[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38878-38880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18469]
[[Page 38877]]
-----------------------------------------------------------------------
Part V
Environmental Protection Agency
-----------------------------------------------------------------------
Sixty-Fourth 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. 74, No. 148 / Tuesday, August 4, 2009 /
Notices
[[Page 38878]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2009-0206; FRL-8425-6]
Sixty-Fourth 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.
-----------------------------------------------------------------------
SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its 64\th\ report to the Administrator of
EPA on June 25, 2009. In the 64\th\ ITC report, which is included with
this notice, the ITC has no revisions to the TSCA section 4(e) Priority
Testing List at this time.
DATES: Comments must be received on or before September 3, 2009.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0206, 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-2009-0206. 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-
2009-0206. 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.
Docket: All documents in the docket are listed in the docket 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 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-DOM 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 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.
[[Page 38879]]
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
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 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 64\th\ ITC Report
The ITC has no revisions to the TSCA section 4(e) Priority Testing
List at this time.
B. Status of the Priority Testing List
The Priority Testing List includes 2 alkylphenols, 12 lead
compounds, 16 chemicals with insufficient dermal absorption rate data,
and 207 HPV Challenge Program orphan chemicals.
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Dated: July 27, 2009.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.
Sixty-Fourth Report of the TSCA Interagency Testing Committee to the
Administrator of the Environmental Protection Agency
Table of Contents
Summary
I. Background
II. ITC's Activities During this Reporting Period (November 2008 to
May 2009)
III. The TSCA Interagency Testing Committee
Summary
The ITC has no revisions to the Toxic Substances Control Act
(TSCA) section 4(e) Priority Testing List at this time.
The TSCA section 4(e) Priority Testing List is Table 1 of this
unit.
Table 1.--TSCA Section 4(e) Priority Testing List (May 2009)
----------------------------------------------------------------------------------------------------------------
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)-
----------------------------------------------------------------------------------------------------------------
55 December 2004 203 High Production Recommended
Volume (HPV) Challenge
Program orphan
chemicals
----------------------------------------------------------------------------------------------------------------
56 August 2005 4 HPV Challenge Program Recommended
orphan chemicals
----------------------------------------------------------------------------------------------------------------
60 May 2007 12 Lead and lead Recommended
compounds
----------------------------------------------------------------------------------------------------------------
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 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. ITC's Activities During this Reporting Period (November 2008 to May
2009)
During this reporting period, the ITC continued to discuss
nanoscale materials and EPA's Nanoscale Materials Stewardship
Program (NMSP) (For details on the NMSP, see the Federal Register
issue of January 28, 2008 (73 FR 4861) (FRL-8344-5), available on-
line at http://www.epa.gov/fedrgstr.) The ITC's initial discussions
of nanoscale materials occurred in 2004 with briefings by scientists
from EPA, National Institute of Environmental Health Sciences
(NIEHS), National Institute for Occupational Safety and Health
(NIOSH), and National Institute of Standards and Technology (NIST)
and a review of the National Toxicology Program (NTP) Toxicological
Evaluation of Nanoscale Materials. At that time, several ITC members
were participating on an informal interagency nanoscale materials
workgroup and were aware of the need to understand the health and
environmental effects of nanoscale materials.
The EPA briefing discussed the potential regulation of nanoscale
materials as new chemicals under TSCA section 5. The NIEHS briefing
described the goal of the NTP research program, i.e., to evaluate
the toxicological properties of major nanoscale materials classes
and use these as model systems to investigate fundamental questions
concerning if and how nanoscale materials can interact with
biological systems. The NIOSH briefing focused on the impact of
nanotechnology on occupational health. The briefing acknowledged
that while the prevalence and types of nanoscale particles in the
workplace were not yet determined, there were concerns that
nanoscale particles could exhibit a high deposition fraction in the
respiratory tract, appear to be toxic and inflammatory to the lung,
and may migrate to systemic sites. The NIST contribution to the
nanotechnology area is to develop needed measurements, data, and
standards; develop infrastructure measurement capabilities; provide
the metrology tools and techniques; and transfer measurement
capabilities to the appropriate communities.
[[Page 38880]]
In 2006, the ITC reviewed EPA's nanotechnology white paper and
received a briefing on EPA's nanotechnology research programs. Since
then, the ITC has discussed the importance of nanotechnology, but
questioned how nanotechnology chemicals for which there are very few
Chemical Abstracts Service Registry (CAS) numbers should be
discussed in ITC reports or added to the ITC's Priority Testing
List.
In 2009, the ITC reviewed the EPA's interim report on the
Nanoscale Materials Stewardship Program (http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf). EPA intends to develop a
proposed TSCA section 8(a) rule to obtain information on the
production, uses, and exposures of existing nanoscale materials. EPA
has indicated that it will ensure that the chemicals where there is
ITC interest as described in this unit are either included in that
action or are otherwise new chemical substances subject to
premanufacture notification (PMN) reporting under TSCA. EPA also
intends to develop a proposed TSCA section 4 rule to develop needed
environmental, health, and safety data. The ITC also noted NIOSH's
guidelines, ``Approaches to Safe Nanotechnology: Managing the Health
and Safety Concerns Associated with Engineered Nanomaterials,'' that
are available at http://www.cdc.gov/niosh/topics/nanotech/safenano.
1. At this time, there are several U.S. Government organizations
on the ITC that continue to have data needs for nanoscale materials.
Many of these nanoscale materials do not have CAS numbers, or have
CAS numbers that may be associated with the non-nanoscale chemical.
a. Occupational exposure data needs include:
i. Recent non-CBI estimates of annual production and/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 numbers of workers associated with
production and downstream uses.
iii. Workplace area and/or personal breathing zone
concentrations to which workers may be exposed during manufacturing,
processing, and downstream use scenarios.
b. Mammalian toxicology data needs include:
i. Human health effects data such as case reports and
epidemiological studies of workers.
ii. Acute, subchronic, chronic, pulmonary, reproductive, and
developmental animal toxicity data as well as pharmacokinetics,
genotoxicity, and carcinogenicity data.
c. Environmental data needs include:
i. Ecological effects data for aquatic and terrestrial
organisms, birds, and wild mammals.
ii. Chemical fate data such as biodegradation, photolysis,
hydrolysis, oxidation, and reduction.
iii. Physical or chemical property data such as melting and
boiling points, partition coefficients as well as metrology data.
2. At this time, the U.S. Government organizations on the ITC
have data needs for occupational exposure and mammalian toxicology
data for the following nanoscale materials, and are reviewing data
submitted in PMNs or in response to the NMSP:
a. Materials having CAS numbers that are only nanoscale at the
molecular level:
C60 fullerenes-CAS No. 135105-52-1 (this is
the generic C60 fullerene; many other CAS numbers exist
for specific C60 fullerene structural isomers, including,
for example, CAS No. 99685-96-8, for [5,6]Fullerene-C60-
Ih)
C90 fullerenes-CAS No. 135113-17-6 (this is
the generic C90 fullerene; other CAS numbers exist for
specific C90 fullerene structural isomers)
b. Materials having CAS numbers that can exist in the nanoscale
and bulk forms:
Carbon black, nano form-CAS No. 1333-86-4
Titanium oxide (TiO2) nanowires-CAS No.
13463-67-7
Titanium oxide (TiO2) nanoparticles--CAS
No. 13463-67-7
Zinc oxide (ZnO), nano form--CAS No. 1314-13-2
Silver, nano form--CAS No. 7440-22-4
Silica [crystalline], nano form--CAS No. 7631-86-9
Quartz (SiO2), nano form--CAS No. 14808-60-
7
Cerium oxide (CeO2), nano form--CAS No.
1306-38-3
Indium tin oxide, nano form--CAS No. 50926-11-9
Indium tin oxide
(In1.69Sn0.15O2
.85), nano form--CAS No. 71243-84-0
Indium tin oxide
(In0.01SnO2), nano form--CAS No.
212075-26-8
Indium tin oxide
(In0.02Sn0.98O1
.99), nano form--CAS No. 180090-96-4
Dendrimers--there are a number of CAS numbers
describing certain compositions of dendrimers
c. Materials with no CAS numbers that either can exist in both
the nano and bulk forms or are only nanoscale:
Single-walled carbon nanotubes
Multi-walled carbon nanotubes
Carbon nanofibers
Quantum dots with Cd core
Quantum dots with Se core
Nanoceramic particles
Nanoclays
III. 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, Alternate
National Oceanographic and Atmospheric Administration
Tony Pait, Member, Chair
Environmental Protection Agency
John Schaeffer, Member
Gerry Brown, Alternate
National Cancer Institute
Vacant
National Institute of Environmental Health Sciences
Scott Masten, Alternate
National Institute for Occupational Safety and Health
Gayle DeBord, Member
Dennis W. Lynch, Alternate
National Science Foundation
Margaret Cavanaugh, Alternate
Occupational Safety and Health Administration
Thomas Nerad, Member, Vice-Chair
Maureen Ruskin, 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, Member
Ronald F. Chanderbhan, Alternate
Technical Support Contractor
Syracuse Research Corporation
ITC Staff
John D. Walker, Director
Carol Savage, Administrative
Assistant
TSCA Interagency Testing Committee (7401M), 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. E9-18469 Filed 8-3-09; 8:45 am]
BILLING CODE 6560-50-S