EPA/Tetrabromobisphenol A; Final Test Rule

Federal Register I Vol. 52, No. 128 I Monday, July 5. 198? / Rules and Regulations 2521f~

28. Section100.302is redesignated§ 103.503,andparagraph(U is revisedto icedas follows:

§ 160.502 5arno~otFry Air BrockCi~usic,Tern’s h:sor, t~J.

Ih) Ef~~!i~cpci.~JThis roculehon‘sill be eFe’~3v~from 10:01)a.m. to 8:03p.m. annu~lis’on thefourW SaturdeyinAugustunlessothurwisespecifiedin theCoastGuardlocal Notice to Meninersanda FederalRegisterNotice. In caseofpostponement,this regulationwill be ineffectthe follo’ning day.

29. Sactio:r100.303is redesignated§ 300.504,andparagraph(U) is revisedto readasfellows:

§ 100.504 Night in Venice,GreatEggHarbor Bay,City of OceanCity, NJ.

(b) Effectiveperiod. This regulationwill be effectivefrom 4:30 p.m. to 11:45p.m. annuallyon thefourth SaturdayinJuly unlessotherwisespecifiedin theCoastGuardLocal Notice to MarinersandaFederalRegisterNotice.* * * * *

30. Section100.301is redesignatedas§ 100.101,andparagraph(b) is revisedto read as follows:

§ 100.101 Harsar&Yale~egatta,ThamesRiver, NewLondon,CT.

* * *

(b) Effectiveperiod.This regulationwill be effectivefrom 10:00a.m. to 1:30p.m. annuallyon thefirst or secondSaturdayin Juneas publishedin theCoastGuardLocal Notice to MarinersandaFederalRegisterNotice. In caseofpostponement,this regulationwill beineffect the following day.* * * * *

31. Section100.305 is redesignated§ 100.102,andparagraph(b) is revisedto readasfollows:

§ 100.102 ConnecticutRiverRaft Race.* * * * *

(b) Effectiveperiod.This regulationwill beeffective from 9:00 a.m. to 2:00p.m. annuallyon thefirst SaturdayinAugustunlessotherwisespecifiedin theCoastGuardLocal Notice to Marinersanda Federal RegisterNotice.* * * * *

32. Section100.306is redesignated§ 100.505and paragraph (b) is revisedtoread asfollows:

§ 100.505 New Jersey Offshore GrandPrtx.* * * * *

(b) Effectiveperiod.This regulationv~iilbeeffective from 8:00 a.m. to 5:00p.m. annually on the third Wednesdayin

July unlessotherwisespecifiedin theCoastGuardLocal Notice to MarinersandaFederalRegisterNotice.

33. ~cction 100,307is redesignuf 3f 100303cadparagraph(U) is LuVj:~ 3 to

a

ç 100.103 t~tiunatSweepstakesRegatta,Red5a~k,N.J.

[I) Effectiveperiod. This regulationwill be effectivefrom 5:00 am. to ~0Op.m. annuailyon thethird weehend(SaO.nday andSunday)in Augustunlessotherwisespecifiedin the CoastGuardLocal Notice to Marinersarida FederalRegisterNotice.* * * * *

34. Section100.308is redesignated§ 103.104,andparagraph(b) is revisedto readasfollows:

§ 100.104 EmpireStateRegatta,Albany,N.Y.* * * * *

(b) Effect!yeperiod. This regulationwill be effective from 6:00 a.m.Fridaythrough6:00 a.m.Monday, annuallyonthefirst or secondweekend(Friday,Saturday,SundayandearlyMonday)inJuneunlessotherwisespecifiedin theCoastGuardLocal Noticeto MarinersandaFederalRegisterNotice.* *

§ 100.1281 and100.1202 [Redesignatedas§ 100.1103and100.1104 Respectively]

35. Sections100.1201and100.1202areredesignated§ 100.1103and100.1104,respectively.

PART 174—STATENUMBERING ANDCASUALTY REPORTING SYSTEMS

36. The authoritycitation for Part174is revisedto readasfollows:

Authority: 46 U.S.C.4302,12302;49 CFR1.46.

37. Section174.121 is revisedto readasfollows:

§ 174.121 Forwardingof casualty oraccidentreports.

Within 30 daysof the receipt ofacasualtyor accidentreport, eachstatethathasanapprovednumberingsystemmust forward a copy of that report to theCommander of the CoastGuard Districtin which thestatecapitol is located,exceptthat Ohio and Minnesota mustforward reports to Commander,NinthCoast Guard District, Cleveland Ohio.

Dated:June29, 1987.R.E. Kramek,CAPT.,US.coastGuard,ChiefofStoffActing.IFR Doe. 87—15058Filed 7—2—87; 8:45 amlBJWNG CODE ~91O-14-M

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Part 709

[OPTS—4200M-;FRL-3225-01

TetrabrornobiophericI A; FinalTestRule

AGENCY: EnvironmentalProtectionAgency(EPA).

AcTlON: Final rule.

SUMMAP~Y:EPA is issunga final testrule, undersection4 of theToxicSubstancesControlAct (TSCA),requiringmanufacturersand processorsof tetrabromobisphenolA (TBBPA. GASNo. 79—94—7) to performtestingforchemicalfateandenvironmentaleffects.Thetesting requirementsincludebiodegradationstudiesin sediment!waterandsoil, an acutetoxicity studyin afreshwateralga,acuteandearlylifestagetoxicity studiesin fish, apartiallife-cycle toxicity studyin abenthicinvertebrate,achronic toxicity study inan aquaticinvertebrate,andbioconcentrationstudiesin fish andinvertebrates.

DATES: In accordancewith 40 CER23.5,this rule shall bepromulgatedforpurposesof judicial reviewat 1p.m.eastern(daylightorstandardasappropriate)time on July 20, 1987.Theseregulationsshall becomeeffective onAugust19, 1987.The incorporationbyreferencein theregulationsis approvedby theDirectorof theFederalRegisterasof July 6, 1987.

FOR FURTHER INFORMATION CONrACTEdwardA. Klein, Director,TSCAAssistanceOffice (TS—799), Office ofToxic Substances,Rm. E—543, 401 M St.,SW., Washington,DC26000,(202)554—1404.

SUPPLEMENTARY INFORMATIONI EPA isissuing a final test ruleundersection4(a)of TSCA to require chemical fateand environmentaleffects testingofTBBPA.

I. Introduction

A. TestRuleDevelopmentUnder TSGA

This final rule is partof the overallimplementation of section4 of TSCAPub.L 94—469,90 Stat. 2003etseq.,15

U.S.C. 2601etseq.),which containsauthority for EPA to require thedevelopmentof data relevant toassessingthe risk to health and theenvironment posedby exposuretoparticular chemical substancesormixtures (chemicals).

Under section4(a)(l) of TSCA, EPAmustrequiretestingof a chemicalto

2522Q Federal_Register I Vol. 52, No. 128 I Monday, July 6, 1987 / Rulesand Regulations

develop health or environmental data ifthe Administrator finds that:

(A)(i) themanufacture,distribution incommerce,processing,use,or disposalof achemicalsubstanceor mixture,or thatanycombination of suchactivities, maypresentan unreasonablerisk of injury to health or theenvironment.

(ii) thereareinsufficient data andexperienceupon which the effects of suchmanufacture,distributionin commerce,processing,use, or disposalof suchsubstanceor mixture or of any combination of suchactivitieson healthor the environmentcanreasonablybedeterminedor predicted,and

(iii) testingof suchsubstanceormixturewith respectto sucheffectsis necessarytodevelopsuchdata;or

(Bitt) a chemicalsubstanceor mixtureis orwill be producedin substantialquantities,and(I) it entersormayreasonablybeanticipatedto entertheenvironmentinsubstantialquantitiesor (Ii) thereis or maybe significantorsubstantialhumanexposureto suchsubstanceormixture,

(ii) thereareinsufficientdataandexperienceuponwhichtheeffectsof themanufacture,distributionin commerce,processing,use,ordisposalof suchsubstanceor mixtureorof anycombinationof suchactivitieson healthor theenvironmentcanreasonablybedeterminedor predicted,and

(iii) testingof suchsubstanceormixturewith respectto sucheffectsis necessarytodeveiopsuchdata.

A morecompletediscussionof thestatutorysection4 findings is providedin theAgency’sfirst proposedtest rulepublishedin theFederalRegisterof July18, 1980(45FR 48510).

B. RegulatoryHistory

TheInteragencyTesting Committee(ITC) designatedTBBPA for prioritytestingconsiderationin its 16th Report,publishedin theFederalRegisteronMay 21, 1985 (50FR 20930).II wasrecommendedby theJTC that TBBTAbeconsideredfor chemicalfate testing.includingwatersolubility, soiladsorptioncoefficient,andpersistence;environmentaleffectstesting,includingacuteandchronictoxicity to fish,aquaticinvertebratesandalgae:andbioconcentrationpotentialin fish.

EPA respondedto the ITCsrecommendationsfor TBBPA by issuinga proposedrule, publishedin theFederal Registerof May 15, 1986 (51 FR17872),whichwould requirethatTBBPAbe testedfor biodegradationinsediment/water,soil, andsludge,acutetoxicity in freshwateralgae,fish, andinvertebrates,early life stagetoxicity infish, chronic toxicity to invertebrates,andbioconcentrationpotential in fishandinvertebrates.In addition, theAgencyproposedto includeteststodeterminethe toxicity of TBSPA tohenttiic organismsin the final ruleforTFdIPA if anyof thesedimentbioassay

methodsreferencedin theproposedrulewere determined to be appropriateor ifthecommentsreceivedon theproposedrule indicatedtheavailability of otherappropriatesedimentbioassaymethods.

Theproposedrulecontainedachemicalprofile of TBBPA, a discussionof EPA’s TSCA section4(a) findings,andtheproposedteststandardsto beused.

II. Responseto Public Comments

The Agencyreceivedwrittencommentson theTBBPA proposedrulefrom theBrominatedFlameRetardantIndustryPanel(BFRIP or thePanel)onJuly 14, 1985 (Ref.1). AmeribromInc.,Ethyl Corporation,GreatLakesChemicalCorporation,andDowChemicalCompanyaremembersofBFRJP.Ethyl andGreatLakesaretheonly manufacturersof TBBPA in theU.S.;Ameribromis the oniy knownimporterof TI3BPA; andDow is oneofthemanyU.S. processorsof TBBPA. Apublic meetingwasalsorequestedbyBFRIP andwasheld on August21, 1986.Thecommentsreceivedby the Agencyin responseto theTBBPA proposadrulearediscussedbelow.

A. The ‘May Presentan UnreasonableRisk” Finding

TheGreatLakesChemicalCompanycommentedthat theAgencyhasusedoutdatedandflawed information,monitoringdatafrom ResearchTriangleInstitute(RTI), to reachdecisionson theproposedtests,and therefore, has notsatisfiedthestatutoryrequirementofsection4(a)(1J(A)(i) of TSCA (Refs.2and 3). Great Lakes claims that, in the 9yearssincethe RTI dataweregenerated,it hasmademanyimprovementsin thehandlingof processwastes,andproceduresarenowemployedto either containorrecycleallbyproductsandprocesswastes.

TheAgencydisagreeswith thecommentsfrom GreatLakesthat thestatutoryrequirementof section4(aJ(1)(A)(i) ofTSCA hasnot beensatisified.TheAgencyusesaweight-of-evidenceapproachin makinga section4~aJ(l)(AJ(i)finding in whichbothexposureandtoxicity information areconsideredto makethefinding thatthechemicalsubstancemaypresentanunreasonablerisk. The strongartheAgency’sscientific basisfor suspectingpotential toxicity, the fewerexposuredataareneededto supportthepotentialrisk finding. In thecaseof THOPA, theAgencybelievesthat the monitoringdata from RTI [Ref. 3) andthe limitedset of currentrn.onitoringdata fromGroatLakes(Ref. 4), receivedfollowingsubmissionof commentson theproposedrule, provide evidencethat

TBBPA hasbeenreleasedandcontinuesto bereleasedto theenvironment.TheRTI study reporteddetectionof TBBPAin sedimentsat levelsup to 330partspermillion (ppm)andsoilsat levelsup to150ppm nearaTBBPA productionsite.The Great Lakes monitoring datarepresentresultsfrom analysisofTBBPA in five soil/sedimentsamplesobtained from locations that were eitherapartof theearlierRTI studyorfromsomeundisclosedlocations.TBBPA wasdetectedin four of thefive samplesfromGreat Lakes at levelsranging between5.4 ppm and106ppm. Although datafrom Great Lakes showreduced levelsof TBBPA, in comparisonto the levelsreportedby RTI in 1978,at two samplinglocations,this informationis too sparseanddoesnot significantlyalleviatetheAgency’sconcernfor releaseof TEBPAinto the environment consideringTBBPA’s high aquatictoxicity. TBBPA islikely to entertheenvironmentasaresultof inadequatetreatmentanddisposalof wastesgeneratedfrom theTBBPA manufacturingprocess,fromdrying andpackagingoperations,fromtransportof TBI3PA andwastescontainingTBBPA, andfrom useofTBBPA asanadditiveflame retardant.Releaselevelshavebeensubmittedbythemanufacturersof TBBPA undersection8(a)of TSCA asconfidentialbusinessinformation (CBI). Theavailablephysical/chemicaldata(i.e.,low watersolubility andlog P of 4.5)andtheavailabledatafor acutetoxicityto marinealgae,invertebratesandfish(i.e., EG~or LC50 <1 mg/U demonstratethepotentialfor TBBPA tobioconcentrateandto causechronictoxicity in aquaticorganisms.

B. Notification to ForeignGovernments

Great Lakes Chemical CompanycommentedthatEPA shouldinterpretsection12(b) of TSCA to require nonotification to foreign governmentsuntiltestdataareavailable(Ref. 2).

Section12(b)of TSCA requiresanypersonwho exportsor intendsto exportachemicalsubstanceor mixture tonotify EPA of suchexportationto aparticularcountry if dataarerequiredundersection4 for that chemical.EPA isrequiredto send the importingcountryanoticeto identify theregulatedchemicalandindicatetheavailability of the testdataon the chemical.The Agencyhasinterpretedsection12(h) of TSCA toapplyat thetime a final rule ispromulgatedundersection4 of TSCA,sincethis rearesentsthe Agency’scommitmentto proceedwith datacollectionwith respectto specificchemicals.While theresultsof requiredtesting maynot be availablefor some

Federal Register / Vol. 52, No. 128 / Monday, July 6, 1987 / Rules and Regulations 25221

time, anoticeto the foreigngovernmentabouttheexportof sucha chemicalservosto alert it to the Agency’statin thecbcnical. It givesthegovir aai’at

e~.1or inity to requestdatetimI bea may currentlypossess~a or datamay becomea. d~U’ as

edrib of section4 testingacti~ltt~s.continuingto resiewissees

rotatingto theapplicationof Seutb)n1n~b)requirementsto exportersofm ction 4 chemicals.However,EPA isnut preparedto changeits intcrpmtationin the contextof this rule.

C. CiiemicalFate

1. BiodegradabilityTestin Water

The PanelcommentedthatbecauseofT13I3PA’s tendencyto partition fromv. aterinto sediment,testingforbiodegradabilityin waterwill provideonly limited usefulinformationon thechemicalfateof TI3BPA.

Thetestmethodologyproposedby theAgencyfor this test(Gore-ChamberMethodby Bourquinetal), however,providesdataon biodegradability(i.e.,rae of carbondioxide evolution andextentof transformation)of thechemicalin acombinedsediment/waterenvironment(Ref. 5).

2. InherentBiodegradability:ModifiedSemi-continuousActivatedSludge(SEAS)Test

ThePanelrecommendedusingtheresultsto beobtainedfrom the inherentbiodegradabilityin soil testto predictbiodegradationof TBBPA In activatedsledgebecausebiodegradationis duetothesametypesof bacteriain both.

EPA believesmanydifferencesexistbetweensoil andactivatedsludgewhichinfluencetheir bacterialcompositionandactivity (i.e., moisture,temperature,p11, etc.).However, thereviewofinformationcollectedfollowing theproposedruleshowsthatactivatedsludgeis notcurrentlybeingusedintreatmentof TBBPA processwastes.Therefore,themodifiedSCAStest,whichprovidesdataon biodegradabilityof achemicalsubstancein activatedsludge,is not beingrequiredin this finalrule.

D. EnvironmentalEffects

1. ActivatedSludgeRespirationInhibition Test

TheAgencyis not requiringthis testin thefinal rule becausethereis noneedto determinethe inhibitoryconcentrationin sludgeif activatedsludgeis not beingusedin the treatmentof TBBPA wastesandtheSCAS testisnot beingperformed.

2. Algal AcuteToxicity Test forFreshwaterAlgae

The Panelrecommendsusng themadr:ealgaedatag~nermmtedby theAgencyat its Gulf Breezefacility to

an assessmentof the toxicity toP oshwateralgae(Ref. 6).

The Agencydisagreeswith thePanel’srecommendationbecausethereareinsufficient comparativetoxicology dataavailablefor organicchemicalsstructurallyrelatedto TBBPA todemonstratethat thesensitivitiesofmarineandfreshwateralgaearesimilar.

3. GammacusAcuteToxicity Test

The Panelclaimsthatacceptableculturingandtestingguidelinesarenotavailablefor Gammarusandthat lackofpublisheddataon Gammaruswill notallowfor the relativeassessmentof thetoxicity results.

The Agencyhaspublishedanadequatetestguidelinefor Gammarusandpublisheddataon Gammarusarealsoavailable.However,following thepublicationof theTBBPA proposedrule,theAgencyreceiveddataon acutetoxicity of TBBPA to mysid shrimp(PJysidopsisbahia) from its Gulf Breezefacility (Ref. 7) and,therefore,doesnotseeanyfurtherneedto requireanotheracutetoxicity testwith an invertebrateat this time.

4. DaphnidChronicToxicity Test

ThePanelagreesthata daphnidchronic toxicity studywill provideusefulinformation in evaluatingtheenvironmentaleffectsof TBBPA.However, it recommendsthetestbeperformedby a staticrenewalmethodinsteadof in a flow-throughsystembecauseof thedifficulty in providingadequatealgalfood for thedaphnidsina flow-throughsystem.

The Agencybelievesthat a staticrenewalmethodcanprovidereliableinformation aslong astheTSCAtestguideline is followedandthe testsubstance(TBBPA) is maintainedat thedesiredconcentrationwithin thetestchambersthroughperiodicmeasurementsof its concentrationbetweentherenewalperiods.WhileEPA prefersthat this testbeperformedin aflow-through system,the final rulepermitsuseof eitherflow-throughorstaticrenewalmethod.

5. FishEarly Life StageToxicity Test

The Panelcommentedthat EPAprovidesno justificationfor its proposalto usea 96-hourLC50 of 0,40mg/L as thepoint for decidingwhetherfatheadminnowsorrainbow trout are to be usedto conductthe fish earlylife stagetoxicity test.ThePanelrecommends

that fatheadminnowsbe usedin armyfish earlylife stagetoxicity testing,evenii the98-hourLG50 is greaterthan 0.40rr.g/L, becausetesting laboratorieshaveexperiencedconsiderabledifficulty inreachingthepercenthatchabilityofgreeneggsrequiredfor therainbowtrout testto bevalid.

TheAgencycitedt1~eLG50 valueofrainbowtrout (0.40 mg/L) asameanstoensurethat asensitivefish speciesistestedfor chronictoxicity (Ref. 8). it ispossiblethat therecan be substantialvariationin LG50’s asa resultof minordifferencesin testwater, procedures,fish stock,andother variablesbetweenlaboratories.Therefore,the final ruleprovidesthat if thefatheadminnowUc50is anyvalue in therangebetween0.88—2.0 mg/L, five timesbelowor abovetheLG30 valuefor rainbowtrout, eitherspeciesmaybe usedfor theearlylifestagetoxicity test.If theLC50 value forfatheadminnowis equalto or greatertEen 2.0 mg/U, then rainbow trout mustbeusedin this testin accordancewiththestatedguideline.

6. BioconcentrationTestin Fish(FatheadMinnows)

ThePanelcommentedthatthesturlywith bluegill sunfish submittedto EPAin the TSCA section8(d)datareportingprovidesa soundbasisfor evaluatingthebioconcéntrationpotentialof TI3BPAin fish (Ref. 9).

TheAgencyfinds thebioconcentrationstudywith bluegillsubmittedby thePanelto be unreliable(i.e.,loading wasvery high,environmentalvariableswerenotreported,etc.).TheAgency’sconcernswith this studywerecommunicatedto aPanelmemberalongwith a requestforsubmissionof any additionalinformationthat couldeliminatetheseconcerns.Therewasno responsefromthePanelmemberon this matter.Therefore,abioconcentrationstudy infish is includedasarequirementin thefinal rule.

7. BioconcentrationTestin Oysters

ThePanelcommentedthat theproposed1-yearreportingrequirementwill notallow sufficientlime to conductthetestingbecausethe studyforbioconcent,rationin oystersrequirestheacutetoxicity testwith oystersas arange-findingstudy,andbecauseoysterstudiesusuallycanbeperformedonlyfrom April to Septemberwithoutsupplementingfood..The Panelrecommendsthat 2yearsbo permittedfor this study.

The Agencybelievesthat adding6monthsto theproposed1-yearreporting

25222 Federal Register / Vol. 52, No. 128 / Monday, July 6, 1987 / Rules and Regulations

requirementwill be sufficientto conduct

thetesting.

Ill. Final Test Rule for TBBPA

A. FYndinys

EPA is basingits final chemical fateand environmental effectstestingrequriementsfor TBBPA on theauthority of section4(a)(1)(A)of TSCA.

EPA finds that the manufacture,processing,use,and disposalof TBi3PAmay presentan unreasonablerisk ofinjury to the environment becauseTBBPA hasthe potential to persist in theenvironment,bioconcentratein aquaticorganisms,andcauseadverseeffectsinaquaticandbenthicorganisms.Thesefindings arebasedon theevidenceofexposure,availablephysical/chemicaldata,andavailabletoxicity datadiscussedin Unit II of this preambleandin Unit II of thepreambleto theproposedrule.

EPA alsofinds that theavailabledataon TBBPA areinadequateto fullycharacterizethechemicalfate andenvironmentaleffectsfollowing releaseof TBBPA to the environment.

Thestructureof TBBPA suggests,byanalogyto otherpolyhalogenatedcompounds,thatTBBPA maybepersistent.Biodegradationstudiesinsediment/waterandsoil areneededtoreasonablydetermineTBBPA’spersistencein theenvironment.

Thereis also thepotential,basedonits estimatedbioconcentrationfactor of1,300, for TBBPA to bioconcentrateinaquaticorganisms.Testswith aquaticorganismsarerequiredto accuratelymeasureTBBPA’s ability tobioconcentrate.

As discussedin thepreambleto theproposedrule, theexistingacutetoxicitydatefor aquaticorganismsexperimentallyexposedto TBBPAdemonstratethatTBBPA canbeexpectedto be acutelytoxic to aquaticorganismsat low to moderateconcentrationsandto bechronicallytoxic to fish andaquaticinvertebratesatvery low concentrations.FromEPA’sevaluationof theavailabletoxicity data,theexperimentalacutetoxicity dataforfreshwateralgaeandoneadditional fishspeciesexposedto TBBPA arenecessaryto determinewhetherfreshwateralgaearemoresensitivethanmarinealgaeandto determinetherelativesensitivityof differentfishspec:es.EPA also finds that therearenotoxicity data on benthicorganismsandno chroniceffectsdataon fish andaquaticinvertebrates.

EPA finds that sufficientdataareavailable for watersolubility, log Kow,log Koc, andacutetoxicity to marineuniceltularalgaeandaquatic

invertebratesto reasonablydetermineor predict thesecharacteristicsforTBBPA.

Finally, EPA finds that testingisnecessaryto developthechemicalfateandenvironmentaleffectsdatadescribedabove.EPA believesthat thedataresultingfrom this testingwill berelevant to a determinationastowhetherthemanufacture,processing,use,or disposalofTBBPA doesor doesnot presentanunreasonablerisk ofinjury to theenvironment.

B. RequiredTestingandTestStandards

On thebasisof thesefindings, theAgencyis requiringchemicalfate andenvironmentaleffectstestingbeconductedfor TBBPA in accordancewith specifictestguidelinessetforth in40 CFR Parts796,797, and798.Revisionsto theseguidelineswereproposedin theFederal Registerof January 14, 1986 (51FR 1522), and werepromulgatedin theFederal Registerof May 20, 1987 (52 FR19056).

In theaquaticenvironment,TBBPA isexpectedto partitionstrongly tosedimentbasedon its log Pvalueof 4.5Therefore,theAgencybelievesthatdeterminingthe toxicity of TBBPA tobenthicorganismsis important incharacterizingtheenvironmentaleffectsof TBBPA. SincetheAgencydid notreceiveanycommentson thesedimentbioassaymethodsreferencedin theproposedruleor on theavailability ofalternatesedimentbioassaymethods,theAgencyis requiringthat testing thetoxicity of TBBPA to benthicorganismsbe conductedin accordancewith themethodit hasselectedas beingappropriatefrom thosereferencedin theproposedrule,

1. Chemicalfatetests to beconductedfor TBBPA are: (a) biodegradabilityinsediment/water,usingtheCore-ChamberMethoddescribedby Bourquinet al (Ref. 5) and(b) aerobicandanaerobicbiodegradabilityin soil, usingthe guidelineat40 CFR 796.3400.

2. Environmentaleffectsteststo beconductedfor TBBPA are: (a) acutetoxicity to freshwateralgae,SelenastrumCapricornatom, usingthetestguidelineat 40 GFR797.1050;(b)acutetoxicity to Pirnephalespromelcms(fatheadminnow) in aflow-throughsystem,using theguidelineat 40 CFR797.1400;(c) partial life-cycle toxicity tothe midge (chironomustentans)conductedin a flow-throughsystemusingTBBPA-spikedclean,freshwatersedimentshavinglow, medium,andhighorganiccarboncontentin accordancewith the methoddescribedby Adamsetat. (Ref. 10); [d) chronic toxicity to theinvertahrateDaphnia,testedin arenewalor a flow-throughsystem,using

theguidelineat 40 CFR797.1330;(e)earlylife stagetoxicity to fish conductedin a flow-through system,using theguideline at 40 CFR 797.1600(the testspeciesfor the fish early life stagetest isfatheadminnow (Pimephalespromelas)if the LC~value for fatheadminnow isequal to or lessthan 0.08 mg/L, eitherfathead minnow or rainbow trout if theg6-hour LC50 for fatheadminnow is inthe rangebetween0.08—2.0mg/U, andrainbow trout if the 96-hour L~ forfatheadminnowis greaterthanor equalto 2.0 mg/L); (f) bioconcentrationin thefatheadminnow (Pimephalespromelas)using theguidelineat 40 CFR 797.1520;and(g) bioconcentrationin theoyster(Crassostreavirginica) usingtheguidelineat 40 CFR 797.1830.

TheAgencyis requiringthat theabovereferencedTSGA ChemicalFateandEnvironmentalEffectsTestGuidelinesandrevisionsandothercitedmethodsbe theteststandardsfor thepurposesof therequiredtestsforTBBPA. TheTSCA testguidelinesforchemicalfate andaquatictoxicitytesting specifygenerallyacceptedminimum conditionsfor determiningchemicalfateandaquaticorganismtoxicities for substanceslike TBBPA towhichaquaticlife is expectedto beexposed.

The requiredmethodsof Bourguinetal. (1977) for investigatingthebiodegradationrate of TBBPA insediment/waterandAdamsat al. forinvestigatingthetoxicity of TBBPA tobenthicorganismsspecifygenerallyacceptedminimum conditions(Refa.5and10). TheAgencybelievesthat thesetestmethodsreflectthecurrentstate-of-the-sciencefor testingthefate andeffectsof chemicalssuchasTBBPA insediment/watersystems.

C. TestSubstance

EPA is requiring that TBBPA ofgreaterthan98 percentpurityshall beusedas the testsubstance.TBBPA ofsuchpurity is availableaccordingtocommentsreceivedfrom thePanel(Ref.1).

D. PersonsRequiredto Test

Section4(b)(3ffB) specifiesthat theactivitiesfor which the Agencymakessection4(a) findings (manufacture,processing,distributionin commerce,use, and/ordisposal)determinewhobearsthe responsibilityfor testing achemical.Manufacturersarerequiredtotestif the findingsarebasedonmanufacturing(‘manufacture”isdefinedin section 3(7)of ThEA toinclude import”). Processorsarerequiredto testif thefindings arebasedon processing.Both manufacturersand

FederalRegister I Vol. 52, No. 128 / Monday, July 6, ~937 / Rules and Regulations

processorsarerequiredto testif theexposuresgiving riseto thepotentialrisk occurduringuse,distrik’ tion incommerce,or disposal.

BecauseEPA hasfound ib.manufacturing,processing,u.~e,anddisposalof TBBPA give rise to exposurethatmayleadto anunreasonablerisk,EPA is requiringthat persons~homanufactureorprocess,or who intendto manufactureor process,TBI3PA, otherthanasan impurity, at any time fromtheeffectivedateof thefinal testruletotheendof thereimbursementperiodaresubjectto the testingrequirementscontainedin this final rule. The endofthereimbursementperiodwill be5years after the last final report issubmitted or an amount of time equal tothat which wasrequired to developdataif more than 5 yearsafter the submissionof the last final report required underthe testrule.

BecauseTSCA contains provisions toavoid duplicativetesting,not everyperson subject to this rule mustindividually conduct testing.Section4(b)(3)(A) of TSCA provides that EPAmay permit two or more manufacturersor processorswho are subject to theruleto designateonesuchperson or aqualified third person to conduct thetestsand submitdataon their behalf.Section4(c) providesthatanypersonrequiredto testmayapplyto EPA for anexemptionfrom the requirement.EPApromulgatedproceduresfor applyingforTSCA section4(c) exemptionsin 40 CFRPart790.

Manufacturers (including importers)subjectto this rule arerequiredtosubmiteitheraletterof intent toperformtestingor anexemptionapplicationwithin 30 daysafter theeffective dateof thefinal testrule. Therequiredproceduresfor submittingsuchlettersandapplicationsaredescribedin40 CFR Part790.

Processorssubject to this rule, unlessthey are also manufacturers, will not berequired to submit letters of intent ofexemptionapplications, or to conducttesting, unlessmanufacturers fail tosubmit noticesof intent to testor laterfail to sponsor therequired tests.TheAgencyexpectsthat the manufacturerswill passan appropriateportionof thecostsof testingon to processorsthroughthe pricing of their products or otherreimbursementmechanisms.Ifmanufacturersperformalltherequiredtests,processorswill be grantedexemptionsautomatically.ifmanufacturersfail to submitnoticesofintent to test or fail to sponsorall therequired tests,the Agencywill publish aseparatenoticein theFederalRegisterto notify processorsto respond;this

procedureis describedin 40 CFR Part790.

EPA is not requiringthesubmissionofequivalencedataas a condition forexemotionfrom therequiredtestingforTB1IPA. As notedtnt Unit IiI.C,, EPA isinterestedin evaluatingtheeffectsattributableto TBBPA andhasspecifieda relativelypuresubstancefor testing.

Manufacturersandprocessorssubjectto this testrulemust comply with thetestrule developmentandexemptionproceduresin 40 CERPart790 for single-phaserulemaking.

E. ReportingRequirements

EPA is requiringthatall datadevelopedunderthis rule be reported inaccordancewith itsTSCA GoodLaboratoryPractice(GLP)standards,whichappearin 40 CFR Part792,

In accordancewith 40 CFR Part790undersingle-phaserulemakingprocedures,test sponsorsarerequiredtosubmitindividual studyplanswithin 45daysbeforeinitiation of eachstudy.

EPA is required by TSCA section4(b)(1)(C) to specifythetime periodduringwhich personssubject to a testrulemustsubmittestdata.Specificreportingrequirementsfor eachof therequiredtestfollow:

Thebiodegradationstudiesinsediment/waterandsoil, theacutetoxicity studiesin freshwateralgaeandfish, andthebioconcentrationstudyinfish shall be completed and the finalresultssubmittedto EPA within 1 yearof theeffectivedateof thefinal testrule.An interimprogressreportfor eachofthesestudiesshall beprovidedto theAgency6 monthsafter theeffective dateof this rule.

The bioconcentration study in oystershall be completedand the final resultssubmitted to EPA within 18 months ofthe effective date of the final test rule.The fish early life stagetoxicity study,the midge partial life-cycle toxicitystudyin sediments,andthe daphaidchronictoxicity studyshall becompletedandthe final resultssubmittedto EPA within 2 yearsof theeffectivedate of the final test rule.Interimprogressreportsfor eachofthesestudiesshall beprovidedto theAgency at6 monthintervalsaftertheeffectivedateof this rule, until thefinalreportis submittedto EPA.

TSCA section14(b)governsAgencydisclosureof all testdatasubmittedpursuantto section4 of TSCA. Uponreceiptof datarequiredby this rule, theAgencywill publisha noticeof receiptin theFederalRegisterasrequiredbysection4(d).

Personswho exporta chemicalsubstanceormixturewhich is subjecttoa section4 testruleare subjectto the

exportreportingrequirementsof scchant12(b) of TSCA. Final regulationsintereretingthe requirementsof sechvnt12(b) arein 40 CFR Part707.In bnfiof the effective dateof this tort rub’.expcrterof TBBPA mustreportto F),\the first annualexportor intendedexportof TBBPA to any onecountry.EPA v~illnotify theforeign countryconcerningthe testrule for thechain.

F. EnforcementProvisions

TheAgencyconsidersfailure tocomply with any aspectof a section4ruleto be aviolation of section15 ofTSCA. Section15(1)of TSCA makesitunlawful for anypersonto fail or reruseto complywith anyruleor orderissuedundersection4. Section15(3) of TSCAmakesit unlawful for anypersonto failor refuseto: (1) establishor maintainrecords,(2) submit reports,notices,orotherinformation,or (3) permit accesstoor copyingof recordsrequiredby theAct orany regulationorrule issuedunder TSCA.

Additionally, TSCA section15(4)makesit unlawful for anypersonto failorrefuseto permit entryor inspectionccrequiredby TSCA section11. Section11appliesto any“establishment,facility.or otherpremisesin which chemicalsubstancesormixturesaremanufactured,processed,stored,orb’ ‘dbeforeor after theirdistribution incommerce . . . “TheAgencyconsidersa testingfacility to be aplacewherethechemicalis heldorstoredand,therefore, subject to inspection.Laboratoryinspectionsanddataauditswill beconductedperiodicallyinaccordancewith the authorityandproceduresoutlinedin TSCA section11by duly designatedrepresentativesoftheEPAfor thepurposeof determiningcompliancewith thefinal rule forTBBPA. Theseinspectionsmaybeconductedfor purposeswhich includeverification that testinghasbegun,schedulesarebeingmet, andreportsaccuratelyreflect theunderlyingrawdata,interpretations,andevaluations,and to determinecompliancewith TSCAGLP standardsandthe teststandardsestablishedin therule.

EPA’s authority to inspecta testingfacility alsoderivesfrom section4(b)(1)of TSCA which directsEPA topromulgatestandardsfor thedevelopmentof testdata.Thesestandardsaredefinedin section3(12)(B)of TSCA to includethoserequirementsnecessaryto assurethatdatadevelopedundertestingrulesare reliableandadequate,andsuchotherrequirementsasarenecessaryto providesuchassurance.TheAgencymaintainsthat

25224 Federal Register/ Vol. 52, No. 128 / Monday, july 6, 1987 / Rules and Regulations

laboratoryinspectionsarenecessarytoprovidethis assurance.

Violators of TSCA are subject tocriminal and civil liability. Personswhosubmit materially misleading or falseinformation in connectionwith therequirementof anyprovisionof this rulemay be subject to penaltieswhich maybe calculatedasif theyneversubmittedtheir data. Under the penaltyprovisionsofsection16 of TSCA, anypersonwhoviolatessection15 of TSCA couldbesubjectto a civil penaltyof up to $25,000foreachviolationwith eachdayofoperationin violationconstitutingaseparateviolation. This provisionwouldbeapplicableprimarily tomanufacturersthat fail to submitaletterof intentor an exemptionrequestandthatcontinuemanuFacturingafter thedeadlinesfor suchsubmissions.

This provisionwould alsoapplytoprocessorsthat fail to submita letterofintentor an exemptionapplicationandcontinueprocessingaftertheAgencyhasnotifiedthem of their obligationtosubmit suchdocuments(see40 CFR790.48(b)).Knowing or willful violationscould leadto the impositionof criminalpenaltiesof up to $25,000for eachdayofviolation andimprisonmentfor up to 1year.In determiningtheamountofpenalty,EPA will takeinto accounttheseriousnessof theviolation andthedegreeof culpability of theviolatoraswell as all theother factorslistedinTSCA section16. Otherremediesareavailableto EPA undersection17 ofTSCA, suchasseekinganinjunction torestrainviolations of TSCA section4.

Individuals aswell ascorporationscouldbesubjectto enforcementactions.Sections15 and16 of TSCA applyto“any person”who violatesprovisionsofTSCA. EPA may,at its discretion,proceedagainstindividuals aswell ascompaniesthemselves.In particular,this includesindividuals who reportfalseinformation or who causeit to bereported.In addition,thesubmissionoffalse, fictitious, or fraudulentstatementsis a violation under18 U.S.C.1001.

IV. EconomicAnalysisof Final RuleTo assessthepotentialeconomic

impactof this rule, EPA haspreparedaneconomicanalysis(Ref. ii) thatevaluatesthepotential for significanteconomicimpacton the industry asaresultof therequiredtesting.Theeconomicanalysisestimatesthe costsofconductingthe requiredtesting anduvaluntesthepotential for significantahverseeconomicimpact as a resultofthesetest costsby examiniagfourmarketcharacteristicsof TI3T3PA: (1)Pricesensitivityof demand,(2) industrycost characteristics,(3) ind.;sinvstructure,and (4) marketexpectations.If

thereis no indication of adverseeffect,no furthereconomicanalysiswill beperformed;however,if thefirst level ofanalysisindicatesapotentialforsignificanteconomicimpact,amorecomprehensiveanddetailedanalysisisconductedwhichmorepreciselypredictsthemagnitudeanddistributionof the expectedimpact.

Total testing costsfor the final rule forTBBPA are estimatedto range from$141,790to $184,640.In orderto predictthe financialdecisionmakingpracticesof manufacturing firms, thesecostshavebeenannualized.Annualized costsarecomparedwith annualrevenueasanindicationof potentialimpact.Theannualizedcostsrepresentequivalentconstantcostswhichwould haveto berecoupedeachyear of the paybackperiodin orderto financethetestingexpenditurein thefirst year.

The annualizedtestcosts(usinga costof capitalof 25 percentovera periodof15 years)rangefrom $35,448to $46,160.Basedon thelower boundof the1984estimatedproductionvolumefor TBBPAof 59.8million poundsto 83.7millionpounds,theunit testcostswill rangefrom about0.66 to 0.08centsperpound.In relation to the selling price of $1.16perpoundfor TBBPA, thesecostsareequivalent to 0.05 to 0.07percentofprice.

Basedon thesecostsandtheusesofTBBPA, theeconomicanalysisindicatesthat thepotentialfor significantadverseeconomicimpactasaresultof thistesting ruleis low. This conclusionisbasedon thefollowing observations:

1. Theestimatedunit test costsarevery low, 0.07percentof currentpriceinthe upper-bound case;

2. Theoverall demandfor TBBPAappearsrelativelyinelastic;

3. Producersof TBBPA mayexerciseadegreeof control overprice; and

4. The marketexpectationsfor TBBPAenduseproductsappearfavorable.

Referto the economicanalysisfor acompletediscussionof testcostestimationandthepotentialforeconomicimpactresultingfrom thesecosts.

V. Availability of TestFacilities andPersonnel

Section4(b)f1) of TSCA rectuiresEPAto consider“the reasonablyforeseeableavailability of thefacilities andpersonnelneededto performthetestingrequiredunderthe rule.” Therefore,EPAconducteda studyto assesstheavailability of test facilities andpersonnelto bundletheadditionaldemandfor testin3 servicescrea.tcdbysection4 test rules. Copiesof thu study,ChemicalTesting Industry:Profite ofToxicologicalTesting.canbe obtained

throughtheNationalTechnicalInformationService(NTIS), 5285 PortRoyalRoad,Springfield,VA 22161 (PB82—1407730).On the basisof this study.theAgencybelievesthat therewill beavailabletestfacilitiesandpersonneltoperforn~thetesting in this rule.

VI. Rulemaking Record

EPA has establisheda record for thisrulemaking proceeding[docket numberOPTS-.42083A].This recordincludes:

A. SupportingDocumentation

(1) FederalRegisternoticespertainingtothis rule consistingof:

(a) NoticecontainingtheITC designationof TBBPA to thePriority List (50FR 20930~.May 21, 1985).

(b) RulesrequiringTSCA section8(a)and8(d) reportingan TBBPA (50FR 20910;May21, 1985).

(c) Noticeof EPA’sproposedtestrule onTBBPA (51 FR17672;May 15,1986).

(d) TSCA testguidalinesfinal rule (40 CFRParts796, 797, and79a; September27, 1985).

(a)Noticeof final rulemakingon datareimbursement(48FR 31786;July 11, 1983).

(I) Noticeof interim final ruleon single-phase test rule developmentandexemptionprocedures(50 FR20652;May 17,1955).

(g) TSCA GLPstandards(48FR 53992;November29, 1983).

(2) Supportdocumentsconsistingof:(a) TBBPA technicalsupportdocumentfor

proposedrule(SyracuseResearchCorporation;November15, 1985).

(b)Economicimpactanalysisof final testrule for TBBPA.

(3) Communicationsconsistingof:(a) Written public comments.(b)Transcriptsof publicmeeting.(c) Summariesof phoneconversations.(4) Reports—publishedandunpublished

factualmaterials.

B. References(1) Commentsfrom theBrominatedFlame

RetardantIndustryPanel(BFRIP) on EPA’8ProposedTest Rule for TetrabromobisphenolA to Public InformationOffice,USEPA(July14. 1986).

(2) Copyof commentspresentedby DavidL. McAllister of GreatLakesChemicalCorporationon EPA’sProposedTestRulefurTetrabromohisphenolA at apublic meeting.(August21, 1985).

(3) U.S.EnvironmentalProtectionAgency.EnvironmentalMonitoring NearindustrialSites:BrominatedChemicals(Part I).Washington,DC, Office of ToxicSubstances,USEPA.Contract5&~l—1978.EPA—560/6—73--002. (1978).

(4) GreatLakes ChemicalCorp., WestLafayette,IN 47906.Reporton soil analysisfor Tetn,~bro:nobisphenotA from GreatlakesChemicalCorp. Letterwith resultson sampleanalysishorn DL. MeAtlister to NarendraCh~udtairi,Washington,DC, Office of To~icSubstance,u78,PA (March4, 1987).

15) Bournin, A.W., Hood,MA., annG~rnus~,Rh., ‘An artificial microbialeunsyshufur ustermtn~ngeffects and fateo~tuxicant:iia a salt.n;arshenvironment.”

Federal Register I Vol. 52, No. 128 / Monday, July 6, 1987 / Rules and Regulations 2.~225

Dovclupz’;cntsin inJustrial A.nicrobio,ua.It’ lhj’~’l91 (1977).

(51 [59. EnvironmentalPreUttion A’ ‘a~C.urn n~.lResearchLat a Iur’, U.S

ha’ a ,, IL 32 01. Prcbn,ina S rer.or; 0f ‘~of’f PUPA on ntaai,;’ , RuinS a

Mu, ndunn from G.E.Vi~ain ta Fe..We. Sudan,ho, Olii~eof ‘fux Solo.., eu a,USEPA (A Jgust9, 1985).

17) U.S. EnvironmentalProtuctionA,’Unvroan,r.aialResearchLaboratory.GuS’B; care, FL 32561. Acutetoxi’-it~’oftetrahrmnobisphenolA to mysiPs.lniatnurandumfrom L.R. GooR’nentoNarendraChaudhari,Washinpion,DC, CTasofTox:cSubstances,USEPA(September211986).

(8) GreetLakesChemicalCorp., V.”stLafaveH~,IN 47905.Acute toxicity of TJIPR~to blue~ilisonfish)Project *“l15ut’~O3—50)andrainbow trout (Project~1150o—O3--51).Latterwith attachedstudiesfrom D.CMcFaddentoNmendraChaudhari,Washington,DC, Officeof ToxicSubstances,USEPA (August1, 1985).

(9) GreatLakesChemicalCorp.,WestLafayette,IN 47905.ThebioaccumulationoftetrabromobisphenolA in thebluegill sunfish.Letter with attachedstudiesfrom D.CMcFaddento NarendraChaudhari,Washington,DC, Office of Toxic Substanccs,USEPA(August1. 1985).

(10) Adams,W.J. Kimerle,R.A., andMosh~r,E.G.. ‘Aquatic safetyassessmentofchemicalssorbedto sediments,”AquaticTo icologyandHazardAssessjssent.’SoveinthSyin,uaaium,ASTM SIP 854, R.D. Cardwt.ll,R. Pn~rnly,andR.C. Behncr,Las.,AmericanSociety for TestingandMaterials,l’htlrid~iphI~.pp. 429-~53(1933).

(11) U.S.EnvironmentalProtectionAgr nay.EconomicImpactAnalysisof FinalTestRatefor TetrabronrobisphenolA. Washington,DC,Offtcao~ToxicSubstances,USEPA (March24, 1987).

VII. OtherRegulatoryRequirements

A. GlossaficotiozzofRule

UnderExecutiveOrder12291, EPAmustjudgewhetheraregulationis“major” and therefore subject to therequirementof aRegulatoryImpactAnalysis.EPA hasdeterminedthat thistestrule is not majorbecauseit doesnotmeetany of the criteria set forth insection1(b)of theOrderi.e., it will nothaveanannualeffecton the economyofat least$100million, will not causeamajor increasein prices, and will nothave a significant adverseeffect oncompetition or the ability of U.S.enterpriseto competewith foreignenterprises.

Thisregulationwassubmittedto theOffice of ManagementandBudget(0MB) for reviewasrequiredbyExecutive Order 12291.Any writtencommentsfrom 0MB to EPA, andanyEPA responseto thosecomments,areincluded in the rulemaking record.

B. RegulatoryFlexibilityAct

UndertheRegulatoryFlexibility Act(15U.S.C.601 at seq.,Pub. L. 96—354,

September19, 1980),EPA is certifyingthat this test rule will not huve asin’nificant impact on a subst’n’ialnumberof small businessesbecznu’e:(1)‘1 boy arenot likely to par orm testingtl.cnise~vcs,or to part:ctp~~to tm thec’rgsmezat;onof the tesWgctforl; (2) tacywill experienceonly very mincr costs,ifany, in securingexemptionfrom testingreqJirenients;and(3) they areuntikeiyto be affectedby reimbursementrequtrements.

C. PaperworkReductionAct

0MB hasapprovedthe informationcollection requirementscontainedin thisfinal rule undertheprovisionsof thePaperworkReductionAct of 1980,44U.S.C.3501 et seq.,andhasassigned0MB control number2070—0033.

List of Subjectsin 40 CFR Part799

Testing,Environmentalprotection,Hazardoussubstances,Chemicals,Reportingandrecordkeepingrequirements,Incorporationbyreference.

Dated: June26, 1987.Victor J. Kimrn.ActingAssistantAdministratorfor PesticidesandToxicSubstances.

PART 799—jAMENDED]

Therefore,40 CFR Part799 isamendedas follows:

1. Theauthoritycitation for Part 799continuesto readas follows:

Authority: 15 U.S.C.2603,2611, 2625.

2. Section799.4000is addedto readasfollows:§799.4000 Tetrabromoblsphenol A.

(a) Identificationof testsubstance.(1)TetrabromobisphenolA (TBBPA, CASNo. 79—94—7)shall betestedinaccordancewith this section.

(2) TetrabromobisphenolA of at least98 percentpurity shallbe usedas thetestsubstance.

(b) Personsrequiredto submitstudyplans,conducttests,andsubmitdata.All personswho manufacture (includingimport) or processor intendtomanufactureor processtetrabromobisphenol A, other than as animpurity, afterAugust19, 1987,to theend of the reimbursementperiod shallsubmitlettersof intent to conducttesting,submitstudyplans,conducttests,andsubmitdataorsubmitexemptionapplicationsas specifiedinthis section,SubpartA of this Part, andParts 790 and 792of this chapterforsingle-phaserulemaking.

(c) Chemica/fate.—(i)Biodegradabilityin sedirnent/water—(i)Requiredtesting. Biodegradation testing

in sediment/watershall be conductedv~ithTI3BPA using clean,freshwatersedimentsin accordancewith themethod describnci in an AAV. Bourquinartin’le entitled “An Artificial MicrcbialEcosystemfor DeterminingEffectsandFateof Toxic~ntsin a St lt-MatshEnvironment”, publichedinDcvelnpmeirts in Indu‘~triaIMicrobiology, Vol. 18, Chapter11, 1977,which is incorporatadby reference.Themethodis availablefrom the Office oftheFederalRegister’InformationCenter,11th andL St., NW., Washington,DC,20408. and in the EPA OPTSReadingRoom,Em. 0—004NortheastMall, 461 MSt., SW., Washington,130 20460.Thisincorporationby referencewasapprovedby theDirectorof theFederalRegisterin accordancewith 5 U.S.C.552(a)and 1 CFR Part 51. The method isincorporatedasit existson the effectivedateof the final rule andanoticeof anychangeto the methodwill bepublishedin theFederalRegister.

(ii) Reportingrequirements.(A) Thebiodegradationtestin sediment/watershall be completed and the final reportsubmittedto EPA within 1 yearof theeffectivedateof thefinal rule.

(B) An interim progressreportshall besubmittedto EPA 6 monthsaftertheeffective dateof the final rule.

(2) Inherentbiodegradabilityin soil—(i) Requiredtesting. Inherentbiodegradabilityin soil teststo assessaerobicandanaerobicbiodegradabilityshall be conductedwith TBBPA inaccordancewith § 796.3400of thischapter.

(ii) Reportingrequirements.(A) Theinherentbiodegradabilityin soil testsshall becompletedandthe final reportsubmittedto EPA within 1 yearof theeffectivedateof thefinal rule.

(B) An interimprogressreportshallbesubmittedto EPA 6 monthsaltertheeffective dateof the final rule.

(d) Environmentaleffects—(1)Algalacutetoxicity—(i)Requiredtesting.Algal acutetoxicity testing shall beconductedwith TBBPA usingSelenastrumcapricornuturn inaccordancewith § 797.1050of thischapter.

(ii) Reportingrequirements.(A) Thealgal acutetoxicity test shall becompletedand thefinal report submittedto EPA within 1 year of the effectivedate of thefinal rule.

(B) An interim progressreport shall besubmitted to EPA 8 monthsafter theeffectivedate of the final rule.

(2) Fish acutetoxicity—(i)Requiredtesting.Fish acutetoxicity testing shallbe conductedwith TBBPA usingPirnephalespromeias(fathead minnow)

25228 Federal Register I Vol. 52, No. 128 / Monday, July 6, 1987 / Rules and Regulations

in accordancewith § 797.1400of thischapter.

(ii) Reportingrequirements.(A) Thefish acute toxicity testshall becompletedand the final report submittedto EPA within 1 year of the effectivedate of thefinal rule.

(B) An interim progressreport shall besubmitted to EPA 6 monthsafter theeffectivedate of the final rule.

(3) Midgepartial life-cycletoxicity insedirnents.—(i)Requiredtesting.A 14-day toxicity test in a flow-throughsystemshall be conductedwith themidge (Chironomustentans)usingTBBPA-spiked clean,freshwatersedimentshaving low, medium, and highorganiccarboncontentin accordancewith theAmericanSociety for TestingandMaterialsSpecialTechnicalPublication 8.54 (ASTM STP 854),entitled “Aquatic SafetyAssessmentofChemicalsSorbedto Sediments,”byW.J.Adamset.al., andpublishedinAquaticToxicologyandHazardAssessment:SeventhSymposium,ASTM STP 854, pp. 429—453, R.D.Cardwell et. at., Eds.1985,which isincorporatedby reference.Themethodis availablefrom the Office of theFederalRegisterInformationCenter,11th andL St., NW., Washington,DC,20408,andin theEPA OPTSReadingRoom, Rm 0—004NortheastMall, 401 MSt., SW., Washington,DC 20460.Thisincorporationby referencewasapprovedby theDirectorof theFederalRegisterin accordancewith 5 U.S.C.552(a)andI CFR Part 51. The method isincorporatedas it existson theeffectivedateof this rule anda noticeof anychangeto themethodwill bepublishedin theFederal Register.

(ii) Reportingrequirements.(A) The14-daytoxicity testwith midgeusingsedimentsshall beconductedandthefinal reportsubmittedto EPA within 2yearsof the effective dateof the finalrule.

(B) Interim progressreportsshall besubmittedto EPA at 6-monthintervalsbeginning6 monthsafter theeffectivedateof thefinal rule, until thefinalreportis submittedto EPA.

(4) Daphnidchronic toxicity—(i)Recur/redtesting.Daphnid chronictoxicity testingshah be conductedwithTBBPA usingDaplrnia magnaor D.pu/ear in accordancewith § 797.1330ofthis chapter.

(ii) Reportingrequirements.(A) Thedaphnirl chronictoxicity test shall beco:nplatedandthe final reportsubmittedto EPA within 2 yearsof theeffectivedateof the final rule.

(B) Interior progressreportsshall besubmitted to EPA at 6-monthintervalsbeginning 6 monthsafter the effective

dateof the final rule, until thefinalreport is submitted to EPA.

(5) Fish early life stagetoxicity—ti)Requiredtesting.A fish early life stagetoxicity testshallbe conductedwithTBBPA. The testspeciesshall befathead minnow (Pimephalespromelas)if the98-hourLC~for fatheadminnowconductedin accordancewithparagraph (d)(2) of this section is equalto or lessthan 0.08 mg/L the testspeciesshall be either fathead minnowor rainbow trout if the96-hour LC50 forfatheadminnowis between0.08—2.0mg/L the testspeciesshall be rainbowtroutif the98-hourLC50 for fatheadminnow isgreaterthanor equalto 2.0 mg/L Thefish early life stagetoxicity test shall beconductedin accordancewith § 797.1600of this chapter.

(ii) Reportingrequirements.(A) Thefish earlylife stagetoxicity testshall becompletedand the final report submittedto EPA within 2years of the effectivedate of the final rule.

(B) Interim progressreports shall besubmitted to EPA at 6-month intervalsbeginning 6 months after the effectivedate of the final rule, until the finalreport is submitted to EPA.

(6) Bioconcentrationin fish—b)Requiredtesting.A bioconcentrationtestshall beconductedwith TBBPAusingPimephalesprornelas(fatheadminnow)in accordancewith § 797.1520of this chapter.

(ii) Reportingrequirements.(A) Thebioconcentrationtestin fish shalt becompleted and the final report submittedto EPA within 1 yearof theeffectivedateof the final rule.

(B) An interim progressreportshall besubmitted to EPA 6-months after theeffectivedate of the final rule.

(7) Bioconcentrationin oyster—{i)Requiredtesting.A bioconcentrationtest shall be conductedwith TBBPAusing G’rassostreavirginica (oyster) inaccordancewith § 797.1830of thischapter.

(ii) Reportingrequirements.(A) Thebioconcentrationtestin oystershall becompletedandthe final report submittedto EPA within 18 monthsof the effectivedateof the final rule.

(B) interim progressreportsshall besubmittedto EPA at 6~monthintervalsbeginning6 monthsafter the effective(late of the final rule, until the finalreport is submittedto EPA.

(e) Effectivedate.Theeffective dateofthe final rule is August 19, 1987.(Informationcollection requirementshave

beenapprovedby theOffice of ManagementandBudget undercontrolnumber2070—0033)

[FR Doe. 87—15241Filed 7—2—87; 8:45 am]58.UNG CODE 6560-5O-M

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 86—348; RM-53571

Radio Sroadcasting Services; LaureI~DEAGENCY: FederalCommunicationsCommission.

ACTION: Final rule.

SUMMARY: This documentallotsChannel237Ato Laurel,Delaware,asafirst FMchannelat therequestof TrayD. Hill.With this action,this proceedingisterminated.

DATES: August13, 1987.The windowperiodfor filing applicationswill openon August14, 1937,andcloseonSeptember14, 1987.FOR FURTHER INFORMATION CONTACT

MontroseH. Tyree, MassMediaBureau,(202)634—6530.

SUPPLEMENTARY INFORMATIONI This is asummaryof the Commission’sReportandOrder,MM DocketNo. 86—348,adoptedJune11, 1987,andreleasedJune29, 1937.The full text of this Commissiondecisionis availablefor inspectionandcopyingduringnormal businesshoursintheFCC DocketsBranch(Room230),1919M Street.NW., Washington,DC.The completetext of this decisionmayalsobepurchasedfrom theCommission’scopycontractors,InternationalTranscriptionService,(202)857—3800,2100 M Street,NW., Suite140,Washington,DC 20037.

List of Subjectsin 37 CFR Part73

Radiobroadcasting.

PART 73—EAMENDEDI

1. Theauthority citation for Part73continuesto readas follows:

Authority: 47 USC,154. 303.

§ 73.202 [Amended]2. Section73.202(b).theTable of FM

Allotments, in. theenL—y for Laurel,Delawrcre,Channel237Ais added.

FederalComenunOcatloasCommiision,Mark N. Upp.chief A/iocotio:u B.”oc’c/c, Pu/icc rmdflrciosDiv/slut:, l.~ctc,‘lu~juBureau.

]FR Due. 87—15203Filed 7—2—87:8:45 tm]atcuaGcoos5712-O1-M