[Federal Register Volume 70, Number 89 (Tuesday, May 10, 2005)]
[Notices]
[Pages 24574-24576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9324]


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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:[email protected].
    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:[email protected].

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 athttp://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 athttp://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