[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17658-17665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9396]



[[Page 17657]]

_______________________________________________________________________

Part V





Environmental Protection Agency





_______________________________________________________________________



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

  Federal Register / Vol. 63, No. 68 / Thursday, April 9, 1998 / 
Notices  

[[Page 17658]]



ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41049; FRL-5773-5]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The TSCA Interagency Testing Committee (ITC), established 
under section 4(e) of the Toxic Substances Control Act (TSCA), 
transmitted its Forty-First Report to the Administrator of the EPA on 
November 28, 1997. In the Forty-First Report, which is included with 
this notice, the ITC revised the TSCA section 4(e) Priority Testing 
List by recommending 29 alkylphenol ethoxylates, alkylphenols, and 
polyalkylphenols and removing 6 alkylphenols, 10 diaryl ethers, and 3 
siloxanes.
    There are no designated or recommended with intent-to-designate 
chemicals or chemical groups in the Forty-First Report. EPA invites 
interested persons to submit written comments on the Report.

DATES: Written comments must be received on or before May 11, 1998.

ADDRESSES: Each comment must bear the docket control number OPPTS-
41048. All comments should be sent in triplicate to: OPPT Document 
Control Officer (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower, 
Washington, DC 20460.
    Comments and data may also be submitted electronically to: oppt. 
[email protected]. Follow the instructions under Unit IV of this 
notice. No Confidential Business Information (CBI) should be submitted 
through e-mail.
    All comments which contain information claimed as CBI must be 
clearly marked as such. Three sanitized copies of any comments 
containing information claimed as CBI must also be submitted and will 
be placed in the public record for this notice. Persons submitting 
information on any portion of which they believe is entitled to 
treatment as CBI by EPA must assert a business confidentiality claim in 
accordance with 40 CFR 2.203(b) for each such portion. This claim must 
be made at the time that the information is submitted to EPA. If a 
submitter does not assert a confidentiality claim at the time of 
submission, EPA will consider this as a waiver of any confidentiality 
claim and the information may be made available to the public by EPA 
without further notice to the submitter.

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, telephone: (202) 554-1404, TDD: (202) 554-0551, 
e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency 
Testing Committee's Forty-First 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 Forty-First Report

    The most recent revisions to the Priority Testing List are included 
in the ITC's Forty-First Report. The Report was received by the EPA 
Administrator on November 28, 1997, and is included in this notice. 
Twenty-nine alkylphenol ethoxylates, alkylphenols, and polyalkylphenols 
are being recommended because:
    1. TSCA production and importation volumes are reported in the 
multimillion pound range.
    2. Releases to the environment can occur from wastewater treatment 
and agricultural uses.
    3. Alkylphenol ethoxylates can degrade to alkylphenols, which can 
persist in the environment and be highly toxic to aquatic organisms.
    4. Exposure to alkylphenols and alkylphenol ethoxylates may affect 
endocrine and other important human and animal system functions.
Alkylphenol ethoxylates, alkylphenols, and polyalkylphenols are being 
recommended to determine if there are unpublished studies that contain 
data to meet the needs of the U.S. Government organizations represented 
on the ITC and to complete the list of alkylphenols and alkylphenol 
ethoxylates that were recommended in the ITC's 37th Report (61 FR 4188, 
February 2, 1996)(FRL-4991-6), and 39th Report (62 FR 8578, February 
25, 1997)(FRL-5580-9).

III. Status of the Priority Testing List

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

IV. Public Record and Electronic Submissions

    The official record for this notice, as well as the public version, 
has been established for this notice under docket control number OPPTS-
41048 (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 include any 
information claimed as CBI, is available for inspection from 12 noon to 
4 p.m., Monday through Friday, excluding legal holidays. The official 
record is located in the TSCA Nonconfidential Information Center, Rm. 
NE-B607, 401 M St., SW., Washington, DC.
    Electronic comments can be sent directly to EPA at:

    [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 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number OPPTS-41048. Electronic comments on this 
notice may be filed online at many Federal Depository Libraries.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.

    Authority: 15 U.S.C. 2603.

    Dated: April 1, 1998.

Charles M. Auer,

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

Administrator, U.S. Environmental Protection Agency

Summary

    This is the 41st 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 29 alkylphenols,

[[Page 17659]]

alkylphenol ethoxylates, and polyalkylphenols and removing 6 
alkylphenols, 3 siloxanes, and 10 diaryl ethers. The revised TSCA 
section 4(e) Priority Testing List follows as Table 1.

                    Table 1.--The TSCA Section 4(e) Priority Testing List (November 1997)\1\                    
----------------------------------------------------------------------------------------------------------------
                Report                           Date                Chemical/Group               Action        
----------------------------------------------------------------------------------------------------------------
26...................................  May 1990...............  8 Isocyanates..........  Recommended with intent-
                                                                                          to-designate          
27...................................  November 1990..........  62 Aldehydes...........  Recommended with intent-
                                                                                          to-designate          
28...................................  May 1991...............  Chemicals with low       Designated             
                                                                 confidence Reference                           
                                                                 Dose (RfD).                                    
                                                                  Acetone                                       
                                                                  Thiophenol                                    
30...................................  May 1992...............  5 Siloxanes............  Recommended            
31...................................  January 1993...........  24 Chemicals with        Designated             
                                                                 insufficient dermal                            
                                                                 absorption rate data.                          
32...................................  May 1993...............  32 Chemicals with        Designated             
                                                                 insufficient dermal                            
                                                                 absorption rate data.                          
35...................................  November 1994..........  24 Chemicals with        Designated             
                                                                 insufficient dermal                            
                                                                 absorption rate data.                          
36...................................  May 1995...............  9 High Production        Recommended            
                                                                 Volume Chemicals                               
                                                                 (HPVCs).                                       
37...................................  November 1995..........  22 Alkylphenols and      Recommended            
                                                                 alkylphenol                                    
                                                                 ethoxylates.                                   
39...................................  November 1996..........  23 Nonylphenol           Recommended            
                                                                 ethoxylates\2\.                                
41...................................  November 1997..........  29 Alkylphenols,         Recommended            
                                                                 alkylphenol                                    
                                                                 ethoxylates, and                               
                                                                 polyalkyphenols\2\.                            
----------------------------------------------------------------------------------------------------------------
\1\The list of discrete chemicals currently on the Priority Testing List is available from the Executive        
  Director of the ITC.                                                                                          
\2\Data requested under the ITC's Voluntary Information Submissions Policy described in this Report.            

I. Background

    The TSCA ITC was established by section 4(e) of the Toxic 
Substances Control Act (TSCA) ``to make recommendations to the 
Administrator respecting the chemical substances and mixtures to which 
the Administrator should give priority consideration for the 
promulgation of a rule for testing under section 4(a).... At least 
every six months..., the Committee shall make such revisions in the 
Priority Testing List as it determines to be necessary and to transmit 
them to the Administrator together with the Committee's reasons for the 
revisions'' (Pub. L. 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et 
seq.). The ITC recommends chemical substances for information 
reporting, screening, and testing to meet the data needs of its member 
U.S. Government organizations. Since its creation in 1976, the ITC has 
submitted 40 semi-annual (May and November) Reports to the EPA 
Administrator transmitting the Priority Testing List and its revisions. 
ITC Reports are published in the Federal Register; they are available 
from http://www.epa.gov/fedrgstr or the ITC. The ITC meets monthly and 
produces its revisions of the Priority Testing List with the help of 
staff and technical contract support provided by EPA. ITC members and 
support personnel are listed at the end of this Report.

II. TSCA Section 8 Reporting

A. TSCA Section 8 Rules

    Following receipt of the ITC's Report and addition of chemicals to 
the Priority Testing List, the EPA's Office of Pollution Prevention and 
Toxics (OPPT) promulgates TSCA section 8(a) Preliminary Assessment 
Information Reporting (PAIR) and TSCA section 8(d) Health and Safety 
Data (HaSD) rules for new chemicals added to the Priority Testing List. 
These rules require producers and importers of chemicals recommended by 
the ITC to submit production and exposure reports under TSCA section 
8(a) and producers, importers, and processors of chemicals recommended 
by the ITC to submit unpublished health and safety studies under TSCA 
section 8(d). These TSCA section 8(a) reports and section 8(d) studies 
must be submitted to EPA within 60 days of the rules' effective date. 
TSCA section 8(a) reports and 8(d) submissions are indexed in databases 
maintained by the ITC and the EPA, respectively.

B. ITC's Use of TSCA Section 8 Data

    To determine if revisions to the Priority Testing List are 
necessary, the ITC reviews the TSCA section 8(a) and 8(d) information 
and other available data on chemicals and chemical groups (e.g., TSCA 
section 4(a) and 4(d) studies, TSCA section 8(c) submissions, TSCA 
section 8(e) ``substantial risk'' notices, ``For Your Information'' 
(FYI) submissions to EPA, unpublished data submitted to U.S. Government 
organizations represented on the ITC, and published papers). Revisions 
can include changing recommendations to designations, modifying 
recommendations, or removing chemicals from the Priority Testing List.

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

    In its 40th Report (62 FR 30580, June 4, 1997)(FRL-5718-3), the ITC 
proposed a policy promoting more efficient use of TSCA section 8(d) 
resources. The ITC received comments on its policy from the Chemical 
Manufacturers Association (CMA) (Ref. 2, Russell, 1997). In response to 
these comments, the ITC has revised the policy, now referred to as the 
ITC's Voluntary Information Submissions Policy (VISP).
    Under the VISP, the ITC will now:
    1. Request specific information necessary to meet information needs 
of U.S. Government organizations represented on the ITC (e.g., specific 
health and ecological effects data, use information, etc.).
    2. List studies that the ITC is not requesting (e.g., studies on 
waste streams).
    3. Provide an opportunity for producers, importers, processors, and 
users of chemicals recommended by the ITC or a consortium representing 
those producers, importers, processors, and users to notify the ITC 
Executive Director in writing (by e-mail or letter) that studies will 
be provided voluntarily to the ITC as ITC FYI submissions. This

[[Page 17660]]

notification must be received within 30 days of the date the ITC Report 
is published in the Federal Register.
    4. Ask those producers, importers, processors, and users of 
chemicals who notify the ITC (see Unit II.C.3. of this Report) to 
provide the EPA with an electronic list (table) of studies within 60 
days of the date the ITC Report is published in the Federal Register 
and ITC FYI submissions within 90 days of the date the ITC Report is 
published in the Federal Register. The electronic table should contain 
columns for the Chemical Abstracts Service (CAS) Registry number, 
chemical name, study date, study title, Document Control Number (DCN), 
and a column indicating whether the study will be submitted on disk as 
a WordPerfect 6.1 file or as a hard copy. The EPA will add DCNs to the 
table and send it back to the submitter and to the ITC Executive 
Director. In addition, the EPA will send to each submitter of the 
electronic table, adhesive labels containing DCNs. These labels should 
be affixed to the first page of each ITC FYI study submitted as a hard 
copy, not a document containing multiple studies, or the first page of 
an ITC FYI study printed from an electronic copy (only a hard copy of 
the first page of each electronic study should be submitted).
    5. Encourage producers, importers, processors, and users who submit 
an electronic table of studies to submit the TSCA electronic cover 
sheet (including an abstract) for each study to the EPA within 90 days 
of the date the ITC Report is published in the Federal Register. The 
TSCA electronic cover sheet is available from http://www.epa.gov/
opptintr/itc. The DCN should be recorded on each TSCA electronic cover 
sheet. CBI must not be recorded on the TSCA electronic cover sheet and 
must not be sent by e-mail. Individual TSCA electronic cover sheets 
must be sent by e-mail to [email protected]. The EPA will send 
each final TSCA electronic cover sheet to the ITC Executive Director. 
Multiple TSCA electronic cover sheets (one for each study) can be sent 
on 3 \1/2\ disks or a CD ROM; the disks or CD ROM should be mailed to 
the Document Processing Center (7407), ET-G-099, Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. For those producers, importers, processors, and 
users who submit a TSCA electronic cover sheet for each study, the ITC 
will extend the deadline for providing ITC FYI submissions to 120 days 
from the date the ITC Report is published in the Federal Register.
    6. Request that two hard copies of each ITC FYI study (or 
preferably one disk or CD ROM containing each study as a WordPerfect 
6.1 file) should be mailed to the Document Processing Center (7407), 
ET-G-099, Attn: FYI Coordinator, Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 
20460. It is not necessary to submit cover letters for each ITC FYI 
study because:
    a. A TSCA electronic cover sheet bearing a DCN would have been 
submitted for each ITC FYI study.
    b. The first page of the ITC FYI study would bear the adhesive 
label containing the pre-assigned DCN. EPA will provide the ITC 
Executive Director with an electronic (preferable) or hard copy of each 
ITC FYI study.

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

A. Alkylphenols and Alkylphenol Ethoxylates

    The ITC-CMA Alkylphenols and Ethoxylates Dialogue Group was formed 
by the ITC's Alkylphenols and Ethoxylates Subcommittee and the CMA's 
Alkylphenols and Ethoxylates Panel. The Dialogue Group was established 
in March 1996 to facilitate the ITC's retrieval of information on uses, 
exposures, and health and ecological effects of alkylphenols and 
alkylphenol ethoxylates and the CMA's understanding of data needed by 
the U.S. Government organizations represented on the ITC. Since the 
establishment of this Dialogue Group, numerous activities have occurred 
(see the ITC's 38th Report (61 FR 39832, July 30, 1996)(FRL-5379-2), 
39th Report (62 FR 8578, February 25, 1997)(FRL-5580-9), and 40th 
Report. During this reporting period, the Dialogue Group met to 
discuss:
    1. Results of a qualitative survey of Panel member companies 
regarding production or importation of alkylphenols, alkylphenol 
ethoxylates, and polyalkylphenols.
    2. TSCA section 8(d) studies submitted for alkyphenols and 
alkyphenol ethoxylates recommended in the 37th Report (FRL-4991-6) (61 
FR 4188, February 2, 1996).
    3. Data needs of U.S. Government organizations represented on the 
ITC.
    4. Ongoing and planned studies sponsored by the Panel.
    5. Development of Structure Activity Relationships (SARs).
    6. Voluntary testing processes that might be used to provide needed 
data.
    In its survey of member companies, the Panel identified 29 
alkylphenols, alkylphenol ethoxylates, and polyalkylphenols out of 74 
remaining on the Priority Testing List that were produced, imported, or 
used in 1995, but recommended that the results of this informal survey 
should not be viewed as representative of the entire industry. The 
Dialogue Group acknowledged that about 500 TSCA section 8(d) studies 
were submitted in equal numbers by Panel member companies and non-Panel 
member companies for the alkylphenols and alkylphenol ethoxylates 
recommended in the 37th Report. Most of those studies provided data on 
acute toxicity, dermal irritation, or eye irritation of mixtures 
containing alkylphenols and alkylphenol ethoxylates.
    The ITC members proposed studies to address the data needs for 
alkylphenols and alkylphenol ethoxylates (see Unit IV.A.1.d. of this 
Report). The Panel described planned studies that may meet some of the 
data needs listed in Unit IV.A.1.d. of this Report. Development of 
SARs, voluntary testing and uses of alkylphenols and alkylphenol 
ethoxylates will be discussed in more detail in future Dialogue Group 
meetings. The Dialogue Group acknowledged that during the past 10 
years, the Panel has sponsored many studies to evaluate the safety of 
alkylphenols and alkylphenol ethoxylates.

B. Isocyanates

    The ITC-CMA Isocyanates Dialogue Group was formed by the ITC's 
Isocyanates Subcommittee and CMA's Diisocyanates Panel. The Dialogue 
Group was established in November 1996 to facilitate the ITC's 
retrieval of information on uses, exposures, and health effects of 
isocyanates and the CMA's understanding of data needed by the U.S. 
Government organizations represented on the ITC. Since the 
establishment of this Dialogue Group, numerous activities have occurred 
(see the ITC's 38th, 39th, and 40th Reports). This Dialogue Group 
continues to discuss production, commercial uses, and health and safety 
data for 8 of 43 isocyanates that were recommended in the ITC's 26th 
Report (55 FR 23050, June 5, 1990).

C. Siloxanes

    The ITC-Silicones Environmental Health and Safety Council (SEHSC) 
Dialogue Group was formed by the ITC's Siloxanes Subcommittee and 
SEHSC. This Dialogue Group was established in March 1993 to facilitate 
the ITC's retrieval of information on uses, exposures, and health 
effects of siloxanes and the SEHSC's

[[Page 17661]]

understanding of data needed by the U.S. Government organizations 
represented on the ITC. Since the establishment of this Dialogue Group, 
numerous activities have occurred (see the ITC's 37th, 38th, 39th, and 
40th Reports). During this reporting period, the Dialogue Group met to 
discuss ongoing reproductive effects, biochemical toxicology, 
pharmacokinetic, metabolism, and immunology studies of siloxanes 
sponsored by SEHSC member companies. The studies sponsored by these 
companies are being conducted on 5 of 56 siloxanes that were 
recommended in the ITC's 30th Report (57 FR 30608, July 9, 1992).

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         
----------------------------------------------------------------------------------------------------------------
                                      Alkylphenols and          Recommended              November 1997          
                                       Alkylphenol Ethoxylates                                                  
                                                                                                                
                                      C5 Alkylphenols           do                       do                     
                                                                                                                
136-81-2............................  Phenol, 2-pentyl-.......  do                       do                     
3279-27-4...........................  Phenol, 2-(1,1-           do                       do                     
                                       dimethylpropyl)-.                                                        
25735-67-5..........................  Phenol, 4-sec-pentyl-...  do                       do                     
26401-74-1..........................  Phenol, 2-sec-pentyl-...  do                       do                     
                                                                                                                
                                      C6 Alkylphenols           do                       do                     
                                                                                                                
2446-69-7...........................  Phenol, 4-hexyl-........  do                       do                     
                                                                                                                
                                      C7 Alkylphenols           do                       do                     
                                                                                                                
1987-50-4...........................  Phenol, 4-heptyl-.......  do                       do                     
72624-02-3..........................  Phenol, heptyl derivs...  do                       do                     
84605-25-4..........................  Phenol, 1-methylhexyl     do                       do                     
                                       derivs..                                                                 
                                                                                                                
                                      C8 Alkylphenols           do                       do                     
                                                                                                                
140-66-9............................  Phenol, 4-(1,1,3,3-       do                       do                     
                                       tetramethylbutyl)-.                                                      
71902-25-5..........................  Phenol, octenylated.....  do                       do                     
                                                                                                                
                                      C9 Alkylphenols           do                       do                     
                                                                                                                
68081-86-7..........................  Phenol, nonyl derivs....  do                       do                     
91672-41-2..........................  Phenol, 2-nonyl-,         do                       do                     
                                       branched.                                                                
                                                                                                                
                                      C10 Alkylphenols          do                       do                     
                                                                                                                
27157-66-0..........................  Phenol, decyl-..........  do                       do                     
                                                                                                                
                                      C12 Alkylphenols          do                       do                     
                                                                                                                
74499-35-7..........................  Phenol, (tetrapropenyl)   do                       do                     
                                       derivs..                                                                 
                                                                                                                
                                      C14 Alkylphenols          do                       do                     
                                                                                                                
70682-80-3..........................  Phenol, tetradecyl-.....  do                       do                     
                                                                                                                
                                      C16 Alkylphenols          do                       do                     
                                                                                                                
2589-78-8...........................  Phenol, 4-hexadecyl-....  do                       do                     
25401-86-9..........................  Phenol, 2-hexadecyl-....  do                       do                     
                                                                                                                
                                      C18-C30 Alkylphenols      do                       do                     
                                                                                                                
68784-24-7..........................  Phenol, C18-C30-alkyl     do                       do                     
                                       derivs..                                                                 
                                                                                                                
                                      Monosubstituted           do                       do                     
                                       Polyalkylphenols                                                         
                                                                                                                
68954-70-1..........................  Phenol, polyethylene      do                       do                     
                                       derivs..                                                                 
68891-67-8..........................  Phenol, polypropene       do                       do                     
                                       derivs..                                                                 
68908-55-4..........................  Phenol, polybutene        do                       do                     
                                       derivs..                                                                 
112375-88-9.........................  Phenol, polyisobutylene   do                       do                     
                                       derivs..                                                                 
112375-89-0.........................  Phenol, poly(2,4,4-       do                       do                     
                                       trimethylpentene)                                                        
                                       derivs..                                                                 
                                                                                                                
                                      C8 Alkylphenol            do                       do                     
                                       Ethoxylates                                                              
                                                                                                                
9004-87-9...........................  Poly(oxy-1,2-             do                       do                     
                                       ethanediyl), -                                                  
                                       (isooctylphenyl)--hydroxy-.                                                            
9063-89-2...........................  Poly(oxy-1,2-             do                       do                     
                                       ethanediyl), -                                                  
                                       (octylphenyl)--hydroxy-.                                                            
                                                                                                                
                                      C12 Alkylphenol           do                       do                     
                                       Ethoxylates                                                              
                                                                                                                
9014-92-0...........................  Poly(oxy-1,2-             do                       do                     
                                       ethanediyl), -                                                  
                                       (dodecylphenyl)--hydroxy-.                                                            
26401-47-8..........................  Poly(oxy-1,2-             do                       do                     
                                       ethanediyl), -                                                  
                                       (4-dodecylphenyl)-                                                       
                                       -hydroxy-.                                                     
                                                                                                                
                                      C13 Alkylphenol           do                       do                     
                                       Ethoxylates                                                              
                                                                                                                
61723-87-3..........................  Poly(oxy-1,2-             do                       do                     
                                       ethanediyl), -                                                  
                                       (tridecylphenyl)--hydroxy-.                                                            
                                                                                                                
                                      C16 Alkylphenol           do                       do                     
                                       Ethoxylates                                                              
                                                                                                                
59911-95-4..........................  Poly(oxy-1,2-             do                       do                     
                                       ethanediyl), -                                                  
                                       (4-hexadecylphenyl)-                                                     
                                       -hydroxy-.                                                     
                                                                                                                
                                      Alkylphenols              Removed                  do                     
                                                                                                                
1322-69-6...........................  (1,1,3,3-                 do                       do                     
                                       Tetramethylbutyl)phenol                                                  
                                       (mixed isomers).                                                         
29932-96-5..........................  (1,1,3,3-                 do                       do                     
                                       Tetramethylbutyl)phenol                                                  
                                       (mixed isomers).                                                         

[[Page 17662]]

                                                                                                                
30105-54-5..........................  (1,1,3,3-                 do                       do                     
                                       Tetramethylbutyl)phenol                                                  
                                       (mixed isomers).                                                         
62744-41-6..........................  (1,1,3,3-                 do                       do                     
                                       Tetramethylbutyl)phenol                                                  
                                       (mixed isomers).                                                         
1300-16-9...........................  Nonylphenol (mixed        do                       do                     
                                       isomers).                                                                
1331-57-3...........................  Dodecylphenol (mixed      do                       do                     
                                       isomers).                                                                
                                                                                                                
                                      Diaryl Ethers             do                       do                     
                                                                                                                
101-84-8............................  1,1'-Oxybisbenzene......  do                       do                     
3586-14-9...........................  1-Methyl-3-               do                       do                     
                                       phenoxybenzene.                                                          
13826-35-2..........................   3-                       do                       do                     
                                       Phenoxybenzenemethanol.                                                  
28299-41-4..........................  1,1'-                     do                       do                     
                                       Oxybis[methylbenzene].                                                   
28984-89-6..........................  Phenoxy-1,1'-biphenyl...  do                       do                     
42874-96-4..........................  2-Chloro-1-(3-            do                       do                     
                                       methylphenoxy)-4-                                                        
                                       (trifluoromethyl)benzen                                                  
                                       e.                                                                       
50594-77-9..........................  3-[2-Chloro-4-            do                       do                     
                                       (trifluoromethyl)phenox                                                  
                                       y] phenol, acetate.                                                      
51632-16-7..........................  1-(Bromomethyl)-3-        do                       do                     
                                       phenoxybenzene.                                                          
63734-62-3..........................  3-[2-Chloro-4-            do                       do                     
                                       (trifluoromethyl)phenox                                                  
                                       y]benzoic acid.                                                          
72252-48-3..........................  3-[2-Chloro-4-            do                       do                     
                                       (trifluoromethyl)phenox                                                  
                                       y] benzoic acid,                                                         
                                       potassium salt.                                                          
                                                                                                                
                                      Siloxanes                 do                       do                     
                                                                                                                
107-51-7............................  Octamethyltrisiloxane     do                       do                     
                                       (L3).                                                                    
141-62-8............................  Decamethyltetrasiloxane   do                       do                     
                                       (L4).                                                                    
141-63-9............................  Dodecamethylpentasiloxan  do                       do                     
                                       e (L5)                                                                   
----------------------------------------------------------------------------------------------------------------

A. Chemicals Added to the Priority Testing List

    1. Alkylphenols, alkylphenol ethoxylates, and polyalkylphenols--a. 
Recommendation. Add 29 alkylphenols, alkylphenol ethoxylates, and 
polyalkylphenols to the Priority Testing List to obtain information to 
meet U.S. Government data needs.
    b. Rationale for recommendation. Twenty-nine alkylphenols, 
alkylphenol ethoxylates, and polyalkylphenols are being recommended 
because:
    i. TSCA production and importation volumes are reported in the 
multi-million pound range.
    ii. Releases to the environment can occur from wastewater treatment 
and agricultural uses.
    iii. Alkylphenol ethoxylates can degrade to alkylphenols, which can 
persist in the environment and be highly toxic to aquatic organisms.
    iv. Exposure to alkylphenols and alkylphenol ethoxylates may affect 
endocrine and other important human and animal system functions. 
Alkylphenols, alkylphenol ethoxylates, and polyalkylphenols are being 
recommended to determine if there are unpublished studies that contain 
data to meet the needs of the U.S. Government organizations represented 
on the ITC and to complete the list of alkylphenols and alkylphenol 
ethoxylates that were recommended in the ITC's 37th and 39th Reports.
    c. Supporting information. As noted in the 37th, 38th, and 39th 
Reports, ITC used its Substructure-based Computerized Chemical 
Selection Expert System (SuCCSES) to identify the alkylphenols and 
alkylphenol ethoxylates that were added to the Priority Testing List. 
Following the SAR rationale for adding alkylphenols and alkylphenol 
ethoxylates to the Priority Testing List that was described in the 37th 
Report, only 29 alkylphenols, alkylphenol ethoxylates, and 
polyalkylphenols with a single-alkyl chain in either the para or ortho 
position are being added to the Priority Testing List in this Report. 
One of the alkylphenols being added to the Priority Testing List (4-
(1,1,3,3-tetramethylbutyl)phenol, CAS No. 140-66-9) was added to the 
Priority Testing List in the ITC's 11th Report (47 FR 54626, December 
3, 1982) and removed from the Priority Testing List in the 13th Report 
(48 FR 55674, December 14, 1983) because the producers conducted 
chemical fate and aquatic toxicity testing. It is being added to the 
Priority Testing List at this time to obtain information to meet other 
U.S. Government data needs.
    d. Implementation of ITC's VISP promoting more efficient use of 
TSCA section 8(d) resources. The ITC is implementing its VISP (to 
promote more efficient use of TSCA section 8(d) resources) for 23 
nonylphenol ethoxylates recommended in its 39th Report and the 29 
alkylphenols, alkylphenol ethoxylates, and polyalkylphenols added to 
the Priority Testing List in this Report.
    Under its VISP, the ITC requests:
    1. Specific information to meet data needs of U.S. Government 
organizations represented on the ITC:
    a. Fish and amphibian multigeneration reproductive effects data.
    b. Avian acute toxicity data (oral feeding and egg exposure 
studies).
    c. Avain reproductive effects data.
    d. Fish and wildlife field data.
    e. Bioaccumulation or bioavailability data.
    f. Health effects data, including absorption, toxicokinetics, 
systemic toxicity, endocrine disruption, reproductive effects, and 
carcinogenicity data.
    g. SARs to estimate effects or degradation.
Data needs 1a-1e and 1g are also applicable to the alkylphenols and 
alkylphenol ethoxylates recommended in the 37th Report for which the 
ITC has reviewed unpublished studies submitted under TSCA section 8(d) 
and determined that they do not meet U.S. Government data needs listed 
in Unit IV.A.1.d.1.a.-g. of this Report.
    2. No submissions on the following:
    a. Any data on non-isomeric mixtures containing <90% of the 
recommended alkylphenols, alkylphenol ethoxylates, or polyalkylphenols, 
Exception: Absorption data.
    b. Dermal irritation data.
    c. Eye irritation data.
    d. Corrosivity data.
    e. Data on waste streams.
    3. The EPA to revoke the TSCA section 8(a) PAIR and TSCA section 
8(d) HaSD rules for the ITC's 38th Report for which EPA published a 
stay on December 11, 1996 (61 FR 65186)( FRL-5577-6) (Ref. 1, Fung, 
1997). In its 39th Report, the ITC eliminated the use of alternate CAS 
numbers for nonylphenol ethoxylates recommended in the 38th Report.
    4. The EPA not to promulgate TSCA section 8(d) HaSD rules for the

[[Page 17663]]

nonylphenol ethoxylates recommended in the ITC's 39th Report and the 
alkylphenols, alkylphenol ethoxylates, and polyalkylphenols added to 
the Priority Testing List in this 41st Report (Ref. 1, Fung, 1997).
    5. Producers, importers, processors, and users of alkylphenols, 
alkylphenol ethoxylates, and polyalkylphenols recommended by the ITC in 
its 37th, 39th, and 41st Reports or a consortium representing those 
producers, importers, processors, and users to follow the generic 
procedures listed in Unit II.C.3-6 of this Report.
    6. The EPA to promulgate (upon receipt of a letter from the ITC 
Chair) a TSCA section 8(d) HaSD rule for the alkylphenols and 
alkylphenol ethoxylates recommended in the 39th and 41st Reports. The 
ITC will submit this letter if there is no notification of intent to 
submit studies or if studies voluntarily submitted are insufficient to 
satisfy data needs.
    As noted in Unit III.A. of this Report, the ITC has reviewed 
reports and studies submitted in response to the PAIR and HaSD rules 
promulgated for alkylphenols and alkylphenol ethoxylates recommended in 
the 37th Report. Based on its review, the ITC recognizes that there are 
many non-CMA Panel member companies that produce, import, process, or 
use alkylphenols and alkylphenol ethoxylates. The ITC encourages all 
companies to submit studies following the procedures described in the 
VISP.

B. Chemicals Removed From the Priority Testing List

    1. Alkylphenols and Alkylphenol Ethoxylates. The ITC is removing 
six alkylphenols from the Priority Testing List that were recommended 
in the 37th Report. The rationales for these removals are listed in 
Table 3.

   Table 3.-- Alkylphenols Being Removed From the Priority Testing List 
------------------------------------------------------------------------
            CAS No.                 Chemical name          Rationale    
------------------------------------------------------------------------
1322-69-6                        (1,1,3,3-            Already           
                                  Tetramethylbutyl)p   represented by   
                                  henol(mixed          (1,1,3,3-        
                                  isomers)             tetramethylbutyl)
                                                       phenol (mixed    
                                                       isomers) (CAS No.
                                                       27193-28-8) and  
                                                       no data submitted
                                                       in response to   
                                                       TSCA section 8(a)
                                                       PAIR rule (61 FR 
                                                       7421, February   
                                                       28, 1996)(FRL-   
                                                       4996-9) .        
29932-96-5                       (1,1,3,3-            do                
                                  Tetramethylbutyl)p                    
                                  henol (mixed                          
                                  isomers)                              
30105-54-5                       (1,1,3,3-            do                
                                  Tetramethylbutyl)p                    
                                  henol (mixed                          
                                  isomers)                              
62744-41-6                       (1,1,3,3-            do                
                                  Tetramethylbutyl)p                    
                                  henol (mixed                          
                                  isomers)                              
                                                                        
1300-16-9                        Nonylphenol (mixed   Already           
                                  isomers)             represented by   
                                                       nonylphenol      
                                                       (mixed isomers)  
                                                       (CAS No. 25154-52-
                                                       3) and no data   
                                                       submitted in     
                                                       response to TSCA 
                                                       section 8(a) PAIR
                                                       rule (61 FR 7421,
                                                       February 28,     
                                                       1996).           
                                                                        
1331-57-3                        Dodecylphenol        Already           
                                  (mixed isomers)      represented by   
                                                       dodecylphenol    
                                                       (mixed isomers)  
                                                       (CAS No. 27193-86-
                                                       8) and no data   
                                                       submitted in     
                                                       response to TSCA 
                                                       section 8(a) PAIR
                                                       rule (61 FR 7421,
                                                       February 28,     
                                                       1996).           
------------------------------------------------------------------------

    2. Diaryl ethers--a. Rationale for removal. The ITC is removing 10 
diaryl ethers from the Priority Testing List (Table 2) because:
    i. There are no current U.S. Government data needs.
    ii. Routine uses are not likely to result in environmental releases 
or exposures to workers, consumers, or the general population.
    iii. There is information to predict water solubilities, vapor 
pressures, atmospheric, and aquatic half lives, rodent acute 
toxicities, irritancy potential, aquatic toxicity, and binding to 
estrogen receptor(s).
    b. Supporting information. In its 29th Report (56 FR 67424, 
December 30, 1991), the ITC recommended a group of 14 alkyl, bromo, 
chloro, and hydroxy-methyl diaryl ethers for physical chemical 
properties, biodegradation rate, health effects, and ecological effects 
screening tests. The 14 diaryl ethers were selected from 261 aryl 
ethers (55 diaryl ethers) by using SuCCSES. The 14 were selected 
because of their potential to intercalate with DNA (56 FR 67424, 
December 30, 1991). SuCCSES is used by the ITC to identify chemicals 
with shared substructures and associated health or ecological effects 
(Ref. 4, Walker, 1991; Ref. 5, Walker, 1995). The ITC removed 4 of the 
previously recommended diaryl ethers from the Priority Testing List in 
its 35th Report (59 FR 67596, December 29, 1994).
    The ITC reviewed all the PAIR reports and all the TSCA section 8(d) 
studies and concluded that the 10 remaining diaryl ethers were likely 
to be used as intermediates or starting materials, but not as end 
products. The ITC estimated that these diaryl ethers should:
    1. Be metabolized through ortho or para hydroxylation.
    2. Have water solubilities 20 milligram/liter (mg)/(L).
    3. Have vapor pressures 2 x 10-2 millimeter 
Mercury (mm)(Hg)             @ 25  deg.C.
    4. Have atmospheric-half lives <1 day.
    5. Have aquatic-half lives <1 week.
    6. Have low-binding affinity for estrogen receptor(s).
    To analyze existing data, the ITC organized the 10 remaining diaryl 
ethers into 2 SuCCSES categories:
    1. Non-fluoromethyl diaryl ethers.
    2. Trifluoromethyl diaryl ethers.
    Based on available data, the ITC estimated that non-fluoromethyl 
diaryl ethers (alkyl, aryl, bromo, diaryl ether, and hydroxymethyl 
diaryl ethers) would have rodent oral LD50 values >2 gram/
kilogram (g)/(kg) and that most would be mild irritants, be negative in 
an Ames assay, have low-oncogenicity potential, and have 
LC50 values <1 mg/L for aquatic organisms. The ITC 
recognized that 1-methyl-3-phenoxybenzene could have marginal 
oncogenicity potential based on a positive Ames assay and that 1-
(bromomethyl)-3-phenoxybenzene could have moderate oncogenicity 
potential based on its structural relationship to benzyl chloride, a 
known alkylating agent.
    During its review of data for these chemicals, the ITC used SuCCSES 
to identify three additional non-fluoromethyl alkyl diaryl ethers:

[[Page 17664]]

    1. Phenoxytetrapropylene benzene (mixture of isomers) (CAS No. 
68938-96-5).
    2. Decylphenoxybenzene (mixture of isomers) (CAS No. 69834-17-9).
    3. 1,1'-Oxybis-benzene, tetrapropylene derivatives (mixture of 
isomers) (CAS No. 119345-02-7). At the present time, ITC is deferring 
these chemicals based on the data reviewed for other diaryl alkyl 
ethers.
    Based on available data, the ITC estimated that trifluoromethyl 
diaryl ethers would have rodent oral LD50 values >1 g/kg and 
that most would be mild irritants, be negative in an Ames assay, have 
low-moderate oncogenicity potential and have LC50 values >1 
mg/L for aquatic organisms. The ITC recognized that the trifluoromethyl 
diaryl ethers are structurally similar to diaryl ether herbicides 
except they lack a nitro group (Acifluorfen, 
Fomesafen, Lactofen, and 
Oxyfluorfen) or a branched carboxylic acid group 
(Verdict). The ITC is aware of the possibility that the 
trifluoromethyl diaryl ether moiety may play a possible receptor-
mediated role in oncogenicity.
    3. Silicone chemicals--a. Rationale for removal. The ITC is 
removing octamethyltrisiloxane (L3, CAS No. 107-51-7), 
decamethyltetrasiloxane (L4, CAS No. 141-62-8), and 
dodecamethylpentasiloxane (L5, CAS No. 141-63-9) from the 
Priority Testing List because:
    i. Annual production and importation volumes are less than 1 
million pounds.
    ii. Routine uses are not likely to result in substantial 
environmental releases or human exposurures.
    b. Supporting information. Fifty-six siloxanes were recommended for 
health effects testing in the ITC's 30th Report (57 FR 30608, July 9, 
1992) to meet the data needs of the U.S. Government organizations 
represented on the ITC. After this recommendation, the ITC's Siloxanes 
Subcommittee and the Silicones Environmental Health and Safety Council 
(SEHSC) established a Dialogue Group to develop a TSCA Test Submissions 
database (TSCATS)-compatible computer file of physical and chemical 
properties, health effects and use data, and to develop health effects 
data to meet the needs of the U.S. Government organizations represented 
on the ITC. The ITC-SEHSC computer file has been used by other 
organizations and serves as the prototype TSCA section 8 database for 
the EPA's TSCA Electronic Commerce Workgroup. The ITC accepted a letter 
of commitment (LOC) from the SEHSC to discuss ongoing and planned 
siloxanes testing that is being conducted to meet the data needs 
described in the ITC's 30th Report (Ref. 3, SEHSC, 1996). The testing 
(on the 5 siloxanes remaining on the Priority Testing List) is being 
conducted voluntarily as part of an April 9, 1996, Memorandum of 
Understanding (MOU) between EPA and the Dow Corning Corporation; the 
MOU describes a model Product Stewardship program. The LOC provides the 
ITC and SEHSC member companies the opportunity to discuss protocols, 
planned and ongoing studies, and to meet as often as necessary with Dow 
Corning Corporation and the SEHSC until the testing program has been 
completed.
    As a result of continuing discussions, the ITC removed 43 of the 
previously recommended siloxanes chemicals from the Priority Testing 
List in its 37th Report and five siloxanes from the Priority Testing 
List in its 39th Report. The ITC is removing three linear siloxanes 
(L3, L4, and L5) from the Priority 
Testing List in this Report (Table 2). L3, L4, 
and L5 have annual production and import volumes less than 1 
million pounds and are used primarily for industrial and/or commercial 
applications such as solvent cleaning, carriers, water displacement, 
and polyurethane foam blowing that are not likely to result in 
substantial environmental releases or human exposures.
    The five siloxanes remaining on the Priority Testing List are 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)   
                                                                        
                                            Polymers                    
                                                                        
63148-62-9................................  Dimethyl silicones and      
                                             siloxanes                  
------------------------------------------------------------------------

V. References

    1. Fung, V.A. September 15, 1997, letter from Dr. Victor A. Fung, 
ITC Chairperson to the Honorable Carol M. Brown, Administrator, U.S. 
Environmental Protection Agency, 401 M St., SW., Washington, DC.
    2. Russell, S. July 7, 1997, E-mail from Steven Russell, Esq. to 
Dr. John D. Walker. ``Comments of the Chemical Manufacturers 
Association on the 40th Report of the TSCA Interagency Testing 
Committee before the U.S. Environmental Protection Agency.''.
    3. SEHSC. July 26, 1996, Letter of Commitment from Bill Smock, 
Executive Director, SEHSC, 1767 Business Center Drive, Suite 302, 
Reston, VA to John Walker, Executive Director, ITC, U.S. Environmental 
Protection Agency (7401), 401 M St., SW., Washington, DC.
    4. Walker, J.D. Chemical selection by the TSCA Interagency Testing 
Committee: Use of computerized substructure searching to identify 
chemical groups for health effects, chemical fate and ecological 
effects testing. The Science of the Total Environment 109/110:691-700 
(1991).
    5. 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).

VI. 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
        Paul Campanella, Member
        David R. Williams, Alternate

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

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

    National Institute for Occupational Safety and Health
        Albert E. Munson, Member
        Christine Sofge, Alternate

    National Science Foundation
        Linda Duguay, Member

    Occupational Safety and Health Administration
        Lyn Penniman, Member

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

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

    Department of Agriculture

[[Page 17665]]

        Clifford P. Rice, Alternate

    Department of Defense
        David A. Macys, Member

    Department of the Interior
        Barnett A. Rattner, Member

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

    National Library of Medicine
        Vera Hudson, Member

    National Toxicology Program
        NIEHS, FDA, and NIOSH Members

    Counsel
        Mary Ellen Levine, Office of General Counsel, EPA

    Technical Support Contractor
        Syracuse Research Corporation

    ITC Staff
        John D. Walker, Executive Director
        Norma S.L. Williams, Executive Assistant
TSCA Interagency Testing Committee, U.S. EPA/OPPT (MC/7401) 401 M St., 
SW., Washington, DC 20460, Phone: 202-260-1825, Fax: 202-260-7895, E-
mail: [email protected].
[FR Doc. 98-9396 Filed 4-8-98; 8:45 am]
BILLING CODE 6560-50-F