EPA/Toxic Substances; Biphenyl; Test Rule...Agency (EPA). *CTiOP~.Final rule. SUMMARY: This rule promulgates EPA’s-decision to require manufacturers and processors to test biphenyl

37182 FederalRegister / Vol. 50, Mo. 177 [Thursday, September12, 1985/ Rules and Regulations

40 CFRPart 799

LOPTS—42031A; FRL-2871-5J

Toxic Substances; Blphenyt Test Rule

AGENCY: EnvironmentalProtectionAgency(EPA).*CTiOP~.Final rule.

SUMMARY: This rule promulgatesEPA’s-decisionto requiremanufacturersandprocessorsto testbiphenyl (CAS No: 92—52—4) for environmentaleffectsandchemicalfateundersection4(a) of theToxic SubstancesControl Act (TSCA)accordingto protocolsto besubmittedto andapprovedby EPA. This regulationis in compliancewith theInteragencyTestingCommittee’s(ITC) designationof biphenylfor priority testingconsideration.DATES: In accordancewith 40 CFR23.5(50 FR 7271), this ruleshallbepromulgated forpurposesof judicialreview at 1:00 p.m. eastern(“daylight”or “standard”asappropriate)time onSeptember28, 1985.This rule shallbecomeeffectiveon October28, 1985.FOR FURThER INFORMATiON CONTACT:EdwardA. Klein, Director,TSCAAssistanceOffice, Office ofToxicSubstances,Rm.E-.543,,401 M St., SW.,Washington.DC 20460.Toll Free:(800-.424—9085).In Washington.DC; (554—1404).SUPPLEMENTARYINFORMATION In theFederalRegisterof May 23, 1983(48 FR23080),EPA issueda’proposedruleundersection-4(aiof TSCA to-requiretestingof biphenyl forenvironmental-effectsandchemicalfate.TheAgency-isnow promulgatingafinal rule.

L Introduction

This noticeis partof theoverallimplementationof section4oftheToxicSubstancesControlAct (TSCA; Pub.I..94—469,90 Stat.2008et seq., 15 U.S.C.2603et seq.)which containsauthorityfor EPA-to requiredevelopmentof datarelevantto assessingthe risks to healthandtheenvironmentposedby exposureto particularchemicalsubstancesormixtures. -

Under section4(a)(1)of TSCA. EPAmustrequiretestingof achemicalsubstanceto develophealthorenvironmentaldataif theAdministratorfinds that:

(A)(i) the manufacture,distribution incommerce,processing,use.ordisposalof achemicalsubstanceor mixture.or that anycombina(ion of suchactivities.maypresentan unreasonabler~sk-ofiniury to-healthor theenvironment,

(ii) thereare insufficientdataand

experienceuponwhich the effectsof suchmanufacture.distribution in commerce.processing.use.ordisposalof suchsubstanceor mixtureorof anycombinationof suchactivities on healthor theenvironmentcanreasonablybedeterminedorpredicted.and

(iii) testing-ofsuchsubstanceor mixturewith respectto sucheffectsis necessarytodevelopsuchdata;or

fB)(i) achemicalsubstanceor mixtureis orwill beproducedin substantialquantities.and(fl it entersormayreasonablybeanticipatedto entertheenvironmentinsubstantialquantitiesor (II) thereis or maybesignificantor substantialhumanexposure

- to suchsubstanceor mixture.(if) there’areinsufficientdataand

experienceuponwhich theeffectsof the’manufacture,distribution in commerce~processing.use,ordisposalof suchsubstanceormixtureorof anycombinationof suchactivitieson healthor theenvironmentcanreasonablybedeterminedorpredicted.and

(iiil testingof suchsubstanceor mixturewith respectto sucheffectsis necessarytodevelopsuchdata.-

Fora morecompleteunderstandingofthe statutorysection4 findings,thereaderis directedto theAgency’sfIrstproposedtestrule package.—.chloromethaneandchlorinatedbenzenes,publishedin theFederal-Registerof July 18~198G(45 FR 48524)..andto the secondpackage— -

dichloromethane.nitrobenzene,andi.i,i-trichloroethane~publishedin the:FederalRegisterof June5. 1981(48~FR30300)for in-depthdiscussionsof thegeneralissuesapplicableto-thisaction.

IL Background -

A. Profile - - -

Biphenyl (GAS No.92—52—4)is a solidorganiccompoundat ambienttemperatureandpressure(Ref. 1).Approximately13 million- poundsofbiphenylweredomestically,producedin1984 (Ref. 2). Biphen3disusedprimarilyto producedye carriers,heat~transferfluids, andalkylatedbiphenyls(Ref. 3).As discussedin theproposedrule andits accompanyingtechnicalsupportdocument,theuse/disposalpatternforbiphenylsuggeststhat biphenylhasthepotential to be releasedinto theenvironmentat significantconcentrationsfrom dye-carrierapplicationsthroughwastewaterdischargeor from leakageof heat-transferfluids.

B. ITCRecommendations -

The InteragencyTestingCommittee(ITC) designatedbiphenyl for prioritytestingconsiderationin itsTenth Report,publishedin the Federal--Registeron- -

May 25, 1982 (47 FR 22585).TheITCrecommendedthat biphenyl’betested

for chronictoxicity to fish andinvertebrates,toxicity to aquaticmacrophytes,andchemicalfate. TheITC basedits designationof biphenyl r’f

substantialproduction,on therepor~-~.use/disposalpatternof biphenylanoonthe potentialpersistenceof biphenyland.biphenyl byproductsin theaquatic -

environment. -

The ITC wasconcernedabouttheenvironmentalreleaseof bipheñyl fromits useasa fungicide. Use of biphenylasa fungicide is regulated.undertheFederalInsecticide,Fungicide,and -

RodénticideAct (FIFRA) andassuchcannotberegulatedunderTSCA [seeTSCA section3(2)(B)(ii)).

TheITC wasalsoconcernedthatmono- anddichlorobiphenylmight beproducedby thechlorinationof biphenylat dye-carrierwastetreatmentfacilities.EPAhasconcludedthat releaseofmono- anddichlorob~phenylsresultingfrom chlorinationof biphenylat dye-carrierwastetreatmentfacilities islikely to be insignificantbecauseof lowmeasuredconcentrationsof biphenylindye-carrierwastetreatmentplanteffluentsandtheextremelylowestimatedconcentrationsof mono- anddichlorobiphenylsthatmight beproducedas a resultof chlo,rinationofsucheffluents. . -

C. ProposedRuleEPAissueda proposedrulepublished

in theFederalRegisterof May 23. 1983(48 FR 23080)which would requirethattestingof biphenylbeperformedfor theenvironmentaleffectsandchemicalfatecharacteristicslistedbelow:

1. Acuteaquaticmacrophytetoxicity2. Chronicfish toxicity3. Chronicdaphnidtoxicity4. Acuteoystertoxicity5. Oysterbioconcentratibnand,

chronicoystertoxicity . -

6.’ Ae~-obicandanaerobicbiodegradation

In theproposal,theEPAbaseditstestingrequirementson the authority ofsection4(a)(1)(A) ofTSCA. It found that:Environmentalreleaseofbiphenyl fromthe chemical’suseanddisposalmaypresentan unreasonablerisk of effectsto aquaticorganisimsbecauseexistingdatasuggestthatbiphenyl mayhavethepotential to produceacuteeffectsinaquaticplants,as well aschroniceffectsin aquaticvertebratesandinvertebrates,andbecauseof detectedconcentrationsof biphenylin the aquaticenvironment.In addition,EPAfound thatsuchreleasesof biphenylmaypresentanunreasonablerisk of effectsto sedimentorganismsbecauseof the potentialof -

FederalRegister / Vol.. 50, No. 177 / Thursday, September12, 1985 I Rules and Regulations’ 37183

biphenyl to partition from watertosediments, to persistandpossiblyaccumulatein aerobicandanaerobicsediments,to bioconcentrateor promoteacuteeffectsin benthicorganisms.andbecauseof detectedlevelsof biphenyl insediments.EPA found that thereareinsufficientdatato reasonablydetermineor predict the environmentaleffectsandchemicalfateof biphenyland that testingis necessaryto developsuch data.

III. Public Comment

A public meetingon theproposedrulewasheld August8, 1983.

Commentsreceivedby theAgencyinresponseto the proposedrule forbiphenylweresubmittedby the industryBiphenyl Ad HocGroup(BAHG), E.I.DuPontdeNemoursandCompany(Dupont), theAmericanTextileManufacturersInstitute.Incorporated(ATMI) and the NaturalResourcesDefenseCouncil. Incorporated(NRDC).Technicalcommentsfrom the BAHG,which representsChemol,CoastalStatesMarketing. Gulf. Koch Chemical.~vthnsantoIndustrial Chemicals.DowChemical,andSybronChemicalCompany,andcommentsfrom theAMTI.are addressedin Units Ill. A and Bbelow.Legal commentsreceivedfrom -

the remainingcommentorsareaddressedin-Units IlL C throughF..

.4. EnvironmentalEffectsTesting

The BAHG.has.commentedthat thereleaseof biphenylduring its useanddisposalis insignificant. -

The Agencydoesagreethatquantitiesof biphenyl being releasedto theenvironmentresultin relatively lowreportedconcentrations(<1 to 15)g/linwaterand 1 to 8)g/g insedixnent)(Refs.4 through1Z). However,basedon thesemeasuredconcentrations.andinconjunctionwithexistingtoxicitydata.the Agencybelievesthereis sufficientconcernfor further testing.

TheBAHG hascommentedthatbiphenyl concentrationsinwater andsedimentare notsignificantandbiphenyl is not toxic or persistentin the’aquatic andsedimentenvironment.TheBAHG furtherstatesthat”... existingtoxicity dataconclusivelydemonstratesthat biphenyldoesnot presentanunreasonablerisk to organismsin theaquaticor sedimentenv~ronment”.

TheAgency believesthatBAHG hasnot provideddatato substantiateitsposition thatbiphenyI”... doesnotpresentan unreasonablerisk toorganismsin the aquaticorsedimentenvironment or that detectedconcentrationsof biphenyl are’ -

insignificant. _ - , -‘

Further,the Agencynotesthat theindustryresponsethatL~5ovaluesgenerallyare1 to 10 ppm.ignores the 24hourLC~0of 0.73 mg/I (ppm) and the rioobservedeffectlevel (NOEL) of <0.25mg/I (ppm) forDaphniamagnareportedby Adamset al. (Ref. 13).

Acute toxicity datahavebeenreportedfor fish (fatheadminnows.rainbowtrout. sheepsheadminnows,bluegill, goldenshiner,andcatfish)withLCao’s rangingfrom 1.5 to <10 mg/I(Refs.15 through21). Reportedacutetoxicities for variousinvertebratesrangefrom 1.9 to 4.7mg/I. (Refs.19, 21 and 22).

No datahavebeenreportedforchronictoxicity of biphenyl to fish oraquaticinvertebrates.However, thereare indicationsof chronictoxicity toaquaticinvertebratesfrom theacutedatareportedby Heidoiph et a].. (Ref.14) in which-theconcentrationofbiphenyl requiredto producean LC,50value inD. Magnais 5 timeshigherat 24hoursthan at 48 hours.In addition.studiesby theAnalyticalBiochemistryLaboratories,Inc. on theacutetoxicityof Therminol~’to fatheadminnows~Ref.23) produced24-hourand96-hourLC~’swhich indicatethat biphenylmayproducechroniceffectsin freshwaterfish.No dataon acuteor chronictoxicity to aquaticlife exposedtobiphenyl contaminated’sedimenthavebeenreported.

Giventherangeof biphenylconcentrationsproducingacute-effectsin aquaticorganisms.the indication ofchroniceffectsobservedfrom availableacutetoxicity testdata,andtheabsenceof chronictoxicity data-on aquaticorganismsexposedby ingestionofbiphertyl contaminatedsediments,theBAHG contentionthat biphenyldoesnotpresentanunreasOnablerisk toorganisms-intheaquaticor sedimentenvironmentcannotbesubstantiated.

TheB~AHGresponsedoesnotconsideranotheraspectof biphenyltoxicity which would beaddressedby

- chronictesting.namelythetoxicity tootherlife stages(eggsand larvae)whichtypically aremoresensitiveto toxicantsthan the life stagesusedin acutetoxicity tests.TheAgencybelievesthattheuseof acutetoxicity testdataaloneis not adequateto evaluatetheoverallrisk toaquaticorganismsunlessthereisa largemargin of safetyrelativetoenvironmentalconcentrationsandno

- evidenceof chronictoxicity.TheBAHG commentthat the log P for

biphenyl is toosmall andnottypical ofthe typesof chemicalsthatare knowntohavehighaccumulativetoxicity is notrelevantto theconcernfor chronictoxicity ofbiphenyl to other life stages.

- The log Pof biphenyl(4.02measured::3:95 to ‘17’ estimated)(Refs. 24 and25) is

largeenoughto expectthat thechemicalwill sorbto sediments(concentrationsup to 8 ppm havebeenreportedinsediments)andalsowill betakenup byaquaticorganisms.Given that the acutetoxicity datafor biphenyl show a rangeof LG50’s for aquaticorganismsfrom 0.73mg/I to <10.0mg/I (Refs.13 through23)and thatwater(<1 to 5)g/l) andsedimentconcentrations(1 to 8)g/g)havebeenfound (Refs.4 through12). theimportantquestionis whetherthesediment-boundbiphenylisbioavailable.No testdataareavailableto evaluatethis concern.BAHGcommentsdo notprovide-abasisfordiscountingthebioavailabilityofbiphenyl associatedwith sediment.

The BAHG feelsthatexistingdataareadequateandno further testingisneeded.TheBAHG specificallyrespondedto theproposedaquaticmacrophytetestingand theacute,chronicandbioaccumulationtestingwith oysters.TheBAHG feelsthat thereis no justification to requiretestingwiththeaquaticmacrophyteLemnagibba.The following reasonsweregiven: (1~Thereareno datawhich wouldindicateLemnais moresensitivethanalgae~(2)surfacewaterconcentrations-are toolow tojustify Lemnatesting,and(3)Lemnaisalsonot theprevalentspeciesin theriver systemswherebiphenylmanufacturingoccursor textiledischargesare located.

The Agency agreesthat thereare-nodatawhich would indicatethatLemnais moresensitiveto biphenylthanalg8e.Consequently,EPA~swithdrawingtheproposedrule requiringtestingof Lemnafor biphenyl.However,EPA believesthat informationfor macrophytesisusefulandhasdecidedto developdatato determinea comparative -

toxicologicalprofile betweenthe aquaticmacrophyteLemnagibba andtheaquaticalgaeSe/enastrumcapricornutum.This comparativestudyshallbeundertakenby EPA.

In responseto the requirementforacute,chronicandbioaccumulationtestswith oysterstheBAHG statedthat,“theremay besomejustificationforacutescreeningtestswith benthicfreshwaterorganismssuchasmidgesoramphipod.”TheBAHG furtherstateswith referenceto chronicandbioaccumulationstudies,”. . . thestudiesnotonly go beyondwhat ITCrecommended,they arenotscientificallyjustified.” The ITC did recommendchronictests.Industryapparentlyfeelsthat someacutetoxicity testswithbenthicorganismsmight be justified.Thereasonfor testingwith the oysteristhat this organismis a filter feederandcanbeusedto testthetoxicity of

37184- FederalRegisterI Vol. 50, No. 177 / Thursday; September12, 1985 I Rules and Regulations

biphenylboundto sediments(suspendedorganicparticles,clay. etc.).Basedon the log P of biphenyl,someuptakeof the chemicalcanbeexpectedif the chemicalis bioavailable.Forpurposesof hazardassessment,theAgency needsto know the uptakeanddepurationof biphenylandthepossibletoxic effects,acuteandchronic,of thechemical takenup from sedimentaswell as from thewatercolumn.Therequirementsfor testingbiphenylinoystersis consistentwith theAgency’smandateto requiretestingthatwillprovidedatato assessthechemicalsrisks.

TheBAHG assertsthat the testswhich theAgency hasproposedare“extensive”and “costly”. BAHG didnot, however,explainor substantiatewhat it meansby “extensive”and‘costly”. The testsproposedby th~agencyconstitutea minimal datasti,The limited numberof testsproposedare essentialto performingan adequateenvironmentalhazardandriskassessmentfor biphenyLBasedon theresultsof EPA’s economicanalysis.theeconomicimpactof conductingtherequiredtestsis expected-to be minimal(seeUnitV). -

B. ChemicalFate’

Commentswerenotreceivedwithrespectto theproposedchemicalfatstesting.

C. ProtocolSubmissionandthePhasedTestRoleProcess

The NaturalResourcesDefenseCouncil (NRDC) submittedcomments-concerningtheneedfor requrngvalidatedprotocolsandrecommendedmodificationof theAgency’stwo-phasetestruleprocess.NRDCstatedthat theAgency shouldrequiretestsponsorsto-usevalidatedreferenceprotocol..or give-

adequatejustificationfor any deviationsfrom theseprotocols.NRDCcited theAgency’s two-phasetestrule process(asdescribedat47 FR 13012 March 28,1982) asan apparent“reversal” of EPA’spreviouspolicy whichhasrequiredthatspecificEPA, FIFRA or OECD testingprotocolsbefollowedby personsrequiredto testundersection4(a)ofTSCA. Theproposedpolicy of -

demandingonly that testsponsorsselectprotocolslistedin Agencyguidelines,ordevelopprotocolson their own, wascitedas an approach“apparentlydevelopedin responseto industrycriticism that the requirementsaretoorigid and would inhibit innovationintestingmethodologies.”Thecommenterfurthir characterizedthis decisionascompromisingtherecognizedneedforreliablo-andadequatedata. -

TheAgency disagreeswith NRDC’sview that the two-phasetestruleprocessbasedon EPA’s reviewandapprovalof chemical-specificstudyplanswould compromisetheability ofthe testrule to generatereliableandadequatedata.In general,EPAbelievesthat issuanceof generictestmethodologyguidelines,ratherthangenerictestrequirements,providesmoreflexibility for testfacilitates,testsponsors,andEPAitself in arriving atcost-effective,scientifically soundtestmethodologies,andfacilitatestheincorporationof scientificjudgmentwherenecessaryon a chemical-specificbasis.Thisapproachalsoencouragesscientificinnovationandthedevelopmentof moresophisticatedandscientificallyadvancetestingmethodologies.With eithersingle-phaseor two-phaserulesa publiccommentperiodandan opportunityfor a publicmeetingwill allow interestedpartiestoreview andcommenton thechemical-specific teststandards.After thiscommentperiod,EPA will issuea finalruleadoptingchemical.speciflcteststandardsas requiredundersection4(b)(1)(B)of TSCA. A moredetaileddiscussionof theAgency’sviewsontheseandotherrelatedissuesmaybefoundin the agency’sTest RuleDevelopmentandExemptionProceduresfinal nile publishedin the Fed~’a1-

Registerof October1G~1964(49 FR39774). -

NRDC alsostated-thattheAgencyshouldmodifythetiming of the’ two-phasetestruledevelopmentprocesssothatsubsequenttestrules.completewith specificprotocolsfor testing,arepublishedwithin oneyearof EPA’sreceiptof theITC’s recommendations.NRDCcontendedthat applicationof the -

two-phaserulemakingprocessin thecaseof thebiphenylrulehasresultedintheAgency’sfailure to meetthe-statutorydeadlinesfor initiatingrulemaking.

EPA doesnotagreethat theAgencyhasnotmet its statutoryresponsibilityfor biphenyl.TheAgency’sstatutoryobligationunderTSCA section4(e)(1)(B)wasfulfilled with theissuanceof theproposedtestrule for biphenyl.In sodoing,EPA initiatedrulemakingundersection4(a) to requiretestingappropriateto theactualexposurestobiphenyl.

EPA sharesNRDC’S desirethat testrulesshouldbecompletedasrapidlyaspossibleandtheAgencyis continuingtoexplorewaysto betterachievethatobjective.

D. IdentificationofBiphenylProcessingActivities

Dupont commentedthatEPA shouldidentify, to the extentpracticable.thoseactivities which the Agencyconsidersti-be biphenyl “processing”activities.Dupont believedthat by identifyingthoseactivitieswhich the Agencyconsidersto beprocessing,personswho“process”biphenylas opposedto thosepersonswho “use” biphenyl would beput on notice that theyare subjectto thetestrule.

TheAgencyconsidersthat“processing” includesany preparationof biphenyl fordistribution in commerceas partof a mixture,an article,or anyproductcontainingor composedofbiphenyl.Processingalsoincludestheuseof biphenyl asa reactantorintermediatetoproduceanotherchemicalsubstancefor distributionincommerce.If a companyonly usesanddiscardsbiphenyl, thecompanyis notaprocessorof biphenyl.

A processoris. amongotherthings,onewho preparesa chemicalsubstanceor mixture for distributionin commerce,after its manufacture,in thesameordifferent form of physicalstatefrom thatin which it wasreceivedby theprocessor(seeTSCA section3(10)). Onewho mixes, reacts,purifies,separates,repackages,or otherwise“prepares”achemicalsubstanceor mixture fordistribution in commerceis a processor.Thus,a personwho reactsbiphenyltomakeanotherchemicalsubstancefordistributionin commerceis a processorsubjectto this section4 testrule.

E. PersonsSubjectto The TestingReqwreinent.s

BecausetheAgency foundin itsproposalthat theuseanddisposalofbiphenylmay presentan unreasonablerisk to theenvironment,EPA proposedthatpersonswho manufactureorprocess,or intend to manufactureorprocess,biphenylwould be subjecttothe testingrequirementsof a final rule,Citing legislativehistoryto support itspositions,Dupontcommentedthat theAgencycanrequireonly thosebiphenylmanufacturersandprocessorstosponsortestingwhosemanufacturingandprocessingactivities resultin theuseor disposalactivities which theAgency identifiedin makingits “maypresentanunreasonablerisk” finding.

The Agencyhasreviewedthelegislativehistory citedby Dupontandtheplain languageof section4(b)(3)(B)anddisagreeswith Dupont’sposition asstatedabove.Thelegislativehistorywhich Dupont citesas supportingitspositioncannotbeentitled toomuch

FederalRegister I Vol. 50, No. 177 / Thursday. September12, 1985 I Rules and Regulations 37185

weight.The languagein the HouseReport (Committeeon Interstateand -

ForeignCommerce),which spokeof theneedfor a connectionbetweentheuseidentified undera section4(a) findingand the personresponsiblefor testing,accompaniedlanguageof a Housebillwhich wasneverenacted(Ref. 26).Similarly, the languagein the Senatebillto which Dupontreferswasneverenacted.Both the HouseandSenatelanguagewhich tied testingresponsibilitiesto specificusesof achemicalsubstanceand thosewhomanufacturedandprocessedthechemicalsubstancefor suchuseswaseliminatedin the ConferenceCommittee,The versionof section4(b)(3)(B) thatwasfinally enactedbyCongressrequiresthat all personswhomanufactureor processa chemicalsubstance-besubjectto thetestingrequirementsif the insufficiencyof datafindings undersection4(a)(1)(A)(ii) or4(a)(1)(B)(ii) arebasedon distribution incommerce,use,or disposal.

The plain languageof TSCA section4(b)(3)(B)(iii), unlike the HouseorSenatebills citedby Dupont,doesnotrestricttestingresponsibilitiesto onlythosewho manufactureorprocessforcertainuses.In theabsenceof a clearcontraryindicationin theConferenceReport.theAgencymustfollow thestatute’splain languageandrequirethatall personswho manufactureorprocessor intendto manufactureor process.biphenyrbe subjectto the requirementsof this final rule. (Unit IV.D.J - -

F. Basisfor the“MayPresent”FindingTheAgency basedits proposed

finding underTSCA section4(a)(1)(A).uponthe position that theuseanddisposalof biphenyl-containingdyecarriersandheattransferfluids result intheenvironmentalreleaseof biphenylthat n~Rypresentan unreasonablerisktoaquaticorganisms.Dupontcommentedthat theAgency did notadequatelysupportits position that theuseof biphenyl may presentanunreasonableenvironmentalrisk.Dupont contendedthat theuseofbiphenylasa heattransferfluid doesnotresult in releaseof biphenylto theenvironment.Thus,Dupontsuggestedthat EPAmust providebettersupportfor.its finding that theuseof biphenylmaypresentanunreasonableenvironmentalrisk.

EPA hasconsideredDupont’scommentsandstill believesthat theenvironmentalreleaseof biphenyl canresultin an unreasonablerisk to theenvironment.While theAgencyacknowledgesthatheat transferfluidspills can be reprocessed,thereisnoabsolutecertaintythat thesespills will

be reprocessed.Therefore,if theseoccurtheremay be anenvironmentalhazard.

With regardto biphenyl’suseas a dyecarrier, it hasbeenreportedthatat least95 percentof thebiphenyl is releasedtowastewatertreatmentfacilities andlessthan 5 percentis releasedasvapor.(Ref.27). This smallpercentagereleasedasvaporwill havea short half-life andwillmostlikely be oxidizedby hydroxylradicalsthroughreactiveoxidizableintermediates~to nontoxicproductssuchascarbondioxide (Ref. 28).

However,approximately17 millionpoundsof biphenyl thatis usedasa dyecarrieris releasedfor wastewatertreatments.Although much of thisdisposedbiphenyl is expectedto besubsequentlyreleasedto theatmosphereduring aer-”tion&~~rationsandoxidized, approx~mate1vI ~-~imillionpoundsfrom thesewastewat~~’treatmentplantsis expectedto partitioninto theplant sludge,anda certainportion(0.3—1.4million pounds)may becontainedin thewastewatereffluent.(Refs.29 and30).

The’Agencyagreeswith Dupont thatuseof biphenylasa heattransferfluidanddyecarriermaynotdependingontheplaceandmethodof releaseimmediatelyresultin sufficientenvironmentalreleaseto- posea-potentialenvironmentalrisk. However,oncebiphenyl is disposedof intowastewatertreatmentplantsafter being-used,a sufficientenvironmentalreleasedoesoccurto resultin a potential risk to-aquaticorganisms.Biphenyl hasbeendetected-inwaterandsedimentin avarietyof locationsin theUnitedStates.(Refs.4-through12).EPA believesthatthis environmentalcontaminationhasprobablyresultedfrom theuseanddisposalof biphenyl.Thus,theAgency•is basingits section4(a)(1)(A)findingfor thefinal ruleupon theenvironmentalreleaseof biphenylresultingfrom its useanddisposal.

IV. FinalTestRulefor Biphenyl

A. FindingsTheEPAis basingits final testing

requirementsfor biphenylon theauthority,of section4(a)(1)(A)of TSCA.EPA finds that environmentalreleaseofbiphenyl from the chemical’suseanddisposalmaypresentan unreasonablerisk of adverseeffectsto aquatic -~

organismsbecauseof theexistingdatawhich suggestthatbiphenylmayhavethepotential to producechroniceffectsin aquaticvertebratesandinvertebratesandbecauseof detectedconcentrationsof biphenyl in theaquaticenvironment.In addition,EPAbelievesthatsuchreleasesof biphenyl maypresentanunreasonablerisk of adverseeffectsto

sedimentorganisms.This belief is basedon detectedlevelsof biphenyl insedimentsandon thepotentialofbiphenyl to partitionfrom water intosediments,to persistandpossiblyaccumulatein aerobicandanaerobicsediments,and to bioconcentrateandproduceeffectsin benthicorganisms.EPAbelievesthat thereare insufficientdatato reasonablydetermineor predictthe environmentaleffectsandchemicalfateof biphenyland that testingisnecessaryto developsuchdata.

B.—RequiredTesting

EPAis requiringthat testingofbiphenylbeperformedfor theenvironmentaleffectsandchemicalfatetestslisted below:

1. Chronic fish toxicity2. Chronic daphidtoxicity3. Acute oystertoxicity4. Oysterbioconcentrationand

chronicoystertoxicity5. Aerobic andanaerobic

biodegradation

C. TestSubstance

EPAis proposingthatbiphenyl of 99percentpurity beusedas thetestsubstancebecausebiphenyl of thispurity is readilyavailablecommerciallyandmayprovidemoredefinitiveinformationon biphenyltoxicity thanbiphenylof lowerpurity.

D. PersonsRequiredToTest

Section4{b)(3)(B) specifies-thattheactivitiesfor which theAgencymakessection4(a) findings(manufacture..processing,distribution,use, and/ordisposal)determinewho bearstheresponsibility-for testing.Manufacturers~are requiredto testif thefindings arebasedon manufacturing(“manufacture”is definedin section3(7) of TSCAtoinclude “import”). Processors-arerequiredto testif the findingsare basedon processing.Both manufacturersandprocessorsare requiredto testif theexposuresgivingrise to the potentialrisk occurduringuse,distribution,ordisposal.BecauseEPAhasfoundthatthe useanddisposalof biphenyl maypresentan unreasonablerisk to- theenvironment,personswho manufacture-orprocess,or who intendtomanufactureor process,biphenylat anytimefrom theeffectivedateof this testrule to the endof the reimbursementperiodare subjectto the rule. Theendofthereimbursementperiodfor thebiphenyltestrulewill be5 yearsafter -

thesubmissionof thelastfinal reportrequiredunderthetestrule,

BecauseTSCA containsprovisionstoavoid duplicativetesting,not everypersonsubjectto this rule must

37186 FederalRegisterI Vol. 50, No. 177 / Thursday, September12, 1985 / Rules and Regulations

individually conducttesting.Section4(b)(3)(A) of TSCA provides thatEPAmaypermit two or moremanufacturersorprocessorswho are subjectto the ruleto designateonesuchpersonor aqualifiedthird personto conductthetestsandsubmitdataon their behalf.Section4(c) providesthatany personrequiredto testmayapply to EPAfor anexemptionfrom that requirementasdiscussedin Unit IV. E.

E. TestRuleDevelopmentDevelopmentof this testrule for

biphenyl will bea two-phaseprocess.InPhaseI. this testrule is beingpromulgatedforbiphenylspecifyingcertainenvironmentaleffectsandchemicalfatecharacteristicsfor whichtestdataareto be developed.In PhaseII. following promulgationof thePhaseItestrule, thosepersonssubjectto therulewill berequiredto developstudyplansfor thedevelopmentof datapertainingto theeffectsand -

characteristicsspecifiedin thePhaseIrule.

Within 30 daysfrom the effectivedateof this final PhaseI testrule forbiphenyl, manufacturersmustsubmit toEPA a letterstatingtheir intentiontosponsortestingor anapplicationforexemption.Test sponsorsmustsubmit -

their studyplaneto-EPAwithin 90daysfrom theeffectivedateof thisPhaseItestrule. After anopportunityfor publiccomment,EPAwill promulgatea nileadoptingthestudyplans,asproposedor

modified, asthe teststandardsandschedulesfor biphenylfor thetestsrequiredby thePhaseI rule. Testingwillalso besubjeerto EPA’s TSCA GoodLaboratoryPractices(GLP) standards.-Persons who submitthe studyplans-willbeobligatedto perform thetestsinaccordancewith the teststandardsandschedulesdeveloped.Modificationstothe adoptedstudyplanscanbemadeonlywith EPAapproval.

Processorswill not berequiredtosubmit lettersof intent,exemptionapplications,andstudyplane,andtoconducttesting,unlessmanufacturersfail to sponsortherequiredtests.Thebasisfor this decisionis thatmanufacturersare expectedto indirectlypassthecostsof testingon to processorsthrough anyincreasein thepriceofbiphenyl, -

F ReportingRequirements

EPAis requiringthat all datadevelopedunderthis rulebe reportedinaccordancewith- theTSCA GoodLaboratoryPractice(GLP) standardswhich appearin 40 CFRPart792.Thesefinal GLPstandardsapply to this rule.

EPAis requiredby TSCA section4(b)(1)(C) to specifythe timeperiod.

duringwhich personssubjectto a testrulemustsubmit testdata.Thesedeadlineswill beestablished~nthesecondphaseof-this rulemakinginwhich studyplansareapproved.Theproceduresfor thesecondphaserulemakingare describedin 40 CFRPart790.

TSCA section14(b)governsAgency- disclosureof all testdatasubmittedpursuantto section4 of TSCA. Uponreceiptof datarequiredby this rule, theAgencywill publisha noticeof receiptin the FederalRegisterasrequiredbysection4(d).

G~EnforcementProvisionsTheAgencyconsidersfailure to

complywith anyaspectof a section4rule to be a violation of section15 ofTSCA. Section15(1) of TSCA makesitunlawful for anypersonto fail or refuseto complywith anyrule ororderissuedundersection4. Section15(3)of TSCAmakesit unlawful for anypersonlofailor refusetx (1) Establishor maintainrecords,(2) submitreports,notices,orotherinformation,or (3) permitaccesstoor copyingof recordsrequiredby theAct of any regulationissuedunderTSCA~

Additionally,TSCA section15(4)makesit unlawful forany personto failor refusetopermitentryor inspectionasrequiredby sectionIL Section11appliesto any.“establishment,facility,or otherpermisesin. which chemical -

substancesor mixturesaremanufactured,processed.stored~or heliibeforeoraftertheir distributionincommerce.... .“ TheAgencyconsidersa testingfacility to be aplacewherethechemicalisheld orstoredand.therefore,subjectto inspection,.Laboratoryauditsand/orinspectionswill beconductedpe~iodicailyinaccordanr.ewith proceduresoutlinedinTSCAsection11 by designatedrepresentativesof theEPAfor thepurposeof determiningcompliancewiththe final rule forbiphenyl.Theseinspectionsmaybeconductedforpurposeswhich includeverification thattestinghasbegun,thatschedulesarebeingmet, that reportsaccuratelyreflecttheunderlyingrawdataandinterpretationsandevaluatiOnsthereof,and that thestudiesare beingconductedaccordingto theTSCA GLPstandardsandthe teststandardsestablishedin thesecondphaseof this rulemaking.

EPA’s authorityto inspecta testingfacility alsoderivesfrom section4(b)(1)of TSCA, which directsEPA topromulgatestandardsfor thedevelopmentof testdata.Thesestandardsaredefinedin section3(12)(B)of TSCA to includethoserequirementsnecessaryto assurethatdatadeveloped

undertestrulesare reliableandadequate,andsuchotherrequirementsas arenecessaryto providesuchassurance,TheAgency maintainsthatlaboratoryinspectionsarenecessarytc~provide this assurance.

Violatorsof TSCA aresubject tocriminal andcivil liability. Personswhosubmitmateriallymisleadingor falseinformationin connectionwith therequirementof anyprovisionof this rulemay besubjectto penaltiescalculatedasif theyhaveneversubmittedtheirdata.Underthepenaltyprovisionofsection16 of TSCA. anypersonwhoviolatessection15 coulcibesubjectto acivil penaltyof up to $25,000perday foreachviolation. Intentionalviolationscould leadto the impositionof criminalpenaltiesof up to $~ ~ for eachdayof violation ani iin~ ,imentfor up to1 year.OtherramediL.~are availabletoEPAundersections7 and17 of TSCA,suchasseekinganinjunction to restrainviolationsof TSCA section4.

Individuals aswell ascorporationscould besubjectto enforcementactions.Sections15 and 16 of TSCA apply to“any person”who violatesvariousprovisionsof TSCA. EPA may,at itsdiscretion,proceedagainstindividualsas well as companiesthemseivesInparticulatthis includesindividualswhoreportfalseinformationor who causeitto bereported.In addition, thesubmissionof false,fictitious, orfraudulentstatementsis a violationunder18 u.s.c.1001.

V. EconomicAnalysisof Rule

To assesstheeconomicimpactof thisrule.EPAhaspreparedan economicanalysisthatevaluatesthepotential forsignificanteconomicimpactson theindustryas a result of therequiredtesting.Theeconomicanalysisestimatesthecostsof conductingtherequiredtestingandevaluatesthe potential forsignificantadverseeconomicimpactasa resultof thesetestcostsby examiningfour marketcharacteristicsof bipheriyl:(1) Price sensitivity of demand,(2)industrycostcharacteristics,(3)industrystructure,and (4) marketexpectations.

The totalcostsof conductingtherequiredenvironmentaleffectstestsareestimatedto rangefrom $47,500to$116,100.Annualizedcostsrangefrom$12,303to $30,070.Basedon thesecostsand themarketcharacteristicsofbiphenyl, theeconomicanalysisindicatesthat the potential forsignificant adverseeconomicimpactasa resultof this testrule is low. Althoughthe marketexpectationsfor biphenyl in’its majorusesarenot optimistic and thepricesensitivityof demandappears

FederalRegister / VoL 50, No. 177 I Thursday. September12, 1985 / Rules and Regulations 37187

relatively elastic, this conclusionissupportedby thefollowingobservations:

1. The annualunit costof the testingrequiredrn this rule is very low. Basedon anestimated1984productionlevel of13 million poundsandanualtestcostsrangingfrom $12,303to $30,070,theunitcostsof testingrangefrom a low of 0.09centsper pound to amaxirnwnof 0.23centsperpound.Thisrepresents-

approximately0.13to 0.33percentofcurrentprice.

2. Biphenyl is producedas-asecondaryproducttobenz~by all butone producer,It is unlikely that therelatively small ønit testcostswouldhavea s~gnificantadverseeffecton theoverall profitability of theseoperations.

Referto theEconomicAnalysis (Ref.2) for a completediscussionof testcostestimationand the potentialforeconomicimpact-resultingfrom thesecosts.

VI. Availability of TestFacilitiesandPersonnel

Section4(bJ(1)of TSCArequiresEPAto consider“the reasonablyforeseeableavailability of thefacilities andpersonnelneededto perform thetestingrequiredundertherule.”Therefore.EPAconductedastudytoassessthe -

availability-of testfacilitiesandpersonnelto handletheadditionaldemandfor testingservicescreatedbysection4-testrules.Copiesof thestudy.“ChemicalTestingI~idustry~Profi’eofToxicologn~LTesth” Octobei~1~.,.canbeobtainedthroughtheNa&~miTechniaUnfo~tionService(NTIS) -

Springfield.Virginia, (PB82-140773).On thebasisof this study, theAgency

believes-thattherewill beavailabletestfacilities andpersonnelto p&farn~the-testingrequired-inthis testrule..

VU. Public Record -

EPA hasestablisheda publicrecordfor this rulemaking(docketnumberOPTS—42031J,Thisrecordincludesbasicinformation consideredby theAgencyindevelopingthis rule andappropriateFederalRegisternotices.TheAgencywill supplementtherecordwithadditionalinformationas it is received.

This recordincludes-thefollowinginformation: - -

A. SupportingDocumentation

(1) FederalRegisternoticespertainingto this rule, consistingofz

(a)Noticeof final rule on biphenyl.(b) Notice of proposedrule on

biphenyl.May 23,1983(48FR 23080).(c) Noticecontainingthe ITC

designationof bip~enylto thePriorityList. May 25, 1982 (47 FR 22585).

(d) Notice of final rule on EPA’s TSCAGoodLaboratoryPracticeStandards.Nov. 29, 1983 (48 FR 53922).

(e) Notice of final rule on testruledevelopmentandexemptionprocedures,Oct. 10, 1984 (49 FR 39774).

(I’) Noticeof final rule~oncerningdatareimbursementJuly 11. 1983 (48FR31785). -

(2) Supportdocuments,consistingofi(a) Biphenyl technicalsupport

documentfor proposedrule. -

(b) Economicimpactanalysisof finaltestrule for biphenyl. -

(3) Communications,consistingof:(a) Writtenpublic comments.(b) Summariesof telephone

conversations. --

(c) Meetingsummariesincludingtranscriptof public meetingheld on.proposedrule Aug. 8, 1983.

(d) Reports—publishedandunpublishedfactualmaterials,includingcontractors’reports.

B. References(1) Hawley, G.G. TheCondensedChemical

Dic~ionary~9th ed.New York: Van NostrandReinhold. pp. 315—318.1977.

(2) MathtecbInc. EcomicAnalysisfor theFinal Rule:Biphenyl.Washington.D.C. Officeof Toxic Substances,U.S. EnvironmentalProtectionAgency.ContractNo. 88-01—66301985 (June). -

(3) Kirk.Othmer.Wannemacher,R..Demaria.A.. “Dye carriers”,1nKJrk-OthmerEncyclopediaofChemicolTechnology.3rded.,Vol.8. NewYork: Wiley.Interscience.Pp.

-151—158.1979.(4) Elder. V.A, Proctor,B.L, Ffrtes,R.A.

‘Organiccompoundsneardumpaites-inNiagaraFails.,NewYoi*~’.B~oesedMass.Sped.8(9J’.409-415..1981.

(51 Elder, V.A. Proctor,B.L Hites.,R,A.“OrganiccompoundsfoundneardumpsitesinNiagaraFalls.New York”. Environ.Sci.Technol.15(W):1237—1243...198’L

(6) Kites, R.A. “Analysis of traceorganiccompoundlinNewEnglandrivers”./.Chroniotogr.Sd.1157O-574~1973.

(7’) Jungclaus.G.A,Lopez-AvilaV., antiKites, R.A. “Organiccompo~indsin anindustrialwastewatera casestudyon theirenvironmentalimpact”. Environ. Sci.Technol.12(11:88—96.1978.

(8) NIH/USEPA. NationalInstitutesofHealth/U.S.EnvironmentalProtectionAgency. ComputerPrintout(NIH—EPA):WATERDROPdatabase.Washington,DC:NIH. U.S.Dept. HealthandHumanServices/Officeof Toxic Substances,USEPA.1982.

(9) Macleodet a]. “intertaboratorycomparisonsof selectedtracehydrocarbonsfrom marinesediments.”And. Chem.54(3):388-392.1982.

(10) Tincher,W.C. 1973. “Effect of polysterfiber processingeffinentsanwaterquality.”ReportERC-i873.Atlanta.Georgia Georg4aInstituteof Technology.51p.

(‘11) Steinheimer.T.R., Pereira,W.E., andJohnson.S.M. “Applicationof capillarygaschromatographymassspectrometrycomputertechniquesto synopticsurveyof organic

md~enalin bedsediment.”.4nu/. Chern. 4cta.129(1):57—67.1981.- (12) Shackelford. WM. and Keith. LH.“Frequency of organic compounds ideniifiedin water.” Athens. CA: EnvironmentalResearchLab, U.S. Environmental ProtectionAgency.EPA Pub. 1976.

(13) Adams, W.J. et al. “Acute toxicity ofbiphenyl to Daphnia magna.”Monsantoreport ES—82—SS—64.St.Louis. MO: MonsantoCompany.1982.

(14) Heidoiph. B., Gledhill, W.E. “Acutetoxicity of biphenyl to Daphniamogna.”Monsanto Report ES—83--SS—18.Si Louis,MO: Monsanto Company. 1983. - -

(15) Kirk-Othmer. Weaver, W.C., Simmons.P.B. andThompson,Q.E. ~‘Biphenylandterphenyl.” In.~Kirk-OthmerEncyclopediaofChemical Technology.3rd ad., vol. 7. NewYork: Wiley-lnterscience.pp. 782.793.1979.

(16) Dow ChemicalCo. (May 1).InteragencyTestingCommitteeResponse:1.1’.BiphenyLMidland, MI. 1981.

(17) Haas,J.M., Earhart,H.W.. Todd,A.S.“Environmentalconsiderationsconcerningtheselectionofdye carriersolvents.”!.Am.Assoc.TextChem.Color. Book-ofPaper-s.(19741:442—447.1974.

(18) Batcheider.Ti.. Dow ReportES—iBi.Dow ChemicalCo.. Midland, MI. 1977.

(19) Dill, D.C. eta]. “Comparisonof thetoxicities of biphenyl,monochlorobiphenyiand2.2’.4.4’-tetrachlorobiphenylto fish anddaphnida.”in.~“Aquatic toxicology andhazardassessment,fifth conferenceASTMSTP768.” Pearson,J.G.,Foster,R.B,. andBishop.WE., eds.Philadelphis:AmericanSocietyfor Testing,andMaterials.1982. pp.245—258.

(20) Gaffney. P.E,“Carpetandrugindustrycasestudy lb Biological effects.”J.WaterP0/JUL Control Fed.4~2)~731-2737.1978,

(21) DIII, D.C., andEmmitte, ).A. “Staticacutetoxicity testswith freshwaterorganismsexposedto water solutionsofbiphenyL2-. 3-, and4-monochlorobipbenyi(MCB) and2.2’.4.4’tetrachlorobiphenyl(2,2’,4,4’TCB).” ReportES-394.Midland.. M1Dow ChemicalU.S.A. 1980.

(22)LeBlanc,G.A. “Acute toxictty ofpriority pollutantsto waterflea (Daphniomagna).” Bull. Environ.Contain. Toxicol.24:684—691.1981.

(23) MonsantoChemicalCompany.TSCAsec.8(d)submiss4on878213565.Acutetoxicityof therminol’ to fatheadminnows.FinalReport.1979. Washington.D.C. Office ofToxic Substances,U.S. EnvironmentalProtectionAgency.1985.

(24) Hutchinson., T.C. etal. “Thecarre~atioriof the toxicity to algaeof hydrocarbonsandhalogenatedhydrocarbonswith theirphysical-chemicalproperties.”In: AfghanBK.MacKay0. eds.“HydrocarbonsandHalogenatedHydrocarbons in the AquaticEnvironment,”Environ.Sc:.Res., Vol. 16.New York: PlenumPress,pp. 577—586.1980.

(25) Hansch.C. andLeo. A. “Substituentconstantsfor correlationanalysisinchemistryandbiology.” New York Wiley.1979.

(28) Rep. No.94—1341,94th Cong..2dSeas.(1976);Reprint in. LegislativeHistoryof theToxicSubstancesControlActat 3(~.

37188 FederalRegister/ Vol. 50, No. 177 / Thursday, September12, 1985 / Rules and Regulations

127) Meylan. W.M., andHoward. P.1-I.“Chemical market imput/output analysisofselectedchemical substancesto assesssourcesof environmentalcontamination.Task II: Biphenyl anddiphenytoxide.” SRCNo. L1273.-07.Washington.D.C.: OfficeofToxic Substances.U.S. EnvironmentalProtectionAgency.Contract68’-0’1’-3224—TaskII. 1977.

(28) Freitag.0.et a!. “Ecotoxicologicalprofile analysis.”EcotoxicologyEnvir. Safety5(71:60-87.7982. -

(29) Caffney.P.E. “Carpetandrug industrycasestudy I: Waterandwastewatertreatmentplant operation.”!. WaterPollutionControl Fed. 48(11):2590—2598.1976:

(30) Gordon M; A.W.. and Gordon, M.“Analysis of volatile organiccompoundsin a -

textile finishingplanteffluent.” Tmns; Kans.Acad.Sci. 42 (3—4): 149—157.1981.

ConfidentialDusinessInformation(CBJ),while part of therecord, is not

vaiiable for public review.A publicversionof the record, from which CBIhasbeendeleted,is availableforinspectionin theOPTSReadingRm.E—107, 401 M St. SW., Washington.DCfrom 8 a.m.to 4 p.m.,MondaythroughFriday, exceptlegal holidays.

VIII. OtherRegulatoryRequirements

A. Executive Order 12291 -

UnderExecutiveOrder12291. EPAmust judge whetheraregulationis.“Major” and,theiefore..subjectto therequirementof a RegulatoryImpactAnalysis.This testruleis not majorbecauseit doesnot meetany of thecritieria setforth in section.1(b)of theorder.First, thetotal costof all theproposedtestingfor biphenyl-is$47300to $116,100overthemarketlife ofbiphenyl.Second,thecostof thetesting-is not likely to result in a majorincrease-

in users’costor prices.Finally, basedonourpresentanalysis;EPA doesnot.believethat therewill bea significantadverseeffectsasaresultof this nile. -

This proposedregulationwassubmittedto the Office of ManagementandBudget(0MB) for review as.requiredby ExecutiveOrder12291.Anycommentsfrom 0MB to EPA. andanyEPA responseto thosecomments,areincludedin the rulemakingrecord.

B. RegulatoryFlexibility Act

Under theRegulatoryFlexibility Act(15 U.S.C.601.Pub.L. 96—354,September19, 1980),EPA is certifyingthat this testrule, if promulgated.will nothaveasignificantimpacton asubstantialnumberof small businessesbecause:(1)Theyareriot expectedto perform testingthemselves,or to participateinorganizationof thetestingeffort; (2) theywill experienceonly veryminor costsifanyin securingexemptionfrom testingrequirements;and(3) theyareunlikely

to beaffectedby reimbursement

requirements.

C. PaperworkReductionActTheOffice of ManagementandBudget

(0MB) hasapprovedthe informationcollectionrequirementscontainedin thisruleunderthe provisionsof thePaperworkReductionAct of 1980. 44U.S.C.3501 et seq. andhas0MB controlnumber2070-0033. -.

List of Subjectsin 40CFRPart799

Testing,Environmentalprotection.HazardousSubstances,Chemicals,Recordkeeping-andreportingrequirements.-

Dated:September3. 1985. -

J.A. Moore,AssistantAdministratorforPesticidesandToxicSubstances.

PART 799—(AMENDEDJ

Therefore.40 CFR Part799isamendedasfollows:

1.The authority citation for Part799continuesto read.asfollows:

Authority 15 U.S.C. 2603, 2611. 2625.

2. Part799is amendedby adding§ 799.925 in SubpartB to readasfollows: . -

799.925 Biph.nyl. - -

ja) Identificationof test substance.(1)BIpheny! (,CASNo. 92—52-4~shallbetestedin accordancewith this rule.

(2) Biphenyl of at least99 percentpurity shallbeusedas-thetestsubstance.

(bLPërsonsrequiredto submit studyplans, conduct tests andsubmit data.All personswho manufactureor processBiphenyl from theeffectivedateof this -

rule~October28, 1985] to theendof thereimbursementperiodshallsubmitlettersof intent toconducttestingorexemptionapplications,submitstudyplans,conducttestsandsubmitdataasspecifiedin this section,SubpartA ofthis Part andPart790—TestRuleDevelopmentandExemptionProceduresof this Chapter.

(c) Environmental effects testing—(1)Fish early life stage taxi city testing—(i)Required testing. Testingusingflow-through.systemsshallbeconductedwithrainbow trout to developdataon thechronictoxicity of biphenylto aquaticvertebrates.

(ii) Study plans.Forguidanceinpreparingstudyplansit is recommendedthat theOTS EnvironmentalEffects TestGuidelinesfor theFishEarly Life StageToxicity test (EG—Il), publishedby NTIS(PB 82—232992),beconsulted.Additionalguidancemaybe obtainedby consultingPesticideAssessmentGuidelines,Subdivisionfor HazardEvaluation:

Wildlife andAquaticOrganismspublishedby NTIS (PB 83—153908).

(2) Dczphnidchronic toxicity testing—(I) Requiredtesting.Testingusingflow-throughsystemsshallbeconductedwithdaphnidsto developdataon thechronictoxicity of biphenyl to aquaticinvertebrates.

(ii) Study plans. For guidanceinpreparingstudyplans,it isrecommendedthat the OTS.EnvironmentalEffectsTestGuidelinesfor the DaphnidChronicToxicity test(EG—2). publishedby NTIS (PB 82—232992),beconsulted,Additionalguidelinesmaybeobtainedby -

consultingPesticideAssessmentGuidelinesfor HazardEvaluation~Wildlife andAquatic Organisms(PB 83—153908),andreferencescitedin- thesupportdocumentfor theproposedtestrule.

(3) Oyster acute toxicity testing—{i)Requiredtesting.Testingusingsystemsthat control for biphenylevaporationshall be conductedwith oysterstodevelopdataon theacutetoxicity ofsediment.associatedbiphenyl to benthicinvertebrates.

(ii) Studyplans.For guidanceinpreparingstudyplans,it isrecommendedthattheOTS -

EnvironmentalEffectsTest.Guidelinesfor theOyst& AcuteToxicity Test(EG—5)~publishedby NTIS (PB 82—232992),beconsulted.A’dditional guidancemaybeobtainedby consultingthePesticideAssessmentGuidelinesfor Hazard-EvaluatiomWildlife andAquaticOrganisms(PB 83-153908).Becausethetesting requirestheuseof sediment-associatedbiphenyl, thepaperof LynchandJohnson(1982),which is availableinthepublic recordfor this rulemaking,shouldalsobe consulted.

(4) Oysterbioc.oncentrationtesting—(I) Requiredtesting. Testing usingsystemsthat control for bipheny~evaporationshall beconductedwithoystersto developdataon thepotentialchronic toxicity andbioconcentrationofsediment-associatedbiphenylto benthicinvertebrates.

(ii) Study plans. Forguidanceinpreparingstudyplans,it isrecommendedthattheOTSEnvironmentalEffectsTestGuidelinesfor the OysterBioconcentrationTest(EG—6), publishedby NTIS (PB 82—232992),be consulted.Additionalguidancemay be obtainedby consultingthe PesticideAssessmentGuidelinesforHazardEvaluations:Wildlife andAquatic Organisms(PB 83—153908)andreferencescited in the supportdocumentfor the proposedtestrule. Becausethetesting requirestheuseof sediment-associatedbiphenyl, thepaperof Lynch

FederalRegisterj VoL 50, Nc. 177 1 Thnrs~ay,September12 1985 / Rules and Regulations- - 37189

andJohnson(1982), which is availableinthe public recordfor this rulemaking.shouldbe consulted.

(d) Chemica/fatetesting’—{l) Aerobicbiodegradation—(i)Requiredtesting.Testing usir?g systems thatcontrol forandquantify biphenyl evaporationthatusea ratio of undisturbedsedimenttowaterof 3’1—2’1~andthat provideamassbalanceof biphenyl distrib~atedinwaterarid sediment,volatilizedor -

degradedtaCO2or otherproductsbeforeandafterbiodegradationshall beconductedto developdataon thepersistence-ofbiphenyiin aerobicsediments.

iii) Studypiazrs. Forguidanceinprepanngstudyplans, it is -

recommended that theOECDTestGuidelinefor inherentbiodegradabilityin soil (304A) publishedby O~Dbeconsulted.

(2)Anaerobicbj~e ~ciati~ —(i)Requiredtesting.Testingua-~ngsystemsthatcontrol for andquantifybiphenylevaporationthat usearatio ofundistu.thed sedimentto waterof 31—2:1 andthat providea massbalanceofbiphenyl distributedin waterandsediment,volatilized or degradedto CO2or otherproductsbeforeandafterbiodegradationshallbe.conductedwithbiphenyl to developdataon the. -

persistenceof biphenylin anaerobicsediments.

(ii) S~udypkrns.For guidance-inpreparing studyplans.itis -

recommendedthat the OTSChemicalFateTestGuidelinesforA~aerobicBiodegradation (CG—20504.pued~b~NTIS (PR82-233008),becaasu&ted..

(e) Availability oftestguidelines.TheOTSEnvironmentalEffe~sTestGuidelinescited in this fInal rule~eavailablefrom the NationalTechnicalInformationService,5285PortRoyal.Road,Springfield,Virginia 22161(703-.487—4.650).

(Informationt~1lectionrequirementsapprovedby the Office of ManagementandBudgetunder controlnumber2070—0033.)

[FR Doc. 85—21811Filed 9—fl—&5 8:45auiJBIWNG cODE ss�o-so-ia