[Federal Register Volume 72, Number 13 (Monday, January 22, 2007)]
[Notices]
[Pages 2756-2761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-837]
[[Page 2755]]
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Part III
Environmental Protection Agency
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Fifty-Ninth 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. 72, No. 13 / Monday, January 22, 2007 /
Notices
[[Page 2756]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2006-0961; FRL-8110-2]
Fifty-Ninth 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 59\th\ ITC Report to the Administrator
of EPA on December 13, 2006. In the 59\th\ ITC Report, which is
included with this notice, the ITC is revising the TSCA section 4(e)
Priority Testing List by removing 22 chemicals. Phenol, 4-(1,1-
dimethylethyl)- is being removed because a recently submitted
reproductive effects study meets ITC's data needs. Five tungsten
compounds and 16 chemicals with insufficient dermal absorption rate
data are being removed because their production volumes or worker
numbers indicate low potential for occupational exposures.
DATES: Comments must be received on or before February 21, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2006-0961, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2006-0961. 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. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0961. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket's
index available at http://www.regulations.gov. Although listed in the
index, some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
For submission of studies, see Unit IV.A.1. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator,
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].
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 person
listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
that you mail to EPA, 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 claimed as CBI. In addition to one complete version
of the comment that includes 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. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions
[[Page 2757]]
or organize comments by referencing a Code of Federal Regulations (CFR)
part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
The Toxic Substances Control Act (TSCA) (15 U.S.C. 260l et seq.)
authorizes the Administrator of EPA to promulgate regulations under
section 4(a) of TSCA 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 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.
You may access additional information about the ITC at http://www.epa.gov/opptintr/itc.
A. The ITC's 59\th\ Report
The ITC is revising the TSCA section 4(e) Priority Testing List by
removing 22 chemicals. Phenol, 4-(1,1-dimethylethyl)- is being removed
because a recently submitted reproductive effects study meets ITC's
data needs. Five tungsten compounds and sixteen chemicals with
insufficient dermal absorption rate data are being removed because
their production volumes or worker numbers indicate low potential for
occupational exposures.
B. Status of the Priority Testing List
The Priority Testing List includes 2 alkylphenols, 5 tungsten
compounds, 16 chemicals with insufficient dermal absorption rate data
and 243 High Production Volume (HPV) Challenge Program orphan
chemicals.
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Dated: January 12, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
Fifty-Ninth Report of the TSCA Interagency Testing Committee to the
Administrator, U.S. Environmental Protection Agency
Table of Contents
Summary
I. Background
II. TSCA Section 8 Reporting
A. TSCA Section 8 Reporting Rules
B. ITC's Use of TSCA Section 8 and Other Information
C. Previous Requests to Add Chemicals to the TSCA Section 8(a) PAIR
Rule and TSCA Section 8(d) HaSDR Rule
III. ITC's Activities During this Reporting Period (June to November
2006)
IV. Revisions to the TSCA Section 4(e) Priority Testing List:
Chemicals Removed from the Priority Testing List
1. Chemicals with insufficient dermal absorption rate data.
2. Phenol, 4-(1,1-dimethylethyl)-.
3. Tungsten compounds.
V. References
VI. The TSCA Interagency Testing Committee
Summary
The ITC is revising the Toxic Substances Control Act (TSCA)
section 4(e) Priority Testing List by removing 22 chemicals. Phenol,
4-(1,1-dimethylethyl)- is being removed because a recently submitted
reproductive effects study meets ITC's data needs. Five tungsten
compounds and sixteen chemicals with insufficient dermal absorption
rate data are being removed because their production volumes or
worker numbers indicate low potential for occupational exposures.
The TSCA section 4(e) Priority Testing List is Table 1 of this
unit.
Table 1.--TSCA Section 4(e) Priority Testing List (November 2006)
----------------------------------------------------------------------------------------------------------------
ITC Report Date Chemical name/group Action
----------------------------------------------------------------------------------------------------------------
31 January 1993 2 Chemicals with Designated
insufficient dermal
absorption rate data
----------------------------------------------------------------------------------------------------------------
32 May 1993 10 Chemicals with Designated
insufficient dermal
absorption rate data
----------------------------------------------------------------------------------------------------------------
35 November 1994 4 Chemicals with Designated
insufficient dermal
absorption rate data
----------------------------------------------------------------------------------------------------------------
37 November 1995 Branched 4-nonylphenol Recommended
(mixed isomers)
----------------------------------------------------------------------------------------------------------------
41 November 1997 Phenol, 4-(1,1,3,3- Recommended
tetramethylbutyl)-
----------------------------------------------------------------------------------------------------------------
53 November 2003 5 Tungsten compounds Recommended
----------------------------------------------------------------------------------------------------------------
55 December 2004 238 High Production Recommended
Volume (HPV) Challenge
Program orphan
chemicals
----------------------------------------------------------------------------------------------------------------
56 August 2005 5 HPV Challenge Program Recommended
orphan chemicals
----------------------------------------------------------------------------------------------------------------
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 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
[[Page 2758]]
U.S.C. 2601 et seq.). ITC Reports are available from the ITC's
website (http://www.epa.gov/opptintr/itc) within a few days of
submission to the EPA Administrator and from the EPA's website
(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) may add the chemicals from
the revised Priority Testing List to the TSCA section 8(a)
Preliminary Assessment Information Reporting (PAIR) or TSCA section
8(d) Health and Safety Data Reporting (HaSDR) rules. The PAIR rule
requires manufacturers (including importers) of chemicals added to
the Priority Testing List to submit production and exposure reports
(http://www.epa.gov/opptintr/chemtest/pubs/pairform.pdf). The HaSDR
rule requires manufacturers (including importers) and can require
processors of 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).
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 the 52\nd\ ITC Report (http://www.epa.gov/opptintr/itc).
C. Previous Requests to Add Chemicals to the TSCA Section 8(a) PAIR
Rule and TSCA Section 8(d) HaSDR Rule
In its 56\th\ ITC Report the ITC requested that EPA add 243 of
the 251 HPV Challenge Program orphan chemicals on the Priority
Testing List to TSCA section 8(a) PAIR and 8(d) HaSDR rules (Ref.
2). In its 58\th\ ITC Report the ITC removed the 8 HPV Challenge
Program orphan chemicals listed in Tables 2 and 3 of the 56\th\ ITC
Report from the Priority Testing List and requested that EPA not add
them to the TSCA section 8(a) PAIR and 8(d) HaSDR rules (Ref. 3).
Additional information on the HPV Challenge Program orphan chemicals
and EPA's September 2006 amended Policy Regarding Acceptance of New
Commitments to Sponsor Chemicals under the HPV Challenge Program is
available at http://www.epa.gov/hpv/pubs/general/hpvpolcy2.htm.
III. ITC's Activities During this Reporting Period (June to November
2006)
In its 56\th\ and 58\th\ ITC Reports, the ITC appended lists of
new HPV chemicals with 1998 or 2002 Inventory Update Rule (IUR)
production or importation volume data greater than or equal to 1
million pounds (Refs. 2 and 3). In response to public comments, the
ITC made available on its website (http://www.epa.gov/opptintr/itc)
the sources of publicly available health effects and environmental
data for new HPV chemicals. The ITC provided these data sources to
facilitate the efforts of Federal and State agencies, interested
stakeholders, and members of the public to obtain basic health
effects and environmental data for new HPV chemicals.
Despite efforts to provide these data sources for new HPV
chemicals, appending these lists to the 56\th\ and 58\th\ ITC
Reports (Refs. 2 and 3) caused confusion. The ITC regrets the
confusion caused by these efforts and therefore provides the
following clarifications:
The ITC intentionally listed these new HPV chemicals in
appendices and did not add them to the TSCA section 4(e) Priority
Testing List.
The EPA promulgates TSCA section 8(a) and TSCA 8(d)
rules for ITC chemicals only after they have been added to the TSCA
section 4(e) Priority Testing List.
The ITC requests comments from readers who found the
sources of basic health effects and environmental data for new HPV
chemicals either useful or not useful, and if useful, how the
sources were used.
During this reporting period, the ITC discussed:
Chemicals with insufficient dermal absorption rate
data.
Alkylphenols.
Tungsten compounds.
Brominated flame retardants.
Health-based screening levels.
Tetrahydrofuran.
Methyl iodide.
Chlorine dioxide.
IV. Revisions to the TSCA Section 4(e) Priority Testing List: Chemicals
Removed from the Priority Testing List
1. Chemicals with insufficient dermal absorption rate data. In
its 31\st\, 32\nd\, and 35\th\ ITC Reports, the ITC added 24, 34,
and 25 chemicals, respectively, to the Priority Testing List and
designated them for testing to develop dermal absorption rate data
(Refs. 4, 5, and 6). The ITC removed methyl methacrylate and diethyl
phthalate from the Priority Testing List in its 34\th\ ITC Report
(Ref. 7) and cyclohexanone from the Priority Testing List in its
36\th\ ITC Report (Ref. 8). Methyl methacrylate, diethyl phthalate,
and cyclohexanone were removed from the Priority Testing List
because dermal absorption rate data were identified after these
chemicals were added to the Priority Testing List. In its 45\th\ ITC
Report (Ref. 9), the ITC removed an additional 47 chemicals
(designated for dermal absorption rate testing) from the Priority
Testing List, because the EPA published a rule proposing dermal
absorption rate testing for these chemicals (Ref. 10). In 2004, the
EPA reviewed more recent production volume, exposure, and dermal
absorption rate data and promulgated a rule requiring dermal
absorption rate testing for 34 of these chemicals (Ref. 11). The
rationales for EPA's decision not to finalize testing requirements
for the other 13 chemicals in the proposed rule are described in
reference 11. At this time, dermal absorption rate data have been
developed for 32 of the 34 chemicals. Dimethyl sulfate (CAS No. 77-
78-1) was dropped from consideration because it was considered too
corrosive to test. Nonane (CAS No. 111-84-2) has been referred to
EPA's compliance staff because a letter of intent to commence
testing has not been received. In this 59\th\ ITC Report, the ITC is
removing 16 chemicals with insufficient dermal absorption rate data
from the Priority Testing List (See Table 2 of this unit.).
Table 2.--Chemicals with insufficient dermal absorption rate data being
removed from the Priority Testing List
------------------------------------------------------------------------
TSCA Inventory
CAS No. Name ITC Report
------------------------------------------------------------------------
61-82-5 1H-1,2,4-Triazol-3- 32
amine
------------------------------------------------------------------------
75-25-2 Methane, tribromo- 32
------------------------------------------------------------------------
75-34-3 Ethane, 1,1- 32
dichloro-
------------------------------------------------------------------------
76-22-2 Bicyclo[2.2.1]hept 31
an-2-one, 1,7,7-
trimethyl-
------------------------------------------------------------------------
99-65-0 Benzene, 1,3- 32
dinitro-
------------------------------------------------------------------------
100-25-4 Benzene, 1,4- 31
dinitro-
------------------------------------------------------------------------
105-46-4 Acetic acid, 1- 31
methylpropyl
ester
------------------------------------------------------------------------
107-66-4 Phosphoric acid, 31
dibutyl ester
------------------------------------------------------------------------
110-83-8 Cyclohexene 31
------------------------------------------------------------------------
123-92-2 1-Butanol, 3- 31
methyl-, acetate
------------------------------------------------------------------------
532-27-4 Ethanone, 2-chloro- 31
1-phenyl-
------------------------------------------------------------------------
540-88-5 Acetic acid, 1,1- 31
dimethylethyl
ester
------------------------------------------------------------------------
1300-73-8 Benzenamine, ar,ar- 32
dimethyl-
------------------------------------------------------------------------
6423-43-4 1,2-Propanediol, 32
dinitrate
------------------------------------------------------------------------
7631-90-5 Sulfurous acid, 31
monosodium salt
------------------------------------------------------------------------
7681-57-4 Disulfurous acid, 31
disodium salt
------------------------------------------------------------------------
Five of these chemicals had reported production volumes of <
500,000 pounds and 11 had no production volumes reported to EPA in
response to the 2002 IUR (Ref. 12). Further, 8 of the 11 chemicals
with no 2002 IUR data had no production volumes reported to EPA in
response to the 1994 or 1998 IURs (Refs. 13 and 14). The ITC is
removing these 16 chemicals because their
[[Page 2759]]
production volumes indicate low potential for occupational
exposures.
There are 16 chemicals with insufficient dermal absorption rate
data remaining on the Priority Testing List (See Table 3 of this
unit.).
Table 3.--Chemicals with insufficient dermal absorption rate data remaining on the Priority Testing List
----------------------------------------------------------------------------------------------------------------
CAS No. TSCA Inventory Name ITC Report Status
----------------------------------------------------------------------------------------------------------------
75-12-7 Formamide 35 Screening Information
Data Set (SIDS) &
International Council
of Chemical
Associations (ICCA)
----------------------------------------------------------------------------------------------------------------
88-72-2 Benzene, 1-methyl-2- 32 SIDS
nitro-
----------------------------------------------------------------------------------------------------------------
89-72-5 Phenol, 2-(1- 32 SIDS & HPV Challenge
methylpropyl)- Program
----------------------------------------------------------------------------------------------------------------
90-04-0 Benzenamine, 2-methoxy- 32 SIDS
----------------------------------------------------------------------------------------------------------------
95-13-6 1H-Indene 32 American Chemistry
Council (ACC), Soap
and Detergent
Association (SDA) &
Synthetic Organic
Chemical Manufacturers
Association (SOCMA)
Extended (E) HPV
Challenge Program
----------------------------------------------------------------------------------------------------------------
96-18-4 Propane, 1,2,3- 35 SIDS & ICCA
trichloro-
----------------------------------------------------------------------------------------------------------------
99-08-1 Benzene, 1-methyl-3- 35 Sponsored HPV chemical
nitro-
----------------------------------------------------------------------------------------------------------------
100-63-0 Hydrazine, phenyl- 32 Appendix A, 58\th\ ITC
Report
----------------------------------------------------------------------------------------------------------------
106-49-0 Benzenamine, 4-methyl- 32 SIDS & ICCA
----------------------------------------------------------------------------------------------------------------
108-44-1 Benzenamine, 3-methyl- 32 SIDS
----------------------------------------------------------------------------------------------------------------
108-87-2 Cyclohexane, methyl- 31 Moderate production
volume (MPV) 2002
chemical
----------------------------------------------------------------------------------------------------------------
121-14-2 Benzene, 1-methyl-2,4- 32 SIDS
dinitro-
----------------------------------------------------------------------------------------------------------------
287-92-3 Cyclopentane 31 SIDS, ICCA, & HPV
Challenge Program
----------------------------------------------------------------------------------------------------------------
540-59-0 Ethene, 1,2-dichloro- 32 MPV 1998 & 2002
----------------------------------------------------------------------------------------------------------------
542-92-7 1,3-Cyclopentadiene 35 HPV orphan chemical
----------------------------------------------------------------------------------------------------------------
626-17-5 1,3- 32 Sponsored HPV chemical
Benzenedicarbonitrile
----------------------------------------------------------------------------------------------------------------
Twelve of the sixteen chemicals with insufficient dermal
absorption rate data remaining on the Priority Testing List are
included in EPA's HPV Challenge Program, the Organization for
Economic Cooperation and Development (OECD) SIDS Program, ICCA HPV
Initiative, or the ACC, SDA, and SOCMA EHPV Program.
Two of the sixteen chemicals with insufficient dermal absorption
rate data remaining on the Priority Testing List are MPV chemicals
(production or importation volumes ranging from 500,000 to 999,999
pounds). One of the 16 chemicals, phenylhydrazine, was listed in
Appendix A of the 58\th\ ITC Report (Ref. 3) because it was a new
HPV chemical in 2002. The last chemical, 1,3-cyclopentadiene is a
HPV Challenge Program orphan chemical that remains on the Priority
Testing List to provide potential sponsors the opportunity to
voluntarily submit or develop data, including dermal absorption rate
data.
The ITC encourages the manufacturers or sponsors of the 16
chemicals in Table 3 of this unit to voluntarily develop dermal
absorption rate data using the methods discussed in reference 11 and
submit studies using one of the following methods:
Hand Delivery: John D. Walker, OPPT/ITC (7401M), EPA,
EPA East Bldg., Rm. 5353, 1201 Constitution Ave., NW., Washington,
DC. Attention: FYI-ITC.
Mail: Document Control Office (7407M), Office of
Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
Attention: FYI-ITC.
2. Phenol, 4-(1,1-dimethylethyl)-. Eighty-eight alkylphenols,
polyalkylphenols, alkylphenol ethoxylates, and alkylphenol
polyethoxylates were added to the Priority Testing List in the
37\th\, 39\th\, 41\st\, and 46\th\ ITC Reports (Refs. 18-21). Fifty
of these chemicals were removed from the Priority Testing List in
the 43\rd\, 46\th\, and 48\th\ ITC Reports (Refs. 21-23) because:
a. No domestic production or importation volumes were reported
to the EPA in response to 1986, 1990, 1994, or 1998 IURs (Refs. 13,
14, 24, and 25),
b. No domestic production or importation volumes were reported
to the EPA in response to the February 28, 1996 PAIR rule (Ref. 26),
c. No TSCA section 8(d) studies were submitted to the EPA in
response to the February 28, 1996 HaSDR rule (Ref. 26),
d. No domestic production or importation volumes were reported
to the EPA in response to the January 11, 2000 PAIR rule (Ref. 27),
e. No domestic production or importation volumes were reported
to the EPA in response to the July 5, 2000 PAIR rule (Ref. 28),
f. No TSCA section 8(e) or FYI studies were available for these
chemicals as of September 1998, or
g. Use and health and safety data were voluntarily submitted to
the ITC by the Chemical Manufacturers Association Alkylphenols and
Ethoxylates Panel.
Thirty-five of these chemicals were removed from the Priority
Testing List in the 50\th\ and 51\st\ ITC Reports (Refs. 29 and 30)
because:
No domestic production or importation volumes were
reported to the EPA in response to 1986, 1990, 1994, and 1998 IURs
(Refs. 13, 14, 24, and 25) or reported to the EPA in response to the
July 5, 2000 PAIR rule (Ref. 28).
Data developed in response to the EPA's HPV Challenge
Program could be used to predict toxicity, or
The Alkyl Phenol Ethoxylates Research Consortium
(http://www.aperc.org) provided information to meet the ITC's data
needs.
The three remaining alkyphenols on the Priority Testing List
are: Phenol, 4-(1,1-dimethylethyl)- (CAS No. 98-54-4); phenol, 4-
(1,1,3,3-tetramethylbutyl)- (CAS No. 140-66-9); and phenol, 4-nonyl-
, branched (CAS No. 84852-15-3) (Ref. 30). For phenol, 4-(1,1-
dimethylethyl)-, the ITC anticipated receiving the ongoing
reproductive effects study. For phenol, 4-(1,1,3,3-
[[Page 2760]]
tetramethylbutyl)- and phenol, 4-nonyl-, branched, the ITC
anticipated receiving amphibian toxicity data, avian reproductive
effects data, and fish reproductive effects data.
The ITC received the recently completed 2-generation
reproductive effects study in rats for phenol, 4-(1,1-
dimethylethyl)-, more commonly referred to as 4-tert-butylphenol
(Ref. 31). The ITC is removing 4-tert-butylphenol from the Priority
Testing List because the reproductive effects study meets the ITC's
data needs.
There are amphibian toxicity data for phenol, 4-(1,1,3,3-
tetramethylbutyl)- and phenol, 4-nonyl-, branched. In an amphibian
toxicity study of phenol, 4-nonyl-, branched, the 96 hour
LC50 for toad (Bufo boreas) tadpoles was 120 microgram/
Liter ([mu]g/L) (Ref. 32). Two amphibian toxicity studies of phenol,
4-(1,1,3,3-tetramethylbutyl)- were discussed in a recent review
(Ref. 33). One was categorized as ``not valid'' (Ref. 34) and the
other as ``use with care'' (Ref. 35). These studies may be
sufficient to meet the ITC's amphibian toxicity data needs for
phenol, 4-(1,1,3,3-tetramethylbutyl)- and phenol, 4-nonyl-,
branched. However, the ITC is leaving phenol, 4-(1,1,3,3-
tetramethylbutyl)- and phenol, 4-nonyl-, branched on the Priority
Testing List because it needs time to:
Determine if the existing fish reproductive effects
data are sufficient to meet the ITC's data needs.
Review the EPA's Safer Detergents Stewardship
Initiative (http://www.epa.gov/dfe/pubs/projects/formulat/sdsi.htm).
Determine if phenol, 4-(1,1,3,3-tetramethylbutyl)- or
phenol, 4-nonyl-, branched should be tested for avian reproductive
effects.
3. Tungsten compounds. Of the 22 tungsten compounds added to the
Priority Testing List in the 53\rd\ ITC Report (Ref. 36) and 56\th\
ITC Report (Ref. 2), 12 were removed in the 58\th\ ITC Report (Ref.
3). At this time the ITC is removing 5 additional tungsten compounds
from the Priority Testing List (See Table 4 of this unit.).
Table 4.--Tungsten compounds being removed from the Priority Testing
List
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
7783-03-1 Tungstate (WO4\2\-),
dihydrogen, (T-4)-
------------------------------------------------------------------------
7783-82-6 Tungsten fluoride (WF6), (OC-
6-11)-
------------------------------------------------------------------------
12028-48-7 Tungstate (W12(OH)2O38\6\-),
hexaammonium
------------------------------------------------------------------------
12036-22-5 Tungsten oxide (WO2)
------------------------------------------------------------------------
12138-09-9 Tungsten sulfide (WS2)
------------------------------------------------------------------------
The ITC is removing these five tungsten compounds from the
Priority Testing List because production volume and worker numbers
data submitted in response to the December 7, 2004 PAIR rule (Ref.
37) indicate low potential for occupational exposure.
Table 5 of this unit lists the tungsten compounds remaining on
the Priority Testing List.
Table 5.--Tungsten Compounds Remaining on the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
1314-35-8 Tungsten oxide (WO3)
------------------------------------------------------------------------
7440-33-7 Tungsten
------------------------------------------------------------------------
10213-10-2 Tungstate (WO4\2\-),
disodium, dihydrate, (T-4)-
------------------------------------------------------------------------
11120-25-5 Tungstate (W12(OH)2O40\10\-
), decaammonium
------------------------------------------------------------------------
13472-45-2 Tungstate (WO4\2\-),
disodium, (T-4)-
------------------------------------------------------------------------
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 on-line at: http://www.epa.gov/fedrgstr.
2. ITC. 2005. Fifty-Sixth Report of the ITC. Federal Register
(70 FR 61520, October 24, 2005) (FRL-7739-9). Available on-line at:
http://www.epa.gov/fedrgstr.
3. ITC. 2006. Fifty-Eighth Report of the ITC. Federal Register
(70 FR 39187, July 11, 2006) (FRL-8073-7). Available on-line at:
http://www.epa.gov/fedrgstr.
4. ITC. 1993. Thirty-First Report of the ITC. Federal Register
(58 FR 26898, May 5, 1993) (FRL-4583-4). Available on-line at:
http://www.regulations.gov, EPA-HQ-OPPT-2006-0961.
5. ITC. 1993. Thirty-Second Report of the ITC. Federal Register
(58 FR 38490, July 16, 1993) (FRL-4630-2). Available on-line at:
http://www.regulations.gov, EPA-HQ-OPPT-2006-0961.
6. ITC. 1994. Thirty-Fifth Report of the ITC. Federal Register
(59 FR 67596, December 29, 1994) (FRL-4923-2). Available on-line at:
http://www.regulations.gov, EPA-HQ-OPPT-2006-0961.
7. ITC. 1994. Thirty-Fourth Report of the ITC. Federal Register
(59 FR 35720, July 13, 1994) (FRL-4870-4). Available online at
http://www.regulations.gov, EPA-HQ-OPPT-2006-0961.
8. ITC. 1995. Thirty-Sixth Report of the ITC. Federal Register
(60 FR 42982, August 17, 1995) (FRL-4965-6). Available on-line at:
http://www.epa.gov/fedrgstr.
9. ITC. 2000. Forty-Fifth Report of the ITC. Federal Register
(65 FR 75544, December 1, 2000) (FRL-6399-5). Available on-line at:
http://www.epa.gov/fedrgstr.
10. EPA. 1999. Proposed Test Rule for In Vitro Dermal Absorption
Rate Testing of Certain Chemicals of Interest to Occupational Safety
and Health Administration. Federal Register (64 FR 31074, June 9,
1999) (FRL-5760-3). Available on-line at: http://www.epa.gov/fedrgstr.
11. EPA. 2004. Final Test Rule for In Vitro Dermal Absorption
Rate Testing of Certain Chemicals of Interest to Occupational Safety
and Health Administration. Federal Register (69 FR 22402, April 26,
2004) (FRL-7312-2). Available on-line at: http://www.epa.gov/fedrgstr.
12. EPA. 2002 Reporting Notice; 2002. Partial Updating of TSCA
Inventory Data Base; Production and Site Reports; Federal Register
(67 FR 18615, April 16, 2002) (FRL-6826-5). Available on-line at:
http://www.epa.gov/fedrgstr.
13. EPA. 1994. Partial Updating of TSCA Inventory Data Base;
Production and Site Reports; Technical Amendment. Federal Register
(59 FR 30652, June 14, 1994) (FRL-4869-7). Available on-line at:
http://www.regulations.gov, EPA-HQ-OPPT-2006-0961.
14. EPA. 1998. Partial Updating of TSCA Inventory Data Base;
Production and Site Reports; Technical Amendment. Federal Register
(63 FR 459503, August 28, 1998) (FRL-6028-3). Available on-line at:
http://www.epa.gov/fedrgstr.
15. EPA. 2006. Preliminary Assessment Information Reporting;
Addition of Certain Chemicals. Federal Register (71 FR 47122, August
16, 2006) (FRL-7764-9). Available on-line at: http://www.epa.gov/fedrgstr.
16. EPA. 2006. Health and Safety Data Reporting; Addition of
Certain Chemicals. Federal Register (71 FR 47130, August 16, 2006)
(FRL-7764-7). Available on-line at: http://www.epa.gov/fedrgstr.
17. EPA. 2006. Withdrawal of Certain Chemicals from Preliminary
Assessment Information Reporting and Health and Safety Data
Reporting Rules. Federal Register (71 FR 57439, September 29, 2006)
(FRL-8096-5). Available on-line at: http://www.epa.gov/fedrgstr.
18. ITC. 1995. Thirty-Seventh Report of the ITC. Federal
Register (61 FR. 4188, February 2, 1996) (FRL-4991-6). Available on-
line at: http://www.epa.gov/fedrgstr.
19. ITC. 1996. Thirty-Ninth Report of the ITC. Federal Register
(62 FR 8578, February 25, 1997) (FRL-5580-9). Available on-line at:
http://www.epa.gov/fedrgstr.
20. ITC. 1997. Forty-First Report of the ITC. Federal Register
(63 FR 17658, April 9, 1998) (FRL-5773-5). Available on-line at:
http://www.epa.gov/fedrgstr.
21. ITC. 2000. Forty-Sixth Report of the ITC. Federal Register
(65 FR 75552, December 1, 2000) (FRL-6594-7). Available on-line at:
http://www.epa.gov/fedrgstr.
22. ITC. 2000. Forty-Third Report of the ITC. Federal Register
(65 FR 65234, October 31, 2000) (FRL-6049-5). Available on-line at:
http://www.epa.gov/fedrgstr.
23. ITC. 2001. Forty-Eighth Report of the ITC. Federal Register
(66 FR 51276, October 5, 2001) (FRL-6786-7). Available on-line at:
http://www.epa.gov/fedrgstr.
24. EPA. 1986. Partial Updating of TSCA Inventory Data Base;
Production and Site Reports. Federal Register (51 FR 21438, June 12,
1986). Available on-line at: http://www.regulations.gov, EPA-HQ-
OPPT-2006-0961.
25. EPA. 1990. Partial Updating of TSCA Inventory Data Base;
Production and Site
[[Page 2761]]
Reports; Technical Amendment. Federal Register (55 FR 39586,
September 27, 1990) (FRL-3770-4). Available on-line at: http://www.regulations.gov, EPA-HQ-OPPT-2006-0961.
26. EPA. 1996. Preliminary Assessment Information and Health and
Safety Data Reporting; Addition of Certain Chemicals. Federal
Register (61 FR 7421, February 28, 1996) (FRL-4996-9). Available on-
line at: http://www.epa.gov/fedrgstr.
27. EPA. 2000. Preliminary Assessment Information and Health and
Safety Data Reporting; Addition of Certain Chemicals. Federal
Register (65 FR 1548, January 11, 2000) (FRL-5777-2). Available on-
line at: http://www.epa.gov/fedrgstr.
28. EPA. 2000. Preliminary Assessment Information and Health and
Safety Data Reporting; Addition of Certain Chemicals. Federal
Register (65 FR 41371, July 5, 2000) (FRL-6589-1). Available on-line
at: http://www.epa.gov/fedrgstr.
29. ITC. 2002. Fiftieth Report of the ITC. Federal Register (67
FR 49530, July 30, 2002) (FRL-7183-7). Available on-line at: http://www.epa.gov/fedrgstr.
30. ITC. 2003. Fifty-First Report of the ITC. Federal Register
(68 FR 8976, February 26, 2003) (FRL-7285-7). Available on-line at:
http://www.epa.gov/fedrgstr.
31. Charles Rivers Laboratories, Edinburgh, Scotland. Final
Report: p-tert-butylphenol Two Generation Reproduction Study in Rats
Study No. 493595 Report No. 24804. Unpublished report sponsored by
SASOL GmbH (Germany) and SI Group-Switzerland GmbH (Formerly
Schenectady Pratteln GmbH, Switzerland). February 2006.
32. Dwyer, F.J.; Mayer, F.L.; Sappington, L.C.; Buckler, D.R.;
Bridges, C.M.; Greer, I.E.; Hardesty, D.K.; Henke, C.E.; Ingersoll,
C.G.; Kunz, J.L.; Whites, D.W.; Augspurger, T.; Mount, D.R.;
Hattala, K.; and Neuderfer, G. 2005. Assessing contaminant
sensitivity of endangered and threatened aquatic species: Part I.
Acute toxicity of five chemicals. Archives Environmental
Contamination Toxicology. 48:143-154.
33. Van Miller, J.P. Staples CA. 2005. Review of the potential
environmental and human health-related hazards and risks from long-
term exposure to p-tert-octylphenol. Human and Ecological Risk
Assessment. 11:319-351.
34. Kloas, W.; Lutz, I.; Einspanier, R. 1999. Amphibians as a
model to study endocrine disruptors: II. Estrogenic activity of
environmental chemicals in vitro and in vivo. Science of the Total
Environment. 225:59-68.
35. Crump, D.; Lean, D.; and Trudeau, V.L. 2002. Octylphenol and
UV-B radiation alter larval development and hypothalamic gene
expression in the Leopard Frog (Rana pipiens). Environmental Health
Perspectives. 110:277-284.
36. ITC. 2004. Fifty-Third Report of the ITC. Federal Register
(69 FR 2467, January 15, 2004) (FRL-7335-2). Available on-line at:
http://www.epa.gov/fedrgstr.
37. EPA. 2004. Preliminary Assessment Information Reporting;
Addition of Certain Chemicals. Federal Register (69 FR 70552,
December 7, 2004) (FRL-7366-8). Available on-line 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
Dianne Poster, Member, Vice Chair
National Oceanographic and AtmosphericAdministration
Tony Pait, Member
Environmental Protection Agency
John Schaeffer, Member
Gerry Brown, Alternate
National Cancer Institute
Alan Poland, Alternate
National Institute of Environmental Health Sciences
John Bucher, Member
Scott Masten, Alternate
National Institute for Occupational Safety and Health
Dennis W. Lynch, Member
Mark Toraason, Alternate
National Science Foundation
Cindy Lee, Member
Marge Cavanaugh, Alternate
Occupational Safety and Health Administration
Maureen Ruskin, Member, Chair
Thomas Nerad, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
Daphne Moffett, Member
Glenn D. Todd, Alternate
Consumer Product Safety Commission
Jacqueline Ferrante, Member
Department of Agriculture
Clifford P. Rice, Member
Laura L. McConnell, Alternate
Department of Defense
Laurie Roszell, Member
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
Carol Savage, Administrative Assistant
TSCA Interagency Testing Committee (7401), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; e-mail address:
[email protected]; url: http://www.epa.gov/opptintr/itc.
[FR Doc. E7-837 Filed 1-19-07; 8:45 am]
BILLING CODE 6560-50-S