Nanoscale Materials Stewardship Program and Inventory Status of
Nanoscale Substances under the Toxic Substances Control Act; Notice of
Availability
[Federal Register: July 12, 2007 (Volume 72, Number 133)]
[Notices]
[Page 38083-38085]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy07-60]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2004-0122; FRL-8139-2]
Nanoscale Materials Stewardship Program and Inventory Status of
Nanoscale Substances under the Toxic Substances Control Act; Notice of
Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: On October 18, 2006, EPA invited stakeholders to participate
in the design, development, and implementation of a Nanoscale Materials
Stewardship Program (NMSP) under the Toxic Substances Control Act
(TSCA). NMSP is a voluntary program intended to complement and support
EPA's new and existing chemical programs under TSCA and will help
provide a firmer scientific foundation for regulatory decisions by
encouraging the development of key scientific information and
appropriate risk management practices for nanoscale chemical substances
(``nanoscale materials''). As part of this process, EPA is announcing
the availability of two draft documents for public review and comment:
``TSCA Inventory Status of Nanoscale Substances--General Approach'' and
``Concept Paper for the Nanoscale Materials Stewardship Program under
TSCA.'' The first document describes EPA's current thinking regarding
whether a nanoscale material is a ``new'' or ``existing'' chemical
substance under TSCA. The second document describes the Agency's
general approach, issues, and considerations for NMSP and is intended
to serve as a starting point for continuing work with stakeholders on
the detailed design of NMSP.
DATES: Comments must be received on or before September 10, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2004-0122, 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-2004-0122. 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-
2004-0122. 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. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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: 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: James Alwood, Chemical Control
Division, Office of Pollution Prevention and Toxics (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-8974; e-mail address: alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use nanoscale materials that are chemical
substances subject to the jurisdiction of TSCA. Potentially affected
entities may include, but are not limited to:
• Chemical manufacturers (NAICS code 325), e.g., persons
manufacturing, importing, processing, or using chemicals for commercial
purposes.
• Petroleum and coal product industries (NAICS code 324),
e.g., persons manufacturing, importing,
[[Page 38084]]
processing, or using chemicals for commercial purposes.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be interested in this
action. Other types of entities not listed inthis unit could also be
interested. 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.
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-ROM 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.
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.
C. Where Can I Access More Information About Nanotechnology?
For more information about nanotechnology under TSCA, go to http://www.epa.gov/oppt/nano
.
II. Background
A. What is the Applicable Legal Authority?
NMSP is a voluntary program intended to complement and support
EPA's new and existing chemical programs under TSCA. TSCA provides EPA
authority to assure that new and existing chemical substances are
manufactured, processed, used, and disposed of in a manner that
protects against unreasonable risks to human health and the
environment. TSCA applies to ``chemical substances.'' Nanoscale
materials which meet the TSCA definition of ``chemical substances'' are
subject to TSCA.
B. What Action is the Agency Taking?
EPA is announcing the availability of two documents for public
review and comment. One document, entitled ``TSCA Inventory Status of
Nanoscale Substances--General Approach,'' (``TSCA Inventory paper'')
describes EPA's general approach to determining whether a nanoscale
material is a ``new'' or ``existing'' chemical substance under TSCA.
The other document, entitled ``Concept Paper for the Nanoscale
Materials Stewardship Program under the TSCA,'' is a concept paper
describing a general approach, issues, and considerations for NMSP.
In a separate notice in this Federal Register, EPA is also issuing
the draft Information Collection Request (ICR) covering the information
collection related activities related to NMSP and the estimated
paperwork burdens associated with those activities. Under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., 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 control number issued
by the Office of Management and Budget (OMB). PRA also applies to
voluntarily submitted information. Before submitting an ICR to OMB for
review and approval, the agency must first solicit comment on the draft
ICR. The draft ICR covering the potential information collection
activities related to NMSP is also being made available for public
review and comment.
C. Why is EPA taking this Action?
There is a growing class of materials commonly referred to as
engineered nanoscale materials. Materials having structures with
dimensions in the nanoscale (approximately 1-100 nanometers (nm)), also
known as nanoscale materials or nanoscale substances, may have
organizations and properties different than the same chemical
substances with structures at a larger scale.
Nanoscale materials that meet the TSCA section 3(2)(A) definition
of ``chemical substance'' are subject to TSCA. TSCA provides EPA with a
strong framework for ensuring that new and existing chemical substances
are manufactured and used in a manner that protects human health and
the environment. TSCA distinguishes between ``new'' and ``existing''
chemical substances. Existing chemicals are those substances contained
on the TSCA Inventory. New chemicals are those substances not contained
on the TSCA Inventory. Under section 5 of TSCA, EPA requires
manufacturers of nanoscale materials that are new chemicals, to notify
the Agency 90 days prior to manufacture. The draft paper, ``TSCA
Inventory Status of Nanoscale,'' is intended to explain the Agency's
current thinking on this question of ``new'' versus ``existing'' within
the context of nanoscale materials.
On October 18, 2006, EPA launched a collaborative process and
invited stakeholders to participate in the design, development, and
implementation of a NMSP under TSCA. EPA is developing NMSP to
complement and support its new and existing chemical efforts on
nanoscale materials. As outlined in the ``Concept Paper for the NMSP
under TSCA,'' the program is envisioned primarily for manufacturers of
nanoscale materials that would be considered existing chemical
substances under TSCA (though persons at a variety of stages of product
development are also encouraged to participate). Manufacturers of
existing chemical substances are not required to submit pre-manufacture
notices to EPA under section 5 of TSCA. NMSP will also help provide a
firmer scientific foundation for regulatory decisions by encouraging
the development of key scientific information and appropriate risk
management practices for nanoscale chemical substances (``nanoscale
materials'').
EPA developed the concept paper to outline its initial thinking
about NMSP. The Agency will be working collaboratively with other
Federal agencies and stakeholders to further develop and implement
NMSP. Although dependent on the outcome of this development process,
the Agency envisions that the components of the program could include:
[[Page 38085]]
• Assembling existing data and information from
manufacturers and processors of existing chemical nanoscale materials.
• Encouraging the development of test data needed to provide
a firmer scientific foundation for future work and regulatory/policy
decisions.
• Identifying and encouraging use of a basic set of risk
management practices in developing and commercializing nanoscale
materials.
The concept paper outlines proposed ideas for reporting on
nanoscale materials in commerce, developing data on representative
nanoscale materials, and identifying risk management practices. It
describes who may wish to participate, the reporting expectations for
participants, what the program could entail and what EPA intends to do
with the data generated from the program. It also describes the
potential benefits of participation.
EPA will use the data from NMSP to gain an understanding of which
nanoscale materials are produced, in what quantities, how they are
used, and the data that is available for such materials. EPA scientists
will use data collected through this program, where appropriate, to aid
in determining how and whether certain nanoscale materials or
categories of nanoscale materials may present risks to human health and
the environment.
This release of the two draft documents for public review and
comment are an important part of the collaborative development process
for NMSP. These draft documents are intended to further discussion
about NMSP and will serve as the foundation for establishing the
details of NMSP.
The Agency also intends to conduct a public meeting to obtain
further public comment on these documents and any other issues
pertaining to a NMSP and will announce that meeting date in a separate
Federal Register notice. EPA will consider all comments and announce
the availability in the Federal Register of the final versions of the
ICR, TSCA Inventory paper and a document that describes NMSP. Once the
details of NMSP have been announced, EPA will implement NMSP.
III. Request for Comments
While EPA is seeking comment on all aspects of NMSP and the TSCA
Inventory paper, the Agency is especially interested in comments on the
following items:
1. Whether the data elements that have been identified in NMSP are
appropriate for nanoscale materials.
2. Timing and phasing of submissions under the NMSP basic and in-
depth programs and whether approaches for tiering data submissions are
appropriate.
3. Who would participate in NMSP and how to encourage
participation, especially from small and medium sized enterprises.
4. What criteria to use for NMSP program evaluation and views on
the timing and nature of any reports the Agency may issue.
5. How to engage industry and other stakeholders in the NMSP in-
depth program and approaches for generating test data.
6. The processes and roles for EPA, participants, and other
stakeholders during development and evaluation of data for the in-depth
program.
7. Possible approaches for identification and use of alternative
sources of data, in order to minimize the burden of information
collection associated with NMSP.
8. Uses for the data submitted to EPA under the NMSP program.
9. Issues relevant to scope, definitions, and descriptions.
10. The suitability of the approach for determining the TSCA
Inventory status of nanoscale materials discussed in the TSCA Inventory
paper referenced in Unit II.C.
11. Whether, in combination, the TSCA Inventory paper and the NMSP
concept paper are sufficiently clear in how EPA plans at this time to
address nanoscale materials that are new or existing chemicals under
TSCA and the NMSP and, if needed, an indication of areas where further
clarification may be warranted.
IV. Summary of Next Steps
As indicated previously, EPA intends to use a collaborative process
that involves stakeholders in the design, development, and
implementation of NMSP. In addition to providing comments on the draft
documents released by this document, EPA invites you to participate in
the process. If you would like EPA to notify you as the stewardship
program moves forward, please sign-up at http://www.epa.gov/oppt/nano/nano-contact.htm.
EPA will announce the date and logistics of a public meeting on
NMSP in a separate Federal Register notice and the TSCA nanotechnology
website http://www.epa.gov/oppt/nano.
Following consideration of all comments received on this notice,
EPA will announce availability in the Federal Register of the final
versions of the ICR, TSCA Inventory paper, and a document that
describes NMSP. Once the details of the NMSP have been developed and
announced, EPA will implement NMSP.
List of Subjects
Environmental protection, Chemicals, Hazardous substances,
Nanoscale materials.
Dated: July 9, 2007.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. E7-13558 Filed 7-11-07; 8:45 am]
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