38878 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

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 64th

report to the Administrator of EPA on 

June 25, 2009. In the 64th 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 email. 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: 

TSCA-Hotline@epa.gov. 

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 TSCAcovered 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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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 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 64th 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 insufficient dermal absorption rate data Designated 

32 May 1993 10 Chemicals with insufficient dermal absorption rate data Designated 

35 November 1994 4 Chemicals with insufficient dermal absorption rate data Designated 

37 November 1995 Branched 4-nonylphenol (mixed isomers) Recommended 

41 November 1997 Phenol, 4-(1,1,3,3-tetramethylbutyl)- Recommended 

55 December 2004 203 High Production Volume (HPV) Challenge Program orphan chemicals Recommended 

56 August 2005 4 HPV Challenge Program orphan chemicals Recommended 

60 May 2007 12 Lead and lead compounds 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 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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38880 Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices 

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: 

savage.carol@epa.gov; url: http:// 

www.epa.gov/opptintr/itc. 

[FR Doc. E9–18469 Filed 8–3–09; 8:45 am] 

BILLING CODE 6560–50–S 

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