
[Federal Register: January 28, 2008 (Volume 73, Number 18)]
[Notices]               
[Page 4861-4866]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja08-52]                         


[[Page 4861]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2004-0122; FRL-8344-5]

 
Nanoscale Materials Stewardship Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  This document describes the design and format of EPA's 
Nanoscale Materials Stewardship Program (``the program'') for nanoscale 
materials under the Toxic Substances Control Act (TSCA). On July 12, 
2007, EPA sought public comment on a concept paper that outlined its 
initial thinking on the design and development of the program, and 
several related documents. Based on ideas in the concept paper, written 
public comments, comments at public meetings, and scientific peer 
consultations on material characterization and risk management 
practices, EPA has developed this document to provide the final 
description and format of the program. EPA will consider refinements to 
the program over time based on experience and additional feedback from 
participants.

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 (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, 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 affected by this 
action. Other types of entities not listed in this unit could also be 
affected, such as researchers who develop and/or study nanoscale 
materials. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the descriptions in Unit II. 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. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPPT-2004-0122. All documents 
in the docket are listed in the docket's index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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.
    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.

II. Nanoscale Materials Stewardship Program Introduction

    EPA is implementing its Nanoscale Materials Stewardship Program 
``the program'' to complement and support its new and existing chemical 
efforts on nanoscale materials under the Toxic Substances Control Act 
(TSCA) (15 U.S.C. 2601). The program is to include but is not limited 
to engineered nanoscale materials (also known as nanoscale materials or 
nanoscale substances) manufactured or imported for commercial purposes 
as defined in 40 CFR 720.3(r).
    With this document, EPA is inviting interested parties to 
participate in a ``basic'' program by submitting existing data on the 
engineered nanoscale materials they manufacture, import, process, or 
use. To help participants compile existing data and provide available 
information in a consistent format, EPA has developed an optional form 
for participants to use. The Agency is also inviting interested parties 
to participate in an ``in-depth'' program to test engineered nanoscale 
materials they manufacture, import, process, or use.
    EPA intends to publish a summarized interim report approximately 1 
year after the initiation of the program that will be based on data 
reported during the first 6 months of the basic program. EPA will then 
develop a more detailed report that reflects its evaluation of the 
program approximately 2 years after initiation of the program.

A. Background

    The Nanoscale Materials Stewardship Program is intended to:
     Help the Agency gather existing data and information from 
manufacturers, importers, processors, and users of existing chemical 
nanoscale materials to build EPA's knowledge base in this area.
     Identify and encourage use of risk management practices in 
developing and commercializing nanoscale materials.
     Encourage the development of additional test data needed 
to provide a firmer scientific foundation for future work and 
regulatory/policy decisions.
     Encourage responsible development of nanoscale materials.
    One approach for describing ``responsible development'' has been 
offered by the National Research Council (NRC) in the context of its 
first triennial review of the National

[[Page 4862]]

Nanotechnology Program as required under section 5(a) of the 21st 
Century Nanotechnology Research and Development Act (Public Law 108-
153). In that review, the NRC characterizes ``responsible development'' 
``...as the balancing of efforts to maximize the technology's positive 
contributions and minimize its negative consequences. Thus, responsible 
development involves an examination both of applications and of 
potential implications. It implies a committment to develop and use 
technology to help meet the most pressing human and societal needs, 
while making every reasonable effort to anticipate and mitigate adverse 
implications or unintended consequences.'' (Ref. 1)
    On July 12, 2007, EPA released for public comment a Concept Paper 
for the Nanoscale Materials Stewardship Program under TSCA, (``concept 
paper''), a draft TSCA Inventory Status of Nanoscale Substances--
General Approach, (``TSCA Inventory Paper'') (72 FR 38083) (FRL-8139-
2), and a proposed Information Collection Request (ICR) (72 FR 38079) 
(FRL-8140-2) regarding the stewardship program. Based on the 
information in those documents and public comments, EPA is announcing 
the final format of the stewardship program.
    This document describes the process for reporting on existing 
chemical nanoscale materials under the program, reporting on risk 
management practices for those nanoscale materials, and developing data 
on representative nanoscale materials. This document also describes the 
factors that interested parties could consider in deciding whether to 
participate in the program, what EPA will do with the data, and how it 
will report on and evaluate the program. It also describes the 
potential benefits, incentives, and EPA outreach activities that could 
affect participation in the program.
    EPA reminds participants that participation in the program does not 
relieve or replace any requirements under TSCA that a manufacturer, 
importer, processor, or user of nanoscale materials may otherwise have.
    EPA received numerous public comments supporting the stewardship 
program. Several commenters did not support developing a voluntary 
program because they wanted EPA to focus on issuing TSCA regulations 
regarding nanoscale materials. Other commenters asked EPA to consider 
issuing regulations under TSCA while implementing the program; they 
mentioned using information gathering authorities under section 8 of 
TSCA or its significant new use authority under section 5(a)(2) of 
TSCA. One specific commenter noted that the National Pollution 
Prevention and Toxics Advisory Committee (NPPTAC) overview document 
(Ref. 2) recommended that EPA initiate activities to utilize TSCA 
section 8(a) and 8(d) to complement any voluntary program it considers. 
While implementing the program, EPA will continue to consider, as 
appropriate, the timing and use of all of its authority under TSCA for 
nanoscale materials.
    EPA also received numerous public comments either supporting or not 
supporting the approach outlined in the TSCA Inventory Paper. 
Commenters who did not support EPA's approach stated, among other 
things, that the Agency should consider physical characteristics when 
determining new versus existing chemical nanoscale materials under 
TSCA. However, the information provided by commenters has in large part 
already been considered by EPA, and did not, in the Agency's judgment, 
compel modification of the basic approach described in the TSCA 
Inventory Paper as previously issued for comment. Therefore, this 
approach will remain unchanged. EPA has developed a response to 
comments document for the public comments received regarding the TSCA 
Inventory Paper that is available in the public docket for this 
announcement.
    EPA received several public comments on changes it should make to 
the concept paper, including definitions, materials that should or 
should not be included in the program, types of participants, and 
additional data elements that could be reported under the program. 
Rather than revise the concept paper EPA will continue to use it as a 
description of who EPA envisions participating and what nanoscale 
materials they would report, and has referenced the concept paper in 
the following paragraphs.
    EPA received only a few minor comments on the ICR, which only 
resulted in minor amendments to the ICR that did not affect the overall 
substance of the ICR. For example, EPA amended the worksheet to the 
optional form by listing additional physical and chemical properties 
that could be relevant to nanoscale materials, and revised the form to 
clarify instructions and the presentation of requested information. The 
revised ICR was submitted to OMB for approval and underwent additional 
public comment as part of its submission to OMB under the Paperwork 
Reduction Act (72 FR 63175, November 8, 2007) (FRL-8493-9). The ICR is 
discussed in more detail in Unit III. of this document.

B. Program Participants

    The program encompasses participants who manufacture, process, use, 
or import nanoscale materials for commercial purposes, including those 
who:
     Manufacture or import engineered nanoscale materials.
     Physically or chemically modify or process an engineered 
nanoscale material.
     Physically or chemically modify or process a non-nanoscale 
material to create an engineered nanoscale material.
     Use engineered nanoscale materials in the manufacture of a 
product.
    Others, including researchers who develop or study engineered 
nanoscale materials may also participate. Any participation in the 
program is voluntary. Both new and existing chemical substances (as 
determined by the status of the substance on the TSCA inventory of 
chemical substances) can be included in the program, regardless of 
whether they qualify for exemptions from TSCA new chemical reporting.
    Annex A of the concept paper further describes and provides 
examples regarding who could report and the types of materials that 
could be reported. The description is not meant to be exclusive. EPA 
received public comments on changes it should make to Annex A of the 
concept paper, including definitions or materials that should or should 
not be included in the program. EPA has not attempted to make 
definitive boundaries for reporting nanoscale materials under the 
program. The Agency has given examples and definitions in the concept 
paper to describe those nanoscale materials that may be reported under 
the program. EPA encourages anyone who manufactures, imports, 
processes, or uses nanoscale materials as described in Annex A of the 
concept paper and has pertinent information as described in Annex B of 
the concept paper or the ICR to participate in the program. If you have 
further questions please consult the person listed as the technical 
contact under FOR FURTHER INFORMATION CONTACT.

C. Program Components

    EPA will implement the program in two parts. One part, a basic 
program, invites participants to report all known or reasonably 
ascertainable information regarding specific nanoscale materials, 
including risk management practices. Under the basic program EPA 
encourages participants to forward available data on nanoscale 
materials to

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the Agency within 6 months of today's announcement of the program. Data 
received within the 6-month period will be used in preparing the 
interim report on the program. Participants may continue to submit new 
data that become available on any nanoscale material reported to EPA 
during the initial 6-month period. Participants may also identify 
additional nanoscale materials for which they may choose to submit 
information under the basic program.
    The other part, an in-depth program, entails development of data. 
EPA is inviting participation in the in-depth program through this 
notice. Participants in the in-depth program would develop a plan and 
submit data over a longer period of time to be determined in the plan. 
EPA intends to conduct both the basic and in-depth program for the next 
2 years although it may make adjustments or decide on future steps or 
direction of the program at an earlier point as sufficient experience 
is gained. For example, some testing initiated under the in-depth 
program is likely to extend beyond the 2-year point.
    1. Basic program. The types of data that EPA has identified for 
reporting are detailed in Annex B of the concept paper and the ICR. 
These data include information on material characterization, hazard, 
use, potential exposures, and risk management practices. On September 
6-7, 2007, (Ref. 3), EPA conducted a public scientific peer 
consultation on material characterization to receive views and comments 
on the type of material characterization information to be reported for 
nanoscale materials under the stewardship program. Comments from the 
scientific peer consultation and other public comments generally agreed 
with the types of data detailed in Annex B of the concept paper and the 
ICR. Several commenters also noted that not all data would be 
applicable to all nanoscale materials. EPA agrees and expects that 
participants will submit only data that are pertinent to their 
particular nanoscale materials.
    Participants may provide data in any format or on any form that 
they choose; however, EPA has also developed an optional data 
submission form for participants. The optional form was developed based 
on the Agency's Premanufacture Notice (PMN) Form (EPA Form No. 7710-25) 
that is used for reporting to EPA regarding new chemical substances 
under TSCA. The optional form is designed for manufacturers and 
importers of chemical substances and EPA does not expect that 
researchers or other interested parties will fill out the entire form. 
The optional form identifies additional physical and chemical 
properties that may pertain to characterizing and evaluating nanoscale 
materials. Participants are encouraged but not required to use this 
form to submit information to EPA. Based on EPA's experience with the 
PMN form, it will be easier for EPA to evaluate the information if the 
optional reporting form is used.
    Several commenters stated that filling out the entire form could be 
a burden, especially to small and medium-sized businesses not familiar 
with TSCA. While participants are encouraged to submit as much data and 
explanation as possible, they are not required to fill out the entire 
form to participate in the program. Nonetheless, the more complete the 
information provided to EPA, the greater benefit to both EPA and 
program participants (who may receive feedback from the Agency). More 
information is available about the data to be reported in the ICR for 
the program.
    EPA invites participants to provide the information described in 
Annex B of the concept paper, the ICR, and the reporting form to the 
extent it is known or reasonably ascertainable to them. EPA is not 
requesting that participants in the basic program develop additional 
data. If the information identified is not available or applicable to 
the nanoscale material, participants would not submit those data. EPA 
encourages participants in the basic program to provide additional data 
if and when they become available. It would also be informative for 
participants to describe why information is not available or 
applicable. EPA requests that each nanoscale material be reported 
separately. If using the form, one form would be submitted for each 
nanoscale material. Participants who wish to identify nanoscale 
materials collectively, e.g. submit one form for a group of similar 
nanoscale materials, are requested to describe the parameters that form 
the basis for grouping.
    EPA received numerous public comments regarding the need to 
establish target dates for submission of data under the program, noting 
that some participants in voluntary initiatives often wait until the 
latter stages of the program before submitting data or otherwise 
participating. Commenters suggested targets ranging from 3 to 9 months 
for submitting data under the basic program while allowing for a more 
flexible approach under the in-depth program. In response to these 
public comments, EPA is establishing a target of 6 months from today 
for participants to report under the basic program. In conducting its 
interim evaluation as described in Unit II.F., EPA intends to consider 
only data reported within the first 6 months of the program. In 
addition, the more data EPA receives during this 6-month period the 
easier it will be to fully integrate those data into the more 
comprehensive 2-year report. Data submitted during the first 6 months 
of the program will be a factor when the Agency considers whether to 
use regulatory information gathering authority under TSCA.
    As noted earlier, participation in the stewardship program does not 
relieve or replace any requirements under TSCA that a manufacturer, 
importer, processor, or user of nanoscale materials may otherwise have. 
Manufacturers or importers who want further guidance on determining the 
Inventory status of specific nanoscale materials or submitting PMNs 
should consult the person listed as the technical contact under FOR 
FURTHER INFORMATION CONTACT. Where, for example, there is a requirement 
to submit a PMN, participation in the program would not satisfy this 
requirement; a separate PMN would need to be filed. If a manufacturer 
of a nanoscale material that is a new chemical substance under TSCA 
submits a premanufacture notification to EPA, they are encouraged to 
also participate in the stewardship program by submitting that 
information to EPA. Alternatively, the PMN submitter may simply notify 
EPA of the PMN submission of a nanoscale material it wants to include 
in the stewardship program.
    2. In-depth program. The data and experience generated by the basic 
program, including input from the interim program evaluation will help 
to inform the types of in-depth data that need to be developed. In-
depth data development will likely apply to a smaller set of 
representative nanoscale materials designated for further evaluation by 
participants who agree to sponsor the development of data for a 
particular nanoscale material. EPA and the sponsor(s) would sort 
through the data development approach and elements. For example, EPA 
and the sponsor(s) can review existing data, conduct preliminary 
assessments, and identify additional data needed to better characterize 
hazard, risk, and exposure issues for the material. Once testing has 
been identified, and considering input from stakeholders, EPA and the 
sponsor(s) will jointly develop a plan of action that could include:
     Characterizing the physical/chemical properties of the 
material.

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     Testing for health and environmental hazards.
     Determining fate and transport characteristics.
     Monitoring or estimating exposures and releases.
     Evaluating the effectiveness of engineering controls and 
protective equipment.
     Developing a model worker education program.
     Other evaluations and/or actions as appropriate.
    In some cases, a particular sponsor may choose to implement one or 
more aspects of the plan, or a consortium of sponsors and other 
stakeholders may work together to implement aspects of the plan. The 
last three bullets are specific examples of areas where input from the 
Occupational Safety and Health Administration and the National 
Institute of Occupational Safety and Health would be valuable. At the 
completion of the plan, EPA and sponsors, considering input from 
stakeholders, will again review the information gathered; conduct final 
assessments; and consider any further action.
    Entities who want to participate in the in-depth program would 
notify EPA as described further in Unit II.H. As soon as potential 
sponsors are identified, EPA will coordinate the process for in-depth 
data development. EPA will begin to coordinate meetings for the in-
depth program 90 days after announcement of the program. To avoid 
duplication of testing, the in-depth program will be coordinated with 
EPA's research program, other federal testing and research programs, 
and internationally through the Organization for Economic Cooperation 
and Development's Working Party on Manufactured Nanomaterials. EPA will 
also coordinate with the Canadian government to encourage participation 
of Canadian companies in the in-depth program or participation of 
American companies in Canadian data development activities which will 
allow joint development and sharing of data by both countries.

D. CBI

    Recognizing that this is a program that involves voluntary 
submissions of information and that the application of TSCA to all the 
data submitted in connection to the program cannot be determined in 
advance, EPA is advising participants in the stewardship program that 
submission of information under the program will constitute consent for 
the Agency to treat this information as if it had been submitted under 
TSCA. Claims of confidentiality will therefore be handled in accordance 
with 15 U.S.C. section 2613 and 40 CFR parts 2 and 720. EPA has a long 
history of successfully handling and protecting TSCA CBI information.
    EPA encourages participants to give careful consideration to what 
information they will and will not claim as CBI. EPA encourages 
participants to make as much data as possible available to the public. 
The more information that is available to the public, the more 
transparent EPA will be able to be in demonstrating benefits and 
knowledge learned from the stewardship program. Under some 
circumstances, EPA will also, where possible, share aggregated data 
with the public. One important aspect of EPA's strong commitment to 
transparency is involving stakeholders and the public in its programs 
and processes.
    With permission of the submitting company, EPA would also share CBI 
with other governments who agree to protect the information from 
disclosure in an appropriate manner. EPA has included a box to check on 
the reporting form if participants are willing to allow such sharing. 
EPA would contact a participant before releasing any data and provide 
the reasons for doing so. One possible purpose for sharing data would 
be to improve consistency of approaches among trading partners while 
protecting CBI and maintaining a consistently high level of health and 
environmental protection. If the data are confidential business 
information, it may also be used by other Federal agencies that have 
TSCA CBI clearance, in accordance with CBI procedures. Non-confidential 
portions of this information may be used by the public, academics, 
states, local and tribal governments, as well as foreign governments 
and international organizations.

E. Risk Management Practices

    The objectives of typical risk management programs are to consider 
alternatives to minimize or eliminate exposures and releases of 
hazardous materials. In its (``Approaches to Safe Nanotechnology - An 
Information Exchange with NIOSH''), NIOSH stated in the executive 
summary: ``Given the limited amount of information for determining if 
engineered nanoparticles pose an occupational health risk, it is 
prudent to take precautionary measures to minimize worker exposures'' 
(Ref. 4). Recognizing the uncertainties surrounding the evolving 
science and technology of nanoscale materials, EPA also encourages use 
of exposure mitigation practices for nanoscale materials.
    EPA invites each participant in the basic program to submit 
available data on risk management practices for nanoscale materials it 
manufactures, imports, processes, or uses. A participant who has 
already developed a risk management plan is invited to include the plan 
as part of its submission under the basic program. EPA encourages 
participants who do not have a risk management plan to consider 
developing one. Participants will find information describing risk 
managment practices on page 13, section II.C. of the optional reporting 
form. Participants could also consider information that is relevant to 
risk management practices for nanoscale materials in the report of the 
public scientific peer consultation on risk management practices EPA 
conducted in October 2006. EPA included input from this scientific peer 
consultation when developing risk management considerations (See the 
Final Meeting Summary Report, http://www.epa.gov/opptintr/nano/
nanopublicmeetingsummaryfinaloct2006.pdf). EPA is not prescribing 
specific risk management practices that would be used for all nanoscale 
materials.
    EPA encourages anyone with additional information on risk 
management practices for nanoscale materials to submit the information 
to EPA. New information that EPA receives in the program or is 
available from other sources may result in EPA amending the information 
it considers relevant to risk management practices for nanoscale 
materials.

F. EPA Use of the Data

    EPA will use the data from the stewardship program to gain a better 
understanding of the nature of nanoscale materials that are produced; 
the quantities in which they are produced; how they are or will be 
used; any hazards, exposures, or releases associated with those 
materials; and how these hazards are being addressed. 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. EPA may use the data for a variety of purposes 
including building new assessment methods and models or incorporating 
the data into existing models with regard to hazard, exposure, and 
fate. The data will help increase EPA's capacity to assess benefits 
from nanoscale materials. As EPA reviews specific data that are 
submitted it may find other uses for the data.

[[Page 4865]]

    EPA will also evaluate the information submitted under the program 
to make the following determinations:
     Identify the data that may be useful to evaluate a 
specific nanoscale material. EPA may contact participants on a case-by-
case basis to clarify if further data are available or why certain data 
were unavailable or not submitted.
     Identify any additional risk management practices for 
participants to consider.
     Identify nanoscale materials or categories of nanoscale 
materials that warrant future concerns or actions based on existing 
information, or should be treated as a lower priority for further 
consideration.
    If the hazard, exposure, and fate data submitted by a participant 
indicate that potential risks may exist for a specific nanoscale 
material, EPA may work with the participant to determine possible 
actions to avoid, reduce, or mitigate potential risks.
    If the data submitted by a participant indicate that the 
participant is manufacturing a nanoscale material that is reportable 
under section 5 of TSCA (15 U.S.C. 2613) as a new chemical substance, 
EPA will inform the participant of that situation, the applicable TSCA 
requirements, and the TSCA section 5 enforcement policy (http://
www.epa.gov/compliance/resources/policies/civil/tsca/tscasec5erpamend-
060889.pdf). EPA encourages manufacturers, importers, and processors of 
nanoscale materials to consult with EPA regarding questions of the TSCA 
Inventory status of such materials before beginning commercial 
activity. EPA will work with program participants who also have 
reporting requirements under section 5 of TSCA to minimize or eliminate 
duplicative reporting of the same information.
    EPA intends to publish an interim report approximately 1 year after 
announcement of the program. The purpose of the report would be to 
describe participation in the basic component of the program during its 
first 6 months. The report would summarize, to the extent possible, 
considering CBI claims, who reported, the types of data available, the 
reasons some data were reported as not being available, additional data 
that would be useful to improve risk assessment and any activities for 
which data are being used. The report is expected to address only the 
data received within 6 months of this announcement of the program. As 
suggested by several commenters, EPA will also issue quarterly updates 
on the OPPT nanotechnology website (http://epa.gov/oppt/nano/index.htm) 
regarding the number of submissions received and any activity under the 
in-depth program.
    EPA also intends to develop a more detailed report and evaluation 
of the program approximately 2 years after announcement of the program. 
This report will describe how the stewardship program addressed the 
objectives identified in Unit II.A. EPA welcomes suggestions for 
criteria to evaluate the program. At the time of the 2-year report, EPA 
intends to determine the future direction of the basic reporting phase 
as well as in-depth data development, although it may make adjustments 
or decide on future steps at an earlier point as sufficient experience 
is gained. This would also include consideration of information 
gathering authorities under TSCA.

G. Benefits of Participation

    EPA believes that participation in the stewardship program will 
encourage responsible development of nanoscale materials and will 
benefit all stakeholders. Development and sharing of data on nanoscale 
materials to the fullest extent possible will enhance each 
stakeholder's ability to make informed decisions regarding nanoscale 
materials. Applying a stewardship approach will help participants to 
identify and develop appropriate environmental health and safety plans 
in their workplaces as well as throughout an industrial supply chain. 
EPA is committed to an open and transparent process in the development 
and implementation of the stewardship program.
    EPA sought comments and ideas on incentives for participation in 
the stewardship program and how it could identify and reach out to the 
many small and medium sized nanotechnology businesses. Many of these 
entities have limited experience with TSCA and may have limited 
resources for participation in a voluntary stewardship program. EPA 
will use information from its own small business office to meet with 
small and medium sized nanotechnology companies to assist these 
companies with understanding TSCA and participating in the stewardship 
program.
    EPA received two comments that participants in the stewardship 
program who become aware they should have submitted a PMN for a 
nanoscale material submitted to the program, be allowed to submit a PMN 
without penalty. Several commenters also suggested that program 
participants should be exempt from future EPA reporting requirements 
EPA may issue for nanoscale materials. EPA will not exempt anyone from 
TSCA requirements for participating in the program.
    EPA will also acknowledge participants in the program on EPA's OPPT 
webpage, provided the participants have not claimed their identity as 
CBI or otherwise object to such acknowledgement.

H. How to Participate

    EPA encourages anyone with further questions to consult the person 
listed as the technical contact under FOR FURTHER INFORMATION CONTACT. 
Send submissions for the basic program, requests to participate in the 
in-depth program, or any other input regarding the program to these 
addresses:
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: Nanoscale 
Materials Stewardship Program.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 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: Clearly mark any documents as pertaining to the 
Nanoscale Materials Stewardship Program. If you are claiming 
information as CBI or other information whose disclosure is restricted 
by statute you must clearly label the information that is CBI. If you 
are using the reporting form follow the instructions on the reporting 
form. If information is claimed as confidential, a sanitized version 
(including attachments) should be provided. Do not submit information 
that you consider to be CBI or otherwise protected through 
regulations.gov or e-mail. If you submit an electronic submission, EPA 
recommends that you include your name and other contact information in 
the body of the submission and with any disk or CD-ROM you submit. If 
EPA cannot read your submission due to technical difficulties and 
cannot contact you for clarification, EPA may not be able to consider 
your submission. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. Given security measures for mail, EPA does not recommend mail 
for a disk or CD-ROM because the equipment used to

[[Page 4866]]

scan the mail may destroy the disk or CD-ROM.

III. Paperwork Reduction Act Notice

    The Office of Management and Budget (OMB) has approved the 
information collection activities associated with the Nanoscale 
Materials Stewardship Program (NMSP) under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq. and has assigned OMB control number 2070-
0170. EPA has prepared an Information Collection Request (ICR) that 
describes the information collection activities and EPA's estimated 
burden, which is summarized in this unit. The ICR is identified by EPA 
ICR No. 2250.01. A copy of the ICR and public comments (described in 
Unit II.A. of this document) are available under Docket ID No. EPA-HQ-
OPPT-2007-0572.
    As described in more detail in the ICR, the annual burden for this 
collection of information is estimated to average 154.3 hours per 
response for the basic NMSP, and 2,500 hours for the in-depth NMSP, 
based on 240 responses for the basic NMSP and 15 responses for the in-
depth NMSP. According to the PRA, ``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. 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 number 
for this collection activity appears in this document, in the Federal 
Register document announcing the approval of the ICR, and on the 
optional collection instrument or form.

IV. Statutory and Executive Order Reviews

    This document describes the design and format of EPA's Nanoscale 
Materials Stewardship Program, which is a voluntary program to collect 
data for nanoscale materials under TSCA. This action is not a 
regulatory action or a significant guidance document under Executive 
Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
October 4, 1993), as amended by Executive Order 13422 on January 18, 
2007 (72 FR 2763). As such, this action does not require review by OMB 
under Executive Order 12866.
    In addition, Executive Orders 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997) and 13211, entitled Actions Concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001), do not apply to this action because it is not 
``economically significant'' as defined by section 3(f) of Executive 
Order 12866. Nor does this action establish an environmental standard 
that may have a negatively disproportionate effect on children, or 
otherwise have any significant adverse effect on the supply, 
distribution, or use of energy.
    This action is not subject to the notice-and-comment requirements 
under the Administrative Procedure Act or any other statute. As such, 
it is not subject to the provisions of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.). Further, today's action is expected to 
only have a limited impact because only entities that volunteer to 
participate in the NMSP will be impacted.
    Based on EPA's experience with review of PMNs; State, local, and 
Tribal governments have not been impacted by these activities, and EPA 
does not have any reason to believe that any State, local, or Tribal 
government would be impacted by this action. As such, the Agency 
concludes that this action will not have substantial direct effects on 
the States or on the relationship between the national government and 
the States or on the distribution of power and responsibilities among 
the various levels of government, as specified in Executive Order 
13132, entitled Federalism (64 FR 43255, August 10, 1999). Nor does 
this action significantly or uniquely affect the communities of tribal 
governments as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 10, 1998). In addition, EPA has determined that this action 
would not impose any enforceable duty, contain any unfunded mandate, or 
otherwise have any affect on small governments subject to the 
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that require 
the Agency's consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).
    This action will not have an adverse impact on the environmental 
and health conditions in low-income and minority communities. 
Therefore, under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), the Agency is not required 
to and has not considered environmental justice-related issues.

V. References

    1. A Matter of Size: Triennial Review of the National 
Nanotechnology Initiative, The National Academies Press. p. 73 (2006).
    2. NPPTAC 2005. Overview of Issues for Consideration by NPPTAC. 
Document ID EPA-HQ-OPPT-2002-0001-0068. http://www.regulations.gov/
fdmspublic/component/main.
    3. Material Characterization of Nanoscale Materials; Notice of 
Public Meeting, August 13, 2007 (72 FR 45244) (FRL-8144-1).
    4. NIOSH 2007. National Institute for Occupational Safety and 
Health, December 2007, Approaches to Safe Nanotechnology--An 
Information Exchange with NIOSH. http://www.cdc.gov/niosh/topics/
nanotech/safenano/summary.html.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, 
Nanoscale materials.

    Dated: January 22, 2008.
James B. Gulliford,
Assistant Administrator, for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. E8-1411 Filed 1-25-08; 8:45 am]

BILLING CODE 6560-50-S
