Federal Register / Vol. 73, No. 18 / Monday, January 28, 2008 / Notices 4861 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2004–0122; FRL–8344–5] 

Nanoscale Materials Stewardship 

Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

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 

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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/nanopublicmeeting

summaryfinaloct2006.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. 

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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 indepth 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 email. 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 

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4866 Federal Register / Vol. 73, No. 18 / Monday, January 28, 2008 / Notices 

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 indepth 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 

FEDERAL COMMUNICATIONS 

COMMISSION 

[WT Docket No. 08–7; DA 08–78] 

Comment Sought on Petition for 

Declaratory Ruling That Text Messages 

and Short Codes Are Title II Services 

or Are Title I Services Subject to 

Section 202 Non-Discrimination Rules 

AGENCY: Federal Communications 

Commission. 

ACTION: Notice. 

SUMMARY: In this document, comment is 

sought on a December 11, 2007 petition 

for declaratory ruling (Petition) filed by 

Public Knowledge, Free Press, 

Consumer Federation of America, 

Consumers Union, EDUCAUSE, Media 

Access Project, New America 

Foundation, and U.S. PIRG (Petitioners). 

The Petitioners ask the Federal 

Communications Commission 

(Commission) to clarify the regulatory 

status of text messaging services, 

including short-code based services sent 

from and received by mobile phones, 

and declare that these services are 

governed by the anti-discrimination 

mstockstill on PROD1PC66 with NOTICES