Document ID: EPA-HQ-OPPT-2010-0572-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2015-04-06T04:00Z

Economic Analysis for the TSCA Section 8(a) Proposed Reporting Requirements for Certain Chemical Substances as Nanoscale Materials
                                RIN 2070 - AJ54
                                       
                                       
Economic Analysis for the TSCA Section 8(a) Proposed Reporting Requirements for Certain Chemical Substances as Nanoscale Materials
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                                March 12, 2015

                        -- Does not contain TSCA CBI --

                                  Prepared by
                      Economic and Policy Analysis Branch
                  Economics, Exposure and Technology Division
                  Office of Pollution, Prevention, and Toxics
                     U.S. Environmental Protection Agency
                           1200 Pennsylvania Avenue
                             Washington, DC 20460

                                March 12, 2015

                        -- Does not contain TSCA CBI --

                                  Prepared by
                      Economic and Policy Analysis Branch
                  Economics, Exposure and Technology Division
                  Office of Pollution, Prevention, and Toxics
                     U.S. Environmental Protection Agency
                           1200 Pennsylvania Avenue
                             Washington, DC 20460

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                      This Page Intentionally Left Blank
                                 Contributors

The EPA analysts responsible for this report are Kristen Loughery and Lynne Blake-Hedges of the Economic and Policy Analysis Branch; Economics, Exposure and Technology Division; Office of Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt Associates, Inc. under EPA Contract No. EP-W-08-010.

Table of Contents
Table of Contents	i
Table of Figures	iii
Executive Summary	iv
Chapter 1  -  Introduction	1-1
1.1	Statutory Authority	1-1
1.2	Regulatory and Programmatic Background	1-1
1.3	Statement of Need	1-3
1.4	Summary of Methodology	1-4
1.5	Organization of This Report	1-5
Chapter 2  -  Affected Entities	2-1
2.1	Chemical Substances Subject to this Rule	2-1
2.2	The Regulated Community	2-1
2.3	Estimated Number of Large (non-Small) and Small Business	2-4
2.4	Estimated Number of Nanomaterials per Company	2-6
Chapter 3  -  Industry Compliance Costs	3-1
3.1	Introduction	3-1
3.2	Wage Rates	3-1
3.3	Unit Industry Compliance Costs	3-1
3.4	Discounting Methods	3-7
3.5	Total Industry Compliance Costs	3-8
Chapter 4  -  Agency Costs	4-1
4.1	Introduction	4-1
4.2	EPA Costs	4-1
Chapter 5  -  Total Social Costs and Sensitivity Analyses	5-1
Chapter 6 - Sensitivity Analyses	6-1
6.1	Annual Industry Growth Rate	6-1
6.2	Number of Nanomaterials per Firm	6-6
6.3	Annual Nanomaterials Growth Rate	6-12
6.4	Summary of all Analyses	6-17
Chapter 7  -  Benefits	7-1
7.1	Market Failure	7-1
7.2	Benefits of Information-Based Policies	7-1
7.3	Potential Users of Information Generated by the Proposed Rule	7-3
Chapter 8  -  Small Entity Impact Analysis	8-1
8.1	Select a Relevant Small Business Definition	8-1
8.2	Estimate the Number of Small Businesses	8-2
8.3	Estimate the Cost-to-Sales Ratio for Small Companies	8-4
Chapter 9  -  Other Impact Analyses	9-1
9.1	Paperwork Reduction Act (PRA)	9-1
9.2	Unfunded Mandates Reform Act (UMRA)	9-1
9.3	Executive Order 13132  -  Federalism	9-2
9.4	Executive Order 13175  -  Consultation and Coordination with Indian Tribal Governments	9-2
9.5	Executive Order 13045  -  Children's Health	9-2
9.6	Executive Order 12898  -  Environmental Justice	9-2
9.7	Executive Order 13211  -  Energy Supply, Distribution, or Use	9-3
9.8	National Technology Transfer and Advancement Act	9-3
Appendix A  -  Wage Rate Calculations	A-1
A.1	Derivation of Industry Unit Wage Rates	A-1
A.2	Derivation of Agency Unit Wage Rates	A-2
Appendix B  -  Small Business Sensitivity Analysis	B-1
B.1	Estimation of the number of nanomaterials per small Firm	B-1
B.2	Conclusions	B-2
Appendix C - References	C-1
Table of Figures
Table 1-1: TSCA-authorized Reporting Requirements	1-1
Table 2-1: Small Business and Large Business Characteristics of Subset	2-5
Table 2-2: Estimated Number of Small Business and Large Businesses	2-5
Table 2-3: Estimated Nanomaterials per Firm, with R&D Exclusion	2-7
Table 3-1: Loaded Industry Wage Rates, 2013$	3-1
Table 3-2: Industry One-Time Cost Estimate to Familiarize with the Rule (2013$) (per Firm)	3-2
Table 3-3: Industry Burden Estimate to Complete the Proposed Form (per Report)	3-3
Table 3-4: Industry Cost Estimate to Complete the Proposed Form (2013$) (Per Report)	3-3
Table 3-5: Industry Burden and Cost of Electronic Reporting Requirements	3-6
Table 3-6: Industry Burden and Cost of Electronic Reporting Requirements (Subsequent Years, per Firm) (2013$)	3-6
Table 3-7: Industry Cost Estimate to Maintain Records (2013$) (per Report)	3-7
Table 3-8: Total Annual Industry Burden Hours	3-8
Table 3-9: Total Annualized Industry Costs	3-10
Table 4-1: Estimate of Agency Hours for the Proposed Rule	4-1
Table 4-2: Agency Cost and Burden Hour Estimate for the Proposed Rule	4-2
Table 5-1: Total Social Burden and Cost of the Proposed Rule	5-1
Table 6-1: Estimated Number of Reports (Increased Annual Growth Rate Scenario)	6-1
Table 6-2: Total Annual Industry Labor Burden (Increased Annual Growth Rate Scenario)	6-3
Table 6-3: Annual Industry Labor Costs (Increased Annual Growth Rate Scenario)	6-4
Table 6-4: Agency Cost Estimate for the Proposed Rule (Increased Annual Growth Rate Scenario)	6-5
Table 6-5: Total Social Costs for the Proposed Rule (Increased Annual Growth Rate Scenario)	6-5
Table 6-6: Estimated High- and Low-End Estimated Number of Commercially Relevant Nanomaterials per Firm	6-6
Table 6-7: Total Annual Industry Burden Hours (Low-and High-End Nanomaterials Estimates Scenario)	6-8
Table 6-8 : Annual Industry Labor Costs (Low-and High-End Nanomaterials Estimates Scenario)	6-9
Table 6-9: Agency Cost Estimate for the Proposed Rule (Low-and High-End Nanomaterials Estimates Scenario)	6-10
Table 6-10: Total Social Costs for the Proposed Rule	6-11
Table 6-11: Total Industry Burden Hours (Increased Nanomaterials Growth Scenario)	6-13
Table 6-12: Annual Industry Labor Costs (Increased Nanomaterials Growth Scenario)	6-14
Table 6-13: Agency Cost Estimate for the Proposed Rule (Increased Nanomaterials Growth Scenario)	6-15
Table 6-14: Total Social Costs for the Proposed Rule	6-16
Table 6-15: Comparison of Annualized Costs of Sensitivity Analysis (Millions 2013$)	6-17
Table 8-1: Ultimate Parent NAICs Codes for the 20 Small Businesses in Subset	8-2
Table 8-2: Small Business and Large Business Characteristics of Subset	8-3
Table 8-3: Small Business and Large Business Estimates	8-3
Table 8-4: Characterization of Economic Impacts	8-5
Table 8-5: Estimate of Impacts on Small Business Subset	8-5
Table 9-1: Industry Burden Estimates for the Proposed Rule	9-1
Exhibit A-1: Detail of Labor Categories Used in the Analysis	A-3
Exhibit A-2: Derivation of Loaded Industry Wage Rates	A-3
Exhibit A-3: Derivation of Loaded Agency Wage Rates	A-3
Exhibit B-1: Number of Nanomaterials per Company after the R&D Exclusion	B-3

Executive Summary
This economic analysis estimates and evaluates the costs and benefits of collecting information for certain chemical substances when they are manufactured or processed as nanoscale materials. through a rule proposed by the U.S. Environmental Protection Agency (EPA), under the authority granted by Section 8(a) of the Toxic Substances Control Act (TSCA). The proposed rule would require that persons who currently manufacture (including import), or process certain nanoscale materials (alternately described as "nanomaterials companies" and "nanomaterials firms" in this report), and/or persons who begin to manufacture, (including import), or process nanoscale materials (as defined by the proposed rule) after the effective date of this rule, to electronically report to EPA certain information including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data. 
The proposed rule builds on a history of Federal and international oversight of nanotechnology. EPA has developed a Nanomaterial Research Strategy (NRS) and previously conducted a Nanoscale Materials Stewardship Program (NMSP) to collect information on nanoscale materials in commerce (both discussed in Chapter 1). Other Federal agencies have also collaborated to better understand the opportunities and risks posed by nanotechnology, as have members of the Organisation for Economic Co-operation and Development (OECD).
EPA estimates that there are approximately 800 U.S. nanomaterials manufacturers, and processors subject to TSCA and believes this to be a high-end estimate of the number of nanomaterial firms subject to the rule (see Chapter 2). Around 500 firms (nearly 65 percent of firms) are estimated to be small businesses with less than $4 million in revenue, and these firms are exempt from the reporting requirements of the proposed rule. Each of the remaining 300 firms is expected to report on approximately five commercially-relevant nanoscale materials in the first year of the rule. While this analysis assumes that the number of nanoscale materials firms remains constant over the 10-year analysis period, the total number of regulated nanoscale materials is assumed to double. 
Under the proposed rule, industry is estimated to incur a burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 million and $1.5 million, respectively (see Chapter 3), while the Agency is expected to use approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million and $0.06 million respectively (see Chapter 4). Discounted over a 10-year period at three and seven percent, total annualized costs are estimated to be approximately $2.80 million and $3.08 million, respectively.
As required by the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement Fairness Act of 1996, a small entity impact analysis conducted in Chapter 8 is based on small business definitions provided by the U.S. Small Business Administration (SBA). EPA found that the costs of the proposed rule did not exceed 1 percent of the value of sales for any of the small businesses evaluated.
The rule is expected to provide benefits to EPA and the public. Increased and improved data on the production, sale, and use of nanoscale materials in the U.S. will allow EPA to more effectively determine whether additional risk assessment and management measures are needed. This information will lead to reduced cost of risk-based decision making and improved decisions concerning nanoscale materials. These benefits are discussed qualitatively in Chapter 7 of this report.

  -  Introduction
This report estimates and evaluates the costs and benefits expected to result from an information collection rule for nanoscale material manufacturers and processors proposed by the U.S. Environmental Protection Agency (EPA) under the authority granted by Section 8(a) of the Toxic Substances Control Act (TSCA). The proposed rule would require that persons who currently manufacture (including import), or process certain nanoscale materials (alternately described as "nanomaterials companies" and "nanomaterials firms" in this report), and/or persons who begin to manufacture (including import), or process nanoscale materials (as defined by the proposed rule) after the effective date of this rule, to electronically report to EPA certain information, described in detail below. Section 1.1 provides background information on EPA's statutory authority for the proposed rule; Section 1.2 reviews the regulatory background; Section 1.3 discusses the need for the regulation; Section 1.4 presents a brief summary of the methodology used in the analysis; and Section 1.5 describes the organization of the remainder of this report.
 Statutory Authority
Under Section 8(a) of TSCA, EPA has statutory authority to impose information reporting and recordkeeping requirements on manufacturers and processors of chemical substances used in commerce. Insofar as the information is known, or readily available, EPA may issue an information collection rule requiring the following items:
Table 1-1: TSCA-authorized Reporting Requirements
Reporting Elements
(A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture for which such a report is required. 
(B) The categories or proposed categories of use of each such substance or mixture. 
(C) The total amount of each such substance and mixture manufactured or processed, or reasonable estimates of the total amount to be manufactured or processed. 
(D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture. 
(E) All existing data concerning the environmental and health effects of such substance or mixture. 
(F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure. 
(G) In the initial report under paragraph (1) on such substance or mixture, the manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method.
Source: TSCA Section 8(a), Paragraph (2), Subparagraphs (A) through (G)

 Regulatory and Programmatic Background
Nanoscale materials, alternately referred to in this report as nanomaterials, constitute a unique class of chemicals. Nanomaterials are chemical substances organized in structures with dimensions measuring from 1 to 100 nanometers (nanoscale). Under the proposed rule, reporting would be required of certain solid chemical substances manufactured or processed in the range of 1 to 100 nanometers at ambient conditions.
Several regulatory and programmatic activities precede or coincide with the proposed rule. These activities are briefly described in this section. The Nanoscale Materials Stewardship Program (NMSP), a voluntary information collection program for nanomaterials manufacturers, processors, and users established by EPA in January 2008, is described in Section 1.2.1. The broader EPA Nanomaterial Research Strategy (NRS) is described in Section 1.2.2. The government-wide National Nanotechnology Initiative (NNI) is described in Section 1.2.3. Sections 1.2.4 and 1.2.5 present two international programs to encourage global collaboration in nanotechnology regulation.
EPA Nanoscale Materials Stewardship Program (NMSP)
On January 28, 2008, EPA formally instituted the Nanoscale Materials Stewardship Program (NMSP). The NMSP was a voluntary information collection program to assemble data from manufacturers, importers, and processors, and users of industrial nanomaterials subject to TSCA. In addition to industry and commercial organizations, researchers were also invited to participate in the NMSP (EPA, 2007). By the end of the program, 31 companies and associations had responded under the Basic program, submitting information on 132 nanomaterials (EPA, 2009d).
According to the NMSP Interim Report (EPA, 2009b), the program has "considerably increased [EPA's] understanding of the types of nanoscale materials in commerce." Submissions typically provided physical and chemical properties, commercial uses, manufacturing processes, and risk management practices; however, very few submissions provided data on exposure and toxicity. Overall, EPA considers the NMSP a success for having informed EPA's regulatory understanding of nanomaterials; however, a significant number of the environmental health and safety data gaps remain. 
EPA Nanomaterial Research Strategy (NRS)
The Nanomaterial Research Strategy (NRS) is a document released by the EPA Office of Research and Development (ORD) on September 29, 2009 describing EPA's strategy for conducting and supporting research to understand the environmental health and safety implications of exposure to manufactured nanomaterials and the ways in which nanotechnology can be used in environmental protection applications (EPA, 2009c). The document has three main purposes: (1) to guide EPA researchers and managers as they conduct EPA's research program; (2) to assist scientists in other organizations as they plan their own research programs; and (3) to inform the public of how EPA intends to generate scientific information to guide environmental decisions related to nanomaterials (EPA, 2009c).
The NRS focuses on developing scientific information for nanomaterial decision support. EPA has focused the NRS on four areas to take advantage of its scientific expertise as well as fill the gaps of information not addressed by other organizations. The four research themes are:
*       Sources, Fate, Transport, and Exposure
*       Human Health and Ecological Research to Inform Risk Assessment and Test Methods
*       Risk Assessment Methods and Case Studies
*       Preventing and Managing Risks
The NRS is the guiding document for the EPA Nanotechnology Research Program. EPA plans to collaborate across government, industry, and the international community to implement this strategy (EPA, 2009c).
U.S. National Nanotechnology Initiative (NNI)
The 21st Century Nanotechnology Research and Development Act of 2003 resulted in the implementation of the National Nanotechnology Initiative (NNI). The NNI created a framework for a comprehensive nanotechnology R&D program by establishing shared goals, priorities, and strategies. The NNI consists of individual and cooperative nanotechnology-related activities of 25 federal agencies with a range of research and regulatory roles and responsibilities. EPA coordinates its nanotechnology research activities with other federal agencies through the NNI (EPA, 2009b).
OECD Working Party on Manufactured Nanomaterials (WPMN)
In 2006, the Organisation for Economic Co-operation and Development (OECD) Chemicals Committee established its Working Party on Manufactured Nanomaterials (WPMN). The objective of the WPMN is to promote international cooperation in human health and environmental safety-related aspects of manufactured nanomaterials. The WPMN is engaged in a variety of projects to further the understanding of the properties and potential risks of nanomaterials (EPA, 2009b).
International Organization for Standardization (ISO) Technical Committee 229
The International Organization for Standardization (ISO) has established a technical committee to develop international standards for nanotechnology. This technical committee, ISO/TC229, is working to develop standards for terminology and nomenclature, metrology and instrumentation, including specifications for reference materials, test methodologies, modeling and simulation, and science-based health, safety and environmental practices (EPA, 2009b).
 Statement of Need
Executive Order 12866 requires regulatory Agencies to identify the specific market failure that a significant rule addresses. The major causes of market failure identified in the Office of Management and Budget (OMB) guidance (OMB, 2003) on Executive Order 12866 are externality, natural monopoly, market power, and inadequate or asymmetric information. The proposed rule is designed to address the issue of inadequate information about nanomaterial manufacture and use in commerce and, to the extent that new information indicates the presence of negative externalities, inform future rulemaking and/or legislation governing the manufacture, processing, and use of nanomaterials.
Inadequate Information
Economic theory requires that buyers and sellers have complete information about the costs and benefits of their economic choices to produce an efficient allocation of resources. When buyers or sellers do not have perfect information, rational decision making cannot occur and a market failure exists. As an example, a producer may not consider substituting a less hazardous chemical for a hazardous chemical if knowledge about either chemical's hazard is unknown or uncertain. More complete information on the hazards associated with the chemical will allow a producer to make more socially efficient decisions.
There are many reasons why information regarding the hazards associated with a chemical substance may not be widely known. Two of these reasons are:
*       Producers may know this information but have no incentive to act on it or reveal it to their customers (because the costs are not borne by, and are therefore external to, the producer).
*       This information may be unknown to both the producers and their customers.
The first of these reasons is known as asymmetric information; that is, a case in which consumers and producers do not have the same level of information regarding the aggregate production, uses, and hazards of a chemical substance. Typically, the producers' level of information regarding these items, particularly hazards, exceeds the consumers' level of information.
In the second case, chemical production, use, and hazard information is inadequate and/or unavailable (i.e., unknown to both consumers and producers). Producers may have little incentive to acquire such information due to the potential costs associated with its acquisition. Information is by nature a public good; that is, non-rival (one person's use of information does not diminish the amount remaining for other users) and non-excludable (once made available, information cannot be easily withheld from others). Thus, where information is provided by one person, others are free to use and benefit from that information without having made a contribution to its development. This situation reduces the incentive to provide the information, resulting in a failure of the market to efficiently provide the information. In addition, individual consumers are unlikely to be willing to pay the cost of collecting and reporting information if they can use information developed and paid for by others.
Externalities
Externalities are another cause of market failure. An externality occurs when the actions of one economic agent impose costs (or benefits) on parties that are "external" to the market transaction; that is, these costs (or benefits) are not borne by the producers or consumers directly involved. Such is the case where manufacturing or other business activities harm human health or the environment in excess of the costs borne by the parties to this activity, resulting in negative externalities. When information is missing about the human health and environmental costs to society, or when these costs are external to producers' decision making, the costs are not incorporated into business decisions. The result can be the overuse and/or overproduction of certain harmful products.
EPA often intervenes when negative externalities pose risks to human health and the environment. For example, risks may arise as a result of chemical exposure to the general population from the manufacture, processing, and use of chemicals. As a first step in mitigating externalities, the EPA Office of Pollution Prevention and Toxics (OPPT) routinely screens chemicals for the potential risks they may pose. This screening is used to determine if risks from the manufacture, processing, or use of chemicals are of sufficient concern to warrant risk management. Given that EPA's TSCA Inventory recognizes more than 75,000 chemicals in commerce, chemical risk screening represents a significant effort. Risk is a function of hazard and exposure and when information on either is lacking, EPA's ability to effectively identify significant risks arising from externalities is compromised.
Effect of the Proposed Rule
The proposed rule will address market failure due to inadequate information by ensuring that basic information about the production, use, and environmental health and safety impacts of manufactured nanomaterials is available to the public. This information can be used by consumers, producers, the public sector, and others to make more informed decisions regarding the production, sale, and use of nanomaterials. The information may also be used to resolve externalities. To the extent that the provision of this information induces the producers to account for external social costs, either due to fear of litigation or due to the benefits of corporate stewardship, increased availability of information will address the negative externalities generated by producing or using these chemicals.
 Summary of Methodology
This analysis seeks to quantify, to the extent possible, the costs to society of the proposed rule by identifying the costs to industry (and to small entities, in particular) associated with performing the required reporting and recordkeeping, and the costs to EPA of administering the rule. Industry costs consist of the collection, compilation, and submission of required information for the nanomaterials handled by each reporting firm. Agency costs include reviewing and processing the data received as a result of the rule. Small entity impact is defined as a small business' estimated cost of compliance with the proposed rule as a percent of sales. Data sources for this analysis include burden estimates derived from information collection requests for similar regulations, compensation data acquired from government publications, and supplementary market research to produce an estimate of the number of affected entities. EPA believes the inputs for this analysis (e.g., estimated number of nanoscale materials) are high-end estimates and that the final burden and cost estimates may therefore be overestimated.
This report qualitatively discusses the benefits of the proposed rule based on the value of the information it will provide. The benefits analysis was undertaken to address the implicit call for cost-benefit balancing contained in TSCA, as well as the requirements of Executive Order 12866.
 Organization of This Report
The remainder of this report provides EPA's economic analysis in support of the proposed rule. The affected chemical substances and companies are characterized in Chapter 2. Chapter 3 estimates industry cost of complying with the proposed rule, and Chapter 4 estimates government costs associated with the administration of the proposed rule. Chapter 5 presents the total social costs. Chapter 7 addresses the benefits of the proposed rule using a "value of information" framework. Chapter 8 provides the small entity impact analysis for the proposed rule, as mandated by the Regulatory Flexibility Act (RFA), and amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA). Several additional impact analyses are presented in Chapter 9, including: a burden hour analysis, which responds to the requirements of the Paperwork Reduction Act (PRA); an unfunded mandates statement, which is required by the Unfunded Mandates Reform Act (UMRA); an environmental justice statement, which addresses the requirements of Executive Order 12898; and a children's health statement, which is mandated by Executive Order 13045. Note that all dollar amounts in this analysis are reported in 2013 dollars.

  -  Affected Entities
This chapter presents information about the manufacturers, production, and uses of nanoscale materials subject to the proposed rule. Section 2.1 provides a definition of nanoscale materials affected by the rule; Section 2.2 describes and estimates the population of affected organizations; Section 2.3 divides the population estimate into large (non-small) and small businesses subpopulations; and Section 2.4 estimates the number of nanoscale materials handled by each reporting firm subject to TSCA.
 Chemical Substances Subject to this Rule
The proposed rule requires the reporting and maintenance of records concerning chemical substances as nanoscale materials. The proposed rule would apply to chemical substances containing primary particles, aggregates, or agglomerates in the size range of 1-100 nm in at least one dimension. This proposed rule would not apply to chemical substances that only have trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size. Reporting is also required if the chemical substance has different morphology or is coated with different chemical substances.
Nanomaterials of a single molecular identity may vary both in the number of dimensions at the nanoscale and the measurements in each dimension. For example, silver nanomaterials are available as nanoparticles (i.e., nanoscale in three dimensions) as well as nanorods (i.e., nanoscale in two dimensions). Silver nanoparticles and nanorods are also available in dozens of different particle sizes and diameters, respectively. Each of these configurations constitutes a distinct physical form. In addition, nanomaterials with different shapes, morphology, or coatings are also required to be reported. 
The rule would not require manufacturers or processors to report information that has already been submitted to EPA. The reporting requirements of this proposed rule would not apply to any person for a nanoscale material submitted as a new chemical notice under section 5 of TSCA to EPA since January 1, 2005. In addition, any person who has already reported part of or all of the required information under the Nanoscale Materials Stewardship Program would not need to report that information again. If, however, information required by this proposed rule had not been reported or new information is now available reporting of that information would be required. 
 The Regulated Community
As previously noted, the proposed rule affects firms manufacturing and/or processing chemical substances at the nanoscale. The rule applies to organizations operating in the U.S. and thus under EPA's jurisdiction. Only those organizations handling nanoscale materials with TSCA-covered applications are subject to the rule. 
The NMSP ICR (EPA, 2007) estimated that at the time of its publication, the population of organizations involved in the manufacture or application of nanomaterials was approximately 600, based on an estimate of the size of the global nanotechnology industry from the National Science Foundation (NSF) (Roco, 2005). Due to the age of these data and their limitations, this report provides updated estimates of the number of U.S.-based nanomaterials manufacturers, processors, and distributors and the relative size of these firms.
Three sources were used to estimate the number of U.S.-based nanomaterials firms and to construct a representative selection of firms used to estimate both the number of large and small businesses and the number of nanomaterials supplied by each firm. The sources are:
*       Lux Research: Nanotech Report(TM), 5th ed. (2007)
*       BCC Research: Nanotechnology: A Realistic Market Assessment (2008)
*       Nanowerk: Company & Labs Directory (2009)
These sources are described in more detail in the sections below.
Lux Research Nanotech Report(TM)
The Lux Research Nanotech Report(TM) (Lux Research, 2007) is a market research report covering the field of nanotechnology. The Nanotech Report describes four categories of products: nanomaterials, nanointermediates, nano-enabled products, and nanotools. For each product in these categories, the Nanotech Report provides properties, fabrication methods, key applications, environmental/health/safety concerns, and general market descriptors such as market size, market drivers, and market challenges. For select products, it also shares major market players and patents. The report suggests that there are over 1,500 nanotechnology companies worldwide but does not provide details regarding estimation methods.
The Nanotech Report also profiles 121 nanotechnology companies worldwide. Eighty-four of these companies (69.42 percent) are based in the U.S., and of these U.S. companies, 31 companies (36.90 percent) are involved in the manufacture of nanomaterials.
Lux describes its selection of 121 nanotechnology companies as "a representative sample of companies across regions, sectors, and company types." As such, multiplying the base estimate of nanotechnology companies worldwide (1,500) by the percent of the group that are based in the U.S. (69.42 percent) and by the percent of identified U.S. companies in that group that are nanomaterials manufacturers (36.90 percent) produces an estimate of 384 nanomaterials manufacturers in the U.S.
This estimate is limited for several reasons. Lux Research does not describe the methodology used to arrive at the estimate of 1,500 nanotechnology companies worldwide, nor does it describe sampling methods that would verify the representativeness of the sample. Further, Lux acknowledges that the sample in its report includes the best known companies by design, but it does not specify any other selection criteria. EPA believes the slightly larger worldwide estimate derived from the BCC Research Nanotechnology Report (described in the following section) is a more reliable estimate for the purposes of this analysis. EPA also recognizes the inherent limitations of the Lux sample; however, given the report's description of its sample, EPA assumes the sample to be representative of the overall number of U.S. nanomaterials manufacturers.
BCC Research Nanotechnology Report
The BCC Research report Nanotechnology: A Realistic Market Assessment (BCC Research, 2008) is also a market research report covering the field of nanotechnology. The report divides the nanotechnology market into three segments: nanomaterials, nanodevices, and nanotools. It then discusses the nanotechnology market's size and structure, funding sources, and environmental, health, and safety concerns and regulation in general terms.
Due to the poorly defined and evolving nature of the nanotechnology market, the BCC report acknowledges that sizing the market is difficult, if not impossible. It suggests that estimates of the number of companies with "nanotechnology activities" worldwide can be as high as 1,600.
The report refers to a sample of 165 nanotechnology companies profiled by BCC Research and provides summary information on this sample; however, the report does not include the companies in the sample. Of the 165 companies in the sample, 112 companies (67.88 percent) are based in the U.S. Additionally, of the full 165 company sample, 125 companies (75.76 percent) are nanomaterials manufacturers. However, the report does not specify how many or what percent of the U.S. companies are specifically involved in the manufacture of nanomaterials. Combining the reported percentages yields an estimate of 85 companies in the sample (51.42 percent of the sample) that are U.S. nanomaterials manufacturers.
Multiplying the estimated total number of nanotechnology companies worldwide (1,600) by the percent of the sample that are based in the U.S. (67.88 percent) and by the percent of the sample that are nanoscale materials manufacturers (75.76 percent) suggests an estimated 823 U.S. nanoscale materials firms. 
This estimate is potentially limited for two reasons. BCC Research does not describe the methodology used to arrive at the high-end estimate of 1,600 companies with "nanotechnology activities" worldwide, nor does it explain its method for selecting a subset of these nanotechnology companies to profile in its report. Thus, the set of profiled companies may not be a representative sample. EPA recognizes the inherent limitations of this sample; however, based on EPA best professional judgment, the Agency considers 823 companies to be a reasonable, and potentially high-end, estimate of the number of U.S. nanomaterials firms for the purposes of this analysis.
Nanowerk Company & Labs Directory
Nanowerk (Nanowerk, 2009) is an online resource for information on nanotechnology and nanoscience. The site provides an introduction to nanotechnology in layman's terms, nanotechnology news coverage, general information about the nanotechnology market, and disclosure of the environmental, health, and safety concerns around nanotechnology. It also claims to maintain "the most extensive industry database" of nanomaterials suppliers in its Company & Labs Directory.
The Company & Labs Directory lists manufacturers and suppliers in five categories of nanomaterials: Carbon Nanotubes, Fullerenes, Fibers and Wires, Nanoparticles, and Quantum Dots. The database provides each company's name, a brief description, and country of origin. According to aggregate statistics found on the website, the database contains 262 companies, 120 of which are identified in the listing as U.S. companies. Many of these companies manufacture several nanomaterials and are therefore listed in multiple nanomaterials categories.
The Nanowerk databases are compiled from publicly available information on nanotechnology manufacturers' websites. According to Michael Berger of Nanowerk (Berger, 2009), the lists are regularly maintained and updated with new findings. Although it claims to be the most comprehensive source available, the Company & Labs Directory is a "best effort undertaking" rather than a comprehensive listing of all suppliers. Notably, the databases exclude companies not known to Nanowerk and companies without publicly listed information.
Conclusion: Estimate of Regulated Community and Representative Selection
As noted above, EPA considers the 823 companies, estimated using BCC Research's data, to be a reasonable estimate of the current number of U.S. nanomaterials firms for the purposes of this analysis. This estimate reflects probable growth in the population since EPA's judgment in the NMSP ICR (EPA, 2007) that the population at that time was approximately 600 companies. Due to uncertainty in predicting the future nanomaterials market, EPA assumes that the number of U.S. nanoscale materials firms remains constant over the analysis period; however, the number of nanomaterials handled by each reporting firm is assumed to double over the analysis period of 10 years (see section 2.4 for more details).
This analysis uses a selection of firms assumed to be representative of firms in the market to estimate the percent of U.S. nanomaterials firms that are large or small businesses and to estimate the number of nanomaterials manufactured, processed, or sold by large and small businesses. To construct this selection, EPA compiled a list of the U.S. nanomaterials manufacturers profiled by Lux Research and Nanowerk. To avoid duplicates, the Agency considered companies found in both sources to be the same if they had identical or similar names and/or addresses. Based on this method, the selection includes 12 companies defined by Lux Research as nanomaterials firms, 101 companies defined by Nanowerk as nanomaterials firms, and an additional 19 companies defined by both Lux and Nanowerk as nanomaterials firms, for a total of 132 companies in the selection.
 Estimated Number of Large (non-Small) and Small Business
The general exemptions to TSCA 8(a) reporting (as described within the statute itself) apply to the proposed rule, including exemptions for small businesses that eliminate the reporting and recordkeeping requirements under the rule. Under TSCA regulations, according to 40 CFR 704.3, a manufacturer of a chemical substance is defined as small if it meets either of the following criteria: (1) total annual sales of the company, combined with those of any parent company, are below $40 million and annual production volume (including importation volume) at each facility is less than or equal to 100,000 pounds; or (2) total annual sales of the company, combined with those of any parent company, are below $4 million. Based on EPA's experience with NMSP and PMN submissions, a small business exemption that allows manufacturers not to report quantities of nanoscale materials up to 100,000 pounds would exclude a large proportion of potential reporting under the rule. For the purposes of this rule, EPA therefore proposes that the definition of "small business" be any company whose annual sales, when combined with that of a parent, are less than $4 million.
To estimate the number of small and large businesses in the  total number of U.S. nanomaterials firms, EPA matched the selection described above to the Dun & Bradstreet (D&B) corporate database to identify company and parent company sales, measured the percentage of companies defined as small and large within the group, and applied these percentages to the estimate of the total number of firms. The specific procedures and results of the analysis are described in the following sections.
Search and Matching Procedure
EPA attempted to obtain sales data from the Dun & Bradstreet corporate database for the 132 companies in the selection described above, following a rigorous search and matching procedure. The procedure began with a basic search by company name for each company in the selection. Companies for which the initial search returned a single match were checked for a U.S. address and considered positively matched. Companies for which the initial search returned multiple matches were subsequently filtered by zip code. Companies not found in the D&B database were considered unmatched.
As noted above, the relevant small business definition for this rulemaking considers the sales of the parent company when classifying a subsidiary as a small business. Therefore, for the matched companies identified in the D&B database as subsidiaries of a parent company, the parent company's sales were recorded. For all other matched companies, the company's sales were recorded. The complete D&B search and matching procedure is described in further detail in Chapter 8.
A total of 103 companies in the selection were found in the D&B database. Of these, 83 companies have no parent company, and 20 companies have a parent company; however, one of the parent companies was already a member of the selection, thus reducing the matched subset to 83 + 20  -  1 = 102 companies. An additional two companies were identified as joint ventures, and one company was verified closed. Twenty-six companies remained unmatched against the D&B database.
Annual sales data were obtained from the D&B database and internet-based searches for 95 of these 102 companies. Using these data, the companies in this selection can be categorized as large or small businesses under the TSCA 8 definition of small business.
Results and Analysis
Of the 95 nanomaterials manufacturers and parent companies with observed annual sales, 61 companies (64.2 percent of this subset) meet the small business definition with less than $4 million in reported annual sales, and 34 companies (35.8 percent of this subset) do not meet the small business definition, having $4 million or more in reported annual sales. These results are provided in Table 2-1.
Table 2-1: Small Business and Large Business Characteristics of Subset
                              Population Category
                                Sales Threshold
                       Actual Number of Firms in Subset
                               Percent of Subset
                               Small Businesses
                                < $4 million
                                      61
                                     64.2%
                               Large Businesses
                                >= $4 million
                                      34
                                     35.8%
                                     Total
                                      --
                                      95
                                     100%
Source: D&B, 2009; Lux Research, 2007; Nanowerk, 2009.

Multiplying the percent of U.S.-based nanomaterials manufacturers that meet the small business definition (64.2 percent) by the previously estimated number of U.S.-based nanomaterials manufacturers (823 companies) yields an estimate of 528 small business nanomaterials firms and a complementary estimate of 295 large (non-small) business nanomaterials firms. 
Table 2-2: Estimated Number of Small Business and Large Businesses
                                   Category
                                Sales Threshold
                      Est. Number of Nanomaterial Firms 
                                   Percent 
                               Small Businesses
                                < $4 million
                                      528
                                     64.2%
                               Large Businesses
                                >= $4 million
                                      295
                                     35.8%
                                     Total
                                      --
                                      823
                                     100%
Source: BCC Research, 2006; D&B, 2009.

Based on these estimates, 295 firms are expected to submit chemical reports each year under the proposed rule. EPA assumes that the number of nanomaterials firms will remain constant over the next ten years. EPA has conducted an alternative analysis, presented in Section 6.1 that accounts for potential growth in the number of firms manufacturing nanomaterials. 

 Estimated Number of Nanomaterials per Company
In the NMSP ICR (EPA, 2007), EPA estimated that large businesses participating in the NMSP would submit information on two nanomaterial products. This section presents updated estimates of the number of nanomaterials per firm that will be subject to the proposed rule.
To estimate the number of nanomaterials per firm, EPA researched the 34 large businesses in the D&B-matched subset (of 95 companies), compiled a list of nanomaterials supplied by each large business, excluded specific nanomaterials without TSCA uses, and calculated the median number of nanomaterials per firm. The specific procedures and results of the analysis are described below. 
Nanomaterial Identification Procedure
The identification of the nanomaterials produced by each large business was performed by manual examination of online product offerings. This procedure captured both nanomaterials supplied for direct sale and nanomaterials supplied as a component in a larger product. The procedure only captured nanomaterials with verified TSCA uses, based on the industries and applications advertised on each manufacturer's website. The final count distinguishes nanomaterials by chemical and physical structure, as well as size at the nanoscale. The count also distinguishes nanomaterials identified as distinct products by their manufacturers. As defined in this chapter, to qualify as a nanomaterial, at least 10 percent of a chemical substance has to exist in a form with two or more dimensions at the nanoscale.
Of the 34 large business nanomaterials firms identified, 26 had product information available on a company website. Of these, 23 firms manufactured nanomaterials for TSCA-related uses. The number of identified TSCA-related nanomaterials manufactured per firm varied widely, from one nanomaterial up to 66 nanomaterials.
Results and Analysis
The median number of TSCA-related nanomaterials per large business in the reduced selection for this analysis (n = 23) is 13 nanomaterials. EPA considers 13 nanomaterials per reporting business to be a reliable estimate for the purposes of this analysis, as small businesses are exempt from the requirements of this rule. The proposed rule also exempts chemicals with strictly research and development (R&D) applications. The estimates presented in this section include chemicals for R&D applications, and estimates presented in the following section exclude them.
R&D Exclusion
The general exemptions to TSCA 8(a) reporting (as described within the statute itself) apply to the proposed rule including exemptions for chemicals with strictly research and development applications.
In the NMSP Interim Report (EPA, 2009b), EPA identified a total of 234 unique existing nanomaterials from various sources including the NMSP. Of these, 91 nanomaterials (38.89 percent) were found to be "commercially relevant," defined as being commercially available in five or more forms such as unique sizes or chemical and physical structures. The remaining 143 nanomaterials (61.11 percent) were considered produced for research and development applications.
EPA therefore estimates a current average of 5.06 nanomaterials (38.89 percent of 13 nanomaterials) with commercial relevance per reporting business. As previously mentioned, the total number of nanomaterials subject to the proposed rule is assumed to double over the analysis period of 10 years. As a result, it is assumed that nanomaterials firms will report on approximately 0.56 additional nanomaterials per year.
Table 2-3: Estimated Nanomaterials per Firm, with R&D Exclusion
                              Population Category
                            Nanomaterials per Firm
                             R&D Exclusion (%)
                             R&D Exclusion (#)
                  "Commercial" Nano-materials per Firm[a]
                                       
                                       
                                       
                                       
                                  First Year
                               Subsequent Years
                             Reporting Businesses
                                      13
                                    61.11%
                                     7.94
                                     5.06
                                     0.56
Notes:
a The total number of nanomaterials subject to the proposed rule is assumed to double over the analysis period of 10 years. As a result, it is assumed that nanomaterials firms will report on approximately 0.56 additional nanomaterials per year.
Source: D&B 2009; EPA, 2007; EPA, 2009b; Company websites.

  -  Industry Compliance Costs
 Introduction
This chapter presents estimates of the total costs that nanomaterial manufacturers and other entities may incur due to the requirements included in the proposed rule and discusses the method used to measure each. 
 Wage Rates
The proposed rule involves activities that 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. This section presents the estimated wage rate in each labor category.
Loaded wage rates for managerial, technical, and clerical personnel are derived by combining data on wages and fringe benefits with estimates of overhead rates following the methodology described in "Wage Rates for Economic Analysis of the Toxics Release Inventory Program" (EPA, 2002b). Wage and fringe benefit data for each labor category are calculated using the December 2013 quarterly estimates from the Employer Costs for Employee Compensation (ECEC) Supplemental Tables available on the BLS website (BLS, 2014). The loaded wage rate for managerial labor is $77.82; for technical labor, $64.55; and for clerical labor, $30.35. Table 3-1 presents the basic data used to calculate the loaded wage rates for all three categories of labor, and Appendix A provides more detailed information on the estimation of these wage rates.
Table 3-1: Loaded Industry Wage Rates, 2013$
Labor Category
Base Wages[a]
Fringe Benefits[a] + Overhead Factor[b]
Loaded Wages
                                  Managerial
                                    $46.25 
                                     1.68
                                    $77.82 
                                 Professional/
                                   Technical
                                    $38.16 
                                     1.69
                                    $64.55 
                                   Clerical
                                    $18.05 
                                     1.68
                                    $30.35 
Notes:
[a] Wage rates and fringe benefits are calculated  using the December 2013 quarterly estimates from BLS (2014).
[b] An overhead rate of 17% of base wages is used here, based on methodology and assumptions in EPA (2002a) and EPA (2002b).
Source: BLS, 2014.
 Unit Industry Compliance Costs
Rule Familiarization
The proposed rule requires reporting businesses and their staff to become familiar with the 8(a) rule and its various requirements. Rule familiarization is estimated to require 0.55 hours of technical labor and 0.27 hours of managerial labor. This burden is equivalent to the rule familiarization burden estimated in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a), because the reporting requirements for the proposed information collection rule are similar to those required by a PMN form. Since this analysis assumes that no additional nanomaterials firms enter the market over the 10-year analysis period, rule familiarization costs are only incurred in the first year of the rule. As shown in Table 3-2, the labor cost associated with rule familiarization is $56.51.
Table 3-2: Industry One-Time Cost Estimate to Familiarize with the Rule (2013$) (per Firm)
                              Reporting Activity
                        Clerical Labor (at $30.35/hour)
                       Technical Labor (at $64.55/hour)
                       Managerial Labor (at $77.82/hour)
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
Rule Familiarization
                                       0
                                    $0.00 
                                     0.55
                                    $35.50 
                                     0.27
                                    $21.01 
                                     0.82
                                    $56.51
Source: BLS, 2014; EPA, 2009a.

Form Completion
The proposed rule requires reporters to gather and submit information consisting of all of the reporting elements found on the full NMSP reporting form. The reporting element burden estimates used here are taken from the NMSP ICR (EPA, 2007) with the exception of clerical burden. The burden estimates in the NMSP ICR assume that data elements are reported on a form whereas the proposed rule requires electronic reporting though CDX. The total per-report industry burden of the proposed rule is estimated to be 136.60 labor hours. This burden estimate is presented in Table 3-3 below. 
Table 3-3: Industry Burden Estimate to Complete the Proposed Form (per Report)
                               Reporting Element
                                Clerical Hours
                                Technical Hours
                               Managerial Hours
                                  Total Hours
                                       1
Submitter information
                                     0.00
                                     2.00
                                     1.00
                                     3.00
                                       2
Chemical identity information
                                     0.00
                                     7.50
                                     1.00
                                     8.50
                                      3A
Physical properties
                                     0.00
                                     2.00
                                     0.50
                                     2.50
                                      3B
Additional physical properties
                                     0.00
                                     4.00
                                     1.00
                                     5.00
                                       4
Description of uses
                                     0.00
                                     3.00
                                     1.50
                                     4.50
                                       5
Amount of substance to be manufactured/imported
                                     0.00
                                     1.00
                                     1.50
                                     2.50
                                       6
Description of byproducts
                                     0.00
                                     0.50
                                     0.00
                                     0.50
                                       7
Human exposure and environmental release
                                     0.00
                                     52.00
                                     9.50
                                     61.50
                                       8
Physical properties related to understanding and assessing exposures and releases
                                     0.00
                                     4.00
                                     1.00
                                     5.00
                                       9
Overview of lifecycles
                                     0.00
                                     10.00
                                     2.00
                                     12.00
                                      10
Release point control technology
                                     0.00
                                     2.00
                                     0.40
                                     2.40
                                      11
Worker exposure information
                                     0.00
                                     2.00
                                     0.40
                                     2.40
                                      12
Protective equipment or engineering control
                                     0.00
                                     2.00
                                     0.40
                                     2.40
                                      13
Information on cleaning/reuse/disposal of used protective equipment
                                     0.00
                                     1.00
                                     0.20
                                     1.20
                                      14
Additional procedures or other equipment intended to mitigate exposures to nanoscale materials
                                     0.00
                                     1.00
                                     0.20
                                     1.20
                                      15
Description of worker training and hazardous communication
                                     0.00
                                     1.00
                                     0.20
                                     1.20
                                      16
Number of individuals other than workers exposed to the chemical and duration of exposure
                                     0.00
                                     1.00
                                     0.20
                                     1.20
                                      17
Manner or method of disposal for consumer use of products
                                     0.00
                                     2.00
                                     0.40
                                     2.40
                                      18
Test data in the submitter's possession of information on health/environmental effects
                                     0.00
                                     7.20
                                     10.00
                                     17.20
                                                                          Total
                                     0.00
                                    105.20
                                     31.40
                                    136.60
Source: EPA, 2007

Table 3-4 combines the estimated reporting burden and loaded wage rates for all three labor categories to estimate the per-report cost of complying with the reporting requirements.
Table 3-4: Industry Cost Estimate to Complete the Proposed Form (2013$) (Per Report)
                              Reporting Activity
                        Clerical Labor (at $30.35/hour)
                       Technical Labor (at $64.55/hour)
                       Managerial Labor (at $77.82/hour)
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                Form Completion
                                       0
                                    $0.00 
                                     105.2
                                  $6,790.37 
                                     31.4
                                  $2,443.63 
                                     136.6
                                   $9,234.00
Source: BLS, 2014; EPA, 2007.

 Electronic Reporting  
The proposed rule would require submitters to register with EPA's Central Data Exchange (CDX) and use the Chemical Information Submission System (CISS) to prepare and submit a data file. CDX is EPA's electronic system for environmental data exchange to the Agency. CDX also provides the capability for submitters to access their data through the use of web services. EPA developed CISS for use in submitting data for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. CISS, a web-based reporting tool, provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily.
EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources.
 EPA estimated that affected facilities would incur additional burden and cost due to the electronic reporting requirements of the proposed rule. This includes costs in the first year to complete a subscriber agreement and register with CDX. Some respondents will incur CDX costs in subsequent years due to employee turnover or compromised electronic signatures. These costs are offset by reductions in reporting and recordkeeping costs due to electronic reporting. Understanding the electronic reporting requirements is expected to be part of rule familiarization discussed in Section 3.4.1 and are not included again in this section.
Some company users who have already registered with CDX to meet other EPA electronic reporting requirements, for example to submit Premanufacture Notices (PMNs) or to report under the Chemical Data Reporting rule (CDR), will not need to register again as a result of this rule. While EPA expects that some nanomaterial manufacturers and processors will have employees who have registered with CDX, there is no way to determine how many new users would need to register as a result of this rule. Therefore, the Agency assumes that all affected submitters would register with CDX and, thus, incur an associated cost. This high-end assumption likely results in an overestimation of the costs associated with the final rule.
When registering with CDX, users are assigned to one of two roles in the CDX system, an Authorized Official or a Support Registrant.
      Authorized Official (AO):  The AO is the person legally responsible for the submission.  The AO is typically a senior official for the respondent. The AO is the only user who can start a new form, or reopen a completed form to begin the amendment process, and is the only user who can electronically sign and submit a form. AOs can also assign Support Registrants to edit and complete forms on his or her behalf. AOs must submit a subscriber agreement to EPA, and register with CDX.
      Support Registrants:  A Support Registrant is a person designated by an AO to submit supporting documents on his or her behalf.  Support Registrants can edit a submission that is created by the AO. Support Registrants are only allowed to edit the submissions to which the AO has granted him or her access. Support Registrants do not have any access rights to create or submit a form.  Once the AO creates a form, they will provide the Support Registrant with a passphrase to access the submission and complete all sections of the form. Once the Support Registrant has finished completing the form, the AO will access the submission, review it, and submit it.  Support Registrants must register with CDX, but do not need to submit a subscriber agreement to EPA.
This analysis uses a simplifying assumption that an average of five employees at each respondent will register with CDX: one manager (who will serve as AO) four technical staff members (who will serve as Support Registrants).  
First Year Costs
Respondents will incur electronic reporting costs in the first year to register with CDX, submit a subscriber agreement, contact EPA's CDX Help Desk and perform ongoing problem resolution to resolve problems with their certifications or agreements.
      Subscriber Agreement/Electronic Signature Agreement.  An AO must complete a subscriber agreement in order to establish their identity and their relationship to the entity for which they will submit electronic documents, as well as to document a unique correlation with the device that will be used to create their electronic signature. While users can comply with the subscriber agreement provisions in CDX either by submitting a paper subscriber agreement with a wet-ink signature, or by submitting an electronic signature agreement, this analysis assumes that all will submit electronic signature agreements. Preparing, submitting, and filing a subscriber agreement and an electronic signature agreement is estimated to require an average of 15 minutes of time per registrant (EPA, 2011). Because only an AO must complete the subscriber and electronic signature agreement, this is assumed to be managerial time. In addition, the burden estimate is assumed to include identity verification through a third party electronic verification process that is an available service through CDX.
      CDX Registration.  CDX users will need to register with CDX, which involves selecting a user name and password, providing contact information, and identifying the facility and the registrant's role (e.g., AO or Support Registrant) at the facility.  This is estimated to take an  average of 10 minutes per user (EPA, 2011). Because there are assumed to be one manager and four technical staff registering, this results in an estimate that each respondent (business) will spend 10 minutes of managerial time and 40 minutes of technical time to register with CDX.  
      Help Desk.  CDX users are assumed to spend an average of 4 minutes contacting EPA's CDX Help Desk for technical support (EPA, 2011), which results in an estimate of 4 minutes of managerial time and 16 minutes of technical time per respondent.  
      Problem Resolution.  Three percent of respondents each year are assumed to spend an average of one hour of technical time working with EPA's CDX Help Desk to resolve problems involving their registrations or agreements (EPA, 2011).
 Subsequent Year Costs 
In subsequent years, respondents may incur electronic reporting costs due to employee turnover and compromised electronic signatures as well ongoing problem resolution.
      Employee Turnover.  It is assumed that each year 10 percent of CDX users will be replaced by new employees, who will have to comply with the subscriber agreement and/or CDX registration requirements (EPA, 2011). Thus, in subsequent years 10 percent of AOs will spend 15 minutes of managerial time to complete a subscriber agreement. In addition, 10 percent of all users (both managerial and technical) will spend10 minutes to register with CDX.
      Report Compromised Signature.  Each year 1 percent of respondents are assumed to report a compromised or surrendered electronic signature, which requires the submittal of a new subscriber agreement (EPA, 2011). This will entail 15-20 minutes of managerial time to report the compromised signature and prepare, submit, and file a new agreement, plus an additional 4 minutes contacting the Help Desk for a total of approximately 24 minutes.
      Help Desk.  CDX users are assumed to spend an average of 4 minutes contacting EPA's CDX Help Desk for technical support (EPA, 2011), which results in an estimate of 4 minutes of managerial time and 16 minutes of technical time per respondent.  
      Problem Resolution.  Three percent of respondents each year are assumed to spend an average of one hour of technical time with EPA's CDX Help Desk to resolve problems involving their registrations or agreements (EPA, 2011).
Table 3-5 and Table 3-6 present the first year burden and costs and subsequent year labor burden and costs for electronic reporting.
   Table 3-5: Industry Burden and Cost of Electronic Reporting Requirements
                        (First Year, per Firm) (2013$)
                              Reporting Activity
                        Clerical Labor (at $30.35/hour)
                       Technical Labor (at $64.55/hour)
                       Managerial Labor (at $77.82/hour)
                          Number of Annual Activities
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                       
                                    Burden
                                     Cost
                               CDX Registration
                                     0.00
                                    $0.00 
                                     0.67
                                    $43.25 
                                     0.17
                                    $13.23 
                                       1
                                     0.84
                                    $56.48
             Electronic Subscriber Agreement/ Electronic Signature
                                     0.00
                                    $0.00 
                                     0.00
                                    $0.00 
                                     0.25
                                    $19.46 
                                       1
                                     0.25
                                    $19.46
                                   Help Desk
                                     0.00
                                    $0.00 
                                     0.24
                                    $15.49 
                                     0.06
                                    $4.67 
                                       1
                                     0.30
                                    $20.16
                              Problem Resolution
                                     0.00
                                    $0.00 
                                     1.00
                                    $64.55 
                                       0
                                    $0.00 
                                     0.03
                                     0.03
                                     $1.94
                                                                         Totals
                                     1.42
                                    $98.04

Table 3-6: Industry Burden and Cost of Electronic Reporting Requirements (Subsequent Years, per Firm) (2013$)
                              Reporting Activity
                        Clerical Labor (at $30.35/hour)
                       Technical Labor (at $64.55/hour)
                       Managerial Labor (at $77.82/hour)
                          Number of Annual Activities
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                       
                                    Burden
                                     Cost
                               CDX Registration
                                     0.00
                                    $0.00 
                                     0.67
                                    $43.25 
                                     0.17
                                    $13.23 
                                     0.10
                                     0.08
                                     $5.65
             Electronic Subscriber Agreement/ Electronic Signature
                                     0.00
                                    $0.00 
                                     0.00
                                    $0.00 
                                     0.25
                                    $19.46 
                                     0.10
                                     0.03
                                     $1.95
                                   Help Desk
                                     0.00
                                    $0.00 
                                     0.24
                                    $15.49 
                                     0.06
                                    $4.67 
                                     0.10
                                     0.03
                                     $2.02
                         Report Compromised Signature
                                     0.00
                                    $0.00 
                                     0.00
                                    $0.00 
                                     0.40
                                    $31.13 
                                     0.01
                                     0.00
                                     $0.31
                              Problem Resolution
                                     0.00
                                    $0.00 
                                     1.00
                                    $64.55 
                                     0.00
                                    $0.00 
                                     0.03
                                     0.03
                                     $1.94
                                                                         Totals
                                     0.17
                                    $11.87

Recordkeeping
Reporting businesses will be required to compile and maintain records of the collected information. Based on estimates taken from the Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notification (EPA, 1994) which estimates the burden associated with PMN form completion and submission, estimates of recordkeeping of paper records is expected to require one hour of technical labor, and one hour of clerical labor per report for all reporters. Estimates from this RIA were used in the NMSP ICR (EPA, 2007) to estimate about half the burdens presented in Table 3-3. However, the original PMN burden estimates from the 1994 RIA include recordkeeping costs (EPA, 1994, pages III-13 and III-14). To account for the additional recordkeeping burden not captured by these estimates EPA used the additional two hour recordkeeping burden for polymer exception submissions, which have more stringent recordkeeping requirements than PMNs (EPA, 1994, page IV-6). In addition this two hour burden is consistent with the estimate of 1 to 3 hours of recordkeeping burden per Section 8(a) notice presented in the Information Collection Request for Toxic Substance Control Act Section 8(a) Chemical-Specific Information Gathering Rules (EPA, 2006). 
This proposed rule would require electronic reporting, however, which is expected to reduce the recordkeeping burden. EPA assumes that the final rule will reduce recordkeeping burden by half because of the efficiencies in creating and storing documents electronically. The full recordkeeping burden and associated cost estimates are presented in Table 3-7.

Table 3-7: Industry Cost Estimate to Maintain Records (2013$) (per Report)
                              Reporting Activity
                        Clerical Labor (at $30.35/hour)
                       Technical Labor (at $64.55/hour)
                       Managerial Labor (at $77.82/hour)
                               Total Labor Cost
                                       
Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                 Recordkeeping
                                      0.5
                                    $15.17 
                                      0.5
                                    $32.27 
                                       0
                                    $0.00 
                                       1
                                    $47.44
Source: BLS, 2014; EPA, 1994.
 Discounting Methods
Discounting refers to the economic conversion of future costs (and benefits) to their present values, accounting for the fact that society tends to value future costs or benefits less than comparable near-term costs or benefits. Discounting is important when the values of costs or benefits occur over a multiple year period and may vary from year to year. Discounting enables the accumulation of the cost and benefit values from multiple years at a single point in time, accounting for the difference in how society values those costs and benefits depending on the year in which the values are estimated to occur.
The proposed rule requires that firms incur a one-time cost related to the reporting and maintenance of records pertaining to each nanoscale material manufactured or processed for redistribution and use in the United States. 
Costs are discounted over a 10-year period using rates of three and seven percent. The 10-year analysis period was selected because the number of nanomaterials is assumed to double over the next 10 years. The analysis assumes that first year costs are incurred at the beginning of the period; as a result, costs incurred during the first year do not need to be discounted. Costs accrued in subsequent years are discounted (for the discount rate r = 3 percent and r = 7 percent and t = time in years) back to the beginning of the 10-year period (present value), as follows:
  Present Value=t=110(Undiscounted Value)t(1+r)t
                                                                               
This analysis also presents the 10-year annualized costs of the rule. Conceptually, the annualized cost is equivalent to the level annual payment that one would have to make to pay off a debt equal to the net present value of the costs for a given interest rate (the discount rate). The costs are annualized such that the net present value of the costs is equivalent to a stream of 10 equal payments assuming that all costs are incurred at the end of each year.
Annualized Cost=(PV)*r*(1+r)10(1+r)11-1
                                                                              (

 Total Industry Compliance Costs
As explained in Chapter 2, EPA estimates that 295 reporters will submit chemical reports for an average of 5.06 nanomaterials per firm in the first year of the rule, resulting in approximately 1,493 reports. The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period, with an average of approximately 0.56 additional nanomaterials per firm in subsequent years, resulting in annual total of 165 additional reports annually. As indicated in Table 3-9, the total cost of the rule to nanomaterials firms drops from approximately $13.9 million in the first year of the rule to approximately $1.53 million in subsequent years (without discounting). The annualized cost of the rule over the 10-year analysis period is $2.71 million with a three percent discount rate and $2.97 million with a seven percent discount rate.
Table 3-8: Total Annual Industry Burden Hours
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                    Rule Familiarizationc Burden (per Firm)
             Form Completion and Recordkeeping Burden (per Report)
                 Electronic Reporting Requirements (per Firm)d
                             Total Burden Per Firm
                       Total Industry Number of Reportsb
                             Total Industry Burden
                                       1
                                      295
                                     5.06
                                     0.82
                                     137.6
                                     1.42
                                      698
                                     1,493
                                    206,098
                                       2
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       3
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       4
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       5
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       6
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       7
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       8
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                       9
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                      10
                                      295
                                     0.56
                                     0.00
                                     137.6
                                     0.17
                                      77
                                      165
                                    22,755
                                     Total
                                       -
                                     10.10
                                       -
                                       -
                                       -
                                       -
                                     2,978
                                    410,893
Notes:
a EPA assumes that the number of firms remains constant over the analysis period.
b The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 3-9: Total Annualized Industry Costs
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                     Rule Familiarizationc Cost (per Firm)
             Form Completion and Recordkeeping Cost (per Report)d
              Electronic Reporting Requirements Cost (per Firm)e
                             Total Cost (per Firm)
                          Discounted Cost (Per Firm)
                       Total Industry Number of Reportsb
                     Total Industry Cost (Millions 2013$)
                           Industry Discounted Cost
                               (Millions 2013$)
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                               3 % Discount Rate
                               7 % Discount Rate
                                       
                                       
                               3 % Discount Rate
                               7 % Discount Rate
                                       1
                                      295
                                     5.06
                                    $56.51 
                                    $9,281 
                                    $98.04 
                                   $47,021 
                                   $47,021 
                                   $47,021 
                                     1,493
                                    $13.87 
                                    $13.87 
                                    $13.87 
                                       2
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $5,046 
                                    $4,858 
                                      165
                                    $1.53 
                                    $1.49 
                                    $1.43 
                                       3
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,899 
                                    $4,540 
                                      165
                                    $1.53 
                                    $1.44 
                                    $1.34 
                                       4
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,757 
                                    $4,243 
                                      165
                                    $1.53 
                                    $1.40 
                                    $1.25 
                                       5
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,618 
                                    $3,965 
                                      165
                                    $1.53 
                                    $1.36 
                                    $1.17 
                                       6
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,484 
                                    $3,706 
                                      165
                                    $1.53 
                                    $1.32 
                                    $1.09 
                                       7
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,353 
                                    $3,463 
                                      165
                                    $1.53 
                                    $1.28 
                                    $1.02 
                                       8
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,226 
                                    $3,237 
                                      165
                                    $1.53 
                                    $1.25 
                                    $0.95 
                                       9
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $4,103 
                                    $3,025 
                                      165
                                    $1.53 
                                    $1.21 
                                    $0.89 
                                      10
                                      295
                                     0.56
                                    $0.00 
                                    $9,281 
                                    $11.87 
                                    $5,198 
                                    $3,984 
                                    $2,827 
                                      165
                                    $1.53 
                                    $1.17 
                                    $0.83 
                                     Total
                                       -
                                     10.1
                                       -
                                       -
                                       
                                       
                                       
                                       
                                     2,978
                                       -
                                       -
                                       -
                                       
                                                                Annualized Cost
                                    $9,180 
                                   $10,081 
                                       
                                    $2.71 
                                    $2.97 
Notes:
a EPA assumes that the number of firms remains constant over the analysis period.
b The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
e Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding.

  -  Agency Costs
 Introduction
EPA will also incur costs in administering the proposed rule. Specifically, EPA will be required to provide industry and public assistance to facilitate compliance and process submissions. These costs are discussed in Section 4.2.
 EPA Costs
The proposed rule requires EPA to provide industry and public assistance (e.g., provide guidance and facilitate compliance), process submitted reports, and maintain the information technology systems that support these activities. Based on previous estimates of Agency time used in economic analyses of Preliminary Assessment Information Reporting (PAIR) rules, which require Agency activity similar to that required under the proposed rule, it is estimated to take 1.25 labor hours per report to provide industry and public assistance and 3.13 labor hours per report to provide data processing and systems support for a total of 4.38 labor hours per report (EPA, 2003a) when the reporting is accomplished through non-electronic reporting. The electronic reporting required by the proposed rule is expected to result in cost savings to EPA.
This analysis used the same methodology as that in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA, 2009a) to calculate EPA burden savings from electronic reporting. Potential Agency burden savings associated with the electronic reporting of the respective TSCA reports were characterized based on information in the CDX Business Case Analysis regarding the estimated monetary benefit from using CDX. Of the six Program Data Flows studied in the CDX Business Case Analysis, monetary benefits from using CDX as compared to a paper submission baseline were quantified for two flows: TRI (Toxic Release Inventory) and e-NOI (electronic Notice of Intent under the National Pollution Discharge Elimination System). Benefits ranged from eleven percent savings (e-NOI) to 22 percent savings (TRI) compared to the cost of the baseline process. For this analysis, EPA assumed an average annual savings of 16.5 percent. Applying the 16.5 percent annual savings to burden estimates described above results in an estimated 1.25/report for providing industry and public assistance and 3.13/report for data processing and systems support.

Table 4-1: Estimate of Agency Hours for the Proposed Rule
Administrative Activity for All Reporters
Hours
Industry/Public Assistance
                                 1.25 / report
Data Processing and Systems Support Personnel
                                 3.13 / report
Total
                                 4.38 / report
Source: EPA, 2003a.

EPA assumes that, on average, a Federal GS-13, Step 5 full-time equivalent (FTE) will conduct its collection and administrative activities under the proposed rule. The annual 2013 fully loaded salary for a GS-13, Step 5 FTE is $161,446. This estimate includes a base salary of $100,904 plus a 60 percent load increase to account for benefits and overhead (i.e., $60,542). Dividing the fully loaded annual salary by 2,087 hours (i.e., the number of hours in a work year as defined by OPM) yields an hourly FTE wage rate of $77.36. Appendix A provides a detailed description of these calculations.
Multiplying 4.38 hours by the $77.36 hourly FTE wage rate yields a total cost of approximately $339 to administer and process a chemical report. Further, as explained in Chapter 3, approximately 1,493 chemical reports will be filed in the first year of the rule and 165 reports in subsequent years. As shown in Table 4-2, the total Agency hours and costs for the proposed rule are estimated to total 6,539 hours and $0.51 million in the first year of the rule before decreasing to 723 hours and $0.06 million in subsequent years. The annualized costs of the rule over the 10-year analysis period are $0.10 million with a three percent discount rate and $0.11 million with a seven percent discount rate. 
     Table 4-2: Agency Cost and Burden Hour Estimate for the Proposed Rule
                                     Year
                                Wage Rate (FTE)
                               Hours per Report
                            Agency Cost per Report
                           Total Number of Reportsa
                                     Total
                       Discounted Cost (Millions 2013$)
                                       
                                       
                                       
                                    (2013$)
                                       
                                     Hours
                             Cost (Millions 2013$)
                               3% Discount Rate
                               7% Discount Rate
                                       1
                                    $77.36
                                     4.38
                                     $339
                                     1,493
                                     6,539
                                     $0.51
                                    $0.51 
                                    $0.51 
                                       2
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.05 
                                       3
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.05 
                                       4
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.05 
                                       5
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.04 
                                       6
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.04 
                                       7
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.04 
                                       8
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.05 
                                    $0.03 
                                       9
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.04 
                                    $0.03 
                                      10
                                    $77.36
                                     4.38
                                     $339
                                      165
                                      723
                                     $0.06
                                    $0.04 
                                    $0.03 
                                     Total
                                       -
                                     43.8
                                       -
                                     2,978
                                    13,046
                                       
                                       -
                                       -
                                       -
                                       
                                                                Annualized Cost
                                    $0.10 
                                    $0.11 
Notes:
aThe total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

  -  Total Social Costs and Sensitivity Analyses
Table 5-1 presents the total social burden and costs of the proposed rule in the first and subsequent years, and the annualized costs discounted over the 10-year period using three and seven percent discount rates. As indicated, the total burden of the rule is expected to be approximately 423,939 hours over the 10-year analysis period, while the annualized costs are expected to be from approximately $2.80 million with a three percent discount rate and approximately $3.08 million with a seven percent discount rate. 
Table 5-1: Total Social Burden and Cost of the Proposed Rule
                                     Year 
                                Burden (Hours)
                           Discounted Costs (2013$)

                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
                                       1
                                    206,098
                                     6,539
                                    212,637
                                    $13.87 
                                    $0.51 
                                    $14.38 
                                    $13.87 
                                    $0.51 
                                    $14.38 
                                       2
                                    22,755
                                      723
                                    23,478
                                    $1.49 
                                    $0.05 
                                    $1.54 
                                    $1.43 
                                    $0.05 
                                    $1.48 
                                       3
                                    22,755
                                      723
                                    23,478
                                    $1.44 
                                    $0.05 
                                    $1.49 
                                    $1.34 
                                    $0.05 
                                    $1.39 
                                       4
                                    22,755
                                      723
                                    23,478
                                    $1.40 
                                    $0.05 
                                    $1.45 
                                    $1.25 
                                    $0.05 
                                    $1.30 
                                       5
                                    22,755
                                      723
                                    23,478
                                    $1.36 
                                    $0.05 
                                    $1.41 
                                    $1.17 
                                    $0.04 
                                    $1.21 
                                       6
                                    22,755
                                      723
                                    23,478
                                    $1.32 
                                    $0.05 
                                    $1.37 
                                    $1.09 
                                    $0.04 
                                    $1.13 
                                       7
                                    22,755
                                      723
                                    23,478
                                    $1.28 
                                    $0.05 
                                    $1.33 
                                    $1.02 
                                    $0.04 
                                    $1.06 
                                       8
                                    22,755
                                      723
                                    23,478
                                    $1.25 
                                    $0.05 
                                    $1.30 
                                    $0.95 
                                    $0.03 
                                    $0.98 
                                       9
                                    22,755
                                      723
                                    23,478
                                    $1.21 
                                    $0.04 
                                    $1.25 
                                    $0.89 
                                    $0.03 
                                    $0.92 
                                      10
                                    22,755
                                      723
                                    23,478
                                    $1.17 
                                    $0.04 
                                    $1.21 
                                    $0.83 
                                    $0.03 
                                    $0.86 
                                     Total
                                    410,893
                                    13,044
                                    423,939
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       
                                                               Annualized Costs
                                    $2.71 
                                    $0.10 
                                    $2.80 
                                    $2.97 
                                    $0.11 
                                    $3.08 
Source: EPA, 2003a; OPM, 2013

 - Sensitivity Analyses
To show the possible range of costs and burden associated with the proposed rule, EPA conducted several alternative analyses that estimate how sensitive the cost and burden estimates presented in Chapter 3 and Chapter 4 are to changes in the estimated number of nanoscale materials and firms subject to the proposed rule. EPA conducted three sensitivity analyses, estimating: 1) costs based on a potential growth in the number of firms subject to the proposed rule over the 10 year period; 2) a low and high cost based on the range of number of reports submitted by a firm in year one; and 3) a low and high cost based the growth rate of the number of nanomaterials over the ten year period 
 Annual Industry Growth Rate 
In Chapter 3 and Chapter 4, EPA assumes that the number of firms subject to the rule will remain static throughout the period of analysis. As an alternative analysis, EPA estimated the cost to industry and the Agency assuming an annual growth rate of 5.8 percent in the number of firms subject to the rule. The growth rate of 5.8 percent was calculated using the number nanomaterials firms identified in the 2005 NMSP ICR (611) and the number of firms estimated in this report (823) and calculated using the formula below:
Growth Rate=∆Number of FirmsFirms year 1(Number of years)=823-611611(2011-2005)=0.058
Estimated Number of Nanomaterials
To be consistent with the main analysis presented in Chapter 3 and Chapter 4 EPA assumes each firm will submit 5.06 reports in its first year and 0.56 reports in each subsequent year (see Section 2.4). The total number of reports submitted each year is the sum of the first-year reports submitted by new firms and subsequent-year reports submitted by existing firms for a total of 4,354 reports over the 10-year period. 

Table 6-1: Estimated Number of Reports (Increased Annual Growth Rate Scenario)
                                     Year
                                Number of Firms
                               Reports per Firm
                                     Total
                                       
                                   New Firms
                                Existing Firms
                                     Total
                                  First Year
                               Subsequent Years
                                   New Firms
                                Existing Firms
                                     Total
                                       1
                                      295
                                       0
                                      295
                                     5.06
                                     0.56
                                     1,493
                                       0
                                     1,493
                                       2
                                      17
                                      295
                                      312
                                     5.06
                                     0.56
                                      86
                                      165
                                      251
                                       3
                                      18
                                      312
                                      330
                                     5.06
                                     0.56
                                      91
                                      175
                                      266
                                       4
                                      19
                                      330
                                      349
                                     5.06
                                     0.56
                                      96
                                      185
                                      281
                                       5
                                      20
                                      349
                                      369
                                     5.06
                                     0.56
                                      101
                                      195
                                      297
                                       6
                                      21
                                      369
                                      390
                                     5.06
                                     0.56
                                      106
                                      207
                                      313
                                       7
                                      23
                                      390
                                      413
                                     5.06
                                     0.56
                                      116
                                      218
                                      335
                                       8
                                      24
                                      413
                                      437
                                     5.06
                                     0.56
                                      121
                                      231
                                      353
                                       9
                                      25
                                      437
                                      462
                                     5.06
                                     0.56
                                      127
                                      245
                                      371
                                      10
                                      27
                                      462
                                      489
                                     5.06
                                     0.56
                                      137
                                      259
                                      395
                                     Total
                                       -
                                       -
                                       -
                                       -
                                       -
                                     2,474
                                     1,880
                                     4,354
  

Industry, Agency and Total Costs
Table 6-2 presents the annual industry labor burden for both new and existing firms. There are 295 firms expected to submit reports in year 1, and a total 489 firms are estimated to submit reports by the end of the 10 year period. Each new firm is estimated to incur 699 labor burden hours in their first year and 77 hours each subsequent year. The total industry labor burden is estimated to be 600,828 hours. The costs per firm and total industry costs are presented in Table 6-3. Total annualized costs are $3.85 million with a 3 percent discount rate and $4.07 million with a 7 percent discount rate. 
Agency costs are derived following the method described in Section 4.2. EPA expects that approximately 4,354 reports will be submitted over the next 10 years, resulting in a total Agency burden of 19,071 labor hours. Table 6-4 presents Agency burden and cost estimates for each year over the 10-year period. Annualized costs are expected to be $0.14 million with a three percent discount rate and $0.15 million with a 7 percent discount rate. 
The 5.8 percent linear growth rate in the number of nanomaterials firms over a 10-year period is expected to yield a total social burden of 619,898 hours and total annualized social costs of $3.99 million with a 3 percent discount rate ($4.22 million with a 7 percent discount rate). 

Table 6-2: Total Annual Industry Labor Burden (Increased Annual Growth Rate Scenario)
                                     Year
                                Number of Firms
                          Total Number of Reports[a]
                Rule Familiarization Burden (Hours per Firm)[b]
        Form Completion and Recordkeeping Burden (Hours per Report)[c]
         Electronic Reporting Requirements Burden (Hours per Firm)[d]
                    Total Burden per Firm (Hours per Firm)
                          Total Industry Burden Hours
                                       
                                   Existing
                                      New
                                     Total
                                       
                                   Existing
                                      New
                                       
                                   Existing
                                      New
                                   Existing
                                      New
                                       
                                       1
                                       0
                                      295
                                      295
                                     1,493
                                       0
                                     0.82
                                      138
                                       0
                                     1.42
                                       0
                                      699
                                    206,058
                                       2
                                      295
                                      17
                                      312
                                      251
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    34,657
                                       3
                                      312
                                      18
                                      330
                                      266
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    36,669
                                       4
                                      330
                                      19
                                      349
                                      281
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    38,757
                                       5
                                      349
                                      20
                                      369
                                      296
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    40,923
                                       6
                                      369
                                      21
                                      390
                                      313
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    43,166
                                       7
                                      390
                                      23
                                      413
                                      334
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    46,185
                                       8
                                      413
                                      24
                                      437
                                      352
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    48,660
                                       9
                                      437
                                      25
                                      462
                                      372
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    51,212
                                      10
                                      462
                                      27
                                      489
                                      396
                                       0
                                     0.82
                                      138
                                     0.17
                                     1.42
                                      77
                                      699
                                    54,540
                                     Total
                                       -
                                       -
                                       -
                                     4,354
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                    600,828
Notes:
a The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years.
b Derived in Table 3-2
c Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding.

Table 6-3: Annual Industry Labor Costs (Increased Annual Growth Rate Scenario)
                                     Year
                                Number of Firms
                          Total Number of Reports[a]
                 Rule Familiarization Cost (per Firm)b (2013$)
         Form Completion and Recordkeeping Cost (per Report)c (2013$)
             Electronic Reporting Requirements (per Firm)d (2013$)
                          Total Cost per Firm (2013$)
                     Total Industry Cost (Millions 2013$)
                       Discounted Cost (Millions 2013$)
                                       
                                   Existing
                                      New
                                     Total
                                       
                                   Existing
                                      New
                                   Existing
                                      New
                                   Existing
                                      New
                                   Existing
                                      New
                                       
                                   Existing
                                      New
                                       1
                                       0
                                      295
                                      295
                                     1,493
                                    $0.00 
                                    $56.51 
                                       0
                                    $9,281 
                                       0
                                    $98.04 
                                       0
                                   $47,119 
                                    $13.90
                                    $13.90 
                                    $13.90 
                                       2
                                      295
                                      17
                                      312
                                      251
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $2.34
                                    $2.27 
                                    $2.18 
                                       3
                                      312
                                      18
                                      330
                                      266
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $2.47
                                    $2.33 
                                    $2.16 
                                       4
                                      330
                                      19
                                      349
                                      281
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $2.61
                                    $2.39 
                                    $2.13 
                                       5
                                      349
                                      20
                                      369
                                      296
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $2.76
                                    $2.45 
                                    $2.11 
                                       6
                                      369
                                      21
                                      390
                                      313
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $2.91
                                    $2.51 
                                    $2.08 
                                       7
                                      390
                                      23
                                      413
                                      334
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $3.12
                                    $2.61 
                                    $2.08 
                                       8
                                      413
                                      24
                                      437
                                      352
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $3.28
                                    $2.67 
                                    $2.04 
                                       9
                                      437
                                      25
                                      462
                                      372
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $3.45
                                    $2.73 
                                    $2.01 
                                      10
                                      462
                                      27
                                      489
                                      396
                                    $0.00 
                                    $56.51 
                                    $9,281 
                                    $9,281 
                                    $11.87 
                                    $98.04 
                                    $5,209 
                                   $47,119 
                                     $3.68
                                    $2.82 
                                    $2.00 
                                     Total
                                       -
                                       -
                                       -
                                     4,354
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       
                                       
                                       
                                       
                                                                Annualized Cost
                                    $3.85 
                                    $4.07 
Notes:
a The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years.
b Derived in Table 3-2
c Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding.

Table 6-4: Agency Cost Estimate for the Proposed Rule (Increased Annual Growth Rate Scenario)
                                     Year
                                  Wage Rate 
                               Hours per Report
                            Agency Cost per Report 
                                    (2013$)
                           Total Number of Reportsa
                                     Total
                       Discounted Cost (Millions 2013$)

                                       

                                    Burden
                             Cost (Millions 2013$)
                               3% Discount Rate
                               7% Discount Rate
                                       1
                                    $77.36
                                     4.38 
                                     $339 
                                     1,493
                                     6,539
                                    $0.51 
                                    $0.51 
                                    $0.51 
                                       2
                                    $77.36
                                     4.38 
                                     $339 
                                      251
                                     1,099
                                    $0.09 
                                    $0.08 
                                    $0.08 
                                       3
                                    $77.36
                                     4.38 
                                     $339 
                                      266
                                     1,165
                                    $0.09 
                                    $0.08 
                                    $0.08 
                                       4
                                    $77.36
                                     4.38 
                                     $339 
                                      281
                                     1,231
                                    $0.10 
                                    $0.09 
                                    $0.08 
                                       5
                                    $77.36
                                     4.38 
                                     $339 
                                      296
                                     1,296
                                    $0.10 
                                    $0.09 
                                    $0.08 
                                       6
                                    $77.36
                                     4.38 
                                     $339 
                                      313
                                     1,371
                                    $0.11 
                                    $0.09 
                                    $0.08 
                                       7
                                    $77.36
                                     4.38 
                                     $339 
                                      334
                                     1,463
                                    $0.11 
                                    $0.09 
                                    $0.08 
                                       8
                                    $77.36
                                     4.38 
                                     $339 
                                      352
                                     1,542
                                    $0.12 
                                    $0.10 
                                    $0.07 
                                       9
                                    $77.36
                                     4.38 
                                     $339 
                                      372
                                     1,629
                                    $0.13 
                                    $0.10 
                                    $0.07 
                                      10
                                    $77.36
                                     4.38 
                                     $339 
                                      396
                                     1,734
                                    $0.13 
                                    $0.10 
                                    $0.07 
                                     Total
                                       -
                                     43.80
                                       -
                                     4,354
                                    19,071
                                       -
                                       -
                                       -
                                       
                                                                Annualized Cost
                                    $0.14 
                                    $0.15 
Notes:
aThe total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

Table 6-5: Total Social Costs for the Proposed Rule (Increased Annual Growth Rate Scenario)
                                     Year 
                                Burden (Hours)
                           Discounted Costs (2013$)

                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 
                                       1
                                    206,058
                                     6,539
                                    212,597
                                    $13.90 
                                    $0.51 
                                    $14.41 
                                    $13.90 
                                    $0.51 
                                    $14.41 
                                       2
                                    34,657
                                     1,099
                                    35,757
                                    $2.27 
                                    $0.08 
                                    $2.35 
                                    $2.18 
                                    $0.08 
                                    $2.26 
                                       3
                                    36,669
                                     1,165
                                    37,834
                                    $2.33 
                                    $0.08 
                                    $2.42 
                                    $2.16 
                                    $0.08 
                                    $2.24 
                                       4
                                    38,757
                                     1,231
                                    39,988
                                    $2.39 
                                    $0.09 
                                    $2.48 
                                    $2.13 
                                    $0.08 
                                    $2.21 
                                       5
                                    40,923
                                     1,296
                                    42,220
                                    $2.45 
                                    $0.09 
                                    $2.54 
                                    $2.11 
                                    $0.08 
                                    $2.18 
                                       6
                                    43,166
                                     1,371
                                    44,537
                                    $2.51 
                                    $0.09 
                                    $2.60 
                                    $2.08 
                                    $0.08 
                                    $2.15 
                                       7
                                    46,185
                                     1,463
                                    47,648
                                    $2.61 
                                    $0.09 
                                    $2.70 
                                    $2.08 
                                    $0.08 
                                    $2.15 
                                       8
                                    48,660
                                     1,542
                                    50,202
                                    $2.67 
                                    $0.10 
                                    $2.77 
                                    $2.04 
                                    $0.07 
                                    $2.12 
                                       9
                                    51,212
                                     1,629
                                    52,841
                                    $2.73 
                                    $0.10 
                                    $2.83 
                                    $2.01 
                                    $0.07 
                                    $2.08 
                                      10
                                    54,540
                                     1,734
                                    56,274
                                    $2.82 
                                    $0.10 
                                    $2.92 
                                    $2.00 
                                    $0.07 
                                    $2.07 
                                     Total
                                    600,822
                                    19,071
                                    619,898
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       
                                                               Annualized Costs
                                    $3.85 
                                    $0.14 
                                    $3.99 
                                    $4.28 
                                    $0.15 
                                    $4.22 
Source: EPA, 2003a; OPM, 2013

 Number of Nanomaterials per Firm
Low and High-End Estimates for the Number of Nanomaterials per Firm
As described in Section 2.4, the median number of TSCA-related nanomaterials manufactured per firm is 13 (based on a subgroup of 34 firms), and after excluding those produced for R&D purposes (approximately 61 percent of all nanomaterials), EPA estimated 5.06 to be "commercially relevant" and therefore subject to the proposed rule. The number of nanomaterials produced by the 34 businesses in the subgroup ranged from 1 to 66. As a sensitivity analysis, EPA has estimated industry and Agency burden associated with the proposed rule using the high and low values from this range. Assuming a low-end estimate of 1 nanomaterial, on average each firm will report on 0.39 nanomaterials in the first year and 0.04 in the subsequent years. Using the high-end estimate of 66 nanomaterials, a firm will submit 25.67 reports in the first year and 2.85 reports in all future years. 
Table 6-6: Estimated High- and Low-End Estimated Number of Commercially Relevant Nanomaterials per Firm
                              Population Category
                            Nanomaterials per Firm
                             R&D Exclusion (%)
                             R&D Exclusion (#)
                   "Commercial" Nano-materials per Firma

                                  First Year
                               Subsequent Years
                             Reporting Businesses
                                       1
                                    61.11%
                                     0.61
                                     0.39
                                     0.04

                                      66
                                    61.11%
                                     40.33
                                     25.67
                                     2.85
Notes:
a The total number of nanomaterials subject to proposed rule is assumed to double over the analysis period of 10 years. (see section 2.4 for more details) 
          
Industry, Agency and Total Costs
Low-end estimates. Based on the number of firms and the burden estimates derived in Section 2.3 and Section 3.3, and using the low-end estimate of 0.39 reports in the first year and 0.04 in the subsequent years, the total industry burden is 16,491 hours in the first year and 1,673 hours future years, with an annualized cost of $0.21 million with a 3 percent discount rate ($0.23 with a 7 percent discount rate) Table 6-7 and Table 6-8 present the industry cost and burden estimates.

Table 6-9 contains the Agency burden estimate of 504 hours in the first year and 52 hours each subsequent year, and the annualized cost of estimates of $0.01 million with a 3 percent discount rate ($0.01 million with a 7 percent discount rate).

Table 6-10 presents the total social costs of $0.22 million with a 3 percent discount rate and $0.24 million with a 7 percent discount rate.

High-end estimates. Using the high end estimate of 25.67 reports in the first year, and 2.85 reports in each subsequent year, the industry burden is 1,042,657 hours in the first year and 115,737 hours in each subsequent year, with an annualized cost of $13.76 million with a 3 percent discount rate ($15.10 with a 7 percent discount rate). The industry burden and cost estimates are presented in Table 6-7 and Table 6-8 respectively. 
Table 6-9 presents the total Agency burden estimate of 33,168 hours in the first year and 3,682 in each subsequent year, and the annualized Agency cost estimate of $0.50 million with a 3 percent discount rate ($0.55 with a 7 percent discount rate). 
Table 6-10 contains the total social costs and burden of using the high end-estimate. The total social burden is 2.12 million hours over the ten year period, and the annualized cost is $14.26 million with a 3 percent discount rate and $15.66 with a 7 percent discount rate. 

Table 6-7: Total Annual Industry Burden Hours (Low-and High-End Nanomaterials Estimates Scenario)
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                    Rule Familiarizationc Burden (per Firm)
             Form Completion and Recordkeeping Burden (per Report)
                 Electronic Reporting Requirements (per Firm)d
                             Total Burden Per Firm
                       Total Industry Number of Reportsb
                             Total Industry Burden

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     295.0
                                     0.39
                                     25.67
                                     0.82
                                     137.6
                                     1.42
                                     55.90
                                     3,534
                                      115
                                     7,573
                                    16,491
                                   1,042,657
                                       2
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       3
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       4
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       5
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       6
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       7
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       8
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                       9
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                      10
                                     295.0
                                     0.04
                                     2.85
                                     0.00
                                     137.6
                                     0.17
                                     5.67
                                      392
                                      12
                                      841
                                     1,673
                                    115,737
                                     Total
                                       -
                                     0.75
                                     51.32
                                       -
                                       -
                                       -
                                       -
                                       
                                      221
                                    15,139
                                    31,544
                                   2,084,293
Notes:
a EPA assumes that the number of firms remains constant over the analysis period.
b The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 6-8 : Annual Industry Labor Costs (Low-and High-End Nanomaterials Estimates Scenario)
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                   Rule Familiarization  Cost (per Firm)[b] 
                                    (2013$)
    Form Completion and Recordkeeping Burden  Cost (per Report)[b] (2013$)
             Electronic Reporting Requirements (per Firm)b (2013$)
                             Total Burden Per Firm
                       Total Industry Number of Reportsb
                              Total Industry Cost
                                (Millions $2013)

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                               3% Discount Rate 
                               7% Discount Rate 

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      295
                                     0.39
                                     25.67
                                    $56.51
                                    $9,281
                                    $98.04
                                    $3,774
                                   $238,409
                                      115
                                     7,573
                                    $1.11 
                                    $70.33
                                     $1.11
                                    $70.33
                                       2
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.11 
                                     $7.58
                                     $0.11
                                     $7.30
                                       3
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.11 
                                     $7.36
                                     $0.10
                                     $6.82
                                       4
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.10 
                                     $7.14
                                     $0.09
                                     $6.37
                                       5
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.10 
                                     $6.94
                                     $0.09
                                     $5.96
                                       6
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.10 
                                     $6.73
                                     $0.08
                                     $5.57
                                       7
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09 
                                     $6.54
                                     $0.08
                                     $5.20
                                       8
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09 
                                     $6.35
                                     $0.07
                                     $4.86
                                       9
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09 
                                     $6.16
                                     $0.07
                                     $4.54
                                      10
                                      295
                                     0.04
                                     2.85
                                     $0.00
                                    $9,281
                                    $11.87
                                     $383
                                    $26,464
                                      12
                                      841
                                    $0.09 
                                     $5.98
                                     $0.06
                                     $4.25
                                     Total
                                       -
                                     0.75
                                     51.32
                                       -
                                       -
                                       -
                                       -
                                       
                                      221
                                    15,139
                                       
                                       
                                       
                                       
                                       
                                                                Annualized Cost
                                    $0.21 
                                    $13.76 
                                    $0.23 
                                    $15.10 
Notes:
a EPA assumes that the number of firms remains constant over the analysis period.
b The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding

Table 6-9: Agency Cost Estimate for the Proposed Rule (Low-and High-End Nanomaterials Estimates Scenario)
                                     Year
                                  Wage Rate 
                               Hours per Report
                            Agency Cost per Report 
                           Total Number of Reportsa
                                 Total Burden
                       Discounted Cost (Millions 2013$)

                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                    $77.36
                                     4.38 
                                     $339 
                                      115
                                     7,573
                                      504
                                    33,168 
                                    $0.039 
                                    $2.57 
                                    $0.039 
                                    $2.57 
                                       2
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.004 
                                    $0.28 
                                    $0.004 
                                    $0.27 
                                       3
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.004 
                                    $0.27 
                                    $0.003 
                                    $0.25 
                                       4
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.004 
                                    $0.26 
                                    $0.003 
                                    $0.23 
                                       5
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.004 
                                    $0.25 
                                    $0.003 
                                    $0.22 
                                       6
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.003 
                                    $0.25 
                                    $0.003 
                                    $0.20 
                                       7
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.003 
                                    $0.24 
                                    $0.003 
                                    $0.19 
                                       8
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.003 
                                    $0.23 
                                    $0.002 
                                    $0.18 
                                       9
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.003 
                                    $0.22 
                                    $0.002 
                                    $0.17 
                                      10
                                    $77.36
                                     4.38 
                                     $339 
                                      12
                                      841
                                      52
                                    3,682 
                                    $0.003 
                                    $0.22 
                                    $0.002 
                                    $0.15 
                                     Total
                                       -
                                     43.80
                                       -
                                      221
                                    15,139
                                      969
                                    66,311
                                       -
                                       
                                       
                                       -
                                       
                                                                Annualized Cost
                                    $0.01 
                                    $0.50 
                                    $0.01 
                                    $0.55 
Notes:
aThe total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

Table 6-10: Total Social Costs for the Proposed Rule
                                     Year 
                                Burden (Hours)
                      Discounted Costs ( Millions 2013$)

                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 

                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                       1
                                    16,491
                                   1,042,657
                                      504
                                    33,168
                                    16,994
                                   1,059,651
                                    $1.11 
                                    $70.33 
                                    $0.04 
                                    $2.57 
                                     $1.15
                                    $72.90
                                    $1.11 
                                    $70.33 
                                    $0.04 
                                    $2.57 
                                     $1.15
                                    $72.90
                                       2
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.11 
                                    $7.58 
                                    $0.00 
                                    $0.28 
                                     $0.11
                                     $7.86
                                    $0.11 
                                    $7.30 
                                    $0.00 
                                    $0.27 
                                     $0.11
                                     $7.56
                                       3
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.11 
                                    $7.36 
                                    $0.00 
                                    $0.27 
                                     $0.11
                                     $7.63
                                    $0.10 
                                    $6.82 
                                    $0.00 
                                    $0.25 
                                     $0.10
                                     $7.07
                                       4
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.10 
                                    $7.14 
                                    $0.00 
                                    $0.26 
                                     $0.11
                                     $7.41
                                    $0.09 
                                    $6.37 
                                    $0.00 
                                    $0.23 
                                     $0.10
                                     $6.61
                                       5
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.10 
                                    $6.94 
                                    $0.00 
                                    $0.25 
                                     $0.10
                                     $7.19
                                    $0.09 
                                    $5.96 
                                    $0.00 
                                    $0.22 
                                     $0.09
                                     $6.17
                                       6
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.10 
                                    $6.73 
                                    $0.00 
                                    $0.25 
                                     $0.10
                                     $6.98
                                    $0.08 
                                    $5.57 
                                    $0.00 
                                    $0.20 
                                     $0.08
                                     $5.77
                                       7
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09 
                                    $6.54 
                                    $0.00 
                                    $0.24 
                                     $0.10
                                     $6.78
                                    $0.08 
                                    $5.20 
                                    $0.00 
                                    $0.19 
                                     $0.08
                                     $5.39
                                       8
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09 
                                    $6.35 
                                    $0.00 
                                    $0.23 
                                     $0.10
                                     $6.58
                                    $0.07 
                                    $4.86 
                                    $0.00 
                                    $0.18 
                                     $0.07
                                     $5.04
                                       9
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09 
                                    $6.16 
                                    $0.00 
                                    $0.22 
                                     $0.09
                                     $6.39
                                    $0.07 
                                    $4.54 
                                    $0.00 
                                    $0.17 
                                     $0.07
                                     $4.71
                                      10
                                     1,673
                                    115,737
                                      52
                                     3,682
                                     1,724
                                    117,462
                                    $0.09 
                                    $5.98 
                                    $0.00 
                                    $0.22 
                                     $0.09
                                     $6.20
                                    $0.06 
                                    $4.25 
                                    $0.00 
                                    $0.15 
                                     $0.06
                                     $4.40
                                     Total
                                    31,544
                                   2,084,293
                                      969
                                    66,311
                                    32,513
                                   2,116,806
                                       -
                                       
                                       -
                                       
                                       
                                       -
                                       -
                                       
                                       -
                                       
                                       
                                       -
                                       
                                                               Annualized Costs
                                    $0.21 
                                    $13.76 
                                    $0.01 
                                    $0.50 
                                    $0.22 
                                    $14.26 
                                    $0.23 
                                    $15.10 
                                    $0.01 
                                    $0.55 
                                    $0.24 
                                    $15.66 
Source: EPA, 2003a; OPM, 2013

 Annual Nanomaterials Growth Rate
Low and High-End Estimates in the Growth Rate of the Number Nanomaterials per Firm
The main analysis presented in this report assumes that the number of nanomaterials reported per firm will double over the next 10 years (or an annual growth rate of approximately 8 percent). EPA calculated two alternative cost scenarios: 1) assuming the number of nanomaterials per firm will grow by 50 percent over the next 10 years, and 2) assuming the number of nanomaterials per firm quadruples over the next 10 years. For both analyses, EPA assumes that each firm will still manufacture 13 nanomaterials in year 1 and report on the 5.06 commercially relevant nanomaterials subject to the proposed rule. 
Industry, Agency and Total Costs 
Low-end estimates. A 50 percent increase in the number of nanomaterials manufactured by each firm over the next 10 years will result in approximately 0.28 additional reports each year, for a total of 2,239 reports over the 10 year period. As indicated in Table 6-11 and Table 6-12, industry will incur a labor burden of 206,058 hours in the first year and 11,461 hours in each subsequent year and the annualized cost will be $2.09 million with 3 percent discount rate ($2.36 million with a 7 percent discount rate). 
Table 6-13 contains the total Agency burden and cost under this scenario; 9,807 hours in the first year and 363 in each subsequent year and an annualized cost of $0.08 million with a 3 percent discount rate and $0.09 million with a 7 percent discount rate. 
The combined industry and Agency burden of this scenario is 319,011 hours over the 10-year period with an annualized social cost of $2.17 million with a 3 percent discount rate and $2.45 with a 7 percent discount rate. The total social costs are presented in Table 6-15.
High-end estimates. Assuming the number of nanomaterials per firm quadruples over the next 10 years, approximately 1.69 reports will be submitted every year after year 1, for a total of 5,971 reports over the 10-year period. As shown in Table 6-11 and Table 6-12, industry is estimated to incur a labor burden of 206,098 hours in the first year and 68,517 hours in each subsequent year. The annualized costs of this scenario are approximately $5.23 million with a 3 percent discount rate and $5.49 million with a 7 percent discount rate. 
Table 6-13 present the Agency burden and costs estimates of this scenario. The Agency burden is estimate to be 6,538 hours in the first year and 2,179 in each subsequent year. The annualized cost is $0.19 million with a 3 percent discount rate and $0.20 million with a 7 percent discount rate. 
The total social burden of this scenario is presented in See Table 6-14 and is 1,141,719 hours over the 10-year period with an annualized social cost of $5.43 million with a 3 percent discount rate and $5.69 million with a 7 percent discount rate.

Table 6-11: Total Industry Burden Hours (Increased Nanomaterials Growth Scenario)
                                     Year
                              Number of Firms[a]
                              Reports per Firm[b]
                   Rule Familiarization[c] Burden (per Firm)
             Form Completion and Recordkeeping Burden (per Report)
                Electronic Reporting Requirements (per Firm)[d]
                             Total Burden Per Firm
                      Total Industry Number of Reports[b]
                             Total Industry Burden

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     295.0
                                     5.06
                                     5.06
                                     0.82
                                     137.6
                                     1.42
                                    698.50
                                      699
                                     1,493
                                     1,493
                                    206,058
                                    206,058
                                       2
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       3
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       4
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       5
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       6
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       7
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       8
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                       9
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                      10
                                     295.0
                                     0.28
                                     1.69
                                     0.00
                                     137.6
                                     0.17
                                     38.85
                                      232
                                      83
                                      498
                                    11,461
                                    68,517
                                     Total
                                       -
                                     7.59
                                     20.24
                                       -
                                       -
                                       -
                                       -
                                       
                                     2,239
                                     5,971
                                    309,204
                                    822,708
Notes:
[a] EPA assumes that the number of firms remains constant over the analysis period.
[b] The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
[c] Derived in Table 3-2
[d] Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding
 
Table 6-12: Annual Industry Labor Costs (Increased Nanomaterials Growth Scenario)
                                     Year
                              Number of Firms[a]
                              Reports per Firm[b]
                Rule Familiarization Cost (per Firm)[b] (2013$)
    Form Completion and Recordkeeping Burden  Cost (per Report)[b] (2013$)
            Electronic Reporting Requirements (per Firm)[b] (2013$)
                             Total Burden Per Firm
                      Total Industry Number of Reports[b]
                     Total Industry Cost (Millions $2013)

                                      Low
                                     High

                                      Low
                                     High
                                      Low
                                     High
                               3% Discount Rate 
                               7% Discount Rate 

                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      295
                                     5.06
                                     5.06
                                    $56.51
                                    $9,281
                                    $98.04
                                    $47,119
                                    $47,119
                                     1,493
                                     1,493
                                    $13.90 
                                    $13.90
                                    $13.90
                                    $13.90
                                       2
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.75 
                                     $4.49
                                     $0.72
                                     $4.32
                                       3
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.73 
                                     $4.36
                                     $0.68
                                     $4.04
                                       4
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.71 
                                     $4.23
                                     $0.63
                                     $3.77
                                       5
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.69 
                                     $4.11
                                     $0.59
                                     $3.53
                                       6
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.67 
                                     $3.99
                                     $0.55
                                     $3.30
                                       7
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.65 
                                     $3.87
                                     $0.52
                                     $3.08
                                       8
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.63 
                                     $3.76
                                     $0.48
                                     $2.88
                                       9
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.61 
                                     $3.65
                                     $0.45
                                     $2.69
                                      10
                                      295
                                     0.28
                                     1.69
                                     $0.00
                                    $9,281
                                    $11.87
                                    $2,621
                                    $15,667
                                      83
                                      498
                                    $0.59 
                                     $3.54
                                     $0.42
                                     $2.51
                                     Total
                                       -
                                     7.59
                                     20.24
                                       -
                                       -
                                       -
                                       -
                                       
                                     2,239
                                     5,971
                                       
                                       
                                       
                                       
                                       
                                                              Annualized Costs 
                                    $2.09 
                                    $5.23 
                                    $2.36 
                                    $5.49 
Notes:
[a] EPA assumes that the number of firms remains constant over the analysis period.
[b] The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 additional reports per year.
[c] Derived in Table 3-2
[d] Derived from Table 3-3, Table 3-5, Table 3-6, and Table 3-7
Values may not calculate exactly due to rounding
 
Table 6-13: Agency Cost Estimate for the Proposed Rule (Increased Nanomaterials Growth Scenario)
                                     Year
                                  Wage Rate 
                               Hours per Report
                            Agency Cost per Report 
                          Total Number of Reports[a]
                                 Total Burden
                       Discounted Cost (Millions 2013$)

                               3% Discount Rate
                               7% Discount Rate

                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                    $77.36
                                     4.38 
                                     $339 
                                     1,493
                                     1,493
                                   6,538.03
                                   6,538.03
                                    $0.51 
                                    $0.51 
                                    $0.51 
                                    $0.51 
                                       2
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.03 
                                    $0.16 
                                    $0.03 
                                    $0.16 
                                       3
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.03 
                                    $0.16 
                                    $0.02 
                                    $0.15 
                                       4
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.03 
                                    $0.15 
                                    $0.02 
                                    $0.14 
                                       5
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02 
                                    $0.15 
                                    $0.02 
                                    $0.13 
                                       6
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02 
                                    $0.15 
                                    $0.02 
                                    $0.12 
                                       7
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02 
                                    $0.14 
                                    $0.02 
                                    $0.11 
                                       8
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02 
                                    $0.14 
                                    $0.02 
                                    $0.10 
                                       9
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02 
                                    $0.13 
                                    $0.02 
                                    $0.10 
                                      10
                                    $77.36
                                     4.38 
                                     $339 
                                      83
                                      498
                                    363.22
                                   2,179.34
                                    $0.02 
                                    $0.13 
                                    $0.02 
                                    $0.09 
                                     Total
                                       -
                                     43.80
                                       -
                                   2,239.05
                                   5,970.80
                                   9,807.04
                                   26,152.10
                                       -
                                       
                                       
                                       -
                                       
                                                               Annualized Costs
                                    $0.08 
                                    $0.19 
                                    $0.09 
                                    $0.20 
Notes:
[a]The total number of nanomaterials subject to the rule is assumed to double in the 10-year analysis period. As a result, nanomaterials firms will report on an average of approximately 0.56 additional nanomaterials per firm in subsequent years for a total of 165 reports per year.
Source: EPA, 2003a; OPM, 2013

Table 6-14: Total Social Costs for the Proposed Rule
                                     Year 
                                Burden (Hours)
                      Discounted Costs ( Millions 2013$)

                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 

                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                     Low 
                                     High
                                       1
                                    206,058
                                    206,058
                                     6,538
                                     6,538
                                    212,596
                                    212,596
                                    $13.90 
                                    $13.90 
                                    $0.51 
                                    $0.51 
                                    $14.41
                                    $14.41
                                    $13.90 
                                    $13.90 
                                    $0.51 
                                    $0.51 
                                    $14.41
                                    $14.41
                                       2
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.75 
                                    $4.49 
                                    $0.03 
                                    $0.16 
                                     $0.78
                                     $4.65
                                    $0.72 
                                    $4.32 
                                    $0.03 
                                    $0.16 
                                     $0.75
                                     $4.48
                                       3
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.73 
                                    $4.36 
                                    $0.03 
                                    $0.16 
                                     $0.76
                                     $4.52
                                    $0.68 
                                    $4.04 
                                    $0.02 
                                    $0.15 
                                     $0.70
                                     $4.18
                                       4
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.71 
                                    $4.23 
                                    $0.03 
                                    $0.15 
                                     $0.73
                                     $4.38
                                    $0.63 
                                    $3.77 
                                    $0.02 
                                    $0.14 
                                     $0.65
                                     $3.91
                                       5
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.69 
                                    $4.11 
                                    $0.02 
                                    $0.15 
                                     $0.71
                                     $4.26
                                    $0.59 
                                    $3.53 
                                    $0.02 
                                    $0.13 
                                     $0.61
                                     $3.65
                                       6
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.67 
                                    $3.99 
                                    $0.02 
                                    $0.15 
                                     $0.69
                                     $4.13
                                    $0.55 
                                    $3.30 
                                    $0.02 
                                    $0.12 
                                     $0.57
                                     $3.42
                                       7
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.65 
                                    $3.87 
                                    $0.02 
                                    $0.14 
                                     $0.67
                                     $4.01
                                    $0.52 
                                    $3.08 
                                    $0.02 
                                    $0.11 
                                     $0.53
                                     $3.19
                                       8
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.63 
                                    $3.76 
                                    $0.02 
                                    $0.14 
                                     $0.65
                                     $3.89
                                    $0.48 
                                    $2.88 
                                    $0.02 
                                    $0.10 
                                     $0.50
                                     $2.98
                                       9
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.61 
                                    $3.65 
                                    $0.02 
                                    $0.13 
                                     $0.63
                                     $3.78
                                    $0.45 
                                    $2.69 
                                    $0.02 
                                    $0.10 
                                     $0.47
                                     $2.79
                                      10
                                    11,461
                                    68,517
                                      363
                                     2,179
                                    11,824
                                    70,696
                                    $0.59 
                                    $3.54 
                                    $0.02 
                                    $0.13 
                                     $0.61
                                     $3.67
                                    $0.42 
                                    $2.51 
                                    $0.02 
                                    $0.09 
                                     $0.44
                                     $2.61
                                     Total
                                    309,204
                                    822,708
                                     9,807
                                    26,152
                                    319,011
                                    848,860
                                       -
                                       
                                       -
                                       
                                       
                                       -
                                       -
                                       
                                       -
                                       
                                       
                                       -
                                       
                                                               Annualized Costs
                                    $2.09 
                                    $5.23 
                                    $0.08 
                                    $0.19 
                                    $2.17 
                                    $5.43 
                                    $2.36 
                                    $5.49 
                                    $0.09 
                                    $0.20 
                                    $2.45 
                                    $5.69 
Source: EPA, 2003a; OPM, 2013

 Summary of all Analyses
Table 6-15 presents a summary of the costs and assumptions of the sensitivity analyses. As shown in the table, the total annualized industry costs range from $0.21 million per year (with a three percent discount rate) with the assumption that a firm submits 0.39 reports in the first year to $13.76 million per year (with a three percent discount rate) under the assumption a firm submits 25.67 reports in the first year. This would suggest that the cost estimates are more sensitive to the number of reports submitted in the first year, than increased costs in subsequent years (either through the growth in the number of nanomaterials or the number firms subject to the proposed rule). 
Table 6-15: Comparison of Annualized Costs of Sensitivity Analysis (Millions 2013$)
                                   Scenario
                     Annualized Costs at 3% discount rate
                     Annualized Costs at 7% discount rate
                                       
                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
                                 Main Analysis
                                    $2.71 
                                    $0.10 
                                    $2.80 
                                    $2.97 
                                    $0.11 
                                    $3.08 
                  Annual Industry Growth Rate of 5.8 percent
                                 (Section 6.1)
                                    $3.85 
                                    $0.14 
                                    $3.99 
                                    $4.28 
                                    $0.15 
                                    $4.22 
              0.39 Nanomaterials per Firm in Year 1 (Section 6.2)
                                    $0.21 
                                    $0.01 
                                    $0.22 
                                    $0.23 
                                    $0.01 
                                    $0.24 
             25.67 Nanomaterials per Firm in Year 1 (Section 6.2)
                                    $13.76 
                                    $0.50 
                                    $14.26 
                                    $15.10 
                                    $0.55 
                                    $15.66 
    The number of nanomaterials will grow by 50% over 10 years(Section 6.3)
                                    $2.09 
                                    $0.08 
                                    $2.17 
                                    $2.36 
                                    $0.09 
                                    $2.45 
    The number of nanomaterials will quadruple over 10 years (Section 6.3)
                                    $5.23 
                                    $0.19 
                                    $5.43 
                                    $5.49 
                                    $0.09 
                                    $5.69 
Note: Totals may not sum due to rounding 

  -  Benefits
As noted in the NMSP Interim Report (EPA, 2009b), EPA requires additional information to fulfill its mandate under TSCA to fully assess the risks posed by the production, sale, and use of chemical substances manufactured as nanoscale materials in the United States. With this information, EPA will be able to screen these chemicals more effectively to identify whether additional risk assessment and management steps are needed.
By enhancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and expeditiously reduce the potential risks posed by nanoscale materials. The more EPA can base its decisions on actual data rather than on assumptions, the better EPA is able to tailor its risk management decisions to the level of actual risk whether higher or lower than it would be if based on assumptions alone. Ultimately, enhancing the risk screening process will have positive consequences for human and ecosystem health and will enable a more efficient allocation of EPA's and society's resources. EPA would have an increased ability to anticipate industry trends, particularly for chemicals for which EPA has concerns.
The benefits resulting from the proposed rule are discussed qualitatively in this section. Quantification of the benefits of the proposed rule would require more specific information about each user's use patterns and preferences as well as the changes in these patterns and preferences that would result from the additional information made available under the proposed rule. These data are not readily available and collecting such data would be cost-prohibitive. For example, one approach would be to conduct a national willingness-to-pay (WTP) survey of the general public to determine the value that the public places on the availability of the information resulting from the proposed rule. However, such a survey, or a survey to collect similar information, has not been conducted.
 Market Failure
When buyers or sellers do not have perfect information, rational decision making cannot occur and a market failure exists. Information regarding the hazards associated with a chemical substance may not be widely known for several reasons. In one case, known as asymmetric information, consumers and producers do not have the same level of information regarding the aggregate production, uses, and hazards of a chemical substance.  Because information is a public good, producers are reluctant to provide information (that is, businesses may perceive the high costs of collecting and disclosing information to be greater than the benefits from increased access to chemical information). Individual consumers are simultaneously unlikely to be willing to pay the cost of collecting and reporting information if they can use information developed and paid for by others.
In addition to concerns about these direct costs, industry may have a disincentive to disclose data due to the possibility of liability or regulation (Applegate, 1991). For example, some firms releasing Toxic Release Inventory (TRI) data saw a negative response in financial markets, indicating further reasons why businesses may be reluctant to disclose information (Konar and Cohen, 1997). As a result, data on the chemicals subject to the proposed rule may be produced below what is optimal for society. 
 Benefits of Information-Based Policies
The proposed rule will supply information on nanomaterial production to which the Agency (or the public) does not currently have access. Increasing and improving the amount of available data serves to reduce inefficiencies, described above, arising from asymmetric information.
Increased and improved data on the production, sale, and use of nanomaterials in the U.S. would allow EPA and others to use the data more effectively as part of screening and prioritization programs. Screening chemicals for potential risks is an essential first step in developing and prioritizing risk management activities. Effective risk-screening by EPA depends on the ability to characterize chemical uses accurately and to predict potential exposures. Current screening activities are greatly hampered by the incomplete and inconsistent nature of available data. In addition, EPA's current screening activities are further hampered by the fact that EPA must rely on relatively limited public sources of information. This proposed rule will benefit society by filling these information gaps and contributing to better assessments of potential risks and risk management decisions.
The proposed rule will increase publicly available data about a chemical's potential risks and consequently is likely to result in (a) a reduction in the cost of risk-based decision making about the chemical, and (b) an improvement in the expected outcome of the decisions.
* Reduced cost of risk-based decision making. By making new information about potentially toxic substances available to the public (including EPA and other government agencies), this proposed rule can replace other information-gathering, management, and dissemination activities related to nanomaterials. Once the data are publicly available, information users and decision makers will avoid the time and resource costs required to individually perform these activities. In effect, the proposed rule increases the efficiency (and strength) of the decision-making process.
* Improved outcome of decisions. Information-based policies contribute to better decisions by redirecting resources toward their most highly valued uses. With incomplete information regarding toxic chemicals, public and private decision makers are not able to assess adequately the benefits and costs of actions that involve these substances. For example, EPA decisions regarding whether, when, and how to target chemicals for further risk assessment can be misdirected if basic risk-screening information is unavailable or inadequate. With more information to supplement the data provided in the NMSP and fill gaps in the current understanding of the benefits and risks of nanoscale substances, EPA can better direct its limited resources toward high-priority risks. Improved information can therefore help lead to more socially optimal reductions in risks to humans and the environment.
The proposed rule will generate both types of benefits. First, it will provide data that are otherwise unavailable or reduce EPA's and other decision-makers' reliance on databases and information sources that are inadequate for accurately characterizing the risks associated with the nanomaterials in commerce that need to be evaluated and potentially regulated. As discussed in Chapter 4, EPA will bear the cost of collecting and managing the data; however, by providing more reliable and complete data on nanomaterial uses and exposures, the rule will also allow EPA to save time and resources in screening chemicals and in developing risk management priorities.
Second, the proposed rule will allow EPA to better prioritize its risk management activities -- to move more quickly in addressing nanomaterials that pose relatively high risks (and/or relatively low risk-management costs).
For example, potential problems from incomplete information include the designation of an inappropriately high priority level to a chemical substance, resulting in unnecessary effort and resource expenditures for both regulated parties and EPA in cases where adequate data would have led the Agency to act differently. Similarly, if a business cannot provide adequate data for its product, that product may be subject to regulations which are unsuitable for its true hazard level (Applegate, 1991). In these cases, it is in the best interest of the business to disclose information about its chemical production. Reporting through TSCA ensures the public that the chemical information provided by firms is credible, and thus is more likely to be utilized efficiently (Cohen and Santhakumar, 2007). As described by Konar and Cohen (1997), information provision can also serve as informal regulation, providing financial incentives for reducing behaviors which may lead to negative externalities.

Specific benefits that accrue from the use of the information generated by this proposed rule are discussed in the following sections.

 Potential Users of Information Generated by the Proposed Rule
EPA is expected to be the primary user of the information generated by the proposed rule, although other public and private organizations, in particular those interested in managing the health and environmental risks posed by nanomaterials, will also use the data. The information is expected to be applied and disseminated by these users in a number of ways; however, it will primarily serve to reduce the costs of screening and managing chemical risks and to improve risk management decisions. The American public will be the ultimate beneficiaries of the proposed rule. By lowering the cost of decision-making in the public sector, the rule will free up resources for other public or private uses. Similar gains will also result from cost savings in private-sector decision-making. By improving risk management decisions, the rule will also help to better target risk management activities to the areas where the net benefits (i.e., risk reductions net of control costs) are expected to be the largest.
The users and beneficiaries of the reporting program and the benefits they derive from improved data on nanomaterials are discussed in more detail in the sections below.
EPA Risk-Screening and Management Programs
EPA's Office of Pollution Prevention and Toxics (OPPT) has a multifaceted approach to managing chemical risks. Chemicals enter OPPT's system primarily through a request by the Interagency Testing Committee or a request by the public or are otherwise identified by the Agency. The chemicals then enter one of several more detailed screening processes. Depending on the outcome of these screening processes, the next step may include entering one of EPA's risk management programs. EPA's current programs and tools to evaluate and manage chemical risks include: 
   *    Risk Screening. OPPT screens chemicals on the TSCA Inventory to identify potential risks and determine whether more detailed assessments should be undertaken. With the data currently available, EPA does not have the information needed to effectively and systematically screen most nanomaterials, some of which may not even be included in the inventory. The proposed rule would supply exposure-related information that the Agency does not currently have, recognizing that industry has a greater knowledge than EPA about its own operations and the uses of chemicals it manufactures and/or sells. Without this information, EPA would likely: (1) not screen these chemicals, (2) screen them using outdated or anecdotal exposure information, or (3) screen them but rely on exposure estimates using modeling data. Therefore, data collected as a result of the proposed rule will improve the Agency's ability to screen nanomaterials in commerce, allowing the Agency to better focus its chemical screening programs and to identify potentially risky situations earlier than otherwise possible.
* Master Testing List. The data collected under the proposed rule for nanomaterials would also help to determine which chemicals substances belong on the Master Testing List (MTL). The MTL is a list of chemicals identified by the Agency as having inadequate data for health and/or environmental risk assessments. OPPT uses the MTL to establish priorities for chemical testing, keep the public informed, solicit input from industry on specific chemical exposure and risk assessment needs, and to encourage industry to perform testing. Exposure-related manufacturing, processing, and use data would enable EPA to better target testing needs to situations in which potential exposures are known to occur, thereby increasing the efficiency of efforts in these programs and facilitating earlier completion of critical testing needs.

* Design for the Environment (DfE) program. EPA's DfE program incorporates principles and strategies from both the Existing Chemicals review program, by focusing on specific chemical uses and establishing partnerships with industry to develop voluntary long-range plans for risk management. The data collected under the proposed rule would help to identify use cluster candidates for this program. The data could be used to assist in ranking activities, identifying high-risk areas, and developing realistic approaches for reducing risk.
Other Federal Risk Management Programs
Other governmental agencies, such as the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer Product Safety Commission (CPSC), share regulatory authority over chemical substances or products containing them. In the case of NIOSH, the agency compiles summaries of available information and recommends exposure limits. Therefore, EPA serves as a conduit for chemical hazard information between the chemical producers and these other agencies.
OSHA currently manages occupational exposure to chemicals by setting a variety of chemical and personal protection standards, by requiring preparation of emergency response and process safety management plans and by requiring provision of health and safety data to workers for chemicals used in the workplace. OSHA will be able to use the data collected under the proposed rule to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential. The information provided by the proposed rule could increase OSHA's ability to manage chemical hazards, exposures, and risks in occupational settings.
NIOSH will also benefit from the exposure-related information collected under the proposed rule. The exposure information that NIOSH uses to determine occupational safety and health in businesses nationwide may be based on outdated information collected under the National Occupational Exposure Survey (NOES). Completed in 1983, NOES collected information such as plant site location, plant site SIC, information on the plant site's occupational safety and health programs, occupational titles of workers potentially exposed, the number of employees per occupational title, information on process steps, and trade names of products. Recognizing that some of the nanomaterials reported under the proposed rule may have been developed in the last decade, NIOSH could use the data in place of the NOES data to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential.
CPSC also could use the new data directly in conducting its exposure and risk assessment activities (e.g., screening consumer products for chemical hazards). CPSC obtains risk information to screen chemical hazards from a network of hospital emergency rooms. This information is limited to injuries and illnesses resulting from acute exposures only.
Additional data required by the proposed rule would provide a better source of reliable information on the chemicals used in consumer products. CPSC would improve its ability to identify the nanomaterials used in consumer products and, with consideration of hazard data, to identify chemical - consumer use situations presenting greater potential risk. The information could improve CPSC's ability to meet its program objective of protecting the public from chemical hazards in consumer products.
State and Local Programs
The data collected under the proposed rule will also help state and local authorities with rulemaking, information collection, and voluntary program activities. Because state and local governments must address chemicals, use patterns, and exposure scenarios that may be unique or isolated, state and local agency access to improved data on nanomaterials will assist in identifying situations that pose potentially high risks for individual states or locations within those states.
Nongovernmental Organization (NGO) Initiatives and Private-Sector Stewardship
Many private-sector organizations have a strong interest in reducing risks and providing leadership in preventing pollution while still maintaining productive economic enterprises. These organizations can better meet these objectives by developing a better understanding of how chemicals are used in general. This will allow them to more effectively manage risks and participate in community, regional, and national priority setting for chemicals.
The publicly available (non-CBI) information collected under the proposed rule can support activities typically undertaken by NGOs, such as tracking industry trends, organizing grassroots involvement in risk-based decision-making, and conducting outreach and educational programs. These organizations could use the new data to identify and establish priorities for risks; to evaluate chemicals and chemical use patterns to determine areas of concern; to identify and promote pollution prevention opportunities; and to focus pollution prevention, public outreach, and education initiatives and activities.
Industry can use the collected data to improve corporate product stewardship programs through access to use information reported by multiple companies. The American Chemistry Council's Responsible Care program is one example of a corporate product stewardship program that could use this information. Use information supplied under the rule could be used to further strengthen this program. The Responsible Care program requires companies to take responsibility for their products from cradle to grave, which requires an understanding of how their product is being used not only by their customers, but also further down the value chain. Despite this private effort, some companies have told EPA that they do not know how their chemicals are used. Non-CBI information provided by multiple companies could give an individual company a better understanding of the downstream uses of its products, therefore enabling more effective implementation of the Responsible Care concepts.

  -  Small Entity Impact Analysis
This chapter estimates the impact that the proposed rule may have on small entities by examining the relationship between the compliance costs and company sales for small companies.
The Regulatory Flexibility Act (RFA) of 1980, as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, requires regulators to assess the effects of regulations on small entities, including businesses, nonprofit organizations, and governments. In some instances, agencies also are required to examine regulatory alternatives that may reduce adverse economic effects on significantly impacted small entities. The RFA requires agencies to prepare an initial and final regulatory flexibility analysis for each rule unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA, however, does not specifically define "a significant economic impact on a substantial number" of small entities. Sections 603 and 604 of the RFA require that regulatory flexibility analyses identify the types, and estimate the numbers, of small entities to which the rule will apply; and describe the rule requirements to which small entities will be subject and any regulatory alternatives, including exemptions and deferral, that would lessen the rule's burden on small entities.
The major steps followed in the analysis are described below.
 Select a Relevant Small Business Definition
The RFA relies on the definition of "small business" found in the Small Business Act, which authorizes the Small Business Administration (SBA) to develop definitions for "small business" for industries in each North American Industry Classification System (NAICS) code. These definitions can be based either on a company's number of employees or its sales, depending on SBA's criteria for that industry. As nascent fields, nanotechnology manufacturing, processing, and distribution have not been assigned NAICS codes under the most recent classification system, NAICS 2012. This analysis therefore applies the SBA small business definitions to a subset of nanomaterials companies matched in the D&B database (further described in Section 8.2) according to the NAICS listed for the global parent company of each company in that database. 
Note that there are two definitions of small business used in this Economic Analysis. The first definition, which has been used in the previous chapters of this Economic Analysis, is used to determine if a nanomaterials firm is exempt from the proposed rule requirements. According to this definition, which was adapted from the standard TSCA definition provided in 40 CFR 704.3, a manufacturer of a TSCA Section 8(a) chemical substance is defined as small if  total annual sales of the company, combined with those of any parent company, are below $4 million. The second definition, which is used only in this chapter, is based on the small business definitions found in the SBA for the various industries. The small business thresholds for the industries identified in the D&B database range from 100 to 1,000 employees. Twenty companies in the subset meet the SBA small business definition. Thus, although considered small businesses for the purposes of this small entity impact analysis, they are expected to incur the full compliance costs of the rule. All twenty of these nanomaterials firms are expected to experience an impact of less than one percent of sales.
Table 8-1: Ultimate Parent NAICs Codes for the 20 Small Businesses in Subset
                          Ultimate Parent NAICS Code
                                  Description
                                Number of Firms
                           Small Business Threshold
                                    325130
                    Synthetic Dye and Pigment Manufacturing
                                       3
                           Less than 1,000 employees
                                    325180
                 Other Basic Inorganic Chemical Manufacturing
                                       4
                           Less than 1,000 employees
                                    325998
    All Other Miscellaneous Chemical Product and Preparation Manufacturing
                                       2
                            Less than 500 employees
                                    331221
                       Rolled Steel Shape Manufacturing
                                       1
                           Less than 1,000 employees
                                    334413
                Semiconductor and Related Device Manufacturing
                                       1
                            Less than 500 employees
                                    335991
                   Carbon and Graphite Product Manufacturing
                                       1
                            Less than 750 employees
                                    423220
                     Home Furnishing Merchant Wholesalers
                                       1
                            Less than 100 employees
                                    423330
         Roofing, Siding, and Insulation Material Merchant Wholesalers
                                       1
                            Less than 100 employees
                                    423510
          Metal Service Centers and Other Metal Merchant Wholesalers
                                       2
                            Less than 100 employees
                                    541712
Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
                                       4
                            Less than 500 employees
Note: NAICS codes, descriptions, and small business definitions are all from the 2012 NAICS
Source: D&B, 2009; SBA, 2014

 Estimate the Number of Small Businesses
To estimate the number of small and large businesses in the population of U.S. nanomaterials firms, EPA matched the selection described in Chapter 2 to the Dun & Bradstreet (D&B) corporate database to identify company and parent company sales and employment, measured the percentage of companies defined as small and large within the selection (based on the SBA definitions), and applied these percentages to the total estimate of firms.
EPA attempted to obtain sales and employment data from the Dun & Bradstreet corporate database for the 132 companies in the selection described in Chapter 2, following a rigorous search and matching procedure. The procedure began with a basic search by company name for each company in the selection. Companies for which the initial search returned a single match were checked for a U.S. address and considered positively matched. Companies for which the initial search returned multiple matches were subsequently filtered by zip code. Companies not found in the D&B database were considered unmatched.
As noted above, the SBA small business definitions consider either the sales or employment of parent companies when classifying a subsidiary as a small business. Therefore, for the matched companies identified in the D&B database as subsidiaries of a parent company, the parent company's data were recorded. For all other matched companies, the company's data were recorded.
A more intensive matching procedure was subsequently applied to the set of companies not matched in the original procedure. After undertaking basic online research, each unmatched company was identified as either (a) owned or acquired by a parent company; (b) a joint venture between two or more companies; (c) out of business; or (d) none of these. This information was then used to perform a new round of matching in the D&B database, yielding several more matches. For the matched companies identified by this procedure, the parent company's data were recorded.
Several special cases occurred during the search and matching process. In two cases, a company had multiple apparent registrations under a single name and at a single address; however, these entries were not linked in the D&B database, as generally are companies with shared ownership, thus causing difficulty in identifying the parent company. In one of these cases, the entries were few enough in number to identify the parent company; however, in the other case, the parent could not be identified.
A total of 103 companies in the selection were found in the D&B database. Of these, 83 companies have no parent company, and 20 companies have a parent company; however, one of the parent companies was already a member of the selection, thus reducing the matched subset to 83 + 20  -  1 = 102 companies. An additional two companies were identified as joint ventures, and one company was verified closed. Twenty-six companies remained unmatched against the D&B database. 
Annual sales data were obtained from the D&B database and internet-based searches for 95 of these 102 companies. Of the 95 nanomaterials manufacturers and parent companies found with sales data, 34 have annual sales equal to or greater than $4 million and are therefore subject to the proposed rule. Within this subset, 20 companies (58.8 percent) meet the SBA small business definitions for their respective NAICS classifications, and 14 companies (41.2 percent) do not meet the SBA small business definitions. These results are provided Table 8-2. All of these companies are considered large businesses under the rule definition of small business.
Table 8-2: Small Business and Large Business Characteristics of Subset
                                   Category
                           Number of Firms in Subset
                               Percent of Subset
Small Businesses
                                      20
                                     58.8%
Large Businesses
                                      14
                                     41.2%
Total
                                      34
                                    100.0%
Note: Entries may not sum to total due to rounding.
Source: D&B, 2009; Lux Research, 2007; Nanowerk, 2009.

Multiplying the percent of U.S.-based nanomaterials manufacturers that meet the SBA small business definitions (58.8 percent) by the previously estimated number of U.S.-based nanomaterials manufacturers subject to the proposed rule (295 companies) yields an estimate of around 174 small business nanomaterials firms and a complementary estimate of around 121 large (non-small) business nanomaterials firms that are subject to the rule. All of these companies would be considered large businesses under the rule definition of small business.
Table 8-3: Small Business and Large Business Estimates
                              Population Category
                             Est. Number of Firms 
                                   Percent 
                               Small Businesses
                                      174
                                     58.8%
                               Large Businesses
                                      121
                                     41.2%
                                     Total
                                      295
                                    100.0%
Note: Entries may not sum to total due to rounding.
Source: BCC Research, 2006; D&B, 2009.

 Estimate the Cost-to-Sales Ratio for Small Companies
As previously stated, the number of nanomaterials produced for commercial applications by the 174 small U.S.-based nanomaterials manufacturers, processors, and distributors estimated above is assumed to double over the analysis period. It is assumed that nanomaterials firms will produce 5.06 regulated nanomaterials in the first year of the rule, and an additional 0.56 nanomaterials per year in subsequent years. (Appendix B presents a sensitivity analysis for the cost-to-sales ratio based on the number of nanomaterials produced.) As indicated in Table 3-9, the total cost of the rule over the 10-year analysis period is $2.71 million with a three percent discount rate and $2.97 million with a seven percent discount rate. On a per-firm basis, annualized costs are approximately $9,180 with a three percent discount rate and $10,081 with a seven percent discount rate. 
Past small business analyses developed by EPA have used a lower impact threshold of compliance costs of less than 1 percent of sales and a higher impact threshold as compliance costs of greater than 3 percent of sales to evaluate whether or not the economic impacts faced by the small entities are significant. Therefore, to determine the magnitude of any potential adverse impact of the proposed rule on small entities, annualized per-company compliance costs were compared to annual sales. D&B data for the 20 small businesses (by SBA definitions) identified among the 34 companies in the 95-company subset of U.S.-based nanomaterials firms (with D&B sales data) subject to the proposed rule were used to develop cost-to-sales ratios for these companies, which are believed to be representative of cost-to-sales ratios for the estimated 174 small businesses.
Given expected annualized per-company costs ranging between approximately $9,180 and $10,081, a one percent-of-sales threshold for economic impact equates to sales thresholds of approximately $918,000 and $1,008,000, respectively; in other words, in order for the compliance cost to exceed one percent of sales, sales must be less than these values. Similarly, three percent-of-sales thresholds for economic impact range from approximately $306,000 to $336,000. These equivalences are show in Table 8-4.
                Table 8-4: Characterization of Economic Impacts
                             Economic Impact Type
                           Cost-to-Sales Percentage
                  Equivalent Sales Dollar Threshold ($1,000)
                                    ($2013)
                                       
                                       
                                Annualized (3%)
                                Annualized (7%)
                                 Higher Impact
                                    > 3%
                                   < $306
                                   < $336
                                 Lower Impact
                                   1% to 3%
                                 $306 to $918
                                 $336 to 1,008
                              Less than 1% Impact
                                    < 1%
                                   > $918
                                  > $1,008

Table 8-5 summarizes the estimated cost impacts for the subset of small business, and applies these percentages to estimate impacts to the estimated 174 impacted small businesses. As indicated, all 20 small businesses (100.0 percent) from the subset, and thus all small businesses in the estimated 174 subject to the rule, are expected to experience an impact of less than one percent of sales.  
Table 8-5: Estimate of Impacts on Small Business Subset
                             Economic Impact Type
                           Cost-to-Sales Percentage
                                    Subset
                     Estimated Total Number of Small Firms
                                       
                                       
                               3% Discount Rate
                               7% Discount Rate
                                       
                                       
                                       
                                    Number
                                    Percent
                                    Number
                                    Percent
                                    Number
                                    Percent
                                 Higher Impact
                                    > 3%
                                       0
                                     0.0%
                                       0
                                     0.0%
                                       0
                                     0.0%
                                 Lower Impact
                                   1% to 3%
                                       0
                                     0.0%
                                       0
                                     0.0%
                                       0
                                     0.0%
                              Less than 1% Impact
                                    < 1%
                                      20
                                     0.0%
                                      20
                                     0.0%
                                      174
                                     00.0%
                                     Total
                                      --
                                      20
                                    100.0%
                                      20
                                    100.0%
                                      174
                                    100.0%
Source: D&B, 2009; EPA, 2009a.
 
In EPA's judgment, the cost estimates presented in this analysis are over-estimates. There are several reasons why the rule may impact certain small businesses more than others. Recently chartered companies may have lower sales at the time of reporting and therefore experience a relatively higher impact under the rule as a percentage of current annual sales. Some firms may sell only a single nanomaterial that comprises (and limits) its entire revenue stream, raising the impact of the rule as a percent of sales; other firms may offer a broad portfolio of products other than nanomaterials. In EPA's judgment, no companies are expected to experience a prohibitive cost or burden under the proposed rule.

  -  Other Impact Analyses
Several statutes and executive orders (EOs) pertain to the proposed rule. This chapter presents statements discussing paperwork reduction, unfunded mandates, regulatory planning and review, tribal governments, children's health, and environmental justice, among others.
 Paperwork Reduction Act (PRA)
According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that requires Office of Management and Budget (OMB) approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0067 (EPA ICR No. 1198).  The proposed rule will impose a burden requiring additional OMB approval.  The ICR addendum is available for comment in the public docket for the proposed rule.
 This section estimates the burden and costs for both the respondents and the Agency associated with the recordkeeping and reporting requirements of the proposed rule.  In this context, the term "burden" is interpreted as the total time, effort, or financial resources expended by people to generate, maintain, retain, disclose, or provide information to or for a federal agency. This includes the time needed by regulated entities to review instructions and to develop, acquire, install, and use technology and systems to collect, validate, verify, and disclose information. Time taken to adjust existing ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task is also included. In this section, burden hours for both the industry respondents and the government are estimated. 
Table 9-1 presents a summary of the total burden and costs to industry associated with the proposed rule over the first three years of its promulgation. The data used to populate this table are explained in greater detail in Chapter 3.  
          Table 9-1: Industry Burden Estimates for the Proposed Rule
                                     Year
                             Reporting Population
                      Rule Familiarization Burden (Hours)
                                     Form
                 Completion and Record Keeping Burden (Hours)
                   Electronic Reporting Requirements (Hours)
                               Number of Reports
                             Total Burden (Hours)
                                       1
                                      295
                                     0.82
                                    137.60
                                     1.42
                                     1,493
                                    206,098
                                       2
                                      295
                                     0.00
                                    137.60
                                     0.17
                                      165
                                    22,754
                                       3
                                      295
                                     0.00
                                    137.60
                                     0.17
                                      165
                                    22,754
                                    Average
                                      295
                                     0.27
                                    137.60
                                     0.59
                                      608
                                    83,869
Notes: Values may not calculate due to rounding.
See Chapter 3 for more details.

 Unfunded Mandates Reform Act (UMRA)
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Public Law 104-4), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. Based on EPA's experience with similar information collection rules, State, local, and tribal governments have not been affected by this reporting requirement, and EPA does not have any reason to believe that any State, local, or tribal government will be affected by this rulemaking. 
 Executive Order 13132  -  Federalism
Under Executive Order 13132, "Federalism" (64 FR 43255, August 10, 1999), EPA has determined that the proposed rule does not have "federalism implications" because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in the executive order. The proposed rule establishes reporting and recordkeeping requirements that apply to manufacturers and processors of certain chemicals. Because EPA has no information to indicate that any state or local government manufactures or processes the chemical substances covered by this action, the proposed rule does not apply directly to states and localities and will not affect state and local governments. Thus, EO 13132 does not apply to the proposed rule.
 Executive Order 13175  -  Consultation and Coordination with Indian Tribal Governments
As required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this proposed rule does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Thus, EO 13175 does not apply to the proposed rule.
 Executive Order 13045  -  Children's Health 
Executive Order 13045, "Protection of Children from Environmental Health Risks and Safety Risks" (62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each regulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the Agency has reason to believe may disproportionately affect children.
EPA interprets EO 13045 as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. The proposed rule does not establish an environmental standard intended to mitigate health or safety risks and will not have an annual effect on the economy of $100 million or more, nor does it otherwise have a disproportionate effect on children. Nevertheless, the information obtained from the reporting required by this rule will be used to inform the Agency's decision-making process regarding chemicals to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemicals in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.
 Executive Order 12898  -  Environmental Justice
Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations" (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
The Agency believes that the information collected under this proposed rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with various chemicals manufactured and used at the nanoscale. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.
The proposed rule is directed at all nanoscale substances for which basic production, use, and toxicity information is currently unavailable. All consumers of these chemicals and the products made from them and all workers who come into contact with these chemicals could benefit if data regarding the chemicals' health and environmental effects were developed. Therefore, it does not appear that the costs and the benefits of the proposed rule will be disproportionately distributed across different geographic regions or among different categories of individuals.
 Executive Order 13211  -  Energy Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211, "Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.
 National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. 
The proposed rule does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

 -  Wage Rate Calculations
This appendix describes the derivation of the fully loaded wage rates and inflation factors used in calculating costs of labor, materials, and other inputs. All cost estimates are presented in 2011 dollars. 
The fully loaded unit labor cost for managerial, professional/technical, and clerical labor in the regulated industry and for EPA staff is estimated by adding fringe benefits and overhead costs to the hourly wage or annual salary for each category following the method described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). This appendix describes the method employed to estimate the fully loaded unit labor costs for each labor category and presents the results of the analysis.
Labor categories used in the analysis correspond to the U.S. Bureau of Labor Statistics (BLS) Standard Occupational Classification (SOC) system. In March 2004, BLS began using the North American Industry Classification System (NAICS) instead of the Standard Industrial Classification (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS). Exhibit A-1 summarizes the crosswalk between old and new occupational titles, and lists the SOC titles that correspond to the managerial, professional/technical, and clerical labor categories used in this analysis (Weinstein and Loewenstein, 2004).
Exhibit A-1: Detail of Labor Categories Used in the Analysis
Labor Category Used in the Analysis
BLS Old Title (OCS)
BLS New Title (SOC)
Managerial
Executive, administrative, and managerial 
Management, business, and financial
Professional/Technical
Professional specialty and technical
Professional and related
Clerical
Administrative support, including clerical 
Office and administrative support
Source: BLS (2014); Weinstein and Loewenstein (2004).

Derivation of Industry Unit Wage Rates
Wages and fringe benefit data for managerial, professional/technical, and clerical labor are from the BLS Employer Costs for Employee Compensation (ECEC) historical data for December 2013 (BLS, 2014).
The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS report (BLS, 2014). Fringe benefits as a percentage of wages are calculated separately for each labor category. For example, the wage rate for professional/ technical labor in 2013 was $38.16, and the average fringe benefit was $19.90. Therefore, fringe benefits as a percentage of wages were $19.90/$38.16, or approximately 52 percent (see Exhibit A-2).
An additional loading factor of 17 percent is applied to wages to account for overhead. This approach is used for consistency with Office of Pollution Prevention and Toxics (OPPT) economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 2002 (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report, August 2002 (EPA, 2002a). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For example, fully loaded wage for professional/technical labor in 2013 is $38.16 x (1+ 0.52 + 0.17) = $64.55. 
Fully loaded costs for managerial and clerical labor are calculated in a similar manner, as shown in Exhibit A-2.
Exhibit A-2: Derivation of Loaded Industry Wage Rates
                                Labor Category
                       Data Source for Wage Information
                                     Wage
                                Fringe Benefit
                               Fringes as % wage
                              Overhead as % wage1
                           Fringe + overhead factor
                                 Loaded Wages
                                       
                                       
                                      (a)
                                      (b)
                                  (c)=(b)/(a)
                                      (d)
                                 (e)=(c)+(d)+1
                                  (f)=(a)x(e)
                                  Managerial
BLS ECEC, Private Manufacturing industries, "Management, business, and financial occupations"2
                                    $46.25 
                                    $23.71 
                                    51.26%
                                      17%
                                     1.68
                                    $77.82 
                            Professional/ Technical
BLS ECEC, Private Manufacturing industries, "Professional and related occupations"2
                                    $38.16 
                                    $19.90 
                                    52.15%
                                      17%
                                     1.69
                                    $64.55 
                                   Clerical
BLS ECEC, Private Manufacturing industries, "Office and administrative support occupations"2
                                    $18.05 
                                    $9.23 
                                    51.14%
                                      17%
                                     1.68
                                    $30.35 
Notes:
1 The wage and fringe benefit rates are calculated as the average of the quarterly rates in 2013.
2 An overhead rate of 17% was used based on assumptions in Rice (2002) and U.S. EPA (2002).

Derivation of Agency Unit Wage Rates
Unit wage rates for EPA staff are calculated based on annual federal salaries for the Washington-Baltimore area published by the Office of Personnel Management (OPM) and effective January 2013 (OPM, 2013). The average salary for one full-time equivalent (FTE) staff member is estimated as the salary for a GS-13 Step 5 employee, which is $100,904 annually without fringe benefits and overhead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary of $161,446 (see Exhibit A-3: Derivation of Loaded Agency Wage Rates).
The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled "the benefits multiplication factor" in the EPA guide, but has been used in many EPA OPPT ICRs to reflect both fringe benefits and overhead for federal staff. For example, it was used in a document supporting EPA ICR No. 1139.06 (EPA, 2000), with the following explanation:
      The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor). The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead.
Fully loaded costs for Agency labor are shown in Exhibit A-3: Derivation of Loaded Agency Wage Rates.
Exhibit A-3: Derivation of Loaded Agency Wage Rates
Labor Category
Data Source for Wage Information
Date
Wage
Fringe Benefit
Fringes as % wage
Overhead as % wage
Fringe + overhead factor
Loaded Wages

(a)
(b)
(c)=(b)/(a)
(d)
(e)=(c)+(d)+1
(f)=(a)x(e)
                                 EPA staff FTE
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step 5 pay rates [a]
                                    Jan-13
                               $100,904 (annual)
                                      --
                          [Included in 60% overhead]
                                    60% [b]
                                     1.60
                               $161,446 (annual)
                                       
                                       
                                       
                                    $48.35
                                   (hourly)
                                       
                                       
                                       
                                       
                                $77.36 (hourly)
Notes:
[a] The Agency salary is the unloaded federal GS-13 Step 5 salary ($100,904 for 2013), from the OPM salary table for the Washington-Baltimore-Northern Virginia Locality Pay Area (OPM, 2013). Hourly rates are based on annual salary divided by 2,087 hours.
[b] The 60% fringes-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9).

  -  Small Business Sensitivity Analysis
The following presents an alternative small business analysis to demonstrate the sensitivity of the small business analysis to changes in the assumed number of nanomaterials produced by each small firm. The current small business analysis in Chapter 8 assumes that both small and large firms produce on average 5.1 "commercial" nanomaterials per firm. In this alternative analysis we calculate the number of nanomaterials manufactured separately for large and small firms and how this change affects the number of small businesses significantly affected by the proposed rule. 
Estimation of the number of nanomaterials per small Firm 
In Section 2.4 of this report EPA calculates the number of nanomaterials produced by each firm, based on a subset of 34 large businesses, using the TSCA-based definition of annual revenue greater than $4 million. Within this group of 34 companies, EPA then calculated the median number of nanomaterials and makes the assumption that both small and large businesses produce the same number of nanomaterials. However, this assumption may overestimate the impact of the requirements on small businesses. In this appendix, we present the costs to small businesses using the subset of 34 businesses that are currently used in Chapter 2 to estimate the average number of nanomaterials produced by small and large companies as opposed to all companies. 
Of the 34 nanomaterial-producing firms identified in Chapter 2, 26 had product information available on a company website. Twenty-three of these firms manufactured nanomaterials for TSCA-related uses. Of these 23 firms, 12 are small and 11 are large using SBA's NAICS-specific sales or employee-based definitions. EPA calculated the median number of nanomaterials for these 12 small companies to be 11.5 nanomaterials. This is slightly lower than the median number for all companies, 13, which is used to calculate the number of nanomaterials per firm in Section 2.4. Based on results in Chapter 2, EPA estimated that the number of nanomaterials that are produced for R&D purposes is 61.11 percent. Subtracting 61.11 percent R&D nanomaterials from the total number of nanomaterials produces an estimate of 4.47 "commercial" nanomaterials produced by each small firm. This is slightly fewer than the 5.06 "commercial" nanomaterials estimated for all companies in Section 2.4.3 of this report. 
 
Exhibit B-1: Number of Nanomaterials per Company after the R&D Exclusion
                                 Company Size
                            Nanomaterials per Firm
                             R&D Exclusion (%)
                             R&D Exclusion (#)
                   "Commercial" Nano-materials per Firm
All Large Businesses under TSCA definition 
                                     13.0
                                    61.11%
                                      7.9
                                      5.1
Subset of Small Businesses (SBA definition)
                                     11.5
                                    61.11%
                                      7.0
                                     4.47
Note: Small businesses included here are the set of companies considered large under the TSCA definition (and therefore subject to the proposed rule) but also considered small under the NAICS-specific SBA definition.

Conclusions
EPA completed an analysis of impacts on small entities in Chapter 8 and found that no small businesses were impacted at greater than 1% of their sales. Costs to these entities were based upon the reporting costs per nanomaterial. In this section, EPA's calculations suggest that the number of nanomaterials that a small entity will necessarily report on could be overestimated. In this case, it follows that costs would also be overestimated if there are fewer reports required. Therefore, it is reasonable to conclude that no small entities would be impacted at greater than one percent of sales under the alternative estimate of the number of nanomaterials presented above.

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