FederalRegister / Vol. 51, No. 174 I Tuesday, September9, 1966 I Rules and Regulations 32073

40 CFR Part 799

[OPTS-42043A; FRL.-3042-6(a)]

Toxic Substances; 1,2-Dichloropropane; TestingRequirements

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

SUMMARY: TheEPA (alsoAgency)isissuingafinal testruleundersection4(a) of theToxic SubstancesControlAct(TSCA) thatrequiresmanufacturersandprocessorsof 1,2-dichloropropane(DCPCAS Number78-87—5) to testthischemicalfor neurotoxicity,mutagenicity(chromosomalaberrations),reproductiveeffects,developmentaltoxicity, acutetoxicity to marineandfreshwateralgaeandmysidshrimp,andchronictoxicity to mysid shrimpandDaphniamagna.Elsewherein this issueof theFederalRegister,theAgencyisalsoproposingteststandardsandreportingdeadlinesfor thesetests.

DATES: In accordancewith 40 CFR 23.5,this rule shallbepromulgatedforpurposesofjudicial reviewat 1 p.m.eastern[“daylight” or ‘standard”asappropriate]time on September23, 1986.This ruleshall becomeeffectiveOctober23, 1986.

FOR FURTHER INFORMATION CONTACT:EdwardA. Klein, Director,TSCAAssistanceOffice (‘l’S—799), Office ofToxic Substances,Rm. NE—G004,401 MSt., SW., Washington,D.C. 20480.Tollfree (800—424—9065).In Washington,DC:(554—1404).OutsidetheUSA: (Operator—202—554—1404).

32080 FederalRegister I Vol. 51, No. 174 / Tuesday,September9, 1986 / Rules and Regulations

SUPPLEMENTARY INFORMATION: OnJanuary6. 1984, the EPA proposed,undersection4(a) of TSCA thatmanufacturersandprocessorsof 1,2-dichioropropaneconducthealthandenvironmentaleffectstesting of thatchemical(49FR 899).EPA is now issuinga final rulerequiringhealthandenvironmentaleffects testingof 1.2dichioropropane.

I. Introduction

1 his noticeis part of theoverallimplementationof section4 of the ToxicSubstancesControl Act (TSCA. Pub. I..94—469; 90 Stat. 2006et soq: i~U.S.C.2P03 et .ceq ) which containsauthorityfor PS.’. to requredevelopmentof datarelevantto assessingthe risks to healthandthe environmentposedliv exposureto particularchemicalsubstoncesormixtures.

Undersect;on4)a)(1)of TSCA, EPAmust requiretesting of a chemicalsubstanceto develophealthorenvironmentaldataif theAdministratorfinds that:

(A~litthe manufacturedistrbiithir ince~nrnc’iii. proc&ss:n~ isp.. or h~sposaIat achemicalsubstanie or mixture, or that anycornb:nrtionof suchactivities, may presentso :in~nusOnatile risk if in’ tory to healthor tothe pu’, ronrnent.

In) thereareinsufficient data andexperienceupon which the effectsof suchrnanof..cture.distrieitiun in commerce,processing,use,or disposalof suchsubstanceor mixtureor of ,in~combinationof suchactivitieson healthorthe environmentcanreasonablybe determinedor predicted,and

(iii) testing of suchsubstanceor mixturewith respectto sucheffectsis necessarytodevelopsuch data: or

achemicalsubstanceor mixtureis or~tll be producedin substantialquantities.and(It entersor mayreasonablybeant:l:ipatcui to enterthe environmentinsob~tactiaIquantitiesor (II) thereis ormaybesignificant or substantialhumanexposureto suchsubstanceor mixture.

bit thereareinsefficient data andexperienceupon which theeffects(if themlnutactrire,distribution in commerce,processing,useor disposalof suchsubstanceor rn storeorof anycombinationof suchactivitieson healthor theenvironmentcartreasonubl bedeterminedor predicted,and

(iii) testingof suchsubstanceor mixture~sthrespectto sucheffectsis necessarytodevurtopsuchdata.

For a morecompleteunderstandingofthestatutorysection4 findings, thereader is directed to theAgencY’s firstproposedtest rulepackage(ciloromethaneandchlorinatedbenzenes,publishedin the FederalRegisterof July 18. 1980, (45 F’R 48510))andto the secondpackage(dichloromethane.r.itrobenzene,and1,1.i-trichloroethane.publishedin theFederal Registerof June5. 1981: (46 FR

30300)) for in-depthdiscussionsof thegeneralissuesapplicableto this action.

H. Background

.4. P,ofile

1.2-Dichioropropane(CaftCl2: CASNo. 78—87--5) is a highly volatile.colorless,stableliquid with achloroformlikeodor.Theusesof 1.2-dichloropropane(DCP)areas a captiveintermediatein the productionofperchioroethylene:as a solventin ionexchangeresin manufacture,toluenodiisocyanateproduction,photographicfilm manufacture.papercoating.annpetroleumcatalyst regeneration:andina mixturethat is marketedas a SOt)

fumigant(pestic:’le).Tue Dow ChemicalCc.mpanr is the

only manufacturerof isolatedDCP in theUnitedStates.The estimatedannualisolatedproductionis approximately75million poundsfor 1982 basedoninformationsuppliedby theDowChemicalCompany(Refs.1 and2). Over95 percentof this isolatedproductionisusedon siteby Dow asacaptiveintermediatein the productionofperchloroethylene.Approximately3million poundsof DCPis marketedbyDow annuallyas a specialtysolvent forindustrial use.An estimated20 millionpoundsof DCP is alsoproducedasabyproductin a mixturemarkeuiudas asoil fumigant: theremaining7 millionpoundsis incinerated.Small quantitiesof DCParealsoproducedinauvertentlyduring the manufactureof severalotherlow molecularweight chlorinatedaliphaticcompounds.As of 1982,Downo longersellsDCPfor consumeruse inpaint strippers,paint, varnish,andfurniture finish removers(Ref. ‘I).

B. ITC Recommendations

Section4(e) of TSCA establishedanInteragencyTosting Committee(ITC) torecommendto EPA a list of chemicalstobeconsideredfor testing undersection4(a) of the Act. The ITC designated1.2-dichloropropane(DCP)for priorityconsiderationin its Third Reportpublishedin the Federal RegisterofOctober30. 1978 (43 FR 50630).The lSCrecommendedthat1,2-dichloropropanebe testedfor the following healtheffects:carcinogenicity,mutagenicitv.teratogenicity.andothertoxic effects(with emphasison reproductiveandneurologicaleffects).TheITC alsorecommendedthat an epidemiologicalstudy be performed.The followingenvironmentaleffectstestswererecommendedby theITC: chronictoxicity to fish andinvertebrates,effectson avian andmammalianreproductionandbehavior,andeffectson soilin~ertebralesand terrestrialinsects.

ThefTC’s testingrecommendationswere basedon high productionvolume(estimatedat 71 million pounds),widespreaduseas a solvent,andpotential for high environmentalandhumanexposure.The ITC believedinsufficient informationwasavailoblecharacterizethe carcinogenic.mutagenic.andteratogenicpotentialofDCP. Reproductiveandneurologicaleffectstesting wasrecommendedbecauseof a statedstructural simiiarttsto 1.2-clibromo-3-chloropropane(DBCPIa known hun’,an reproductivetoxicunt~Ac epidemiologicstudy wasrem nsmendedfor 1.2-dichioropropaucbecausect insufficrent informattonaunt the c.homicabs)r:manhealtheffects anda potentially largeexpu~::pattern.

The ITC recommendeden~ironrsen;aeffects tests for 1.2-dichloroproocacbecauseof its belief d~atthechernicasvolatilily and high specific gravity meu,result in localizedimpactson thoseenvironmentsreceivingcontinuousexposureassociatedwith thischemical’suseanddisposal.Also,accordingto the JTC, the potentialforDCP to hioaccumulatesuggestedtheneedfor environmentaleffectstestingdeterminethe biological significanceofexposure.

C. ProposedRule

EPA issueda proposedrule, publisheiin theFederalRegisterof January6, 198(49 FR 899) whichwould requirehealthandenvironmentaleffectstestingfor1.2-dichioropropane.

In evaluatingthe ITC’s testingrecommendationsfor 1,2-dichioropropane(DCP), EPA consideredall availablerelevantinformationincluding informationpresentedin theITC’s report recommendingtestingconsideration:productionvolume. use.exposure.andreleaseinformationreportedby the manufacturerof DCPunderTSCA section8(a) (40 CFR Part712—ChemicalInformationRule,SubpartB—ManufacturersReporting—PreliminaryAssessmentInformation);unpublishedhealthandsafetystudiessubmittedby themanufacturerandprocessorsof DCPundertheTSCAsection.8(d) HealthandSafetyDataReportingRuIc 140 CFR Part716); andotherpublishedandunpublisheddataavailable to the Agency. Onthe basisofthe evaluation,asdescribedin theproposedrule andits accompanyir.gtechnicalsupport document(included inthe public record for this action). EPAproposednervousssstem effects.reproductiveeffects, teratogenicitv(developmentaltoxicity). andmutagenicity testingrequirements.as

Federal Register / Vol. 51, No. 174 / Tuesday, September 9, 1988 / Rules and Regulations 32081

well asacuteandchronictoxicity testsfor aquatic invertebratesand an aquaticplant test for DCPundersection4(a)(1)(8)of TSCA. By theseactions.EPA respondedto thefTC’s designationof 1,2-dichloropropane.

In basingits proposedDCPhealthandenvironmentaleffectstestingon theauthorityof section4(a)(1)(B)of TSCA,EPA found that 1,2-dichioropropaneismanufactured,processed.andusedinsubstantialquantities,andmayresultinsubstantialhumanexposure.EPA alsofound that 1,2-dichioroproparie entersormay reasonably be anticipated to enterthe environmentin substantialquantitites.Furthermore,EPA foundthatthereareinsufficientdataavailabletoreasonablydetermineor predicttheresultof this exposureandreleasein theareas of mutagenic, teratogenic,reproductive, and neurotoxic effects,and acute and chronic toxicity foraquatic invertebratesand aquaticplants. Finally, EPA found that testing isnecessaryto develop the data neededtoevaluatethe Potential for DCP’sexposureand releaseto causetheseeffects.Thesefindings were based onthe following information, as reported inthe DCPSupportDocument:

1. Although Dow Chemical Companyis the only manufacturer of 1,2-dichloropropane in the United States,the marketingvolume (3 million poundsin 1982),the 1,2-dichioropropaneproduction volume (an estimated41million pounds in 1981)and the 1,2-dichloropropane production capacity(41—144 million pounds, basedon DCPco-product propyleneoxide productioncapacity)weresubstantial.

2. Information available at that timeindicatedthat a substantial number ofconsumerswere potentially exposedtoDCP, sinceDCPwas then a componentof 10 products available as paintLvarnishes,and furniture finish removers.Also, a large number of workers invarious occupationswere potentiallyexposedto 1.2-dichioropropane.According to a 1972—74 NationalOccupational Hazard Survey, there areover 700,000workers exposedto 1,2-dichioropropane resulting from itsmanufacture. This conclusionis basedon the National Institute forOccupational Safety and Health’sidentification of 18 occupationsin 17industries, involving over9,000 workersusing1,2-dichloropropane innonagricultural applications.Furthermore, l,2-dichloropropane hadbeenidentified as a contaminant ofground water and drinking water. TheSuffolk County Department of HealthServices,Long Island, New York,identified I ,2-dichloropropanefrom non-

pesticidal sourcesin ground water. Also,thePhiladelphiaWaterDepartmentidentified1,2-dichloropropaneinfinished drinking water (8.1 ~.tg/L).Theestimatedtotal annual load of 1,2-dichloropropaneto theaquaticenvironment was approximately 4.9million pounds. EPA concludedthat thisexposurepattern constituted“substantial exposure”as that term isusedin section4 of TSCA.

3. Therewereinsufficientdataon theteratogenic,reproductive,mutagenic,andneurotoxiceffectsupon which toreasonablydetermineor predicttheeffectsof exposure.Healtheffectstesting,therefore,wasdeterminedto benecessaryto developthesedata.

4. Acute, subchronic,andchroniceffectstestsandanoncogenicitytestwere not proposedfor 1,2-dichioropropane.TheDow ChemicalCompanyhasconductedteststodeterminetheacuteandsubchroniceffectsof 1,2-dichloropropaneby theinhalation route ofexposurein rats,mice, and rabbits. NTP has performed a90-daysubchronicstudy,as well as a 2-yearbioassayto determinetheoncogenicpotential of 1,2-dichloropropane. An epidemiologicalstudy was not proposed becausetheexposurepattern to 1,2-dichloropropanewasso general EPA doubted that anexposedpopulationcouldbeidentifiedthat wasnot exposedto this chemicaland other chemicalssimultaneously.

5. Substantial quantities of 1,2-dichloropropane were releasedto theenvironment. The atmosphericcompartment is readily contaminatedwith 1,2-dichioropropane because1,2-dichioropropaneis veryvolatile (vaporpressure=50mmHg at 25 C). Totalatmospheric releasesof 1,2-dichloropropane were estimatedto beapproximately 1.4X 10~pounds peryear.Also, quantities of 1,2-dichioropropanereleasedto the aquatic environmentwere estimatedto be 4.9 million poundsannually.

8. There were insufficient data tocharacterize theeffects of 1,2-dichloropropaneon aquaticinvertebratesand aquatic plants. EPAproposedstudieson acuteand chronictoxicity to aquaticinvertebratesandeffectson algae.There were sufficientdatato characterizetheeffectsof 1,2-dichioropropane on soil invertebrates,terrestrial insects,and fish.

7. TheAgencydid not proposeanavianreproductiontestfor 1,2-dichloropropanebecausethenrecentunpublishedresearchat an EPAlaboratory(ERL-Corvallis)hadshownthat achemicalasvolatile as1,2-dichloropropaneis very unlikely to yield

usefulresultsif testedfor avian toxicity

accordingto availablemethodology.

Ill. Responseto Public Comments

The commentsreceivedby theAgencyin responseto theproposedrulefor 1,2-dichloropropanewere from DowChemicalCompany.TheAgencydid notreceiveanycommentswhich, in theAgency’sjudgment,rebuttedthesubstantialproduction,humanexposure,andenvironmentalreleasefindings for1,2-dichloropropane.However,newinformation on the mutageniceffectsofDCP has becomeavailable sincepublicationof theproposedrule andhasledEPA to reconsiderits testingrequirementfor genemutation.Majorissuesidentifiedduringthecommentperiodarediscussedbelow. Allquotationsaretakenfrom Dow’s writtencomments(Ref. 2).

A. Productiort,ReleaseandExposure

Dow concludedin its commentsthatthere is neither substantial norsignificant human exposureto 1,2-dichloropropane and that there is nosubstantial releaseto the environment,thus making the proposed testingunnecessary.This conclusionis basedon “a comprehensiveanalysisof newinformation on the quantity of 1,2-dichioropropane produced, the limitedamount released,and more importantly,the low exposurelevelsanticipated andpreliminary results of recentandcurrentlyongoingtoxicologicalstudies.”

EPA disagreeswith this conclusionand is now basing its section4(a)(l)(b)finding on more recentproduction andexposureinformation (seeUnit IV.A)containedin an exposureassessmentdocument (Ref. 3) prepared by Versar,Inc. under contract with EPA. Theisolatedproduction volumecited byDow in the comments(approximately 75million poundsannually) is the samefigure used in the Agency’sanalysis ofreleaseand exposurefor isolated DCP.The Agency’sanalysis also examinesreleasesand exposurefrom inadvertentproduction of DCP.

In discussingtheaquaticreleaseofDCP, Dow cited afigure (10,000lbs/yr at<1 ppm) only for the releasedueto thepropyleneoxideprocess(DCPis aco-product of propyleneoxide production).While acknowledgingthat “Dow cannotauthoritativelycommenton the releasesfrom other ion exchangemanufacturers,”Dow did statethat“Dow’s ion exchangemanufacturingprccessdoesnot resultin any releaseof1.2-dichloropropaneinto theenvironment.”The contentionthat DCPis releasedto the aquaticenvironmentonly as a resultof Dow’s on-site

32082 Federal Register / Vol. 51, No. 174 / Tuesday, September 9, 1986 I Rules and Regulations

processingis directly contradictedbytheongoingPhiladelphiaGeographicAreaMultimediaPollutantSurveyconductedby EPA/IEMD (seeUnit IV.A). This surveyfound levelsof DCP inthe ambient air of the city ofPhiladelphia,in airat theNortheastWater Pollution Control Plant, whichreceivestheindustrialdischargefromtheRohmandHaasCompany(anindustrial userof DCP),andin the intakeandtreatedwaterof theBaxterWaterTreatmentPlant,also on theDelawareRiver. TheAgencybelievesthat thesemonitoring data,alongwith otheravailableexposureinformation,supportits finding of significantreleaseandexposure.

With regardto occupationalexposure.Dow doesnot believethat thereissignificantor substantialhumanoccupationalexposureto 1,2-dichioropropanebecause“there areprobablylessthan 500personspotentiallyoccupationallyexposedto1,2-dichioropropane.”The Agencydoesnot agree,becausealthoughthat figureis probablyagood estimatefor thenumberof workersdirectly exposedviainhalationat DCP productionandindustrialusefacilities, it doesnot takeinto accountdirect inhalationexposureto DCPdueto industrialwastewatertreatment,public wastewatertreatment,and sewermaintenance,or indirectinhalation exposureto DCP by non-production workers employedat DCPproductionandusefacilities(seeUnitII.C).

B. Mutagenicity1. In the proposed test rule for DCP,

EPA had proposed requiring aDrosophilasex-linked recessivelethaltest.Dow Chemical Companyin itscommentspointed out that the NationalToxicology Program (NTP) hadevaluatedthe mutagenicpotential ofDCP in Drosophilaafter injection andinhalation exposure.The Agencyhasreviewedthe NTP Drosophilasex-linkedrecessivelethal (SLRL) test, whichyielded negativeresults.The Agencyfinds that the genemutation data onDCP are adequate to reasonably predictthe potential of DCP to causegenemutation. Therefore, EPA will notrequire further testing for genemutationat this time.

2. Dowalso commentedon theproposedtiered testing schemefordeterminationof mutageniceffects,stating their belief that“EPA hasnotarticulatedwhichhumanrisks arerelatedto this testingandfurthermorehasnot specifiedor describedthemethodologyby which thedatacouldbeusedto assessthoserisks.” Dow alsobelieves“the schemeincorporatesa

rigid decisiontreethat precludesanyscientificjudgementandevaluationtodeterminewhetherfurther testing isnecessary.”TheAgencydisagreeswiththesecommentsfor the followingreasons.

As described in detailin the finalPhaseI test rulefor the C9 aromatichydrocarbonfraction (50 FR 20662,20668—71),the Agencybelievesthatthereis a consensusin thescientificcommunityon both the needfor, andthemannerof. identifying mammalianmutagens,andthat its proposedschemefor identifying theseagentsis in keepingwith thoserecommendedby expertsinthe field of mammalianmutagenesis.Further,while EPA recognizesthat thereis, as yet. no generallyacceptedsinglemethodologyfor estimatinghumanriskfrom mutagenicagents,it is theAgency’s view that appropriatemethodologiesdo exist andareusable.

In the caseof DCP, only thesecondtier of mutagenicitytesting(dominantlethalassay)is beingrequiredat thistime, without an automatictriggerto theendpoint test(heritabletranslocationassay).This decisionis basedonavailableinformationfor astructurallysimilar chemical,1,2-dibromo-3-chloropropane(DBCP), indicatingthatmicearenot sensitiveto DBCPin thedominantlethalassay(Ref. 5). Theratisthereforethe recommendedspeciestousein the dominantlethalassayforDCP,but cannotberecommendedfortheheritabletranslocationassaybecauseasuccessfulassayhasnot beenconductedwith therat to date.Resultsfrom thedominantlethalassaywill bereviewed by the Agency, and a decisionmadeat thattime concerningtheneedfor anyfurtherchromosomalaberrationstesting.

3. Dow Chemical Company believesthat “if testing for chromosomaleffectsis to be done, the micronucleus assayispreferableto thedominantlethal test.”In their written comments,Dowcomparesthetwo testsnoting several“advantages”to the micronucleusassaycomparedto thedominantlethaltest.TheAgencydoesnot believethat thissubstitutionis acceptable.becausethemicronucleusassayin ratswouldprovideinformationbasicallythe sameasthat alreadyprovidedby theNTPassaysin both cytogeneticandsisterchromatidexchangeassays.It wouldnot assesschromosomaleffectson germcell tissueswhich aremeasuredby thedominantlethalassay.

C. Reproductive/Terntogenic Effects

Dow ChemicalCo. citedseveralstudiespreviouslyconductedorcurrently underwayin supportof theirbelief that “it is unnecessaryto initiate

aninhalationreproductionstudy”pendingcompletionof a Dowsubchronic(13-week)study.The otherstudiescited in thecommentsarea 10-weekinhalation studyof reproductiveeffectson maleandfemaleratsof ShellDD, apesticidemixture,andthe NTPcarcinogenbioassayin whichobservationswere madeforreproductiveeffects.

TheAgencydoesnot agreewith thiscommentfor the following reasons.TheDow 13-weeksubchronicstudy hasnotyetbeenmadeavailableto the Agency.andthe Agencydoesnotbelievea 13-weekstudy cansubstitutefor a two-generationstudy on reproduction.Thecommentnotesthata testicularweightdecreasewasnotedin rabbitsdosedwith 1.2-dichioropropanefor 2 weeks;this effecthadnot beenobservedin theDow 13-weekstudy.Pendingcompletiorof histopathologyin this latterstudy.Dow did not seeareasonto undertakereproductionstudy.The Agencydoesnot agreebecausealthoughsomechemicalsdemonstratetesticularhistopathologyat lower doselevelstharfertility effects,otherchemicalscausefertility effectsat lowerdoselevelstharthosedoseswhichcausedetectabletesticularhistopathology.

Thetest substance(Shell DD) usedinthe 10-weekinhalation studycited byDow is a mixturecontainingothercompoundsthat areacutelytoxic orallyand/orexhibit other toxicologicaleffectsthatdo not allow assessmentofDCPby itself.

Sincethe carcinogenbioassaystudy inot atwo generationstudy,the Agencybelievesit cannotsubstitutefor atwo-generationreproductiveeffectsstudy.particularlyin thecaseof DCP, achemicalwith substantialreleaseandexposure.

D.?’ieurotoxicity

For theproposedneurotoxicitytesting.Dow commentedthat thconlyreportedeffectsin an inhalationassayinvolved exposuresat 1,000and1,500ppm. Dow notedthatno effectswereseenin a 2-weekstudyor in a NTP 2-year cancerbioassay.Lastly, Dow nolecthat a13-weekstudyis forthcoming.Fortheinhalation assay,theAgencybelievesthat the methodsusedto asses~‘neurotoxiceffectsarenot sufficientlysensitiveto detectpossibleeffects.Forthetwo other studiescited, neitherwasdesignedto detectneuropathologicalchangesandthus the Agencybelievesthat they areinappropriateforevaluatingthe poasibleeffects.

Federal Register I Vol. 51, No. 174 / Tuesday, September 9, 1986 I Rules and Regulations 32083

E. Other ToxicEffects

Shell Oil Companysubmitteda reporttitled “Toxicology of five chemicals:Theacuteoral andpercutaneoustoxicity,skin andeye irritancy andskinsensitizingpotentialof DCP(lightends)”,however,the datado notaddressanyof theendpointsrequiredinthis testrule.

F. EnvironmentalEffects

Dow ChemicalCompanybelievesthatenvironmentaleffectstesting is notnecessary“becausetherearesufficientdataalreadyavailableto predicttheeffectsof the currentexposuresofaquaticspeciesto 1,2-dichioropropane.”This conclusionrelieson a nationalmeanlevel for DCP to assertthatexposurelevelsare11,000times belowthe no-observed-effectslevel (NOEL)and26.000times lower thanthedaphnidstaticacuteLC50, andon an “in general”rule of thumbto assertthat algaltestingis unnecessary.TheAgencydisagreeswith this comment,however,becausethedaphnidtestwasconductedwithunmeasuredconcentrations,thusmaking theresultsquestionableif notinvalid, anda “national mean” is aninvalid basisfor comparison.Site-specificdataareneededfor suchacomparison,asnow areavailableto theAgencyfor theDelawareRiver. Also, aNOEL hasnot beenestablishedfor thischemical.TheAgencydoesnot believethat extrapolatingfish or invertebratedata to estimatepossibleeffectslevelsin algaeis appropriatefor this test rule,becausealthougha correlationin toxicresponsemayexist betweenthetwogroupsof organismsfor certainchemicalsor categoriesof chemicals,noevidenceis availableto supportthe ideathat this relationshipholds true for allchemicals.TheAgencyis concernedinthis test rule with thedevelopmentofdatato allow hazardassessmentof aspecificchemical,DCP,anddoesnotbelievedataexist to supporttheextrapolationof fish or invertebratedatafor DCPto possibleeffectslevel inalgae.

IV. Final Test Rule for 1,2-Dichioropropane

A. FindingsEPA is basingits I,2-dichloronropane

healthandenvironmentaleftecttestingrequirementson theauthorityof section4(a)(1)(B)of TSCA. EPA finds thatDCPis producedandreleasedto theenvironmentin substantialquantities.andthat themanufacture,processing,use,anddisposalmayresultinsubstantialhumanexposureto thischemical.Thesefindings arebasedonthe following information:

1. Although Dow ChemicalCompanyis the only manufacturerof isolatedDCPin theUnited States,theisolatedproduction volume (estimated74.9million poundsin 1982), themarketingproductionvolume (estimatedat 3million poundsin 1982),andtheinadvertent(not isolated)productionvolume (estimatedat 20 million poundsin 1982)aresubstantial(Refs.1, 2 and3).

2. In orderto assesshumanandenvironmentalexposureto 1,2-dichloropropane,theAgencycontractedwith Versar,Inc. to developacomprehensiveexposureassessment(Ref. 3). Thedocumentexaminedexposuresasa resultof TSCA-regulatedenvironmentalreleases,includingmonitoringdatafrom theIntegratedEnvironmentalManagementProjectforPhiladelphia,Pennsylvania:releasesandexposuresrelatedto the pesticidaluseof DCP werenot investigated.Thefollowing information is summarizedfrom this document,andindicatesthesubstantialreleaseof andexposuretoDCP:

a. Thetotal estimatedannualenvironmentalreleasesfrom productionandindustrialuseare772,000lbs to theair, 198,000lbs to water, and178,000lbsto land disposalsitesfor a total of1,146,000lbs.Thesereleasesincludeprocessemissionsto theair, secondaryair emissionsresultingfromvolatilizationduring wastewatertreatment,releasesto waterinwastewatereffluent, air releaseviaincineration,andlanddisposalof solidwasteresidues,tars, andashresiduesfrom incineration.

b. Occupationalexposureto DCPinvolvesapproximately500workersexposedto direct inhalation(estimatedto rangefrom 31 to 410g/person/yr)atDCPproductionandindustrialusefacilities. An estimated900workersmaybeexposedto direct inhalation (0.020to0.27 g/person/yr)asaresultof thevolatilizationof DCPfrom wastewaterduringtreatmentoperations.Thereisalsopotential for exposure(4.8to 100mg/yr) to DCPof non-productionworkersat DCP productionandusefacilities.

c. Thegeneralpopulationsof fivemetropolitanareasareexposedtoatmosphericconcentrationsof DCPas aresultof airbornereleasesduringproductionandindustrialuseof DCP,andvolatilizationof DCPduringwastewatertreatment.This atmosphericexposureresultsin dosesestimatedat36 to 240 mg/person/yr.Approximately880,000peoplein the city ofPhiladelphia.PA areestimatedto ingestan averageof 0.043 pg/kg/day,or 1.1mg/yr,anda maximumof 0.43 ~.&g/kg/

day.or II mg/yr,of DCPasa resultoftheconsumptionof drinking watercontaminatedwith DCPfrom industrialwastewaterdischargeof thechemical.

d. Monitoring informationhasalsobeenprovidedby theongoingPhiladelphiaGeographicAreaMultimediaPollutantSurvey,conductedby EPA/IEMD (Ref. 3). DCPwasmeasuredin Philadelphiaat averagelevelsof 0.2 to 3.5 ~g./m~ in theambientair of varioussectorsof the city, and36.7 to 569.8~g,/m~ in air downwindoftheNortheastWaterPollutionControlPlant(NEWPCP),whichreceivestheindustrialdischargefrom the RohmandHaasCompany.

e. A monitoring studywasconductedat theNEWPCPandin theDelawareRiver. Samplingsiteswerechosen(1)neartheBaxterDrinking WaterPlantupstream from the NEWPCP; (2) midwaybetweentheNEWPCPandtheBaxterplant, to showupstream(tidal)movementof DCP from NEWPCP; and(3) two milesupstreamof Baxter.

The datafrom the threelocationsindicatethatdiluted effluentfromNEWPCPreachestheBaxterDrinkingWaterPlant,but thatconcentrationsdropsignificantly upstreamof the tidalexcursion.Tidalexcursionof theNEWPCPeffluent affectstheintakewaterfor theBaxterDrinking WaterPlant sincethe wateris withdrawnduring high tide.Dataobtainedfrom thePhiladelphiaWaterDepartmentduringtheIEMD monitoringstudy showthatthe averageDCPconcentrationin theintakewaterover1982 through1983was1.8 ~g/l, andtheaverageconcentrationin thetreatedwaterwas1.5 ~g/l.

3. Thereareinsufficientdataon thedevelopmental,reproductive.mutagenic(chromosomalaberrations),andneurotoxiceffectsuponwhich toreasonablydetermineor predicttheeffectsof exposurefrom themanufacturing,processing,use,anddisposalof DCP. Healtheffectstesting.therefore.is necessaryto developthesedata.As indicatedin the proposedtestrule (49 FR 899: January6, 1984). therearesufficientdatato characterizetheacute,subchronicandchroniceffectsofDCP. andan NTP 2-yearbioassayhasbeencompletedandis adequatetodeterminetheoncogenicpotentialofDCP.

4. Thereareinsufficientdata tocharacterizetheeffectsof DCPonaquaticinvertebratesandaquaticplantsfrom its manufacture,processing,anduse.EPA is requiringthatstudiesbeconductedon acuteandchronictoxicityto aquaticinvertebratesandacuteeffectson algae.Therearesufficientdatato characterizetheeffectsof DCP

32.OM FederalRe~usterI Vol. 51, No. 174 / Tuesday,Sep~mber9. 198tI Rules and Regalatlorti

on soil invertebrates,terrestrialinsects.

andfish.

H. RequiredTesthig

EPAis requiringthat12-dichloropropanebete~tedfordevelopmental,reproductive,mutagenic(chromosomalaberrations),andneurotoxiceffects,aswell asacuteandchronictoxicity to aquaticinvertebratesandacutetoxicity to algae.

C. TestSubstance

EPA is requiringthat 1.2-dichloropropane of at least99 percentpurity be usedas the testsubstance.DCPof this purity is availablecommercially.EPAhasspecifiedarelatively puresubstancefor testingbecausetheAgencyis interestedinevaluatingtheeffectsattributedto DCPitself. This requirementwill increasethelikelihoodthatany toxic effectsobservedarerelatedto DCPandnot toanyimpurities

D. PersonaRequiredto Test

Section4(b)(3)(B) of TSCA specifiesthat theactivitiesfor which the Agencymakessection4(a)findings(manufacture,processing,distribution,useand/ordisposal)determinewhobearstheresponsibilityfor testing.Manufacturersarerequiredto test if thefindings are basedon manufacturing(“manufacture”is definedin section3(7)of TSCA to include “import”).Processorsare requiredto testif thefindingsarebasedon processing.Bothmanufacturersandprocessorsarerequiredto test if theexposuresgivingriseto thepotentialrisk occurduringuse, distribution,or disposal.

BecauseEPA hasfound that availabledataareinadequateto reasonablydetermineor predictthe effectsonhumanhealthandtheenvironmentas aresultof themanufacturing, processing.use,anddisposalof DCP,EPA isrequiringthat personswho manufactureorprocess,or who intendtomanufacture or processthis chemical, atanytime from the effectivedateof thistestrule to the endof the reimbursementperiod, be subjectto therule. Theendofthe reimbursementperiodwill be5yearsafterthelast final reportissubmittedor anamountof time equal tothat which wasrequiredto developdataif more than5 yearsafter thesubmissionof the last final report requiredunderthe teatrule. As discussedin theAgency’s test rule andexemptionprocedures(40CFR Part 790),EPAexpectsthat manufacturerswill conducttestingandthat processorswillordinarily beexemptedfrom testing.

BecauseTSCAcontainsprovisionstoavoidduplicativetesting,notevery

- personsubjectto this rulemustindividually conducttesting.Section4(b)(3)(A) of TSCA providesthatEPAmaypermit two ormoremanufacturersor processorswho aresubjectto a testrule to designateonesuchpersonoraqualifiedthird personto conductthetestsandsubmit data on their behalf.Section4(c) providesthatanypersonrequiredto testmay applyto EPA for anexemptionfrom thatrequirement.TheAgency anticipatesthat the currentmanufacturerof DCPwill sponsortherequiredtesting.Manufacturersandprocessorswho aresubjectto the testingrequirementsof this rulemust complywith the testrule andexemptionproceduresin 40 CFR Part790.Manufacturers (including importers)subjectto this rulearerequiredtosubmiteithera letterof intent toperformtestingoran e.xemptionapplicationwithin 30 daysafter theeffective date of thefinal testrule. Therequiredproceduresfor submittingsuchlettersandapplicationsaredescribedin40 CFR Part 790.

Processorssubjectto this rule, unlessthey arealsomanufacturers,will notberequiredto submitlettersof intentorexemptionapplications,or to conducttestingunlessmanufacturers fail tosubmitnoticesof intent to testor laterfail to sponsorthe requiredtests.TheAgency expectsthat the manufacturerswill passan appropriateportionof thecostsof testingon to processorsthroughthepricing of their productsorreimbursementmechanisms.Ifmanufacturersperformall the requiredtests,processorswill begrantedexemptionsautomatically.Ifmanufacturersfail to submitnoticesofintent to test or fail to sponsorall therequiredtests,theAgencywill publish aseparatenoticein theFederalRegisterto notify processorsto respond:thisprocedureis describedin 40 CFR Part790.

EPA is not requiringthe submissionofequivalencedataas a condition forexemptionfrom the requiredtesting.Asnotedin Unit IV. C., EPA is interestedinevaluatingthe effectsattributabletoDCPitself andhasspecifieda relativelypuresubstancefor testing.

E. Test RuleDevelopmentandExemptions

Elsewherein today’s FederalRegister.the Agencyis proposingthatcertainTSCA testguidelinesbe utilized as teststandardsfor the developmentof dataunderthis rule for 1,2-dichloropropane.As discussedin that noticeandinpreviousnotices(50 FR 20652),EPA hasreviewedthemethodfor developmentoftestrulesandhasdecidedthat for mostsection4 rulemakings,theAgency will

utilize single-phaserulemaking.In lightof this decision.EPAhas reevaluatedtheprocessfor developingteststandardsfor section4 rulemakingsinitiated underatwo-phaseprocessandhasdeterminedthat for certainof thesetwo-phaserules,TSCA testguidelinesareavailablefor promulgationasrelevantteststandards.EPA hasdecidedthatwhereTSCA or otherappropriatetestguidelinesareavailable,the Agencyin mostcaseswillproposetherelevantguidelinesas theteststandardsfor thoserules.

EPAbelievesthat, in line with itscommitmentto expeditethe section4rulemakingprocess,it is appropriatetoproposethe applicableTSCA testguidelinesas teststandardsat the sametime asa PhaseI final testrule is issued.With regardto therulemakingfor DCP,TSCA testguidelinesare available forall thetestingrequirementsincludedinthis PhaseI final rule. Thus, in theaccompanyingnotice, the Agency isproposingtheseTSCA test guidelinesastest standards.

The public, including themanufacturers and processorssubject tothePhaseI rule, will haveanopportunityto commenton the useofthe TSCA testguidelines. The Agencywill review thesubmittedcommentsandwill modify theTSCA guidelines,whereappropriate, when the teststandardsarepromulgated.

During thedevelopmentof a test ruleunderthetwo-phaseprocess,personssubjectto thePhaseI final rule arenormallyrequiredto submitproposedstudyplanswithin 90 daysafter theeffectivedateof thePhaseI rulemaking.See40 CFR790.50fa)(2).However,becauseEPA is proposingapplicableTSCA testguidelinesasthe teststandardsfor the studiesrequiredbythis PhaseI final rule, personssubjecttothe rule. i.e., manufacturersandprocessorsof DCP. arenot requiredtosubmit proposedstudyplansfor therequiredtestingat this time. Personssubjectto this rule, however,arestillrequiredto submitnoticesof intent totest or exemptionapplicationsinaccordancewith 40 CFR 79045.For therule, once;he test standardsarepromulgated.personswho havenotifiedEPA of their intent to test must submitstudyplans)whlrh adhereto thepr~rn.li~atedtest standards)no laterthan 45 daysijef~rethe initiation ofeach,requiredtest~Processorsof DCPsubjectto this rue. unlessthey arealsomanufacturers,will not berequiredtosubmit lettersof intent, exemptionapplications,or studyplans(beforetesting is initiated)unlessmanufacturers

Federal Register / Vol. 51, No. 174 / Tuesday,September9, 1986 / Rulesand Regulations 32085

fail to sponsorthe requiredtests(seeUnit IV. D).

Becausepersonssubject to this rulefor DCP arenot requiredto submitproposedstudyplansfor approval,EPAwill grant conditionalexemptionsunderthis rule following EPA’s’receiptof aletterof intent to conducttherequiredtests.ratherthan afterreceiptandapprovalof a studyplan. Notice ofEPA’s adoptionof theproposedteststandardsanddeadlineswill beannouncedin a final PhaseII test rule.

In the accompanyingFederalRegisternotice, EPA is proposingdeadlinesforthe submissionof testdata.Suchdeadlinesarerequiredundersection4(b)(1)IC) of TSCA. Theseproposeddatasubmissiondeadlinesareopenforpublic commentandmaybe modified,whereappropriate,when the final PhaseII testrule is promulgated.

F. ReportingRequirements

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

EPA is requiredby TSCA section4(b)(1)(C) to specifythe time periodduring whichpersonssubjectto a testrule mustsubmit testdata.The Agencyis proposingthesedeadlineselsewherein today’s FederalRegister.

TSCA section12(b) requiresthatpersonswho exportor intend to exportto a foreigncountryany1,2-dichloropropanesubjectto the testingrequirementsof this rulenotify EPA ofsuchexportationor intent to export.While theresultsof requiredtestingmaynot be availablefor sometime, anoticeto theforeign governmentthat theseexportedsubstancesaresubjectto testrulesservesto alert them to theAgency’s concernaboutthesubstances.It givesthesegovernmentstheopportunity to requestsuchdatathat theAgencymay currentlypossesspluswhateverdatamaybecomeavailableasa resultof testing activities.Thus, upontheeffective dateof this rule, personswho export or intend to export DCPmustsubmitnoticesto the Agencypursuantto TSCA section12(b)(1)and40 CFR Part 707.For additionalinformation,see49 FR 45581,November19. 1984—Notificationof ChemicalExport; Applicability of Final Test Rules.

TSCA section14(b)governsAgencydisclosureof all testdatasubmittedpursuantto section4 of TSCA. Uponreceiptof datarequiredby this rule, theAgencywill announcethereceiptwithin15 daysin the Federal Register asr~’quiredby section4(d). Test datari :eivedpursuantto this rule will ben ide availablefor public inspectionby

anypersonexceptin thosecaseswheretheAgencydeterminesthat confidentialtreatmentmust beaccordedpursuanttosection14(b) of TSCA.

C. EnforcementProvisions

The Agencyconsidersfailure tocomply with anyaspectof asection4rule to beaviolation of section15 ofTSCA. Section15(1)of TSCA makesitunlawful for anypersonto fail or refuseto comply with anyruleor orderissuedundersection4. Section15(3) of TSCAmakesit unlawful for anypersonto failor refuseto: (1) Establishor maintainrecords.(2) submitreports,notices,orotherinformation,or (3) permit accesstoor copyingof recordsrequiredby theAct or anyregulationissuedunderTSCA.

Additionally. TSCA section15(4)makesit unlawful for anypersonto failor refuseto permitentryor inspectionasrequiredby section11. Section11appliesto any“establishment,facility.or otherpremisesin which chemicalsubstancesor mixturesaremanufactured,processed,stored,or heldbeforeor after theirdistributionincommerce....’The Agencyconsidersa testingfacility to bea placewherethechemicalis heldor storedand,therefore,subjectto inspection.Laboratoryaudits/inspectionswill beconductedperiodicallyin accordancewith theproceduresoutlined in TSCAsection11 by designatedrepresentativesof the EPAfor the purposeofdeterminingcompliancewith thefinalrule for DCP.Theseinspectionsmaybeconductedfor purposeswhich includeverification that testinghasbegun,thatschedulesarebeingmet, that reportsaccuratelyreflectthe underlyingrawdataandinterpretationsandevaluationsthereof,andthat thestudiesarebeingconductedaccordingto theTSCA GLP standardsandthe teststandardsproposedruleof thisrulemaking.

EPA’s authority to inspect a testingfacility alsoderivesfrom section4(b)(1)ofTSCA, whichdirectsEPA topromulgatestandardsfor thedevelopmentof testdata.

Thesestandardsaredefinedinsection3(12)(B)of TSCA to includethoserequirementsnecessaryto assurethat datadevelopedundertesting rulesarereliableandadequate,andsuchotherrequirementsasarenecessarytoprovidesuchassurance.TheAgencymaintainsthat laboratoryinspectionsarenecessaryto provide this assurance.

Violatorsof TSCA aresubjecttocriminal andcivil liability. Personswhosubmit materiallymisleadingorfalseinformation in connectionwith therequirementof any provisionof this rule

maybe subjectto penaltiescalculatedasif theyhadneversubmittedtheirdata.Under thepenaltyprovision ofsection16 of TSCA, anypersonwhoviolatessection15 could besubjectto acivil penaltyof up to $25,000perday foreachviolation with eachdayofoperationin violation constitutingaseparateviolation. This provisionwouldbe applicableprimarily tomanufacturersor processorswho fail tosubmit a letterof intentor an exemptionrequestandwho continuemanufacturingor processingafterthedeadlinesfor suchsubmissions.Thisprovisionwould alsoapply toprocessorsthatfail to submita letterofintent or an exemptionapplicationandcontinueprocessingafter theAgencyhasnotified themof their obligationtosubmit suchdocuments(see40 CFR790.48(b)).Intentionalviolations couldleadto the impositionof criminalpenaltiesof up to $25,000for eachdayofviolation and’imprisonmentof up to oneyear.In determiningthe amountofpenalty,EPA will takeinto accounttheseriousnessof the violation andthedegreeof culpability of theviolatoraswell astheotherfactorslisted in section16. Otherremediesareavailableto EPAundersections7and17 of TSCA, suchasseekingan injunctionto restrainviolationsof TSCA section4.

Individualsaswell ascorporationscouldbe subjectto enforcementactions.Sections15 and16 ofTSCA apply to“any person”who violatesvariousprovisionsof TSCA. EPA may, at it8discretion,proceedagainstindividuals -

aswell ascompaniesthemselves.Inparticular,this includesindividualswhoreportfalseinformation or who causeitto bereported.In addition,thesubmissionof false,fictitious, orfraudulentstatementsis a violationunder18 U.S.C. 1001.

V. Economic Analysis of RuleTo assessthepotentialeconomic

impact of this rule, EPA haspreparedaneconomicanalysisthat evaluatesthepotentialfor significanteconomicimpactson theindustry as aresultof therequiredtesting.The economicanalysisestimatesthecostsof conductingtherequiredtesting andevaluatesthepotentialfor significantadverseeconomicimpactasa resultof thesetestcostsby examiningfourmarketcharacteristicsof DCP: (1) Pricesensitivityof demand,(2) industrycostcharacteristics.(3) industrystructure,and(4) marketexpectations.

Total direct testingcostsfor the finalrulefor DCPareprojectedto rangefrom$325,620to $416,670.SinceDCP, asmanufacturedby thesole manufacturer.

32086 Federal Register / Vol. 51, No. 174 / Tuesday, September 9. 1988 / Rules and Regulations

is abyproductof propyleneoxidemanufacture,thedirectcostsof testinghavebeendispersedovertheannualproductionof propyleneoxide. Inaddition, thecostsfor teratogeniceffectstesting for propyleneoxide,requiredin apreviousrule (Ref. 4),;bavebeenaddedto thecorrespàndingcostsfor DCP.

Theannualizedtest costs(using acostof capitalof 25 percentoveraperiodof15 years)rangefrom $93,914to $122,296.BaseduponDow Chemical’s1984estimatedproductionvolume of 907million poundsof propyleneoxide, theestimatedunit testcostsfor DCPandpropyleneoxiderangefrom 0.010to0.013 centsperpound.Theseunit costsareequivalentto 0.02 to0.03 percentofthecurrentpriceof propyleneoxide.

Basedon thesecostsand theeconomiccharacteristicsof theDCPindustry, theeconomicanalysisindicatesthat the potential for adverseeconomiceffectdue to the estimatedtestcostsis low. Thisconclusionisbasedupon the following observations:

1. Propyleneoxide, the main productin DCPproduction,isusedmainly asacaptive intermediate and has arelativelyinelasticdemand.

2. The marketexpectationsforpropyleneoxide andmanyof itsderivativesarefavorable.

3. Dow manufacturesDCPandpropyleneoxideat two highly integratedplants whereminor cost increasescanbe dispersedover numerousendproducts.

4. Theestimatedtotalunit testcosts(i.e., the testcostsfor DCP andpropyleneoxide)arenegligible,or lessthan 0.013centsperpoundor 0.03peznentof propyleneoxidepricein theupper-bo~indcase.

Refer to the economicanalysisfor acompletediscussionof testcostestimationand the potential foreconomicimpactresultingfrom thesecosts.

VI. Availability of Test Facilities andPersonnel

Section4(b)(1) of TSCA requiresEPAto consider“the reasonablyforeseeableavailability of thefacilitiesandpersonnelneededto perform the testingrequiredundertherule.” Therefore.EPAconductedastudy to assesstheavailability of testfacilitiesandpersonnelto handlethe additionaldemandfor testing servicescreatedbysection4 testrules.Copiesof the study.“ChemicalTesting Industry: Profile ofToxicologicalTesting,”October,1981.canbe obtainedthrough theNationalTechnicalInformationService,5285PortRoyal Road.Springfield,Va. 22161 (PB82—140773).On thebasisof this study.the Agencybelievesthattherewill he

availabletestfacilities andpersonneltoperformthe testingrequiredin this testrule.

VII. Public Record

EPA hasestablishedarecordfor thisrulemaking(docketnumberOPTS-42043).This recordincludesthebasicinformationtheAgencyconsideredindevelopingthisrule, andappropriateFederalRegisternotices.TheAgencywill supplementtherecordwithadditionalinformationasit is received.

This recordincludesthe followinginformation:

A. SupportingDocumentation

(1) FederalRegisternoticespertainingto this rule consistingof:

(a) Noticeof proposedrule on 1,2-dichloropropane(January6. 1984;49 FR899).

(b) Noticecontainingthe ITCdesignationof i.2-dichloropropanetothe PriorityList (October30. 197ft 43 FR50630).

(c) Noticeof final ruleon EPA’s TSCAGoodLaboratoryPracticeStandards(November29, 1983;48 FR 53922).

(d) Noticeof final rule on test ruledevelopmentandexemptionprocedures(October10, 1984;49 FR 39774).

(e) Interim final rule for testruledevelopmentandexemptionprocedures(May17, 1985;50 FR 20852).

(f) Noticeof final rule concerningdatareimbursement(July 11, 1983; 48 FR31786).

(g)Notice offinal ruleon the C9aromatic hydrocarbon fraction (May 17,1985;50 FR20662).

(2) Supportdocumentsconsistingof:(a)1,2-Dichloropropaaetechnical

supportdocumentfor proposedtestrule.(b) Economicimpactanalysisof final

test rulefor 1.2-dichloropropane.(3) Communicationsconsistingof:(a) Written public comments.(b) Summariesof telephone

conversations.(c) Meetingsummaries.(4) Reports—publishedand

unpublishedfactualmaterials.

B. References(1) Dow. The Dow ChemicalCompan’~.letter

to Mr. StevenD. Newburg-Rinn,Chief.TestRulesDevelopmentBrdnch(TS—7~8l.Office01 Toxic Substances.IJSEPA. Washington.DC. (1983)

(2) Dow. ToeDow ChemicalCompanyCommentson1.2.dichloropropaneproposedtest rule. FederalRegister49.899Sul’mittedto TSCA Public InformationOffce (TS—793).Office of PesCridesand‘1 u\IC Substances.USUPA. Washe~ton,tiC. ControlNumberOVFS-.-42043i 984)

3) Vorsar,Inc. ExposureAs3essme~ofur testrulesdevelopmentfor 1.~-diubloro~ropaneWashington.DC: U.S. Environmental

ProtectionAgency,Office of ToxicSubstances.ContractNo. 68—02—3968.

(4) EPA. Noticeof final rule onpropyleneoxide testingrequirements.FederalRegister50:48762.(November27, 1983).

(5) USEPA. U.S.EnvironmentalProtectionAgency. Responseto TRDB requestonmutagenicitydatareviewof 1.2-dichloropropane.Intra-agencymemorandumto KatherineHart. ExistingChemicalAssessmentDivision. from theToxic EffectsBranch.HealthandEnvironmentalReviewDivision. May 13,1986.

Confidential BusinessInformation(CBI), while part of therecord, is notavailablefor public review.A publicversionof therecord, from whichCBIhasbeendeleted,is availableforinspectionfrom 8 a.m.to 4 p.m..MondaythroughFriday, exceptlegalholidays,inRim NE-G004,401 M StreetSW..Washington,DC.

VIII. Other Regulatory Requirements

A. ExecutiveOrder12291

Under ExecutiveOrder 12291.EPAmustjudgewhethera regulationis“major” and,therefore,subjectto therequirementof aRegulatoryImpactAnalysis.The regulation for thischemicalsubstanceis not major becauseit doesnot meetanyof thecriteria setforth in section1(b) of theorder. First.theannualcostsof testingareexpectedto rangefrom $93.914to $122,296overtheexpectedmarketlife of 1,2-dichloropropane. Second,becausethecost of therequiredtestingwill bedistributedoveralargeproductionvolume, therule will have only veryminoreffectson the producer’scostsorusers’pricesfor this chemicalsubstance.Finally, taking into accountthenatureof themarketfor thissubstance,thelow level of costsinvolved,andthe expectednatureof themechanismsfor sharingthecostsof therequiredtesting.EPAconcludesthattherewill be no significantadverseeconomicimpact of any typeasa resultof this rule.

This regulationwassubmittedto theOffice of ManagementandBudget[0MB) for review asrequiredbyExecutiveOrder12291.Any writtencommentsfrom 0MB to EPA, andanyEPA responseto thosecomments,areincludedin thepublic record.

B. Re,)tuIutor-yFiexibilityAct

Under the RegulatoryFlexibility Act.[15 U.S.C. 601 etseq..Pub. L. 96—354.September19. 1980), EPA certifiesthatthis test rule will not havea sign:ficantirnpict on a substantialnumberof srn~illbusinessfur thefollowing reasons:

Federal Register / Vol. 51. No.174 / Tuesday, September9, 1986/ Rules andRegulations 32(’87

(1) Thereareno small manufacturersof 1.2-dichloropropane.

(2) Small processorsarenotexpectedto performtesting themselves,or toparticipatein the organizationof thetesting effort.

(3) Small processorswill experienceonly minor costsif anyin securingexemptionfrom testing requirements.

(4) Small processorsareunlikely to beaffectedby reimbursementrequirements.

EPA concludesthat therewill be nosignificantadverseeconomicimpactofany typeasa resultof this rule.

C. PapenvorkReductionAct

The informationcollectionrequirementscontainedin this rulehavebeenapprovedby theOffice ofManagementandBudget(0MB) undertheprovisionsof thePaperworkReductionAct of 1980,44 U.S.C.3501etseq.,andhavebeenassigned0MBcontrol number2070—0033.

List of Subjects in 40 CFR Part799

Testing,Environmentalprotection.Hazardoussubstances,Chemicals,Recordkeepingandreportingrequirements.

Dated:August2. 1986.j.A. Moore,AssistantAdmiaistrotorfor PesticidesandToxicSubstances.

PART 799—LAMENDED]

Therefore,40 CFR Part799 isamendedasfollows:

1. Theauthoritycitation for Part799continuesto readasfollows:

Authority: 15 U.S.C. 2603.2611, 2625.

2. Section799.1550is added, to read

asfollows:§ 799.1550 1,2-Oichloropropan..

(a) Identificationof testsubstance.(1)1.2-Dichloropropane(CAS No. 78—87—5)shall be testedin accordancewith thissection.

(2) 1.2-Dichloropropaneof at least99percentpurity shall be usedas thetestsubstance.

(b) Personsrequiredto submitstudyplans,conducttests,andsubmitdata.(1) All personswho manufactureorprocess1.2-dichloropropane,fromOctober23. 1986 to theendof thereimbursementperiodshall submitlettersof intent to test,exemptionapplications,aridshall conducttestsinaccurdancewith Part 792of this chapterandsubmit dataasspecifiedinparagraphs(a); (b) (1), (2). (3), a~d(4):(c) [1. )t), [1). and[4); and(d) of thisscct:un:SubpartA of this Part:andParts791) and792of this chapterfor two-phaserulemaking.

(2) Personssubjectto this sectionarenot subjectto the requirementsofH 790.50(a)(2). (5), (6), and(b) (2) and(4), and790.87(a)(1)(ii) of this chapter.

(3) Personswho notify EPA of theirintent to conducttestsin compliancewith therequirementsof this sectionmustsubmit plansfor thosetestsnolaterthan45 daysbeforetheinitiationofeachof thosetests.

(4) In additionto the requirementsof§ 790.87(a)(2) and(3) of this chapter,EPA will conditionallyapproveexemptionapplicationsfor this rule ifEPA hasreceivedaletterof intent toconductthe testingfrom whichexemptionis soughtandEPA hasadoptedtest standardsandschedulesina final rule.

(c) Healtheffectstesting—(1)Neurotoxicitv—(i)Requiredtesting.Thefollowing neurotoxicitytestingshall beconductedfor 1,2-dichloropropane:

(A) A neuropathologytest.(B) A motoractivity test.(C) A functionalobservational

battery.(ii) [Reserved](2) Mutageniceffects—(i)Required

testing.A dominantlethalassayshall beconductedwith 1.2-dichloropropane.

(ii) [Reserved](3) Developmentaltoxicity—(i)

Requiredtesting.A developmentaltoxicity testshall beconductedwith 1.2-dichloropropane.

(ii) [Reservedj(4) Reproductiveeffects—(i)Required

testing.A two-generationreproductiveeffectsstudyshall be conductedwith1.2-dichioropropane.

(ii) [Reserved](d) Environmentaleffectstesting—(1)

Mysidacutetoxicity—{i)Requiredtesting.A mysid shrimp acutetoxicitytest shall be conductedwith 1.2-dichloropropane.

(ii) [Reserved](2) Algal acutetoxicity—(i)Required

testing.An algal acutetoxicity test shallbe conductedwith 1.2-dichloropropane.

(ii) [Reserved](3) Daphnidchronictoxicity—(i)

Requiredtesting.A daphnidchronictoxicity testshall be conductedwith 1,2-dichloropropane.

(ii) (Reserved](4) Mysidshrimpchronictoxicity—(i)

Requiredtesting.A mysidshrimpchronictoxicity testshall be conductedwbh 1.2-dichioropropane.

di) lReser’.’ecil.

tlnlurma bun cailectionrequirementsupprc~edby theOfiic~of Managementandbud~:urrdercontrolnumber2070—0033)

1< 11,0. 36—.31iZ5OFiled 9—8—88: 8:45 am)StLL,P40 CODE 6560-SO-U ~r4~c