44830 .Federal.Register' f Vol. 52. NO'.224 I Friday, November 20. 1987 I. Notices"

ENVIRONMENTAL PROTECTIONAGENCY

(OPTS-4t~ FRL-3292-3}

Twenty-First. Report of theInteragency Testing Committee to theAdministrator; Receipt of Report andRequest for Comments RegardingPriority. LIst.of Chemicals

AGENCY:Env~onmental Pro-tectiOR.Agency (EPA)i.. .ACTION:Notft:e-.

SUMMARY:The: Interagency TestingCommittee (ITC). established undersection 4(et of the Toxic SubstancesControl Act (TSCA). transmitted itsTwenty-First Report to theAdministrator of EPA on Octaber 30.1987. This report. which revises andupdates the Committee's priority' list ofchemicals. adds six chemicals to the list

. for priority consideratian by EPA in thepromulgation of test rules under section4(a) of the Act. The new chemicals areAcid Blue .40.Acid form of Acid Blue 40.Acid Blue 45. Acid form af Acid Blue 45.Disperse Blue 56 and Disperse Red 60.These chemicals are not designated for .response within 12 manths. The Twenty-,First Report is Included in this notice.The Agency invites interested personsto submit written comments on theReport. and to-attend a Focus meeting tohelp narrow and focus the issues raisedby the lTC's recommendations.Members af the public arc also invitedto inform EPA if they wish to be notifiedaf subsequent public meetings on thesechemicals. ITC also notes the removal ofthree chemicals from the priority listbecause EPA has responded to the lTC's .previous recommendatians for testing afthe chemicals. . .

DATES:Written comments should besubmitted by December 21. 1981. AFocus Meeting.on the six new. chemicals .will be held an December 15. 1987;ADDRESS: Send written submissions to:TSCA Public Information Office (TS-793). Office of Pesticides and Toxic'. .Substances. Environmental ProtectiQn'Agency. Rm. NE G-004. 401 M St.. SW..Washington. DC Z0460.

Submissions should bear thedocument control number {OPTS-41028).

The public .record' supporting' thi!'action. incl,uding comments. is available,for public Inspection. in Rm. NE G-004 atthe address nated above from 8 a.m. to'4p.m.. Monday thraugh Friday. except-legal holidays. The Focus Meutlng will.be held at EPA Headquarters, Rm. 1()3::NE Mall. 401 M St.. SW.. Wa'shington.DC. P.eFsonspl~nning.to-attend. the

Register adding the substances'recommended in the ITC's Twent~First ..Report to the TSCA'seclion 8(d) Healthand Safety Data Reporting Rufe-(40 CFRFar' 716}.The section 8(d) rute'requiresthe reporting of unpublished health andsafety studies on the listed chemicals.These chemicals will also be 'added te)the TSCA section 8(a).PreliminlUY .Assessment Infarmation Rule (40 CFRPart 712~published elsewhere- m thiS' -issue. The section 8(a} rule' requires. thereporting of productian votume. use. .exposure. and release infarmation anthe listed chemicals.

A Focus Meeting will be held todiscuss relevant issues pertaining tothese chemicals and to narrow the rangeof issues/effects which will-be the focus

I. Background of the Agency's subsequent a'ctivities "in .

TSCA (Pub.L.94-469'.90Stat. Z003et responding to the ITCrecommendations. '

seq;:15 V.S.C.Z601et seq.) authorizes The Focus Meeting will be held onthe Administrator of EPAto promulgate .December 15.1987at 1 p.m. at EPAregulations under section 4(0')requiring Headquarters. Rm.'103NE~all. 401M .testing of chemical.substances,and . . St.. SW.. Washington. DC. This meeting'mixtures in order to develop data . is.inte,nded.tosupplement and expand. .relevant to determiningthe risks that upon.written comments submitted in .such chemical substances and mixtures respanse to this,natice.ma~ present to health and.the' '",' . Persons ~ishing'to attend this meetingenvlro!,ment.. . ' . or subsequent meetings on these '

Sechon 4(e) of1SCA established an chemicals should call the'TSCA' 'Interagency T~sting'Committ~e .to make,' Assistance Office at Uie'telephonerecommendaho~s to the Admmlstrator' number listed above at least one weekof EPA on chemical substances and i ad ."

I t t b . " n vance.m x ures 0 e given priority .. .consideration in proposing test rules A.'Iwrl.tte.ns~bmlsslons.s~ouldbeurunder section 4(a).Section 4(e)directs the Idenhfymgdocket num~er (OPT5-the Committee to revise its list of 410Z8).recommendations at least every 6 III. Status of List'months as necessary. The ITCmay I dd

"dd

' h.

"designate"up to 50 S b t d

n a Ihon to a mg t e SIXu s ances an ' d t. t h .i I. h

mixtures at anyone time for priority rec~mme~ a la?s 0 t e prIOrty 1st.t e .cansideration by the Agency.For such ITCs T~enty'-Flrst Rc~ortnates the .designations. the Agency must within 12 '7moval of thre~ chemicals fromthe hst.months either initiate rulemakingor smce.the last I1C repqrt,because EPAissue in the Federal Register its reasons has.respondr-d to the Committee's prior

,for.nQtdoingso. The ITC'sTwenty-First recommendations far testing of theReport was received by the chemicals. Subsequent to ITC'sAdministrator on October 30.1987.and preparation of its Twentieth Report.follows this Notice.The Report adds six EPAresponded to the ITC's

. substances to the TSCAsection 4(e), recommendations for three additionalpriority list. chemicals.The three chemicals removed. . and the dates af publication in theII. ~rltten a~d Oral.Commentsand-. ' Federal Register af EPA's responses toPublic MeetlOgs h r't e ITC lor these chemicals are:

Cyclohexane. May Zo.1987 (5ZFR19096): Z.6-0di.tert-butylphenol. Jurte 25.1987 (5Z'FR Z3862);and 3.4-dichlorobenzotrifluoride. June 23. 1987(5Z'FR 23547). ' '

.The current list contains threedesignated sub!ltances.,one chemical'recommended with intent-to-designate.and lZ recommended substances.

Aulhorily: 1,5U.s.c. .2603. . .

Focus Meeting and/or seeking to.beinformed of subsequent public meetings .on these chemicals. shauld notify lbe.

'TSCA Assistance Office at the address:listed belo.w. To ensure seating'accommodations at the Focus Meeting..persons interested in attending areasked to notify EPA at least one weekahead of the scheduled date.FOR FURTHER INFORMATION CONTACT:

Edward A. Klein.Director,TSCAAssistance Office (1'5-799). Office ofToxic Substances. EnvironmentalProtection Agency. 401 M St" SW"Washington. DC 20460,'(ZOZ-554-1404J,SUPPLEMENTAR.YINFORMATION:EPAhasreceived the Report of the TSCAInteragency Testing'Committ~e to theAdministra tor.

. EPA invites interested persons tosubmit detailed comments on the ITC'sOEiwrecommendations. The Agency-is,interested In receiving informationconcerning additional or angaing health.and safety studies on the subject '

chemicals as well 'as informationrelating to,the human and environmental' .exposure to' these chemleals. A notice ispublished elsewhere in today:s Federal.

HeinOnline-- 52 Fed. Rea, 44830 1987

federal Register I Vol. 52, No. 224 I Friday, November 20, 1907 l Notices:.

44831

Dated: November 12. 1987.

J. Merenda,

Director. Existing Chemical AssessmentDivision, Office of Toxic Substances.

SummarySection 4 of the Toxic Substances

Control Act of 1976 (TSCA. Pub. L. 94-469) provides for the testing ofchemicals in commerce that may presentan unreasonable risk of injury to healthor the environment. It also provides forthe establishment of a Committee (ITC),composed of representatives from eightdesignated Federal agencies, torecommend chemical substances andmixtures (chemicals} to which theAdministrator of the U.S. EnvironmentalProtection Agency (EPA) should givepriority consideration for thepromulgation of testing rules.

Section 4(e)(1)(A) of TSCA directs- theCommittee to recommend to the EPAAdministrator chemicals to'which theAdministrator should give priorityconsideration for the promulgation oftesting rules pursuant to section 4(a).The Committee is required to designatethose chemicals, from among itsrecommendations. to which theAdministrator should respond within 12months by either' initiating a rulemakingproceeding under section 4(a) orpublishing the Administrator's reasonfor not initiating such a procl!Cding. Atleast every 6 months. the Committeemakes those revisions in the TSCAsection 4(e) Priority List that itdetennines to be necessary andtransmits them to the EPAAdministrator.

As a result of its deliberations, theCommittee is revising the TSCA section4(e) Priority List by. the addition or sixchemicals. .

The Priority List is divided into threeparts: Part A contains thoserecommended chemicals and groups.designated for priority considerationand response by the EPA Administrator

within 12months. Part B conta!ns . TSCAInteragency Testing Committee.chemicals and groups of chenllcalsrecommended with intent-to-deslgnate. Statutory Member Agencies and TheirThis category was established by the Representatives

Committee in its seventeenth report (50 Council on Environmental QualityFR 47603; November.19, 1985).to take Carroll Curtis, Membetadvantage of rules promulgahng . Department of Commerce .automatic reporting requirements for Patrick D. Cosslett Membernon-designated ITC recommendations Raimundo Prat, Alternateunder the section 8(a) Preliminary . Environmental Protection AgencyAssessment rule and the TSCAsection . John D.Walker, Memberand Vice8(d) Health and Safety Data Reporting Chairperson

.rule. Information received fol1o~in8" Laurence'S. Rosenstein. Alternate. recommendation with inte~t-to- . National Cancer Institute

designate may innuence the Committee Richard Adamson. Memberto either designate Of-not desi.8nate the ,. Elizabeth 1<.'Weisburger. Altematechemicals or groups of chemicals In 8". . N.ationallnstiiute of Environmentalsubsequent report to the A~niinistrator.. Health Scie'nces,PartCcontainschemicalsand groups<!f Jalpes 1<. Selkirk,Memberand. : : .'

chemicals that have been recommendedfor priority consideration by EPAwithout being designated for.responsewithin 12 months. The changes to thePriority List are presented. together withthe types of Lesting recommended, in thefollowingTable 1: .TABLE 1.-ADDITIONS TO THE SEC-

TION (e) PRIORITYLIST, NOVEMBER1987

Chemical/Group ~ Recommendedstudies

A. Designated for respons8'within'12 months:None.

B. Recommended wlY"

,ntent-to-Designate:None. .

C. Recommended Without Being Designatedlor Response With

r

' 12Months:Acid Blue 401 (CAS' Health Effects:

No. 6424-85-7). Genoto?,icity for eachAcid form of Acid of the six dyes.

Blue 402 (CAS Chemical. Fate~ None.No. 6247-34-3). . EcologicalEffects:

Acid Blue 453 (CAS . None.No. 2861-02-1).

Acid form of AcIdBlue 454 (CASNo. 128~6-9).

Disperse Blue 561(CAS No. 12217-79-7).

Disperse Red 60"(CAS No. 17418-58-5).

aA Index Names (9CI).12-Anthracenesulfonic acid. 4-[(4-

(acetytamino)phenyl)amino)-1-amino-9,tO-dihydro-9.10-dioxo-, monosodium salt.. 22-Anthracenesulfonic acid, 4-[(4-(acetylamino)phenyl)amino)-1-amino-9; to-dihydro-9.10-dioxo-

3 2.6-Anthracenedisulfonic acid, 4,8-dia-mino-9,t O-dihydro-1",5-dihydi'oxy-9,t ():'dioxo-,. .disodium salt.

4 2,6-Anthracenedisulfonicacid, 4,8.dia-mino-9,1 0-dihydro-1,5-dihydroxy.9,1 O-dioxo-

I 9,1a-Anthracenedione, t.5~iaminochloro-4,8-dihydroxy-

"9,10-~nthracenedione, t-amin0-4-hydroxy-2-phenoxy- .

ChairpersonNational Institute for-Occupational

Safety and HealthBryan D. Hardin, MemberRodger L. Tatken. Alternate

National Science FoundationRodger W. Baier. MemberJarvis L. Moyers, Alternate

Occupational Safety and HealthAdministra tion

Stephen Mallinger, Alternate'

Liaison Agencies and TheirRepresentatives

Consumer Product Safety CommissionLakshmi C. Mishra

Department of AgricultureRichard M. Parry, Jr..Elise A.B.Brown.

Department of Defense. VacantDepartment of The Interior. SarahGeroutd'1Food and DrugAdministration

Arnold BorsettiNational Library of Medicine

Vera HudsonNational ToxicologyProgram

Dorothy Canter

Committee StaffRobert H. Brink.Executive SecretaryNorma Williams, ITCCoordinator

. Support Staff

Alan Carplen-Office or the GeneralCounsel, EPA .

Notes

The Committee acknowledges and Isgra teful for the' assistance. and supportgiven the ITC by the staff of DynamacCorporation (technical supportcontractor) and personnel of the EPAOffice of Toxic Substances..

Chapter I-Introduction

1.1 Background. The TSCAInterageJ;lcy Testing Committee(Committee) was established undersection 4(e) of the Toxic SubstancesControl Act of 1976 (TSCA. Pub. L. 94-469). The specific mandate of the.Committee is to recommend to theAdministrator of the U.S. Environmenta).Protection Agency (EPA) chemicatsubstances' and mixtures. in commercethat should be giv~mpriorityconsideration for.the promulgationoftesting rules to detennlne their potentialhazard to human health B.nd/or theenvironment. TSCA specifies that theCommlttee's'recommendations shall be. .in t~e form. of the Priority List. which isto be publishe~ in the Federal Register.The Committee is directed. by section

I Appolnled on June 10. 19S7.

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.. -- ----....

44832 Federal Register I Vol. 52, No. 224 I Friday, November 20, 1987 I Notices, .

4(e)(1)(A) of the TSCA to designatethose.chemicals'on the Priority List fowhich the EPA Administrator shouldrespond within 12 months by eitherinitiating a rulemaking proceeding undersection 4(a) or publishing theAdministrator's reason for not initiatingsuch a proceeding. There is no statutorytime limit for EPA response regardingchemicals that ITC has recommendedbut not designated for response within12 months.

At least every 6 months, theCommittee makes those revisions in thesection 4(e) Priority List that itdetermines to be necessary andtransmits them to the EPAAdministra tor.

The Committee is composed ofrepresentatives from eight statt;ltorymember agencies and seven liaiso!1 .

agencies. The specific representativesand their affiliations are named in thefront of this report. The Committee's" ,chemical review procedures and priorityrecommendations are described inprevious reports (Refs. 1 through 5).

1.2 Committee's previous reports.Twenty previous reports to the EPAAdministrator have been issued,by theCommittee and published in the FederalRegister (Refs. 1 through 5). Ninety-sixentries (chemicalsaod groups of '

chemicals) were recommended forpriority consideration by the EPAAdministrator and designated fQr :"response within i2 months. In addition,eight chemicals and one grouJlof '

chemicals were recommendedwit~outbeing so designated. , " , '

1.3 Committee's activities during'this reporting period, Between April 18,1987 and October 15, 1987, the .Committee continued to review'chemicals from its fourth and fifth" .scoring exercises, and from nominationsby Member Agencies. Liaison Agenciesand State Agencies. The Committee alsobegan reviewing chemicals from itssixth scoring exercise, which wascompleted in January 1987. .

The Committee contacted chemicalmanufacturers and trade associations torequest information that would be of'value in its deliberations. Most of thosecontacted provided unpublishedinformation on current production.exposure. uses, and effects of chemicalsunder study by the Committee.

, Duringthis reporting period, the .Committee reviewed availableinformation on 56 chemicals. Six wereselected for addition to the section 4(e)Priority List, and thirty-one weredeferred indefinitely. The remainingchem\cals are still under study.

In.us twentieth report to the EPAAdministrator (Ref. 5, ITC. 1987), the

Committee placed ethylbenzt!ne (CASNo. 10Q-41-4) on the Priority List in the"Recommended with Intent-to-Designate" category. The Committeerecommended that ethylbenzene betested for acute toxicity to freshwateralgae and invertebrates and to saltwateralgae, invertebrates and fish.Subsequently, the Committee learnedthat ~cute toxicity. testing ofethylbenzene with freshwaterinvertebrates has recently beencompleted at the University ofWisconsin. The Committee also hasbeen'informed (Ref. 6, SOCMA, 1987).that a consortium of ethylbenzeneproducers, the Styrene and

. " Ethylbenzene Association, voluntarily, has sponsored studies on the other acute

toxicity tests recommended by the B Ch. I d G f,

h . h df d ' emlcasan roupsoCO~~I~tee.T e Committee as e erre Chemicals Recommendeda decIsion on'whether or not to .' withIntent-to-Designate:designateethylbenzenependinga 1.Ethylbenzene 1 May1987.

, review of the data developed during the C, Chemicalsand Groupsofabove studies. Chemicals Recommended

, ' ., . Without Being Designated1.4 The 7SCAsection 4(e)Priority fOr Response Within 12

List. Section4(e)(1)(B)of TSCA directs Months:the Committeeto:". · ,. make such . 1.Diisodecylphenylphosphite...Nov.1985,revisions in the [priority)list as it 2.C.t DisperseBlue79 Nov.1986.determines to be necessary and. · · 3. Methyl.ethylketoxime , Nov.1986."

h h Ad i . 4.N-[S-[bls[2- May1987.transmit t em to t e m mstratQr (acetyloxy)ethyl]amino]-2- '

togethe~with the Committee's reasons [(2-brom0-4.6-for the revisions." Under this authority, dinitropheriyl)azo]-4-methoxytJie:'Committeeis revising the Priority . ph8f'!yI]-acetamide.List by adding six chemicals: Acid Blue 5.N-[S-[bis[2-40 and its related acid form,Acid Blue (acetyloxy)ethyl]amlno]-2-

45 and its rela,tedacid form,Disperse . f~;:::~e"r:~azo]-4.Blue~6and Disperse Red60.Three l1I,ethoxyphenyl]-acetamide,'chemicals are being removed from the 6.N-[5..[bi~[2- ' IMay1987.Priority List at this time. Cyclohexane (acetyloxy)ethyl]amino]-2.(CASNo.110-28-7)and 2,6-di-tert- [(2-chloro-4.6-,butylphenol(CASNo.128-3~2) were dinitrophenyl)az~]-4-ethoxysubjects of Notices of Proposed ph~nyl].acetamlde,R I k' (52 FR 19096' M 20 1987 7, ACidBlue40 :

1

Nov. 1987.Udema 109 . , ay, 8, 2.Anthracenesulfonic acid, Nov.1987.

. an 52 FR 23862;June 25, 1987. 4-£(4-respectively) and 3,4- (acetylamino)phenyl)amino]-.dichlorobenzotrifluoride (CAS No. 328- ,1-amino-9,10-dihydro-9,10-84-7) which was the subject of a Testing diox~.Consent Order (52 FR 23547; June 23, 9, Acl~ E!lue4S :

1

Nov.1987.

1987) . ' 10, 2,6-Anthracel\9dlsulfonlc Nov.1987.. ,ac;id, .4,8-c1iamino-9,10-clihy- '

With the six new recommendations .: dro.,1,S,dihydroxy-9,10-clioxo-~

and three removals noted in this rep9rt;, 11.Di~perse BlueS6..., ~ N'9v.198~.sixteen entries now appear on' the 12. Disperse Re~ 60 Noy.198 .section 4(e) Priority List. The PriorityList is'divided in the following Table 2into three parts; namely, A. Chemicalsand Groups of Chemicals Designated forResponse Within 12 Months, B.Chemicals and Groups of ChemicalsRecommended with Intent-to-Designate.and C, Chemicals and Groups ofChemicals Recommended Without BeingDesignated for Response Within 12Months. Table 2 follows:

.. ..

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, TABLE 2- THE TSCA SECTION 4(e)PRIORITVLIST

[November 1987]

EntryDateof

designation

A. Chemicals and Groups ofChemicals Recommendedand Designated for Re-sponse Within12 Months:

1. Tributyl phosphate ....................2. Isopropanol ,....................3. 'Methylteft-butylether .............

Nov.1986.May1987.May1987.

EntryDate of

recommen.dation

May1987,

References

, (1) Sixteenth Repo'rt of the TSCAInteragency Testing Committee to theAdministrator, Environmental ProtectionAgency. TSCA Interagency Testing,Committee, May 21. 1985. 50 FR 2093,0-20939,Includes references to Reports 1 tbrough 15and an annotative list of removats.

(2) Seventeenth Report of the TSCAInteragency Testing Committee; to theAdministrator. Environmental Pro.tli!~iion'

. " 4 I~.' . " . '. .

. 'Federal"Register / 'vat '52.N'o.'224I Frida'y:'November20. 1987 l NotiCes 44833

Agency. TSCA'lnteragency TestingCommittee. November 19. 1~85. 50 PR 47603-47612.

(3) Eighteenth Ri!port of the TSCAInteragency Testing Committee to theAdministrator. Environmental ProtectionAgency. TSCA Interagency. Testing , "Committee. May 19. 1986. 51 Fn 18368-18375.,

(4t Nineteenth Report of the TSCA ,

.InteragencY Testing Committee to theAdministrator. Environmental ProtectionAgency. TSCA Interagency TestingCommittee. November 14. 1986. 51 FR 41417-41432-

(5) Twentieth Report of theTSCAInteragency Testing Committee to theAdministrator. Environmental Protection.Agency.TSCAInteragencyTesting ,

Commillee. May ZOo1987. 52 Fit 19020-19026.(6) SOCMA. Letter of October 14. 1967.

from Eric A. Clarke. Executive Director of theStyrene and Ethylbenzene Association.Synthetic Organic Chemical Manufacturers

Association. Inc.. 't~ a: Brink. Exe~uiive ' , .

Secretary. Intera8,e~c:~ T~sfing' ,Co,!!~Utee,:

Chapter 2-Recommendations of-the .'Committee, :" ~ ., , , ..

2.1 Chemicals recommend,ed for' "priority considerptioij by tfte. Ef.A' .",Administrator. As pi'o,vi,de,d ~y ~~~tio!"4(e){1)(B)of TSCA. the C9mmittf!e is '

adding the followingChemical '.

substances to.the section 4(e) PriorityList:Acia Blue40 and its related acid ,

form. Acid''Blue 45 and,'its related, acm. .form. Disperse Blue 56 and Disperse Red60. The recommenda'tion of these .chemicals is being made afterconsidering the factors identified I'nsection 4(e)(1)(A) and other relevantinformation. as well as the professionaljudgment of Committee members.

Heinonline -- 52 Fed. Rea. 44833 1987

2.2 C.hemicals de;ignated/or responsewithin 12months. None.. " '. '"

. .2.3,Chemicals recommended with,"inten,t-to-designate~.None~:

2.4 Chemicals recommended without'being designated Iqr resporise within 12months-Summary of recommended '

studies. It is recommended that selectedarninuanthraqulnone dyes be t~s~edforthe following: "

t. Chemical fate: None.. ,...2.Health,effects: Acid Blue 40 and its '

related acid for genotoxicity.Acid Blue 45 and its related acid for

genotoxici ty.Disperse'BJue 56 for genotoxiclty.Disperse Red 60 for genotoxiclty.3. Ecological effects: None. '

8/WNG CODE 6560-50-11