[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42554-42559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21206]


      

[[Page 42553]]

_______________________________________________________________________

Part V





Environmental Protection Agency





_______________________________________________________________________



Forty-Second Report of the TSCA Interagency Testing Committee; Notice

  Federal Register / Vol. 63, No. 152 / Friday, August 7, 1998 / 
Notices  

[[Page 42554]]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41050; FRL-5797-8]


Forty-Second Report of the TSCA Interagency Testing Committee to 
the Administrator; Receipt of Report and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The TSCA Interagency Testing Committee (ITC), established 
under section 4(e) of the Toxic Substances Control Act (TSCA), 
transmitted its Forty-Second Report to the Administrator of the EPA on 
May 29, 1998. In the Forty-Second Report, which is included with this 
notice, the ITC revised the TSCA section 4(e) Priority Testing List by 
recommending four chemicals: 3-Amino-5-mercapto-1,2,4-triazole, ethyl 
silicate, glycoluril, and methylal. There are no ``designated'' or 
``recommended with intent-to-designate'' chemicals or chemical groups 
in the Forty-Second Report. EPA invites interested persons to submit 
written comments on the Report.

DATES: Written comments on the Forty-Second ITC Report should be 
received by September 8, 1998.

ADDRESSES: Comments on the Forty-Second 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), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Send six copies of 
written comments to: Document Control Office, Rm. G-099, Office of 
Pollution Prevention and Toxics (7407), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. All submissions should 
bear the docket control number OPPTS-41050.
    Comments may also be submitted electronically by sending electronic 
mail (e-mail) to the ITC ([email protected]) or the TSCA Docket 
([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 encryption. Comments will 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 
docket control number OPPTS-41050. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on the 
Forty-Second Report may be filed online at many Federal Depository 
Libraries. Additional information on electronic submissions can be 
found in Unit IV of this preamble.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
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 Forty-Second 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 these chemicals and chemical groups may present to health or 
the environment. Section 4(e) of TSCA established the ITC to recommend 
chemicals and chemical groups to the Administrator of the EPA for 
priority testing consideration. Section 4(e) of TSCA directs the ITC to 
revise the TSCA section 4(e) Priority Testing List at least every 6 
months.

II. The ITC Forty-Second Report

    The most recent revisions to the Priority Testing List are included 
in the ITC's Forty-Second Report. The Report was received by the 
Administrator of the EPA on May 29, 1998, and is included in this 
notice. Four chemicals: 3-Amino-5-mercapto-1,2,4-triazole, ethyl 
silicate, glycoluril, and methylal are being recommended because:
    1. 3-Amino-5-mercapto-1,2,4-triazole is being considered for health 
effects testing based on concerns related to effects on thyroid hormone 
activity.
    2. Ethyl silicate is under review for mutagenicity and subchronic 
or chronic toxicity testing based on potential human exposures and 
suspicions of genotoxicity or carcinogenicity.
    3. Glycoluril is under review for carcinogenicity testing based on 
a potential for human exposure and a suspicion of carcinogenicity.
    4. Methylal is under review for carcinogenicity testing based on 
its potential for human exposure and a suspicion of carcinogenicity.

III. Status of the Priority Testing List

    The current TSCA section 4(e) Priority Testing List contains 11 
chemical groups; of these, 4 chemical groups were designated for 
testing.

IV. Public Record, Electronic Comment Submission, and Oral Comments

    The EPA invites interested persons to submit detailed comments on 
the ITC's Forty-Second Report.
    An official record has been established for this notice, as well as 
a public version, under docket control number OPPTS-41050 (including 
comments and data submitted electronically as described below). A 
public version of this record, including printed paper versions of 
electronic comments and data, which does not contain any information 
claimed as CBI, is available for inspection from 12 noon to 4 p.m., 
Monday through Friday, excluding legal holidays. The public record is 
located in the TSCA Nonconfidential Information Center, Rm. NE-B607, 
Environmental Protection Agency, 401 M St., SW., Washington, DC. 
Electronic comments can be sent directly to the ITC at 
[email protected] and to the TSCA Docket at [email protected].
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comments will be 
accepted on disks in WordPerfect 5.1/6.1 file format or ASCII file 
format.
    The official record for the ITC's Forty-Second 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 this unit.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, Health 
and safety.

    Authority: 15 U.S.C. 2603.

Dated: July 27, 1998.

Charles M. Auer,

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

Forty-Second Report of the TSCA Interagency Testing Committee

Administrator, U.S. Environmental Protection Agency
Summary
    This is the 42nd Report of the TSCA Interagency Testing Committee 
(ITC) to the Administrator of the U.S.

[[Page 42555]]

Environmental Protection Agency (EPA). In this Report, the ITC is 
revising its TSCA section 4(e) Priority Testing List by recommending 3-
amino-5-mercapto-1,2,4-triazole, ethyl silicate, glycoluril, and 
methylal. The revised TSCA section 4(e) Priority Testing List follows 
as Table 1.

                       Table 1.--The TSCA Section 4(e) Priority Testing List (May 1998)\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 Reference                           
                                                                 Dose (RfD).                                    
                                                                  Acetone                                       
                                                                  Thiophenol                                    
30...................................  May 1992...............  5 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        Recommended            
                                                                 volume chemicals                               
                                                                 (HPVCs).                                       
37...................................  November 1995..........  22 Alkylphenols and      Recommended            
                                                                 alkylphenol                                    
                                                                 ethoxylates\2\.                                
39...................................  November 1996..........  23 Nonylphenol           Recommended            
                                                                 ethoxylates\2\.                                
41...................................  November 1997..........  29 Alkylphenols,         Recommended            
                                                                 alkylphenol                                    
                                                                 ethoxylates, and                               
                                                                 polyalkyphenols\2\.                            
42...................................  May 1998...............  3-Amino-5-mercapto-      Recommended            
                                                                 1,2,4-triazole\2\.                             
42...................................  May 1998...............  Glycoluril\2\..........  Recommended            
42...................................  May 1998...............  Methylal\2\............  Recommended            
42...................................  May 1998...............  Ethyl silicate\2\......  Recommended            
----------------------------------------------------------------------------------------------------------------
\1\ The Priority Testing List is available from the ITC's web site (http://www.epa.gov/opptintr/itc).           
\2\Data requested using the ITC's Voluntary Information Submissions Policy (VISP), see http://www.epa.gov/
opptintr/itc/visp.htm.                                                                                        

I. Background

     The 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 to the Priority 
Testing List as it determines to be necessary and transmit them to the 
Administrator together with the Committee's reasons for the revisions'' 
(Public Law 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et seq.). 
Since its creation in 1976, the ITC has submitted 41 semi-annual (May 
and November) Reports to the EPA Administrator transmitting the 
Priority Testing List and its revisions. In 1989, the ITC began 
recommending chemical substances for information reporting, screening, 
and testing to meet the data needs of its member U.S. Government 
organizations. ITC Reports are available from http://www.epa.gov/
opptintr/itc within a few days of submission to the Administrator and 
from http://www.epa.gov/fedrgstr after publication in the Federal 
Register. The ITC meets monthly and produces its revisions to the List 
with administrative and technical support from the ITC staff and 
contract support provided by EPA. ITC members and staff are listed at 
the end of this Report.

II. TSCA Section 8 Reporting

A. TSCA Section 8 Rules

    Following receipt of the ITC's Report by the EPA Administrator and 
addition of chemicals to the Priority Testing List, the EPA's Office of 
Pollution Prevention and Toxics (OPPT) promulgates TSCA section 8(a) 
Preliminary Assessment Information Reporting (PAIR) and TSCA section 
8(d) Health and Safety Data (HaSD) rules for chemicals added to the 
List. These rules require producers and importers of chemicals 
recommended by the ITC to submit production and exposure reports under 
TSCA section 8(a) and producers, importers, and processors of chemicals 
recommended by the ITC to submit unpublished health and safety studies 
under TSCA section 8(d). These rules are automatically promulgated by 
OPPT unless requested not to do so by the ITC.

B. ITC's Use of TSCA Section 8 and ``Other Information''

    The ITC reviews the TSCA section 8(a) PAIR reports, TSCA section 
8(d) HaSD studies, and ``other information'' that becomes available 
after the ITC adds chemicals to the List. ``Other information'' 
includes 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, ITC-FYI voluntary submissions, 
unpublished data submitted to U.S. Government organizations represented 
on the ITC, published papers, as well as use, exposure, effects, and 
persistence data that are voluntarily submitted to the ITC by 
manufacturers, importers, processors, and users of chemicals 
recommended by the ITC. The ITC reviews this information and determines 
if data needs should be revised, if chemicals should be removed from 
the List, or if recommendations should be changed to designations.

C. Policy Promoting More Efficient Use of TSCA Section 8 Resources

    In its 40th Report (62 FR 30580, June 4, 1997) (FRL-5718-3), the 
ITC proposed the Voluntary Information Submissions Policy (VISP) to 
promote more efficient use of TSCA section 8 resources. After the 40th 
and 41st (63 FR 17658, April 9, 1998) (FRL-5773-5) Reports were 
delivered to the EPA Administrator, the VISP was revised and posted on 
the ITC's web site (http://www.epa.gov/opptintr/itc/visp.htm). 
Revisions to the VISP included eliminating the need to submit a list of 
studies, changing the milestone for notifying the ITC Director from 30 
to 60 days, and providing clearer guidance for submitting electronic 
data. The VISP is part of the ITC's Voluntary Information Submissions 
Innovative Online Network

[[Page 42556]]

(VISION) that is described in the ITC's web site (http://www.epa.gov/
opptintr/itc/vision.htm). The ITC's VISION currently includes the VISP, 
the TSCA Electronic HaSD Reporting Form (http://cyber22.dcoirm.epa.gov/
oppt/tsca.nsf/HaSDForm?openform), and instructions for the Form (http:/
/www.epa.gov/opptintr/itc/tsca-hlp.htm). The VISP provides examples of 
data needed by ITC member U.S. Government organizations, examples of 
studies that should not be submitted, the 60-, 90- and 120-day 
milestones for meeting the objectives of the VISP, guidelines for using 
the TSCA Electronic HaSD Reporting Form, and instructions for 
electronically submitting full studies. The ITC implemented the VISP in 
its 41st Report for the alkylphenols, alkylphenol ethoxylates, and 
polyalkylphenols recommended in its 37th (61 FR 4188, February 2, 1996) 
(FRL-4991-6), 39th (62 FR 8578, February 25, 1997) (FRL-5580-9), and 
41st Reports.

III. ITC's Dialogue Group Activities During this Reporting Period 
(November 1997 to May 1998)

 Alkylphenols and Ethoxylates (AP&E)

    The Chemical Manufacturers Association (CMA)-ITC AP&E Dialogue 
Group was formed by the CMA's AP&E Panel and the ITC's AP&E 
Subcommittee in March 1996 following the submission of the ITC's 37th 
Report to the EPA Administrator in November 1995. The Group was created 
to facilitate the ITC's retrieval of information on uses, exposures and 
health, and ecological effects of alkylphenols and alkylphenol 
ethoxylates, and the Panel's understanding of data needed by the U.S. 
Government organizations represented on the Subcommittee. Since the 
creation of this Dialogue Group, numerous activities have occurred: see 
the ITC's 38th (61 FR 39832, July 30, 1996) (FRL-5379-2), 39th, 40th, 
and 41st Reports. As a result of the Dialogue Group activities, the 
Panel voluntarily provided the ITC with a database of 255 studies for 
the alkylphenols and alkylphenol ethoxylates recommended in the 37th 
Report and the nonylphenol ethoxylates recommended in the 39th Report. 
In addition, at least 25 non-Panel member companies provided 240 
submissions on alkylphenols and alkylphenol ethoxylates (each 
submission contains one or more studies) in response to the TSCA 
section 8(d) rule for the alkylphenols and alkylphenol ethoxylates 
recommended in the 37th Report.
    The AP&E Dialogue Group met twice during this reporting period. On 
February 11 and April 22, 1998, the Dialogue Group met to discuss:
    1. Use and exposure data for certain alkylphenols and alkylphenol 
ethoxylates.
    2. Progress and results of ongoing environmental and toxicological 
studies being conducted or sponsored by chemical manufacturers on the 
Panel, (e.g., mammalian in vitro and in vivo toxicology, mammalian 
pharmacokinetic, biodegradation, aquatic toxicity, and avian acute 
toxicity studies).
    3. The ITC's VISION.
    4. Information being generated by the Society of the Plastics 
Industry (e.g., dialogue with the Food and Drug Administration (FDA) to 
estimate dietary exposure to tris-nonylphenyl phosphite, nonylphenyl 
ethoxylates, and nonylphenols).
    5. Historic AP&E monitoring and research conducted by the U.S. 
Geological Survey.
    6. Recent AP&E monitoring conducted by the Silent Spring Institute 
(published in Environmental Science and Technology 32:861-869; 1998).
    7. EPA's ambient water quality criteria document for nonylphenol.
    8. OPPT's Risk Management-1 (RM-1) document on p-nonylphenol.
    9. Organization for Economic Cooperation and Development (OECD) 
Screening Information Data Set (SIDS) dossiers on nonylphenol and 
nonylphenol ethoxylates.
    10. European nonylphenol ethoxylates risk reduction activities.

IV. 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.

                       Table 2.--Revisions to the TSCA Section 4(e) Priority Testing List                       
----------------------------------------------------------------------------------------------------------------
               CAS No.                      Chemical name                Action                    Date         
----------------------------------------------------------------------------------------------------------------
16691-43-3..........................  3-Amino-5-mercapto-1,2,4- Recommended............  May 1998               
                                       triazole.                                                                
496-46-8............................  Glycoluril..............  Recommended............  May 1998               
109-87-5............................  Methylal................  Recommended............  May 1998               
78-10-4.............................  Ethyl silicate..........  Recommended............  May 1998               
----------------------------------------------------------------------------------------------------------------

A. Chemicals Added to the Priority Testing List

    At this time, the ITC is requesting that the EPA not promulgate a 
TSCA section 8(d) rule for any of the recommended chemicals. The ITC is 
encouraging producers, importers, processors, and users of the 
recommended chemicals to use its VISION (http://www.epa.gov/opptintr/
itc/vision.htm) to provide voluntary electronic information submissions 
and establish a dialogue with the ITC to discuss needed data.
    1. 3-Amino-5-mercapto-1,2,4-triazole
    i. Recommendation. 3-Amino-5-mercapto-1,2,4-triazole is being 
recommended to obtain annual production/importation volumes and trends, 
use, exposure, and health effects data needed by U.S. Government 
organizations represented on the ITC.
    ii. Rationale for recommendation. 3-Amino-5-mercapto-1,2,4-triazole 
is being considered for health effects testing based on concerns 
related to effects on thyroid hormone activity. Before designating 3-
amino-5-mercapto-1,2,4-triazole for priority testing consideration by 
the EPA Administrator, the ITC wants to review the PAIR data and the 
needed data listed below:
    iii. Data needed
    a. Recent non-Confidential Business Information (CBI) estimates of 
annual production or importation volume data and trends.1
---------------------------------------------------------------------------

    1E-mail voluntary information submissions to 
[email protected].
---------------------------------------------------------------------------

    b. Use information, including percentages of production or 
importation that are associated with different uses.1
    c. Estimates of the number of humans and concentrations of 3-amino-
5-mercapto-1,2,4-triazole to which humans may be exposed from use, 
manufacturing, or processing.1
    d. Health effects.2
---------------------------------------------------------------------------

    2Provide voluntary information submissions through http://
www.epa.gov/opptintr/itc/vision.htm.
---------------------------------------------------------------------------

    iv. Supporting information. There is a need to determine potential 
toxicity of

[[Page 42557]]

3-amino-5-mercapto-1,2,4-triazole based on concerns related to effects 
on thyroid hormone activity (Ref. 3, Takaoka et al., 1994). Non-CBI 
data reported to the EPA indicated that about 250,000 pounds of 3-
amino-5-mercapto-1,2,4-triazole were imported into the United States in 
1993. 3-Amino-5-mercapto-1,2,4-triazole is reportedly used in organic 
synthesis, processing of silver halide photographic materials, as an 
antioxidant for aluminum and as a viscosity index improver, dispersant, 
and antioxidant for lubricating oils. No published data were found on:
    a. Environmental releases.
    b. Environmental fate.
    c. Occupational exposures.
    d. Concentrations of 3-amino-5-mercapto-1,2,4-triazole to which 
humans may be exposed.
 A few data related to potential effects were found. 3-Amino-5-
mercapto-1,2,4-triazole was not included in the National Institute for 
Occupational Safety and Health (NIOSH) National Occupational Exposure 
Survey (NOES), and guidelines for occupational exposures have not been 
established by NIOSH or Occupational Safety and Health Administration 
(OSHA). Schafer et al. (Ref. 2, 1982) reported that 3-amino-5-mercapto-
1,2,4-triazole has an LD50 > 316 mg/kg body weight of quails 
(Coturnix coturnix). 3-Amino-5-mercapto-1,2,4-triazole was reported to 
be one of five chemicals structurally related to 3-amino-1,2,4-triazole 
(Amitrol), a herbicide that affected thyroid hormone activity 
(Ref. 3, Takaoka et al., 1994). In studies with rats, 3-amino-5-
mercapto-1,2,4-triazole was also reported to be a metabolite of 
Amitrol (Ref. 1, Grunow et al., 1975).
    2. Glycoluril
    i. Recommendation. Glycoluril is being recommended to obtain annual 
production/importation volumes and trends, use, exposure and health 
effects data needed by U.S. Government organizations represented on the 
ITC.
    ii. Rationale for recommendation. Glycoluril is under review for 
carcinogenicity testing based on a potential for human exposure and a 
suspicion of carcinogenicity. The suspicion of carcinogenicity is based 
on a potential for the formation of a nitrosamide. A document prepared 
for the U.S. Government organization nominating glycoluril to the ITC 
is available on the ITC's web site (glycoluril document) and in the 
TSCA Docket for the ITC's 42nd Report (Ref. 5, TRI, 1997b). Before 
designating glycoluril for priority testing consideration by the EPA 
Administrator, the ITC wants to retrieve and review the most current 
data on exposures and health effects. Data already included in the 
glycoluril document should not be submitted to the ITC. Data needed are 
listed below.
    iii. Data needed
    a. Recent non-CBI estimates of annual production or importation 
volume data and trends.1
    b. Use information, including percentages of production or 
importation that are associated with different uses.1
    c. Estimates of the number of humans and concentrations of 
glycoluril to which humans may be exposed from use, manufacturing or 
processing.1
    d. Health effects.2
    iv. Supporting Information. Data reported to the EPA in 1986, 1990 
and 1994 indicated that the non-CBI annual production/importation 
volumes for glycoluril ranged from 10,000 to 1,000,000 pounds. 
Available use information suggested that glycoluril may be used as a 
slow-release nitrogen fertilizer, but its use may be limited because of 
the chemical's cost. It has also been reported that glycoluril resins 
have been used in paint and coating formulations. No published data 
were found on:
    a. Environmental releases.
    b. Environmental fate.
    c. Ecological effects.
    d. Health effects.
    e. Occupational exposures.
    f. Concentrations of glycoluril to which humans may be exposed. 
Glycoluril was not listed in the Registry of Toxic Effects of Chemical 
Substances (RTECS) or in NIOSH's NOES and guidelines for occupational 
exposures have not been established by NIOSH or OSHA.
    3. Methylal
    i. Recommendation. Methylal is being recommended to obtain 
production/importation volume data and trends, use, exposure, health 
effects, especially in vivo mammalian metabolism and chronic effects 
data needed by U.S. Government organizations represented on the ITC.
    ii. Rationale for recommendation. Methylal is under review for 
carcinogenicity testing based on its potential for human exposure and a 
suspicion of carcinogenicity. The suspicion of carcinogenicity is based 
on mutagenicity data from a number of bacterial and mammalian systems 
and the potential for methylal to be metabolized to formaldehyde, a 
rodent carcinogen. A document prepared for the U.S. Government 
organization nominating methylal to the ITC is available on the ITC's 
web site (methylal document) and in the TSCA Docket for the ITC's 42nd 
Report (Ref. 6, TRI, 1997c). Before designating methylal for priority 
testing consideration by the EPA Administrator, ITC wants to retrieve 
and review the most current data on exposures and health effects. Data 
already included in the methylal document should not be submitted. Data 
needed are listed below.
    iii. Data needed
    a. Recent non-CBI estimates of annual production or importation 
volume data and trends.1
    b. Use information, including percentages of production or 
importation that are associated with different uses.1
    c. Estimates of the number of humans and concentrations of methylal 
to which humans may be exposed from use, manufacturing, or 
processing.1
    d. Health effects, especially, in vivo mammalian metabolism and 
chronic effects.2
    iv. Supporting information. Data reported to the EPA in 1990 
indicated that the non-CBI annual production/importation volume for 
methylal was in the range of 1.2 to 6.4 million pounds. Methylal is 
reportedly used in perfumery, as a chemical intermediate in the 
manufacture of artificial resins and in organic synthesis, a solvent, 
and a special fuel. NOES human exposure data from 1981-1983 were found, 
as well as threshold limit values for human exposures. According to the 
NOES, 156,795 workers, including 21,092 female employees, were 
potentially exposed to methylal. No published data were found on the 
ecological effects of methylal, in vivo mammalian metabolism, chronic 
effects or concentrations of methylal to which humans were exposed. 
Published acute, subchronic, mutagenic effects, environmental releases, 
and environmental fate data were located as well as some metabolism 
data.
    4. Ethyl silicate
    i. Recommendation. Ethyl silicate is being recommended to obtain 
production/importation volume data and trends, use, exposure and health 
effects, especially in vivo mammalian mutagenicity and subchronic or 
chronic effects data needed by U.S. Government organizations 
represented on the ITC.
    ii. Rationale for recommendation. Ethyl silicate is under review 
for mutagenicity and subchronic or chronic toxicity testing based on 
potential human exposures and suspicions of genotoxicity or 
carcinogenicity. These suspicions are based on in vitro mammalian 
mutagenicity data. A document prepared for the U.S. Government 
organization nominating ethyl silicate to the ITC is available on the 
ITC's web site (ethyl silicate

[[Page 42558]]

document) and in the TSCA Docket for the ITC's 42nd Report (Ref.4, TRI, 
1997a). Before designating ethyl silicate for priority testing 
consideration by the EPA Administrator, the ITC wants to retrieve and 
review the most current data on exposures and health effects. Data 
already included in the ethyl silicate document should not be submitted 
to the ITC. The ITC has an ongoing dialogue with the Silicones 
Environmental Health and Safety Council (SEHSC) related to previously-
recommended siloxanes and anticipates that SEHSC will establish a 
dialogue with the ITC to discuss data needed for ethyl silicate. Data 
needed are listed below.
    iii. Data needed
    a. Recent non-CBI estimates of annual production or importation 
volume data and trends.1
    b. Use information, including percentages of production or 
importation that are associated with different uses.1
    c. Estimates of the number of humans and concentrations of ethyl 
silicate to which humans may be exposed from use, manufacturing or 
processing.1
    d. Health effects, especially in vivo mammalian mutagenicity and 
subchronic or chronic effects.2
    iv. Supporting information. In the ITC's 28th Report (56 FR 41212, 
August 19, 1991), ethyl silicate and 36 other alkoxysilanes were 
recommended for ecological effects testing. In its 32nd Report (58 FR 
38490, July 16, 1993), at EPA's request, all 37 alkoxysilanes were 
removed from the Priority Testing List, before TSCA section 8(a) PAIR 
or section 8(d) HaSD rules were promulgated (58 FR 38490, July 16, 
1993). At the time alkoxysilanes were removed from the List, the EPA 
indicated that other chemicals had a higher priority than the 
alkoxysilanes. The ITC acknowledged that there were no existing U.S. 
Government data needs, but agreed to reconsider any of these chemicals 
if data were needed in the future.
    Data reported to the EPA indicated that the non-CBI annual 
production/importation volume for ethyl silicate was in the range of 7 
to 20 million pounds in 1989 and 1 to 100 million pounds in 1993.
    Ethyl silicate is reportedly used in weatherproofing and hardening 
stone; in the manufacture of weatherproof and acid-proof mortars, 
cements, refractory bricks, other molded objects; in heat- and 
chemical-resistant paints, protective coatings for industrial buildings 
and castings; in lacquers, as abonding agent; and as a chemical 
intermediate. NOES data from 1981-1983 were found as well as threshold 
limit values for human exposures, and data on concentrations of ethyl 
silicate to which humans may be exposed. According to the NOES, 10,422 
workers, including 2,566 female employees, were potentially exposed to 
ethyl silicate. No published available data were found on:
    1. Environmental releases.
    2. Ecological effects.
    3. Chronic health effects.
    4. Mutagenicity from in vivo mammalian test systems.
Published data included those related to:
    1. Acute and subchronic effects.
    2. Metabolism.
    3. Mutagenicity from in vitro mammalian test systems.

V. References

     All references are available in the TSCA Docket for the ITC's 42nd 
Report. The TSCA Docket is located in the TSCA Nonconfidential 
Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC.
    1. Grunow, W., H.J Altman, and C. Boehme. Uber den Staffwechsel von 
3-Amino-1,2,4-triazol in Ratten [On the Metabolism of 3-Amino-1,2,4-
triazole in Rats]. Archives of Toxicology. 34(4):315-324. 1975.
    2. Schafer, Jr., E.W., R.B. Brunton, E.C. Schafer, and G. Chavez. 
Effects of 77 Chemicals on Reproduction in Male and Female Coturnix 
Quail. Ecotoxicology and Environmental Safety. 6:149-156. 1982.
    3. Takaoka, M., M. Teranishi, and S. Manabe. Structure-Activity 
Relationships in 5-Substituted 3-Amino-1,2,4-Triazoles-Induced Goiters 
in Rats. Journal of Toxicology and Pathology. 7:429-434. 1994.
    4. TRI. 1997a. Ethyl Silicate--summary of data for chemical 
selection by the National Cancer Institute (NCI) Chemical Selection 
Working Group. Prepared by Technical Resources International, Inc. 
under NCI Contract No. NO2-CB-50511 (1/96; rev. 9/96, rev. 8/97).
    5. TRI. 1997b. Glycoluril--summary of data for chemical selection 
by the National Cancer Institute (NCI) Chemical Selection Working 
Group. Prepared by Technical Resources International, Inc. under NCI 
Contract No. NO2-CB-50511 (6/97; rev. 9/97).
    6. TRI. 1997c. Methylal--summary of data for chemical selection by 
the National Cancer Institute (NCI) Chemical Selection Working Group. 
Prepared by Technical Resources International, Inc. under NCI Contract 
No. NO2-CB-50511 (7/96; rev. 8/97).

VI. TSCA Interagency Testing Committee

    Statutory Organizations and Their Representatives

    Council on Environmental Quality
        Brad Campbell, Member
        Juliet Healey, Alternate

     Department of Commerce

          National Institute of Standards and Technology
            Malcolm W. Chase, Member
            Barbara C. Levin, Alternate

          National Oceanographic and Atmospheric Administration
            Nancy Foster, Member
            Teri Rowles, Alternate
            Richard S. Artz, Alternate

     Environmental Protection Agency
        Paul Campanella, Member
        David R. Williams, 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
        Albert E. Munson, Member
        Christine Sofge, Alternate

    National Science Foundation
        A. Frederick Thompson, Member
        Joseph Reed, Alternate

    Occupational Safety and Health Administration
        Lyn Penniman, Member
        Val H. Schaeffer, Alternate

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

    Consumer Product Safety Commission
        Jacqueline Ferrante, Member

    Department of Agriculture
        Clifford P. Rice, Member

    Department of Defense
        Colonel Richard Drawbaugh, Member
        Captain Kenneth Still, Alternate

    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
        Scott Sherlock, OPPT, EPA

    Technical Support Contractor

[[Page 42559]]

        Syracuse Research Corporation

    ITC Staff
        John D. Walker, Executive Director
        Norma S.L. Williams, Executive Assistant

TSCA Interagency Testing Committee, Environmental Protection Agency, 
Office of Pollution Prevention and Toxics (MC/7401), 401 M St., SW., 
Washington, DC 20460, telephone: 202-260-1825, fax: 202-260-7895, e-
mail: [email protected], url: http://www.epa.gov/opptintr/itc.

[FR Doc. 98-21206 Filed 8-6-98; 8:45 am]
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