October 30, 2007

Page 1 of 28 SUPPORTING STATEMENT FOR AN
INFORMATION COLLECTI ON REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title of the Information Collection

Title: Information Collection in Suppo rt 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 informati on collection to assemble existing data and information from manufacturers, importers, a nd processors of nanoscale materials regulated under the Toxic Substances Control Act (TSCA). EP A will also collaborate with manufacturers, importers, and processors of nanoscale materials in an effort to generate more detailed information of certain specific na noscale materials. Under this second effort, OPPT and industry will work together to generate data and anal yses that will more fully characterize certain nanoscale materials to increase understanding of the environmental health and safety implications of manufactur ed nanoscale materials.

This collection of information will info rm the process by which EPA establishes appropriate chemical management efforts to pr otect human health and the environment from
unreasonable risk from nanoscale materials. Th is collection will faci litate and support EPA’s Stewardship Program for Nanoscale Materials, which includes indus try and the interested public in characterizing the safe manufacture, processi ng, distribution, use, st orage, 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 chemi cal substances organized in structures in the scale of approximately 1 to 100 nanometers, and may have differe nt organizations and properties than the same chemical substances in a larger size. Nanoscal e materials can be found in electronics, sunscreens, cosmetics, automotiv e, and medical products, as well as paints and coatings, metal-cutting tools, sports equipment, stain-free clothing and ma ttresses, 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 pr edicts that the market worldwide for nanotechnology products and services will r each $1 trillion by 2015. Nanotechnology is expected to transform virtually ever y 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 TS CA for potential human health and environmentalOctober 30, 2007

Page 2 of 28 risks before they are manufactur ed and enter commerce. Other nanoscale materials have the same molecular identity as chemical substances already on the TSCA Inve ntory and, as such, are not subject to new chemical notification. The a pplication of TSCA §5 ne w chemical authorities
to nanoscale materials is curren tly under consideration within EP A. The Agency has authority under TSCA §8(a) to collect inform ation regarding chemicals alrea dy in commerce. While the stewardship program is focused on nanoscale ma terials already in commerce, it could also include nanoscale materials that would be report able 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 da ta available on these types of subs tances. As of this date, there has been no other effort to systematically co llect comprehensive information on the properties
and characteristics of nanoscale materials.

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

• Encourage responsible developm ent 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 need ed 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 st ewardship program will provide important
baseline information on health and environmen tal effects, exposures, risks, management practices, and data needs that will assist EPA and others in properly assessing and managing
risks related to nanoscale material s. Non-confidential por tions of this information will also be made available to help the public understa nd how nanoscale material s 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 manage ment, 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 acti ons, or should otherwise be treated as a lower priority for further consideration.October 30, 2007

Page 3 of 28 The data may also be used by other Federal agencies. Non-confiden tial portions of this information may be used by the public, academics, St ates, local and tribal government, as well as foreign governments and inte rnational organizations.

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

3(a) Non-Duplication

There has been no other effort to systemati cally collect such information about nanoscale
materials.

3(b) Public Notice Required Pr ior 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 th e ICR but noted that the estimates of the number of NMSP participants and responses ma y be too high and that EPA should not measure success of the program based on the estimated number of participan ts. As the commenter did not offer any basis for an alternative estimate, EP A 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 firm s and assumed a certain percentage have nanoscale materials that could be reported unde r the program, EPA acknowledges that they could
be an overestimate.

Two commenters noted that the proposed re porting form could be a considerable burden to fill out especially for smaller entities. Wh en developing the optional form, EPA considered that it might not be suitable for all particip ants, 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 provide s 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, par ticipants 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 re gulated and which do not, the data had to meet the Data Quality Act Guidelines and other EPA Qu ality 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, th e 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 whic h nanoscale materials are produced, in what quantities they are produced, how they are used, and the data that is available for such materials.October 30, 2007

Page 4 of 28 EPA scientists will use data collected through this program, wh ere appropriate, to aid in determining how and whether cer tain nanoscale materials or categories of nanoscale materials may present risks to human health and the envi ronment. EPA will use the data to build new assessment models or incorporate the data into ex isting 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 pu rposes. 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 firs t year of the program a nd less burden in the last two years, because EPA is encouraging repor ting within the first six months of the announcement of the program. This change doe s not reflect a change in the total burden estimate. EPA has also updated some burden estima tes 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 NM SP. 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 Novemb er 23, 2005, the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) provide d to EPA for consideration an Overview
Document on Nanoscale Material s (NPPTAC 2005). The June 23, 2005, public meeting and the
NPPTAC Overview Document elicited broad stak eholder support for the idea of a stewardship program which identified specific issues relevant to the prog ram that EPA is considering.

As described in the NPPTAC Overview Docu ment, 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 mate rials on September 6-7, 2007. The approach is consistent with OMB Memorandum dated Sept ember 19, 2007 “Updated Principles for Risk Analysis.” EPA also conducted another pub lic 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 an d 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.October 30, 2007

Page 5 of 28 3(d) Effects of Less Frequent Collection

There is no set frequency of submissi on under this voluntary information collection request. Participants in the voluntary program (i .e., the manufacturers, importers, and processors of nanoscale materials) will determine whethe r and when to submit information under this program, including whether to submit all of the info rmation 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 collec tion option for the Agency to consider.

3(e) Compliance with General OMB Guidelines

This collection of information is consis tent with all OMB guidelines under 5 CFR 1320.6, and OMB Guidance.

3(f) Confidentiality

If respondents wish to claim information s ubmitted as confidentia l business information (CBI), they may do so at the time of subm ission. Respondents may clai m 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 stew ardship 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 Pr otection Manual (October 2003 editi on), 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 stewardshi p program does not in clude questions of a
sensitive nature.

3(h) Electronic Reporting

.

Submitters are asked to provide informati on 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 expens es for EPA and respondents, it is not feasible
to devise a direct electronic submission sc heme 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 Syst em (NAICS) codes, Chemical Manufacturing (Code 325) and Petroleum and Coal Products (Code 324).October 30, 2007

Page 6 of 28 4(b) Information Requested

EPA is establishing two information collecti on 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 re gard to the information requested and the participants. Although all particip ants are expected to provide the information requested for the basic program, only some of the participants are expected to volunteer fo r the in-depth program. The information requested for the basic progra m is discussed in sec tion 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 re questing that respondents develop additional data for the basic program.. If the information requested is not available or applicable to the nanoscale s ubstance, 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. In formation requested includes:

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

2. Common or trade name of chemical. Chemical identity and molecula r structure of substance.

3. The following physical and environmental fa te properties and information would be helpful to characterize the nanoscale ma terial 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 distributi on Octanol/water partition coefficient Henry’s Law constant Volatilization from water pH Volatilization from soil Flammability Explodability Adsorption coefficient Shape Agglomeration state/disp ersion state Crystal structure Chemical composition – includ ing spatially averaged (bul k) and spatially resolved heterogeneous composition Surface area Surface chemistry Surface charge Porosity

4. Description of all uses incl uding expected consumer uses.October 30, 2007

Page 7 of 28 5. Estimate of the total amount of substan ce to be manufactured/imported including the amounts for each use category.

6. Description of byproducts and impurities resu lting from manufactur e, 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 informati on identified in item 3 above, the following physical properties would be helpful fo r understanding and assessing exposures and
releases:

surface reactivity av erage particle weight average particle surface ar ea rate of sorption aggregation rate of diffusion wet and dry transport ra te 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 technol ogy is used, the rationale for selecting the control, and, if available, data and m easurement methods of waste treatment or purification efficiency studies for the na noscale material including any analytical
methods used.

11. Regarding worker exposure information, pe rsonal or area monitoring data (in mass concentrations, surface area per mass, number of particles, et c.) for the nanoscale material, including the measurement me thod(s) used to generate the data.

12. For each protective equipment or engineeri ng control listed as worker protection, the rationale for selecting the pr otective equipment or engineer ing 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 us ed protective equipment (gloves, respirator cartridges, etc.).

14. Additional procedures or other equipment inte nded to mitigate exposures to the nanoscale
material.October 30, 2007

Page 8 of 28 15. Description of worker training and hazard co mmunication (MSDS, other) specific to the
nanoscale material.

16. Estimate of the total number of individuals ot her 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 characterizat ion of the nanoscale material in the subject organism and test medium.

To facilitate this information collection re quest, EPA has developed an optional form for participants to use, which is based on the PM N reporting form (EPA Form No. 7710-25). Copies of both the PMN form and the optional form for th is information collection request are attached to this ICR. It is not essential that respondent s use the optional form provided. By supplying the
information described in the form to the ex tent it is known or reas onably ascertainable, respondents do not incur the burden of providing unn ecessary 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 facilit ating 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 ev aluating the nanoscale material. For example, respondents may identify pollution prevention tec hniques 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 comp arison 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 ma terials’ properties, details on their production and use, and descriptions of existing risk manageme nt practices. In an effort to generate a more detailed view of certain specific nanoscale material s following an analysis of data from the basic program, EPA is proposing to collaborate with so me 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 comme rce, 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 ma terials in commerce. EPA, respondents and other stakeholders will then use these data to help assess hazard, exposure,October 30, 2007

Page 9 of 28 and ultimately, risk in the contex t of the entire product chain and life-cycle. This evaluation will assist EPA, respondents, and othe rs in working towards a suite of protective risk management practices and developing better risk-assessm ent protocols, tools, and methodologies.

As envisioned, the data needed to meet the goals for such a program could require testing for material characterization, h ealth and environmental hazard te sting, monitoring of exposures and releases, and testing of protective equipment. EPA would determine the specific data needs and regimen of testing in consul tation 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 cr iteria for consideration could include: production volume , potential for exposure, life-cycle/di sposal considerations, data gaps (or conversely, the availability of data), the po tential for information gathered on one nanoscale substance to shed light on others, and any other criteria that could a ffect either the risk profile of
the nanoscale substance or the ab ility of EPA to effectively over see other TSCA applications. For example, a particular type of carbon nanot ube (CNT) that has been well-characterized and subject to health testing, and that also appears in many pr oducts, 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 pr oducing 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 progr am 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 coul d 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 protectiv e equipment and treatment technologies;

• Assessing the ability to recy cle the nanoscale material an d/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 pr ivate groups. EPA would also consider the testing of an individual substa nce that is representative of a class or classes of nanoscale
materials.October 30, 2007

Page 10 of 28 At the completion of the action plan, EPA and participants with input from other stakeholders will again meet to review the in formation gathered; conduct further assessments; develop and apply appropriate ri sk-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 co ntext 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 re port of the data submitted.

5(b) Collection Methodology and Management

EPA encourages submission of data by elec tronic 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 partic ipant 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 assi stance 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 t echnical and other nonfinancial assistance to manufacturers, importers , and processors of chemical substances. Moreover, EPA has taken certain steps to mi nimize for all respondents the reporting burdenOctober 30, 2007

Page 11 of 28 associated with this collection. Finally, EPA will provide the se rvices 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 th is 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 vol untary program . This will enable EPA to report on the response and th e progress of the stewardship program, and to begin to evaluate data receive d, 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 stewards hip program described in section 4(b) of this ICR. The basic program and the in-depth program differ with regard to the informa tion 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 Responde nt Burden (Basic Program)

Participants in the basic reporting component of the Na noscale 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 fo r each activity are calc ulated 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 multip lied 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 subm itting the requested inform ation 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 othe r employee duties that require familiarity with EPA, State, and other Federal agency requests for chemical in formation 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 notOctober 30, 2007

Page 12 of 28 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 accoun ting 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 partic ipants in the stewardship program.

Table 1. Industry Burden Estimates for NM SP 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 1 1

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

Page 13 of 28 In estimating the burdens for this ICR, EPA assumed the high end of the burden range estimated in the PMN regulatory impact assess ment for those reporting elements that are identical to the PMN form (EPA 1994). To esti mate 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 st aff working with the nanotech industry. The estimates for reporting elements 3b and 8-17 are thus based on best professi onal judgment (BPJ).

For reporting element 18, the submitter is reque sted 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 utili zed the burden estimates from the TSCA Section 8(d) ICR, which covers the Health an d Safety Data Reporting Rule (EPA 2006).

In summary, the estimated burden per responde nt 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, techni cal, and clerical pe rsonnel are derived by combining data on wages and fringe benefits wi th estimates of overhead rates. The basic methodology is described more fully in Wage Rates for Economic Anal ysis of the Toxics Release Inventory Program (EPA 2002). Average wages and fringe benefits for managerial, professional/technical, and clerical labor 2 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 benef its (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 wage s to account for overhead. The fringe benefits loading factor and the overhead loading factor ar e then added to the base wage to calculate a fully loaded wage rate.

The data used to calculate the wage rate s and the results are shown in Table 2. The estimated fully loaded wage rates are $65.36 pe r hour for managerial staff, $54.65 per hour for technical staff, and $27.00 pe r hour for clerical staff.

2 BLS uses the Standard Occupational Classification sy stem. 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 Wages a Fringe
Benefits a 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 to tal 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@$54.6 5/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 NM SP 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 Agen cy’s estimate, therefore, isOctober 30, 2007

Page 16 of 28 based on several assumptions. Alth ough 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 separa te industry within the North American Industrial Classification System (NAICS). Rather, nanotechno logy encompasses a range of technologies that are deployed across a br oad spectrum of industries including:

• Electronics

• Health Sciences

• Materials

• Environment

• Energy

Because the nanotech “industry” is not well de fined, 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 i ndustry based on data from the National Science Foundation (NSF). The NSF estimates are base d 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 estim ates that 42 percent are involved in the manufacturing or application of nanoscale mate rials (Roco 2005). The remainder of the industry is composed of specialized serv ice providers (legal, financial), research organizations and trade associations, government entities and equipment vendors. Thus, based on these data sources the total universe of companies ma nufacturing and applying nanotech was estimated to about 600 firms in 2005 (1,455 x 0.42 = 611).

Not all of the nanoscale materials manufact ured, 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 pr oducts already on the market, the Woodrow Wilson International Center’s Project on Emerging Nanotechnologies estimates that approximately one-third of existing products wo uld 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 Pr oduct Safety Commission (e.g., garments; sporting goods) (Wilson Center 2006). However, it is impo rtant to note that th is 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 Cent er inventory covers only consumer products and excludes many industrial app lications of nanotech already in use. For these reasons, EPAOctober 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 Manuf acturing Sciences, ther e are a total of 600 nanotechnology manufacturers wher e 80 percent are small busine sses with less than 20 staff (NCMS 2006). If this distribution is representative of the firms th at 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 th at the program particip ation rate for large nanotech businesses will be greater than that for small businesses. A number of factors will probably contribute to this, including large comp anies’ familiarity with the chemical regulatory program and EPA, as well resources and staff av ailability. Further, EP A’s experience suggests that large businesses tend to account for a majo rity 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 nanos cale 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 res ponses from 60 large businesses and 120 small
businesses over the thr ee-year ICR period.

EPA further assumes that each large compa ny 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 submi ssions from small businesses for a total of 240
submissions. 3

Since EPA is encouraging submissions to be re ported within the firs t 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 re sponses 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 br eaks down the total burden and cost by year.

3 60 large businesses will submit two responses each and 120 small bus inesses 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 whil e 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 ge neral steps involved for the review will be similar. For the NMSP basic program, EPA assume s 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 sh eet and outreach material is allo cated to Year 1, while the burden for the summary report is sp lit between years 2 and 3.

Agency Costs

The costs associated with Agency activi ties undertaken in su pport of the NMSP are estimated by multiplying Agency burdens from Table 5 by an appropriate government employee wage rate. EPA assumes that these activitie s are accomplished by a GS-13, Step 5 federal employee (EPA 1994). The 2006 hourly wage rate fo r 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., incl uding fringe benefits and overh ead) 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 pert aining 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

p repares a summary report, duri ng which the physiochemical

p roperties of the substance have been verified. This report is

p resented 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 th e 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 characterize s 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-ti me costs associated with preparing an d 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 includ e 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 summ ary report). The total agency burden is 5,688 hours and the to tal 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 Co st Estimates for the Basic Program

The total estimated industry burden, from Ta ble 4, is 37,032 hours and the total estimated costs are $1.99 million. The total estimated Agen cy 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 $2,369,232October 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 smalle r 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 existi ng data, conduct preliminary assessments, and identify additional data needed to better characterize hazard, ri sk, and exposure issues for the material. Once these needs are identified, a plan of action would be deve loped in consultation
with EPA and other stakehol ders 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 st akeholders would again meet to review the information gathered; conduct final assessmen ts; develop and apply appropriate risk management measures for the substance; and cons ider 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 pa rticipating groups is unknown, and the specific in-depth program’s elements will differ for each of the s ubstances, 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 (E PA 2002). For example, participants in the
VCCEP conducted assessments th at could also occur under th e 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-D epth 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 fina l 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 Paperwor k Reduction Act. The testing costs associated with conducting the hazard asse ssments are not paperwork burd ens, 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 no t considered part of th e 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 prep are 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 summar y (see Table 10). Assuming 15 substances are enrolled in the program, which on average will incl ude 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 c ould be developed for each substance. In the ICR for the VCCEP, EPA estimated a res pondent burden of 500 hours (425 technical hours, 50 clerical hours, and 25 mana gerial hours) for a Tier 1 expos ure 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 simila r 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 a ssociated 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 coul d also be developed fo r each substance under the In-Depth NMSP. In the ICR for the VCCE P, EPA estimated the respondent burden for a Tier 1 risk assessment at 300 hours (255 technica l hours, 30 clerical hours, and 15 managerialOctober 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 repr esent a burden of 800 hours per substance (see Table 10).

Action Plans and Final Summary

EPA assumes that the action plans and agr eed-upon risk management measures will be presented in summary documents, likely produced by the participants. Therefore, EPA is estimating that these documents combined w ill require a respondent burden of 100 hours (85 technical hours, 10 clerical hour s, 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 bur den (Table 10) with appropriate Industry labor rates (from Table 2) to estimate the re spondent 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 th e number of elements per res ponse. 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 responde nts are estimated by multiplying the burdens and costs per respondent by the number of respo ndents (15). As shown in Table 13, the total estimated respondent burden is 37,500 hours and the total estim ated 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 se veral current EPA-sponsored chemical testing programs. Again it is important to note that participants will like ly 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 fo r managing and participat ing 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 estim ated an Agency burden of 1,100 hours per year, divided among GS-11, GS-14, and GS-15 level em ployees. 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 co mbined 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 Basic NMSP In-Depth NMSP Total Entity 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 $4,373,769October 30, 2007

Page 26 of 28 6(d) Changes in Burden Estimates

This is a new ICR; therefore there is no cha nge 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 tota l time, effort, or financial resources expended by persons to generate, maintain, retain, or disclo se or provide information to or for a Federal agency. An agency may not conduct or sponsor, a nd 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 co llection 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 Federa l 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 dock et is available through Regulations.gov at http://www.regulations.gov. Use this tool to su bmit or view public comments, access the index listing of the contents of the public docket, a nd to access those documents in the public docket that are available electronically. Once in the system, select “searc h,” then key in the docket ID number identified above. Also, you can send co mments 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 in clude 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 doc uments directly (copie s 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 Compensati on 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 a nd Toxics; Economics, Exposure, and Technology Division. July 10. Availabl e in Docket: EPA-HQ-OPPT-2005-0055.

EPA 2002. U.S Environmental Protection Agenc y. Supporting Statement for a Request for OMB Review under the Paperwork Reduction Ac t: 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 Secti on 5 Premanufacture Notifications . Washington, DC: Office of Pollution Prevention and Toxics; Economics, E xposure, and Technology Division; Regulatory Impacts Branch, September 9, 1994.

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OPM 2006. Salary Table 2006 DCB, for the Loca lity 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

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### 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 Fo rm (Already Approved under 2070-0012)