[Federal Register Volume 69, Number 10 (Thursday, January 15, 2004)]
[Notices]
[Pages 2468-2473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-894]



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Part V





Environmental Protection Agency





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Fifty-Third Report of the TSCA Interagency Testing Committee to the 
Administrator of the Environmental Protection Agency; Receipt of Report 
and Request for Comments; Notice

  Federal Register / Vol. 69, No. 10 / Thursday, January 15, 2004 / 
Notices  

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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: [email protected].
    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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This notice is directed to the public in general. It may, however, 
be of particular interest to you if you manufacture (defined by statute 
to include import) and/or process TSCA-covered chemicals. Potentially 
affected entities may include, but are not limited to:
    [sbull] Chemical Industry, e.g., NAICS 325, Manufacturers.
    [sbull] 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.

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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 [email protected], 
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.


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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.

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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: 
[email protected]; url: http://www.epa.gov/opptintr/itc.
[FR Doc. 04-894 Filed 1-14-04; 8:45 am]
BILLING CODE 6560-50-S