Nanoscale Materials; Notice of Public Meeting, 24574-24576 [05-9324]
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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
associations between respiratory health
conditions and long-term exposures to
ambient air pollutants in the study
community. The epidemiologic analysis
will examine the association of air
quality parameters with a higher
prevalence of respiratory conditions,
with lower lung function, or with higher
levels of exhaled nitric oxide after
appropriate control for other
determinants of respiratory health.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in 40
CFR are listed in 40 CFR part 9 and are
identified on the form and/or
instrument, if applicable.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is 0.4
hours per parent questionnaire and 0.75
hours per set of child respiratory health
measures. This survey will not be
repeated. Burden means the total time,
effort, or financial resources expended
by persons to generate, maintain, retain,
or disclose or provide information to or
for a Federal agency. This includes the
time needed to review instructions;
develop, acquire, install, and utilize
technology and systems for the purposes
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
Respondents/Affected Entities:
Entities potentially affected by this
action are school officials, parents and
children in the Detroit and Dearborn
Public Schools.
Estimated Number of Respondents:
18,500.
Frequency of Response: Once.
Estimated Total Annual Hour Burden:
8,250 hours.
Estimated Total Annual Cost:
$113,468, includes $0 annualized
capital or O&M costs and $113,468 in
Labor costs.
Dated: May 3, 2005.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. 05–9319 Filed 5–9–05; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
[OPPT–2004–0122; FRL–7700–7]
Nanoscale Materials; Notice of Public
Meeting
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: EPA will conduct a public
meeting on nanoscale materials to
discuss a potential voluntary pilot
program for certain nanoscale materials
and the information needed to
adequately inform the conduct of the
pilot program. Nanoscale materials are
chemical substances containing
structures in the length scale of
approximately 1 to 100 nanometers, and
may have different molecular
organizations and properties than the
same chemical substances in a larger
size. Some of the nanoscale materials
are new chemical substances subject to
notification requirements under section
5 of the Toxic Substances Control Act
(TSCA) and, therefore, are subject to
review for potential human health and
environmental risks before they are
manufactured and enter commerce.
Other nanoscale materials are existing
chemical substances that may enter
commerce without notification to EPA.
EPA is considering a potential voluntary
pilot program for such nanoscale
materials. To that end, EPA is
requesting comments at the public
meeting on: (1) The scope and purpose
of a voluntary pilot program for
nanoscale materials that are existing
chemical substances, (2) kinds of
information that are relevant to the
evaluation of potential risks from
exposure to nanoscale materials, (3)
chemical characterization and
nomenclature of nanoscale materials for
regulatory purposes, and (4)
identification of interested stakeholders.
These comments will inform EPA on
possible approaches to protect human
health and the environment from
exposure to such chemical substances.
DATES: The meeting will be held on June
23, 2005, from 9 a.m. to 5 p.m.
Requests to provide oral comments at
the meeting must be received in writing
by the technical person listed under FOR
FURTHER INFORMATION CONTACT: before
June 9, 2005. Please note that time for
oral comments may be limited,
depending on the number of requests
received.
Requests to attend the meeting may be
submitted to the technical person listed
under FOR FURTHER INFORMATION
CONTACT: by June 16, 2005. Please note
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that this advance request will assist in
planning adequate seating; however,
members of the public can attend
without prior notification to the
technical person. Requests for special
accommodations may be submitted to
the technical person by June 16, 2005.
Written comments, identified by
docket identification (ID) number
OPPT–2004–0122, may be submitted to
the docket at any time before the
meeting date.
The meeting will be held at
the Washington Plaza, 10 Thomas Circle
NW., Washington, DC 20005.
ADDRESSES:
For
general 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.
For technical information contact:
Flora Chow, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8983; e-mail
address:chow.flora@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general, and may be of particular
interest to those persons who
manufacture, import, process, or use
nanoscale materials that are chemical
substances subject to TSCA jurisdiction.
Potentially affected entities may
include, but are not limited to:
• Chemical manufacturers (NAICS
325), e.g., persons manufacturing,
importing, processing, or using
chemicals for commercial purposes.
• Petroleum and coal product
industries (NAICS 324), e.g., persons
manufacturing, importing, processing,
or using chemicals for commercial
purposes.
Since other entities may also be
interested, the Agency has not
attempted to describe all the specific
entities that may have an interest in this
matter. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
E:\FR\FM\10MYN1.SGM
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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
B. How Can I Get Copies of this
Document and Other Related
Information?
1. Docket. EPA has established an
official public docket for this action
under docket ID number OPPT–2004–
0122. The official public docket consists
of the documents specifically referenced
in this action, any public comments
received, and other information related
to this action. Although, a part of the
official docket, the public docket does
not include Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
The official public docket is the
collection of materials that is available
for public viewing at the EPA Docket
Center, Rm. B–102 Reading Room, EPA
West, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket
Center is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The EPA docket center
reading room telephone number is (202)
566–1744 and the telephone number for
the OPPT Docket, which is located in
EPA Docket Center, is (202) 566–0280.
2. Electronic access. You may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register listings
athttps://www.epa.gov/fedrgstr/. An
electronic version of the public docket
is available through EPA’s electronic
public docket and comment system,
EPA Dockets. You may use EPA Dockets
athttps://www.epa.gov/edocket/ to
submit or view public comments, access
the index listing of the contents of the
official public docket, and to access
those documents in the public docket
that are available electronically.
Although, not all docket materials may
be available electronically, you may still
access any of the publicly available
docket materials through the docket
facility identified in Unit I.B.1. Once in
the system, select ‘‘search,’’ then key in
the appropriate docket ID number.
II. Background
About two decades ago, research
indicated that certain nanoscale
materials exhibit unexpectedly unique
and novel properties. The existence of
structures at the nanoscale level may
confer a distinct set of physical,
chemical, and biological properties.
EPA is interested in whether
commercial activities of nanoscale
materials may present a potential risk to
human health and the environment
because of their unique physical
structure and consequent properties.
Available information on potential
hazards and exposures is limited (Refs.
1 and 2). Therefore, EPA is considering
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how best to evaluate the risks associated
with nanoscale materials and how to
manage those risks. TSCA is often
viewed as a regulatory gap filler, which
is intended to provide regulatory and
information collection authority lacking
in some other environmental statutes
(Refs. 3, 4, and 5). TSCA applies to
chemical substances and mixtures. The
term ‘‘chemical substance’’ means any
organic or inorganic substance of a
particular molecular identity. The term
specifically excludes: Pesticides;
tobacco or tobacco products; certain
nuclear materials; firearms and
ammunition; food; food additives;
drugs; cosmetics; and medical devices.
Chemical substances when used in
these other categories fall under the
jurisdiction of other federal laws.
Among TSCA’s regulatory tools are
reporting requirements that apply prior
to manufacture or import of any new
chemical substance, and the ability of
EPA to regulate a substance prior to
commencement of manufacture if it
appears that it may involve
unreasonable risk of injury to health or
the environment. A chemical substance
is ‘‘new’’ if it is not on the TSCA
Chemical Substance Inventory (the
TSCA Inventory), EPA’s official list of
existing chemical substances. Therefore,
a chemical substance that is a nanoscale
material not on the TSCA Inventory
(i.e., a new chemical substance) must be
reported to EPA in a premanufacture
notification (PMN) under section 5 of
TSCA before commercial activities are
allowed. EPA has authority under
section 5 to review potential health and
environmental risks of all aspects of the
commercial activities (Ref. 3). Once a
new chemical substance completes the
PMN process and has been listed on the
TSCA Inventory, the chemical substance
is considered to be an existing chemical
substance. A chemical substance that is
a nanoscale material on the TSCA
inventory (i.e., an existing chemical
substance), absent other requirements, is
not subject to EPA review prior to
manufacture or use. Existing chemical
substances that present an unreasonable
risk of injury to human health or the
environment may be regulated under
section 6 of TSCA (Ref. 3). Because
currently available chemical
representation and nomenclature
conventions may not be adequate for
some nanoscale materials, ambiguity
exists regarding how and when to
distinguish nanoscale materials as new
or existing chemical substances. In the
current state of development of
structural characterization upon which
nomenclature conventions are based,
issues remain.
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In addition to regulatory tools, EPA
engages in voluntary partnerships with
the chemical industry and other
stakeholders to facilitate risk reduction
activities. These activities are generally
less resource intensive and offer more
flexible approaches to management of
potential risks. Recent examples of
voluntary programs on existing
chemicals are the High Production
Volume (HPV) Challenge Program and
the Voluntary Children’s Chemical
Evaluation Program (VCCEP). Both
programs are designed to provide
information on certain groups of
chemicals. Evaluation of this
information will enable a better public
understanding of potential hazards and
exposures.
EPA is considering a pilot program of
voluntary reporting of information
pertaining to nanoscale materials that
are existing chemical substances.
Information derived from a pilot
program will allow EPA and the affected
industry to better understand the issues
with respect to potential risks and for
EPA to gain experience in the
evaluation of such types of chemical
substances.
EPA expects that the following
parameters will be important in the
context of a potential voluntary pilot
program to provide information on
nanoscale materials.
• What should be the scope of a
voluntary pilot program?
• What information should be
included in a voluntary pilot program?
What other pertinent information
regarding the properties of the particular
nanoscale material would be relevant to
EPA review?
• How long should a voluntary pilot
program last?
• How should participants in the
voluntary pilot program be identified?
• What should trigger a voluntary
submission under the pilot program?
• How likely would it be for
companies to volunteer for such a
program? What could be the incentive
structure to encourage participation?
• Should participation in a voluntary
pilot program have TSCA Inventory
consequences? A voluntary pilot
program would not affect the TSCA
Inventory status of a nanoscale material
that is an existing chemical substance.
As indicated previously, nanoscale
materials that are not listed on the
TSCA Inventory are considered new
chemical substances. These new
chemical substances require the
submission of a PMN before they can be
manufactured or used for commercial
purposes.
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Federal Register / Vol. 70, No. 89 / Tuesday, May 10, 2005 / Notices
III. Issues for EPA and stakeholders
In general, EPA is requesting
comments on the following issues: (1)
The scope and purpose of a voluntary
pilot program for nanoscale materials
that are existing chemical substances,
(2) kinds of information that are relevant
to the evaluation of potential risks from
exposure to nanoscale materials, (3)
chemical characterization and
nomenclature of nanoscale materials for
regulatory purposes, and (4)
identification of interested stakeholders.
Comments in these specific areas will be
particularly helpful:
• Feasibility and value of a voluntary
pilot program.
• Scope and design of a voluntary
pilot program, including elements such
as: purpose (e.g., R & D, use involving
environmental release, any commercial
use), administration, outcomes,
duration, and next steps.
• Information that would be useful in
the evaluation of potential effects on
human health and the environment
from exposure to nanoscale materials.
• Size, dimensions, and shapes of
chemical substances that should be
considered nanoscale materials.
• Types of information (e.g., unique
and novel properties) that would be
useful to provide for purposes of:
informing the voluntary pilot program;
and helping to name and characterize
nanoscale materials (including features
to distinguish them from otherwise
similar chemical substances that do not
involve nanoscale structures).
• Manufacturing processes for
nanoscale materials and how they relate
to identities of the products from the
nanoscale manufacturing processes.
• Identification of interested
stakeholders.
IV. References
The following references have been
placed in the official docket that was
established under docket ID number
OPPT–2004–0122 for this action as
indicated in Unit I.B.2.
1. Aitken, R.J., Creely, K.S., Tran, C.L.
2004. Nanoparticles: An Occupational
Hygiene Review. Suffolk, U.K.: Health
and Safety Executive, Research Report
274.
2. VDI Technologiezentrum GmbH.
2004. Industrial Application of
Nanomaterials - Chances and Risks.
Technology Analysis. Luther W, ed.
Dusseldorf, Germany: Future
Technologies No. 54.
3. USEPA. 2005. Considerations
Relevant to Toxic Substances Control
Act (TSCA) Application to Nanoscale
Materials. Office of Prevention,
Pesticides and Toxic Substances. Office
of Pollution Prevention and Toxics.
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4. Federal Register. June 3, 2003.
TSCA Section 8(e): Notification of
Substantial Risk; Policy Clarification
and Reporting Guidance. 68 FR 33129.
5. Federal Register. January 12, 2005.
TSCA Section 8(e) Reporting Guidance;
Correction, Clarification of
Applicability, and Announcement
Regarding the Issuance Questions and
Answers. 70 FR 2162.
C. New Business—Regulations
• Capital Adequacy Risk-Weighting
Revisions—Final Rule
Dated: May 5, 2005.
James M. Morris,
Acting Secretary, Farm Credit Administration
Board.
[FR Doc. 05–9426 Filed 5–6–05; 2:19 pm]
BILLING CODE 6705–01–P
List of Subjects
Environmental protection, Chemicals,
Hazardous substances, Nanotechnology,
Nanoscale materials.
Dated: April 25, 2005.
Susan B. Hazen,
Assistant Administrator for Prevention,
Pesticides and Toxic Substances.
[FR Doc. 05–9324 Filed 5–9–05; 8:45 am]
BILLING CODE 6560–50–S
FARM CREDIT ADMINISTRATION
Sunshine Act Notice; Farm Credit
Administration Board; Regular Meeting
AGENCY: Farm Credit Administration.
SUMMARY: Notice is hereby given,
pursuant to the Government in the
Sunshine Act (5 U.S.C. 552b(e)(3)), of
the regular meeting of the Farm Credit
Administration Board (Board).
DATE AND TIME: The regular meeting of
the Board will be held at the offices of
the Farm Credit Administration in
McLean, Virginia, on May 12, 2005,
from 9 a.m. until such time as the Board
concludes its business.
FOR FURTHER INFORMATION CONTACT:
Jeanette C. Brinkley, Secretary to the
Farm Credit Administration Board,
(703) 883–4009, TTY (703) 883–4056.
ADDRESSES: Farm Credit
Administration, 1501 Farm Credit Drive,
McLean, Virginia 22102–5090.
SUPPLEMENTARY INFORMATION: This
meeting of the Board will be open to the
public (limited space available). In order
to increase the accessibility to Board
meetings, persons requiring assistance
should make arrangements in advance.
The matters to be considered at the
meeting are:
Open Session
A. Approval of Minutes
• April 14, 2005 (Open and Closed)
B. Reports
• Corporate/Non-Corporate Report
• Risk Profile of U.S. Agriculture
• Risk Profile of the Farm Credit
System
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FEDERAL FINANCIAL INSTITUTIONS
EXAMINATION COUNCIL
Interagency Advisory on the Unsafe
and Unsound Use of Limitation of
Liability Provisions and Certain
Alternative Dispute Resolution
Provisions in External Audit
Engagement Letters
Federal Financial Institutions
Examination Council.
ACTION: Proposed interagency advisory;
request for comment.
AGENCY:
SUMMARY: The Federal Financial
Institutions Examination Council
(FFIEC), on behalf of the Office of Thrift
Supervision (OTS), Treasury; the Board
of Governors of the Federal Reserve
System (Board); the Federal Deposit
Insurance Corporation (FDIC); the
National Credit Union Administration
(NCUA); and the Office of the
Comptroller of the Currency (OCC),
Treasury (collectively, the Agencies), is
seeking public comment on a proposed
Interagency Advisory on the Unsafe and
Unsound Use of Limitation of Liability
Provisions and Certain Alternative
Dispute Resolution Provisions in
External Audit Engagement Letters. The
proposal advises financial institutions’
boards of directors, audit committees,
and management that they should
ensure that they do not enter any
agreement that contains external auditor
limitation of liability provisions with
respect to financial statement audits.
DATES: Comments must be received on
or before June 9, 2005.
ADDRESSES: Comments should be
directed to: FFIEC, Program
Coordinator, 3501Fairfax Drive, Room
3086, Arlington, VA 22226; by e-mail to
FFIEC-Comments@fdic.gov; or by fax to
(703) 516–5487. Comments will be
available for public inspection during
regular business hours at the above
address. Appointments to inspect
comments are encouraged and can be
arranged by calling the FFIEC at (703)
516–5588.
FOR FURTHER INFORMATION CONTACT:
OTS: Jeffrey J. Geer, Chief
Accountant, at jeffrey.geer@ots.treas.gov
or (202) 906–6363; or Patricia
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]]>Agencies
[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24574-24576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9324]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2004-0122; FRL-7700-7]
Nanoscale Materials; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: EPA will conduct a public meeting on nanoscale materials to
discuss a potential voluntary pilot program for certain nanoscale
materials and the information needed to adequately inform the conduct
of the pilot program. Nanoscale materials are chemical substances
containing structures in the length scale of approximately 1 to 100
nanometers, and may have different molecular organizations and
properties than the same chemical substances in a larger size. Some of
the nanoscale materials are new chemical substances subject to
notification requirements under section 5 of the Toxic Substances
Control Act (TSCA) and, therefore, are subject to review for potential
human health and environmental risks before they are manufactured and
enter commerce. Other nanoscale materials are existing chemical
substances that may enter commerce without notification to EPA. EPA is
considering a potential voluntary pilot program for such nanoscale
materials. To that end, EPA is requesting comments at the public
meeting on: (1) The scope and purpose of a voluntary pilot program for
nanoscale materials that are existing chemical substances, (2) kinds of
information that are relevant to the evaluation of potential risks from
exposure to nanoscale materials, (3) chemical characterization and
nomenclature of nanoscale materials for regulatory purposes, and (4)
identification of interested stakeholders. These comments will inform
EPA on possible approaches to protect human health and the environment
from exposure to such chemical substances.
DATES: The meeting will be held on June 23, 2005, from 9 a.m. to 5 p.m.
Requests to provide oral comments at the meeting must be received
in writing by the technical person listed under FOR FURTHER INFORMATION
CONTACT: before June 9, 2005. Please note that time for oral comments
may be limited, depending on the number of requests received.
Requests to attend the meeting may be submitted to the technical
person listed under FOR FURTHER INFORMATION CONTACT: by June 16, 2005.
Please note that this advance request will assist in planning adequate
seating; however, members of the public can attend without prior
notification to the technical person. Requests for special
accommodations may be submitted to the technical person by June 16,
2005.
Written comments, identified by docket identification (ID) number
OPPT-2004-0122, may be submitted to the docket at any time before the
meeting date.
ADDRESSES: The meeting will be held at the Washington Plaza, 10 Thomas
Circle NW., Washington, DC 20005.
FOR FURTHER INFORMATION CONTACT: For general 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.
For technical information contact: Flora Chow, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8983; e-mail
address:chow.flora@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
particular interest to those persons who manufacture, import, process,
or use nanoscale materials that are chemical substances subject to TSCA
jurisdiction. Potentially affected entities may include, but are not
limited to:
Chemical manufacturers (NAICS 325), e.g., persons
manufacturing, importing, processing, or using chemicals for commercial
purposes.
Petroleum and coal product industries (NAICS 324), e.g.,
persons manufacturing, importing, processing, or using chemicals for
commercial purposes.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may have an
interest in this matter. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
[[Page 24575]]
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPPT-2004-0122. The official public
docket consists of the documents specifically referenced in this
action, any public comments received, and other information related to
this action. Although, a part of the official docket, the public docket
does not include Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. The official
public docket is the collection of materials that is available for
public viewing at the EPA Docket Center, Rm. B-102 Reading Room, EPA
West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The EPA docket center reading room telephone
number is (202) 566-1744 and the telephone number for the OPPT Docket,
which is located in EPA Docket Center, is (202) 566-0280.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register
listings athttps://www.epa.gov/fedrgstr/. An electronic version of the
public docket is available through EPA's electronic public docket and
comment system, EPA Dockets. You may use EPA Dockets athttps://
www.epa.gov/edocket/ to submit or view public comments, access the
index listing of the contents of the official public docket, and to
access those documents in the public docket that are available
electronically. Although, not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.1.
Once in the system, select ``search,'' then key in the appropriate
docket ID number.
II. Background
About two decades ago, research indicated that certain nanoscale
materials exhibit unexpectedly unique and novel properties. The
existence of structures at the nanoscale level may confer a distinct
set of physical, chemical, and biological properties.
EPA is interested in whether commercial activities of nanoscale
materials may present a potential risk to human health and the
environment because of their unique physical structure and consequent
properties. Available information on potential hazards and exposures is
limited (Refs. 1 and 2). Therefore, EPA is considering how best to
evaluate the risks associated with nanoscale materials and how to
manage those risks. TSCA is often viewed as a regulatory gap filler,
which is intended to provide regulatory and information collection
authority lacking in some other environmental statutes (Refs. 3, 4, and
5). TSCA applies to chemical substances and mixtures. The term
``chemical substance'' means any organic or inorganic substance of a
particular molecular identity. The term specifically excludes:
Pesticides; tobacco or tobacco products; certain nuclear materials;
firearms and ammunition; food; food additives; drugs; cosmetics; and
medical devices. Chemical substances when used in these other
categories fall under the jurisdiction of other federal laws.
Among TSCA's regulatory tools are reporting requirements that apply
prior to manufacture or import of any new chemical substance, and the
ability of EPA to regulate a substance prior to commencement of
manufacture if it appears that it may involve unreasonable risk of
injury to health or the environment. A chemical substance is ``new'' if
it is not on the TSCA Chemical Substance Inventory (the TSCA
Inventory), EPA's official list of existing chemical substances.
Therefore, a chemical substance that is a nanoscale material not on the
TSCA Inventory (i.e., a new chemical substance) must be reported to EPA
in a premanufacture notification (PMN) under section 5 of TSCA before
commercial activities are allowed. EPA has authority under section 5 to
review potential health and environmental risks of all aspects of the
commercial activities (Ref. 3). Once a new chemical substance completes
the PMN process and has been listed on the TSCA Inventory, the chemical
substance is considered to be an existing chemical substance. A
chemical substance that is a nanoscale material on the TSCA inventory
(i.e., an existing chemical substance), absent other requirements, is
not subject to EPA review prior to manufacture or use. Existing
chemical substances that present an unreasonable risk of injury to
human health or the environment may be regulated under section 6 of
TSCA (Ref. 3). Because currently available chemical representation and
nomenclature conventions may not be adequate for some nanoscale
materials, ambiguity exists regarding how and when to distinguish
nanoscale materials as new or existing chemical substances. In the
current state of development of structural characterization upon which
nomenclature conventions are based, issues remain.
In addition to regulatory tools, EPA engages in voluntary
partnerships with the chemical industry and other stakeholders to
facilitate risk reduction activities. These activities are generally
less resource intensive and offer more flexible approaches to
management of potential risks. Recent examples of voluntary programs on
existing chemicals are the High Production Volume (HPV) Challenge
Program and the Voluntary Children's Chemical Evaluation Program
(VCCEP). Both programs are designed to provide information on certain
groups of chemicals. Evaluation of this information will enable a
better public understanding of potential hazards and exposures.
EPA is considering a pilot program of voluntary reporting of
information pertaining to nanoscale materials that are existing
chemical substances. Information derived from a pilot program will
allow EPA and the affected industry to better understand the issues
with respect to potential risks and for EPA to gain experience in the
evaluation of such types of chemical substances.
EPA expects that the following parameters will be important in the
context of a potential voluntary pilot program to provide information
on nanoscale materials.
What should be the scope of a voluntary pilot program?
What information should be included in a voluntary pilot
program? What other pertinent information regarding the properties of
the particular nanoscale material would be relevant to EPA review?
How long should a voluntary pilot program last?
How should participants in the voluntary pilot program be
identified?
What should trigger a voluntary submission under the pilot
program?
How likely would it be for companies to volunteer for such
a program? What could be the incentive structure to encourage
participation?
Should participation in a voluntary pilot program have
TSCA Inventory consequences? A voluntary pilot program would not affect
the TSCA Inventory status of a nanoscale material that is an existing
chemical substance. As indicated previously, nanoscale materials that
are not listed on the TSCA Inventory are considered new chemical
substances. These new chemical substances require the submission of a
PMN before they can be manufactured or used for commercial purposes.
[[Page 24576]]
III. Issues for EPA and stakeholders
In general, EPA is requesting comments on the following issues: (1)
The scope and purpose of a voluntary pilot program for nanoscale
materials that are existing chemical substances, (2) kinds of
information that are relevant to the evaluation of potential risks from
exposure to nanoscale materials, (3) chemical characterization and
nomenclature of nanoscale materials for regulatory purposes, and (4)
identification of interested stakeholders. Comments in these specific
areas will be particularly helpful:
Feasibility and value of a voluntary pilot program.
Scope and design of a voluntary pilot program, including
elements such as: purpose (e.g., R & D, use involving environmental
release, any commercial use), administration, outcomes, duration, and
next steps.
Information that would be useful in the evaluation of
potential effects on human health and the environment from exposure to
nanoscale materials.
Size, dimensions, and shapes of chemical substances that
should be considered nanoscale materials.
Types of information (e.g., unique and novel properties)
that would be useful to provide for purposes of: informing the
voluntary pilot program; and helping to name and characterize nanoscale
materials (including features to distinguish them from otherwise
similar chemical substances that do not involve nanoscale structures).
Manufacturing processes for nanoscale materials and how
they relate to identities of the products from the nanoscale
manufacturing processes.
Identification of interested stakeholders.
IV. References
The following references have been placed in the official docket
that was established under docket ID number OPPT-2004-0122 for this
action as indicated in Unit I.B.2.
1. Aitken, R.J., Creely, K.S., Tran, C.L. 2004. Nanoparticles: An
Occupational Hygiene Review. Suffolk, U.K.: Health and Safety
Executive, Research Report 274.
2. VDI Technologiezentrum GmbH. 2004. Industrial Application of
Nanomaterials - Chances and Risks. Technology Analysis. Luther W, ed.
Dusseldorf, Germany: Future Technologies No. 54.
3. USEPA. 2005. Considerations Relevant to Toxic Substances Control
Act (TSCA) Application to Nanoscale Materials. Office of Prevention,
Pesticides and Toxic Substances. Office of Pollution Prevention and
Toxics.
4. Federal Register. June 3, 2003. TSCA Section 8(e): Notification
of Substantial Risk; Policy Clarification and Reporting Guidance. 68 FR
33129.
5. Federal Register. January 12, 2005. TSCA Section 8(e) Reporting
Guidance; Correction, Clarification of Applicability, and Announcement
Regarding the Issuance Questions and Answers. 70 FR 2162.
List of Subjects
Environmental protection, Chemicals, Hazardous substances,
Nanotechnology, Nanoscale materials.
Dated: April 25, 2005.
Susan B. Hazen,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 05-9324 Filed 5-9-05; 8:45 am]
BILLING CODE 6560-50-S
