[Federal Register Volume 66, Number 64 (Tuesday, April 3, 2001)]
[Notices]
[Pages 17768-17774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8133]



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Part IV





Environmental Protection Agency





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

  Federal Register / Vol. 66, No. 64 / Tuesday, April 3, 2001 / 
Notices  

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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-41055; FRL-6763-6]


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

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  The Toxic Substances Control Act (TSCA) Interagency Testing 
Committee (ITC) transmitted its 47\th\ ITC Report to the Administrator 
of the EPA on November 30, 2000. In the 47\th\ ITC Report, which is 
included in this notice, the ITC adds 37 indium chemicals and 4 other 
chemicals discussed in the 46\th\ ITC Report as recommended chemicals 
to its Priority Testing List. The ITC requests TSCA section 8(a) 
Preliminary Assessment Information Reporting (PAIR) rules for the 
appropriate CAS numbered chemicals and TSCA section 8(d) Health and 
Safety Data reporting rules be promulgated by the EPA for these 
chemicals and the 8 nonylphenol polyethoxylate degradation products 
placed on the Priority Testing List in the 46\th\ ITC Report. The ITC 
is also placing three chloroalkenes as recommended chemicals on the 
ITC's Priority Testing List in order to solicit information on use, 
exposure, ecological effects, environmental fate, and health effects 
under the ITC's Voluntary Information Submission Policy (VISP). This 
action is part of the ITC's ongoing efforts to screen chemicals with 
potential to persist and bioconcentrate.

DATES:  Comments, identified by docket control number OPPTS-41055, must 
be received on or before May 3, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPPTS-41055 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division 
(7408), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: John D. Walker, ITC Executive 
Director (7401), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (202) 260-1825; fax: 
(202) 260-7895; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This notice is directed to the public in general. It may, however, 
be of particular interest to you if you manufacture (defined by statute 
to include import) and/or process TSCA-covered chemicals and you may be 
identified by the North American Industrial Classification System 
(NAICS) codes 325 and 32411. Because this notice is directed to the 
general public and other entities may also be interested, the Agency 
has not attempted to describe all the specific entities that may be 
interested in this action. If you have any questions regarding the 
applicability of this action to a particular entity, consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    You may also access additional information about the ITC and the 
TSCA testing program through the web site for the Office of Pollution 
Prevention and Toxics (OPPT) at http://www.epa.gov/opptintr/, or go 
directly to the ITC Home Page at http://www.epa.gov/opptintr/itc/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-41055. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center, North 
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. 
The Center is open from noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Center is (202) 
260-7099.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-41055 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2.  In person or by courier. Deliver your comments to: OPPT 
Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 
401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the DCO is (202) 260-7093.
    3.  Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. 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 standard disks in 
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPPTS-41055. 
Electronic comments may also be filed online at many Federal Depository 
Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be

[[Page 17769]]

disclosed except in accordance with procedures set forth in 40 CFR part 
2. In addition to one complete version of the comment that includes any 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public version of the official record. Information not marked 
confidential will be included in the public version of the official 
record without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views and comments on the 47\th\ ITC 
Report. You may find the following suggestions helpful for preparing 
your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. Provide specific examples to illustrate your concerns.
    5. Make sure to submit your comments by the deadline in this 
notice.
    6. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

    The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.) 
authorizes the Administrator of the EPA to promulgate regulations under 
TSCA 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) of TSCA directs the ITC to revise the TSCA 
section 4(e) Priority Testing List at least every 6 months.
    1. The 47\th\ ITC Report. The 47\th\ ITC Report was received by the 
EPA Administrator on November 30, 2000, and is included in this notice. 
In the 47\th\ ITC Report, the ITC:
    i. Adds 37 indium chemicals (see Table 2 of the 47\th\ ITC Report) 
and 4 other chemicals discussed in the 46\th\ ITC Report as recommended 
chemicals to its Priority Testing List. The ITC requests TSCA section 
8(a) PAIR rules for the appropriate CAS numbered chemicals and TSCA 
section 8(d) Health and Safety Data reporting rules be promulgated by 
the EPA for these chemicals and the 8 nonylphenol polyethoxylate 
degradation products placed on the Priority Testing List in the 46\th\ 
ITC Report. The chemicals, for which needed information was not 
provided in response to the VISP published in the 46\th\ ITC Report, 
are: Pentachlorothiophenol (CAS No. 133-49-3, from the class 
``polychlorobenzenethiols''); tetrachloropyrocatechol (CAS No. 1198-55-
6, from the class ``polychlorophenols''); p-toluidine, 5-
chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl- (CAS No. 
1806-24-2, from the class ``chlorotrifluoromethylphenoxy benzenes'') 
benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-2-ethoxy-1-
methyl-2-oxo- (CAS No. 88185-22-2, from the class 
``chlorotrifluoromethylphenoxy benzenes''). In addition, no information 
was provided on the following eight nonylphenol polyethoxylate 
degradation products: 4-nonylphenol ethoxylate (CAS No. 104-35-8); 4-
nonylphenol diethoxylate (CAS No. 20427-84-3); 4-nonylphenoxy acetic 
acid (CAS No. 3115-49-9); 4-nonylphenoxy ethoxy acetic acid (CAS No. 
106807-78-7); 4-nonylphenoxy diethoxy acetic acid (CAS No. 108241-00-
5); 4-nonylphenoxy triethoxy acetic acid; 4-nonylphenol triethoxylate; 
and 4-nonylphenol tetraethoxylate.
    ii. Places three chloroalkenes [1,3-butadiene, 1,1,2,3,4-
pentachloro-4-(1-methylethoxy)- (CAS No. 68334-67-8); 3-butenoic acid, 
2,2,3,4,4-pentachloro-, butyl ester (CAS No. 75147-20-5); and 
2,2,3,4,4-pentachloro-3-butenoic acid (CAS No. 85743-61-9)] as 
recommended chemicals on the Priority Testing List in order to solicit 
information on use, exposure, ecological effects, environmental fate, 
and health effects under the ITC's VISP. This action is part of the 
ITC's ongoing efforts to screen chemicals with potential to persist and 
bioconcentrate.
    2. Status of the Priority Testing List. The current TSCA section 
4(e) Priority Testing List as of November 2000 can be found in Table 1 
of the 47\th\ ITC Report which is included in this notice.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.


    Dated: March 23, 2001.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.


Forty-Seventh Report of the TSCA Interagency Testing Committee to the 

Administrator, U.S. Environmental Protection AgencyTable of Contents

Summary

The TSCA Section 4(e) Priority Testing List (November 2000)
I. Background
II. TSCA Section 8 Reporting
    A. TSCA section 8 rules
    B. ITC's use of TSCA section 8 and ``other information''
    C. Promoting more efficient use of information submission 
resources
    D. Requests related to promulgation of TSCA section 8(a) PAIR 
and section 8(d) HaSD reporting rules
III. ITC's Activities During this Reporting Period (May to October 
2000): Information Solicitations
IV. Revisions to the TSCA Section 4(e) Priority Testing List: 
Chemicals added to the Priority Testing List:
    A. Indium Chemicals
    B. Chloroalkenes
    C. Polychlorophenols and Polychlorobenzenethiols
    D. Chlorotrifluoromethylphenoxy Benzenes
V. References
VI. The TSCA Interagency Testing Committee

Summary

    This is the 47\th\ Report of the Toxic Substances Control Act 
(TSCA) Interagency Testing Committee (ITC) to the Administrator of the 
U.S. Environmental Protection Agency (EPA). In this Report, the ITC is 
adding 37 indium chemicals and four other chemicals discussed in the 
46\th\ Report which was published in the Federal Register of December 
1, 2000 (65 FR 75552) (FRL-6594-7) to its Priority Testing List so that 
TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR) 
and TSCA section 8(d) Health and Safety Data (HaSD) reporting rules 
will be promulgated by the EPA. There is reason to believe the indium 
chemicals have potential to cause cancer in humans. The four chemicals 
discussed in the 46\th\ Report that are being added to the Priority 
Testing List are, pentachlorothiophenol and tetrachloropyrocatechol 
(from the class polychlorophenols and polychlorobenzenethiols), and p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.- trifluoro-2-nitro-N-phenyl 
and benzoic acid, 3-[2-chloro-4-(trifluoromethyl) phenoxy]-, 2-ethoxy-
1-methyl-2-oxo (from the class chlorotrifluoromethylphenoxy benzenes). 
The four chemicals are being

[[Page 17770]]

added to the Priority Testing List, because information solicited in 
the ITC's 46\th\ Report under the Voluntary Information Submissions 
Policy (VISP) was not provided to the ITC. The ITC is also asking EPA 
to promulgate TSCA section 8(a) PAIR and TSCA section 8(d) HaSD 
reporting rules for the 8 nonylphenol polyethoxylate degradation 
products that were added to the Priority Testing List in the ITC's 
46\th\ Report, because information requested for these chemicals was 
not voluntarily provided to the ITC. The ITC is placing three 
chloroalkenes on the Priority Testing List in order to solicit 
information on use, exposure, ecological effects, environmental fate, 
and health effects under VISP. This action is part of the ongoing 
effort to screen chemicals with potential to persist and 
bioconcentrate. The revised TSCA section 4(e) Priority Testing List 
follows as Table 1 of this unit.

                      Table 1.--The TSCA Section 4(e) Priority Testing List (November 2000)
----------------------------------------------------------------------------------------------------------------
               Report                           Date                 Chemical/Group               Action
----------------------------------------------------------------------------------------------------------------
28..................................  May 1991...............  Chemicals with low         Designated
                                                                confidence reference
                                                                dose (RfD).
                                                                   Acetone..............
                                                                   Thiophenol...........
30..................................  May 1992...............  5 Siloxanes..............  Recommended
31..................................  January 1993...........  13 Chemicals with          Designated
                                                                insufficient dermal
                                                                absorption rate data.
32..................................  May 1993...............  16 Chemicals with          Designated
                                                                insufficient dermal
                                                                absorption rate data.
35..................................  November 1994..........  4 Chemicals with           Designated
                                                                insufficient dermal
                                                                absorption rate data.
37..................................  November 1995..........  10 Alkylphenols and 2      Recommended
                                                                alkylphenol
                                                                polyethoxylates.
39..................................  November 1996..........  8 Nonylphenol ethoxylates  Recommended
41..................................  November 1997..........  18 Alkylphenols, 5         Recommended
                                                                polyalkylphenols and 6
                                                                alkylphenol
                                                                polyethoxylates.
42..................................  May 1998...............  3-Amino-5-mercapto-1,2,4-  Recommended
                                                                triazole.
42..................................  May 1998...............  Glycoluril...............  Recommended
42..................................  May 1998...............  Methylal.................  Recommended
42..................................  May 1998...............  Ethyl Silicate...........  Recommended
46..................................  May 2000...............  8 Nonylphenol              Recommended
                                                                polyethoxylate
                                                                degradation products.
47..................................  November 2000..........  37 Indium chemicals......  Recommended
47..................................  November 2000..........  Pentachlorothiophenol....  Recommended
47..................................  November 2000..........  Tetrachloropyrocatechol..  Recommended
47..................................  November 2000..........  p-Toluidine, 5-chloro-     Recommended
                                                                .alpha.,.alpha.,.alpha.-
                                                                trifluoro-2-nitro-N-
                                                                phenyl.
47..................................  November 2000..........  Benzoic acid, 3-[2-chloro- Recommended
                                                                4-
                                                                (trifluoromethyl)phenoxy
                                                                ]-, 2-ethoxy-1-methyl-2-
                                                                oxo.
47..................................  November 2000..........  3 Chloroalkenes..........  Recommended
----------------------------------------------------------------------------------------------------------------

I. Background

    The ITC was established by section 4(e) of TSCA ``to make 
recommendations to the Administrator respecting the chemical substances 
and mixtures to which the Administrator should give priority 
consideration for the promulgation of a rule for testing under section 
4(a).... At least every six months..., the Committee shall make such 
revisions to the Priority Testing List as it determines to be necessary 
and transmit them to the Administrator together with the Committee's 
reasons for the revisions'' (Public Law 94-469, 90 Stat. 2003 et seq., 
15 U.S.C. 2601 et seq.). Since its creation in 1976, the ITC has 
submitted 46 semi-annual (May and November) Reports to the EPA 
Administrator transmitting the Priority Testing List and its revisions. 
ITC Reports are available from the ITC's web site (http://www.epa.gov/opptintr/itc) within a few days of submission to the Administrator and 
from http://www.epa.gov/fedrgstr after publication in the Federal 
Register. The ITC meets monthly and produces its revisions to the 
Priority Testing List with administrative and technical support from 
the ITC staff, ITC members and their U.S. Government organizations, and 
contract support provided by EPA. ITC members and staff are listed at 
the end of this Report.

II. TSCA Section 8 Reporting

    A. TSCA section 8 rules. Following receipt of the ITC's Report (and 
the revised Priority Testing List) by the EPA Administrator, the EPA's 
Office of Pollution Prevention and Toxics (OPPT) promulgates TSCA 
section 8(a) PAIR and TSCA section 8(d) HaSD reporting rules for 
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 
rules are automatically promulgated by OPPT unless otherwise requested 
by the ITC.
    B. ITC's use of TSCA section 8 and ``other information.'' The ITC 
reviews the TSCA section 8(a) PAIR reports, TSCA section 8(d) HaSD 
studies and ``other information'' that becomes available after the ITC 
adds chemicals to the Priority Testing List. ``Other information'' 
includes TSCA section 4(a) and 4(d) studies, TSCA section 8(c) 
submissions, TSCA section 8(e) ``substantial risk'' notices, ``For Your 
Information'' (FYI) submissions, unpublished data submitted to and from 
U.S. Government organizations represented on the ITC, published papers, 
as well as use, exposure, effects, and persistence data that are 
voluntarily submitted to the ITC by manufacturers, importers, 
processors, and users of chemicals recommended by the ITC. The ITC 
reviews this information and determines if data needs should be 
revised, if chemicals should be removed from the Priority Testing List 
or if recommendations should be changed to designations.
    C. Promoting more efficient use of information submission 
resources. The Voluntary Information Submissions Innovative Online 
Network (VISION) is accessible through the world wide web (http://www.epa.gov/opptintr/itc/vision.htm). VISION includes the VISP and 
links to the TSCA Electronic HaSD Reporting Form (http://www.epa.gov/opptintr/.er/hasd.htm). The EPA recently revised section 3.2 of the 
TSCA Electronic HaSD Reporting Form in response to ITC requests to 
provide

[[Page 17771]]

more details on requested use and exposure information (see 46\th\ 
Report). The VISP provides examples of data needed by ITC member U.S. 
Government organizations, examples of studies that should not be 
submitted, the milestones for submitting information, guidelines for 
using the TSCA Electronic HaSD Reporting Form and instructions for 
electronically submitting full studies. The TSCA Electronic HaSD 
Reporting Form can be used to provide electronic information on ITC 
voluntary submissions, TSCA section 8(d) studies (to meet data needs of 
the ITC member U.S. Government organizations), FYI submissions, and 
TSCA section 8(e) studies.
    The ITC encourages chemical producers, importers, processors, and 
users to voluntarily provide electronic information via VISION on 
chemicals for which the ITC is soliciting voluntary information and to 
establish a dialogue with the ITC to discuss needed data. To enhance 
visibility, the ITC will be adding all chemicals to the Priority 
Testing List for which it is voluntarily soliciting information along 
with a request that EPA not immediately promulgate TSCA section 8(a) 
PAIR and section 8(d) HaSD reporting rules. If the ITC does not receive 
voluntary electronic information submissions to meet its data needs 
according to the procedures in VISP, the ITC may then request that EPA 
promulgate TSCA section 8(a) PAIR and section 8(d) HaSD reporting rules 
to determine if there are unpublished data to meet those needs. The ITC 
strongly encourages those companies that must respond to a TSCA section 
8(d) HaSD reporting rule to provide data by using the TSCA Electronic 
HaSD Reporting Form.
    D. Requests related to promulgation of TSCA section 8(a) PAIR and 
section 8(d) HaSD reporting rules. In this Report, the ITC is asking 
the EPA to promulgate TSCA section 8(a) PAIR and section 8(d) HaSD 
reporting rules for 37 indium chemicals; pentachlorothiophenol; 
tetrachloropyrocatechol; p-toluidine, 5-chloro- 
.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl; benzoic acid, 3-[2-
chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo; and 8 
nonylphenol polyethoxylate degradation products. Reporting rules are 
being requested for pentachlorothiophenol; tetrachloropyrocatechol; p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl; 
benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2- ethoxy-1-
methyl-2-oxo; and the 8 nonylphenol polyethoxylate degradation products 
because needed information was not provided in response to the 
voluntary information solicitations published in the 46\th\ Report. At 
this time, the ITC is requesting that EPA not promulgate TSCA section 
8(a) PAIR and section 8(d) HaSD reporting rules for the 3 chloroalkenes 
(1,3-butadiene, 1,1,2,3,4-pentachloro-4-(1-methylethoxy)-; 3-butenoic 
acid, 2,2,3,4,4-pentachloro-; and 3-butenoic acid, 2,2,3,4,4-
pentachloro-butyl ester) to allow chloroalkenes producers, importers, 
processors, and users an opportunity to voluntarily provide the 
requested information.

III. ITC's Activities During this Reporting Period (May to October 
2000): Information Solicitations

    In its 46\th\ Report, the ITC discussed its strategies to screen 
chemicals for persistence and bioconcentration potential (http://www.epa.gov/opptintr/itc). These strategies are referred to as 
Degradation Effects Bioconcentration Information Testing Strategies 
(DEBITS). DEBITS provides a means to prioritize chemicals based on 
degradation, ecological, or human health effects and bioconcentration 
information. During this reporting period, the ITC continued to focus 
its efforts on structural classes of chemicals from a subset of 42 
moderate production volume (MPV) chemicals (production/importation 
volumes between 100,000 and 1,000,000 pounds) with estimated or 
measured bioconcentration factors (BCFs) > 250 and about 70 
structurally related non-MPV chemicals (also with BCFs > 250). In its 
46\th\ Report, the ITC solicited information on three such structural 
classes:
    1. Polychlorophenols and polychlorobenzenethiols,
    2. Chlorotrifluoromethylphenoxy benzenes, and
    3. Perfluorinated chemicals.
    During this reporting period, the ITC continued its review of 
chemicals with potential to persist and bioconcentrate and decided to 
solicit information on chloroalkenes. The ITC is seeking information on 
uses, exposures, health effects, and ecological effects from the 
manufacturers, importers, and processors of chloroalkenes. The ITC is 
requesting that solicited information be electronically submitted 
before February 28, 2001, consistent with the 90-day milestone of the 
VISP (http://www.epa.gov/opptintr/itc/visp.htm) for submitting data 
through the TSCA Electronic HaSD Reporting Form. DEBITS will continue 
to be used to prioritize chemicals with potential to persist and 
bioconcentrate.

IV. Revisions to the TSCA Section 4(e) Priority Testing List: 
Chemicals Added to the Priority Testing List

A. Indium Chemicals

    1. Recommendation. Indium chemicals are being added to the Priority 
Testing List to obtain importation, production, use, exposure, and 
health effects information to meet U.S. Government data needs.
    2. Rationales for recommendation. There is clear evidence that 
indium phosphide causes tumors in rats and mice. As a result, indium 
phosphide and other indium chemicals are considered to be potentially 
carcinogenic to humans. Use of indium chemicals in the semiconductor 
and other industries may be increasing. Existing exposure limits may 
not be adequate to protect workers exposed to indium phosphide and 
other indium chemicals from an increased risk of lung cancer.
    3. Supporting information. In a 2-year inhalation study there was 
clear evidence of carcinogenic activity of indium phosphide (Chemical 
Abstract Service number (CAS No.) 22398-80-7) in male and female F344/N 
rats and male and female B6C3F1 mice (http://ntp-server.niehs.nih.gov/htdocs/Results_Status/Resstati/M882472.Html). In this study, the 
incidence of benign and malignant neoplasms were increased in the lungs 
of male and female rats and mice at doses of 0.03, 0.1, and 0.3 
milligram/meter\3\ (mg/m\3\). There was also an exposure-related 
increase in the incidence of benign and malignant neoplasms of the 
liver in male and female mice.
    For indium and certain indium chemicals, the National Institute for 
Occupational Safety and Health's (NIOSH) Recommended Exposure Limit 
(REL), the American Council of Government Industrial Hygienists (ACGIH) 
threshold limit value (TLV), and the Occupational Safety and Health 
Administration's (OSHA) Permissible Exposure Limit (PEL) for 
construction and shipyard industries is 0.1 mg/m\3\. The current 
occupational exposure limits may not be adequate to protect workers 
exposed to indium phosphide and other indium chemicals from increased 
risk of lung cancer, because benign and malignant neoplasms were 
increased in the lungs of both sexes of rats and mice at doses lower 
than the PEL, REL, and TLV. Furthermore, experimental studies in 
hamsters suggest that indium arsenide may induce effects in the lung 
comparable to indium phosphide. These studies raise the concern for 
other indium chemicals and their potential health effects.

[[Page 17772]]

    The indium chemicals are believed to be increasingly used in the 
manufacture of semiconductors, injection lasers, solar cells, 
photodiodes, and light-emitting diodes. Worker exposures may occur 
during manufacturing and handling of these materials. However, there 
are no publicly available reports in the literature that assess 
workplace exposures to indium phosphide or other indium chemicals.
    4. Information needs. The ITC needs:
    i. Recent non-CBI estimates of annual production or importation 
volume data and trends, and use information, including percentages of 
production or importation that are associated with different uses;
    ii. Estimates of the number of humans and concentrations of indium 
chemicals to which humans may be exposed in each relevant use, 
manufacturing, or processing scenario;
    iii. Health effects data including pharmacokinetics, genotoxicity, 
subchronic toxicity, reproductive, and developmental toxicity, 
carcinogenicity and any human data from occupationally exposed workers.
     The ITC seeks this information in order to adequately assess the 
extent and degree of exposure and potential hazard associated with the 
indium chemicals. Information is requested on the 37 indium-containing 
chemicals in Table 2 of this unit. Manufacturers, processors, and users 
of indium chemicals are encouraged to provide importation, production, 
use, exposure, and health effects information using the TSCA Electronic 
HaSD Reporting Form (http://www.epa.gov/opptintr/.er/hasd.htm).

   Table 2.--Indium Chemicals Being Added to the Priority Testing List
------------------------------------------------------------------------
                 CAS No.                           Chemical name
------------------------------------------------------------------------
923-34-2................................  Triethylindium
1303-11-3...............................  Indium arsenide
1312-41-0...............................  Indium antimonide
1312-43-2...............................  Indium (III) oxide
1312-45-4...............................  Indium (III) telluride
4194-69-8...............................  Indium (III) citrate
7440-74-6...............................  Indium
7783-52-0...............................  Indium (III) fluoride
10025-82-8..............................  Indium (III) chloride
12018-95-0..............................  Copper indium diselenide
12030-14-7..............................  Indium (II) sulfide
12030-24-9..............................  Indium (III) sulfide
12056-07-4..............................  Indium selenide
 12672-70-7.............................  Indium chloride
12672-71-8..............................  Indium (I) oxide
13464-82-9..............................  Indium (III) sulfate
13510-35-5..............................  Indium (III) iodide
13770-61-1..............................  Indium (III) nitrate
13966-94-4..............................  Indium (I) iodide
14166-78-0..............................  Indium (III) fluoride
 14280-53-6.............................  Indium (I) bromide
 14405-45-9.............................  Indium tris(acetylacetonate)
 20661-21-6.............................  Indium (III) hydroxide
 22398-80-7.............................  Indium (I) phosphide
 25114-58-3.............................  Indium (III) acetate
 25617-98-5.............................  Indium nitride
 50926-11-9.............................  Indium tin oxide
 55326-87-9.............................  Indium hydroxide
 71243-84-0.............................  Indium tin oxide
 13465-09-3.............................  Indium (III) bromide
13465-10-6..............................  Indium (I) chloride
13709-93-8..............................  Indium (III) borate
27765-48-6..............................  Indium (III) tetrafluoroborate
66027-93-8..............................  Indium (III) sulfamate
66027-94-9..............................  Hydroxybis(trifluoroacetato-
                                           ,O)indium
67816-06-2..............................  Indium (III) 2-ethylhexanoate
68310-35-0..............................  Indium (III) neodecanoate
------------------------------------------------------------------------

B. Chloroalkenes

    1. Recommendation. Three chloroalkenes are being added to the 
Priority Testing List to obtain information on uses, exposures, 
environmental releases, pharmacokinetics, subchronic toxicity, 
mutagenicity, reproductive and developmental effects, carcinogenicity, 
and ecological effects. At this time, the ITC is requesting that EPA 
not promulgate TSCA section 8(a) PAIR and section 8(d) HaSD reporting 
rules for these chemicals in order to allow chloroalkenes producers, 
importers, processors, and users an opportunity to voluntarily provide 
the requested information.
    2. Rationales for recommendation. Two chloroalkenes are believed to 
be produced in substantial amounts and are predicted to persist and 
bioconcentrate in the environment. The third chloroalkene is a likely 
hydrolysis product of one of the other chloroakenes. All three 
chemicals present suspicion of toxicity based either on mutagenicity 
data or shared structural similarities with hexachloro-1,3-butadiene.
    3. Supporting information. Chloroalkenes under review include 4 
chemicals: Hexachloro-1,3-butadiene (CAS No. 87-68-3); 1,3-butadiene, 
1,1,2,3,4-pentachloro-4-(1-methylethoxy)- (CAS No. 68334-67-8); 3-
butenoic acid, 2,2,3,4,4-pentachloro-butyl ester (CAS No. 75147-20-9); 
and 2,2,3,4,4-pentachloro-3-butanoic acid (CAS No. 85743-61-9). All 
except the 2,2,3,4,4-pentachloro-3-butenoic acid meet the DEBITS 
criteria and have BCFs >250. However, 2,2,3,4,4-pentachloro-3-butenoic 
acid is a hydrolysis product of 3-butenoic acid, 2,2,3,4,4-pentachloro-
butyl ester. The ITC is not soliciting information on hexachloro-1,3-
butadiene because data are being developed under the Organization for 
Economic Cooperation and Development (OECD) Screening Information Data 
Set (SIDS) program (http://www.oecd.org//ehs/guide/sd97-1.htm). 
Hexachloro-1,3-butadiene was included to provide opportunities to 
develop Structure Activity Relationships (SARs).
    1,3-Butadiene, 1,1,2,3,4-pentachloro-4-(1-methylethoxy)- meets the 
DEBITS criteria of ultimate predicted aerobic biodegradation rate of > 
2-3 months and estimated log octanol-water partition coefficient (log 
P) ranging from 3 to 6. 1,3-Butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)- is a MPV chemical with a log P of 5.14 and estimated BCF 
of 509. The only health effects data for 1,3-butadiene, 1,1,2,3,4-
pentachloro-4-(1-methylethoxy)- were from acute toxicity tests in rats 
that estimated the LD50 to be 1,210 mg/kilogram (kg) body 
weight (Mallinckrodt, 1978a). No ecological effects data were obtained 
for this chemical. 1,3-Butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)- is structurally similar to hexachloro-1,3- butadiene 
and, therefore, may share some common metabolic pathways and related 
toxicities. Hexachloro-1,3-butadiene is known to be metabolically 
converted by glutathione S-transferase to the glutathione conjugate, 
and then to a cysteine sulfoxide, which is cytotoxic to the kidney 
proximal tubular cells. This metabolic activation is believed to be 
responsible for the nephrotoxicity associated with the chemical.
    3-Butenoic acid, 2,2,3,4,4-pentachloro- butyl ester is another MPV 
chemical with BCF>250. It has an estimated log P of 4.42, and an 
estimated BCF of 1797. There are no ecological effects data for 3-
butenoic acid, 2,2,3,4,4-pentachloro- butyl ester. Acute toxicity and 
genotoxicity studies were available for the chemical. The rat oral 
LD50 value was 2.09 gram (g)/kg body weight (Mallinckrodt, 
1978b). Negative results were obtained in a reverse mutation assay 
using Salmonella typhimurium (TA-1535, TA-1537, TA-1538, TA-98, and TA-
100) and Saccharomyces cerevisiae (D4) with or without metabolic 
activation (Mallinckrodt, 1984a). There was no significant increase in 
6-thioguanine resistant mutation frequency in Chinese hamster ovary 
cells with or without metabolic activation (Mallinckrodt, 1984c). There 
was a positive response in an Escherichia coli microsuspension assay 
for DNA damage and in the frequency of sister chromatid exchange and 
chromosomal aberrations from Chinese hamster ovary cells (Mallinckrodt, 
1984b,d,e).

[[Page 17773]]

    3-Butenoic acid, 2,2,3,4,4-pentachloro-butyl ester is likely 
hydrolyzed to 2,2,3,4,4-pentachloro-3-butenoic acid. The latter 
chemical has a predicted aerobic biodegradation rate of > 2-3 months, 
an estimated log P of 3.38, an estimated BCF of 3, but its production 
volume is less than 10,000 pounds per annum. Like its butyl ester, 
2,2,3,4,4-pentachloro-3-butenoic acid has some genotoxic activity. It 
caused reverse mutation in Salmonella typhimurium strain TA100 both 
with and without metabolic activation (Reichert et al. 1984) and 
induced both unscheduled DNA synthesis (with and without activation) 
and morphological transformation in Syrian hamster embryo fibroblasts 
(Schiffmann et al. 1984). 3-Butenoic acid, 2,2,3,4,4-pentachloro-butyl 
ester presents a suspicion of toxicity based on existing data and its 
metabolic relationship and structural similarity to 2,2,3,4,4-
pentachloro-3-butenoic acid.
    Information Profiles for 1,3-butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)-, 3-butenoic acid, 2,2,3,4,4-pentachloro-butyl ester and 
2,2,3,4,4-pentachloro-3-butenoic acid will be available on the ITC's 
web site (http://www.epa.gov/opptintr/itc).
    4. Information needs. The ITC needs information on uses, exposures, 
environmental releases, pharmacokinetics, subchronic toxicity, 
mutagenicity, reproductive and developmental effects, carcinogenicity, 
and ecological effects for 1,3-butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)-; 3-butenoic acid, 2,2,3,4,4-pentachloro- and 3-butenoic 
acid, 2,2,3,4,4-pentachloro-butyl ester. In addition, the ITC needs 
hydrolysis rate data for 3-butenoic acid, 2,2,3,4,4-pentachloro-butyl 
ester. If the information is not voluntarily submitted in accordance 
with VISP, the ITC will ask EPA to promulgate TSCA section 8(a) PAIR 
and section 8(d) HaSD reporting rules in a subsequent Report.

C. Polychlorophenols and Polychlorobenzenethiols

    1. Recommendation. Pentachlorothiophenol (CAS No. 133-49-3) and 
tetrachloropyrocatechol (CAS No. 1198-55-6) are being added to the 
Priority Testing List so that final TSCA section 8(a) and 8(d) rules 
will be promulgated by the EPA.
    2. Rationale for recommendation. Information solicited in the 
46\th\ Report for pentachlorothiophenol and tetrachloropyrocatechol was 
not provided to the ITC.
    3. Supporting information. Pentachlorothiophenol and 
tetrachloropyrocatechol meet the DEBITS criteria for persistence and 
bioconcentration. Pentachlorothiophenol has an estimated BCF of 7066. 
Tetrachloropyrocatechol's measured BCF ranges from 316-5011. There are 
no publicly available ecological effects and limited health effects 
data for pentachlorothiophenol. Tetrachloropyrocatechol has been shown 
to be highly toxic to fish but little is known about health effects in 
mammalian species. Pentachlorothiophenol and tetrachloropyrocatechol 
are metabolites of pentachlorophenol. Pentachlorothiophenol has also 
been detected in the urine of human populations exposed to 
hexachlorobenzene. The carcinogenicity, reproductive effects and 
developmental toxicities of hexachlorobenzene and pentachlorophenol are 
well known. The ITC believes that pentachlorothiophenol and 
tetrachloropyrocatechol present a suspicion of toxicity given the 
metabolic relationship and structural similarity to hexachlorobenzene 
and pentachlorophenol. Detailed information supporting the addition of 
pentachlorothiophenol and tetrachloropyrocatechol to the Priority 
Testing List was provided in the ITC's 46\th\ Report.
    4. Information needs. The ITC needs information on uses and data on 
exposures, environmental releases, pharmacokinetics, subchronic 
toxicity, reproductive and developmental effects, carcinogenicity, and 
ecological effects for pentachlorothiophenol and 
tetrachloropyrocatechol. The ITC also needs mutagenicity data for 
pentachlorothiophenol. Manufacturers, processors, and users of these 
chemicals are encouraged to provide importation, production, use, 
exposure, and health effects information using the TSCA Electronic HaSD 
Reporting Form (http://www.epa.gov/opptintr/.er/hasd.htm).

D. Chlorotrifluoromethylphenoxy Benzenes

    1. Recommendation. p-Toluidine, 5-chloro- .alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-phenyl (CAS No. 1806-24-2) and benzoic acid, 3-[2-
chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo (CAS No. 
88185-2-2) are being added to the Priority Testing List so that final 
TSCA section 8(a) and 8(d) rules will be promulgated by the EPA.
    2. Rationale for recommendation. Information solicited in the 
46\th\ Report for p-toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-phenyl and benzoic acid, 3-[2-chloro-4-
(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo was not provided to 
the ITC.
    3. Supporting information. Eight chlorotrifluoromethylphenoxy 
benzenes were listed in the ITC's 46\th\ Report. All were estimated to 
persist and seven had estimated BCFs > 250. Six 
chlorotrifluoromethylphenoxy benzenes were highly toxic to fish. One 
member of this class, Lactofen is a well-studied herbicide, considered 
by the U.S. EPA to be a probable human carcinogen. As a result of the 
oncogenicity and other adverse health effects associated with Lactofen, 
there is a heightened concern for potential toxicity of the other 
chlorotrifluoromethylphenoxy benzenes which have not been extensively 
investigated. Information was solicited for 4 of 8 
chlorotrifluoromethylphenoxy benzenes listed in the ITC's 46\th\ 
Report. Lactofen and three HPV chemicals were not included in the 
solicitation.
    In response to the solicitation, the ITC learned that one of these 
chemicals, phenol, 5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-nitro- 
(CAS No. 42874-63-5) is a process intermediate that is not isolated 
from storage nor packaged for distribution in commerce. Another 
chlorotrifluoromethylphenoxy benzene for which information was 
solicited, benzene, 2-chloro-1-(3-methylphenoxy)-4-(trifluoromethyl)- 
(CAS No. 42874-96- 4) was previously added to a TSCA section 8(d) HaSD 
reporting rule as a result of its addition to the Priority Testing List 
in the ITC's 29\th\ Report (56 FR 67424, December 30, 1991). Since it 
is already included in a TSCA section 8(d) HaSD reporting rule (47 FR 
38780, October 4, 1982) and the reporting period is 10 years in length, 
benzene, 2-chloro-1-(3- methylphenoxy)-4-(trifluoromethyl)- does not 
have to be added to the Priority Testing List to facilitate that 
action. The other two chlorotrifluoromethylphenoxy benzenes, p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl 
and benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-
methyl-2-oxo are being added to the Priority Testing List, because no 
information was submitted in response to the 46\th\ Report 
solicitation. Detailed information supporting the addition of p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl 
and benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1- 
methyl-2-oxo to the Priority Testing List was provided in the ITC's 
46\th\ Report.
    4. Information needs. The ITC needs information on uses, exposures, 
environmental releases, ecological effects, pharmacokinetics, 
subchronic

[[Page 17774]]

toxicity, reproductive and developmental effects, mutagenicity, and 
carcinogenicity for p-toluidine, 5- chloro-.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-phenyl and benzoic acid, 3-[2- chloro-4-
(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo.

V. References

    1. Mallinckrodt Inc. 1978a. Initial Submission: Acute oral toxicity 
(LD50) test in rats (Final Report) with cover letter dated 
02/27/92; 10/13/78; EPA Doc. No. 88-920001282; Microfiche No. 
OTS0535871.
    2. Mallinckrodt Inc. 1978b. Initial Submission: Letter submitting 
one enclosed acute toxicity series study with cover letter dated 02/27/
92. EPA Doc. No. 88-920001280; Microfiche No. OTS0535869.
    3. Mallinckrodt Inc. 1984a. Mutagenicity evaluation of M-388-48A in 
the Ames Salmonella/microsome plate test with cover letter dated 12/28/
84; 03/01/78; EPA Doc. No. FYI-OTS-0185-0376; Microfiche No. 
OTS0000376-0.
    4. Mallinckrodt Inc. 1984b. Escherichia coli microsuspension assay 
for DNA damage with compound M276; 02/23/84; EPA Doc. No. FYI-OTS-0185-
0376; Microfiche No. OTS0000376-0.
    5. Mallinckrodt Inc. 1984c. CHO/HGPRT forward mutation assay M276; 
02/23/84; EPA Doc. No. FYI-OTS-0185-0376; Microfiche No. OTS0000376-0.
    6. Mallinckrodt Inc. 1984d. In vitro sister chromatid exchange in 
Chinese hamster ovary cells with M276; 07/13/84; EPA Doc. No. FYI-OTS-
0185-0376; Microfiche No. OTS0000376-0.
    7. Mallinckrodt Inc. 1984e. In vitro chromosomal aberrations in 
Chinese hamster ovary cells with M276; 12/19/84; EPA Doc. No. FYI-OTS-
0185-0376; Microfiche No. OTS0000376-0.
    8. Reichert D, Neudecker T, Scheutz S. 1984. Mutagenicity of 
hexachlorobutadiene, perchlorobutenoic acid and perchlorobutenoic acid 
chloride. Mutation Research. 137:89-94.
    9. Schiffmann D, Reichert D, Henschler D. 1984. Induction of 
morphological transformation and unscheduled DNA synthesis in Syrian 
hamster embryo fibroblasts by hexachlorobutadiene and its putative 
metabolite pentachlorobutenoic acid. Cancer Letters. 23:297-306.

VI. TSCA Interagency Testing Committee

Statutory Organizations and Their Representatives
Council on Environmental Quality
    Vacant
 Department of Commerce
      National Institute of Standards and Technology
        Robert Huie, Member
        Barbara C. Levin, Alternate
      National Oceanographic and Atmospheric Administration
        Teri Rowles, Alternate
 Environmental Protection Agency
    Paul Campanella, Member
    David R. Williams, Alternate
National Cancer Institute
    Vacant
National Institute of Environmental Health Sciences
    Scott Masten, Member
    William Eastin, Alternate
National Institute for Occupational Safety and Health
    Albert E. Munson, Member
    Mark Toraason, Alternate
National Science Foundation
    A. Frederick Thompson, Member
    Marge Cavanaugh, Alternate
Occupational Safety and Health Administration
    Val H. Schaeffer, Member, Chair
    Lyn Penniman, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
    William Cibulas, Member
Consumer Product Safety Commission
    Jacqueline Ferrante, Member
    Treye Thomas, Alternate
Department of Agriculture
    Clifford P. Rice, Member
Department of Defense
    Barbara Larcom, Member
    Kenneth Still, Alternate
    Jose Centeno, Alternate
Department of the Interior
    Barnett A. Rattner, Member, Vice Chair
Food and Drug Administration
    Ronald Lorentzen, Member
    Raju Kammula, Alternate
    David Hatten, Alternate
National Library of Medicine
    Vera W. Hudson, Member
National Toxicology Program
    NIEHS, FDA, and NIOSH Members
Counsel
    Scott Sherlock, OPPT, EPA
Technical Support Contractor
    Syracuse Research Corporation
ITC Staff
    John D. Walker, Executive Director
    Norma S. L. Williams, Executive Assistant
TSCA Interagency Testing Committee, Office of Pollution Prevention and 
Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460; telephone: (202) 260-1825; fax: (202) 260-
7895; e-mail address: [email protected]; url: http://www.epa.gov/opptintr/itc.
[FR Doc. 01-8133 Filed 4-2-01; 8:45 am]
BILLING CODE 6560-50-S