[Federal Register Volume 66, Number 64 (Tuesday, April 3, 2001)]
[Notices]
[Pages 17768-17774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8133]
[[Page 17767]]
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Part IV
Environmental Protection Agency
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Forty-Seventh Report of the TSCA Interagency Testing Committee to the
Administrator, Receipt of Report and Request for Comments; Notice
Federal Register / Vol. 66, No. 64 / Tuesday, April 3, 2001 /
Notices
[[Page 17768]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41055; FRL-6763-6]
Forty-Seventh Report of the TSCA Interagency Testing Committee to
the Administrator; Receipt of Report and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its 47\th\ ITC Report to the Administrator
of the EPA on November 30, 2000. In the 47\th\ ITC Report, which is
included in this notice, the ITC adds 37 indium chemicals and 4 other
chemicals discussed in the 46\th\ ITC Report as recommended chemicals
to its Priority Testing List. The ITC requests TSCA section 8(a)
Preliminary Assessment Information Reporting (PAIR) rules for the
appropriate CAS numbered chemicals and TSCA section 8(d) Health and
Safety Data reporting rules be promulgated by the EPA for these
chemicals and the 8 nonylphenol polyethoxylate degradation products
placed on the Priority Testing List in the 46\th\ ITC Report. The ITC
is also placing three chloroalkenes as recommended chemicals on the
ITC's Priority Testing List in order to solicit information on use,
exposure, ecological effects, environmental fate, and health effects
under the ITC's Voluntary Information Submission Policy (VISP). This
action is part of the ITC's ongoing efforts to screen chemicals with
potential to persist and bioconcentrate.
DATES: Comments, identified by docket control number OPPTS-41055, must
be received on or before May 3, 2001.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper
receipt by EPA, it is imperative that you identify docket control
number OPPTS-41055 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Acting Director, Environmental Assistance Division
(7408), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (202) 554-1404; e-mail address: [email protected].
For technical information contact: John D. Walker, ITC Executive
Director (7401), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (202) 260-1825; fax:
(202) 260-7895; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This notice is directed to the public in general. It may, however,
be of particular interest to you if you manufacture (defined by statute
to include import) and/or process TSCA-covered chemicals and you may be
identified by the North American Industrial Classification System
(NAICS) codes 325 and 32411. Because this notice is directed to the
general public and other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
interested in this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
You may also access additional information about the ITC and the
TSCA testing program through the web site for the Office of Pollution
Prevention and Toxics (OPPT) at http://www.epa.gov/opptintr/, or go
directly to the ITC Home Page at http://www.epa.gov/opptintr/itc/.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-41055. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the TSCA Nonconfidential Information Center, North
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC.
The Center is open from noon to 4 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Center is (202)
260-7099.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPPTS-41055 in the subject line on
the first page of your response.
1. By mail. Submit your comments to: Document Control Office
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT
Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall,
401 M St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the DCO is (202) 260-7093.
3. Electronically. You may submit your comments electronically by
e-mail to: [email protected], or mail your computer disk to the address
identified above. Do not submit any information electronically that you
consider to be CBI. Electronic comments must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on standard disks in
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic
form must be identified by docket control number OPPTS-41055.
Electronic comments may also be filed online at many Federal Depository
Libraries.
D. How Should I Handle CBI Information That I Want to Submit to the
Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be
[[Page 17769]]
disclosed except in accordance with procedures set forth in 40 CFR part
2. In addition to one complete version of the comment that includes any
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public version of the official record. Information not marked
confidential will be included in the public version of the official
record without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
We invite you to provide your views and comments on the 47\th\ ITC
Report. You may find the following suggestions helpful for preparing
your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. Provide specific examples to illustrate your concerns.
5. Make sure to submit your comments by the deadline in this
notice.
6. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.
II. Background
The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.)
authorizes the Administrator of the EPA to promulgate regulations under
TSCA section 4(a) requiring testing of chemicals and chemical groups in
order to develop data relevant to determining the risks that such
chemicals and chemical groups may present to health or the environment.
Section 4(e) of TSCA established the ITC to recommend chemicals and
chemical groups to the Administrator of the EPA for priority testing
consideration. Section 4(e) of TSCA directs the ITC to revise the TSCA
section 4(e) Priority Testing List at least every 6 months.
1. The 47\th\ ITC Report. The 47\th\ ITC Report was received by the
EPA Administrator on November 30, 2000, and is included in this notice.
In the 47\th\ ITC Report, the ITC:
i. Adds 37 indium chemicals (see Table 2 of the 47\th\ ITC Report)
and 4 other chemicals discussed in the 46\th\ ITC Report as recommended
chemicals to its Priority Testing List. The ITC requests TSCA section
8(a) PAIR rules for the appropriate CAS numbered chemicals and TSCA
section 8(d) Health and Safety Data reporting rules be promulgated by
the EPA for these chemicals and the 8 nonylphenol polyethoxylate
degradation products placed on the Priority Testing List in the 46\th\
ITC Report. The chemicals, for which needed information was not
provided in response to the VISP published in the 46\th\ ITC Report,
are: Pentachlorothiophenol (CAS No. 133-49-3, from the class
``polychlorobenzenethiols''); tetrachloropyrocatechol (CAS No. 1198-55-
6, from the class ``polychlorophenols''); p-toluidine, 5-
chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl- (CAS No.
1806-24-2, from the class ``chlorotrifluoromethylphenoxy benzenes'')
benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-2-ethoxy-1-
methyl-2-oxo- (CAS No. 88185-22-2, from the class
``chlorotrifluoromethylphenoxy benzenes''). In addition, no information
was provided on the following eight nonylphenol polyethoxylate
degradation products: 4-nonylphenol ethoxylate (CAS No. 104-35-8); 4-
nonylphenol diethoxylate (CAS No. 20427-84-3); 4-nonylphenoxy acetic
acid (CAS No. 3115-49-9); 4-nonylphenoxy ethoxy acetic acid (CAS No.
106807-78-7); 4-nonylphenoxy diethoxy acetic acid (CAS No. 108241-00-
5); 4-nonylphenoxy triethoxy acetic acid; 4-nonylphenol triethoxylate;
and 4-nonylphenol tetraethoxylate.
ii. Places three chloroalkenes [1,3-butadiene, 1,1,2,3,4-
pentachloro-4-(1-methylethoxy)- (CAS No. 68334-67-8); 3-butenoic acid,
2,2,3,4,4-pentachloro-, butyl ester (CAS No. 75147-20-5); and
2,2,3,4,4-pentachloro-3-butenoic acid (CAS No. 85743-61-9)] as
recommended chemicals on the Priority Testing List in order to solicit
information on use, exposure, ecological effects, environmental fate,
and health effects under the ITC's VISP. This action is part of the
ITC's ongoing efforts to screen chemicals with potential to persist and
bioconcentrate.
2. Status of the Priority Testing List. The current TSCA section
4(e) Priority Testing List as of November 2000 can be found in Table 1
of the 47\th\ ITC Report which is included in this notice.
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Dated: March 23, 2001.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Forty-Seventh Report of the TSCA Interagency Testing Committee to the
Administrator, U.S. Environmental Protection AgencyTable of Contents
Summary
The TSCA Section 4(e) Priority Testing List (November 2000)
I. Background
II. TSCA Section 8 Reporting
A. TSCA section 8 rules
B. ITC's use of TSCA section 8 and ``other information''
C. Promoting more efficient use of information submission
resources
D. Requests related to promulgation of TSCA section 8(a) PAIR
and section 8(d) HaSD reporting rules
III. ITC's Activities During this Reporting Period (May to October
2000): Information Solicitations
IV. Revisions to the TSCA Section 4(e) Priority Testing List:
Chemicals added to the Priority Testing List:
A. Indium Chemicals
B. Chloroalkenes
C. Polychlorophenols and Polychlorobenzenethiols
D. Chlorotrifluoromethylphenoxy Benzenes
V. References
VI. The TSCA Interagency Testing Committee
Summary
This is the 47\th\ Report of the Toxic Substances Control Act
(TSCA) Interagency Testing Committee (ITC) to the Administrator of the
U.S. Environmental Protection Agency (EPA). In this Report, the ITC is
adding 37 indium chemicals and four other chemicals discussed in the
46\th\ Report which was published in the Federal Register of December
1, 2000 (65 FR 75552) (FRL-6594-7) to its Priority Testing List so that
TSCA section 8(a) Preliminary Assessment Information Reporting (PAIR)
and TSCA section 8(d) Health and Safety Data (HaSD) reporting rules
will be promulgated by the EPA. There is reason to believe the indium
chemicals have potential to cause cancer in humans. The four chemicals
discussed in the 46\th\ Report that are being added to the Priority
Testing List are, pentachlorothiophenol and tetrachloropyrocatechol
(from the class polychlorophenols and polychlorobenzenethiols), and p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.- trifluoro-2-nitro-N-phenyl
and benzoic acid, 3-[2-chloro-4-(trifluoromethyl) phenoxy]-, 2-ethoxy-
1-methyl-2-oxo (from the class chlorotrifluoromethylphenoxy benzenes).
The four chemicals are being
[[Page 17770]]
added to the Priority Testing List, because information solicited in
the ITC's 46\th\ Report under the Voluntary Information Submissions
Policy (VISP) was not provided to the ITC. The ITC is also asking EPA
to promulgate TSCA section 8(a) PAIR and TSCA section 8(d) HaSD
reporting rules for the 8 nonylphenol polyethoxylate degradation
products that were added to the Priority Testing List in the ITC's
46\th\ Report, because information requested for these chemicals was
not voluntarily provided to the ITC. The ITC is placing three
chloroalkenes on the Priority Testing List in order to solicit
information on use, exposure, ecological effects, environmental fate,
and health effects under VISP. This action is part of the ongoing
effort to screen chemicals with potential to persist and
bioconcentrate. The revised TSCA section 4(e) Priority Testing List
follows as Table 1 of this unit.
Table 1.--The TSCA Section 4(e) Priority Testing List (November 2000)
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Report Date Chemical/Group Action
----------------------------------------------------------------------------------------------------------------
28.................................. May 1991............... Chemicals with low Designated
confidence reference
dose (RfD).
Acetone..............
Thiophenol...........
30.................................. May 1992............... 5 Siloxanes.............. Recommended
31.................................. January 1993........... 13 Chemicals with Designated
insufficient dermal
absorption rate data.
32.................................. May 1993............... 16 Chemicals with Designated
insufficient dermal
absorption rate data.
35.................................. November 1994.......... 4 Chemicals with Designated
insufficient dermal
absorption rate data.
37.................................. November 1995.......... 10 Alkylphenols and 2 Recommended
alkylphenol
polyethoxylates.
39.................................. November 1996.......... 8 Nonylphenol ethoxylates Recommended
41.................................. November 1997.......... 18 Alkylphenols, 5 Recommended
polyalkylphenols and 6
alkylphenol
polyethoxylates.
42.................................. May 1998............... 3-Amino-5-mercapto-1,2,4- Recommended
triazole.
42.................................. May 1998............... Glycoluril............... Recommended
42.................................. May 1998............... Methylal................. Recommended
42.................................. May 1998............... Ethyl Silicate........... Recommended
46.................................. May 2000............... 8 Nonylphenol Recommended
polyethoxylate
degradation products.
47.................................. November 2000.......... 37 Indium chemicals...... Recommended
47.................................. November 2000.......... Pentachlorothiophenol.... Recommended
47.................................. November 2000.......... Tetrachloropyrocatechol.. Recommended
47.................................. November 2000.......... p-Toluidine, 5-chloro- Recommended
.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-
phenyl.
47.................................. November 2000.......... Benzoic acid, 3-[2-chloro- Recommended
4-
(trifluoromethyl)phenoxy
]-, 2-ethoxy-1-methyl-2-
oxo.
47.................................. November 2000.......... 3 Chloroalkenes.......... Recommended
----------------------------------------------------------------------------------------------------------------
I. Background
The ITC was established by section 4(e) of TSCA ``to make
recommendations to the Administrator respecting the chemical substances
and mixtures to which the Administrator should give priority
consideration for the promulgation of a rule for testing under section
4(a).... At least every six months..., the Committee shall make such
revisions to the Priority Testing List as it determines to be necessary
and transmit them to the Administrator together with the Committee's
reasons for the revisions'' (Public Law 94-469, 90 Stat. 2003 et seq.,
15 U.S.C. 2601 et seq.). Since its creation in 1976, the ITC has
submitted 46 semi-annual (May and November) Reports to the EPA
Administrator transmitting the Priority Testing List and its revisions.
ITC Reports are available from the ITC's web site (http://www.epa.gov/opptintr/itc) within a few days of submission to the Administrator and
from http://www.epa.gov/fedrgstr after publication in the Federal
Register. The ITC meets monthly and produces its revisions to the
Priority Testing List with administrative and technical support from
the ITC staff, ITC members and their U.S. Government organizations, and
contract support provided by EPA. ITC members and staff are listed at
the end of this Report.
II. TSCA Section 8 Reporting
A. TSCA section 8 rules. Following receipt of the ITC's Report (and
the revised Priority Testing List) by the EPA Administrator, the EPA's
Office of Pollution Prevention and Toxics (OPPT) promulgates TSCA
section 8(a) PAIR and TSCA section 8(d) HaSD reporting rules for
chemicals added to the Priority Testing List. These rules require
producers and importers of chemicals recommended by the ITC to submit
production and exposure reports under TSCA section 8(a) and producers,
importers, and processors of chemicals recommended by the ITC to submit
unpublished health and safety studies under TSCA section 8(d). These
rules are automatically promulgated by OPPT unless otherwise requested
by the ITC.
B. ITC's use of TSCA section 8 and ``other information.'' The ITC
reviews the TSCA section 8(a) PAIR reports, TSCA section 8(d) HaSD
studies and ``other information'' that becomes available after the ITC
adds chemicals to the Priority Testing List. ``Other information''
includes TSCA section 4(a) and 4(d) studies, TSCA section 8(c)
submissions, TSCA section 8(e) ``substantial risk'' notices, ``For Your
Information'' (FYI) submissions, unpublished data submitted to and from
U.S. Government organizations represented on the ITC, published papers,
as well as use, exposure, effects, and persistence data that are
voluntarily submitted to the ITC by manufacturers, importers,
processors, and users of chemicals recommended by the ITC. The ITC
reviews this information and determines if data needs should be
revised, if chemicals should be removed from the Priority Testing List
or if recommendations should be changed to designations.
C. Promoting more efficient use of information submission
resources. The Voluntary Information Submissions Innovative Online
Network (VISION) is accessible through the world wide web (http://www.epa.gov/opptintr/itc/vision.htm). VISION includes the VISP and
links to the TSCA Electronic HaSD Reporting Form (http://www.epa.gov/opptintr/.er/hasd.htm). The EPA recently revised section 3.2 of the
TSCA Electronic HaSD Reporting Form in response to ITC requests to
provide
[[Page 17771]]
more details on requested use and exposure information (see 46\th\
Report). The VISP provides examples of data needed by ITC member U.S.
Government organizations, examples of studies that should not be
submitted, the milestones for submitting information, guidelines for
using the TSCA Electronic HaSD Reporting Form and instructions for
electronically submitting full studies. The TSCA Electronic HaSD
Reporting Form can be used to provide electronic information on ITC
voluntary submissions, TSCA section 8(d) studies (to meet data needs of
the ITC member U.S. Government organizations), FYI submissions, and
TSCA section 8(e) studies.
The ITC encourages chemical producers, importers, processors, and
users to voluntarily provide electronic information via VISION on
chemicals for which the ITC is soliciting voluntary information and to
establish a dialogue with the ITC to discuss needed data. To enhance
visibility, the ITC will be adding all chemicals to the Priority
Testing List for which it is voluntarily soliciting information along
with a request that EPA not immediately promulgate TSCA section 8(a)
PAIR and section 8(d) HaSD reporting rules. If the ITC does not receive
voluntary electronic information submissions to meet its data needs
according to the procedures in VISP, the ITC may then request that EPA
promulgate TSCA section 8(a) PAIR and section 8(d) HaSD reporting rules
to determine if there are unpublished data to meet those needs. The ITC
strongly encourages those companies that must respond to a TSCA section
8(d) HaSD reporting rule to provide data by using the TSCA Electronic
HaSD Reporting Form.
D. Requests related to promulgation of TSCA section 8(a) PAIR and
section 8(d) HaSD reporting rules. In this Report, the ITC is asking
the EPA to promulgate TSCA section 8(a) PAIR and section 8(d) HaSD
reporting rules for 37 indium chemicals; pentachlorothiophenol;
tetrachloropyrocatechol; p-toluidine, 5-chloro-
.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl; benzoic acid, 3-[2-
chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo; and 8
nonylphenol polyethoxylate degradation products. Reporting rules are
being requested for pentachlorothiophenol; tetrachloropyrocatechol; p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl;
benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2- ethoxy-1-
methyl-2-oxo; and the 8 nonylphenol polyethoxylate degradation products
because needed information was not provided in response to the
voluntary information solicitations published in the 46\th\ Report. At
this time, the ITC is requesting that EPA not promulgate TSCA section
8(a) PAIR and section 8(d) HaSD reporting rules for the 3 chloroalkenes
(1,3-butadiene, 1,1,2,3,4-pentachloro-4-(1-methylethoxy)-; 3-butenoic
acid, 2,2,3,4,4-pentachloro-; and 3-butenoic acid, 2,2,3,4,4-
pentachloro-butyl ester) to allow chloroalkenes producers, importers,
processors, and users an opportunity to voluntarily provide the
requested information.
III. ITC's Activities During this Reporting Period (May to October
2000): Information Solicitations
In its 46\th\ Report, the ITC discussed its strategies to screen
chemicals for persistence and bioconcentration potential (http://www.epa.gov/opptintr/itc). These strategies are referred to as
Degradation Effects Bioconcentration Information Testing Strategies
(DEBITS). DEBITS provides a means to prioritize chemicals based on
degradation, ecological, or human health effects and bioconcentration
information. During this reporting period, the ITC continued to focus
its efforts on structural classes of chemicals from a subset of 42
moderate production volume (MPV) chemicals (production/importation
volumes between 100,000 and 1,000,000 pounds) with estimated or
measured bioconcentration factors (BCFs) > 250 and about 70
structurally related non-MPV chemicals (also with BCFs > 250). In its
46\th\ Report, the ITC solicited information on three such structural
classes:
1. Polychlorophenols and polychlorobenzenethiols,
2. Chlorotrifluoromethylphenoxy benzenes, and
3. Perfluorinated chemicals.
During this reporting period, the ITC continued its review of
chemicals with potential to persist and bioconcentrate and decided to
solicit information on chloroalkenes. The ITC is seeking information on
uses, exposures, health effects, and ecological effects from the
manufacturers, importers, and processors of chloroalkenes. The ITC is
requesting that solicited information be electronically submitted
before February 28, 2001, consistent with the 90-day milestone of the
VISP (http://www.epa.gov/opptintr/itc/visp.htm) for submitting data
through the TSCA Electronic HaSD Reporting Form. DEBITS will continue
to be used to prioritize chemicals with potential to persist and
bioconcentrate.
IV. Revisions to the TSCA Section 4(e) Priority Testing List:
Chemicals Added to the Priority Testing List
A. Indium Chemicals
1. Recommendation. Indium chemicals are being added to the Priority
Testing List to obtain importation, production, use, exposure, and
health effects information to meet U.S. Government data needs.
2. Rationales for recommendation. There is clear evidence that
indium phosphide causes tumors in rats and mice. As a result, indium
phosphide and other indium chemicals are considered to be potentially
carcinogenic to humans. Use of indium chemicals in the semiconductor
and other industries may be increasing. Existing exposure limits may
not be adequate to protect workers exposed to indium phosphide and
other indium chemicals from an increased risk of lung cancer.
3. Supporting information. In a 2-year inhalation study there was
clear evidence of carcinogenic activity of indium phosphide (Chemical
Abstract Service number (CAS No.) 22398-80-7) in male and female F344/N
rats and male and female B6C3F1 mice (http://ntp-server.niehs.nih.gov/htdocs/Results_Status/Resstati/M882472.Html). In this study, the
incidence of benign and malignant neoplasms were increased in the lungs
of male and female rats and mice at doses of 0.03, 0.1, and 0.3
milligram/meter\3\ (mg/m\3\). There was also an exposure-related
increase in the incidence of benign and malignant neoplasms of the
liver in male and female mice.
For indium and certain indium chemicals, the National Institute for
Occupational Safety and Health's (NIOSH) Recommended Exposure Limit
(REL), the American Council of Government Industrial Hygienists (ACGIH)
threshold limit value (TLV), and the Occupational Safety and Health
Administration's (OSHA) Permissible Exposure Limit (PEL) for
construction and shipyard industries is 0.1 mg/m\3\. The current
occupational exposure limits may not be adequate to protect workers
exposed to indium phosphide and other indium chemicals from increased
risk of lung cancer, because benign and malignant neoplasms were
increased in the lungs of both sexes of rats and mice at doses lower
than the PEL, REL, and TLV. Furthermore, experimental studies in
hamsters suggest that indium arsenide may induce effects in the lung
comparable to indium phosphide. These studies raise the concern for
other indium chemicals and their potential health effects.
[[Page 17772]]
The indium chemicals are believed to be increasingly used in the
manufacture of semiconductors, injection lasers, solar cells,
photodiodes, and light-emitting diodes. Worker exposures may occur
during manufacturing and handling of these materials. However, there
are no publicly available reports in the literature that assess
workplace exposures to indium phosphide or other indium chemicals.
4. Information needs. The ITC needs:
i. Recent non-CBI estimates of annual production or importation
volume data and trends, and use information, including percentages of
production or importation that are associated with different uses;
ii. Estimates of the number of humans and concentrations of indium
chemicals to which humans may be exposed in each relevant use,
manufacturing, or processing scenario;
iii. Health effects data including pharmacokinetics, genotoxicity,
subchronic toxicity, reproductive, and developmental toxicity,
carcinogenicity and any human data from occupationally exposed workers.
The ITC seeks this information in order to adequately assess the
extent and degree of exposure and potential hazard associated with the
indium chemicals. Information is requested on the 37 indium-containing
chemicals in Table 2 of this unit. Manufacturers, processors, and users
of indium chemicals are encouraged to provide importation, production,
use, exposure, and health effects information using the TSCA Electronic
HaSD Reporting Form (http://www.epa.gov/opptintr/.er/hasd.htm).
Table 2.--Indium Chemicals Being Added to the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
923-34-2................................ Triethylindium
1303-11-3............................... Indium arsenide
1312-41-0............................... Indium antimonide
1312-43-2............................... Indium (III) oxide
1312-45-4............................... Indium (III) telluride
4194-69-8............................... Indium (III) citrate
7440-74-6............................... Indium
7783-52-0............................... Indium (III) fluoride
10025-82-8.............................. Indium (III) chloride
12018-95-0.............................. Copper indium diselenide
12030-14-7.............................. Indium (II) sulfide
12030-24-9.............................. Indium (III) sulfide
12056-07-4.............................. Indium selenide
12672-70-7............................. Indium chloride
12672-71-8.............................. Indium (I) oxide
13464-82-9.............................. Indium (III) sulfate
13510-35-5.............................. Indium (III) iodide
13770-61-1.............................. Indium (III) nitrate
13966-94-4.............................. Indium (I) iodide
14166-78-0.............................. Indium (III) fluoride
14280-53-6............................. Indium (I) bromide
14405-45-9............................. Indium tris(acetylacetonate)
20661-21-6............................. Indium (III) hydroxide
22398-80-7............................. Indium (I) phosphide
25114-58-3............................. Indium (III) acetate
25617-98-5............................. Indium nitride
50926-11-9............................. Indium tin oxide
55326-87-9............................. Indium hydroxide
71243-84-0............................. Indium tin oxide
13465-09-3............................. Indium (III) bromide
13465-10-6.............................. Indium (I) chloride
13709-93-8.............................. Indium (III) borate
27765-48-6.............................. Indium (III) tetrafluoroborate
66027-93-8.............................. Indium (III) sulfamate
66027-94-9.............................. Hydroxybis(trifluoroacetato-
,O)indium
67816-06-2.............................. Indium (III) 2-ethylhexanoate
68310-35-0.............................. Indium (III) neodecanoate
------------------------------------------------------------------------
B. Chloroalkenes
1. Recommendation. Three chloroalkenes are being added to the
Priority Testing List to obtain information on uses, exposures,
environmental releases, pharmacokinetics, subchronic toxicity,
mutagenicity, reproductive and developmental effects, carcinogenicity,
and ecological effects. At this time, the ITC is requesting that EPA
not promulgate TSCA section 8(a) PAIR and section 8(d) HaSD reporting
rules for these chemicals in order to allow chloroalkenes producers,
importers, processors, and users an opportunity to voluntarily provide
the requested information.
2. Rationales for recommendation. Two chloroalkenes are believed to
be produced in substantial amounts and are predicted to persist and
bioconcentrate in the environment. The third chloroalkene is a likely
hydrolysis product of one of the other chloroakenes. All three
chemicals present suspicion of toxicity based either on mutagenicity
data or shared structural similarities with hexachloro-1,3-butadiene.
3. Supporting information. Chloroalkenes under review include 4
chemicals: Hexachloro-1,3-butadiene (CAS No. 87-68-3); 1,3-butadiene,
1,1,2,3,4-pentachloro-4-(1-methylethoxy)- (CAS No. 68334-67-8); 3-
butenoic acid, 2,2,3,4,4-pentachloro-butyl ester (CAS No. 75147-20-9);
and 2,2,3,4,4-pentachloro-3-butanoic acid (CAS No. 85743-61-9). All
except the 2,2,3,4,4-pentachloro-3-butenoic acid meet the DEBITS
criteria and have BCFs >250. However, 2,2,3,4,4-pentachloro-3-butenoic
acid is a hydrolysis product of 3-butenoic acid, 2,2,3,4,4-pentachloro-
butyl ester. The ITC is not soliciting information on hexachloro-1,3-
butadiene because data are being developed under the Organization for
Economic Cooperation and Development (OECD) Screening Information Data
Set (SIDS) program (http://www.oecd.org//ehs/guide/sd97-1.htm).
Hexachloro-1,3-butadiene was included to provide opportunities to
develop Structure Activity Relationships (SARs).
1,3-Butadiene, 1,1,2,3,4-pentachloro-4-(1-methylethoxy)- meets the
DEBITS criteria of ultimate predicted aerobic biodegradation rate of >
2-3 months and estimated log octanol-water partition coefficient (log
P) ranging from 3 to 6. 1,3-Butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)- is a MPV chemical with a log P of 5.14 and estimated BCF
of 509. The only health effects data for 1,3-butadiene, 1,1,2,3,4-
pentachloro-4-(1-methylethoxy)- were from acute toxicity tests in rats
that estimated the LD50 to be 1,210 mg/kilogram (kg) body
weight (Mallinckrodt, 1978a). No ecological effects data were obtained
for this chemical. 1,3-Butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)- is structurally similar to hexachloro-1,3- butadiene
and, therefore, may share some common metabolic pathways and related
toxicities. Hexachloro-1,3-butadiene is known to be metabolically
converted by glutathione S-transferase to the glutathione conjugate,
and then to a cysteine sulfoxide, which is cytotoxic to the kidney
proximal tubular cells. This metabolic activation is believed to be
responsible for the nephrotoxicity associated with the chemical.
3-Butenoic acid, 2,2,3,4,4-pentachloro- butyl ester is another MPV
chemical with BCF>250. It has an estimated log P of 4.42, and an
estimated BCF of 1797. There are no ecological effects data for 3-
butenoic acid, 2,2,3,4,4-pentachloro- butyl ester. Acute toxicity and
genotoxicity studies were available for the chemical. The rat oral
LD50 value was 2.09 gram (g)/kg body weight (Mallinckrodt,
1978b). Negative results were obtained in a reverse mutation assay
using Salmonella typhimurium (TA-1535, TA-1537, TA-1538, TA-98, and TA-
100) and Saccharomyces cerevisiae (D4) with or without metabolic
activation (Mallinckrodt, 1984a). There was no significant increase in
6-thioguanine resistant mutation frequency in Chinese hamster ovary
cells with or without metabolic activation (Mallinckrodt, 1984c). There
was a positive response in an Escherichia coli microsuspension assay
for DNA damage and in the frequency of sister chromatid exchange and
chromosomal aberrations from Chinese hamster ovary cells (Mallinckrodt,
1984b,d,e).
[[Page 17773]]
3-Butenoic acid, 2,2,3,4,4-pentachloro-butyl ester is likely
hydrolyzed to 2,2,3,4,4-pentachloro-3-butenoic acid. The latter
chemical has a predicted aerobic biodegradation rate of > 2-3 months,
an estimated log P of 3.38, an estimated BCF of 3, but its production
volume is less than 10,000 pounds per annum. Like its butyl ester,
2,2,3,4,4-pentachloro-3-butenoic acid has some genotoxic activity. It
caused reverse mutation in Salmonella typhimurium strain TA100 both
with and without metabolic activation (Reichert et al. 1984) and
induced both unscheduled DNA synthesis (with and without activation)
and morphological transformation in Syrian hamster embryo fibroblasts
(Schiffmann et al. 1984). 3-Butenoic acid, 2,2,3,4,4-pentachloro-butyl
ester presents a suspicion of toxicity based on existing data and its
metabolic relationship and structural similarity to 2,2,3,4,4-
pentachloro-3-butenoic acid.
Information Profiles for 1,3-butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)-, 3-butenoic acid, 2,2,3,4,4-pentachloro-butyl ester and
2,2,3,4,4-pentachloro-3-butenoic acid will be available on the ITC's
web site (http://www.epa.gov/opptintr/itc).
4. Information needs. The ITC needs information on uses, exposures,
environmental releases, pharmacokinetics, subchronic toxicity,
mutagenicity, reproductive and developmental effects, carcinogenicity,
and ecological effects for 1,3-butadiene, 1,1,2,3,4-pentachloro-4-(1-
methylethoxy)-; 3-butenoic acid, 2,2,3,4,4-pentachloro- and 3-butenoic
acid, 2,2,3,4,4-pentachloro-butyl ester. In addition, the ITC needs
hydrolysis rate data for 3-butenoic acid, 2,2,3,4,4-pentachloro-butyl
ester. If the information is not voluntarily submitted in accordance
with VISP, the ITC will ask EPA to promulgate TSCA section 8(a) PAIR
and section 8(d) HaSD reporting rules in a subsequent Report.
C. Polychlorophenols and Polychlorobenzenethiols
1. Recommendation. Pentachlorothiophenol (CAS No. 133-49-3) and
tetrachloropyrocatechol (CAS No. 1198-55-6) are being added to the
Priority Testing List so that final TSCA section 8(a) and 8(d) rules
will be promulgated by the EPA.
2. Rationale for recommendation. Information solicited in the
46\th\ Report for pentachlorothiophenol and tetrachloropyrocatechol was
not provided to the ITC.
3. Supporting information. Pentachlorothiophenol and
tetrachloropyrocatechol meet the DEBITS criteria for persistence and
bioconcentration. Pentachlorothiophenol has an estimated BCF of 7066.
Tetrachloropyrocatechol's measured BCF ranges from 316-5011. There are
no publicly available ecological effects and limited health effects
data for pentachlorothiophenol. Tetrachloropyrocatechol has been shown
to be highly toxic to fish but little is known about health effects in
mammalian species. Pentachlorothiophenol and tetrachloropyrocatechol
are metabolites of pentachlorophenol. Pentachlorothiophenol has also
been detected in the urine of human populations exposed to
hexachlorobenzene. The carcinogenicity, reproductive effects and
developmental toxicities of hexachlorobenzene and pentachlorophenol are
well known. The ITC believes that pentachlorothiophenol and
tetrachloropyrocatechol present a suspicion of toxicity given the
metabolic relationship and structural similarity to hexachlorobenzene
and pentachlorophenol. Detailed information supporting the addition of
pentachlorothiophenol and tetrachloropyrocatechol to the Priority
Testing List was provided in the ITC's 46\th\ Report.
4. Information needs. The ITC needs information on uses and data on
exposures, environmental releases, pharmacokinetics, subchronic
toxicity, reproductive and developmental effects, carcinogenicity, and
ecological effects for pentachlorothiophenol and
tetrachloropyrocatechol. The ITC also needs mutagenicity data for
pentachlorothiophenol. Manufacturers, processors, and users of these
chemicals are encouraged to provide importation, production, use,
exposure, and health effects information using the TSCA Electronic HaSD
Reporting Form (http://www.epa.gov/opptintr/.er/hasd.htm).
D. Chlorotrifluoromethylphenoxy Benzenes
1. Recommendation. p-Toluidine, 5-chloro- .alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-phenyl (CAS No. 1806-24-2) and benzoic acid, 3-[2-
chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo (CAS No.
88185-2-2) are being added to the Priority Testing List so that final
TSCA section 8(a) and 8(d) rules will be promulgated by the EPA.
2. Rationale for recommendation. Information solicited in the
46\th\ Report for p-toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-phenyl and benzoic acid, 3-[2-chloro-4-
(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo was not provided to
the ITC.
3. Supporting information. Eight chlorotrifluoromethylphenoxy
benzenes were listed in the ITC's 46\th\ Report. All were estimated to
persist and seven had estimated BCFs > 250. Six
chlorotrifluoromethylphenoxy benzenes were highly toxic to fish. One
member of this class, Lactofen is a well-studied herbicide, considered
by the U.S. EPA to be a probable human carcinogen. As a result of the
oncogenicity and other adverse health effects associated with Lactofen,
there is a heightened concern for potential toxicity of the other
chlorotrifluoromethylphenoxy benzenes which have not been extensively
investigated. Information was solicited for 4 of 8
chlorotrifluoromethylphenoxy benzenes listed in the ITC's 46\th\
Report. Lactofen and three HPV chemicals were not included in the
solicitation.
In response to the solicitation, the ITC learned that one of these
chemicals, phenol, 5-(2-chloro-4-(trifluoromethyl)phenoxy)-2-nitro-
(CAS No. 42874-63-5) is a process intermediate that is not isolated
from storage nor packaged for distribution in commerce. Another
chlorotrifluoromethylphenoxy benzene for which information was
solicited, benzene, 2-chloro-1-(3-methylphenoxy)-4-(trifluoromethyl)-
(CAS No. 42874-96- 4) was previously added to a TSCA section 8(d) HaSD
reporting rule as a result of its addition to the Priority Testing List
in the ITC's 29\th\ Report (56 FR 67424, December 30, 1991). Since it
is already included in a TSCA section 8(d) HaSD reporting rule (47 FR
38780, October 4, 1982) and the reporting period is 10 years in length,
benzene, 2-chloro-1-(3- methylphenoxy)-4-(trifluoromethyl)- does not
have to be added to the Priority Testing List to facilitate that
action. The other two chlorotrifluoromethylphenoxy benzenes, p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl
and benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-
methyl-2-oxo are being added to the Priority Testing List, because no
information was submitted in response to the 46\th\ Report
solicitation. Detailed information supporting the addition of p-
toluidine, 5-chloro-.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-N-phenyl
and benzoic acid, 3-[2-chloro-4-(trifluoromethyl)phenoxy]-, 2-ethoxy-1-
methyl-2-oxo to the Priority Testing List was provided in the ITC's
46\th\ Report.
4. Information needs. The ITC needs information on uses, exposures,
environmental releases, ecological effects, pharmacokinetics,
subchronic
[[Page 17774]]
toxicity, reproductive and developmental effects, mutagenicity, and
carcinogenicity for p-toluidine, 5- chloro-.alpha.,.alpha.,.alpha.-
trifluoro-2-nitro-N-phenyl and benzoic acid, 3-[2- chloro-4-
(trifluoromethyl)phenoxy]-, 2-ethoxy-1-methyl-2-oxo.
V. References
1. Mallinckrodt Inc. 1978a. Initial Submission: Acute oral toxicity
(LD50) test in rats (Final Report) with cover letter dated
02/27/92; 10/13/78; EPA Doc. No. 88-920001282; Microfiche No.
OTS0535871.
2. Mallinckrodt Inc. 1978b. Initial Submission: Letter submitting
one enclosed acute toxicity series study with cover letter dated 02/27/
92. EPA Doc. No. 88-920001280; Microfiche No. OTS0535869.
3. Mallinckrodt Inc. 1984a. Mutagenicity evaluation of M-388-48A in
the Ames Salmonella/microsome plate test with cover letter dated 12/28/
84; 03/01/78; EPA Doc. No. FYI-OTS-0185-0376; Microfiche No.
OTS0000376-0.
4. Mallinckrodt Inc. 1984b. Escherichia coli microsuspension assay
for DNA damage with compound M276; 02/23/84; EPA Doc. No. FYI-OTS-0185-
0376; Microfiche No. OTS0000376-0.
5. Mallinckrodt Inc. 1984c. CHO/HGPRT forward mutation assay M276;
02/23/84; EPA Doc. No. FYI-OTS-0185-0376; Microfiche No. OTS0000376-0.
6. Mallinckrodt Inc. 1984d. In vitro sister chromatid exchange in
Chinese hamster ovary cells with M276; 07/13/84; EPA Doc. No. FYI-OTS-
0185-0376; Microfiche No. OTS0000376-0.
7. Mallinckrodt Inc. 1984e. In vitro chromosomal aberrations in
Chinese hamster ovary cells with M276; 12/19/84; EPA Doc. No. FYI-OTS-
0185-0376; Microfiche No. OTS0000376-0.
8. Reichert D, Neudecker T, Scheutz S. 1984. Mutagenicity of
hexachlorobutadiene, perchlorobutenoic acid and perchlorobutenoic acid
chloride. Mutation Research. 137:89-94.
9. Schiffmann D, Reichert D, Henschler D. 1984. Induction of
morphological transformation and unscheduled DNA synthesis in Syrian
hamster embryo fibroblasts by hexachlorobutadiene and its putative
metabolite pentachlorobutenoic acid. Cancer Letters. 23:297-306.
VI. TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Vacant
Department of Commerce
National Institute of Standards and Technology
Robert Huie, Member
Barbara C. Levin, Alternate
National Oceanographic and Atmospheric Administration
Teri Rowles, Alternate
Environmental Protection Agency
Paul Campanella, Member
David R. Williams, Alternate
National Cancer Institute
Vacant
National Institute of Environmental Health Sciences
Scott Masten, Member
William Eastin, Alternate
National Institute for Occupational Safety and Health
Albert E. Munson, Member
Mark Toraason, Alternate
National Science Foundation
A. Frederick Thompson, Member
Marge Cavanaugh, Alternate
Occupational Safety and Health Administration
Val H. Schaeffer, Member, Chair
Lyn Penniman, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Jacqueline Ferrante, Member
Treye Thomas, Alternate
Department of Agriculture
Clifford P. Rice, Member
Department of Defense
Barbara Larcom, Member
Kenneth Still, Alternate
Jose Centeno, Alternate
Department of the Interior
Barnett A. Rattner, Member, Vice Chair
Food and Drug Administration
Ronald Lorentzen, Member
Raju Kammula, Alternate
David Hatten, Alternate
National Library of Medicine
Vera W. Hudson, Member
National Toxicology Program
NIEHS, FDA, and NIOSH Members
Counsel
Scott Sherlock, OPPT, EPA
Technical Support Contractor
Syracuse Research Corporation
ITC Staff
John D. Walker, Executive Director
Norma S. L. Williams, Executive Assistant
TSCA Interagency Testing Committee, Office of Pollution Prevention and
Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460; telephone: (202) 260-1825; fax: (202) 260-
7895; e-mail address: [email protected]; url: http://www.epa.gov/opptintr/itc.
[FR Doc. 01-8133 Filed 4-2-01; 8:45 am]
BILLING CODE 6560-50-S