Document ID: EPA-HQ-OPPT-2007-0572-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-07-12T04:00Z

SUPPORTING STATEMENT FOR AN

INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a) Title of the Information Collection

	Title: Information Collection in Support of EPA’s Stewardship Program
for Nanoscale Materials 

	EPA ICR No.:  2250.01

	OMB Control No.:  2070-new	

	1(b) Short Characterization

	EPA intends to initiate a voluntary information collection to assemble
existing data and information from manufacturers, importers, and
processors of nanoscale materials. EPA also intends to collaborate with
manufacturers, importers, and processors of nanoscale materials, in an
effort to generate more detailed information of certain specific
nanoscale materials.  Under this second effort OPPT and industry will
work together to generate data and analyses that will more fully
characterize certain nanoscale materials, and to increase understanding
of the environmental health and safety implications of manufactured
nanoscale materials.

	These data will inform the process by which EPA establishes appropriate
chemical management efforts to protect human health and the environment
from unreasonable risk from nanoscale materials.  This collection will
facilitate and support EPA’s Stewardship Program for Nanoscale
Materials which is a comprehensive stewardship program with industry and
the interested public committed to the safe manufacture, processing,
distribution, use, storage and disposal of nanoscale materials. 

2.  NEED FOR AND USE OF THE COLLECTION 

	2(a) Need/Authority for the Collection 

	Nanoscale materials or nanomaterials are chemical substances organized
in structures in the scale of approximately 1 to 100 nanometers, and may
have different organizations and properties than the same chemical
substances in a larger size.  Nanoscale materials can be found in
electronics, sunscreens, cosmetics, automotive and medical products as
well as paints and coatings, metal-cutting tools, sports equipment,
stain-free clothing and mattresses, and ink. (NNI 2006)  Only in the
last several years have these substances been introduced into commerce
in any significant degree. There are estimated to be hundreds of
nanotechnology products already on the market.  The National Science
Foundation predicts that the market for nanotech products and services
will reach $1 trillion by 2015.  It is expected to transform virtually
every aspect of the economy and life. 

	Some nanoscale materials are recognized as new chemical substances
subject to notification requirements under section 5 of TSCA because
they are not contained on the TSCA Inventory.  Therefore, they are
subject to review for potential human health and environmental risks
before they are manufactured and enter commerce.  Other nanoscale
materials have the same molecular identity as chemical substances which
are already on the TSCA Inventory and as such are not subject to new
chemical notification.  The application of TSCA §5 new chemical
authorities to nanoscale materials is currently under consideration
within EPA.  The Agency has authority under TSCA §8(a) to collect
information regarding chemicals already in commerce.    While the
stewardship program is focused on those nanoscale materials already in
commerce it could also include nanoscale materials that would be
reportable to EPA under section 5 of TSCA.  Participation in the
voluntary stewardship program will not relieve manufacturers, importers,
and processors of their obligations under TSCA or other applicable
statutes.

	It is recognized that some of these substances, because of their small
size, exhibit novel and enhanced properties not present in substances of
larger dimensions.  It is also widely recognized that there is limited
data available on these types of substances.  As of this date, there has
been no other effort to systematically collect such comprehensive
information .

	To assist in assessing health and environmental effects of these
nanoscale materials in commerce, EPA is creating the Stewardship Program
for Nanoscale Materials.  EPA’s Stewardship Program for Nanoscale
Materials is intended to: 

Encourage responsible development of nanoscale materials; 

Help the Agency assemble existing data and information from
manufacturers and processors of existing chemical nanoscale materials; 

Identify and encourage use of a basic set of risk management practices
in developing and commercializing nanoscale materials; and 

Encourage the development of test data needed to provide a firmer
scientific foundation for future work and regulatory/policy decisions. 

This voluntary information collection will provide EPA baseline
information on nanoscale materials in commerce.

	2(b) Use/Users of the Data

	The information collected through the stewardship program will provide
important baseline information on health and environmental effects,
exposures, risks, management practices, and data needs that will assist
EPA and others in properly assessing and managing risks related to
nanoscale materials.

	Non-confidential portions of this information will also be made
available to help the public understand how nanoscale materials are
being used.  Data collected through this stewardship program will be
used by EPA scientists to assist in determining how and whether certain
nanoscale materials may present risks to human health and the
environment.    If the hazard, exposure, and risk data submitted by
participants indicate that potential unreasonable risks may exist, the
data will be used by EPA and the manufacturer to determine the
appropriate action necessary to avoid or mitigate the risks. 
Furthermore, such information could be used for risk management, hazard
communication and right-to-know purposes, and product labels. EPA may
also use the information to identify nanoscale materials that may not
warrant future concerns or actions, or should otherwise be treated as a
lower priority for further consideration. 

	The data may also be used by other Federal agencies.  Non-confidential
portions of this information may be used by the public, academics,
states, local and tribal government, as well as foreign governments and
international organizations. 

3. NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 

	3(a) Non-Duplication 

	There has been no other effort to systematically collect such
comprehensive information. 

	3(b) Public Notice Required Prior to ICR Submission to OMB 

	Prior to submission to OMB, this ICR will be made available to the
public for comment through a Federal Register notice.  The public will
have 60 days to provide comments.  The comments received will be given
consideration when completing the supporting statement that is submitted
to OMB.

	3(c) Consultations

	OPPT held a public meeting on June 23, 2005 to discuss a potential
voluntary pilot

program for certain nanoscale materials and the information needed to
adequately inform the conduct of the pilot program.  On November 23,
2005, the National Pollution Prevention and Toxics Advisory Committee
(NPPTAC) provided to EPA for consideration an Overview Document on
Nanoscale Materials (NPPTAC 2005).    SEQ CHAPTER \h \r 1 While the June
23, 2005, public meeting and the NPPTAC Overview Document elicited broad
stakeholder support for the idea of a stewardship program, these public
processes have also identified specific issues relevant to the program
that EPA is still considering.

<	As a result EPA intends to hold public peer consultations on materials
characterization and risk management practices as described in the
NPPTAC Overview Document.  EPA will also hold a general public meeting
during the ICR process to obtain further public input on any aspect of
this information collection request and the stewardship program.

>

	3(d) Effects of Less Frequent Collection

	

	The frequency of the submission of information under this voluntary
information collection request is not under the Agency's control. 
Manufacturers, importers, and processors of nanoscale materials will
determine whether to submit information under this program.  Less
frequent collection would mean respondents would not submit data at all.
 However, submission of this data will allow EPA to better carry out its
mandate to protect the public from unreasonable risks to health and the
environment.

	3(e) Compliance with General OMB Guidelines

	  SEQ CHAPTER \h \r 1 This collection of information is consistent with
all OMB guidelines under 5 CFR 1320.6.  

	3(f) Confidentiality 

	EPA expects that some of the information submitted to EPA in response
to the information request will be claimed confidential. If respondents
wish to claim information submitted as confidential business information
(CBI), they may do so. Respondents may claim all or part of a document
confidential if there is a legitimate need to do so as described in 40
CFR part 2.  EPA is advising potential participants in the stewardship
program that submission of information under the program will constitute
consent for the Agency to disclose this information as if it had been
submitted under TSCA.  Claims of confidentiality will therefore be
handled pursuant to 15 U.S.C. section 2613 and 40 CFR parts 2 and 720. 
EPA will follow the procedures for handling CBI as set forth in the TSCA
CBI Protection Manual (October 2003 edition), which calls for careful
protection of CBI. EPA will disclose information that is covered by a
claim of confidentiality only to the extent permitted by, and in
accordance with, the procedures in 40 CFR part 2. 

 

	3(g) Sensitive Questions 

	The information requested under the stewardship program does not
include questions of a sensitive nature.

	3(h) Electronic Reporting. 

	Submitters are asked to provide information electronically by putting
their information on a CD, which they would then mail or otherwise
deliver to EPA.  Because of time constraints, security issues related to
the electronic transfer of CBI and potential expenses for both the EPA
and the possible reporters, it is not feasible to devise a direct
electronic submission scheme for this collection.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 

	4(a) Respondents/SIC Codes 

	Respondents affected by the collection activity may include, but are
not limited to the following NAICS groups, 325 (Chemical Manufacturing)
and 324 (Petroleum and Coal Products).  The North American Industrial
Classification System (NAICS) codes have been provided to indicate which
entities might be affected by this information collection activity. This
listing is not intended to be exhaustive and other types of entities not
listed in this table could also be affected.

	4(b) Information Requested

	EPA is requesting that respondents provide all the information
described below to the extent it is known or reasonably ascertainable. 
EPA is not requesting that respondents develop additional data for this
information collection request.  If the information requested is not
available or applicable to the nanoscale substance, participants simply
would not submit those data.  However, it would be informative for
respondents to describe to EPA why the information is not available or
applicable: 

Company name and other identifying information, address of company and
site, technical contact and related information.

Common or trade name of chemical.  

Chemical identity and molecular structure of substance.  

The following physical and environmental fate properties and information
would be helpful to characterize the nanoscale material where relevant
and reasonably ascertainable:  

	Physical state				Vapor pressure 

	Density				Solubility in water or other solvents

	Melting temperature   			Boiling/sublimation temperature

	Spectra					Dissociation constant

	Particle size distribution    		Octanol/water partition coefficient

	Henry’s Law constant 		Volatilization from water

	pH 					Volatilization from soil

	Flammability				Explodability

	Adsorption coefficient 		Shape

	Agglomeration state/dispersion state   				

	Crystal structure	

Chemical composition – including spatially averaged (bulk) and
spatially resolved heterogeneous composition 

	Surface area 				Surface chemistry 

	Surface charge 	 		Porosity

Description of all uses including expected consumer uses.

Estimate of the total amount of substance to be manufactured/imported
including the amounts for each use category.  

Description of byproduct resulting from manufacture, process, use or
disposal of chemical. 

For each type of workplace in the lifecycle, the same information
requested on pp. 8-10 of the EPA PMN form (7710-25) would be helpful for
releases and exposures, with the following additions.

In addition to the above properties and information the following
physical properties would be helpful for understanding and assessing
exposures and releases:  

	surface reactivity				average particle weight

	average particle surface area			rate of sorption

	aggregation					rate of diffusion

	wet and dry transport				rate of gravitational settling

	bioaccumulation/biomagnification		biodegradation	

	particle count					rate of deposition

	surface/volume ratio				average aerodynamic diameter		

	mobility through soil                                       

	influence of Redox and photochemical reaction

A brief overview of the lifecycle including all workplaces that
manufacture, process, or use the nanoscale chemical and all expected
consumer uses.

For each release point for which control technology is used, rationale
for selecting the control, and, if available, data and measurement
methods of waste treatment or purification efficiency studies for the
nanoscale material.

Regarding worker exposure information, personal or area monitoring data
(in mass concentrations, surface area per mass, number of particles,
etc.) for the nanoscale material, including the measurement 	method(s)
used to generate the data.

For each protective equipment or engineering control listed as worker
protection, rationale for selecting the protective equipment or
engineering controls, and data (and methods used to generate the data)
that were used in making the selection or that may help to indicate the
effectiveness of the protective equipment or engineering controls.

Information on cleaning/ reuse/ disposal of used protective equipment
(gloves, respirator cartridges, etc.). 

Additional procedures or other equipment intended to mitigate exposures
to the nanoscale material.

Description of worker training and hazard communication (MSDS, other)
specific to the nanoscale material. 

Estimate of the total number of individuals other than workers exposed
to the chemical and duration of exposure. 

Manner or method of disposal for consumer use of products containing the
nanoscale material. 

Any test data in the submitter’s possession regarding information on
health/environmental effects, environmental fate, worker safety, and
material characterization, including any data related to
characterization of the nanoscale material in the subject organism and
test medium. 

	To facilitate this information collection request, EPA has developed a
form based on the PMN reporting form (EPA Form 7710-25).  Copies of both
the PMN form and the proposed form for this information collection
request are attached.  It is not essential that respondents use the
proposed form.  By supplying the information described in the form to
the extent it is known or reasonably ascertainable, respondents do not
incur the burden of providing unnecessary information.  In addition,
many of the potential respondents are familiar with the PMN form, thus
further reducing the reporting burden.

	EPA has limited the level of detail of information described in the
form to the information which would be most useful in facilitating
EPA’s to evaluation of the potential risks of the nanoscale material. 
However, respondents may include additional or optional information that
they believe EPA should consider when evaluating the nanoscale material.
 For example, respondents may identify pollution prevention techniques
being employed by the submitter that may be relevant to the Agency's
assessment.  EPA encourages submitters to provide information on the
benefits of the nanoscale material in comparison to existing chemical
substances including macroscale forms of the same chemical substance,
information on the substitutes, and any additional information available
to them on waste management techniques.

	4(c) The In-Depth Program

	The information collection described in 4(b) will provide EPA,
respondents, and the public with baseline information on nanoscale
materials’ properties, details on their production and use, and
descriptions of existing risk management practices.  In an effort to
generate a more detailed view of certain specific nanoscale materials
following an analysis of data from the basic program, EPA is proposing
to collaborate with some respondents in an in-depth program.  This
second program, which builds on data from the basic program, will allow
OPPT and respondents to work collaboratively to generate data and
analyses that will more fully characterize the nanoscale materials in
commerce, and to develop insights into the nanotechnology industry as a
whole.

	The primary purpose of the in-depth program is to generate human health
hazard, environmental hazard, release, and exposure data on particular
nanoscale materials in commerce.  EPA, respondents and other
stakeholders will then use these data to help assess hazard, exposure,
and ultimately, risk in the context of the entire product chain and
life-cycle.  This evaluation will assist EPA, respondents, and others in
working towards a suite of protective risk management practices and
developing better risk-assessment protocols, tools, and methodologies.

	As envisioned, the data needed to meet the goals for such a program
could require testing for material characterization, health and
environmental hazard testing, monitoring of exposures and releases, and
testing of protective equipment.  EPA would determine the specific data
needs and regimen of testing in consultation with respondents and with
input from other stakeholders.

	OPPT has experience with similar collaborative chemical evaluation
programs, such as the Voluntary Children’s Chemical Evaluation Program
(VCCEP).  The VCCEP enlisted sponsors for 20 chemicals, and features
three tiers of testing and analysis. Under the VCCEP process, a peer
consultation is conducted by a group of scientific experts on each tier
of data submitted by a sponsor.  EPA considers the results of the peer
consultation when announcing whether additional higher tier information
is needed. OPPT also manages the High Production Volume (HPV) Challenge
program, under which chemical producers submit a base set of testing
data on chemicals produced at or above a one-million-pounds-per-year
threshold.

	4(d) Basic Outline of the In-Depth Program 

	Participation in the in-depth program will be determined by the mutual
interest of EPA and the participants. Respondents may volunteer
nanoscale materials for the program, and EPA may also identify specific
nanoscale materials of interest.  The criteria for consideration could
include: production volume, potential for exposure, life-cycle/disposal
considerations, data gaps (or conversely, the availability of data), the
potential for information gathered on one nanoscale substance to shed
light on others, and any other criteria that could affect either the
risk profile of the nanoscale substance or the ability of EPA to
effectively oversee other TSCA applications.  For example, a particular
type of carbon nanotube (CNT) that has been well-characterized and
subject to health testing, and that also appears in many products, may
be a good candidate because data may be transferable to other types of
CNTs.  A widely-used nanoparticle that is not well understood from a
risk perspective may also be considered for the in-depth program.

	Once candidates are identified, respondents producing the candidate
nanoscale substance could join as either individuals or consortia.  EPA
envisions somewhere between five and 25 participants, depending on
OPPT’s resources and respondents’ interest in pursuing the program.

	Companies or consortia joining the program would meet and correspond
with EPA to conduct preliminary assessments using available information,
and to identify outstanding data needs.  When these needs are
identified, a plan of action would be developed in consultation with EPA
and with input from other stakeholders.

	Examples of elements that could be included in an action plan:

Characterizing the physical/chemical properties of the material;

Testing for health and environmental hazards;

Monitoring or estimating exposures and releases;

Evaluating the effectiveness of protective equipment and treatment
technologies; and/or

Developing a worker education program.  

	To minimize costs and burden, the elements in an action plan should
coincide with any ongoing research, whether sponsored by EPA or by
private groups.  EPA would also consider testing of an individual
substance that is representative of a class or classes of nanoscale
materials.

	At the completion of the action plan, EPA and participants with input
from other stakeholders will again meet to review the information
gathered; conduct further assessments; develop and apply appropriate
risk-management measures for the substance; and consider any further
action.  Any further action beyond what is called for in the action
plan, would be considered on a case-by-case basis.

	The goal of the in-depth program would be to cooperate with
participants in assessing hazard, exposure, and ultimately, risk in the
context of the entire product chain and life-cycle, and as a result of
these assessments, to work towards a suite of protective risk management
practices.

  SEQ CHAPTER \h \r 1 5.  THE INFORMATION COLLECTED - AGENCY ACTIVITIES,
COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

	Under this stewardship program, EPA will perform the following
activities:

- review the data submitted;

- analyze submissions for confidentiality and provide appropriate
protection for confidential data;

- file and store submissions; 

- use the data to inform the assessment and management of any risks from
nanoscale materials; and

- provide an aggregated report of the data submitted.

	5(b)	Collection Methodology and Management

	EPA encourages submission of data by electronic means as described in
3(h) above.  EPA believes electronic submission reduces the reporting
burden on industry, because it is intended to reduce both the cost and
the time required to enter, review, edit and transmit the data. 
Electronic submission may also improve data quality because it
facilitates correcting incorrect data or adding omitted data.  There is
no other new technology applicable to the collection of this information
that would minimize the collection burden, nor has EPA been able to
identify a more efficient, less expensive or more flexible means of
obtaining the data.

	5(c)	Small Entity Flexibility

	The reporting elements associated with the stewardship program are
applicable to all affected entities, regardless of size of business. 
However, EPA provides specialized assistance to respondents,
particularly to small entities.  TSCA section 26(d) established the TSCA
Assistance Office, now known as the Environmental Assistance Division
(EAD), to provide technical and other non-financial assistance to
manufacturers, importers and processors of chemical substances. 
Moreover, EPA has taken certain steps to minimize for all respondents
the reporting burden associated with this collection.  Finally, EPA will
provide the services of pre-notice communications coordinators and other
personnel to assist persons in a comprehensive manner for purposes of
submitting information for nanoscale materials in the stewardship
program.   

	5(d)	Collection Schedule

	Does not apply.  The submission of information under this collection is
initiated by the respondents.

6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

	6(a)	Nanoscale Materials Stewardship Program (Basic Program)

	6(a)(1)	Estimates of Respondent Burden	

Participants in the basic Nanoscale Materials Stewardship Program (NMSP)
will be asked to undertake the following activities:

Review the NMSP data request;

Determine which provisions are applicable to their activities; and

Gather and submit information regarding the identified data elements.

Each of these activities may require efforts by employees in three broad
labor classifications (managerial, technical, and clerical).  Costs for
each activity are calculated by estimating the labor hours required in
each labor category and multiplying those burdens by the wage rate for
each labor category.  These costs are then multiplied across all of the
respondents expected to submit information under the NMSP.

The methodology and calculations used in this analysis assume that the
employee responsible for collecting, filling out, and submitting the
requested information has a reasonable level of familiarity with the
company and knowledge of operations at the site. It is assumed that for
most entities these tasks are similar to other employee duties that
require familiarity with EPA, State, and other Federal agency requests
for chemical information and does not require additional familiarization
or training to comply. In addition, this analysis focuses on the
marginal costs of submitting information for this specific request and
not the total costs to the company to comply with a range of other
Federal and State environmental, health, and safety regulations (e.g.,
initial employee training, costs associated with collecting and storing
records or file maintenance) or accounting requirements that rely on
this type of information. EPA cautions that these assumptions and burden
estimations may not be appropriate for the many small businesses in the
nanotechnology industry, or other businesses that may not have prior
experience with the chemical regulatory system. 

	Respondent Activities

Section 5 of Toxic Substance Control Act (TSCA) provides EPA with the
authority to review the potential health and environmental risks
associated with any new chemical substance. EPA’s main tool for this
review is the premanufacture notification (PMN) process, which requires
any manufacturer or importer of a substance not listed on the TSCA
Chemical Substance Inventory (i.e., a “new” chemical) to file a PMN
at least 90 days prior to beginning manufacture or importation. Since
much of the information that EPA expects will be useful in assessing the
potential risk from nanoscale materials is similar to the information
collected in the PMN, EPA is utilizing a modified version of the PMN
form to collect NMSP data. Table 1 lists the reporting elements being
collected, along with EPA’s estimated burden for providing this
information. In estimating 

Table 1. Industry Burden Estimates for NMSP Basic Program Reporting
Elements 

Reporting Element	Hours	Source

	Clerical	Technical	Managerial	Total

	1	General instructions & manager certification; Submitter information
2.5	2	1	5.5	RIB, 1994

2	Chemical identity info	2	7.5	1	10.5

	3A	Physical properties 	0.5	2	0.5	3

	3B	Additional physical properties	1	4	1	6	*

4	Description of uses 	0.75	3	1.5	5.25	RIB, 1994

5	Amount of substance to be manufactured/imported 	0.75	1	1.5	3.25

	6	Description of byproducts	0	0.5	0	0.5

	7	Human exposure and environmental release	5.5	52	9.5	67

	8	Physical properties related to understanding and assessing exposures
and releases	1	4	1	6	*

9	Overview of the lifecycles	1	10	2	13

	10	Release point control technology 	0.2	2	0.4	2.6

	11	Worker exposure information	0.2	2	0.4	2.6

	12	Protective equipment or engineering control	0.2	2	0.4	2.6

	13	Information on cleaning/reuse/disposal of used protective equipment
0.1	1	0.2	1.3

	14	Additional procedures or other equipment intended to mitigate
exposures to nanoscale materials	0.1	1	0.2	1.3

	15	Description of worker training and hazardous communication specific 
0.1	1	0.2	1.3

	16	Number of individuals other than workers exposed to the chemical and
duration of exposure	0.1	1	0.2	1.3

	17	Manner or method of disposal for consumer use of products	0.2	2	0.4
2.6

	18	Test data in the submitter’s possession of information on
health/environmental effects	1.7	4.5	11	  =SUM(LEFT)  17.2 	TSCA 8(d)
ICR, 2006

Total 	17.9	102.5	32.4	152.8	--

* Based on professional judgment

the burdens for this Information Collection Request (ICR), EPA assumed
the high end of the burden range estimated in the PMN regulatory impact
assessment for those reporting elements that are identical to the PMN
form (RIB 1994). To estimate the burdens for most of the remaining
elements, the Agency consulted in-house experts from the New Chemicals
Program who are responsible for PMN review, and other Agency staff
working with the nanotech industry. The estimates for reporting elements
3b and 8-17 are thus based on best professional judgment (BPJ). 

For reporting element 18, the submitter is requested to provide any test
data in its possession that indicates the environmental or health
effects of the chemical, and a description of any other data known to
the submitter concerning the environmental or health effects of the
chemical. For this element, the Agency utilized the burden estimates
from the TSCA Section 8(d) ICR, which covers the Health and Safety Data
Reporting Rule (EPA 2006). 

In summary, the estimated burden per respondent to participate in the
NMSP is 152.8 hours. 

	6(a)(2)	Estimates of Respondent Cost 

	Derivation of Appropriate Wage Rates

Loaded wage rates for managerial, technical, and clerical personnel are
derived by combining data on wages and fringe benefits with estimates of
overhead rates. EPA selected average wage rates for managerial,
technical, and clerical labor from the most-recent unpublished Bureau of
Labor Statistics (BLS) data for manufacturing sectors made available to
EPA (BLS 2005). 

The cost of fringe benefits (such as paid leave and insurance) specific
to each labor category are from unpublished BLS data made available to
EPA (BLS 2005). An additional loading factor of 17 percent is applied to
wages to account for overhead. The fringe benefits loading factor and
the overhead loading factor are then added to the base wage to calculate
a fully loaded wage rate. 

  SEQ CHAPTER \h \r 1 

Table 2. Industry Labor Category and Loaded Hourly Rate

Labor Category	Loaded Hourly Rate ($2005)

Managerial	$63.61

Technical	$53.02

Clerical	$26.37

	Table 3 combines the estimated burdens from Table 1 with the fully
loaded wage rates listed in Table 2 to estimate the cost to industry of
collecting and submitting the data identified in the basic NMSP. As seen
in Table 3, the total estimated cost per response is $7,968. These
estimates are in 2005 dollars.

	Estimation of the Number of NMSP Participants and Responses

	

	Nanotechnology is not identified as a separate industry within the
North American Industrial Classification System (NAICS). Rather,
nanotechnology encompasses a range of technologies that are deployed
across a broad spectrum of industries including: 

Electronics

Health Sciences

Materials

Environment

Energy

Table 3. Respondent Burden and Cost for NMSP Basic Program Reporting
Elements

Reporting Element	Hours*	Cost*

	C	T	M	Total	C	T	M	Total

($2005)

	@$26.37/hr	@$53.02/hr	@$63.61/hr

	1	General instructions & manager certification; Submitter information
2.5	2	1	5.5	$65.93	$106.04	$63.61	$236

2	Chemical identity info	2	7.5	1	10.5	$52.74	$397.65	$63.61	$514

3A	Physical properties 	0.5	2	0.5	3	$13.19	$106.04	$31.81	$151

3B	Additional physical properties	1	4	1	6	$26.37	$212.08	$63.61	$302

4	Description of all uses including expected consumer uses	0.75	3	1.5
5.25	$19.78	$159.06	$95.42	$274

5	Estimate of total amount of substance to be manufactured/imported
including the amount of use in each use category	0.75	1	1.5	3.25	$19.78
$53.02	$95.42	$168

6	Description of byproduct resulting from manufacture, process, use, or
disposal of chemical	0	0.5	0	0.5	$0.00	$26.51	$0.00	$27

7	Human exposure and environmental release	5.5	52	9.5	67	$145.04
$2,757.04	$604.30	$3,506

8	Physical properties related to assessing exposures and releases	1	4	1
6	$26.37	$212.08	$63.61	$302

9	Overview of the lifecycles	1	10	2	13	$26.37	$530.20	$127.22	$684

10	Release point control technology 	0.2	2	0.4	2.6	$5.27	$106.04	$25.44
$137

11	Worker exposure information	0.2	2	0.4	2.6	$5.27	$106.04	$25.44	$137

12	Protective equipment or engineering control 	0.2	2	0.4	2.6	$5.27
$106.04	$25.44	$137

13	Information on cleaning/reuse/disposal of used protective equipment
0.1	1	0.2	1.3	$2.64	$53.02	$12.72	$68

14	Additional procedures or other equipment intended to mitigate
exposures to nanoscale materials	0.1	1	0.2	1.3	$2.64	$53.02	$12.72	$68

15	Description of worker training and hazardous communication specific 
0.1	1	0.2	1.3	$2.64	$53.02	$12.72	$68

16	Number of individuals other than workers exposed to the chemical and
duration of exposure	0.1	1	0.2	1.3	$2.64	$53.02	$12.72	$68

17	Manner or method of disposal for consumer use of products 	0.2	2	0.4
2.6	$5.27	$106.04	$25.44	$137

18	Test data in the submitter’s possession of information on
health/environmental effects	1.7	4.5	11	  =SUM(LEFT)  17.2 	$44.83
$238.59	$699.71	$983

Total	17.9	102.5	32.4	152.8	$472.02 	$5,434.55 	$2,060.96 	$7,968

C = clerical labor; T = technical labor; and M = managerial labor.

Entities potentially eligible to participate in the voluntary program
may include, but are not limited to, the following NAICS industries, 325
(Chemical Manufacturing) and 324 (Petroleum and Coal Products).  This
list is not intended to be exhaustive, but rather provides an indication
of the kinds of industries that may be involved in the manufacture or
importation of nanoscale materials. 

Because the nanotech “industry” is not well defined, there are few
reliable estimates of its overall size and composition. EPA reviewed
numerous data sources on the nanotech industry and made an estimate of
the overall size of the industry based on data from the National Science
Foundation (NSF). The NSF estimates are based on industry surveys by a
nanotech market research firm. NSF estimates that in 2005 there were
some 1,455 companies involved in nanotechnology worldwide. Of these, NSF
estimates that 42 percent are involved in the manufacturing or
application of nanoscale materials (Roco 2005). The remainder of the
industry is composed of specialized service providers (legal,
financial), research organizations and trade associations, government
entities and equipment vendors. Thus, based on these data sources the
total universe of companies manufacturing and applying nanotech was
about 600 firms in 2005 (1,455 x 0.42 = 611). 

Not all of the nanoscale materials manufactured, imported, or used by
these firms will constitute “chemical substances” according to the
TSCA definition. TSCA applies to chemical substances exclusive of the
following in the circumstances specified in TSCA section 3::

Pesticides 

Tobacco and tobacco products 

Nuclear material 

Firearms and ammunition 

Food and food additives 

Drugs and medical devices

Cosmetics. 

	In its 2006 review of nanotech consumer products already on the market,
the Woodrow Wilson International Center’s Project on Emerging
Nanotechnologies estimates that approximately one-third of existing
products would fall under TSCA regulatory purview (if they were
considered “new chemicals”), with most of the remainder falling
under the regulatory authority of the Food and Drug Administration
(e.g., sunscreens and other health and beauty aids; medical devices) and
the Consumer Product Safety Commission (e.g., garments; sporting goods)
(Wilson Center 2006). However, it is important to note that this review
focused on products, not raw materials, and that some of the products
that would potentially be excluded from TSCA regulation may themselves
be based on materials that would be considered new chemicals under TSCA.
Further, the inventory covers only consumer products and excludes many
industrial applications of nanotech already in use. For these reasons,
EPA believes the Wilson Center’s estimate that one-third of nanotech
products currently on the market would potentially be regulated under
TSCA is probably not a useful indicator for this ICR. 

According to the National Center for Manufacturing Sciences, 80 percent
of nanotechnology manufacturers are small businesses with less than 20
staff (NCMS 2006). If this distribution is representative of the firms
that could potentially participate in the NMSP, then the universe of
potential participants includes roughly 480 small businesses (600 x 0.8)
and 120 large businesses. For purposes of this ICR, EPA estimates that
the program participation rate for large nanotech businesses will be
greater than that for small businesses. A number of factors will
probably contribute to this, including large companies’ enhanced
familiarity with the chemical regulatory program and EPA, and their
superior resources and staff expertise. EPA has used a participation
rate of 50 percent for large businesses and 25 percent for small
businesses for this ICR. These voluntary participation rates results in
responses from 60 large businesses and 120 small businesses over the
three-year ICR period. 

EPA further assumes that each large company participating will submit
information on two nanoscale substances and each small business
participating will submit information on one nanoscale substance.
EPA’s experience suggests that large businesses tend to account for a
majority of the PMNs submitted each year and it is expected that large
businesses will submit information on nanoscale substances more
frequently than small businesses. Over the three-year ICR period, EPA
thus anticipates 120 submissions from large businesses and 120
submissions from small businesses.  

	6(a)(3)	Total Respondent Burden and Cost (Basic Program)

Table 4 summarizes the total number of responses and respondent burdens
and costs associated with the NMSP. The total burden for 240 responses
is 36,672 hours, and the total respondent cost is $1.9 million.

Table 4. NMSP  Basic Program Respondent Cost and Burden

Item	Burden (hrs)	Cost ($)

Burden and Cost per Response	152.8	$7,968

No. of Responses	240

Total 	36,672	$1,912,320

	6(a)(4)	Agency Burden and Costs (Basic Program)

This section estimates the burden and cost that will be incurred by EPA
in connection with the NMSP. As the Agency developing, implementing, and
operating the program, EPA will undertake a number of activities,
including:

Conducting pre-notice consultations;

Reviewing and discussing submissions;

Filing and storing submissions;

Analyzing requests for confidentiality and providing appropriate
protection; and

Writing a summary report of the NMSP basic program.

	Agency Burdens

EPA estimated the Agency burdens associated with the NMSP basic program
based upon the burdens estimated for the PMN program (RIB 1994). These
burdens are shown in Table 5 below. It is important to note that while
EPA is using the PMN costs as a template for the review of NMSP
submissions, the actual review will likely differ in form and substance
from the PMN review. However, EPA expects the general steps involved for
the review will be similar. For the NMSP basic program, EPA assumes that
100 percent of submissions will require each of these steps. As shown in
the table, EPA’s estimated burden per submission is 22.2 hours. EPA
also estimates a one-time burden of 300 hours to write a summary report
on the NMSP basic program (not shown in Table 5).

	Agency Costs

	The costs associated with Agency activities undertaken in support of
the NMSP are estimated by multiplying Agency burdens from Table 5 by an
appropriate government employee wage rate (RIB 1994). EPA assumes that
these activities are accomplished by a GS-13, Step 5 federal employee
(RIB 1994). The 2006 hourly wage rate for this labor category in the
Washington, DC locality is $42.00 per hour (OPM 2006). EPA applied a
factor of 1.6 (RIB 1994) to obtain a fully loaded labor rate (i.e.,
including fringe benefits and overhead) of $67.20 per hour. The total
agency cost per response is $1,492, as shown in Table 6.

Table 5. Agency Activities and Estimated Burden per Response

Review Step	Description	Burden (Hours)

1	Pre-notice consultations	These discussions allow potential submitters
and the Agency to communicate any issues pertaining to the submission.
4.8

2	Administrative prescreen / notice receipt	The Agency performs an
administrative review of each submission to verify information received
and logs the receipt of data.	4.8

3	Chemical Review and Search Strategy (CRSS)	An Agency chemist conducts
an initial chemistry review and prepares a summary report, during which
the physiochemical properties of the substance have been verified. This
report is presented at a CRSS meeting, where the chemistry needed for
subsequent hazard and risk assessments is discussed and evaluated by
Agency staff.	5

4	Engineering and exposure identification	The Agency also reviews the
areas of environmental fate, human toxicity, and ecological effects by
reviewing submitted data and researching other published research.	3

5	Structure Activity Team (SAT)	Base on the information gathered in
previous steps, the Agency convenes a SAT meeting to assess the
potential hazards and risk of the substance and assign a level of
concern.	1.2

6	Exposure and Fate Evaluation	During this phase of the Agency’s
review, staff estimates the degree of human exposure and environmental
exposure.	1.6

7	Focus Meeting	The Agency characterizes and discusses the risk posed by
the substance and determines the risk of the substance.	1.8

Total	22.2

Note: Does not include one-time costs associated with preparing a
summary report on the NMSP (estimated at 200 hours)

Table 6. Agency Burden and Costs per Response Under the NMSP Basic
Program

Review Step	Hours	Total Cost

($2006)

1	Prenotice consultations	4.8	  =c2*67.2 \# "$#,##0.00;($#,##0.00)"  $
322.56 

2	Administrative prescreen / notice receipt	4.8	  =c3*67.2 \#
"$#,##0.00;($#,##0.00)"  $ 322.56 

3	CRSS	5.0	  =c4*67.2 \# "$#,##0.00;($#,##0.00)"  $ 336.00 

4	SAT	1.2	  =c5*67.2 \# "$#,##0.00;($#,##0.00)"  $  80.64 

5	Engineering/Exposure	3.0	  =c6*67.2 \# "$#,##0.00;($#,##0.00)"  $
201.60 

6	Exposure/Fate	1.6	  =c7*67.2 \# "$#,##0.00;($#,##0.00)"  $ 107.52 

7	Focus Meeting	1.8	  =c8*67.2 \# "$#,##0.00;($#,##0.00)"  $ 120.96 

Total	22.2	$1,491.84

Note: Assumes review activities are accomplished by GS-13, Step 5
employee at a loaded rate of $67.20/hr. 

Does not include one-time costs associated with preparing a summary
report on the NMSP (estimated at 200 hours). 

	Total Agency Burdens and Costs

	EPA multiplied the Agency burden and cost per response shown in Table 6
by the expected number of submissions shown in Table 4. The total burden
and costs shown in Table includes that associated with the one-time
Summary Report on the NMSP. The total agency burden is 5,628 hours and
the total Agency cost is $378,202.

Table 7. Agency Burden and Cost Associated with the NMSP Basic Program

Item	Burden per Response	Cost per Response	No. of Responses	Total Burden
Total Cost ($2006)

Agency review and response	22.2	$1,492	240	5,328	$358,080

Summary Report	--	--	1	300	$20,160

Total	  =SUM(ABOVE)  22.2 	$1,492	--	5,628	$378,240

	6(a)(5)	Total Annual Burden and Cost Estimates 

The total estimated industry burden, from Table 4, is 36,672 hours and
the total estimated costs are $1.9 million. The total estimated Agency
burden for administering the NMSP, from Table 7, is 5,628 hours and the
total estimated cost is $378,240 

As shown in Table 8, over the three-year ICR period the total combined
burden (industry and Agency) is estimated at 42,300 hours and the total
combined cost (industry and Agency) is estimated at $2.29 million. On an
annual basis, the combined industry and Agency burden is 14,100 hours
and the combined industry and Agency cost is $763,520. 

Table 8. NMSP Basic Program Burden and Costs for Industry and Agency

Entity Type	Total (3 Years)	Annual

	Burden (Hours)	Cost	Burden (Hours)	Cost

Industry	36,672	$1,912,320	12,224	$637,440

Agency	5,628	$378,240	1,876	$126,080

Total	42,300	$2,290,560	14,100	$763,520

	6(b)	In-Depth Nanoscale Materials Stewardship Program 

	6(b)(1)	Estimates of Respondent Burden (In-Depth Program)

	The In-Depth NMSP will apply to a smaller set of nanoscale materials
designated for further evaluation by mutual agreement of EPA and NMSP
participants.  Under the In-Depth NMSP, EPA and participants would
review existing data, conduct preliminary assessments, and identify
additional data needed to better characterize hazard, risk, and exposure
issues for the material. Once these needs are identified, a plan of
action would be developed in consultation with EPA and other
stakeholders that could include:

Characterizing the physical/chemical properties of the material;

Testing for health and environmental hazards;

Monitoring or estimating exposures, releases, and fate;

Evaluating the effectiveness of protective equipment; and/or

Developing a model worker education program.  

	At the completion of the action plan, all stakeholders would again meet
to review the information gathered; conduct final assessments; develop
and apply appropriate risk management measures for the substance; and
consider any further action.  Any step that would go beyond what is
called for in the action plan, would be considered on a case-by-case
basis.

	Because the number of participating groups is unknown, and the
program’s particulars will differ for each of the substances, it is
not possible at this time to accurately estimate the costs and burdens
for the In-Depth Program.  Nevertheless, EPA believes its experience
with the Voluntary Children’s Chemical Evaluation Program (VCCEP)
sheds some light on the potential costs and burdens.  For example,
participants in the VCCEP conducted assessments that could also occur
under the In-Depth NMSP. While the hazard assessments under the VCCEP
involved a very specific set of tests which would not be applicable to
substances enrolled in the In-Depth NMSP, OPPT does have estimates of
costs for most tests that might be conducted as part of the In-Depth
program (although it is important to note that lab testing costs are not
considered reporting burdens for ICR purposes).

	As a preliminary estimate, EPA assumes 15 substances will take part in
the In-Depth NMSP over the first three years of this ICR.  As currently
envisioned, each substance will require an action plan, and preliminary
and final assessments.  The program could also call for a suite of
risk-management practices and sundry action items, which would likely be
formalized in a final summary document.

	For the purposes of this ICR, the elements of the In-Depth NMSP must be
divided into reporting burdens and non-reporting burdens. Only reporting
(that is, paperwork) burdens are relevant to the ICR requirements of the
Paperwork Reduction Act.  The testing costs associated with conducting
the hazard assessments are not paperwork burdens, but the preparation
and submittal to EPA of robust summaries of test results are. 
Additional paperwork burdens include preparing and submitting additional
assessments, the action plan, and any summary documents.  Efforts
expended to participate in meetings are not considered part of the
reporting burden, nor is the implementation of any risk-management
measures.

	Hazard Assessments

	EPA is not able to accurately estimate the number of hazard tests or
even the type of hazard testing that would be included under the
In-Depth NMSP, as these tests will be determined by a variety of factors
unknown at this time.  In light of previous experience, EPA
conservatively assumes that participants will prepare robust summaries
of five hazard tests per substance, which will cover both the initial
and final hazard assessments.  EPA estimates that robust summaries
require 15 hours of technical time and 5 hours of clerical time each. 
Assuming 15 substances are enrolled in the program, a total of 75 robust
summaries will be prepared, representing a total burden of 1,500 hours
(see Table 9). 

	Exposure Assessments

	Preliminary and final exposure assessments could be developed for each
substance.  In the ICR for the VCCEP, EPA estimated a respondent burden
of 500 hours (425 technical hours, 50 clerical, and 25 managerial) for a
Tier 1 exposure assessment. A preliminary exposure assessment for the
In-Depth NMSP will likely be similar in nature and scope to the Tier 1
VCCEP assessment, thus EPA assumes a similar burden of 500 hours per
substance.  A final exposure assessment will likely be more complex, and
EPA assumes the burden will be similar to the 1,000 hours estimated for
the VCCEP Tier 2 exposure assessment (850 technical, 100 clerical, 50
managerial).  EPA further assumes that the burden estimates for these
assessments include the paperwork burden associated with summarizing any
monitoring or exposure testing conducted.  Assuming 15 substances, the
exposure assessments would represent a burden of 22,500 hours (see Table
9).

	Risk Assessments

	Preliminary and final risk assessments could also be developed for each
substance under the In-Depth NMSP.  In the ICR for the VCCEP, EPA
estimated the respondent burden for a Tier 1 risk assessment at 300
hours (255 technical, 30 clerical, and 15 managerial).  A final risk
assessment will again likely correspond to a VCCEP Tier 2 risk
assessment, with an estimated respondent burden of 500 hours (425
technical, 50 clerical, 25 managerial).  Assuming 15 substances, the
risk assessments would represent a burden of 12,000 hours (see Table 9).

	Action Plans and Final Summary

	EPA assumes that the action plans and agreed-upon risk management
measures will be presented in summary documents, likely produced by the
participants.  Therefore, EPA is estimating that these documents
combined will require a respondent burden of 100 hours (85 technical, 10
clerical, 5 managerial).  These burdens are detailed in Table 9.

Table 9. Respondent Burdens for the In-Depth NMSP Reporting Elements

Program Element	Hours per Response

	Technical	Clerical	Managerial	Total

Robust summaries 

(hazard assessments)*	15	5	0	20

Exposure assessments	Prelim: 425

Final: 850

Total: 1,275	Prelim: 50

Final: 100

Total: 150	Prelim.: 25

Final: 50

Total: 75	Prelim: 500

Final: 1,000

Total: 1,500

Risk assessments	Prelim: 255

Final: 425

Total: 680	Prelim: 30

Final: 50

Total: 80	Prelim: 15

Final: 25

Total: 40	Prelim: 300

Final: 500

Total: 800

Action plans and summary	85	10	5	100

* Burden estimates are per robust summary. As indicated in the text, EPA
estimates an average of five robust summaries may be developed per
substance.

6(b)(2)	Estimates of Respondent Cost (In-Depth Program)

	Table 10 combines estimates of respondent burden with appropriate
industry labor rates (from Table 2) to estimate the respondent cost of
the In-Depth NMSP reporting elements. 

Table 10. Respondent Cost for the In-Depth NMSP Reporting Elements

Program Element	Labor Cost  per Response

	Technical

($53.02/hr)	Clerical

($26.37/hr)	Managerial

($63.61/hr)	Total ($)

Robust summaries 

(hazard assessments)*	$795	$132	$0	$927

Exposure assessments	$67,601	$3,956	$4,771	$76,328

Risk assessments	$36,054	$2,110	$2,544	$40,708

Action plans and summary	$4,507	$264	$318	$5,089

* Cost estimates are per robust summary. As indicated in the text, EPA
estimates an average of five robust summaries may be developed per
substance.

6(b)(3)	Total Respondent Burden and Cost (In-Depth Program)

	The total burden and cost per respondent are estimated by multiplying
the burdens and costs per reporting element by the number of elements
per response. As shown in Table 11, the estimated burden per response is
2,500 hours and the total estimated cost per response is $126,760. 

Table 11. Respondent Burden and Cost for the In-Depth NMSP Reporting
Elements

Reporting Element	Burden and Cost per Element	No. of Elements per
Response	Burden and Cost Per Response

	Burden	Cost

Burden	Cost

Robust summaries (hazard assessments)*	20	$927	5	100	$4,635

Exposure assessments	1,500	$76,328	1	1,500	$76,328

Risk assessments	800	$40,708	1	800	$40,708

Action plans and summary	100	$5,089	1	100	$5,089

Total

2,500	$126,760

	The total burdens and costs for all respondents are estimated by
multiplying the burdens and costs per respondent by the number of
respondents (15). As shown in Table 12, the total estimated respondent
burden is 37,500 hours and the total estimated respondent cost is $1.9
million.

Table 12. Total Respondent Burden and Cost for the In-Depth NMSP

Reporting Element	Burden and Cost per Response	No. of Responses	Burden
and Cost Per Response

	Burden	Cost

Burden	Cost

Robust summaries (hazard assessments)	100	$4,635	15	1,500	$69,525

Exposure assessments	1,500	$76,328

22,500	$1,144,920

Risk assessments	800	$40,708

12,000	$610,620

Action plans and summary	100	$5,089

1,500	$76,335

Total	2,500	$126,760

37,500	$1,901,400

	Costs and burdens of participation in the program may be shared by
multiple companies working through consortia, as is the case with
several current EPA-sponsored chemical testing programs. And it
important to again note that participants will likely incur other costs,
such as costs for testing and risk-management measures, that are not
included in the reporting burdens estimated in this ICR.

6(b)(4)	Agency Burden and Costs (In-Depth Program)

	This section estimates the burden and cost that will be incurred by EPA
in connection with the In-Depth NMSP.  Agency burdens for managing and
participating in the In-Depth NMSP are assumed to require a similar
amount of staff time and a similar labor mix as the VCCEP. In the ICR
for the VCCEP, EPA estimated an Agency burden of 1,100 hours per year,
divided among GS-11, GS-14, and GS-15 level employees.  Based on the
number of expected responses to the VCCEP (209) versus the number of
expected responses to the In-Depth NMSP (15), EPA assumes the In-Depth
NMSP will be proportionally less burdensome for the Agency.  Thus the
Agency burden is estimated at 650 hours annually, as detailed in Table
13.  The Agency cost associated with this burden is $45,778.

Table 13. Agency Burden and Cost for the In-Depth NMSP

Item	GS-15, Step 1	GS-14, Step 1	GS-11, Step 1	Total

Labor rate ($/hr)	$82.43	$70.08	$41.60

Hours	Cost	Hours	Cost	Hours	Cost	Hours	Cost

Hours and cost	295	$24,317	235	$16,469	120	$4,992	650	$45,778

Note: Agency personnel hourly wage rates are taken from the OMB pay
tables for Washington, DC.  60% is added to the base wage to account for
fringe and overhead

	6(b)(5)	Total Annual Burden and Cost Estimates (In-Depth Program)

Over the three-year ICR period the total combined burden (industry and
Agency) for the In-Depth NMSP is estimated at 38,150 hours and the total
combined cost (industry and Agency) is estimated at $1.95 million. On an
annual basis, the combined industry and Agency burden is 12,717 hours
and the combined industry and Agency cost is $649,059. These totals are
shown in Table 14.

Table 14. In-Depth NMSP Burdens and Costs, Total and Annual

Entity Type	Total (3 Years)	Annual

	Burden (Hours)	Cost	Burden (Hours)	Cost

Industry	37,500	$1,901,400	12,500	$633,800

Agency	650	$45,778	217	$15,259

Total	38,150	$1,947,178	12,717	$649,059

	6(c)	Total and Annual Burden and Cost Estimates, Basic NMSP and
In-Depth NMSP  

	As shown in Table 15, the total combined burden (industry and Agency)
for both the Basic NMSP and In-Depth NMSP is estimated at 80,450 hours
and the total combined cost (industry and Agency) is estimated at $4.24
million.  On an annual basis, the combined burden (industry and Agency)
for both the NMSP and In-Depth NMSP is estimated at 26,817 hours and the
combined cost (industry and Agency) is estimated at $1.41 million. 

Table 15. Total and Annual Burden and Cost, Basic NMSP and In-Depth NMSP

Entity Type	Basic NMSP	In-Depth NMSP	Total

	Burden	Cost	Burden	Cost	Burden	Cost

Total, 3 Years

Industry	36,672	$1,912,320	37,500	$1,901,400	  =b5+d5  74,172 	  =c5+e5
\# "$#,##0;($#,##0)"  $3,813,720 

Agency	5,628	$378,240	650	$45,778	  =b6+d6  6,278 	  =c6+e6 \#
"$#,##0;($#,##0)"  $424,018 

Total	42,300	$2,290,560	38,150	$1,947,178	  =b7+d7  80,450 	  =c7+e7 \#
"$#,##0;($#,##0)"  $4,237,738 

Annual

Industry	12,224	$637,440	12,500	$633,800	  =b9+d9  24,724 	  =c9+e9 \#
"$#,##0;($#,##0)"  $1,271,240 

Agency	1,876	$126,080	217	$15,259	  =b10+d10  2,093 	  =c10+e10 \#
"$#,##0;($#,##0)"  $141,339 

Total	14,100	$763,520	12,717	$649,059	  =b11+d11  26,817 	  =c11+e11 \#
"$#,##0;($#,##0)"  $1,412,579 

	6(d)	Changes in Burden Estimates

This is a new ICR; therefore there is no change in burden estimates from
that previously approved by OMB.

	6(e)	Burden Statement

	The annual public burden for this collection of information is
estimated to average 51 hours per response for the Basic NMSP, and 833
hours for the In-Depth NMSP. According to the Paperwork Reduction Act,
“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 numbers for EPA’s regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in 40
CFR part 9 and included on the related collection instrument or form, if
applicable.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under EPA Docket ID No.
EPA-HQ-OPPT-2007-0572, which is available for public viewing online at  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov .  The
Pollution Prevention and Toxics 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.

	An electronic version of the public docket is available through
Regulations.gov at http://www.regulations.gov. Use this tool to submit
or view public comments, access the index listing of the contents of the
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select “search,”
then key in the docket ID number identified above. Also, you can send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA. Please include the EPA Docket ID No.
EPA-HQ-OPPT-2007-0572 in any correspondence.

REFERENCES

BLS 2006. U.S. Bureau of Labor Statistics. May 2005 National
Industry-Specific Occupational Employment and Wage Estimates: Sectors
31, 32, and 33 – Manufacturing. May 24, 2006,
http://www.bls.gov/OES/current/naics2_31-33.htm

BLS 2005a. Unpublished Employer Costs for Employee Compensation  (ECEC)
data received by Carol Rawie, US EPA, from Raphael Branch, US Bureau of
Labor Statistics, September 16, 2005. The data is not seasonally
adjusted (email from Raphael Branch to Carol Rawie, November 17, 2005).

EPA 2006. TSCA Section 8(d) ICR for the Health and Safety Data Reporting
Rule.  

EPA 2002. Supporting Statement for a Request for OMB Review under the
Paperwork Reduction Act: Data Submissions for the Voluntary Children’s
Chemical Evaluation Program, April.   HYPERLINK
"http://www.epa.gov/EPA-TOX/2002/April/Day-16/o-t9221.htm" 
http://www.epa.gov/EPA-TOX/2002/April/Day-16/o-t9221.htm 

NCMS 2006. National Center for Manufacturing Sciences,   HYPERLINK
"http://www.ncms.org/publications/PR/2006-3-13NanoSurvey.htm"  2005 NCMS
Survey of Nanotechnology in the U.S. Manufacturing Industry: Abstract ,
National Science Foundation, March 6, 2006.

NNI  2006.  National Nanotechnology Initiative, Nanotech Facts,
Application and Products, August 22, 2006.    HYPERLINK
"http://www.nano.gov/html/facts/appsprod.html" 
http://www.nano.gov/html/facts/appsprod.html 

NPPTAC 2005. Overview of Issues for Consideration by NPPTAC.  Document
ID EPA-HQ-OPPT-2002-0001-0068.    HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main" 
http://www.regulations.gov/fdmspublic/component/main  

OPM 2006. Salary Table 2006 DCB, for the Locality Pay Area of
Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. U.S. Office of
Personnel Management.   HYPERLINK
"http://www.opm.gov/oca/06tables/html/dcb_h.asp" 
http://www.opm.gov/oca/06tables/html/dcb_h.asp 

							

RIB 1994. Regulatory Impacts Branch. Regulatory Impact Analysis of
Amendments to Regulations for TSCA Section 5 Premanufacture
Notifications. Washington, DC: U.S. EPA/OPPT/EETD/RIB, September 9,
1994.

Roco 2005. M.C. Roco, “Nanotechnology,” National Science Foundation,
presented at 2nd Annual International Symposium on Nanotechnology and
Occupational Health, University of Minnesota, October 3, 2005.  
HYPERLINK
"http://www.nsf.gov/crssprgm/nano/reports/nni_05_1003_minn_tutoria.pdf" 
http://www.nsf.gov/crssprgm/nano/reports/nni_05_1003_minn_tutoria.pdf 

Wilson Center 2006. Woodrow Wilson International Center, Project on
Emerging Nanotechnologies. Nanotech Consumer Products Inventory. March
10, 2006.   HYPERLINK "http://www.nanotechproject.org/index.php?id=46" 
http://www.nanotechproject.org/index.php?id=46 

ATTACHMENTS

All attachments are included in the electronic docket (EPA Docket ID No.
EPA-HQ-OPPT-2007-0572) at   HYPERLINK "http://www.regulations.gov" 
www.regulations.gov , unless otherwise noted.

ATTACHMENT A - 	Nanoscale Materials Stewardship Program Data Submission
Form

 60 large businesses will submit two responses each and 120 small
businesses will submit one response each. 

 Note: there is no corresponding burden for industry. 

Page   PAGE  7  of   NUMPAGES  25