21018 Federal Resister / Vol. 52. No~107 / Thursday. June 4, 1987 / Rules and Regulations

81. On page 40643, first column, in* 268.50(a)(3), “may store” should read“stores”.

82. On page 40643. first column, in§ 268.50(d). “or a nationwide variancecontained in Subpart C of this part” Isinserted following “petition under§ 268.6” and before “or an approved?

PART 268, APPENDIX I—CORRECTEDJ

83. On page 40645,in the equationbelow Step 7.2.3, the colon after“Percent” but before “dry solids” shouldbe deleted.

§ 271.1 tCorT.Ctedj

89. On page 40653, third column, in§ 271.1(j), insert “November 7, 1986” Inthe first column of Table I and revisethe third column of Table I to read “51FR 40572.”

90. On page 40654. first column, in* 271.1(j), revise the fourth column ofTable 2 to read “November 7, 1986, 51FR 40572.”

[FR Doc. 87-12723 FlIed 6-3-87; &45 amjS&UNG CO~~N

40 CFR Parts 704, 796 and 799.[OPTS-42076A FRL-3213—SJ

Anthraquinone Final Reporting andRecordkeeping RequirementsandTest Ruts

AGENCY: Environmental ProtectionAgency (EPA).ACflON Final rule.

SUMMARY: EPA is issuing a final rule,under section4 of the Toxic SubstancesControl Act (TSCA), requiringmanufacturers and processGra of 9,10.arithraquinone (CAS No. 84—65—1),hereinafter anthraquinone, to performtesting for water solubility,bioconcentration, sedimenttoxicity tobenthic organisms, and acute toxicity toaquatic organisms. TheAgency is alsorequiring annual reporting, under section8 of TSCA. by manufacturers (includingimporters) of anthraquinone of thevolume of this substance manufacturedor imported during their latest corporatefiscal year. The rule precludesduplicativereporting during those yearsthat industry must report under theInventory Update Rule. Testing forbiodegradation and chronic toxicity to

84. Onpage 40645, third column, in thelast line of Step7.4.1, “or should read“or”.

85. On page40646,first column. In thesecondline of Step8.5, “110” should’read “100”,

86. On page40646,secondcolumn, Intheseventh line of the note to Step8.8,“is” should be inserted after “device”but before “defined”.

87. On page40647,secondcolumn, inthe third line of Step9.2. “estractlon”should read “extraction”.

88. On page40648, the equationbelowStep9.11 should read asfollows

aqua tic organismswill be required if theacutetoxicity, sedimenttoxicity, orbioconcentration test results suggestahazard potential and the annualproduction/importation level reaches orexceeds3 million pounds (lb). This rulerequires the sametesting as EPA’sproposed rule on anthraquinone.DATIS: In accordance with 40 CFR 23.5,this rule will be promulgated forpurposesof judicial review at 1 p.m.eastern (“daylight” or “standard,” asappropriate) time on June 18, 1987.

- Theseregulations will becomeeffectiveon July 20, 1987.The incorporation byreference of certain publications listedin the regulationsis approvedby theDirectorof the Federal Registeras ofJuly 20, 1987.FOR FURTHER INFORMATION CONTACT:Edwin A. Klein, Director, TSCAAssistance Office (TS—799), Office ofToxic Substances,Rm. E—543,401 M St.,SW., Washington. DC 20460, (202—554—

1404).SUPPLEMENTARYINFORUATIOSt EPA isIssuinga final test rule under section4(a) of TSCA to require chemical fateand environmentaleffects testing ofanthraquinone. Under section 8(a) EPAwill also require manufacturers(including importers) to reportannuallyto EPA the volume of anthraquinonemanufactured o; imported during theirlatest corporate fiscal year.

I, Introduction

A. TestRule DevelopmentUnder 7~5C4This notice Is part of the overall

Implementation of section 4 of TSCA(Pub.L 94—469,90Stat, 2003 ci seq.,15U.S.C,2601 ci seq.),which containsauthority for EPA to require thedevelopment of data relevant to

assessingthe risk to health and theenvironment posed by exposuretoparticular chemicalsubstancesormixtures,

Under section 4(aJ(1) ofTSCA, EPAmust require testing of a chemicalsubstance to develop health orenvironmental data if the Administratorfinds that:

(A)(I) the manufacture, distribution incommerce, processing. use, ordisposal of achemical substance or mixture, or that anycombination of such activities, may presentan unreasonable risk of injury to health or theenvironment.

(11) there areinsuffidentdata andexperience upon which the effects of such

maaufacture. distribution in commerce,processing. use, or disposal ofsuch substance

• or mixture orof any combination of suchactivities onhealth or the environment canreasonably be determined or predicted, and

(iii) testing of such substance or mixturewith respect to such effects is necessary todevelop such data; or

(B)(i) achemical substance or mixture is orwill be produced In substantial quantities,and (I) it enters or may reasonably beanticipated to enter the environment insubstantial quantities or (II) there Is or maybe significant or substantial human exposureto such substance ormixture,

(ii) there are insufficient dats andexperience upon which the effects of themanufacture, distribution In commerce,processing, use, or disposal of such substanceor mixture or of any combination of suchactivities on health or the environment canreasonably be determined or predicted.and

(iii) testing of such substance or mixturewith respect to such effects is necessary todevelop such data.

For a more complete understanding ofthe statutory section 4 findings, thereader is directed to the Agency’s firstproposed test rule package published inthe Federal Register of July 18, 1980 (45FR 48510), for an in.depth discussion ofthe general issues applicable to thisaction,B. RegulatoryHistory

As published in the Federal Registerof November29, 1984 (49FR 46931), theInteragency TestingCommittee (ITC)designatedanthraquinone for prioritytesting considerationand recommendedchemicalfate testing, Including watersolubility and biodegradation, andecologicaleffects testing, includingacute toxicity to fish, aquaticinvertebrates, and algae, and chronictoxicity to aquaticorganisms,conditional upon results of acute tests.TheAgency evaluated the ITC -

recommendation and on April 23, 1985held a public meeting to announce itspreliminary testing decision. Subsequentto the public meeting, Mobay ChemicalCorp.- submitted confidential business

S solids IStep ‘IJs w,~5h~01 ~slts fUIsr.d (54.p tior 9.5~

Federal Register I Vol. 52, No. 107 1 Thursday. June 4, 1987 / Rules and Regulations 21019

inkrmetion (CBJ) data on theconcentration of anthraquinone ni wastewater from the alkaline pulping process(Ref. 25). These data were considered inthe drafting of the proposed test rule.

The Agency responded to the ITC’srecommendations for anthrequinone byissuing, in the Federal Register ofNovember 6, 1985 (50 FR 46090). aproposed test rule (40 CFR 780.500) anda proposed reporting and recordkeepingrequirement(40 CFR 704.69, which íabeing redesignated as 40 CFR 704.30 inthe final rule) for production andimportation data. Based on section4{aKl)(B) of TSCA. EPA proposed tieredtesting, with the first tier includingwater solubility acutetoxicity tochinook salmon or coho salmon, bluegill,and rainbow trout: acutetoxicity to theinvertebratesDaphniamagnaor 1).pulexand oyster marine sedimenttoxicity to the amphipod, Rhepoxynhisabronius-,andoyster bioooncentration.Under section 8 of TSCA, EPA proposedthat manufacturers (including importers)of anthraquinone be required to submitan annual reportto EPAstating thevolume of anthraquinone manufacturedor wiported during their latest corporatefiscal year. Also proposed under section4(a) of TSCA was a second tier oftesting which would be triggered if theresults of Tier I tests indicated a hazardpotential and the reported production!importation volume reached orexceeded 3 million lb per year. Thesecond tier of tests included chronictoxicity in the most sensitive fish.chronic toxicity in Daphnia~biodegradability in sludgesystems.andbiodegradation rate,

The proposed rule contained achemical profile of anthraquinone. adiscussion of EPA’s TSCA section 4(a)findings, and a description of the testsubstance to be used. The proposed rulealso specified the test standards to beused and the reporting requirements.H. Pablic Comment

Comments were submitted to theAgency by CIL, Inc., on September19,1985 (Ref. 1) and February 26,1986 (Ref.2). The first set of comments respondedto materials discussed tRef. 3)at thepublic meeting held on April 23,1985 toannounce the Agency’s preliminarytestingdecision. Several of thesecomments are no longer relevantsincethe proposed testing reflected theAgency’s consideration of informationsubmitted by industry subsequent to thismeeting. The comments which are stillrelevant to the proposed rule areaddressed below. The second set ofcomments (Ref. 2) were submitted Inresponseto the proposed role and eraalso addressed below.

A. increasedUseofAnthraquinoneCli commented that the increased use

of anthraquinone in the pulping industryis unlikely to surpass 1.,5 to 2.0 million lbfor many years. CIL reasoned that thereis an economic incentive to useanthraquinone primarily outside the U.S.where increased pulping capacity isneeded (by improving efficiency), butcapital outlay cannot be Justified (Ref.1). EPA has reexamined the use ofanthraqinnone in pulping operations andits original estimate that anthraquinoneuse could be expected to rise to 7 millionlb per year. EPA now concludes that thecurrent use level of 1 to 2 million lb peryear is not likely to rise significantly inthe near term (Ref. 11). Although EPA’sestimate of anthraquinone’s future use isnot as optimistic. the Agency will stillrely on a productionfimport trigger forsecond tier testing of 3 million lb peryear. This level was orginally selectedbecause environmental release wasexpected to become significant at thislevel without the cost of conditionaltesting posing a significant adverseeconomic impact on the market.

B. BiodegmdotionCII. commented that anthraquinone is

easily and completely biodegraded (Ref.1), citing studies by Weston (Ref. 4) andMobay (Ref. 5). According to Cli. theWeston study showed anthraquinone at500 milligrams per liter (mg/U to have ahalf life of 5 days with either acclimatedor unacdimated seed organisms in anactivated sludge biodegradation studyunder aerobic conditions, while theMobay study. at an anthraquinoneconcentration of 2.4 mg/I., indicated ahalf.life inexcess of 20 days (using anacclimated seed).

EPA does not find these studiesadequate because theywere notactually done in activated sludgebiodegradation systems. Rather, moculawere provided from acclimated andunacclimated semi-continuous activatedsludge (SCAS) systems for biochemicaloxygen demand (SOD) tests. The SODtest is not an adequate test fordetermining removability in waste watertreatment. It is a screening test designedto determine whether a compound isreadily degraded. The SOD test is ofgreatest value for quantitative riskassessment if the test results indicatevery rapid biodegradation or nobiodegradation. When the results are atneither extreme, they are less reliable,and more sophisticated testing isneeded.

The Weston study found a SOD alter5 days of ~1and 45 percent oftheoretical oxygen demand Inacclimated and unaccilmated cultures,

respectively, while Mobay found a BOOafter 20 days of 40 percent and 15percent inacclimated and uriacdima tedcultures. Although the Weston resultsindicate biodegradation could be rapid,the lack of a significant differencebetween the results of the acclimatedversus unaccilmated cultures is a resultfully consistent with the BOO beingexerted by the dispersarit rather thananthraquinone. As a result, it is difficultto draw meaningful conclusions aboutanthraquinone’s degradability from thisstudy. Also, the concentration of 500mg/Lexceeds the anticipated watersolubility range of anthraquinone, andalthough the precise effect that thephysical state of an organic chemicalmay have on these tests is unknown, itis best to conduct them at or below thesolubility limitat an environmentallyrelevant concentration.

The DOD tests by Mobay indicatebiodegradation occurs more slowly, andthe conclusions in the Mobay reportregarding anthraquinone’sbiodegradability are reasonable.However,Mobay’s findingsnotwithstanding, there is still a need fortesting of anthraquinone atenvironmentally relevant concentrationsto providebiodegradation rates inenvironmentally relevant media, Le.,surface waters and waste watertreatment systems. BOD tests do notprovide these data, regardless of howcarefully they are done.

In a final comment on biodegradation.CII. remarked that in anaerobicdigestion tests, there was no impact onthe anaerobic digestion process byanthraquinone when present at levelsexpected to be released to theenvironment (Ref. 1). The Agency agreesthat anthraquinone’s adverse effect onanaerobic digestion does not occurunless concentrations are 10 ppm orgreater (Ref. 6).C. Aquatic Toxicity

Cli commented that the study byMacPhee and Ruelle (Ref. 7), whichIndicatedthat anthraquinone w~ismoderately toxic. “did not use aprotocol which meets the standards forrational scientific decision,” castingdoubt on the validity of the results. Cliwas concerned specifically withexcessive fish loading, oxygendepletion, and the use of acetone tomaintain chemicals in solution. Thisscreening study tested 1.888 chemicals,and the results spanned the full range ofresponse from nontox.ic to very toxicusing uniform test conditions with thetest chemical as the variable. EPArealizes that as a screening study theMacPhee and Ruelle study does not

21020 Federal Register / Vol. 52, No. 107 / Thursday, June 4. 1987 / Rules and Regulations

provide definitive acute toxicity data.The study is useful, however, inindicating compounds that might betoxic. In the case of anthraquinone, thestudy indicated moderate toxicity with a13-hour LC100 of 10 ppm. The speciesused in this study—coho salmon,chinook salmon, and squawfish—havenot been tested with anthraquinone inother studies to refute these findings.Therefore, as proposed in the November6, 1985 notice, EPA is now requiringacute toxicity tests ineither cohosalmon or chinook salmon to determineif anthraquinone is indeed toxic to thesespecies.

CII. also commented that tests carriedout by the Pulp and Paper ResearchInstitute of Canada (Ref. 8) usingrainbow trout showed that the additionof anthraquinone to Kraft liquors hadlittle effect on the latter’s toxicity. Thesetests were reviewed by EPA, but thelack of measured concentrations ofanthraquinone or a description of themethodology made it difficult todetermine if these tests were conductedunder environmentally relevantconditions.

The study of rainbow trout which EPAwill require by this rule will determinethe toxicity of anthraquinone itselfunder defined conditions to allow EPAto fully evaluate its toxicity.

D. WaterSolubiityCII. submitted a paper by Geake and

Lemon (Ref. 9)which indicated asolubility limit for anthraquinone of0.624 mg/L EPA reviewed this paperarid is not confident that 0.624 mg/I.represents the true water solubility forthe following reasons: (1) Concentration-time studies were not done to determineif true equilibrium saturation had beenreached; (2) excess anthraquinone in theform of colloids cannot be removed byfiltration but only by centrifugation. Thepresence of colloids would cause thesolubility limit to appear to be greaterthan its true value: (3) the cOlorimetricprocedure used to measureconcentration had an accuracy of only±20percent; a more sensitive analyticalprocedure is needed to measure theconcentration of anthraqulnone in waterin the range of I ppm or Lese and (4) itappears that the temperature at whichthe solubility was determined was 50 ‘C;it should be determined at 12 ‘C and 22‘C. temperatures which more closelyapproximate the temperatures of coldand warm water bodies In theenvironment. Therefore, as proposed Inthe November 8. 1985 notice, EPA Isrequiring that water solubility ofanthraquinone be determined by thegenerator column method (40 CFR798.1860). This method eliminates the

problems encountered by Geake andLemon, i.e., iii the generator columnmethod, equilibrium is achieved rapidly,the effects of colloids are eliminated.and the solubility limit can be measuredprecisely down to the part per billion(ppb) range.

Cli also commented that thedetermination of the precise solubilitylevel will not negate the acceptability ofprevious biodegradation and toxicityresults from tests conducted above thesolubility limit, since organisms In thesetests were exposed to anthraquinone atthe saturation orsolubility limit. EPA.however, believes that the physical stateof an organic chemical may have aneffect on test results when the chemicalis added to levels in excess of itssolubility. As an example, the authors ofa study, inwhich anthraquinone wasused at concentrations exceeding itssolubility. speculated that the observedmortality was due to undissolvedanthraquinone clogging the gills of thefish rather than a toxic chemical action(Ref. 21). Therefore, EPA is requiringthat tests be conducted atenvironmentally relevant concentrationswhich EPA has projected to be belowthe solubility limit.

CIL also commented that closederivatives, precursors or analogues ofanthraquinone, such astetrahydroanthraquinone (TI-fAQ),anthrahydroquinone (AHQ), and 1.4-dihydro-9,10-dihydroxyanthracene(ODA), can also be used in thepulpingprocess with effects equivalent to thoseof anthraquinone and with similarenvironmental fates (Ref. 2). Cli wasconcerned that the burden of conductingthe proposed testing would not beequitably distributed. In the use ofTI-fAQ. AHQ, and DDA in pulping, someanthraquinone is produced, but anyrelease to the environment would mostprobably be a mixture of anthraqulnone,THAQ, AHQ, and DDA (Ref. 22). Such amixture would not have the toxicity ofanthraquinone alone, especially sincethe toxicity of THAQ. AHQ, and ODAmay differ from anthraquinone due totheir greater solubility in water. Also,the Agency has no evidence that THAQ.AHQ, and DDA are currently being usedIn the U.S., even though they can besubstituted for anthraquinone In thepulping process and may be moreefficacious due to their greater solubility(Ref. 22).

For the above reasons, the Agencyhas decided not to make themanufacturers of THAQ, AHQ, andDDA subject to this rule at this time: theAgency plans to further evaluate theextent of use of alternatives and theneed for their testing.

Ill. Final Test Rule for Anthraquinone

A. Findings

EPA is basing Its final testingrequirements for anthraquinone on theauthority of section 4(a)(1)(B) of TSCA.Existing data indicate thatanthraquinone is or will be imported insubstantial quantitiesand thatsubstantial environmental release maybe reasonably anticipated to occur.Annual imports of anthraquinone are813,000 lb (Ref. 10) and could rise in thefuture. Discharge data from one woodpulping plant using anthraquinone as acatalyst show that the plant is currentlyreleasing effluents with anthraquinoneconcentrations in the upper part perbillion to lower part per million range.There are approximately 100 pulpingplants in the U.S. that could potentiallyuse anthraquinone in their processing(Ref. 12). If this use of anthraquinoneincreases, such releases could becomewidespread.

EPA also finds that the data nowavailable are insufficient to reasonablydetermine or predict the chemical fateand environmental effects of releasesfrom the use, processing, and disposal ofanthraquinone.

There is also no acceptable measuredvalue for anthraquinone’s solubility inwater, and the reported values of 0.05mg/U (Ref. 13) and 0.5 mg/L (Ref. 4) arenot supported by data. A third value forwater solubility is EPA’s estimate of 0.3mg/U (Ref. 14). The Agency finds thatthe water solubility of anthraquinonemust be determined to enable the properdesign of other studies.

The Agency finds that thebiodegradation studies submitted byCII., Inc. (Ref. 4) and Mobay ChemicalCorp. (Ref. 5) are, as BOD tests, notadequate for determining removabilityin waste water treatment. Additionally.these tests were conducted atconcentrations exceeding theanticipated water solubility range ofanthraquinone, and presented a half-liferange (5 days and greater than 20 days)too broad to reasonably predictanthraquinone’s persistence in theenvironment. This broad range isparticularly unsatisfactory since thetypical waste treatment residence timesfor thedye and pulp industries are 6 and8 days, respectively (Refs. 15 and 16).Also, as stated in Unit 11. of thispreamble. the BOD in the Weston studymay have been exerted by thedispersant rather than anthraquinone.The Agency also finds that thesubmitted studies are not necessarilyrelevant to assessing biodegradation bymicrobial populations in natural waters,which possess a different arrayof

Federal Register / Vol. 52, No. 107 1 Thursday, June 4, 1987 I Rules and Regulations 21021

microbial communities and physical andchemical characteristics than wastetreatment systems.

With regard to the release andchemical fate information presented inthe proposed rule, EPA expects thatpotential exposure to anthraquinone willbe greatest for fish, aquaticinvertebrates, and benthic organisms.EPA fmds that there are no toxicity orbioconcentration data on benthicorganisms and no chronic effects dataon fish and aquatic invertebrates.

After reviewing and evaluating theexisting acute toxicity data for aquaticorganisms experimentally expo8ed toanthraquinone, EPA has determined thatadditional data are necessary todetermine whether salmonids aresensitive as suggested by the MacPheeand Ruelle study (Ref. 7). EPA also findsthat additional acute toxicity studies offish and aquatic invertebrates arenecessary since the existing studieswere done at concentrations exceedingthe anticipated water solubility range ofanthraquinone.

EPA finds that sufficient data areavailable from the study done byChillingworth (Ref. 17) to reasonablypredict anthraquinone’s toxicity toalgae.

Finally, EPA finds that testing isnecessary to develop thechemical fateand environmentaleffects datadescribed above. EPA believes that thedata resulting from this testing will berelevant to a determination as towhether themanufacture, processing, oruse of anthraquinone does ordoes notpresent an unreasonable risk of injury tothe environment.

B. RequiredTestingandTestStandardsOn thebasis of these findings, the

Agency is requiring that chemical fateand environmental effects testing beconducted on anthraquinone inaccordance with EPA’s TSCA GoodLaboratory Practice standards In 40 CFRPart 792 and specific test guidelines setforth in Title 40 of the Code of FederalRegulations orother published testmethods as enumerated below. Testmethods under Part. 796 and 797 werepublished in the Federal Register ofSeptember27, 1985 (50 FR 39252);proposed revisions were published inthe Federal Register of January 14. 1986(51 FR 1522) and final revisions werepublished in the Federal Register of May20. 1987 (52 FR 19056).

In view of theprospect for a growingmarket for anthraqwnone owing to itsuse in the pulping industry and theprojected economic impact (see sectionIV. of this preamble, EconomicAnalysisof Test Rule) of the full set of aquatictests EPA believes would be necessary

to adequately assess the environmentalrisks of anthraquinone. the Agency isrequiringthat testing be conducted intwo tiers. By tiering testing, EPA expectsto obtain limited data now from the firsttier to better assess thepotential forexpanded releases of anthraquinone topose significant risks. Should theproduction or importation ofanthraquinoneexpand substantially andthe results of the first tierof testing meetthe specified triggers, the second tier oftesting will provide the more completedata needed to evaluate the possiblerisks associated with substantiallylarger aquatic releases of the chemical.

EPA Is requiring that the first tiertesting of anthraquinone be conductednow to determine (1) the water solubilityto properly design the subsequentrequired tests, using the TSCA guidelineentitled “Water Solubility, GeneratorColumn Method” as specified in* 796.1860 the solubility shall bedetermined at 12 C and 22 ‘C asallowed under § 796.1860(b)(3) becauseof the temperaturerequirements for fishacute toxicity tests of cold and warmwater species under ~797.1400(d)(3)(iii);(2) theacute toxicity to chinook salmon.Oncorhynchustshawytscha,orcohosalmon, Oncorhynchuskisutch (coldwater species); bluegill.Lepomismacrochirus(warm water species); andrainbow trout,So/mogcirdneri (coldwater species), using the TSCAguideline entitled “Fish acute toxicitytest” as specified in * 797.1400 asmodified; (3) the acute toxicity to theinvertebratesDaphniomagnaor D.pulex,and oyster, Crassostreavirginica,using the TSCA guidelines entitled“Daphnid acute toxicity test” asspecified in § 797.1300 and as modifiedand “Oysteracute toxicity test” asspecified in ~797.1800 as modified; (4)the sediment toxicity to either themarine amphlpod, Rhepoxyniusabronius.accordingto themethod ofR.C. Swartz et al., “PhoxocephahdAmphipod Bioassay for MarineSediment Toxicity”, published in theAmerican Society for Testing andMaterials SpecialTechnical Publication854 (ASTM STP 854). R. D. Caldwell etat. (eds.) (Ref. 18) or the freshwatermidge. Chironomustetans,according tothe method of W.J. Adams et al.,“Aquatic safety assessments ofchemicals sorbed to sediments”, alsopublished in ASTM STP 854 (Ref. 23);and (5) bioconcentration in oyster.Crassostreavirginica, using theTSCAguideline entitled “Oysterbioconcentration test” as specified in* 797.1830 as modified.

EPA is allowing Industry a choice ofeither of the two above-referencedsediment toxicity tests because the

Agency wishes to allow themanufacturers of anthraqwnone theopportunity to conduct this testing usingthe species and methods required inother section 4 test rules concurrentlyunder development orpublished. It alsoallows industry to select a species thatis more representative of the streamsand waters receiving effluents frompulping plants and a species that may bemore available for testing.

In order to evaluate the potentialhazard of the median lethalconcentrations (LC5O’s) generated by theTier I tests, EPA is requiring that theLC5O’s be compared to thepredictedenvironmental concentrations (PEC’s)for anthraquinone inwater andsediment, i.e., 5 ppb and 0.1 ppmrespectively, which have beendetermined from reported dischargelevels (see the proposed rule).

EPA is also requiring that a secondtier of tests shall be conducted if twotriggers are met—a hazard trigger and aproduction/import level trigger. Thehazard trigger will be met if one or moreof themedian lethalconcentrations(LC5O’s) generated by theTier I tests areless than 100 times thepredictedenvironmental concentrations. Theproduction/import level trigger will bemet when annual production/importlevels reach 3 million lb. EPA willrequire annual reporting under section8(a) to monitor the production/importlevels of anthraquinone, and will notifyindustry if the production/import triggeris met.

Ifboth triggers are met, EPA isrequiring that selection of the Tier IItests be based on the results of the Tier 1tests as follows. If the most sensitivefish, i.e., the fish with the lowest LC5O asdetermined by the above-required acutetoxicity tests, has an LC5O less than 100times thepredicted environmentalconcentration (PEC) forwater (i.e., lessthan 500 ppb), testing of anthraquinoneshall be conducted to determine thechronic toxicity to themost sensitivefish, using the TSCA guideline entitled“Fish early lifestage toxicity test” asspecified in ~797.1600 as modified. If thedaphnid has a median effectiveconcentration (EC5O) as determined bythe above required acute toxicity testwhich is less than 100 times the PEC forwater (i.e., less than 500 ppb), testing ofanthraquinone shall be conducted todetermine the chronic toxicity todaphuids, using the TSCA guidelineentitled “Daphnid chronic toxicity test”as specified in * 797.1330 as modified.

The required partial life cycle testingof either RhepoxyniusorChironomuswillprovide data on sensitive life stagesof benthic invertebrates. Current state of

21022 Federal RegIster / Vol. 52 No.. 10? / Tlezsday, June 4, ~W’ / Rules and Regutatlorm

the art in beatlic invertebrate LestUihas net progressed to allowfull chronictesting.

If the LC5i) for the moat ienaittve fish.or the EC5O for the dapbnid or oyster, 4less than 100 times the PEC to water(i.e.. less than 500 ppb), out the LC5O ktrRhepoxyRiusor ChJrOnOWA~Sin thesediment toxicity test is less than lOStimes the PEC in sediment (t,e., Less than10 ppm), or if the oysterbioconcentration factor is greater than3.000, then EPA is requiring that testingof anthraquinone shall be cunthicted todetermine (1) the biodngra’dability inactivated sludge systems, using the testmethod entitled “Inherentbiodegradability: Modified SCAS (semi-continuous act.ivitated sludge) test forchemical substances that are waterinsoluble or water insoluble andvolatile” as specified in ~795,45(originally proposed under ~796~3341(see 50 FR 46793; Nov. 13. 1985)J and ~2)biodegradation rate using the protocoldescribed in a study by Bourquin et aL(Ref. 19j.

EPA chose to trigger second tiertesting with an increase m production/import level for two reasons. First, asthe use of anthraqtiinone increases, theAgency’s concerns for environmentalrelease and the potential forunreasonable risk to the environmentincrease. Under such conditions, theneed for further test’mg to fullycharacterize the hazard potential andchersecal fate of anthraquinone becomesessential. If thedata developed in thefirst tier of testing do not meet at leastone of the hazard triggers describedabove, there would be no potential totrigger further testing and thus no needfor continued section 8(a) reporting EPAthen would remove the section 8(a)reporting requirement and publishanotice of such action m the FederalRegister.

However. if these data suggestconcern and if anthraquinone imecontinued to increase $03 million lb peryear, the second tie, of testing isconsidered essentiaL EPA alanchose aproduction/import level of 3 mIllion lbper year because it representssubstantial market growth of thechemical over current levels and a levelat which EPA’s analysis indicates th.second-tier tests will not cause anadverse economic impact (See sectionIV. of this preamble. Economic Analysisof Test Rule). The section 8(a) reportswill be the means to determine when the3-million lb trigger is meL

The Agency is requiring that theabove-referenced TSCA Chemical Fateand Environmental Effects TestGuidelines as revised elsewhere in thisissue of the Federal Register and other

thted methads be considered the teststandards for the purposes ofreqstred tests foranthraqulnone Theproposed test rule foranthra~axtoespecified that the revinens to theguidelines proposed to the Jasmary 1&1988 issue of the Federal Register (Si FM1522) would be ap abie to this ntis.EPA proposed revisions to theTSCAtest guidelines $0 provide more explicitguidance on the necessary minimumelements for each study end to avoidrepetitive cbemicaI~by-chemicalchangesto theguidelines ~ their adoption as teatstandards for chemical-specific testrules. The guideline revisions publishedin the Federal Register of May 3), 1987(52 FR 19056). kw tests included in thisfinal rule are adopted in the teststandards for the testing ofanthraqu,inone. EPA has responded tocomments concennog these guidelinesin the record for that rulemaking (ReL24). These final revisions apply to thetest standards far anthraquinone. TheTSCA guidelines for chemical fate andaquatic toxicity testing specify generallyaccepted minimal conditions fordetermining chemical fate and aquatic~tma1 toxicities for substances ilk.anthraquinone to which aquatic life isexpected to be exposed. The Agencybelieves that the conduct of the requiredstudies inaccordance with these teststandards is necessary to assure that theresults are reliable and adequate.

The Agency’s review of the guidelines.which occurs on a yearly basis asdescribed in the Federal Register ofSeptember22, 1982 (47 FR 41167), hasfound no reason to conclude that theseguidelines generally need to be modifiedsignificantly. However, severalchemical-specific modiflcatime weredeemed necessary to ensure that the I~cot~mntrationsare environmentallyrelevant and are adequatelymaintainedthroughout theduration of the test.These modifications are specified in* 799.SOS, which follows this preasubte

Additionally, theAmerican Societyfor Testing and Materials (ASTM)guidelines (Rels. 1$ and 23) and the testprocedures employed by Bourqusnet al.(ReL 19) specify, in EPA’s judgment.minimum test conditions and practicesfor acceptable investzgations ofanthraquuxme’s toxicity in sediment tomarine amphipod and freshwater midge,and rate of biodegradation. Although theAgency has not issued TSCA testingguidelines los benthic invertebratesorbiodegradation rate, the testingprocedures found in these referencesreflect the current state of the art fursuch testing and are being required fortesting anthraquinone’s toxicity tobenthic invertebrates eruibiodegradation rate.

C TestSubstance

EPA Is requiting that 9.10-anthra~Anooeof at Least 19 percentpurity be used as the lest substanceAnthraqurnone of this purity isonsnznezcially available at nominal cost(Ref. 20). EPA has specified a highlypure substance for testing because theAgency ininterested in evaluating theeffects attributable (a aathreqain*meitseiLD. PeisonsSubjectto theRule

1. Fin’sonarequiredto test,Section4(b4(3~B~dTSCA specifies that theactivities for which the EPA makessection 4(a) findings (manufacture,processing. distribstion, use, and/ordisposal) detecrulne who bears theresponsibility for testing. Manufacturer,are required to test if the fmdings arebased on manufacturing (“manufacture’is defined in section 3(7) of TSCA toinclude “Import”). Processor, arerequired to test if the findings are basedon processing. Both manufacturers andprocessors are required to test if theexposures giving rise to the potentialrisk occur during use, distribution, ordisposal.

Because EPA has found that existIng~data are inadequate to assess thechemical fate and environmentaltoxicity of anthraquinone entering theenvironment as a result of theprocessing, use, and disposal of thischemical. EPA is requiring that personswho manufacture and/or process, orwho intend to manufacture and/orprocess, anthraquinone at any time fromthe effective date of this final test rule tothe end al the reimbursement period aresubject to the testing requirementscontained in this final rule. The end ofthe remib~rserneniperiod will be 5years after the last final report issubmitted or an amount of timeequal tothat which was required to developdata, if more than 5 years after thesubmission of the last final reportrequired onder the test rule.

Because TSCA contains provisions toavoid duplicative testing, not everyperson subject to this rule mustindividuallyconduct testing. Section4(bX3)(A) of TSCA provides that EPAmay permit two or more manufacturersor processors who are subject to the ruleto designate one such person onqualified third person to conduct thetests and submit data on their behalLSection 4(c) provide, that any personrequired to test may apply to EPA for anexemption from the requirement EPApromulgated procedures for auplying forTSCA section 4(c) exemptions in 40 CFRPert790.

FederalRegister/ Vol. 52, No. 107 / Thursday,June 4, 1987 / Rules and Regulations 21023

Manufacturers (including importers)subject to this rule are required tosubmit either a letter of intent toperform testing or an exemptionapplication within 30 days after theeffective date of the final test rule. Therequired procedures for submitting suchletters and applications are described in40 CFR Part 790.

Processors subject to this rule, unlessthey are also manufacturers, will not berequired to submit letters of intent orexemption applications, or to conducttesting, unless manufacturers fail tosubmit notices of intent to test or laterfail to sponsor the required tests. TheAgency expects that the manufacturerswill pass an appropriate portion of thecosts of testing on to processors throughthe pricing of their products onreimbursement mechanism. Umanufacturers perform all the requiredtests, processors will be grantedexemptions automatically. Ifmanufacturers fail to submit notices ofintent to test or fail to sponsor all therequired tests, the Agency will publish aseparate notice in the Federal Registerto notifyprocessors to respond. Thisprocedure Is described In 40 CFR Part790.

EPA is not requiring the submission ofequivalence data as a condition forexemption from the required testing foranthraquinone. As noted in Unit 1ll.C.above, EPA Is interested in evaluatingthe effects attributable to anthraquinoneand has specified a relatively puresubstance for testing.

Manufacturers and processors subjectto this test rule must comply with thetest rule development and exemptionprocedures in 40 CFR Part 790 for single-phase rulemaking.

2. Personsrequiredtosubmitproductionandimport information.Persons (other than small manufacturersand importers) who manufacture orimport anthraquinone after the effectivedate of this final rule will be required tosubmit section 8(a) data under this rule.Although TSCA section 8(a)(3)(A)(il)would allowEPA to require reporting bysmall manufacturers and smallimporters of anthraqulnone (becauseanthraquinone is concurrently beingmade subject to a section4 rule), EPAhas determined that iuch reporting isnot necessary to achieve the purposes ofthis rule.E. ReportingRequirements

1. Undersection4. EPA is requiringthat all data developed under this rulebe reported in accordance with ItsTSCA Good Laboratory Practice (GLP)standards, which appear in 40 CFR Part792.

In accordance with 40 CFR Part 790under single-phase rulemakingprocedures, test sponsors are required tosubmit individual study plans within 45days before initiation of each study.

Subsequent to the issuance of theproposed test rule for anthraqulnone,the Agency decided that interim reportsfor the testing required for substancesunder section 4 of TSCA should besubmitted at 6-month intervals, ratherthan at 3-month intervals, which will besufficient to keep EPA informed of thecurrent status of required testing and ofany difficulties which the testing facilitymay encounter during the course oftesting. In addition, this change willlessen the reporting burden on testsponsors. Accordingly, the finalreporting requirements for the testingrequired for anthraquinone reflect arequirement for 8-month, rather than 3-month, Interim testing reports.

EPA is required by TSCA section4(b)(1)(C) to specify the time periodduringwhich persons subject to a testrule must submit test data. Specificreporting requirements for each of thefinal test standards follow:

a. The water solubility and acutetoxicity tests shall be completed and thefinal results submitted to EPA within 1year of the effective date of the final testrule. An interim progress report shall beprovided 6 months from the effectivedate of this rule.

b. The oyster bioconcentration testshall be completed and the final resultssubmitted to EPA wIthin 18 months ofthe effective date of the final test rule.Interim progress reports shall beprovided at 8 months and 12 monthsfrom the effective date of this rule.

c. The sediment toxicity test shall becompleted and the final resultssubmitted to EPA within 2 years of theeffective date of the final test rule.Interim progress reports shall beprovided at 6 months, 12 months, and 18months from the effective date of thisrule. The allotted time to complete thistest was extended from 18 months to 2years to be consistent with other section4 rules.

d. The fish and daphnid chronictoxicity tests shall be completed and thefinal results submitted to the AgencyWIthin 2 years of the date that EPApublishes a Federal Register notice ornotifies the test sponsor by certifiedletter that production/imports havereached 3 million lb per year and Tier Itest results necessary to trigger chronicaquatic toxicity testing were obtained. Ifthis testing Is triggered. Interim pro~resareports shall be provided at 6 months, 12months, and 18 months from the date ofpublication of theFederal Registernotice or receipt of notification. The

allotted time to complete these tests wasextended from 1 year to 2 years to beconsistent with other section 4 rules.

e. The biodegradability in activatedsludge and biodegradation rate testsshall be completed and the final resultssubmitted to EPA within 1 year of thedate that EPA publishes a FederalRegister notice ornotifies the testsponsor by certified letter thatproduction/imports have reached 3million lb per year if those criterianecessary to trigger biodegradationtesting are met. If this testing istriggered. an interim progress reportshall be provided 6 months from thedate of publication of the FederalRegister notice or receipt of notification.

TSC4% section 14(b) governs Agencydisclosure of all test data submittedpursuant to section 4 of TSCA. Uponreceipt of data required by this rule, theAgency will publish a notice of receiptin the Federal Register as required bysection 4(d).

Persons who exporta chemicalsubstance ormixture which is subject toa section 4 test rule are subject to theexport reporting requirements of section12(b) of TSCA. Final regulationsInterpreting the requirements of section12(b) are in 40 CFR Part 707 (December16, 1980’, 45 FR 82844). In brief, as of theeffective date of this test rule, anexporterof anthraquinone must reportto EPA the first annual exportorintended export of anthraquinone to anyone country. EPA will notify the foreigncountry concerning the test rule for thechemical.

2. Undersection& Any person whomanufactures or imports anthraquinone(other than small manufacturers andimporters) after the effective date of thisrule must submit a report 60 days afterthe conclusion of their corporate fiscalyear in which they manufactured orimported anthraquinone.

Any person who manufactures orimports anthraqulnone (other than smallmanufacturers and importers) in a yearfollowing that for which an initial reportwas submitted must submit a new reportfor each corporate fiscal year in whichhe/she manufactures or imports thenamed substance. This report is due 60days after the conclusion of theircorporate fiscal year in which theymanufactured or importedanthraquinone.

The report must contain the followingInformation:

(1) Company name and address.(2) Name, address, and telephone

number of the principal technicalcontact

(3)The quantity (by weight) ofanthraquinone manufactured or

2~A Federal Register I Vol. 52. No. 107 / Thursday. tune 4. 1W / Rules and Regulat~ne

imported ckning the latestcorporatefiscal year.

If this report is submitted within theyear preceding the start of a repuctin~period under the Inventory Update Rule.the submitter will not be required toreport the same information again forthat reporting period. The details of thisexemption are set forth in40 CFR 710.36.F. EnforcementPrm*ions

The Agency cousulers failure tocomply with any aspect at a section 4rule or a section 8 rule to be a violationof section 15 of TSCA. Section 15{1) of1’SCA makes it unlawful for any personto fail or refuse to comply with any rulsor order issued under section 4. Section15(3) of TSCA makes it unlawful for anyperson to fail or refuse to (1) Establishor maintain records. (2) submit reports.notices, or other information, or (3)permit access to orcopying at recordsrequired by the Act or any regulation orrule issued under TSCA.

Additionally, TSCA section 15(4)makes it unlawful for any person to failor refuse to permit entry or inspection asrequired by section 11, Section 11applies to any ‘establishment, facility,or other premises in which chemica4substances or mixtures aremanufactured, processed, stored, or heldbefore orafter their distribution ‘incommerce * * .“ ‘The Agencyconsiders a testing facility to ben placewhere the chemical is held or storedand, therefore, subject to inspection.Laboratory inspections and data auditswill be conducted periodically inaccordance with the authority andprocedures outlined in TSCA section 11by duly designated representatives ofthe EPA for the purpose of determiningcompliance with any final rule foranthraquinone. l’hese inspections maybe conducted for purposes whichinclude verification that testing hasbegun. that schedules are being met, andthat reports accurately reflect theunderlying raw data and tn$erpretatlons,and evaluations to determinecompliance with TSCA GLP stnodard.and the test standards established in therule.

EPA’s authority to inspect a testhi~facility also derives from sectins 4(b)(1}of the TSCA, which directs EPA topromulgate standards for thedevelopment of test data. Thesestandards are defined in section 3(12)(~of TSCA to include th~ezequirein~sitsnecessary to assure that data developedunder testing rules are reliable andadequate, and to include sech otherrequirements as are necessary toprovide such assurance. The Agencymaintains that laboratory inspectionsare necessary to provide this assura~.

Violators oil’ A are subject tocriminal andcivil liability. Persons wIusubmit materially misleading or falseinformation in connection with therequirement of any provision of this rulemay be sub4ect to penalties which maybe calculs ted as if they never submittedtheir data. Under the penalty provisionof section 14 of T9CA. any person whoviolates section 15 could be subject to acivil penalty of up to S25~000for eachviolation with each day of operation inviolation constituting a separateviolatiosi. This provision would beapplicable primarily to manufacturersthat fail to sebinit a letter ofintent or anexeriptksi request and that oontiaremanufacturing after the deadlines forsubmissions. This provision would alsoapply to processors that fail to submit aletter of intent or an exemptionapplication sort continue processingafter the Agency has notified them oftheir obligation to submit suchdocuments (see ~) CP.lt ?60.4~b)).Intentional violations could teed to theimposition of criminal penalties ofup to$25,000 for each day of violation andimprisonment for up to I yeer. indetermining the amount of penalty; EPAwill take late account the seriousness ofthe violation and the degree ofculpability of the violator, as well as allother factors listed inTSCA sectIon 16.Other remedies are available to EPAunder section 17 of TSCA. such asseeking an in)unction to restrainviolations of TSCA section 4.

Individuals as well as corporationscouldbe subject to enforcement actions.Sections 15 and 16 ofT~Aapplyto“any person” who violates pro~isionsofTSCA. EPA may. at its discretion,proceed against individualsas well ascompanies themselves. In particulue.this includes individualswho reportfalse information orwho cause it to bereported. In addition, the submission offalse, fictitious, or fraudulent statementsis a violation under 18 U.S~C1901.

IV. EconomicAnalysts of Final TestRule

To assess the potential economicimpact of this rule, EPA has pret*red aneconomic analysis (Ref. 11) thatevaluates the potential for significanteconomic impacts on the indu~tryas aremit of the required testing. Theeconomic analysis estimates thecosts ofconducting the required testing ~levaiua~the potential for eigrificantadverse ~oeac impact as a r~lt ofth~test cts by ezaawth~fm~market charecteristics of antlw.i.nm(1)Price massitivity of d~nd..(2$industry mist characteristIcs. (39indusfry structure, and (4~marketexpectations, if thare is no indicat~of

adverse effect, no further economicanalyns is performed; however, if thefirst level of analysis indicates apotential for significant economicimpact, a more comprehenstve anddetailed analysis is conducted whichmore precisely predicts themagnitudeand distribution of the expected impact

Total testing costs for the first tier oftesting specified in the final rule forenthraqinnone are estimated to rangefrom $61,~X)to $68.500. The cost citperforming the alternative sedimenttoxicity test using Cliimnomus will becomparable to the cost of testingRhepoxynius. Any slight difference wiltnot substantially affect the economicimpact of this role. The total costs forthe second tier of testing are estimatedto range from $95,600 to $124,300. Inorder to predict the financial decision-making practices of manufacturingfirms, these costs have been annualized.Annualized costs are compared withannual revenue as an indication ofpotential impact. The annualized costsrepresent equivalent constant costswhich would have to be recouped eachyear of the payback period in order tofinance the testing expenditure in the-first year.

The annualized costs of themandatory minimum (tier I) tests (usinga coat of capital of 25 percent over aperiod of 15 years) range from $13,400 to$17,800. Based on an estimated minimumannual importation level of one millionpounds, the unit test costs will rangefrom 1.34 to 1.8 cents per pound. Inrelation to a selling price of $2.25 perpound for anthraquinone. these costs areequivalent to 0.58 to 0.8 percent of price.

The annualized costs of theconditional (tier II) tests range from$24,800 to $32.200. When production/imports reach 3 million poundsper year.the unit test costs of the tier U tests willbe from 0.83 to LW cents per pound. Inrelation to the current selling price, thecombined tier I and tier Ii unit costs (2.1to 2.8 ces~per pound) are equivalent to0.93 to 1.3 percent of prae.

EPA estimates that the cost ofpreparing and sebmitttng the section8(a) report will be minimal. Smallmanufacturers and importers are exemptfrom repcxting, and these is no officialform to be completed. Acompany maysubmit the information in whatevermanner it finds appropriate. Acompany’s coat of reporting under theruin w~beafmxthonoftheco~aIlabor ~ dulag the ~wting sadthe nttaa’of hans it takes for them tocemply. EPA stflafr, that the directfiling cost for the section ~aJ reportranges from $150 to $500.

Federal Register I Vol. 52, No. 107 / Thursday, June 4, 1967 / Rules and Regulations 21023

Based on these costs and the uses ofanthraquinone. the economic analysisindicates that the potential forsignificant adverse economic impact asa result of this testing rule is low. Thisconclusion is based on the lowestimated unit test costs. Refer to theeconomic analysis for a completediscussion of test onst estimation andthe potential for economic impactresulting from these costs.

V. Availability of Test FacilitiesandPersonnel

Section 4(b)(1) of TSCA requires EPAto consider “the reasonably foreseeableavailability of the facilities andpersonnel needed to perform the testingrequired under the rule.’ Therefore, EPAconducted a study to assess theavailability of test facilities andpersonnel to handle the additionaldemand for testing services created bysection 4 test rules. Copies of the study,Chemical Testing lndustiy: Profile ofToxicological Testing, can be obtainedthrough the NTIS (PB 82—140773). On thebasis of this study, the Agency believesthat there will be available test facilitiesand personnel to perform the testing inthis rule.

VI. Rulemaking RecordEPA has established a public record

for this rulemaking proceeding [docketnumber OVFS-42076AJ. This recordincludes:A. SupportingDocume.ntation

(1) Federal Register notices pertainingto this rule consisting of:

(a) Notice containing the fl’Cdesignation of anthraquinone to thePriority List (49 FR 46931; November 29,1984).

(b) Rules requiring TSCA section 8 (a)and {d) reporting on anthraquinone (49FR 46739, 49 FR 48741; November 28.1984).

(c) Notice of EPA’s proposed test ruleon anthraquinone (50 FR 46090November 6, 1965).

(d) Notice containing TSCA testguidelines cited as test standards forthis rule [52 FR 19056; May 20, 1987).

(e) Notice of TSCA test guidelinesrevisions (51 FR 1522 January 14, 1986).

(f) Notice of final rulemaking on datareimbursement $8 FR 31786; July 11,1983).

(g) Notice of interim final rule onsingle-phase test rule development andexemption procedures ~50FR 20652; May17, 1985).

(h) TSCA CLI’ standards (48 FR 53922;Nov. 29. 1963).

(2) Anthraqulnone economic analysis.(3) Communications after proposal

consisting of:

(a) Written public comments endletters.

(b) Contact reports of telephoneconversations.

(4) Reports—published andunpublished factual materials.

B. References(1) CIL. Inc., North York. Ontario, Canada.

Comments on anthraquinone public meetingof April 23, 1985. Submitted to the Office ofToxic Substances, U.S. EnvironmentalProtectionAgency,Washington.DC 20460.(September19, 1985).

(2) CIL, Inc.. North York, Ontario. Canada.Comments on proposed test rule foranthraquinone. Submitted to the Office ofToxic Substances. U.S. EnvironmentalProtection Agency, Washington. DC 20460.(February 26, 1986).

(3) Handout at anthraquinone publicmeeting. (April 23. 1985).

(4) Roy F. Weston,Inc.,West Cheater,PA19380. “Environmental testing programs foranthraquinone. Section 3. Biodegradabilitytesting.” (April 1980).

(5) Mobay Chemical Corporation. IndustrialChemicals Division, Ptttaburgh, PA 15205.Letter from Bruce Burba of Mobay ChemicalCorp. to Dr. Richard Schauer of IC! UnitedStates. Inc., Wilmington, DE 19897. (October28. 1978).

(8) Roy F. Weston. Inc., West Chester. PA19380. “Environmental testing programs foranthraquinone. Section 4. Impact ofanthraquinone on anaerobic digesters.’(April 1980).

(7) MacPhee, C. and Rue1le, R. “Lethaleffects of 1,888 chemicals upon four speciesof fish from western North America.” ForestWildlife and Range Experiment Station.Moscow, ID. Univ. of Idaho. (November1969).

(8) Pulp and Paper Research Institute ofCanada, Pointe Claire, PQ. Canada. Letterfrom J.M. MacLeod to Dr. H.H. Holton, CAChemicals, Montreal, Quebec. Canada.(November 29. 1977).

(9) Geake. A. and Lemon. J.T.“Semiquinone formation by anthraqulnoneand some simple derivatives.” 7’ronaaction,of the FaradaySociety34:1409-1427 (1938).

(10) USITC. US. International TradeCommission. Imports of Benzenoid Chemicalsand Products, 1983. Publication No. 1548.Washington. DC U.S. Government PrintingOffice, (1984).

(11) USEPA. U.S. Environmental ProtectionAgency. Economics and Technology Division.“Economic evaluation of final test rule foranthraquinone.” (September ~, 1986).

(12) Denit. J.D., Dellinger, R.W.. and W.D.Smith. “Development Document for EffluentLimitations Guidelines New SourcePerformance Standards and PretreatmentStandards for the Pulp. Paper and Paperboardand the Builders’ Paper and Board Mills PointSource Categories”. USEPA. (October 1982).

(13) IC! Americas, Inc., Wilmington. DE19897. Indirect Food Additive Petition for theuse of 9.1O..anthraquinone as a puiptegprocessing aid. Volume I. Section H.Submitted to Food and Drug Administration.(August 9, 1978).

(14) USEPA. U.S. Environmental ProtectionAgency. “Chemical property and

environmental behavior estimates forchemicals on the 15th ITC priority list.” Intra-agency memo from Pat Harrigan. EED, to JeffDavidson, TRDB. (November 29,1984).

(15) Games, LM. and Hites. R.A.“Compo8ition. treatment efficiency, andenvironmental significance of dyemanufacturing effluents.~’ AnalyticalChemistry. 49 :433—440. (1977).

(18) Zanella, E.F., McKelvey, RD., andJoyce.T.W. “Effect of anthraquinone ontoxicity and treatability of bleached kraftpulp mill effluents.” Toppi62(2)85-87. (1979).

(17) Chillingworth. M.A. “The toxiaty ofarninoanthraquinone dyes to fish and algae.”In: Dyes and the Environment. American DyeManufacturers Institute. Inc. (1974). Asreported at 49 FR 46937~November 29. 1984.

(18) Swartz, R.C.. DeBen, WA.. Jones,J.K.P., Lambertson. JO., and Cole. F.A.“Phoxocephalid amphipod bioassay formarine sediment toxicity.” in. AquahcToxicology and Hazard Assessment; SeventhSymposium, ASTM STP 854. Ri). Caidwell, R.Purdy, and R.C. Bahner. Eds.. AmericanSociety for Testing and Materials.Philadephia. pp. 284—307 (1985).

(19) Bourquin. A.W.. Hood, MA.. andGarnas, R.L “An artificial microbialecosystem for determining effects and fate oftoxaants in a saltrnarsh environment.” Ch. 11In Vol. 18 of Developments in IndustrialMicrobiology. Published by the Society forIndustrial Microbiology. (1977).

(20) Chemical Marketing Reporter. pg. 13.(Oct. 1. 1984).

(21) Roy F. Weston, Mc., West Chester, PA19380. “Environmental testing programs foranthraquinone. Section & Acate toxicity tofi.h: (April 1980).

(22) Syracuse ResearchCorporation,Merrill Lane. Syracuse, New York 13210.“Anthraquinoee Derivatives.’ TechnicalSupport Document. (October 24. 1986).

(23) Adams, W.j., Kimerle. R.A., andMosher, R.G., “Aquatic safety assessment ofchemicals sorbed to sediments.” In: AquaticToxicology and Hazard Assessment: SeventhSymposium. ASTM STP 854. Ri). CaIdwell, P..Purdy, and R.C. Bahner, Eds., AmericanSociety for Testing and Materials,Philadelphia. PA. pp. 429-453 (1985).

(24) USF2A. “Response to PublicComments. Proposed Revision of TSCA TestGuidelines as published in 51 FR 1522(January 14. 1986)”. Teat Rules DevelopmentBranth, Existing Chemicals AssessmentDivision. Office of Toxic Substances,Environmental Protection Agency.Washington. D.C. (january 1987).

(25) USEPA. U.S. Environmental ProtectionAgency. “Anthraquinone concentrations inwater columns and bottom sediments ofreceiving streams as a result of its use inpulping.” lntraagency memo from NancyChiu. Modeling Section. Design andDevelopment Branch, Exposure EvaluationDivision, to Catherine Roman, TRDB. Non—CBI version. July 25. 1985.

The record is available for inspectionfrom 8 a.m. to 4 p.m., Monday throughFriday. except legal holidays, in Rm.NE-G004, 401 M St.,SW., Washington,DC 20460.

21028 Federal Register / Vol. 52, No. 107 / Thursday. June 4, 1987 / Rules and Regulations

VII. Other Regulatory Requirements

A. Classification of Rule

Under Executive Order 12291, EPAnust judge whether a regulation is“ma;or” and therefore subject to therequirement of a Regulatory ImpactAnalysis. EPA has determined that thistest rule is not major because it does notmeet any of the criteria set forth insection 1(b) of the Orden i.e., it WdI nothave an annual effect on the economy ofat least $100 million, will not cause amajor increase in prices, and will nothave a significant adverse effect oncompetition or the ability of U.S.enterprise to compete with foreignenterprises.

This regulation was submitted to theOffice of Management and Budget(0MB) for review as required byExecutive Order 12291. Any writtencomments from 0MB to EPA, and anyEPA response to those comments, areincluded in the rulemaking record.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act(15 U.S.C. 601 et seq., Pub. L 96-354,September19, 1980), EPA is certifyingthat this test rule willnot have asignificant impact on a substantialnumber of small businesses because: (1)They are not likely to perform testing

~niselves,or to participate in theganization of the testing effort; (2) they

.vill experience only veryminor costs, ifany. in securing exemption from testingrequirements; (3) they are unlikely to beaffected by reimbursementrequirements; and (4) they are exemptfrom the section 8(a) reportingrequirements.

C. PaperworkReductionAct

0MB has approved the informationcollection requirements contained in thisfinal rule under the provisions of thePaperwork Reduction Act of 1980, 44U.S.C. 3501 et seq,, and has aasi~ned0MB control numbers 2070-0033 and2070—0067,

List of Subjects in 40 CFR Parts 704, 795and 799

Testing, Environmental protection,Hazardous substances, Chemicals,Reporting and recordkeepingrequirements, Incorporation byreference.

Dated: May 22. 1987.Victor J, Kimm,AssistantAdministratorforPesticidesandToxicSubstances.

Therefore, 40 CFR Chapter I is~ndedas follows:

PART 704—~AMENDEDJ

1. Part 704 is amended as follows:a. The authority citation for Part 704

continues to read as follows:AuthorIty: 15 U.S.C. 2607.

b. By adding 4 704.30 to read as

follows~4704.30 Anthraquinone,

(a) Substance for which reportingisrequired.The chemical substance forwhich reporting is required under thissection is 9,10-anthraquinone (ChemicalAbstract Service Registry Number 84—65-1).

(b) Persons who must report. Unlessexempt asprovided in 4 704.5. persons(other than small manufacturers andimporters) who manufacture or import9.1O.anthraquinone for commercialpurposes after July 20, 1987 are subjectto the reporting requirements of thissection. Persons may be required toreport more than once in response tothis section.

(c) Whentorepoit Persons describedin paragraph (bJ of this section mustsubmit a report within 60 days of thecompletion of every corporate fiscalyear during which they manufactured orimported 9.10-anthraquinone after July20, 1987. Persona must submit a separatereport for each corporate fiscal year inwhich they are subject to this section.

(d) Whatinformationto report.Allpersons subject to this section shallreport the following information to EPA.

(1) Company name and headquartersaddress.

(2)Name, address, and telephonenumber (including area code) of thecompany’s principal technical contact,

(3) The quantity (In pounds) of 9,10-anthraquinonemanufactured orimported during the person’s latestcomplete corporate fiscal year.

(e) Whereto sendreports.Reportsmust be submitted by certified mail tothe Document Control Office,Environmental Protection Agency. TS—790,401 M St., SW., Washington, DC20460. Attn: TSCA 8(a).

PART 795—CAUENDEDI

2.Part 795 is amended as follows:a. The authority citation for Part 796

continues to read as follows:Authority 15U.s.c260s, 2811. 2825.

b. By adding a new Subpart Bconsisting at this timeof 4 795.45 to readas follows:

Subpart 0—Provisional Chemical FateGuidelines

4195.45 Inherent biodegradablfltyModified SCAS test tsr chemicalsubstances that are water insoluble orwater Insoluble and volatile.

(a) Introductoryinforrnation—(1)Prerequisites.(i} Water solubility of thetest chemical must be established.

(ii) The organic carbon content of thetest chemical must be established.,

(2) Guidanceinformation,(i)Information on the relative proportionsof the major components of the testchemical will be useful in interpretingthe results obtained.

(ii) Information on the toxicity of thechemical may be useful to theinterpretation of low results and in theselection of appropriate testconcentrations.

(33 Standarddocuments.ThisTestGuideline has been based on the paperscited under paragraph (d) (1) and (2) ofthis section.

(bJ Method—(1)Introduction,purpose.scope,relevance,applicationandlimitsoftest—(i)Themethod.(A) The methodis an adaptation of the Soap andDetergent Association Semi-ContinuousActivated Sludge (SCAS) procedure forassessing the primary biodegradation ofalkylbenzene sulphonate. The methodinvolves exposure of the chemical torelatively highconcentrations ofmicroorganisms over a long time period(possibly several months). The viabilityof the microorganisms is maintainedover this period by daily addition of asettled sewage Feed,

(B) Since the conditions provided bythe test are highly favorable to theselection and/or adaptation ofmicroorganisms capable of degradingthe test chemicaL the procedure mayalso be used to produce microbialinocula adapted to selected chemicalsfor use in other tests. The test isapplicable to organic chemicals that arewater insoluble or water insoluble andvolatile and that are not inhibitory tobacteria at the test concentration,

(ii) Referencechemicals.In somecases when investigating a newchemical, reference chemicals may beuseful; however, specific referencechemicals cannot yet be recommended.Data on several chemicals used ininterlaboratory tests are provided (seeTable 1 in this paragraph) primarily sothat calibration of the method may beperformed from time to time and topermit comparison of results whenanother method is employed.

Federal Register / Vol. 52, No. 107 1 Thursday, June 4, 1987 / Rules and Regulations 21027

TABLE 1.—ExAMPLEs OF REsulTs OFSCAS TEST 014 VARIOUS CisEMI-CALS UsED IN THE OECD/EEC tN-TERLABORATORY TEST

Test chemicalO~.

(mg/H

O~-O~(mg/

U

Por.centagebiodeg-rada~ban

bioe~m.mation

14-Acetylaminoben-zone sulphonate_.

Tetrapropy$eneben-zone sulphonate....

4.Nitjophenol .

Diethytene gtycoL....Aniline ~

Cyctopentarietevacarboxytate.._

172

17.316.916.51&9

17$

2.0

~.40.8021.7

3.2

85

51.495.39~.805.9

81.1

Duration of test is 40 days. except 120 daysfor cyclopentane tetracarboxylale.

(iii) Principleof thetestmethod.(A)Activated sludge from a sewagetreatment plant is placed In an aeration(SCAS) unit. The teat chemical andsettled domestic sewage are added, andthe mixture is aerated for 23 hours. Theaeration is then stopped. the sludge isallowed to settle, and the supernatantliquor is removed. The sludge remainingin the aeration chamber is then mixedwith a further aliquot of test chemicaland sewage and the cycle is repeated.

(B) This method requires use of achemical-specific analytical techniqueor HC_labeled test chemical Thepurpose of the method is to determinethe fate of the test chemical in aconventional activated sludge treatmentplant. To this end, a complete massbalance for the test chemical isestablished by quantifying parentchemical in settled effluent sludge solids(insoluble test chemicals whethervolatile or not), effluent plus solids(insoluble test chemicals whethervolatile or not), and off gases (volatiletest chemicals only). The identificationand quantification of degradationproducts in all phases arerecommended, but not required.

(iv) Quality criterio.—(.A)Reproducibility.When primarybiodegradation is considered. veryprecise data are obtained for chemicalsthat are extensively degraded. Theresults reported in the reference underparagraph (d)(1) of this section suggest95-percent confidence limits of less than±3percent. and this includesinterlaboratory tests. As would beexpected, wider confidence limits areobtained for less biodegradablechemicals.

(B) Possibilityofstandardization.Since the method uses a feed of settledsewage, absolute standardization is notpossible unless this feed were replacedby synthetic sewage. However, since themethod is designed to give an indicationof the biodegradability potential of achemical and is not a simulation testsuch standardization is unnecessary.

(C) Possibilityof automation.Automation of this method would bepossible but would be expensive. As themethod i8 not labor intensive, theexercise would offer few advantages.

(2) Descriptionofthetestprocedure—(i) Preparations.(A) The aeration unitsare cleaned and fixed in a suitablesupport. The air inlet tubes areconnected to the supply manifold. Asmall laboratory-scale air compressor isused to aerate the units, and the air ispresaturated with water to reduceevaporation losses from the units.

(B) If the test chemical is volatile,exhaust gases from the aeration unitsshall be passed through a suitable trap(such as Amberlite XAD—4, Rohxn andHaas, Phila., PA) to remove volatilizedorganics.

(C) A sample of mixed liquor from anactivated sludge plant treatingpredominantly domestic sewage isobtained. Approximately 150 milliliters(ml) of the mixed liquor are required foreach aeration unit.

(D) The organic carbon analyzer iscalibrated using potassium hydrogenphthalate.

(E) Stock solutions of the testchemicals are prepared: Theconcentration normally required is 400milligrams per liter (mg/li) as organiccarbon which gives a test chemicalconcentration of 20 mg/li carbon at thestart of each aeration cycle if nobiodegradation is occurring.

(F) if the test chemical is insoluble inwater at 400 mg/li it may be necessaryto use ultrasound dispersion to obtain auniform stable suspension.Alternatively, test chemical may beadded directly to the aeration units.

(G)The organic carbon content of thestock solutions is measured.

(ii) Testconditions. A highconcentration of aerobicmicroorganisms is used, and theeffective detention period is 38 hours.The carbonaceous material in thesewage feed is oxidized extensivelywithin B hours of the start of eachaeration cycle. Thereafter, the sludgerespires endogenously for the remainderof the aeration period, during which timethe only available substrate is the testchemical unless this is also readilymetabolized. These features, combinedwith daily reinoculation of the test when

domestic sewage is used as the medium.provide highly favorable conditions forboth adaptation and biodegradation.

(iii) Performanceofthe test. (A) Asample of mixed liquor from a suitableactivated sludge plant is obtained andaerated during transportation to thelaboratory. Each aeration unit is filledwith 150 ml of mixed liquor, and theaeration is started. After 23 hours,aeration is stopped, and the sludge isallowed to settle for 45 minutes. The tapis opened, and 100 ml of the supernatantliquor is withdrawn. A sample of settleddomestic sewage is obtainedimmediately before use, and 100 ml areadded to the sludge remaining in eachaeration unit. Aeration is 8tarted anew.At thisstage no test chemicals areadded, and the units are fed daily withdomestic sewage only until a clearsupernatant liquor is obtained onsettling. This usually takes up to 2weeks, by which time the dissolvedorganic carbon in thesupernatant liquorat the end of each aeration cycle shouldbe less than 12 rng/L

(B) At the end of this period theindividual settled sludges are mixed,and 50 ml of the resulting compositesludge are added to each unt.

(C) One hundred nil of settled sewageare added to the control units, and 95 mlof settled sewage plus 5 ml of theappropriate test chemical stock solutionor suspension (400 mg organic carbon/L)to the test units. If test chemical isadded directly to aeration units, 100 mlof settled sewage is added, as in thecontrol units.

(D) Aeration is started again andcontinued for 23 hours. The sludge isthen allowed to settle for 45 minutes andthe supernatant drained off andanalyzed for parent chemical. Beforeanalysis the Liquors are filtered throughwashed 0.45-micrometer membranefilters and certifuged. Temperature ofthe sample must not exceed 40 ‘C whileit is in the centrifuge.

(E) If the test chemical is insoluble orexpected to sorb significantly to sludgesolids, settled sludge is alsocollected byan appropriate means (suchascentrifugation) and extracted to removetest chemical, and the extract isanalyzed for parent chemical.

(F) If the test chemical is volatile,traps for removing volatile organics fromexhaust gases are also extracted and theextracts analyzed for parent chemical.

(G) The fill and draw procedure underparagraph (b)(2)(iii) (C) through (F) ofthis section is repeated daily throughoutthe test.

(H) Before settling, it may benecessary to clean the walls of the unitsto prevent the accumulation of solids

21028 Federal Register I Vol. 52. No. 107 / Thursday, June 4, 1987 / Rules and Regulations

above the level of the liquid. A separatescraper or brush is used for each unit toprevent cross contamination.

(I) The length of the test for chemicalsshowing little or no biodegradation isindeterminate, but experience suggeststhat this should be at least 12 weeks.

(c) Dataandreporting—(1) Treatmentof the results. (i) The concentration ofparent chemical in settled effluentsludge solids (insoluble test chemicalswhether volatile or not), effluent plussolids (insoluble test chemicals whethervolatile ornot), and off-gases (volatiletest chemicals only) is plotted versustime for the test units. Asbiodegradation is achieved the level ofthe test chemical will decrease andapproach a steady state. Once the levelsof the test chemical are found to beconstant over three consecutivemeasurements, three furthermeasurements are made.

(ii) An example of the application ofspecific analytical technique to theSCAS test is discussed in the referencein paragraph (d)(2) of this section.

(d) Ljtemture references.Foradditional background information onthis test guideline the followingreferences should be consulted:

(1) “A Procedure and Standards forthe Determination of theBiodegradability of Alkyl BenzeneSulphonate and Linear AlkylateSuiphonate”, Journal of the AmericanChemicalSociety,42:986,1965.

(2) Games, LM., King, J.E.. andLarson, R.J. “Fate and distribution of aquaternary ammonium surfactantoctadecyltrimethylammonium chloride(OTAC), in wastewater treatment.”EnvironmentalScienceandTechnology.16:483-488, 1982.(Information collection requirements areapproved by the Office of Management andBudget under control number 2070-0067.)

PART 799—(AMENDEDj

3. Part 799 is amended as follows:a. The authority citation for Part 799

continues to read as follows:Authority~15 U.S.C~2803, 2811. 2625~b. By adding f 799.500, to read as

follows;* 799.500 AnthraqulnonL

(a) Identification of test substance. (1)9,10-anthraquinone (CAS No. 84—65--i)(hereinafter “anthraquinone”) shall betested in accordance with this section.

(2) Anthraquinone of at least 99percent purity shall be used as the testsubstance.

(b) Persons required to submit studyplans, conduct tests, and submit data.All persons who manufacture, import orprocess anthraquinone, other than as an

impurity, from July 20, 1987 to the end ofthe reimbursement period shall submitletters of intent to conduct testing orexemption applications, submit studyplans. conduct tests (in accordance withPart 792 of this chapter), and submitdata as specified in this section, SubpartA of this Part, and Part 790 of thischapter for single-phase rulemaking.

(c) First tier chemicalfate andenvironmental effects testing—(i)Water solubility—(i) Required testing.Water solubility tests shall beconducted with anthraquinone inaccordance with the test guidelinespecified under ~796.1860 of thischapter. The tests shall be conducted at12 ‘C and 22 ‘C for use in tests with coldand warm waterspecies.

(ii) Reportingrequirements.(A) Thewater solubility tests shall be completedand the final results submitted to theAgency within 1 year of the effectivedate of the final rule.

(B) A progress report shall besubmitted 6 months after the effectivedate of the final rule.

(2) Fish acute toxicity—(i) Requiredtesting. (A) Fish acute toxicity tests shallbe conducted with anthraquinone usingchinook salmon, Oncorhynchustshawytscha. or coho salmon.Oncorhynchus kisutch (cold waterspecies); bluegill, Lepomis macrochirus(warm water species); and rainbowtrout. So/mo gairdneri (cold waterspecies) in accordance with the testguideline specified under 1 797.1400 ofthis chapter, except for paragraph(c)(4)(i) of § 797.1400.

(B) For the purposes of this section,the following provisions also apply:

(1) A minimum of 20 fish each shall beexposed to each of five or more testsubstance concentrations. The highestconcentration shall be less than or equalto the solubility limit of anthraquinone.At least one concentration shall bebetween I part per billion (ppb) and 10ppb.

(2)The total and dissolved (e.g..filtered) concentrations of the testsubstance shall be measured in eachtest chamber and the delivery chamberbefore the test to ascertain whether it isin solution.

(3) The test shall be performed underflowthrough conditions.

(ii) Reporting requirements. (A) Thefish acute toxicity tests shall becompleted and the final resultssubmitted to the Agency within 1 year ofthe effective date of the final rule.

(B) A progress report shall besubmitted 8 months after the effectivedate of the final rule.

(3) Aquatic invertebrate acutetoxicity—(i) Required testing. (A)Aquatic invertebrate acute toxicity tests

shall be conducted with anthraquinoneusing Daphnia magna or D. pulex andoyster, Crassostrea vfrginica. using thetest guidelines specified underH 797.1300 and 797.1800 of this chapter.except for paragraph (c)(4)(ii) of§ 797.1300.

(B) For the purpose of this section as itrelates to § 797.1300 of this chapter. thefollowing provisions also apply:

(1) A minimum of 20 daphnids perconcentration shall be exposed to five ormore concentrations of the testsubstance chosen in a geometric seriesin which the ratio is between 1.5 and 2.0(e.g., 2, 4, 8, 16, 32, and 64 milligrams perliter (mg/L)). The highest concentrationshall be less than or equal to thesolubility limit of anthraquinone. Atleast one concentration shall bebetween 1 ppb and 10 ppb. An equalnumber of daphnids shall be placed intwo or more replicates. If solvents,solubilizing agents or emulsifiers have tobe used, they shall be commonly usedcarriers and shall not possess asynergistic or antagonistic effect on thetoxicity of the test chemical. Theconcentration of solvent shall notexceed 0.1 milliliter per liter (ml/l}

(2) The test shall be performed underflowthrough conditions.

(3) The total and dissolved (e.g.filtered) concentrations of the testsubstance shall be measured in eachtest chambei. and the delivery chamberbefore the test to ascertain whether it isin solution,

(4) The stability of the stock solutionfor the duration of the experiment mustbe analyzed and reported.

(5) The pH of the test solution shall be7.

(C) For the purpose of this section asit relates to * 797.1800 of this chapter thefollowing provisions also apply:

(I) The highest test concentrationshall be less than or equal to thesolubility limit of anthraquinone.

(2) At least one test concentrationshall be between 1 ppb and 10 ppb.

(3) The total and dissolved (e.g.,filtered) concentrations of the testsubstance shall be measured in eachtest chamber and the delivery chamberbefore the test to ascertain whether it isin solution.

(ii) Reporting requirements. (A) Theinvertebrate acute toxicity tests shall becompleted and the final resultssubmitted to the Agency within 1 year ofthe effective date of the final rule.

(B) A progress report shall besubmitted 8 months after the effectivedate of the final rule.

(4)Sediment toxicity to benthicinvertebrates—(i) Required testing. Asediment toxicity test shall be

Federal Register I Vol. 52, No. 107 / Thursday, June 4, 1987 I Rules and Regulations 21029

conducted using one of the followingtwo methods. (A) Rhepoxynius partiallife cycle toxicity in sediment: A 10-daytoxicity test in a static seawater systemshall be conducted with the marineamphipod. Rhepoxynius obronius. usingclean sediments having low, medium.and high organic~carboncontent spikedwith anthraquinone in theconcentrationrange of 0.01 to I part per million (ppm),according to the test guideline specifiedin the American Society for Testing andMaterials Special Technical TestingPublication 854 (ASTM STP 854)entitled. “Phoxocephalid AinphipodBioassay for Marine Sediment Toxicity.”by R.C. Swartz, W.A. DeBen, J.K.P.Jones. J.O. Lamberson, and F.A. Coleand published in Aquatic Toxicologyand Hazard Assessment. SeventhSymposium, ASTM STP 854, pp. 284-307,R.D. Caldwell, R. Purdy, and R.C.Bahner, Eds., 1985, which isincorporated by reference. (B)Chironomus partial lifecycle toxicity insediment: A 14-day toxicity test in aflowthrough system shall be conductedwith the freshwater midge, Chirononuistentans, using clean, natural sedimentshaving low, medium, and high organiccarbon content spiked withanthraquinone in the concentrationrange of 0.01 to I ppm, according to thetest guideline specified in the AmericanSociety for Testing and MaterialsSpecial Technical Testing Publication854 (ASTM STP 854) entitled, “AquaticSafety Assessments of ChemicalsSorbed to Sediments,” by W.J. Adams,R.A. Kimerle, and R.G. Mosher andpublished in Aquatic Toxicology andHazard AssessmenL’ SeventhSymposium, ASTM STP 854. pp. 429-452,LD. Caldwell, R. Purdy, and R.C.Bakner, Eds., 1985, which isincorporated by reference. The ASTMSTP 854 is available for inspection at theOffice of the Federal Register, Rin. 8401.1100 L St., NW., Washington. D.C. Thisincorporation by reference wasapproved by the Director of theOffice ofthe Federal Register in accordance with5 U.S.C. 552(a) and I CFR Part 51. Thismaterial is incorporated as It exists onthe effective date of this rule, and anotice of any change in this material willbe published in the Federal Register.Copies of the incorporated material maybe obtained from the Document ControlOfficer (TS-793). Office of ToxicSubstances, EPA, Rm. 107,401 M St.,SW., Washington, DC 20460. and fromthe American Society for Testing andMaterials (ASTM). 1916 Race SLPhiladelphia, PA 19103.

(ii) Reporting requirements. (A) Thesediment toxicity test shall becompleted and the final results

submitted to the Agency within 2 yearsof the effective date of the final rule.

(B) Progress reports shall be submittedat 6-month intervals beginning B monthsafter the effective date of the final rule.

(5) Bioconcentrotion..—(i)Requiredtesting. (A) A bioconcentration test shallbe conducted with anthraquinone usingoyster, Crassostreci vii~inica,inaccordance with the test guidelinespecified under * 797.1830 of thischapter. except for paragraph (c)(4) (ii)and (vi)(A) of § 797.1830.

(B) For the purpose of this section thefollowing provisions also apply:

(1) At least two concentrations shallbe tested which are at least a factor of10 apart to assess the propensity of thesubstance to bioconcentrate. Theconcentrations selected should notstress or adversely affect the oystersand should be less than one-tenth theECSO determined in either the range-finding or 96-hour definitive test under§ 797.1800 of this chapter. The testconcentrations shall be less than thesolubility limit of the test substance inwater and shall be close to 1 ppb to 10ppb. The limiting factor of how low onecan test is based on the detection limitsof the analytical methods, Theconcentration of the test substance inthe test solution should be at least 10times greater than the detection limit inwater.

(2) The test shall not be started untilthe test substance delivery system hasbeen observed to be functioningproperly and the test substanceconcentrations have equilibrated (i.e.the concentration does not vary morethan 20 percent). Analyses of two sets oftest solution samples taken prior to testinitiation should document thisequilibrium. At initiation (time 0), thetotal and dissolved (e.g, filtered)concentrations of test substance shall bemeasured in the delivery chamber andeach test chamber prior to the additionof oysters to the test chambers toascertain whether it is in solution.

(ii) Reporting requirements.(A) Thebioconcentration test shall be completedand the final results submitted to theAgency within 18 months of the effectivedate of the final rule.

(B) Progress reports shall be submittedat 6-month intervals beginning 6 monthsafter the effective date of the final rule.

(d) Second-tier chemical fate andenvironmental effects testing. Thefollowing second-tier tests shall beconducted if EPA determines that thetotal annual volume of anthraquinonemanufactured and imported in theUnited States during a single calendaryear exceeds 3 million pounds. and theacute toxicity testing triggers described

in this paragraph are met. EPA willmonitor the production and importationvolume of anthraquinone by therequirement under § 704.30 of thischapter that manufacturers andimporters of anthraquinone submitsection 8(a) reports to the Agency. EPAwill publish notification in the FederalRegister or notify the test sponsors bycertified letter if the manufacture!importation volume trigger and an acutetoxicity trigger are met.

(1) Biodegradabilityin actlvated9ludgesystems—(i) Requiredtesting.(A) Biodegradability tests in activatedsludge systems shall be conducted withanthraquinone in accordance with thetest method entitled “Inherentbiodegradability: Modified SCAS (semi-continuous activated sludge) test forchemical substances that are waterinsoluble or water insoluble andvolatile” as specified under § 795.45 ofthis chapter except for paragraphs(b)(2)(i) (E), (F) and (iii)(c) of § 795.45, ifEPA determines that the production!importation volume of anthraquinone inthe United States during a singlecalendar year exceeds 3 million pounds,and any of the following conditions ismet: (A) The LC5O of the most sensitivefish or the ECSO of the daphnid oroyster. as determined by the acutetoxicity tests conducted in accordancewith paragraph (c) (2) or (3) of thissection, respectively, is less than 100times the predicted environmentalconcentration (PEC) in water, i.e., lessthan 500 ppb; (B) the LC5O ofRhepoxynius or Chironomus, asdetermined by the sediment toxicity testconducted in accordance withparagraph (c)(4) of this section, is lessthan 100 times the PEC in sediment, I.e.,less than 10 ppm; or (C) the oysterbioconcentration factor, as determinedby the oyster bioconcentration testconducted in accordance withparagraph (c)(5) of this section, isgreater than 3,000.

(B) For the purpose of this section thefollowing provisions also apply:

(I) A stock solution of C24-labeledanthraquinone shall be prepared at aconcentration of 2 rng/L which gives atest substance concentration of 0.1 mg/Lanthraquinone at the start of eachaeration cycle if no biodegradation isoccurring.

(2) If anthraquinone is insoluble inwater at 2 mg!L, it may be necessary touse ultrasound dispersion to obtain auniform stable suspension.Alternatively. C‘tlobeled anthraquinonemay be added directly to the aerationunits to give a concentration of 0.1 mg/Lanthraquinone at the start of eachaeration cycle.

21030 Federal Register / Vol. 52, No. 107 / Thursday, June 4, 1987 / Rules and Regulations.

(3) One hundred ml of settled sewageare added to the control units, and 95 mlof settled sewage plus 5 ml of the C’~-labeled anthraquinone stock solution orsuspension (2 mg anthraquinone/1) areadded to the test units. If test substanceis added directly to aeration units. 100ml of settled sewage are added, as in thecontrol units.

(ii) Reporting requirements.(A) Thebiodegradability tests in activatedsludge systems shall be completed andthe final results submitted to the Agencywithin 1 year of the date of EPA~snotification of the test sponsor bycertified letter or Federal Register noticeannouncing that the total annual volumeof anthraqwnone manufactured andimported in the United States during asingle calendar year exceeds 3 millionpounds and that one or more of thetriggers described in paragraph (d)(1)(i)of this section has been met

(B) A progress report shall besubmitted 6 months after EPA’snotification of the test sponsor bycertified letter or the publication of theFederal Register notice announcing thattesting is necessary.

(2) Biodegradation rote—fl) Requiredtesting. Biodegradation rate tests shallbe conducted with anthraquinone atToncentratons at or below the water

lubility as determined under thesting specified in paragraph (cJ(1)(i) of

,Iiis section, and close to the predictedenvironmental concentration insediment, i.e., 0.1 ppm, in accordancewith the test guideline described in thearticle by A.W. Bourquin et al. entitled“An Artificial Microbial EcosystemforDetermining Effects and Fate ofToxicants in a Salt-MarshEnvironment.” if EPA determines thatthe production/importation volume ofanthraquinone in the United Statesduring a single calendar year exceeds 3million pounds. and any of the followingconditions is met: (A) the LC5O of themost sensitive fish species or the EC5Ofor the daphnid or oyster, as determinedby the acute toxicity tests conducted inaccordance with paragraphs (c) (2) and(3) of this section respectively, is lessthan 100 times the predictedenvironmental concentration (PEC) inwater, i.e., less than 500 ppb; (b) theLC5O of Rhepoxynius or Chironomua, asdetermined by the sediment toxicity testconducted in accordance withparagraph (c)(4) of this section. is lessthan 100 times the PEC in sediment, i.e.,less than 10 ppm; or (C) the oysterbioconcentration factor, as determined~‘ the oyster bioconcentration test

iicted in accordance with~graph(c)(5) of this section, is

greater than 3,000. The A.W. Bourquin et

al. article, entitled “An ArtificialMicrobial Ecosystem for DeterminingEffects and Fate of Toxicants in a Salt-Marsh Environment” published inDevelopments in IndustrialMicrobiology, Vol. 18. Chapter 11. 1977,I.. incorporated by reference and isavailable for inspection at the Office ofthe Federal Register. Rm. 8401, 1100 LSt.. NW., Washington. DC Thisincorporation by reference wasapproved by the Director of the Office ofthe Federal Register in accordance with5 U.S.C. 552~a)and 1 CFR Part 51. Thismaterial is incorporated as it exists onthe date of approval, and a notice of anychange in this material will be publishedin the Federal Register. Copies of theincorporated material may be obtainedfrom the Document Control Officer (TS-793), Office of Toxic Substances, EPA,Rm. NE-C004, 401 M St.. SW.,Washington. DC 20460. and from theSociety for Industrial Microbiology.P.0.8.12534, Arlington,, VA 22209-8534.

(ii) Reporting requirements. (A)Biodegradation rate tests shall becompleted and the final resultssubmitted to the Agency within 1 year ofthe date of EPA’s notification of the testsponsor by certified letter or a FederalRegister notice announcing that the totalannual volume of anthraquinonemanufactured and imported in theUnited States during a single calendaryear exceeds 3 million pounds and thatone or more of the triggers described inparagraph (d)(2)(i) of this section hasbeen met.

(B) A progress report shall besubmitted 6 months after EPA’snotification of the test sponsor bycertified letter or the publication of theFederal Register notice announcing thattesting is necessary.

(3) Fishchronic toxicuty—(i) Requiredtesting. (A) Fishchronic toxicity testsshall be conducted with anthraquinonein accordance with the test guidelinespecified under § 797.1600 of thischapter. except for paragraph (c)(6)(iv)of § 797.1600, if EPA determines that theproduction/importation volume ofanthraquinone in the United Statesduring a single calendar year exceeds 3million pounds. and if the most sensitivefish species (with the lowest medianlethal concentration (LC5O)) in the acutetoxicity tests conducted in accordancewith paragraph (c)(2) of this section hasan LCSO less than 100 times thepredicted environmental concentration(PEC) in water. I.e., less than 500 ppb.

(B) For the purpose of this section. thefollowing provisions also apply:

(1) Prior to the addition of the testsubstance to the dilution water, it isrecommended that the test substance

stock solution be analyzed to verify theconcentration. After addition of the testsubstance, the total and dissolved (e.g..filtered) concentrations of the testsubstance shall be measured at thebeginning of the test in each testchamber and delivery chamber toascertain whether it is in solution. Theconcentration of test substance shall bemeasured in one replicate at each testconcentration at least once a weekthereafter. Replicates should bealternated each week. If a malfunctionin the delivery system is discovered,water samples shall be takenimmediately from the affected testchambers and analyzed.

(2)The highest concentration shall beless than or equal to the solubility limitof anthraquinone.

(3)At least one test concentrationshall be between 1 ppb and 10 ppb.

(ii) Reporting requirements.(A) Fishchronic toxicity tests shall be completedand the final results submitted to theAgency within 2 years of the date ofEPA’s notification of the test sponsorbycertified letter or a Federal Registernotice announcing that the total annual,volume of anthraquinone manufacturedand imported in the United States duringa single calendar year exceeds 3 millionpounds and that the trigger described inparagraph (d){3)(i)(A) of this section hasbeen met.

(B) Progress reports shall be submittedat 8-month intervals beginning B monthsafter EPA’s notificationof the testsponsor by certified Letter or thepublication of the Federal Registernotice announcing that testing isnecessary.

(4) Daphnidchronic toxicity—(i)Required testing. (A) Daphnid chronictoxicity test shall be conducted withanthraquinone using Daphnia magna orD. pulex in accordance with the testguideline specified under § 797.1330 ofthis chapter. except for paragraph(c)(4)(ii) of § 797.1330, if EPA determinesthat the total annual volume ofanthraquinone manufactured andimported in the United States during asingle calendar year exceeds 3 millionpounds, and the median effectiveconcentration (EC5O) determined inaccordance with paragraph (c)(3) of thissection is less than 100 times the PEC inwater, is., less than 500 ppb.

(B) For the purposes of this section.the following provisions also apply

(7) A minimum of 20 daphnida perconcentration shall be exposed to five ormore concentrations of the substancechosen in a geometric series in whichthe ratio is between 1.5 and 2.0. (e.g., 2.4,8.16,32,64 mg/U. An equal numoerof daphnida shall be placed in two or

Federal Register I Vol. 52, No. 107 I Thursday, June 4, 1987 / Rules and Regulations 2103

more replicates. The highestconcentration shall be less than or equalto the solubility of anthraquinone. Atleast one concentration shall bebetween I ppb and 10 ppb. Solutionsshall be analyzed for chemicalconcentration prior to use and atdesignated times during the test.

(2) The pH of the test solution shall be7.

(3)The total and dissolved (e.g..filtered) concentrations of testsubstance shall be measured in eachtest chamber and the delivery chamberbefore the test to ascertain whether It isin solution.

(4) The test shall be performed underflowthrough conditions;

(5) The stability of the stock solutionfor theduration of the experiment mustbe analyzed and reported.

(ii) Reporting requirements. (A) Thedaphnid chronic toxicity test shall becompleted and the final resultssubmitted to the Agency within 2 yearsof the date of EPA’s notification of thetest sponsor by certified letter or aFederal Register notice announcing thatthe total annual volume ofanthraquinone manufactured andimported in the United States during asingle calendar year exceeds 3 millionpounds and that the trigger described inparagraph (d)(4)(i) of this section hasbeen met.

(B) Progress reports shall be submittedat 6-month intervals beginnIng 6 monthsafter EPA’s notification of the testsponsor by certified letter or thepublication of theFederal Registernotice announcing that the testing isnecessary.

(d) Effectivedate.The effective dateof this final rule foranthraquinone isJuly 20. 1987.(Information collection requirements havebeen approved by the Office ofManagementand Budget under control number 2070-0033.)

IFR Doc. 87-12724 Filed64-87; 8.45 am]coos ~

GENERAL SERVICES

ADMINISTRATION

41 CFRPart101-40

LFPMR AmdL 041

Transportation andTrafficManagement

AGENCY: Federal Supply Service, GSA.ACT*ON: Final rule.

Amendment G—79 (51 FR 24329, July 3.1986), by updating and correcting certainreferences to the Code of FederalRegulations (CFRJ. and by revising thelist of GSA regional offices to reflectrecent GSA organizational changes. Inaddition, this amendment announces therevision of GSA Form 3080. Thisamendment is necessary to provideclearer guidance to civilian executiveagencies about transportation andtraffic management requirements.IFflCT1VE DATE June 4,1987.POR FURTHER IN~ORMAT1ONCONTACTJoseph M. Napoli, Regulations andPolicy Division, FTS 557—1256 orcommercial 703—557—1256.$UPPLEUENTARYINFORMATION: Section201(a) of the Federal Property andAdministrative Services Act of 1949. asamended (40 U.S.C. 481(a)), detailsGSA’. transportation and trafficmanagement responsibilities whichinclude: (a) Prescribing policies andmethods of procurement and supply ofpersonal property and nonpersonalservices, including related functionssuch as transportation and trafficmanagement; (b) representing executiveagencies in negotiations with carriers orother public utilities before Federal andState regulatory bodies; and (c)providing traffic management servicesto any Federal agency upon its request.GSA I. responsible. among other things,forproviding traffic managementguidance to civilian executive agencies.

FPMR Amendment G-79, effectiveJuly 3, 1986, was issued to clarify, revise,and update various policies andprocedures in the area of transportationand traffic management. Since then,GSA has determined that certainadministrative changes in 41 CFR Part101-40 are necessary to correct severaleditorial flaws, to update the listing ofGSA regional offices reorganized aszone office., and to addres. the newGSA Form 3080 which was revised Inboth title and content to make the formmore compatible with the CentralizedHousehold Goods TrafficManagementProgram (41 CFR Subpart 101-40.2).

GSA has determined that this rule isnot a major rule for the purposes ofExecutive Order 12291 of February 17,1981, because it is not likely to result inan annual effect on the economy of $100million ormore; a major Increase Incosts to consumersor others; orsignificant adverse effects. GSA hasbased all administrative decisionsunderlying this rule on adequateInformation concerning the need for, andthe consequences of, this rule; hasdetermined that the potential benefits tosociety from this rule outweigh thepotential costs and has maximized the

net benefits; and has chosen thealternative approach involving the leastnet cost to society.

List of Subjects in 41 CFR Part 101-30

Freight, Government propertymanagement, Moving of householdgoods. Office relocation, Transportation

For the reasons set forth in thepreamble, 41 CFR Part 101-40 isamended as follows:

PART 101-40-—TRANSPORTATIONAND TRAFFIC MANAGEMENT

1. The authority citation for Part 101—40 continues to read as follows:

Authority: Sec. 205(c), 63 Stat. 39090U.S.C. 486(c)).

‘2. Section 101-40.000 is revised to readas follows:* 101-40.000 Scope of part.

This part prescribes regulations thatapply to the freight and household goodstransportation and traffic managementactivities of executive agencies,including any wholly ownedGovernment corporation. Except forprovisions to debar orsuspend carriersIn accordance with Subpart 9.4 of theFederal Acquisition Regulation (48 CFRSubpart 9.4). this part does not apply tothe Department of Defense orany otherexecutive agency exempted from theseregulations pursuant to the FederalProperty and Administrative ServicesAct of 1949, as amended. It also coversarrangements for transportation andrelated services by bill of lading typecommitments. These regulations aredesigned to ensure that alltransportation and traffic managementactivities will be carried out in a manner(or method) most advantageous to theGovernment in terms of service,economy, and efficiency.

3. Section 101-40.001 is revised to readas follows:

* 101-40.001 DefInitIons.‘~GSACentral Office” means the

General Services Administration.Federal Supply Service, Office ofCustomer Support Management. Traveland Transportation ManagementDivision. Washington, DC 20406.

“GSA regional office” means the GSATraffic and Travel Services ZoneOffice(s), Federal Supply ServiceBureau, specified in § 101—40.101—1(a).

Subpart 101-40.1—General Provisions

4. Section 101-40.101—1 is revised toread as follows:

SUMMARY: The General ServicesAdministration (GSA) amends 41 CFRPart 101-40 by correcting certain minortechnical errors found in FPMR