[Federal Register Volume 61, Number 147 (Tuesday, July 30, 1996)]
[Notices]
[Pages 39832-39838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19333]


      
      

[[Page 39831]]


_______________________________________________________________________

Part X





Environmental Protection Agency





_______________________________________________________________________



Thirty-Eighth Report of the TSCA Interagency Testing Committee to the 
Administrator Receipt of Report, Request for Comments, Solicitation of 
Use and Exposure Data

  Federal Register / Vol. 61, No. 147 / Tuesday, July 30, 1996 / 
Notices  

[[Page 39832]]



ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41045; FRL-5379-2]


Thirty-Eighth Report of the TSCA Interagency Testing Committee to 
the Administrator Receipt of Report, Request for Comments, Solicitation 
of Use and Exposure Data

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-Eighth Report to the Administrator of the EPA on 
May 31, 1996. In its Thirty-Eighth Report, which is included with this 
notice, the ITC revises the Priority Testing List by adding a group of 
18 nonylphenol ethoxylates to the List for consideration by the EPA 
Administrator for promulgation of test rules under section 4(a) of the 
Act. The ITC also removes two previously recommended High Production 
Volume Chemicals (HPVC), two previously designated Oxygenated Fuel 
Additives and previously recommended white phosphorus. The ITC's 
reasons for removing these chemicals from the List are described in the 
Thirty-Eighth Report. There are no designated or recommended with 
intent-to-designate chemicals or chemical groups in the Thirty-Eighth 
Report. EPA invites interested persons to submit written comments on 
the Report.
DATES: Written comments on the Thirty-Eighth ITC Report should be 
submitted by August 29, 1996.

ADDRESSES: Comments on the Thirty-Eighth Report should be submitted to 
both the ITC and the TSCA Public Docket. Send one copy of written 
submissions to: John D. Walker, ITC Executive Director, U.S. EPA 
(7401), 401 M St., SW., Washington, DC 20460. Send six copies of 
written submissions to: TSCA Public Docket Office (7407), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, Rm. 
B-607 NEM, 401 M St., SW., Washington, DC 20460.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic comments 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number OPPTS-41045. No ``Confidential Business Information'' 
(CBI) should be submitted through e-mail. Electronic comments on the 
Thirty-Eighth Report may be filed online at many Federal Depository 
Libraries. Additional information on electronic submissions can be 
found in Unit III of this document.
    The public record supporting this action, including comments, is 
available for public inspection in Rm. B-607 NEM at the address noted 
above from 12:00 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 Street, 
SW., Rm. ET-543B,Washington, DC 20460, (202) 554-1404, TDD (202) 554-
0551, e-mail: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency 
Testing Committee's Thirty-Eighth 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. The most recent revisions to this List are included in 
the ITC's Thirty-Eighth Report. The Report was received by the 
Administrator on May 31, 1996, and is included in this Notice. The 
Report recommends a group of 18 nonylphenol ethoxylates to the list and 
removes white phosphorus, 2 High Production Volume Chemicals (HPVC) and 
2 Oxygenated Fuel Additives from the list.

II. Status of List

    The current TSCA section 4(e) Priority Testing List contains 2 
chemicals and 10 chemical groups; of these 2 chemicals and 3 chemical 
groups were designated for testing.
    A notice will be published at a later date in the Federal Register 
adding certain of the substances recommended in the ITC's Thirty-Eighth 
Report to the TSCA section 8(d) Health and Safety Data Reporting Rule 
(40 CFR part 716), which requires the reporting of unpublished health 
and safety studies on the listed chemicals. That notice will also add 
certain of the chemicals to the TSCA section 8(a) Preliminary 
Assessment Information Rule (40 CFR part 712). The section 8(a) rule 
requires the reporting of production volume, use, exposure, and release 
information on the listed chemicals.

III. Electronic and Oral Comments

    The EPA invites interested persons to submit detailed comments on 
the ITC's Report.
    A record has been established for this notice under docket number 
[OPPTS-41045] (including comments and data 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, excluding legal holidays. The public 
record is located in the TSCA Non-confidential Information Center, Rm. 
NE-B607, 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 ecryption.
    The official record for the Thirty-Eighth 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.
    Authoriy: 15 U.S.C. 2603.

    Dated: July 18, 1996.

Charles M. Auer,

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

Thirty-Eighth Report of the Interagency Testing Committee to the 
Administrator

Summary

    This is the 38th Report of the TSCA Interagency Testing Committee 
(ITC) to the Administrator of the U.S.

[[Page 39833]]

Environmental Protection Agency (EPA). In this Report, the ITC is 
revising its TSCA section 4(e) Priority Testing List by recommending 18 
nonylphenol ethoxylates and removing white phosphorus, 2 High 
Production Volume Chemicals (diethylene glycol monoethyl ether acetate 
and diethylene glycol dimethyl ether), and 2 Oxygenated Fuel Additives 
(ethyl tert-butyl ether and tert-amyl methyl ether). 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 Section4(e) Priority Testing List (May 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             Acetone             Designated        
28.........  May 1991             Thiophenol          Designated        
29.........  November 1991        10 Alkyl-, bromo-,  Recommended       
                                   chloro-,                             
                                   hydroxymethyl                        
                                   diaryl ethers                        
30.........  May 1992             13 Siloxanes        Recommended       
31.........  January 1993         24 Chemicals with   Designated        
                                   no dermal                            
                                   toxicity data                        
32.........  May 1993             32 Chemicals with   Designated        
                                   insufficient                         
                                   dermal absorption                    
                                   data                                 
35.........  November 1994        24 Chemicals with   Designated        
                                   insufficient                         
                                   dermal absorption                    
                                   data                                 
36.........  May 1995             10 High Production  Recommended       
                                   Volume Chemicals                     
37.........  November 1995        28 Alkylphenols     Recommended       
                                   and Ethoxylates                      
38.........  May 1996             18 Nonylphenol      Recommended       
                                   Ethoxylates                          
------------------------------------------------------------------------

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 37 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.
    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. The 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'' studies, ``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.

II. 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         
----------------------------------------------------------------------------------------------------------------
  ...................................  Nonylphenol ethoxylates  Recommended              5/96                   
                                        (NPEs)                                                                  
07311-27-5...........................  Ethanol, 2-[2-[2-[2-(p-                                                  
                                        nonylphenoxy)                                                           
                                        ethoxy]ethoxy]ethoxy]-                                                  
09016-45-9...........................  Nonylphenol                                                              
                                        polyethylene glycol                                                     
                                        ether                                                                   
20636-48-0a..........................                                                                           
26027-38-3a..........................                                                                           
26064-02-8a..........................                                                                           
27177-01-1a..........................                                                                           
37205-87-1a..........................                                                                           
20427-84-3...........................  Ethanol, 2-[2-(p-                                                        
                                        nonylphenoxy)ethoxy]-                                                   
26027-38-3...........................  p-Nonylphenol                                                            
                                        polyethylene glycol                                                     
                                        ether                                                                   
27986-36-3a..........................                                                                           
37205-87-1a..........................                                                                           
98113-10-1a..........................                                                                           
26571-11-9...........................  Nonylphenol                                                              
                                        octa(oxyethylene)ethan                                                  
                                        ol                                                                      
27176-93-8...........................  Nonylphenoxydiglycol                                                     
27177-05-5...........................  Nonylphenol                                                              
                                        hepta(oxyethylene)etha                                                  
                                        nol                                                                     
27177-08-8...........................  Nonylphenol                                                              
                                        nona(oxyethylene)ethan                                                  
                                        ol                                                                      
27986-36-3...........................  Nonylphenoxy ethanol                                                     
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                                                                 

[[Page 39834]]

                                                                                                                
65455-72-3...........................  Decaethylene glycol,                                                     
                                        isononylphenyl ether                                                    
68412-54-4...........................  Nonylphenoxypolyoxyetha                                                  
                                        nol                                                                     
152143-22-1a.........................                                                                           
127087-87-0..........................  Nonylphenol                                                              
                                        polyethylene glycol                                                     
                                        ether                                                                   
NAb..................................  Nonoxynol-2                                                              
NA...................................  Nonoxynol-3                                                              
NA...................................  Nonoxynol-7                                                              
NA...................................  alpha-(p-Nonylphenol)-                                                   
                                        omega-                                                                  
                                        hydroxypoly(oxyethylen                                                  
                                        e)                                                                      
                                                                                                                
7723-14-0............................  White phosphorus         Remove previously        5/96                   
                                                                 designated chemical                            
12185-10-3a..........................                                                                           
----------------------------------------------------------------------------------------------------------------
  ...................................  High Production Volume   Remove previously        5/96                   
                                        Chemicals                recommended chemicals                          
111-96-6.............................  Diethylene glycol                                                        
                                        dimethyl ether                                                          
112-15-2.............................  Diethylene glycol                                                        
                                        monoethyl ether                                                         
                                        acetate                                                                 
----------------------------------------------------------------------------------------------------------------
  ...................................  Oxygenated Fuel          Remove previously        5/96                   
                                        Additives                recommended chemicals                          
637-92-3.............................  Ethyl tert-butyl ether                                                   
994-05-8.............................  Tert-amyl methyl ether                                                   
----------------------------------------------------------------------------------------------------------------
a Alternate CAS number.                                                                                         
b Not Assigned                                                                                                  



III. Rationale for the revisions

A. ITC's Activities During this Reporting Period

    Alkylphenols and ethoxylates, isocyanates and siloxanes. During the 
six months covered by this Report, the ITC evaluated several chemicals 
and chemical groups and the ITC's Subcommittees met with two Chemical 
Manufacturers Association (CMA) Panels and the Silicones Environmental 
Health and Safety Council (SEHSC). To facilitate communication between 
U.S. Government organizations needing data on alkylphenols and 
ethoxylates and the manufacturers, importers, processors, users and 
distributors of these chemicals, an ITC Subcommittee and the CMA's 
Alkylphenols and Ethoxylates Panel established the ITC-CMA Alkylphenols 
and Ethoxylates Dialog Group. To learn more about potential consumer 
uses of isocyanates, the ITC's Isocyanates Subcommittee met with the 
CMA's Diisocyanates Panel. To promote cogent discussions of siloxanes 
health and safety data the ITC's Siloxanes Subcommittee continued to 
meet with SEHSC.
    Diaryl ethers. The ITC is evaluating published and unpublished data 
for the diaryl ethers recommended in its 29th Report (56 FR 67424, 
December 30, 1991). The ITC is interested in meeting with 
manufacturers, importers, processors, and users of these chemicals to 
discuss use and exposure data and to develop Structure Activity 
Relationships for predicting potential degradability and safety.

B. Specific Rationales

    1. Recommended chemicals-- a. Nonylphenol ethoxylates. 
Recommendation. Nonylphenol ethoxylates are being added to the Priority 
Testing List to obtain TSCA section 8(a) exposure information and TSCA 
section 8(d) health and safety studies.
    Rationale for recommendation. Nonylphenol ethoxylates are being 
recommended to meet the data needs of the Department of the Interior, 
the EPA, and the Food and Drug Administration. Currently, these needs 
include data on chemical composition of components and impurities, 
environmental fate of components and impurities and health and 
ecological effects, toxicokinetics and potential endocrine-modulating 
effects. The ITC will consider information discussed during meetings of 
the ITC-CMA Alkylphenols and Ethoxylates Dialog Group and review 
documents submitted under TSCA section 8 before determining if these 
chemicals should be removed from the Priority Testing List or 
designated for testing to meet U.S. Government data needs.
    Nonylphenol ethoxylates are also being recommended to supplement 
the list of alkylphenols and ethoxylates that was recommended in the 
37th Report (61 FR 4188, February 2, 1996)(FRL-4991-6). The rationale 
described in the 37th Report for alkylphenols and ethoxylates also 
applies to the nonylphenol ethoxylates listed in Table 2.
    Supporting information--Nonylphenol ethoxylates. The Substructure-
based Computerized Chemical Selection Expert System (SuCCSES) is used 
to identify chemicals with shared substructures and associated health 
or ecological effects and similar TSCA production or importation 
volumes (Ref. 16). SuCCSES was used to identify the alkylphenols and 
ethoxylates that were added to the Priority Testing List in the 37th 
Report.
    After the 37th Report was transmitted to the EPA Administrator, the 
ITC-CMA Alkylphenols and Ethoxylates Dialog Group developed a strategy 
to identify important nonylphenol ethoxylates. First, a nonylphenol 
ethoxylate substructure from SuCCSES and a nonylphenol ethoxylate name 
fragment was used to search the original TSCA Inventory. Second, the 
nonylphenol ethoxylates identified by this search were compared to 
those listed in the Code of Federal Regulations title 21, parts 174-186 
(indirect food additives), the Cosmetic Toiletries and Fragrances 
Association Dictionary, the U.S. Pharmacopoeia/National Formulary and 
the Food Chemical News Guide. Third, the nonylphenol ethoxylates 
identified by this comparison were screened against nonylphenol 
ethoxylates in the OPD Chemical Buyers Directory, McHutcheon's 
Functional Materials and Chemcyclopedia '96. This strategy produced a 
list of 18 nonylphenol ethoxylates (Table 2). For these 18 nonylphenol 
ethoxylates there were several Chemical Abstract Service (CAS) numbers 
including alternate CAS

[[Page 39835]]

numbers, and several chemical names including many synonyms (Table 3).

    Table 3.-- Chemical Names, Synonyms and Ethoxylate Units (EO) for   
 Nonylphenol Ethoxylates Added to the Revised TSCA Section 4(e) Priority
                              Testing List                              
------------------------------------------------------------------------
                                                               Average  
          Chemical Names                   Synonyms           Number of 
                                                               EO Units 
------------------------------------------------------------------------
Ethanol,2-[2-[2-[2-(p-             Nonoxynol-4                         4
 nonylphenoxy)                                                          
 ethoxy]ethoxy]ethoxy]-.                                                
Nonylphenol polyethylene glycol    Ethoxylated nonylphenol           > 1
 ether.                                                                 
  ...............................  Nonylphenol polyglycol            > 1
                                    ether                               
  ...............................  Nonylphenol polyethylene          > 1
                                    oxide                               
  ...............................  Nonylphenoxypoly(oxyethy          > 1
                                    lene)ethanol                        
  ...............................  Poly(oxy-1,2-                     > 1
                                    ethanediyl), alpha-                 
                                    (nonylphenyl)-omega-                
                                    hydroxy                             
  ...............................  Poly(oxyethylene) mono            > 1
                                    (nonylphenol) ether                 
  ...............................  Nonoxynol-5                       > 5
  ...............................  Nonoxynol-6                       > 6
Ethanol, 2-[2-(p-                                                    1.5
 nonylphenoxy)ethoxy]-.                                                 
p-Nonylphenol polyethylene glycol  Glycols, polyethylene,            > 1
 ether.                             mono(p-nonylphenyl)                 
                                    ether                               
  ...............................  Alpha-(p-nonylphenyl)-            > 1
                                    omega-                              
                                    hydroxypoly(oxyethylene             
                                    )                                   
  ...............................  Nonoxynol-1                     > 1.5
Nonylphenol                        Nonoxynol-9                         9
 octa(oxyethylene)ethanol.                                              
Nonylphenoxydiglycol.............  Ethanol, 2-[2-                      2
                                    (nonylphenoxy)ethoxy-               
Nonylphenol                        Nonylphenol                         8
 hepta(oxyethylene)ethanol.         octaethoxylate                      
  ...............................  Nonylphenol octaglycol              8
                                    ether                               
  ...............................  Nonoxynol-8                         8
Nonylphenol                        Nonylphenol decaethylene           10
 nona(oxyethylene)ethanol.          glycol ether                        
Nonylphenoxyethanol..............  Nonylphenoxyglycol              1-1.5
  ...............................  Ethanol, 2-                     1-1.5
                                    (nonylphenoxy)-                     
Poly(oxy-1,2-ethanediyl), alpha-                                     > 1
 (isononylphenyl)-omega-hydroxy.                                        
Poly(oxy-1,2-ethanediyl), alpha-                                      >1
 (2-nonylphenyl)-omega-hydroxy.                                         
Decaethylene glycol,                                                  10
 isononylphenyl ether.                                                  
Nonylphenoxypolyoxyethanol.......  Poly(oxy-1,2-                     > 1
                                    ethanediyl), alpha-                 
                                    (nonylphenyl) omega-                
                                    hydroxy - branched                  
Nonylphenol polyethylene glycol    Poly(oxy-1,2-                     > 1
 ether.                             ethanediyl), alpha (4-              
                                    nonylphenyl)-omega-                 
                                    hydroxy - branched                  
Nonoxynol-2......................                                      2
Nonoxynol-3......................                                      3
Nonoxynol-7......................                                      7
alpha-(p-Nonylphenol)-omega-                                    1 to 100
 hydroxypoly(oxyethylene).                                              
------------------------------------------------------------------------

    During development of the strategy by the ITC-CMA Alkylphenols and 
Ethoxylates Dialog Group, issues related to the complex nomenclature 
and chemical composition of nonylphenol ethoxylates were discussed. 
During these discussions, it was recognized that for some nonylphenol 
ethoxylates it is possible to quantify the average number of ethoxylate 
(EO) units, while for others that are complex mixtures or polymers, it 
is only possible to state that the average number of EO units is > 1 
(Table 3). Obtaining recent production and importation volumes for 
nonylphenol ethoxylates that are complex mixtures or polymers was a 
concern for the Dialog Group because these chemicals were exempt from 
reporting requirements of the EPA's 1986, 1990 and 1994 TSCA section 
8(a) Inventory Update Rules (51 FR 21438, June 12, 1986; 55 FR 39586, 
September 27, 1990; 59 FR 30652, June 14, 1994). However, the Dialog 
Group recognized that the TSCA section 8(a) Preliminary Assessment 
Information Rule (PAIR) that EPA automatically promulgates for any 
chemicals that the ITC adds to the Priority Testing List requires the 
submission of recent production and importation volume data for all 
chemicals on the List, including complex mixtures or polymers. The ITC 
will review the PAIR data for all alkylphenols and ethoxylates that are 
on the List and use these data as well as use and exposure data and 
other information provided to the ITC-CMA Alkylphenols and Ethoxylates 
Dialog Group to determine which alkylphenols and ethoxylates should be 
removed from the List and which should be considered for designation.
    Existing U.S. Government data needs. The ITC identified the same 
data needs for nonylphenol ethoxylates that were identified for 
alkylphenols and alkylphenol ethoxylates in its 37th Report. These data 
needs are summarized above in the rationale for recommendation.
    Completed activities of the ITC-CMA Alkylphenols and Ethoxylates 
Dialog Group. The Dialog Group discussed the history of the ITC's 
recommendation, nomenclature issues, chemical composition data, uses of 
alkylphenols and ethoxylates, ongoing testing and (as discussed above) 
strategies for identifying nonylphenol ethoxylates. The Dialog Group 
discussed the TSCA Test Submissions (TSCATS) compatible database that 
the SEHSC-ITC-EPA workgroup developed for silicone chemicals. The 
Dialog Group committed to develop a database for alkylphenols and 
ethoxylates that would include elements that were compatible with 
TSCATS, the Confidential Business Information Tracking System (CBITS) 
and the TSCA submissions electronic cover sheet and abstract form.
    2. Removal of Chemicals from the Priority Testing List-- a. White 
Phosphorus. Based on concerns of the Department of Interior (DOI), 
white phosphorus was recommended for chemical fate and ecological 
effects testing in the ITC's 29th Report (56 FR 67424, December 30, 
1991). These concerns included the paucity of data on the persistence 
of white phosphorus in wetland sediments, the adverse

[[Page 39836]]

effects of white phosphorus to birds and wildlife that feed on 
sediments contaminated with white phosphorus, and the potential for 
food chain effects including possible elimination of endangered species 
that may feed on carcasses of birds and wildlife that die from white 
phosphorus poisoning. In response to the ITC's recommendations, the EPA 
added white phosphorus (CAS number 7723-14-0) to TSCA section 8(a) and 
8(d) rules (58 FR 13556, March 12, 1993). This CAS number also applies 
to yellow, red and black phosphorus. After these rules were published, 
the ITC asked EPA to add a second, less commonly used CAS number 
(12185-10-3) for white phosphorus to TSCA section 8 rules to assure 
retrieval of unpublished TSCA section 8 data that were indexed on that 
CAS number. The EPA added this CAS number to TSCA section 8 rules that 
were published on December 27, 1993 (58 FR 68311). The ITC reviewed 
published data and data submitted in response to these rules. These 
data demonstrated the persistence of white phosphorus in sediments, but 
did not provide any new information to alleviate the DOI's concerns for 
the ecological effects of white phosphorus. As a result, the ITC 
designated white phosphorus for ecological effects testing in its 34th 
Report (59 FR 35720, July 13, 1994).
    The ITC did not receive any comments on the EPA's Toxic Release 
Inventory (TRI) data for white phosphorus that were referenced in its 
29th Report. In this Report, the ITC referenced the 1988 and 1989 TRI 
which reported that over 3,000,000 pounds of white phosphorus were 
released to the environment. Prior to publishing its 34th Report, the 
ITC considered whether data from the 1991 and 1992 TRI (which reported 
that about 300,000 pounds of white phosphorus were released to the 
environment) would be sufficient environmental release to justify a 
designation under TSCA section 4(e)(1)(A)(ii). Under this section of 
TSCA, the ITC must consider ``the quantities in which the substance or 
mixture enters or will enter the environment'' before designating any 
chemical to the EPA Administrator for priority testing consideration. 
The ITC determined that these releases were sufficient and referenced 
the 1991 and 1992 TRI in its 34th Report when it designated white 
phosphorus. After the 34th Report was published, the EPA received a 
letter from the CMA which identified serious errors in white phosphorus 
environmental release data reported by industry under the requirements 
of the TRI (Ref. 5). According to the CMA, the 1993 TRI releases of 
white phosphorus should have been about 27,000 pounds, not 318,000 
pounds (Ref. 5). According to the 1994 TRI (which includes releases 
from Federal facilities) about 50,000 pounds of white phosphorus were 
released to the environment (Ref. 15).
    After reviewing the 1995 CMA letter and the 1994 TRI data, EPA 
requested that the ITC withdraw its designation of white phosphorus 
because ``errors made by industry in TRI reporting have resulted in a 
serious misconception about the actual environmental releases of white 
phosphorus and 1994 TRI data indicate that environmental releases of 
white phosphorus are almost an order of magnitude less than that upon 
which the ITC based it decision to designate this chemical for testing 
under section 4 of TSCA'' (Ref. 8). In this request EPA also committed 
``to explore alternative ways to have the needed testing conducted'' 
(Ref. 8).
    After reviewing the 1994 TRI data, letters from the CMA and the 
EPA, and considering EPA's commitment to explore alternative testing 
mechanisms, the ITC is withdrawing its designation and removing white 
phosphorus from the Priority Testing List.
    b. Oxygenated Fuel Additives. The ITC designated the oxygenated 
fuel additive, methyl tert-butyl ether (MTBE) (CAS number 1634-04-4) 
for health effects testing in its 20th Report because of concerns for 
widespread human exposure to low level fugitive emissions of MTBE at 
gasoline pumps and the need for chronic health effects data (52 FR 
19020; May 20, 1987). In response to the ITC's designation, the EPA and 
MTBE manufacturers negotiated a TSCA section 4 Enforceable Consent 
Agreement (ECA) to develop pharmacokinetics, genotoxicity, subchronic 
toxicity, reproductive effects, developmental toxicity, neurotoxicity, 
and oncogenicity data (53 FR 10391, March 31, 1988). The ITC removed 
MTBE from the Priority Testing List in its 22nd Report (53 FR 18196, 
May 20, 1988). EPA and other Federal Agencies continue to assess the 
risks of human exposure to MTBE.
    Subsequent to this designation, the ITC recommended ethyl tert-
butyl ether (ETBE) (CAS number 637-92-3) and tert-amyl methyl ether 
(TAME) (CAS number 994-05-8) for health effects testing to meet the 
data needs of the U.S. EPA (59 FR 35720, July 13, 1994). Subsequently, 
EPA promulgated TSCA section 8(a) and 8(d) rules for ETBE and TAME (59 
FR 60716, November 28,1994) and met with ETBE and TAME manufacturers to 
discuss testing to meet these data needs.
    On September 21, 1994, and March 23, 1995, the EPA received letters 
from the ARCO Chemical Company announcing their intention to 
voluntarily conduct health effects tests for ETBE (Refs. 1 and 2). 
These letters indicate that pharmacokinetics, genotoxicity, subchronic 
toxicity, and neurotoxicity testing will be conducted first, followed 
by developmental toxicity and reproductive effects testing. EPA's 
Office of Pollution Prevention and Toxics (OPPT) added ETBE to its 
Master Testing List (MTL) as a member of the category of ``Oxygenated 
Fuel Additives'' to obtain test data to support ongoing activities in 
EPA's Office of Air and Radiation (OAR).
    On March 21, 1995, OPPT published a TSCA section 4 ECA for TAME (60 
FR 14910)(FRL-4935-4). The ECA requires pharmacokinetics, genotoxicity, 
subchronic toxicity, developmental toxicity, and reproductive toxicity 
testing. Testing will be conducted by the TAME Producers Group which is 
comprised of the following companies: Amerada Hess Corporation, Chevron 
U.S.A. Products Company, Citgo Petroleum, Exxon Company U.S.A., and 
Texaco Refining and Marketing. In addition, TAME is being considered 
for inclusion in the Screening Information Data Set (SIDS) program, a 
voluntary international testing program operated under the auspices of 
the Organization for Economic Cooperation and Development (OECD). OPPT 
also added TAME to its MTL as a member of the ``Oxygenated Fuel 
Additives'' category to obtain test data to support ongoing OAR 
activities.
    The ITC is removing ETBE and TAME from the Priority Testing List at 
this time because testing programs for both chemicals are likely to 
meet EPA's data needs. If further testing of ETBE or TAME is needed, 
the EPA may request that the ITC designate the chemicals for testing. 
In the future, the EPA may nominate other oxygenated fuel additives to 
the ITC.
    c. High Production Volume Chemicals (HPVCs)/Glycol Ethers. 
Diethylene glycol monoethyl ether acetate (DGEEA) (CAS number 112-15-2) 
and diethylene glycol dimethyl ether (DGDME) (CAS number 111-96-6) were 
members 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). SuCCSES was used to select these HPVCs during the ITC's 
sixth scoring exercise. These HPVCs had annual production volumes 
exceeding 1 million pounds, but no 90-day subchronic toxicity data to 
identify

[[Page 39837]]

potential health effects concerns. In its 36th Report (60 FR 42982, 
August 17, 1995)(FRL-4965-6), the ITC solicited specific use and 
exposure information on DGEEA, DGDME, and ten other 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), Eastman 
Chemical Company and Ferro Corporation responded to that solicitation 
for DGEEA and DGDME, respectively (Refs. 7 and 9). Both DGEEA and DGDME 
are used as solvents in various applications. Ferro reported that DGDME 
is also used in reaction medium for the synthesis of certain chemicals 
and that the use of DGDME as a solvent in semiconductor cleaning 
operations has decreased. In their letters, both manufacturers stated 
that exposures to DGEEA and DGDME are low.
    Although 90-day subchronic toxicity studies are not available for 
DGEEA or DGDME, existing toxicity data on these and related glycol 
ethers and acetates indicate that such studies are not necessary to 
further identify potential health effects concerns.
    DGEEA is expected to be metabolized to diethylene glycol monoethyl 
ether (DGEE) (CAS number 111-90-0), based on the metabolism of other 
glycol ether acetates (Ref. 13). Subchronic toxicity studies in which 
rats, mice and pigs were fed DGEE for 90 days have been conducted (Ref. 
10). There was reduced growth in rats and mice at the highest dose 
levels (5.0% and 5.4%, respectively). Hemoglobin was reduced and 
relative kidney weights increased in all 3 species at the highest dose 
levels. In pigs (the most sensitive species in this study), three 
deaths due to uremia were recorded within the first 3 weeks of exposure 
at the highest dose level of 1,500 mg/kg after which the dose was 
reduced to 1,000 mg/kg. The no-observed effect levels established from 
these studies were 250 mg/kg/day for rats, 850 to 1,000 mg/kg/day for 
mice and 167 mg/kg/day for pigs. These DGEE data satisfy the need for 
subchronic toxicity testing of DGEEA.
    DGDME caused dose-dependent testicular toxicity in male rats 
following short-term (10 to 20 days) exposure by inhalation (Ref. 12) 
and oral administration (Ref. 4). DGDME also caused developmental 
toxicity when administered to rabbits (Ref. 14) and pregnant CD-1 mice 
(Ref. 11). Following administration of doses of DGDME, to the male rat 
(Ref. 3) and the pregnant CD-1 mouse (Ref. 6) some of the DGDME was 
metabolized to the well-studied reproductive toxicant, ethylene glycol 
monomethyl ether (EGME) (CAS number 109-86-4), and its toxic 
metabolite, methoxyacetic acid. Since 10- to 20-day repeated dose 
studies with DGDME have identified potential toxicities of concern, 90-
day subchronic toxicity testing for the purposes of general toxicity 
screening is not warranted.
    The ITC is removing DGEEA and DGDME from the Priority Testing List 
because sufficient screening data exist to identify potential 
subchronic toxicities of concern and no additional U.S. Government data 
needs were identified at this time.

References

    1. ARCO. Letter from Dr. Larry S. Andrews, Manager, Toxicology 
Regulatory Compliance, ARCO Chemical Company to Mr. Charles M. Auer, 
Director, Chemical Control Division, OPPT/EPA, Washington, DC 
(1994).
    2. ARCO. Letter from Dr. Larry S. Andrews, Manager, Toxicology 
Regulatory Compliance, ARCO Chemical Company to Mr. Charles M. Auer, 
Director, Chemical Control Division, OPPT/EPA, Washington, DC 
(1995).
    3. Cheever, K.L., Richards, D.E., Weigal, W.W., Lal, J.B. 
Dinsmore, A.M. and Daniel, F.B. Metabolism of Bis (2-methoxyethyl) 
Ether in the Adult Male Rat: Evaluation of the Principal Metabolite 
as a Testicular Toxicant. Toxicology and Applied Pharmacology. 
94:150-159 (1988).
    4. Cheever, K.L., Weigal, W.W., Richards, D.E., Lal, J.B., and 
Plotnick, H.B. Testicular Effects of Bis (2-methoxyethyl) Ether in 
the Adult Male Rat. Toxicology and Industrial Health. 5:1099-1110 
(1989).
    5. CMA. Letter from Ms. Cecilia W. Spearing, Manager, Chemical 
Manufacturers Association's Phosphorus Panel to Mr. Charles M. Auer, 
Director, Chemical Control Division, OPPT/EPA, Washington, DC 
(1995).
    6. Daniel, F.B., Cheever, K.L. Bagley, K.B., Richards, D.E., 
Weigal, W.W., and Eisenmann, C.J. Bis (2-methoxyethyl) Ether: 
Metabolism and Embryonic Disposition of a Developmental Toxicant in 
the Pregnant CD-1 Mouse. Fundamental and Applied Toxicology. 16:567-
575 (1991).
    7. Eastman. Letter from Dr. Roderick D. Gerwe, Senior Technical 
Associate, Eastman Chemical Company, Kingsport, Tennessee to Dr. 
John D. Walker, Executive Director, ITC, OPPT/EPA, Washington, DC 
(1995).
    8. EPA. March 5, 1996 Letter from Mr. Charles M. Auer, Director, 
Chemical Control Division, OPPT/EPA, Washington, DC to Dr. Victor 
Fung, Chairperson, ITC, National Cancer Institute, Bethesda, MD 
(1996).
    9. Ferro. Letter from Mr. Edward J. Ballow, Product Manager, 
Ferro Corporation, Zachary, Louisiana to Dr. John D. Walker, 
Executive Director, ITC, OPPT/EPA, Washington, DC (1995).
    10. Gaunt, I.F., Colley, J., Grasso, P., Landsdown, A.B.G., and 
Gangolli, S.D. Short-term Toxicity of Diethylene Glycol Monoethyl 
Ether in the Rat, Mouse, and Pig. Food and Cosmetics Toxicology. 
6:689-705 (1968).
    11. Hardin, B.D. and Eisenmann, C.J. Relative Potency of Four 
Ethylene Glycol Ethers for Induction of Paw Malformations in the CD-
1 Mouse. Teratology. 35:321-328 (1987).
    12. Lee, K.P., Kinney, L.A., and Valentine, R. Comparative 
Testicular Toxicity of Bis (2-methoxyethyl) ether and 2-
methoxyethanol in rats. Toxicology. 59:239-258 (1989).
    13. NTP. Project Report No. 11 ``The In Vitro Hydrolysis of 2-
Methoxyethyl Acetate, 2-Ethoxyethyl Acetate and 2-Butoxyethyl 
Acetate by Rat Blood.'' Study report submitted to the National 
Toxicology Program (NTP) by Research Triangle Institute under 
Contract No. N01-ES-1- 5007 (1986).
    14. Schwetz, B.A., Price, C.J., George, J.D., Kimmel, C.A., 
Morrissey, R.E., and Marr, M.C. The Developmental Toxicity of 
Diethylene and Triethylene Glycol Dimethyl Ethers in Rabbits. 
Fundamental and Applied Toxicology. 19:238-245 (1992).
    15. TRI (Toxic Release Inventory). Database retrieval 3/1/96. 
U.S. Environmental Protection Agency (1996).
    16. 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).

TSCA Interagency Testing Committee

Statutory Organizations and Their Representatives

    Council on Environmental Quality
        Brad Campbell, Member
        Ann Holbrow, Alternate

     Department of Commerce
        Edward White, Member

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

    National Cancer Institute
        Victor Fung, Member
        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
        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


[[Page 39838]]


    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, (202) 260-1825, Fax (202) 260-7895; Internet: 
[email protected].

[FR Doc. 96-19333 Filed 7-29-96; 8:45 am]
BILLING CODE 6560-50-F