EPA/Testing Consent Order; Triethylene Glycol … · three triethylene glycol ethers conduct...
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13470 Federal Register / Vol. 54, No. 82 / Monday, April 3, ~gag / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 799 [OPTS—~2080D; FRL-3548—3] Testing Consent Order~ Trlethyleñe Glycol Monomethyt~ Monoethyl, and Monobutyl Ethers AGENCY: Environmental Protection Agency (EPA). ACTtON: Final rule. SUMMARY: This rule announces that EPA has signed an enforceable Testing Consent Order with five manufacturers of triethylene glycol monomethyl ether (TGME; CAS No. 112—35—6), triethylene glycol monoethyl ether ~TGEE;~AS No. 112—50—5). or triethylene glycol monobutyl ether (TGBE; CAS No. 143— 22—6), who have agreed to perform certain toxicologic tests with TGME. This action is in response to the TSCA Interagency Testing Committee’s (ITC) designation of these three chemicals for priority testing. Also, appearing elsewhere in this issue of the Federal Register, is a final rule requiring developmental neurotoxicity testing of TGME. EFFECTWE DATE: April 3, 1989. FOR FURThER INFORMATION CONTACT: Michael M. Stahl, Director, TSCA Assistance Office (TS—799), Office of Toxic Substances, Room EB—44, 401 M Street, SW., Washington. DC 20460, (202) 554—1404, TDt) (202) .554—0551. SUPPLEMENTARY NFORMAT~ON: Under procedures described in 40 CFR Part 790. five manuFacturers of TGME, TGEE, or TGBE have entered into a Testing Consent Order with EPA in which they have agreed to perform certain toxicologic tests on TGME. This rule amends Subpart C of 40 CFR.Part 799 to add T{~ME, TGEE arid TGBE to the list of chemical substances and mixtures subject to Testing Consent Orders for which the export notification requirements of 40 CF’R Part 707 apply. Public reporting burden for this collection of information is estimated to average 506 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing-the collection of information. Send comments regarding the burden estimate or any other aspect of this - collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM— 223, U.S. Environmental Protection Agency, 401 M Street SW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs,. Office of Management and Budget -- - TOMB). Washington, DC 20503. - - I. ITC Recommendations - The Interagency Testing Committee (ITC) designated TGME, TGEE and - TOBE for priority testing consideration in its Sixteenth Report published in the Federal Register of May 21, 1985 (50 FR 20930), and recommended pharma cokinetic and metabolic studies. The results of those studies would determine whether subchronic studies with emphasis on hematologic effects, - as well as reproductive and developmental toxicity tests, should be performed. II. Proposed Test Rule EPA issued a proposed test rule, published in the Federal Register of Ma3 15, 1966 (51 FR 17683), requiring that manufacturers and processors of the three triethylene glycol ethers conduct toxicologic testing on the glycot ethers they manufacture or process. This - testing was based on EPA findings of the potential for unreasonablerisk under TSCA section 4(a)(i)(A) and a finding of substantial production and exposure under TSCA section 4(aXl)(B). These findings are more fully described in the proposed rule. A two-stage test rule was proposed. Subchronic toxicity, developmental toxicity, neurotoxicity, developmental neurotoxicity, and lower- tier mutagenicity comprised the first stage. Following review of data from these tests EPA would decide if the second-stage tests, oncogenicity, upper- tier mutagenicity, and reproductive toxicity, were needed. - Ill. Testing Consent Order Negotiation Following the test rule proposal, The Chemical Manufacturers Association (CMA) informed EPA that members of CMA’s Glycol Ether Panel were - - sponsoring a series of tests on TGME. They planned to conduct a 90-day dermal toxicity test and a dermal developmental toxicity study in the rabbit, an in vivo mouse micronucleus test, and an Ames assay. They had already initiated an oral Chernoff- Kavlock developmental toxicity screen in the rat and a 21-day dermal range- finding study in the rabbit, with the high dose at 1 gram/kilogram (g/kg) as a limit test, and an in vitro dermal absorption study using human skin. These tests were done on all three glycol ethers, - with no obvious toxicity differences between the chemical substances. By February 1987, EPA informed CMA that EPA was considering the option of a Testing Consent Order. On May 19, 1987, EPA issued a notice (52 FR 18738) to this effect, requesting public ~articipalion and ~nnouncinga meeting an May 28, 1987, to initiate testing negotiations. - After several scientific theetings, CMA’s-Glycol Ethers Panel submitted to EPA a draftConsent Order.on September30, 1987, which included all but one of the first-stage tests proposed by EPA for TGME, TGEE and TGBE, with TGME as the test substance representing all three. The only testing not agreed upon was for developmental neurotoxicity. After a period of intensive discussion on developmental neurotoxicity testing, a final Consent Order, excluding developmental neurotoxicity, was signed by March 8, 1989 by Cain Chemical Inc., The Dow Chemical Company, Eastman Kodak Company, Shell Chemical Company, and Union Carbide Corporation. In this Consent Order, the manufacturers igreed to perform certain toxicologic ests on TGME by specific dates according to the test standards in the Appendix of the Order. The final test rule for developmental neurotoxicity testing of TGME is published elsewhere in this Federal Register. EPA is deferring final decisions on further testing of TGEE and TGBE (51 FR 17883) until the results of the Consent Order testing are available (see Unit V). IV. Use and Exposure These glycot ethers are primarily co- produced during the manufacture of lower molecular weight glycol ethers. About 5 percent of production is purified further for use as chemical intermediates, but the majority is sold in a technical grade for use as adiluent in brake fluid. Preliminary data from the National Occupational Exposure Survey (NOES), conducted by the National institute for Occupational Safety and Health tNIOSH) from 1980 to 1983, indicate that approximately 250,000 workers, including 8,000 females, were potentially exposed to brake fluids in the workplace in 1980 (Ref. 1). Although there are no data on actual levels of dermal exposure in the workplace, the nature of brake system maintenance and repair suggests that complete exposure of both hands occurs regularly, even daily, for many professional mechanics. EPA has recently prepared an updated exposure profile ofmechanics (at least 175.000 estimated) exposed to brake fluids with at least one contact per day, resulting in estimated exposures ranging from 520 to 2,300 milligrams (mg) /day for 250 days per year (Ref. 2). Furthermore, there is a potential for consumer exposure, since some individuals can be expected to
Transcript of EPA/Testing Consent Order; Triethylene Glycol … · three triethylene glycol ethers conduct...
13470 Federal Register/ Vol. 54, No. 82 / Monday, April 3, ~gag/ Rulesand Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part799
[OPTS—~2080D;FRL-3548—3]
TestingConsentOrder~TrlethyleñeGlycol Monomethyt~Monoethyl,andMonobutyl Ethers
AGENCY: EnvironmentalProtectionAgency(EPA).ACTtON: Final rule.
SUMMARY: ThisruleannouncesthatEPAhassignedanenforceableTestingConsentOrderwith five manufacturersof triethyleneglycol monomethylether(TGME; CAS No. 112—35—6),triethyleneglycol monoethylether~TGEE;~AS No.112—50—5). or triethyleneglycolmonobutylether(TGBE; CAS No. 143—22—6), who haveagreedto performcertaintoxicologic testswith TGME.This actionis in responseto theTSCAInteragencyTestingCommittee’s(ITC)designationof thesethreechemicalsforpriority testing.Also, appearingelsewherein this issueof theFederalRegister,is a final rulerequiringdevelopmentalneurotoxicitytestingofTGME.EFFECTWE DATE: April 3, 1989.FOR FURThER INFORMATION CONTACT:MichaelM. Stahl,Director,TSCAAssistanceOffice (TS—799), Office ofToxic Substances,RoomEB—44,401 MStreet,SW., Washington.DC20460,(202) 554—1404,TDt) (202).554—0551.SUPPLEMENTARY NFORMAT~ON:Underproceduresdescribedin 40 CFR Part790.five manuFacturersofTGME,TGEE, orTGBE haveenteredinto aTestingConsentOrderwith EPA in whichtheyhaveagreedto performcertaintoxicologic testsonTGME. ThisruleamendsSubpartC of 40 CFR.Part799toaddT{~ME,TGEEarid TGBEto thelistof chemicalsubstancesandmixturessubjectto Testing ConsentOrdersforwhich theexportnotificationrequirementsof 40 CF’R Part707apply.
Public reportingburdenfor thiscollection of informationis estimatedtoaverage506 hoursperresponse,including time for reviewinginstructions,searchingexistingdatasources,gatheringandmaintainingthedataneeded,andcompletingandreviewing-thecollectionof information.Sendcommentsregardingtheburdenestimateor any otheraspectof this -
collection of information,includingsuggestionsfor reducingthisburden,toChief, InformationPolicy Branch,PM—223, U.S.EnvironmentalProtectionAgency,401 M StreetSW., Washington,DC 20460; andto theOffice of
InformationandRegulatoryAffairs,.Office ofManagementandBudget - -
- TOMB). Washington,DC 20503. - -
I. ITC Recommendations- TheInteragencyTestingCommittee
(ITC) designatedTGME, TGEEand -
TOBEfor priority testingconsiderationin its SixteenthReportpublishedin theFederalRegisterof May21, 1985(50FR20930),andrecommendedpharmacokineticandmetabolicstudies.Theresultsof thosestudieswoulddeterminewhethersubchronicstudieswith emphasison hematologiceffects, -
aswell as reproductiveanddevelopmentaltoxicity tests,shouldbeperformed.
II. ProposedTestRule
EPA issuedaproposedtestrule,publishedin theFederalRegisterofMa315, 1966 (51 FR 17683),requiringthatmanufacturersandprocessorsof thethreetriethyleneglycol ethersconducttoxicologic testingon theglycotetherstheymanufactureor process.This -
testingwasbasedon EPAfindings ofthepotentialfor unreasonableriskunderTSCA section4(a)(i)(A) andafinding of substantialproductionandexposureunderTSCA section4(aXl)(B).Thesefindings aremorefully describedin theproposedrule. A two-stagetestrulewasproposed.Subchronictoxicity,developmentaltoxicity, neurotoxicity,developmentalneurotoxicity,andlower-tiermutagenicitycomprisedthefirststage.Following review ofdatafromthesetestsEPAwould decideif thesecond-stagetests,oncogenicity,upper-tier mutagenicity,andreproductivetoxicity, wereneeded. -
Ill. TestingConsentOrderNegotiation
Following the testruleproposal,TheChemicalManufacturersAssociation(CMA) informedEPA thatmembersofCMA’s Glycol EtherPanelwere - -
sponsoringaseriesof testson TGME.Theyplannedto conducta90-daydermaltoxicity testandadermaldevelopmentaltoxicity studyin therabbit,an in vivomousemicronucleustest,andan Amesassay.Theyhadalreadyinitiatedan oralChernoff-Kavlock developmentaltoxicity screenin therat anda21-daydermalrange-finding studyin therabbit, with thehighdoseat 1 gram/kilogram(g/kg)asalimittest,andanin vitro dermalabsorptionstudyusing humanskin. Thesetestsweredoneon all threeglycol ethers, -
with no obvioustoxicity differencesbetweenthechemicalsubstances.
By February1987,EPA informedCMAthatEPA wasconsideringthe optionofaTestingConsentOrder. OnMay 19,1987,EPA issuedanotice(52 FR 18738)
to this effect,requestingpublic~articipalion and~nnouncinga meetinganMay 28, 1987, to initiate testingnegotiations. -
After severalscientifictheetings,CMA’s-Glycol EthersPanelsubmittedtoEPAa draftConsentOrder.onSeptember30,1987,which includedallbut oneof thefirst-stagetestsproposedby EPA for TGME, TGEEandTGBE,with TGME as the testsubstancerepresentingall three.The only testingnot agreedupon wasfor developmentalneurotoxicity.After a periodof intensivediscussionon developmentalneurotoxicitytesting,afinal ConsentOrder,excludingdevelopmentalneurotoxicity,wassignedby March8,1989by CainChemicalInc.,The DowChemicalCompany,EastmanKodakCompany,ShellChemicalCompany,andUnion CarbideCorporation.In thisConsentOrder, themanufacturersigreedto performcertaintoxicologicestson TGME by specificdates
accordingto the teststandardsin theAppendixof theOrder.Thefinal testrulefor developmentalneurotoxicitytestingofTGME is publishedelsewherein this FederalRegister.EPA is deferringfinal decisionson further testingofTGEEandTGBE (51 FR 17883)until theresultsof theConsentOrdertesting areavailable(seeUnit V).
IV. Use andExposure
Theseglycot ethersareprimarily co-producedduringthemanufactureoflowermolecularweightglycol ethers.About 5 percentof productionis purifiedfurtherfor useaschemicalintermediates,but themajority is sold ina technicalgradefor useasadiluentinbrakefluid.
Preliminarydatafrom theNationalOccupationalExposureSurvey(NOES),conductedby theNationalinstitute forOccupationalSafetyandHealthtNIOSH)from 1980 to 1983, indicatethatapproximately250,000workers,including 8,000females,werepotentiallyexposedto brakefluids in theworkplacein 1980 (Ref. 1). Although therearenodataon actual levelsof dermalexposurein theworkplace,thenatureof brakesystemmaintenanceandrepairsuggeststhatcompleteexposureof both handsoccursregularly,evendaily, for manyprofessionalmechanics.EPA hasrecentlypreparedanupdatedexposureprofile ofmechanics(atleast175.000estimated)exposedto brakefluids withat leastonecontactper day,resultinginestimatedexposuresrangingfrom 520 to2,300milligrams (mg)/day for 250 daysperyear(Ref. 2). Furthermore,thereis apotential for consumerexposure,sincesomeindividuals canbe expectedto
FederalRegister / -Vol. ~4, No. ~2 / Monday, April 3, 1989 / Rules and Regulations 13471
performbrakemaintenance,inchidingaddition of brakefluid, on theirautomobiles. -
V. TestingProgram
Theproposedtestrulewould haverequiredthat mostof the testsbeperformeddermally,sincethat is theroute ofhumanexposure,andthemanufacturersagreethat this would bemostusefulfor riskassessment.ThisConsentOrderhowever,requiresthattheroute of administrationfor the -
developmentaltoxicity andsubchronicneurotoxicitytestsbeoral to assurethata sufficientdosewill beadministeredfor hazardidentification.
As TGME hasrelativelyiow acutetoxicity by theoralordermalroute, thepreviouslycompletedstudyby CMAprior to the issuanceof theOrderusedthe1 g/kg limit testfor theinitial range-finding. This studyfoundessentiallynoeffect in the21-daytestin the rabbit.BecauseEPAfoundapossiblemaximumhumandermalexposureof 3,900mg/day(Ref. 3), or56 mg/kg/dayfor a70kgperson,the high doseof thetestshouldbe greaterthan the1 g/kg limit testdose.Dow scientistswereableto apply4 g/kg percutaneouslyto theSprague-Dawleyrat (Ref. 3) in asecondrange-finding study.However,in ordertoapproacha100-foldmargin ofexposurefor TGME, thehigh doseshould beatleast5 g/kg for neurotoxicitytests, -
whichwould requireoral dosing.Despitetherequirementto conductsomeof thesetestsvia the oralroute,themanufacturerssubjectto theOrderhaveinformedEPA that theyplanto doboth oralsubchronicneurotoxicityanddermalsubchronicregulartoxicitystudiesin theSprague-Dawleyrat, sincethey believethedermalrouteto be moreinformative,
In theConsentOrder,thefivemanufacturersagreeto conductthefollowing studiesin accordancewith thecited testguidelines.A dermalsubchronicstudy will beconductedintheSprague-Dawleyrat accordingto 40CFR 798.2250,usingat least4 g/kgasthehigh dose.Threecombinedoralsubchronicneurotoxicitytestswill beconductedin the Sprague-Dawleyrat,usingat least5 g/kg asahigh dose,accordingto 40 CFR 798.6050,798.6200,and798.6400.Developmentaltoxicitystudiesin theSprague-Dawleyrat andtherabbitwill beconductedby theoralgavagerouteof exposureusing at least5g/kg as a high dose,accordingto 40 CFR798.4900.The high doseslistedabovewill be requiredunlessrange-findingstudiesindicatethatlower doseswiltproduceadequatetoxicity for anevaluation.
The remainingstudiesto be performedarethreemutagenicitytests:theSalmonellatyphimuriumreversemutationassay,40 ~FR 798.5265;detectionof genemutationin somaticcells in culture,40 CF’R 798.5300;andamousein vivomicronucleusassay,40CFR 798.5395.If anyof theseindicateahazard for genetictoxicity, EPA willconsidertheneedfor furthertesting.
TESTING PLAN FOR TGME
Test - Teststandards Report’
Mutagenicity . -
Salmonella 40 CFR 798,5265. 12t~pharniduni. .
Somaticcells 40 GFR 798.5300.. 12Hi culture.
Mouse 40 CFR 7985395. 12micronucleus.
Developmental 40 CPA 798.4900. 12toxicity.
Subctironic 40 CFR 798.2250.. 18toxicity.
SubctwonicneurotoxicityNeurobeha- 40 CPA 798.6050.. 18
vioral battery.Motor activity ..... 40 CPA 798.6200.. 18Neuropatho- 40 CFR 798.6400. 18
logy.
The aboveTable delineatesthe tests,teststandards,andfinal reportingdatesfor all the testsincorporatedin theTesting ConsentOrder.Theteststandardswith modificationsareattachedto theOrder.EPA will usethedatageneratedby theseteststodeterminethepotentialrisk to humanhealthfrom exposureto TGME and todeterminewhetheranyadditionaltestingof TGME, TGEE,orTGBEisnecessary.
EPA believesthat testingmaynot benecessaryfor all threeglycol ethers.Inthe lower congeners(the rnonoethyleneglycol ethers)themethyl compoundisthemosttoxic of the threeindevelopmental(Ref. 5), reproductive(Refs.6, 7, and8), andneurotoxiceffects(Refs.9 and10). Therefore,EPAwillwait until theTGME testingiscompletedbeforedeterminingwhethertesting on theothertwo is necessary.Although EPA doesnot intendtowithdrawat this time its May 15, 1986(51 FR 17883)proposalfor testingtriethyleneglycolethers,EPA will notissueanyfinal testrules on the typesoftestscoveredin thisTestingConsentOrderfor anyof the threetriethylenegiycol ethersin theproposedtestruleduringtheperiodin whichtesting onTGME is conductedpursuantto theConsentOrderto EPA~ssatisfaction.
VI. Export Notification
The issuanceof theConsentOrdersubjectsanypersonwho exportsorintendsto exportTGME,TGEE,orTGBE to theexportnotificationrequirementsof section12(b) of TSCA.The specificrequirementsarelistedin40 CFR Part707.OnJune23, 1987,EPA.established40 CFR799.5000asalistingof ConsentOrdersissuedby EPA (52FR23548).This listing servesasnotificationto personswho exportor who intendtoexportchemicalsubstancesor mixtureswhicharethesubjectof TestingConsentOrdersthat40 ~FR Part707 applies.
VII. RulemakingRecord
EPA hasestablishedarecordfor thisrule andthe ConsentOrder(docketnumberOPTS-42080D).This recordcontainsthe informationEPAconsideredin developingtheConsentOrderandincludesthefollowing:
A. SupportingDocumentation
(1) TestingConsentOrder for TGME,TGEE, andTGBE
(2) FederalRegisternoticespertainingto this rule and theConsent Orderconsistingof:- (a)Notice containingtheITCdesignationof TGME, TGEE, andTGBE.
(b) RulesrequiringTSCA sections8(a) and(ci) reportingonTGME, TGEE,andTGBE.
(c) ProposedTSCA section4(a) testruleon TGME, TGEK andTGBE.
(d) Notice solicitinginterestedpartiesfor TestingConsentOrdernegotiationonTGME TGEE,andTGBE.
(3) Communicationsconsistingof:(a)Letters. -
(b) Contactreportsof telephoneconversations.
(c) Meetingsummaries.
B. References
(1) NIOSH.NationalOccupationalExposureSurvey(1980—1983).Cincinnati, OH: Departmentof HealthandHumanServices.NationalInstitutefor OccupationalSafetyandHealth(1985).
(2) OTS.Memorandumfrom R. CraigMatthiessento CarolGlasgowonResponseto Commenton Exposuretothe TriethyleneGlycol Ethers,Office ofToxic Substances(July 10, 1980).
(3) OTS.Reportby RogerSwampontestrulesexposureanalysisoftriethyleneglycol monomethylether,triethylen~glycol monoethylether,triethyleneglycolmonobutyl ether.Office of Toxic Substances(July 24,1985). -
(4) Yano, B.L., Phillips,J.E. andBattjes.j.E. “Triethyleneglycolrnonomethylether:2-weekdermal
‘Months after effective date of ConsentOrder.
13472 Federal Register 1 VoL 54, No. 62/ Monday, April 8, 1989 / Rules and Re~Wations
toxicity study in maleandfemaleSprague-Dawleyrats.” Dow ChemicalCompanyID: K-005610-oo1t19871.
(5) EuropeanChemicalIndustryEcology& ToxicologyCentre.(ECETOC).TechnicalReportNo. 17.“Thetoxicologyof glycol ethers anditsrelevanceto man:anup-datingofECETOCTechnicalReportNo.4.” -
Brussels,Belgium:ECETOC(1985).(6) NTP. “Ethyleneglycol monomnethyl
ethenReproductionandfertility.assessmentin CD—i micewhenadministeredin drinking water.” NTISPublication~85—163136fXABWashington,DC (1985).
(7) NTP. “2-Ethoxyethanol:Reproductionandfertility assessmentinCD—i mice when administered inwater.” NTIS Publication*85-.118851/XAB Washington,DC[1984).
[8) NTP. “Ethylene glycol monobutylether: Reproduction and fertilityassessmentin CD—i micewhenadministeredin drinking water.” NTiSPublication#85—226827/XABWashington,DC (1985).
(9) Goldberg.M.E.,Haun.C.andSmyth,H.F., Jr. “Toxicologic implicationof alteredbehaviorinducedby anindustrialvapor.” ToxicologyandAppliedPharmacology4:148—162(1962).
(10)Goldberg.M.E.,Johnson,H.E.,Pozzani,U.C. andSmyth,H.P., Jr. “Effectof repeatedinhalationof vaporsofindustrialsolventson animalbehavior.I. Evaluationof ninesolventvaporsonpole-climbperformance in rats.”AmericanIndustrialHygieneAssociationJow’nof 25:369—375(1964).
VIII. Other RegulatoryRequirementsPaperwork Reduction Act-
The information collectionrequirementscontainedin thisrulehavebeenapprovedby 0MB undertheprovisionsof thePaperworkReductionAct, 44 U.S_C.3.502et seq.andhavebeenassigned0MB control number2070—0033.
Public reportingburdenfor thiscollectionofinformationis estimatedtoaverage506hoursperresponse,including time for reviewinginstructions,searchingexisting datasources,gatheringandmaintainingthedata needed,andcompletingandreviewingthe collectionof information.
Sendcommentsregardingtheburdenestimateor anyotheraspectof thiscollection ofinformation, includingsuggestionsfor reducingthis burden,toChief, InformationPolicy Branch,PM—.223, U,S. EnvironmentalProtectionAgency,401 M St., SW., Washington,DC20460; andto theOffice ofInformationandRegulatoryAffairs, Office ofManagementandBudget,Washington,
DC 20503,marked “Attention: Desk
Officer for EPA.” . -
List of Subjectsin ‘10 CFR Part799Testingprocedures,Environmental
protection,HazardoussubstancesChemicals,Chemical export,Recordkeepingand reportingrequirements.
- Dated:March24, 1989.SusanF.Vogt,ActingAssistcrritAdministratorfarPesticidesandToxicSubstances.
Therefore, 40 CFR Part 799isamendedasfollows:
PART 799—.-(AMENDED]
1. The authority citation for Part 799continuesto readasfollows:
Authori!y~15 USC.2603,2611.2625.
2. Section799.5000is amendedbyadding triethyleneglycol monomethyl,monoethyl, andmonobuteylethersin thetablein CASNumberorder, to readasfollows:
§799.5000 TestIngconsentorders.* * a * -a
,. Substance !ederator mixture
nameTesttng Register
citation
112-35-6 Thethyleneglycolmono-methyt
Healtheffects.
53FR_.April 3,1989.
- ether.112-50-5 Triethylene
glycolmon~ethytether.
HealtheffectS.
.....do.
143—22-6 Thethyleneglycofmonobu-tyt ether.
Healtheffects.
._do.
[FR Doc. 89—7789 Filed 3—31—83,8:45 amj
BILU~GCODEe560-Se-M
40 CFR Part 799
IOPTS—420&OE; FRL-3549-2]
TriethyleneGlycot Monomethyt Ether~Finai Test Rule
AGENCY: EnvironmentalProtectionAgency(EPA).ACTION: Final rule.
SUMMARY:EPA is issuingafinal testruleundersection4 of theToxic SubstancesControl Act (TSCA)requiringmanufacturersandprocessorsof
triethyleneglycolmonomethylether(TGME,CAS No. 112-35-4) to performdevelopmentalneurotoxicitytesting.This action is in responseto the TSCAInteragency TestingCommittee’s [ITC)designationofTGME for priority testing.Also, appearingelsewherein this issueof theFederalRegister,is aTestingConsent Orderrule for triethyteneglycolmonomethylether, triethylene glycolmonoethylether,andtriethylene glycolmonobutyl ether.DATE~For purposesof judicial reviewin accordancewith 40 CF’R 23.5, this ruleshall bepromulgated at 1 p.m. eastern(standard or daylight as appropriate)time on April 17, 1989.This ruleshallbecomeeffective onMay 17, 1989.FOR FURThER INFORMATION CONTACT:Michael M. Stahl, Director, TSCAAssistanceOffice (TS—799), Office ofToxic Substances,RoomEB—44, 401 MStreetSW., Washington,DC 20460,(202)554—1404,TDD (202) 554—0551.SUPPLEMENTARY INFORMATION: EPA ispromulgating a final testrulerequiringdevelopmentalneurotoxicitytestingofTGME.
Public reportingburden for thiscollection of information is estimatedat1375hours including time for reviewinginstructions, searchingexisting datasources,gathering and maintaining thedata needed,and completing andreviewingthe collectionof information.Sendcommentsregardingtheburdenestimateor anyotheraspectof thiscollection of information,includingsuggestionsfor reducing this burden, toChief. Information PolicyBranch, PM—223,U.S. Environmental ProtectionAgency,401 M Street, SW., Washington,DC 20460;andto the OfficeofInformationandRegulatoryAffairs,Office of ManagementandBudget(0MB), Washington. DC 20503.
1.introduction
A. Test Rule Development Under TSCA
This final rule is partof the overallimplementationof section4 of TSCA(Pub.L 94—469,90 Stat. 2003et seq.,15U.S.C. 2601et seq.),whichcontainsauthorityfor EPA to require thedevelopmentof data relevant toassessingtherisk to health and theenvironmentposedby exposuretoparticularchemicalsubstancesormixtures(chemicals).
Under section 4(a) of TSCA. EPAmustrequiretestfngof achemicalto developdataif theAdministratormakescertainfindingsas describedin TSCA undersection4(a)(1) (A) or (B). Detaileddiscussionsof thestatutory section4findingsareprovidedin theAgency’sfirst andsecondproposedtestrules
FederalRegister I Vol. 54, No. 62 / Monday, April 3, i9&9 / Rules and Regulations 13473
publishedin theFederalRegistersofJuly 18,1980 (45FR 48510)andJune5,1981 (46FR 30300).
B. RegulatoryHistory -
TheInteragencyTestingCommittee(ITC) designatedTGME for prioritytestingconsiderationin its sixteenthreportpublishedin theFederalRegisterof May 21, 1985 (5(1 FR 20930).Inresponseto this designation,EPA issueda proposedtestrule in theFederalRegisterof May 15, 1986 (51FR 17683)requiringthatmanufacturersandprocessorsof TGME testthechemicalfor developmentalneurotoxicityamongotherhealtheffects,undersections4(a)(1) (A) and(B) of TSCA. EPArecentlyenteredaConsentOrderwithfive manufacturersof triethyleneglycolethersto conductcertaintoxicologictestsof TGME (noticepublishedelsewherein this FederalRegister).Regardingdevelopmentalneurotoxicitytesting,EPAhaschosento proceedbyissuinga final testrule.
II. Responseto CommentsThe proposedrule (51 FR 17883)also
proposedthedevelopmentalneurotoxicityguideline(40 CFR795,250),andcommentswerereceivedon boththeproposedruleandguideline.Responsesto commentson theguidelinewerepublishedwhentheguidelinewaspromulgatedwith thediethyleneglycolbutyl etheranddiethyleneglycol buty~etheracetatefinal testrule (53 FR 5932;February26, 1988).
Only theChemicalManufacturersAssociation(CMA) Glycol EthersProgramPanelandtheAmericanIndustrial HealthCouncil(AIHC)commentedon theproposedtestrule. -
Responsesto thosecommentsaregivenbelow.
A. Findings
EPAbasedtheproposedtestruleonboth TSCA sections4(a)(1)(A) and(B).
CMA andAll-IC commentedthattheAgencydid not provide justification forthesection4(a)(1)(A)finding. CommentsI through4 addressthis finding.
1. CommenL~CMA commentedthat“the toxicity dataon whichEPA reliesdo not demonstrateanylikelihood ofunreasonablerisks”. Theyfurther wenton to state“EpA arguesthatadverseeffectswould be expectedfromhumanexposuresto the triethyleneglycolethers(51 FR 17885).” -
Response:EPA hasnot reachedanyconclusionas to effectsof exposure,buthasmerelyfound“that theuseof thetriethyleneglycol ethers* * * mayprestmtanunreasonablerisk’EPA hasbasedits finding of potentialunreasonablerisk on fi) a toxicity-
predictionby useof astructure-activity -
relationship,discussedbelowin EPA’sresponseto comments2 and3a,and(2)humanexposurepotentialasdiscussedin the responseto comment5. Findingsaredetailedin Unit Ill.A. Testingisrequiredbecauseavailabledataareinsufficient to showwhether“adverseeffectswould beexpected”.If EPAknewwith certaintytheextentof therisk, EPA would not requiretesting.
2. Comment.’AIHC commentedonEPA’s structure-activityrelationship(SAR) analysis,whichwasconductedonly with ethyleneglycol monomethylether(EGME).AIHC believesthatamorerefinedSAR analysisshouldbeused.TheAIHC commentsreferto thefact that“Dataon seriesof glycol ethersand experienceusingsimilarmaterialshasneverresultedin neurologiceffectssimilar to thoseobservedwith EGME forany otherglycol ether”.
Response.’EPA is not awareofspecificneurotoxicitytestingon thehighercongeners,thediethyleneortriethyleneglycol ethers,but Goldbergetci, (Refs.1 and2) havedoneadultneurotoxicitytestingwith themonoethylenecompounds,just asNelsonet ci. (Refs.3,6, and7) havedonewith developmentalneurotoxicity.Furthermore,theresultsof GoldbergetaL’s1962studywith EGME (Ref. 1) onactiveavoidanceparalleledthe effectsseenin theoffspring exposedin uterotoEGME (Ref. 3). In addition,effectsofEG1’vfE seenin adult humans[Ref. 4) arecomparableto thesymptoms,ataxiaandlethargy,seenin rat acutetoxicitystudieswith TGME [Ref. 5). Withoutdataon the highercongeriers,EPA -
believesit cannotreasonablypredicttheneurotoxicity potentialof TGME, andthat testing is necessary. -
3a. Comment.’AIHC alsocommentedthatEPA’suseof a singlestudy(Ref. 3)to supporttherequirementfordevelopmentalneurobehavioraltoxicitytestingmaybeinadequate.
Response:In additionto the referenceusedin theproposedrule to supporttherequirementfor developmentalneurotoxicity(Ref. 3), Nelson’sgrouptestedanotherethyleneglycol ether,ethyleneglycolmonoethylether(EGEE).following prenatalexposurein rats(Refs.6 and7). At 100ppm (Ref. 6)statistically significantchangesoccurredwith the-rotorodtest,the activity wheel-test,andavoidanceconditioning.At 200ppm,amaternallytoxic dose,evengreateralterationswereobservedinthesetests(Ref.7). All theseresults(Refs.3, 6, and7), constituteanadequatebasisfor concernaboutthepotential(or developmentallyneurotoxiceffects.
3b. Comment:AIHC andCMAquestionedtheuseof a1984paperbyNelsonet cii. (Ref. 3) to supportthefinding. The commentsquotedall orpartof thefollowing sentencein this papen“The absenceof morerobustdifferenceshereraisesdoubtregardingthebiologicalsignificanceof thedifferencein this group,ascomparedwith thoseseenin the2ME 7—13 group.”
OtherAIHC andCMA commentsdiscussthefollowing problemswith theprotocolof thesamepaper:(1) Noappropriatecontrolsof theexposedmales;and(2) no randomizationinassigningfemalesin thevariousexposuregroups,which theyfelt mightaccountfor the “consistencyof theneurochemicalfindings”.
Response: Thesecomments(3a,3b)refer to toxicity testingin theNelsonpaper(Ref. 3) (paternalexposure,neurochemicalalterations)whichEPA isnot requiringin this rule, andwhichdonot bearon theproposedfinding thatTGMIE exposuremay presentanunreasonablerisk of developmentalneurotoxicity.
4. Comment.’CMA alsocommentedontherationalefor developmentalneurotoxicitytestingfor risk assessmentpurposes,andconcludedthat “althoughsuchtestingmaybeof academicinterest,it is of no provenvalue to therisk assessmentneedsthatmustexist tojustify section4 testingrequirements”.
Response:At the time of theproposaLEPA hadnot previouslyrequireddevelopmentalneurotoxicitytesting andhadneverusedsuchtestingfor riskassessmentpurposes.However,EPAhaslong recognizedthat thereis a needfor this testing,asis discussedbelow.To fulfill this need,EPAhasdevelopedaguidelinefor this test(40CFR 795.250).
In theearly1970’s,thescientificcommunitybecameconcernedthatexposureof the mother to drugsor toxicchemicalsmay resultin neurologiceffectsin theoffspring, asreportsproliferatedindicatingthatchildrenbornto chronicalcoholicmothersnotonly hadphysicalmalformations,but anincreasedincidenceof mentalretardationorperformancedeficits(Refs.8 and9). Thefetalalcoholsyndrome,asit is now termed(Ret.10).is no longerconsideredan unproven-theory, andtherehavebeennumerousstudiesinvestigatingneurobehavioralproblemsin offspringexposedto othersubstancesin utero [Ref. 11).
Scientistsfrom variousgovernmentalagencies(NationalInstifute forEnvironmentalHealthSciences,NIEHS;NationalCenterfor ToxicologicalResearch.NCTR: FoodandDrug
- Administration,FDA: National
13474 FederalRegister/ Vol. 54, No. 82 1 Monday, April 3, 1989 / Rulesand Regulations
Toxicology Program,NTP NationalInstitute for OccupationalSafetyandHealth, NIOSH: andEPA)institutedaCollaborativeBehavioralTeratologyStudy(CBTS) in 1978 to evaluatetheintra- andinterlaboratoryreliability andsensitivityof severalbehavioraltestmethodsasapreliminaryfor developingtestsusefulfor “safetyevaluationin theareaof postnatalfunction” (Ref. 12).CBTS wasinitiated, in part, becauseof abeliefthatavailabletestshadnot beenvalidatedsufficiently for regulatoryagencies’risk assessmentneeds.
In addition,EPA’s ScientificAdvisoryPanel(SAP)recentlyreviewedtherationalefor developmentalneurotoxicitytestingandconcludedthatEPA shouldrequirethatsuchtestingbeconductedin anumberof instancesincluding “strongstructure-activityrelationshipsto known neurotoxicants”(Ref. 13).
5. Comment.’CMA submittedtheonlycommenton thesection4(a)(1)(B)finding, stating that theNIOSH figuresarenot specificenoughaboutthenumberof personsexposedto thechemicalor thedurationorextentofanysuchexposureto serveasthebasisfor requiringtesting underTSCAsections4(a)(1)(B). CMA alsoassertedthatEPA failedto takeinto accountinstructionsto theworkerabouthandlingthefluid carefully.
Response.EPAbelievesthattherecordsupportstheTSCA section -
4(a)(1)(B)finding of “significantorsubstantialhumanexposure”for TOME.EPA hasroutinelyusedandintendstocontinueto useNIOSH surveystatisticsto makesection4(a)(I)(B) findingswhereappropriateunlessbetterestimatesof occupationalexposurearedeveloped.Furthermore,EPAhasrecentlypreparedanupdatedexposurepro’file oftheestimated175,000mechanicsexposedto brakefluidswithat leastonecontactperdayresultinginexposuresrangingfrom 250 to 2,300mg/dayfor 250daysperyear(Ref. 14). Inaddition,theNIOSH figuresarenot thetotal basisfor the section4(a)(1)(B)finding, andasstatedin theproposedrule, EPA believesthatconsumerexposurealsooccursthroughtheuseofproductscontainingTGME, sincesomeindividualscanbeexpectedto addbrakefluid or performbrakemaintenanceon their own automobiles.ThusEPA hasproperlyconcludedthatsubstantialnumbersof peoplemaybeexposedto TGME aridthat manyofthesepeoplemaybeexposedtosignificantlevels of TGME.
B. RouteofExposureComment:Severalcomments
suggestedthat theoral routeof exposure
would bemoreappropriatethanthedermalroutein treatingfemalescagedwith offspring.
Response:EPAagreesandhaschangedthe routeofadministrationtooralby gavage.
C. EconomicImpactComment.’CMA commentedthatthe
proposedtestingwouldbe tooexpensiveandwould haveasubstantialeconomicimpact on manufacturers.
- Response:EPA hasgreatlyreducedthe impactof this final testrulebyrequiringtestingonly ofTGME, whichwill representall threeof theglycolethersin theproposedtestrule. If EPAconcludesthat testingof theothertwo isnecessaryafterevaluatingthedatafromthis test,it will requirethis by aseparatefinal rule. - -
Ill. FinalTestRule
A. FindingsThis testrule is basedon theauthority
of TSCA section4(a)~1)(A) and[B).Undersection4(a)(1)(A) EPA finds thattheuseof TGME maypresentanunreasonablerisk of developmentalneurotoxicityon thebasisof SAR withEGME andEGEE(Refs.3, 6, and7), bothof which demonstratedevelopmentalneurotoxicity,andtheexposureto brakefluid whichmaycontainTGMEduringuseat levelsup to 250 to 2,300mg/dayfor up to 250daysperyearbymechanics(Ref. 14). Otherworkplacepersonnelmaybeexposedto evenhigherlevels(Ref. 20). Undersection4(a)(1)(B)EPA finds thatTGME isproducedin substantialquantities(30million lbs. in 1986) (Ref. 15). EPA alsofinds that thereis or maybesubstantialhumanexposureto brakefluids (whichmaycontainTOME) in theworkplace,whereapproximately250,000workersincluding 8,000 females(Ref. 16)areexposed.An updatedexposurereport(Ref. 14)confirmsexposurein thatanestimated175,000of these250,000workersaremechanicsexposedtobrakefluids at leastonceaday.Therealsomaybe substantialconsumerexposureto TGME duringmaintenanceof’ consumers’own vehicles.EPA alsofinds thatthereis ormaybe significanthumanexposureto TGME in theworkplace.
EPA alsofinds thattherearenoavailabledatato reasonablypredictordeterminethedevelopmentalneurotoxicityof TGME andthat testingis necessaryto developthis data.
Dataresultingfrom the developmentalneurotoxicityscreenwill helpEPAdeterminewhetherTGME isdevelopmentallyneurotoxicandwhetherfurther testingis necessary,and
arerelevantto determiningwhetherexposureto TOMEduringusedoesordoesnot presentanunreasonablerisk tohumanhealth.
B. Required Testing and Test Standard
EPAis requiringthatdevelopmentalneurotoxicitybeconductedon TGME inaccordancewith thespecificguidelinein40 CFR 795.250,aspublishedin theFederalRegisterof February26, 1988 (53FR 5947).
C, TestSubstance
EPA is requiringthatTGME of at least90 percentpurity shall be usedasthetestsubstance.TGME of suchpurity isavailableat reasonablecost.
D, PersonsRequiredTo Test
Section4(b)(3)(B) specifiesthattheactivitiesfor whichEPA makessection4(a) findings(manufacture,processing,
distribution in commerce,use,and/ordisposal)determinewho bearstheresponsibilityfor testingachemical.Manufacturersandpersonswho intendto manufacturethechemicalarerequiredto testif thefindings arebasedon manufacturing(“manufacture”isdefinedin section3(7) of TSCA toinclude“import”). Processorsandpersonswho intendto processthechemicalarerequiredto testif thefindingsarebasedon processing.Manufacturersandprocessorsandpersonswho intend to manufactureandprocessthe chemicalarerequiredto testif theexposuresgiving riseto thepotentialrisk occurduringdistributionin commerce,use,ordisposalof thechemical.
BecauseEPA hasfound thattheuseofTGME givesriseto exposurethatmay
- leadto anunreasonablerisk, EPA isrequiringthat personswho manufactureor process,or who intendtomanufactureorprocess,TGME, otherthanasan impurity, at any time fromtheeffectivedateof this final testrule totheendof thereimbursementperiodaresubjectto thetesting requirementscontainedin this final rule, The endofthereimbursementperiodwill be 5yearsafter thelast final report issubmittedor anamountof time equaltothatwhichwasrequiredto developdata,whicheveris later.
BecauseTSCA containsprovisionstoavoidduplicativetesting,not everypersonsubjectto this rule mustindividually conducttesting.Section4(b)(3)(A)of TSCAprovidesthatEPAmaypermit two or moremanufacturersor processorswho aresubjectto the ruleto designateonesuchpersonor aqualifiedthird personto conductthetestsandsubmitdataon theirbehalf.
FederalRegister/ Vol. 54, No, 62 / Monday~April-a, 1989 / Rules-and Regulations 13475
Section4(c) providesthatanypersonrequiredto testmayapplyto EPA for anexemptionfrom therequirement.EPApromulgatedproceduresfor applyingforTSCA section4(c) exemptionsin 40 CFRPart790.
Manufacturers(includingimporters)subjectto this rulearerequiredtosubmiteithera letterof intent toperformtestingor anexemptionapplicationwithin 30 daysaftertheeffectivedateof this final testrule.Therequiredproceduresfor submittingsuchlettersandapplicationsaredescribedin40 CFRPart 790.Although EPAhasnotidentified anyindividualswhomanufactureTOME as abyproduct.suchpersonswill besubjectto therequirementsof this testrule.
Processorssubjectto this rule, unlessthey arealsomanufacturers,will not berequiredto submit lettersof intentorexemptionapplications,or to conducttesting,unlessmanufacturersfail tosubmitnoticesof intent to testor laterfail to sponsorthe requiredtests.EPAexpectsthatthemanufacturersWill passan appropriateportion of thecostsoftesting on to processorsthroughthepricing of theirproductsor other -
reimbursementmechanisms.If - -
manufacturersperformall therequiredtests,processorswill begrantedexemptionsautomatically.If -
manufacturersfail to submitnoticesofIntentto testor fail to sponsorall therequiredtests,EPA will publishaseparatenoticein theFederalRegisterto notify processorsto respond;thisprocedureis describedin 40 CFRPart790.
EPA is not requiringthesubmissionofequivalencedataasaconditionforexemptionfrom the requiredtestingforTGME. As notedin Unit HLC., EPAisinterestedin evaluatingtheeffectsattributableto TGME andhasspecifiedarelativelypuresubstancefor testing.
Manufacturersandprocessorssubjectto this testrulemustcomply with thetest rule developmentandexemptionproceduresin 4A) CFR Part790 for single-phaserulemaking.
E. ReportingRequirements - -
EPArequiresthatall datadevelopedunderthis rulebereportedinaccordancewith its TSCA GoodLaboratoryPractice(GLP)standards,whichappearin 40 CFRPart792.
In accordancewith 40 CFR Part790,undersingle-phaserulemaking -
procedures,testsponsorsarerequiredtosubmitindividual studyplansat least45daysbeforeinitiation of’ eachtest.
EPA is requiredby TSCA section4(b)(1)(C)to specifythe timeperiodduringwhich personssubjecttoa testnile mustsubmit testdata. -
- Theproposedrulewould haverequiredthat for rangefinding for thisdevelopmentalneurotoxicitytest,developmentaltoxicity testing in theratbecompletedbeforeinitiating thedevelopmentalneurotoxicitystudy.However,developmentaltoxicity testingin therat is beingperformedby themanufacturersunderanegotiatedTestingConsentOrderusingtheTSCAguideline in 40 CFR 798.4900,asmodified(Ref. 17), anddevelopmentalneurotoxicitytestingunderthis ruleshall beinitiated whentheresultsof thedevelopmentaltoxicity studyaresubmittedto EPA. if neitherdevelopmentalormaternaltoxicity isseenin thedevelopmentaltoxicitystudy,the high dosein thedevelopmentalneurotoxicitystudyshallbe5 grams/kilogram(gfkg). Thedevelopmentalneurotoxicitytestresultsshall besubmittedwithin 21 monthsofEPA’spublication in theFederal -
Registerof anoticearmouricingthereceiptof thedevelopmentaltoxicitytestresults.Interim progressreportsforthedevelopmentalneurotoxicitystudyshall beprovidedto EPA at B-monthintervalsafterthe initiation of this test.until thefinal reportis submittedtoEPA. -
TSCA section14(b)governsAgencydisclosureof all testdatasubmittedpursuantto section4 of TSCA. Uponreceiptof datarequiredby thisrule,EPA will publisha noticeof receiptintheFederalRegisterasrequiredbysection4(d),
Personswho exportachemicalwhichis subjectto a section4 testrulearesubjectto theexportreportingrequirementsof section12(b)of TSCA.Final regulationsinterpretingtherequirementsof section12(b)arein 40CFR Part707.In brief, asof theeffectivedataof this testrule, anexporterofTGMEmustreportto EPA thefirstannualexportor intendedexportofTOME to eachcountry.EPA will notifytheforeign countryconcerningthetestrulefor TOME.
F EnforcementProvisions -
EPA considersfailure to comply withanyaspectof asection4 ruleto beaviolation of section15 of TSCA. Section15(1)of TSCA makesit unlawful for anypersonto fail or refuseto comply withanyruleor orderissuedundersection4.Section15(3)of TSCA makesit unlawfulfor anypersonto fail or refuseto~(1)Establishormaintainrecords,(2) submitreports,notices,orother information,or(3) permitaccessto or copyingofrecordsrequiredby TSCA or anyregulationorrule issuedunderTSCA.
Additionally, TSCA section15(4)makesit unlawful for anypersonto fail
or refuseto permit entryor inspectionasrequiredby TSCA sectionii. Section11appliesto any“establishment,facility.orotherpremisesin which chemicalsubstancesormixturesaremanufactured,processed,stored,or heldbeforeor after their distributionincommerce * * .“ EPA considersatestingfacility-to be aplacewherethechemicalis heldorstoredand,therefore,subjectto inspection.Laboratoryinspectionsanddataauditswill beconductedperiodicallyinaccordancewith theauthorityandproceduresoutlined in TSCAsection11by duly designatedrepresentativesofEPA for thepurposeof determiningcompliancewith this final ruleforTGME.Theseinspectionsmay beconductedfor purposeswhich includeverification that testinghasbegun,schedulesarebeingmet,andreportsaccuratelyreflecttheunderlyingrawdata,interpretations,andevaluations,andto determinecompliancewith TSCAGLP standardsandtheteststandardsestablishedin this rule.
EPA’s authorityto inspecta tes~fngfacility alsoderivesfrom section4(b)(1)of TSCA, which directsEPA topromulgatestandardsfor thedevelopmentoftest data.Thesestandardsaredefinedin section3(123(B)of TSCA to include thoserequirementsnecessaryto assurethatdatadevelopedundertesting rulesarereliableandadequate,andto include suchotherrequirementsasarenecessarytoprovide suchassurance.EPA maintainsthat laboratoryinspectionsarenecessaryto provide this assurance,
Violators of TSCAaresubjecttocriminal andcivil liability, Personswhosubmitmateriallymisleadingorfalseinformationin connectionwith therequirementof anyprovision of this rulemay besubjectto penaltieswhichmaybecalculatedas if theyneversubmittedtheirdata.Underthepenaltyprovisionsof section18 of TSCA, anypersonwhoviolatessection15 of TSCAcouldbesubjectto a civil penaltyof up to $25,000for eachviolation with eachdayofoperationin violation constitutingaseparateviolation. This provisionwouldbe applicableprimarily tomanufacturersthat fail to submitaletterof intent oran exemptionrequestandthatcontinuemanufacturingafterthedeadlinesfor suchsubmissions.Thisprovision~ouId alsoapplytoprocessorsthat fail to submita letter ofintentor an exemptionapplicationandcontinueprocessingafterEPA hasnotified themof their obligation tosubmit suchdocuments(see40 CFR790.26(b)).Knowingor willful violationscouldleadto the impositionof criminal
13476 Federal Register / Vol. 54, No. 62 / Monday, April 3, 1989 / Rules and Regulations
penaltiesof up to $25,000for eachdayofviolation or imprisonmentfor up to 1year,orboth. In determiningtheamountof penalty,EPAwill takeinto accounttheseriousnessof theviolation andthedegreeof culpability of theviolatoraswell asall theotherfactorslistedin -
TSCA section16. Otherremediesare -
availableto EPA undersection17 ofTSCA, suchas seekinganinjunction torestrainviolations of TSCA section4.
Individualsaswell ascorporationscouldbe subjectto enforcementactions.Sections15 and16 of TSCA applyto“any person”who violatesprovisionsofTSCA. EPA may,at its discretion,proceedagainstindividualsaswell ascompaniesthemselves.In particular,this includesindividualswho reportfalseinformationorwho causeit to bereported.In addition,thesubmissionoffalse,fictitious, or fraudulentstatementsis aviolationunder18 U.S.C.1001.
IV. EconomicAnalysisof FinalRule
To assessthepotentialeconomicimpactof this rule, EPA haspreparedaneconomicanalysis(Ref. 18) thatevaluatesthepotentialfor significanteconomicimpacton theindustryasaresultof therequiredtesting.Theeconomicanalysisestimatesthecostofconductingtherequiredtestingandevaluatesthepotentialfor significantadverseeconomicimpactasaresultofthesetestcostsby examiningfourmarketcharacteristicsof TOME: (1)Price sensitivity of demand,(2) industrycostcharacteristics,(3) industrystructure,and(4) marketexpectations.Ifthereis no indication of adverseeffect,no furthereconomicanalysisisperformed;however,if thefirst level ofanalysisindicatesapotential forsignificanteconomicimpact,amorecomprehensiveanddetailedanalysisisconductedwhichmorepreciselypredictsthemagnitudeanddistributionof theexpectedimpact.
Total testingcostsfor thefinal ruleforTGME are estimatedto rangefrom$113,800to $151,900.To predictthefinancial decision-makingpracticesofmanufacturingfirms, thesecostshavebeenannualized.Annualizedcostsarecomparedwith annualrevenueasanindicationof potentialimpact.Theannualizedcostsrepresentequivalentconstantcostswhichwould haveto berecoupedeachyearof thepaybackperiodto financethetestingexpenditurein thefirst year. -
Theannualizedtest costs(usinga cost-of capitalof 7percentovera periodof - -
15 years)rangefrom$13,494to $16,677. -
Basedon the 1986estimatedproductionvolumefor TOMEof 29.6millionpounds,the unit test costswill beabout0.06centsperpound.In relation to the
sellingpriceof’ $5.00per gallonfor -
TOME, thesecostsareequivalentto 0.17percentof’ price. - - --
Basedon thesecostsandtheusesofTOME, theeconomicanalysisindicates-that thepotential for significantadverseeconomicimpactasaresultof thistestingrule is low. This conclusionisbasedon thefollowing observations:
1.The estimatedunit testcostsareverylow, 0,17percentof currentpriceintheupper-boundcase.
2. Theoveralldemandfor TOMEappearsrelativelyinelastic.
Referto theeconomicanalysisfor a -
completediscussionof testcostestimationandthepotential foreconomicimpactresultingfrom thesecosts. - -
V. Availability of TestFacilitiesandpersonnel
Section4(b)(1) of TSCArequiresEPAto consider“the reasonablyforeseeableavailability of thefacilitiesandpersonnelneededto performthe testingrequiredunderthe rule”. Therefore,EPAconductedasurveyto assessthe - -
availability of testfacilities and --
personnelto handletheadditionaldemandfor testingservicescreated.by-
this section4 testrule (Ref. 19). Onthebasisof this study,EPA believesthat -
therewill beavailabletestfacilitiesandpersonnelto performthetesting.specifiedin this rule.
VI. RulemakingRecord -
EPA hasestablishedarecordfor thisrulemakingproceeding(docketnumberOPTS42080E).Thisrecordincludes:
A. SupportingDocumentation
(1) FederalRegisternoticespertainingto this rule consistingof: - -
(a)Notice containingtheITCdesignationof TGME to the Priority List(50F’R 20930;May 21, 1985).
(b) RulesrequiringTSCA section8(a)and8(d)reportingonTOME (50FR -
20909;May 21, 1985).-(c) Notice of EPA’s proposedtestrule
on TOME (51 FR 17883;May 15, 1986).(d) TSCAdevelopmental
neurotoxicitytestguidelinefinal rule (53FR 5947;February26, 1988).
(e) Noticeof final rulemakingondatareimbursement(48FR 31786;July11,1983).
(f) Noticeof interim final ruleonsingle-phasetestruledevelopmentandexemptionprocedures(50FR 20652;May17, 1985). -
(g) TSCA 012 standards(48 FR 53992;November29, 1983).
(2) Communicationsconsistingof:(a)Written public comments.(b) Transcriptof public meeting.
(c) Summariesof phone - - -
conversations.(d) Summariesof public méelings.-
(e)Letters. - -
B.References
(1) Goldberg,M.E., Haun,C. andSmyth,H.F., Jr. “Toxicologic implicationof alteredbehaviorinducedby anindustrialvapor.” Toxicology and -
AppliedPharmacology4:148-162(1962).(2) Goldberg,M.E., Johnson,H.E.,
Pozzani,U.C. andSmyth,H.F., Jr. “Effectof repeatedinhalation ofvaporsofindustrialsolventson animalbehavior.I. Evaluationof nine solventvaporsonpole-climbperformancein rats.”AmericanIndustrialHygieneAssociationJournal25:369—375(1964). -
(3) Nelson,B.K., Brightwell, W.S.,Burg, J.R., andMassari,V.j. “Behavioralandneurochernicalalterationsin theoffspringof ratsaftermaternalor -
paternalinhalationexposureto theindustrialsolvent2-methoxyethanol.”Pharmacology,Biochemistry& Behavior20:269—279(1984).
(4) Zavon,M.R., “Methyl cellosolveintoxication.” AmericanIndustrialHygiene Association Journal24:36—41(1963). -
(5) MB ResearchLaboratories,Inc. -
Reporton oralLD5Oin ratsfor Olin(1977)andcoverletter from NicholasBaroneof Olin Corporationon TSCA8(d) submission878216036.ReceivedbytheOffice of ToxicSubstances,USEPA,June12, 1985.
(6) Nelson,BK., Brightwell, S.,Setzer,J.V.,Taylor, B.J., andHornung,R.W.“Ethoxyethanolbehavioralteratologyinrats.” Neurotoxicology2:231—249(1981).
(7) Nelson,B.K., Brightwell, W.S. andSetzer,J.V.“Prenatalinteractionsbetweenethanolandtheindustrialsolvent2-ethoxyethanolin rats:Maternalandbehavioralteratogeniceffects.”NeurobehavioralToxicologyondTeratology4:387—394(1982).- (8) Jones,K.L., Smith, D.W.,
Streissguth,A.P. andMyrianthopoulos,N.C. “Outcomein offspringof chronicalcoholicwomen.”Lancet1:1076-1078(1974).
(9) Hanson,J.W.,Jones,K.L andSmith,D.W. “Fetal alcoholsyndrome.Experiencewith 41 patients.”JournaloftheAmericanMedicalAssociationZ35:145&—1460(1976).
- (10)Jones,K.L. andSmith,D.W.“Recognitionof thefetal alcoholsyndromeirrearly infancy.” Lancet11:999—1001.(1973). -
(11)Riley, E.P. andVorhees,C.V.(Eds.).“Handbookof BehavioralTeratology”.NY: Plenum(1986).
(12)Kimmel, C.A. andBuelke-Sam,J.“Collaborativebehavioralteratology
FedeI’al RegisterI Vol. 54. No. 62 / -Monday. April 3, 1989 f Rules and Regulations - - 13477
study: Backgroundandoverview.’NeumbehavioralToxicologyandTeratology7:541—545(1985).
(13)FederalInsecticide,Fungicide,andRoderiticideAct ScientificAdvisoryPanelSubpanel.A setofscientificissuesbeingconsideredby theAgencyconcerningneurotoxicitytesting underFIFRA. Reportof SAPsubpanelrecommendations.October16, 1987. -
(14) OTS.Memorandumfrom R. CraigMatthiessento CarolGlasgowonResponseto Commenton ExposuretotheTriethyleneGlycol Ethers.Office ofToxic Substances(July 7, 1988). -
(15)USITC. “Syntheticorganic - -
chemicals.UnitedStatesproductionandsales,1986.” Washington.DC: U.S. - -
InternationalTradeCommission,U.S.GovernmentPrintingOffice (1986).
- (16)NIOSH.NationalOccupationa’ExposureSurvey(1980—1983).Cincinnati,OH: Departmentof Health -
andHumanServices.NationalInstitutefor OccupationalSafetyandHealth(1985).
(17) USEPA.“TestingConsentOrderfor triethyleneglycol moriomethyl,morioethyl,andrnonobutylethers.”U.S.EnvironmentalProtectionAgency(1989).
(18) 0Th. “Economicimpactanalysisof final test rulefor t:iethyieneglycolmonomethylether.” Office of ToxicSubstances(1968). - -
(19)Mathtech,Inc. MemorandumfromJ.K. Orrell to EdmundCoe,0Th, onDevelopmentalNeurotoxicityLaboratoryCapability.(SeptemberiS.1988). -
(20)OTS.Reportby RogerSwampontestrulesexposureanalysisoftriethylenegIycc’i monornethyiether,triethyleneglycol monoethylether,triethyleneglycol monobutyl ether.Office of Toxic Substances(July 24,1985). -
VII. OtherRegulatoryj~equirements -
A. E~.ecutiwas Order 12291
UnderExecutiveOrder12291,EPAmustjudgewhetherarule is “major”and thereforesubjectto therequirementof aRegulatoryImpactAnalysis.EPAhasdeterminedthat this testruleis notmajorbecauseit doesnot meetanyofthe criteria setforth in section1(b) oftheOrder i.e., it will not haveanannualeffecT on theeconomyof at least$100million, will not causeamajor increasein costsorprices,andwill not haveasignificantadverseeffect on competitionor theability of U.S. enterpriseto -
competewith foreignenterprises.This rule wassubmittedto 0MB for
review asrequiredby ExecutiveOrder
12291.Any writtencommentsfrom 0MBto EPA, andanyEPA responseto thosecomments,areincludedin the - -
rulemakingrecord. - - -
E.RegulatoryFlexibility Act --
UndertheRegulatoryFlexibility Act{5 U.S.C.601 etseq.,Pub.L 96 354, -
September19. 1980), EPA is certifying -
that this test rulewill not haveasignificantimpact on a substantialnumberof smallbusinessesbecause.~(1)they arenotlikely to performtesting - -
themselves,or to participatein theorganizationof the testing effort; (2) they
— will experienceonly veryminor costs,ifany, in securingexemptionfrom testingrequirements;and(3) theyareunlikely
- to beaffectedby reimbursement -
requirements. -
C’. Pacerwoi-kReductionAct
- Theinformation collection - -
requirementscontainedin this rulehavebeenapprovedby 0MB undertheprovisionsof thePaperworkReductionAct, 44 U.S.C.3502 et seq.andhavebeenassigned0MB control number2070—0033. -
Public reportingburdenforthis‘collection of information is estimatedat- 1375hours,including time for reviewing
instructions,searchingexistingdatasources,gatheringandmaintainingthedataneeded,andcompletingandreviewingthecollectionof information.
Sendcommentsregardingtheburdenestimateorany otheraspectof thiscollectionof information, includingsuggestionsfor reducLrig thisburden,toChief, InformationPolicy Branch.PM—223,U.S. EnvironmentalProtectionAgency,401 M St., SW., Washington,DC20460:andto theOffice of InformationandRegulatoryAffairs, Office ofManagementandBudget.Washington.DC 20503,marked“Attention: Desk -
Officer for EpA.”
List of Subjectsin 40 CFR Part799
Testing,Environmentalprotection.Hazardoussubstances,Chemicals.Recordkeepingandreporting -
requirements.
Dated:March24. 1989.SusanF. Vogt, - -
Acting.4sslstcntAdministratorforPesticidesandToxicSubstances. -
Therefore,40CFR Part799 is - -
amendedasfollows: -
PART 799—~AMENDED] - -
- 1. Theauthority citation for Part799 -
continuesto readasfollows:
Authority: -15 U,S.C.2603.2611, 2625.-
- 2. By adding§ 799.4440to readas
follows: - -
§ 799.4440 Thethyleneglycot monomethylether. - - - - - -
(a) Identificationoftestsubstance.(1)Triethyleneglycol monomethylether(TGME. CASNo. 112-35-6)shall be -
- testedin accordancewith this section.(2) TGME of at least90 percentpurity
shall be usedasthetestsubstance.ft) Persons required to submitstudy
plans. conduct tests, anti submit data. -
All personswhomanufactureorprocessTGME, otherthanasanimpurity, afterMay 17, 1989,to theendof thereimbursementperiodshall submitlettersof intent to conducttesting,submit studyplans,conducttestsandsubmit data,orsubmit exemption-applicationsss specifiedin thissection,SubpartA of this part, andParts790 and792 of this chapterfor single-phaserulemaking.
(c) Developmentalneurotoxicity—(1)Requiredtesting- Developmentalneurotoxicitytestingshall be performedin theSprague-Dawleyrat by gavageinaccordancewith § 795.250of this - - -
chapterexceptfor the provision inparagraph(c)(3)(iii) of’ § 795.250.
(2) Forthepurposeof this section.thefollowing provisionalsoapplies:
(I) Doselevelsanddoseselection.Intheabsenceof developmentaltoxicity ormaternaltoxicity themaximumdoseshall be5 gramsfkilogram.
(ii) [Reserved)
E3) Reportingrequirernents—(i)Thedevelopmentalneurotoxicitytestshallbecompletedandthefinal reportsubmittedto EPA within 21 monthsoftheinitiation of the test.Thetestshallbeinitiatedwithin 44 daysof thepublicationin theFederalRegisterofnoticeof EPA’s receiptof TOMEdevelopmentaltoxicity data.
(ii) Pr-ogressreportsshall besubmittedto EPA at 6- month intervals,beginningsix monthsaftertheinitiation of the test,
(d) Effectivedate. (1) Theeffectivedateof thefinal rule is May 17, 1989.
(2) Theguidelinecited in this sectionis referencedhereasit existson May 17,1989.
(Informationcollectionrequirementshavebeenapprovedby theOffice of ManagementendBudgetundercontrolnumber2070—0033.)[FR Doc. 89—7708Filed 3—31—89: 8.45am]5JUJP~000E 556G-5O-~
