97-4620. Thirty-Ninth Report of the TSCA Interagency Testing Committee (ITC) to the Administrator; Receipt of Report, Request for Comments  

  • [Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
    [Notices]
    [Pages 8578-8583]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-4620]
    
    
    
    [[Page 8577]]
    
    _______________________________________________________________________
    
    Part III
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
    _______________________________________________________________________
    
    
    
    Thirty-Ninth Report of the Interagency Testing Committee to the 
    Administrator; Receipt of Report, Request for Comments; Notice
    
    Federal Register / Vol. 62, No. 37 / Tuesday, February 25, 1997 / 
    Notices
    
    [[Page 8578]]
    
    
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    [OPPTS-41046; FRL-5580-9]
    
    
    Thirty-Ninth Report of the TSCA Interagency Testing Committee 
    (ITC) to the Administrator; Receipt of Report, 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 Thirty-Ninth Report to the Administrator of the EPA on 
    November 27, 1996. In the Thirty-Ninth Report, which is included with 
    this Notice, the ITC revised the TSCA section 4(e) Priority Testing 
    List by recommending 2,4,6-tribromophenol, re-recommending 23 
    nonylphenol ethoxylates and removing 5 siloxanes. Moreover, the ITC 
    requested that EPA stay certain provisions in the Agency's October 29, 
    1996, TSCA section 8(a) and 8(d) information reporting rules for the 
    nonylphenol ethoxylates recommended in the ITC's Thirty-Eighth Report
        There are no designated or recommended with intent-to-designate 
    chemicals or chemical groups in the Thirty-Ninth Report. EPA invites 
    interested persons to submit written comments on the Report.
    DATES: Written comments on the Thirty-Ninth ITC Report should be 
    received by March 27, 1997.
    
    ADDRESSES: Comments on the Thirty-Ninth 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 docket number OPPTS-41046.
        Comments may also be submitted electronically by sending electronic 
    mail (e-mail) to: walker.johnd@epamail.epa.gov or to the EPA at: 
    ncic@epamail.epa.gov. 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 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 number OPPTS-41046. No TSCA ``Confidential Business 
    Information'' (CBI) should be submitted through e-mail. Electronic 
    comments on the Thirty-Ninth 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, 
    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 Thirty-Ninth 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 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 Thirty-Ninth Report
    
        The most recent revisions to the Priority Testing List are included 
    in the ITC's Thirty-Ninth Report. The Report was received by the EPA 
    Administrator on November 27, 1996, and is included in this Notice. The 
    Report recommends 2,4,6-tribromophenol, re-recommends 23 nonylphenol 
    ethoxylates and removes 5 siloxanes from the Priority Testing List. 
    2,4,6-Tribromophenol is being recommended to meet the data needs of the 
    National Institute of Environmental Health Sciences (NIEHS). The 
    nonylphenol ethoxylates are being re-recommended to meet the data needs 
    of the Department of the Interior (DOI), the EPA, the Food and Drug 
    Administration (FDA) and the NIEHS and to eliminate any ambiguities in 
    TSCA section 8(a) and 8(d) reporting resulting from the previous use of 
    alternate Chemical Abstracts Service (CAS) registry numbers in the 
    ITC's Thirty-Eighth Report (61 FR 39832; July 30, 1996; FRL-5379-2). 
    The ITC re-examined these alternate CAS registry numbers and determined 
    that five were not associated with any of the listed nonylphenol 
    ethoxylate chemical names. In the Thirty-Ninth Report, the ITC revised 
    the list of nonylphenol ethoxylates by providing Ninth Collective Index 
    names for all CAS-numbered nonylphenol ethoxylates, including the five 
    not previously associated with a unique chemical name. This process 
    eliminated the need for alternate CAS registry numbers. The ITC 
    requested that the EPA stay certain provisions in the October 29, 1996, 
    TSCA section 8(a) and 8(d) rules (61 FR 55871; FRL-5397-9) promulgated 
    for the nonylphenol ethoxylates originally recommended in the ITC's 
    Thirty-Eighth Report (61 FR 39832; July 30, 1996; FRL-5379-2). The EPA 
    issued the stay which was published on December 11, 1996 (61 FR 65186; 
    FRL-5577-5). Nothing in this Notice changes the status of the stayed 
    rules affecting the nonylphenol ethoxylates. These rules remain stayed, 
    and the EPA will address their future status in a subsequent Federal 
    Register Notice.
    
    III. Status of the Priority Testing List
    
        The current TSCA section 4(e) Priority Testing List contains 1 
    individual chemical and 11 chemical groups; of these, 4 chemical groups 
    were designated for testing.
    
    IV. Electronic Comments
    
        The EPA invites interested persons to submit detailed comments on 
    the ITC's Thirty-Ninth Report.
        A record has been established for this Notice under docket number 
    OPPTS-41046 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 TSCA ``Confidential Business Information'' (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 Non-
    Confidential Information Center, Rm. NE-B-607, Environmental Protection 
    Agency, 401 M St., SW., Washington, DC 20460. Electronic comments can 
    be sent directly to the ITC at: walker.johnd@epamail.epa.gov and to the 
    EPA at: ncic@epamail.epa.gov.
    
    [[Page 8579]]
    
        Electronic comments must be submitted as an ASCII file avoiding the 
    use of special characters and any form of security 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 Thirty-Ninth 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.
        Authority: 15 U.S.C. 2603.
    
        Dated: February 13, 1997.
    
    Charles M. Auer,
    
    Director, Chemical Control Division, Office of Pollution Prevention and 
    Toxics.
    
    Administrator, U.S. Environmental Protection Agency
    
    Summary
    
         This is the 39th 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 recommending 2,4,6-tribromophenol, re-
    recommending 23 nonylphenol ethoxylates and removing 5 siloxanes. 
    2,4,6-Tribromophenol is being recommended to meet the data needs of the 
    National Institute of Environmental Health Sciences (NIEHS). The 
    nonylphenol ethoxylates are being re-recommended to meet the data needs 
    of the Department of the Interior (DOI), the EPA, the Food and Drug 
    Administration (FDA) and the NIEHS and to eliminate any ambiguities in 
    TSCA section 8(a) and 8(d) reporting resulting from the previous use of 
    alternate CAS numbers in the ITC's 38th Report (61 FR 39832, July 30, 
    1996). 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 (November 1996)                     
    ----------------------------------------------------------------------------------------------------------------
                    Report                           Date                Chemical/Group               Action        
    ----------------------------------------------------------------------------------------------------------------
    26...................................  May 1990                 10 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-,       Recommended            
                                                                     chloro-, 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                 10 High Production       Recommended            
                                                                     Volume Chemicals                               
                                                                     (HPVCs)                                        
    37...................................  November 1995            28 Alkylphenols and      Recommended            
                                                                     Ethoxylates                                    
    39...................................  November 1996            23 Nonylphenol           Recommended            
                                                                     Ethoxylates                                    
    39...................................  November 1996            2,4,6-Tribromophenol     Recommended            
    ----------------------------------------------------------------------------------------------------------------
    
    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 6 months..., the Committee shall make such 
    revisions in the 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 38 semi-annual 
    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. ITC's Activities During this Reporting Period (May to October, 
    1996)
    
        Alkylphenols and ethoxylates. The ITC-Chemical Manufacturers 
    Association (CMA) Alkylphenols and Ethoxylates Dialog Group met to 
    discuss environmental monitoring, ecological effects, biodegradation 
    and mammalian toxicology studies. This Dialog Group was established to 
    facilitate the ITC's retrieval of information on uses, exposures and 
    effects of alkyphenols and ethoxylates, and the CMA's understanding of 
    data needed by the DOI, the FDA, the EPA and the NIEHS.
        Siloxanes. The ITC-Silicones Environmental Health and Safety 
    Council (SEHSC) Dialog Group met to discuss ongoing health effects and 
    exposure studies. This Dialog Group was established to facilitate the 
    ITC's retrieval of information on uses, exposures and effects of 
    siloxanes, and the SEHSC's understanding of data needed by the FDA.
        Isocyanates. During this reporting period, the ITC received 
    information from the CMA's Diisocyanates Panel. The ITC's Isocyanates 
    Subcommittee will review this information and discuss potential 
    consumer uses, occupational exposures and health effects of isocyanates 
    with the CMA Panel.
        High Production Volume Chemicals (HPVCs). Through its 36th Report 
    and letters to manufacturers and importers of HPVCs, the ITC is 
    receiving use and exposure data for the 10 HPVCs remaining on the 
    Priority Testing List. The ITC is reviewing these data.
        Diaryl ethers. The ITC has identified manufacturers and importers 
    of diaryl
    
    [[Page 8580]]
    
    ethers and is interested in working with them to obtain use and 
    exposure data. Diaryl ethers were recommended in the ITC's 29th Report 
    (56 FR 67424, December 30, 1991). An invitation to discuss use and 
    exposure data and to develop Structure Activity Relationships for 
    diaryl ethers was announced in the ITC's 38th Report (61 FR 39832, July 
    30, 1996)(FRL-5379-2).
        2,4,6-Tribromophenol. Representatives of the ITC met with the CMA's 
    Brominated Flame Retardants Industry Panel (BFRIP) Manager and 
    representatives from a 2,4,6-tribromophenol manufacturer to discuss the 
    data needs of the NIEHS. The ITC representatives provided the CMA with 
    a copy of the National Toxicology Program (NTP) data summary for 2,4,6-
    tribromophenol (Ref. 5, NTP, 1996). The 2,4,6-tribromophenol 
    manufacturer's representatives provided the ITC with a list of health 
    effects, chemical fate, and ecological effects studies that were 
    previously submitted under TSCA section 8(d) and reviewed by the ITC. 
    These representatives also provided the ITC with a list of 2,4,6-
    tribromophenol producers, applications, commercial activities and sales 
    statistics. The ITC is interested in promoting a dialog that is 
    mutually beneficial to the NIEHS and the BFRIP.
    
    III. TSCA Section 8 Reporting
    
        Following receipt of the ITC's Report and the addition of chemicals 
    to the Priority Testing List, 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 rule's effective date. Unless otherwise noted in Unit IV A of this 
    ITC Report, the ITC is requesting that the EPA exempt manufacturers and 
    importers of chemicals added to the List from submitting studies 
    conducted on mixtures (e.g., formulated products) containing a subject 
    substance at a level below 1 percent of the mixture, unless a purpose 
    of the study includes the investigation of the effects of an 8(d) rule-
    listed substance at levels below 1 percent (40 CFR 716.20(b)(4)).
        TSCA section 8(a) and 8(d) submissions are indexed and 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 8(e) ``substantial risk'' notices, ``For Your Information'' 
    (FYI) submissions to EPA, 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 recommended 
    testing, or removing the chemical or chemical group from the List.
    
    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         
    ----------------------------------------------------------------------------------------------------------------
    118-79-6............................  2,4,6-Tribromophenol      Recommended              11/96                  
                                           Nonylphenol ethoxylates  Recommended              11/96                  
    7311-27-5...........................  Ethanol, 2-[2-[2-[2-(4-                                                   
                                           nonylphenoxy)                                                            
                                           ethoxy]ethoxy]ethoxy]-                                                   
    9016-45-9...........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-                                                    
                                           (nonylphenyl)-.omega.-                                                   
                                           hydroxy-                                                                 
    20427-84-3..........................  Ethanol, 2-[2-(4-                                                         
                                           nonylphenoxy)ethoxy]-                                                    
    20636-48-0..........................  3,6,9,12-                                                                 
                                           Tetraoxatetradecan-1-                                                    
                                           ol, 14-(4-nonylphenoxy)-                                                 
                                                                                                                    
    26027-38-3..........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-(4-                                                 
                                           nonylphenyl)-.omega.-                                                    
                                           hydroxy-                                                                 
    26264-02-8..........................  3,6,9,12-                                                                 
                                           Tetraoxatetradecan-1-                                                    
                                           ol, 14-(nonylphenoxy)-                                                   
    26571-11-9..........................  3,6,9,12,15,18,21,24-                                                     
                                           Octaoxahexacosan-1-ol,                                                   
                                           26-(nonylphenoxy)-                                                       
    27176-93-8..........................  Ethanol, 2-[2-                                                            
                                           (nonylphenoxy)ethoxy]-                                                   
    27177-01-1..........................  3,6,9,12,15-                                                              
                                           Pentaoxaheptadecan-1-                                                    
                                           ol, 17-(nonylphenoxy)-                                                   
    27177-05-5..........................  3,6,9,12,15,18,21-                                                        
                                           Heptaoxatricosan-1-ol,                                                   
                                           23-(nonylphenoxy)-                                                       
    27177-08-8..........................  3,6,9,12,15,18,21,24,27-                                                  
                                           Nonaoxanonacosan-1-ol,                                                   
                                           29-(nonylphenoxy)-                                                       
    27986-36-3..........................  Ethanol, 2-                                                               
                                           (nonylphenoxy)-                                                          
    37205-87-1..........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-                                                    
                                           (isononylphenyl)-                                                        
                                           .omega.-hydroxy-                                                         
    51938-25-1..........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-(2-                                                 
                                           nonylphenyl)-.omega.-                                                    
                                           hydroxy-                                                                 
    65455-72-3..........................  3,6,9,12,15,18,21,24,27-                                                  
                                           Nonaoxanonacosan-1-ol,                                                   
                                           29-(isononylphenoxy)-                                                    
    68412-54-4..........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-                                                    
                                           (nonylphenyl)-.omega.-                                                   
                                           hydroxy-, branched                                                       
    98113-10-1..........................  NP 9                                                                      
    127087-87-0.........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-(4-                                                 
                                           nonylphenyl)-.omega.-                                                    
                                           hydroxy-, branched                                                       
    152143-22-1.........................  Poly(oxy-1,2-                                                             
                                           ethanediyl), .alpha.-(4-                                                 
                                           nonylphenyl)-.omega.-                                                    
                                           hydroxy-, branched,                                                      
                                           phosphates                                                               
    NAa.................................  Nonoxynol-2                                                               
    NA..................................  Nonoxynol-3                                                               
    NA..................................  Nonoxynol-7                                                               
    NA..................................  .alpha.-(4-Nonylphenol)-                                                  
                                           .omega.-hydroxypoly-                                                     
                                           (oxyethylene)-                                                           
                                                 5 Siloxanes        Remove previously        11/96                  
                                                                     Recommended chemicals                          
    69430-24-6..........................  Cyclopolydimethylsiloxan                                                  
                                           e (Dx)                                                                   
    68083-14-7..........................  Dimethyl, diphenyl                                                        
                                           siloxanes and silicones                                                  
    67762-90-7..........................  Dimethyl silicones and                                                    
                                           siloxanes, reaction                                                      
                                           products with silica                                                     
    68037-74-1..........................  Dimethylmonomethylpolysi                                                  
                                           loxanes                                                                  
    70131-67-8..........................  Dimethyl silicones and                                                    
                                           siloxanes hydroxy                                                        
                                           terminated                                                               
    ----------------------------------------------------------------------------------------------------------------
    aNot Assigned.                                                                                                  
    
    
    [[Page 8581]]
    
    A. Chemicals Added to the Priority Testing List
    
        Recommendations
        a. 2,4,6-Tribromophenol-- rationale for recommendation. The ITC is 
    recommending 2,4,6-tribromophenol at this time because the NIEHS needs 
    chronic toxicology and 2-year carcinogenesis study data. As part of its 
    continuing efforts to coordinate testing activities, the ITC is 
    recommending and not designating 2,4,6-tribromophenol because it is 
    currently promoting a dialog between a 2,4,6-tribromophenol 
    manufacturer and the NIEHS to explain the need for chronic toxicity and 
    2-year carcinogenesis study data.
        Background. Previous activities of the ITC, EPA and NTP for 2,4,6-
    tribromophenol are summarized below.
        ITC. In the ITC's 25th Report, 2,4,6-tribromophenol and six other 
    brominated flame retardants were recommended for chronic health effects 
    testing, chronic ecological effects testing, and physical/chemical 
    properties and persistence testing (54 FR 51114, December 12, 1989). In 
    response to the 25th Report, as noted below, the EPA required the 
    submission of TSCA section 8(a) and 8(d) data.
        In the ITC's 33rd Report, 2,4,6-tribromophenol was removed from the 
    Priority Testing List to give adequate priority to testing needs for 
    other chemicals, e.g., those with U.S. Government data needs (59 FR 
    3764, January 26, 1994). At the time 2,4,6-tribromophenol was removed 
    from the List, the ITC acknowledged that there were no existing U.S. 
    Government data needs, but agreed to reconsider the chemical if data 
    were needed in the future.
        At this time, the ITC is requesting that the EPA not promulgate 
    additional TSCA section 8 rules for 2,4,6-tribromophenol for the 
    following reasons. First, the ITC has reviewed the TSCA section 8(a) 
    and (d) data submitted under the previously-promulgated rules. Second, 
    under the previously-promulgated TSCA section 8(d) rule, the ITC will 
    learn of any new studies that are initiated. Third, the ITC believes 
    that a dialog with the U.S. producer is likely to provide use and other 
    relevant data that could not be obtained by re-promulgating these 
    rules.
        EPA. 2,4,6-Tribromophenol was included in a 1987 EPA TSCA section 4 
    test rule requiring that manufacturers and importers of 12 chemicals 
    test for the presence of certain chlorinated and brominated dibenzo-p-
    dioxins and dibenzofurans (52 FR 21412, June 5, 1987). None of the 
    seven 2,4,6-tribromophenol samples that were analyzed contained 
    concentrations of brominated dibenzo-p-dioxins and dibenzofurans that 
    were above the levels of quantitation (0.1 ppb for 2,3,7,8-
    tetrabrominated dibenzo-p-dioxin and 1 ppb for 2,3,7,8-tetrabrominated 
    dibenzofuran).
        2,4,6-Tribromophenol was also included in 1989 EPA TSCA section 8 
    rules promulgated for the ITC. These rules required the submission of 
    production and exposure data and unpublished health and safety data 
    under TSCA sections 8(a) and 8(d), respectively (54 FR 51131, December 
    12, 1989).
        NTP. At the July 15, 1996 meeting of the NTP Interagency Committee 
    for Chemical Evaluation and Coordination, the NIEHS identified data 
    needs for 2,4,6-tribromophenol. The NIEHS needs chronic toxicology and 
    2-year carcinogenesis study data for 2,4,6-tribromophenol based on the 
    absence of toxicology and carcinogenicity data and carcinogenicity data 
    for 2,4,6-trichlorophenol, (Ref. 5, NTP, 1996).
        Existing Data. 2,4,6-Tribromophenol is a chemical intermediate that 
    is produced in closed process equipment, kept within that equipment and 
    reacted to make flame retardants (Ref. 1, GLCC, 1996a). Recent 
    production volumes ranged from 1 to 15 million pounds (Ref. 6, Walker, 
    1994).
        The number of employees involved in the production, packaging, or 
    handling of 2,4,6-tribromophenol is quite small. While the exact number 
    of operators is confidential information, less than 50 workers have the 
    potential for intermittent exposure to 2,4,6-tribromophenol during 
    their normal workday (Ref.1, GLCC, 1996a). The use of closed processes 
    limits potential exposure, but even this exposure is controlled through 
    the use of local exhaust ventilation, personal protective equipment and 
    other industrial hygiene practices where dust or vapor exposure might 
    occur (Ref. 1, GLCC, 1996a). Flaked 2,4,6-tribromophenol contains 
    particles (estimated to be 1 to 10 mm) which do not easily become 
    airborne.
        During domestic production of 2,4,6-tribromophenol, air emissions 
    are regulated by State permits and releases to surface waters either do 
    not occur or occur after discharge to Publicly Owned Treatment Works 
    (Ref. 1, GLCC, 1996a). The only operation where 2,4,6-tribromophenol is 
    not in closed reactors or piping is the flaking and packaging 
    operation. Vapors and fine particulates from this process are 
    controlled by a local exhaust system. Using a ``worst case'' assumption 
    that the manufacturing facility operated 24 hour/day, 365 days per year 
    (8,760 hours), annual point source emissions would be less than 90 
    pounds per year (Ref. 2, GLCC, 1996b).
        2,4,6-Tribromophenol was not found to be mutagenic in the Ames 
    assay (Ref. 8, Zeiger et al., 1987) or in the mouse lymphoma assay 
    (Ref. 4, NCI, 1996). Doses ranging from 2,000 to 8,000 mg/kg were 
    required to produce acute effects in laboratory animals by oral, dermal 
    or inhalation exposures (Ref. 5, NTP, 1996).
        The TSCA section 8 data for 2,4,6-tribromophenol were recently 
    published in two reviews (Refs. 6 and 7, Walker, 1994; 1996). Data 
    cited in the 1996 review indicated that 2,4,6-tribromophenol can be 
    highly toxic to fish (LC50 values <1 mg/l)="" but="" less="" toxic="" to="" daphnids,="" in="" acute="" toxicity="" tests.="" health="" effects="" studies="" cited="" in="" the="" 1994="" review="" are="" summarized="" below.="" in="" a="" 28-day="" dermal="" toxicity="" study,="" groups="" of="" 4="" rabbits/sex/dose="" were="" used.="" doses="" of="" 0,="" 100,="" 300="" and="" 1,000="" mg/kg="" were="" applied="" as="" skin="" suspensions="" 5="" days="" a="" week="" for="" 4="" weeks.="" at="" the="" highest="" dose="" (1,000="" mg/="" kg)="" 1="" male="" rabbit="" died.="" at="" doses="" of="" 100="" and="" 300="" mg/kg="" 2,4,6-="" tribromophenol="" was="" slightly="" irritating,="" but="" there="" were="" no="" treatment-="" related="" effects="" on="" body="" weight,="" clinical="" chemistry="" or="" organ="" weights="" (ref.="" 6,="" walker,="" 1994).="" in="" a="" developmental="" toxicity="" screening="" study,="" groups="" of="" 5="" pregnant="" rats="" were="" administered="" gavage="" doses="" of="" 2,4,6-tribromophenol="" in="" corn="" oil="" from="" gestation="" day="" 6="" to="" 15.="" doses="" of="" 0,="" 10,="" 30,="" 100,="" 300,="" 1,000="" and="" 3,000="" mg/kg/day="" were="" administered.="" all="" rats="" receiving="" 3,000="" mg/kg/day="" died;="" animals="" receiving="" 1,000="" mg/kg/day="" showed="" increased="" post="" implantation="" losses="" and="" a="" slight="" decrease="" in="" number="" of="" viable="" fetuses.="" rats="" receiving="" 300="" mg/kg/day="" or="" less="" showed="" no="" compound-related="" differences="" in="" maternal="" body="" weight,="" number="" of="" viable="" fetuses,="" resorptions,="" implantations="" or="" corpora="" lutea="" when="" compared="" with="" the="" controls="" (ref.="" 6,="" walker,="" 1994).="" in="" an="" inhalation="" study,="" groups="" of="" 5="" male="" and="" 5="" female="" rats="" were="" exposed="" to="" 0,="" 0.1="" and="" 0.9="" mg/l="" 2,4,6-tribromophenol="" for="" 6="" hours/day,="" 5="" days/week="" for="" 3="" weeks.="" exposures="" to="" both="" doses="" of="" 2,4,6-tribromophenol="" produced="" liver="" and="" kidney="" lesions.="" at="" necropsy,="" 4/5="" male="" and="" 5/5="" female="" rats="" in="" the="" 0.1="" mg/l="" dose="" group="" were="" emaciated="" (ref.="" 6,="" walker,="" 1994).="" the="" niehs="" data="" needs="" are="" supported="" by="" carcinogenicity="" data="" for="" a="" close="" structural="" analog,="" 2,4,6-trichlorophenol="" (cas="" no.="" 88-06-2).="" in="" a="" feeding="" study="" 2,4,6-trichlorophenol="" was="" a="" carcinogen="" in="" male="" rats="" and="" male="" and="" female="" mice,="" inducing="" lymphomas="" or="" leukemias="" in="" [[page="" 8582]]="" male="" f344="" rats;="" and="" increasing="" the="" incidence="" of="" hepatocellular="" carcinomas="" or="" adenomas="" in="" male="" and="" female="" b6c3f1="" mice="" (ref.="" 3,="" nci,="" 1979).="" b.="" nonylphenol="" ethoxylates--rationale="" for="" recommendation.="" twenty-="" three="" (23)="" nonylphenol="" ethoxylates="" are="" being="" re-recommended="" to="" eliminate="" any="" ambiguities="" in="" tsca="" section="" 8(a)="" and="" 8(d)="" reporting="" resulting="" from="" the="" previous="" use="" of="" alternate="" cas="" numbers="" in="" the="" itc's="" 38th="" report="" (61="" fr="" 39832,="" july="" 30,="" 1996).="" background.="" eighteen="" (18)="" nonylphenol="" ethoxylates="" were="" recommended="" in="" the="" itc's="" 38th="" report="" (61="" fr="" 39832,="" july="" 30,="" 1996).="" alternate="" cas="" registry="" numbers="" were="" listed="" for="" some="" of="" these="" nonylphenol="" ethoxylates.="" the="" use="" of="" alternate="" cas="" numbers="" produced="" some="" ambiguities="" in="" the="" tsca="" section="" 8(a)="" and="" 8(d)="" rules="" that="" were="" promulgated="" for="" the="" nonylphenol="" ethoxylates="" (61="" fr="" 55871,="" october="" 29,="" 1996).="" the="" itc="" re-examined="" these="" alternate="" cas="" registry="" numbers="" and="" determined="" that="" five="" were="" not="" associated="" with="" any="" of="" the="" listed="" nonylphenol="" ethoxylate="" chemical="" names.="" the="" itc="" revised="" the="" list="" of="" nonylphenol="" ethoxylates="" by="" providing="" ninth="" collective="" index="" names="" for="" all="" cas-numbered="" nonylphenol="" ethoxylates,="" including="" the="" five="" not="" previously="" associated="" with="" a="" unique="" chemical="" name.="" this="" process="" eliminated="" the="" need="" for="" alternate="" cas="" registry="" numbers.="" the="" itc="" is="" requesting="" that="" the="" epa="" stay="" certain="" provisions="" in="" the="" october="" 29,="" 1996="" tsca="" section="" 8(a)="" and="" 8(d)="" rules="" promulgated="" for="" nonylphenol="" ethoxylates="" (61="" fr="" 55871)="" because="" of="" ambiguities="" in="" reporting="" requirements="" associated="" with="" the="" use="" of="" alternate="" cas="" registry="" numbers="" in="" the="" itc's="" 38th="" report="" (61="" fr="" 39832,="" july="" 30,="" 1996).="" the="" itc="" is="" requesting="" that="" the="" epa="" promulgate="" the="" tsca="" section="" 8(a)="" and="" 8(d)="" rules="" using="" the="" 23="" nonylphenol="" ethoxylates="" in="" table="" 2="" of="" this="" itc="" report.="" b.="" chemicals="" removed="" from="" the="" priority="" testing="" list="" silicone="" chemicals.="" fifty-six="" (56)="" silicone="" chemicals="" were="" recommended="" for="" health="" effects="" testing="" in="" the="" itc's="" 30th="" report="" to="" meet="" the="" data="" needs="" of="" the="" food="" and="" drug="" administration="" (fda)="" (57="" fr="" 30608,="" july="" 9,="" 1992).="" after="" this="" recommendation,="" the="" itc's="" silicones="" subcommittee="" established="" a="" dialog="" group="" with="" the="" silicones="" environmental="" health="" and="" safety="" council="" (sehsc).="" the="" itc-sehsc="" dialog="" group="" has="" discussed="" unpublished="" toxicity="" data,="" current="" use="" and="" exposure="" data,="" and="" developed="" a="" prototype="" computer="" file="" of="" physical="" and="" chemical="" properties,="" health="" effects="" and="" use="" data="" that="" could="" be="" used="" by="" other="" government="" and="" trade="" organizations.="" as="" a="" result="" of="" the="" dialog="" group's="" discussions,="" the="" itc="" removed="" 43="" of="" the="" previously-recommended="" silicone="" chemicals="" from="" the="" priority="" testing="" list="" in="" its="" 37th="" report="" (61="" fr="" 4188,="" february="" 2,="" 1996;="" frl-4991-6).="" as="" a="" result="" of="" further="" dialog="" group="" discussions,="" the="" itc="" is="" removing="" five="" more="" siloxanes="" from="" the="" list="" in="" this="" report="" (table="" 3).="" the="" eight="" siloxanes="" remaining="" on="" the="" list="" are="" included="" in="" table="" 4.="" table="" 3.--previously-recommended="" silicone="" chemicals="" removed="" from="" the="" priority="" testing="" list="" ------------------------------------------------------------------------="" cas="" no.="" chemical="" name="" removal="" rationale="" ------------------------------------------------------------------------="" 69430-24-6...................="" cyclopolydimeth="" toxicity="" of="" ylsiloxane="" cyclopolydimethylsiloxa="" (dx)="" ne="" is="" likely="" to="" be="" predicted="" from="" testing="" octamethylcyclotetrasil="" oxane="" (d4),="" decamethylcyclopentasil="" oxane="" (d5)="" and="" dodecamethylcyclohexasi="" loxane="" (d6)="" (see="" table="" 4).="" cyclopolydimethylsiloxa="" ne="" is="" used="" only="" as="" a="" site-limited="" intermediate="" to="" manufacture="" d4,="" d5="" and="" d6.="" 68083-14-7...................="" dimethyl,="" low="" exposure="" potential="" diphenyl="" based="" on="" annual="" siloxanes="" and="" production="" volume="" and="" silicones="" specialized="" uses.="" 67762-90-7...................="" dimethyl="" toxicity="" of="" siloxane="" silicones="" and="" polymers="" bearing="" cas="" siloxanes,="" numbers="" 67762-90-7,="" reaction="" 68037-74-1="" and="" 70131-67-="" products="" with="" 8="" is="" likely="" to="" be="" silica="" predicted="" from="" testing="" dimethyl="" silicones="" and="" siloxanes="" bearing="" cas="" number="" 63148-62-9="" (see="" table="" 4).="" dimethyl="" silicones="" and="" siloxanes="" is="" a="" siloxane="" polymer="" of="" lower="" molecular="" weight,="" lower="" cross-="" linking="" ability="" and="" greater="" bioavailability="" potential="" than="" these="" 3="" siloxane="" polymers.="" 68037-74-1...................="" dimethylmonomet="" toxicity="" of="" siloxane="" hylpolysiloxan="" polymers="" bearing="" cas="" es="" numbers="" 67762-90-7,="" 68037-74-1="" and="" 70131-67-="" 8="" is="" likely="" to="" be="" predicted="" from="" testing="" dimethyl="" silicones="" and="" siloxanes="" bearing="" cas="" number="" 63148-62-9="" (see="" table="" 4).="" dimethyl="" silicones="" and="" siloxanes="" is="" a="" siloxane="" polymer="" of="" lower="" molecular="" weight,="" lower="" cross-="" linking="" ability="" and="" greater="" bioavailability="" potential="" than="" these="" 3="" siloxane="" polymers.="" 70131-67-8...................="" dimethyl="" toxicity="" of="" siloxane="" silicones="" and="" polymers="" bearing="" cas="" siloxanes="" numbers="" 67762-90-7,="" hydroxy="" 68037-74-1="" and="" 70131-67-="" terminated="" 8="" is="" likely="" to="" be="" predicted="" from="" testing="" dimethyl="" silicones="" and="" siloxanes="" bearing="" cas="" number="" 63148-62-9="" (see="" table="" 4).="" dimethyl="" silicones="" and="" siloxanes="" is="" a="" siloxane="" polymer="" of="" lower="" molecular="" weight,="" lower="" cross-="" linking="" ability="" and="" greater="" bioavailability="" potential="" than="" these="" 3="" siloxane="" polymers.="" ------------------------------------------------------------------------="" the="" eight="" siloxanes="" remaining="" on="" the="" priority="" testing="" list="" shown="" in="" table="" 4.="" table="" 4.--siloxanes="" remaining="" on="" the="" priority="" testing="" list="" ------------------------------------------------------------------------="" cas="" no.="" chemical="" name="" ------------------------------------------------------------------------="" cyclic="" siloxanes..........................="" 556-67-2................................="" octamethylcyclotetrasiloxane="" (d4)="" 541-02-6................................="" decamethylcyclopentasiloxane="" (d5)="" 540-97-6................................="" dodecamethylcyclohexasiloxan="" e="" (d6)="" linear="" siloxanes..........................="" 107-46-0................................="" hexamethyldisiloxane="" (l2)="" 107-51-7................................="" octamethyltrisiloxane="" (l3)="" 141-62-8................................="" decamethyltetrasiloxane="" (l4)="" 141-63-9................................="" dodecamethylpentasiloxane="" (l5)="" polymers..................................="" 63148-62-9..............................="" dimethyl="" silicones="" and="" siloxanes="">a..............................                              
      9016-00-6a .............................                              
    ------------------------------------------------------------------------
    aAlternate CAS numbers are listed for this chemical.                    
    
    
    [[Page 8583]]
    
    References
    
        (1) GLCC. November 13, 1996, Letter from Mr. Robert C. Campbell, 
    TSCA Compliance Manager, Great Lakes Chemical Corporation (GLCC), West 
    Lafayette, Indiana to Dr. John D. Walker, Executive Director, ITC, U.S. 
    EPA, Washington, DC (1996a).
        (2) GLCC. November 15, 1996, Letter from Mr. Robert C. Campbell, 
    TSCA Compliance Manager, Great Lakes Chemical Corporation (GLCC), West 
    Lafayette, Indiana to Dr. John D. Walker, Executive Director, ITC, U.S. 
    EPA, Washington, DC (1996b).
        (3) NCI. Bioassay of 2,4,6-trichlorophenol for possible 
    carcinogenicity (CAS No. 88-06-2) (Technical Report Series No. 155; 
    Department of Health Education and Welfare (DHEW) Publication No. (NIH) 
    79-1711). DHEW, Washington, DC. 115 pp. (1979).
        (4) NCI. NCI/DCB Short-term test program. Ames Salmonella 
    typhimurium/mouse lymphoma L5178Y, H. Seifried, Ph.D., Project Officer 
    (1996).
        (5) NTP. Draft NTP data summary for 2,4,6-tribromophenol (CAS No. 
    118-79-6). NTP, Research Triangle Park, NC. 19 pp. (1996).
        (6) Walker, J.D. Testing decisions of the TSCA Interagency Testing 
    Committee for brominated flame retardants: A review of decisions and 
    health and safety data. pp. 185-220. In The Future of Fire Retarded 
    Materials: Applications and Regulation. Fire Retardant Chemicals 
    Association, Lancaster, PA. (1994).
        (7) Walker, J.D. Testing decisions of the TSCA Interagency Testing 
    Committee for chemicals on Canada's Domestic Substances List and 
    Priority Substances List: Di-tert-butylphenol, ethyl benzene, 
    brominated flame retardants, phthalate esters, chloroparaffins, 
    chlorinated benzenes and anilines. pp. 18-54. In T.W. LaPoint, F.T. 
    Price, and E.E. Little (eds.), Environmental Toxicology and Risk 
    Assessment: Fourth Volume, ASTM STP 1241, ASTM, Philadelphia (1996).
        (8) Zeiger, E., B. Anderson, S. Haworth, T. Lawlor, K. Mortelmans 
    and W. Speck. Salmonella mutagenicity tests: III. Results from testing 
    of 255 chemicals. Environmental Molecular Mutagenicity 9 (Suppl.9), 1-
    110 (1987).
    
    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
            H.B. Matthews, Alternate
    
        National Institute for Occupational Safety and Health
            Henryka Nagy, Member, Vice Chair
            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 Rice, Member
    
        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. 
    Internet:walker.johnd@epamail.epa.gov
    
    [FR Doc. 97-4620 Filed 2-24-97; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
02/25/1997
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice.
Document Number:
97-4620
Dates:
Written comments on the Thirty-Ninth ITC Report should be received by March 27, 1997.
Pages:
8578-8583 (6 pages)
Docket Numbers:
OPPTS-41046, FRL-5580-9
PDF File:
97-4620.pdf