[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Notices]
[Pages 30580-30585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14578]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41048; FRL-5718-3]


Fortieth Report of the TSCA Interagency Testing Committee to the 
Administrator; Receipt of Report and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The TSCA Interagency Testing Committee (ITC), established 
under section 4(e) of the Toxic Substances Control Act (TSCA), 
transmitted its Fortieth Report to the Administrator of the EPA on 
April 28, 1997. In the Fortieth Report, which is included with this 
notice, the ITC revised the TSCA section 4(e) Priority Testing List by 
removing two isocyanates that were recommended in the 26th Report, one 
high production volume chemical, trichloromethane sulfenyl chloride 
that was recommended in the 36th Report and 2,4,6-tribromophenol that 
was recommended in the 39th Report. The ITC is also proposing 
procedures for chemical trade associations and producers, importers, 
processors, and users of future ITC-recommended chemicals to 
voluntarily provide data needed by U.S. Government organizations 
represented on the ITC and thereby reduce the need for the EPA to 
promulgate TSCA section 8 rules for these chemicals.
    There are no designated or recommended with intent-to-designate 
chemicals or chemical groups in the Fortieth Report. EPA invites 
interested persons to submit written comments on the Report.

DATES: Written comments on the Fortieth ITC Report should be received 
by July 7, 1997.

ADDRESSES: Comments on the Fortieth Report should be submitted to both 
the ITC and the TSCA Docket. Send one copy of written comments to: John 
D. Walker, ITC Executive Director (7401), U.S. Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Send six copies of 
written comments to: Document Control Office, Rm. ET-G-099, Office of 
Pollution Prevention and Toxics (7407), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. All submissions should 
bear the document control number OPPTS-41048.
    Comments may also be submitted electronically by sending electronic 
mail (e-mail) to the ITC ([email protected]) or the EPA 
([email protected]). Electronic comments are preferred by the ITC. 
Electronic comments must be submitted as an ASCII file avoiding the use 
of special characters and any form of security encryption. Comments 
will also be accepted on disks in WordPerfect 5.1/6.1 file format or 
ASCII file format. All comments in electronic form must be identified 
by the document control number OPPTS-41048. No TSCA ``Confidential 
Business Information'' (CBI) should be submitted through e-mail. 
Electronic comments on the Fortieth Report may be filed online at many 
Federal Depository Libraries. Additional information on electronic 
submissions can be found in Unit IV of this document.
    The public record supporting this action, including comments, is 
available for public inspection in the TSCA Non-Confidential 
Information Center (NCIC), Rm. NE B-607 at the address noted above from 
12 noon to 4 p.m., Monday through Friday, except legal holidays.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,

[[Page 30581]]

Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, 202-554-1404, TDD 202-554-0551.

SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency 
Testing Committee's Fortieth Report to the Administrator.

I. Background

    TSCA (Pub. L. 94-469, 90 Stat. 2003 et seq.; 15 U.S.C. 260l et 
seq.) authorizes the Administrator of the EPA to promulgate regulations 
under section 4(a) requiring testing of chemicals and chemical groups 
in order to develop data relevant to determining the risks that such 
chemicals and chemical groups may present to health or the environment. 
Section 4(e) of TSCA established the Interagency Testing Committee 
(ITC) to recommend chemicals and chemical groups to the Administrator 
of the EPA for priority testing consideration. Section 4(e) directs the 
ITC to revise the TSCA section 4(e) Priority Testing List at least 
every 6 months.

II. The ITC Fortieth Report

    The most recent revisions to the Priority Testing List are included 
in the ITC's Fortieth Report. The Report was received by the EPA 
Administrator on April 28, 1997, and is included in this notice. The 
Report removes two isocyanates that were recommended in the 26th Report 
(55 FR 23050, June 5, 1990), one high production volume chemical, 
trichloromethane sulfenyl chloride, that was recommended in the 36th 
Report (60 FR 42982, August 17, 1995)(FRL-4965-6), and 2,4,6-
tribromophenol that was recommended in the 39th Report (62 FR 8578, 
February 25, 1997)(FRL-5580-9).
    Trichloromethane sulfenyl chloride is being removed from the 
Priority Testing List because adequate subchronic toxicity data have 
been submitted to the ITC, monitoring data indicate that 
trichloromethane sulfenyl chloride is not likely to result in 
significant exposures to workers, and no additional U.S. Government 
data needs have been identified at this time.
    The ITC is removing 2,4,6-tribromophenol from the Priority Testing 
List after reviewing data obtained from the Chemical Manufacturers 
Association's Brominated Flame Retardants Industry Panel Manager and 
representatives from a 2,4,6-tribromophenol manufacturer. These data 
demonstrated that:
    1. 2,4,6-tribromophenol is used as a chemical intermediate to 
produce bis(tribomophenoxy)ethane, tetrabromobisphenol (a carbonate and 
epoxy oligomers), brominated epoxy resins and other flame retardants.
    2. Greater than 99% of 2,4,6-tribromophenol produced as an end-
product is shipped overseas to be used as an intermediate in the 
production of flame retardants.
    3. Environmental and workplace monitoring indicate that 2,4,6-
tribromophenol is not likely to result in substantial environmental 
releases or significant exposures to workers, consumers, or the general 
population.
    Finally, the two isocyanates are being removed from the Priority 
Testing List because these chemicals are used as non-isolated 
intermediates and this use, combined with a low estimated vapor 
pressure (< 10-5 millimeter(mm) Mercury(Hg)@25 deg. C) for both 
chemicals, is not likely to result in environmental releases or 
exposures to workers, consumers, or the general population.
    The ITC is also proposing procedures for chemical trade 
associations and producers, importers, processors, and users of future 
ITC-recommended chemicals to voluntarily provide data needed by U.S. 
Government organizations represented on the ITC and thereby reduce the 
need for the EPA to promulgate TSCA section 8 reporting rules for these 
chemicals. The proposed procedures consist of:
    1. Refining section 8 data needs.
    2. Encouraging electronic data submissions.
    3. Providing incentives for producers, importers, processors, and 
users of chemicals recommended by the ITC to voluntarily submit section 
8 information in a form that is rapidly reviewed by the ITC and to 
establish partnerships with the ITC.
    The ITC offers chemical trade associations, producers, importers, 
processors, and users that provide the ITC with easy-to-review 
(electronic) submissions and establish partnerships with the ITC the 
opportunity to potentially eliminate promulgation of TSCA section 8(a) 
preliminary assessment information reporting and section 8(d) health 
and safety data reporting rules.

III. Status of the Priority Testing List

    The current TSCA section 4(e) Priority Testing List contains 11 
chemical groups, four of which were designated by the ITC for testing.

IV. Public Record

    EPA invites interested persons to submit detailed comments on the 
ITC's Fortieth Report.
    A record has been established for this notice under document 
control number OPPTS-41048 including comments submitted electronically 
as described below. A public version of this record, including printed 
paper versions of electronic comments, which does not contain any 
information claimed as CBI, is available for inspection from 12 noon to 
4 p.m., Monday through Friday, except legal holidays. The public record 
is located in the TSCA Non-Confidential Information Center (NCIC), Rm. 
NE B-607, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460.
    Electronic comments can be sent directly to the ITC at:
    [email protected] and to the EPA at 
[email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of security encryption. Comments 
will also be accepted on disks in WordPerfect 5.1/6.1 file format or 
ASCII file format.
    The official record for the ITC's Fortieth Report, as well as the 
public version as described above, will be kept in paper form. 
Accordingly, EPA will transfer all comments received electronically 
into printed, paper form as they are received and will place the paper 
copies in the official record which will also include all comments 
submitted directly in writing. The official record is the paper record 
maintained at the EPA address in ``ADDRESSES'' at the beginning of this 
document.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.

    Authority: 15 U.S.C. 2603.


    Dated: May 28, 1997.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

Administrator, U.S. Environmental Protection Agency

Summary
    This is the 40th Report of the TSCA Interagency Testing Committee 
(ITC) to the Administrator of the U.S. Environmental Protection Agency 
(EPA). In this Report, the ITC is revising its TSCA section 4(e) 
Priority Testing List by removing two isocyanates that were recommended 
in the 26th Report (55 FR 23050, June 5, 1990), one High Production 
Volume Chemical, trichloromethane sulfenyl chloride that was 
recommended in the 36th Report (60 FR 42982, August 17, 1995)(FRL-

[[Page 30582]]

 4965-6), and 2,4,6-tribromophenol that was recommended in the 39th 
Report (62 FR 8578, February 25, 1997)(FRL-5580-9). The ITC is also 
proposing procedures for chemical trade associations and manufacturers, 
importers, processors, and users of ITC-recommended chemicals to 
voluntarily provide data needed by the U.S. Government organizations 
represented on the ITC and thereby reduce the need for the EPA to 
promulgate TSCA section 8 rules for these chemicals. Comments on this 
Report should be submitted both to the ITC and the TSCA Public Docket. 
The revised TSCA section 4(e) Priority Testing List follows as Table 1.

                       Table 1.--The TSCA Section 4(e) Priority Testing List (April 1997)\1\                    
----------------------------------------------------------------------------------------------------------------
               Report                         Date                 Chemical/Group                Action         
----------------------------------------------------------------------------------------------------------------
26.................................  May 1990..............  8 Isocyanates............  Recommended with intent-
                                                                                         to-designate           
27.................................  November 1990.........  62 Aldehydes.............  Recommended with intent-
                                                                                         to-designate           
28.................................  May 1991..............  Chemicals with Low         Designated              
                                                              Confidence RfD.                                   
                                                               Acetone................                          
                                                               Thiophenol.............                          
29.................................  November 1991.........  10 Alkyl-, bromo-, chloro- Recommended             
                                                              , hydroxymethyl diaryl                            
                                                              ethers.                                           
30.................................  May 1992..............  8 Siloxanes..............  Recommended             
31.................................  January 1993..........  24 Chemicals with          Designated              
                                                              insufficient dermal                               
                                                              absorption rate data.                             
32.................................  May 1993..............  32 Chemicals with          Designated              
                                                              insufficient dermal                               
                                                              absorption rate data.                             
35.................................  November 1994.........  24 Chemicals with          Designated              
                                                              insufficient dermal                               
                                                              absorption rate data.                             
36.................................  May 1995..............  9 High Production Volume   Recommended             
                                                              Chemicals (HPVCs).                                
37.................................  November 1995.........  28 Alkylphenols and        Recommended             
                                                              Ethoxylates.                                      
39.................................  November 1996.........  23 Nonylphenol             Recommended             
                                                              Ethoxylates.                                      
----------------------------------------------------------------------------------------------------------------
\1\The list of discrete chemicals currently on the Priority Testing List is available from the ITC.             

I. Background

    The TSCA Interagency Testing Committee (ITC) was established by 
section 4(e) of the Toxic Substances Control Act (TSCA) ``to make 
recommendations to the Administrator respecting the chemical substances 
and mixtures to which the Administrator should give priority 
consideration for the promulgation of a rule for testing under section 
4(a).... At least every six months..., the Committee shall make such 
revisions in the Priority Testing List as it determines to be necessary 
and to transmit them to the Administrator together with the Committee's 
reasons for the revisions'' (Pub. L. 94-469, 90 Stat. 2003 et seq., 15 
U.S.C. 2601 et seq.). Since its creation in 1976, the ITC has submitted 
39 semi-annual (May and November) Reports to the EPA Administrator 
transmitting the Priority Testing List and its revisions. These Reports 
have been published in the Federal Register and are also available from 
the ITC. The ITC meets monthly and produces its revisions of the List 
with the help of staff and technical contract support provided by EPA. 
ITC members and support personnel are listed at the end of this Report.

II. TSCA Section 8 Reporting

    TSCA section 8 rules. Following receipt of the ITC's Report and the 
addition of chemicals to the Priority Testing List, the EPA's Office of 
Pollution Prevention and Toxics adds new chemicals from the List to 
TSCA section 8(a) and 8(d) rules that require manufacturers and 
importers of these chemicals to submit TSCA section 8(a) production and 
exposure data and manufacturers, importers and processors of the listed 
chemicals to submit TSCA section 8(d) health and safety studies within 
60 days of the rules' effective date.
    ITC's use of TSCA section 8 data. TSCA section 8(a) and 8(d) 
submissions are indexed in databases that are maintained by EPA. The 
ITC reviews the TSCA section 8(a) and 8(d) information and other 
available data on chemicals and chemical groups (e.g., TSCA section 
4(a) and 4(d) studies, TSCA section 8(c) submissions, TSCA section 8(e) 
``substantial risk'' notices, ``For Your Information'' (FYI) 
submissions to EPA, unpublished data submitted to U.S. Government 
organizations on the ITC and published papers) to determine if 
revisions to the List are necessary. Revisions can include changing a 
general recommendation to a specific designation for testing action by 
the EPA Administrator within 12 months, modifying the recommendation, 
or removing the recommended or designated chemical or chemical group 
from the List.

III. Procedures Promoting More Efficient Use of TSCA Section 8 
Resources

A. Introduction

    The ITC recognizes that substantive industry and government 
resources may be consumed to:
    1. Promulgate TSCA section 8(a) and 8(d) rules.
    2. Retrieve and submit data in response to these rules.
    3. Index and review the submitted data.
The ITC is proposing procedures (described below) that promote more 
efficient use of these resources and that, in some cases, could 
eliminate the need to promulgate future TSCA section 8(a) Preliminary 
Assessment Information Reporting (PAIR) and section 8(d) Health and 
Safety Data rules.

B. Procedures

    In future Reports to the EPA Administrator, the ITC will implement 
the following procedures to promote more efficient use of TSCA section 
8(a) and 8(d) resources:
    1. The ITC will recommend additional chemicals, add these chemicals 
to the TSCA section 4(e) Priority Testing List, and describe specific 
data necessary to meet the needs of U.S. Government organizations 
represented on the ITC. Studies for which data are not required under 
TSCA section 8(a) and 8(d) will be listed, if appropriate; e.g., 
studies on

[[Page 30583]]

mixtures and waste streams of certain chemicals.
    2. In the Report describing additional chemical(s) added to the 
Priority Testing List, the ITC will:
    a. Ask the EPA not to promulgate TSCA section 8(a) PAIR and TSCA 
section 8(d) Health and Safety Data rules.
    b. Provide an opportunity for manufacturers, importers, processors, 
and users of chemicals recommended by the ITC to voluntarily provide 
FYI submissions. Two copies of FYI submissions should be mailed to the 
Document Processing Center (7407), Attn: FYI Coordinator, Information 
Management Division, Office of Pollution Prevention and Toxics, U.S. 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
The cover letter should clearly identify the ITC as the recipient of 
the submission.
    Specific requested information should be submitted (e.g., exposure 
and use information or toxicity studies) either by individual companies 
and/or by a consortium as follows:
    i. Manufacuturers, importers, processors, or users of chemicals 
recommended by the ITC or a consortium representing all those 
manufacturers, importers, processors or users must submit an e-mail or 
letter of intent to the ITC Executive Director within 30 days of the 
date the ITC Report is published in the Federal Register.
    ii. The e-mail or letter of intent must include a list of the types 
of data that will be voluntarily submitted and a timetable for the 
submission of the data.
    iii. The timetable should reflect the time needed by the ITC to 
review the data before the next ITC Report is submitted to the EPA 
Administrator. The e-mail and mailing addresses of the ITC Executive 
Director are given at the end of this Report.
    3. In a subsequent Report to the EPA Administrator, the ITC can ask 
the EPA to promulgate TSCA section 8(a) PAIR and TSCA section 8(d) 
Health and Safety Data rules for recommended chemical(s) if 
insufficient voluntary information is submitted to evaluate the 
recommended chemical(s). FYI studies should not be re-submitted as TSCA 
section 8 studies.

C. Supplemental Information

    The ITC has had some success in obtaining voluntary exposure, use, 
and toxicity data from manufacturers, importers, processors, and users 
of chemicals that have been recommended and added to the Priority 
Testing List and establishing partnerships with chemical trade 
associations representing those manufacturers, importers, processors, 
and users. The ITC wants to pursue these voluntary approaches to data 
sharing and offers a few examples that have been successful in the 
past. In addition the ITC offers data to support its 30-day information 
request.
    1. Brominated flame retardants. The voluntary submission from the 
Chemical Manufacturers Association's (CMA) Brominated Flame Retardants 
Industry Panel (BFRIP) Manager and a manufacturer of 2,4,6-
tribromophenol provided production, importation, use, and exposure data 
in a form that was rapidly and easily reviewed by the ITC. In response 
to voluntarily providing these data in an easily-reviewed form, the ITC 
requested that the EPA not promulgate a PAIR for 2,4,6-tribromophenol 
and rapidly removed 2,4,6-tribromophenol from the List (see Unit V.A.1 
of this ITC Report).
    2. Propylene glycol ethers. The partnership with the CMA's 
Propylene Glycol Ethers Panel provided data needed by the Consumer 
Product Safety Commission (CPSC) that resulted in removal of all 
propylene glycol ethers from the Priority Testing List (60 FR 42982, 
August 17, 1995).
    3. Silicones. The partnership with the Silicones Environmental 
Health and Safety Council (SEHSC) provided data needed by the Food and 
Drug Administration (FDA) and produced an electronic database of TSCA 
section 8(d) studies in a format compatible with the TSCA Test 
Submissions (TSCATS) database that resulted in removal of 43 of 56 
siloxanes from the List (61 FR 4188, February 2, 1996).
Note: The ITC encourages manufacturers, importers, processors, or users 
of chemicals recommended by the ITC to develop TSCATS-compatible 
databases and to submit electronic information in a form that is 
rapidly and easily reviewed by the ITC, e.g. the TSCA Electronic Cover 
Sheet developed by the EPA and the CMA. TSCATS can be searched on the 
Right-to-Know web site (http:www.rtk.net), where in the future it will 
be possible to retrieve the TSCA Electronic Cover Sheet.
    Thirty-day information requests. The ITC believes that 30 days from 
the date the ITC Report is published in the Federal Register is 
sufficient time for industry to submit an e-mail or letter of intent. 
The ITC sends its Reports to hundreds of chemical trade associations, 
chemical manufacturers, importers, processors, and users as well as 
numerous public health and environmental groups and chemical industry 
publications immediately after transmitting its Reports to the EPA 
Administrator. With this advanced notice of recommended chemicals, 
prior to Federal Register publication, the ITC recognizes that chemical 
trade associations, and manufacturers, importers, processors, and users 
of chemicals recommended by the ITC actually have 60- to 120-days 
notice of the number and type of chemicals that are recommended.

IV. ITC's Partnership Activities During This Reporting Period 
(November 1996 to April 1997)

    Alkylphenols and ethoxylates. The ITC-CMA Alkylphenols and 
Ethoxylates Dialogue Group was established in March 1996 to facilitate 
the ITC's retrieval of information on uses, exposures, health effects, 
and ecological effects of alkyphenols and ethoxylates, and the CMA's 
understanding of data needed by the U.S. Department of the Interior 
(DOI), the FDA, the EPA, the National Institute of Environmental Health 
Sciences (NIEHS), and the U.S. Department of Agriculture (USDA). This 
dialogue group met to discuss ongoing mammalian toxicology studies.
    Isocyanates. The ITC-CMA Diisocyanates Dialogue Group was 
established in November 1996 to facilitate the ITC's retrieval of 
information on uses, exposures, and health effects of diisocyanates and 
the CMA's understanding of data needed by the CPSC, the Department of 
Defense (DOD), the EPA, the National Institute for Occupational Safety 
and Health (NIOSH), and the Occupational Safety and Health 
Administration (OSHA). This dialogue group met to discuss production 
and commercial uses of diisocyanates.
    Siloxanes. The ITC-SEHSC Dialogue Group was established in March 
1993 to facilitate the ITC's retrieval of information on uses, 
exposures, and health effects of siloxanes, and the SEHSC's 
understanding of data needed by the FDA. This dialogue group met to 
discuss ongoing health effects and exposure studies.

V. Revisions to the TSCA Section 4(e) Priority Testing List

    Revisions to the TSCA section 4(e) Priority Testing List are 
summarized in Table 2.

[[Page 30584]]



                        Table 2.-- Revisions to the TSCA Section 4(e) Priority Testing List                     
----------------------------------------------------------------------------------------------------------------
               CAS No.                       Chemical name                Action                   Date         
----------------------------------------------------------------------------------------------------------------
118-79-6............................  2,4,6-Tribromophenol......  Removed...............  4/97                  
                                      High Production Volume                                                    
                                       Chemicals.                                                               
594-42-3............................    Trichloromethane          Removed...............  4/97                  
                                       sulfenyl chloride.                                                       
                                      Isocyanates...............                                                
4035-89-6...........................    Tris(isocyanatohexyl)biu  Removed...............  4/97                  
                                       ret.                                                                     
5873-54-1...........................    1-Isocyanato-2-((4-       Removed...............  4/97                  
                                       isocyanatophenyl)methyl)b                                                
                                       enzene.                                                                  
----------------------------------------------------------------------------------------------------------------

A. Chemicals Removed From the Priority Testing List

    1. 2,4,6-Tribromophenol--a. Rationale for removal. The ITC is 
removing 2,4,6-tribromophenol from the Priority Testing List after 
reviewing data obtained from the CMA's BFRIP Manager and 
representatives from a 2,4,6-tribromophenol manufacturer. These data 
demonstrated that:
    i. 2,4,6-tribromophenol is used as a chemical intermediate to 
produce bis(tribomophenoxy)ethane, tetrabromobisphenol A carbonate and 
epoxy oligomers, brominated epoxy resins, and other flame retardants.
    ii. Greater than 99% of 2,4,6-tribromophenol produced as an end-
product is shipped overseas to be used as an intermediate in the 
production of flame retardants.
    iii. Environmental and workplace monitoring indicate that 2,4,6-
tribromophenol is not likely to result in substantial environmental 
releases or significant exposures to workers, consumers, or the general 
population.
    b. Supporting information. 2,4,6-Tribromophenol was recommended in 
the ITC's 39th Report because the NIEHS needed chronic toxicology and 
2-year carcinogenesis study data (62 FR 8578, February 25, 1997). 
2,4,6-Tribromophenol was recommended and not designated because the ITC 
wanted to promote a dialogue between 2,4,6-tribromophenol manufacturers 
and the NIEHS to explain the need for chronic toxicity and 2-year 
carcinogenesis study data.
    Representatives of the ITC and NIEHS met with the CMA's BFRIP 
Manager and representatives from a 2,4,6-tribromophenol manufacturer to 
discuss data needs. The ITC and NIEHS representatives provided the CMA 
with a copy of the 39th Report that summarized existing health and 
safety data for 2,4,6-tribromophenol. The manufacturer's 
representatives provided the ITC with a list of studies that were 
previously submitted under TSCA section 8(d) and a list of producers, 
applications, commercial activities, and sales statistics.
    2. High Production Volume Chemicals (HPVCs)/trichloromethane 
sulfenyl chloride--a. Rationale for removal. Trichloromethane sulfenyl 
chloride (CAS No. 594-42-3) is being removed from the Priority Testing 
List because adequate subchronic toxicity data have been submitted to 
the ITC, monitoring data indicate that trichloromethane sulfenyl 
chloride is not likely to result in significant exposures to workers, 
and no additional U.S. Government data needs have been identified at 
this time.
    b. Supporting information. Trichloromethane sulfenyl chloride was a 
member of a group of 35 HPVCs that were recommended for 90-day 
subchronic toxicity testing in the ITC's 27th Report (56 FR 99534, 
March 6, 1991). The Substructure-based Computerized Chemical Selection 
Expert System (SuCCSES) was used to select these HPVCs during the ITC's 
sixth scoring exercise. SuCCSES is used to identify chemicals with 
shared substructures and associated health or ecological effects and 
similar TSCA production or importation volumes (Ref. 3, Walker, 1995). 
These HPVCs had annual production volumes exceeding one million pounds, 
but no 90-day subchronic toxicity data to identify potential health 
effects concerns. In its 36th Report (60 FR 42982, August 17, 1995), 
the ITC solicited specific use and exposure information on 12 HPVCs to 
facilitate its ability to decide whether these chemicals should be 
removed from the Priority Testing List or designated for testing.
    As noted in the 37th Report (61 FR 4188, February 2, 1996)(FRL-
4991-6), Zeneca, Inc. offered on September 19, 1995, to submit use and 
exposure information. Zeneca, Inc. provided use and exposure 
information to the ITC on August 14, 1996 (Ref. 4, Zeneca, 1996). 
Zeneca reported that of the 7.5 million pounds trichloromethane 
sulfenyl chloride produced per year, about 7 million pounds are 
completely consumed in an on-site enclosed process to produce a 
fungicide. Zeneca also reported that about 0.4 million pounds are 
shipped to a customer and completely consumed in an on-site enclosed 
process to produce a fungicide and that about 0.1 million pounds are 
shipped to a customer and completely consumed in the production of 
other substances. During manufacturing and use, about 5 workers per 
site handle trichloromethane sulfenyl chloride. Exposures to workers 
were less than 25% of the 1971 OSHA Permissable Exposure Level (PEL) of 
0.1 parts per million (ppm) (0.8 milligram (mg)/meter (m)3). 
The OSHA PEL was promulgated to protect workers against significant 
risks of eye and respiratory tract irritation, nausea, and pulmonary 
edema.
    ICI Americas (now Zeneca) submitted a 1952 study; 2 dogs, 7 guinea 
pigs, and 7 rats were exposed to a nominal concentration of 1 ppm 
trichloromethane sulfenyl chloride for 3 months, 8 hours a day, 5 days 
a week (Ref. 1, ICI Americas, 1952). Exposures to dogs caused 
lacrimation, rhinorrhea, nausea, retching, coughing, and sneezing. At 
the termination of exposure, one dog was sacrificed (the other was held 
for observations, but no reports were provided) and the gross and 
microscopic pathology were indicative of bronchopneumonia. Exposures to 
guinea pigs caused lacrimation, rhinorrhea, and increased respiration; 
6 guinea pigs died of pneumonia after 3 weeks. The rats survived, but 
microscopic examinations of lung tissue revealed thin ruptured alveolar 
walls, indicative of highly-irritating chemicals that can penetrate the 
lung.
    ICI Americas (now Zeneca) submitted a 1987 study; groups of 18 male 
and 18 female Sprague-Dawley CD rats were exposed to trichloromethane 
sulfenyl chloride vapor for 6 hours per day, 5 days per week for 
between 70 and 72 exposure days (Ref. 2, ICI Americas, 1987). 
Cumulative concentrations were within 90% of the target concentrations 
of 0 (control), 0.1, 0.6, and 4 mg/m3. Treatment-related 
decreases, relative to control values, were noted in body weights in 
females at the 4 mg/m3 exposure level. Increased incidences 
of salivation (4 mg/m3 exposure level for males) and 
sneezing (0.6 and 4 mg/m3 exposure level for females; 4 mg/
m3 exposure level for males) were noted during the study. At 
the time of necropsy, mucus was found in the

[[Page 30585]]

tracheas of 2 of 18 female and 4 of 18 male rats at the 4 mg/
m3 exposure level. Microscopic observations of acute 
inflammation and hypertrophy and/or hyperplasia of the respiratory 
nasal epithelium were noted in both sexes at the 4 mg/m3 
exposure level. These microscopic alterations were apparently caused by 
the toxic and irritating properties of trichloromethane sulfenyl 
chloride. In conclusion, subchronic trichloromethane sulfenyl chloride 
exposures in Sprague-Dawley rats produced treatment-related nasal 
passage and lung alterations in the 0.6 and 4 mg/m3 exposure 
levels. The no-observable-effect level (NOEL) in Sprague-Dawley rats 
was 0.1 mg/m3.
    3. Isocyanates--a. Rationale for removal. Two isocyanates are being 
removed from the Priority Testing List because these chemicals are used 
as non-isolated intermediates and this use, combined with a low 
estimated vapor pressure (< 105 millimeter (mm) mercury (Hg) 
@25 deg. C) for both chemicals, is not likely to result in 
environmental releases or exposures to workers, consumers, or the 
general population.
    b. Supporting information. In its 26th Report, the ITC recommended 
a group of 43 isocyanates for physical and chemical property testing in 
response to a nomination from the EPA to support its TSCA New Chemicals 
Program (55 FR 23050, June 5, 1990). The ITC removed 28 of these 
isocyanates from the Priority Testing List in its 35th Report (59 FR 
67596, December 29, 1994) and 5 more isocyanates in its 37th Report (61 
FR 4188, February 2, 1996)(FRL-4923-2).
    In its 37th Report, the ITC also solicited consumer use and 
exposure data, information on the presence of diisocyanates in 
commercially available products and information on exposures that 
result from their use. In response to this solicitation, the ITC 
established a dialogue with the CMA's Diisocyanates Panel and obtained 
information on commercial uses. As a result, the ITC is removing 2 
isocyanates from the Priority Testing List: tris(isocyanatohexyl)biuret 
(CAS No. 4035-89-6) and isocyanato-2-((4-
isocyanatophenyl)methyl)benzene (CAS No. 5873-54-1). There are 8 
isocyanates remaining on the List (Table 3).

       Table 3.--Isocyanates remaining on the Priority Testing List     
------------------------------------------------------------------------
                 CAS No.                           Chemical name        
------------------------------------------------------------------------
91-08-7.................................  2,6-Toluene diisocyanate (2,6-
                                           TDI)                         
101-68-8................................  4,4'-Diphenylmethane          
                                           diisocyanate (MDI)           
329-01-1................................  (,,-
                                           Trifluoro-m-tolyl)isocyanate 
584-84-9................................  2,4-Toluene diisocyanate (2,4-
                                           TDI)                         
4098-71-9...............................  Isophorone diisocyanate       
5124-30-1...............................  1,1'-Methylenebis(4-          
                                           isocyanatocyclohexane)       
26447-40-5..............................  1,1'-                         
                                           Methylenebis(isocyanatobenzen
                                           e)                           
26471-62-5..............................  Toluene diisocyanate (80% 2,4-
                                           TDI; 20% 2,6-TDI)            
------------------------------------------------------------------------

VI. References

    (1) ICI Americas. Subchronic inhalation study with dogs, guinea 
pigs and rats (1952). DCN 88-920007341 and Fiche No. 
OTS0538474.1
---------------------------------------------------------------------------

    1Studies are available at the EPA's TSCA Non-Confidential 
Information Center from noon until 4 p.m., Monday through Friday. 
The center is located in Rm. B-607 of EPA's NE Mall, 401 M St., SW., 
Washington, DC. Studies on microfiche are also available from the 
National Technical Information Service, 5285 Port Royal Road, 
Springfield, VA 22161, and the Chemical Information Systems, Inc., 
7215 York Road, Baltimore, MD 21212. Studies can be retrieved by 
using either the document control number (DCN) or fiche number 
(Fiche No.).
---------------------------------------------------------------------------

    (2) ICI Americas. Subchronic inhalation study with rats (1987). DCN 
88-920007422 and Fiche No. OTS054675.2
---------------------------------------------------------------------------

    2Ibid.
---------------------------------------------------------------------------

    (3) Walker, J.D. Estimation Methods Used by the TSCA Interagency 
Testing Committee to Prioritize Chemicals for Testing: Exposure and 
Biological Effects Scoring and Structure Activity Relationships. 
Toxicology Modeling 1:123-141 (1995).
    (4) Zeneca. August 14, 1996 letter from Ms. Terry L. Wells, Product 
Regulatory Specialist, Zeneca Specialities, Wilmington, Delaware to Dr. 
John D. Walker, Executive Director, ITC, OPPT/EPA, Washington, DC 
(1996).

VII. TSCA Interagency Testing Committee

    Statutory Organizations and Their Representatives

    Council on Environmental Quality
        Brad Campbell, Member
        Douglas Sanders, Alternate

     Department of Commerce
        Edward White, Member

     Environmental Protection Agency
        David R. Williams, Member
        Lois Dicker, Alternate

    National Cancer Institute
        Victor Fung, Member, Chair
        Harry Seifried, Alternate

    National Institute of Environmental Health Sciences
        William Eastin, Member, Vice Chair
        H.B. Matthews, Alternate

    National Institute for Occupational Safety and Health
        Henryka Nagy, Member
        David A. Dankovic, Alternate

    National Science Foundation
        Linda Duguay, Member

    Occupational Safety and Health Administration
        Lyn Penniman, Member
        Christine Whittaker, Alternate

    Liaison Organizations and Their Representatives
    Agency for Toxic Substances and Disease Registry
        William Cibulas, Member

    Consumer Product Safety Commission
        Val Schaeffer, Member
        Lakshmi C. Mishra, Alternate

    Department of Agriculture
        Clifford P. Rice, Alternate

    Department of Defense
        David A. Macys, Member

    Department of the Interior
        Barnett A. Rattner, Member

    Food and Drug Administration
        Edwin J. Matthews, Member
        Raju Kammula, Alternate

    National Library of Medicine
        Vera Hudson, Member

    National Toxicology Program
        NIEHS, FDA, and NIOSH Members

    Counsel
        Mary Ellen Levine, Office of General Counsel, EPA

    Technical Support Contractor
        Syracuse Research Corporation

    ITC Staff
        John D. Walker, Executive Director
        Norma S.L. Williams, Executive Assistant
TSCA Interagency Testing Committee, U.S. EPA/OPPT (MC/7401) 401 M St., 
SW., Washington, DC 20460, Phone: 202-260-1825, Fax: 202-260-7895, E-
mail: [email protected].
[FR Doc. 97-14578 Filed 6-3-97; 8:45 am]
BILLING CODE 6560-50-F