestspositivefor HDDs/HDFs.Thesefirmsmust reportto EPA on productionvolume, use,exposure,disposal,andprocessconditionsunderwhichtheirproductsaremanufactured.Thesecondsetconsistsof firms manufacturingorimporting anyof the32 chemicalssubjectto testingfor whichquantitativeanalysesfor HDDs/HDFshasalreadybeenconducted.Thesefirms will berequiredto report testresultsandtestprotocols,andthe firmswill fall into thefirst setif the resultssubmittedindicateHDD/HDF contamination.The third setis composedof processorsof precursorchemicalsandmanufacturers/importersof chemicalsfree from HDD/HDFcontaminationwhenat leastonemanufactureror importerof thesamechemicaltestspositivefor HDD/HDFcontamination.Processorsof precursorchemicalswill berequiredto submitdataon processandreactionconditionsfor their chemical.If manufacturers!importersof chemicalsfree from HDD/HDF contaminationarerequiredtoreport, thatdeterminationwill be madein a rulemakingfollowing the receiptarid evaluationof the testing data.

Reportingonpreviouslyconductedtestsshould cost reportingfirms from$273 to $546 for eachchemicalpreviouslytested(Ref. 37). Thosecostsincludefrom 2 to 4 hoursof managerial

laborto reviewtherule, 4 to 8 hoursoftechnicallabor to collect the testandmethodologydata,and2 to 4 hoursofclerical labor. Any firms reportingpositiveidentificationof HDD/HDFcontaminationwill also be subjectto thecostsdetailedbelow.

Firms subjectto reportingduetopositiveresults indicatingcontaminationmustreportthe following information:chemicalproductionvolume, use,processandreactionconditions,disposal,andexposuredata.Thisinformationshouldbesubmittedon theEPA form printedunder§ 766.64. It isestimatedthat completionof this formwill requirefrom40 to 80 hoursfrom1industrialchemistand1 processengineer(Ref. 37). In addition,4 to 8hoursof managerialtime will berequiredfor initial review of therule,legalreviewof therule, andfinal reviewof the form. Four to 8 hoursof clericaltime will berequiredfor completionofthe form. Forfirms reportingon multiplechemicals,managerialandclerical timemaybe a onetime cost.The directcostsof filing the formwill rangefrom $1,607to $3,214per chemical(Ref. 37).

Firmsrequiredto reportbecausetheymanufacturea chemicalmadefrom aprecursorchemicallistedin this rulemustprovide their productionandprocessandreactionconditions.Thedirectcostsof filing the formwill fall inthe rangeof $944 to $2,551.Thecostsarebasedon thecontributionof from 20 to60 hoursof laborfrom 1 industrialchemistand1 processengineer,plusmanageriallaborto review theinformationandclerical laborto preparethesubmission(Ref. 37).

2. Section8(c): Submissionof two setsof adversereactionconditionsarespecifiedin this rule. Any reportsofsignificantadversereactionsto HDDs/HDFsmust be submittedbymanufacturersof anyof the 32chemicalslisted for testing in this rule.Oncethe testinghasbeenconducted,thosefirms finding a positivetestresultindicatingcontaminationby HDDs/HDFsfor anyof the 32 chemicalswill besubjectto thesecondpartof the section8(c) DataCall-In for reportsofsignificantadversereactionsto thechemicalstestingpositive for HDD/HDFcontamination,

Of the 32 chemicalssubjectto this testrule, anindeterminatenumbermay beidentified ascontaminatedwith HDDs/HDFs. Without knowingthe numberoffirms whichcurrentlymaintainrecordsof significantadversereactionduetoHDD/HDF contaminationandthenumberof contaminatedchemicals,theprecisecostsof the section8(c)requirementcannotbedetermined.The

FederalRegister / Vol. 52, No. 108 / Friday, June 5, 1987 I Rules and Regulations 21433

costsfor any individualfirm requiredtoreport will beccmposedof thefollowingelements:review of the rule, file searchfor recordssubjectto reporting, reviewof any recordsidentified for CBI, costsfor copyingidentifiedrecords,andthecost for submissionto EPA.

Both fixed andvariablecostswill beincurredby eachfirm manufacturingorimportingachemicalidentified ascontaminatedwith HDDs/HDFs.It isestimatedthat for eachfirm reporting,1to 2 hoursof manageriallaborwill beexpendedto reviewthis rule, and3 to 6hoursof technicallaborwill beexpendedto searchfiles for reportsofsignificantadversereactions.For eachsuchreportlocated,thereportingfirmwill incur clericalcoststo reproduceandpreparethedocumentfor submissionandadditionalmanagerialcoststoreviewthe reportfor CBI. The directcostsfor eachfirm subjectto this DataCall-In will be from$150 to $300, plus$80per10 pagereportsubmitted(Ref.38).

Everyfirm subjectto the initialsection8(c) requirementwill incur coststo review therule andconducta filesearch.tf anyreportsarelocated,preparationandreview of the responseto the Agencywill entail additionalcosts.Firms manufacturingor importingchemicalswhichtestpositivefor HDD/HDF contaminationwill also incurcostsfor reviewof the rule, file search,anresponseto the Agency.Thoughthefirms subjectto thesecondpart of thesection6(c) requirementhavereviewedtherule previouslyto respondto thefirstreportingrequirement,it is assumedthatrulereview andfile searchwill berepeatedbecauseof the time lagbetweeninitial responseandcompletionof testing.The maximumtotal fixed costfor theinitial responsewill befrom$2,260to $4,520plus $80perreportof asignificantadversereaction(Ref. 38).Totalcost of the section8(c)requirementfor contaminatedchemicalswill dependuponthe numberofcontaminatedchemicals.

3. Section8(dJ:Submissionof two setsof unpublishedhealthandsafetystudiesarespecifiedin the rule. Anyunpublishedhealthandsafetystudiesfor }-IDDs/HDFs mustbesubmittedbymanufacturersof anyof thelistedchemicals.Oncetestinghasbeenconducted,firms finding positiveresultsof HDD/HDFcontaminationwill besubjectto this section8(d) rule, Of thechemicalssubjectto this rule, anindeterminatenumbermaybecontaminated.Without knowing thenumbercontaminated,the precrsecostsof the call-in cannotbedetermined.

Companiessubjectto this rule mustconductfile searches,copy the studies,

list studiesin progressor knownbut notin posessionofthe respondent,andreview the studiesfor CBI. Both fixedandvariablecostswill be incurredbyeachfirm manufacturingor importingachemicalidentifiedascontaminated.Itis estimatedthatfor eachreportingfirm,1 to 2 hoursof manageriallaborwill beexpendedfor initial review of this rule,and3 to 6 hoursof technicallaborwillbe expendedto searchflies forunpublishedhealthandsafetystudies.Compilingarid transcribinglists ofstudiesshould takerio morethan 1additionalhour of clerical labor.Foreachstudylocated,thereportingfirmwill incur additional clericalcoststoreproduceandpreparethedocumentforsubmission,andadditionalmanagerialcoststo review the reportfor CDI. Thedirectcostsfor eachfirm subjectto thissection8(d) requirementwill be from$170 to $320, plus $80per15 pagestudysubmitted(Ref. 39). Additional costsmaybeincurredfor submissionof on-going ornewly initiated studies.

Everyfirm subject to the initialreportingof unpublishedhealthandsafetystudieswill incur coststo reviewtherule andconducta file search.If anyreportsarelocated,preparationandreview of the responseto EPA willentailadditionalcosts.Firmsmanufacturingor importingchemicalstestingpositivefor HDD/HDFcontaminationwill also incurcostsforreviewof the rule, file search,andresponseto theAgency. Firms subjecttothesecondpartof the section8(d)reportingwill havereviewedtherulepreviouslyto respondto thefirstrequirement,but it is assumedthat rulereviewandfile searchwill be repeatedbecauseof thetime lagbetweeninitialresponseandtest completion.

The maximumtotal fixed cost for theinitial responsewill be from $2,540to$4,810plus $80per studysubmitted(Ref.39). Total costof the section8(d)requirementsfor HDD/HDFcontaminatedchemicalswill dependupon thenumberof chemicalstestingpositivefor contamination.

VI. Availability of Facilities

Section4(b)(1)(CJof TSCA requiresthat in the developmentof atest rule theAdministratorconsider“the reasonablyforeseeableavailability of the facilitiesandpersonnelneededto performthetesting requiredundertherule.”Pursuantto this requirement,EPAconducteda surveyof commercialanalytic testinglaboratoriestodeierminetheavailability of facilities,equipment,andpersonnelnecessarytoperformthe testsoutlinedin this rinalrule (Ref. 41).

A list of 57 laboratorieswascompiled,consistingof 17 laboratorieswithcurrentcontractsunderthe EPA’sSuperfundContractLaboratoryProgram,and40 laboratoriesfrom the1984Directory of theAmericanCouncil ofIndependentLaboratories.Twenty-five -

laboratories(the 17 EPAcontractlabsand8 otherschosenat random)werecontactedby telephone.

The laboratorycapacitysurveyidentifiedanumberof commercialanalyticaltesting laboratorieswith highresolutionCC/MS systemsandexperienceusingthesesystems,thoughnot necessarilyexperiencewithdetectingHDDs/HDFsin commercialchemicalproducts.In written commentsto theproposedrule andin asubsequentpublicmeeting,industryrepresentativesstatedthat testing 14 chemicalsin 1 yearwould strainthecapacityof qualifiedtesting laboratories.EPA consideredthesecomments,andin response,isextendingtheproposedtime limit forsubmissionof testresultsfor the10brominatedchemicalsby 1 year.

Informationgatheredin supportof thisfinal rule showsareducedlikelihood ofstrainingthecapacityof qualifiedtesting laboratoriesto performtherequisiteanalyses.In theproposedrule,14 chemicalswereincludedin the list ofcammercialchemicalssubjectto testingrequirements.EPA projectedthat54 setsof sampleswould requiretesting.Forthis final rule, only 12 commercialchemicalsaresubjectto testing,andEPA projectsthat32 setsof sampleswillbe tested.

In additionto thecommerciallaboratoriesidentified in thelaboratorycapacitysurvey,CMA hassubmittedalist of qualified laboratoriesin itscommentson the replicability of testingresults.Supplementedby non-commerciallaboratories(i.e.,universitiesandin-houselaboratoriesofmajorchemicalcompanies)suchasthoseidentified by CMA, andgivenanextrayear to completetheanalysesonapproximatelyone-halfthenumberofsamplesprojectedin theproposedrule,testingshould proceedwithout anyrestrictionsdueto capacityavailability.

VII. Section8 Reporting

A. ReportingUnderSection8(a)

Undersection8(a)j1)(A) of TECA,EPA may requirechemicalmanufacturersandprocessorstomaintainsuchrecordsandsubmitsuchreportsas theAgencymayreasonablyrequire.The informationto be submittedis that which is knownto or isreasonablyascertainableby thepe:sonmaking the report(section8(a)(2j).

21434 Federal Register / Vol. 52,No. 108 / Friday, June 5, 1987 / Rules and Regulations

Further. section8(a)(1)(A) generallyexemptssmallmanufacturersandprocessorsfromrecordkeepingandreportingrequirements,exceptin certainlimited circumstances.Of particularrelevanceto this rule, section8(a)(3)(A)(ii) authorizesEPA to overridethe small manufacturerexemptionforchemicalssubjectto arule proposedorpromulgatedundersection4 of TSCA.Section8(a)(2)alsonotesthat to theextentfeasible,EPA should not requireunnecessaryorduplicativereporting.

Undersection8(a) of TSCA, EPAproposedto requiremanufacturersofchemicalslistedfor testingto submitresultsof anytesting,performedprior tothe effectivedateof this rule, whichshowsconcentrationsof anyHDDs/HDFsin anyof thechemicalslistedfortesting.EPA alsoproposedto requireunderTSCA section8(a) thatmanufacturersof anychemicalin whicha positive testresultis reported,reportproductionvolume, processandreactionconditions,exposure,use,anddisposaldataon theEPA Form7910—51,printedunder§ 786.30(e)(5)in theproposedrule.Also underTSCA section8(a), EPAproposedto requiremanufacturers(exceptsmall manufacturersasdefinedunder§ 766.3) of anychemicalmanufacturedusinganyof thechemicalslistedasprecursorsto reportproductionvolume,processandreactionconditions,use,exposure,anddisposaldatafor eachsuchchemical,usingtheDioxin/FuranReportForm.

Comment39.’ EPA should not requireextensiveproductionandprocessinformationon precursorchemicalsandshould setalevel of productionbelowwhich informationneednot besubmitted.Thereportingrequiredin theproposalis excessive(Kodakp. 2).

Responseto Comment39: EPApartiallyagreeswith this comment,andhassetthe level of productionsuggestedby Kodakbelowwhich informationneednot be submitted.EPA disagreesabouttheneedfor productionandprocessinformation;only with this datacanEPAdeterminewhetherotherchemicalsshould be listedfor testing.To lessenreportingrequirementsfor chemicalsmadefrom precursors,EPA haseliminatedall reportingof productionvolume, use,exposure,anddisposaldata,whichis not neededfor thedecisionto requiretesting.EPA’s intentis to discoverwhetheranyadditionalchemicalsaremanufacturedunderconditionsthat couldproduceFIDDs/HDFs.For this purpose,only processandreactionconditiondataareneeded.

SinceEPA hasallowed an exemptionfrom testingfor chemicalsproducedinannualquantitiesof 100kilograms orlessfor researchanddevelopment

purposes,it is reasonableto allow thesameexemptionfor chemicalsproducedfrom precursorchemicals.Suchchemicalswould not becometestingcandidates.Therefore,a responsibleofficial from anychemicalmanufacturermaycertify thata chemicalproducedfrom alistedprecursoris producedinquantitiesof 100kilogramsor lessperyear,andusedonly for researchanddevelopmentpurposes,in lieu ofsubmittingprocessandreactioncondition information for thatchemical.

Comment40: EPA should specify theconditionswhichfavorHDD/HDFformationandrequirereportingonly insituationswherecontaminationis likely,to reducethereportingburden.(Kodakp. 2; p. 1 in commentto proposedamendmentaddingadditionalprecursors;EDF p. 3 in commentstoproposedamendmentaddingadditionalprecursors;CMA p. 8 in commentstoproposedamendmentaddingadditionalprecursors).

Responseto Comment40.’ Theseconditionsaresetout anddiscussedinthesupportdocument(Ref. 43)usedbyEPA to selectchemicalsfor testing.Theseconditionshavebeenappliedtoconfidentialprocessandreactiondatasentto EPA by severalmanufacturersseekingto convinceEPA that theseconditionsarenot presentduringthemanufacturingprocessfor theirchemicals.In reviewingtheprocessdatasubmitted,EPA discoveredseveralborderlinedecisionpoints, andmadedecisionsbasednot on asingle factor,suchasheat,but on a combinationoffactors,includingdurationof theprocess,compositionof thereactionvessel,presenceof oxygen,etc.If EPAsetout specifictemperature,pressure,andalkalinity conditions,it couldmissalargebody of datathatwould beborderline,andfor whichnon-submissioncouldbejustified.Therefore,EPA prefersto makedecisionsonwhetherthereareadditional chemicalswhich arecandidatesfor testing.EPAhaseliminatedmostof the reportingrequirementsandkept only theprocessandreactionconditiondataneededtodetermine,on a case-by-casebasis,whethera chemicalis manufacturedunderoneconditionor a combinationofconditionsthat mayleadto HDD/HDFcontamination.

Comment41: EPA should considerasmall quantityexemptionfor specialtyandresearchanddevelopmentpurposesfor both chemicalsto be testedandforprecursorchemicals.A reasonablecut-off for this purposeis 100 kilogramsperyear.(Kodak p. 2).

Responseto Gomment41: EPA agreeswith thesmall quantityexemptionforresearchanddevelopmentportion of

this comment,andhasaddedsuch anexemptionin this final rule. EPAbelievesit is not likely thata chemicalproducedin small quantitiesforresearchanddevelopmentpurposeswillcauseanunreasonablerisk, basedonthe expectationthat personsusingsuchachemicalwill betrainedto recognizeandprotectagainstpotentialhazardsfrom suchchemicals.Therefore,EPAhasaddedanexemptionfor both testchemicalsandchemicalsmadefromprecursorswhichareproducedinquantitiesof 100kilograms or lessperyear,andwhichareusedfor researchanddevelopmentpurposes.Suchadeterminationcannotbemadeforspecialtychemicalsnot usedonly forresearchanddevelopment,however,withoutknowing specificallyhow suchchemicalsareusedandcouldbeused.

B. ReportingUnderSection8(c) of TSCA

Undersection8(c) of TSCA, EPAproposedto requiremanufacturersofchemicalslisted for testingto submitreportsof significantadversereactionsallegedto havebeencausedby HIJDs/HDFs.EPA alsoproposedto requiremanufacturersof chemicalslisted fortestingto submit,90 daysaftersubmissionof atestresultshowingcontaminationby HDDs/HDFsabovethe appropriate LOQ, reports ofsignificantadversereactionsallegedtohavebeencausedby the chemicaltested.All suchsubmissionswere tofollow the proceduressetout in 40 CFRPart717.

The commentsreceivedonsubmissionof allegationsof significantadversereactionsaskedfor clarificationof the requirements.Clarification oftheserequirementshasbeenmadeinthis final rule.

C. ReportingUnderSection8(d)ofTSCA

Undersection8(d) of TSCA, EPAproposedto requireanychemicalmanufacturersto submithealthandsafetystudieson anyHDDs/HDFs,andmanufacturersof chemicalslisted fortesting for which contaminationaboveanyLOQ is reportedto submit,90 daysaftersubmissionof the positivetestresult, all healthandsafetystudiesonthe testedchemical.All submissionswere requiredto follow the proceduressetout in Part 718of this Chapter.

Commentsreceivedon reportingundersection8(d) of TSCA requestedclarification of requirements.Suchclarificationhasbeenmadein this final -

rule.

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 I Rules and Regulations 21435

VIII. Relationshipto Section12(h) ofTSCA

Section12(bfll) of TSCA providesfornotification to theAdministratorof anyintentionto exportanychemicalforwhichsubmissionof datais requiredundersection4 of TSCA or section5(b)of TSCA. The Administratoris requiredto notify thegovernmentof anycountryto which exportoccursof thenatureoftherequirementandtheavailability ofdatasubmittedto theAgencyfor thatchemical,

Regulationsrequiringnotification toEPA of exportor intendedexportof anychemicalfor whichdataarerequiredunderTSCA section4 arecodified at 43CFR 707.60through707.75.Theyspecifywho must notify theAgency, whennotificationtakesplace,therequiredcontentsof thenotice, andpermissiontoasserta claim of confidentiality for anyof the information.EPAhasinterpretedsection12(b)of TSCA andtheregulationsunder40 CFR 707.60through707.75to applyat the time a rule ispromulgatedundersection4 of TSCA.(See45FR 82850,December16, 1980).However, the regulationsandstatutedonot specifya time whensuchnotification requirementswill cease.

Comment42: EPA’s interpretationofits regulationsrequiresexportnotificationat the time a testingrequirementis issuedundersection4 ofTSCA, ratherthanat thetime whendataresultingfrom thoserequirementsareavailable.Suchnotificationwill unfairlystigmatizeachemical,andshouldbedelayeduntil testingshowslevelsofHDDs/HDFsabovetheLOQs. (CMA atpp.46 and47).

Responseto Gomment42: EPAcontinuesto believethat its previouslypublishedinterpretationof section12(b)andits regulationsareappropriate.Notification will commenceinaccordancewith applicableregulations.EPA’s noticeto foreigngovernments,however,will statethat theAgencyisonly testingfor potentialcontaminationandis not imposingregulatoryconstraintson thesechemicals.Theintentionof thenoticewill he to avoidmakinganystatementswhichunfairlystigmatizethe chemical.EPA hasconcludedthat it should specifyfor thisrulecircumstancesunderwhichnotificationrequirementsundersection12(b)maybe terminatedfor specificchemicalS.

The resultsof the testing requiredunderthis rule will yield definiteresults—eitherthey will showcontaminationby HDDs/HDFsor nocontaminationby HDDs/HDFsat thetargetLOQs. if contaminationof aspecificsubstanceproducedby a

specificprocessis shown,it isappropriateto continueto requireexportnotification undersection12(b) so thatforeigngovernmentscanbe providedwith the testingresults.However,ifthereis no contaminationshownat thetargetLOQs for a specificsubstanceproducedby a specificproce~s,thereisno furtherconcernfor adversehealtheffectsresultingfrom HDD/HDFcontaminationof thatsubstanceand,thus, no reasonfor themanufacturertocontinuenotification to EPA, or for EPAto continueto notify the foreigngovernmentsaboutthatmanufacturer’sexports.

Accordingly,EPA hasconcludedthatit is appropriateto amendits section12(b) rule to endnotificationrequirementsin suchsituations.Theamendmentto 40 CFR Part 707addinganew § 707.72providesthatwhentestresults showingthat aspecificsubstanceproducedby a specificprocesshasno HDDs/HDFsabovethetargetLOQsaresubmittedto EPAunderthis testrule, exportnotification to EPAis no longerrequiredof anypersonwhois exportingthat substanceproducedbythat process.

IX. ComplianceandEnforcement

The Agencyconsidersfailure tocomply with anyaspectof a section4rule to bea violation of section15 ofTSCA, Section15(1)(A)of TSCA makesit unlawful for anypersonto fail orrefuseto comply with anyrule or orderissuedundersection4. Section15(3)ofTSCA makesit unlawful for anypersonto fail or refuseto: “(A) eCtablishormaintainrecords,(B) submitreports,notices,orotherinformation,or(C)permit accessto or copyingof recordsrequiredby this Act or arule” issuedunderTSCA.

Additionally, TSCA section15(4)makesit unlawful for anypersonto failorrefuseto permitentryor inspectionasrequiredby section11. Section11(a)appliesto any“establishment,facility,or otherpremisesin which chemical8ubstancesor mixturesaremanufactured,processed,stored,or heldbeforeor after their distribution incommerce The Agencyconsidersa testing facility to be a placewherethechemicalis held or storedand,therefore,subjectto inspection.Laboratoryinspectionsanddataauditswill be conductedperiodically inaccordancewith the authorityandproceduresoutlined in TSCA section11by duly designatedrepresentativesofthe EPA for the purposeof determiningcompliancewith any final rule forchemicalslistedunder§ 766.20.‘Theseinspectionsmaybe conductedto verifythat testing hasbegun,schedulesare

beingmet,reportsaccuratelyreflect th~underlyingraw dataandinterpretationsandevaluations,andto determinecompliancewith TSCA CoodLaboratoryPractices(CLP) standardsandthe test standardsestablishedin therule.

EPA’s authority to inspecta testingfacility is alsoderivedfrom section4(b)(1) of TSCA, which directsEPA topromulgatestandardsfor thedevelopmentof testdata.Thesestandardsaredefinedin section3(12)(B)of TSCA to include thoserequirementsnecessaryto assurethatdatadevelopedundertesting rulesarereliableandadequate,andto includesuchotherrequirementsasarenecessarytoprovidesuchassurance.TheAgencymaintainsthat laboratoryinspectionsarenecessaryto provide this assurance,

Violatorsof TSCA aresubjecttocriminal andcivil liability. Personswhosubmitmaterially misleadingor falseinformationin connectionwith therequirementof anyprovisionof this rulemaybe subjectto penaltieswhichmaybe calculatedas if they neversubmittedtheir data.Underthepenaltyprovisionof section16of TSCA, anypersonwhoviolatessection15 could be subjectto acivil penaltyof up to $25,000for eachviolationwith eachday of operationinviolation constitutinga separateviolation. Knowing or willful violationscouldleadto theimposition of criminalpenaltiesof up to $25,000for eachday ofviolation andimprisonmentfor up to 1year.In determiningthe amountofpenalty,EPA will takeinto accounttheseriousnessof the violation andthedegreeof culpability of theviolatoraswell as all theotherfactorslistedinsection16. Otherremediesareavailableto EPA undersection17 of TSCA, suchasseekinganinjunctionto restrainviolationsof TSCA section4~

Individuals aswell as corporationscould he subjectto enforcementactiocs,Sections15 and16 of TSCA applyto“any person”who violatesvariousprovisionsof TSCA, EPA may,at itsdiscretion,proceedagainstindividualsas well ascompaniesthemselves,Inparticular,this includesindividuals whoreportfalseinformationor who causeitto be reported.in addition,thesubmissionof false,fictitious, orfraudulentstatementsis aviolationunder18 U.S.C. 1001.

X. RulemakingRecord

EPA hasestablisheda recordfor thisrulemaking(OPTS—83002).This recordincludesbasicinformationconsideredby theAgencyin developingthis finalrule andappropriateFederalRegisternotices.

21436 Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations

This recordincludesthe followingkindsof information:

1. Federal Registernotices pertainingto this rule.

2. Studyof availability of testfacilities andpersonnel.

3. Economicanalyses.4. Communicationsbeforeproposal

consistingof written public andintra- orinteragencymemorandaandcommentsandsummariesof telephoneconversations.

5. Reports—publishedandunpublishedfactualmaterials.

6. Commentsreceivedin responsetotheproposedrule andtheproposedamendmentto the rule from thefollowing organizations:Ametibrom,IncorporatedCamL’ridge isotope Laboratories,Inc.ChemicalManufacturersAssociation,

Inc.Dow ChemicalCompanyEastmanKodak CompanyEthyl CorporationEnvironmentaiDefenseFundGreatLakesLhemical CompanyImperiaI Chemicals,Inc.PlatteChemical CompanyUniroyal Chemical,Inc.Vulcen Chemicals,Inc.Worker’s institute for Safety andHealth2.4-0 ‘lark Force

CCI. while part of therecord, is riotarailabie for public review. A publicversion of the record, from which CDIhasbeendeleted,is availableforinspection,in the OPTSReadingRoom,

~ tOe 11 °t SW 1’ ~‘c} t~~D—nCC, Horn B am, to 4 p.m.,MondaythroughFriday, exceptlegalholidays.

Xi, fiafarereces

(1) AIbro ci at. ‘A RadioinirnueoassavforChtorir:etedDihenzo-p-Dioxins.” ecologyon,] /1 tm/Icr!P/tern:nco!ogv.60:132-1-36.1979.

(2) 0-ndieraetat. “Polychiorioafect‘ii H CD rCwi~ c

cu t-anrtnr; to the2,g7,3-TCDOcyorsoiiomacetc.p:otein,P~t-tHinductionandtoxteuy” i’oxicole. 32:131—n4-4, 1903.

(9) Eno:l:eraci a) “Comp-c’ti:i;e boning incyft cc :‘,B-TCtMJ r ep’c~eEfeuteofcur-tue ro ti--c atimt:eeofhebmorneieo’hit:heevts—a06982Docdm-?!COj !Oar/oocology.32:9221. 1983.

(ct PetIt-n,).5., Bet-n-cs0.19... ‘ 1-teccbthHa~e:rdDream;emit for ChlorinatedD;m-rine sodCtbi’rnob,rene:Otherthan 2,3.76-f(ILl).”Prce~nicdat theSymposiumon ed—ancesinrisOtto nsk assessmentfor Systemic;tC’xtcants

and chemicalmixtures.Cincinnati. Ohio.Octaher25. 1964.

(5) Bombergerat al.”l-lexachtorohenzenu:Chemistryof formationand identifiedsources,’SRi draft report to USEPA, Otfice ofPesticidesandToxic Substances.ContractNo. 68-4)2-3978.1984.

(6) Bradlaw, J.A.,Casterlinel-L.. Culture:ARapidScreenfor Detectionof PlanarPotachioninatedOrganicCompounds.”

Journalof Associationof Official AnolyticalGhemistry.62:904—916.1979.

(~)Crummetetal.Review andTrends intheAnalysis for PCDD/PCDF.Dow ChemicalCompanyAnalytical Laboratories.1986.

(8) Cull etal. “Polychlorodibenzo-P-DioxinsandDibenzofuransin TechnicalPentachiorophenol-Resultsof a CollaborativeAnalytical Exercise.”Ghemosphere,13:

10:1157—1165.1984.(9) Czuczwaei al. “Polychiorinated

DibenzodioxinsandDibenzofuransinSedimentsfrom Siskiwit Lake,IsleRoyale.”Ghemosohere,14: 6/7:823—626.1985.

(10) Czuczwa,J.M.,Hites,R.A.“EnvironmentalPateof Combustion-GeneratedPoiychlorinatedDioxins andFurans.”Environnsento)ScienceandTechnology,18:6:444—450.1984.

(11) Dioxins ‘84: Reporton Dioxins, Updateto November1984. Compiledby theFederalHealthOffice, FederalEnvirontnentalAgency,FederalRepublicof Germany.

(lot Dow ChemicalCompany.Directtestimonyof David 3’. Buzzeili beforeEPAinme: DocketNo. 413 ci el. Exhibit 810. Oct.14,1980.

(13) DynamacCorporation,EnvironrnerttalControl Division.Pre-flegolatoryAnafysisofFlameRetardents.EPA ContractNo. 68--Ui—6239. May 7, 1982.

(14) EnvironmentalDefenseFund andNationalWildlife Federation.Petitionto EPAto initiate roicmakingsto preventand reduceenvironmentalcontaminationby dioxins andfurans.October22, 1984.

(15) Espositoetat. tJSFPA,“Dtoxtns.”Cincinnati, Ohio. USEPAindustrialEnvironmentalResearchLaboratory,EPA800/2—80—197. 3980,

(15) G-ierthy atat. “Application of an invitro KeratinizationAssayto Extractsof SootFt-on-i a Fire in e PCB ContainingTransforcner.”lc,press.Fo~tciojnen:elandAppliedToxicolr’g;’. 1965.

(17) UdderT.H., 0-inert W.,“Standardizationof an Et.SBioassayforPCDDsandPCDFs,” Ghemcsphere,14:183—193. 1983.

(78) i--Mare et at, “Agricultural HerbicideUse andRisk of Lyn:pho—,ns ar:d Soft TtssueSat-c-ut-cia,”Journalof theArneiicenh-ieCi~c-a!A~aoc;oicoo-,255: 9: 1111—11’17.Sept. 20-36.

(19j fiotzinger at a “Pat rhiurinetedDibenzn-p-DioxinsandDcbenzcfurans:Ps

ilcoerta,-ticc-lApproach.’’ C/ionosphere.10:19— 25. 1981.

(OPt Kr.nteon, ~C.,PolandA.,‘Kero1nt.c-ei ‘:0 of mousete:,-atonrecc)) line

2.; :,r,:’.8-trire otorod:Le~zo-pclcoxmi: cc /n actro mode

tot lox-ian’;.’ Cell

22:27—30. 1988.(2!) Mesone’, ci. ‘ C’~Wafelerinelr:d

rl:hrnz-oluraItm)PCfJFnI (lorrelationb-ct---.eonin vice- and In v/Do ccructure-actcrelatione)tips.’’ Toxicolog’n 32:1, 3085.

(22) Mufiinney Ci al. “Slructure Spectf:c:ty‘and iho Dioxin Receptor.”tn: ChlorinatedDioxins andRelatedCon—pounds:Incoaclonthe Enrironment,”by Hulzingeratal. Ed.PergamonPress,p. 367. 1082.

(23) Mcfiinney etal. “DevelopmentandReliability of a Radioimmunoassayfor 2,3,7,8-Tetrachlomodihenzo-p-Dioxin.”In: Impact ofChlorinatedDioxins andRelatedCompoundson theEnvironment.Hutzinger,eds.Oxford:PenagamonPresspp. 67—69. 1981.

(24) MidwestResearchinstituie (MRI).Guidelinesfor theDeterminationofPolyhalogenatedDto-xins and-Dibenzofuransin CommercialProducts.EPA contractNo.68—02—3938:MRI ProjectNo. 8201—A(41).1985.

(25) Moore 81 a!. “ComparativeToxicity of3 HalogenatedDibenzofuransin GuineaPigs,Mice, andRhesusMonkeys.”N.YAcademyof ScienceAnnual,320, pp. 151-163.1979.

(26) Pattersonet a!, “2,3,7,8-Tetrachlorodibenzo-p-DioxinLevelsinAdiposeTissueof ExposedandControlPersonsin Missouri,”Journalof theAmericanMedicalssociarion.Vol. 256.19:2683-2586,November21, 1986,

(27) Poland,A.. Knutson J.C., “2,3,7,8-Tetrachlorodthenzo-pDioxin andRelutedHaiogenatedAromatic Hydrocarbons:Examinattonof theMechanismof Toxicity.”AnnualReviewPharmacologyandToxicology.22:517.1982.

(23) Sofa st at. Binding to the2,3,7,8-TCDDReceptorandAHH/EROD Induction:In vitroQSAR.BanburyReport18: BiologicalMechanismsof Dioxin Action. Cold SpringI lot-honLaboratory.1934.

(29) Schwetzel al. “Toxicology ofChlorinatedDthanzo-p-Dioxins.”EnvironmentalheaPSPerspectives.5:87-89.1973. -

(30)Thornsatal. “PclybrominatedOibenzodioxinsandFuransfrom thePyrotysisof FlameRetardants.”Chemosphere,Vol. 15, No. 5, pp. 649—652. -~

PergamonPress,1986.(31)Thornsatat. “Poiyb-romninated

Dibenzofurans(PBDF) andDibenzodioxtns(PBDD) from thePyrolysisof NealBrominatedDiphenvielhera,Biphenyis andPlasticivlixtures of TheseCompounaa.”Cheznosphere(In Press).

(32) USEPAOWES,ann OSWER. “DioxirtStrategy,”Washington,D.C. Off-tue of WaterReguiatioitsaridStandardsandOffice ofSolid WasteandEmergencyResponseincon)unctionwith theDioxin Strategy ISSitForce,1983.

(33) 00-PA, OW. “Ambient WaterQualityCriteriaDocuncentfor 2.3,7.8-Tetracftlorodibenzo-pDioxin.” ‘Washington,D.C. EPA 44~t/5--84—087.19.34.

(34) USEPA, ORD,OHEA, and5198-0.“Heaitt,Assessn,entDocttrneniforPolychlcrinateniDibenzo-pDioxins.”September1985.

(33-) 050-8-. f-ellen from 12/aicird6;-ieeeo’:e,-.Chatonani,Dioxin T~x:c

un;:V ,‘vi.’thc’dotogv SuSanrinD ,, adf.orion lawn, Coeinn’an.t--xc’crit:-cc.Contneit;e.c,tc Lee1.-I. 0-cmos,i1OJi Eoecmba”4, 1088-. SA23—EG--87--898.

(93-) US/EPAOPTS and015. P’ereac.a)Cr;-ro.’nunice/ion Loin Lit-. Stephen.B/it at, Ei’A.to Dr. PolarTong.OW, HERO.CRLE.. reLi-eec/catScreeningMethods for tImDeiec8onof PHOtOs andPi-IDFs. lone 3, 1985.

(37) USEPA,OPTS,OTS and510.Economicsn-aiystsof final sectionElba)reprintingrule for chemicalspotentiallycontaminatedwtth polyhalogenateddibeozo-p-dioxtnsand polyhalogenateddihenzofurans,December,1988.

(38) USEPA,OPTS,OTS andETD.Economicanaysisof final DataCati’ln underTSCA section8(c) of allegationsof significant

Federal Register I Vol. 52, No. 108 I Friday, june 5, 1987 I Rules and- Regulations 21437

adversereactionsfor chemicalspotentiallycontaminatedwith polyhalogenateddibenzo-p-dioxinsandpo!yha!ogenateddibenzofurans.December,1986.

(39) USEPA,OPTS, OTS andETD.Economicanalysisfor requirementunderTSCA section(d) for submissionofunpublishedhealthandsafetystudiesforchemicalspotentially contaminatedwithpolyhalogenateddibenzo-p-dioxinsandpolyha!ogenateddibenzofurans.December,1986.

(40) IJSEPA,OPTS.Reportof TheDioxinUpdateCommittee.Reviewof the‘l’oxicology, Bioavatlability,Pharmacokinetics,Mechanismof Action, andHuman Risks Associatedwith Dioxins.August 1986.

(41) USEPA,OPTS,01’S and ETD.Ecot~omicanalysisof final section4 testingrule for chemicalspotentiallycontaminatedwith polyhalogenateddibenzo-p-dioxinsandpolyhalogenateddibenzofurans.January,1987.

-(42) USEPA,OPTS,OTS. Memo fromDeniseM. Keehner,Chief,ChemicalRegulationBranch,ExposureEvaluationDivision, to theRulemakingRecord.May 4,1987.

(43) Versar, Inc. List of chemicalscontaminated or precursors to contaminationwith incidentallygeneratedpolychiorinatedandpolybrominateddibenzodtoxinsanddibenzofurans.EPA contractNo. 8&..02—3968,TaskNo. 48. 1985. -

XII. Other RegulatoryRequirements

A. ExecutiveOrder12291

Under ExecutiveOrder12201,EPAmust judge whether a regulation is“Major” and, therefore, subject to therequirement of a Regulatory ImpactAnalysis.This test rule is not majorbecauseit doesnot meetany of thecriteria set forth in section 1(b) of theOrder. First, the effecton the economyisnot expectedto exceedthe advantagesto the public of testing 12 chemicalsandreporting on thosecontaminated,plussomeadditional reporting. The totalcostsof testing are expectedto be$2.37million. No significant increasesinpricesareexpectedto occuras a resultof this rule, as reported in the economicimpactanalysis.No significantadverseeffectsareexpectedon competition,employment,investment,productivity,innovationoron theability ofUnitedStates-basedenterprisesto competewith foreign-basedenterprises.

This final regulationwassubmittedtothe Office of Managementand Budget(0MB) for review as required byExecutiveOrder12291.Any writtencommentsfrom 0MB to EPA andanyEPA responseto thosecomments,areincludedin the rulemakingrecord.

B. RegulatoryFlexibility ActUnderthe RegulatoryFlexibility Act

(15 U.S.C.601 et seq..Pub. L. 96-354,September19, 1980),EPA is certifying

that this test rule, if promulgated,willnot haveasignificant impacton asubstantialnumberof small businessesbecause:(1) Very few small chemicalmanufacturersandimporterswill berequiredto test chemicalsandreport,end(2) small manufacturershavebeenexemptedfrom a majorreportingrequirement.

For this rule, the definition of smallbusinessis the onecodified at 40 CFR704.3. For this certification, thetotalannualsalesfigure of $4 million, or $40million andlessthan100,000poundsannual production wasusedas thecutoff to denote small chemicalmanufacturersandimporters.

Of the firms likely to berequiredtotest,fourqualify assmall businesses.Thesefourfirms do not representasubstantialnumberof all small chemicalmanufacturing firms. For eachof thesefour firms, amortized test and reportingcostsareprojected to be lessthan 0.1percent of annual sales,approximatelythe samepercentageexperiencedbylarger manufacturing and importingcompanies.

G. PaperworkReductionAct

0MB hasapprovedthe informationcollection requirements containedin thisfinal rule under the provisions of thePaperwork Reduction Act of 1980,44U.S.C.3501et seq.,and has assigned0MB control numbers2070-0033forreportingunder section4, 2070-0004forsubmissionof health and safety studiesunder section8(d), 2070-0017forsubmissionof allegationsof significantadversereactionsundersection8(c),and 2070—0054for submissionofinformationundersection8(a).

List of Subjectsin 40 CFR Parts707and766

Chemicals, Environmental protection,Hazardousmaterial,Healthandsafety,Recordkeepingandreportingrequirements,Significantadversereactions,Testing.

Dated:May 20,1987.John A. Moore,,-lss/stontAdrninistmtorforPesticidesandToxicSubstances.

Therefore, 40 CFR Chapterusamendedas follows:

PART 707—~AMENOED]

1. In Part 707:a. The authority citation forPart 707

continuesto readasfollows:

AuthorIty: 15 U.S.C.28111b)and2612.

§ 707.72 TerminatIonof reporting

requirements.(a) Thereportingrequirementsof

SubpartD of this Partareterminatedforcertainspecificchemicalsubstancesandmixturesassetforth in this paragraph.

(1) Whenduta requiredunderPart766of this chapterhavebeensubmittedtoEPA for a specificchemicalsubstanceproducedby a specificprocess,andthedatashowno positive testresultasdefinedin § 766.3 of this chapter,reportingis no longerrequiredbypersonswho exportor intend to exportthatsubstanceproducedby thatprocess.

(2) [Reserved](b) [Reserved]2. By addingPart768 to readas

follows:

PART 766—DIBEP4ZO-PARA-DIOXINS/DIBENZOFURANS

Subpart A—General ProvisionsSec.766.1 Scopeandpurpose. -

786.2 Applicability anddurationof this Part.766.3 Definitions.786.5 Compliance.786.7 Submissionof information.706.10 Test standards.786.12 Testingguidelines.768.14 Contentsof protocols.766.18 Developingtheanalyticaltest

method. -

768.18 Methodsensitivity.

SubpartB—SpecificChemicalTestlng/ReportingRequirements -

760.20 Who musttest.786.25 Chemicalsubstancesfor testing.788.27 CongenersandLOQsfor which

quantitationis required.78628 Expertreviewof protocols.786.32 Exclusionsandwaivers.786.35 Reportingrequirements.766.38 Reportingon precursorchemical

substances,AuthorIty: 15 U.S.C.2603 and2607.

§ 766.1 Scopeandpurpose.(a) This Part identifies requirement8

for testing under section4 of theToxicSubstancesControl Act (TSCA), 15U.S.C.2603, to ascertainwhethercertainspecifiedchemicalsubstancesmaybecontaminatedwith halogenateddibenzodioxins(HDDs)/dibenzofurans(HDFs)asdefinedin § 766.3,andrequirementsfor reportingundersection8 of TSCA, 15 U.S.C. 2607.

(b) Section766.35(b)requiresmanufacturersandprocessorsofchemicalsubstancesidentified in§ 768.25 to submit to EPA: (1) Anyexistingtestdatashowinganalysisofthe chemicalsubstancesforconcentrationsof HDDs/HDFs,applicableprotocols,andtheresultsof

b. By addinga new § 707.72toSubpatD to read as follows:

21438 Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations

theanalysisfor HDDs/HDFs, (2)allegationsof significantadversereactionsto HDDs/HDFs,compiledinaccordancewith Part 717of this chapter,and(3) healthand safetystudieson theHDDs/HDFs,in accordancewithapplicableprovisionsof Part716 of thischapter.

(c) Section766.35(a)requiresmanufacturersand,undercertaincircumstances,processorsof chemicalsubstancesidentified in § 766.25tosubmitlettersof intent to testandprotocolsfor theanalysisof thechemicalsubstancesfor thepresenceofHDDs/HDFs.Section766.20requiresthesemanufacturersandprocessorstotest their chemicalsubstancesfor thepresenceof HDDs/HDFs.Anysubmissionsmust be in accordancewiththe EPA ProceduresGoverningTestingConsentAgreementsandTestRulescontainedin Part790of this chapterandany modifications to suchprocedurescontainedin this Part.

(d) Section766.32specifiesconditionsunderwhich personsrequiredto testmay requestan exclusionor waiverfrom testing.

(ci Deadlinesfor submissionto EPA ofprotocols,reports,studies,andtestresultsarespecifiedin Part 790 SubpartC and§ 766.35.

(fJ Sections766.10,766.12, 766.14,766.16.and766.18prescribeanalyticalmethodsrequired; § 766.27prescribestarget levelsof quantitation(LOQ) foreachcongenerfor which quantitationisrequired.

(g) If resultsof existingtestsor testsperformedunderthis Partindicatethepresenceof HDDs/HDFsin theidentified chemicalsubstanceabovetheLOQ specifiedin § 766.27, § 786.35(c)requiresthefollowing additionalreportingon thespecifiedchemicals:production,process,use,exposureanddisposaldataundersection8(a) ofTSCA; healthandsafetystudiesundersection8(d) of TSCA; andreports ofallegebonsof significantadversereactionsundersection8(c) of TSCA. Insomecases,additional reporting mayberequiredof manufacturersreportingriocontaminationof the identified chemicalsubstancesunder§ 766.35(c)(2).

(Ii) Section76638requiresmanufacturersof chemicalsubstancesproducedfrom chemicalsubstancesidentified aspossibleprecursorstoHDD!HDF formation, to reportonchemicalsubstancesproducedfromsuchprecursors.

§ 766.2 Applicability anddurationof thispart.

(a) Chemicalsubstancessubjecttotesting. (1) This Part is applicabletoeachpersonwho, at any time during the

durationof this Part,manufactures(and/orimports),or processes,achemicalsubstanceidentified under§ 766.25.

(2) The durationof this Partfor anytesting requirementfor any chemicalsubstanceis theperiod commencingwith the effectivedateof this Part to theendof the reimbursementperiod, asdefinedin § 766.3, for eachchemicalsubstance.All reportingrequirementsfor any chemicalsubstancelisted under§ 766.25shall be in effectfor thesameperiod asthe testingrequirement.

(b)Precursorchemicalsubstances,(1)This Part is applicableto eachpersonwho manufactures(and/orimports) achemicalsubstancefrom anyprecursorchemicalsubstanceidentified in§ 766.38.

(2) The requirementfor precursorreportingunder§ 766.38shall be ineffectuntil threeyearsafter the effectivedateof thisPart.

(3) Small manufacturersareexemptfrom reportingprocessandreactionconditiondata on chemicalsubstancesmadefrom precursorchemicalsubstanceslistedunder§ 766.38.

§ 766.3 Definitions.The definitions in section3 of TSCA

andthe definitions of §~704.3, 716.3,717.3, and790.3 of this chapteralsoapplyto this Part.

“Congener”meansanyoneparticularmemberof aclassof chemicalsubstances.A specificcongenerisdenotedby uniquechemicalstructure,for example2,3,7,8-tetrachlorodibenzofuran.

“Dibenzofuran”meansanyof afamilyof compoundswhichhasasanucleusatriple-ring structureconsistingof twobenzenerings connectedthrougha pairof bridgesbetweenthe benzenerings.The bridgesareacarbon-carbonbridgeandacarbon-oxygen-carbonbridgeatboth substitutionpositions.

“Dibenzo-p-dioxin”or “dioxin” meansany of a family of compoundswhich hasas a nucleusa triple-ring structureconsistingof two benzeneringsconnectedthroughapairof oxygenatoms.

“Guidelines” meanstheMidwestResearchInstitute (MR1) publicationGuidelinesfor theDeterminationofPolyhalogenatedDioxinsandDibenzofuransin CommercialProducts,EPA contractNo. 68—02—3938; MRIProjectNo. 8201—A(41), 1985.

HDD” or ‘2,3,7,8-HDD” meansany ofthe dibenzo-p-dtoxinstotally chlorinatedor totally brominatedat the followingpositionson themolecularstructure:2,3,7,8; 1,2,3,7,8;1,2,3,4,7,8;1,2,3,6,7,8;1,2,3,7,8,9;and1,2,3,4,7,8.9.

“HDF” or 2,3,7,8-HDF”meansanyofthe dibenzofuranstotally chlorinatedortotally brominatedat thefollowingpositionson themolecularstructure:2,3,7,8;1,2,3,7,8;2,3,4,7,8;1,2,3,4,7,8;1,2,3,6,7,8;1,2,3,7,8,9;2,3,4,6,7,8;1,2,3,4,6,7,8;and1,2,3,4,7,8,9.

“Homolog” meansa groupof isomersthathavethesamedegreeofhalogenation.For example,thehomologousclassof tetrachlorodibenzo-p-dioxins consistsof all dibenzo-p-dioxins containingfour chlorine atoms.Whenthe homologousclassesdiscussedin this Partarereferredto, the followingabbreviationsfor theprefix denotingthenumberof halogensareused:

tetra-,T (4 atoms)penta-,Pc (5 atoms)hexa-,Hx (6 atoms)hepta-,Hp (7 atoms)“HRGC” meanshigh resolutiongas

chromatography.‘HRMS” meanshigh resolutionmass

spectrometry.“Level of quantitation” or “LOQ”

meansthe lowest concentrationatwhichHDDs/HDFscanbe reproduciblymeasuredin a specificchemicalsubstancewithin specifiedconfidencelimits, asdescribedin this Part.

“Polybrominateddibenzofurans”refers to anymemberof a classofdibenzofuranswith two to eight brominesubstituents.

“Polybrominateddibenzo-p-dioxin”or‘PBDD” meansto anymemberof aclassof dibenzo-p-dioxinswith two to eightbrominesubstituents.

‘Polychlorinateddibenzofuran”meansanymemberof a classofdibenzofuranswith two to eight chlorinesubstituents.

“Poiychlorinateddibenzo-p-dioxin”or“PCDD” meansanymemberof a classof dibenzo-p-dtoxinswith two to eightchlorine substituents.

“Polyhalogenateddtbenzofurun”or“PHDF” meansany memberof a classofdibenzofuranscontainingtwo to eightchlorine, bromine,or a combinationofchlorine andbrominesubstituents.

“Polyhalogenateddibenzo-p-dioxin”or “PHDD” meansanymemberof aclassof dibenzo-p-dioxinscontainingtwo to eight chlorine substituentsor twoto eight bromine substituents.

‘Positive testresult” means:(1) Anyresolvablegaschromatographicpeakforany2,3,7,8-HDDorHDF which exceedsthe LOQ listedunder§ 766.27for thatcongener,or (2) exceedsLOQsapprovedby EPA under§ 766.28.

“Precursor”meansa chemicalsubstancewhich is not contaminateddueto theprocessconditionsunderwhich it is manufactured,but becauseofits molecularstructure,andunder

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 2143~

favorableorocessconditions,it maycauseor aid theformation of HDDs/HDFs in otherchemicalsin which it isusedasa feedstockor intermediate.

“QA” meansquality assurance.“QC” meansquality control.“Reimbursementperiod”meansthe

periodthat beginswhen thedatafromthelast test to be completedunderthisPart for a specificchemicalsubstancelisted in § 766.25 is submittedto EPA,andendsafteranamountof time equalto thatwhich hadbeenrequiredtodevelopthat dataor 5 years,whicheveris later.

“‘rsCA” meanstheToxic SubstancesControlAct, 15 U.S.C.2601 etseq.

§ 766.5 Compliance.Any personwho fails or refusesto

comply with anyaspectof this Partis inviolation of section 15 of TSCA. Section15(1)makesit unlawful for anypersonto fail or refuseto comply with anyruleor orderissuedundersection4, Section15(3) makesit unlawful for anypersonto fail orrefuseto submitinformationrequiredunderthis Part.Section16providesthata violation of section15rendersa personliable to the UnitedStatesfor acivil penaltyandpossiblecriminal prosecution.Undersection17of TSCA, the district courtsof theUnitedStateshavejurisdiction torestrainanyviolation of section 15.

§ 766.7 Submissionof information.All information (includinglettersof

intent, protocols,data,forms,studies,andallegations)submittedto EPA underthis Part mustbeartheapplicableCodeof FederalRegulations(CFR) sectionnumber(e.g., § 766.20)andmustbeaddressedto: DocumentControlOffice(TS—790),Office of PesticidesandToxicSubstances,EnvironmentalProtectionAgency. 401 Nt Street,SW., Washington,DC 20460.

§ 766.10 Teststandards.Testing requiredunderSubpartB of

this Partmustbeperformedusing theprotocolssubmittedto andreviewedbythe EPA expertpanelestablishedunder§ 786.28. All new data,documentation,records,protocols,specimens,andreportsgeneratedas a resultof testingunderSubpartB of this Part mustbefully developedandretainedinaccordancewith Part 792of this chapter.Theseitemsmust be madeavailableduring aninspectionor submittedtoEPA uponrequestby EPA or itsauthorizedrepresentative.Laboratoriesconductingtesting for submissiontoEPA in responseto a test rolepromulgatedundersection4 of TSCAmustadhereto theTSCA GoodLaboratoryPractices(GLPs) published

in Part 792 of this chapter.Sponsorsmust notify thelaboratorythat thetestingis beingconductedpursuanttoTSCA section4. Sponsorsare alsoresponsiblefor ensuringthatlaboratoriesconductingthe testingabideby theTSCA GLP standards.Atthetime testdataaresubmitted,manufacturersmust submitacertificationto EPA that thelaboratoryperformingthe testing adheredto theTSCA CLPs.

§ 766.12 Testing guideilnes.

Analytical testmethodsmustbedevelopedusingmethodsequivalenttothosedescribedor reviewedinGuidelinesfor theDeterminatiouofPolyhalogenotedDibenzo-p-dihxir~sandDibenzofuransin CommercialProducts.Copiesareavailablefrom the TSCAAssistanceOffice, (TS—799),Office ofToxic Substances,EnvironmentalProtectionAgency, 401 M St., SW.,Washington,DC 20460(800—424—9065).Copiesarealso locatedin thepublicdocketfor this Part(docketno. OPTS—83002)andareavailablefor inspectionin theOPTS ReadingRm.,NE—G004, 401M St., SW., Washington,DC, from 8 a.m.to 4 p.m.,MondaythroughFriday,exceptlegal holidays.

§ 766.14 Contentsof protocols.

Protocolsshould includeall partsoftheQualityAssurancePlanforMeasurementof BrominatedorChlorinatedDibenzofuransandDibenzoa’ioxins,asstatedin theGuidelines.For eachchemicalsubstanceandeachprocess,themanufacturermustsubmit a statementof how manygradesof thechemicalsubstanceitproduces,a justification for selectionofthe specificgradeof chemicalsubstancefor testing, specificplansfor collectionof samplesfrom theprocessstream,naming thepoint of collection, themethodof collecting thesample,andanestimateof how well thesampleswillrepresentthematerial to becharacterized;a descriptionof howcontrolsamples(blanks)andHDD/HDF-reinforcedcontrolsamples.orisotopicallylabeledcompounds(standards)andduplicatesampleswillbehandled;a descriptionof thechemicalextractionandcleanupproceduresto beused;how extractionefficiencyandmeasurementefficiencywill be established;anda descriptionofinstrumenthardwareandoperatingconditions,including typeandsourceofcolumns,carrier gasandflow rate,operatingtemperaturerange,andionsourcetemperature.

§ 766.16 Developingtheanalyticaltestmethod.

Becauseof the matrix differencesofthechemicalslistedfor testing,no onemethodfor sampleselection,preparation,extractionandcleanup isprescribed.For analysis,HighResolutionGasChromatography(HRGC)with High ResolutionMassSpectrometry(HRMS) is the method-ofchoice,but othermethodsmaybeusedif theycan be demonstratedto reachthetargetLOQs as well asHRGC/HRMS.

(a)Sampleselection.The chemicalproductto be testedshould besampledso that the specimenscollectedforanalysisarerepresentative-ofthewhole.Additional guidancefor sampleselectionis providedunder § 766.12.

(b) Samplepreparation.The samplemustbe mechanicallyhomogenizedandsubsampledasnecessary.Subsamplesmustbespikedon reinforcedwithsurrogatecompoundsor with standardstocksolutions,andthesurrogatesorstandardsmustbethoroughlyincorporatedby mechanicalagitation.Additional guidanceis providedunder§ 766.12.

(c) Sampleextractionandcleanup.The spikedsamplesmustbetreatedtoseparatetheHDDs/HDFsfrom thesamplematrix. Methodsarereviewedinthe Guidelinesunder§ 766.12,but thefinal methodor methodsareleft to thediscretionof theanalyst,providedtheinstrumentalresponseof thesurrogatesmeetsthe criteria listed in theQualityAssurancePlanfor MeasurementofBrominatedor ChlorinatedDibenzofuransandDibenzodioxins,appendixesB andC of the Guidelines.Cleanuptechniquesaredescribedin theGuidelines.Theseare chosenat thediscretion of theanalystto meettherequirementsof thechemicalmatrix.

(d) Analysis.Themethodof choiceisHigh ResolutionGasChromatographic/High ResolutionMassSpectmometricDetermination,(HRGC/HRMS)butalternatemethodsmay beusedif themanufacturercandemonstratethat themethodwill reachthe targetLOQsaswell asHRGC/HRMS.Specificoperatingrequirementsarefoundin theGuidelines.

§ 766.18 Methodsensitivity.

The targetlevel of quantitationrequiredunder§ 766.27for eachHDD/HDF congeneris thelevel whichmustbe attemptedfor eachresolvedHRGCpeakfor that congener.For at leastoneproductsample,at least two analysesofthesameisotopically labeledHDD/HDFinternal calibrationstandardsspikedtoafinal productconcentrationequal tothe LOQ for that congenermust be

21440 FederalRegister / Vol. 52, No. 108 / Friday, June 5,1987! Rules and Regulations

reproduciblyextracted,cleanedup, andquantifiedto within ±20percentof eachother.For eachspikedproductsample,the signal to noiseratio for thecalibrationstandardpeaksaftercomplete extraction and cleanup mustbe10:1 orgreater.Therecoveryof theinternalcalibrationstandardsin theextractedand cleanedup productsamplesmust be within 50 to 150percentof the amountspiked,andtheresultsmustbe correctedfor recovery.Subpart B—Specific Chemical Testingf

Reporting Requirements

§ 776.20 Who musttest.(a) Any personwho manufactures,

imports,or processesa chemicalsubstancelistedin § 766.25musttestthat chemicalsubstanceandmustsubmit appropriateinformationto EPAaccordingto theschedulesdescribedin§ 766.35.Chemicalsubstancesmanufactured,importedor processedbetweenJanuary1, 1984 andthedateofpromulgationof this Partaresubjecttotestinguponthe effective dateof thisPart. All other chemicalsubstancesaresubjectto testingimmediatelyuponmanufacture,import or processing.EPAexpectsthatonly manufacturersandimporterswill performtesting,andthatthecost of testing will bepassedon toprocessorsthroughthepricingmechanism,therebyenablingthem toshare in the costof testing. However,processorswill be calledupon tosponsortesting should manufacturersandimportersfail to do so.A processormay applyfor anexemptionfrom testinguponcertification to EPA thatamanufactureror importeris testing thechemicalsubstancewhich thatpersonprocesses.

(b) If no manufactureror importerdescribedin § 766.20submitsa letterofintent to perform-testingwithin theperioddescribedunder§ 766.35(a),or anexemptionapplicationunder§ 790.45(a),or arequestfor anexclusionor waiverunder § 766.32,E-PA will issueanoticein theFederal Register to notify allprocessorsof thatchemicalsubstance.The noticewill statethatEPA hasnotreceivedanyof thedocumentsdescribedin theprevioussentence,andthatcurrentprocessorswill have30daysto submit eitheraletter of intent toperformthetestor submitan exemptionapplication.

(c) If no manufacturer,importerorprocessorsubmitsaletter-ofintent toperformtestingof a specificchemicalsubstanceproducedby aspecificprocess,EPAwill notify all -

manufacturers,importers,andprocessors,either by noticein theFederal Register or by letter, that all

exemptionapplications will be deniedandthatwithin 30 daysallmanufacturers,importers,andprocessorswill bein violation of thisPart until a proposedstudy plan issubmittedfor required testing.

(d) Manufacturers, importers, andprocessorswho are subject to this Partmustcomply with the testruledevelopmentandexemptionproceduresin Part790of this chapter,exceptasmodified in this Part.

§ 766.25 Chemical substancesfor testing.(a)Listing of chemicalsubstances,

Chemical substancesrequired to betestedfor HDDs/HDFs under this rulearelisted in this section.Thelisting isby ChemicalAbstracts Service(CAS)Numberandcommonname.

Note.-.--Forpurposesof guidanceonly, EPAlists thechemicalsubstancessubjecttotestingunderthis Partin two classes—thoseknownto bemanufacturedor importedbetweenJanuary1, 1984, andpromulgationofthis Part, andthosenot knownto bemanufacturedor importedat thetime ofpromulgationof this Part.

(1) Chemicalssubstancesknownto bemanufacturedbetweenJanuary1, 1984anddateofpromulgationof this Part.

CAS No. chemaatname

79-94-7 Tetrabromobisphenol-A.118—75—2 2,3,5,6-Tetrach~oro-2.5-cyc!ohexadiene-1 4.

dione.I 18-79—6 2.4,6-Tnbromophenot.120-83—2 2.4-Dichtorophenot.

1163—19—5 Decabromodiphenytoxide.4162-48—2 Totrabromotxsphenot-A-bisethocylate.

21850—44—2 1etrabromobisphenol-A-bis~2,3-dibrocnopropytether.

25327-89—3 AHyl ether of tetrabromobisphenol-A.32534-81-9 Peritabromodiphenytoxide.32536—52—0 Octabromodiphenytoede.37853-50—1 1 ,2-BIs(tribromophenoxyt-ethane.55205-38-4 Tetrabromobispfienol-A cbacrytate,

(2) Chemicalsnotknownto bemanufacturedbetweenJanuary1, 1984andthedate ofpromulgationof thisPart.

CA5 No. Chemicalname

79-95-8 Tefrachtorobisphenol-k87—10—5 3,4’,5-Tribromosalicylaniiide.87-65—0 2,6-Dicotorophenot. -

95-77—2 3,4-Oichloropfienol.95-95-4 2,4,5-Trichtorophenot.99-28—5 2,6-Dibromo-4-nitrophenof.

120—36-8 2~2.4-(Dichtoropherioxy~-propionic acid,320-72-9 3,5-Dichlorosaicyc9c acid.488-47—1 Tetrabromocatechot.576—24—9 2.3.Dichtorophenol.583-78-8 2,5-Dic’nloropbenot.608-71—9 Pentabromophenol.615-58-7 2,4-Oibromophenol.933-75-5 2,3,6-Tnchlorophsnol.

1940—42—7 4-Bromo~2,5-dichIorophenol.2577-72-2 3,5-Oibromosalicylanilide.3772—94-9 Pentachlorophenyt taurate.

37853-81—5 Btsmettiyteeher of tetrabromobisphenol-A.A%y’.amine tetrachiorophenate.Tetrabrornobisphenol.B.

(b) Gradeto be tested.If thesameprocessis usedto manufactureall

gradesof thesamechemicalsubstance,only onegradeneedbe tested.Thegradeto betestedmust be thegradesubjectto themost intenseheatandalkalinity for the longestdurationoftime, manufacturedundereachdifferentprocess.If the heat,alkalinity anddurationof reactiondo not differ forvariousgrades,the testsubstancemustbe thegradeof chemicalsubstancewiththehighestvolume of sales.

§ 766.27 Congenersand LOOs for whichquantitationIs required.

Quantitationat thetargetLOQ shownfor eachof thefollowing HDDs/HDFswhichmaybe presentin the chemicalsubstancesis requiredfor thechemicalsubstanceslisted under§ 766.25.Analysismusttakeplacefor eitherchlorinatedor brominateddibenzodioxinsor dibenzofurans,whicheveris predominantlyexpectedtooccurin the chemicalsubstanceto betested.Only chlorinated and brominatedcongenersneedbequantified;forchemicalsubstancescontainingpredominantly chlorine atoms, onlycongenerstotally chlorinated at thenumbered positions needbe quantified;for chemicalsubstancescontainingpredominantly bromine atoms, onlycongenerstotally brominatedat tilenumbered positions needbe quantified.

chiosnated dioxins Brominated dioxins LOQ

2,3,7,8-TCDD 2,3,7,8.TBDD 0.1 ppb.1 .2.3,7,8-PeCOD I .2,3,7,8-PeBDO 0.5 ppb.1 ,2,3,4,7,8.HxCDD I,2.3,4,7,8-HxBDD 2.5 ppb.1 .2,3,6.7,8-HxCDD 1 ,2,3,5,7,8-HxBDD 2.5 ppb.1 ,2.3,7,8,9-HxCDO 1 ,2,3,7,8,9-HxBDD 2.5 ppb.1 ,2,3,4,6,7,8-HpcDD 1 ,2,3,4,6,7,8.HpUDD 100 ppb.2,3.7,s-TCDF 2,3,7,8-TBDF 1 ppb.1,2,3,7,8-PeCDF 1,2,3,7,8-PeBDF 5 ppb.2,3,4,7,8.PeCDF 2,3,4,7,8-PeBDF 5 ppb.1,2,3,4,7,8-HxCDF 1,2,3,4.7,8-HxBDF 25 ppb.1,2,3,6,7,8’HxCDF 1,2,3,6,7,8-HxBDF 25 ppb.1,2,3,7,8,9-HxCDF 1,2,3,7,8,9-HxSOF 25 ppb.2,3,4,6,7,8~FlxCDF 2,3,4,6,7,8-HxBDF 25 ppb1,2,3,4,6,7,8-H~CDF 1,2,3,4,6,7,8-HpBDF 1 ppr~.1,2,3,4,7,8,9-HpCDF 1,2,3,4,7,8,9-HpBOF 1 ppr,,.

§ 766.28 Expertreviewof protocols.

EPA will gathera panelof expertsinanalysisof chemicalmatricesfor HDDs/HDFsto reviewthe protocolsfor testingsubmittedto EPA. Thepanelmemberswill be employeesof EPA and/orofotherU.S. Governmentagencieswhohavehadexperiencein analysisofchemicalmatricesand/orchemicalwastesfor HDDs/HDFs.Thepanelwillrecommendto theDirector, EPA Officeof Toxic Substances,whethertheprotocolsubmittedis likely to allowanalysisdownto thetargetLOQs, or ifnot,whethertheprotocolrepresentsagood faith effort on thepartof the testerto achievethelowest possibleLOQs.The final determinationto acceptor

Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / Rules and Regulations 21441

rejecttheprotocolwill be madeby theDirector, Office of Toxic Substances.EPA will reviewthe submittedprotocolsas rapidly aspossibleandwill completethe review within 90 daysafter receipt.EPA may requiresubmissionof revisedprotocols.Commentsandrecommendationswill be transmittedtothesubmitter,andif revisionsarerequired,a final protocolmustbesubmittedto EPA within 90 daysafterEPA transmitssuchrecommendations.

§ 766.32 Exclusionsandwaivers.(a)Reasonsfor exclusionsand

waivers.Any personsubjectto thetestingrequirementsof this Part mayrequestanexclusionorwaiver fromtestingfor anyoneof thefollowingreasons:

(1) Exclusionsmaybegrantedif. (i)Testingof theappropriategradeof thechemicalsubstancehasalreadybeencarriedout, eitheranalyticaltestingatthe lowestLOQ possible,withappropriateQA/QC, orawell-designedbioassaywith appropriate QA/QC or;

(ii) Processandreactionconditionsofthechemicalsubstancesuchthat noFIDDs/HDFscouldbe producedunderthoseconditions;

(2) Waiversmaybegrantedif. (i) Aresponsiblecompanyofficial certifiesthat the chemicalsubstanceis producedonly in quantitiesof 100kilogramsorlessper year,only for researchanddevelopmentpurposes;or

(ii) In thejudgementof EPA, thecostof testing would drive the chemicalsubstanceoff the market,or preventresumptionof manufactureor import ofthechemicalsubstance,if it is notcurrentlymanufactured,andthechemicalsubstancewill beproducedsothat no unreasonablerisk will occurdueto its manufacture,import, processing,distribution,use,or disposal.(in thiscase,themanufacturermust submittoEPA all datasupportingthedeternunation.)

(iii) Waiversmay beappropriatelyconditionedwith respectto suchfactorsas time andconditionsof manufactureor use.The gradeof decabromodiphenyloxideproducedby Dow ChemicalCompany(Dow) for theNationalToxicology Program(NTP)bioassayonthat chemicalis excludedfrom thetesting requirementunderthis Part.Provided,however,that this exclusionwill not apply if Dow fails to supply toEPA within 60 daysof theeffectivedateof this sectionevidenceshowingwhichgradewas usedfor the NTPbioassay.

(h) Timing. Exclusionor waiverrequestsanddetailedsupportingdatamust be submittedto EPA within 60daysfrom theeffective dateof this Partfor personsmanufacturing,importing or

processinga chemicalsubstanceasofthedateof promulgation,or 60 daysprior to thedateof resumptionofmanufactureor import for achemicalsubstanceproducedby a specificprocessif the chemicalsubstanceis notmanufactured,importedorprocessedasof thedateof promulgation. -

(c) Publication. Within 10 daysofreceiptof anyexclusionor waiverrequest,EPA will issuein theFederalRegistera notice of suchreceipt. EPAwill alsoissuea noticeof its decisiononeachexclusionor waiver requestwithin60 daysof receipt.

(d) Decisj’on. TheEPA Directorof theOffice of Toxic Substanceswill makethe decisionto grantordenywaiversorexclusions.

§ 766.35 Reportingrequirements.(a) Lettersof intent, exemption

applications,andprotocols—(1)Lettersof intent. (i) Personswho havemanufacturedor importedchemicalsubstanceslisted under§ 766.25betweenJanuary1, 1984,andtheeffective dateof this Partarerequiredtosubmit under§ 790.45of this chapteraletterof intent to testor anexemptionapplication.Theselettersmust besubmittedno laterthan September3,1987.

(ii) Personswho commencemanufacture,import or processingof achemicalsubstancelisted under§ 766.25that has not been manufactured,importedor processedbetweenJanuary1, 1984and the effective date of this Partmustsubmitunder§ 790.45of thischapter,within 60 daysafter thecommencementof manufacture,import,or processingof the chemicalsubstance,a letterof intent to test or an exemptionapplication.

(iii) Personswho commencemanufacture,import or processingof achemicalsubstancelistedunder§ 766.25betweentheeffective dateof this Partandtheendof thereimbursementperiodfor thatparticularchemicalsubstanceproducedby a specificprocessmustsubmit under§ 790.45of this chapter,within 60 daysafter the commencementof manufacture,import or processingofthechemicalsubstance,a letterof intentto test or anexemptionapplication.

(2) Protocols. (i) Eachpersonwho ismanufacturingor processingachemicalsubstancelistedin § 766.25as of theeffectivedateof this Partwho submitsanoticeof intent to testunder§ 766.35(a)(1Jmust submit aprotocolforthe testas follows:

(A) The protocols for eachchlorinatedchemicalsubstanceproducedby eachprocessto be testedmustbe submittedto EPA no later than 12 monthsafter theeffective date of this Part.

(B) The protocolfor eachbrominatedchemicalsubstanceproducedby eachprocessto be testedmust be submitted -

to EPA no laterthan 24 monthsafter theeffective dateof this Part.

(ii) For chemicalsubstancesproducedby a specificprocessnot manufacturedor processedas of the effective dateofthis Part,apersonwho beginsmanufactureandsubmits a noticeofintent to testmust submitprotocolsforthetestasfellows:

(A) Protocolsfor testing mustbesubmitted12monthsaftermanufacturebeginsfor chlorinatedchemicalsubstances.

(B) Protocolsfor testing mustbesubmitted24monthsaftermanufacturebeginsfor brominatedchemicalsubstances.

(iii) For personswho havebeengrantedexemptions,waiversorexclusionsfrom testing,protocolsmustbesubmitted12 monthsafterexpirationof the exemption,waiveror exclusionfor chlorinatedchemicalsubstances,and24 monthsafterexpirationof theexemption,waiveror exclusionforbrominatedchemicalsubstances.

(b) information thatmustbesubmittedto EPA. (1) Personswhomanufactureor import a chemicalsubstancelisted under§ 766.25mustreportno laterthanOctober5, 1987 or90 daysafterthepersonfirstmanufacturesor imports thechemicalsubstance,whicheveris later, theresultsof all existingtestdatawhichshowthatchemicalsubstancehasbeentestedforthe presenceof HDDs/HDFs.

(2) Any manufactureror importerof achemicalsubstancelistedin § 766.25inpossessionof unpublishedhealthandsafetystudieson HDDs/HDFsisrequiredto submit copiesof suchstudiesto EPA no laterthan October5, 1987 or90 daysafter thepersonfirstmanufacturesor imports thechemicalsubstance,whicheveris later.Thefollowing provisionsof Part716 of thischapterapply to submissionof thesestudies:§~716.3, 716.10(a)(1) and(4);716.20(a)(1), (2), (3), (4), (7), (8) and(10);716.25;716.30; 716.35(a)(1), (2), and(4) [ifapplicable);716.35(b) and(c); 716.40(a)and(b); 716.50; 716.55;and716.60(a)(2).

(3) No laterthan October5, 1987 or 90daysafter thepersonfirst manufacturesor imoorts thesubstancelisted in§ 766.25,anymanufactureror importerof achemicalsubstancelisted in§ 766.25must submit recordsrequiredtobe heldunderPart717 of this chapteronanyHDDs/HDFs.

(4) Test results.(i) Test resultsmustbe repentedto EPA not laterthan 270daysafterEPA’s transmissionofcommentsor ‘180 daysafter a final

21442 Federal Register / Vol. 52, No. 103 / Friday, June 5, 1987 / Rules and Regulations

protocolis submittedto EPA, whicheveris shorter. -

(ii) For purposesof reportingtestresultsto EPA, andfor furtherreportingtriggered by a positive test resultunder§ 766.35(c),apositivetestresultisdefinedat § 766.3. -

(iii) Reportingof testresultsmustfollow procedures-setout in Part790ofthis chapter,exceptasmodifiedin thisPart.

(c) information requiredto besubmittedto EPA aftersubmissionof apositivetestresult.(1) Any personwhosubmits a positive test result for aspecificchemicalsubstancelistedunder§ 766.25must submitto EPA no laterthan 90 daysafter the date ofsubmissionof thepositivetestresultthefollowing:

(i) A completedform (EPA7910—51)for that chemicalsubstance.Theformappears at paragraph (d)(5) of thissection and copiesare available fromtheTSCA AssistanceOffice, (TS—799),Office of Toxic Substances,Environmental Protection Agency,401MSt., SW., Washington, DC, 80460.Oneform must be submittedfor eachchemicalsubstancefor which apositivetest resulthas beensubmitted.

(ii) Healthandsafetystudiesfor thechemicalsubstancefor which a positivetest resulthas beenreported. Thefollowing provisions of Part 716 of thischapterapplyto submissionof thesestudies:§~716.3; 716.10(a)(1), (2), (3)and(4); 716.20;716.25;716.30;716.35(a)(1), (2), and(4), [if applicable);716.35(b)and(c); 716.40(a)and(b); 716.50;716.55;716.60(a)(2).

(iii) Copies of recordson the chemicalsubstancesrequired to be held underPart717of this chapter.(2) If apositivetest resulton achemicalsubstanceis receivedfrom onepersonbut not from others;-EPA mayissuea noticein theFederalRegisterlisting that chemicalsubstanceandrequiringanypersonmanufacturing,importing orprocessingthatchemicalsubstancewho hasnot submittedapositive testresultto submit theinformation required in Part II of EPAForm 7910—51 (appearingin § 766.35(d)).Such anoticewill be publishedonly ifEPA needsadditional processdata tomakea determination of unreasonablemis-k.

(d) Dioxin! Furan Reporting Form:BtLUNG CODE 6560-50-U

FederalRagistee/ Vol. 52, No. 100 / Friday, June 5, lOb? / RulesandRegulatiors

P,’ci~1 of 6UnOedle~hnviionn~-lalPmtaciionAge~cy

Washington, DC 20460 ,

~ E PA D~ox~ns/FuransReport ~o~ie0~7

Men compleied. send :n.sform io

DocumentControl OfficerOffice of Toxic Substances,1 S-793US EnvironmentalProtectionAgency401 M Street, SWWashington,DC 20460

~uinentcontrolNu’nbe,Dockeir4uiriber

Part — General Information

SectionA — SubmitterIdentification confi-—) dential

Mark (X) the “Confidential” box next to an subsection ou c/aim as conf,dentiot —

la. ~~ttin9 ~

Company

Mailing address (number and Street)

City, State, and ZIP Code

Section B — Chemical Identity Information (Usea separate form for eachchemical reported.)

Mark IXJ Co, idenibox next to en ubs n ou claim as confidential.1. Chemicat name and CAS Registry Number

Part II — Process and Release Information

SectionA — Flow Diagram

MarR(.~Jhe~,~,’ç,onf~”dentia/”boxnext to any subsection you claim as confidential.Completethis Sectionfor eachunit process.Provide ageneralprocessblock flow diagramthat dentifiesmajor unitoperationsandtreatmentprocessesand indicatethetypesand points of reteaseof byproductsand residuals.(Seeexample/attached.)(1 (Includeintermediates,coproductsandbyproductsproducedby the process.(2) Prude a block for eachmajorunit operation(e.g.. reactor,washer,1,/Iration. aii emissioncontrol, aerationlagoon,etc.) in the production processandin the residualsmanagementprocess.(3) tdentifyprocessinputsuchasraw materials,reagents,andsolvents by chemicalor commonnameandCAS number.andindicatethe point of introductionwith arrows.(4) For cactiunit operatfonin whichthetemperatureis not ambient,specifytemperatureor temperaturerangein eachblockof the flow diagram.(5) Specify operatingpressureor pressurerangein eachblockof theflow diagramfareachunit operationin which thepressure is not atmospheric(6) identify thecomposit~onof thereactionveaselwherever oneis used(e.g.. stain/asssteel, glass.linedj

(7) Number all pointsin theflow diagram from which th~chemicalsubstance will be released oto the environment.(SeeexampleI)

~Mark (~)thisbox if you attachacononuahort sheet

‘ri’’ F~,rin7710 ~ i~ PP

to0~Co

to

Csto

0

Ca

z0

i-i(aCo

~‘rj“l

0~I:)

-I

0aCo

i-iCocc’

aCoCr,

a

ctOttcca0aC/)

EXAbs’PLE i - PROCESS BLOCK FLOW D1AGRAM

PRODUCTION

PHENOL

CHLOROPHENOLSRECYCLE

CHLOROPHENOLSRECYCLE

WASTEWATERTOTREATMENT

TREATMENT

C)

WASTEWATER FROM

PENTAC H LO RO PHE NOL

STILL BOTTOMSTO INCINERATOR

WASTEWATER FROMOTHER PUOCESPE:-;

SPILLS, FLOOR SWEEPINGSTO LANDFILL

PRODUCT Pr~.(~CCHG

INTERMEDIATEE:

105 SLUDGETO LANDFILL

TREATED EFFLUENTTONPDES DISCHARGE

CO~PROOUCI ~ . C:5: HCL

Federal Register / Vol. 52, No. ‘108 I Friday, June5, 1987 / F~u1esandRegulations

Section B — Environmental Releaseand Disposal

Page 3 of i

21445

Yot. must makeseoarate confidentiality claims br the release number and the amount of the substance released end other release and disposalinformation. Mark )xl the “Confident~a!”box next to eachitem youclaim as confidential

Ill — Enter the number uf eachreleasepoint identified in the processdexcription, part II, SectionA.42) — Estimatethe amountof the chemicalsubstancereleaseddirectly to the env,ronmentor into control technology(in kg/day or kg/bat c/i),(3) — Mark 4x} this column if entries in columnsll)and/or 12) ate confdential(4) — Identify the media (air, land, or water) to which the substancew,ll be releasedfrom the reteosepoint(5) — Describecontrol technology, if any, that will be usedto limit the releaseOt the substanceto the environment.For releasesdisposedof on

lend, characterizethe disposalmethod5) — Mark (x) this Column i-f entries in columns(4) and/or (5) are confidentialIll — Idontify the destination(s) of releasestowater.

ReieaseNumber

..J.~L,.

Amountot substancereleased

~

Cont,-dentialJ~L..

Mediaofrelease

,,..~____

Control techrioio5

y~ ~

coi-,rdentiai

~

~l--~--~*----.~

171 Mark (a)the destfnationls) POWIpobl,./y owned Noo.ijubieof releases to water liiialiOOiii ,e~ikS) .‘naler,~,,v

---~

CiSc,(eee’cily)

-.-~-*-

Mark el ti-is ben ii youalrch acrir,irinnai.On

F”tif.”n 7711 i~1 re cc

21448 Federal Register / Vol. 52, No. 108 / Friday, June 5, 1987 / RulesandRegulations

Part III — Production, Import, and Use lnformat~on

Page 4 of 6

Mark (a) the “Confideniiaf” box next to any item you claim as confidential.

‘I. Production votume — Report the production volume during the past 12 months of production. Also report the maximumproduction volume for any consecutive12-month periodduring the past 3 yearsof production. Confi

~_..,..,4 denti&Past 1 2.rnonth production (kg/year) Maximum I 2.month production (kg/year)

2. UseInformation — You mustmake separateconfidentiality claims for the description of the categoryof use,the percentof productionvolume devoted to eachcategory, the formulation of the substance,and other useinformation. Mark lx) the “Confident~al”boxnextto anyitem you claim asconfidential,(14— Describe eachcategory of useofthe chemicafsubstanceby function and application.42)— Mark(s) this column if entry in column (Ills confidential.13)— Estimate the percent of total production for the past 3 yearsdevotedto eachcategoryof use.(4(— Mark (xl this column if entry in column (31 isconfidential.(5) — Estimate the percent of the substanceasformulated in mixtures, suspensions,emulsions,solutions, or gelsasmanufactured

for commercialpurposesat sitesunder your control associatedwith eachcategoryof use.(61— Mark (xl this column if entry in column (5) is confidential.(74— Mark (xl whether the useissite-limited, industrial, commercial, or consumer. Mark more than one column if appropriate.(8)— Mark lx) this column if entries in column (7) areconfidential.Readthe Instructions Manual for examples.

Categoryof use

(1)

.Cc’nfi’dent~el

(2)

r

Production(percent)

(3)

.Confi-dential

(4)

“—

.Formulation(percent)

(5)

,Confi-dentist

(6)

Mark (x) appropriatecolumn(s)(7)

,ConS-dentist

(8)

-—~

Site-limited

—~

Indus-trial

Corn-mercial

Con-sumer

-‘

D Mark )x) this box if you attacha contnuaiionsheet.

- 3. Hazard information — Include in the notice a copy or reasonable facsimileof any hazardwarning statement, label,material safety datasheet,or other intormstion which will beprovided to any personregardingprotective equipmentor practicesfor the satehandling, transport, use, or disposal of the newchemicalsubstance. List in part IV any hazard inlormation you include.

Mark (xl this box if you attach hazard information

EPA Form 7710-51 l9’86)

FederalRegister/ Vol. 52, No. 108 / Friday, June 5, 1987 / Rulesand Regulations

Page 5 of

(5) —. Estimatethe maximum numberof workers involved ineach activity.

(64— Mark (xlthis columnif entry in column (5(is conf~dential(7) and(81— Estnmxte the maximum duration of the activity for

any worker in hoursperday end daysperyear.(9) — Mark(s) this column if entries in column (71 and/or (81 are

confidential

21447

4. Occupational Exposure —.. You must make separate conlidentiality claims for the description of worker activity, priysical form of thesubstances, number of workers exposed, and durationof activity. Mark (xl the “Confidential” boxnext to anyitOm youclaim asconfidential.

(ft — Describe the activities in which workers may be exposed tothe chemical substance. Include activities in whichworkers wear protective equipment

(2) — Mark (xl this column it entry in column (1)5 confidential(31— Indicate the physical form(s) of the chemical substancs at

the time of exposure.— Mark (x( this column if entry in column13) is confidential

Worker ActivityConfi.dentist

PhysicalForms

Conti.dantiat

Maximum number Confi-densi& Hrs/day Days/yr dentlel

(1) (2) i’3) P7) i’5) (6) (7/ (8) (9)

D Mark lx) this box if you attach a continuation sheet.

EPA Form 7710-51 (9-66)

21448 FederalRegister / Vol. 52, No. 108 / Friday, June 5, 1987 / RulesandRegulations

Part IV — List of AttachmentsPage 6 of 6

Attach continuation sheets(or sectionsof the form and optional information after this page.Clearly identify the attachment and thesectionof theform to which it relates, if appropriale. Numberconsecutivelythe pagesof the attachments.In column (2) below, enter theinclusive pagenumbersof eachattachment.Mark(s) the “Confident~at”boa nextto anyattachment narrie you cleimasconfidential. Readthe Instructions Manual for guidanceonhow to claim anyinformation in an attachment asconfidential.

Attachmentname

(1)

Attachmentpagenumbers

(2)

ConS.dentiaf

(3)

0 fxtart (xl this box ‘if you attacha continuationsheet.Enter the attachmentnameand number.

Certificationcertify that to thebest of my knowledgeandbelief:

1. The company named in part I, sectionA, subsection 1 a of this form manufactures, imports, or proceses,other than in small quantities for researchpurposes,the substanceidentified in part I, sectionB.

2. All informationprovidedin this noticeis comp(eteandtruthful as of thedateof subrr,)ssion.

Signatureof authorizedofficial Date ConS-darned

Signatuie of agent (if applicable) Date Confi.dernial

EPA Form 7710-51 (9-86)

FederalRegister / Vol. 52, No. 108 / Friday, June5,1987/ RulesandRegulations 21449

Genera~Instructions

EPA Form 7710-51, Dioxins/Furans ReportYou mustprovideall information requestedin this formtotheextentthat it is known to or reasonablyascertainableby you.

Part 1 — General information

You must providethe chemicalidentity of the chemicalsubstancereportedon, evenif you claim the identity asconfideritiaI -

Part II — ProcessandReleaseInformation

You mayneedadditionalcopiesof partII, sectionsAandBif thereareseveralmanufactureoperationsthatyou willdescribe in the form. You should reproducethesesec-tionsasneeded.

Part iii — Production, Import, and UseInformation

You must provide productionvolume, percentof produc-tion used for each usecategory, and whether use isindustrial, commercial or consumer.Also included is acopy of any hazardwarninganda report of occupationalexposure.Copiesmay be made of any partof the form ifadditIonal spaceis needed.

Part IV list of A~achments

You should attach additional sheetsif you do not haveenoughspaceon theform to answera questionfully. Inpart IV, list all attachmentsyou includewith theform.

Optional information

You may include with the form anyinformation thatyouwant EPA to considerin evaluatingthe substance,Confidentiality Claims

You mayclaim any information in this form asconfiden-tial, Toassertaclaimon theform, mark(x) the“Confiden-tial” box next to the information thatyou claim asconfi-dential. To asserta claim in an attachment,circle orbracketthe information you claim asconfidential.

A. GeneralInstructions

Completetheform using a typewriteror by printing legi-bly in black ink, AU information must be in English.Pro-vide all information requestedon theform to the extentthat you know or can reasonablyascertainit. You may8ttachcontinuation sheetsto any subsectionor item ontheform, Mark (x) theappropriatebox on the form if youattachcontinuationsheets.

Theuseof theterm “manufacture” n this form tncludesboth manufactureandimport. Manufacturersandimpor-tarsmustIu)iycomplywith the informnatiortrequircmcnirssot forth in the PolyhalogenatedDib~nio-p-ci~o.~Ii-ts/DibenzoFuransTesting and Reporting RequirementsRule, However, importersarerIot requiredto submitanydata under section8(a) of TSCA which relatessolely toexposureto humansortheenvironmentoutstdethe Urn-tedStates.

Any manufactureror importerusing this form maypho-tocopy the form, sectionsof the form, or theseinstruc-tions as frequentlyas needed.

B. Certification

Theofficial namedin Part I, sectionA of theform, asthepersonsubmitting the notice, must sign thecertificationon page6 of the form. This official is responsiblefor thetruth andaccuracyof eachstatementin the certification.

C. AssertingConfidentiality Claims

A manufactureror importermay asserta claim of confi-dentIality for any information submittedto EPA on thisform.To assertconfidentialityclaimsfor specific informa-tion on the form (e.g., submitter identity, processdata,oruseinformation),mark(x)in the“Confidential” boxontheform locatedto the right of the information. Markingtheseboxeswill provide a quick reference for EPA todeterminewhat informatton IS confidenttal, thus aidingpropertreatmentof confidential busInessinformation.

Part I — GeneralInformation

Section A — SubmitterIdentificationPerson submitting notice -— Enter informatton on the

offtcial who stgnedthe generalcertification on Page6.

Section B — ChemicalIdentity Information

ChemicalNameand ~AS Registry Number — List thecomm-onnameandChemicalAbstractsRegistrynumber,if available,for thechemicalon which you arereportlng.

II. ProcessandReleaseInformation

Section A — Flow Diagram

Flow diagram — Submit a blockflow diagramfor eachmajor unit operationandtreatmentprocessinvolved inmanufacturingthe chemicalon which you arereporting.Includethefollowing information:

(1) identify theproductprocess,andchemicalinterme-diates, coproducts and byproductsproducedby th-eprocess;

(2) provide a blockfor eachmajorunit operation(e.g.,reactor,washer,filtration, air emissioncontrol, aera-tion lagoon,etc.)in the productionprocessand in therestdualsmanagementprocess;

(3) tdentify all processinput such as raw materials,reagents,solvents,etc. by chemicalor commonnameand CAS number, andindicatethe point of introduc-tion wIth arrows;

(4) for each Unit operationin which thetemperatureisnot amb~c-nt,specify temperatureor temperaturerangein eachblockof the flow diagram;

(5) specify operating pressureor pt-essurarange ineacnblock of the flow diagram for eachunit spatationin which pressureis not atmospheric;

(C) identify the composition of the reaction vesselwhereveroneis used;

(7) numberall points in the flow diagramfrom whichthechemicalsubstancewt) I be releasedinto theenvir-onment. SeetheexampleprovIded.

EPA Form 7710-51(9-86)

.21450 FederalRegister I Vol. 52, No. 108 / Friday,June 5, 1987 / RulesandRegulations

Section B — Environmental ReleaseandDisposal

Co/umn(l) Foreachreleasepoint indicatedin theflowdiagram (part II, section A), enter the correspondingnumber.

Column(2) — Estimatethe amount of the chemical(inkg/day for continuousoperationsor kg/batchfor batchoperations)that will be releasedfrom the releasepointbefore entering control technology. Baseyour estimateon your maximum 12-monthproductionvolume.

Column (4) — Enter the medium(air, water, land) intowhich the releasestreamdischarges(whether or notcontrol technologyis used).

Column(5~—For releasesto theair andwater,describethe type of technologyusedto control thereleaseof thechemical.Examplesof control technologiesinclude car-bon filter, scrubber, and biological treatment(primary,secondary,etc.).Give ascompleteadescriptionaspossi-ble. Enter“none” if no control technologyis usedandthesubstanceis releaseddirectly to the environment.Fordisposal on land, describe the landfill site construction(including liners) and handling procedures.Describelandfill containers.Column(7,)—Mark(x) theappropriatebox and/orspecifyother destinationsof water releases.Columns~3)and~6,)— Notethat you must make separateconfidentialityclaimsfor the releasenumberandamountof chemical substancereleasedand other releaseanddisposal information.Part lii — Production. Import, and UseInformation-A. Production InformationProduction volume — Report the production volume forthe past 12 monthsof production.Also reportthe maxi-mum productionvolume for any consecutive12-monthperiod during the past3 yearsof manufacture.Providethis information in kilograms. Includein your reporttheamountsproducedby personsundercontractto you. Ifpart of the amountmanufacturedis for export, includethis amount in your reports.

B. Use Information

Column(1)— Identify each possiblecategoryof useof thechemicalsubstanceby describingits function andappli-cation. “Function” is relatedto theinherentphysicalandchemical propertiesof the substance(e.g., degreaser,catalyst,plasticizer, ultraviolet absorber).“Application”refersto the useof thesubstancein particular processesor products(e.g.,adegreasermaybeusedforcleaningoffabricatedmetal parts).Following are someexamplesofhow you should describecategoriesof use:o a dispersedye carrier for finishing polyester fiberso a cross-linkingagentfor epoxy-likecoatingsfor metal

surfaces° a flame retardantfor surfaceapplication on cotton

apparel,textile homefurnishings,andexteriorcanvasproducts

° asurfactantin automobilespraywax° a colorantfor paperandothercellulosics

Column(3) — Report thepercentof the total productionvolumeduringthe past12 monthsmanufacturedfor eachcategoryof use.

Column(5)— Estimatethe weight percentof thechemi-cal substancecontainedin any formulatedmixture, sus-pension,emulsion,solution, or gel associatedwith eachcategoryof use as manufactured-forcommercial pur-posesat sitesunderyour control.Wherethesubstanceisdistributed from your site neat, -enter N/A for notapplicable.

For example:

Surfactant inautomobilespray wax

FormulatedPro-

Colorantfor paper colorant (solution)and otherce)lulosics

Column (7)— Mark (x) to indicateif the categoryof use issite-limited.Also mark (x) to indicatewhetherthe useisfor industrial, commercial, and/or consumer use asdefinedbelow.Mark morethanonebox, if appropriate.Forexample,asurfactantin anautomobilewaxmayhavea consumerusein liquid wax, a commercialusein autowashes,and an industrial use by automobile manu-facturers.

Site-limited: The substanceis usedonly on the contig-uousproperty unit where it is manufacturedand notintentionallydistributedoutsidethatsiteexceptforwastedisposal.This includesall factories,storagespace,andwarehousesat the site. An examplewould bean inter-mediatewhich is further reactedon-site to produceachemical product.Industria/:Thechemicalsubstanceor productscontainingthe substanceare usedonly at the site of other manufac-turersor processors,e.g., textile dyeing, paint formula-tion, useof a resin to manufactureanarticle. -

Commercial:The chemical substanceor products con-taining the substanceare usedby a commercial enter-prise providing a consumerservice,e.g.,useby commer-cial dry cleaning establishments, use by paintingcontractors,or use by roofers in commercial buildingconstruction.Consumer: Thechemicalsubstanceor productscontain-ing the substanceare used by private individuals in orarounda residence,or during recreation,or for anyotherpersonaluseor enjoyment,e.g.,automotivepolish,dyedwearingapparel,householdcleaners,etc.

Columns (2), (4). (6). (8) — Note that you must makeseparateconfidentiality claims for the description of thecategoryof use,thepercentof productiondevotedto eachcategory,andotheruseinformation.The information inthis sectionis usedto evaluatepotentialexposureof thechemical.If you wish to provide any additional informa-tion whichwouldassistin thisanalysis,it maybesubmit-tedasoptional information.

Categoryof Use

Cross-linkingagentfor epoxy.typecoatingsfor metalsurfaces

Flameretardantforcottonapparel

duct asManufactured

none;distributedneat

none;disttibutedneat

spray autowax(suspension)

Percent of Chem-ical Substance

N/A

N/A

4

55

EPA Form7710-51 (9-86)