[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]



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Part V





Environmental Protection Agency





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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  

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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.

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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.

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     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)
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              ITC Report                         Date             Chemical Name/Group             Action
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31                                     January 1993             2 Chemicals with         Designated
                                                                 insufficient dermal
                                                                 absorption rate data
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32                                     May 1993                 10 Chemicals with        Designated
                                                                 insufficient dermal
                                                                 absorption rate data
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35                                     November 1994            4 Chemicals with         Designated
                                                                 insufficient dermal
                                                                 absorption rate data
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37                                     November 1995            Branched 4-nonylphenol   Recommended
                                                                 (mixed isomers)
----------------------------------------------------------------------------------------------------------------
41                                     November 1997            Phenol, 4-(1,1,3,3-      Recommended
                                                                 tetramethylbutyl)-
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55                                     December 2004            203 High Production      Recommended
                                                                 Volume (HPV) Challenge
                                                                 Program orphan
                                                                 chemicals
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56                                     August 2005              4 HPV Challenge Program  Recommended
                                                                 orphan chemicals
----------------------------------------------------------------------------------------------------------------
60                                     May 2007                 12 Lead and lead         Recommended
                                                                 compounds
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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.

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    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]
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