Nanoscale Materials; Notice of Public Meeting
[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]
[Page 24574-24576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-81]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2004-0122; FRL-7700-7]
Nanoscale Materials; Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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 at http://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 at
http://www.regulations.gov/ 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]
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