October 30, 2007 

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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). 
October 30, 2007 

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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 
October 30, 2007 

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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 Total Source

1 General instructions & manager certification; Submitter 

information 2.5 2 1 5.5 

2 Chemical identity info 2 7.5 1 10.5 

3A Physical properties 0.5 2 0.5 3 

(a) 

3B Additional physical properties 1 4 1 6 (b) 

4 Description of uses 0.75 3 1.5 5.25 

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 

(a) 

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 

(b) 

18 Test data in the submitter’s possession of information on 

health/environmental effects 1.5 7.2 10 18.7 (c) 

Total 17.7 105.2 31.4 154.3 -- 

(a) EPA, 1994 

(b) Based on best professional judgment 

(c) TSCA 8(d) ICR (EPA 2006); see Table 11

 

1

 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). 
October 30, 2007 

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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. 
October 30, 2007 

Page 14 of 28 

Table 2. Industry Labor Category and Loaded Hourly Rate 

Labor Category Wagesa

Fringe 

Benefitsa

Overhead (17% of 

base wage)b

Loaded Wage Rate 

(2006 $) 

Managerial $39.77 $18.83 $6.76 $65.36 

Technical $32.38 $16.77 $5.50 $54.65 

Clerical $16.07 $8.20 $2.73 $27.00 a

 Source: BLS 2007. 

b

 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. 
October 30, 2007 

Page 15 of 28 

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

Hours* Cost* 

C T M 

Reporting Element C T M Total @$27.00/hr@$54.65/hr @$65.36/hr

Total 

(2006$) 

1 General instructions & manager 

certification; Submitter information 2.5 2 1 5.5 $67.50 $109.30 $65.36 $242.16 

2 Chemical identity info 2 7.5 1 10.5 $54.00 $409.88 $65.36 $529.24 

3A Physical properties 0.5 2 0.5 3 $13.50 $109.30 $32.68 $155.48 

3B Additional physical properties 1 4 1 6 $27.00 $218.60 $65.36 $310.96 

4 Description of all uses including 

expected consumer uses 0.75 3 1.5 5.25 $20.25 $163.95 $98.04 $282.24 

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 $20.25 $54.65 $98.04 $172.94 

6 Description of byproduct resulting 

from manufacture, process, use, or 

disposal of chemical 0 0.5 0 0.5 $0 $27.33 $0.00 $27.33 

7 Human exposure and environmental 

release 5.5 52 9.5 67 $148.50 $2,841.80 $620.92 $3,611.22

8 Physical properties related to 

assessing exposures and releases 1 4 1 6 $27.00 $218.60 $65.36 $310.96 

9 Overview of the lifecycles 1 10 2 13 $27.00 $546.50 $130.72 $704.22 

10 Release point control technology 0.2 2 0.4 2.6 $5.40 $109.30 $26.14 $140.84 

11 Worker exposure information 0.2 2 0.4 2.6 $5.40 $109.30 $26.14 $140.84 

12 Protective equipment or engineering 

control 0.2 2 0.4 2.6 $5.40 $109.30 $26.14 $140.84 

13 Information on 

cleaning/reuse/disposal of used 

protective equipment 0.1 1 0.2 1.3 $2.70 $54.65 $13.07 $70.42 

14 Additional procedures or other 

equipment intended to mitigate 

exposures to nanoscale materials 0.1 1 0.2 1.3 $2.70 $54.65 $13.07 $70.42 

15 Description of worker training and 

hazardous communication specific 0.1 1 0.2 1.3 $2.70 $54.65 $13.07 $70.42 

16 Number of individuals other than 

workers exposed to the chemical 

and duration of exposure 0.1 1 0.2 1.3 $2.70 $54.65 $13.07 $70.42 

17 Manner or method of disposal for 

consumer use of products 0.2 2 0.4 2.6 $5.40 $109.30 $26.14 $140.84 

18 Test data in the submitter’s 

possession of information on 

health/environmental effects 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 $477.90 $5,749.18 $2,052.30 $8,279.38

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

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 
October 30, 2007 

Page 16 of 28 

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 
October 30, 2007 

Page 17 of 28 

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. 
October 30, 2007 

Page 18 of 28 

Table 4. NMSP Basic Program Respondent Cost and Burden 

Year 

No. of 

Responses 

Burden per 

Response 

(hours) 

Total Response 

Burden (hours)

Cost per 

Response 

($2006) 

Total 

Response 

Cost ($2006) 

1 144 22,219 $1,192,176 

2 72 11,110 $596,088 

3 24 3,703 $198,696 

Total 240 

154.3 

37,032 

$8,279 

$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. 
October 30, 2007 

Page 19 of 28 

Table 5. Agency Activities and Estimated Burden per Response

Review Step Description 

Burden 

(Hours)

1 Pre-submission 

consultations 

These discussions allow potential submitters and the Agency to 

communicate any issues pertaining to the submission. 

4.8 

2 Administrative 

prescreen / 

submission 

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 Structure 

Activity Team 

(SAT) 

Based 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. 

3 

5 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. 

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: 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 

Review Step Hours 

Total Cost 

(2006$) 

1 Pre-submission consultations 4.8 $322.56 

2 Administrative prescreen / submission receipt 4.8 $322.56 

3 CRSS 5.0 $ 336.00 

4 SAT 1.2 $80.64 

5 Engineering/Exposure 3.0 $201.60 

6 Exposure/Fate 1.6 $107.52 

7 Focus Meeting 1.8 $120.96 

Total 22.2 $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. 
October 30, 2007 

Page 20 of 28 

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

Year 

No. of 

Responses 

Burden per 

Response 

(hours) 

Total Response 

Burden (hours)

Burden for 

One Time 

Tasks 

Total 

Burden 

1 144 3,197 60 3,257 

2 72 1,598 150 1,748 

3 24 533 150 683 

Total 240 

22.2 

5,328 360 5,688 

Table 8. Agency Cost Associated with the NMSP Basic Program

Year 

No. of 

Responses 

Cost per 

Response 

(hours) 

Total Response 

Cost (hours) 

Cost for 

One Time 

Tasks 

Total 

Burden 

(2006$) 

1 144 $214,848 $4,032 $218,880 

2 72 $107,424 $10,080 $117,504 

3 24 $35,808 $10,080 $45,888 

Total 240 

$1,492 

$358,080 $24,192 $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 

Type 

Burden 

(Hours) Cost 

Burden 

(Hours) Cost 

Burden 

(Hours) Cost 

Burden 

(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
October 30, 2007 

Page 21 of 28 

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. 
October 30, 2007 

Page 22 of 28 

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 

Exposure assessments 

Prelim: 50 

Final: 100

Total: 150 

Prelim: 425 

Final: 850

Total: 1,275 

Prelim: 25 

Final: 50

Total: 75 

Prelim: 500 

Final: 1,000

Total: 1,500 

Risk assessments 

Prelim: 30 

Final: 50

Total: 80 

Prelim: 255 

Final: 425

Total: 680 

Prelim: 15 

Final: 25

Total: 40 

Prelim: 300 

Final: 500

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 
October 30, 2007 

Page 23 of 28 

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 

Program Element 

Clerical 

($27.00/hr) 

Technical 

($54.65/hr) 

Managerial 

($65.36/hr) 

Total Cost 

(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. 
October 30, 2007 

Page 24 of 28 

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

Burden and Cost per 

Element 

Burden and Cost Per 

Response 

Reporting Element Burden Cost 

No. of Elements 

per Response 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 

Action plans and 

summary 100 $5,242 

1 

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 

Total 

Burden and Cost 

Reporting Element Burden Cost 

No. of 

Responses Burden Cost 

Robust summaries (hazard 

assessments) 100 $4,775 1,500 $71,625 

Exposure assessments 1,500 $78,631 22,500 $1,179,465

Risk assessments 800 $41,936 12,000 $629,040 

Action plans and summary 100 $5,242 1,500 $78,630 

Total 2,500 $130,584 

15 

37,500 $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. 
October 30, 2007 

Page 25 of 28 

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 Total 

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 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 

Entity Type 

Burden 

(Hours) Cost 

Burden 

(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 Total 

Type Burden Cost Burden Cost Burden Cost 

Industry 37,032 $1,986,960 37,500 $1,958,760 74,532 $3,945,720 

Agency 5,688 $382,272 650 $45,778 6,338 $428,050 

Total 42,720 $2,369,232 38,150 $2,004,538 80,870 $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 

Type 

Burden 

(Hours) Cost 

Burden 

(Hours) Cost 

Burden 

(Hours) Cost 

Burden 

(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
October 30, 2007 

Page 26 of 28 

 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): 
October 30, 2007 

Page 27 of 28 

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
October 30, 2007 

Page 28 of 28 

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 Description

A TSCA Section 5 authority 

B TSCA Section 8 authority 

C Optional Reporting Form for NMSP Base Program 

D Premanufacture Notice Submission Form (Already Approved under 2070-0012)