Fifty-First Report of the TSCA Interagency Testing Committee to the Administrator; Receipt of Report and Request for Comments
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: February 26, 2003 (Volume 68, Number 38)]
[Notices]
[Page 8975-8988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe03-118]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2002-0075; FRL-7285-7]
Fifty-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.
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SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its 51\st\ ITC Report to the Administrator
of the United States Environmental Protection Agency on November 26,
2002. In the 51\st\ ITC Report, which is included in this notice, the
ITC is adding 43 vanadium compounds to its Priority Testing List and
removing 39 chemicals from the Priority Testing List.
The ITC is asking EPA to add 43 vanadium compounds to the TSCA
section 8(a) Preliminary Assessment Information Reporting (PAIR) rule
and rescinding its requests to add 2 chemicals to the TSCA section 8(a)
PAIR rule and 36 chemicals to the TSCA section 8(d) Health and Safety
Data Reporting rule.
The ITC continues to request voluntary information submissions
directly from trade organizations, producers, and importers, while
working to improve the utility of the Voluntary Information Submissions
Innovative Online Network (VISION) and Voluntary Information
Submissions Policy (VISP).
DATES: Comments, identified by docket ID number OPPT-2002-0075, must be
received on or before March 28, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Acting Director, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
For technical information contact: John D. Walker, ITC Executive
Director (7401M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7526;
fax: (202) 564-7528; e-mail address: walker.johnd@epa.gov.
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 under the North American Industrial Classification System
(NAICS) codes 325 (Chemical Manufacturing) and 32411(Petroleum
Refineries). 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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPPT-2002-0075. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the EPA Docket Center, Rm.
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The EPA Docket Center Reading
Room telephone number is (202) 566-1744 and the telephone number for
the OPPT Docket, which is located in EPA Docket Center, is (202) 566-
0280.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a
[[Page 8977]]
brief description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPPT-2002-0075. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to oppt.ncic@epa.gov,
Attention: Docket ID Number OPPT-2002-0075. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Building Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2002-0075. 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) 564-8930.
D. How Should I Submit CBI To the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be 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 docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket 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 on the various options we
propose, new approaches we have not considered, the potential impacts
of the various options (including possible unintended consequences),
and any data or information that you would like the Agency to consider
during the development of the final action. 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. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the notice or collection
activity.
7. Make sure to submit your comments by the deadline in this
notice.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID 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. 260l et seq.)
authorizes the Administrator of the EPA to promulgate regulations under
section 4(a) of TSCA requiring testing of chemicals and chemical
mixtures in order to develop data relevant to determining the risks
that such chemicals and chemical mixtures may present to health or the
environment. Section 4(e) of TSCA established the ITC to recommend
chemicals and chemical mixtures 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.
A. The 51th ITC Report
The 51th ITC Report was transmitted to the EPA's Administrator on
November 26, 2002, and is included in this notice. In the 51\st\ ITC
Report, the ITC:
1. Adds 43 vanadium compounds to its Priority Testing List and
removes
[[Page 8978]]
thiophenol, 7 alkylphenols and alkylphenol ethoxylates, 3 Degradation
Effects Bioconcentration Information Testing Strategies (DEBITS)
chemicals, and 28 indium chemicals from the Priority Testing List.
2. Asks EPA to add 43 vanadium compounds to the TSCA section 8(a)
PAIR rule and rescinds its request to add 3H-pyrazol-3-one, 5-((2-
chloro-5-nitrophenyl)amino)-2,4-dihydro-2- (2,4,6-trichlorophenyl)-
(CAS No. 30707-68-7) and phenol, 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl)ethylidene]bis- (CAS No. 1478-61-1) to the TSCA
section 8(a) PAIR rule.
3. Rescinds its request to EPA to add 8 nonylphenol polyethoxylate
degradation products and 28 indium compounds to the TSCA section 8(d)
Health and Safety Data Reporting rule.
4. Continues to request voluntary information submissions directly
from trade organizations, producers, and importers, while working to
improve the utility of VISION and VISP.
B. Status of the Priority Testing List
The current TSCA 4(e) Priority Testing List as of November 2002 can
be found in Table 1 of the 51\st\ ITC Report, which is included in this
notice.
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Dated: February 19, 2003.
Wardner G. Penberthy,
Acting Director, Chemical Control Division, Office of Pollution
Prevention and Toxics.
Fifty-First Report of the TSCA Interagency Testing Committee to the
Administrator, U.S. Environmental Protection Agency
Table of Contents
Summary
The TSCA Section 4(e) Priority Testing List (November 2002)
I. Background
II. TSCA Section 8 Reporting
A. TSCA Section 8 Reporting Rules
B. ITC's Use of TSCA Section 8 and Other Information
C. Previous and New Requests to Add Chemicals to TSCA Section 8(a) PAIR
Rule
D. Rescinding Requests to Add Chemicals to TSCA Section 8(a) PAIR Rules
E. Previous Requests to Add Chemicals to TSCA Section 8(d) HaSDR Rules
F. Rescinding Requests to Add Chemicals to TSCA Section 8(d) HaSDR
Rules
III. ITC's Activities During this Reporting Period (May to November
2002)
A. Voluntary Information Submissions
B. DEBITS
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List: Vanadium Compounds
B. Chemicals Removed From the Priority Testing List
1. Thiophenol.
2. Seven alkylphenols and alkylphenol ethoxylates.
3. DEBITS 1 chemical.
4. Indium compounds.
V. References
VI. TSCA Interagency Testing Committee
Summary
In this 51\st\ Report, the ITC is adding 43 vanadium compounds to
the Priority Testing List. The ITC is removing thiophenol, 7
alkylphenols and alkylphenol ethoxylates, 3 Degradation Effects
Bioconcentration Information Testing Strategies (DEBITS) chemicals, and
28 indium chemicals from the Priority Testing List.
The ITC is asking the United States Environmental Protection Agency
(USEPA) to add 43 vanadium compounds to the Toxic Substances Control
Act (TSCA) section 8(a) Preliminary Assessment Information Reporting
(PAIR) rule and rescinding its request to add 3H-pyrazol-3-one, 5-((2-
chloro-5-nitrophenyl)amino)-2,4-dihydro-2- (2,4,6-trichlorophenyl)-
(CAS No. 30707-68-7) and phenol, 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl)ethylidene]bis- (CAS No. 1478-61-1) to the TSCA
section 8(a) PAIR rule. The ITC is rescinding its request to USEPA to
add 8 nonylphenol polyethoxylate degradation products, and 28 indium
compounds to the TSCA section 8(d) Health and Safety Data Reporting
(HaSDR) rule.
The ITC will continue to request voluntary information submissions
directly from trade organizations, producers, and importers, while
working to improve the utility of the Voluntary Information Submissions
Innovative Online Network (VISION) and Voluntary Information
Submissions Policy (VISP).
The revised TSCA section 4(e) Priority Testing List follows as
Table 1.
Table 1.--The TSCA Section 4(e) Priority Testing List (November 2002)
----------------------------------------------------------------------------------------------------------------
ITC Report Date Chemical name/Group Action
----------------------------------------------------------------------------------------------------------------
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 2 Alkylphenols Recommended
-------------------------------------
41 November 1997 1 Alkylphenol Recommended
-------------------------------------
42 May 1998 3-Amino-5-mercapto-1,2,4- Recommended
triazole
-------------------------------------
42 May 1998 Glycoluril Recommended
-------------------------------------
47 November 2000 9 Indium compounds Recommended
-------------------------------------
48 May 2001 Benzenamine, 3-chloro- Recommended
2,6-dinitro-N,N-
dipropyl-4-
(trifluoromethyl)-
-------------------------------------
[[Page 8979]]
49 November 2001 Stannane, dimethylbis[(1- Recommended
oxoneodecyl)oxy]-
-------------------------------------
50 May 2002 Benzene, 1,3,5-tribromo- Recommended
2-(2-propenyloxy)-
-------------------------------------
50 May 2002 1-Triazene, 1,3-diphenyl- Recommended
-------------------------------------
51 November 2002 43 Vanadium compounds 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 50 semi-annual (May and November) Reports to the USEPA
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 and ITC Members and their U.S. Government organizations
and contract support provided by USEPA. ITC Members and Staff are
listed at the end of this report.
II. TSCA Section 8 Reporting
A. TSCA Section 8 Reporting Rules
Following receipt of the ITC's Report (and the revised Priority
Testing List) by the USEPA Administrator, the USEPA's Office of
Pollution Prevention and Toxics (OPPT) appends the chemicals added to
the Priority Testing List to TSCA section 8(a) PAIR and TSCA section
8(d) HaSDR rules. The PAIR rule requires producers and importers of
Chemical Abstract Service (CAS)-numbered chemicals added to the
Priority Testing List to submit production and exposure reports (http:/
/www.epa.gov/opptintr/chemtest/pairform.pdf). The HaSDR rule requires
producers, importers, and processors of all chemicals (including those
with no CAS numbers) added to the Priority Testing List to submit
unpublished health and safety studies under TSCA section 8(d) that must
be in compliance with the revised HaSDR rule (Ref. 1). All submissions
must be received by USEPA within 90 days of the reporting rules Federal
Register publication date. The reporting 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 rule reports, TSCA
section 8(d) HaSDR rule 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. To avoid duplicate reporting, the ITC carefully
coordinates its information solicitations and reporting requirements
with other national and international testing programs, e.g., the
National Toxicology Program (NTP) (http://ntp-server.niehs.nih.gov/),
the Organization for Economic Cooperation and Development (OECD)
Screening Information Data Set (SIDS) Program (http://www.oecd.org),
and the USEPA's High Production Volume (HPV) Challenge Program (http://
www.epa.gov/opptintr/chemrtk/volchall.htm).
C. Previous and New Requests to Add Chemicals to TSCA Section 8(a) PAIR
Rules
The ITC has requested in previous reports that USEPA add the
following chemicals to the TSCA section 8(a) PAIR rules: Benzenamine,
3-chloro-2,6-dinitro-N,N-dipropyl-4- (trifluoromethyl)- (CAS No. 29091-
20-1) (48\th\ Report, Ref. 2); stannane, dimethylbis[(1-
oxoneodecyl)oxy]- (CAS No. 68928-76-7) (49\th\ Report, Ref. 3); and
benzene, 1,3,5-tribromo-2-(2-propenyloxy)- (CAS No. 3278-89-5) and 1-
triazene, 1,3-diphenyl- (CAS No.136-35-6) (50\th\ Report, Ref. 4).
The ITC requests that USEPA add the 43 vanadium compounds described
in this 51\st\ Report to the TSCA section 8(a) PAIR rule.
D. Rescinding Requests to Add Chemicals to TSCA Section 8(a) PAIR Rules
The ITC is rescinding its 48\th\ Report (Ref. 2) request to add 3H-
pyrazol-3-one, 5-[(2-chloro-5-nitrophenyl)amino]-2,4- dihydro-2-
(2,4,6-trichlorophenyl)- (CAS No. 30707-68-7) to the TSCA section 8(a)
PAIR rule because of decreasing production volume trends from 1990 to
the present. The ITC is also rescinding its 48\th\ Report (Ref. 2)
request to add phenol, 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl)ethylidene]bis- (CAS No. 1478-61-1) to the TSCA
section 8(a) PAIR rule because the ITC has learned that the predicted
bioconcentration factor (BCF) of 500 is below the BCF threshold
currently considered for action by USEPA under its Persistent,
Bioaccumulative and Toxic (PBT) Chemical Program (http://www.epa.gov/
opptintr/pbt).
E. Previous Requests to Add Chemicals to TSCA Section 8(d) HaSDR Rules
The ITC has requested in previous reports to the USEPA Adminstrator
that the following chemicals be added to TSCA section 8(d) HaSDR rules:
3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- (3-amino-5-mercapto-
1,2,4-triazole) (CAS No. 16691-43-3) and imidazo[4,5-d]imidazole-
2,5(1H,3H)-dione, tetrahydro- (glycoluril) (CAS No.
[[Page 8980]]
496-46-8) (42\nd\ Report, Ref. 5); 9 indium compounds (47\th\ Report,
Ref. 6); benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-
(trifluoromethyl)- (CAS No. 29091-20-1) (48\th\ Report, Ref. 2);
stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7) (49\th\
Report, Ref. 3); and benzene, 1,3,5-tribromo-2-(2-propenyloxy)- (CAS
No. 3278-89-5) and 1-triazene, 1,3-diphenyl- (CAS No.136-35-6) (50\th\
Report, Ref. 4). At this time, the ITC is requesting that USEPA not add
vanadium compounds to the TSCA section 8(d) HaSDR rule to allow
producers and importers of vanadium compounds an opportunity to
voluntarily provide the information requested in section IV.A.3. of
this report.
For 3H-1,2,4-triazole-3-thione, 5-amino-1,2-dihydro- (3-amino-5-
mercapto-1,2,4-triazole) and imidazo[4,5-d]imidazole-2,5-(1H,3H)-dione,
tetrahydro- (glycoluril), the ITC requests that the TSCA section 8(d)
HaSDR rule require the submission of pharmacokinetics, subchronic
toxicity, immunotoxicity, genotoxicity, carcinogenicity, reproductive
effects and developmental toxicity, and ecological effects studies.
Only studies for which 3-amino-5-mercapto-1,2,4-triazole or glycoluril
is £= 90% of the test substance by weight should be
submitted.
For the 9 indium compounds remaining on the Priority Testing List,
the ITC requests that the TSCA section 8(d) HaSDR rule require the
submission of pharmacokinetics, genotoxicity, subchronic and chronic
toxicity, and reproductive effects and developmental toxicity studies.
Only studies where indium compounds are £= 90% of the test
substance by weight should be submitted.
For benzenamine, 3-chloro-2,6-dinitro-N,N-dipropyl-4-
(trifluoromethyl)-, the ITC requests that the TSCA section 8(d) HaSDR
rule require the submission of biodegradation, bioconcentration,
pharmacokinetics, subchronic toxicity, mutagenicity, reproductive
effects and developmental toxicity, carcinogenicity, and ecological
effects studies. Only studies where benzenamine, 3-chloro-2,6-dinitro-
N,N-dipropyl-4- (trifluoromethyl)- is £= 90% of the test
substance by weight should be submitted.
For stannane, dimethylbis[(1-oxoneodecyl)oxy]-, the ITC requests
that the TSCA section 8(d) HaSDR rule require the submission of
hydrolysis, biodegradation, bioconcentration, pharmacokinetics,
subchronic toxicity, mutagenicity, neurotoxicity, reproductive effects
and developmental toxicity, carcinogenicity, and ecological effects
studies. Only studies where stannane, dimethylbis[(1-oxoneodecyl)oxy]-
is £= 90% of the test substance by weight should be
submitted.
For benzene, 1,3,5-tribromo-2-(2-propenyloxy)-, the ITC requests
that the TSCA section 8(d) HaSDR rule require the submission of
biodegradation, bioconcentration, pharmacokinetics, subchronic
toxicity, neurotoxicity, reproductive effects and developmental
toxicity, carcinogenicity, and ecological effects studies. Only studies
where benzene, 1,3,5-tribromo-2-(2-propenyloxy)- is £= 90% of
the test substance by weight should be submitted.
For 1-triazene, 1,3-diphenyl-, the ITC requests that the TSCA
section 8(d) HaSDR rule require the submission of pharmacokinetics,
genotoxicity, subchronic and chronic toxicity, reproductive effects and
developmental toxicity studies. Only studies where 1-triazene, 1,3-
diphenyl- is £= 90% of the test substance by weight should be
submitted.
F. Rescinding Requests to Add Chemicals to TSCA Section 8(d) HaSDR
Rules
The ITC is rescinding its request to USEPA to add 8 nonylphenol
polyethoxylate degradation products and 28 indium compounds to the TSCA
section 8(d) HaSDR rule. The request to add 8 nonylphenol
polyethoxylate degradation products to the TSCA section 8(d) HaSDR rule
is being rescinded because the ITC learned that they are not
commercially produced (Table 2 of this unit). Data on the 8 nonylphenol
polyethoxylate degradation products were summarized in the 46\th\
Report (Ref. 7). The ITC is rescinding its request to add 28 indium
compounds to the TSCA section 8(d) HaSDR rule because no PAIR reports
were submitted for these chemicals in response to the July 26, 2001,
PAIR rule (1,000 pound reporting threshold) (Ref. 8). Data on the
indium compounds were summarized in the 47\th\ Report (Ref. 6).
Table 2.--Nonylphenol Polyethoxylate (NPE) Degradation Products Being
Removed From the Priority Testing List
------------------------------------------------------------------------
Nonylphenol polyethoxylate
CAS No. degradation product
------------------------------------------------------------------------
104-35-8 4-nonylphenol ethoxylate (NP1EO)
-----------------------------------
20427-84-3 4-nonylphenol diethoxylate (NP2EO)
-----------------------------------
51437-95-7 4-nonylphenol triethoxylate (NP3EO)
-----------------------------------
7311-27-5 4-nonylphenol tetraethoxylate
(NP4EO)
-----------------------------------
3115-49-9 4-nonylphenoxy acetic acid (NP1EC)
-----------------------------------
106807-78-7 4-nonylphenoxy ethoxy acetic acid
(NP2EC)
-----------------------------------
108149-59-3 4-nonylphenoxy diethoxy acetic acid
(NP3EC)
-----------------------------------
184007-22-5 4-nonylphenoxy triethoxy acetic acid
(NP4EC)
------------------------------------------------------------------------
[[Page 8981]]
III. ITC's Activities During this Reporting Period (May to November
2002)
A. Voluntary Information Submissions
To promote more efficient use of information submission resources,
the ITC developed the VISP and the VISION. The VISP is described in the
ITC's 41\st\ Report (Ref. 9), while the VISION is described in the
ITC's 42\nd\ Report (Ref. 5). The ITC developed the VISP and VISION as
tools to provide a more cost-effective method for chemical producers,
importers, processors, and users of ITC-recommended chemicals to
provide voluntary information. Except for a few industries, the ITC
received voluntary information submissions through the VISION on < 15%
of the chemicals for which voluntary information was solicited. The ITC
has not yet determined the reasons for the apparent low utilization of
the VISION. In its 50\th\ Report (Ref. 4), the ITC requested comments
on procedures that could be implemented to make the VISION or other
procedures for submitting voluntary information more effective.
The American Chemistry Council (ACC) provided an explanation of the
chemical industry's limited participation in the VISION (Ref. 10). The
ACC expressed concerns about the need to protect Confidential Business
Information (CBI), the problems associated with soliciting voluntary
submissions on non-HPV chemicals, the potential non-existence of
specific data being requested by the ITC, and the resources required to
submit studies in portable document format (PDF).
To supplement the efforts to obtain studies in PDF through the
VISION, the ITC Staff has been contacting the producers and importers
of ITC-recommended chemicals to obtain voluntary information
submissions. These efforts were highly successful for the chemicals
identified through DEBITS. The ITC Staff will continue to contact the
producers and importers of ITC-recommended chemicals to obtain
voluntary information submissions as it continues its efforts to
improve the utility of the VISP and VISION.
During this reporting period, the ITC acknowledges the voluntary
information submissions from the following organizations: 3M
Corporation; Albemarle Corporation; Amfine Chemical Corporation;
Alkylphenol & Ethoxylates Research Council; Akzo Nobel Chemicals, Inc.;
BASF Corporation; Bayer Corporation; Biddle Sawyer Corporation; Canon
USA, Inc.; Ciba Specialty Chemicals Corporation; Cognis Corporation;
Crompton Corporation; E.I. duPont de Nemours and Company; Eastman
Chemical Company; ExxonMobil Corporation; Great Lakes Chemical Company;
Hercules, Inc.; Lonza, Inc.; Lubrizol Corporation; Magruder Color
Company; Noveon, Inc.; Schenectady International, Inc.; Society of
Plastics Industry; and Strucktol Company.
Following the transmittal of this 51\st\ Report to the USEPA
Administrator, the ITC Staff will contact the producers and importers
of the 9 indium compounds remaining on the Priority Testing List to
obtain the following information to adequately access the extent and
degree of exposure and potential hazard associated with indium
compounds:
1. Recent non-CBI estimates of annual production or importation
volume trends.
2. Use information, including percentages of production or
importation that are associated with different uses.
3. Estimates of the number of workers and concentrations of indium
compounds to which workers may be exposed during manufacture or
processing including smelting processes, leaching processes, recovery
of scrap material, deposition of film coatings, soldering, and
production of electrical components including, but not limited to
semiconductors.
B. DEBITS
In its 45\th\ through 50\th\ Reports (Refs. 2-4, 6, 7, and 11), the
ITC described its strategies to screen and evaluate chemicals with
persistence and bioconcentration potential. These activities are
referred to as DEBITS. DEBITS provides a means to prioritize chemicals
for information reporting and testing based on degradation and
bioconcentration potential and availability of effects data. For DEBITS
1, the ITC used criteria to screen 12,685 chemicals and ultimately
review 458, the disposition of which was described in the 45\th\
through 50\th\ Reports (Refs. 2-4, 6, 7, and 11). As a result of
implementing DEBITS 1, the Priority Testing List contains three
chemicals with persistence and bioconcentration potential that the
USEPA may consider for its PBT Program: Benzenamine, 3-chloro-2,6-
dinitro-N,N-dipropyl-4- (trifluoromethyl)-; stannane, dimethylbis[(1-
oxoneodecyl)oxy]-; and benzene, 1,3,5-tribromo-2-(2-propenyloxy)-.
DEBITS 2 started with 8,511 chemicals with production volumes >
10,000 lbs reported to USEPA in response to the 1998 Inventory Update
Rule (IUR). From these 8,511 chemicals, 30 non-HPV chemicals were
identified that had 1998 production volumes > 50,000 lbs, predicted
biodegradation half-lives > 2 months and predicted bioconcentration
factors > 1,000. The ITC contacted manufacturers and importers of these
30 DEBITS 2 chemicals to solicit voluntary information on production
and uses, and unpublished toxicity data. The ITC received production
and use information for 22 DEBITS 2 chemicals and unpublished toxicity
studies for 13 DEBITS 2 chemicals. After reviewing this and other
available information the ITC deferred the 30 DEBITS 2 chemicals for
information reporting rules. A brief rationale for deferring each
DEBITS 2 chemical is given in Table 3 of this unit.
Table 3.--Rationales for Deferring 30 DEBITS 2 Chemicals
------------------------------------------------------------------------
CAS No. Chemical name Rationale
------------------------------------------------------------------------
118-74-1 Benzene, hexachloro- Not domestically
produced or
imported
--------------------------------
128-69-8 Perylo[3,4-cd:9,10- Potential low
c'd']dipyran- bioavailability
1,3,8,10-tetrone
--------------------------------
133-14-2 Peroxide, bis(2,4- Low exposure
dichlorobenzoyl) potential from
use
--------------------------------
423-50-7 1-Hexanesulfonyl Perfluorinated
fluoride, chemical referred
1,1,2,2,3,3,4,4,5, to USEPA
5,6,6,6-
tridecafluoro-
--------------------------------
509-34-2 Spiro[isobenzofuran- Not domestically
1(3H),9'- produced or
[9H]xanthen]-3- imported
one, 3',6'-
bis(diethylamino)-
--------------------------------
[[Page 8982]]
678-39-7 1-Decanol, Perfluorinated
3,3,4,4,5,5,6,6,7, chemical referred
7,8,8,9,9,10,10,10- to USEPA
heptadecafluoro-
--------------------------------
3006-86-8 Peroxide, Low exposure
cyclohexylidenebis potential from
[(1,1- use
dimethylethyl)
--------------------------------
3864-99-1 Phenol, 2-(5-chloro- Adequate toxicity
2H-benzotriazol-2- studies available
yl)-4,6-bis(1,1-
dimethylethyl)-
--------------------------------
4051-63-2 [1,1'-Bianthracene]- Potential low
9,9',10,10'- bioavailability
tetrone, 4,4'-
diamino-
--------------------------------
4162-45-2 Ethanol, 2,2'-[(1- Not domestically
methylethylidene)b produced or
is[(2,6-dibromo- imported
4,1-
phenylene)oxy]]bis-
--------------------------------
&qd rt;13417-01-1 1- Perfluorinated
Octanesulfonamide, chemical referred
N-[3- to USEPA
(dimethylamino)pro
pyl]-
1,1,2,2,3,3,4,4,5,
5,6,6,7,7,8,8,8-
heptadecafluoro-
--------------------------------
15667-10-4 Peroxide, Low exposure
cyclohexylidenebis potential from
[(1,1- use
dimethylpropyl)
--------------------------------
16090-14-5 Ethanesulfonyl Perfluorinated
fluoride, 2-[1- chemical referred
[difluoro[(trifluo to USEPA
roethenyl)oxy]meth
yl]-1,2,2,2-
tetrafluoroethoxy]-
1,1,2,2-
tetrafluoro-
--------------------------------
25637-99-4 Cyclododecane, Included in OECD
hexabromo- (HBCD) Risk Assessment
of brominated
flame retardants
and specific
isomer of HBCD
previously
designated in
ITC's 25\th\
Report (Ref. 12)
--------------------------------
29512-49-0 Spiro[isobenzofuran- Not domestically
1(3H),9'- produced or
[9H]xanthen]-3- imported
one, 6'-
(diethylamino)-3'-
methyl-2'-
(phenylamino)-
--------------------------------
31148-95-5 1- Low exposure
Phenanthrenecarbon potential from
itrile, use
1,2,3,4,4a,9,10,10
a-octahydro-1,4a-
dimethyl-7-(1-
methylethyl)-,
(1R,4aS,10aR)-
--------------------------------
40567-16-6 Butanoyl chloride, Low exposure
2-[2,4-bis(1,1- potential from
dimethylpropyl)phe use
noxy]-
--------------------------------
41556-26-7 Decanedioic acid, Low measured BCF
bis(1,2,2,6,6-
pentamethyl-4-
piperidinyl) ester
--------------------------------
50598-28-2 1- Perfluorinated
Hexanesulfonamide, chemical referred
N-[3- to USEPA
(dimethylamino)pro
pyl]-
1,1,2,2,3,3,4,4,5,
5,6,6,6-
tridecafluoro-
--------------------------------
51461-11-1 Butanamide, N-(3- Not domestically
amino-4- produced or
chlorophenyl)-4- imported
[2,4-bis(1,1-
dimethylpropyl)phe
noxy]-
--------------------------------
51772-35-1 1-Naphthalenamine, Low exposure
N-[(1,1,3,3- potential from
tetramethylbutyl)p use
henyl]-
--------------------------------
58798-47-3 3H-Indolium, 2-[[(4- Not domestically
methoxyphenyl)meth produced or
ylhydrazono]methyl imported
]-1,3,3-trimethyl-
, acetate
--------------------------------
64022-61-3 1,2,3,4- Low exposure
Butanetetracarboxy potential from
lic acid, use
tetrakis(2,2,6,6-
tetramethyl-4-
piperidinyl) ester
--------------------------------
67584-57-0 2-Propenoic acid, 2- Perfluorinated
[methyl[(tridecafl chemical referred
uorohexyl)sulfonyl to USEPA
]amino]ethyl ester
--------------------------------
68259-36-9 1-Naphthalenamine, Low measured BCF
N-phenyl-ar-
(1,1,3,3-
tetramethylbutyl)-
--------------------------------
68555-73-7 1- Perfluorinated
Heptanesulfonamide chemical referred
, N-ethyl- to USEPA
1,1,2,2,3,3,4,4,5,
5,6,6,7,7,7-
pentadecafluoro-N-
(2-hydroxyethyl)-
--------------------------------
68555-76-0 1- Perfluorinated
Heptanesulfonamide chemical referred
, to USEPA
1,1,2,2,3,3,4,4,5,
5,6,6,7,7,7-
pentadecafluoro-N-
(2-hydroxyethyl)-N-
methyl-
--------------------------------
72869-85-3 Chromate(1-), Low exposure
bis[3,5-bis(1,1- potential from
dimethylethyl)-2- use
(hydroxy-
.kappa.O)benzoato(
2-)-.kappa.O]-,
hydrogen, (T-4)-
--------------------------------
[[Page 8983]]
75627-12-2 Xanthylium, 3,6- Potential low
bis(ethylamino)-9- bioavailability
[2-
(methoxycarbonyl)p
henyl]-2,7-
dimethyl-,
molybdatesilicate
--------------------------------
106246-33-7 Benzenamine, 4,4'- Low exposure
methylenebis[3- potential from
chloro-2,6-diethyl- use
------------------------------------------------------------------------
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List: Vanadium Compounds
1. Recommendation. Forty-three vanadium compounds 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 (Table 4 of this unit). These compounds were identified by
searching reference sources and chemical databases maintained by
agencies in the United States and Canada. The ITC believes the list of
vanadium compounds in Table 4 of this unit includes those most likely
to be in current use. Toxicological effects of vanadium compounds were
recently summarized by the International Program on Chemical Safety
under the auspices of the World Health Organization (WHO) (Ref. 13).
Table 4.--Vanadium Compounds Being Added to the Priority Testing List
------------------------------------------------------------------------
CAS No. Vanadium compounds
------------------------------------------------------------------------
1314-34-7 Vanadium oxide (V2O3) [Vanadium
trioxide]
-----------------------------------
1314-62-1 Vanadium oxide (V2O5) [Vanadium
pentoxide]
-----------------------------------
1686-22-2 Vanadium, triethoxyoxo-, (T-4)-
[Triethyl orthovanadate]
-----------------------------------
3153-26-2 Vanadium, oxobis (2,4-pentanedionato-
.kappa.O,.kappa.O')-, (SP-5-21)-
-----------------------------------
5588-84-1 Vanadium, oxotris(2-propanolato)-,
(T-4)- [Vanadium triisopropoxide
oxide]
-----------------------------------
7440-62-2 Vanadium
-----------------------------------
7632-51-1 Vanadium chloride (VCl4), (T-4)-
[Vanadium tetrachloride]
-----------------------------------
7718-98-1 Vanadium chloride (VCl3) [Vanadium
trichloride]
-----------------------------------
7727-18-6 Vanadium, trichlorooxo-, (T-4)-
[Vanadium oxytrichloride]
-----------------------------------
7803-55-6 Vanadate (VO31-), ammonium [Ammonium
metavanadate]
-----------------------------------
10049-16-8 Vanadium fluoride (VF4) [Vanadium
tetrafluoride]
-----------------------------------
10213-09-9 Vanadium, dichlorooxo- [Vanadyl
dichloride]
-----------------------------------
10580-52-6 Vanadium chloride (VCl2) [Vanadium
dichloride]
-----------------------------------
11099-11-9 Vanadium oxide [Polyvanadic acid]
-----------------------------------
11115-67-6 Ammonium vanadium oxide
-----------------------------------
11130-21-5 Vanadium carbide
-----------------------------------
12007-37-3 Vanadium boride (VB2)
-----------------------------------
12035-98-2 Vanadium oxide (VO)
-----------------------------------
12036-21-4 Vanadium oxide (VO2)
-----------------------------------
12070-10-9 Vanadium carbide (VC)
-----------------------------------
12083-48-6 Vanadium, dichlorobis (.eta.5-2,4-
cyclopentadien-1-yl)-
-----------------------------------
12166-27-7 Vanadium sulfide (VS)
-----------------------------------
12439-96-2 Vanadium, oxo[sulfato(2-)-kappa.O]-,
pentahydrate [Vanadyl sulfate
(VOSO4), pentahydrate]
-----------------------------------
12604-58-9 Vanadium alloy, base, V,C,Fe
(Ferrovanadium)
-----------------------------------
13470-26-3 Vanadium bromide (VBr3)
-----------------------------------
13476-99-8 Vanadium, tris(2,4-pentanedionato-
.kappa.O,.kappa.O')-, (OC-6-11)-
[Vanadium tris(acetylacetonate)]
-----------------------------------
[[Page 8984]]
13497-94-4 Silver vanadium oxide (AgVO3)
-----------------------------------
13517-26-5 Sodium vanadium oxide (Na4V2O7)
[Sodium pyrovanadate]
-----------------------------------
13718-26-8 Vanadate (VO31-), sodium [Sodium
metavanadate]
-----------------------------------
13721-39-6 Sodium vanadium oxide (Na3VO4)
[Sodium orthovanadate]
-----------------------------------
13769-43-2 Vanadate (VO31-), potassium
[Potassium metavanadate]
-----------------------------------
13930-88-6 Vanadium, oxo[29H,31H-
phthalocyaninato(2-)-
.kappa.N29,.kappa.N30,.kappa.N31,.k
appa.N32]-, (SP-5-12)-
-----------------------------------
14059-33-7 Bismuth vanadium oxide (BiVO4)
-----------------------------------
19120-62-8 Vanadium, tris(2-methyl-1-
propanolato)oxo-, (T-4)- [Isobutyl
orthovanadate]
-----------------------------------
24646-85-3 Vanadium nitride (VN)
-----------------------------------
27774-13-6 Vanadium, oxo[sulfato(2-)-.kappa.O]-
[Vanadyl sulfate]
-----------------------------------
30486-37-4 Vanadium hydroxide oxide (V(OH)2O)
-----------------------------------
39455-80-6 Ammonium sodium vanadium oxide
-----------------------------------
53801-77-7 Bismuth vanadium oxide
-----------------------------------
65232-89-5 Vanadium hydroxide oxide phosphate
-----------------------------------
68130-18-7 Vanadium hydroxide oxide phosphate
(V6(OH)3O3(PO4)7)
-----------------------------------
68815-09-8 Naphthenic acids, vanadium salts
-----------------------------------
68990-29-4 Balsams, copaiba, sulfurized,
vanadium salts
------------------------------------------------------------------------
2. Rationale for recommendation. Long-term inhalation exposure to
vanadium pentoxide increased the incidence of lung tumors in male and
female mice. As a result, vanadium pentoxide and other vanadium
compounds may be potentially carcinogenic to humans. Existing
occupational exposure limits for vanadium dusts were primarily
developed to protect workers from irritation and acute pulmonary
effects and may not be sufficiently protective against an increased
risk of lung cancer.
3. 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
vanadium chemicals to which humans may be exposed in each relevant
manufacturing or processing scenario.
iii. Health effects data including pharmacokinetics, genotoxicity,
subchronic toxicity, reproductive and developmental toxicity, 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 various
forms of vanadium.
4. Supporting information. Vanadium is widely distributed in low
amounts as a constituent of mineral ores and crude petroleum deposits.
The U.S. consumption of vanadium compounds was reported to be 3,210
metric tons in 2001 (Ref. 14). The majority of vanadium was utilized as
an alloying agent in the steel industry or in the production of
ferrovanadium and other metal alloys. A smaller portion of vanadium was
used as industrial catalysts and in the production of pesticides, dyes,
inks, and pigments. More recent applications of vanadium compounds are
thought to include manufacture of semiconductors, vanadate glasses, and
electro-optical switches. There were over 5,000 potentially exposed
workers reported in the National Occupational Exposure Survey conducted
between 1980 and 1983. Vanadium exposure has been found in over 300
personal air samples reported in OSHA's Integrated Management
Information System since 1995. Worker exposures are known to occur
during manufacture and handling of vanadium containing materials, such
as welding operations or during cleaning of oil-fired furnaces and
boilers. General population exposure to vanadium most likely occurs
through ingestion of food-bearing soil residue and inhaled air in areas
with high levels of residual fuel oil consumption (Ref. 15).
For vanadium pentoxide and most vanadium dusts and fumes, NIOSH's
Recommended Exposure Limit (REL) is a ceiling value of 0.05 milligram/
meter cubed (mg/m\3\). The American Council of Government Industrial
Hygienists (ACGIH) threshold limit value (TLV) for vanadium pentoxide
is 0.05 mg/m\3\ as an 8-hour time weighted average. OSHA's Permissible
Exposure Limit (PEL) is a 0.1 mg/m\3\ ceiling for vanadium pentoxide
fumes and a 0.5 mg/m\3\ ceiling for respirable dust. These occupational
exposure limits were developed to protect against respiratory tract
irritation and acute pulmonary effects and may not be adequate against
an increased risk of lung cancer.
In a 2-year inhalation study, NTP found clear evidence of
carcinogenic activity of vanadium pentoxide (CAS No. 1314-62-1) in male
and female
[[Page 8985]]
B6C3F1 mice (http://ntp-server.niehs.nih.gov/htdocs/LT-studies/
tr507.html).
The incidence of benign and malignant neoplasms was
increased in the lungs of the experimental animals at doses of 1, 2,
and 4 mg/m\3\. There was also some lesser evidence of increased lung
tumor incidence in male and female rats at similar exposure levels.
Exposures to vanadium pentoxide caused a spectrum of nonneoplastic
lesions in the respiratory tracts of rats and mice, including
epithelial hyperplasia, inflammation and fibrosis. The NTP report
raises concerns for other vanadium chemicals and their potential health
effects.
B. Chemicals Removed From the Priority Testing List
1. Thiophenol. Thiophenol (CAS No. 108-98-5) was designated in the
ITC's 28\th\Report (Ref. 16) because there was a low confidence in the
Reference Dose (RfD) and no Reference Concentration (RfC). The USEPA's
RfC/RfD Workgroup requested that the ITC review health effects data for
thiophenol and recommend health effects testing that would increase the
confidence in the RfD and provide a RfC. Since thiophenol was
designated, the ITC has learned that it is not currently produced in
the United States, that the NTP has conducted developmental toxicity
(Refs. 17 and 18) and reproductive effects (Ref. 19) studies, and that
Japan is developing a SIDS dossier. Thiophenol is being removed from
the Priority Testing List because it is no longer produced and the ITC
anticipates the SIDS dossier will address the testing data needs
recommended by the ITC.
2. Seven alkylphenols and alkylphenol ethoxylates. The ITC is
continuing to review data on the alkylphenols and alkylphenol
ethoxylates that were recommended in ITC Reports 37 (Ref. 20), 39 (Ref.
21), and 41 (Ref. 9). For these chemicals the ITC has reviewed the PAIR
reports submitted by producers and voluntary information provided by
the Alkylphenol & Ethoxylates Research Council (APERC). At this time
the ITC is removing from the Priority Testing List 4 alkylphenols from
the 37th Report (Ref. 20) 1 nonylphenol ethoxylate from the 39\th\
Report (Ref. 21) and 2 alkylphenols from the 41st Report (Ref. 9)
(Table 5 of this unit).
Table 5.--Alkylphenols and Alkylphenol Ethoxylates Being Removed From the Priority Testing List
----------------------------------------------------------------------------------------------------------------
ITC Report CAS No. Chemical name Rationale for removal
----------------------------------------------------------------------------------------------------------------
37 80-46-6 Phenol, 4-(1,1- Sponsored in HPV
dimethylpropyl)- Challenge Program
-------------------------------------
37 88-18-6 Phenol, 2-(1,1- Sponsored in HPV
dimethylethyl)- Challenge Program
-------------------------------------
37 1806-26-4 Phenol, 4-octyl- No longer used by APERC
Members
-------------------------------------
37 25154-52-3 Phenol, nonyl- Not commercially
available
-------------------------------------
39 27986-36-3 Ethanol, 2- \1\
(nonylphenoxy)-
-------------------------------------
41 1987-50-4 Phenol, 4-heptyl- \2\
-------------------------------------
41 72624-02-3 Phenol, heptyl derivs. Sponsored in HPV
Challenge Program
----------------------------------------------------------------------------------------------------------------
\1\ Ethanol, 2-(nonylphenoxy)- (CAS No. 27986-36-3) is likely to be degraded in the environment to branched 4-
nonylphenol (CAS No. 84852-15-3); data developed from testing branched 4-nonylphenol (CAS No. 84852-15-3) in
response to the HPV Challenge Program may be used to predict toxicity of 2-(nonylphenoxy)ethanol.
\2\ The ITC learned that there is only a single product being sold and purchased as heptylphenol (phenol, heptyl
derivs., CAS No. 72624-02-3). CAS No. 1987-50-4 for Phenol, 4-heptyl- denotes a linear structure of the C7
chain and was previously used and reported on the IUR though it is not the most appropriate CAS number for the
commercial heptylphenol product.
There are 2 alkylphenols from the 37\th\ Report (Ref. 20) and 1
alkylphenol from the 41\st\ Report (Ref. 9) remaining on the Priority
Testing List (Table 6 of this unit).
Table 6.--Alkylphenols Remaining on the Priority Testing List
------------------------------------------------------------------------
ITC Report CAS No. Chemical name
------------------------------------------------------------------------
37 98-54-4 Phenol, 4-(1,1-
dimethylethyl)-
-------------------------------
37 84852-15-3 Phenol, 4-nonyl-,
branched
-------------------------------
41 140-66-9 Phenol, 4-(1,1,3,3-
tetramethylbutyl)-
------------------------------------------------------------------------
For phenol, 4-(1,1-dimethylethyl)- (CAS No. 98-54-4), the ITC
anticipates reviewing the SIDS dossier and the ongoing reproductive
effects study. For phenol, 4-(1,1,3,3-tetramethylbutyl)- (CAS No. 140-
66-9) and phenol, 4-nonyl-, branched (CAS No. 84852-15-3), the ITC
anticipates receiving amphibian toxicity data, avian reproductive
effects data, and fish reproductive effects data.
3. DEBITS 1 chemical. 3H-Pyrazol-3-one, 5-((2-chloro-5-
nitrophenyl)amino)-2,4-dihydro-2-(2,4,6-trichlorophenyl)- is being
removed from the Priority Testing List because of decreasing production
volume trends from 1990 to the present. Phenol, 4,4'-[2,2,2-trifluoro-
1-(trifluoromethyl)ethylidene]bis- is being removed from the Priority
Testing List because the ITC has learned that the predicted BCF of
approximately 500 is not sufficient to be considered by USEPA's PBT
Program. Pentachlorothiophenol (CAS No. 133-49-3) is being removed from
the Priority Testing List because of low exposure potential from
current use.
[[Page 8986]]
4. Indium compounds. Twenty-eight indium compounds are being
removed from the Priority Testing List because no production or
importation data were submitted to USEPA in response to the July 26,
2001, PAIR rule (Ref. 8) (Table 7 of this unit).
Table 7.--Indium Compounds Being Removed From the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
923-34-2 Indium, triethyl-
-----------------------------------
1303-11-3 Indium arsenide (InAs)
-----------------------------------
1312-41-0 Antimony, compd. with indium (1:1)
-----------------------------------
1312-45-4 Indium telluride (In2Te3)
-----------------------------------
4194-69-8 1,2,3-Propanetricarboxylic acid, 2-
hydroxy-, indium(3+) salt
-----------------------------------
7783-52-0 Indium fluoride (InF3)
-----------------------------------
12018-95-0 Copper indium selenide (CuInSe2)
-----------------------------------
12030-14-7 Indium sulfide (InS)
-----------------------------------
12030-24-9 Indium sulfide (In2S3)
-----------------------------------
12056-07-4 Indium selenide (In2Se3)
-----------------------------------
12672-70-7 Indium chloride
-----------------------------------
12672-71-8 Indium oxide
-----------------------------------
13510-35-5 Indium iodide (InI3)
-----------------------------------
13770-61-1 Nitric acid, indium(3+) salt
-----------------------------------
13966-94-4 Indium iodide (InI)
-----------------------------------
14166-78-0 Indium fluoride (InF3), trihydrate
-----------------------------------
14280-53-6 Indium bromide (InBr)
-----------------------------------
14405-45-9 Indium, tris(2,4-pentanedionato-
.kappa.O,.kappa.O')-, (OC-6-11)-
-----------------------------------
25617-98-5 Indium nitride (InN)
-----------------------------------
55326-87-9 Indium hydroxide
-----------------------------------
71243-84-0 Indium tin oxide (In1.69Sn0.15O2.85)
-----------------------------------
13465-09-3 Indium bromide (InBr3)
-----------------------------------
13465-10-6 Indium chloride (InCl)
-----------------------------------
13709-93-8 Boric acid (H3BO3), indium(3+) salt
(1:1)
-----------------------------------
27765-48-6 Borate(1-), tetrafluoro-, indium(3+)
(3:1)
-----------------------------------
66027-94-9 Indium, hydroxybis(trifluoroacetato-
.kappa.O)-
-----------------------------------
67816-06-2 Hexanoic acid, 2-ethyl-, indium(3+)
salt
-----------------------------------
68310-35-0 Neodecanoic acid, indium(3+) salt
------------------------------------------------------------------------
With these actions, there are nine indium compounds remaining on
the Priority Testing List (Table 8 of this unit). Indium phosphide
remains on the Priority Testing List due to carcinogenicity concerns
based on experimental animal studies (Ref. 22). The other eight indium
compounds remain on the Priority Testing List because PAIR reports were
submitted for these chemicals and the ITC needs health effects data
(see section II.E. of this report).
Table 8.--Indium Compounds Remaining on the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name
-----------------------------------------------------------------------
1312-43-2 Indium oxide (In2O3)
----------------------------------
[[Page 8987]]
7440-74-6 Indium
----------------------------------
10025-82-8 Indium chloride (InCl3)
----------------------------------
13464-82-9 Sulfuric acid, indium(3+) salt
(3:2)
----------------------------------
20661-21-6 Indium hydroxide (In(OH)3)
----------------------------------
25114-58-3 Acetic acid, indium(3+) salt
----------------------------------
22398-80-7 Indium phosphide (InP)
----------------------------------
17906-67-7 Indium tin oxide
----------------------------------
66027-93-8 Sulfamic acid, indium(3+) salt
------------------------------------------------------------------------
V. References
1. USEPA. 1998. Revisions to Reporting Regulations Under TSCA
Section 8(d) (63 FR 15765, April 1, 1998) (FRL-5750-4). Available
online at: http://www.epa.gov/fedrgstr/
2. ITC. 2001. Forty-Eighth Report of the ITC. Federal Register (66
FR 51276, October 5, 2001) (FRL-6786-7). Available online at: http://
www.epa.gov/fedrgstr/
3. ITC. 2001. Forty-Ninth Report of the ITC. Federal Register (67
FR 10298, March 6, 2002) (FRL-6820-8). Available online at: http://
www.epa.gov/fedrgstr/
4. ITC. 2001. Fiftieth Report of the ITC. Federal Register (67 FR
49530, July 30, 2002) (FRL-7183-7). Available online at: http://
www.epa.gov/fedrgstr/
5. ITC. 1998. Forty-Second Report of the ITC. Federal Register (63
FR 42554, August 7, 1998) (FRL-5797-8). Available online at: http://
www.epa.gov/fedrgstr/
6. ITC. 2001. Forty-Seven Report of the ITC. Federal Register (66
FR 17768 April 3, 2001) (FRL-6763-6). Available online at: http://
www.epa.gov/fedrgstr/
7. ITC. 2000. Forty-Sixth Report of the ITC. Federal Register (65
FR 75552 December 1, 2000) (FRL-6594-7). Available online at: http://
www.epa.gov/fedrgstr/
8. USEPA. 2001. Preliminary Assessment Information Reporting;
Addition of Certain Chemicals (66 FR 38955, July 26, 2001) (FRL-6783-
6). Available online at: http://www.epa.gov/fedrgstr/
9. ITC. 1998. Forty-First Report of the ITC. Federal Register (63
FR 17658, April 9, 1998) (FRL-5773-5). Available online at: http://
www.epa.gov/fedrgstr/
10. ACC. 2002. Comments on 50\th\ TSCA Interagency Testing
Committee Report. Docket ID Number OPPT-2002-0026 (67 FR 45929, July
30, 2002). September 13, 2002 letter from the American Chemistry
Council, Arlington, VA.
11. ITC. 2000. Forty-Fifth Report of the ITC. Federal Register (65
FR 75544, December 1, 2000) (FRL-6399-5). Available online at: http://
www.epa.gov/fedrgstr/
12. ITC. 1989. Twenty-Fifth Report of the ITC, Receipt of Report
and Request for Comments Regarding Priority Testing List of Chemicals.
Federal Register (54 FR 51114, December 12, 1989). Available online at:
http://www.epa.gov/fedrgstr/EPA-TOX/pre1994/hisindex.htm#Toxic
Substances Control Act (TSCA) Interagency Testing Committee (ITC)
Reports.
13. WHO. 2001. Vanadium Pentoxide and Other Inorganic Vanadium
Compounds. Concise International Chemical Assessment Document 29. World
Health Organization, Geneva, Switzerland. Available online at: http://
www.inchem.org/documents/cicads/cicads/cicad29.htm
14. Reese, Robert G., Jr. 2001. Vanadium. The Mineral Yearbook--
Minerals and Metals. Available online at: (http://minerals.usgs.gov/
minerals/pubs/commodity/vanadium/700401.pdf).
15. ATSDR. 1992. Toxicological Profile of Vanadium. Available
online at: http://www.atsdr.cdc.gov/toxprofiles/tp58.html
16. ITC. 1991. Twenty-Eighth Report of the ITC, Receipt of Report
and Request for Comments Regarding Priority List of Chemicals. Federal
Register (56 FR 41212, August 19, 1991). Available online at: http://
www.epa.gov/fedrgstr/EPA-TOX/pre1994/hisindex.htm#Toxic
Substances Control Act (TSCA) Interagency Testing Committee (ITC)
Reports.
17. NTP. 1994. Developmental Toxicity of Thiophenol (CAS No. 108-
98-5) in Sprague-Dawley (CD[reg]) Rats. NTIS# PB94-155009.
Available online at: http://ntp-server.niehs.nih.gov/htdocs/TT-studies/
TER92133.html
18. NTP. 1994. Developmental Toxicity of Thiophenol (CAS No. 108-
98-5) in New Zealand White Rabbits. NTIS# PB94-201183 .
Available online at: http://ntp-server.niehs.nih.gov/htdocs/TT-studies/
TER92134.html
19. NTP. 1996. Reproductive Toxicity of Thiophenol II (CAS No: 108-
98-5) Administered by Gavage to Sprague-Dawley Rats. National
Toxicology Program. NTIS# PB96-211735. Available online at:
http://ntp-server.niehs.nih.gov/htdocs/RT-studies/RACB94001.html
20. ITC. 1996. Thirty-Seventh Report of the ITC. Federal Register
(61 FR 4188, February 2, 1996) (FRL-4991-6). Available online at:
http://www.epa.gov/fedrgstr/
21. ITC. 1997. Thirty-Ninth Report of the ITC. Federal Register (62
FR 8578, February 25, 1997) (FRL-5580-9). Available online at: http://
www.epa.gov/fedrgstr/
22. NTP. 2001. Toxicology and carcinogenesis studies of indium
phosphide (CAS No. 22398-80-7) in F344/Nrats and B6C3F1 mice
(inhalation studies). National Toxicology Program Technical Report.
2001 July; 499:1-4433 (http://ehp.niehs.nih.gov/ntp/members/tr499/
tr499-full.pdf).
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
[[Page 8988]]
Barbara C. Levin, Alternate
National Oceanographic and Atmospheric Administration
Thomas P. O'Connor, Member
Teri Rowles, Alternate
Environmental Protection Agency
Gerry Brown, Member
Paul Campanella, Alternate
National Cancer Institute
Alan Poland, Member
David Longfellow, Alternate
National Institute of Environmental Health Sciences
Scott Masten, Member, Chair
William Eastin, Alternate
National Institute for Occupational Safety and Health
Mark Toraason, Member, Vice Chair
Dennis W. Lynch, Alternate
National Science Foundation
Marge Cavanaugh, Member
Occupational Safety and Health Administration
Val H. Schaeffer, Member
Lyn Penniman, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Daphne Moffett, Alternate
Consumer Product Safety Commission
Treye Thomas, Member
Jacqueline Ferrante, Alternate
Department of Agriculture
Clifford P. Rice, Member
Laurau L. McConnell, Alternate
Department of Defense
Barbara Larcom, Member
Kenneth Still, Alternate
Jos[eacute]
Centeno, Alternate
Department of the Interior
Barnett A. Rattner, Member
Food and Drug Administration
David Hatten, Member
National Library of Medicine
Vera W. Hudson, Member
National Toxicology Program
NIEHS, FDA, and NIOSH Members
Technical Support Contractor
Syracuse Research Corporation
ITC Staff
John D. Walker, Director
Norma S. L. Williams, Executive Assistant
TSCA Interagency Testing Committee, Office of Pollution Prevention and
Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7527;
fax number: (202) 564-7528; e-mail address: williams.norma@epa.gov;
url: http://www.epa.gov/opptintr/itc
[FR Doc. 03-4522 Filed 2-25-03; 8:45 am]
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