FederalRegister I \‘ol. 51, No. 130 / Tuesday, July 8, 1986 / Rules and Regulations 24657

Eachplant emits more than 100tonsofVOC peryear from flexo~aphicprocesses,andas such is subjectto RuIe~115.2C1.Basedon Arrow’s contentiotithat water-basedand/orhigh solidscontentink would riot be availablebytheSIP compliancedateand that ‘add-on” control equipmentwaseconomicallyinfeasible,on TuneIU,1933, theTACB issuedtwo BoardOrdersto Arrow extendingtheir SIPcompliancedate for both plantsuntilDecember31, 1985.TheTACB did not,however,submit the SIP compliancedateextensionsto EPA for revisiontotheSJi~,andthusthe SIP-requiredcompliancedateremainedDecember31,1982~OnJanuary30, 1984, andOctober9, 1985,EPA notifiedArrow’s CarrolitonandFarmersBranchfacilities,respeclively,undersection113(a)(1)oftheCleanAirAct that theywereoperatingin violation of theTexasSIP.Subsequently,theTACB developedtheSeptember20, 1985DCOsthat arenowproposedfor approvalunderthis notice.TheTACB transmittedthe DCOs to EPAon September27, 1985. EPAreviewedtheDCOs,’ andfoundthat they satisfythe requirementsof section113(d)of theCleanAir Act, including public noticeandhearingrequirementsandsection121 of theCleanAir Act regardingconsultationwith generalpurposelocalgovernments.The full texts of theseorderswerepublishedon January7,1986.at 51 FR 627~

SincetheUCOsareapprovedby EPA,compliancewith their termsprecludefederalenforcementactionundersection113 of theCleanAir ActagainstArrow for violations coveredby theOrderduringtheperiodthattheOrdersarein effect. Further,enforcementunderthecitizen suit provisionof section304of theCleanAir Act aresimilarlyprecluded.The approvedOrdersconstituteanaddition to theTexasSIP.However,compliancewith theOrderswill not precludeassessmentof anynon-compliancepenaltyundersection120of theCleanAir Act, unlessthesourceis entitled to anexemptionundersection120~a)(2)[13) or [C).

AU interestedpersonswereinvited tosubmitwritten commentson theproposedapprovalaction. No commentswere received.Thepublic should beadvisedthat this actionwill be effectiveon thedatelisted in the effective datesectionof this rulemaking.Undersection307(b)(1)of the Act, petitions forjudicial review of this actionmust be

I “EPA Re~iewof Thxas State De~avedCump%anceOrdersFor Arrow. incorporated,DallasCocnty.Tesa~.September20.1985:Octoher—“cyvrrnb~r1985”.This evaluationis av~ilsbteat theIP5tOc 6 address given pre~crusty in this rrOt~cO.

filed in. theUnited StatesCourtofAppealsfor theappropriatecircuitwithin 60 daysof thedateof publicationof this noticeof final rulemaking.Thisactionmay not bechallengedlater~nproceedingsto enforceits requirementstSeeSec.30?tb)~2)l.

EachDCOaffectsonly oneentity andinvolvesan “Order”, ratherthana“Rule”, andthereforethis actionis notsubjectto the requirementsof theRegulatoryFlexibility Act or toExecutiveOrder12291.

TheNotice of Approvalis issuedundertheauthorityof sections113 and301 of theCleanAir Act~42U.S.C.7413and7601..

List of Subjectsin 40 CFR Part65

Air pollution control..

Dated:lune23, 1986~Lee M. Thomas,Administrator

[FR Doc86—15267Filed 7—7—85;8:45 am]BILUNG CODE 6560-50-U

40CFR Part 799

(OPTS..47002F;FRL-3028-7)

ChlorinatedBenzenes;FinalTest Rule

AGENCY: EnvironmentalProtectionAgency(EPA)~AcTION; Final rule

SUMMARY: EPA is issuingafinal rule,undersection4 of theToxic SubstancesControlAct (TSCA). requiring:(1)Manufacturersandprocessorsof1,2,4-trichioroberizene(TCB) to conduc}oncogenicilytestingof 1,2,4-TCI3.ICASNo. 120—82—1), (2) manufacturersandprocessorsof monochlorobenzene(MCI3) to conductreproductiveeffectstestingof MCB (CAS No. 108—90—7),(3)manufacturersandprocessorsof ortho-andpara-dichlorobenzenes(1,2- and1,4-DCBs) to conductreproductiveeffectstesting of 1,2- and1,4-DCBs -

(CAS Nos. 95-50-1and. 106-46—7,respectively),and(4) manufacturersandprocessorsof 1,2,4,5-tetrachloroberizene(l,2,4,5-~TC&CASNo. 95-94—3) toconductreproductiveeffectsand.developmentaltoxicity testingof1,2,4,5-TCB.This rule requiresthat thehealth effectstesting for thesechlorinatedbenzenesbe performedaccordingto the TSCA HealthEffects

PART 65—~AMENDEDT

Part65 o~Chapter1. Title 40 of theCodeof FederalRegulationsis amendedasfollows:

Subpart SS—Texas

1, The authoritycitation for Part65cop,tinuesto readasfollows:

Authority: 42 U.S.C7413 and 7601.2. In ~65.481,.two.enlriesareaddedto

thetableliii alphabetical.orderasfollows;

§ 65.481 EPA approval of State delayedcomplianceordersissuedto majorstationarysources.* * * t *

TestingGuidelinesin 40 CFR Part 798for the requiredhealth.effects;EPA isalsoterminatingits rulemakingprocessfor subchronkjchronicandoncogenicitytesting of 1,2,4,5-TCB.

DATES: In accord~ncewith 40 CFR Part23.5(50FR7~271kthis ruleshall bepromulgatedfor pu?posesof judicialreviewat 1:00 easterndaylight time onJuly’22, 1986.Theseregulationsshallbecomeeffectiveon August 21, 1980.

FOR FURTHER iNFORMATION CONTACT:EdwardA. Klein, Director,TSCAAssistanceOffice (TS—799), Office ofToxic Substances,RatE—543,401 M St.,SW., Washington,D.C. 20460.Toll free:(600—424—9065).In Washington,D.C.:•(554—1404).OutsidetheUSA: (Operator—202—554—1404).SUPPI.EMENTARY INFORMATION: EPA isissuinga final testruleundersection4(a)of ISCA in responseto theInteragencyTestingCommittee’s(ITC)1977andl978designaLions of thechlorinatedbenzenesfor healtheffectstestingconsiderationandto satisfya1984courtorderrequiringthe.Agencytotakefinal actionon its July 18, 1980proposedtestrule(45FR 48524) for thechlorobenzenesby June1988..

L Introduction

A. TestRule DevelopmentUnder TSCA

This noticeis partof theoverallimplementationof section4 of TSCA(Pub.L 94—469,90 Stat2003 etseq.,15U.S.C.2601et seq.)whichcontainsauthority for EPA to requirethe

s~Sorace . Location Order.No. re~utatrons-~ . cnvotved

Oats01

~proposal

Final

coc’rrpti.

ancedate

Arrow tndustries,tnc~ Oarrotton, TX _.._.._, TACS No. 85—10 115.201 117/86 12131/CSArrOw tcaluslriesjnc.._.,..,_........~Farmers Scanch, TX....,__ TACBNo. 85—11 . ~.t15.2o1 T/7/86 12/31/85

24658 FederalRegister / Vol. .51, No. 130 / Tuesday, July 8, 1986 / Rules and Regulations

developmentof datarelevanttoassessingtherisks to healthandtheenvironmentposedby exposuretoparticularchemicalsubstancesormixtures.

Undersection4(a)(1)of TSCA, EPAmustrequiretestingof achemicalsubstanceto develophealthorenvironmentaldataif theAdministratorfinds that:

fA)(i) themanufacture,distribution incommerce,processing,use,ordisposalof achemicalsubstanceormixture,or thatanycombinationof suchactivities.maypresentanunreasonablerisk of injury to healthor theenvironment.

(ii) thereareinsufficientdataandexperienceuponwhichtheeffectsof suchmanufacture,distributionin commerce,processing,use,ordisposalof suchsubstanceormixtureor of anycombinationof suchactivitieson healthor theenvironmentcanreasonablybedeterminedor predicted,and

(iii) testingof suchsubstanceormixturewith respectto sucheffectsis necessarytodevelopsuchdata;or

(B)(i) a chemicalsubstanceor mixtureis orwill beproducedin substantialquantities,and(I) it entersormayreasonablybeanticipatedto entertheenvironmentinsubstantialquantitiesor (H) thereis ormaybesignificantor substantialhumanexposureto suchsubstanceormixture,

(ii) thereareinsufficient dataandexperienceuponwhich theeffectsof themanufacture,distributionin commerce.processing,use,ordisposalof suchsubstanceor mixtureor of anycombinationof suchactivitieson healthor theenvironmentcanreasonablybedeterminedor predicted,and

(iii) testingof suchsubstanceormixturewith respectto sucheffectsis aecessarytodevelopsuchdata.

Fora morecompleteunderstandingofthestatutorysection4 findings, thereaderis directedto theAgency’sfirstproposedtest rulepackagepublishedJuly 18, 1980 (45FR 48510) for in-depthdiscussionsof thegeneralissuesapplicableto this action.

B. RegulatoryHistory

In theFederalRegisterof October12,1977 (42FR 550”5), theInteragencyTesting Committee(ITC) designatedmonochlorobenzeneandthedichlorobenzenesfor healthandenvironmentaleffectstestingconsideration.On October30, 1978 (43FR 50630),the ITC alsodesignatedtn-,tetra-andpentachlorobenzenesforhealthandenvironmentaleffectstestingconsideration.TheAgencyrespondedtothe ITC’shealtheffectstestingrecommendationsby issuingin theFederalRegisterof july 18, 1980 (45FR48524).a proposedhealtheffectstestrule for thechlorobenzeneschemicalcategoryrequiring testingof specificmembersof both groupsof chlorinatedbenzenes.

During October1980EPA held severalpublic meetingsto hearandrespondtooral commentspresentedon variousaspectsof theproposedrule. Theminutesfor thesemeetingsarecontainedin therecordfor this action.

In theFederalRegisterof December7,1983 (48FR 54836),EPA issuedaproposedrule-relatednoticeandrequestfor commentson a proposednegotiatedtestingagreementfor reproductiveeffectstestingof certainchlorinatedbenzenes,anda tentativedecisiontowithdrawanumberof thehealtheffectstestingrequirementstheAgencypreviouslyhadproposed.

In late 1983,however,theNaturalResourcesDefenseCouncil (NRDC) andtheIndustrial Union Departmentof theAmericanFederationof Labor-Congressof IndustrialOrganizations(AFL—CIO)filed anactionunderTSCA section20whichchallenged,amongother things,EPA’s utilization of negotiatedtestingagreementsin lieu of initiatingrulemakingunderTSCA section4(a) forfour ITC-designatedchemicalsubstances.In anAugust23, 1984Opinion andOrder, thedistrict courtfound that in EPA’s responsestochemicalsdesignatedby the1TC, non-enforceablenegotiatedagreementsmaynotbe adoptedby EPAin lieu ofrequiringtesting throughenforceablesection4(a) testrules(seeJVRDCandAFL—CIOv. EPA, 595 F. Supp.1255(S.D.N.Y.1984)).

TheCourtalso agreedwith anotherNRDC complaintagainstthelengthoftime EPA hadtakento issuethefinaldecisionon thehealtheffectstestingofthechlorinatedbenzenes.In thecourt’sFinal JudgmentandOrderof October30,1984,EPAwasdirectedto issueits finaldecisionon thechlorinatedbenzeneshealtheffectstestingby June1986.

In accordancewith thecourt’sopinion,EPAdecidednot to adopttheindustrytesting programdiscussedin itsDecember7, 1983notice,andannouncedthis decisionin theFederalRegisterissueof December28, 1984 (49FR50408).

Also in theFederalRegisterofDecember28, 1984 (49FR 50408),EPAissueda noticewithdrawingseveralportionsof theJuly 1980proposedtestruleon thebasisof insufficientexposure.adequatetestingin progress,or theavailability of datato reasonablypredict therisk of certainhealtheffectsthat thosechlorinatedbenzenesmaypresentto humans.This removedfromfurtherconsiderationthe followinghealtheffectstesting:(1) Structuralterutogenicity(developmentaltoxicity)testing for MCB, 1,2-DCB, 1,4-DCB,and1,2,4-TCB; (2) subchronic/chroniceffectstesting of MCB, 1,2-DCB, 1,4-DCB and

1,2,4-TCB;and (3) oncogenicityandreproductiveeffectstesting ofpentachlorobenzene.

Having decidedto withdraw certainportionsof thehealtheffectstestruleproposalandnot to adopta negotiatedtestingprogram,theAgencycontinuedwith the rulemakingprocessfor thefollowing portionsof the chlorinatedbenzeneshealtheffectstestingproposal:(1) Oncogenicitytestingof 1,2,4-TCB; (2)chnonic/subchronictoxicity,oncogenicity,teratogenicity(developmentaleffects),andreproductiveeffectstestingof 1,2,4.5-tetrachlorobenzene;and(3) reproductiveeffectstestingof MCB and1.2- and1,4-DCBs.

EPAalsostatedin its December28,1984notice,that the final ruleconcerningthechlorobenzenehebltheffectstestingrequirementswould bepromulgatedin asinglephase,suchthattherule would include teststandardsandreportingrequirements.In theproposedrule, EPAsetforth proposedreportingrequirementsanddatasubmissiondeadlinesandproposedthatthetestingshouldbedoneinaccordancewith theapplicableproposedteststandards,with possiblechemical-specificmodifications(45 FR43565;July 18, 1980).In the FederalRegisterof November27, 1985 (50FR48805),the EPA issueda noticerevisingits proposedrule of July 18, 1980, byupdatingthe proposed’healtheffectstestingrequirementsto reflecttheincorporationof currentTSCA testguidelinesissuedby EPA’s Office ofToxic Substances.In the updatednotice,EPAproposedthat the remaininghealtheffectstestsfor thechlorinatedbenzeneswould beperformedinaccordancewith the,methodologiescitedin theTSCA HealthEffects TestGuidelinesin 40 CFRPart 79B. By doing.so thetestingrequirementswould followcurrentAgencypolicy andensurecurrentandgenerallyacceptedminimalconditionsfor determiningthehealtheffectsof testsubstanceslike thechlorinatedbenzenes.

The Agencyhasalso publisheda finalruleandanadvancenoticeof proposedrulemakingforenvironmentaleffectstestingof thesechlorinatedbenzones(51FR 11728,April 7, 1986and49FR1760,January13, 1984,respectively).This finalrule addressesonly thehealtheffectsdecisionsfor thechlorinatedbenzenes.

Therefore,in accordancewiih theFinalOrderandJudgmentin NRDCandAFL—ClO v. EPA, theAgency is to~ingthis final actionon the rerndiningportionsof the chlorinatedber:zenesproposedhealtheffectstest ruic to

comply with the court’s order.

24659FederalRegister / Vol. 51. No. 130 / Tuesday, July’ 8. 1986 / Rules and Regulations

II. Public Comment

Thecommentsreceivedby theAgencyin responseto theproposedrulefor thechlorinatedbenzeneswerefromtheaffectedindustry aridseveraltradeassociations.TheAgencydid notreceiveanycommentswhicit in the-Agency’sjudgment.rebuttedthefindingsof potentialunreasonableriskandinsufficientdatafor reproductiveeffectsfor MCB and1,2- and1,4-DCBs,oncogeniceffectsfor 1.2,4-TCB.,andreproductionanddevelopmentaltoxicitytestingof 1,2,4,5-TCB.

In theproposedrule, theAgencyraiseda numberof issuesfor comment.Severalof theissuesareno longerapplicableto this rulemakingin. light of.additional datareceivedandthewithdrawal of portionsof theproposedrule. Majorissuesrelevantto theremainingrulemakingandcommentsreceivedarediscussedbelow.

1. Shouldanyadditional,chlorinatedbenzenesbeincorporatedin thesampledesignatedfor testing?Shouldanybedeleted?Alternatively,should allchlorinatedbenzenesthat aremembersof thecategory,asdefinedby EPA, betested?

Many commentswere receivedon thisissue.However,whenconsidering:(1)Thewithdrawalof theproposedtestingrequirementsin this noticetogetherwiththosewithdrawnin December1984, (2)thatmuchof theproposedtesting hasnow beenconducted,and(3) thatverylittle of. theoriginally designated.representativetestsampleandproposedtestrequirementsremain,EPA hasdecidednot to requiretestingunderacategory-basedapproach.for the:remaining,testingrequirements.

2. Is the Agency’s’requirementthat.thechlorinatedbenzenetestchemicalsbe99.9percentpurewith no morethan0.05-percentberizeneand0.05percenthexachlorobenzeneappropriate’?~

The ChlorobenzeneProducersAssociation(CPA) commented.thatthemostappropriate-approachto purity ofmaterialsto betestedis to selectthe’purestmaterial that’ is representativeofthatwhich’is availablein commercialquantities,ratherthanusinglaboratory-’pure, 99.9percentmaterial..CPAindicatedthatcommercialgradesof highpurity MCB, 1.2—DCB, l,4-DCB, 1,Z,4-~TCB, and‘1,2,4,5-TCB are (orrecentlyhavebeen)available-,All of theseproductscontain lessthan 0.05percenthexachlorobenzeneandlessthan0.05percentbenzene,However,.CPA feltthatrequiringpun tiesof 99.9percentisnot practicalfor severalof theseproducts,norrepresentativeofeconomicallyfeasiblepunities incommercialproducts.

The Agencybelievesthat in mostinstancestestingshouldberequiredfora “representative”commercig~a~oLatest substance.However, the EPAbelievesthat testingof apurergrade.maybe appropriatewhen.a,kxmwrsimpurity orcontaminantin a commercialproduct is a suspectedcauseof adverseeffectsandis itself beingcharactertzedby othertests,orwhenthetestsubstanceis beingtestedas-representa~i.veo5ada~gegrouparid, testdataon apurerform wouid~be~insure.reliableextrapofationto othergroup-members.

EPA will designatethepurity of thetestchemicalsselectedwhichwilLgeneratedataexpectedto reasonahlydefinethelikely toxicologicalefi’ects ofthecommercialvariatio-s.of. the test-chemicalin themarker’piace EPAinitially believedthat a 99.9 percent-pureMCB, 1~2-andi,4-DCB, 1,2,4-TC3and~1,2,4,5-TCBwoulcLbestdef’h~etheilkefytoxic effectsof thecommerciallyavailable-chlorinated’benzenez.However,on thebasiso~industrycommentsandtheNationa’~Toxtcolagy’Program’s~NTP)useof a testnu~terialcharacterizedashavingpuritiesgreaterthan 99 percentfor its oncogenicity’studiesof MCD, 1,2- andI.4-DCB, EPA isrevisingits’purity requireme~Lt~besimilar to thatof NTP’s, which theAgencybelievesis acceptable.

3. Are theresignificantstudies.that.havenot cometo theattentionof EPAwhichwould pruvide sufficient dataandexperiencefor e~4~ratioxrof the-chlorinatedbenzenes?

Commenterssuggestedthat.EPAfailed to cite-numerousdat&from.thaexistingliteraturewhich.areoLeriticalimportancein evaluating.the:chlorobenzenecompounds.TheAgencyhasreceivedthedatacitedby thecommentersandfinds that tile dataareinsufficient for evaluationof the-chlorinatedbenzenes.Forthemostpartthefollowing studieseitherhad’deficienciesin. performanceorinsufficient informationrepo~e~.to.fi.rll~evaluatethestudy-.

a. OneconsmentesnotedaDow’ChemicalU.S.A~studyin dogs.with’1,2,4,5-tetrachlorobenzene;The’ehemicalwasadministeredin the diet at5rng/kgjdayfor 2 years..Ne--cilatiomwas~given.EPA believesthaithis study.wasdeficientin that it wasno.t~conductedat.themaximumtolerateddose,only onedosewasused..the.pathology-dataweranot submittedfor evaluationby theEPA.andinsufficient information’wasprovidedon methodologyanchsesultsforthe EPA to properlyassessitssignificance.

b. Cragg,ST.,Wolfe, G.F.,andSmith~C.C. “Toxicity of 1,2,4-trichlorobenzene

in Rhesusmonkeys:Comparisonof twoin vivamethodsfor estimatingP—450activi.ty.” ToxicologyandAppliedPharmacology.45(1):340.1978.

This studywasonly reportedasanabstract.Therewasnot enoughinformationgivenfor anextrapctlationofrisk to humans.

c. Gage,J.C. “The subacuteinhalationtoxicity of 109 industrial chemicals.”Brllith JournalofIndustrial Medicine.27:1—18. 1978.

Th’rs studyusedfar toofew animals(twci~t~four malesandfemalesat threedoselevels)and therewasup to a 20percentimpurity of 1,2,3-trichtorobenzenein the1,2,4-tnichlo~’obenzenesample.In addition,nomicroscopicexaminationswereperformed.

d. Powers,M.D. et’al. “Repeatedtopical applicationsof 1,2.4-trichlorobenzene.”ArchivesofEnvironmentalHealth.30:165—167.1975.

In this studyhistopathologywasonlydoneon five organsystems,thenumberof animal’s(rabbits)persexwasnotreported’,andpreventionof licking orrubbing thechemicaloff theearwasnotdone.In addition,no clinical chemistryor hematologyexaminationswereperformed.Therefore,basedon this.study. it would be difficult for theAgency toperforman adequateriskestimatefor humans.

e. Smith, C.C.,Cragg,S,T., andWolfe,G.F.“Subacutetoxicity of 1,2,4-tr.ichlorobenizenein subhumanprimates.”FederniProceedings.36:248,1978.

This sti:mdy wasonly reportedasanabstract.Therewasno indication ofmicroscopicexaminationand.therewas-not enoughinformationgiven,foranadequaterisk estimatefor humans,

L Watanabe,P.G.,Yakel,H.O.,andKociba,R.J.“Subchronictoxicity studyofinhaled1,2.4-tricblorobenzeneinrats”. Dow ChemicalCompany.197&

This.wasnotacompletesubchronic.study.becauseno microscopicexaminationswereperformed.Theobservationsweremainlyconcernedwith porphyrinmetabolism..

g. ICI AmericasInc. 1980.The long-terminhalationstudiesof

1,4-DCBhavebeenreviewed.In thesestudies,the’1,4-DCB wasadministeredat two doselevels (75 and500 ppm) for15 months.to’niiceand20 monthsforrats.Thestudiesdid not indicatesignificanttoxicity of 1,4-DCB in eitherratsormiceat500 ppm.Therefore,EPA

- cannot.characterizethedose-responsecurvefrom the informationsubmitted.Since.previousstudieshaveindicatedtoxicity to,thekidneysandliver fromthis chemical~itis reasonableto assume

23660 Federal Register/ Vol. 51, No. 130 / Tuesday, July 8, 1986 I Rules and Regulations

that 1.4-DCBdoesinducedamageto’these-organsat a higherlevel ofexposureand that theauthorswerenotsufficientlydosingthetestanimalstoelicit a toxic response.In addition,EPAcannotanalyzetheveryslightindicationsof toxicity at 500ppm in ratsbecauseonly five animals/sex/dosegroupweresacrificedat themostsignificanttimes(i.e. at 26, 52 and76weeks).Although the authorsstatedthatthestudieswereconductedto evaluatepotentialoncogenicityof 1,4-DCB,EPAbelievesthat thesestudiesare tooshortto beconsideredas adequatenegativeoncogenicitystudies.

In summary,thesestudiesare notadequateeither in themselvesor incombinationwith othersubchronicdatato reasonablypredictthechronic!subchroniceffectsof 1,2,4-TCB.Norarethestudiessufficientto eliminateEPA’sconcernfor 1,2,4-TCB’s oncogenicpotential.

4. Whatstrain(s)of rat is (are)mostappropriatefor assessingtheoncogeniceffectsof thechlorinatedbenzenes?

Mostcommentersfelt that EPAshouldnot specifyspeciesor strainsfor thesetests.Theyfelt thatselectionof speciesfor assessingany toxicologic responseisbestmadeby theinvestigatorswho willconductthe studybecauseexperiencewith thespeciesandstrainis critical tothe appropriateinterpretationof datafrom anystudy.

EPA realizesthat investigatorshavesubstantialexperiencewith thespeciestheyuse.Nevertheless,for uniformityofexperimentaldesign,for theproperconductof oncogenicitystudiesbyseverallaboratories,and for themeaningfulinterpretationofoncogenicitystudiesconductedbetweenlaboratories,theAgencyissuesguidelinesfor theconductofoncogenicitystudiesandbelievesit isappropriatein certaininstancestospecifythespeciesandstrainsto beused.Theseguidelinesandspecificationsare basedon a thoroughreviewof theliterature,consultationswith appropriatescientists,and inputfrom public comments.

EPA originally consideredrequiringthe useof theSprague-Dawleyrat in theoncogenicitytestingof 1,2,4-TCB.Thiswasbasedon a studyby Maltoni et al.(Ref. 1) which indicateda significanttumorigeniceffectby benzenein therat,This studyprovided~n EPA’s estimationsufficientevidenceto suggesttherodent(Sprague-Dawley.rat) as the testspeciesfor an oncogenicstudywith chlorinatedber.zenes.However,EPA now believesthat becauseoncogenicitytestingconductedby NTP on MCB, 1,2- and1,4—DCB utilized the Fischer—344rat, therequiredoncogenicitytesting for 1,2,4-

TCB should alsousetheFischer—344ratas oneof the2 testspecies.EPAbelievesthis testspecieswill provideastrongerbasison which to makeacomparativeanalysis.

5. Shouldtestingfor reproductiveeffectsberequiredfor chlorinatedbenzenes?

Commenterssuggestedthat thetesticulareffectsobservedin dogsandthe increasedovarianweightsin ratsexposedto MCB, ascitedby EPA in itsfindings forproposedreproductiveeffectstesting(45 FR 48544),do notprovidesufficientevidencesuggestingan unreasonablerisk of reproductiveeffects.

EPAdisagrees.EPAbelievesbotheffectsare suggestiveof a potentialreproductivehazardwhich cannotbeignoredorpostponedfor futureconsideration.TheAgencybelievesthishazardpotentialmust beelucidatedbyfull reproductiveeffectstestingof theappropriatechlorobenzenes.

6. HasEPAoverlookeda testthatcouldbemoreinformativein theassessmentof reproductiveproblemsassociatedwith theproposedtestchemicals?

Commenterssuggestedthat amonitoring programfor malefertilityandchromosomalbreakagein humansoccupationallyexposedto thechlorinatedbenzenesberun in parallelwith testsfor thesameendpointsin -

laboratoryanimals.EPAbelievesthereproductiveeffects

studiesbeingrequiredwill generateadequateinformationon thepotentialreproductiveeffectsthesechemicalsmaycause.Theneedfor furtherstudiesas suggestedin thecommentwill beconsidereduponevaluationof therequiredtestingresults.

III. DecisionTo TerminateRulemakingProcessforSubchronicandOncogenicityTestingRequirementsfor1,2,4,5-Tetrachlorobenzene

After proposinghealtheffectstestingfor 1,2,4,5-tetrachlorobenzene(1,2,4,5-TCB), theAgencyreceivedadditionalinformation which indicatedthatproductionof thetetrachlorobenzeneswasperformedin a closedprocess.EPAlearnedthat thechemicalswereusedaschemicalintermediates,primarily in theproductionof pentachloronitrobenzerme.The potentialfor exposurein thissystemwasestimatedto be less than100 workers.After reviewingthisinformation,EPA consideredterminatingits rulemakingprocessfor1,2,4,5-TCB.

However,during‘the Fall of 1983,EPAreceivedinformation concerningtheuseof tetrachloroberizenesasa temporarytransformerretrofilling dielectricfluid in

railroadequipmentwhich wasbeingoperatedby the SoutheasternPennsylvaniaTransitAuthority(SEPTA).EPAbegana reviewof thisuse to determinewhetherhumanexposure-to the chemicalswas -

significantly increasedoverthat alreadyknown.Early in 1984, EPAreceivedinformationaboutfurtheruseoftetrachlorobenzeriesin retrofillingelectricaltransformersother thanrailroad equipment.Whenreviewingthis information,togetherwith that forrailroaduse,EPA concludedthepotentialexistedfor a greaternumberofpeopleto beexposedto thetetrachlorobenzenes,andthat exposureswould be to a moregeneralpopulation:i.e., satisfyingtherisk findings underTSCA section4(a)(1)(A).

Meanwhile,theNationalToxicologyProgram(NTP) initiatedactivity to testthechemicalfor oncogenicity.BecauseNTPhasinitiated its pre-chronictestingprogramfor 1,2,4,5-TCB.EPAhasdecidedto terminateits rulemakingprocessfor subchronicfchroniceffectsandoncogeniceffectstestingand isnotifying thepublic of this decisioninthis noticeat this time. EPA remainsconcernedaboutthereproductiveandteratogenic(developmental)hazardpotential,1,2,4,5-TCBmay posetohumanhealthandis requiringthistestingasdescribedbelow.

IV. Final TestRule for MCB, 1,2,-and1,4-nCR,1,2,4-TCB,and 1,2,4,5-TCB

A. Findings

1. 1,2,4-Trichlorinatedbenzene.TheEPA is basingthefinal oncogenicitytestingrequirementfor 1,2,4-TCBon theauthorityof section4(a)(1)(A) ofTSCA.EPAfinds thatthe manufacture,processing,useanddisposalof 1,2,4-TCB maypresentanunreasonableriskof cancerto humans,that thereareinsufficientdatato reasonablydetermineorpredicttheeffectsof suchactivitieson humanhealth,and thattestingis necessaiyto developthesedata.Thebasesfor thesefindings,whicharesummarizedin thefollowingparagraphsin IV.A., aresetforth in theAgency’schlorinatedbenzeneasupportdocument.

Approximately10 to 20 million poundsof 1,2,4-trichlorobenzeneareproducedannuallyin the United States.l,2,4-TCBis usedasa dyecarrier,syntheticintermediate,dielectricfluid, andasasolvent,NIOSH estimatedthat theseusescouldresult in 86,340workersbeingexposedto ‘1,2,4-TCBeachyear(Ref. 2).An industrysurveyindicatedapproximately40,000workersarepotentiallyexposedto 1,2,4-TCB (Ref. 3).

FederalRegister / Vol. 51, No. 130 I Tuesday, July 8. 1986 / Rules and Regulations 24581

TheAgencyhasreceivednoadditionalinformation which would contradicttheexposureestimatesdiscussedhere.EPAbelievesthateitherfigure representssufficienthumanexposureto makea“may presentanunreasonablerisk”finding underTSCA 4(a)(1)(A).

After reviewingavailableliteraturefor individual membersof thechlorobenzenesgroup,EPA hasconcludedthat thereis sufficientinformation to indicatethat1,2,4-TCBmay presentanoncogenichazardtohumans.Monochlorobenzenewasreportedto inducea significant increasein neoplasticnodulesof the liver in highdose(120mg/kg) maleratswhenadministeredby gavagein corn oil toboth ratsandmice (Ref. 4), Studiesreviewedby EPA in its 1980ChlorinatedBenzeneSupportDocument(Ref. 5) haveshownthathexachlorobenzene(HCB)will inducehepatomas,liverhaemangioendotheliomas,andthyroidalveolaradenomasin hamsters:hepatomasin mice;andliver, kidney,adrenal,andparathyroidtumorsin rats.It wasconcludedthat the NTPbioassayon 1,2-DCBshowedno evidenceofcarcinogenicityin maleor femaleratsandmice(Ref. 9). However,EPAbelievestheNTP study results,particularly on thedose-relatedincreasein malignanthistiocytic lymphomasfound in this study,maysuggestthattheir significancein thestudymaybeunderestimatedwhencomparedwiththe NTP study resultsfor 1,4-DCB.TheNTP bioassayon 1,4—DCBwaspositivefor ratsandmice (Ref. 7). EPAbelievesthat thesedatasubstantiateaconcernfor theoncogenicpotentialof 1,2,4-TCB.

Otherchronicstudiesfor 1.4-DCBconcludedthat it wasnot oncogenictoboth ratsandmiceundertheconditionsof thestudy (Refs.8 and9). However,EPA believesthesestudiesareof limitedvaluebecauseof theshortenedexposureperiods,theabbreviatedhistopathologicalexaminations,andabackgroundincidenceof respiratorydiseasein manyof the testanimals.Viewed in the light of thepositiveNTPbioassayfor 1,4—DCB, theydo notalleviateEPA’s concernfor theoncogenicitypotentialof 1,2,4-TCB.

Positive resultsfrom testing1,2,4-TCBin a cell transformationbioassay(onewith uncertaincorrelationtooncogenicitybecauseof the low numberof chemicalsthathavebeentestedintheassay)(Ref. 10) also increasesuspicionfor its potentialoncogenichazard.-Althoughshort-termniutagenicitytesting hasproducedmixedresultswith a high numberofnegativeresultsfor all thecltlorobenzenesexamined,the

correlationbetweenthe negativefindings for thesetestsfor this classofchemicalsandtheirpotentialoncogenicityis unknown.Therefore.predictionof potentialoncogenicactivity from short-termtestsis severelylimited for thechlorobenzenesandoncogenicitytestingis necessarytodeterminetheoncogenicpotential.

EPA concludeson thebasisofoccupationalexposure,the celltransformationresultsfor 1,2,4-TCB,andthe oncogenicityof structurallyrelatedchlorinatedbenzenes,that1,2,4-TCBmaypresentanoricogenicrisk tohumans.

2. Mono-anddichloi-inatedbenzenes.TheEPA is alsopromulgatinga finalreproductiveeffects testingrequirementfor MCB and1,2- and1,4—DCBs basedontheauthorityof section4(a)(1)(A) ofTSCA. EPA finds that themanufacture,processing.useanddisposalof MCBand1,2- and‘1,4-DCBs maypresentanunreasonableriskof reproductiveeffectsto humans,that thereareinadequatedatato reasonablydetermineor predictthe effectsof suchactivities on humanhealth,andthattesting is necessaryto obtainthis data.Approximately200 to 300 million poundsof MCB, and100to 150million poundsofDCBsareproducedannually.EPAbelievestheusesof thechemicals,which aresetforth in theAgency’schlorinatedbenzenesupportdocumentprovide for sufficienthumanexposuresto thesechemicals.EPA also believesthatadequateevidencefor apotentialreproductiveeffect in humansexposedto MCB existsbecausestudieshavedemonstratedMCB’s ability to affect thereproductiveorgansof ratsanddogs(Ref. Ii). ForDCBs,EPAbelievestheclosestructuralsimilarity betweenMCBandtheDCB’s provideda reasonablebasison which to concludethey too maypresentareproductivehazard.

EPA acknowledgesthat thecombinedreproductiveeffectsstudiesandembryo/fetalteratologyscreenon 1,2,4-TCB (Ref. 12). whichproducednegativeresultsasdiscussedin theDecember1984notice(48FR 54842),doespresentsomequestionregardingtheDCBs’potential for causing.areproductivehazardin humans.However,becausethedataprovide suggestiveevidencewhich conflictswith availablesuggestivedataon the reproductiveeffectspotentialof MCB, EPA believesthatonly by actualstudycan thepotentialof MCB andtheDCB’s to causethis effectbesatisfactorilyestablished.

EPAis also awareof areproductiveeffectsstudy for MCB that hasrecentlybeenconductedunderthe sponsorshipof thechlorohenzeneproducers(Ref. 13).

At this time EPA hasreceivedinterimdatafrom this studydescribinghistopathologicalchangesin the testesof male Sprague-Dawleyratsexposedto450 ppm MCB. If the studycomplieswiththe teststandardsestablishedunderthisrule it may be submittedin satisfactionof therule’s testrequirementsfor MCB.Shouldthestudynot meetthe teststandardsdescribedfor MCBreproductiveeffectstestingunderthisrule, but themanufacturersbelieveditprovidesadequatedatato reasonablydetermineor predictthe reproductiveeffectsof the manufacturer,processing,use,anddisposalof MCB, suchmanufacturersmaypetition EPA towithdraw the test rule. Similarly, if themanufacturersbelievetheMCB studyresultssubstantiallyalterthe Agency’sbasisfor requiringreproductiveeffectstestingof 1,2- or 1,4-DCB, theymaypetitionfor reconsiderationof thoserequirements.

EPA concludesthat on thebasisof thehigh occupationalexposuresto MCB,1,2- and1,4-DCBs,the suggestiveevidenceof MCB’s potential to causereproductiveeffects,andtheclosestructuralsimilarity betweenMCB andDCBs, bothMCB and1,2- and1,4-DCBsmaypresentanunreasonablerisk ofreproductiveeffectsto humans.

3. 1,2,4,5-Tetrachlorinatedbenzene.TheAgencyis basingthefinalreproductiveandteratogenic(developmental)effectstestingrequirementsfor 1,2,4,5-TCBon theauthorityof section4(a)(1)(A).EPA findsthat theuseof 1,2,4,5-TCBmaypresentanunreasonablerisk of reproductiveandteratogenic(developmental)effectsto humans,that thereareinsufficientdatato reasonablydetermineor predictsucheffectson humans,andthattestingis necessarytodevelopthesedata.Thebasesfor thesefindingsaresummarizedin thefollowing paragraphs.

a. Exposure.EPA believesa liquidsolutioncontaining1,2,4,5-TCB.which isbeingusedasatemporarydielectricretrofilling fluid for usein PCB-containingelectricaltransformers,posesa significantsourceof potential 1,2.4,5-TCB exposureto humans.Electricaltransformerscancontainhundredstothousandsof gallons of dielectric fluid.PCBtransformerstypically containabout500gallonsof PCBs,although theycancontainup to 1,650gallons.Currently,thereareanestimated140,000PCB transformersin usein the UnitedStates.Therearealsoanestimated34million transformerscontainingmineraloil that arecontaminatedwith PCBs tovaryingdegrees.EPA believesall of the140,000PCB transformersandmanyofthe mineral oil transformerscontaining

.-,~1~ FederalRegister I Vol. 51, No. 130 / Tuesday, July 8, 198& I Rulesand Regulations

over50 ppm PCBsarepotentialcandidatesfor retrofilling with thel,2,4,5-TCB containingflui±EPAbelievesthatbecauseof thetypicalliquid volumeof thesetransformers,sufficientquantitiesof 1,2.4,5~TCBarepresentfor humanexposure.

EPA believestherearefourpopulationgroupspotentiallyat risk ofexposurefrom the usel,2,4,5-TCB asatemporarydielectric fluid: (1) Personsinvolved in the actualretrofill ofexistingequipment,.(2) personsinvolvedin the servicing/maintenanceof theequipment,(3) otherworkers(recognizingthat transformersin otherthanelectricalsubstationsarefor themostpartusedexclusivelyin“commercial” areasincludingmanufacturingplants),and (4) membersof thegeneralpopulation(consideringtransformerlocationsnearofficebuildings,shoppingmalls, andapartmentbuildings).

EPA’s experiencewith theuse,servicing,andretrofillirig of PCBtransformersandPCB contaminatedtransformerssuggeststhat theseactivitieshaveresultedinwidespreadhumanexposureto PCBsandthat it isreasonableto assumethesameexposurepotential thatexistsfor PCBswill alsoexist for 1,2,4,5-TCB.Althoughcurrentcontrolsexist to reducethePCBexposureto humansvia inspectionoftransformers,recordkeeping,andrequiredremovalprograms,EPAbelievesthat becauseinsufficienthealtheffectsdataexistfor 1,2,4,5-TCBtosupporttheneedfor continuedsafehandlingof “retrofilled transformers,oncethePCBsareremoved,thecareexhibitedin servicingPCBcontainingorcontaminatedtransformerscanreasonablybeexpectedto berelaxed,ifnot eliminated.

b.Reproductiveeffecis. Althoughtherearenoreproductiveeffectsstudiesfor the tetrachlorobenzenes,EPAbelievesthat reproductiveeffectsmayoccurfrom sufficientexposuretothetetrachlorobenzenes.EPAanticipatesantifertility effectswill notoccurexceptpossiblyat doselevelscausingothertoxic symptoms,andthat thereis a highprobabilitythateffectson theneonatewill resultfrom inuterodosingand/oron postnatalgrowth anddevelopmentthroughexcretionof thetetrachlorobenzenesthroughthemother’s milk. Subsequenteffectsongrowth anddevelopmentof theyoungadultarealsopossible.

Thefetaleffectsdemonstratedtodatehavebeenreducedlitter sizewith a fewotherequivocaleffectson survivingembryosasseenin thefollowing non-reproductiveeffectsstudies(Refs. 14, 15and16]. Althoughevidenceof effectson

the surviving embryo/fetusis limited tol,2,3,4-TCBexposureonly (Ref. 16), theobservationthattheother two isomers(1,2,4,5,-.-and 1,2,3,5-TCB)causereducedlitter sizesandaccumulatein thefetusandthemother(Ref. 14),indicatethatapotential risk of effectson growthanddevelopmentpostnataflymayoccurgiven sufficientexposure.

The chlorinatedhydrocarbonsareknownto gainaccessto thefetusvia theplacentaand to the neonatevia theplacentaand themilk supply. In thecaseof thetetrachlorobeezenes.pasageinto thefetushasbeendemonstratedwith effects(Refs.14 and 16).

Kacewet al. (Ref. 14)analyzedtetrachlorobenzeneresiduesin organsand tissuefrom Sprague-Dawleyratfetusesanddamsdosedduring days6—15 of gestation.Theisomer1,2,4,5-TCBwasfound to accumulateto thegreatestdegree;Accumulationof 1,2,3,5-TCBwasfoundto be approximately100—200timeslessin fetalandmaternaltissue.Therewasno evidencethat 1,2,3,4-TCBaccumulatedin eitherthe fetusor thedam.

Two morehighlychlorinatedbenzenes,penta-andhexachlorobenzenes,havebeenshown’to causefetaleffects(Refs,17 and13).Althoughaccumulationof thesetwoanalogswould probablybegreater,tetrachlorobenzenesmaybeexpectedtobehavein a similarmanner.

Thesedataindicatea potential risk ofeffectson growthanddevelopmentfortetrachiorobeazenes.However,EPAconcludesbecausethereare noreproductiveeffectsstudiesfor 1,2,4,5-TCB or other tetrachlorobenzerieisomersto characterizetheir potentialeffectson growthanddevelopment,reproductiveeffectstestingis necessary.EPAbelievesthat sufficienthumanexposureto 1,2,4,5-TCBexistsfrom itsuseasa temporarydielectricretrofilbngfluid to supporta TSCA section4(a)(1)(A)finding to requiretesting.Atthis timeEPA is requiringthat only1,2,4,5-TCBbetestedfor reproductiveeffectsaccordingto theTSCAtestguidelinesbecauseavailabledataindicaiethat1,2,4,5-TCBaccumulatesinbody tissuesto a greaterdegreethantheothertetrachlorobenzeneisomers.Basedon thedataresultingfrom thesestudies,EPAwill reevaluatetheneedforreproductivetestingof theothertetrachlorobenzeneisomers.

c.DevelOpmentaltoxicity.Althoughnoneof the tetrachlorobenzeneisomershavedemonstratedunequivocalpotentialto causeterata,developmentaleffectsfrom in uterodosinghavebeendemonstratedfor all, threeisomers.Kacewet at. (Ref. 14)administeredeach’isomerat 0, 50. 100or 200mg/kg body

weight in corn oil to 8—10ratspergroupfrom day6—15of gestation.Fetaleffectsweredemonstratedin reducedlittersizeswhentheratsweredosedwith1,2,3,4, or 1,2,3,5-TCBat 200mg/kg.Thefetaleffectsfrom l,2,4,5-TCBcouldnotbe determiedbecauseonly onedarnsurvivedat this doselevel.However,Kitchin andEbron(Ref.15) foundareducednumberof implantationsin ratsexposedto thesameisomer,1,2,4,5-TCB.

In the1,2,3,4-TCBgroupat 200mg/kg.notonly reducedlitter sizeoccurredbutretardedossificationandanextra14thrib wasfound.Although litter sizereductionwastheonly statisticallysignificantfetaleffectnoted,only 5 litterwereseenat this doselevel (Ref. 14). IImorelitters havebeenexamined,terataand/orretardedgrowthmayhavebeendetected.

In the 1,Z,3,5-TCBgroup dosedat 200mg/kg. only onemalformationoccurredin 6 litters,butdelayedosteogenesisinthe craniumandsternebrae,smallpupsizesand thepresenceof a 14thrib andclubbedfoot led to theconclusionthat ifmorelitters hadbeenexamined,statisticalsignificancein someof theseparametersmayhavebeenfoundinadditionto thereducedlitter sizes(Ref.14).

In the1,2.4,5-TCBgroupdosedat 200mg/kg,no fetaleffects couldbedeterminedbecauseall butoneof thedamsdiedapproximately6.5 days(meantime to deaths)afterthe

- beginningof dosing.An adequateNOELmaynot havebeendemonstratedby thelessthan10 litters perdoselevel usedinthesestudies.

Kitchin andEbron (Refs.15 and 16)studiedtheeffectsof two of the isomers1,2.3,4,-TCBand1,2.,3,5-TCBon maternalenzymeinductionandembryonicgrowthat C). 30, 100,300 or 1000 mg/kgbody weight on 10 ratspergroupfromday8-13of gestation.TheTCB wasadministeredin gumtragacanthinsteadof thecornoil usedby Kacewat at. (Ref.14). Embryoswere examinedatday14of gestation.

Theisomer1,2,3,4-TCBdemon’trateda reductionin crown-rumplengthandheadlength at 300mg/kg.Exceptforenzymeinduction,no othermaternaltoxicity occurredat this doselevel.At1000mg/kg,37 percentof thedarnsdiedandno fetal determinationsweremade(Ref.16).

Exposureto1.2,4,5-TCBdemonstrateda reducednumberof implantsa~lOOt)mg/kg; reducedmaternalweightgainalsooccurredat this doselevel, andliver enzymeinduction occurredat nildoselevels (Ref.15).

The studiesby Kacewet al. andKitchin andEbronareadquateto

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indicatethat fetaleffectsmaybeproducedby all of theTCB isomers.

The teratologicaldataavailableforthetetrachlorbenzenesdemonstrateeffectson development.However,EPAbelievesthat theavailablestudiesarenot adequateto reasonablypredicttherisk of developmentaleffectsthat 1,2,4,5-TCB, or othertetrachloroberizeries,maypresentto humansandthatdevelopmentaltoxicity testingisnecessary.EPAbelievessufficienthumanexposureexiststhrough1.2,4,5-TCB’s useasa temporarydielectricretrofilling fluid to supportaTSCAsection4(a)(1)(A)finding to requiretesting.At this time EPA is requiringthatonly 1,2,4,5-TCBbe testedfordevelopmentaltoxicity accordingto theTSCA testguidelinesbecauseavailabledataindicate that 1,2.4,5-TCBaccumulatesin body tissuesto a greaterdegreethan theothertetrachioro-benzeneisomers.Basedon thedataresultingfrom thesestudies,EPA willreevaluatetheneedfor developmentaleffects testingof theothertetrachlorobenzeneisomers.

B. TestStandardsOnNovember27, 1985 (50FR 48805),

EPA issueda noticeproposingthe useofthe‘I’SCA guidelinesin placeof theproposedtest standards,issuedin theFederalRegisteron May 9, 1979 (44FR27334),andJuly 20, 1979 (44FR 44054),for therequiredhealtheffectstestingofthechlorinatedbenzenes.As describedin theNovember27, 1985 notice. EPAhadpreviouslyissuedachangein itsteststandardspolicy (March 26. 1982;47FR 13012) thateliminatedthe useof rigidgenerictesting requirementsorstandards,asproposedon (uly 18, 1980,for thehealtheffectstestingof thechlorinatedbenzenes.EPAbelievesthatpublic commentsaddressingtheoriginalgenericteststandardsaswell asthoseprovidedduring the public commentperiodfor this action,addressingtheirapplicablityto the requiredtesting forthechlorinatedbenzenes,havebeenadequatelyconsideredin thepreparationof the TSCAguidelines.EPA believesthat becauseof this effort,and theannualreviewsof theguidelinesby EPA, theoriginal proposedteststandardshavebeenmodifiedto apointwheretheresultingtest ctataWill reflectstate-af-the-arttoxicologicalprocedures,andensurecurrentandgenerallyacceptableminimal conditionsfordeterminingthehealtheffectsof thechlorinatedbenzenes.Therefore,theremaininghealtheffectstestsfor thechlorinatedbenzenesshell heperformedin accordancewith the methodologiescited in theTSCA }lcalth EffectsTestGuidelinesin 40 CFR Part 798. published

in theFederalRegisteron September27,1985 (50FR 39252).

At this time theAgencyis requiringthatoncogenicitytestingfor 1.24-TCBbe conductedby testing1,24-TCB in twomammalianspecies(themouseandtheFischer-344rat).The Agencyis requiringthat theoncogenicitytestingbeperformedin accordancewith themethodologycitedin theTSCA HealthEffectsTestGuidelineat40 CFR Part798.3300andtheTSCA GoodLaboratoryPracticeStandardsin 40 CFRPart792.EPA is requiring that1,2,4-TCBbeadministeredin the feed.

EPAalso is requiringthatreproductiveeffectstesting for MCB and1,2- and1,4-DCBsbe conductedbytestingMCB, 1,2- and1,4-DCBs in the 2-generationreproductiveandfertilitystudyin the Sprague-Dawleyrat,TheAgencyis requiringthatthereproductiveand fertility effectstestingbeperformedin accordancewith themethodologycitedin theTSCA HealthEffectsTestGuidelineat 40 CFR Part798.4700.EPA is requiringthat therouteof administrationfor MCB, and1.2- and1,4-DCBsbeinhalation.

EPA is alsorequiringthatreproductiveeffectsanddevelopmentaleffectstestingfor 1,2.4,5-TCBbeconducted.The Agencyis requiringthatthereproductiveandfertility effectstestingbeperformedin accordancewiththemethodologycited in theTSCAHealthEffectsTestGuidelinesat 40 CFRPart798.4700.TheAgencyis requiringthat thedevelopmentaleffectstestingbeperformedin accordancewith themethodologycitedin theTSCA HealthEffectsTestGuidelinesat 40CFR Part798,4900.EPAis requiringthat thereproductiveandfertility effectstestingbeconductedusingtheSprague-Dawleyrat andthatthedevelopmentaleffectstestingbedonein theFischer344ratand theNew ZealandWhite rabbit(both specieswerepreviouslyusedinthedevelopmentaleffectstestingofMCB, 1,2- and1,4-DCB).1,2,4,5-TCBshall beadministeredin the feed in thereproductiveandfertility effectsstudyandshall beadministeredby oralgavagein thedevelopmentaleffectsstudy.Developmentaleffectstestingofthetetrachlorobenzenesby Kacew,at at.(Ref. 14)demonstratedtheeffectiveuseof this routeof administration.

C’. TestSubstar~ce

EPAis requiringthat MCB, 1,2- andI ,4-DCB,12.4-1GB,and1,2,4,5-TCB,containingno more than0.05percentbenzeneand005 percent.hexachlorobenzene,he usedas thetestsubstancesfor the testsrequiredby thisrule. Thepurity of the testsubstancesmust be at least99 percent.EPA is

awarethat commerciallyavailablechlorinatedbenezeneshavebeenofferedat a 99.9percentlevel of purity.However,becauseNTP oncogenicitytestinghasutilized purities specifiedasgreaterthan99 percent,EPAbelievesrequiringasimilar purity for therequiredtestingin this rule will beacceptable.

D. PersonsRequiredTo Test

Section4(b)(3)(B) specifiesthat theactivities for which theEPA makessection4(a) findings (manufacture,processing,distribution,useand/ordisposal)determinewho bearstheresponsibilityfor testing.Manufacturersarerequiredto testif thefindingsarebasedon manufacturing(“manufacture”is definedin section3(7)of TSCA toinclude“import”). Processorsarerequiredto testif thefindingsarebasedon processing.Both manufacturersandprocessorsarerequiredto testif theexposuresgiving rise to thepotentialrisk occurduringuse,distribution,ordisposal.

BecauseEPAhasfoundthatinsufficientdataexistto reasonablydeterminetheeffectson humanhealthfrom themanufacture,processing,use,anddisposalof MCB,1,2- and1,4-DCBsand 1,2.4-TCB,and theuseof 1,2,4,5-TCB, EPA is requiringthatpersonswhomanufacture(or import) and/orprocessMCB, 1,2- or’1,4-DCB. 1,2,4,-TCB, or1,2,4’5-TCB, at anytime from theeffectivedateof the final testrule to theendof the reimbursementperiodbesubjectto the testingrequirementscontainedin this rule for eachof thechemicalstheymanufacture(or import)and/orprocess.Theendof thereimbursementperiodwill be5 yearsafterthe lastfinal reportis submittedfora givenchemicaloran amountof timeequalto thatwhichwasrequiredtodevelopdataif morethan 5 yearsafterthesubmissionof thelastfinal reportrequiredunderthetestrule.

BecauseTSCA containsprovisionstoavoidduplicativetesting.noteverypersonsubjectto this rulemustindividually conducttesting.Section4(b)(3)(A) ofTSCA providesthatEPAmay permit two or moremanufacturersor processorswhoaresubjectto the ruleto designateonesuchpersonor aqualifiedthird personto conductthetestsandsubmitdataon their behalf.Section4(c) providesthatanypersonrequiredto testmayapply to EPAfor armexemptionfrom therequirement.EPApromulgatedproceduresfor applying forTSCA section4(c) exemptionsin 40 CFRPart790.

Manufacturers(including importers!subjectto thisrulearerequiredto

24664 FederalResister / Vol. 51, No. 130 I Tuesday, July 8, 1986 I Rules and Regulations

submit eitheraletter of intent toperformtestingor anexemptionapplicationwithin 30 daysaftertheeffectivedateof thefinal testruIe.~Therequiredproceduresfor submittingsuchlettersandapplicationsare describedin40 CFRPart 790.

Processorssubjectto this rule, unlesstheyarealsomanufacturers,will notberequiredto submitlettersof intentorexemptionapplications,or toconducttesting,unlessmanufacturersfail tosubmit noticesof intent to testor laterfail to sponsortherequiredtests.TheAgencyexpectsthat themanufacturerswill passan appropriateportion of thecostsof testingon to processorsthroughthe pricing of their productsorreimbursementmechanisms.Ifmanufacturersperformall the requiredtests,processorswill begrantedexemptionsautomatically.Ifmanufacturersfail to submitnoticesofintent to testor fail to sponsorall therequiredtests,theAgency will publishaseparatenoticein the FederalRegisterto notify processorsto respond;thisprocedureis describedin 40 CFRPart790.

EPA is not requiringthesubmissionofequivalencedataasa conditionfor -

exemptionfrom therequiredtestingforMCB, 1,2-or 1,4-DCB, 1,2,4-TCB,or1,2,4,5-TCB.As floted in Unit IV.C. EPAis interestedin evaluatingtheeffectsattributableto thesechlorinatedbenzenesandhasspecifieda relativelypuresubstancefor testing.

Manufacturersandprocessorswhoaresubjectto this testrule mustcomplywith the testruledevelopmentandexemptionproceduresin 40 CFR Part790 for single-phaserulemaking.

E. ReportingRequirements

EPA is requiringthat all datadevelopedunderthisrule bereportedinaccordancewith its TSCA GoodLaboratoryPractice(GLP) standardswhichappearin 40 CFR Part792.

In accordancewith 40 CFRPart 790undersingle-phaserulemakingprocedures,testsponsorsarerequiredtosubmit individual studyplansat least4&daysprior to the initiation of eachstudy.

EPA is requiredby TSCA section4(b)(1)(C) to specifythe timeperiodduringwhichpersonssubjectto a testrulemustsubmit testdata.TheAgency isrequiringthat manufacturersandprocessorsresponsiblefor theoncogenicitytestingof 1.2,4-TCBreportthestudyresultswithin 53 monthsaftertheeffectivedateof this rule.Manufacturersandprocessorsresponsiblefur the reproductiveeffectstestingof MCD, or 1,2- or 1,4-DCB, or1,2.4.5-TCBmust report thesestudyresultswithin 29 monthsafter the

effectivedateof this rule. Manufacturersandprocessorsresponsiblefor thedevelopmentaleffectstestingof 1,2,4,5-TCB mustreportthe studyresultswithin12 monthsafterthe effectivedateof thisrule.

TSCA section14(b)governsAgencydisclosureof all testdatasubmittedpursuanttosection4 of TSCA.Uponreceiptof datarequiredby this rule,theAgencywill publisha noticeof receiptin theFederalRegisterasrequiredbysection4(d).

Personswho exporta chemicalsubstanceormixture which is subjecttoa section-4 testrulearesubjectto theexport reportingrequirementsof section12(b) of TSCA. Final regulationsinterpretingtherequirementsof section12(b)are in40 CFR Part707 (45FR82844).In brief, asof theeffectivedateof this testrule, andexporterof MCB,1,2- or1,4-DCB,1,2,4-TCB,or 1,2,4,5-TCBmustreportto EPA thefirst annualexportor intendedexportof anyofthesechemicalsto anyonecountry.EPAwill notify theforeign countryconcerningthe test rulefor thechemical.

F. EnforcementProvisionsTheAgencyconsidersfailure to

complywith anyaspectof a section4rule to bea violation of section15 ofTSCA. Section15(1) of TSC:~makesitunlawful for any personto fail or refuseto complywith anyruleor orderissuedundersection4. Section15(3) of TSCAmakesit unlawful for anypersonto failor refuseto: (1) Establishor maintainrecords,(2) submitreports,notices,orotherinformation,or (3) permitaccesstoorcopyingof recordsrequiredby theAct orany regulationor rule issuedunderTSCA.

Additionally, TSCA section15(4)makesit unlawful forany personto failor refuseto permitentryor inspectionasrequiredby section11.Section11appliesto any“establishment,facility,or otherpremisesin which chemicalsubstanceormixturesaremanufactured,processed.stored,or heldbeforeor aftertheir distributionincommerce.. .“ TheAgencyconsidersatestingfacility to bea placewherethechemicalis heldorstored,andtherefore,subjectto inspection.Laboratoryinspectionsanddata auditswill beconductedperiodically inaccordancewith theauthorityandproceduresoutlined in TSCA section11by duly designatedrepresentativesoftheEPA for the purposeof determiningcompliancewith thefinal rulefor MCB,1,2,-and 1,4-DCBs,1,2,4-TCB,and1,2,4.5-TCB.Theseinspectionsmaybeconductedfor purposeswhich includeverification that testinghasbegun,thatschedulesare beingmet,that reports

accuratelyreflect the underlyingrawdataand interpretationsandevaluationsto determinecompliancewith TSCA GLP standardsandtheteststandardsestablishedin the rule.

EPA’s authority to inspecta testingfacility alsoderivesfrom section4(b}(l)of theTSCA, which directsEPA topromulgatestandardsfor thedevelopmentof testdata,Thesestandardsaredefinedin section3(12)(BJof TSCA to include thoserequirementsnecessaryto assurethatdatadevelopedundertestingrulesarereliableandadequate,and suchotherrequirementsas arenecessaryto providesuchassurance.TheAgencymaintainsthatlaboratoryinspectionsarenecessarytoprovide this assurance.

Violatorsof TSCA aresubjecttocriminal andcivil liability. Personswhosubmitmateriallymisleadingor falseinformationin connectionwith therequirementof anyprovisionof this rulemaybesubjectto penaltieswhich maybecalculatedasif theyneversubmittedtheir data.Underthepenaltyprovisionof section16 of TSCA, anypersonwhoviolatessection15 couldbesubjectto acivil penaltyof up to $25,000for eachviolationwith eachdayof operationinviolationconstitutinga separateviolation.This provisionwould beapplicableprimarily to manufacturersorprocessorsthat fail to submita letterofintentor anexemptionrequestand thatcontinuemanufacturingor processingafter thedeadlinesforsuchsubmissions.

Thisprovisionwould also apply toprocessorsthat fail to submit a letterofintent or anexemptionapplicationandcontinueprocessingafter theAgencyhasnotified them of their obligationtosubmit suchdocuments(see40 CFR790.28(b)).Intentionalviolationscouldleadto theimposition of criminalpenaltiesof up to $25,000for eachday ofviolationand imprisonmentfor up to 1year.In determiningtheamountofpenalty,EPAwill take into accounttheseriousnessof theviolationand thedegreeof culpabilityo~theviolatoraswell as all theother factorslistedinsection18. Otherremediesareavailableto EPAundersection17 of TSCA. suchasseekinganinjunction to restrainviolationsof TSCA section4.

Individualsas well ascorporationscouldbesubjectto enforcementactions~Sections15 and16 of TSCA apply to“any person”who violatesvariousprovisionsof TSCA. EPAmay, at itsdiscretion,proceedagainstindividualsaswell ascompaniesthemselves.inparticular, this includesindividualswhoreportfalseinformationor who causeitto bereported.In addition. thesubmissionof false, fictitious, or

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fraudulentstatementsis a violationunder18 U.S.C.1001.

V. EconomicAnalysisof RuleTo assessthepotentialeconomic

impact of this rule, EPAhaspreparedaneconomicanalysis(Ref. 14) thatevaluatesthe potentialfor significanteconomicimpactson theindustryas aresultof therequiredtesting.Theeconomicanalysisestimatesthecostsofconductingthe requiredtestingandevaluatesthepotential for significantadverseeconomicimpactasa resultofthesetestcostsby examiningfourmarketcharacteristicsof thesechlorinatedbenzenes:(1) Pricesensitivityof demand,(2) industrycostcharacteristics,(3) industrystructure,and (4) marketexpectations.If theseindicationsarenegative,no furthereconomicanalysisis performed;however,if the first level of analysisindicatesa potential for significanteconomicimpact,amorecomprehensiveanddetailedanalysisis conductedwhich morepreciselypredictsthemagnitudeanddistributionof theexpectedimpact.

Total directtestingcostsfor the finalrule for MCB, 1,2-DCB and1,4-DCB areprojectedto rangefrom $590,229to$768,141.Sincethethreechemicalsareproducedjointly, thedirectcostsoftestinghavebeendispersedover thetotal productionof thethreechlorobenzenes.IncludingthecostsforenvironmentaleffectstestingwhichEPAhasproposedin a prior rule (Ref. 14), thetotal costsof testingMCB, 1,2-DCBand1,4-DCBrangefrom $595,021to$774,551.

The total directcoststesting1,2,4-’TCBrangefrom$582,627to $747,009.Because1,2,4-TCB is commerciallymanufactureredasajoint productwith1,2,3-TCB,thedirectcostsof testinghavebeendispersedoverthetotalproductionfor both trichlorobenzenes.Including thecostsfor environmentaleffectstestingfor 1,2,4-TCBand1,2,3-TCB whichEPA haspreviouslyproposed,raisesthetotal testingcostsfor l,2,4.TCBto $587,064to $779,348.

Theestimatedrangeof testcostsfor1,2,4,5-tetrachlorobenzeneis from$181,000to $240,000.Becausetheproductionlevel of tetrachlorobenzeneis ConfidentialBusinessinformation(CB1), thequantitativeimpact projectedby EPAmust remainCBI.

The annualizedtestsçosts(usingacostsof capitalof 25 percentoveraperiodof 15 years)rangefrom $154,194to 5200.717for MCB,. I,2-DCB and1.4-DCB andfrom $152,132to $201,960forl.2,4-TCB.Basedupon themostrecentproductiondata.the unit testcostsforthe mono-anddichlorobenzenesrange

from 0.04to 0.05centsperpound.Thesecostsareequivalentto 0.11 to 0.12percentof the list priceof MCB, 0.11 to0.14percentof theunit salesvalueof1,2-DCB, and0.10to 0.13percentof theunit salesvalueof 1,4-DCB.

Unit testcostsfor 1,2,4-TCBrangefrom 0.94to 1.24centsperpoundafteradjustingfor upstreamtestingcosts.Thesecostsrepresentfrom 1.5 to 2.0percentof 1,2,4-TCBprice.

Basedon thesecostsand theusesofthesechlorinatedbenzenes,theeconomicanalysisindicatesthat thepotential for significantadverseeconomicimpactas a resultof this testrule is extremelylow. ForMCB, DCBsandTCBs,this conclusionis baseduponthe following observations:

1.The estimatedunit testcostsarelow andshouldnot affectdemand,and

2. The demandfor thesecompoundsaschemicalintermediatesis dispersedovernumerousendmarkets.

Thepotentialfor significantadverseeconomicimpactontetrachlorobenzeneproductionis low. Thisconclusionisbaseduponthefollowing observation.

1. Productionof tetrachlorobenzeneisexpectedto besubstantialin thenear-term; and

2. Reviewof theindustrystructureandcostcharacteristicsoftetrachiorobenzenemanufactureindicatesthat themanufactureriscollectingmonopolyprofits whichwillnot besignificantly affectedby thetestingcosts.

Referto theeconomicanalysis(Ref.14) for a completediscussionof testcostsestimationandthepotential foreconomicimpactresultingfrom theseCosts.

VI. Availability of TestFacilitiesandPersonnel

Section4(b)(1)of TSCArequiresEPAto consider“the reasonablyforeseeableavailability of thefacilities andpersonnelneededto performthetestingrequiredundertherule.” Therefore,EPAconducteda studyto assesstheavailability of testfacilities andpersonnelto handletheadditionaldemandfor testingservicescreatedbysection4 testrules.Copiesof thestudy,ChemicalTestingIndustry:Profile ofToxicologicalTesting,canbeobtainedthroughtheN’TIS (PB82—140773).On thebasisof this study,the Agencybelievesthat therewill be availabletestfacilitiesandpersonnelto performthe testinginthis rule. -

VII. RulemakingRecord

numberOPTS-47002F).Thisrecord

includes:

A. SupportingDocumentation

(1) FederalRegisternoticesdesignatingthechlorinatedbenzenestothepriority list [42 FR 55028and43 FR50830)andall commentsreceivedon thechlorinatedbenzenes.

(2) FederalRegisternotice of EPA’sproposedhealtheffectstestruleonchlorinatedbenzenes(45 FR 48424)andall commentsreceivedon theproposedtesting.

(3) FederalRegisternotice (48FR54836)requestingcommenton thenegotiatedtestingprogramandproposeddecisionto withdrawcertainproposedtestingrequirements,andcomments,received.

(4) FederalRegisternotice[49 FR50408)announcingits final decisiontowithdrawseveralproposedtestingrequirements.

(5) FederalRegisternotice(50 FR48805)announcinga revisionto theproposedteststandards,andcommentsreceived.

(6) Communicationsconsistingofletters,contactreportsof telephoneconversations,andmeetingsummaries.

(7)Proposedteststandardsforoncogenicity,reproductiveeffects(44 FR44054and 27334)andcommentssubmittedonthosestandardswhichmay befound in public docketsNos.OPTS—46005and46003.

(8) Transcriptof September25, 1984Public Meeting.

B. References(1) Maltoni, C., andScarnato,C. “First

experimentaldemonstrationof thecarcinogeniceffectsof benzene.Med. Lavoro.5: 352—357.1979.

(2) NationalInstituteof OccupationalSafety,andHealth.NationalOccupationalHazardSurveyDataBase.Washington,DCU.S.Departmentof Health,Education,andWelfare.1979. -

(3) Hull andCompany.“Employeeexposureto trichlorobenzeneproducts.”Preparedby Hull andCompanyofCreenwich,Connecticutfor theChtorobenzeneProducersAssociation.October22, 1980.

(4) NationalToxicoingyProgram.“NTPtechnicalreporton thetoxicology and

.carcinogenesisstudiesof chlorobenzene.”U.S. Departmentof HealthandHumanServices.October1985. NIH PublicationNumber88—2517.

(5) U.S.EnvironmentalProtectionAgency.“Assessmentof testingneeds:chlorinatedbenzenes.”Officeof PesticidesandToxicSubstances.U.S. EnvironmentalProtectionAgency.July1980.

(6) NationalToxicologyProgram.“NT?EPA hasestabhshedapublic record - technicalreporton thetoxicologyandfor this rulemakingproceeding[doc*et carcinogenesisstudiesof 1,2-

24666 FederalRegister I Vol. 51, No. 130 I Tuesday, July 8, 1986 / Rules and Regulations

dichlorobenzene.”U.S.Departmentof HealthandHumanServices.October1965.NIHPublicationNumber86—2511.

(7) NationalToxicologyProgram.“NTPdraft technicalreporton the toxicologyandcarcinogenesisstudiesof 1,4- -

dichlorobenzene.”U.S. Departmentof HealthandHumanServices.March 1988.Nil-IPublicationNumber88—2575.

(8) Imperial ChemicalIndustrialLimited.“Para-dich)orobenzene:long terminhalationstudyin the raL” ReportNumberCTL/P1447.Receivedby theTestRulesDevelopmentBranchof theU.S. EnvironmentalProtectionAgency,Washington,D.C., on March23, 1982.

(9) Imperial ChemicalIndustriesLimited.“Para-dichlorobenzene:long term ir,hatationstudyin themouse.”ReportNumberCTL/P/478. Receivedby theTestRulesDevelopmentBranchof theU.S. EnvironmentalProtectionAgency,Washington.D.C., on March23, 1982.

(10) Shimada,T., et a!. “Study of effectsonculturedliver cellsof threechlorinatedbenzenes.”Finalreport.NaylorDanaInstitute.AmericanHealthFoundation.Valhalla, New York. December5. 1983.

(11) MonsantoCompany.TSCASection8(d) submission8DHQ—1078-0212(1).‘Industrialbio-testdraftreportof 90-daysubacutevapor inhalationtoxicIty studywithmonocholorobenzane,in beagledogsandalbinorats.Office of PesticidesandToxicSubstances,U.S. EnvironmentalProtectionAgency,Washington,D.C., 1978.

(12) Robinson,S., eta!. “Multigenerationstudyof 1,2,4-trichlorobenzenein rats.”Journalof ToxicologyandEnvironrnentalilealth. 8:489—500.1981.

(13) ChlorobenzeneProducersAssociation.Letter fromAlan W. Rautio to Don R. Clay.May 8, 1986.

(14) Kacew,S., Ruddick,JA., Parulekar,V.E., etal. “A teratologicalevaluationandanalysisof fetal tissuelevelsfollowingadministrationof tetrachlorobenzeneisomersto the rat.” Teratology.29:21—27.1984.

(15) Kitchin, K. T. andEbron, M.T.“Maternalhepaticeffectsof 1,2,4,5-tetrachlorobenzenein therat.”EnvironmentalResearch.32:134—144.1983a.

(16) Kitchin, K.T. andEbron,M.T.“Maternalhepaticandembryoniceffectsof1,2,3,4-tetrachlorobenzenein therat.”Toxicology.26:243—256.1983b.

(17) Khera,K.S. andVilleneuve,D.C.‘Teratogenicitystudieson halogenatedbenzenes(pentachloro-,pentachioronitro-,hexabromo-in rats.” Toxicology.5:117:122.1975.

(18) Courtney,K.D. “Hexachlorobenzene(HCI3).” A review.EnvironmentalResearch20:225—266.1979.

(19) U.S.EPA.“Economicimpactanalysisoffinal healtheffectsrule for chlorobenzenes.”Office of PesticidesandToxic Substances,U.S.EPA.ContractNo. 68-02-4235.March 11,1986.

The record,containingthe informationconsideredby the Agencyin developingthis decision,is availablefor inspectionfrom 8 am. to 4 p.m.,Monday throughFriday exceptlegalholidays,in Rm. E—

107, 401 M St., SW., Washington,D.C.20460. -

VIII. OtherRegulatoryRequirements

A. Classificationof Rule

UnderExecutiveOrder12291,EPA -

mustjudgewhetheraregulationis“Major” andthereforesubjectto therequirementof a RegulatoryImpactAnalysis.EPAhasdeterminedthat thistestruleis notmajorbecauseit doesnotmeetanyof thecriteriasetforth insection1(b) of the Order,i.e., it will nothaveanannualeffecton theeconomyofat least$iOOmillion, will not causeamajorincreasein prices,andwill nothavea significantadverseeffectoncompetitionor the ability of U.S.enterprisesto competewith foreignenterprises. -

This regulationwassubmittedto theOffice of ManagementandBudget(0MB) for reviewasrequiredbyExecutiveOrder12291.Any writtencommentsfrom 0MB to EPA, and anyEPA responseto thosecomments,areincludedin therulemakingrecord.

B. RegulatoryFlexibility Act

Under theRegulatoryFlexibility Act(15 U.S.C.601 etseq. Pub. L. 96-354,September19, 1980),EPA is certifyingthat this testrule will not haveasignificantimpacton a substantialnumberof smallbusinessesbecause:(1)Theyarenot likely to performtestingthemselves,or to participatein theorganizationof thetesting effort; (2) theywill experienceonly veryminor costs,ifany, in securingexemptionfrom testingrequirements;and(3) they areunlikelyto beaffectedby reimbursementrequirements.

C. PaperworkReductionAct

TheOffice of ManagementandBudget(0MB) hasapprovedthe information -

collectionrequirementscontainedin thisfinal ruleundertheprovisionsof thePaperworkReductionAct of 1980, 44U.S.C.3501etseq.andhasassigned0MB controlnumber2070—0033.

List of Subjectsin 40 CFR Part799

Testing.Environmentalprotection,Hazardoussubstances,Chemicals,Recordkeepingandreportingrequirements.

Dated:June24, 1986.J.A. Moore,AssistantAdministratorforPesticidesandToxicSubstances.

PART 799—~AMENDEDI

Therefore,40 CFR Part799 isamendedasfollows:

1. The authority citation for Part 799continuesto readasfollows:

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

2. Part799 is amendedin SubpartB asfollows:

a.By adding § 799.1051to readasfollows:

§799.1051 Monochlorobenzene.

(a) Identification of testsubstance.(1)Monochlorobenzene(CAS Number108—90—7) (hereinafter“MCB”) sha!lbetestedin accordancewith this section.

(2) MCB of at least99 percentpurityshall beusedas thetestsubstance.

(3) Thetest substanceshall notcontainmore than0.05 percentberizeneand0.05percenthexachlorobenzene.

(b) Personsrequiredto submitstudyplans,conducttestsandsubmitdata.All personswho manufacture(import)or processmonochlorobenzeneother -

thanasanimpurity aftertheeffectivedateof this rule (August21, 1986) to theendof the reimbursementperiodshallsubmitlettersof intent to conducttestingor-exemptionapplications,submitstudyplans,conducttests,andsubmitdataasspecifiedin this section,SubpartA of this Part,andParts790and792 of this Chapterfor single-phaserulemaking.

(c) Healtheffectstesting—(1)Reproductiveandfertility effects—(i)Requiredtesting.(A) A testforreproductiveandfertility effectsshall beconductedwith MCB in accordancewith§ 798.4700of this chapter.

(B) The route of administrationfor thereproductiveandfertility effectstestingof MCB shall beinhalation.

(C) The test speciesshall be theSprague-DawleyRat. - -

(ii) Reportingrequirements.(A) Thereproductiveandfertility effectstestshall becompletedandthefinal resultssubmittedto the Agencywithin 29monthsof the-effectivedateof this rule.

(B) Progressreportsshall be submittedto theAgencyevery6 monthsafter theeffective dateof thefinal rule.

Approvedby theOffice of ManagementandBudgetundercontrolnumber2070—0033)

b. By addingparagraphs(a)(3), (b)(5).(d) andan0MB controlnumberto§ 799.1052to readas follows:

FederalRegister / Vol. 51, No. 130 / Tuesday, July 8, 1986 / Rules and Regulations 24ti67

§ 799.1052 Dichlorobenzenes. -

(a) * *

(3) Forhealtheffectstestingrequiredunder(e). both testsubstancesshall notcontainmore,than0.05percentbenzeneand0.05percenthexachlorobenzene.

(b)* * *

(5) Forhealtheffectstestingrequiredunder(e), all personswho manufacture(import) orprocess1,2-and/or1,4-dichlorobenzene,otherthanasanimpurity, after theeffectivedateof thisrule(August21, 1986) to the endof thereimbursementperiod, for eachof thesechemicalsthat they manufactureand/orprocess,shall submit lettersof intent toconduct testingorexemptionappliiations,submit studyplans,conducttests,andsubmitdataasspecifiedin this section,SubpartA ofthis Part,andParts790and792of thischapterfor single-phaserulemaking.

* * * *

(d) Health effectstesting—(1)Reproductiveandfertility effects—(i)Requiredtesting. (A) A testforreproductiveand fertility effectsshall beconductedwith both 1,2- and1,4-DCBsin accordancewith § 798.4700of thischapter.

(B) Therouteof administration for thereproductiveandfertility effectstestingof both 1.2- and1,4-DCBshall beinhalation.

(C) Thetest speciesshall betheSprague-Dawleyrat.

(ii) Reportingrequirements.(A) Bothreproductiveandfertility effects testsshall be completedandthe final resultssubmittedto theAgency within 29monthsof theeffective dateof this finalrule.

(B) Progressreportsfor both studiesshall besubmittedto the Agencyevery6monthsafter the effectivedateof thefinal rule.

(Approvedby theOffice of ManagementandBudgetundercontrolnumber2070—0033)

c. By addingparagraphs(a)(3), (b)(5),and(e)to § 799.1053to readasfollows:

§ 799.1053 1,2,4-Trlchlorobenzena.(a) * * *

(3) For healtheffects testingrequiredunder(e). the testsubstanceshall notcontainmore than 0.05 percentbenzeneand0.05 percenthexachlorobenzene.

(b) * *

(5) For healtheffectstesticgrequiredunder{e), all personswho manufacture(import) or process1,24-trichlorobenzene,other than asanimpurity, after theeffective dateof thisrule (August21, 1986) to theend of thereimbursementperiodshall submitlettersof intent to conducttestingorexemptionapplications.submit studyplans.conducttests, ad submitdataas

specifiedin this section,SubpartA ofthis Part,andParts790and792of thischapterfor single-phaserulemaking.

(e)Health effectstesting—(1)Oncogenicity—(i)Requiredtesting. (A)A testforoncogeniceffectsshall beconductedwith 1,2,4-TCBin accordancewith § 798.3300of this chapter.

(B) Therouteof administrationfor theoncogenicitytestingfor 1,2.4-TCBshallbevia the animalfeed.

(C) Two rodentspeciesshall beusedandoneshallbe theFischer-344rat.

(ii) Reportingrequirements.(A) Theoncogenicitytestshallbecompletedandthefinal resultssubmittedto the Agencywithin 53 monthsof the effective dateofthis final rule.

(B) Progressreportsshall be submittedto theAgencyevery6 monthsafter theeffectivedateof the final rule,

d. By adding§ 799.1054to readasfollows:

§ 799.1054 1,2,4,5-Tetrachlorobenzene.(a) Identificationof testsubstances.

(1) 1,2,4,5-Tetrochlorobenzene(CASNumber95—94—3) (hereinafter“1,2,4,5-TCB”) shall betestedin accordancewith this section.

(2) 1.2,4,5-TCBof at least99 percentpurity shallbe usedas the testsubstance.

(3) The testsubstanceshallnotcontainmore than0.05percentbenzeneand0.05 percenthexachlorobenzene.

(b) Personsrequiredto submitstudyplans,conducttestsandsubmitdata.All personswho manufacture(import)or process1,2,4,5-tetrochlorobenzene,otherthanasan impurity, after theeffective dateof this rule (August21,1986) to theendof the reimbursementperiodshall submit lettersof intent toconducttestingor ‘exemptionapplications,submit studyplans,conducttests,andsubmitdataasspecifiedin this section,SubpartA ofthis Part,andParts790and792 of thischapterfor single-phaserulemaking.

(c) Healtheffectstesting.—(1)Reproductionandfertility—(i) Requiredtesting. (A) A test for reproductionandfertility effect shall beconductedwith1,2,4,5-TCBin accordancewith§ 798.4700of this chapter.

(B) Therouteof administrationfor thereproductionandfertility testingfor1.2,4,5-TCBshall be dietary.

(C) A rodenttest speciesshall beusedandshall bethe Sprague-Dawleyrat.

(ii) Reportingrequirements.(A) Thereproductionandfertility testshall becompletedandthe final resultssubmittedto the Agencywithin 29monthsof theeffectivedateof this finalrule.

(B) Progressreportsshall besubmittedto theAgencyevery6monthsafter theeffectivedateof thefinal rule.

(2) Developmentaltoxicity.—.{i)Requiredtesting. (A) A testofdevelopmentaltoxicity shall beconductedwith 1,2,4,5-TCBinaccordancewith § 498.4900of thischapter.

(B) Therouteof administrationfor thedevelopmentaltoxicity testingfor1,2,4,5-TCBshall be via oralgavage.

(C) Two rodentspeciesshallbe usedin the study.Oneshall‘be the Fischer-344 rat andthesecondtheNewZealandwhiterabbit.

(ii) Reportingrequirements.(A) l’hedevelopmentaltoxicity testingshallbecompletedandthefinal resultssubmittedto theAgencywithin 12monthsof theeffectivedateof this finalrule.

(B) Progressreportsshall be submittedto the Agencyevery6 months-after theeffectivedateof the final rule.

(Approvedby theOfficeof ManagementandBudgetundercontrolnumber2070—0033)

[FR Doc. 86—15053Filed 7—7—86; 8:45 aml8~WNGCODE 6560-50-U

GENERAL SERVICES

ADMiNISTRATION

48 CFR Parts 508 and 525

EAPO 2800.12CHGE 28j

GeneralServicesAdministrationAcquisition Regulation;RequiredSources of Supply and the TradeAgreements Act

AGENCY: -Office Acquisition Policy, GSA.ACTION: Final rule.

SUMMARY: TheGeneralServicesAdministrationAcquisition Regulation(GSAR), Chapter5, is revisedtoincorporatethesubstanceof GSARAcquisitionCircularsAc—85—5 andAC—86—3.This changeamendssection508.705—73to eliminate- theprohibitionagainstrequestinga pricereductionwhennegotiatingadjustmentstodeliveryschedulesfor delinquentordersundercontractswith workshopsfor theblind or otherseverelyhandicapped.Section525.402is amendedto reflect thecurrentdollar thresholdfor applicabilityof theTradeAgreementsAct.Miscellaneousother changesaremadein Part 508 to reflectcurrentorganizationanddocumenttitles.EFFECTIVE DATE: June-17, 1986.FOR FURTHER INFORMATION CONTACT:Ms. Ida M. Ijatad,Office of GSA