FederalRegister/ Vol. 51. No. 81 / Monday, April 28, 1~86I Rules and Regulations 15771

40 CFR Part 799

(OPTS—420338; FRL-2983-4J

Cresois; Testing Requirements

AGENCY: EnvironmentalPr~actionAgency(EPA).AC’IiON: Final rule.

SUMMARY: The EPA is issuisga finalrule establishingtestingre~airement~undersection4(a) of theTaxicSubstancesControl Act (T~A)formanufacturersandprocessarsofcresols.Cresolsis a chemi~lcategoryconsistingof threecresoli~ners:ortho-cresol(CAS No. 95—4&—7), zz~ta-cresol(CAS No. 108—39—4),andpar~-cresol(CAS No. 106-44—5).The te~ingrequirementsinclude (1) m~genic

effectsstudies(including testsforchrorno8omaiaberrations,genemutations,andcellulartransformations)on specifiedcresolisomers,(2) adevelopmentaltoxicity 8tudy(teratogenicity)with eachcresolisomer,and(3) a two-generationreproductiveeffectsstudy with eachcresolisomer.

OAT~S:In accordancewith 40 CFR 23.5(50 FR 7271:February21, 1985J.this ruleshall be promulgatedfor purposesofjudicial review at 1 p.m. easternl”daylight” or ‘standard”asappropriate)time on May 12. 1986.Thisrule shall becomeeffective on June11,1986.FOR FURThER INFORMATION CONTACT:EdwardA. Klein, Director, TSCAAssistanceOffice (TS.—799). Office ofToxic Substances,Rm. E—543. 401 M St..SW.. Washington.DC 20460.Toll Free:(800—424—9065),In Washington.DC:(554—1404),OutsidetheUSA: (Operator—202—554—1404).

SUPPLEMENTARY INFORMATION In theFederalRegisterof July 11. 1983 (48 FR31812).EPA issueda proposedruleforcresolsundersection4(a)of TSCA torequiretesting of cresolsfor subchronictoxicity, mutagenicity,carcinogenimty,developmentaltoxicity (teratogenicity),reproductiveeffects.neurotoxicity,andskin sensitization.Public commentsonthe proposedrulehavebeenreceivedandreviewed.EPA is now promulgatinga final testrule requiringthatmanufacturersandprocessorsof cresolstest thesechemicalsfor mutageniceffects,developmentaltoxicity. andreproductiveeffects.In addition,~nitsInitial Report (42 FR 55026: October12.1977), theInteragencyTestingCommitteerecommendedthat thecresolsbe testednot only for healtheffects,but alsofor environmentaleffects.However.EPA hasdecidednotto requireenvironmentaleffectstestingbecauseavailableinformationallows

15772 Fed’era~Register / Vol. 51, No. 81 / Monday, April 28. i~aeI Rules and Regulations

EPA to reasonablypr~ictthatexposureof aquaticorganismsIa cresola8houldnot causechroniceff~ts.Further,EPAis finalizing only ap ItioL2 of the testingwhichwasinitially ~znposed.Basedonthe resultsof studie.aennductedinaccordancewith thiszule.a secondrulerequiringchronictesthigof the cresolsmay be issuedlater.

I. Introduction

This documentis p~tof the overallimplementationof s~tion4 of theToxicSubstancesControlAct (TSCA, Pub. L.94—469. 90 Stat. 2003 ~seq. (15 U.S.C.2601et seq.));whi~çhcohtainsauthorityfor EPA to require developmentof dataon assessingthe risks to health and theenvironmentposed~ exposw~etoparticularchemical*bstancesormixtures.

Undersection4(a)l1)of TSCA. EPAmustrequiretesting~ a chemãcalsubstanceor mixtumetodevelophealthor environmentalda~if theAdministratorfinds tkat:

(A)(i) themanufactut~distributionincommerce.processing.~e. or disposalof achemical substanceormxture, or that anycombination of such act~rities.may presentan unreasonablerisk ofin~uryto health or theenvironment.

(ii) there arein ffid~mtdata andexperienceupon which theeffectsof suchmanufacture. distribut~sin comm~ce.processing.use, or disp~alof suchsubstanceor mixture or of any c~binationof suchactivities on health or t~environnientcanreasonablybe determi~dor predicted. and

(iii) testing of suchsthstanceor mixturewith respectto suche~ctsis necessarytodevelopsuchdata:or -

(B)(i) a chemical sut~anceor mixture is orwill beproduced in su~tantiaIquantities,and (I) it entersor mayreasonablybeanticipated to entertheenvironmentinsubstantialquantities or(U) there is or maybe significantot stmbsta~tiaihun’iaaexposureto suchsube~ancsorT~twe.

(ii) thereare ix~uffi~tdataandexperien~upen whicA theeffec~of themanufacture.distribi~in commerce.processing,use,or disp~salof suchsubstancaor mixture or of any conbination of suchactivities on healthor~renvironmentcanreasonablybe de~eri~t~orpreclicted.and

(iii) testingof su~~staj,ceor mixturewith respect to imi~~t.is O~tSI5tY 10

developsuchdeta.

EPA usesawei~M-of-eviclenceapproach is makiiigase~tion4(a)(l)(A$i) 5ndmn~is whichbothexposure andU~xici~mformationareconsideredto snakethefinding that thechemicalmaypres~anunreasonab’erisk. For the iirxling*nder sectois4(a)(1)(Blli}. EPA c~sidersosily

- product~n..xpowr. andreleaseinformatianto ~temine whetherthereis ormayb. sot.~(a~za1release.For thesecondfindi~nnd~both sectiois

4{a)(1) (A) and(B). EPA examinestoxicity andfatestudiesto determinewhetherexistinginformation isadequateto reasonablydetermineorpredictthe effectsof humanexposureto,orenvirunmentalreleaseof. thechemical. In making the third finding.that testing is necessary.EPA considerswhetherany ongoing testing will satisfythe informationneedsfor the chemicalandwhethertesting that the Agencymight requirewould be capableofdevelopingthenecessaryinformation.

For a morecompleteunderstandingofthestatutorysection4 findings, seeEPA’s proposalson chloro4nethaneandchlorinatedbenzenes(45 FR 48510~July18. 1980)anddichloro.methane.nitrobenzene.and1,i.i-trichloroethane(48 FR 30300;June5. 1981).

H. Background

A. Profile

Cresols(CH3C4H4OI-fl is achemicalcategoryof threeisomers:crtho-cresol(CAS No. 95—48—7).meta-cresoi.(CASNo. 108-39—4),andpara-cresol(CAS No.106—44—5).The cresolsareavailablecomrmmercial.lyasindivi.d4~a4~so~tersandasisomermixtures.Theyarealsocontainedin cresylicacid,amixture ofcreselsendotherphenoliccorrrpoimds.U.S. productionof cresolsandcre.sylicacid,or “creeyl~ct”in 1984wasabont117.5 miflion pounds.Of this amount.40.7 million poundswasortho-cresol,and78.8 million wasall othercresols(Ref. 1). Importsof ottho-.mesa-,para-,(meto.przrrjj-cresolmixtures,andcresylicacidwere 14.9million poundsin1984 (Ref. 2). Therefore,thetotalproductionandimports of cresolsandcresylicacid in 1984 wasabout132.4millon powids.

Cresolsareusedaswire enamelsolvents.a~stonsotivecleaners,andorganicin~emiediatesin manufacturingphenolicresinsandphosphateesters.A&iitioaaI usesof eitherindiviâua~isomersor mkxturesareasfollows: in

‘~theproductionof severalherbicidesanddisinfectants;ascleaningcompounds.degreasera.andantioxidants.andin oreflotation.Thelevel I EconomicImpactAnalysis.whrchaccompaniedtheproposedcresolsrule, containsadetaileddescriptionof usesandmanufacturingprocesses.

B. fTCRecommendationsThehdera~encyTestingCommittee

(ITC) designatedcresolsfor priorityconsi~r*tioc.in its Initial Report,publiskedle theF.dealRegistieonOcto~r12. 1977 (42FR 55O~).TheITCrecommand~lthattheAgencyreq~xireinduatryto testcresolsfor thefollowinghealtheffects:carcinogenicity.

mutagenicity,teratogenicity.~nd otherchroniceffects.The ITC alsorecommendedtesting for environmentaleffects,specificallychroniceffectsinfish andother aquaticorganisms.

TheITC’s recommendationswerebasedon thelargevolumeof cresolsproducedin theUnited States.It wasestimatedin the lTCs report that theU.S. productionof cresolsin 1975 wasabout90 million pounds.The ITCreportedanestimatedannualenvironmentalreleaseof approximately45 million pounds.In addition.the ITCwasconcernedthat the wide useofcresolsas industrialsolventscouldleadto substantialoccupationalexposureThe ITC cited theNational Institute forOccupationalSafetyandHealths(NIOSH) estimatesthat roughly 2 millionworkersareexposedto cresols.The ITCalsowasconcernedthat cresolsareusedin manyconsumerproductsandthat theseusescouldresult in a largeconsumerandgeneralpopulationexposure.

C. Propos~dRule

EPA issueda proposedrule, publishedin theFederalRegisterof July11, 1983(48 FR 31812),whichwould requirethatcresoisbe testedfor subchronictoxicity.mutageniceffectsincludingchromosomalaberrations.genemutations,andceUnlar transformations.carcinogenicity,developmentaltoxicity,reproductiveeffects,neurotoxicity.andskin sensitization.

EPA baredits proposedtestingrequirementson the authorityof section4(a)(IHB} of TSCA. The Agencyfoundthat eachof the threecresolisomersismanufactured.processed,andusedinsubstantialquantities.andthat theseusesmayresultin substantialhumanexposure.Furthermore.EPA found thatbetween600,000and1.2 million peopleareexpo8edto cresolseachyearviamanufacturing,processing,and/oruseactivities.Finally. EPA foundthat therewasa lackof datafrom which toreasonablydetermineor predict thevariouseffectsfor which testin’g wasproposedandthat testing wasnecessaryto developsuchdata.

In addition.EPA foundthat thereisevidenceof potentialadversehumanhealthrisks for muta’genicandcarcisogeniceffectsresultingfrom themanufacture,processing,anduseactivitiesassociatedwith cresols.However,theexistingdatawhichsupportthis beliefof potentialrisk fortheseeffectswerefound to beinadequateto reasonablypredictordeterminetheef!ectsof theseexposuresto cresols.Therefore,in its proposedruleEPA determinedthatthe testing of

Feder~Re~ster/ Vol. 51. No. 81 / Monday. April 28. 1986 / Rules and Regulations 15773

cresolsfor mutageni~yandcarcinogenicitycana~obe baseduponsection4(aJ(1)(A)of 1~,CA_EPA alsofound that it is n sury to developsuchdata.

In theproposedrule. EPA alsopresentedits reasonsfor not proposIngtesting for environrnestaleffects.Whilethe releaseof cresolsto theenvironmentis high. theAgency h~determined thatadequateinformationexist.swhichallows EPA to reasor~b1ypredictthatexposureto cresolss~iuldnot causeadversechroniceffer~to aquaticspecies.The Agencynade a preliminaryjudgmentthat no add~ionalenvironmentaleffectstesting is neededat this time andrequ&edpubliccommentsfrom inter~tedpartiesonthis decision.

D. StudiesReceived~ IntitiatedAflerProposedRule

The proposedcres~istestrulespecifiedthat in eta-~d pora-cresolbetestedin the sister c~aomatldexchange(SCE)assayto determnethepotentialfor genemutations.T~tirigof theortho-cresolisomerwasnotrequired becauseof theavailability of at adequatelyconductedSCEassayon that isomer.Hbwever. following ~b1ication of theproposedtestrule, theCiemicalIndustryInstituteof Toxicologyconductedexperime~sto determinethegenotoxicpotentialofortho-,meto-,andpara-cresol,both in vitro andin vivo,usingthe SCEassay~ a measureofgenotoxicity (Ref. 3).

The Agencyhasrenewedthis studyandhas foundii adeq.rateto meettheneedsof theAgency±,rthis proposedtesting requirement(Jef.4). Therefore,the proposedre~uirenentfor meta’-andpara-cresolto be tes~din anSCEassayis not included‘m thisfieal testruleforcresols.

In addition,a maf~rdevelopmentinanother EPA programhas alteredthemakeupof thefinal cresulstest rule.

The ResourceCons,Tvath,nandRecoveryAct (RCRA.asamendedbytheHazardousandSelidWaiteAmendmentsof 1984~WA). reqniresthat appropriatetrea~Wintstandardsmust bemetprior to ~sd d~posalofhazardouswastescoltaini g citedchemicalsubstancell1ef. 5).

The effectof the1~4amendmentsisto establisha statutcaypresumptionagainstland disposalofhazardouswastes.The amendmritsfurtherprovidethat statutorybans on landdisposalwill go into ~fect on specificdatesunlessEPA det~mineson acase•by-casebasisthat laaidisposalisprotective of human ~alth and the

-~environtnentor. priorto land disposal.wasteshave been trestedto a level or

by a methodsuchthat threatsto I’aszrianhealthor theenvironmentareminimized.

In orderto makesuchadetermination.EPA is developingtreatmentstandards for wa.stEs,basedon technologylevelsand screeninglevelsfor chemicalconstituentsofwastes.Wasteswill be prohibitedfromlanddisposal.unlessthe appropriatetreetmentstandardshavebeenobserved.To develop thesescreeninglevels.EPA requiresinformation on thetoxicologicaleffectsand theenvironmentalfatea! thechemic~isubstancescontainedin wastessubjectto regulationunderRCRA.

The chemrcalsinvolved have beenplaced on a prioritizedscheduleforconsideration andanalysisof theavailable data on eachchemicaLFor themajority of substancessub3ectto theHSWA. EPA foundsufFicientdataonwhich to basestandards.However,forsomesubstaxx~eseither insufficientinformation is availobèeto establ~hthesescreeninglevels, or~while theremay besufficient information toestablishsuch standards,confirmatoryor supportinginformation is neededtoverify anyassumptionstheAgencymayhavemadein developingthesestandards.

Cresolsareconstituentsof wastesbrwhich treatmentstandardsmustbe setby November8.1986.Following areview by the Agency,it wasdeterminedthatmsnf5cientreliab4einformationwasavailablefor cresols.Asa resulteitherEPA mustobtainusabledatain orderto setanappropriatetoxicity referencedose(RID), or certainwastscontainingcresolswould bebannedas ofNovember8. 1986 from all landdisposaL

The subchrorxictoxicity studiesincludedin EPA’s proposedtest rule forcresolswould prrwicle the initial dataneededto establishRIDsfor the cresols.However, the Agencyconcludedthatthis rulemakingto requirethis testing(whichhasbeenproposedunderthe

‘lormer two-phasetestrule process)couldnot becompletedin time to obtaindatawithin thescheduleimposedby theHSWA. Therefore.EPA hasinitiatedsubchronictoxicity studiesfor eachofthe threecresolisomersand01’S willnot include suchtestingin thefinalcresolstestrule.

The proposedcresolstest alsoincludedrequirementsthat neurotcixicitytestsbe performedin con)arsctionwiththe subchronicstudies.Theneurotoxicitytestingalso will beconducted by EPA becauseof theefficiencyof perforrmrigsuchtestsjointly with thesubchronicstudies.Therefore. EPA will conduct

neuropathologystudieson theindividual cresolisomersand anexpandedclinical observationof the testanimalsduringthe 90-daysubchronicstudy.

in summary. the following tests in theproposedtestnile for cresoishave eitherbeen adequately peformedor are in theprocessof beingperformed,andtheymeet theneedsof the Agency for thesetesting requirementsandarenotincluded in the final test rule for cresoh:sisterchromatidexchangeassaysonmeta-andpara-cresol:90-daysubchronictoxicity studieson ortho-,ineta-, andparo-cresol:andneoropathologyon ortho.. metoa-,andpara-cresoI.

Finally, theNationalToxicologyProgram(NT?)is consideringcertainhealtheffectstestingof cresols.NTP isplanning to conduct range-findingandsubchronicstudiesandmayinitiatebioassayson oneor morecresolisomers.

III. Responseto Public Comixuents

The commentsreceivedby theAgency in responseto the proposed rulefor cresolswere from theCresolsTaskForce(CITJ, NaturalResourcesDefenseCouncil (NRDC~.ChemicalManufacturer~Association(CMA),Sherwin-Williams,Merichesn,Ciba-Geigy,and the American IndustrialHealth Council (All-IC). The commentsfrom the organizations mentionedabovewere receivedin October 1983. Sincethattime somea! the affiliations of thecommentershavechanged.In May 1984.the CMA establisheda CresolsProgramPanelto addressEPA’s Section4activities on cresols.The Panelconsist-sof the majorU.S. manufacturers andimporters of cresolsand is arefashioningof the CTF. In addition.Sherwin-Williamssold its paro-cresolproductionfacility to PMC SpecialtiesGroup.a subsidiaryof PMC of SunValley, California (Ref. 6). For thisdocumentthe commenterswill continueto be referredto as the CMA, CTF. andSherwin-Williams.

The most extensivecommentsreceivedwere thoseof the CTF. Ingeneral.theCTF’s commentsencompassmostof theothersignificantcommentsreceivedfrom other interestedparties.Becausethe CTF submissionincludesthe samesubject areascoveredby othercornmenters.EPA will direct themajority of its responsesto theCTFsubmission.

The Agencydid not receiveanycommentswhich in the Agency’sjudgment rebutted thesubstantialproductionandsubstantial humanfindings for cresols.The major issues

15774 Federal Register I Vol. 51. No. 81 / Monday, April_28. ‘~1986I Rules and Regulations

identified during thecommentperiod

arediscussedbelow.

A. Commentson ExposureIssues -

1. Substantialprrx’uction. Severalofthecommentersstaredthat thecresoisindustry hasseenadeclineinmanufacturingandsales,andthat it is amaturechemicalindustry.However.noneof thecommentersvolunteeredanyrevisedproductionestimates.

In theproposedtest ruleEPAestimatedthat theannualU.S.productionvolumewas169millionpounds.with another17 million poundsimportedinto the United Stateseachyear.ThemostcurrentEPA estimateisthat in 1984 the productionandimportsof cresolsandcres~iicacidtotalledapproximately132.4 million pounds(Ref.6). TheAgencybelievesthat regardlessof whetherthe total annualproductionandimportationofcresolsis 132.4 or 186million pounds,theseestimatesstillsupportafinding undersection -

4(a)(1)(B)of substantialproduction.2. Substantialhumanexposure.The

CTF. Sherwin-Williams,andMerichemcommentedthat theAgencydoesnothaveabasisfor thefinding ofsubstantialhumanexposure.Theycontendthat EPA hasoverestimatedthenumberof peoplewho areexposedtocresolsin the workplaceandthat EPAdid not considertI~following: whetheror not theexposuietocresolsissignificant.the loc~history of cresolmanufactureandmewithout anyreportsof chronictoxicity, the fact thatcresolsoccurnaturallyin the humanbody, andthat crenlsdo not occurinanyconsumerproduct.- EPA estimatedlathe proposedrulethat between687.~E0and1.2 millionpeoplearepotenthily exposedtocresols.Humanexposureto cresolsmayoccur in facilities which manufactureandprocesscreso~andfrom theuseofproducts which cc~utaincresols.Theseexposureestimatesmadeby EPA areintendedto representtheupper(1.2million people)andlower (687.000people)bound esthnatesof the totalnumberof personsexposedto cresols.The lower bound estimatewasestablishedusingdataprovidedby theCTF and Conoco.The upper boundestimatewasbasaion datafrom theNational Occupat~,nalHazard Survey(NOHS) conductnd in 1972—74.

The CTF comn’anted that EPA’sexposureestimatesare inflated. TheCTF presenteda revisedestimateof126,000peopleexposed.The Task Forceconductedan analysis of the NOHSexposureestimateand concluded that

_theNOHS datas~iportan upper-boundactual exposureci 126,000peopleor 10

--percentof the N~ISestimate(Ref. 7).

TheCTF alsoconcludedthat the NIOSHsurveywasinaccurateandbasedonproductionanduseinformation whichwasout of date.

The CTF commentedthat EPA’sestimatethat627.000peopleareexposedto cresolsfrom theuseof cresolsincleaningcompoundsis also too high. Asa result of this belief, the CTFcommissionedanoccupationalsurveyon this usewhich, accordingto the CTF,showsthat exposuresfrom this use areverylow. The surveywasconductedforthe CTF by the JohnsHopkinsUniversitySchoolof HygieneandPublicHealth. The JohnsHopkins report.onthe basisof a surveyof theBaltimore,Maryland. areaestimatesthatnationwidethereareapproximately148.000mechanicsexposedto cresol-containingcleaningcompounds(Ref. 7).

The CTF alsoconductedananalysisof theNOHSestimatesbasedon -

printouts of the underlyingdataobtainedfrom NIOSH. According to theCTF’s analysis of the data, the NOHSestimatesof 1.2 million peopleexposedto cresolsis overstatedby a factorof atleast 10. The Task Force analysisconcentratedon- the 14 percentof theNOHSestimatederivedfrom 33,063actualandtradenameobservations.TheCTF criticized the accuracyof theNOHS numbers. It statedthat a portionof theNOHS figureswasbasedonproductsthatmay or may not containcresolsandsomein which cresolsarenot used.As a resultof its review of theNOHSsurvey,CTR concludedthat theupper-boundlimit of actualexposureis126.000people.

In addition.theoccupationalsurveyconductedby JohnsHopkins for theCTFonly evaluatesoneusergroup, i.e..automobile mechanicsexposedtocresol-containingcleaningcompounds.In this survey,theestimatesof workersexposedwas148.000.This estimateforonly oneuser group is higher than theC’I’F’s estimatefor the total exposurebasedon CiT’s analysis of the 1972—1974NOHS survey.It is reasonabletoassumethat if 148.00workers areestimatedto be exposedduring oneusepractice. then a much larger number ofpeople would be exposedif all of theother usesfor cresolswere consideredcollectively.

Furthermore,the industrycommentspointed out that cresolsare not found inany end-useconsumerproducts. butonly in industrial products. EPA isawareof this; however,the usesin theautomobile industry and wire enamelmarket and the use of cresolsinatrippers. cleaners,and degreasesaresuchthat substantial numbers of peopleare potentially exposedat theworkplace. --

In 1978.ConocoChemicalsCo.estimatedthe numberof workerspotentially exposedto cresolsin truckandautomobilecleaningcompounds(Ref. 8). Basedon upperboundestimatesof 1978marketpenetrationof cresols-basedcleaners.Conocoestimatedthat627.000mechanicsmay be exposedtocresolsin theseproducts.Thisuseinvolves usingcresol-basedcleaningcompoundsin a tank-dippingprocessusedto cleanlargeitems.usuallyautomobilecarburetors.While this useis still verysubstantialandresultsinhigh occupationalexposure.thecresolsindustry emphasizesthatnewtechniqueshavebeendevelopedwhichhaveminimized the exposureduring thisparticularusepractice.A new dippingproductcalledan immersioncleaner,manufacturedby SafetyKleen Corp..now usedin garagesis essentiallyenclosedandresultsin limitedexposure.This methodcontractswiththe opentank dipping usedin thepast.The industrycontendsthatthis newprocesshasroughlyhalf of themarketfor cresol-ba~edcleaningcompounds.

However,evenif Conoco’s1978estimatewere halved, the resultingexposureestimateswould still be over300,000peoplepotentially exposedduringthis usepractice.

In conclusion.EPA agreeswith theindustry commentson the cresolsproposedrule that theestimateof600,000to 1.2 million peopleexposedisoverstated.However, if EPA acceptstheindustry-generatedestimateof 126,000peopleexposedduring manufacturingandprocessingandthe estimateof300.000people.whichis halfof Conoco’soriginal1978 estimate.approximately126.000to 300,000individuals exposedtocresolsin theworkplaceresults.TheAgencybelievesthat this estimatestillsatisfatorily meetstheexposurecriteria neededto permit it to makeasection4(a)(1)(B) finding. i.e.. thechemicalis producedin substantialquantitieswhichmayresult insubstantialhumanexposure.

3. Inadvertantexposure.The CTFcommentedthatcresolsare foundin thehumanintestincas a naturalproductofthe metabolismof tyrosine.which is oneof the amino acidspresentin the body sprotein. It furthercontendsthat cresolsareubiquitousin the naturalenvironmentandthat industrial releasesof cresolsareminor when comparedtothe estimatedannual volume releasedby natural sources.The Task Forcesuggeststhat thesefactors underminethe validity of an exposure-basedfinding under TSCA section4(a)(1)(B).

However, it is only para-cresol whichnaturally_occurs in the human body. The

Federal Register/ Vol. 51. No. 81 / Monday, April 28, 1988 I Ru,les and Regulations 15775

CTF alsohasignoredthe relationshipbetweencumulativemultimediaexposureandthre~io1dtoxicity levels.Total exposure.intake acidsubsequentuptakeof a chemicalmustbeconsideredfrom all sources.Total additiveuptakemustbe analyzedin termsof dose/responserelationshipsandthresholdtoxic levelsfor chronicandacutetoxiceffects.Naturaloccurrencedoesnotnegatetheeffect of higheranthropogenicor cumulativeexposureseliciting toxicresponses.Therefore.a risk assessmentor an assessmentfor further testing mustconsidercumulativemultimediaexposure.TheAgencybelievesthat anyadditionalexposureto crerolsmaybecausefor concern,presentinganadditiveeffect. i.e..increasedburden,onthe body.An addedloadingofparc-cresolmay possiblypresentacumulativeexposureandthereforeanunknownrisk. TheAgencyhasdeterminedthat this risk should beinvestigated.

4. Levelsof exposure. TheCTF.Merichem.andSherwin-Williamsall -

includedcommentsin their submissionswhich concernedthe levelsof thecresolsto which peoplearepotentiallyexposed.All of thecomments,in onewayor another,statedthatanyexposuresthat mayoccurareso lowthat thereis not causefor undueconcern.TheCTF slatesthat “~ ~ 8-hourexposuresof ashigh as 1 ppm aresustainedonly by a veryfew of themosthighly exposedwoi’ker-s in cresolsmanufacturingfacilities” (Ref. 7).However,it is alsothe workerswho areexposedfor long periodsof time at lowexposurelevelswith whomtheAgencyis concerned.Little informationisknown on thehealthrisks associatedwith this typeof exposureprofile. Eventhough the Thdustrycommentedthatnochronichealthproblemshavebeennoted among personsexposedto cresolsin thepast.therehavebeenno studies,eitherclinical healthor epidemiological.whichproveor dispravethis premise.Therefore,in orderto reasonablydetermineor predicttherisks to workerswho areexposedto cresolsfor a fewhoursa day overseverelyears.theAgencybelievesthat chronicandotherhealtheffectsinformationareneeded.

B. Commentson PersonsSubjecttoTesting

1. Producersofsyntheticcresols.TheSherwin-WilliamsCo.commentedthatsinceit is reportedto bethe onlydomesticproducerof para-.cresol,usedonly in productswherethepora-cresolis consumedin the manufacturing - - -

~process. it shouki not be subject to the- final rule for cresols. It contends that the- Ag~’ncycannotsupporta finding of

substantialhumanexposurefor parc-

creso1.The Agency’sfinding of substa.ritial

occupationalexposureto cresolsisbasedon potentialwidespreadexposuresboth to the individual isomersand to countlessmixtures.Creedsaresold conirnerciallyin varyingmixturesof the threeisomers,two isomers,andsingleisomer, in combination with manyotherchemicalcomponents.Potentialexposuresin the workplace are to allthreeof the isomersasconstituentsofthosemixtures, as well as to thepureisomers.Pam’-cresolis a componentofthosemixtures and hence,a componentof the industrial productsin which thecresolmixturesareused.It is on thisbasisthatpara-cresoln~aniufacturersaresubject to this rule.

Furthermore,it is theAgency’sopinionthatSherwin-Williamsmanufacturespara-cresolin snbstantialquantitiesandthat thepotential forwidespread occupational exposure‘during the manufacturing,distribution,loading, shipping,sampling,processing,and/ordisposalof para-cresolis high.

Therefore,the Agencydoesnot agreewith Sherwin-WilliamsandhasdeterminedthatSherwin-Williamsis amanufacturerof cresolsas definedundersections3 and4 of TSCA. TheAgencyhasmadeno differentiationbetweendifferent methodsof cresolsproduction.

2. Processorsof cresols.The Ciba-GeigyCo.commentsaddressedtheroleof cresolsprocessorsin the conductofandreimbursementfor testsrequiredinthe final rule. Ciba-Geigybelievesthatall processorsshould beexemptfromconductingtestsandsharingcosts.Further,it statedthat if processorsareto be included,then theprocessorsshouldbe divided into two groups.thosewho usecresolsas raw material to formtotally differentchemicalproductsandthose “ * who merely [mix) them and[pass) the resulting formulations on to a

.~widerpubIic”* * “Ciba-Geigyrecommendsthatprocessorswho usecresolssolely as raw materialsto formnewchemicalproductsbe exemptfromthe buraenof testingand/ordatareimbursement”(Ref. 9).EPA doesnot agreethat it shoulddifferentiate betweentypesofprocessorsin the section4 test ruleprocess.The definition of “process” insection 3(10)and the languageof section4(b)(3)(B) do not make a distinction suchthat the responsibilities of the two typesof processors(asdescribedby Ciba-

- - Geigy)should differ in anyway. Ciba-Geigy is a processoras defined undersectionof TSCA becauseit prepares - --

cresols.after its manufacture, for - -

distributionin commerce.However,underEPA’s section4 proceduralrule(50 FR 20652)processorswould berequiredto performtesting or be sublectto reimbursementonly if manufacturersfail to performtesting(SeeUrutsIVDandE).

C. Commentson theEconomicimpact oftheCresolsTestRule

Several of tha public commentssubmittedin respon.seto the cresolsproposedtestrule addressedtheadverseeconomicimpactwhich the testrule would have on the cresoisindustry.The industrycommentsgenerallyfocusedon a belief that EPA hadunderestimatedthecosts-oftesting andon an analysisof the pricesensitivityofand~mpetition within the cresolmarketplace.Theycontendedthat thecresolsindustryis a maturechemicalindustrywhichhasseendecliningsalesin recent years. hi addition, they arguedthatEPA seYere}yunderestimatedthereal economiceffectsof the proposedtestrule andthat the testing costson anannualized urnt costbasisare not minor,as the Agencystated,but would impactheavily on theindust.ry.

When theproposedcresolstest rulewaspublished[July 1983) the Agency’seconomicanalysiswasbasedon thebest available information. The Agencyattemptedto factorin all of thevariables which must be consideredinconductingan economicassessmentofonemarket of the vast chemicalindustry.As a resultof both industrycommentson theproposedruleandtheAgency’s independentacknowledgmentthat the economicvariable-sw~t.hirithecresolsindustryhadchanged.EPAconducted a su’pplenwntal economicanalysis of the proposedcresoltestruleprogram(Ref. 10).

This supplementalreport factoredinrevisedtest costsandneweconomicdataincluding more detailedandcurrentinformation on theaffectedindustry.The conclusionsreachedin the Agencysrevisedeconomicanalysisindicate thatthepotential for adverseeconomiceffectson the cresols-producingindustrydueto theestimatedtesting costscontainedin theproposedrule washigh.Therefore,theAgencyis in generalagreementwith mostof thecommentsabout the economicimpact of theproposedcresolstest rule.

TSCA only requiresthat EPAacknowledgethe existenceof apotentialeconomicimpact ((TSCAsections2 (b)(3) and(c). 4(B)(1}(C), and24(a)(1))j,not necessarilytakeany -

actionbecauseof it. However, theAgency believesthat an alternativetestingapproachcanmitigate the

15776 FederalRegister / vol. 51, No. 81 I Monday. April 28, 1986 / Rules and Regulations

adverseeconomicimpact andalsoobtain thehealtheffectsdatawhich theAgencyhasdeterminedarenecessary.This alternativeapproachis adoptedinthis final cresolstestrsle.

Cresolstesting will be conductedintwo tiers.At this time, selectedmutagenicitytests,developmentaltoxicity studies,andreproductiveeffectsstudieswill be finalized in this rule. Attheconclusionof all of thetesting~equiredin thefir-st testrule therewillbean Agencydecisionpoint at whichtime a reviewof thecollectivedataoncresolswill occur.This collectivedatawill include,but not be limited to, thetestsfinalized in this rule, as well as anyhealtheffectstestingconductedby EPAandNTP.

At thesametime, theAgencywillpublish in the FederalRegister,notificationthat the testingrequiredinthe first cresoltestrulehasbeencompletedandthat theAgencyhasreceivedall of thedata.TheFederalRegisternoticewill announcetheopeningof ashortpublic commentperiodduringwhichtime interestedpartiescan review thedataandsubmitcommentsas to what,if any.additionaltesting shouldbe requiredfor cresols.This review will det~rninethescopeofanyadditionalhigher-tiertesting andthechemicalsubstance(s)which shouldbe tested.

Following that deàion,EPA maypromulgatea secondfinal testrulewhich couldinclude2-yearoncogenicitybioassay(s)anduppes-tiermutagenicityassay(s)on ortho-cresol.meta-cresol.and/orpara-cresol.bt addition,neurotoxicitytestingmaybe includedinthesecondfinal testrulefor cresols.

As explainedin unit ILD. of thisdocument,EPA is cncducting90-daysubchronictoxicity ~udies for eachofthecresolisomersastdhasincludedinthis testingexpandedclinicalobservationsof neurobehavioralcharacteristicsand~uropathologicalexaminations.Ther~ore.theremainingtwo neuro-toxicitystadiesinitiallyproposedfor cresols.i.e.. the functionalobservationbatteryandmotoractivitytest,will not be coniliictedin the firstfinal testrule.

However, if the resultsof thesubchronicandneusotoxicitystudiesconductedby EPA idicate that theeffectof cresolson i~urobehaviorandneuromotorfunctionis apotentialconcern,then thesetwo assayswill befinalizedaspartof t&e secondfinal rulefor cresols.In the serondfinal rule, ifoneis warranted.theneurotoxicity

-testingcouldbe adt~dto any- oncogenicitybioas~yasasatellitedose

group.

Therefore,the upper-tierdefinitivehealtheffectsstudies(oncogenicityandmutagenicity)andneurotoxicitystudies(functional observationandmotoractivity) which havealredybeensetforth in the proposedcresolsrule (July11. 198-3: 48 FR 31812),will continuein aproposedstatusto be finalizedat a laterdateshould the Agencydeterminethatasecondfinal test ruleis necessarytosufficientlycharacterizethehealtheffectsconcernsof cresols.

EPA believesthatthis phasedapproachto the testing requiredin theproposedcresolstestrule is warrantedbecauseit will reducethepossibility ofadverseeconomicimpacton the cresolsindustryresultingfrom theproposedcresolstest rule. Further,andmostimportantly, theAgencybelievesthatthehealtheffectstestingwhichwasinitially proposedin thecresolsproposedrule will ultimately be fullyaddressedin this tieredtest ruleapproach(SeeUnit V for EconomicImpactof Final Rule).

D. Commentson Health EffectsTesting

1. Routeof administrationof testsubstance.The proposedtest rulerequiredthat inhalationbe therouteofadministrationof the testsubstanceinthehealtheffectsstudies(subchronictoxicity, oncogenicity,two-generationreproductiveeffects)for cresols.TheCTF commentsrecommendedthat thisbereconsideredby the Agencyandthatingestionratherthaninhalation beused.The cresolsmanufacturerscontendthatexistingacutedata,usingoral, dermal,andinhalation routes.do not indicatethat cresolsinduceany uniquetoxicityby theinhalationroute.Further.CTFcontendsthat existingdataon cresoisindicatethat thetargetorgansaresystemic(CNS, liver, kidney) andthattheseorgansaretargetsregardlessofthe routeof administrationof thetestsubstance.It is thecommenters’conjecturethatEPA is. or should be,

~interested in systemiceffectsfrom long-term, low level exposures,andthattheseeffectswill be pickedup in theanimaltesting regardlessof the route ofexposure.

TheAgencyhasconsideredthe CTFcomments.While theAgencydoesnotnecessarilyagreewith all of thescientificrationalegivenby the CTF foraltering therouteof administration.EPAwill allow thechangefrom inhalation toingestion.EPA believesthat the gavagesubchronicstudybeingperformedbythe Agencywill give information whichwill enabletheAgencyto makethenecessaryrisk evaluationsfor cresols.Therefore,the Agencyagreesto change

-the routeof administrationfrominhalation to ingestionfor the

developmentaltoxicity andreproductionandfertility effectsstudies.

2. Testsubstance.TheCTFcommentedthat thehealtheffectstestingshould beperformedon an equalmixtureof thethreecresolisomers.i.e..½ortho-cresol.½meic-cresoLand ½para-cresol.The industry believesthatexposuresto workersaremore likely tobe from atrimeric mixture than-fromindividual isomers.CTF statesthat thesingle isomeruseof cresolis generallyasfeedstockin chemicalmanufacture.However,while thesestatementsareprobablythe caseduring themanufactureof cresols,cresolsaresoldcommerciallyasmixturesof threeisomersin a myriad of varyingconcentrations,mixturesof two isomers.particularly meta-andpara-cresol.assingleisomers,andin thecommercialproductcresylicacid.TheAgencybelievesthatwidespreadexposuresareto both individual isomersandcountlessmixtures.It is becauseof theproductionof suchavarietyof mixturesthat theAgencydecidedto testeachisomerseparately.Thereis no “standard”mixture to whichpeoplearemorepredominantlyexposed.In addition,theAgencybelievesthat eachof theisomersis producedin suchsubstantialquantitiesthat eachwarrantsindividualinvestigations.Finally, the Agencybelievesthat themost usefuldata willbe obtainedby using thepurestavailableform of the chemicalbeingstudied.Therefore,the Agencydisagreeswith the industrycommentsandhasdeterminedthat thehealtheffectstestingwill beconductedwith specifiedindividualcresolisomers.

3. Finding of unreasonablerisk. TheCTF commentsthat thereis no basisforafinding of potentialunreasonableriskundersection4(a)(1)(A) of TSCA formutagenicityandcarcinogenicity.Itstatesthat the Agency’s finding is onlybasedon questionableand/orflawedstudies.Most of the mutagenicitystudiesin questionwereconductedfor thecresolsindustry consortiumandsubmittedas a part of their publiccommentsin responseto theITC’sinitial testingrecommendationsforcresols(42 FR 55026; October12. 1977).

TheAgencyhasreviewedthe testsandconsidersthat the positiveresultsseenin severalof the short-termmutagenicitytestsarevalid andsignificant.In addition,thesection4(a)(1)(A) finding of “may presentanunreasonablerisk” for oncogenicitywasbasedon evidencewhich suggeststhatthe threecresolisomershaveacapacityfor promotingtheappearanceof skintumorsin mice. - -

Federal Register I Vol. 51. No. El I Monday, April 28, 1986 / Rules and Regulations - 15777

However,asexplainedin unit III. C. A. Automatictriggers for chronic The sequenceof tieredtests employedof this preamble.the Agencyis not oncogenicitybioassay.As discussedin by EPA in assessingthe rnutagenic

requiringoncogenictestingfor cresolsat the final PhaseI test rules for C9 and potentialof chemicalsubstances,whichthis time. However,afinding of MO. theAgencybelievesthat the useof arerequired,inthis final PhaseI test ruepotentialunreasonablerisk for sequencesof tieredtestsfor for specificcresolisomers,weremutageniceffectsremainsa valid basis mutagenicitytesting andtheuseof previouslydescribedin the proposedfor the mutagenicitytesting requiredin automatictriggersto requirechronic test ruleissuedby theAgencyforthis rule. oncogenicitybioassaysbasedon the cresols(48 FR 31812 July 11. 1983), and

4. Neurotuxicity testing.The CTF resultsof certainmutagenicityassays aremore completelydescribedin thecommentedon the neurotoxicitytests areconsistentwith both current final PhaseI testrule for C~andMO.which wereproposedin the cresolsrule. scientificknowledgeandtheregulatory Although thesegeneraltestsequencesWhile C’I’F apparentlyagreedwith the approachto chemicaltestingestablished areusuallyemployed,the Agencyneedfor someneurotoxicitytesting.it undersection4 of TSCA. Existing data ultimately specifiestherequiredquestionedthe choiceof tests,In showastrongcorrelationbetween mutagenicitytestfor eachspecificaddition, it statedthata general positiveresultsin certainmutagenicity chemicalsubstanceon acase-by-casescreeningprocedureshould be testsandpositive resultsin animal basis.In thecaseof the cresolisomers.conductedbeforeconsideringchronic chroniconcogenicitybioassaysfor a manyof the isomershavealreadybeenlow-levelneurotoxicitytesting.The largenumberof substancestestedin testedin severalmutagenicityassays.most critical of thespecificcomments both typesof systems.Thus, positive Thecresolsmutagenicityschemehashadto do with “weakbasis” for resultsin oneor more of these beendesignedso thatonly selectedrequiringtesting andthe mutagenicityassaysprovidea basisfor isomerswill be testedin specifictestinappropriatenessof neurotoxicity concludingthat thesubstancemaybe an systems.testing asstandardoperatingprocedure oncogenand,in conjuctionwith TheAgencyfeelsthat thereis afor thesetypesof chemicals. evidenceof both an activechemical consensusin thescientific community

The Agencyagreeswith the CTF that structureandthe potentialfor human on theneedfor identifying mammalianneurotoxicitytestingshould beginwith a exposureto the substance,thatsuch mutagens.While it is recognizedthatscreen,andthat wastheapproachthe exposuremaypresentan unreasonable thereis, as yet, no generallyacceptedAgencyproposedin thetest rule. The risk of oncogenicity.If all of these singlemTethodologyfor estimatingproposedtesting is the neurotoxicity mutagenicitytestsyield negativeresults, humanrisk from mutagenicagents.it isscreeningprocedure.It is theAgency’s the likeithoodof thespecifiedchemical the Agency’sview thatappropriategeneralpolicy in implementingTSCA beingoncogenicis small andthechronic methodologiesfor testingdo exist andsection4 to requirethesethree bioassaywill not berequired. arevalid. Therefore,theAgencyneurotoxicitytests,i.e.. neuropathology, Conversely,if anyoneof thesetrigger concludesthat it is appropriateat this

motor activity, andfunctional testsis positive,potentialoncogenicity time to obtainmutagenicitydataonobservationbattery,in testrulesbased of achemicalis suggestedanda chronic cresolsto determinewhetheradditionalon a finding of substantialproduction b~oassayis essentialto confirm or deny upper-tiermutagenicityassays,i.e.,andexposure. thatpotentialandprovideabasisfor mousespecificlocusand/orheritable

However,becauseEPA is conducting judgingwhatoncogenicrisk exposureto translocatjons,arenecessaryfor oneora portion of the proposedneurotoxicity the specificchemicalmaypresent. moreof the threecresolisomers.Anystudies,EPA is notrequiringthat any However, in view of the potential additionalmutagenicitytestingwill beneurotoxicitystudiesbe performedin adverseeconomicimpactof the requiredin a subsequentfinal rule forthis final rule (seeunitsII.D. andHI.C. of proposedcresolsrule on the cresols- cresols.this document).However,basedon the producingindustry(seeunit III. C. of Even though the upper-tierresults of theneurotoxicityevaluations this preamble),theAgencyhasaltered mutagenicitytestsandthe 2-yearconductedby EPA. the Agencymay its approachin thefinal cresolstest rule. bioassayswill not be automaticallyrequirethatthe functionalobservation BecauseEPA is now usingatwo-tiered triggeredasa resultof first andsecondbatteryandmotoractivity evaluations, test rule, thereareno longerautomatic tiers of mutagenicitytesting.thefirstwhich wereproposedfor cresols.be triggersto the oncogenicitybioassaysor andsecondtierswill remainasincludedin the secondfinal test rule. upper-tiermutagenicityassays.i.e., proposed,exceptfor the deletionof the

5. Tieredmutagemicityscheme.The mousespecific locusassayandheritable SCEassaysas discussedin Unit II.D. ofCTF, CMA, AIHC, andNRDC submitted-~‘translocationassay.Thesehigher-tier, this preamble.EPA believestheuseofcommentson theprvposedmutagenicity maredefinitive testswill not be automatictriggersbetweenthesefirsttesting requirementsfor cresols.Someof addressedin this document.A second tiers is suitable.It should be notedthatthe issuescoveredwererelatedto the test rule mayrequire2-yearbioassay(s) this doesnot excludethe public fromchoiceof tests.theautomatictriggersto andupper-tiermutagenicityassay(s),as requestingmodification in the testhigher level mutag~icitytestsand well aspossibleneurotoxicitytesting. program.Provisionsareavailableunderoncogenicitytesting,andmutagenicity b.Mutagenicityas aregulatable section21 of TSCA for the public toas a regulatableendpoint.The Agency’s endpoint.While the industry petitionEPA at anytime to amenda ruleresponseto avarietyof public commentersagreedthat appropriate undersection4.commentson this approach,the test mutagenicityassayscanbe usedfor 8. Otherhealth effectstestingissues.sequences,andtheassays(andtriggers assessingcarcinogenicpotential,they In thecresolsproposedrule, theAgencyfor oncogenicitytesting) contained objectedto the useof themore includedtesting eachcresolisomerforwithin themmaybefoundin thefinal elaborateteststo assessmutagenicrisk skin sensitization.The purposeof thisPhaseI testrule for theC9 aromatic asa separateendpoint.Theyobjectedto - evaluationis to identify the effects,andhydrocarbonfractirm(C9) (50 FR 20662; EPA’s apparentuseof rigid inflexible -- hencepossiblehazard,to apopulationMay 17, 1985)andthe final PhaseI test - testing schemesin favorof a tiered - -- repeatedlyexposedto a testsubstance.rule for mesityl oxide(MO) (50 FR 51857; approachto permit informedscientific - After reflectingupon the inclusionof

December 20, 1985).. judgment. - - - - this testin theproposedrule, EPA has --

FederalRegister I Vol. 51. No. 81 / Monday, Acril 28. 1986 I Rules and Regulations.15778 ________________________

decidedto deletetheskin sensitizationstudy from the final cresolsrule. TheAgencyhasdeterminedthat becauseofthehighly corrosivenatuceof cresolstothe skin, little additional usefulinformationwould be derivedfromconductinga sensitizationstudywithcresols.

E. Commentson EnvironmentalEffectsTesting

TheITC recommendedthat cresolsbetestedfor chroniceffectsin fish andotheraquaticorganisms.The Agencybelievesthat thereis substarrtialreleaseandexpc~ureto ~ environmentbycresols.Howevee,’theAgencymadeaprehm~narydecisionis theproposedtest rule andco~c~dedthatthereissuffIc~citinfor,natio~sto reesonab4ypredictthat cteso~sdo not poseachronicaqu-atictoxicity hazard.Thisinformation includesambientconcentratic~apredlc~dthroughcorrçutermoâeM..aLargec~iantttyofac~tn~citydata.monitodn~dma,andknown b~cnn~tratic~,bioda~ath~.at~persistencevaãues.TheAges~cyacknowledgesthat thereisnoexisting thron~ct~citydataforcresols,but be~ie’vesthat this comhdinfor~at~nalkiws ~PA to reasot~abkypredictwhetheror not exposuseofaquaticc~~an~to cresolsshouldcausechronice~ect’s,

However,EPA wasawarethat theinformationon whichthe Agencymaieits prelimin~ydecisionsis opentomanydifferentinterpcetations.For thisreason.EPAspecificallyrequestedinthecresolsrule that interestedpartiessubmitcommentson this issue.

The Agencyreceivedcommentsfromboth NRDC andCTF.NRDC commentedthat enoughconsiderationwaszu$given

* * * to possiblesubtleor chronicecologicalccnseq~aencesof discharga~duringlapsesof treatmentor todischargesinto ot.herbodie.sof water.”In addition.NRDC wasconcernedthat

* * creso~areacidiccompoundsandcouldaffect thetham~tryofsensitivelocaleswhendischargedinlargequantities.” ‘Th&efere. NBJJCstatesthat enviror izl effectstestingshould be initiatedf~cie.oia.

EPA. in responseto NE~)C’scomments.re-revLewedall of theinformation from whichit made thepreliminarydecisionnot to testcresolsfor environmentaleffects.The Agencybelievesthat the envüortmentaleffectsdataandanalyseswhichexist forcresolsareadequateto pennit theAgencyto makeanevaluationof anypotentialchronice~ectswhich might . -

resultfrom exposureto cresois.TIreinformationonwhichtheAgencybasesits decisionnotto reçisreenvironmental

effectstestingis extensive,andwhenproperly analyzedandinterpreted,canprovide informationon thepotentialof achemicalto causechroniceffects.Further,all of theavailableacute.monitoring, andmodelingdata,inconjunctioawith dataon thetransportandfateof the chemicalin anaquatichabitat,provide animportantsegmentofthe scientific basisfor assessingthe riskresultingfrom thereleaseof thatchemicalinto the environment. -

The CTF commentssupporttheAgency’s preliminarydecisionon theenvironmentaleffectstesting.CTFcontendsthat cresolsdegraderapidly intheenvirnrrrnentandthatconcentrationsof cresalsin the water, evenunderworst-careconditions,would notapproachthelevelsthatwould poseachronicaquatictoxicity hazard.

The Agencyhasreviewedboth setsofcommentsandhasfoundnra basistoalterits initial environmentaltestingdecisi~,n.Therefore,no additionalenvirerrmentaleffectstestingon cresolswill be rer~n~redat this time. TheAgencybthe’,’es that stibstantialisf~rmationisavailable1,~theAgencyto ei’~bIeit tomakean aesese~nentof risk for crescison aqee~icorgenisres.In sectk,ns4{SXIXAXIi3 end(B)(ii’) of TSCA, theAgencymus( find that,thereare insuflicientdataandexperienceupo~iwtiicl~theeffectsto themanufacture.

in commerce.processmg.use, ordi~o~1.s(,s~cl~,bst&i,ceorm~jreorofanymm hinati,a of smith acth~titson’ * *

the~vwonraentcanreaaouab~yhedeterminedor predic~ed.

EPA doesmat believethat it canmakethatfinding fce crescisforenvir~tai effectstestingat thistime. -

F. Comment’on Proto.colSabinissionandthePhasedTestRuleProc.e.ss

T~NRDC s~,ibmitxedcomin~tscencami~~ needfo~requitengvalidatedprntoc~leandrecotamessledrnodifica~.oaof theAgency’stwo-phase

--lestruleprocess,Tlrseco~imaritswereconsideredandaddressedin both thefinal PhaseI test ride for theC. aromatichydrocarbonfraction (50 FR 211662.2C~86—Z0667;May 17, 1985) andthe finalruleon TestRule DevelopmentandExemptionProcedures.pubhahedin theFederalRegisterof October10, 1984 (49FR 39774).

EPA sharesNRDC’s desirethat testrules shm&Id be completedasrapidly aspossible.andtheAgencyhasdecidedtomodify the test ruledevelopment-

processfor cresols.~sewhere in thisissueof theFederalRegistar.EPAisproposingcertainTSCA guidelInesas

- - therequiredteststandardsfor cresols.The Agencyis also proposingthat the -

testdatafrom eachrequiredstudy besubmittedwithin certain time frames.Bytaking this action. EPA believesthattestingwill be initinted moreexpeditiouslythan would occurif thenormal two-phaseprocesswerefollowed(see Unit IV.E.. below).

IV. Final Test Rule for Cresols

A. Findings

EPA is basingthe final testingrequirementsfor creso~son theauthorityof section4{aXl}fB) of TSCA. EPA findsthat eachof the threecresolisomersismanufacti~red.processed.andus-edinsubstantialquantitiesthat mayresult insub&tantialhumanexposure.Furthenmjrr.EPA ü~dsthat thereareinst~cieotdataavai~ab1’eto eitherreasonablyde4ermineor predicttheresultof this expes~irein theareasofmutageoic,deve~r~’oentaItoxicity. andr~codnctiveeffects.Thesefindingsarebasedon the~Ilo~95n~information:

1. Thereare,‘ubstantialamountsofcresobpmd~icedin or importedinto theUnitedStafeseachyesr.It is. estimatedthat prodectionandimports of cresolstotalled132.4 million poundsin 1984.

2. Estinsetesindicatethatbetween148.eoeand3C~,CoOpeopleaceexposedto cresolseachyearvia manufacturing,processing,and/oruseactivities.

3. EPA finds that thereareinsufficientdataon all of thesecited humanhealtheffectsfrom which to reasonablydetermineor predict theresultofexposureto cresolsandthat testingofcnesolsfor theseeffectsis necessarytodevelopsuchdata. -

4. EPA doesnot believethat the finalrulewill resultin a loss to societyof thebenefi-tsof cresolsbecausetheAgency’seconomicevaluationhasshownthat theeconomicimpact of testing thesesubstanceswill beminimal.

In addition,EPA hasfound that (a)thereis evidenceof potentialunreasonablehumanhealthrisks fromn-~itageniceffectsresultingfrom themanufacture.processing,anduse~rtivities associatedwith cresols,andthatwhile thereareexistingdatawhichsupportthis belie! with respectto theseeffects, (b) theseexistingdataareinadequateto reasonablypredictordeterminetheeffectsof theseexposuresto cresols,and(c) testing is necessaryfor theseeffects.Therefore.EPAbelievesthatrequiringtestingof cresolsfor mutagenicitycanalso be baseduponsection4(a}(14{A) of TSCA.

B. ReqthedTesthrg -

EPA is req9l~ringthateachof the three-- cresolisomers.octho-cresol.metn-------——

- cresol,andpara-cresoLshall be tested

Federal Register I Vol. 51. No. 81 1 Monday. April 28. 1986 / Rules and Regulations 15~9

in the following healtheffectsstudies:(1) Mutageniceffectsstudies(includingtestsfor chromosornalaberrations,genem,~tations,andcellulartransformationsa ecified cresolisomers).(2)

~1opmentaltoxicity, and(3) two-generation reproductiveeffectsstudies.

C. TestSubstance

EPA is requiringthat ortho-cresol.mea-cresol,andpara-cresolof atleast99 percentpurity be usedas thetestsubstancesbecausethis gradeis readilyavailableandwill bestallow EPA toassessthehazardspresentedby thevariouscresolisomers.

D. PersonsRequiredto Test

Section4(b)(3)(B) specifiesthat theactivities for which theAgencymakessection44a)findings(manufacture,processing,distribution, useand/ordisposal)determinewho bearsthe -

responsibilityfor testing.Manufacturersarerequiredto testif the findingsarebasedon manufacturing(“manufacture”is definedin section3(7) of TSCA toinclude “import”). Processorsar-arequiredto testif the findings arebasedon processing.Both manufacturersandprocessorsarerequiredto testif theexposuresoccurduringuse, distribution,or disposal.BecauseEPA hasfound thatthe manufacturing,processing,use,anddistributionin commerceof ortho-,m- - -, and/orpam-cresolgive risetop~ tial substantialexposures.EPA isproposingthatpersonswhomanufactureorprocess,or who intendto manufactureor process.anyof thecresolisomersat any time from theeffective dateof this testrule to theendof the reimbursementperiodbe subjectto the rule’s requirementsfor thatisomer.Theendof thereimbursementperiodordinarily will be5 yearsafterthesubmissionof the lastfinal reportrequiredunderthe test rule. Asdiscussedin the Agency’s testruledevelopmentandexemptionprocedures(40CFR Part790),EPA expectsthatmanufacturerswill conducttesting andthat processorswill ordinarilybeexemptedfrom testing.

BecauseTSCA containsprovisionstoavoidduplicativetesting,not everypersonsubjectto this rulemustindividually conducttesting.Section4(b)(3)(A) of TSCA providesthatEPAmay permit two or moremanufacturersor processorswho aresubjectto theruleto designateonesuchpersonoraqualified third personto conductthetestsandsubmitdataon theirbehalf.Section4(c) providesthatanypersonrequiredto testmay apply to EPA for anexemptionfrom thatrequirement.

E. TestRuleDevelopmentandExemptions

Elsewherein this issueof theFederalRegister,the Agencyis proposing thatcertainTSCA guidelinesbe utilized asteststandardsfor thedevelopmentofdataunderthis rule for ortho-, meta-,andpara-cresol.As discussedin thatnoticeandin previousnotices(50 FR20652: May 17, 1985), EPA hasreviewedthemethodfor developmentof testrulesandhasdecidedthat for mostsection4rulemakings.the Agencywill utilizesingle-phaserulemaking.In light of thisdecision.EPA hasreevaluatedtheprocessfor developingteststandardsforsection4 rulemakingsinitiated underatwo-phaseprocessandhasdeterminedthatfor certainof thesetwo-phaserules,TSCA testguidelinesaregenerallyavailablefor promulgationasrelevantteststandards,EPA hasdecidedthatwhereTSCA testguidelinesareavailable,the Agencyin mostcaseswillproposetherelevantguidelinesasthetest standards-forthoserules.

EPA believesthat,in line with itscommitmentto expeditethesection4rulemakingprocess.it is appropriatetoproposethe applicableTSCA testguidelinesas teststandardsat thesametime as aPhaseI final testrule is issued.With regardto therulemakingfor ortho-,meta-,andpara-cresol,TSCA testguidelinesareavailablefor the testing -

requirementsincludedin this PhaseIfinal rule. Thus, in the accompanyingnoticethe Agencyis proposingtheseTSCA guidelinesas teststandards.

Thepublic, including themanufacturersandprocessorssubjecttothePhaseI rule, will haveanopportunity to commenton the useoftheTSCA testguidelinesor to proposealternatetestmethods.TheAgencywillreviewthe submittedcommentsandwillmodify theTSCA testguidelines,whereappropriate,when the teststandardsarepromulgated.

During the developmentof a testruleunderthetwo-phaseprocess,personssubjectto tli?PhaseI final rule arenormally requiredto submit proposedstudyplanswithin 90 daysafter theeffectivedateof the PhaseI final rule(see40 CFR 790.30(a)(2),publishedin theFederalRegisterof May 17. 1985 (50FR20658)).However,becauseEPA isproposingapplicableTSCA testguidelinesasthe teststandardsfor thestudiesrequiredby this PhaseI finalrule, personssubjectto the rule, i.e.,manufacturersandprocessorsof ortho-,meta-, and/orpara-cresol.arenotrequiredto submitproposedstudyplansfor the requiredtesting.Personssubject

~to this rule, however,arestill requiredtosubmit noticesof intent to testor

exemptionapplicationsin accordancewith 40 CFR 790.25. publishedin theFederalRegisterof May 17, 1985 (50 FR20657).For this rule, oncethe teststandardsarepromulgated.personswhohavenotifiedEPA of their intent to testmust submit studyplans(which adhereto thepromulgatedtest standards)nolaterthan30 daysbeforetheinitiation ofeachrequiredtest.

Processorsof ortho-, meta-.and/orpara-cresolsubjectto this rule, unlessthey arealsomanufacturers.will not berequiredto submit lettersof intent.exemptionapplications,or studyplans(beforetesting is initiated) unlessmanufacturersfail to sponsortherequiredtests.Thebasisfor thisdecisionis that manufacturersareexpectedto passan appropriateportionof thetestcosts on to processorsthroughthe pricing of productscontainingortho-, meta-,and/orpara-cresol.

EPA’s final regulationsfor theissuanceof exemptionsfrom testingrequirementsarein 40 CFR Part 790. Inaccordancewith thoseregulations,anymanufactureror processorsubjecttothis PhaseI testrulemaysubmit anapplicationto EPAfor anexemptionfrom conductinganyor all of the testsrequiredunderthis rule. Ifmanufacturersperformall the requiredtesting,processorswill be grantedexemptionsautomaticallywithouthavingto file applications.

Becausepersonssubjectto this rulefor cresolsarenot requiredto submitproposedstudy plansfor approval.EPAwill grantconditionalexemptionsunderthis rule following EPA’s receiptof aletterof intent to conducttherequiredtestsratherthanafter receiptandapprovalsof astudy plan.NoticeofEPA’s adoptionof thefinal teststandardsanddeadlineswill beannouncedin a final PhaseII testrule.

F. ReportingRequirements

EPA is requiringthatall datadevelopedunderthis rule be reportedinaccordancewith the EPA GoodLaboratoryPractice(GLP) standardspursuantto 40 CFR Part792.

EPA is requiredby TSCA section4(b)(1)(C)to specifythe time periodduringwhich personssubjectto a testrule mustsubmit testdata.The Agencyis proposingthesedeadlineselsewherein this issueof the FederalRegister.Theseproposeddatasubmissiondeadlinesareopenfor public commentandmaybe modified,whereappropriate,whenthe final PhaseII testrule is promulgated.

TSCA section12(b) requiresthat~- personswho exportor intendto export

15788 Federal Register / VoL 51, No. 81 I Munday, ApriA 2~.1986 / Rules and Regulations

to aforeigncotir~ryanyortho-.metzz-,and/orpara-cresol.subjectto the testingrequirementsof this r,le. sotify EPA ofsuchexportationorin~t to exportWhile the resultsof requiredtestingmaynot be availablefor sometime, anoticeto the foreign govermmentaixiut theexportof suchsubstancessubjectto testrulesservesto alertit to theAgency’s -

concernaboutthesubstances.It givesthegovernmentthe opportunitytorequests~uchdatathat theAgencymaycurrentlypossessplus whateverdatamaybecomeavail.ableasa resultoftestingactivities.Thus,upontheeffectivedateof this rule, personswhoexportor intendto exportortho-, meta-,and/orpara-cresolmust submitnoticesto the Agencypursuantto TSCA section12(b~(1)and40 CFR Part707.Foradditionalinformation,seetheFederalRegisterof November19, 1984 (49FR45581),

TSCA section14(b)governsAgencydisclosureof all testdatasubmittedpursuantto section4 of TSCA. Uponreceiptof datarequiredby this rule, theAgencywill as.nouncethereceiptwithin15 daysin theFederalRegisterasrequiredby section4(d). Testdatareceivedpursuantto this rule will bemadeavailablefor public inspectionbyanypersonexceptia thosecaseswheretheAgencydeterminesthatconfideatialtreatmentmustbe accordedpursuanttosection14(b) of TSCA.

C. EnforcementProviswr,r

TheAgencyconsidersfailure tocomply wiTh any asprctof asection4rule to lye a violation of section15 ofTSCA. Section15{1) of TSCA makesitunlawful for anypersonto fail or refuseto comply with anyruleor orderissuedundersection4. Section15(3) of TSCAmakesit ~mlawful for anypersonto failor refuseto: (1) Establishor maintainrecordsor (2) submitreports.notices,orotherrecordsrequiredby the Act or anyregulationsissuedunderTSCA.

Additionally, TSCA section15(4)makesit unlawful for anypersonto failor refuseto permitenvyor inspectionasrequiredby sectioit Ii. Section11applies to any “estab~stmsent.facility,or otherpremisesin w1~ichchemicalsubstancesormixturesasemanuf~tured.processed,stored, or heldbeforeorafter their chsti’*ution incon~erce* ~“ TheAgeiw~ycensidersa testingfacik~tyto be aplacewherethechemicalis beki or storedand,therefore.sub~ctto i~pe~ion.Laboratoryamailtsend/orinspectionswill be conductedperiodically inaccordan~zwith ~ocedsres outlinedinTSCA section11 by designatedrepresentativesof the EPA for the -

purposeof detezn’e.ningcomp’iancewith

thefinal rule for ortho-,mew-,andporn-cresol. Theseinspectionsmay beconductedfor purposeswhich includeverification that testin�hasbegun.thatschedulesarebeingmet, thatreportsaccuratelyreflect theunderlyingrawdataandinterpretationsandevaluationsthereotandthat the studiesarebeiagconductedaccordingto EPAGLP standardsandtheteststandardsestablishedin thesecondphaseof thisrulemaking.

EPA’s a~athorityto inspecta testingfacility alsoderivesfrom section4(b)(1)of TSC& whichdirectsEPA topromulgatestandardsfor thedevelopmentof test‘data.Thesestandards’aredefinedin section3(12)(B)of TSCA to includethoserequirementsnecessaryto assurethatdatadevelopedundertestrulesarereliableandadequate,andsuchotherrequirementsasarenecessaryto provide suchassurance.TheAgencymai.ntainsthatlaboratoryinspectionsareaecessarytoprovide this assurance.

Violators ofTSCA aresubjecttocriminal andcivil liability. Personswhosubmitmateriallymisleadingor falseinformationin connectionwith therequirementof anyprovisionof this rulemaybesubjectto penaltiescalculatedasif theyhadneversubmittedtheirdata.Underthepenaltyprovisionsofsection16 ofTSCA, andpersonwhoviolatessection15 couldbe subjectto acivil penattyof up to $2~,000per dayforeachviolation,intentionalviolationscouldleadto thermpositi’on of criminalpenaltiesup to $~,000for eachdayofviolation andimprisonmentfor up to Iyear.Otherremediesareavailableto -

EPA undersections7 and17 of TSCA,suchas seekinganinjunction to restrainviolations of TSCAsection4.

hidlvidualsaswell ascorporationscouldbesubjectto enforcementactions.Sections15 and16 of TSCA apply to“anyperson”who violatesvariousprovisionsof TSCA. EPA may,at itsdiscretion,proceedagainstindividuals

‘‘as well ascompaniesthemselves.Inparticularthis includesindividualswhoreport falseinformation or who causeitto be reported.In addition,thesubmissionof fa’se,fictitious, orfrsude}entstatemesitsis aviolationunder18 U.S.C.1001.

V. EconomicA~eIy~aof FinalTestRule

To assesstheeco’ricymicimpuct of thisrule, EPA haspreparedaueconomicanalysisthatevaluatesthepotentialforsigniflcaiit eaone’micirsipact,on theindustryasareseltof therer~uiredte~in~(Ref. 6). Theec~omicanalysisestrnratesthecostsof condectii’igtherequiredte~tirrgaridevaluatesthe

- potentialfor si~niflcarttadverse

economicimpactasaresultof thesetestcostsby examiningfour marketcharacteristicsof cresols:(1) Pricesensitivityof demand.(2) industry costcharacteristics,(3) industry structure,and(4) marketexpectations.

To4a1testfn~costsfor thefinal rule forcresolsareestimatedto rangefrom$764,095to $1,050,230.This estimateincludesthe~.ts for both the requiredmi.k~~imsermof testsaswell as thecondi~~m~es.

Thees~ia,~ed1US3 productionvolumefor eathof thetiweeisomersisapproxImately28, 28, and4~millionpoundsfor pam-.mete-,andortho-cresol,respectively.Thecostsof testingarefirst allocatedto eachisomeron thebasisøfprodiactionvoiwne.Thetestcostsfor aecisisooierarethen allocatedto theco cal prod~ctzcontainingthe isomerbasedos percentagecomposMisaa~dtotal productionof thecoa~arcia1pro~1uct.Basedon thisallocatiosimethodandthe maximum

of reqa~iredandconditionaltesting,thean~tis.lizedimit costsof testingrangefromaLow of 0.06centsperpoundfor cresyk.cacid,to ab.igh of 1~34centsperpound£orn~ta-andpara-aesolmixtur.ea5Comparedto theunit salesvalnefor t ecoamercaalprodacts,theunit testcoatsrari~from alow of 0.10pe~aatof price to ahigh of 0.42percentof price.

Based~i thesecostsandacon~derationof themarketcharacteristicsof cresolproducts,theecoaomi.canelys~sindi.catesthat thepotential for significanteconomic

- ---impactis low. This conclusionis basedon the followtagthservatrons:(1) Theestimatedunit testcostsaresmallandrepresentarelatively smallpercentageof productunit value(i.e., lessthanonepercentof unit value in theworstcase);(2) relativelystable,andin somecasesmoderate,gr.wth is expectedin mostmarketsfur creso}sand(3) demandinmostof themarketsdoesnot appeartobe verysensitiveto small increasesinprice.Foracompletediscussionof theeconomicixiç~icationsof this rule, seetheeconomicanalysissupportdocument(Ref. 8).VI. Availithi4ity of TestFacilitiesandPersonnel

Section4(’b)(l) of TSCA requiresEPAto consider“the reasonablyforeseeableavailability of the facilities andpersonnelneededto performthe testingrequiredundertherule.” Therefore,EPAconductedastudy to assesstheavailabliityof testfacilities andpersonnelto handlethe additionaldemandfor testingprogramsnegotiatedwith industryinplaceof rulemaking.

FederalR&gister I Vol. 51, No, 81 / Monday, April 28, 1986 / Rules and Regulations 15781

Copiesof thestudy. ‘ChemicalTestingIndustry: Profile of ToxicologicalTesting,” October1981,can be obtainedthrough the NTIS underpublicationnumberPB 82—140773.On the basisofthis study,theAgenqbelievesthattherewill be avaia)~etestfacilities andpersonnelto perfori~the testingrequiredin this testnile.

VII. RulemakingPeard

EPA hasestabli.beda public recordfor this rulemaking(~cketnumber420338). This recort~includesthebasicinformationtheAg~~yconsideredindevelopingthis rule ~ndappropriateFederalRegisternob:es.

This recordinclud~.5the followinginformation:

A. SupportingDocumtnratlon

(1) FederalRegist~~oticespertainingto this final rule coning of:

(a) Notice containi~gthe ITCdesignationof cresokto thePriority List(42 FR 55028.Octob~12, 1977).

(b) Noticeof propt~ecrule on cresols(48FR 31812;July ii.. 19&.3). -

(c) Noticeof final ~uleon EPA’sTSCAGoodLaboratoryPr~tic Standards(48

- FR 53922;November29.1383).(d) Notice of final rulecn testrule

developmentandexemptionprocedures(49FR 39774;Octob~10, :984).

(e)Notice of final ruleconcerningdatareimbursement(48FR31780;july 11,1983). -

(f) Notice of interimfinal ruleon test• rule developmentai~exemption

procedures(50 FR 2LE52: May 17, 1985).(g) Notice of finalsuleon theC5AromaticHydrocarbonFrac:ion(50 FR

20682;May 17, 1985.(h) Notice of finalsuleon mesityl

oxide (50FR 51857;~ecember20,1985).(2) Supportdocun~ntsconristingof:(a) Cresols techni~1support

documentfor propo~drule.(b) Economicimp~tanalyssof

NPRM for cresols.(c) Economic imp~tanalysi.; of final

test rulefor cresols.(3) Cornmunicati~xconsistirgof:(a)Written publicco~.ments.(b) Transcriptiondpoblic meeting.(c) Summariesof pfione

conversations.(d) Meetingsumnsries.(e) Reports—publ~hedand

unpublishedcontra~,r’sreports.

B. References

(1) U.S. IxiternationalTradeCommission.“Syntheticorganicch~ncals.UnitedStatesproductionandsales.p84.” Washington.D.C.: GovernmentPri~ngOffice. USITC pub.

- 1745. 1985. - -

(2) Bureauof CCnNULU.S. DepartmentofCommerce.“U.S.Impcztafor cortsutnptionand generalimports,1~JSA.Cornmodi:yby

countryof origin.” Washington.D.C.GovernmentPrinting Office. FT-246,Annual1984. 1985.

(3) Chenq. M.. Kilgerman.AD. “Evaluationof thegenotoxicityof cresoisusingsister-chromattdexchange(SCE).” MutationResearch137:51—65, 1984.

(4) U.S. Environxnent.alProtectionAgency.MemorandumfromKerry Li DearfieldtoLindaTuxen.“Review of Cenotoxi.cityofCresolsusingSisterChromat-idExchange(SCE).” July 11. 1985. -

(5) U.S. EnvronmentalProtectionAgency.“40 CFR Part280et al.—HazardousWasteManagementSystem:LandDisposalRestrictlonL ProposedRule.” 51 FR 1602January14. 1988.

(6) Mathtech.Inc. EconomicImpactAnalysisof FinalTestRule for Cresols.ContractNo. 88—02-4235.January29. 1988.

(7) CresolsTaskForce.CommentsonEPAsProposedTestRule for Cresols.SubmissionfromRobertV. Zener.CTF toPublic InformationOffice. EPA. October12,1983.

(8) Hall. J.J.Commentsof CONOCOanITClisting of cresols.Letter from J.J. Hall to JoanUrguhart.Public’lnformationOffice, EPA.March14.1978.

(9) CIba-GeigyCorp. Commentsof Ciba-- Geigy onCresolsProposedTest Rule. Letter

fromAnthonyDiBattista to Public -

Information Office. EPA. October10. 1983.(10) Mathtech. Inc. Draft Supplemental

Report on CresolsandCresylicAcid.Memorandumfrom JohnK. Orreil to HollisCall. November28. 1984.

ConfidentialBusinessInformation(CBI), while partof therecord, is notavailable for public review.A publicversionof therecord,from which CBIhas beendeleted, is available forinspectionfrom 8 a.m. to 4 p.m..MondaythroughFriday, exceptlegal holidays,inRm. E—107,401 M St., SW~Washingtoo,D.C.

VIII. Other Regulatory Requirement

A. ExecutiveOrder12291

Under ExecutiveOrder12291,EPAmust judgewhether a regulation is“major” and therefore subject to th.requirement of a Regulatory ImpactAnalysis.This testnile is not major

—becauseit doesnot meetany of thecriteria set forth in section1(b) of theorder. First, the actualannual cost of allthetesting proposedfor cresolsisestimatedat$764.095—S1.050.230overthe market life of the chemical.Second,

- becausethe cost of the requiredtestingwill be distributed aver a largeproduction volume, the rule will haveonly very minor effectson users’ prices(lessthan 1 percenta year) for thischemical evenif all test costswerepassedon. Fin.ally, taking into acco~mtthe nature of the market for thissubstance,the low le~e1of costsinvolved, and the expectednatureof themechanismsfor sharing the costsof the

- required testing. EPA concludesthat

therewill beno significantadverseeconomicaffectsof any typeas a resultof this rule,

This proposedregulationwassubmittedto theOffice of ManagementandBudget (OMB~for review asrequiredby ExecutiveOrder12291.Ans’written commentsreceived from 0MBare included in the Public Recordforthis rulemaking.

B. RegulatoryFlexibility Act

Under the RegulatoryFlexibility Act(15 U.S.C.601 et seq..Pub. Li 96—354.September19. 1980),EPA is certifyingthat this testrule will not haveasignificant impacton a substantialnumberof smallbusinessesfor thefollowing reasons:

1.Therearenot a significantnumberof smallbusinessesmanufacturingorimportingthis chemical.

2. Small processorsarenot expectedto performtesting themselves,orparticipatein theorganizationof thetestingeffort.

3. Small processorswill experienceonly veryminor costs,if any, in securingexemptionfrom testingrequirements.

4. Sn~allprocessorsareunlikely to beaffectedby reimbursementrequirements.

C.PaperworkReductionAct

The informationcollectionrequirementscontainedin this rule havebeenapprovedby the Office ofManagementandBudget(0MB) undertheprovisionsof thePaperworkReductionAct of 1980. 44 U.S.C.3501 etseq.. andhavebeenassigned0MBcontrolnumber(2070—0033).

D. ComprehensiveEnvironmentalResponse,ConipensationandLiabilityAct(“Supeifund”)

The ComprehensiveEnvironmentalResponse.Compensation,and LiabilityAct of 1980 (CERCLA (42 U.S.C.9601 etseq.,Pub. Li 96—510.December10. 1980))requiresthat personsin chargeofvesselsor facilities from whichhazardoussubstanceshavebeenreleasedin quantitiesthatareequal.toor greater than the reportable quantities(RQs) immediately notify the NationalResponseCenter (NRC) of the release.(SeeCERCLA section 103(5).and 50 FR13456: April 4, 1985).TheNationalResponseCenter can be notified at (800)424—8802.exceptfrom the Washington.DCmetropolitanarea, where thetelephonenumberfor notification is(202) 426—2675.All designatedhazardous

- su~aLanceswill have an RQ of onepound until adjusted by regulation under

- CERCLA unlesssuch substancesarealready on thelist of CERCLA --

15782 Federal Register I Vol. 51. No. 81 / Monday, April 28, 1986 / Rules and Regulations

hazardoussubstancesandhavebeenassignedan RQ (seeCERQ.Asection102).Cresoisl~vebeenas~nedan RQof 1,000 pounds.

List of Subjects in 40 CFR Part 799

Testing. Environmental protection.Hazardous substances,Chemicals,Recordkeepingandreporth~requirements.

Dated:April 21, 1986.JohnA. Moore,AssistantAdministratorfor P~2icidesandToxicSubstances.

PART 799—~AUENDED)

Therefore.Part 799 is an~ndedasfollows:

1.Theauthoritycitationcontinuestoread as follows:

Authority: 15 U.S.C.2603.2$tl. 2825.

2. New* 799.1250is addel,to readasfollows:

(iii) Reportingrequirements[Reserved).

(5) Reproductiveeffects—(i)Requiredtesting.A two-generationreproductiveeffects study shall be conducted -

individually with ortho-, meta-.andparo-cresol.

(ii) Teststandards[Reserved).(iii) Reportingrequirements

[Reserved].

(Informationcollectionrequirementshavebeenapprovedby theOffice of ManagementandBudgetundercontrolnumber2070-0033)

[FR Doc86-4409Filed 4—25—~8:8:45 am)~WNO Cool ‘~~-“

aberrotions—(i)Requiredtesting.(A) Lnvitro cytogeneticstestsshall beconductedindividually with ortho-,meta-,andparo-cresol:

(B) An in vivacytogeneticstest shallbe conducted for eachisomerwhichproducesa negativeresult in thein vitrocytogeneticstestconductedpursuanttoparagraph(c)(1)(i)(A) of this section.

(C) A dominant lethalassayshall beconducted for eachisomerwhichproducesa positive result in either thein vitro or thein vivacytogeneticstestconductedpursuantto paragraphs(c)(’l)(i) (A) and (B) of this section.

(ii) Teststandards[Reserved).(iii) Reportingrequirements

[Reserved).(2)Mutageniceffects—gene

rnutations—(i)Requiredtesting.(A) ADNA damageassayshall be conductedwith meta-cresol.

(B) A genemutation in somaticcellsassayshall beconductedindividually

~799.1250 esots. with meta-andpara-cresol.(a) Identificationof testp.thstances. (C) A’sex-linked recessivelethal test

(1) ortho-Cre~i(CAS No. ~..46-7) in Drosophilarnelanogastershall beconductedindividually with ortho- andmeta-cresol (GAS No. 10&-~—4).and paro..~re~ol. -

para-cresol(CAS No. 106-44—5)shalleachbe testedin accordaxEewith this - (D) A sex-linkedrecessivelethal testsection. In Drosophilamelanogastershall be

(2) ortho-, meta-,andpasa~.Cresolof at conductedwith meta-cresol if itleast 99 percent purity shai~beusedas producesa positive result in the DNAthe test substance, damageassayor genemutation in

(b) Personsrequiredto ~bmit study somaticcells assayconducted pursuantplans,conducttests,andsthmitdata. to paragraphs (c)(2)(i) (A) and (B) of this(1) All personswho manufacture or section.processor intend to manufacture or (ii) Teststandards[Reserved].processcresolsfrom the effective date (iii) Reportingrequirementsof this rule (June11, 1986)t~the end of [Reserved].the reimbursementperiod ~iall submit (3) Mutageniceffects—cellular-

letters of intent to conduct~sting or transformation—exemptionapplications,st~yplans. (i) Requiredtesting.(A) A Balb/c-3T3and/or shall conduct testsandsubmit cellular transformation test performeddataasspecifiedin this section,Subpart without metabolic activation shall beA of this Part,andPart790~i t~ conductedindividually with meta-andchapter. para~~cresol.

(2) Personssubjectto thissectionare (B) A Balb/c-3T3 cellularnot subjectto therequireri~ntsof transformationtestperformedwith§ § 790,30(a)(2), (5), and (8~and (b), and metabolic activation shall be conducted790.87(a)(1)(ii)of this chap~r. with.eachisomerwhich produces a

(3) Personswho notify EPA of their negativeresult in the cellularintent to conducttestsin ~mpliance transformationtest without metabolicwith the requirements of thu section activationconductedpursuanttomust submit study plans f~thosetests paragraph (c)(3)(i)(A) of this section.no later than 30 daysbefoitthe (C) A Balb/c-3T3cellularinitiation of each of thosetests. transformation test performed with

(4) In addition to the reqairementsof metabolic activation shall be conducted§ 790.87(a)(2) and (3) of this chapter. with ortho-cresol.EPA will conditionally approve (ii) Teststandards[Reserved].exemptionapplications for this rule if (iii) ReportingrequirementsEPA has receiveda letter ~intent to [Reserved). -

conductthe testingfrom w~ich (4)Developmentaltoxicity—(i)exemptionis soughtand EPAhas Requiredtesting.A developmentaladopted test standards andschedulesin toxicity study shall be conducteda final PhaseII test rule, individually with ortho-, meta-,and

- -. (c) Healtheffectstesting—fl) — ~para-cresoI. -

Mutagenic.effects-.--chronmsornal (ii) Teststandards,[Reserved).