Document ID: EPA-HQ-OPPT-2004-0122-0055
Agency: epa
Document Type: Notice
Title: Nanoscale Materials Stewardship Program and Inventory Status of Nanoscale Substances under the Toxic Substances Control Act; Notice of Availability
Posted Date: 2007-07-12T04:00Z

[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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