2250.01-ss-2007-10-30

October 30, 2007
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 has established a voluntary information collection to assemble existing data and
information from manufacturers, importers, and processors of nanoscale materials regulated
under the Toxic Substances Control Act (TSCA). EPA will also 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 to increase understanding of the environmental health and safety
implications of manufactured nanoscale materials.
This collection of information 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 includes industry and the interested public
in characterizing the safe manufacture, processing, distribution, use, storage, recycling, 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 to a
significant degree. There are estimated to be hundreds of nanotechnology products already on the
market. The National Science Foundation predicts that the market worldwide for
nanotechnology products and services will reach $1 trillion by 2015. Nanotechnology 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 TSCA §5 because they are not listed on the TSCA Inventory.
Therefore, they are subject to review under TSCA for potential human health and environmental
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risks before they are manufactured and enter commerce. Other nanoscale materials have the
same molecular identity as chemical substances 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 nanoscale materials already in commerce, it could also
include nanoscale materials that would be reportable to EPA under TSCA §5. It is important to
note that participation in the voluntary stewardship program will not relieve manufacturers,
importers, or 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 comprehensive information on the properties
and characteristics of nanoscale materials.
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.
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.

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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 information about nanoscale
materials.
3(b) Public Notice Required Prior to ICR Submission to OMB
On July 12, 2007 (72 FR 38079), EPA sought public comment on the draft ICR, and
received four comments in response.
One commenter supported the estimates in the ICR but noted that the estimates of the
number of NMSP participants and responses may be too high and that EPA should not measure
success of the program based on the estimated number of participants. As the commenter did not
offer any basis for an alternative estimate, EPA is retaining the estimates as proposed. The
estimates are based on the best available information to EPA. Because those estimates are based
on market information for all nanotechnology firms and assumed a certain percentage have
nanoscale materials that could be reported under the program, EPA acknowledges that they could
be an overestimate.
Two commenters noted that the proposed reporting form could be a considerable burden
to fill out especially for smaller entities. When developing the optional form, EPA considered
that it might not be suitable for all participants, especially smaller entities with limited
information and resources, which is why the form was proposed as an optional tool to facilitate
reporting, as opposed to requiring participants to use it. EPA also intended that a participant
would not complete each element of the form – just complete those elements that were relevant
to their material. EPA believes that the form helps participants more easily identify the type of
information that may be submitted, and provides a vehicle for organizing and submitting the
information. As such, EPA will continue to make the form available for use as proposed and
will also make it clearer to participants that use of the form is optional. While EPA encourages
participants to use the form, participants may report data in any format they choose. In addition,
anyone who uses the form is not required to fill out the entire form. They may fill in only the
information that is available to them.
Another commenter asserted that because EPA will use the data collected under the
NMSP to determine which chemicals need to be regulated and which do not, the data had to meet
the Data Quality Act Guidelines and other EPA Quality System standards. The commenter also
stated that by making the data submitted publicly available to the extent that they are not
protected from release as CBI, the Agency was required to ensure that the data meet the EPA
Information Quality Guidelines. As previously stated, EPA intends to use the data collected
under the NMSP to gain an understanding of which nanoscale materials are produced, in what
quantities they are produced, how they are used, and the data that is available for such materials.
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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 will use the data to build new
assessment models or incorporate the data into existing models with regard to hazard, exposure,
and fate. EPA will also increase it’s capacity to assess benefits from nanoscale materials. As
with any data submitted to EPA, other uses of the data may arise from reviews and the Agency is
no way restricted from using the data for other purposes. To the extent applicable, EPA intends
to ensure that EPA’s use of the data collected under the NMSP complies with EPA’s Information
Quality Guidelines.
Based on these comments, EPA has estimated additional burden to account for the
development of a fact sheet or other outreach materials to lend assistance to small business
participants in the stewardship program. EPA has modified Table 8 in Section 6(a)(5) of this
ICR to reflect an increase in burden for the first year of the program and less burden in the last
two years, because EPA is encouraging reporting within the first six months of the
announcement of the program. This change does not reflect a change in the total burden
estimate. EPA has also updated some burden estimates and wage rates to reflect the most recent
available information which resulted in minor changes to the total burden estimate.
On July 12, 2007 (72 FR 38083), EPA also sought public comment on a Concept Paper
for the NMSP and a document entitled “TSCA Inventory Status of Nanoscale Materials General Approach.”. EPA received twenty-six comments on these documents. Comments on
these documents are available in at www.regulations.gov under Docket ID No. EPA-HQ-OPPT2004-0122. EPA is in the process of developing a document that will build on the Concept Paper
but provides more details for the NMSP. Copies of the July drafts of these documents are also in
the docket for this ICR.
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). The June 23, 2005, public meeting and the
NPPTAC Overview Document elicited broad stakeholder support for the idea of a stewardship
program which identified specific issues relevant to the program that EPA is considering.
As described in the NPPTAC Overview Document, EPA held a public scientific peer
consultation on risk management practices for nanoscale materials on October 19-20, 2006 and
on material characterization for nanoscale materials on September 6-7, 2007. The approach is
consistent with OMB Memorandum dated September 19, 2007 “Updated Principles for Risk
Analysis.” EPA also conducted another public meeting on August 2, 2007 to obtain comments
and input on all aspects of the NMSP. The reports from all of these meetings are available in
Docket ID No. EPA-HQ-OPPT-2004-0122 and on OPPT’s Nanotechnology under the Toxic
Substances Control Act webpage at http://epa.gov/oppt/nano/index.htm. EPA considered all of
the comments and input from these meetings when designing and structuring the NMSP,
including this ICR.

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3(d) Effects of Less Frequent Collection
There is no set frequency of submission under this voluntary information collection
request. Participants in the voluntary program (i.e., the manufacturers, importers, and processors
of nanoscale materials) will determine whether and when to submit information under this
program, including whether to submit all of the information at once or to submit it in stages. The
Agency believes that this flexibility is important for such a program, given its voluntary nature.
As such, there is no less frequent collection option for the Agency to consider.
3(e) Compliance with General OMB Guidelines
This collection of information is consistent with all OMB guidelines under 5 CFR
1320.6, and OMB Guidance.
3(f) Confidentiality
If respondents wish to claim information submitted as confidential business information
(CBI), they may do so at the time of submission. 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, with any claims of confidentiality 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 deliver to EPA. Because of time constraints, security issues related to
the electronic transfer of CBI, and potential expenses for EPA and respondents, it is not feasible
to devise a direct electronic submission scheme for this voluntary collection effort.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED
4(a) Respondents/SIC Codes
Potential participants in the stewardship program and respondents affected by the
collection activity in this ICR may include, but are not limited to the following groups, using the
North American Industrial Classification System (NAICS) codes, Chemical Manufacturing
(Code 325) and Petroleum and Coal Products (Code 324).
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4(b) Information Requested
EPA is establishing two information collection levels for the stewardship program. The
first level is referred to as the “basic program”, and the second level is referred to as the “indepth program.” These levels differ with regard to the information requested and the
participants. Although all participants are expected to provide the information requested for the
basic program, only some of the participants are expected to volunteer for the in-depth program.
The information requested for the basic program is discussed in section 4(b)(i), and the
information requested for the in-depth program is discussed in section 4(b)(ii) of this ICR.
4(b)(i) Basic Program
EPA is requesting that respondents provide all the information described below to the
extent it is known or reasonably ascertainable by them. EPA is not requesting that respondents
develop additional data for the basic program.. 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. Information requested includes:
1. Company name and other identifying information, address of company and site, technical
contact and related information.
2. Common or trade name of chemical.
Chemical identity and molecular structure of substance.
3. 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
4. Description of all uses including expected consumer uses.

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5. Estimate of the total amount of substance to be manufactured/imported including the
amounts for each use category.
6. Description of byproducts and impurities resulting from manufacture, process, use,
recycling, or disposal of the chemical.
7. For each type of workplace in the lifecycle, the same information requested on pp. 8-10
of the EPA PMN form (EPA Form No. 7710-25) would be helpful for releases and
exposures.
8. In addition to the properties and information identified in item 3 above, 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
9. A brief overview of the lifecycle including all workplaces that manufacture, process, or
use the nanoscale chemical and all expected consumer uses.
10. For each release point for which control technology is used, the rationale for selecting the
control, and, if available, data and measurement methods of waste treatment or
purification efficiency studies for the nanoscale material including any analytical
methods used.
11. 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.
12. For each protective equipment or engineering control listed as worker protection, the
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.
13. Information on cleaning/ reuse/disposal of used protective equipment (gloves, respirator
cartridges, etc.).
14. Additional procedures or other equipment intended to mitigate exposures to the nanoscale
material.

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15. Description of worker training and hazard communication (MSDS, other) specific to the
nanoscale material.
16. Estimate of the total number of individuals other than workers exposed to the chemical
and duration of exposure.
17. Manner or method of recycling or disposal for consumer use of products containing the
nanoscale material.
18. 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 an optional form for
participants to use, which is based on the PMN reporting form (EPA Form No. 7710-25). Copies
of both the PMN form and the optional form for this information collection request are attached
to this ICR. It is not essential that respondents use the optional form provided. 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, and may therefore find the optional
form helpful in providing the requested information under the NMSP.
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 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 recycling and waste management techniques.
4(b)(ii) The In-Depth Program
The information collection described in 4(b)(i) 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. The
in-depth 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,
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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.
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 could join at any given time, depending on OPPT’s resources and respondents’
interest in pursuing the in-depth 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;
Assessing the ability to recycle the nanoscale material and/or the products containing
the nanoscale material at their end-of-life; 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 the
testing of an individual substance that is representative of a class or classes of nanoscale
materials.

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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.

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 submission of the information on a CD-ROM reduces the reporting burden on
industry, because it is intended to reduce both the cost and the time required to enter, review, and
edit the data. Submission of the information electronically may also improve data quality
because it facilitates correcting incorrect data or adding omitted data. The Agency believes that
this approach is the most effective way of submitting the data requested under this ICR, and that
it minimizes the collection burden for the participant and for EPA to process and manage the
data submitted.
5(c)

Small Entity Flexibility

Participation in the stewardship program is voluntary, and there is nothing that would
obligate a small business to participate. If a small business does chose to participate, 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 nonfinancial assistance to manufacturers, importers, and processors of chemical substances.
Moreover, EPA has taken certain steps to minimize for all respondents the reporting burden
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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

While the submission of information under this collection is initiated by the respondents,
EPA will encourage respondents to complete basic reporting (as described in section 4(b)(i) of
this ICR) within six months of the announcement of the start of the voluntary program . This
will enable EPA to report on the response and the progress of the stewardship program, and to
begin to evaluate data received, and make further decisions or adjustments regarding the
stewardship program.

6

ESTIMATING THE BURDEN AND COST OF THE COLLECTION

The estimated burden and costs are presented in two parts to reflect the two information
collection levels for the stewardship program described in section 4(b) of this ICR. The basic
program and the in-depth program differ with regard to the information requested and the
potential participants. Although all participants are expected to provide the information
requested for the basic program, only some of the participants are expected to volunteer for the
in-depth program.
6(a)

Nanoscale Materials Stewardship Basic Program

6(a)(1) Estimates of Respondent Burden (Basic Program)
Participants in the basic reporting component of the 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 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 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 under the stewardship program and not
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the total costs for 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 the assumptions and burden estimations provided in this ICR
may not be appropriate for businesses that may not have prior experience with the chemical
regulatory system.
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 used the
information collection activities and estimates from the ICR related to the PMN form as a
baseline for this ICR, and used the PMN form as a model for creating the optional form that is
being made available for the participants in the stewardship program.
Table 1. Industry Burden Estimates for NMSP Basic Program Reporting Elements
Hours
Reporting Element
Clerical Technical Managerial
1 General instructions & manager certification; Submitter
2.5
2
1
information
2 Chemical identity info
2
7.5
1
3A Physical properties
0.5
2
0.5
3B Additional physical properties
1
4
1
4 Description of uses
0.75
3
1.5
5 Amount of substance to be manufactured/imported
0.75
1
1.5
6 Description of byproducts
0
0.5
0
7 Human exposure and environmental release
5.5
52
9.5
8 Physical properties related to understanding and
assessing exposures and releases
1
4
1
9 Overview of the lifecycles
1
10
2
10 Release point control technology
0.2
2
0.4
11 Worker exposure information
0.2
2
0.4
12 Protective equipment or engineering control
0.2
2
0.4
13 Information on cleaning/reuse/disposal of used protective
0.1
1
0.2
equipment
14 Additional procedures or other equipment intended to
0.1
1
0.2
mitigate exposures to nanoscale materials
15 Description of worker training and hazardous
communication specific
0.1
1
0.2
16 Number of individuals other than workers exposed to the
chemical and duration of exposure
0.1
1
0.2
17 Manner or method of disposal for consumer use of
products
0.2
2
0.4
18 Test data in the submitter’s possession of information on
1.5
7.2
10
health/environmental effects
Total
17.7
105.2
31.4
(a) EPA, 1994
(b) Based on best professional judgment
(c) TSCA 8(d) ICR (EPA 2006); see Table 11
1

Total
5.5
10.5
3
6
5.25
3.25
0.5
67

Source
(a)
(b)
(a)

6
13
2.6
2.6
2.6
1.3

(b)

1.3
1.3
1.3
2.6
18.7
154.3

(c)
--

Estimates exclude burdens for robust summary of studies and any post-reporting follow-up to ongoing studies
(lines 6 and 8 in Table 1 of the TSCA 8(d) ICR).

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In estimating the burdens for this 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 (EPA 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 provide the basic reporting elements
is 154.3 hours.
6(a)(2) Estimates of Respondent Cost (Basic Program)
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. The basic
methodology is described more fully in Wage Rates for Economic Analysis of the Toxics Release
Inventory Program (EPA 2002). Average wages and fringe benefits for managerial,
professional/technical, and clerical labor2 were taken from the Bureau of Labor Statistics (BLS)
Employer Costs for Employee Compensation (ECEC) data for December 2006, for the
manufacturing industries (BLS 2007). The cost of fringe benefits (such as paid leave and
insurance) specific to each labor category is taken from the same BLS series. 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.
The data used to calculate the wage rates and the results are shown in Table 2. The
estimated fully loaded wage rates are $65.36 per hour for managerial staff, $54.65 per hour for
technical staff, and $27.00 per hour for clerical staff.

2

BLS uses the Standard Occupational Classification system. A crosswalk between EPA labor categories is as
follows: EPA Managerial = BLS Management, business, and financial; EPA Technical = BLS Professional and
related; Clerical = BLS Office and administrative support.

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October 30, 2007
Table 2. Industry Labor Category and Loaded Hourly Rate
Fringe
Overhead (17% of
Wagesa Benefitsa
base wage)b
Labor Category
Managerial
$39.77
$18.83
$6.76

Loaded Wage Rate
(2006 $)
$65.36

Technical

$32.38

$16.77

$5.50

$54.65

Clerical

$16.07

$8.20

$2.73

$27.00

a
b

Source: BLS 2007.
Source: EPA 2002.

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 $8,279. These
estimates are in 2006 dollars.

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October 30, 2007
Table 3. Respondent Burden and Cost for NMSP Basic Program Reporting Elements
Hours*

Cost*
C

T

M

C

T

M

Total
Total @$27.00/hr @$54.65/hr @$65.36/hr (2006$)

2.5
2
0.5
1

2
7.5
2
4

1
1
0.5
1

5.5
10.5
3
6

$67.50
$54.00
$13.50
$27.00

$109.30
$409.88
$109.30
$218.60

$65.36
$65.36
$32.68
$65.36

$242.16
$529.24
$155.48
$310.96

0.75

3

1.5

5.25

$20.25

$163.95

$98.04

$282.24

0.75

1

1.5

3.25

$20.25

$54.65

$98.04

$172.94

0

0.5

0

0.5

$0

$27.33

$0.00

$27.33

5.5

52

9.5

67

$148.50

$2,841.80

$620.92

$3,611.22

1
1
0.2
0.2

4
10
2
2

1
2
0.4
0.4

6
13
2.6
2.6

$27.00
$27.00
$5.40
$5.40

$218.60
$546.50
$109.30
$109.30

$65.36
$130.72
$26.14
$26.14

$310.96
$704.22
$140.84
$140.84

0.2

2

0.4

2.6

$5.40

$109.30

$26.14

$140.84

0.1

1

0.2

1.3

$2.70

$54.65

$13.07

$70.42

0.1

1

0.2

1.3

$2.70

$54.65

$13.07

$70.42

0.1

1

0.2

1.3

$2.70

$54.65

$13.07

$70.42

0.1

1

0.2

1.3

$2.70

$54.65

$13.07

$70.42

0.2

2

0.4

2.6

$5.40

$109.30

$26.14

$140.84

1.5

7.2

10

18.7

$40.50

$393.48

$653.60

$1,087.58

Total
17.7 105.2 31.4 154.3
C = clerical labor; T = technical labor; and M = managerial labor.

$477.90

$5,749.18

$2,052.30

$8,279.38

Reporting Element
1 General instructions & manager
certification; Submitter information
2 Chemical identity info
3A Physical properties
3B Additional physical properties
4 Description of all uses including
expected consumer uses
5 Estimate of total amount of
substance to be
manufactured/imported including
the amount of use in each use
category
6 Description of byproduct resulting
from manufacture, process, use, or
disposal of chemical
7 Human exposure and environmental
release
8 Physical properties related to
assessing exposures and releases
9 Overview of the lifecycles
10 Release point control technology
11 Worker exposure information
12 Protective equipment or engineering
control
13 Information on
cleaning/reuse/disposal of used
protective equipment
14 Additional procedures or other
equipment intended to mitigate
exposures to nanoscale materials
15 Description of worker training and
hazardous communication specific
16 Number of individuals other than
workers exposed to the chemical
and duration of exposure
17 Manner or method of disposal for
consumer use of products
18 Test data in the submitter’s
possession of information on
health/environmental effects

Estimation of the Number of NMSP Participants and Responses
NMSP is a voluntary program. So the number of participants or potential responses to
the information collection request is as yet undetermined. The Agency’s estimate, therefore, is
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October 30, 2007
based on several assumptions. Although it is likely that these assumptions may have resulted in
an overestimate, as suggested by one commenter on the draft ICR, the Agency believes that the
estimates are reasonable given the current status of this new voluntary program.
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
Because the nanotech “industry” is not well defined, few reliable estimates of its overall
size and composition exist. 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 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 estimated to 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 incorporate materials that would be considered new
chemicals under TSCA. Further, the Wilson Center inventory covers only consumer products
and excludes many industrial applications of nanotech already in use. For these reasons, EPA
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October 30, 2007
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, there are a total of 600
nanotechnology manufacturers where 80 percent 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’ familiarity with the chemical regulatory
program and EPA, as well resources and staff availability. Further, 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 be more likely to volunteer to submit information on
nanoscale substances than small businesses. Also, EPA assumes that each large company
participating will submit information on two nanoscale substances and that each small business
participating will submit information on one nanoscale substance. 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 that each small business participating will submit information on
one nanoscale substance. As a result, over the three-year ICR period, EPA estimates 120
submissions from large businesses and 120 submissions from small businesses for a total of 240
submissions.3
Since EPA is encouraging submissions to be reported within the first six months of the
program, EPA is allocating the number of submissions by year as follows:
•
•
•

Year 1: 60% (240 * 60% = 144)
Year 2: 30% (240 * 30% = 72)
Year 3: 10% (240 * 10% = 24)

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 basic program of NMSP. The total burden for 240 responses is 36,552 hours
(154.3 hours per response * 240 responses), and the total respondent cost is $1.99 million
($8,279 per response * 240 responses). Table 4 breaks down the total burden and cost by year.

3

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

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October 30, 2007

Table 4. NMSP Basic Program Respondent Cost and Burden
Burden per
Cost per
No. of
Response
Total Response
Response
Year Responses
(hours)
Burden (hours)
($2006)
1
144
22,219
2
72
11,110
154.3
$8,279
3
24
3,703
Total
240
37,032

Total
Response
Cost ($2006)
$1,192,176
$596,088
$198,696
$1,986,960

6(a)(4) Estimated Agency Burden and Costs (Basic Program)
This section estimates the burden and cost that will be incurred by EPA in connection
with the basic reporting component of the NMSP. As the Agency develops, implements, and
operates the program, EPA will undertake a number of activities, including:
•
•
•
•
•
•

Conducting pre-submission consultations
Developing a fact sheet and other outreach materials
Reviewing and discussing submissions
Filing and storing submissions
Analyzing requests for confidentiality and providing appropriate protection
Writing a summary report of the NMSP basic program.

Agency Burdens
EPA estimated the Agency burdens associated with the NMSP basic program are based
upon the burdens estimated for the PMN program (EPA 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 Table 5, EPA’s estimated burden per submission is 22.2 hours.
EPA also estimates a one-time burden of 60 hours to develop and distribute a fact sheet about the
NMSP and 300 hours to write a summary report on the NMSP basic program (not shown in
Table 5). Burden for the fact sheet and outreach material is allocated to Year 1, while the burden
for the summary report is split between years 2 and 3.
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. EPA assumes that these activities are accomplished by a GS-13, Step 5 federal
employee (EPA 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 (EPA 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.

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October 30, 2007
Table 5. Agency Activities and Estimated Burden per Response
Burden
Review Step
Description
(Hours)
1 Pre-submission These discussions allow potential submitters and the Agency to
4.8
consultations communicate any issues pertaining to the submission.
2 Administrative The Agency performs an administrative review of each submission
4.8
prescreen /
to verify information received and logs the receipt of data.
submission
receipt
3 Chemical
An Agency chemist conducts an initial chemistry review and
5
Review and
prepares a summary report, during which the physiochemical
Search
properties of the substance have been verified. This report is
Strategy
presented at a CRSS meeting, where the chemistry needed for
subsequent hazard and risk assessments is discussed and evaluated
(CRSS)
by Agency staff.
4 Structure
Based on the information gathered in previous steps, the Agency
3
Activity Team convenes a SAT meeting to assess the potential hazards and risk of
(SAT)
the substance and assign a level of concern.
5 Engineering The Agency also reviews the areas of environmental fate, human
1.2
and exposure toxicity, and ecological effects by reviewing submitted data and
identification researching other published research.
6 Exposure and During this phase of the Agency’s review, staff estimates the degree
1.6
Fate
of human exposure and environmental exposure.
Evaluation
7 Focus Meeting The Agency characterizes and discusses the risk posed by the
1.8
substance and determines the risk of the substance.
Total
22.2
Note: The table does not include one-time costs associated with preparing and distributing a fact sheet regarding
NMSP and a summary report on the NMSP (estimated at 360 hours).

Table 6. Agency Burden and Costs per Response Under the NMSP Basic Program
Total Cost
(2006$)
Review Step
Hours
1 Pre-submission consultations
4.8
$322.56
2 Administrative prescreen / submission receipt
3 CRSS
4 SAT
5 Engineering/Exposure
6 Exposure/Fate
7 Focus Meeting
Total

4.8
5.0
1.2
3.0
1.6
1.8
22.2

$322.56
$ 336.00
$80.64
$201.60
$107.52
$120.96
$1,491.84

Note: Assumes activities are accomplished by GS-13, Step 5 employee at a loaded rate of $67.20/hr.
Calculations do not include one-time Agency costs.

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October 30, 2007
Total Agency Burdens and Costs (Basic Program)
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 Tables 7
and 8 include one-time costs (e.g., outreach materials and summary report). The total agency
burden is 5,688 hours and the total Agency cost is $380,952.
Table 7. Agency Burden Associated with the NMSP Basic Program
Burden per
Burden for
No. of
Response
Total Response One Time
Year Responses
(hours)
Burden (hours)
Tasks
1
144
3,197
60
2
72
1,598
150
22.2
3
24
533
150
Total
240
5,328
360

Total
Burden
3,257
1,748
683
5,688

Table 8. Agency Cost Associated with the NMSP Basic Program
Cost per
Cost for
No. of
Response
Total Response One Time
Year Responses
(hours)
Cost (hours)
Tasks
1
144
$214,848
$4,032
2
72
$107,424
$10,080
$1,492
3
24
$35,808
$10,080
$24,192
Total
240
$358,080

Total
Burden
(2006$)
$218,880
$117,504
$45,888
$382,272

6(a)(5) Total Annual Burden and Cost Estimates for the Basic Program
The total estimated industry burden, from Table 4, is 37,032 hours and the total estimated
costs are $1.99 million. The total estimated Agency burden for administering the NMSP, from
Table 7, is 5,688 hours and, from Table 8, the total estimated cost is $382,272.
Over the three-year ICR period the total combined burden (industry and Agency) is
estimated at 42,720 hours and the total combined cost (industry and Agency) is estimated at
$2.37 million. In Table 9, the annual burden and cost are presented for each year of the ICR.
Table 9. NMSP Basic Program Burden and Costs for Industry and Agency
Year 1
Year 2
Year 3
Total
Entity
Burden
Burden
Burden
Burden
Type
(Hours)
Cost
(Hours)
Cost
(Hours)
Cost
(Hours)
Cost
Industry 22,219 $1,192,176 11,110 $596,088
3,703 $198,696 37,032 $1,986,960
Agency
3,257
$218,880
1,748 $117,504
683 $45,888
5,688
$382,272
Total
25,476 $1,411,056 12,858 $713,592
4,386 $244,584 42,720 $2,369,232

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October 30, 2007
6(b)

Nanoscale Materials Stewardship In-Depth 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 specific in-depth
program’s elements 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 (EPA 2002). 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, the Agency 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
the generation and submission of data, 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 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.

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October 30, 2007
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
each robust summary requires 15 hours of technical time and 5 hours of clerical time each. This
estimate results in 20 hours per robust summary (see Table 10). Assuming 15 substances are
enrolled in the program, which on average will include five robust summaries, a total of 75 (i.e.,
15 * 5) robust summaries will be prepared. Total burden related to robust summaries per
substance is 1,500 (75 * 20) hours.
Table 10. Respondent Burdens for the In-Depth NMSP Reporting Elements
Hours per Element
Program Element
Clerical
Technical
Managerial
Total
Robust summaries
(hazard assessments)*
5
15
0
20
Prelim: 50
Prelim: 425
Prelim: 25
Prelim: 500
Final: 100
Final: 850
Final: 50
Final: 1,000
Exposure assessments
Total: 150
Total: 1,275
Total: 75
Total: 1,500
Prelim: 30
Prelim: 255
Prelim: 15
Prelim: 300
Final: 50
Final: 425
Final: 25
Final: 500
Risk assessments
Total: 80
Total: 680
Total: 40
Total: 800
Action plans and
summary
10
85
5
100
* Burden estimate is per robust summary. The Agency expects an average of five robust summaries to be developed
per substance.

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 hours, and 25 managerial hours) 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 hours,
100 clerical hours, 50 managerial hours). EPA further assumes that the burden estimates for
these assessments include the paperwork burden associated with summarizing any monitoring or
exposure testing conducted. As presented in Table 10, total burden related to exposure
assessments per substance is 1,500 hours.
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 hours, 30 clerical hours, and 15 managerial
Page 22 of 28

October 30, 2007
hours). 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 hours, 50 clerical hours, 25
managerial hours). The risk assessments represent a burden of 800 hours per substance (see
Table 10).
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 hours, 10 clerical hours, and 5 managerial hours) per substance. These burdens are
detailed in Table 10.
6(b)(2) Estimates of Respondent Cost (In-Depth Program)
Table 11 combines estimates of respondent burden (Table 10) with appropriate Industry
labor rates (from Table 2) to estimate the respondent cost of the In-Depth NMSP reporting
elements.
Table 11. Respondent Cost for the In-Depth NMSP Reporting Elements
Labor Cost per Element
Clerical
Technical
Managerial
Total Cost
Program Element
($27.00/hr)
($54.65/hr)
($65.36/hr)
(2006$)
Robust summaries
(hazard assessments)*
$135
$820
$0
$955
Exposure assessments
$4,050
$69,679
$4,902
$78,631
Risk assessments
$2,160
$37,162
$2,614
$41,936
Action plans and
summary
$270
$4,645
$327
$5,242
* 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 12, the
estimated burden per response is 2,500 hours and the total estimated cost per response is
$130,584.

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October 30, 2007
Table 12. Respondent Burden and Cost for the In-Depth NMSP Reporting Elements
Burden and Cost per
Burden and Cost Per
Element
Response
No. of Elements
Reporting Element
per Response
Burden
Cost
Burden
Cost
Robust summaries
(hazard assessments)*
20
$955
5
100
$4,775
Exposure assessments
1,500
$78,631
1,500
$78,631
Risk assessments
800
$41,936
800
$41,936
1
Action plans and
summary
100
$5,242
100
$5,242
Total
2,500
$130,584
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 13, the total
estimated respondent burden is 37,500 hours and the total estimated respondent cost is $1.96
million.
Table 13. Total Respondent Burden and Cost for the In-Depth NMSP
Burden and Cost per
Response
No. of
Reporting Element
Responses
Burden
Cost
Robust summaries (hazard
assessments)
100
$4,775
Exposure assessments
1,500
$78,631
15
Risk assessments
800
$41,936
Action plans and summary
100
$5,242
Total
2,500
$130,584

Total
Burden and Cost
Burden
Cost
1,500
22,500
12,000
1,500
37,500

$71,625
$1,179,465
$629,040
$78,630
$1,958,760

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. Again it is important to 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 14. The Agency
cost associated with this burden is $45,778.

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October 30, 2007
Table 14. Agency Burden and Cost for the In-Depth NMSP
Item
GS-15, Step 1
GS-14, Step 1
GS-11, Step 1
Labor rate ($/hr)
$82.43
$70.08
$41.60
Hours
Cost
Hours
Cost
Hours Cost
Hours and cost
295
$24,317
235
$16,469
120
$4,992

Total
Hours
Cost
650
$45,778

Note: Agency personnel hourly wage rates are taken from the 2006 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 $1.96 million. On an annual basis, the combined industry and Agency burden is
12,717 hours and the combined industry and Agency cost is $668,179. These totals are shown in
Table 15.
Table 15. In-Depth NMSP Burdens and Costs, Total and Annual
Total (3 Years)
Annual
Burden
Burden
Entity Type
(Hours)
Cost
(Hours)
Cost
Industry
37,500
$1,958,760
12,500
$652,920
Agency
650
$45,778
217
$15,259
Total
38,150
$2,004,538
12,717
$668,179
6(c) Total and Annual Burden and Cost Estimates, Basic NMSP and In-Depth
NMSP
As shown in Table 16, the total combined burden (industry and Agency) for both the
Basic NMSP and In-Depth NMSP is estimated at 80,393 hours and the total combined cost
(industry and Agency) is estimated at $4.34 million. Table 17 lists the burden and cost on an
annual basis, the combined burden (industry and Agency) for both the NMSP and In-Depth
NMSP (based on Tables 9 and 15).
Table 16. Total Burden and Cost, Basic NMSP and In-Depth NMSP
Entity
Basic NMSP
In-Depth NMSP
Type
Burden
Cost
Burden
Cost
Industry
37,032
$1,986,960
37,500
$1,958,760
Agency
5,688
$382,272
650
$45,778
Total
42,720
$2,369,232
38,150
$2,004,538

Total
Burden
74,532
6,338
80,870

Cost
$3,945,720
$428,050
$4,373,770

Table 17. Annual Burden and Cost, Basic NMSP and In-Depth NMSP, by Year
Year 1
Year 2
Year 3
Total
Entity
Burden
Burden
Burden
Burden
Type
(Hours)
Cost
(Hours)
Cost
(Hours)
Cost
(Hours)
Cost
Industry 34,719 $1,845,096 23,610 $1,249,008 16,203 $851,616 74,532 $3,945,720
Agency
3,474
$234,139
1,965
$132,763
900
$61,147
6,339
$428,049
Total
38,193 $2,079,235 25,575 $1,381,771 17,103 $912,763 80,871 $4,373,769
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October 30, 2007

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 154.3
hours per response for the Basic NMSP, and 2,500 hours for the In-Depth NMSP, based on 240
responses for the Basic NMSP and 15 responses for the In-Depth NMSP. According to the
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
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-OPPT2007-0572 in any correspondence.

7

REFERENCES

The following is a list of the documents that are specifically referenced in this document,
along with information about where to access the documents directly (copies are available in the
docket for this ICR, or online as listed in the reference):

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October 30, 2007
BLS 2007. Bureau of Labor Statistics. Employer Costs for Employee Compensation –
Supplemental Tables: December 2006. Office of Compensation Levels and Trends. March 29.
EPA 2006. U.S Environmental Protection Agency Economic Analysis of the Addition of
Chemicals from the 55th, 56th, and 58th ITC Report to the 8(d) Health and Safety Data
Reporting Rule. Office of Pollution Prevention and Toxics; Economics, Exposure, and
Technology Division. July 10. Available in Docket: EPA-HQ-OPPT-2005-0055.
EPA 2002. U.S Environmental Protection Agency. Supporting Statement for a Request for
OMB Review under the Paperwork Reduction Act: Data Submissions for the Voluntary
Children’s Chemical Evaluation Program, April. http://www.epa.gov/EPATOX/2002/April/Day-16/o-t9221.htm
EPA 2002. U.S. Environmental Protection Agency. Wage Rates for Economic Analysis of the
Toxics Release Inventory Program. Office of Environmental Information, Environmental
Analysis Division, Analytical Support Branch. June 10, 2002.
EPA 1994. U.S. Environmental Protection Agency. Regulatory Impact Analysis of Amendments
to Regulations for TSCA Section 5 Premanufacture Notifications. Washington, DC: Office of
Pollution Prevention and Toxics; Economics, Exposure, and Technology Division; Regulatory
Impacts Branch, September 9, 1994.
NCMS 2006. National Center for Manufacturing Sciences, 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. http://www.nano.gov/html/facts/appsprod.html
NPPTAC 2005. Overview of Issues for Consideration by NPPTAC. Document ID EPA-HQOPPT-2002-0001-0068. http://www.regulations.gov/fdmspublic/component/main
OPM 2006. Salary Table 2006 DCB, for the Locality Pay Area of Washington-BaltimoreNorthern Virginia, DC-MD-PA-VA-WV. U.S. Office of Personnel Management.
http://www.opm.gov/oca/06tables/html/dcb_h.asp
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.
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.
http://www.nanotechproject.org/index.php?id=46
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October 30, 2007

8

ATTACHMENTS TO THE SUPPORTING STATEMENT

The attachments listed below can be found in the docket for this ICR, which is accessible
electronically through www.regulations.gov under Docket ID No. EPA-HQ-OPPT-2007-0572.
Attachment
A
B
C
D

Description
TSCA Section 5 authority
TSCA Section 8 authority
Optional Reporting Form for NMSP Base Program
Premanufacture Notice Submission Form (Already Approved under 2070-0012)

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