FederalRegister / VoL 54, No~176 / Wednesday,September1~3, / Rules and Regulations 37799

theie e~ieilSIP ieViSiCO1~f”,dVStOr’8urgumenithat thefiling of a SIP revisionshoulo SuSpendelI Federalenforca~uentauPonwouldgrav’iiv undercuttheenfrcirnent seq~irementsof theCleanALr Act, 42 U,&C, 2413.A vbiletorrpmst:nesth’juct tO theasisungrequuementsof it SIP until aSIPrevision is obtained.Tsninv. NaturalJle;ourcesDefenseCouncil, 421 11,8, 80,62 (1q75); DaquesneLight Do. v. USEP4,1D8 F,2d456. 471(D,C.OLe. 1983):NationalResourcesDefenseCouncilv,fJSEPA,507F~2d905, 915 (9th Os, 1974).

Theotherfact Navistarrefers towhichpurportedlysupportsits argumentthat therehasbeenanimpropermixtureof rulemakingandenforcementis thatUSEPAallegedlyhasmadeaFederalcourtpleadingpartof theadministrativetecord.Navistarcities “Record item261—5,” whichit allegescorrespondstothepleadingstyled,“Defendant’sFirstSetof Requestsfor AdmissionsdatedDecember17, 1987.” Aftera carefulreviewoftheindexto theadministrativerecordandtheadministrativerecordtiself, USEPAcanlocateno suchdocuinenl

In summary.theadministrativerecordcontainsthevery itemsNavistarsuggestsit should:“the identitiesof allpersonsinvolvedin theAgency’sreviewof the SIPrevisionandmemoranda,recordsof conversations.or otherdocumentsreflecting thatrevrew” [Navistarcomment,page23).USEPA’srulemakingon Navistar’s site~specificRACT SIPrevisionhasbeencompletelyindependentof itsenforcementactionasmandatedby theLaw. SeeBethlehemSteelv. U5’EP,4, 638F.2d 9114 (7th Cir. 1950).

Conclusion

IJSEPAis disapprovingthis revisionbecausetheStatehasnot demonstratedthatNavietarscompliancescheduleisexpeditious,thatmeetingtheexistingSIPlimit is technicallyor economicallymfeasiblo,andthat the revisionn not)eopardizeattainmentormaintenance.

Undersection507(b)(1)of theAct,petitions for juda;ial review of thisactionmustbefiled in theUnited Stet~sCourtof Appealsfar theappropriatecircuit by November13, 1989.Thisactionmaynot bechallengedlaterinproceedingsto enforceits requirements.~Sce307(b)(2).)

This actionhasbeenclassifiedas eToble 2 actionby the RegionalAdministratorundertheprocedurespublishedin theFederalRegisteronJanuary19, 1989 (54FR 2214—2225),OnJanuary8, 1989,the Office ofManagementandBudget wah’cd Table 2and3 SI~Previsions(54FR2222)from the

requirementsof section3 of Executive

Order12291f~raperic.dof two years,

List of Subjecisin 40 CFR Part52

llnv~ronmentalprotection,Air,, ilutron control, Ozone,C~,rh~n

monoxide,Hydrocarbon,[ntergovemnmenialoffices,

Authority: 42 U~S.C.74Oi~7542Dated:August Ii, 1989.

Frank1st,Covington.Sctiogiiegioncl,4drninistrcuur.

PART 52-~APPROVALANDPROMULGATIONOFiMPLEMENTATION PLANS

SubpartKK—ONo

Title 40 of theCodeof theFederalRegulations,chapter 1, part 52, isamendedas follows:

1, The authority citation for part 52continuesto read as follows;

Autho8ty: 42 U.S.C. 7401—7642.

2, Section52,1885 is amendedbyaddingparagraph(p) to readasfollows:§ 52.18~5 Contro’ strategy Ozone.4 4 ~ 4

(p) DisapprovaI—O~March10, 1986.theOhio EnvironmentalProtectionAgency(OEPA) submittedasite-specificrevisionto theOhio ozoneSIP forvolatile organic compoundemissionsfrom Navistar’s (Formerly railedinternationalHarvester)onesurfacecoatingline at its Body plant andninelines atits Assemblyplant. Both plantsarelocatedin Springfield,ClarkCounty,Ohio. ClarkCounty is designatednonauaineneritfor thepollutantozoneundersection107 of theCleanAir Act(40 CFR 81.336).

I~RDoc. 88—21459Filed 9—13~-39:8:55 ,np~SILUSG CODE ~sse—5o--e

40 CFR Part799

PORTS-42099A; FRL-3~45ri3J

~4ethy~Ethy’ iCetox~me;FIna~Test Rule

AaENCY: EnvironmentalProtectionAgency (EPA),~Ciit~N: Final rule,

8UMSIARY: EPA is issuingthis final testrule undersectirn4 of the ToxicSubstancesControlAct (TSCA).requiringmanufacturersarid processorsof methyl ethyl ketoxime(MEKO, CASNo. 96—29—7) to performtestingforhealtheffects,Thetesting requirementsinclude ancogerticity, mutagenicity,developmentaltoxicity. reproditcil yetoxicity, neurotoxicity, andpharmacokinetirs. For the

phermarokineticstestoniy, EPA willfinalize the mm standardandreportingrequirementin a sesaratefinal rule,OAThS: Iii accordancewith 40 rEP 2Th5,this rule shall Uspromulgatedfeepurpuecsof indicial reviewat 1 p as.eastern~duylight or standardasappropriate)time on September27, 1989.This ruleshouldbecomeeffective onOctober27, 1989,~O~4FURTh~~~t4FOH~A’r1oNCONTACTMichaelM, Stahl,Director,EnvironmentalAssistanceDivision (TS—799). Officeof Toxic Substances,Rm,EB-44,401 M St., SW., Washington,DC20480,(202) 554-1404,TDD: (202)554’-0551,SUPPL~M~NTARYRIFOnMA11ON; EPA isissuingafinal test ruleundersection4(a) of TSCAto requirehealtheffectstestingfor MEKO.I. iniodudian

A. TestRuleDevelopment(faderTS~-1This final nile is partof theoverall

implementationof section4 of TSCA(Pub.L. 94-469,90 Stat.2003et seq.,15U.S.C.2601 et seq.),which containsauthority for EPA to requirethedevelopmentof data relevant toessess:ngthe risk to health andenvironment posedby exposuretoparticular chemicalsubstancesormixtures (chemicals),

Undersection4(a) of I SCA,EPA mustrequiretesting of achemicalto developdataif theAdministratormakescertainfindingsasdescribedin TSCA undersection4(a)(1)(A) or (B). Detaileddiscussionsof thestatutory section4findingsareprovidedin theEPA’s firstandsecondproposedtest ruleswhichaverspublishedin theFederalRegisterof July 18, 1980 (45FR 48510)andJune5,UU1 (46 FR 30300).

8. Rcg,JoloryhistoryThe InteragencyTestingCommittee

(ITO) designatedMEKO for prioritytesting considerationin it~19thReport,pubiishedIa the Federal RegisterofNovember14,11186 (51 FR41417).ThefTC recommendedthatME’IKO beconsideredfor healtheffectstesting,PEA respondedto theITC’srecommendationsfor MEKO bypublishing anoticeof proposedmuien.takingin theFederalRegisterofSeptember15, 1988 (53 FR 3583s),whichproposedthat~3(O be testedforoncogenicity,mutagenicity,reproductivetoxicity, developmentaltoxicity,neurotoxicity,and pharmacoidnetics,Theproposedride containeda chemicalprofile of MEKO, a discussionof EPA’sTSCA section4(a) findings,andtheproposedteststandardsandreporting*‘equirements,

37800 Federal Register / Vol. 54, No.176/_Wednesday,September13, 1989 / Rules and Regulations

H. Responseto Public Comments

EPA receivedwritten commentsonthe MEKO proposedtestrule fromAllied-Signal, Inc. (Allied), HulaAmerica Inc. (Hula), CosanChemicalCorp. (Cosan), and ICI Americasmc,(id). A public meetingwasalsorequestedby Allied and washeld onDecember15, 1888 (Ref. 18). Alliedsubmitted additional commentsonhuman exposureto MEKO (Ref. 21) andon the economicimpact of therule (Ref.23). The commentssubmittedby thesecompaniesand the EPA’s responsearecontainedin the public record for thisrule (Ref. 24)

A. Routeof Administration

Hula believesthat all major toxicitytestsshould be conductedby theinhalation route and that inhalationisthemajor routeof human exposuretoMEKO. AII~edbelievestheoncogenicitytest should beconductedby inhalation,

EPA believesthat, in addition toinhalation exposure,dermal contactmay also be an important route ofexposureto MEKO (Refs. 3 and 11). EPAhas no information at this time to rejectthe inhalation route for the oncogenicity,in viva mammaliancytogenetics,andneurotoxicity studies,and the final rulehas beenmodified to allow eitherinhalation or oral routesfor thesetests.EPA believestherewill beseveremethodologicalproblems associatedwith performing the developmentalandreproductive toxicity testsby theinhalation route. Themostseriousproblem is that dosing the dams byinhalation requires prolonged separationfrom their offspring (Ref. 40). Becausethe reproductive land developmentalstudies are complimentary,EPA hasconcluded that theyshouldbeconductedby thesameroute.

B. Oncogenicifi~

Hula believesacetoxinteis not agoodanaloguebecausek~KOisasymmetricalandbecauseacetoxitnemaybe anatypical homologiie.

EPA believesthat, aithoughacetoximeis s1’mmetnlcalandthe first memberof ahomologousseries,it is still a gooderealoguefar MEKO andis adeqisateforthe finding thatMEKO maypresentanunreasonablerisk of injury to humanshealth.Sirssctarally MEKO differs fromacetoximeby a singlemethyl group.both chemicalsarerelativelywatersolublearidboth exhibit similar acutetoxicity (Ref. 24).

Allied believesthestudyby Mirvishconcerningacetoximeandthepositiveresultsfrom amouselymphomamutagenicitystudyare not an adequatebasisfor requiringabioassay.

EPA has concluded that the Mirvishstudyof acetoxime,while not sufficientfor usein quantitative risk assessment,is sufficient to raise concernfor thepossibleoncogenicityof MEKO. EPA~suseof structure-activity relationships(SAR) in supporting the section4(a)(1)(A)TSCA finding wasupheld bythe D.C. Circuit Court of Appeals inacasereviewing the final rule for 2-Ethylhexanoic Acid (EHA, Ref. 39). Thecourt stated, “But Congressexplicitlycontemplatedthat EPA would basetestrules on comparisonsamongstructurallysimilar chemicals”(Ref. 41). In addition,the Third Circuit has suggestedthat“structure-activityrelationships”beusedevenwhen there is uncertainty andthat suchuncertainty may “highlight theneedfor testing” (Ref. 42).

EPA believesthe positive results fromthemouselymphomastudyof MEKOprovide further evidencethat MEKOmay be oncogenic.

Allied indicates that neither of thehypothesizedmetabolitesof MEKO,methyl ethyl ketone(MEK), orhydroxylamine,havebeenimplicatedinapositivecarcinogenicresponse.

EPA believes KO itself may beoncogenic.This aloneis sufficient forEPA’s findings under TSCA section4(a)(1)(A). Furtherniore, evenif themetabolitesare not carcinogenic, thereis no assurancethat the parentcompound (MEKO) is not.

Allied believesthat,becausetumorswere observedin male rates in thestudyof acetoxime,the malerat would beanadequatesubject for testing MEKO, andtesting femalesis not necessary,

EPA disagrees.Testing experienceandstandardscientificreferencesindicatetheremaybe substantialsex-relateddifferencesin sensitivity todifferent compounds,EPA is requiringthat femalesaswell asmalesbetested,

Allied expressedgeneralconcernfortheunnecessarysacrificeof animals.

EPA sharesthis concern, and hasmathseveryeffort to designstudieswhich economizeon the numbercfsri malswhile providing adequatenumbersfor acceptablestatisticalanalysis.Industrymayfurtherreducethenumberafanimalsby submittingstudyplanswhich,usesatellitegroupsorthesameanimalsfor differentmaasurcmentta,whereverfeasible.EPAalsonotesthat therearepresentlynoaitenuativeato whole-animaltestirus forthe toxicologicalendpointsrequiredbythis rule.

Allied andHahn believethereis nojustification icr using two speciesin anyoncogenicitystudy of MEKO. Theybelievetestingshould belimited to therat becausethemouseis apoor testspeciesfor a substancewherethey

believe the liver is the soletarget organ.Hula is concernedabout using theB6C3F1mouse.

EPAdisagrees.It hasnot beenestablishedthat the liver is the oniytargetfor possibleMEKO oncogenicity,EPA requires data from two speciesunder its cancerrisk assessmentguidelines.Thus, a negativesinglespeciestestwould be insufficientevidenceto exonerateMEKO. Thisrequirement is consistentwith thoseofthe EPA Office of PesticideProgramsand the Organization for EconomicCooperation and Development(OECD).

EPA has not specifiedthe strain ofmousefor testing MEKO, however, theNational Toxicology Program (NTP)concluded that evenwith the variablerate of-background liver tumors inmales, the B6C3F1mouseis anacceptablespeciesfor oncogenicitystudies(Ref. 19). EPA would considerthe variable rate of background tumorswith other evidencein estimatingpotential human risk from MEKO.

Hula believesthat thereportingrequirements should be extendedto 65months if conductedin only the rat and79months if both rat and mouseareused,

EPA doesnot believe that MEKOpresentsspecialtestingproblemsrequiring an extensionof the reportingrequirements.

a Mb’tagenicity

Allied believesthatbecausethemouselymphomaassayconductedonMEKO was negativewith activation,MEKO would be deactivatedbyenzymesin viva.

EPA believesthe positive results fromthis mouselymphomastudy,withoutactivation,indicatethatMEKO canpotentially causeniutageniceffects,Thenegativeresult obtained by usingenzymesin vitro doesnot necessarilypredicthow MEKO wculd react in viva,norhowit wouldbeprocessedbyhumanenzymesystems.Thisinformationmustbe obtainedthroughfurther testing.In addition,EPAfoundthathydroxyhemina,a possibleasefnibolitsof MEKO, andhydruxylarninehydrochloride,astructurallyrelater!cii emical,aremutagenicin avariety of test systems(Refs.6 and7), Therefore, MEKO may5150 he mutagninic,Allied notedthathydroxylnimincis active in vitro but notasvis’u, Further,nydroxylamirie,aproductof normalcell metabolism,isendogenouslypresentin humanswhereit apparentlydoesnot havemutageniceffect, -

EPA believesin vitro studiesindicatethat hydrexylamineisintrinsically

Federal Regi8ter / Vol. 54, No. 176 / Wednesday,September13, 1989 / Ruie~and Regulations 37801

mutagenic, andaresufficientto raiseconcernfor MEKO. Furtherstudyisneeded to determinethemutagenicriskof MEKO itself,

Allied requeststhat in vitrocytogenetics,sisterchromatidexchange,andAmesSalmonellastudiesof MEKObeing conductedby NTP be evaluatedbefore conducting mutagenicity studiesof MEKO.

EPA’s tieredtestingsystemfor bothgenemutationsandchromosome!aberrationsis explainedin detailin thefinal testrulesfor C9 aromatichydrocarbonfraction(40CER799.2175;50FR 20862;May 17, 1965),anddiethylenetriamine(40CFR 799.1575;50FR 21398;May 23, 1985). -

NIP hasindicatedthat thein vitrocytogeneticsandthe in vitro sisterchromatidexchangestudiesconductedby NTP arenegative(Ref. 31). EPA hasnot reviewedthe studiesbutwill do sowhentheyare available,However,regardlessof the results of NTP’s testing.boththe sex-rehinkedrecessivelethalassayin Drosophila and an In vivomammalianbonemarrowcytogeneticstestarerequired to confirm thenegative.

D. DevelopmentalandReproductiveToxicity

Allied proposedthataprotocolcombiningdevelopmentaltoxicity,neurotoxicity,andreproductivetoxicitybedevised.

EPA believesthata combinedprotocoltestingfor neurotoxicity.developmentaltoxicity, andreproductivetoxicity will compromisetheresultsof thesestudies.Developmentalandreproductivetestsrequiredifferentexposureperiodsanddifferent doselevels.Neurotoxicity testsalsorequirelongerexposuretimesthanthe developmentaltest (Ref. 24, 25, and40). Theoretically, the neurotoxicity andreproductivestudiescouldbecombined.However, at this time, the commenterfailed to establishthat it canbe donesuccessfully.

Allied disagreeswith EPA’sinterpretationof datausedto supporttheneedfor reproductivetoxicity testingof MEKO.

Although EPAbelievesdatafrom the13-weeksubchronic toxicity study (Ref.30) areinadequateto prove that MEKOcauseshypospermatogenesis,thesedatastronglysuggestthatMEKO maycauseadverseeffectson malereproductiveorgans(Ref. 25).

Allied questionsEPA’s useofRamaija’sstudywith hydroxylamine(Ref. 31) to support the needforreproductive toxicity testing, andespeciallythe useof spermatogenesisstagingstudies.

Although theRamaijadatadonotproveconclusivelythathydroxylamineis areproductivetoxicant,EPA believesthedata-suggestthat hydroxylaminehasadverseeffectson spermatogenesisandembryonicviability, Thesestudyresultssupportconcernfor the potentialreproductivetoxicity of hydroxylamine,and henceof MEKO. We alsobelievethat if reproductivetoxicity testingis tobe conducted,It would be prudent toinclude the “histopathology of thetestswith stagingof thesperm”asoutlinedinthe proposedrule. We do not concurwith Allied that stagingof spermis onlyappropriatefor compoundsthataremetabolizedslowly. The purpose of thestagingstudyis to determineif aparticular stageof spermdevelopmentisuniquelysensitiveto the toxic effectsofa compound.Forthis purposequantitation is notnecessary.Sincespermatogenesisis a continual process,andnot a cyclicprocess,all stagesofspermdevelopmentwill bepresent andexposedto a compoundevenif thecompoundis metabolizedandeliminatedrapidly.Although thedatafrom the study by Ramaija are of limitedvalue becauseof the high dosesused,theydo notprovidesuggestiveevidencethat specificstagesof spermdevelopmentmaybemoresensitivetothe effectsof hydroxylamine than otherstages.

Allied questionsEPA’s useof theavailable information onhydroxylaminoas support for developmentaltoxicitytestingof MEKO.

EPA considersnoneof thestudiesavailable on the developmentaltoxicityof hydroxylamine to be adequateforrisk assessment.However, thesedataareconsideredsufficientto raiseconcernfor thedevelopmentaltoxicitypotential of hydroxylamine. Sincehydroxylamineis a possiblemetaboliteof MEKO, EPA believesMEKO mayalsobe developmentally toxic. -

Allied consideredthe results of twodevelopmentaltoxicity tests(Ref. 16) tobe contradictory and thus insufficient tosupportdevelopmentaltoxicity testing.

EPA disagrees(Ref. 25). Both studiesdemonstratedincreasedfrequenciesofskeletalanomaliesand grosslymalformed fetuses.BecauseMEKO lastructurallyrelatedto thechemicalsfrom thesestudies,MEKO may causesimilar effects.

E. Neurotoxicity

Allied andHula believethatexistingdata for KO indicate it is unlikelythatMEKO will causeneurotoxiceffects. -

As a matter of testing policy, thesubstantialproduction,thesubstantialpotentialexposureto MEKO, andthe

lack of adequateneurotoxicity datajustify definitive testing under TSCA,The availabledata are limited (Refs. 1,lit and24). Thereis no evidencethatotherthangrosscageside observationswereconductedin any of the existingstudies,andEPA believesdatafromthesestudies is inadequate forevaluatingthepotentialfor neurotoxic-effectsfromMEKO.

If neurotoxicitytesting is to be -

conducted,Huls recommendsthatsatellitegroupsbe addedto thesubchronicprobestudyfor theoncogenicitytestto conserveanimals,

As prescribedin 40 CFR 798.6400,theneurotoxicity testsmay be combinedwith any othertoxicity testaslong asoneof therequirementsof eitherareviolatedby thecombination.

Hula commentedthat, only ifpathologicevidencefrom examinationof a varietyof neurologictissesprovidesreasonfor concern,should theadditionalproposedneurotoxicitytesting be required.

Nodata were provided by thecommentersto supporttheir contentionthat a persistent nervoussystemeffectmusthave a basis in observablepathology. EPA doesnot agreethat onlythosechemicalsthat testpositiveforneuropathologicaleffectswarranttesting for functional or behavioral typeeffects.The National AcademyofSciencesalsosupports the considerationof both behavior and pathology inevaluation of neurotoxic effects(Refa,43, 44, 45).

Allied believesthat EPA has notconsideredthe availability of contractlaboratories to conduct theneurotoxicity studies,

EPA has determinedthat laboratoriesareavailable to completetheneurotoxicity testing requirements forthe MEKO final rule (Ref. 38).

F. Pharmacokinetics

Allied believesthat thepharmacokineticstestguidelinehasnotundergonefull scientificandtechnicalevaluationandcomment,

Becausenumerouscommentswerereceivedon the genericpharmacokineticsguidelinepublishedinthe MEKO proposedrule (53FR 35838;September15, 1988),EPAhasdecidedtoreevaluatethepharmacokineticsteststandardandreportingrequirementsforMEKO, EPA plans to promulgatethepharmacokineticstest standardandrelatedreportingrequirementsfor~~KO in a separatenile.

C. Exposure

Allied contendsthatMEKO hasinsufficientexposurepotential to pose

37C02 Faderal Register/ Vol. 54, No. 176 / Wednesday,September13, 1.989 / Rules and Regulations

unreasonablerisk of injury sinceworkplaceexposureis controlledd.uingmanufacture,andconsumerandoccupahunalexposureto MEKO fernpaint is low. In supportof this ele~m,Allied submittedtheresultsof anexposurestudy(Ref. 21).

EPA has reviewedthis study (Ref. 2C)and has found that the methodologyusedby Allied in developingexposureestimateswassimilar to themethodologyusedby EPA. Furthermore,the MEKO exposurelevelsand numberof peopleexposedagreewith orexceedthosepreviouslyestimatedby EPA, EPAhasfound that individual exposureeetima~escanvaryagreatdealwithsmall changesin the assumptionsusedfor thecalculations,Exposoreto MEKOis a rangeof valuesdependinguponfactors like ventilation,applicationmethod, duration, amount of paint used,and others.Moreover,asrisk is afunction of loxicity and exposure,levelsof exposurehaveno meaningfordetermining risk until testing isconductedto determinethe toxicity of achemical.EPA believesthepotentialexposureto I~EKOboth with regardtothe large numbers of individualsexposedand the durationandlevelstowhich theyare exposedare sufficienttosupport the TSCA section4 (a)(1) (A)and(B) findings.

H. EconomicImpact

Allied believesthat the costof testingwill forceAllied to abandonitsproductionof MEKO.Theystate thatprice competition for Meko is keen, andforeign suppliersrespond aggressivelytoopportunitiesto gainmarketshare.

EPA believesthateventhoughtheannualizedcostsof testingmay appearhigh relativeto theproductprice, otherfactors indicatethatthepotential foreconomicimpactis moderate.Becausethereareno cost-effectivesubstitutesfor MEKO, thepriceof MEKO canbeincreaseito coverthecostof tooting.Inaddition,becausesmallquantitiesareusedin paints,theincreasedcostofMEKO would havelittle effectenretailpaint prices.EPA believesthe~n&Aetfur aikydresinpaintsis relativelystable,endalkydresinpaintmanufacturerswill continueto uceMLKO in theirformulations.In addn~oa,EPA believesthemarketstructuieofMEitO maychange,but theinarkol willsupporttest’ngfor MEKO, anaMEKOwill continueto be availableto dr:ne~IJeusem.

EPA costroimbo~ocn~entprocedoressubje’~tall manufacturersandirnportmn,enderthe rule, to thesamerequirmrc;itsfor costreimbursement.EPA hassotreceivedadequateinformationforevaluatingthecostsJiuctur~of foreign

Suppliersor of Allied. Foreignsupplierscouldusesubsidies,os Allied hasclaimed,to increasemarketshaie,But,EPA believessubsidiescouldbeusedindependentof a testrulefor MEKO.

Allied believestheanti-skinningagentmarketwill be eliminatedin 5 yearsandthata5-yearamortizationperiodwillmorethandoubleEPA’s estimatedannualburden.

EPA notesthereis someindicationofapossibledecline in thedemandforalkydresinpaints,but doesnot believethatthe anti-skinning market will beeliminatedin 5years.Nonetheless,EPAusedAllied’s estimateof a5-yearamortizationperiodasa worst casescenario.Theincreasedoesnotappropach theprice of thesubstituiesfor MEKO. No datahavebeenprovidedto EPA to justify useof a 5-yearamortizationperiod.

Allied claimskey economicdeterminantsof competitionprofitability, and historical pricecompetitionwereneglectedin EPA’seconomicanalysis.

EPA requestedinformation on coststructure,profitability, and historicalprice competition (Ref. 26). Additionalinformation provided to EPA wasinadequateto changeEPA’s analysis ofeconomicimpact. However,EPAacknowledgesthatAllied mayleavetheMEKO market.

Allied believesthe total costof testingwill be$2.3million.

EPA estimatesthat testingwill costbetween$l,4 and $1.9million. Allied hasnot substantiatedits claim for highercosts;and,without furtherinformation,EPA cannot justify using highercostestimates.Nonetheless,usingAllied’scostfiguresdoesnot significantlychangethe economicviability of MEKOand doesnot change the conclusionoftheeconomicanalysis.

III, FinalTestRule for MEKO

A. Fino’ings

Although findingsundereithersection4(a)(1)(A) or (B) mayindependentlysupporttesting,EPA is basingitsoncogenicity,mutagenicity,developmentaltoxicity, reproductivetoxictiy, neurotoxicicv,andpharmacokinetics testing for K~KOontheauthorityof section4(a)(1) (A) and(B) of TSCA.

Undersection4(a)(1)(li)(i) of TSCA,EPA finds thatMEKO l3 producedinsobstantialquantitiesandtheremaybesuhst~ntiaIhumanexpocureto MEKOduringire manufactaro,processing,anduse.

Althocghthe total annualproductionof ~lKO is confidentialbusinessluformation(Cifi), publicinformation

indicatesthe total imports anddomesticannualproductionarein excessof 5million poundsperyear (Ref. 2). Overtwo million consumersmaybe exposedto MEKO through useof oil-besedpaints.In addition, consumersmay beexposedto MEKO throughuseofhouseholdcleaningproductsaridadhesives,caulking, and repair products(Pals.3, 4, and9). An estimated980,000professionalpaintersmayberoutinelyexpoeedto MEKO throughuseof oil-basedpaints(Ref. 14), andan estimated12,000workersin 1,500plantsmaybeexposedthroughmanufactureandprocessingof MEKO (Refa.10 and11).EPA finds that this productionvolumeand potential exposure to largenumbersof consumersand workersconstitutessufficientbasisfor making afindingundersection4(a)(i)(B)(i) of TSCA.

Under section4(a)(1)(A)(i), EPA findsthatthemanufacture,processing,anduseof MEKO maypresentanunreasonablerisk of injury to humanhealth due to its potential to causeoncogenic,mutagenic, reproductive,developmental,andsubchroniceffects.The finding for potential oncogenicriskis basedupondata which indicate thatacetoxime,a structural analogueofMEKO, causedbenign and carcinogenichepatocellular tumors in mice(Refa. 5and 8). In addition, MEKO is positive inthemouselymphomagenemutation test(Ref. 28)which also raisesconcern thatMEKO may be oncogenic.

Thefinding for potential mutageniorisk is based on data indicating thatMEKO causedgenemutationsin amouselymphoma test (Ref. 28). Inaddition, data on hydroxylamine, apossiblemetabolite of MEKO, indicateshydroxylamine is mutagenicin varioussystems(Refs.6 and7). Becausethereisconcernfor potentialmutagenicityfromhydroxylamine, there is concernforpotentialmutagencirisk fromMEKO,

Thefinding for potential reproductiverisk is basedon adverseeffectson thetestsof ratefrom a00-dayexposuretoMEKO (Ref. 8). In addition,hyth’oxylamine,apossiblemetaboliteofMLKO, appearsto adverselyaffectrroerrnatogenesis,mammaryglanddevelopment,prolactinlevels, cstrouscycle,anddevelopmentof Crcafianfollicles (Refs.5, 6, 30, 31, and37). Thoseresultssuggestpotentialreproductiverisk from MEXO.

1I,e finding for potentialdevelopmentalrisk is basedon daMcromtestsanMtiK, aposs!biemetabolitecfMEKO, whichindicatethatMEK causesskeletalandsoft tisse~abiioi-:nalitiesin ratsat 1,000ppm andsoft tissueabnormalitiesin ratsat 3,000ppm (Ref. 13). in addition,dataon

FederalRegister/ Va!, 54, No, 176 / Wednesday,September13, 1289 / Rulesand Regulations 3~a~a1cydroaylamine(Rafs,5, 6, 30, 32, 37, and‘39), anotherpossiblemetaboliteoft4EKO suggestthat hydrcxylamineisdevelopmentallytoxic. Thesescudiesontie nsataboiitesof MEKO suggestthatMEKO mayalsopotentially causedevelopmentalcifects.

Thefinding for potentialbloodeffectsrisk is basedon datafrom a30-dayoraltoxicity studyof MEKO (Ref. 30)whichsuggestthatMEKO induceshemalyticanemiain theratwith compensatoryerythropoiesiaasdescribedin unit II.E.3,of theproposedrule (53 FR 35838;September15, 1988),andsupportsconcernfor therisk of bloodeffectsfromMEKO.

Although theavailabledataon bloodeffectsareadequatefor risk assessment,it maybe in theinterestof thosesubjectto this rule to furtherassessbloodeffects.The 90-daysubchronicstudy(Ref. 30)doesnot provideano-observed-adverse-effectlevel (NOAEL)for bloodeffectsfor MEKO. Uncertaintyfactorswould be added to the lowest-observed-adverse-effectlevel (LOAEL)to establishacceptablelevelsofexposure.Testing to determinetheNOAEL for blood effects associatedwith subchronicandchronicexposurewould reducethe uncertainty inevaluatingtheseeffects.

The NOAEL for blood effectscould beestablishedin the subchronic range-finding studies for the MEKOoncogenicitytest.Thesedatashouldbedevelopedaccordingto thetestguidelinesat 40 CFR 798,2650,modifiedto directspecificattention towards thehematologyprofile. Hematologydeterminations(hematocrit,hemoglobinconcentrations,erythrocyte count,totalanddifferential leukocytecount, and a

measureof clottingpotential suchasclotting time, prothrombintime,thromboplastintime, or plateletcount,andcertainclinical biochemistrydeterminationson blood)couldbemadeon all groups,including controls,at day30 andat day90 of thetestperiodfortherat.A chranicNOAEL for bloodeffectscouldbeobtainedby modifyingthe oncogenicitystudyto includehematologyandbloodbiochemistry.This couldbeaccomplishedbymodifying theoncogenicitytestguidelineat40 CFR 796.3300to includehematologydeterminationsandcertainclinical biochemistrydeterminationsonbloodfor rats,in accordancewith 40CFR798.3320,thecombinedchronictoxicity/oncogenicitytestguideline.Satellitegroupsof rats may benecessaryto avoid stressto the testanimalsfrombloodsamplingandtoprovide sufficientanimals for adequateblood collections.

The findings for the potential healtheffectsaslistedabovealongwith theexposurecitedabove(Refs.2, 3, 4, 9, 10,11, and14)aresufficientto supportEPA’s finding that themanufacturing,processing,anduseof MEKO maypresentan unreasonablerisk of injury tohumanhealth.

Under section4(a)(1) (A)(ii) and(B)(ii), EPA finds that there areinsufficient data and experiencefromwhich the potential oncogenicity,mutagenicity, reproductive toxicity,developmentaltoxicity, andneurotoxicityfrom manufacturing,processing,anduseof MEKO canreasonablybe determinedor predicted.

Under section4(a)(1) (A)(iii) and(B)(iii), EPA finds that testingof MEKOis necessaryto developsuch data for

oncogerticity,mutagenicity,reproductivetoxicity, developmentaltoxicity, andrieurotoxicity.EPA believesthedataresultingfrom this testingwill berelevantto adeterminationastowhethermanufacturing,processing,anduseof MEKO doesor doesnot presentan unreasonablerisk of injury to humanhealth.

Becauseof theconcernsforoncogenicity,mutagenicity,bloodeffects,reproductivetoxicity, anddevelopmentaltoxicity for thedescribedexposuresto MEKO, EPA finds thatphammacokineticstesting is necessary.Pharrnacokjneticsdatawill beusedformakingextrapolationsof toxicologicdatafrom speciesto species,from routeto routeof administration,andfrom highto low doses.Pharmacokineticsdatawill beusedto detectdifferencesbetweensexesrelative to the metabolicprocessesof absorption,tissuedistribution,biotransformationandexcretion. In addition, thesedata willshow if metabolicprocessesaremodified by different routes ofadministrationorby repeateddosing.

B. RequiredTestingandTestStandards

On thebasisofthefindings presentedin Unit iII.A. of this preamable,EPA isrequiringthathealtheffectstestingbeconductedfor MEKO. The testsshall beconductedin accordancewith EPA’sTSCA Good Laboratory PracticeStandardsin 40 CFR part 792 andinaccordancewith specific test standardsbasedon the guidelinessetforth in 40CFR part 798,or other published testmethodsas specifiedin this test ruleandenumeratedin thefollowing Table.

REQUIRED TESTING, TEST STANDARDS AND REPORTING REQUIREMENTS FOR MEKO

TestTest

standard‘40 CFRc4ation)

‘

Reportingdeadhne forfinal report

Number ofinterim (6

month)reports

required

wealth Effects:Oncogenicity, oral/inhalationDevelopmental toxicity, oral

§ 798.3300§ 798.4900§ 798.4700§ 798.5275

§ 798.5385

§ 798.5395

~798.6050§ 798.6200§ 798.6400

53152918

14/17

18/1718/2118/2118/21

Reproductive toxicity, oralSex-linked recessive lethal assay in Drosophilain vivo mammalian bone marrow cytogonetics tests:

Chromosomal analysis, oral/inhalationor

Micronucleus assay, oral/inhalationFunctional observational battery: Acute and subchronic, oral/inhalationMotor activity test: Acute and subchronic, oral/inhatationNeuropathology: Subchronic oral/inhalationPharmacokinetics 2

(3) (3)

Number of months, beginning with the effective date of this rule. These reporting requirements have been adjusted from those specified in the proposed rule toSt consistent with other test rules under section 4 and to allow additional time i~inhalation tasting is conducted.

2 Pharrnacokinetics test standard and reporting requirements will be promulgated at a later data.[Reserved].

8242

2

2

222

~?!~.~Fcdera Register/ Vol. 54, No. 176 / Wednesday,September13, 1939 / Rules and Ragulattons

The henitheffectsteststo beenuductedfor MF.KO are: (1) An oralorinhalation2-~yeoroncogenicitystudy,using theguidelineat40 CFR 793.3300;(2) anoral 2-speciesdevelopmentaltoxicity studyusingtheguidelineat 40CFR 798.4900;(3) anoral2-generationreproductivetoxicity studyusing thegcidelineat 40 CFR 798.4700andincludinghistopathologyof theovaries,andvaginalcytologyfor thelast3weeksprior to matingto monitortheerirus cycle;(4) sex-linkedrecessivelethalgenemutationassayinDrosophilausingthe guidelineat 40 CFR798.5275,(5) oralor inhalationin vivomammalianbonemarrowcytogeneticstestusingtheguidelinefor eitherthechromosomalanalysisat 40 CFR796.5385or themicronucleusassayat 40CFR 798.5395;and (6) acuteands’abchronic(00-day)oralor inhalationneurotoxicitytests, including: afunctionalobservational battery usingth.e guidelineat 40 CFR 798.6050,and amotoractivity te8t using the guidelineat40 CFR 798,6200,and subchronicneuropathologyusingtheguidelineat 40CFR 796.8400.

Thetestguidelinefor the two-generationreproductive toxicity test (40CFR 798.4700)in the teststandardforMEKO is modified asfollows: Theintegrity of the various cell stagesofspermatogenesisshall be determined,with particularattentiondirectedtowardachievingoptimalquality in thefixation andembedding.Preparationsoftesticularand associatedreproductiveorgansamplesfor histology shouldfollow therecommendationsof LambandChapin (Ref.46), oran equivalentprocedure.Histopathology of the testesshall be conductedon all P and F1 adultmalesat the time of sacrifice,andhistologicalanalysesshall includeevaluationsof thespermatogeniccycle,i.e., thepresenceandintegrity of the 14cell stages.Theseevaluationsshouldfollow theguidanceprovidedbyClermontandPercy(Ref. 47).Informationshall alsobeprovidedregardingthenatureandlevel of lesionsobservedin controlanimalsforcomparativepurposes.

D.ria on femalecyclicity shall heobtainedby performingvaginalsrnm’reandcytologyin parental(P) andfirstgeneration(F1) femalesoverthelast3weeksprior to mating.The cell stagingOlchrnrcteof Sadleil (Ref. 33), andthe

smearmethodin Uafez(Ref. 34),or equivalentmethodssh~uidbeused.Gateshall beprovidedon c~hethartheaniatalis cycling andthecyclelength.

PandF~femalesshall conttnueto r~ee’~poscdto ~~KO for at leastanadditional 2weeksfollowing weaningof

offspringto permit them to begincyclingonceagain.Theyshall thenbesacrificedandtheir ovariesshall beseriallysectionedwith a sufficientnumberofsectionsexaminedto adequatelydetailoocyteandfollicular morphology.Themethodsof Mattison andThorgierseon(Ref. 35) andPedersonandPeters(Ref.3d)mayprovide guidance.The strategyfor sectioningandevaluationis left tothediscretionof theinvestigator,butshall bedescribedin detailin theprotocol and final report. The natureand background level of lesions in thecontrol tissueshall aieobenoted.Grossandhistopathologicevaluationsshall becunductedon themammaryglandsin F1femalesandsecondgeneration(F2) pupssacrificedat weaningandin adult (F1)femalesat theterminationof thestudy.Any abnorrnahtiesshall be describedinthefinal report.

Anin vitro manurtalien cytogeneticsassay,anda sisterchromatiduxchangeteston MEKO were conducted by NTP,which indicatesthatboth of thesetestswerenegative(Ref. 31). NTP is alsoconductingagenemutationassayinSalmonella.EPAwill evaluatethisinformationalongwith lower-tiermutagenicitydatadevelopedthroughthis testruleto determineif themousevisiblespecific locusassay,the rodentdominantlethalassay,therodentheritabletranslocationassay,or othermutagenictesting is necessaryforMEKO. Theseupper-tiermutagenictestsarenot beingrequiredat this time. EPAis requiringthat theTSCA HealthEffectsTestingGuidelinesreferencedinthe table, including all modificationsmadeherein,betheteststandardsfortherequiredtestsfor MEKO. TheTSCAtestingguidelinesfor healtheffectstesting specifygenerally acceptedminimum conditionsfor determiningthehealth effectsfor substancessuchasMEKO to whichhumansareexposed.

C. TestSubstance

EPA is requiringthatMiusO of atleast99 percentpurity beusedasthetestsubstance.MEKO of this purity iscommerciallyavailable.EPA hasspecifiedarelatively pine substancefortetingbecauseEPA 7s interestedinevaluatingtheeffecteattributabletoMEKO itself.

D, PersonsRequiredto Test

Section4(U~(3)(G)of TSCAspecificsthat theectiviticsfor whichEPAmainssection4~a)findings(manufactute,processing,distributionin commerce,are, and/ordisposal)determinewhobearsthe responsibilityfor testingachemical.Manufacturersandpersonswho intendto manufacturethe chemicalarerequiredto testif thefindings are

basedon manufacturing(“manufacture”is definedin section3(7)of TSCA toinclude “import”). Processorandpersonsiehointend to processthechemicalarerequiredto testif thefindingsarebasedon processing.Manufacturersandproccssor~andpersonswho intendto manufacturoorprocessthe chemicalarerequiredto tes’rif expos-uregiving rise to thepotentialrisk occursduringdistributionincommerce,use,or disposalof thechemical.

BecauseEPAha~foundthat thereareinsufficientdataandexperiencetoreasonablydetermineorpredict theeffectsof themanufacture,processing,anduseof MEKO on humanhealth,EPAis requiringpersonswho manufactureand/orprocess,orwho intendtomanufactureand/orprocessMEKO,includingpersonswho manufactureorprocessor intendto manufactureorprocessMEKO asabyproduct,or whoimport or intend to import productswhichcontainIv~KO,at anytime fromtheeffective dateof thefinal testruletotheendof the reimbursementperiodbesubject to the testing requirementscontainedin thisfinal rule. Personswhomanufacture,import, or processMEKOonly asanimpurity arenot subjecttotheserequirements.The endof thereimbursementperiodshall be at least5yearsafterthelast final reportissubmitted,but if it takeslongerthan5yearsto developthedata,thereimbursementperiodshall beextendedanamountof time equalto thatwhichwasrequiredto developthedata,

BecauseTSCA containsprovisionstoavoid duplicative testing, not everypersonsubjectto this mule mustindividually conducttesting.Section4(b)(3)(A)of TSCA providesthatEPAmaypermit two ormoremanufacturersorprocessorswho aresubjectto theruleto designateonesuchpersonor aqualified third personto conductthetestsandsubmitdataon their behalf,Section4(c) providesthatanypersonrequiredto testmayapply to EPA for anexemptionfrom therequirement.EPApromulgatedproceduresfor applyingforTSCA section4(c) exemptionsin 40GEEpart790.

Manufacturers(includingimporterslsubjectto this rule arerequiredtosubmiteitheraletterof intent toperformtestingor anexemptionapplication,within at) daysafter thueffective dataof the final testmis. ‘i’herequiredproceduresfor a’tbmit tin3, suchlettersandapniicationsaredescribedin40 CFR part790.

Processorssubectto thri rule, unlesstheyarealsomanufacturers,arenotrequiredto submitletters of intento”

Federal Register/ Vol. 54, No. 176 / Wednesday,September13, 1989 / Rules and Regulations 37805

exemptionapplications,or to conducttesting,unlessmanufacturers fail tosubmitnotices of intent to testor laterfail to sponsortherequiredtests.EPAexpectsthatthemanufacturerswill passanappropriateportion of thecostsof‘testing on to processorsthroughthepricing of their products or otherreimbursementmechanisms.Ifmanufacturers perform all the requiredtests,processorswill be grantedexemptionsautomatically. Ifmanufacturersfail to submit noticesofintent to testor fail to sponsorall therequiredtests,EPAwill publish aseparatenoticein the Federal Registerto notify processorsto respond; thisprocedure is describedin 40 CFRpart790.

EPA is not requiringthesubmissionofequivalencedata as a condition forexemptionfrom the required testingforMEKO. As noted in Unit IV.B., EPA isinterestedin evaluatingthe effectsattributable to MEKO itself and hasspecifiedarelativelypuresubstancefortesting.

Manufacturersandprocessorssubjectto this testruleshall complywith thetestruledevelopmentandexemptionproceduresin 40 CFR part790for single-phaserulemaking.

E. ReportingRequirements

All datadevelopedunderthis ruleshall be reported in accordancewithTSCA Good Laboratory Practice (GLP)Standardswhichappearin 40 CFR part792.

in accordancewith 40 CFR part 790undersingle-phaserulemakingprocedures,testsponsorsarerequiredtosubmitindividual studyplansat least45daysprior to theinitiation of eachtest.

EPA is requiredby TSCA section4(b)(1)(C) to specifythe time periodduringwhichpersonssubjectto atestrule mustsubmittestdata.EPA’sreportingrequirementsfor eachof the‘test standardsarespecifiedin thetablein Unit HLB. Notethat longerreportingperiodsareprovidedfor inhalation teststo calibrateandsetup inhalationchambers.Progressreportsfor all testsarerequiredat8-monthintervalsstarting6 monthsfrom the effective dateof thefinal testrule.

TSCA section14(b)governsEPAdisclosureof testdatasubmittedpursuantto section4 of TSCA. Upon‘receiptof testdatarequiredby this rule,EPA wili t’ubuisha noticeof receiptinthe f’ednmalRegisteras requiredbyaeCticfl

Persons‘who exportachemicalwhichis subjectto asection4 testfUle aresubjectto theexportreportingrequirementsof section42(b)of TSCA.Final regulationsinterpretingthe

requirementsof section12(b) arein 40GEEpart707. In brief, asof theeffectivedateof thefinal testrule, an exporterofMEKO mustreportto EPA thefirstannualexportor intendedexportofMEKO to eachcountry. EPA will notifytheforeigncountryconcerningthe testrulefor thechemical.

F. EnforcementProvisions

EPA considersfailure to comply withany aspectof asection4 ruleto beaviolation of section15 of TSCA. Section15(1) of TSCA makesit unlawful for anyperson to fail or refuseto comply withany rule or order issuedunder section4.Section15(3) of TSCA makesit unlawfulfor any person to fail or refuse to: (1)Establishor maintain records, (2) submitreports, notices,or other information, or(3) permitaccessto or copying ofrecordsrequiredby TSCA or anyruleissuedunderTSCA. Section15(4)makesit unlawfulfor any person to fail orrefuseto permit entryor inspection asrequired by TSCA section11. SectionIiapplies to any * * establishment,facility, or other premisesin whichchemicalsubstancesor mixtures aremanufactured,processed,stored,orheldbefore or after their distribution incommerce* * *“ EPA considers atestingfacility to be a placewhere thechemicalis held or stored and,therefore, subject to inspection.Laboratoryinspectionsanddataauditswill be conductedperiodically inaccordancewith the authority andproceduresoutlinedin TSCA section11by duly designatedrepresentativesoftheEPA for thepurposeof determiningcompliancewith thefinal ruleforMEKO.Theseinspectionsmay beconductedfor purposeswhichincludeverification that testinghasbegun,schedulesarebeingmet, andreportsaccuratelyreflecttheunderlyingrawdata,interpretations,andevaluations,andto determinecompliancewith TSCAGLP Standardsandthe teststandardsestablishedin therule,

EPA’s authorityto inspectatestingfacility alsoderivesfrom section4(b)(1)of TSCA, whichdirectsEPA topromulgatestandardsfor thedevelopmentof testdata. Thesestandardsaredefinedin section3(12)(Blof ‘I’SCA to includethoserequirementsnecessaryto assurethatdatadevelopedundertest rulesarereliableandadequate,andto include suchotherrequirementsasarenecessarytoprovidesucheassurance.EPA maintainsthat laboratoryinspectionsarenecessaryto providethis assurance,

Violators of TSCA aresubjecttocriminalandcivil liability. Personswhosubmitmaterially misleadingor falseinformot~onin connectionwith the

requirementof anyprovision of this rulemaybe subject to penalties which maybecalculatedas if they neversubmittedtheir data.Underthepenaltyprovisionsof section16 of TSCA, any person whoviolatessection15 ofTSCA could besubjectto acivil penaltyof up to $25,000for eachviolation with eachday ofoperationin violation constitutingaseparateviolation. This provisionappliesprimarily to manufacturerswhofail to submitaletterof intent oranexemptionrequestand continuemanufacturing after the deadlines forsuchsubmissions.This provision alsoappliesto processorswho fail to submitaletterof intentoran exemptionapplicationandcontinueprocessingafterEPA hasnotifiedthemof theirobligation to submitsuchdocuments(see40 GEE 790.48(b)).Knowing orwillful violations could lead to theimposition of criminal penaltiesof up to$25,000for eachday of violation,imprisonment for up to 1 year, or both,In determining theamountof penalty,EPA will take into accounttheseriousnessof theviolation andthedegreeof culpability of theviolator, aswell as all theotherfactorslistedinTSCAsection16. Other remediesareavailableto EPA under section 17 ofTSCA, suchasseekingan injunction torestrainviolationsofTSCA section4.

Individualsaswell ascorporationscouldbesubjectto enforcementactions,Sections15 and16 of TSCA applyto“any person”who violatesprovisionsofTSCA. EPA may.at its discretion,proceedat~ainstindividuals aswell ascompaniesthemselves.In particular,this includesindividualswho reportfalseinformationor who causeit to hereported.In addition,thesubmissionoffalse, fictitious, or fraudulentstatementsis aviolation under18 U.S.C. 1001.

XV, EconomicAnalysis

Tomsassthe potentialeconomicimpact of this rule, EPA haspreparedaneconomicanalysis(Ref. 2) thatevaluatesthe potentialfor significanteconomicimpact on the industryas aresultof therequiredtesting.Theeconomicanalysisestimatesthecostsoiconductingthe requiredtestingandevaluatesthepotentialfor significantadverseeconomicimpact asaresultofthesetestscostsby examiningfourmarketcharacteristicsof MEKO: Pricesensitivity ci demand,industry costchai’a’rieri’stics, industrystructure,andmarketexpectations.Since, in thecaseof MEKO. preliminaryanalysisindicatedsomepotential for significanteconomicimpact,a inure comprehensiveanddetailedanalysiswasconductedto

37C66 FederalRegister/ Vol. 54, No. 170 / Wodnesday,September13, 1989 / Rules and Regulations

morepreciselypredict themagnitudeanddistributionof theexpectedimpact.

Total testingcostsfor lv~KOareestimatedto rangefrom $1.4to $1.9million. To predictthefinancial decisIonmakingpracticesof manufacturingfirms, thesecostshavebeenannualized,Annualizedcostsarecomparedwithcrroualrevenueasan indicationofpotentialimpact.The annualizedcostsrepresentequivalentconstantcostswhichwould haveto be recoupedeachyearof thepaybackperiodto financethetestingexpenditurein thefirst year.EPArecognizesthat thhaiati.onexposureduringtoxicity testingis moreexpensivethanoraldosing.However,sinceexercisingthis option is voluntary,itscosthas not beenincluded in theeconomicanalysis.

The annualizedtestcosts,calculatedusinga costof capitalof 7 percentoveraperiodof 15 years,rangefrom $150,000to $205,000.Thoughtheannualizedunitcostsof thetestsrelative to the productpriceof MEKO appear to be high, EPAbelievesthatthepotentialfor adverseeconomicimpact is moderate.Thisconclusionis basedon the followingobservations:Demandfor MEKOappearsto be inelastic with respect toprice in its largestend useas anantiskinning agentin alkyd paintsbecauseof thehigherpriceofsubstitutes,and themarket for MEKOappearsto bestable.

Refer to the economicanalysis whichis containedin the public rec.ord for thisrulemaking for a complete discussionoftestcostestimationand potential foreconomicimpact resulting from thesecosts(Ref. 2). Someof the informationreviewedin the economicanalysisisconfidential businessinformationandnot available for public reviewHowever,considerationof thisinformationdoesnot changetheconclusionsof the economicanalysis.

V. Avdilability of TestFacilitiesendPersonnel

Section4(blll) of TSCA requiresEPAto considerthereasonablyforeseeableavailabilityof thefacilitiesandpersonnelneededto performthetestingrequiredundertherule. Therefore,EPAconducteda studyto assesstheavailability of test facilities andpersonnel to handle the additionaldemandfor testingservicescreatedbysection4 testrules.Copiesof thestudy,ChemicalTestingIndustry:Profile ofToxicological Testing (PB82—140773),canbe obtainedthroughtheNationalTechnicalinformation Service(NTiS),5285Port Royal Road,Springfleld~VA22181or the docket for this i’ule. On thebasisof this study, EPA believesthattherewill be a railable testfacilitiesand

personnelto performthe testingspecifiedin this rule.

El A ha~recently remewed theavailabilityof contractlaboratoryfacilities to conducttheneurotoxicitytestingrequirements(Ref. 38)andbelievesthat facilitieswill beavailab.Iefor conductingthesetests.Thelaboratoryreviewindicatesthat fewlaboratoriesarecurrently conductingthesetestsaccordingto TSCA testguidelinesandTSCA GLP Standards.However, the barriersfacedby testinglaboratoriesto gearup for thesetestsarenot formidable.Laboratorieswillneedto investin testing equipment andpersonneltraining,but EPA believesthat theseinvestmentswill berecoveredas theneurotoxicity testingprogramunderTSCA section4 continues.EPA’sexpectationsoflaboratoryavailabilitywere borne out under the testingrequirementsof theC~aromatichydrocarbon fraction testrule at 40 GEE799.2175.Pursuant to that rule, themanufacturerswereableto contractwith a laboratory to conduct the testingaccording to TSCA test guidelinesandTSCA GLP Standards.

VI. RulemakingRecordEPA has establisheda record for this

rulemakingproceeding(docketnumberOPTS—42099A).This includes:

A. SupportingDocumentation

(1) Federal Registernoticespertaining tothis rule consisting of:

(a) Noticecontaining the ITC’srecommendationof MEKO to the Priority List(50FR 41417; Nov.14, 1988) andcommentsonMEKO in responseto thatnotice.

(b)Methyl Ethyl Ketoxime; ProposedTestRule andProposedPharrnacokinetics TestGuideline(.53 FR 35838;September15, 1988).

(c) Rule requitingTSCA section8(a)and6(d) reportingon t~KO(51 FR 41328;Nov.14,1088).

(d) TSCA testguidelinescitedasteststandardsfor this rule. 40 CFR part798.

(~)Final ruleonEthyltoluenes,Trimethylbenacass,andtheC5 AromaticHydrocarbonFraction(50FR 20662;May17,1965).

(fl Final rule onDiethylenetriamine(50FR21398,May 23, 1985).

(2) Communications before finalrulemaking, consistingof:

(a) Written public commentsandlettsi~a.(b)Meeting summaries.(c) Telephonecontactreports.(3) Peports—publishadandunpublished

factual materials including: ChemicalTestingIndustry:Profile of ToxicologicalTesting(October, 1981).

B. References

(1) U.S. EnvironmentalProtectionAgency(USEPA).TechnicalSupport in ResponsetoPublic Comments:Methyl Ethyl Ketoxime,SyracuseResearchCorporation. Contractnumber881)80117.Office of Toxic

Suintances,Washington,DC. (December12,1056).

(2) EJSJtPAEconomicImpactAnalysis of?ropos~dTestRote for Methyl EthylK,d,~xime,Mathtesh,inc. Contractnuminr60-’OZ—sZiYt, Office of Toxic Sobstar.ces,Washington,DC. (1959).

(3) USEPA.ConsumerExposureto MethylEthyiKotoxinte from Useof Alkyl Paint,lairegencymemorandumfrom P.Kennedy,ExposureEvaluationDivision, to B. Carton,TestRulesDevelopmentBranch, OffiOeofToxic Substances,Washington,DC.(September30, 1987).

(4) USEPA.NationalHouseholdSurveyofinteriorPainters.Westat,Inc. Office of ToxicSubstances.ExposureEvaluationDivision.Washington,DC. (July 1987).

(5) USEPA. Validation of Toxicity Studieson MEKO endPolicy Paperon Acetoxime.lairs-agencymemorandumfrom P. Fenner-Crisp,HealthandEnvironmentalReviewDivision, to G. Timm, Test RulesDevelopmentBranch,Office of ToxicSubstances.(September24,1987).

(6) USEPA. ChemicalHazard InformationProfile, Hydroxylamine.Preparedby ScienceApplications, Inc., Oak Ridge.TN, for theOffice of Toxic Substances.Washington,DC.(September11,1984).

(7) USEPA.Reviewof GenotoxicitySectionsof CHIP onHydroxylamine.Intre-agencymemorandumfrom Michael C.Cimino, Health and EnvironmentalReviewDivision, to William Thompson,HealthandEnvironmentalReviewDivision. OfficeofToxicSubstances,Washington,DC. (April 7,1988).

(8) USRPA.Basisfor ConclusionthatAcetoximeandMethyl Ethyl KetoxirnearePossibleHumanCarcinogens.Intra-agencymemorandumfrom Don Clay,Director,Officeof Toxic Substances,to JohnA. Moore,AssistantAdministratorfor PesticidesandToxic Substances,Washington,DC. (Janusry29, 1985).

(9) U.S.ConsumerProductSafetyCornmtrsion.CHIPDataRequest,Interagencymemorandumfrom E.W. Leland,to M. Wind,throughW.R. Hobby,Washington,DC(October11,1985).

(10) NationalOccupationalHazardSe.’veyTradeNameingredientDatabase.Copyofcomputerprintout f~r2-butanone,oxime,Washington,DC (May10, 1985 andJuly23,1965).

(ii) USEPA.Methyl Ethyl K~toximc,Assessmentof OccupationalExposureandEnvironmentalReleaseof TO, Intra-agencymemorandumfrom Gr’:g Macek,Economicsand TechnologyDivision, to JohnWalker,TestRulesDevelopmentBranch,Office of ToxicSubstances,Washington.DC(July 16, 1988).

(12) Kerita,H. Experimentalstudiesonmethylethyl ketoximetoxicity”. Departuseatof Hygiene,NagoyaUniversitySchoolofMedicine.“NagoyaJcurnalof MedicalScience”29: 393-418(1967).

(13) NationalToxicologyProgram.Yang,R.S.H. ‘The toxicologycf methyl eth,.lketone.” “ResidenceReviews”,Volume 97.Springer-Verlag, New York Inc. P.O. Box12233,ResearchTrianglePark,NC 27709(1986).

FederalRegister/ Vol. 54, No. 176 / Wednesday,September13, 1989 / Rules and Regulations 37~Ø7

(14)Stoecklein,P.Estimatefor the numberof commercialpaintersIn the U.S.Letter fromP. Stoecklein,American Painting Contracting,St. Louis, MO to L. Borghi, DynamacCorporation,Rockville, 1~(September25,1988).

(15) ICI Americas, Inc.,CentralToxicologyLaboratory.Letterfrom P.L. Pattento D.FarrarRe:Methyl Ethyl KetoximeProposedPharmacoktheticTest Guideline,Wilmington,DE (November18, 1968).

(16)Allied Signal,Inc. EPA’sProposedTSCA section4 TestRulefor Methyi EthylKetoxime,andProposedPharmacokineticsTestGuideline,Letter fromP. Milley,ManagerOxinms,Allied Signal,Inc., toUSEPA,Washington,DC (November14,1988).

(17) Hula America,Inc. DocumentControlNumber OVFS-42099ProposedTestRule forMethyl Ethyl Ketoxime, Letter from JohnHodgson,HulaAmerica, Inc., to USEPA,Washington,DC (November14, 1988).

(13) USEfA. Transcriptof ProceedingsintheMatteroft Requestto PresentOralCommentson MEKO. HeritageReportingCorporation, Official Reporters,1220 L St.NW, Washington,DC (December15, 1988).

(19) NationalToxicologyProgram.Maronpot,R.R.“Liver lesionsin BBC3F1Mice, ExperienceandPosition.”ResearchTrianglePark,NC (1987).

(20) USEPA.Arthur D. Little ReportonMEKO Exposure.Intra-agencymemorandumfrom P. Kennedy,ExpoaureEvaluationDivision, to R. Jones,Teat RulesDevelopmentBranch,Office of Toxic Substances,Washington,DC (January30, 1989).

(21)Allied Signal,Inc. ExposureEvaluationfor Methyl EthylKatoxime in PaintMaflufactureandApolication.Reportpreparedby Arthur 1). Little Inc.,Morristown,NJ(January16, 1989).

(22) CoaenChemicalCorp. Commentsonmethylethyl ketoxime;propoaedrule,Washington,DC (November11,1986).

(23)Allied Signal Inc. EconomicMattersAssociatedWith Allied’s ProductionandSalesof MEKO, Letter from P. Millev, AlliedSignal Inc. to F,. Ccc,RegulatoryImpactsFranch,Officeuf Toxic Substances,Washic~gt~n,DC (january9, 1921).

(241 Syn’ousaResearchInc. TechnicalSupport in Eecpcaeeto PublicCcmnsenta:Methyl Eth~dKe’~axime,ContractNo.

DSc 7 ~.ab O~~‘ ofSuhstances,5V,’sL2r~gtua,DC (9209).

(25) USEPA.Reapons~to Public Commentson Dev~loproautaiandReproductiveToxicityof MEAD, lntra.ap~ncymemorandum.Dcci

11 ~. u 2 .3 92~ian —n a5.evimaDirisirm to 12. lanes,‘1e~tSule~Deeeict:-~uaatBrunah,Ofdceof TonicSn2~taacea,3t’astington,DC (1920).

(20) t92EPA.Raguestfor EcorsomireInformatienin UcriateEPA’s Ecoc,unsieAnalysis for M2XU, Letter irons it, Cue,RegulatoryImoactsC:anch toP,Millas’,rMhe~SignalInc.,Moiri~tossn,NJ (tdeaamber20, 9236).

(It’) National CancerInstitute (Not). MouseLcmgnasagenesisAssaywith No. 6s920IMU NUt No. 169) ImpartpreparedbyMicrobiologicalAssociatesundercontractNc, NO1—CP—41tr34,Sliver Spring,MD(December11, 1085).

(26) Allied Signal, Inc. Methyl EthylKetoxirne(MEKO), Letterfrom J,B. Charm,CorporateProductSafety,Allied Corporation,Morristows,NJ to R.Jones,USEPA,Washington,DC (March 5, 1984).

(29) National Toxicology Program.FiscalYear1988 AnnualPlan, Department of HealthandHumanServices,Public HealthService,NTP—66020,ResearchTrianglePark,NC IJune1988).

(30) Stoll, R., Bodit, F., andMaraud,R.“Teratogenicactionofhydrazineand similarsubstancesIn thechick embryo”.C’omptRondo,Society of Biology, Bordeaux,France,1688-1684.(June16, 1967).

(31) Ramaija, L K. “Comparativeanalysisof theeffectsof N-nitrosoethylurea,hydroxylamine andX-rays on thefertility ofmalemice.” SovietGenetics.PlenumPres,NewYork. 4:1041—1049.(1968).

(32)Zimmerman, W., Gottschewski,G.H.M., “Effects of certainsubstancesonDNA andprotein synthesisin earlyembryonicdevelopmentof the rabbit.”“Bulletin SchweizerischenAkademiederMedizinischenWessenchaften,Saael”.22:166-183.translated for EPA by Scitran,contractNo. 68—01—7362. Office of ToxicSubstances,Washington,DC. (1968).

(33) Sedleir,R. M. F. S. “Cycles andSeasons.”In: ~‘Reproductionin mammals:1.Germ cellsand fertilization.” Austin, C. R.and Short, R.V., eds.NewYork, NY:Cambridge PressChapter 4. (1978).

(34) HeInz,E. S., (Ed), “Reproduction andbreedingtechniquesfor laboratoryanimals”Chapter 10. Lea and Febiger(Pub.).Philadelphia,PA. (1970).

(35) Mattison, 1). R. andThorgiersson,S. S.“Ovarianaryl hydrocarbon hydroxylaseactivity andprimordialoocytetoxicity ofpolycyclicaromatichydrocarbonsin mice.”GaitcarResearch,39:3471—3475.(1979).

(36)Pederson,T. andPeters,H. “Proposalfur classificationofoocytesandfollicles inthemouseovary.” “Journal of ReproductionandFertility”. 17:555—557.(1988).

(37) USEPA.Reviewof StrategyonProposedTesting of MEKO. Intra‘agencymemorandumfrom it. Francis,Healthandittn’rircns.naotalReviewDivision, to CC. Lea,HealthandEnvironmer,iaiReviewDivision,Officeof ToxicSubstances,Washington,DC.(September16, 1937).

(‘38) USEPA.Evaluationuf OSCA ‘feit6 e,,-nt~”tci I

Mathiach,Usc. C’ontract r:ucssbr,’r88—22—4233.RegulatoryImpactsBranuh,’Oiiiceof ToxIcSubstances,Washington.DC. (AnSi 4, 1987).

(39) Do Sesec’,j, in. “Demonstrationofeascyosuc~ffectgcd ht’drcxyiaothusin the5e,vn,~e .~wh— ,,,~r’

Tcecord l96—.S2A—48”A, Waslsirgtors,D.C.(lad).

($~llUSIIPA. HNPJJreview ~ ~

tntra’agaanvmemorandumhero P.Fennrc-Cri~p,ilirecim HealthandEnvironmentalRrsi~wDiviriun 1st 12. Juries,TactRnl~~te’reiocmentSr~ncls,Ofiku ofToxicSubstances.WashingtonDC. (Apt 11 28,102.0).

(41) Ginnniaai.UonufocairareiNoueJo~iunv. USEFul. 659FISt 977, (D.C. Cii, 1982).

(42)AusimontUSASte. so LC’EPA. 338 FISt93, 93 (3rd Cia.1988).

(43) N~tion~iAcademyci Sciences/NationalResearchCouncil. “Principlesfor

EvaluatingChemicalsIn theEnvironment.”National Academyof Sciences,pp. 198-216.Washington,DC (1975).

(44) National Academy of Sciences!National ResearchCouncil. “Principles andProceduresfor EvaluatingtheToxicity ofHouseholdSubstances,”National Academyof Sciences,pp. 111—118. Washington,DC(1977),

(45) NationalAcademyof Sciences/NationalResearchCouncil.“Toxicity Testing:Strategiesto DetermineNeedsandPriorities.”NationalAcademyof Sciences,Pp.62—64 and169—174.Washington,DC(1904).

(48) Clermont,Y. andPercey,B,“Quantitativestudyof the cellpopulationoftheseminiferoustubules in immature rats,”“AmericanJournalof Anatomy.” 180:241—267,(1957).

(47) Lamb,J. andChaptn,R. E.“Experimentalnoodeisof male reproductivetoxicology.” In: “EndocrineToxicity.”Thomas,J. A.,Korach,K. S., andMcLachlan,J. A., ads,NewYork, NY: RavenPress,pp.65—115. (1985).

Confidential businessinformation(GB!), while part of therecord is notavailablefor public review.A publicversionof the record, from which CBIhasbeendeleted,is availableforinspectionin theTSCA Public DocketOffice, Rm. G—004,NE Mall, 401M StreetSW., Washington,DC, from 8 n.m. to 4p.m.,MondaythroughFriday, exceptlegal holidays,

VII. Other RegulatoryRequirarcients

,4. ExecutiveOrder12291

UnderExecutiveOrder12291,EPAmustjudgewhetherarule is “major”andthereforesubjectto therequirementof aRegulatoryImpactAnalysis.EPAhasdeterminedthatthis testrule is notmaJorbacausoit doesnot meet anycfthe criteriaml tenth in sectIon1(b) oftheOrder; i.e., it will not haveanannualeffecton the economyof at least$iojmiliion, avid not causea maiorincrenanin eostscaprices,andwill not has’sasignificantadverseeffect on c’cmpntfiionen’ the ability of U.S. enterprisetooo.mpeinaNtisforeignrnte:’yrises,

~ ~ — ccof lUsinagarnentendBudget (OM’i’) forserious’ccc roeniredby ExecutiveOrder‘Mmii. Any written ec’,nimeutefrom 0M113Ic,’ CPA, endanyEPA aeononce to thosecomments,ore includedin theruleniskirigrecord.

Under tb’s RegulatoryFiexibilitu Act(5 U.S.C.82’l of scsi.,Pub, L. 90-354,September19, 1992),EPA is certifyingthat this test rulewill not has’sasignificantimpacton asubstantialnoxnberof a: all businessesbecauce:(ci)Theyarenot likely cc performtestingthemselves,or to participatein the

$7808 Federal_Register/ Vol. 54, No.176/ Wednesday,_September13, 1989 / Rules and Regulations

orpanizalion of thetestingeffort; (2) theywill experienceonly veryminorcosts, ifany, in securingexemptionfrom testingrequirements;and(3) they areunlikelyto be affectedby reimbursementrequirements.

C. PaperworkReductionAct

0MB hasapprovedthe informationcollection requirements containedin thisfinal rule under the provisions ofthePaperwork Reduction Act of 1980 (44U.S.C. 3501at sea.,Pub. L. 96—511,December11, 1980), and has assigned0MB control number 2070—0033.

Public reporting burden for thiscollection of information is estimatedtototal 12,534hoursandto average1,253hours per test, including time forreviewing instructions, searchingexistingdatasources,gatheringandmaintainingthedataneeded,andcompletingandreviewingthecollectionof information.Sendcommentsorinformation, including suggestionsforreducingthis burden,to Chief,Information PolicyBranch, PM—223, U.S.EnvironmentalProtectionAgency, 401 MStreetSW., Washington,DC 20460;andto the Office of Information andRegulatoryAffairs, Office ofManagementandBudget,Washington,DC 20503.

List of Subjectsin 40 CFR Part799

Testing,Environmentalprotection,Hazardoussubstances,Chemicals,Recordkeepingandreportingrequirements.

Dated:August 28, 1989.VictorJ. Kinun,ActingAssistantAdministratorforPesticidesandToxicSubstances,

Therefore,40 CFR part799 is amendedasfollows:

PART 799-~~AMENDED]

1. Theauthos’ity citation for part799continuesto readas follows:

Authority: 15 U.S.C. 2603, 2611, and2625.

2. By addingnew § 799.2700,to read

asfollows:§ 799.2700 Methy~ethy’ ketox~rne,

(a) Identificationof testsubstance.(1)Methyl ethyl ketoxime(MBKO, CAS No.96-29—7) shall be testedin accordancewith this section.

(2) MEKO of at least99 percentpurityshall be usedas thetestsubstance.

(b) Personsrequiredto submitstudyplans,conducttests,andsubmitdata.All personswho manufacture(includingimport) or processor intendtomanufactureor processMEKO,including personswho manufacture orprocessor intendto manufactureor

processMEKO as a byproduct,orwhoimport or intendto import productswhichcontainMEKO, after thedatespecifiedin paragraph(e) of this sectionto the end of the reimbursementperiod,shall submitlettersof intent to conducttesting, submit study plans, conducttestsandsubmitdata,or submitexemptionapplications, as specifiedinthis section,subpartA of thispart,andparts 790and 792of this chapter forsingle-phaserulemaking.Personswhomanufacture,import, or processMEKOonly as an impurity are not subject totheserequirements.

(c)Health effectstesting—(1)Pharmacokineticstesting—(i)Requiredtesting.Pharmacokineticstesting shallbe conductedwith MEKO in accordancewith paragraph(c)(1)(ii) of this section.

(ii) [Reserved.](2) Oncogenicity—(i)Requiredtesting.

Oncogenicitytestingshall be conductedin accordancewith § 798.3300ofthischapter.

(ii) Routeof administration,MEKOshall beadministeredeitherorally or byinhalation.

(iii) Reportingrequirements.(A)Oncogenicitytestingshall be completedanda final reportsubmittedto EPAwithin 53 monthsof the date specifiedInparagraph(e) of this section.

(B) Interim progressreportsshall besubmitted to EPA at 6-month intervals,beginning 6months after the datespecifiedin paragraph (e) of this section,until submissionof thefinal reporttoEPA.

(3) Developmentaltoxicity—(i)Requiredtesting.Developmentaltoxicity testing shall be conductedin arodent and anonrodentmammalianspeciesin accordancewith § 798.4900ofthis chapter.

(ii) Routeofadministration.MEKOshall beadministeredorally.

(iii) Reportingrequirements.(A)Developmentaltoxicity testingshall becompletedand a final report submittedto EPA within 15 monthsof thedatespecifiedin paragraph (eJ of this section.

(B) Interim progressreports shall besubmitted to EPA at 6-month intervals,beginning 8months after the datespecifiedin paragraph (e)of this section.

(4) Reproductivetoxicity’—(i)Requiredtesting.(A) Reproductivetoxicity testingshallbeconductedorallyin accordancewith § 798.4700of thischapter except for theprovisions inparagraphs (c) (8)(iii) and (9)(i) of§ 798.4700.

(B) For the purposeof this section,thefollowing provisionsalso apply:

(1) The following organs and tissues,or representativesamplesthereof, shallbe preservedin a suitable medium forpossiblefuture histopathological

examination:Vagina,uterus,oviducts,ovaries,testes,epididymides,vasdel’erens,seminalvesicies,prostate,pituitarygland,and, targetorgan(s)ofall Pand F1 animals selectedfor mating.

(2J(i) Full histopathology shall beconductedon the organs andtissueslisted in paragraph(c)(4)(i)(B)(i) of thissectionfor all high doseand control Pand F1 animalsselectedfor mating.

(ii) The integrity of thevarious cellstagesof spermatogenesisshall bedetermined, with particular attentiondirected toward achievingoptimalquality in the fixation and embedding.Preparations of testicular andassociatedreproductive organ samplesfor histology should follow therecommendationsof Lamb and Chapin(1985)under paragraph (d)(1) of thissection,or an equivalent procedure.Histopathology of the testesshall beconductedon all P and F1 adult malesatthe time of sacrifice, and histologicalanalysesshall include evaluationsof thespermatogeniccycle, i.e., the presenceand integrity of the 14 cell stages.Theseevaluations shouldfollow the guidanceprovided by Ciermont and Percy(1957)under paragraph (d)(2) of this section.Information shall also be providedregarding the natureand level of lesionsobservedin control animals forcomparativepurposes.

(iii~Data on femalecyclicity shall beobtainedby conductingvaginalcytologyin PandF1 femalesoverthelast3weeksprior to mating; thecell stagingtechniqueof Sadleir(1978)andthevaginal smearmethod in Hafez (1978)under paragraphs (d)(3) and (d)(7) of thissection, respectively,or equivalentmethodsshouldbeused.Datashall beprovidedon whethertheanimal iscycling andthecyclelength.

(iv~P and F1 femalesshall continuetobeexposedto MEKO for at leastanadditional2 weeksfollowing weaningofoffspringto permit themto begincyclingonceagain.They shall thenbe sacrificedandtheirovaries shall be seriallysectionedwith a sufficient number ofsectionsexaminedto adequatelydetailoocyteandfollicular morphology.Themethodsof Mattison and Thorgierason(1979)and Pedersonand Peters (1988)under paragraphs (d) (4) and(5) of thissection,respectively,may provideguidance.Thestrategyforsectioningandevaluationis left to thediscretionoftheinvestigators,but shall be describedin detailin thestudyplan andfinalreport. The nature and background levelof lesionsin control tissueshall alsobenoted.

(v) Grossandhistopathologicevaluationsshall be conductedon themammaryglandsin F1 femalesandF2

Fed6rsI Register/VoL 54, No. 176/Wednesday,September13, 1989 / Rules and Regulations 37809

pupssacrificedat weaningand in adultF1 femalesat theterminationofthestudy.Any abnormalitiesshall bedescribedin thefinal report.

(ii) Reportingrequirements.(A)Reproductivetoxicity testingshall becompletedand a final report submittedto EPAwithin 29 monthsof thedatespecifiedin paragraph(e)of this section,

(B) interim progressreportsshall besubmittedto EPA at 5-monthintervals,beginningsix monthsafterthedatespecifiedin paragraph(a) of this sectionuntil submissionof thefinal report toEPA.

(5) Mutageniceffects—genemutotions—-(i)Requiredtesting.Thesex-linkedrecessivelethalassayinDrosoohila shall beconductedwithMEKO in accordancewin § 790.5275ofthis chapter.

(ii) Reportingrequirements.(A) Thesex-linkedrecessivelethalassayinDrosophilashallbe completedandafinal reportsubmittedto EPA within 18monthsof the datespecifiedinparagraph(e) of this section.

(B) Interim progressreportsshall besubmittedto EPA at 6-monthintervalsbeginning8monthsafter thedatespecifiedin pssagranh(e) of thin cection.

(6) Mutageniceffects—chramosamalaberrations—.{ilRequiredtesting. (A)An in viva mammalianbonemarrowcytogeneticstest shall beconductedwith i~fls’K0in accordancewith either§ 758,5385(chromosomaianalysis)ofthis chapter,or § 798.5305(micronucleusassay)of this chapterexceptfor theprovisionsin paragmphs(d)(5J (ii), (iii),and(iv) of § § 798.5385and798.5395.

(B) For thepurposeof this section,thefollowing provisions alsoapply if§ 798.5385of this chapteris usedinconductingthetest:

(I) Doselevelsandduration ofexposure.At leastthreedoselevelsshall betested.Thehighestdosetestedshallbethemaximum tolerateddoseorthat doseproducing somesignsofcytotoxicity (e.g., partial inhibitien ofmitosis) or shallbe thehighestdoseattainable. Under oral administration,animalsshallbe exposedonceper dayfor S consecutivedays.Underadministrationby inhalation,animalsshall he exposed6 hoursperdayfor 5consecutivedays.

(2~Routeof administration.Animalsshall beexposedto MEKO eitherorallyorby inhalation.

(C) Forthepurposeof this section,thefollowing provisions aLso apply if§ 793.5395of this chapter is usedinconductingthetest:

(1) Doselevelsandduration ofexposure.At leastthree-doselevelsshall be tested.Thehighestdosetested

shallbe themaximumtolerated doseorthat doseproducing somesignsofcytotoxicity (e.g., achangein theratio ofpolychromaticto normochromaticerythrocytes)or shall be the highestdoseattainable.Underoraladministrationanimalsshall beexposedonceper dayfor 5 consecutivedays.Underadministrationby inhalation,animalsshall be exposed6hoursperdayfor 5 consecutivedays.

(2) Routeof administration.Animalsshall beexposedto MEKO either orallyor by inhalation.

(ii) Reportingrequirements.(A) Theoral in vivo mammaliancytogeneticstestshall becompletedandafinalreportsu~mitiedto EPAwithin 14monthsof thedatespecifiedinparagraph(a) of this section.Theinhalationin viva mammaliancytogenaticatestshadhecompletedanda final reportsubmittedto EPA within17 monthsof thedatespecifiedinparagraph(a) of this section,

(B) Interim progressreportsshall besubmittedto EPAat 6-monthintervals,baqinning6monthsafterthedatespecifiedin paragraph(a) of this section,

(7) Neurotoxicity—() Requiredtosting—(A)Functionalobservationalbac’terys (1) A functional observationalbatteryshall beconductedwith MEKOin accordancewith § 798.8050of thischapterexceptfor theprovisionsinparagraphs(d) (41(u). (5), and(6) ci§ 798.6050.

(2) For thepurposeof this section,thefollowing provisionsalsoapply:

(I~Routeof exposure.Anisealashallbeexposedeitherorally orbyinhalation.

(ii) Lowerdoses.The data from thelower dosesshall showeither gradeddose-dependenteffects in atleast two ciall thedosestested,including thehighestdose,orno neurotoxic(behavioral) effects at any dosetested,

(liiJ Duration andfrequencyofexposure.Fortheoralacutetesting,animalsshall beexposedonce.Fortheoralsubchronictesting,animalsshall beexposedonceperday 5 daysperweekfor a90-dayperiod.For the inhalationacutetesting,animalsshall beexposedfor 8 hours for 1 day.For theinhalationsubcbronictesting,animalsshallbeexposedS hoursperday5 daysperweekfor a90-dayperiod.

(B) Motoractivity. (1) A motoractivity testshall beconductedwithMEKO in accordancewith § 798.6200ofthis chapterexceptfor provisionsinparagraphs(d) (4j(ii), (5), and(6) of§ 793.8200.

(2) For thepurposeof this section,thefollowing provisionsalso apply:

(I) Routeofexposure.Animals shall

beexposedeitherorally orbyinhalation,

(iij Lowerdoses,Thedatafrom thelower dosesshall showeithergradeddose-dependenteffects in at leasttwo ofall thedosestestedincluding thehighestdose,or no neurotoxic(behavioral)effectsat anydosetested,

(iii) Duration andfrequencyofex.posure.For theacuteoral testing,animalsshall be exposedonce.For theoral subc.hronictesting, animalsshall beexposedonceperday 5 daysper weekfor a90-clayperiod.For theacuteinhalation testing,animalsshall beexuosedfor 6hoursfor I day. Fur theinhaictiansuboheonictesting, theanimalsshall beexposedfor 3 hoursperdc.3’ 5 daysperweekfor a90-dayperiod.

(C) Neuropc.thology.(2) Aneuropathologytest shall beconductedwith MEKO in accordancewith§ 798.6400of this chapterexceptfor theprovisionsin paragraphs(d) 141(h), (0),(6), and(8)(iv)(C) of § 798.6400.

(2) For th.e purposeofthis section,thefollowing provision-salsoapply:

(i) Routeofexoosure.Animals emilbe exposedeither orallyor byinhalation,

(ii) Lower doses.Thedatafrom thelower dosesshall showeithergradeddose-dependenteffectsin at leasttwo ofall thedosestestedincluding thehighestdose,orno neurotoxic(behavioral)effectsat anydosetested,

(iii) Durationandfrequencyofexposure.Animalsshall be exposedorally onceperday5 daysperweekfora90-dayperiod;or if exposedbyinhalation,for 6 hoursperday5 daysperweekfor a90-dayperiod.

(iv) Clearing andembedding.Afterdehydration,tissuespecimensshall beclearedwith xyleneandembeddedinparaffinorpamaplastexceptfor theauralnervewhichshould beembeddedinplastic.Multiple tissuespecimens(e.g.,brain,cord,ganglia)maybeembeddedtogetherin onesingleblockforsectioning.All tmssueblocks shall belabeledto provide unequivocalidentification. A suggestedmethodforplasticembeddingis describedbySpenceretat. in paragraph(d)(6) of thissectron.

(ii) Reportingrequirements.(A) Theneurotoxicity testsrequiredunccr thisparagraph(c)(7) andadministeredorallyshall becompletedandthefinal resultssubmittedto EPA within 18 months ofthedatespecifiedin paragraph(a) ofthis section.Theneurotoxicityteatsrequiredunderthisparagraph(c)(7) andadministeredby inhalationshall be

37810 Federal RegisterI Vol. 54, No. 176 / Wednesday,September13, 1989 / Rules and Regulations

completedandthe final resultssubmittedto EPA within 21 monthsofthedatespecifiedin paragraph(a)ofthis section.

(B) Interim progressreportsshall besubmittedto EPA at 6-monthintervalsbeginning6 monthsafter thedatespecifiedin paragraph(e) of this sectionuntil submissionof thefinal reporttoEPA,

(d) References.For additionalbackgroundinformation, thefollowingreferencesshouldbeconsulted.

(I) Lamb, J. andChapin,R.E.“Experimentalmodelsof malereproductive toxicology” In: “EndocrineToxicity.” Thomas,J.A., Korach, K.S.,andMcLachlan,J.A.,eds.NewYork,NY: RavenPress.pp. 85—115. (1985).

(2) Clermont, Y. andPercey,B.“Quantitativestudyof thecellpopulation of the seminiferoustubules inimmaturerats.” “AmericanJournalofAnatomy.” 100:241—267.(1957).

(3) Sadleir,R.M.F.S. “Cyclesandseasons.”In: “Reproduction inMammals:I. GermCellsandFertilization.” Austin, R. andShortR.V.,eds.NewYork, NY: Cambridge Press.Chapter4. (1978).

(4) Mattison,D.R. andThorgiersson,S.S.“Ovarian aryl hydrocarbonhydroxylaseactivity andprimordialoocyte toxicity of polycyclic aromatichydrocarbonsin mice.” ~‘CancerResearch.”39:3471—3475.(1978).

(5) Pederson,T. andPeters,H.“Proposaifor classificationof oocytesandfollicles in themouseovary.”“Journalof ReproductionandFertility.”17:555—557.(1968).

(6) Spencer,P.S.,Bischoff. M., andSchaumburg,H.H. “Neuropathologicalmethodsfor thedetectionof neurotoxicdisease.”In: “ExperimentalandClinicalNeurotoxicology.”Spencer,P.S.andSchaumburg,H,H., eds.Baltimore,MD:Williams andWilkins, pp. 743—757(1980).

(7) Hafez,E.S., ed.,“ReproductionandBreedingTechniquesfor LaboratoryAnimals.” Chapter10. Philadelphia:LeaandFebiger.(1970).

(a)Effectivedates.(1) Theeffectivedateof this final rule is October 27, 1989.

(2) The guidelinesandothertestmethodscited in this sectionarereferencedhereas theyexist onOctober27, 1989.

(icformatlencollectionrequirementshavebeenapprovedby the Office of ManagementandBudgetunderControlNumber2070-0033).[9’R Doc, 89—21497Filed 9—19-89;8:45 am]5~LUNSCODE 555D-aO-M

GENERAL SERVICES

ADM~N1STRA11ON

41 CFRParI3OI—4

[FTRAmendment1]

FederalTravelRegulation

AGENCY: FederalSupplyService,GSA,ACTION: Final rule.

SUMMARY: This final rule amendstheFederalTravelRegulationto increasethe mileagereimbursementrate from22.5 centsto 24 cents per mile for useofprivately owned automobileswhenauthorizedasadvantageousto theGovernment.This FFR amendmentreflectstheresults of the GeneralServicesAdministration’s (GSA’s)reportto Congresson the investigationof the costof operating privately ownedautomobiles.EFFECTIVEDATE: This final rule iseffectivefor travelperformedon or afterSeptember17, 1989.FOR FURTHER INFORMATION CONTACT:RaymondF. Price,Jr., TravelManagementDivision (FBT),Washington,DC 20406,telephoneFT’S557—1253or commercial (703)557—1253.SUPPLEMENTARY INFORMATION: TheTravel ExpenseAmendmentsAct of1975 (Pub.L. 94—22,May 19, 1975)authorizesthe Administratorof GeneralServicesto issueregulations prescribing,within statutory limits, mileageallowancerates.GSA is requiredby lawto periodically investigatethe costofoperatingprivatelyownedvehicles(automobiles,airplanes,andmotorcycles) to employeeswhile onofficial travel and report the results oftheseinvestigationsto the Congress.GSA reported the results of theDecember1988 investigation ofthe costof operatingprivately ownedautomobilesto the Congressindicatingthat thegoverningregulationwould berevisedto reflectanincreasein themileage allowancefor useof privatelyownedautomobiles.Necessaryadjustmentsarereflectedin thisamendmentto the FI’R.

GSA has determined that this rule isnot amajorrule for thepurposesofExecutiveOrder12291of February 17,1981, becauseit is not likely to resultinanannualeffect on the economyof $100million or more, a major increaseincoststo consumersorothers,orsignificantadverseeffects.GSA hasbasedall administrativedecisionsunderlyingthis rule on adequateinformationconcerningthe needfor, andconsequencesof, this rule; hasdeterminedthatthepotentialbenefitstosociety from this rule outweighthe

potential costsandhasmaximizedthenetbenefits;andhaschosenthealternativeapproachinvolving theleastnetcostto society.

List of Subjectsin 41 CFRPart301-4

Government employees,Travel,Travel allowances,Travel andtransportation expenses.

For thereasonssetout in thepreamble,41 CFR part301—4 is amendedas follows:

-PART 301-4—RE~M~URSEMENTFORUSE OF PRIVATELY OWNEDCONVEYANCES

1.The authority citation for part 301—4continuesto read as follows:

AUThORITY: 5 U.S.C.5701—5709;E.O. 11609,July 22, 1971(36 FR 13747).

2. Section301—4.2 is amendedbyrevising paragraphs (a)(2), (d)(1), and(d)(2) to read as follows:

§301-4.2 When use of a prlvately ownedconveyance Is advantageous to theGovernment.

(a) * * *

(2) For useof aprivately ownedautomobile: 24 centsper mile.

(d) * * *

(1) Roundtrip insteadof taxicab tocarrier terminals.Instead of usingataxicab under§ 301—2.3(c),payment on amileagebasis at therate of 24 centspermile andotherallowablecostsassetforth in § 301—4.1(c)shall beallowedforthe round-trip mileage of a privatelyowned automobile usedby an employeegoingfrom eitherthe employee’shomeor placeof businessto aterminalorfrom aterminalto eitherthe employee’shomeor placeof business.However,theamountof reimbursementfor theroundtrip shall not in eitherinstanceexceedthetaxicabfare, including tip, allowableunder§ 301—2.3(c)for a one-waytripbetweentheapplicablepoints.

(2) Roundtrip insteadof taxicabbetweenresidenceandofficeon dayoftravel. Insteadof usingataxicabunder§ 301—2.3(d)(in connectionwith officialtravelrequiringat leastonenight’slodging), paymenton a mileagebasisatthe rateof 24 centspermile andotherallowablecostsassetforth in § 301—4.1(c) shall be allowedfor round-tripmileageof aprivatelyownedautomobileusedby anemployeegoingfrom the employee’sresidenceto theemployee’splaceof businessorreturningfrom placeof businesstoresidenceon a daytravelis performed.However,the amountof reimbursementfor theroundtip shall not exceedthetaxicabfare, including tip, allowable

FederalRegister / Vol. 54, No. 176 I Wednesday,September13, 1989 / Rules and Regulations 37811

under§ 301—2.3(d) for aone-waytripbetweenthe points involved.

Dated: August 24, 1939.RichardG.Austin,ActingAdministratorof GeneralServices.[FR Doc. 89—21478Filed 9-12—89; 8:45 am]SILUNG CODE 6020-244A

41 CFR Parts302-6and 302-12

[FTP Amendment 2]

Federal Travel Regulation

AGENCY: Federal Supply Service, GSA.AcT:oN: Final rule.

SUMMARY: Becauseof achangein thelaw, this final rule amendsthe FederalTravel Regulation to authorize,undercertain conditions,reimbursement ofallowableresidencetransactionexpensesfor employeestransferredfrom an official station in a foreign areato a different nonforeign areaofficialstation than the onefrom which theemployeewastransferredwhenassignedto the foreign post of duty.EFFECTIVE DATE: This final rule iseffectivefor employeeswhoseeffectivedate of transfer(date the employeereportsfor duty at the new nonforeignareaofficial station) is on or afterFebruary19, 1988.FOR FURTHER INFORMATiON CONTACT:DorisL. Jones,Regulations Branch(FBTR),Washington,DC 20406,telephoneFF3557—1253or commercial(703)557—1253.SUPPLEMENTARY 1NFOBMATION: TheContinuing Resoiuti.onfor fiscal year1988, PublicLaw 100—202(101Stat. 1329—430,431)December22, 1987, authorizednew relocationbenefitsfor certaintransferredemployees.Section628 ofthatlaw amended5U.S.C. 5724atospeciflcailyauthorize, under certainspecifiedconditions,reimbursementofallowableresidencetransactionexpensesfor employeestransferredfrom an official stationin aforeign areato add±eraninonforeignarea officialstationthantheonethe employeeleftwhentransferredto the foreign post ofduty.

The GeneralServicesAdministrationhasdeterminedthat this rule is not amajorrule for thepurpcoesof ExecutiveOrder12291of February17, 1981,becauseit is not likely to result in anannualeffecton theeconomyof $100million or more;amajorincreaseincoststo consumersor others;orsignificantadverseeffects.The GeneralServicesAdminieiiationhasbasedalladministrativedecisionsunderlyingthisruleon adequateinformation concerning

theneedfor, andconsequencesof, thisrule; hasdeterminedthat thepotentialbenefitsto society from this ruleoutweigh the potential costs; hasmaximized thenet benefits; and haschosenthe alternative approachinvolving the least net cost to society.

List of Subjectsin 41 CFR Parts352—6and 302—12

Governmentemployees,Transfers,Relocationallowancesand entitlements.

For the reasonsset out in thepreamble,41 CFR parts 302—8 and302—12 are amendedas follows:

PART 302-6—ALLOWANCE FOREXPENSESINCURRED INCONNECTION WITH RESIDENCETRANSACTIONS

1. The authority citation for part 302—6continuesto read as follows:

Authority: 5 U.S.C.5721—5734;20 U.S.C.905(a);E.O. 11809,July 22,1971 (36FR13747).

2. Section302—6.1is amended byrevising the introductory text,paragraphs (a), (b), (c), (d), and (e)(1),and by adding paragraph (g) to read asfollows:

§ 302—6.1 ConditIonsandrequirementsunder whIch allowancesare payable.

To theextentallowableunderthispart302—6, theGovernmentshallreimburseanemployeefor expensesrequired to be paid by him/her inconnectionwith thesaleof oneresidenceat his/herold official station,for purchase (including construction) ofone dwelling at his/hernew officialstation, or for thesettlementof anunexpiredleaseinvolving his/herresidenceoralot on which a mobilehomeusedashis/herresidencewaslocatedat the old official stationprovided the conditionssetforth in thissectionare met:

(a) Transferscovered—agreementrequired.A permanentchange of stationis authorizedorapprovedand, exceptasprovidedin paragraph(g) of this section,the oldandnewofficial stationsarelocatedwithin the 50 States.theDistrictof Columbia,the territoriesandpossessionsof theUnited States,theCommonwealthof PuertoRico, or theformerCanalZonearea(i.e., areasandinstallationsin the Republicof Panamamadeavailableto theUnitedStatesunderthePanamaCanalTreatyof 1377andrelatedagreements(as describedinsection3(a)of thePanamaCanalAct of1979]), andthe employeehassignedanagreementasrequiredin § 302—1.5. (Seeexdhisionsin § 302—6.4.)

(hj Locationandtypeof residenc’e.The residonceor dwelling is theresidenceasdescribedin § 302—1.4(j),

whichmay be amobile homeand/orthelot on whichsuchmobile homeislocatedor will belocated.Thesecriteriaalsoapplyto theformernonforeignareaofficial stationresidenceof employeeswho areeligible for residencetransactionexpensesunderparagraphig) of this section(seedefinition inparagraph(g)(i)(i) of this section).

(c) Title requirements.Thetitle to theresidenceor dwelling at theold ornewofficial station, or the interest in acooperativelyowned dwelling or in anunexpiredlease,is in the nameof theemployeealone, or in the joint namesofthe employeeand one or more membersof his/herimmediatefamily, orsolely inthenameof one or moremembersofhis/her immediate family. For anemployeeto be eligible forreimbursement of the Costsof selling adwelling or terminating a leaseat theold official station, the employee’sinterest in the property must have beenacquired prior to the date the employeewasfirst officially notified of his/hertransfer to the new official station, Inthe caseof employeescoveredbyparagraph (g) of this section, theemployee’sinterest musthave beenacquired prior to the date the employeewasfirst officially notified of his/hertransfer to the foreign area.

(d) Occupancyrequirements.The -

dwelling for which reimbursementofselling expensesis claimedwas, exceptas provided in paragraph (g) of thissection,the employee’sresidenceat thetime he/shewasfirst officially notifiedby competentauthority of his/hertransfer to the new official station,

(e) Timelimitation—(i) initial period.The settlementdatesfor the saleandpurchaseor leaseterminationtransactionsfor which reimbursement isre-questedare not later than 2 yearsafterthe date that the employeereported forduty at the new official station.Foremployeeseligible under paragraph (g)of die section,new official stationmeanstheofficial stationto which theemoloyeereportsfor duty whenraass4gnedor transferredfrom a foreqnarea.* * * * *

(g) Transferfrom aforeign areato anonforei

2narea—(1)Definitions.For

purposesof this paragraph(g), thefollowing definitionsapply:

(i) Fannernonforeipn area officialstation.This term meanstheoft’ic-iaistationfrom which the emT-ioyeewastransferredwhenassignedto the postofduty in theforeignarea.

(ii) Nonfireignarea. Nonforeigaareaincludesthe United States-,its territoriesor possessions,theCommonwealthofPuertoRico, or the formerCanalZone

37812 FederalRegister/ Vol. fit No. 176 / Wednesday,September13. 1989 / Rules and Regulations

area(i.e., areasandinstallationsin theRepublicof PanamamadeavailabletotheUnited Statespursuantto thePanamaCanalTreatyof 1977andtaletedagreements(asdescnbedinsecttcnSin)of thePanamaCanalAct of

‘ii) Foregoarea Foreignarearefersarmy areanot definedasa nonforeign

area.fri Apphcabi/!t~Theprovssionsof

±ispartStiSin araapp1icable4assperifledin this paragraph(g). toemployeeswho havecompletedanae~cedupontour of du’y in aforeigna ~a andinsteadof heioereturnedto thefo~‘Oar nocfbreignareaofficial station,~re reassignedor transferredin theinterestof theGovernmentto s differentoartoreign areaofficial station thantheofficial station from winch theemployeemacs t’snsferrrrdwhenassignedto thein’olgr. postof duty. The distancebe earri theformerandnewofficial

m mustmeetthemileagecriteriaspecifiedin § 3J2~l,7for shortdistance£;a_afers

in) Aothorizedrejxnbursement.GrnernUy,anemployeeis requiredtoserveat leastonetour of duty in aforeignareaandretainaresidencein arunforoignareawith theexpectationofrio mrntng to theformer official stctioninthenonforeignarea.However,tbereareinsrenceswhenanemployeecompletesa tearof duty in aforeign areaandissubsequentlytransferredto adifferentofficial stationor postof duty in anonforeignareathantheonefrom whichhe/sItetransferredwhenassignedto theforeignpost of duty. When this typeoftransfert

5authorizedorapproved,

rainroursententis allowablefor real,esta!eexpensesrequiredto bepaid bytheemployeein connectionwith:

i/l The saleof there&denca[or thesettlementof anune,ciredlease)at theffictal stationfrom which the employee

wastransferredwhenhe/shewasussignedto apostof duty locatedto afor’t.m area;and

(imi ThepurchasetiE a rem’ t,icnueat the‘e nffbdalstationwhra theempioyse

ms ‘ronafcrredin thainterestof theGttt,mnmantfroma postof duty leautodin a foreign areato a ‘mc.rforetgnareaoffiemi stction (otherthan the offrr jalstationfrom whichhe/shewas~rrmsfesredwhenassignedto thefar~tgnpostof duty).

11 .PeLnbur-sepeel ProJtaticjns.Pelmnbursemnentunder:hrs paragraph(~lis prohibtteofor any sale(or sct’iernentof cc unexpiredtease)or porehaaetrtnsactionthatoccursprior to theempluvee’sfirst beingofticially aotiflcdi.penerailyin theform of a changeofofficial station travelauthorization)thatinsteadof returningto theformer

nonforeignareaofficial station,he/shewill bereassignedor transferredto adifferentnonforeignareaofficial stationthan theonefrom whichhe/shewastransferredwhenassignedto theforeignpostof duty.

¶5) Serviceogreementrequired.Asignedserviceagreementshall berequiredasprescribedin § 302.1.5foranyemployeewho is eligible forreimbursementof residencetransactionexpensesauthorizedunderthisparagraph¶g}.

PART 302-12—USEOF RELOCATIONSERVICECOMPAMES

3. The authoritycitation for PartSOil—12 continuesto readas foilows:

Authority: 5 U.SC. sr2j—5734; 20 U.S.C.Sofia);E.O. 12309,July22, 1971 (36FR tr4v(;E.O.12466,February27,1984 (49FR 7349);7.0. 12322, June24, 1995 (50FR 26337).

4. Section302—12.4is amendedbyrevisingparagraph(b)(3) to readasfollows:

§ 302—12.4 GeneralcondittonsandimitatIonsicr eiigibPity.

in) ‘

¶3) Enrployeesassignedor transferredto or from apostof duty in aforeignareaexceptemployeeseligible forrermbursementof residencetransactionexpensesasprovidedin § 302.81(g).

dated:August24. 1939ilirhard C. Austin,4cr.pg .4dministrck’rpfGeneralServices.~rRtoo.59—21479Stied9—12—89: 8:45emJSiLLtiIG 000C 552O~~24-M

CEPAFITMENT OF THE INTERIOR

Bureauof LandManagement

43 CPA PublicLandOrder6747

fiD—943-’09—4214-10;101—270061

Partial Revocationof SecretariniOrderDatedOc:touirr3, 1021;Idaho

*o�iscv:So’escof handManagenmoutInterior.ACTION: Public Land Order.

.SUMMARV:This orderrevokesaSecr&ariaiorderwhichwithdrew Soacesof NatIonal ForestSystemlandire,, sur~oceentryfcr useby theU.S.forestServicefor gtockDrivewayNo,~3in theSawtoothNotionalForest.The‘and ts not neededfor thepurposefor~och t waswithdrawn,This actionwPl opentheland to surfaceentryendallow for aproposedexchange.The land‘a tO remainclosedto mining and

mineralleasingdueto anoverlappingwithdrawal.CFFECTJYEDATE: October13, 1989.

FO9 FURTHER 1NFORMAT~ONCONTACtLarry Lievsa.y,BLM Idaho StateOffice,.3380AmericanaTerrace,Boise, Idaho85706,206—334—1735.

By virtueof theauthorityvestedin theSecretaryof theInteriorby section204of theFederalLandPolicy andMunagementActof 1976,90 Stat.2751,43 U.S.C. 1714,it is orderedas follows:

1. The SecretarialorderdatedOctober8, 1921, is herebyrevokedinsofaras itaffects thefollowing describedland,

‘BoiseMeridianT,7r4.,R142.,

Sec.24, W’455¼.Theareadescribedcootamns80 acres

in MaineCounty.2. At 9:00 a.rn.on October13, 1989, the

landdescribedshall beopenedto suchformsof dispositionasmay by law bemadeof NationalForestSysteniland,suh)entto valid existingrights,theprovisionsof existingwithdrawals,othersagregatiortsof record,andtherequirementsof applicablelaw. Thelandwrll remamclosecto m:n:ngandmineral leasmng.

Datnd:September1. 1309FrankA. ‘Bracken,L1’rde.’ Secretey oftheInterior,fUR IJoc. 89-21506Filed9-12—89:8:45 snilsiwtia coos45mn~~GG-M

DEPARTMENTOF COMMERCE

NationalOceanicandAtmosphericAdministration

SO CPA 217and227

SeaTurtleConservation;ShrimpTrawlingRequirements

AaE’Bcrt NationalMarineFisheries3cr;tee,NOAA, Commerce,ACTION: Reinstatementof regulations.

SUMMARY: NOAA publishedan bosomfinal ruleonAugust10, 1981,. asatemporarysubstitutefor the rulethatrequiresshrimp fishermenin theCult’ otMexico (Golf’) andtheAtlantic Oceanoff thecoastof thesoutheasternUnitedStatesin useTurtleExcluderDevicesfT�Ds) to reduceincidentalcapturesiiecd~ngeredandthreatenedspeciesseaturtles duringshrimp fishingoperations.The interim final rule~,i1cmaedshrhnpflshermenin nt’fshor”watersto choosebetweencontinuing toose“f’F,Ds or to restricttratalingtimes to

spectflcr10S~minuteperiods.Thatruleexpired on September8. 1989, at 12.01