Federal Register / Vol. 58, No. 85 / Wednesday, May 5, 1993 / Notices

ENVIRONMENTAL PROTECTION AGENCY 

### [OPPTS-41038;,FR"5]3-41 Thirty-First Report ofthe TSCA Interagency Testing Committee to the Administrator; Receipt of Report, Request for Comments, Opportunityto InitiateNegotiations for TSCA Section 4 Testing Consent Agreements
AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The TSCA Interagency Testing Committee (ITC), established under section 4(e) ofthe Toxic Substances Control Act (TSCA). transmitted its Thirty-First Report tothe Administrator ofEPA on January 28, 1993. This report Is included with this notice. As noted inthis Report, the ITC revised the PriorityTestingListby adding one group of24 chemicals to the list for priority consideration by the EPA Administrator for promulgation of test rules under section 4(a) ofthe Act. These chemicals are designated for response within 12 months. Therefore, in response to the ITC's designation, EPA will either initiate rulemaking under section 4(a) ofTSCA, enter into

a testing consent agreement, or publish

a Federal Register notice explaining the

reasons fornot initiating such rulemaking within 12 months. The ITC is also revising the recommendations for two chemical groups that were recommended in the ITC's TwentyEighth Report. The propylene glycol ethers and esters group is revised by the addition of2 chemicals and the removal of29. The methyl ethylene glycol ethers and esters group is modified by the removal ofeight chemicals. The ITC's

reasons for revising these chemical groups are stated in the Thirty-First Report. There are no recommended with intent-to-designate chemicals or chemical groups inthe Thirty-First Report. EPA invites interested persons to submit written comments on the Report.

en addition, EPA is soliciting

interested parties for participation in or monitoring ofa consent agreement process for the chemicals that were designated for dermal absorption testing. EPA is also inviting manufacturers and/or processors of chemical substances who wish to participate in testing negotiations for the chemicals designated for dermal absorption testing to develop and submit testing consent agreement proposals to EPA. DATES: Written comments on the ThirtyFirst ITC Report must be received by June4, 1993. Written testing proposals must be received by July 6, 1993. Written notice ofinterest inbeing designated an "interested party" to the development or monitoring ofaconsent agreement for the chemicals designated for dermal absorption testing must be received by July 6, 1993. Those submitting written testing proposals will be considered "interested parties" and do not have to submit separate written notice. EPA will contact all "interested parties" and advise them of meeting dates. ADDRESSES: Send six copies ofwritten submissions to: TSCA Docket Receipts (TS-790), Office ofPollution Prevention and Toxics, Environmental Protection Agency, Rm. ETG-102, 401 M St., SW., Washington, DC 20460. Submissions should bear the document control number (OPPTS-41038; FRL-4583-4). The public record supporting this action, including comments, is available forpublic inspection in Rm. ET G-102 at the address noted above from 8 a.m. to noon and 1p.m. to 4 p.m., Monday through Friday, except legal holidays. FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division {TS799), Office ofPollution Prevention and Toxics, Environmental Protection Agency, 401 M Street, SW., Rm. E543B, Washington, DC 20460, (202) 554-1404, TDD (202) 554-0551. SUPPLEMENTARY INFORMATION: Electronic Availability:.This document, along with a complete list ofChemical Abstract Service numbers, and chemical

names ofchemicals and chemicals in groups on the TSCA section 4(e)Priority TestingList,is available as an electronic file on TheFederal BulletinBoardat 9

a.m. on the date of publication inthe Federal Register. By modem dial 202- 512-1387 or call 202-512-1530 for disks or paper copies.This file Is also available in Postscript,Wordperfect and ASCII. The list ofchemical abstract Service numbers, and chemical names ofchemicals and chemicals in groups on the TSCA section 4(e) Priority TestingList,is available inWordperfect and ASCII.
I. Background

TSCA (15 U.S.C. 2601 et seq.) authorizes the Administrator ofEPAto promulgate regulations under section 4(a) requiring testing ofchemical substances and mixtures ("chemicals") in order to develop data relevant to determining whether such chemicals may present unreasonable risks to health orthe environment Section 4(e) ofTSCA established the Interagency Testing Committee (ITC)torecommend chemicals and chemical groups tothe Administrator ofEPA forpriority testing consideration. Section 4(e) directs the ITC to revise the TSCA section 4(e) PriorityTestingListat least every 6 months. The mostrecent revisions to this List are included inthe ITC's Thirty-First Report.The Report was received by the Administrator on January 28,1993, and is included with this notice. The Report adds 1group of 24 chemicals to the TSCA section 4(e) PriorityTestingListand revises the recommendations for 2 chemical groups that were recommended inthe ITC's Twenty-Eighth Report.
H. Written and Oral Comments on Recommendations

EPA invites interested persons to submit detailed comments on the ITC's

new recommendations. The Agency Is interested in receiving information concerning additional or ongoing health and safety studies on the subject chemicals as well asInformation relating to the human and environmental exposure to these chemicals.

A notice will be published at a later date in the Federal Register adding the substances recommended in the ITC's Thirty-First Report to the TSCA section 8(d) Health andSafety Data Reporting Rule (40 CFR part 716), which requires the reporting ofunpublished health and safety studies on the listed chemicals. That notice will also add the chemicals to the TSCA section 8(a) Preliminary Assessment Information Rule (40CFR part 712). The section 8(a) rule requires the reporting ofproduction volume, use, exposure, and release information on the listed chemicals. III. Status ofList

The ITC'sThirty-First Report notes the addition ofone chemical group to the PriorityTestingListand the revision ofthe recommendations fortwo chemical groups in the Twenty-Eighth Report. The current TSCA section 4(e) Priority TestingListcontains 24 chemicals and 24 chemical groups; 1 chemical group and 11 chemicals are designated for priority testing consideration.
IV. Testing Consent Agreements

1. Solicitationof InterestedParties. EPA's procedures for requiring the testing ofchemical substances under section 4 ofTSCA at 40 CFR 790.22, includes the adoption ofenforceable consent agreements and the promulgation oftest rules. EPA has on
numerous occasions been approached by chemical companies interested in negotiating consent agreements for 26898

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testing ITCchemicals orchemical groups. As aresult ofthese requests, EPA is now Inviting persons Interested in participating in or monitoring negotiations on the chemicals designated in the Thirty-First ITC Report to notify EPA in writing. Those who respond to this solicitation by the deadline established inthis notice will have the status of"interested parties" and will be afforded opportunities to participate in the negotiation process. These "interested parties" wil not incur any obligations by being designated "interested parties."

2. Solicitationof testing proposals for consentagreementnegotiations. EPA is also now soliciting testing proposals for aconsent agreement toperform dermal absorption testing on the 24 chemical substances designated In the ThirtyFirst Report. Followingpublication of this notice, manufacturers and/or processors have 60 days to develop and submit testing proposals for any ofthe chemical substances designated In the Thirty-First Report that they wish EPA to consider as candidates for consent agreement negotiations.

Federal scientists from anumber of the ITC's statutory and liaison organizations includingthe Consumer Product Safety Commission. Environmental Protection Agency, Food and Drug Administration, National Institute forOccupational Safetyand Health, and Occupational Safety and Health Administration, have developed
aproposed federally-harmonized test protocol that willprovide data needed by several U. S. Government Organizations represented onthe ITC. This proposed protocol is entitled "Protocol for in vitroPercutaneous Absorption Studies" and is available to the public through theTSCA Docket Receipts and the Environmental Assistance Division listed above. This document should be reviewed before submitting any testing proposals in response to this notice.

For additional technical information
onthis testing protocol contact Dr.John D. Walker, Executive Director, TSCA Interagency Testing Committee, (202) 260-1820.

All testing proposals submitted should descrie the testing to be performed and explain any deviations from the federally harmonized test protocol that arenecessary to assure the development ofreliable percutaneous absorption data.

EPA will review the submissions and select the most promising submissions

as candidates fornegotiation. Submissions that fully address the ITC's
concerns willhave ahigher chance of
success than those that donot fully address all data needs.

3. Negotiatibnoftesting programand developmentof a testingconsent agreement. EPA will follow the negotiation procedures under 40 CFR 790.22, and to theextent feasible, the timetable outlined in40 CFRpart 790, Appendix A to subpart B.

In the case ofthe 24 substances designated forpriority testing consideration in the Thirty-First ITC Report. EPA believes that obtaining testing through the development of consent agreements would be most feasible ifinterested manufacturers organized atesting consortium. Because ofthe straightforward and relatively inexpensive nature ofthe recommended tests for each ofthe substances (i.e., dermal absorption tests), and the costs toEPA and industry thatwould be incurred should many consent * agreements bepursued, EPAbelieves that negotiating with an organized group ofmanufacturers maybe the most efficient meansto obtain theneeded testing. For additional information about process or negotiations contactFrank Kover, Chief. Chemical Testing and Information Branch. (202) 260-8130.

Authority. 15 U.S.C 2603.
Dated: April 23, 1993. Charles K. Auer, Director, ChemicalControlDivision,Office of

Pollution PreventionandToxics. 

### Thirty-First Report ofthe TSCA Interagency Testing Committee tothe Administrator, Environmental Protection Agency

Summary.The Interagency Testing Committee (ITC)was created under Section 4(e) ofthe Toxic Substances Control Act (TSCA) as an independent advisory committee to the Administrator ofthe U.S. Environmental Protection Agency (EPA)

on setting priorities forthe testing of chemicals. The Committee maintains the TSCA section 4(e)Priority Testing List and transmits revisions oftheList * asa Report to the EPA Administrator at least every 6 months foraction and publication inthe Federal Register. This Report presents the ITC'srevisions to thePriorityTestingListresulting from Its deliberations during thereporting period May through November 1992.

This revision designates a group of 24 chemicals ofregulatory interest to the Occupational Safety and Health Administration (OSHA) for dermal absorption testing. Also, two groups of chemicals previously recommended are revised. The propylene glycol ethers and esters group is revised by adding 2 chemicals and removing 29. The methyl ethylene glycol ethers and esters group is modified by removing eight chemicals.

TABLE 1.-REVISIONS TOTHE TSCA SECTION 4(E) PRIORITYTESTING UST
Group Action Date Concern
OSHA Chemicalswith no dermal absoql data (listed In Table 2)

....... Designated

...... 1/93 Dermal absorption testing Propylene glyc etend este rs (revised)

........................ Recommended 1/93 nrmaton solicitedl Me e ne glycoethers and trs (revised).

............ Recommended 1/93 Information solicited

Chapter 1-Introduction

1.1 Background.Since its creation in 1976 under Section 4(e) ofthe Toxic Substances Control Act (Public Law 94- 469, 90 StaL 2003 at seq., 15 U.S.C. 2601 et seq.), the TSCA Interagency Testing Committee (ITC)has sent 30 semiannual Reports to the Administrator of tho U.S. Environmental Protection Agency (EPA)to advise on setting priorities for the testing ofchemicals. These Reportshave been published in the Federal Register and are also available from the Committee. Inthis, its Thirty-First Report the Committee revises its PrionrtyTestingList with the addition ofone groupand the revision oftwo groups already on the List.A short version ofthe Priority TestingList appears at the end of this Report. The complete Priority TestingList with all individual chemicals in each group is available upon request from the Committee (address and phone number given below) or, electronically available

on TheFederalBulletinBoard(see preamble for the phone number). 26899

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### 26900 F.de.. Regser / Vol. 58, No. 85 / Wednesday, May 5, 1993 / Notices

The Committee meets monthly and produces its Reports with thehelp of staffand technical contract support provided by EPA. Committee membership and support personnel are listed at the end ofthis Report.

Upon receipt ofthe ITCs Reports, the EPA's Office ofPollution Prevention and Toxics issues information gathering rules under Sections 8(a) and 8(d) of TSCA. These rules require that manufacturers and producers submit (1) production and exposure data and (2) health and safety studies, respectively, within 2 months ofthe rule's effective date. These submissions are indexed and stored in data bases by EPA and are then available forreview by the ITC and 

### others.

1.2ITC's activitiesduringthis reporting period. For the period May 28, 1992 to November 5, 1992, the ITC had six meetings. Chemical groups previously recommended after nomination by the National Institute of Occupational Safety and Health (NIOSH) were reviewed. The individual chemicals comprising these groups are here modified. The ITC also accepted the request ofthe Occupational Safety and Health Administration (OSHA) to determine testing needs forindustrial chemicals which may causeharm to exposed workers by absorption through the skin.

1.3. Revision of Previously Recommended Groups.In the ITC's Twenty-Eighth Report, groups of propylne glycol ethers andesters and methyl ethylene glycol ethers and esters
were addedto the TSCA section 4(e) Priority TestingList forreproductive effects and developmental toxicity testing based on concerns raised by NIOSH (56FR 41212, August 19, 1991). NIOSH is concerned with glycol ethers and their esters that are metabolized in humans to known reproductive toxicants. The original groups of glycol ethers and esters were selected from industrial chemicals to which workers

are exposed, and the groups were expanded by adding structurally similar compounds through a substructure search ofthe ITC's Substructure-based Computerized Chemical Selection Exrt System (SuCCSES). gthisreporting period, NIOSH commented thatnot all ofthese chemicals are ofconcern because of theirpossible metabolism to reproductive toxicants. The ITC reconsidered the individual members of the groups. Upon review ofavailable metabolism data and consideration of possible structure/activity relationships, the ITC decided to remove some chemicals from both groups. A chemical

was removed if: (1)it is expected to be metabolized totricarboxylic acid cycle intermediates and therefore oflower


### concern: (2) It is not expected tobe metabolized to reproductive toxicants; (3) there are fewer than 1,000 workers exposed, according to the National Occupational Exposure Survey; or (4) other human exposure (mostly through

consumer uses) isnot considered likely. The Consumer Product Safety Commission (CPSC) expressed an interest in retaining 'some ofthe propylene and methyl ethylene glycol ethers and esters on the Priority Testing Listand adding two chemicals in order
to obtain information submitted under TSCA Sections 8(a) and 8(d). The ITC has a concern that some ofthese chemicals are likely to be used in

consumer products as replacements for ethylene glycol ethers and has no metabolism data available. As a result, the ITCretains some members ofboth groups on the List and adds two chemicals. Chapter 2-Actions taken by the ITC in this Report

2.1 Designatedchemicals.OSHAnominated chemicals for which no dermal toxicity data are available.
L Rationale fortheDesignation OSHA has established Permissible Exposure Limits (PELs)to protect workers from industrial chemicals. In general, PELs are based on inhalation of airborne dusts and vapors. In those

cases where skin absorption could be harmful, the chemicals with PELs are assigned "skin designations." OSHA requested that the ITC help identify chemicals which lack sufficient data for OSHA to determine the need for skin designations and to use their authority to recommend chemicals for priority testing consideration by EPA to obtain these data. To assign a skin designation, OSHA requires acute dermal studies and sufficient dermal absorption data to determine the total exposure ofworkers. The ITC identified 24 chemicals for which no dermal toxicity or absorption data could be located and which are potentially testable under TSCA. These chemicals are listed in the following Table 2:

TABLE 2.-OSHA CHEMICALS DESIGNATED FOR DERMAL ABSORPTION TESTING

CAS No. Chemical Name

60-29-7

..... Ethyl other 7&45-

..... tesy alcohol 76-22-2

..... Camphor 78-92-

. eo-Butyl alcohol TABLE 

### 2.--OSHA CHEMICALS DESIGNATED FOR DERMAL ABSORPTION 

### TESTING--Continued

CAS No. Chenrcal Name

79-20-9

..... Meth acetate 97-77--8

..... D flram 100-25-4

. p.Dlntrobenzene
105-46-4

... seo-Butyl acetate 106-42-3

... p-Xylene 107-31-3

... Methy fomate 107-66-4

... Dibutyt phosphate
108-03-2

...1-Nitropropane 108-87-2

... Methylcyclohexane 109-6"... Pentane 110-83-8

... Cyclohexene 111-84-2

... Nonane 123-92-2

... Isoamyl acetate 142-82-5

... PHeptane 287-92-3

... Cyclopentane 532-27-4

... a-Chloroacetophenone 540-88-5

... terl-Butyl acetate 628-63-7

... n-Amyl acetate 7631-90-. Sodium bisulfite 7681-67-4. Sodium metabisufite
ff. Recommended Tests The group ofchemicals listed in Table 2 above are designated for dermal absorption testing.
I. Supporting Information In ItsJanuary 19, 1989 Air Contaminants Rule (54 FR 2332), OSHA stated that:

The purpose of having the skin designation is to prevent the same toxic effects that the chemical causes through inhalation. The inhalation limit is based on keeping exposure below the limit which will create a significant risk ofmaterial impairment of health. Ifskin absorption is possible, an employee might be below the inhalation limit; however, the additional body burden through skin absorption may create the material impairment which the limit attempts to reduce.

In September 1991, OSHA presented

a list of658 chemical substances and mixtures (its Z-1-A Table in 54 FR 2332-2983) to the ITC to assess the availability ofdermal absorption data and the need fortesting that could be recommended under TSCA. The ITC reviewed the list and determined that 145 polymers, pesticides, complex mixtures, and chlorofluorocarbons (CFCs) are not suitable candidates for consideration because they are not suitable fortesting, they are regulated under other Federal authorities, or they

are not regulable under TSCA. The 

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### I Vol. 58, No. 85 / Wednesday, May 5, 1993 / Notices

remaining chemicals were divided into two groups based onproduction volume: greater or less than I million pounds, based on the 1989 production figures from the EPA Inventory. Chemicals that are vapors atambient temperature, arehighly reactive, have lowtoxicity, are members ofchemical chemicals were identified as having no groups, or have dermal LD50 values dermal toxicity data and are here reported in the Registry ofToxicEffects

. designated for dermal absorption ofChemical Substances were identified testing. The following Figure 1diagrams in each ofthe production groups and are the selection process. deferred for future ITCreview. A group guma aoo N of 16high and 8 low production 26901

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