Fifty-Third Report of the TSCA Interagency Testing Committee to
the Administrator of the Environmental Protection Agency; Receipt of
Report and Request for Comments
[Federal Register: January 15, 2004 (Volume 69, Number 10)]
[Notices]
[Page 2467-2473]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja04-122]
[[Page 2468]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2003-0068; FRL-7335-2]
Fifty-Third Report of the TSCA Interagency Testing Committee to
the Administrator of the Environmental Protection Agency; 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 Fifty-Third Report to the Administrator
of the EPA on December 2, 2003. In the 53\rd\ ITC Report, which is
included with this notice, the ITC is revising the Priority Testing
List by adding 3 pyridinamines and 20 tungsten compounds. The ITC is
requesting that EPA add the 3 pyridinamines and 20 tungsten compounds
to the TSCA section 8(a) Preliminary Assessment Information Reporting
(PAIR) rule. In addition, the ITC is soliciting voluntary use,
exposure, and effects information for 3 pyridinamines, 20 tungsten
compounds, and 43 vanadium compounds through its Voluntary Information
Submissions Innovative Online Network (VISION).
DATES: Comments, identified by docket ID number OPPT-2003-0068, must be
received on or before February 17, 2004.
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, 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, Director, TSCA
Interagency Testing Committee (7401), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (202) 564-7527; 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. Potentially
affected entities may include, but are not limited to:
? Chemical Industry, e.g., NAICS 325, Manufacturers.
? Petroleum Industry, e.g., NAICS 32411, Refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. 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-2003-0068. 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. This Federal Register document may be
accessed electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr/ You may also access
additional information about the ITC at http://www.epa.gov/opptintr/itc/
and VISION at http://www.epa.gov/opptintr/itc/vision.htm.
An electronic version of the public docket is available through
EPA's electronic public docket at http://www.epa.gov/edocket/.
EPA's electronic public docket may be used to submit or view public
comments, access the index of the docket's contents, and to access those
documents in the public docket that are available electronically.
Although not all docket materials may be available electronically, any
of the publicly available docket materials may be accessed 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.
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 brief
description written by the docket staff.
[[Page 2469]]
C. How and to Whom Do I Submit Comments?
Comments may be submitted 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-2003-0068. 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-2003-0068. 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), EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2003-0068. 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 and comments on the 53\rd\ 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
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. 260let seq.)
authorizes the Administrator of the EPA to promulgate regulations under
section 4(a) 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 ITC's 53\rd\ Report
The 53\rd\ ITC Report was transmitted to the EPA's Administrator on
December 2, 2003, and is included in this notice. In the 53\rd\ ITC
Report, the ITC revises the Priority Testing List by adding 3
pyridinamines and 20 tungsten compounds, requests that EPA add the
pyridinamines and tungsten compounds to the TSCA section 8(a) PAIR rule
and solicits voluntary use, exposure, and effects information for
pyridinamines, tungsten compounds, and vanadium compounds.
B. Status of the Priority Testing List
The current TSCA 4(e) Priority Testing List as of November 2003 can
be found in Table 1 of the 53\rd\ ITC Report, which is included in this
notice.
[[Page 2470]]
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Dated: January 8, 2004.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
Fifty-Third 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
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. New Requests to Add Chemicals to the TSCA Section 8(a) PAIR Rule
D. Previous Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule
III. ITC's Activities During this Reporting Period (May to November 2003)
IV. Revisions to the TSCA Section 4(e) Priority Testing List
V. References
VI. The TSCA Interagency Testing Committee
Summary
In this 53\rd\ Report, the ITC is revising the Priority Testing
List by adding 3 pyridinamines and 20 tungsten compounds. The ITC is
requesting that EPA add the 3 pyridinamines and 20 tungsten
compounds to the TSCA section 8(a) Preliminary Assessment
Information Reporting (PAIR) rule.
The 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 2003)
----------------------------------------------------------------------------------------------------------------
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 4-tert-Butylphenol and Recommended
Branched nonylphenol
(mixed isomers)
------------------------------------
41 November 1997 Phenol, 4-(1,1,3,3- Recommended
tetramethylbutyl)-
------------------------------------
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-2,6- Recommended
dinitro-N,N-dipropyl-4-
(trifluoromethyl)-
------------------------------------
49 November 2001 Stannane, dimethylbis[(1- Recommended
oxoneodecyl)oxy]-
------------------------------------
50 May 2002 Benzene, 1,3,5-tribromo-2- Recommended
(2-propenyloxy)-
------------------------------------
50 May 2002 1-Triazene, 1,3-diphenyl- Recommended
------------------------------------
51 November 2002 43 Vanadium compounds Recommended
------------------------------------
53 November 2003 3 Pyridinamines Recommended
------------------------------------
53 November 2003 20 Tungsten compounds Recommended
----------------------------------------------------------------------------------------------------------------
I. Background
The ITC was established by section 4(e) of the Toxic Substances
Control Act (TSCA) ``to make recommendations to the Administrator
respecting the chemical substances and mixtures to which the
Administrator should give priority consideration for the
promulgation of rules 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.). 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 the EPA's web site
http://www.epa.gov/
fedrgstr/after publication in the Federal Register. The ITC
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 Reporting 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) adds the chemicals from the
revised Priority Testing List to the TSCA section 8(a) PAIR and TSCA
section 8(d) Health and Safety Data Reporting (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 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 the EPA within 90
days of the reporting rules Federal Register publication date.
[[Page 2471]]
B. ITC's Use of TSCA Section 8 and Other Information
The ITC's use of TSCA section 8 and other information is
described in previous ITC Reports
(http://www.epa.gov/opptintr/itc/rptmain.htm).
C. New Requests to Add Chemicals to the TSCA Section 8(a) PAIR Rule
The ITC is requesting that EPA add 3 pyridinamines and 20
tungsten compounds to the TSCA section 8(a) PAIR rule. The 3
pyridinamines and 20 tungsten compounds are discussed in Units
IV.A.1. and IV.A.2. of this report.
D. Previous Requests to Add Chemicals to the TSCA Section 8(d) HaSDR Rule
In previous ITC Reports it was requested that the following
chemicals be added to the TSCA section 8(d) HaSDR rule: 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. 496-46-8)
(42\nd\ ITC Report, Ref. 2), 9 indium compounds (47\th\ ITC Report,
Ref. 3); benzenamine, 3-chloro-2, 6-dinitro-N,N-dipropyl-4-
(trifluoromethyl)- (CAS No. 29091-20-1) (48\th\ ITC Report, Ref 4);
and stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7),
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\ ITC Report, Ref.
5). The TSCA section 8(d) studies requested for these chemicals were
listed in the ITC's 51\st\ Report (Ref. 6).
III. ITC's Activities During this Reporting Period (May to November 2003)
During this reporting period, the ITC received voluntary
information submissions from the Color Pigments Manufacturers
Association (CPMA) and the Vanadium Producers and Reclaimers
Association (VPRA) in response to solicitations for the 43 vanadium
compounds listed in the ITC's 51\st\ Report (Ref. 6). The procedures
for submitting voluntary information through the ITC's Voluntary
Information Submissions Innovative Online Network (VISION) are
described on the ITC's web site
(http://www.epa.gov/opptintr/itc/vision.htm).
During this reporting period, the ITC reviewed the PAIR reports
submitted in response to the June 11, 2003, PAIR rule (Ref. 7). This
PAIR rule required submission of reports for benzenamine, 3-chloro-
2,6-dinitro-N,N-dipropyl-4-(trifluoromethyl)- (CAS No. 29091-20-1);
stannane, dimethylbis[(1-oxoneodecyl)oxy]- (CAS No. 68928-76-7);
benzene, 1,3,5-tribromo-2-(2-propenyloxy)- (CAS No. 3278-89-5); and
1-triazene, 1,3-diphenyl- (CAS No. 136-35-6 ) and the 43 vanadium
compounds listed in the ITC's 51\st\ Report. The ITC is continuing
to analyze the data in those reports as well as data submitted
voluntarily.
For the 43 vanadium compounds listed in the ITC's 51\st\ Report
(Ref. 6), the ITC is still soliciting voluntary submissions of:
1. 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.
2. Estimates of the number of humans and concentrations of
vanadium compounds to which humans may be exposed during
manufacturing or processing.
3. Health effects data including pharmacokinetics, genotoxicity,
subchronic toxicity, reproductive and developmental toxicity, and
any human data from occupationally exposed workers.
The ITC is soliciting this information in order to adequately
assess the extent and degree of exposure and potential hazard
associated with the various forms of vanadium.
In addition, the ITC is soliciting voluntary information
submissions for the 3 pyridinamines and 20 tungsten compounds being
added to the Priority Testing List to meet U.S. Government data
needs. The information being solicited is summarized in Unit
IV.A.1.c. and IV.A.2.c. of this report.
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List
1. Pyridinamines--a. Recommendation. Pyridinamines 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. Three pyridinamines are being
recommended: 2-Pyridinamine (CAS No. 504-29-0), 3-pyridinamine (CAS
No. 462-08-8) and 4-pyridinamine (CAS No. 504-24-5).
b. Rationale for recommendation. Pyridinamines are readily
absorbed through the skin and the gastrointestinal tract and widely
distributed in the body, including the brain. They are not
metabolized and are completely excreted through the kidneys. Studies
in animals and humans have shown that pyridinamines are acutely
toxic compounds. Part of this toxic response may be due to their
ability to block K+ channels causing, among other effects,
convulsions. The chronic toxicity of these compounds has not
received adequate evaluation. To determine a priority for testing
members of the pyridinamine class of compounds, additional
information is needed to characterize human exposure potential.
c. Information needs. For each individual pyridinamine: Recent
data or estimates of annual production and importation volume and
trends; information on specific uses, including percentages of
production or importation volume associated with each of these uses;
estimates of the number of persons potentially exposed to each
pyridinamine during its manufacture and use and health effects,
including chronic toxicity data.
d. Supporting information. Pyridinamines are chemicals in
commerce. The annual production volume of 2-pyridinamine exceeded 1
million pounds in 1998; it is used in hair colorants and as an
intermediate in the manufacture of pharmaceuticals. 3-Pyridinamine
is an intermediate in the production of agrochemicals and
pharmaceuticals; it may have end-uses. In addition to its use as a
chemical intermediate, 4-pyridinamine is the active ingredient in
the registered pesticide Avitrol[reg]
and has been evaluated as an
experimental drug to treat several neurological syndromes. Under the
Food and Drug Administration (FDA) Modernization Act of 1997
(http://www.fda.gov/opacom/7modact.html ),
4-pyridinamine was nominated for
inclusion on the list of bulk substances for use in pharmacy
compounding but was not included by the FDA on the initial list.
Human exposure data are limited for pyridinamines. A survey
conducted between 1981 and 1983 by the National Institute for
Occupational Safety and Health estimated that 4,618 workers in 452
facilities representing 3 industries were potentially exposed to 4-
pyridinamine.
2. Tungsten compounds--a. Recommendation. Twenty tungsten
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 2). The ITC
believes the list of tungsten compounds in Table 2 includes those
most likely to be in current use.
Table 2.--Tungsten Compounds Being Added to the TSCA Section 8(a) PAIR Rule
----------------------------------------------------------------------------------------------------------------
CAS No. Chemical name
----------------------------------------------------------------------------------------------------------------
1314-35-8 Tungsten oxide (WO3)
---------------------------------------------
7440-33-7 Tungsten
---------------------------------------------
7783-82-6 Tungsten fluoride (WF6), (OC-6-11)-
---------------------------------------------
7790-85-4 Cadmium tungsten oxide (CdWO4)
---------------------------------------------
7790-60-5 Tungstate (WO4\2\-), dipotassium, (T-4)-
---------------------------------------------
[[Page 2472]]
7783-03-1 Tungstate (WO4\2\-), dihydrogen, (T-4)-
---------------------------------------------
10213-10-2 Tungstate (WO4\2\-), disodium, dihydrate, (T-4)-
---------------------------------------------
11105-11-6 Tungsten oxide (WO3), hydrate
---------------------------------------------
11120-01-7 Sodium tungsten oxide
---------------------------------------------
11120-25-5 Tungstate (W12(OH)2 O40\10\-), decaammonium
---------------------------------------------
12067-99-1 Tungsten hydroxide oxide phosphate
---------------------------------------------
12028-48-7 Tungstate (W12(OH)2 O38\6\-), hexaammonium
---------------------------------------------
12027-38-2 Tungstate(4-),[.mu.12-[orthosilicato(4-)-
.kappa.O:.kappa.O:.kappa.O:.kappa.O':.kappa.O':.kappa.O':.kappa.O
''.kappa.O'':.kappa.O'' :.kappa.O''':kappa.O''':.kappa.O''']]
tetracosa-.mu.-oxododecaoxododeca-, tetrahydrogen
---------------------------------------------
12036-22-5 Tungsten oxide (WO2)
---------------------------------------------
12141-67-2 Tungstate (W12(OH)2 O38\6\-), hexasodium
---------------------------------------------
12138-09-9 Tungsten sulfide (WS2)
---------------------------------------------
13283-01-7 Tungsten chloride (WCl6), (OC-6-11)-
---------------------------------------------
13472-45-2 Tungstate (WO4\2\-), disodium, (T-4)-
---------------------------------------------
14040-11-0 Tungsten carbonyl (W(CO)6), (OC-6-11)-
---------------------------------------------
23321-70-2 Tungsten oxide (WO3), dihydrate
----------------------------------------------------------------------------------------------------------------
b. Rationale for recommendation. Tungsten was recently nominated
for toxicology and carcinogenicity studies to the National
Toxicology Program by the Centers for Disease Control and
Prevention's National Center for Environmental Health
(http://ntp-server.niehs.nih.gov/NomPage/2003Noms.html ).
The nomination was based on recent data showing elevated tungsten body burdens in
residents of Fallon, NV, and the limited data available to assess
the potential long-term adverse health effects of tungsten exposure
(http://www.cdc.gov/nceh/clusters/Fallon ).
The source and pathways of exposure, and the form of tungsten to which Fallon,
NV, residents are exposed is presently poorly understood. The Agency for Toxic
Substances and Disease Registry (ATSDR) has completed community
exposure and health investigations in Churchill County, NV
(http://www.atsdr.cdc.gov/HAC/PHA/region_9.html#nevada )
and is developing a toxicological profile for tungsten
(http://www.atsdr.cdc.gov/toxprofiles/tp186.html ).
Tungsten and tungsten compounds have
numerous important industrial uses. Other than workplace exposure
limits, there are few regulatory controls on the use, emission, and
disposal of tungsten compounds and few data on which to assess the
ecological effects and human health impacts resulting from
environmental and general population exposures. Further information
is needed to more fully evaluate human and environmental exposures
and health effects.
c. Information needs. To meet U.S. Government data needs, the
ITC needs:
1. Recent non-CBI estimates of annual production or importation
volume data and trends, and chemical-specific use information,
including percentages of production or importation that are
associated with different uses.
2. Environmental release and monitoring information, including
occurrence and concentrations in environmental media.
3. Fate and transport data.
4. Ecological effects data, especially for aquatic and sediment
organisms, if there is evidence that tungsten compounds are
mobilized and transported to groundwater, surface water, and sediments.
5. Estimates of the number of exposed humans and concentrations
of tungsten compounds to which humans may be exposed in each
relevant manufacturing, processing, or other occupational scenario.
6. Case studies from occupationally exposed workers and
pharmacokinetics, dermal, inhalation, and oral acute toxicity,
subchronic toxicity, chronic toxicity, genotoxicity,
carcinogenicity, neurotoxicity, reproductive and developmental
toxicity, and epidemiology studies.
The ITC is soliciting this information in order to adequately assess
the extent and degree of exposure and potential hazard associated
with the various forms of tungsten and to determine if additional
test data are needed.
d. Supporting information. Tungsten compounds are naturally
released to the atmosphere by windblown dusts. Tungsten compounds
can be released to surface waters from sources of human origin
(e.g., water effluents from tungsten mining). Deposition of tungsten
aerosols or dusts from both natural and anthropogenic sources is
also a source of tungsten in surface waters. Individuals who work in
manufacturing, fabricating, and reclaiming industries, especially
individuals using hard-metal materials or tungsten carbide machining
tools, may be exposed to higher levels of tungsten compounds than
the general population. Occupational exposure is primarily via
inhalation of dust particles of elemental (metallic) tungsten and/or
its compounds.
Pulmonary fibrosis, memory and sensory deficits, and increased
mortality due to lung cancer have been associated with occupational
exposure to dusts generated in the hard-metal industry.
Historically, the respiratory and neurological effects observed in
hard-metal workers have been attributed to cobalt, not tungsten.
However, based on the presence of tungsten oxide fibers in air
samples taken at some hard-metal facilities and demonstrations that
tungsten oxide fibers are capable of generating hydroxyl radicals in
human lung cells in vitro, it has been suggested that tungsten oxide
fibers may contribute to the development of pulmonary fibrosis in
hard-metal workers. Limited reports associate tungsten exposure with
reproductive and developmental effects such as decreased sperm
motility, increased embryotoxicity, and delayed fetal skeletal
ossification in animals. Tungsten has been observed to cross the
placental barrier and enter the fetus. Dermal or ocular exposure to
tungsten may result in localized irritation.
[[Page 2473]]
V. References
1. EPA. 1998. Revisions to Reporting Regulations Under TSCA
Section 8(d) Federal Register (63 FR 15765, April 1, 1998) (FRL-
5750-4). Available online at: http://www.epa.gov/fedrgstr/.
2. 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/.
3. 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/.
4. 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/.
5. ITC. 2002. Fiftieth Report of the ITC. Federal Register (67
FR 49530, July 30, 2002) (FRL-7183-7). Available online at:
http://www.epa.gov/fedrgstr/.
6. ITC. 2002. Fifty-First Report of the ITC. Federal Register
(68 FR 8976, February 26, 2003) (FRL-7285-7). Available online at:
http://www.epa.gov/fedrgstr/.
7. EPA. 2003. Preliminary Assessment Information Reporting;
Addition of Certain Chemicals. Federal Register (68 FR 34832, June
11, 2003) (FRL-7306-7). Available online at:
http://www.epa.gov/fedrgstr/.
VI. The 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
Thomas P. O'Connor, Member, Vice Chair
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
William Eastin, Alternate
National Institute for Occupational Safety and Health
Mark Toraason, Member, Chair
Dennis W. Lynch, Alternate
National Science Foundation
Marge Cavanaugh, Member
Parag R. Chitnis, Alternate
Occupational Safety and Health Administration
Val H. Schaeffer, Member
Maureen Ruskin, 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
Laura L. McConnell, Alternate
Department of Defense
Barbara Larcom, Member
Warren Jederberg, Alternate
Department of the Interior
Barnett A. Rattner, Member
Food and Drug Administration
Kirk Arvidson, Alternate
Ronald F. Chanderbhan, Alternate
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 (7401), 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. 04-894 Filed 1-14-04; 8:45 am]
BILLING CODE 6560-50-S