11728 Federal Regteter I Vol. 51, No. 66 I Monday, April 7, 1988 / Rules and Regulations

40CFR Part799(OPTS-42050A,(FRI.-2,75-2(am

CsrtalnChlorinatedBsnzsnes;FinalTest Rule

AGENCY EnvironmentalProtectionAgency(EPA).ACTIOIC Final rule.

$UMMARY This rule promulgatesEPA’sdecisionto require manufacturers andprocessorsof 1.2.3-trichlorobenzene(CAS No.87-61—6)to conductenvironmental effectstestingandformanufacturers andprocessorsof 1.2-and 1.4-dichlorobenzene(CASNos.95—50-1.106-46—7,respectively) to conductchemical fate testing.Manufacturersand processorsof 1,2,4-trichlorobenzene(CAS No. 120-82-1)are required toconduct bothchemicalfateandenvironmentaleffectstesting.Thisaction is necessaryto complywith thedesignationof thesesubstancesby theInteragency TestingCommitteeforpriority testingconsiderationunder theToxic SubstanceControlAct (TSCA).DATU In accordancewith 40 CFR 23.4(50 FR 7271:February 21,1985),thIs ruleshall bepromulgated for purposesofjudicial review at 1 p.m. eastern[“daylight” or “standard” asappropriate) time onAprIl 21,1986.ThIsrule shall becomeeffectiveonMay 21,1986. —

PO~FURTHU INFO~MAT10NCONTACYEdwardA. Klein. Director, TSCAAssistanceOffice (TS—799), Office ofToxic Substances,Rm. E—543,401M St.,SW., Washington,DC20460.Toll free(800.424—9065).In Washington. DC(554-1404).OutsidetheUSA~(Operator-202—554—1404).SUPPLEMENTARYa.coRMA’no,~EPAIsrequiring chemicalfate andenvironmental effectstestingof certainchlorinatedbenzenesasdesignatedinthis final rule.L Introduction

This notice Is part of the overallImplementation of sectIon4 of theToxicSubstancesControl Act (TSCA, Pub.L94—469:90Stat. 2006~tseq.; 15 U.S.C.2603etseq.), whichcontainsauthorityfor EPA to requiredevelopmentof datarelevant to the assessmentof the risksto health andtheenvironment posedbyexposur,to particularchemicalsubstance.or mixtures.

Undersection4(a)(1)of TSCA.EPAmustrequire testingof achemicalsubstanceto develophealthorenvironmentaldataif theAdministratorfinds that.

(A)(i) the manufacture,distributionincommerce,processing,use,or disposal

of a chemical substanceor mixture, orthat any combination of suchactivities.may presentan unreasonablerisk ofinjury to health or theenvironment.

(ii) there are insufficient data andexperienceuponwhich the effectsofsuchmanufacture,distribution incommerce,processing,use,or disposalof suchsubstanceor mixture Or of anycombination of suchactivities in healthor the environment can reasonablybedeterminedor predicted, and

(iii) testing of suchsubstanceormixturewith respectto sucheffectsisnecessaryto developsuchdata; or

(B)(i) a chemical substanceor mixtureIs or will be produced in substantialquantities, and (I) it entersor mayreasonablybe anticipated to enter theenvironment in substantial quantities or(U) thereisor may be significantorsubstantial human exposureto suchsubstanceor mixture.

(ii) there are insufficient data andexperienceuponwhich the effectsof themanufacture, distributionin commerce,processing.use,or disposalof suchsubstanceor mixtureor of anycombination of suchactivities on healthor the environmentcan reasonablybedeterminedor predicted, and

(iii) testingof suchsubstanceormixture with respectto sucheffectsisnecessaryto develop suchdata.

For a more.completeunderstandingofthe statutory section4 findings,the

-reader Is directedto theAgency’s firstproposedtest rule package(chloromethaneandchlorinatedbenzenes,publishedin the FederalRegisterof July 18. 1980.(45 CFR48510)]and to the secondpackage(dichloromethane.nitrobenzene.and1,i.1-trichloroethane,pulishedin theFederalRegisterof June5, 1981: (46FR30300)]for in-depthdiscussionsof thegeneralIssuesapplicable to thisaction.IL BackgroundA. Profile

EPAIssueda proposedrulemaking.publishedin the FederalRegisterofJanuary13,1984 (49 FR 1760)whichproposedthat certain chemical fate andenvironmental effects testsbeconductedwith monochlorobenzene.1.2-andi,4-dlchlorobenzenesand1,2,4-and1,2,3-trichlorobenzenes.

The proposedrule, appearingin 40CFRPart799as ‘*799.2900Monochlorobenzene1,2-dichlorobenzene:1,4.dichlorobenzene;1,2.4-trlchlorobenzeneand1.2,3-trichlorobenzene.”1. nowrecodified as“~ 799.1050Chlorinated benzenes.”

The principalusesof thesechlorobenzenesare summarized.inTable 1.

Federal)Register/ VoL 51. No. 86 / Monday, April 7, 1986 / Rules and Regulations 11729

TABLE 1.—P~NC~PALUSESOFSPECWiCO~oaoae4za~ES’

ios-eo-7

p—u-

~a~.0

- aNm.. ..—~

a L~Ifr~

12. P..4..,L.. WOhJU.,i4~... . ~ ~

~‘

—1W ~p ~ —

1,4- 106-46-7 S~cs ~ 1WØaS)-GUIOL’

TnJll,.,.L.~ •

1.2,3. 67.41—S ~E Ii,~das, ~.

VSVI~d~S~ 9~ame — ~L~La-’

12.4. 130-52-I O~T..,M~*....-—

‘U o( iT~ad~ a rJ—”~~v~a ~ —,cIwrIls II $U~ ,,—-— U ~eO,~1W’ ~h,..~.4e ~ungcas $n~~nk.M *~ ~W W flQt,*.__•_ II Ia f~mm.~ç

The rangesof productionIsand/orimport into the UnitedStatesof thesechlorinatedbenzaoe.arepresentedinTable 2.

TABI,E 2.—UNiTED STATES Paoouciio~*I~IO~110RT OF CEaT*ia CHLO~ATEDBa*ZaIES

a~I— ~c==06

.., 195000000a 264000000.12-....... 40.300,000a 47~Y~J~~ 62.300i000.

.. 51,300(0 (52.000.~ 2.75C.~a 5,070.000.

‘Dsa ~u — f~ ~m.1W 1W~‘TSCA ..cno~Na) P~*~aa,yfr~$S3sflUIIt m~n ~,ASp.~4’stlsdOd~J~Is26, 1982 (47 ~ 2~00?.a. ~fo~ag~e~daa i1ssa~dII 48 ~R 270’I (Ala 13.1983), an~PA ~n jr~aaiawiN Nam.A4.c~,.11W ro(mOwd ol a a-. -~-.---‘~ ~

B. ITCRecommendations

Section4(e) of TSCAestablishedonInteragencyTestingCommitteeLITC) torecommendto EPAslist of cbem.iaak~be consideredfor testingunder a’i~i

4(a) of theAct.The ITC designatedthechlorinated

benzenesfor priority ccasidsrationIn It.Initial (mono-anddithkeinatedbenzenes},andThird (tri., taere-~andpentachiorina tedbew~~a)R~poili,publishedin the F.~rstI~ist.rofOctober12, 19fl (42FR 55028)andOctober30. 1978(43FR50630),respectively.The1TC recommendedthatmono-,di-, Iii-; tefra-,andpentachiorinatedbeozenesbeconsideredforhealthandenvinxmientaleffects testing.EPA’Sre~aoneto theITC’s healtheffectstestingrecommendationsfor thesechlorinated

benzeneswaspublishednitbeFsd.r.lRegisterof Jnly16.1980(45FR48524).

The ITC’s testingrecmeodatioou‘for mono-anddichlormatedbenzenesI werebasedon thereported large U.S

productionvolume,of thesecompounds.T TC’aInitial Reportstatedthat theU.S.productionof monoth~oba’ani~wasaver300million poundajyear.Productioncdl,2-amit4-dichlorobon~ewases*im.ted~the

.ITCat5omuhloupoundseath.Inaddition, the LTC wasconcernedthatthemanufactureof mono-anddichloroben~ueandtheirusealoneandin productscouldpresentasenviro~telhazard,part~.ilarlyinlight of thehWsralcue ute of mono-anddichlorobeszzeueand~anticipatedpersistencein theenvironment.

TheITCi recommendation,for fri.,tetre-, andpentachlorinatedberizeneewerebasedon reportsof contaminationof air. water, soil and food chainsbychlorinatedbeizenecompounds.TheITC cited severalpossiblesourcesofcontamination,which includedtheuseof chlorinatedbenzene.aschemicalintermediates,assolventsin themanufactur.of dyes,aslubricantsandpesticides.andastransformeroil,. TheITC also speculatedthatareduction intheuseof po4ythlornated~lphenyl,mayresultin increaseduseofthchlorobenzenesasIrenaformer oils.C ProposedRule

In the FederalRegisterof January13,1984(49FR 1760), EPA issuedaproposedrule which would requirechemicalfateandenvironmental effectstesting for various chlorinated benzenes.

1. 1SCA section4(o)(1XB~kEPAbasedits proposedtestingofmonochlorobeozene,1.2- and1.4-dichiorobeozeneand1.2,4-trichlorobenaeneonthe authorityofsection4(afll)(B) of TSCA. EPAconcludedthat monochlorobensue,1,2-and1.4.dicblcrobensen.,sad1.2.4-trichlorob~!~~.areproducedInsubstantial quantities. andmay enterthe environment in substantialqssnlitias.Pu tharmoreEPAorwu4nil.dthatthereareiasufflcieetdetaavailableto eitherreasonablycIstermIerorpredicttheresult.of this expoMEein th~areasof d~nicslfate andenvironmentaleffectsandthat testingIsnecessaryto developsnobdata.

EPA reachedthesecond’~~’_~thefollowing reasong

a.A,tlI.l.l. informatlos indicatesthattheUn.111t UnitedStet produ~oeand/or ~post volumes~o,

n.—blopoben~e,1,2 and1.4-dichloroben.zeneand1.2.4-‘trichlerobenzene are substantial(seeTable 2).

b. Awailable informationindicatesthattherearesubstantial amountsofmonochlorobenzene.12- and1,4-dichlorobaniene,and1.2,4-trichloroben~nsreleasedto theenv~onmenteachpearviamanufacturing.proceulagand/or useactivities.Environmentalreleaseestimatesof chlorinatedbonzenearesulting from their manufacture arepresentedin Table 3.

T~a.a*A,esJM. ENV~ONM�NTALRELEASEEsiwiss ~J~u.G m� MANUFACTURE OFFCOaOonATEDBEN~s

.c~v~aa~b.~..

MN~.gm.,. 1,

~

._.._._._.

I ~~ — —

1.2.4.TrC~u-lNm....,.........

420.000—605.30065.800

365 000—5920005014.033

‘~~s.mrw~fty,.ntaIrSl~sSiSIt~1atNfrom ISCASSCSOn 844) Pr.wiw4r( Assswnlnf ntQmlaI,or Rule 47 FR260021W vvia~~off (0Iaa ~ l~as.~

In addition,availabledata indicatethattheusesof thesechlorinatedbeizeieamay result in substantialreleaseof rsonochlorobenzene.12- and144.dithlorobenzene.and 1,2,4.trichtm’obenzene into the environment(see~Zable4).TABLE 4—ESTiMATED RELEASES OF CERTAIN

ComaP’rEo BENZEP4ES TO THE ENvIRoN-MENT Faov UsEs’

cti~....s.a06’~rlsM,fhovi I Mi#o,~ M.li,on

~ pcunds potr~os1011 10 altec to iand

U,.~JiIo.,i,a._,_.,_,...

I,4.Och~a__~

2 70 L_<0.7 I 9.1 <0.115,7 ) 11$ 0.6

~ 3.2

‘(RV~?1W2.)

c. EPAmnnrthida’d that thereareinsaiTl~eotdataonthechemicalfatesandenvironmentaleffectsofmonoclorob~’naita~.12-and1,4-dichlorobenzeneand1,2,4-trichlorobenzeumtoreasonablydetermineat predictthe resultsof theu’environmentalrele’..es.andthattestingis necessaryto dtvelopsuchdata.

2.TSC4section4(o)(1J(A).EPAbasedits proposedtestingof 1.2,3-thchlorobenaer~cii theauthorityofTSCAsection4(a)(IXA), becauseEPAconcludedthat1,2,3.U’ithloiobenzenemay presentan unreasonablerisk ofinjury to orgeni~in theaquaticenvirciucent.EPAreachedthisccatJaaã~~nfor the following reasons:

11730 FederalRegisterLVo1 51 No ~ I Monday Apnl 7 1986 / Rules andRegulations

a.Existing toxicity data indicate thatamong the mono-.di-, andfrichlorobenz,nes,1,2.3-trichlorobenzeneis the most toxic toaquaticorganisms(Ref. 3). Toxicitymeasurementsinclude reported48-hourLC5O’s of 0.71mg/L and3.1 mg/I. forrainbow trout and zebradanlos.respectively, and a 24-hour daphnldLC5O of 0.35mg/I. (Ref. 3). In addition.chronic toxicity data ondaphnids showsignificant effectsat concentrationsaslow as0.1 mg/I. (Ref. 3).

b. Available informationindicatesthat the manufactureand usesof 1.2,3-trichlorobenzene(dye carrier, organicsolvent,intermediate and dielectricfluid) arethe principal sourcesof itsenvironmental release.Ware andWest(1977)reported levelsof0.021 to 0.048mg/I. of 1.2,3-trichlorobenzeneinmunicipal discharges(Ref. 5).Usingthesemeasuredlevelsof 1.2,3-

For 1,3-dichlorobenzene.the Agencyconcluded that no further testingshouldbe proposedat this time.Existingdatafor 1.3-dichlorobenzeneadequatejycharacterize its toxicity to aquaticorganismsand availableInformationprovides no basis for believing that 1,3-dichlorobenzenemay presentanunreasonablerisk to the terrestrialenvironment.

For 1.3.5-trichlorobeuzene,the Agencyconcluded that nofurther testing shouldbe proposedundereither TSCA sections4(a)(1) (A) or (B) at this time.Thatconclusionwasbasedprimarily onthefact that data submitted under TSCAsection8(a) indicate that 1.3,5-trichlorobenzeneis not currentlyproduced in the United Statesandthatthe primary usesof 1.3,5-trichlorobenzene, for which It Isimported into theUnited States,areexpectedto result in low environmentalreleasesand exposures.Theanticipatedlow levelof exposureand thelimited

trichlorobenzene andIts potentialbioconcentration factor in fish of 1200—2600X(Ref. 4), the potentialconcentrationof L2.3-trlchlorobenzenein fish is in the rangeof 25 to 120mg/I.(measuredlevelsIn waterX BCP’s forrainbow trout — potentialconcentrationof 1,2,3-trichlorobenzenein fish). Duetothis potential bioconcentrationof 1,2.3,-trichlorobenzene,andits reportedLC.of 0.71mi/L for rainbow trout, theAgencyhasdeterminedthat1.2.3-trichlorobenzenemay presentanunreasonablerisk to aquatic organisms.

c.EPAconcludedthatthere areinsufficient data on theenvironmentaleffectsof 1.2.3-trichlorobenzenetoreasonablydetermineor predicttheeffectsof its environmentalreleaseandthat testingis necessaryto developsuchdata.

On the basisof thesefindings,theAgencyproposed the testrequirementssummarizedin Table 5.

dataonthe chemicalfate andenvironmental effectsof 1.3.5-trichlorobenzenedo not support afinding that thiscompoundmay poseanunreasonableriskof injury to organismsin the aquatic or terrestrialenvironments.

For pentachlorobenzene,the Agencyconcludedthat no additional testingshould be proposedat this time. Thatconclusionwasbasedon the fact thatpentachlorobenzeneis neither producedIn nor imported into the UnitedStatesatthis time.The only formerU.S.pentachlorobenzenemanufacturerand/or importernotifiedEPAthat It nolongermanufacturesand/orimportspentachlorobenzene.

With regard to thetetrachlorobenzenes,theChlorobenzenesProposedRule(January13, 1984,49FR 1760)alsocontainedanAdvanceNoticeof ProposedRulemaking. In reviewingInformation.related to the manufacture of the

various chlorinated benzenes.theAgencydetermined that 1.2.4.5-and1,2,3,5-tetrachlorobenzeneswere neitherproduced In nor importedinto theUnited Statesand thereforeEPAInitially decided not to proposeenvironmentaleffectstesting for thesetwo chemicals.However, in September1983,EPAwas informed that achlorinatedbenzenemanufacturer in theUnited Stateshadreceivedandacceptedan order for a mixture of tn-and tetrachlorinated benzenesto beusedas a substitute for polychiorinatedbiphenyls (PCBs) in transformers. EPAbelievesthat the useoftetrachlorobenzenesin transformersmay result in environmental releaseandexposuresimilar to that demonstratedwith PCBs. It wasEPA’sbelief that anANPR would be an appropriatemechanismto obtain information on thepotential production, use,andenvironmental releaseoftetrachlorobenzenesas a PCB substitute.rn Responseto Public Comments

The onlycommentsreceivedby theAgency1n responseto theJanuary 13,1984~ChlorobenzenesProposedRulewerefrom the ChlorobenzeneProducersAssociation(CPA) (Ref. 6). The majorissuesIdentifiedduringthe commentperiod are discussedbelow in Unit Ill..A. through C.A. Production. Usage. andEnvironmentalRelease

The ChlorobenzeneProducersAssociation(CPA) submitted commentsregardingEPA’s estimatesandconsequent4(a)(1)(B) findings thatsubstantial quantitesofmonochlorobenzene(MCB). 1,2-dichlorobenzene(1,2-DCB). 1,4-dichlorobenzene(1,4-DCB), and 1.2.4-trichlorobenzene(1.2.4-TCB)arereleasedto water, and smallerquantities of MCB, 1,2.DCB,and 1,4-DCBare releasedto air.

TheCPA stated that the agency’sproposedrule Is basedon outdatedinformation that doesnot reflect currentusageandreleasesof thechlorobenzenesandusedMCB asanexample.They stated that EPAhasrelied principally on a materials balancereportfrom 1979 (Ref. 1), and not themore current data by Hull and Company(Refs. 8 and9) submitted by the CPA.

Aside from thesegeneralclaims, theCPAdiscussedbriefly the usesandpossible releasesof only MCB.

EPA’s review of the industrycommentsandtheexistingdata,however, indicatesthat the Agencydidconsiderthe Hull survey andthat theproduction andreleaselevelsof

TABL.E 5—PROPOSEDTESTiNGREQUtREMENTS FOR MONO-, 1.2-Of-.1,4-Of-,Also 1,2,4-Tm-Ceef.0RINATWBENZENES

cN~m.I.dbwOinl PWy...ld UM9

Mc~cUXu~ns..._....._ OtUed 1*1.: A$no~iit~,.~50flwn II5CI~UcU. . Em,.,.-.,~iillIiffscts Sled ~&,... 1001 ~., U iwfp i~*tq

p0051ul S.....iU~.IIsl~~IUS.1,2-U ~ Otsr01U U A0n,aph~~.L0 ~ ~ Uid aId U

- .

~ .lucts Slid ~ 1001 .I..~.If.-.U es~ 1up005151 m.~b~iss.

12.4.TflcNoios~zstts.____. ~TtsiU U MncsCfleflc UNoll ~ II~*~4v~Id.U i,N..q.&.. cOSS.aSnt

En’,...,....eiiflI eff.ctl: Ac~IfI aId dyotic liddly (0 myid Un~.aDA, Ucitpto 51s leusedmsaoØ~l,Lam’~ Sled ~ 1001 ~

1.2.3-Tr OIZIfil....,...... .~.

U saty511011199r0W51II *101501 ,IISCTCØIyISSE.~........t.ieffects:96.Ilot, LC5O or tithed t01m~55.Itott Ec50 tot one

speot.s of Gwmtwt* .~ toxicity toei, ~gx ~Hy1s La,v~~aIls toxicity to myid Wwsi~U Idvureds. dvctlc US p to lopedIf ,o~iId~vr~ LCSO <1 nem.

FederalRegister / Vol. 51, No. 66 / Monday. April 7, 1986/ Rules and Regulations 11731

monochlorobenzenearemostlikelysimilar to thosestated’by theAajncyinthe proposedrule (Ref. 7),Further,theCPA hasnot submittedanytechnicalargumentsor new data thatreducesourconcernsregardingtheother chlorinatedbenzenesand theAgencyseesnoreasonto question its originalconclusionsregardingthe usesandreleasesof thesecompounds.

Data still Indicatethatmonochlorobenzeneis present in theenvironment.In the proposedrule theAgencystated that in a rankingoforganicchemicalsby frequencyofreported detectablelevelsin finished(treated) surfacedrinking water (SRI,NOMS, and NORSdata bases),thefrequenciesof i,4-dichlorobenzeneand1,3,4-trichlorobenzenein surfacewaterwere12.5percent and11.5percent,respectively.In groundwater.1,4,-dichlorobenzene-wasfound to occur In12.95 percent of all samples,andmonochlorobenzeneoccurredin 7.1percent of the samples(Ref. 11).

Sincethe publication of the proposedrule, the Agencyhad identified data thatindicate inonochlorobenzenehas beendetectedin sedimentsof the Buffalo andNiagaraRiver.of New York at a level of30.97mg/kgdryweight(Ref. 12).

B. PhotodegmdationandSoilAdsorption

The CPA commentedthat EPA Isproposingstudiesof atmosphericoxidation by hydroxyl radical for MCB.1,2-dichlorobenzene(1,2-DCB), 1,4-dichlorobenzene(1,4-DCB),and 1,2,4-trichlorobenzene (1,2.4-TCB).Data fromMonsantostudieson MCB weresubmitted to EPAin 1983 (Ref. 13), underTSCA section8(d). The atmosphericoxidationhalf-life forMCD wasfoundtobe lessthan 8 days.Basedupon limiteddata withchlorinated alkanes,theCPAanticipates that hydroxyl radicaloxidation rates would decreaseaschlorination increases.

The CPA concludesthat it Isunnecessaryto require testingof bothDCB’s and1,2,4-TCB.Theystatethat thehydroxyl radical oxidationratesof thesechlorinatedbenzenescouldbeadequatelycharacterizedIf 1,2,4-TCBwere studied and if the results of MDCand TCB are usedto estimatethe ratesfor the DCB’s.

The EPAacknowledgesthemonochlorobenzeneatmosphericoxidation data submitted by Monsantoand the Agency hasalsoidentifiedatmosphericoxidation data (Refs.18and 17) for 1,2-and 1,4-dlchlorobenzeneand 1.2,4-trichlorobenzene,Therefore,the Agency is not requiringany testIngfor atmospheric oxidation vie the

hydroxyl radical for anyof thechlorobenzenesin this final rule.

The CPA alsonotesthat the Agencyhasproposedsoil adsorption testing(Ref. 10) for DCB’s and 1.2.4-TCB.TheCPA commentsthat the supportdocumentpresentsreasonableevidencethat soil partition coefficientscanbeadequatelypredicted from aqueoussolubility. In addition,measuredsoilpartitioncoefficientsfor 1,2-dichlorobenzenehavebeenreportedand do agreewith the calculated value(Ref. 14).Predictedsoil partitioncoefficientsarecomparatively lowlxlO’to 7x1O~),which Indicatesthatchlorobenzenesdo not partition stronglyto soil.Therefore, the CPA concludedthat EPA’sproposed soil absorptiontesting is not scientifically justified forthesematerials.

The CPA maintains that the soiladsorption coefficients(K5j andrates ofatmosphericoxidation for someof theCD’s canbe estimatedfromexperimental data that already exist forother chlorinated benzenecongeners.Although the experimentallydeterminedvalueof K5 for 1,4-dichlorobenzeneis ingoodagreementwith the estimatedvalue, thisdoesnot necessarilymeanthat thevaluesfor highercongenerswillbe Within acceptablelimits (a factorof10) of experimentalvalues. In fact,propertieslike K~becomemoredifficultto predict asmore substituentsareadded to thebasemolecule.Thus,forhigher member.in a series,estimatedvaluesmaydeviatefrom experimentallydeterminedvaluesby factor. of 100orgreater. Such deviationsareconsideredtoo great for conductingriskassessments,particularly for compoundssuchas 1,2,4-trichlorobenzenewhichappearsto be one of the more toxicchlorinatedbenzenes.

In conclusion,EPAbelievesthattestingis justified onthe basisof lack ofexperimentaldataon theK.1. TheAgencyalsoseesthe needfor soilabsorption coefficient testingformonochlorobenzenebut neglectedtopropose thesestudies.Therefore, EPAwill perform this testing.C. ~quaticToxicityTesting

The CPA notesthat EPA hasproposedacute and chronic toxicity testing formysid shrimpwith 1.2,4-and1.2,3-TCBand acute toxicity testing of 1.2,3-TCBfor fathead minnows, silversides,andGammon,..

The CPA hasstatedthat muchof thetesting on 1,2,3-frichlorobenzeneIsnotjustified. No commentsweresubmittedon the proposed testingfor theremaining mono-, dl-, andtrichlorobenzenes.

1.The CPA commentsthatbecauseofthe low production volume and onlymoderateacute toxicity to fish, algaeand invertebrates. chronictoxicitytestingof 1,2,3-TCB is not justified. Theystate that existingfish and Dophniodatacited by EPAshouldbesufficienttocharacterizethe effectsof 1,2,3-TCB(Ref. 6). They note that acute toxicitytesting with mysid shrimpmaybeappropriate. However,CPA commentsthat aslong asboth acuteandchronictesting is donewith 1,2,4-TCBon mysidshrimp, thereis no needto performbothacute and chronic testing with 1,2,3-TCBon mysids.Acute testingalonewould beadequateto establish their relativetoxiities. They statethat a chronictoxicity estimatefor 1,2,3-TCB can beobtained by applying the acute toxicityratio to the 1,2,4-TCBchronicendpoint.If thesedataindicate comparable orlower toxicity of TCB’s to mysidshrimpthan to Dophnia,chronictestingwithmysid shouldnot berequired.UnlesswidespreadTCB levels in natureapproachedthe LC5O level for Daphnic(0.35mg/L). adjusted to allow a safetyfactor, thenchronic testing would not bejustified.

The testingfor 1,2.3-frichlorobenzenewasproposedunder section4(a)(1)(A)of TSCA, basedon potentialunreasonablerisk, and not significantenvironmental release.The CPA has notsubmitted anynewdatathatwoulddissuadethis concern.The Agencynotesthat 1,2,3-TCB is themost toxic of themono-,di-, and trichlorinated benzenes,with LC/EC5O valuesbelow I mg/L forfish, aquaticinvertebrates,andalgae.The Agencydoesnot considersuchvaluesas only “moderate acutetoxicity”.

EPAdisagreesthatacutedataon1,2,3.TCBare sufficient for comparingtoxicity with 1,2.4-TCB, evenwithchronictoxicity data on the latter. Datapresentedby Calamari et al. (Ref. 3),showthat relative toxicity of the variouschlorobenzenesis inconsistent to theextent that estimatingchronictoxicityfor the most toxic of the mono-,di-. andtrichiorinatedbenzenesfrom acutetoxicity of a lesstoxic isomer isinappropriate. In conducting 48-hourstatic bioassaysof a number of thechlorobenzenesusingrainbow trout andzebrafish. Calamari reported that theamountof chemicalrequiredto elicit anLD5O responsedecreasedwithIncreasingchlorine substitution (frommono- to trichlorobenzene).1,2,3-TCBwasthe most toxic of the compoundstested,with more thantwicetheamountof 1.2.4-TCBrequired to produce thesameeffect.

11732 FederalRe~ster/ VoL 51. No. 86 / Monday, April 7. 1968 / Rules and Regulations

In adthtiss,since1.2.3-TCD~peiie ~bethemosttexicof~chlorobe~m~sh—.~ irisSà

1~

toxicity dat& it is p~~y ~tto hivecbeonict.~d~y~a~ thisi~r it shouldbe~ ~d thuchronictoxicity te~gw*~1.2.3-Taon mysidshrimp is only,rui if theacute toxicity to my.~dsis leesthanImg/L

2.The CPA commentsthat the acitetoxicity lestmgof 1,2.3-TCBinGammorusappearsscientificallyInappropriate.TheCPA statesthatthereaieapparentlyfew, If any.chlnrobenzenestudiesreportedfor thisspecies.Therefore,thetestresult.withGommoruswouldnot beasusefulInmakingcomparisonsamongthechlerobeozenesastestresults withother species.Theyaddthatacutetestswith Daphniaor midgeandSheepsheadminnowwouldbe more appropriate.Such testresultscouldthen becompared with resultsfrom otherchlorobenaenea.

EPAconsider,thattestingGomoruswith 1.2,3-TCBis quitesppro9riata.Thepurposeof suchtestingis not tocomparetoxicity of the vax~uschlorobenzeees.butratherto developasoundbasisfar evaluatingthehazardand risk of this chemicaLWhentheaquaticLC5O of.chemicalis lassthan Img/L then asearch isr other sensitivespeciesis warranted.Additional tastingwith Gammoruswill ascertainif thehigh sensitivityof daphnids(Q,35mg/L,(Ref. 15)isunusualor if it is comparablewith other freshwater invertebrates~

The Agencyproposedtestingof both1.2,3-TCBand 1,2,4-TCBen theaquaticmacrophyte Lemnagibba. EPAbelievesthat informationconcerningmaorophytesis usefuland,throughatesting pro~amconductedby EPA,willdevelopdatato determinecomparativetoxicok,gicalpro~esbetweentheaquaticmacruphytaLamiwgiMa andthe aquaticalgae~aaorb~wncapricornuti~forwhichtheAgencyalready has toxisitydata concerning1.2,3-TCBned1,2.4-lu.

The Agencyalesisnot req*lng theseedgermizmdon.rootelongationandearly seedlinggrowthtestingInterrestrialmacrophytes.Althoughthesetestsweremchidedin the proposedrulefor MCD. 1.Z-DCB, 1,4-Dl~and 1,2,4-TCB, afterreevaluatingthereleasepatterns, theAgencydoesnot believetherewill be widespreadexposuretoterrestrial ~antafrom soilscontaminatedwith thechlorinatedbenzenes.

IV. FinalTestRuls forMonochlobsneeee,1.2- ~ 1.4.Dic~ebnesnes,1.2,3.ned1Jê.Trichl.eb..assaeA. F7nrflnr

1. TSC,tsec~ian4(a1((lX8)~The EPA isbasingthetestingofmonochlorcbenzene,1,2-and1.4-dichlorobanzeneand1.2,4-trichlorobenzeneontheauthorityofsection4(aUl)(B) ofTSCA.EPAhasconcludedthatthesethp.ni~jili~produced in substantialquantities.andmay entertheenvfrnnmP~ntInsubsi~atialquantities.Furthermore,EPAha..concludedthattherearelnz~ffi’~entdataav~laht~to either reassnablydetermineorpredicttheresultsof theseexposuresis the areasof chemicalfateandenvironmentaleffect.and thattestingIs necessaryto developsuchdata.

EPAhasreachedthesefor the following rmaons

a. Available iflformation Indicatesthatthe annualUnitedStatesproductionand/or import volumesformoncohlorobmizene,1.2- and1,4-dkhlorobenzene.and 1,2.4-trichlombenzeneaxe substantial(seeTable 2).

b~Available informationln~catesthat tI~eare substantialantoontsofmonochlorobeozene,1.2- and1,4-dIchlorob~uiene,and1,2.4-trichlorobenzenereleasedto theenvironmenteachyearviemanafacturing.procewingand~oruseactivities(seeTable.3 and 4).

c.TheEPAhadconcludedthatthereare insufficientdataon thechemicalfatesand environmentaleffectsofmonochlorobenzene,1,2-and1,4-dichlwobenzene.and1.2.4-trichlonbenzeneto reasonablydetermineor predict the results of theirenviroxmientalreleases.andthattestingIs necessaryto developsuchdata.

2. TSCAsection4(CXIXA). TheEPA Isbasingthe testingof 1,2.3-trlchlorohanzeneonthe authorityofTSCAsection4{a)(IXA), becauseEPAhasnencludedthat1.2,3-trlchlorobenzenemaypresentanunreasonablerisk of injury to organismsin theaquatic environment.EPAhasreachedthis amclusion for the followingreas~

a Exfsthigtoxicity data Indicatethatamosgth mono-,dl-, andtrlcblotobenzene.1.2.3-trichlorobenzeaeis the chlorinatedbenzenemost toxic toaquaticorganisms(Ref. 3).

b.Available informationIndicatesthat th. manufactureandusesof 1,2.3-trichlorobenmnearethe principalsourcesof its environmental release.Ware and Westreported levels of 0.021

to 0.048mg/I..of 1.2.3-tricblorobenzenein .~micipaldisharges(Rd 5).

‘Coni~ringthesemeasuredlevel.,of0.021 teO.Ouemg(L.an estimated10 to100fold dilution byar~iving~sem(HaL 7),, and i,2,3-~ithiorobenzene’sreportedIsocu~fratlonfactoris fiuliof 1,200-2,SOOX(HaL 4) thepotentielconcen~ationin fish as In therangeof0.25mg/kgto 12.0mg/kg (meaamedlevelsin municipulth.chargesXestimateddilution factorsXBCFs barrainbow t~ou1=potiatialcaicen~ationof 1,2.3.TCBin fish)Dueto thispotentialbioconcenfrationof 1.2,3-trichiorobenenee,andits r~rtedLC5Oof 0.71ad/L far rainbowtroeLtheAgencyhasdeterminedthat1.2,3-thchlorobenzenemaypresentanunreesonbieriskto aquaticorgs~wi.-ET1 w530 563 m573 563 lSBT

c. EPA hascondndedthat t~eareinsufficientdataonth. environmentaleffectsof 1.2.3-4rithkiro~netoreasonablydetermineor predict theresult of Its environmental r~is~andthat testingIi necessaryto develop suchdate..B. RequiredTesting

On thebaeisof theseffrnti.p, theAgencyis requiringthetust~summarizedin Table9 to beciniductedin order to determinethe chemicalfateand/or environmentaleffectsci1.2- and1,4-dlchlorobenzene,1,2.4-frichlorsbenmneand1.2,3-trichiorobeozene.C TestSubstances

EPAIsrequiringthat chlorinatedbensenesof 99 percentpurity, availablecommercially,beusedasthe testsubstancesfor the chemicalfate andenvironmentaleffectstesting.Thisstipulationinaeasesthelikelihood thatany toxic effectsobservedaxerelatedtothe chiorinetedbenzenesandnot to anyimpurities.D. PersonRequiredto Test

Section4(bX3)(B) of TSCA specifiesthat the activitiesforwhich the Agencymakessection4(a)findings(manufacture,processing,distribution.useand/or disposal)determinewhobearsthe responsibilityfor testing.Manufacturer.arerequiredto testif thefindingsaxebasedon manufacturing(“manufacture”is definedin section3(7)of TSCA to Include“import”).Processorsarerequiredtotestif thefindingsare basedonprocessing.Bothmanufacturersandprocessorsaxerequiredto testif theexposuresgivingriseto thepotentialrisk occurduringuse.disinbutlon.ordisposal.

EPAha.foundthat(1) mono-. 1,2, di-,1,4di-. and1,2,4-trichlorinated benzene

Federal RegisterI Vol. 51. No. 86 I Monday, April 7. 1986 / Rules andRegulations 11733

are produced in substantial quantities regardingtheseactivities to reasonably thereare insufficientdataandand that their manufacture, processing, predict theeffectson the environment, experienceupon which the effectsof theand useare likely to resultin significant (2) for 1,2.3-trichlorobenzene. manufacture,processingand use ofor substantialexposureto the - manufacture, processingand usemay 1,2.3-TCB on theenvironment canenvironment,and that there are lead to unreasonablerisks to organisgis reasonablybe determinedor predicted.insufficient dataand experience in the aquatic environment and that

TABLE 6—TESTING REQUIREMENTS FOR MO,io-, 1,2,01,1,4.01-AND 1,2,4-TRIcHLoniwa’TEDBENZENES

CIi.~..a’.abuI~iI1s EPA ~ocos~ Fw t.swig ,oa.m.~

~.

.

1,2. ~d t.4-Ok.N.i~,w4 i ~.

1.2,4-Tr~tI~i0tt1flZni.....

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~Iis.~.ciI Iii. Atmo,Jw~,.ox~lbor~ Po.~4r.~cai.Eswwoiin.rial ~Is~ hid ~ ,~.~di~y .isdi~powm .~I.rs.si.I we~x.M~.

CIts.,Vc~(au: Abitoigh.fl~~s~1mou~~ tIy~os~lmacas rid IOU .dI0V~idfl~il1mousmtE nintalV4~slid grim~iioon.ro~.ucrgsson rid .rsp .IS~Ig ~oes~ m ii,.~ mscrcgnyus.

.

OmSI,Veau ~ Ami,.,.ph.,~~bOr ~s h~oz~4rhdjc~rid sod ods~iuio,,~.(~rit Et,Ao.vn.nt.Jsf(sc4 Acid. rid CNOusc 45ICmty ~ tfl~iads(vwt~(AI~ belM): ~II5 tOxIcm(y E VII a~jsbctniaocuiyl. LrPVII g~Cm;slid

1.m,,VI~., rOOt iiouiglioui rid ~ly sss~Ig ~oeVi in Isnssu.si

.

E..~d .f!.~ 9~Iio,, LcSO for f*tfisid n~voe(Pl9~mibe ial.i); N-he, ECSO for or~sçsois ~ 4 04 •~•~ ~ ~•~~5•4~ ~.AS toxI~y4 myedWWIl,~(M)~ ~m~) rid W.’irhudis (A~ m~), civolic lomuody 4 my.d ~~)VLc5os<1xm.

No m~,.byIe~ rli,id.(1) Avnosc~4i~O~htIQfl Niong

~~W4lid)(2) Soul hOIc,pbon G..11c.i,t 411

.00S~’(3) Er on,,.snW illicts 451mg

iinw4WAz proo~sd,w,dl ixCi~On5.(1) Am.ozpn,nc oiidaxn 45l,ng

.Ui~nhl.d~(2) Er o.~’wnlal .fl.ct$ tsstmg

ihutw.utid.’As ~oooiid. *,lfi slCiObOu’l$(1) ~ oudsuon listing

ilinw,stsd.’(2) Le.rma ~a ilin,nated(3) T.,~.,uiaumwocti~1. thong

~id’As pro~cs.d,riti ixCiOflOn:(t) Lrivv ilirwihtid.’

.

NOth~oursd.NOlis*~rsG%sd.NOthsrigr’ous’sd.To bi idOusaid ma fUltiCOrTWig

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-. .... ._

......................._. - ....—....—...._—._...._._.—.——• —...

.___.....____....._.~_.-....—_. ~

....,...__........

.

om~$on~II fI~d by EPA .ehi~V~‘T!sl I.swq r~i~~ud by Vii Agsncy sau be ~I~ouud by EPA.‘Agricy OeM r~fbiM~sV~US ~uig~iSId Mposts 4 IIrrMi’IIl P*III.‘Fs~~tiuIOØ ~ be

Thus, EPA is requiringthat personswho manufactureor process,or whointend to manufactureor processthesechemicals,at anytimefrom the effectivedate of this testrule to the endof thereimbursementperiod, be subject to therule. The end of the reimbursementperiod will be 5 yearsafter the mysidshrimpchronictoxicity testfinal reportis submitted, As discussedin theAgency’stestrule andexemptionprocedures(40 CFR Part790),EPAexpectsthat manufactprers will conducttesting and that processor.willordinarily beexemptedfrom testing.

EPA is, however,exempting fromthesetesting requirementsthosemanufacturers andprocessorswhichproduce and processchlorinatedbenzenesonly asan impurity“Impurity” is defined In 40 CFR 790.3 tomean ‘a chemical substancewhich isunintentionallypreseritwithanotherchemicalsubstance.”The AgencyIsexemptingthosemanufacturersandprocessorsbecausethe EPA’s findingsundersection4(a)(1) (A) and (B) arebasedonexposuresto chlorinatedbenzeneswhich are a result ofintentional processing,distribution Incommerceanduse,andwhich representa potential unreasonablerisk, TheAgencywould find it difficult to apply

both the exemptionand reimbursementprocessesto thosewho manufactureand/or processchlorinated benzenessolelyasan impurity.In fact, theAgency’sreimbuñement regulationsissuedpursuantto section4(c) statethatthosewhomanufacture or processchemicalsubstancesas impuritieswillnot be subject to testrequirementsunless the rule specificallystatesotherwise (40 CFR 791.48(b)).

BecauseTSCA containsprovisionstoavoid duplicative testing.noteverypersonsubject to this rule mustindividually conduct testing.Section -

.4(b)(3)(A) of TSCA providesthat EPAmay permit two or moremanufacturersor processorswhoare subjectto a testrule to designateone suchpersonor aqualified third personto conduct thetestsand submit data on their behalf.Section4(c) providesthat any personrequired to testmay apply to EPAfor anexemption from that requirement TheAgencyanticipates that thecurrentmanufacturers of chlorinated benzeneswill form a reimbursement pool andsponsor the testingrequired.Manufacturers andprocessorswhoaresubject to the testingrequirements ofthis rule must complywith the testruleendexemptionproceduresin 40 CFRPart 790.EPA is not requiringthe

submissionof equivalencedata as acondition for exemption from therequired testing.As noted in Unit IV. B,EPA is interested in evaluating theeffectsattributable to the chlorinatedbenzenesthemselvesand has specifiedrelatively puresubstancesfor testing.

E. TestRuleDevelopmentandExemptions

ElsewhereIn this Issueof theFederalRegister the Agencyis proposing thatcertainTSCA testguidelinesbeutilizedasteststandards for the developmentofdata under this rule for chlorinatedbenzene..As discussedin that noticeand in previousnotices (50 FR 20652),EPAhasreviewedthe method fordevelopmentof test rulesand hasdecidedthat for most section4rulemakings. theAgency will utilizesingle-phaserulemaking. In light of thisdecision,EPAhas reevaluatedtheprocessfor developing teststandards forsection4 rulemakings initiated under atwo-phaseprocessand hasdeterminedthat for certain of thesetwo-phaserules,TSCA testguidelinesareavailableforpromulgation asrelevant teststandards.EPAhasdecidedthat where TSCA orotherappropriatetestguidelinesareavailable,the Agencyin most caseswill

11734 FedualRegietot I VoL 51, ?~. 66 / Monday. Aprii 7, 1~ / Rules and Regulationa

proposetherelaviatu~l-~1sastheteststandardsfort~ i’~..

EPAbeIthM.Mwithñcommitmentii exp’.~~ ssoti~4rulemakingproces..~ iswpreca4atetopropose the applicableTSCA testguidelines asteststandardsat thesametime a PhaseIfinalWith regard to theruleimakirig forchlorinatedbensenes,TSCA testguidelinesare available for all thetestingrequirementsjuclededIn thisPhaseI final rule. Th~.in theaccompanyingnotice,the AgencyisproposingtheseTSCA testguidelinesastest standards.

The public. Including ~manufacturer.andprocessor.subject tothe PhaseI rule, will haveanopportunitytocommenton theuseoftheTSCA test guideliae&TheAgency

~will review the submittedcommentsandwill modify the TSCA g~thlelines,whereappropriate, whetsthe teststandardsarepromulgated.

During thedevelopmentof. test ruleunderthe two-phaseprocess,personssubjectto thePhaseI fins! rule atenormallyrequiredtosnb~itbfl~,usedstudyplanswithin 96daysaftertheeffectivedateof thePhaseI rulemaking(40CFR790.30(a)(2)).However,becauseEPAis proposingapplicable TSCA testguidelinesas theteststandardsfor thestudiesrequiredby thisPhaseI finalrule.personsesbjectto therule.îa.,manufacturersend ~~~0ri~s 01chlorinatedb~,rin...,arenot requiredto submit proposedstudyplane~ therequiredtestingat this t.~e.Par~sa’i.ssubjectto this nile. however,are stillrequiredtosubmitnoticesof Inte~totestor exemptionapplications inaccordancewith 40 CFP.790.2$.Onesthe teststandards are promulg.tod.personswhohave notifiedEPA of theirintent to testmustsubmitstudyplanawhichadhereto thepromofgatedteststandards,no laterthan30dapibefoetheinitiationof eachrequiredtest

Processorsof chlorinated~subjecttothisrule,ezileestheyare.leomanufacturers,will notbereqaEedtosubmitlettersof inteat.mcemptboaapplicationsor s~y (bei~zetestingis iratiated) mai~ctmarsfail to sponsorther~ukud~ Thebauisfor thisdecision1.thatmanufacturersareexpectedto pa enappropriateportionof thetestingonstsonto processorsthro~thepflcm~ofproductscont~1~igchlorinatedbenzenee.

EPA’s final regulationsfeztheIssuanceof exemptionsfrom tastingrequirementsare in 40CYR Part790. Inaccordancewith thoseregulations,anymanufactureror processorsubjecttothis PhaseI testrule may submit an

applicationto EPAkr enex~~from irri.I~~ut~geny 01 thek~requiredunderthisrule.Vmanufactarerspms4.imtU thetestig.proceorswill bev~exemptionsauton~ ly withev.thaving to file applications.

~cz~s parsonsathject to this ruleforchlorinatedben!7en~taregotrequiredto submitproposedstudy plansforapproval.EPAwill grantconditionalexemptionsunder this rule. This.exemptionswill begrantedfollowingEPA’sreceiptof a letter of intent toconductthe requiredtestsratherthanafterreceiptandapprovalof.studyplea.Noticeof EPA’sadaptionof theproposedteststandardsanddeadlineswill beannouncedIn afinal PhaseII test

rn an mpanylngdocumentpublishedelsewherein this Issueof theFederalRegister,EPAis proposing

~ the ufrg~iirin 01 -~

data.Sxmhdea~ieearere~ul,eddarsection4(b)(1)(C)of TSCA. Theseproposeddatasubmissiondeadlinesareopenfor publiccommentandmaybemodified,where appropriate,whenthefinal PhaseII test rule Is promulgated.F. Reportii~gRequirements

EPAIsrequiringthat all datadevelopedunder this rule bereportedInaccordancewith theTSCA GoodLaboratoryPractice(GLI’J standardswhichappere.t 40CFRPart792.

EPA Is requiredby T~Asection4(b)(1)LCI to specify the timeperiodduringwhichpersonssubjectto a testrule mustsubmittest data.The AgencyisproposingthesedeadlineselsewhereIn this issueof the FederalRegister.

TSCA section12(b)requiresthatpersonswhoexportor Intendto exportto aforeigncountryanychlorinatedbes’menetsubjecttothetestIngrequirementsoftWs rule notify~A ofsuchexportationor intent to exportWhiletheresultsofrequiredtestingmaynot beivellablefor some~e. a n~esto the foreigngovernmentthattheseexportedsubstancesaresubjecttotestrules~..a toalertthemto tb,A.gency’sconcernaboutthesubstances.It givesthesegovernmentstheopp~n1wdtytorequestsuchdatethat theAgencymaycurrentlypossesspluswhateverdata may becomeavailableasaresultof testingactivities.Thus,uponthe effectivedateof this rule,perionswho expertor intendto exportanyofthechlorinatedbeiw~en.ssubjectto thisrule meetsubmitnoticestotheAgencypursuanttoTSCAsection12(b)(1) and40CFRPart~)7. Fatadditionalinformation,seethe FederalRqIat.rofNovember19,1984(49FR45581).

TSCA ction14(b)gi~rnsAgencydisdou 01.11~ data bmittedpuisuaottosec~401 ISCA. Uponreceipt of date reqiNsd by~ rule. ~Agency wi~~ the receptwithin15 daysin the F~rt R~t_ enrequired by section4(d). Test datareceivedpursuanttothis rule will bemadeavailablefor public iaap~tinnbyanypersonexceptin thou.ca~wheretheAgencydeterminesthat confidentialtreatmentmostbeaccordedpursuanttosection14(b) of TSCA.C. EnforcementProvisions

TheAgencyconsiders failure tocomply with any aspectof a section4rule to be a violation of section15 ofTSCA. Section15(1) of TSCA makesitunlawful foranypersonto fell or’ refuseto complywith any rule or order issuedunder’section4. Section15(3) of TSCAmakesit unlawful for any personto failat refuset0 (1)Establishor maintainrecerds.(2) submit reports, notices; orotherinformation,or (3) permit accesstoor copying01 record,requiredby theAct oranyregulationIssuedonderTSC~

Additionally,’ TSCA section15(4)makesit eelawfulforanyparsonto failor refusetoperi~tentryor Inspectionasrequiredby section11.Section11appliesto any“establishment,facility.or otherpremisesinwhich chemicalsubstancesormixturesaremanufactured,processed.stored.orheldbeforeor aftertheir distributionincommerce., - .~TheAgencyconsidersa testingfacility to be aplacewherethechemicalIs held or storedand.there.fore,subjectto Inspection.Laboratoryandltsflnspectionswill beconductedperiodicallyin accordancewith theproceduresoutlinedin TSCAsection11by designatedrepresentativesof the EPAfor thepurposeofdeterminingcompliancewith the finalrule for chlorinatedbenzenes.Theseinspectionsmaybe conductedforpurpose,which Include,~riflcetionthattestinghasbegun.that ~edudesarebeingmet, that reports accurately reflectthe underlyingraw data andInterpretationsandevaluationsthereof,andthat the stu~ésarebeingconductedaccording to theTSCA GLP standardsand the teststandardsproposedruleofthis rulemaking.

EPA’s authorityto inspectatestingfac~Iyai,oderivesfrom section4(b)(1)of TSCA. which di5-~ctsEPA topromulgatestandardsfor thedevelopmentof test data.

Thesestandardsaredefinedinsection3(12)(B)of TSCA to includethoserequirementsnecessaryto assurethatdatadevelopedundertestingrules

FederalRegister/ Vol. 51, No. 66 / Monday, April 7. 1986 I Rules and Regulations 11733

arereliable and adequate,andsuchother requirementsasare necessarytoprovide suchassurance.The Agencymaintains that laboratory inspectionsare necessaryto providethisassurance.

Violatorsof TSCA are subjecttocriminal and civil liability. Personswhosubmit materially misleadingOr falseinformation in connectionwith therequirement of any provision of thisrulemay be subject to penaltiescalculatedas if theyhad neversubmittedtheirdata. Under the penaltyprovisionofsection16 of TSCA, anypersonwhoviolatessection15 couldbe subjectto acivil penalty of up to $25,000perday foreachviolation with each day ofoperation in violation constitutingaseparateviolation. This provision wouldbe applicable to manufacturersorprocessorswhowill fail to submit aletter of intent or anexemptionrequestand who continue manufacturing orprocessingafter the deadlinesfor suchsubmissions.Internationalviolationscould lead to the imposition of criminalpenaltiesof up to $25,000for eachdayofviolation and imprisonment of up to 1year. In determiningthe amount ofpenalty. EPAwill take into accounttheseriousnessof theviolation and thedegreeof culpabilityof theviolatoraswell as theotherfactorslistedIn section16. Otherremediesareavailable to EPAunder sections7 and 17 of TSCA,suchas seekingan injunction to restrainviolations of TSCA section4.

Individuals aswell ascorporationscouldbe subjectto enforcementactions.Sections15 and 16 of TSCA applyto“any person”whoviolatesvariousprovisions of TSCA.

EPA may. at its discretion,proceedagainstindividualsaswell ascompaniesthemselves.In particular,this includesindividualswhoreportfalseinformationor who causeit to bereported. In addition, the submissionoffalse, fictitious, or fraudulent statementsis a violation under18 U.S.C.1001.V. EconomicAnalysisofFinal Rule

To assessthe potentialeconomicimpactof thisrule,EPAhaspreparedaneconomicanalysis(Ref. 2) thatevaluatesthepotential for significanteconomicimpacts on the industryasaresult of the required testing.Theeconomicanalysisestimatesthecostsofconductingthe required testing andevaluatesthe potential for significantadverseeconomicimpact asa result ofthesetest costsby examiningfourmarket characteristicsof thesechlorinated benzenes:(1)Pricesensitivityof demand,(2) industrycostcharacteristics.(3) industrystructure,and (4) market expectations.If theseindications are negative,nofurther

economicanalysiswill beperformedhowever,If the first level of analysisindicatesa potential for significanteconomicimpact, a more comprehensiveand detailed analysisis conductedwhich morepreciselypredicts themagnitudeand distributionof theexpectedimpact.

Total testing costsfor the final rule forthedichlorobenzenesareestimatedtorangefrom$4,742 to $6,410and for thetrichlorobenzenesare estimatedtorange from$24,437to $32,339.Theannualizedtestcosts(usingacostofcapital of 25 percent overa period of 15years)rangefrom $1,242to $1,860for thedichlorobenzenesand from $6,330to$8,380for the trfchlorobenzenes,Basedonthe 1984estimatedproductionvolumesof 134.3million poundsfordichlorobenzeneaand 17.05millionpounds for trlchlorobenzenes,the unitcostsrange from 0.001to 0.012centsperpoundfor the dichlorobenzenes,and0.04 to 0.05centsperpound (adjusted forupstream testingcosts)for thetrichiorobensenes.Thesecosts,relativeto 1985sellingprices,are0.0025to 0.0033percentfor dichlocobenzenes.For thetrichlorobe~izenes,thesecostsrepresent0.07to 0.08percentof price.

Basedonthesecostsand theusesofthesechlorinatedbenzenes,theeconomicanalysisIndicatesthat thepotential for significantadverseeconomicImpact asa result of this testrule is extremely low. This conclusionisbasedonthe following observations.

1. The annualunit costof the testingrequiredin thisrule is extremely lowand

2. Sincechlorobenzenesare primarilyused asintermediates,thesetest costwill contribute a verysmall part of thetotal costof thefinal products.

Refer to the economicanalysis(Ref. 2)for a completediscussionof test costestimationandthe potential foreconomicimpact resultingfrom thesecosts.VL Availability of TestFadlitiesandPersonnel

Section4(b)(1) of TSCA requiresEPAto consider“the reasonablyforeseeableavailability of the facilities andpersonnelneededto perform thetestingrequiredundertherule.”Therefore, EPAconducted a study to assesstheavailabilityof testfacilitiesandpersonnelto handlethe additionaldemandfor testingservice,createdbysection4 testnile.. Copie.of the study,“Chemical TestingIndustry:Profile ofToxicologicalTesting.”October,1981,canbe obtainedthroughtheNationalTechnicalinformationService.5285PortRoyalRoad.Springfield.Va. 22181(PB82—140773).

On thebasisof this study, theAgencybelievesthat there will be available testfacilities and personnelto performthetestingrequiredin this test rule.VU. PublicRecord -

EPAhasestablisheda recordfor thisrulemaking (docketnumberOPTS-42050A).This recordincludesthe basicinformationthe Agencyconsideredindevelopingthis rule, andappropriateFederalRegisternotices.The Agencywill supplementtherecordwithadditional information asit is received.

This record includes thefollowingInformation:A. SupportingDocumentation

(1) FederalRegisternoticespertainingto this rule consistingoF~

(a)Noticeof chemicalfate andenvironmental effectsfinal rule onchlorinated benzenes.

(b) Noticeof proposedrule onchlorinated benzenes(January 13, 1984,49 FR 1760).

(c) Noticescontaining the ITCdesignationof chlorinatedbenzenestothePriority list. October 12, 1977 (42FR55028) andOctober 30, 1978(43 FR50630).

(d) Noticeof final rule onEPA’sTSCAGoodLaboratoryPracticeStandards(November29,1983,48 FR53922).

(e) Noticeof final rule on test ruledevelopmentandexemptionprocedures(October 10, 1984,49FR39774).

(f) Interim final rule for Test RuleDevelopmentandExemption Procedures(May 17,1985,50FR 20652).

(g) Noticeof final rule concerning datareimbursement (July 11,1983,48FR31786).

(2) Supportdocumentsconsistingof:(a) Chlorinated benzenestechnical

support document for proposedtest rule.(b) Economicimpactanalysisof final

testrule for chlorinatedbenzene..(3) Communicationsconsistingof:(a) Written public comments.(b) Summarie.of telephone

conversations.(c) Meeting summarie,including

transcript of public meetingon proposedtest rule.

(d) Reports—publishedandunpublishedfactual materials, includingcontractors’ reports.B. References

(1)Johnston,P..Hodge.V.. andSlimak, K. Materials Balance-Task *4-Chlorobenzenes.Preparedby J.R.B.Associates,Inc., for Office of PesticidesandToxic Substances,U.S.Environmental Prote tion Agency.Report 560/13—80—001.(December31,1979).

11736 FederalRegister/ Vol. 51, No. 68 / Monday, April 7, 1988 / Rules and Regulations

(2) Mathtech. Inc. Draft ReportLevel IEconomic Evaluation Chlorobenzenes.Preparedf~EconomicsandTechnologyDivision,Office of PesticidesandToxicSubstances,U.S. EnvironmentalProtectionAgency,ContractNa. 68-01—8630. (1983).

(3) Calamari. D., Galasel,S.,Seth,F.,and Vighi, M. “Toxicity of selectedchlorobenzenesto aquatic organisms.”Chemosphere12(2):253-.282.(1983)~

(4) Oliver, B.G., andNiimi, A.“Bioconcentration of chlorobenzenesfrom water by rainbow troutCorrelations with partition coefficientsand environmental residues.”EnvironmentalScienceThchnology17(5):287—291. (1983).

(5) Ware, S.A., and West,W.L.“Investigation of selectedpotentialenvironmentalcontaminants:halogenatedbenzenes.”Report 560/2—77-004.U.S.Environmental ProtectionAgency, Office of Toxic Substances.(1977).

(6) Cleary, Gottlieb. SteenandHamilton. CommentsFiled by theChlorobenzeneProducersAssociationInResponseto the Mono-, Di-,Trichiorinated BenzenesProposedEnvironmental EffectsTest Rule(January13, 1984).(March 13, 1984).

(7) USEPA. Memorandum from DavePrice to the file. ChlorobenzeneProducersAssociationcommentsonproduction and usageof chlorinatedbenzenes.(December12, 1985).

(8) Hull and Company. “Employeeexposureto chlorobenzeneproducts.”(February. 1980).

(9) Hull and Company. “Investigationof National Hazard Survey (NOHS)survey proceduresasthey affectexployeeexposurereported for mono-and di-chlorobenzene.”(April 14. 1980).

(10) USEPA. “Assessmentofenvironmentaltestingneeds:Mono-, di-,tn-, tetra.andpenta-chlorinatedbenzenes.”TechnicalSupportDocument. (January 13, 1984).

(11) Coniglio,WA. Miller, K. andMacKeever, D. “The occurrenceofvolatile organicsin drinkingwater.”Briefing Document.CriteriaandStandardsDivision. USEPA.Washington, DC. (1980).

(12) USEPA.1981 Buffalo, NewYorkAreaSedimentsSurvey.EPA905/3-84—001. (April 1984).

(3) Monsanto. Atmosphericphotochemistry of monochlorobenzene:Reactionwith hydroxyl radical.” ReportES-80-SS-40.(SubmittedJanuary19,1983).

(14) Chion, C.T., Peter,.LJ, andFreed,V.H. “A physical conceptof soilwater equilibria for nonionic organiccompounds.”Science206:331—332.(1979).

(15) Gilford, I. Memoranda from J.Gilford (HERD) to D. Delarco (ECAD/TRDB). (1983).

(16) Wahner, A. and Zetzsch, C. “Rateconstants for the addition of OH toaromatics and the unimoleculardecayofthe adduct.” Kinetics into aQuasi-Equilibrium.Journal ofPhysicalChemistry87: 4945—4951.(1983).

(17) Atkinson. R. “Kinetics andmechanismsof gasphasereactionsofthe hydroxy! radical with organiccompoundsunder atmosphericconditions.”StatewideAir PollutionResearchCenter,University of.California, Riverside.(May 19. 1985.)

ConfidentialBusinessInformation(CBI), while part of the record, is notavailable for public review. A publicversion of the record,from which CBIhasbeen deleted.is available forinspectionfrom 8 a.m.to 4 p.m., MondaythroughFriday, exceptlegal holidays, inRm. E—107,401 M St..SW., Washington.DC.

VIII. Other Regulatory RequirementsA. ClassificationofRule

Under ExecutiveOrder12291,EPAmust judge whethera regulation is“major” and, therefore,subject to therequirement of a Regulatory ImpactAnalysis.The regulation for thesechemicalsubstancesis not majorbecauseit doesnot meetanyof thecriteria setforth In section1(b) of theorder. First,the annualcostsof testingare expectedto range from $26,000to$54,000over the expectedmarket life ofthesechlorinated benzenes(Ref. 2).Second,becausethecostof the requiredtesting will be distributedover a largeproduction volume, the rule will haveonly veryminoreffectson producers’costsor users’prices for thesechemicalsubstances.Finally, taking into accountthe natureof the market for thesesubstances,the low level of costsinvolved, and the expectednature of themechanismsfor sharing the costsof therequiredtesting.EPA concludesthatthere will be nosignificant adverse

‘economic impact of any typeas a resultof this rule.

This regulationwas submitted to theOffice of Managementand Budget(0MB) for reviewasrequiredbyExecutiveOrder 12291.Any writtencommentsfrom 0MB to EPA. and anyEPAresponseto thosecomments,areincluded in thepublic record.

B. RegulatoryFlexibility ActUnder theRegulatory Flexibility Act.

(15 U.S.C.601 et seq..Pub.L 96-354,September19, 1980),EPAcertifies thatthis testrule will not have a significant

impact on a substantial number of smallbusinessesfor the following reasons:

1. Thereareno small manufacturersofchlorinated beuzenes.

2. Small processorsarenot expectedto perform testing themselves,or toparticipate in the organization of thetestingeffort.

3. Small processorswill experienceonly minor costsif any in securingexemption from testingrequirements.

4. Small processorsare unlikely to beaffectedby reimbursementrequirements.

EPAconcludesthat there will be nosignificantadverseeconomicimpact ofany type as a result of this rule.C. PaperworkReductionAct

The informationcollectionrequirements contained in this rule havebeen approvedby the Office ofManagement and Budget (0MB) underthe provisionsof thePaperworkReductionAct of 1980,44U.S.C.3501etseq..andhave beenassigned0MBconfrol number 2070-0033.Submitcommentson theserequirements to theOffice of Information and RegulatoryAffairs: 0MB: 728 JacksonPlace. NW.;Washington. DC 20503marked“Attention: DeskOfficer for EPA.” Thefinal rulewill respondto any 0MB orpublic commentson the informationcollection requirements.List of SubjectsIn 40 CFRPart799

Testing. Environmental protection.Hazardoussubstances.Chemicals.Recordkeepingand reportingrequirements.

Dated:March27. 1966.J.A. Moore,AssistantAdministrotorforPesticidesandToxicSubstances.

PART 799—4AUENDED)

Therefore. 40 CFRPart 799 isamendedas follows:

1. The authority citation for Part 799continuesto read as follows:

Authority: 15 U.S.C.2603. 2611.2625.

2. By adding ~799.1052to readas

follows:* 799.1052 Olchlorob.nzsn.s.

(a) Identification of testsubstances.(1) 1,2..and1,4-dichlorobenzenes.CASNumbers95-50-1and 106—46—7respectively,shall be testedinaccordancewith this section.

(2)The substancesidentified inparagraph (a)(1) of this section shall be99percent pure and shall be usedas thetest substancesin eachof the testsspecified.

FederalRegisterI Vol. 51, No. 66 / Monday, April 7, 1986 / Rules and Regulations 11737

(b) Persoasrequiredto submit studyplans,conduct teS~,andsubmitdoUr.(1)All personswhomanufactoseorrocesssubstancesidenti~dInaragraph (a)(1) of thiss.etion,othsr

thari asan impurity, fromMay21,1986,to theendof the reimbursementpmiod.shall submit lettersof Intent to testorexemptionapplicationsandshallconduct tests,in accordancewith Part792 of thisChapter,andsubmit data asspecifiedin this section,SubpartA ofthis Part and Part 790 of this Chapter fortwo.phaserulemaking.

(2) Personssubject to thissectionarenot subjectto therequirementsof§ 790.30(a)(2),(5). (6)and(b) and* 790.87(a)(1)(ii)of thisChapter.

(3) Personswhonotify EPAof theirintent to conduct testsin compliancewith therequirementsof thissectionmust submit plans for thosetestsnolater than 30 days before the initiation ofeachof thosetests.

(4) In addition to the requirementsof§ 790.87(a)(2) and (3) of ~ ~EPA will conditionally approveexemptionapplications for this rule ifEPAhasreceiveda letter of intent toconduct thetestingfrom whichexemptionissoughtandEPAhasadoptedtestsstandardsandschedulesin a final PhaseII testrule.

(c) Chemicalfate testing.1,2,-and 1,4-dichlorobenzeneshall eachbe testedfor

~micalfate in accordancewith this:tion.

(1) Soiladsorptioncoefficienttest—(f)Requiredtesting.Testing,usingasystemthatcontrols for evaporation ofthe testsubstance,shall be conductedfor 1,2-and 1,4-dichloroben.zenetodevelopdata on the absorption of theabovechlorobenzenesto sediments.

(ii) [Reserved)(2) [Reserved)3. By adding § 799.1053to readas

follows:

§ 799.1053 ThcNorob.nz.n.s.(a) Identification of testingsubstance.

(1) 1.2,3-and 1,2,4-trichlorobenzenes,CAS Numbers87-81-6and1~-82-1respectively,shall be testedinaccordancewith this section.

(2) The substancesidentifiedInparagraph(a)(1) of thissectionshailbe99 percentpureandshallbeusedasthetestsubstancesineachof thetestsspecified.

(b) Personsrequiredtosubmitstudyplans,conducttests,andsubmitdata.(1) All personswhO manufactureorprocesssubstancesidentified Inparagraph (a)(1) of thissection.otherthan an Impurity, from May 21.1986tothe end of the reimbursement period.shallsubmitaletterof intent totestor

mption applicationsandshall

conducttests,In accordancewithPart792of thisChapter,andsubmitdataasspecifiedin thissection.SubpartA ofthisPartandpart790 of this Chapterfortwo-phaserulemaking.

(2)Personssubjectto thissectionarenot subject to the requirementsof* 790.30(a)(2),(5), (6)and(b) and§ 790.87(a)(1)(ii)of this Chapter.

(3)Personswho notify EPAof theirIntent to conducttestsin compliancewith the requirementsof this sectionmust submit plan. for thosetestsnolater than 30daysbeforethe initiation ofeachof thosetests.

(4)In additionto therequirementsof* 790.87(a)(2)and(3) of thischapter,EPAwill conditionallyapproveexemptionapplicationsfor thisrule IfEPAhasreceivedaletterof intent toconductthetestingfrom whichexemptionis soughtandEPAhasadoptedteststandardsandschedulesina final PhaseII test rule.

(c) Chemicalfate testing.1.2.4-trichlorobenzeneshallbe testedforchemicalfatein accordancewith thissection.

(1) Soil absorptioncoefficienttest—(i)Requiredtesting.Testing,usingasystemthat controlsfor evaporationofthe test substance.shall beconductedfor 1,2.4-trichlorob.nzeneto developdataon theabsorption of theabovechlorobenzensto sediments.

(ii) [Reserved)(2) [Reserved)(d) Environmentaleffectstesting.

1,2,3-and i,2,4-frlchlorobenzenesshallbe testedin accordancewith thissection.

(1)Marineinvertebrateacutetoxicitytesting—fl)—-Requiredtesting.Testingusingmeasuredconcentrations,flowthrough or static renewalsystems,andsystemsthat control for evaporationofthetestsubstance,shall be conductedfor 1.2.3-and1,2,4-trlchlorobenzenes.Testingshall be conductedwith mysldshrimp(Mysidopisbob/a)to developdataonthe acutetoxicity of theabovechlorobenzeneisomersto marineInvertebrates.

(ii) (Reserved](2) Marinefish acutetoxicity

testing—(1)Requiredtesting.Testingusingmeasuredconcentrations,flowthroughsystem.,andsystemsthatcontrol for evaporationof the testsubstanceshall beconductedfor 1,2.3-trichlorobenzene.Testingshall beconductedwith Silversides(Menidiamenidia) to developdataon the acutetoxicity of 1,2,3-trichlorobenzenetosaltwater fish.

(Ii) [Reserved](3) Freshwaterfish acutetax/cRy

testing—fl)Requiredtesting.Testingusingmeasuredconcentrations,flow

through systems.and systemsthatcontrolevaporationof thetestsabstanceshall be conducted(ui 1,2,3-trichlorobenzene.A 96-how’LC5O testshall beconductedwith thefatheadminnow (Pimepholespromelos)todevelopdata on the acutetoxicity ofi,2,3-trichlorobenzeneto freshwaterfish.

(ii) [Reserved](4)Freshwaterin vertebrateacute

toxicitytesting—(i)Requiredtesting.Testing usingmeasuredconcentrations,flow throughor static renewalsystems.and systemsthat control for evaporationof the testsubstanceshall be conductedfor 1,2,3-trfchlorobenzene.A 96-hourECSOshall be conductedforonespeciesof Grammorusto developdata on theacutetoxicity of 1.2,3-trichlorobenzeneto aquatic freshwater invertebrates.

(Ii) [Reserved](5)Mysidshrimpchronictoxicity

testing.—(i)Requiredtesting.Testingusing measuredconcentrations,flowthrough or static renewal systems,andsystemsthatcontrol for evaporationofthe testsubstance’shall beconductedfor 1,2,4-frichlorobenzene.Testingshallbe conductedwith mysidshrimp(Mysidopsisbohia) to developdataonthechronictoxicity of 1.2,4-tiichlorobenzene,shouldthe acuteLC5Oof thischemicalto mysid shrimp bedetermined to be lessthan I ppm.

(ii) (Reserved)(Informationcollectionrequirementshavebeenapproved by the Officeof Managementand6udgetundercontrolnumber2070-0033)(FRDec.se-7475Filed4-4-O~&45 amjUWNO COOSN~O