                                       
Economic Analysis for the Final TSCA Section 8(a) Reporting Requirements for Certain Chemical Substances as Nanoscale Materials
                                RIN 2070 - AJ54
                                       
                                       
Economic Analysis for the Final TSCA Section 8(a) Reporting Requirements for Certain Chemical Substances as Nanoscale Materials
                                RIN 2070 - AJ54
                                       

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


                        -- Does not contain TSCA CBI --


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

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       

                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
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                                 Contributors

The EPA analysts responsible for this report are Lynne Blake-Hedges of the Economic and Policy Analysis Branch; Chemistry, Economics, and Sustainable Strategies Division; Office of Pollution Prevention and Toxics. Analytical and draft preparation support was provided by Abt Associates Inc. under EPA Contract No. EP-W-16-009.

Table of Contents
Table of Contents	i
List of Tables	iii
Executive Summary	v
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	1-5
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	Manufacturers	2-1
2.3	Processors	2-7
2.4	Total Regulated Firms	2-8
Chapter 3  -  Industry Compliance Costs	3-1
3.1	Wage Rates	3-1
3.2	Unit Industry Compliance Costs	3-1
3.3	Discounting Methods	3-9
3.4	Total Industry Compliance Costs	3-9
Chapter 4  -  Agency Costs	4-1
4.1	Wage Rates	4-1
4.2	Unit Agency Costs	4-1
Chapter 5  -  Total Social Costs and Sensitivity Analyses	5-1
Chapter 6 - Sensitivity Analyses	6-1
6.1	Number of Firms	6-1
6.2	Annual Industry Growth Rate	6-1
6.3	Number of Nanomaterials per Firm	6-6
6.4	Annual Nanomaterials Growth Rate	6-14
6.5	Summary of all Analyses	6-22
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 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	8-3
Chapter 9  -  Other Impact Analyses	9-1
9.1	Employment Impact Analysis	9-1
9.2	Paperwork Reduction Act (PRA)	9-5
9.3	Unfunded Mandates Reform Act (UMRA)	9-6
9.4	Executive Order 13132  -  Federalism	9-6
9.5	Executive Order 13175  -  Consultation and Coordination with Indian Tribal Governments	9-6
9.6	Executive Order 13045  -  Children's Health	9-6
9.7	Executive Order 12898  -  Environmental Justice	9-6
9.8	Executive Order 13211  -  Energy Supply, Distribution, or Use	9-7
9.9	National Technology Transfer and Advancement Act	9-7
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-1
Appendix C  -  References	C-1
List of Tables
Table 1-1: TSCA-authorized Reporting Requirements	1-1
Table 2-1: Sample Subset Characteristics	2-5
Table 2-2: Estimated Number of Small and Large Manufacturers	2-5
Table 2-3: Estimated Nanomaterials per Manufacturer, with R&D Exclusion	2-7
Table 2-4: Number of Regulated Processors	2-8
Table 2-5: Estimated Number of Regulated Firms	2-8
Table 3-1: Loaded Industry Wage Rates, 2015$	3-1
Table 3-2: Industry One-Time Cost Estimate to Familiarize with the Rule (2015$) (per Firm)	3-2
Table 3-3: Industry Burden Estimate to Complete the Form (per Report)	3-3
Table 3-4: Industry Cost Estimate to Complete the Form (2015$) (Per Report)	3-3
Table 3-5: Industry Cost for CBI Claim Substantiation (2015$) (Average Per Report)	3-5
Table 3-6: Industry Burden and Cost of Electronic Reporting Requirements	3-7
Table 3-7: Industry Burden and Cost of Electronic Reporting Requirements (Subsequent Years, per Firm) (2015$)	3-8
Table 3-8:  Industry Cost Estimate to Maintain Records (2015$) (per Report)	3-8
Table 3-9: Total Annual Burden Hours - Manufacturers	3-10
Table 3-10: Total Annual Burden Hours - Processors	3-10
Table 3-11: Total Annualized Costs - Manufacturers	3-11
Table 3-12: Total Annualized Costs - Processors	3-12
Table 3-13: Total Annualized Industry Costs	3-13
Table 4-1: Loaded EPA Wage Rates, 2015$	4-1
Table 4-2: Agency Cost Estimate to Administer the Rule (per report)	4-2
Table 4-3: Agency Cost and Burden Hour Estimate for the Final Rule	4-3
Table 5-1: Total Social Burden and Cost of the Rule	5-1
Table 6-1: Low- and High-end Estimates of Number of Firms	6-1
Table 6-2: Total Annual Industry Burden Hours (Number of Firms Sensitivity Analysis)	6-1
Table 6-3: Total Annual Industry Cost (Number of Firms Sensitivity Analysis)	6-2
Table 6-4: Total Annual Agency Burden and Cost (Number of Firms Sensitivity Analysis)	6-3
Table 6-5: Total Social Costs (Number of Firms Sensitivity Analysis)	6-4
Table 6-6: Estimated Number of Manufacturer Reports (Increased Annual Growth Rate Sensitivity Analysis)	6-1
Table 6-7: Estimated Number of Processor Reports (Increased Annual Growth Rate Sensitivity Analysis)	6-2
Table 6-8: Total Annual Industry Labor Burden (Increased Annual Growth Rate Sensitivity Analysis)	6-3
Table 6-9: Annual Industry Labor Costs (Increased Annual Growth Rate Sensitivity Analysis)	6-4
Table 6-10: Agency Cost Estimate for the Final Rule (Increased Annual Growth Rate Sensitivity Analysis)	6-5
Table 6-11: Total Social Costs for the Rule (Increased Annual Growth Rate Sensitivity Analysis)	6-5
Table 6-12: Estimated High- and Low-End Estimated Number of Commercially Relevant Nanomaterials per Manufacturer	6-6
Table 6-13: Annual Manufacturer Burden Hours (Number of Nanomaterials Per Firm Sensitivity Analysis)	6-8
Table 6-14: Annual Processor Burden Hours (Number of Nanomaterials Per Manufacturer Sensitivity Analysis)	6-9
Table 6-15: Annual Manufacturer Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)	6-10
Table 6-16: Annual Processor Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)	6-11
Table 6-17: Agency Cost Estimate for the Rule (Number of Nanomaterials Per Firm Sensitivity Analysis)	6-12
Table 6-18: Total Social Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)	6-13
Table 6-19: Annual Manufacturer Burden Hours (Nanomaterials Growth Sensitivity Analysis)	6-16
Table 6-20: Annual Processor Burden Hours (Nanomaterials Growth Sensitivity Analysis)	6-17
Table 6-21: Annual Manufacturer Labor Costs (Nanomaterials Growth Sensitivity Analysis)	6-18
Table 6-22: Annual Processor Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)	6-19
Table 6-23: Agency Cost Estimate for the Rule  (Nanomaterials Growth Sensitivity Analysis)	6-20
Table 6-24: Total Social Costs (Nanomaterials Growth Sensitivity Analysis)	6-21
Table 6-25: Comparison of Annualized Costs of Sensitivity Analyses (Millions 2015$)	6-22
Table 8-1: Ultimate Parent NAICS Codes for the 19 "Large" Businesses in Subset	8-2
Table 8-2: Small Business and Large Business Characteristics of Subset	8-3
Table 8-3: Estimated Number of Regulated Firms	8-3
Table 8-4: Characterization of Economic Impacts	8-4
Table 8-5: Estimate of Impacts on Small Business Subset	8-4
Table 9-1: Summary of Costs per Firm in First Year (2015$)	9-4
Table 9-2: Summary of Costs per Firm in Subsequent Years (2015$)	9-4
Table 9-3: Industry Burden Estimates for the Final Rule	9-5
Exhibit A-1: Detail of Labor Categories Used in the Analysis	A-1
Exhibit A-2: Derivation of Loaded Industry Wage Rates (2015$)	A-2
Exhibit A-3: Derivation of Loaded Agency Wage Rates	A-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 promulgated by the U.S. Environmental Protection Agency (EPA), under the authority granted by Section 8(a) of the Toxic Substances Control Act (TSCA). The rule requires 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 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. Manufacturers and processors of multiple nanoscale forms of the same existing chemical substance will, in some cases, need to report separately for each discrete form of the reportable chemical substance.  Reporting of these discrete forms are not the same as new chemical reporting under TSCA section 5.
The final 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 823 U.S. nanomaterials manufacturers 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 658 firms (nearly 80 percent of firms) are estimated to be small businesses with less than $11 million in revenue, and these firms are exempt from the reporting requirements of the rule. Each of the remaining 165 manufacturer 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 manufacturers remains constant over the 10-year analysis period, the total number of regulated nanoscale materials is assumed to double. 
For each nanomaterial produced by a manufacturer, EPA estimates that there are 2.32 processors. Thus, there are 1,788 processors subject to the rule in the first year, and 199 in subsequent years. 
Under the rule, industry is estimated to incur a burden of approximately 360,331 hours in the first year and 40,118 hours in subsequent years, with costs of approximately $27.79 million and $3.09 million, respectively (see Chapter 3), while the Agency is expected to use approximately 16,326 hours in the first year and 1,818 hours in subsequent years, with costs of approximately $1.34 million and $0.15 million respectively (see Chapter 4). Discounted over a 10-year period at three and seven percent, total annualized social costs are estimated to be approximately $5.71 million and $6.26 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 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 United States 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 promulgated by the U.S. Environmental Protection Agency (EPA) under the authority granted by Section 8(a) of the Toxic Substances Control Act (TSCA). The rule requires persons who currently manufacture (including import), or process certain nanoscale materials (alternately described as "manufacturers" and "processors" in this report), and/or persons who begin to manufacture (including import), or process nanoscale materials (as defined by the 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 rule; Section 1.2 reviews the regulatory background; Section 1.3 discusses the need for the regulation; Section 0 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 among others:
Table 1-1: TSCA-authorized Reporting Requirements
Reporting Elements
 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. 
 The categories or proposed categories of use of each such substance or mixture. 
 The total amount of each such substance and mixture manufactured or processed, or reasonable estimates of the total amount to be manufactured or processed. 
 A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture. 
 All existing data concerning the environmental and health effects of such substance or mixture. 
 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. 
 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 rule, reporting is 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 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 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 Rule
This rule improves EPA's process for reviewing chemicals and helps to address the market failure of inadequate information. Information gathered under this rule will aid EPA in determining whether future action is needed for a specific nanomaterial. More specifically, this rule will facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on the best available scientific and technical information taking into account the unique characteristics of nanomaterials. This is consistent with the President's memorandum for Executive Agencies regarding Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials. It is important to note that the requirements of the rule are not based on an assumption that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely to cause harm to people or the environment. Should EPA determine that a risk management action is needed and subsequently promulgate such an action, the information provided by this rule will be useful to EPA in developing an action that will help address risks related to externalities.
EPA will make non-confidential information reported under the rule available to the public. To the extent that EPA is able to make information public, the rule will also help to address market failure due to inadequate information by providing basic information about the production, use, and environmental health and safety impacts of manufactured nanomaterials 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 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 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 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 rule. The affected chemical substances and companies are characterized in Chapter 2. Chapter 3 estimates industry cost of complying with the rule, and Chapter 4 estimates government costs associated with the administration of the rule. Chapter 5 presents the total social costs. Chapter 7 addresses the benefits of the rule using a "value of information" framework. Chapter 8 provides the small entity impact analysis for the 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: an employment impact analysis; 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 2015 dollars.
  -  Affected Entities
This chapter presents information about the manufacturers, production, and uses of nanoscale materials subject to the rule. Section 2-1 provides a definition of nanoscale materials affected by the rule; Section 2-1 describes and estimates the population of affected manufacturers, including an estimate of the number of nanoscale materials handled by each reporting manufacturer; Section 2.3 describes and estimates the population of affected processors; and Section 2.4 summarizes the total regulated universe of firms.
Chemical Substances Subject to this Rule
The rule requires the reporting and maintenance of records concerning chemical substances as nanoscale materials. The rule applies to chemical substances that are solids at 25°C and standard atmospheric pressure, and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1 to 100 nm in at least one dimension and exhibit unique and novel characteristics because of their size. This rule does not apply to chemical substances manufactured or processed in forms that contain less than one percent by weight of primary particles, aggregates, or agglomerates in the size range of 1 to 100 nm. Reporting is also required if the chemical substance has different morphology or is coated with different chemical substances. 
EPA is excluding from the requirements of this rule certain biological materials including DNA, RNA, proteins, enzymes, lipids, carbohydrates, peptides, liposomes, antibodies, viruses, and microorganisms, as well as chemical substances which dissociate completely in water to form ions that are less than 1 nm, and chemical substances formed at the nanoscale as part of a film on a surface.
The rule would not require manufacturers or processors to report information that has already been submitted to EPA. The reporting requirements of this 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 rule had not been reported or new information is now available reporting of that information would be required. 
There is also an exemption from reporting for TSCA section 8(a) rules for small manufacturers and processors. For purposes of this rule, EPA is defining and exempting any small manufacturer or processor as a company that has sales of less than $11 million per year. 
The rule applies to organizations operating in the United States, and thus under EPA's jurisdiction. Only those organizations handling nanoscale materials with uses subject to TSCA are subject to the rule.
Manufacturers
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 (2008)
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 Research, 2008 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, 2008 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 United States. 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, 2008 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.
Estimated Number of Nanomaterial Manufacturers
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 manufacturer firms for the purposes of this analysis. This estimate reflects possible growth in the population since EPA's judgment in the NMSP ICR (EPA, 2007) that the population at that time was approximately 600 companies. 
EPA assumes that the number of U.S. nanoscale materials firms remains constant over the analysis period based on an analysis of more current data from BCC Research. A comparison of data from Nanotechnology: A Realistic Market Assessment (BCC Research, 2014) with the data used in this Economic Analysis shows that there has been little change in the number of firms from 2008 to 2014. However, to examine the potential effect of industry growth in the future, EPA did a sensitivity analysis using a growth rate of 11.6 percent (see Section 6.2).
Estimated Number of Exempt Firms
The general exemptions to TSCA section 8(a) reporting (as described within the statute itself) apply to the rule, including exemptions for small businesses that eliminate the reporting and recordkeeping requirements under the rule. For purposes of this rule, EPA is defining and exempting any small manufacturer as a company that has sales of less than $11 million per year.
To estimate the number of small and large manufacturers in the total number of U.S. nanomaterials manufacturer firms, this analysis uses a selection of firms assumed to be representative of firms in the market. 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. EPA matched the selected firms 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. 
EPA attempted to obtain sales data from the Dun & Bradstreet corporate database for the 132 companies 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.
A total of 103 companies in the selection were found in the D&B database. Of these, 83 companies had no parent company, and 20 companies had 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 were categorized as large or small businesses under the rule's definition of small business.
Of the 95 nanomaterials manufacturers and parent companies with observed annual sales, 76 companies (80 percent of this subset) meet the small business definition with less than $11 million in reported annual sales, and 19 companies (20 percent of this subset) do not meet the small business definition, having $11 million or more in reported annual sales. These results are provided in Table 2-1.
Table 2-1: Sample Subset Characteristics 
                              Population Category
                                Sales Threshold
                       Actual Number of Firms in Subset
                               Percent of Subset
Small Businesses
                               < $11 million
                                      76
                                      80%
Large Businesses
                                >= $11 million
                                      19
                                      20%
Total
                                      --
                                      95
                                     100%
Source: D&B, 2009, D&B 2016; Lux Research, 2007; Nanowerk, 2009.

Multiplying the percent of U.S.-based nanomaterials manufacturers that meet the small business definition (80 percent) by the previously estimated number of U.S.-based nanomaterials manufacturers (823 companies) yields an estimate of 658 small business nanomaterials firms and a complementary estimate of 165 large (non-small) business nanomaterials manufacturers. 
Table 2-2: Estimated Number of Small and Large Manufacturers
                              Population Category
                                Sales Threshold
                   Estimated. Number of Nanomaterial Firms 
                                   Percent 
Small Manufacturers
                               < $11 million
                                      658
                                      80%
Large Manufacturers
                                >= $11 million
                                      165
                                      20%
Total
                                      --
                                      823
                                     100%
Source: BCC Research, 2006; D&B, 2009, D&B, 2016

Based on these estimates, 165 manufacturer firms are expected to submit chemical reports each year under the rule. EPA assumes that the number of nanomaterials manufacturers 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 Manufacturing Firm
To estimate the number of nanomaterials per firm, EPA researched the 19 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 manufacturer 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 19 large business nanomaterials firms identified, 14 had TSCA-related use product information available on a company website. The number of identified TSCA-related nanomaterials manufactured per firm varied widely, from one nanomaterial up to 66 nanomaterials.
The median number of TSCA-related nanomaterials per large business in the reduced selection for this analysis (n = 14) is 12 nanomaterials.
R&D Exclusion
The general exemptions to TSCA section 8(a) reporting (as described within the statute itself) apply to the rule, including exemptions for chemicals with strictly research and development applications. Therefore, the rule exempts chemicals with strictly research and development (R&D) 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.
Results
Based on an exclusion for R&D, EPA estimated an average of 4.67 nanomaterials (38.89 percent of 12 nanomaterials) with commercial relevance per reporting business. As previously mentioned, the total number of nanomaterials subject to the rule is assumed to double over the analysis period of 10 years. As a result, it is assumed that nanomaterials manufacturers will report on approximately 0.52 additional nanomaterials per year.
Table 2-3: Estimated Nanomaterials per Manufacturer, with R&D Exclusion
                              Population Category
                            Nanomaterials per Firm
                             R&D Exclusion (%)
                             R&D Exclusion (#)
              "Commercial" Nano-materials per Manufacturer[a]
                                       
                                       
                                       
                                       
                                  First Year
                               Subsequent Years
Manufacturer
                                      12
                                    61.11%
                                     7.33
                                     4.67
                                     0.52
Notes:
a The total number of nanomaterials subject to the 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 0.52 additional nanomaterials per year.
Source: D&B, 2009; D&B, 2016; EPA, 2007; EPA, 2009b; Company websites.

Processors
To determine the number of processors subject to the rule, EPA reviewed new chemical submissions from FY 2013, 2014, 2015, and 2016 (ending May 31, 2016). During this period, there were 37 new chemical submissions for nanomaterials. A total of 65 processors were identified on those submissions. However, when identifying the number of processors in a review of a submission, EPA looks at everything in the submission: for example, production volume and activities identified. If the number of processors identified does not fit with the other data in the submission, or if a number of processors is not identified, then EPA will estimate the number of processors different than what is provided in the submission. For this set of 37 submissions, EPA estimated that there would be 86 processors. Therefore, for this analysis, EPA estimates that there are 2.32 processors per nanomaterial (86/37 = 2.32).  While some individual nanomaterials may have more than 2.32 processors, a number of nanomaterials are sold in formulation from the manufacturers with no additional processing necessary. Additionally, not all processors will process nanomaterials such that they are reportable under the rule.
For the purposes of this economic analysis, we assume that each processor will handle one nanomaterial. As new nanomaterials are introduced in subsequent years (see Section 2.2.3), corresponding new processor firms will become subject to the rule, and will incur costs similar to that of a manufacturer in its first year of regulation. 
Given the number of manufacturers estimated in Section 2.2.2 and the number of nanomaterials per manufacturer estimated in Section 2.2.3, EPA estimated the total number of regulated nanomaterials processors in the first and nine subsequent years after the rule's promulgation. For purposes of this economic analysis, EPA assumes that the same percentage of processor firms will be "large" (with revenue greater than $11 million per year) as determined in Section 2-1 for manufacturers. Therefore, EPA estimates that there will be 1,788 processors subject to the rule in the first year, and 199 in each of the subsequent nine years of the analysis period. These calculations are shown in Table 2-4. For this particular assumption, EPA did not have specific data with which to develop an estimate of the number or percentage of small and large processors. EPA had two available pieces of information to use to inform its assumption. First, EPA had information that it used to develop the estimate of the percentage of small versus large manufacturers. The data and EPA's approach is described in Section 2.2.2 and results are presented in Table 2.1. EPA also had information from the 2014 BCC report (2014, BCC Research, Nanotechnology: A Realistic Market Assessment, November) that describes the size distribution of nanotechnology firms in their research sample.  The BCC report describes nanotechnology firms as those "manufacturing and selling nanotechnology-related products and services". Therefore, the distribution they develop applies to a broader category of firms than processors (e.g., manufacturers, service providers, distributors, etc.). Furthermore, the BCC report defines large firms as those with sales greater than $1 billion annually and indicates that small-medium firms are mainly comprised of those with sales less than $10 million annually. The size distribution developed by BCC is 23% of nanotechnology firms are large and 77% of nanotechnology firms are small-medium.  Despite the BCC report covering a broader universe of firms than processors alone, EPA finds that the BCC report corroborates EPA's assumption. EPA does not find that that the two estimates are significantly different, so for analytical ease, chose to assume the same distribution of 80% large firms and 20% small firms for both manufacturers and processors.
Table 2-4: Number of Regulated Processors
                            Number of Manufacturers
                   Number of Nanomaterials per Manufacturer
                     Number of Processors per Nanomaterial
                          Total Number of Processors
                  Number of Large Processors 
(20% of Total)
                                       
                                  First Year
                               Subsequent Years
                                       
                                  First Year
                               Subsequent Years
                                  First Year
                               Subsequent Years
                                      823
                                     4.67
                                     0.52
                                     2.32
                                     8,917
                                      993
                                     1,788
                                      199

Total Regulated Firms
The total number of firms that are expected to submit reports each year under the rule is determined by combining the number of large manufacturers estimated in Section 2.2 and the number of large processors as estimated in Section 2.3. As shown in Table 2-5, EPA estimates that the rule will affect 1,953 firms in the first year and 364 firms in each subsequent year.

Table 2-5: Estimated Number of Regulated Firms
                              Population Category
                   Estimated. Number of Nanomaterial Firms 
                                       
                                  First Year
                             Subsequent Nine Years
Manufacturers
                                      165
                                      165
Processors
                                     1,788
                                      199
Total
                                     1,953
                                      364


  -  Industry Compliance Costs
This chapter presents estimates of the total costs that nanomaterial manufacturers and processors may incur due to the requirements included in the rule and discusses the method used to measure each. 
EPA assumes the costs to comply the rule are the same for both manufacturer and processor firms. All regulated firms are required only to submit information that is known or reasonably ascertainable.
Wage Rates
The rule involves activities that may require efforts by employees in four labor classifications: attorney, 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 each labor category 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 managerial, professional/technical, and clerical labor are calculated using the December 2015 quarterly estimates from the Employer Costs for Employee Compensation (ECEC) Supplemental Tables available on the BLS website (BLS, 2016a). For attorney, the wage rate was taken from the BLS Occupational Employment Statistics (OES) May 2015 National Industry-Specific Occupational Employment and Wage Estimates (BLS, 2016b). The loaded wage rate for attorney labor is $109.29; managerial labor is $81.18; technical labor is $75.89; and clerical labor is $33.66. Table 3-1 presents the basic data used to calculate the loaded wage rates for all four categories of labor, and Appendix A provides more detailed information on the estimation of these wage rates.
Table 3-1: Loaded Industry Wage Rates, 2015$
Labor Category
Base Wages[a]
Fringe Benefits[a] + Overhead Factor[b]
Loaded Wages
Attorney
                                    $65.51 
                                     1.67
                                   $109.29 
Managerial
                                    $48.66 
                                     1.67
                                    $81.18 
Professional/Technical
                                    $44.06 
                                     1.72
                                    $75.89 
Clerical
                                    $19.91 
                                     1.69
                                    $33.66 
Notes:
[a] Wage rates and fringe benefits are calculated using the December 2015 estimates from BLS (2016a), and May 2015 estimate from BLS (2016b) for Attorney.
[b] An overhead rate of 17% of base wages is used here, based on methodology and assumptions in EPA (2002a) and EPA (2002b).
Unit Industry Compliance Costs
Rule Familiarization
The rule requires reporting businesses and their staff to become familiar with the TSCA section 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 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 $63.66.
Table 3-2: Industry One-Time Cost Estimate to Familiarize with the Rule (2015$) (per Firm)
                              Reporting Activity
                        Clerical Labor (at $33.66/hour)
                       Technical Labor (at $75.89/hour)
                       Managerial Labor (at $81.18/hour)
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
Rule Familiarization
                                       0
                                    $0.00 
                                     0.55
                                    $41.74 
                                     0.27
                                    $21.92 
                                     0.82
                                    $63.66
Source: BLS, 2016a; EPA, 2009a.

Form Completion
The 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 rule requires electronic reporting though CDX. The total per-report industry burden of the rule is estimated to be 137 labor hours. This burden estimate is presented in Table 3-3. 
Table 3-3: Industry Burden Estimate to Complete the 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 Form (2015$) (Per Report)
                              Reporting Activity
                        Clerical Labor (at $33.66/hour)
                       Technical Labor (at $75.89/hour)
                       Managerial Labor (at $81.18/hour)
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                Form Completion
                                       0
                                    $0.00 
                                     105.2
                                    $7,984 
                                     31.4
                                    $2,549 
                                     136.6
                                    $10,533
Source: BLS, 2016a; EPA, 2007.

CBI Claim Substantiation
TSCA requires that anyone seeking protection of confidential business information (CBI) under TSCA must assert a claim, and may be required to substantiate that claim. The Act lists information that is generally not subject to substantiation requirements. Furthermore, the Act states that health and safety data submitted for substances in commercial distribution or for which testing or notification is required under TSCA are not protected as CBI. Based on this, the reporting elements of this reporting rule for nanoscale substances for which a submitter might need to substantiate a claim of CBI, if a claim is made, are:
 Submitter information
 Chemical identity
 Physical properties
 Human exposure and environmental release
 Release point control technology
 Worker exposure information
 Protective equipment or engineering control
 Information on cleaning/reuse/disposal of used protective equipment
 Additional procedures or other equipment intended to mitigate exposures to nanoscale materials
 Description of worker training and hazardous communication
 Number of individuals other than workers exposed to the chemical and duration of exposure
 Manner or method of disposal for consumer use of products
This analysis assumes that the information that is required for a submitter to substantiate a CBI claim is similar to the information described at 40 CFR 2.204(e)(4).. EPA ICR No.1665.12 (OMB Control No. 2020-0003), Renewal of Existing Information Collection Request for Confidentiality Rules (EPA, 2013) describes EPA's process for requesting substantiation of CBI claims from submitters in order to make a final confidential determination in response to a FOIA request or in the course of rulemaking or litigation and provides estimates of burden associated with completing substantiations based on information identified at 40 CFR 2.204(e)(4). Therefore, this analysis uses burden estimates from ICR No. 1655.12 to estimate CBI substantiation for this rule. According to the ICR, submitters spent six hours on each substantiation type reviewing the information, preparing the response, and submitting the response to the Agency (three attorney hours and three manager hours.) EPA assumes that assertion is accomplished via checking a box when completing the form, so the burden is included in the form completion estimate. Finally, because nanomaterials subject to this final rule are already identified on the TSCA inventory, those with chemical identity confidentiality claims are expected to have already have established generic names. Therefore, EPA does not include additional burden estimates to meet the specific substantiation requirements associated with chemical identity claims. 

EPA's current intended approach is to review every fourth submission received and to notify submitters who will be provided an opportunity to comment (substantiate) the CBI claims (EPA, 2016). Therefore, for this analysis, EPA assumes that only 25 percent of those submissions with CBI claims will substantiate. The average per-report burden as described above is adjusted accordingly (e.g., 6 hours x 25% = 1.5 hours).

As shown in Table 3-5, the labor cost associated with CBI claim substantiation is approximately $143 per report.
Table 3-5: Industry Cost for CBI Claim Substantiation (2015$) (Average Per Report)
                                       
                              Reporting Activity
                       Managerial Labor (at $81.18/hour)
                       Attorney Labor (at $109.29/hour)
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
CBI Claim Substantiation
                                     0.75
                                    $60.89 
                                     0.75
                                    $81.97 
                                      1.5
                                    $142.86
Sources: EPA, 2013; BLS, 2016a; BLS, 2016b.

 Electronic Reporting  
The rule requires 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 estimates that affected facilities will incur additional burden and cost due to the electronic reporting requirements of the 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 firm 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 3-6 and Table 3-7 present the first year burden and costs and subsequent year labor burden and costs for electronic reporting.
Table 3-6: Industry Burden and Cost of Electronic Reporting Requirements
(First Year, per Firm) (2015$)
                              Reporting Activity
                       Clerical Labor 
(at $33.66/hour)
                       Technical Labor 
(at $75.89/hour)
                      Managerial Labor 
(at $81.18/hour)
                          Number of Annual Activities
                               Total Labor Cost

                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                       
                                    Burden
                                     Cost
CDX Registration
                                     0.00
                                    $0.00 
                                     0.67
                                    $50.85 
                                     0.17
                                    $13.80 
                                       1
                                     0.84
                                    $64.65
Electronic Subscriber Agreement/ Electronic Signature
                                     0.00
                                    $0.00 
                                     0.00
                                    $0.00 
                                     0.25
                                    $20.30 
                                       1
                                     0.25
                                    $20.30
Help Desk
                                     0.00
                                    $0.00 
                                     0.24
                                    $18.21 
                                     0.06
                                    $4.87 
                                       1
                                     0.30
                                    $23.08
Problem Resolution
                                     0.00
                                    $0.00 
                                     1.00
                                    $75.89 
                                       0
                                    $0.00 
                                     0.03
                                     0.03
                                     $2.28
                                                                         Totals
                                     1.42
                                    $110.31

Table 3-7: Industry Burden and Cost of Electronic Reporting Requirements (Subsequent Years, per Firm) (2015$)
                              Reporting Activity
                       Clerical Labor 
(at $33.66/hour)
                       Technical Labor 
(at $75.89/hour)
                      Managerial Labor 
(at $81.18/hour)
                          Number of Annual Activities
                               Total Labor Cost
                                       
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                       
                                    Burden
                                     Cost
CDX Registration
                                     0.00
                                    $0.00 
                                     0.67
                                    $50.85 
                                     0.17
                                    $13.80 
                                     0.10
                                     0.08
                                     $6.47
Electronic Subscriber Agreement/ Electronic Signature
                                     0.00
                                    $0.00 
                                     0.00
                                    $0.00 
                                     0.25
                                    $20.30 
                                     0.10
                                     0.03
                                     $2.03
Help Desk
                                     0.00
                                    $0.00 
                                     0.24
                                    $18.21 
                                     0.06
                                    $4.87 
                                     0.10
                                     0.03
                                     $2.31
Report Compromised Signature
                                     0.00
                                    $0.00 
                                     0.00
                                    $0.00 
                                     0.40
                                    $32.47 
                                     0.01
                                     0.00
                                     $0.32
Problem Resolution
                                     0.00
                                    $0.00 
                                     1.00
                                    $75.89 
                                     0.00
                                    $0.00 
                                     0.03
                                     0.03
                                     $2.28
                                                                         Totals
                                     0.17
                                    $13.41

Recordkeeping
Reporting businesses will be required to compile and maintain records of the collected information for three years after they are created. 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 TSCA 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 rule requires 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 3-8.

Table 3-8:  Industry Cost Estimate to Maintain Records (2015$) (per Report)
                              Reporting Activity
                       Clerical Labor 
(at $33.66/hour)
                       Technical Labor 
(at $75.89/hour)
                      Managerial Labor 
(at $81.18/hour)
                               Total Labor Cost
                                       
Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                    Burden
                                     Cost
                                 Recordkeeping
                                      0.5
                                    $16.83
                                      0.5
                                    $37.95 
                                       0
                                    $0.00 
                                       1
                                    $54.78
Source: BLS, 2016a; 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 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 165 manufacturer reporters will submit chemical reports for an average of 4.67 nanomaterials per firm in the first year of the rule, while 1,788 processors submit one report each; this results in approximately 2,559 reports during the first year. The total number of nanomaterials subject to the rule is assumed to double over the 10-year analysis period, with an average of approximately 0.52 additional nanomaterials per manufacturer in subsequent years, resulting in annual total of 285 additional manufacturer and processor reports in each subsequent year. As indicated in Table 3-13, the total cost of the rule to nanomaterials firms drops from approximately $27.79 million in the first year of the rule to approximately $3.09 million in subsequent years (without discounting). The annualized industry cost of the rule over the 10-year analysis period is $5.44 million with a three percent discount rate and $5.98 million with a seven percent discount rate.

Table 3-9: Total Annual Burden Hours - Manufacturers
                                     Year
                                Number of Firms
                               Reports per Firmb
                    Rule Familiarizationc Burden (per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                    Electronic Reporting Burden (per Firm)d
                             Total Burden Per Firm
                           Total Number of Reportsb
                              Total Manuf. Burden
                                       1
                                      165
                                     4.67
                                     0.82
                                      139
                                     1.42
                                      652
                                      771
                                    107,616
                                       2
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       3
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       4
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       5
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       6
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       7
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       8
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                       9
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                      10
                                      165
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      86
                                    11,991
                                     Total
                                       -
                                     9.35
                                       -
                                       -
                                       -
                                       -
                                     1,545
                                    215,535
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 0.52 additional nanomaterials per firm in subsequent years.
c Derived in Table 3-2; d Derived from Table 3-3, Table 3-6, Table 3-7, and Table 3-8.
Values may not calculate exactly due to rounding

Table 3-10: Total Annual Burden Hours - Processors
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                    Rule Familiarizationc Burden (per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                    Electronic Reporting Burden (per Firm)d
                             Total Burden Per Firm
                           Total Number of Reportsb
                            Total Processor Burden
                                       1
                                     1,788
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                     1,788
                                    252,715
                                       2
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       3
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       4
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       5
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       6
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       7
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       8
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                       9
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                      10
                                      199
                                     1.00
                                     0.82
                                      139
                                     1.42
                                      141
                                      199
                                    28,127
                                     Total
                                       -
                                       
                                       -
                                       -
                                       -
                                       -
                                     3,579
                                    505,858
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 0.52 additional nanomaterials per firm in subsequent years.
c Derived in Table 3-2 d; Derived from Table 3-3, Table 3-6, Table 3-7, and Table 3-8.
Values may not calculate exactly due to rounding



Table 3-11: Total Annualized Costs - Manufacturers
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                     Rule Familiarizationc Cost (per Firm)
      Form Completion, CBI Subst., and Record-keeping Cost (per Report)d
              Electronic Reporting Requirements Cost (per Firm)e
                             Total Cost (per Firm)
                          Discounted Cost (Per Firm)
                           Total Number of Reportsb
                          Total Cost (Millions 2015$)
                         Manufacturer Discounted Cost
                               (Millions 2015$)
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                               3 % Discount Rate
                               7 % Discount Rate
                                       
                                       
                               3 % Discount Rate
                               7 % Discount Rate
                                       1
                                      165
                                     4.67
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $50,285 
                                   $50,285 
                                   $50,285 
                                      771
                                    $8.30 
                                    $8.30 
                                    $8.30 
                                       2
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $5,430 
                                    $5,227 
                                      86
                                    $0.92 
                                    $0.90 
                                    $0.86 
                                       3
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $5,272 
                                    $4,885 
                                      86
                                    $0.92 
                                    $0.87 
                                    $0.81 
                                       4
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $5,119 
                                    $4,566 
                                      86
                                    $0.92 
                                    $0.84 
                                    $0.75 
                                       5
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,970 
                                    $4,267 
                                      86
                                    $0.92 
                                    $0.82 
                                    $0.70 
                                       6
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,825 
                                    $3,988 
                                      86
                                    $0.92 
                                    $0.80 
                                    $0.66 
                                       7
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,684 
                                    $3,727 
                                      86
                                    $0.92 
                                    $0.77 
                                    $0.61 
                                       8
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,548 
                                    $3,483 
                                      86
                                    $0.92 
                                    $0.75 
                                    $0.57 
                                       9
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,415 
                                    $3,255 
                                      86
                                    $0.92 
                                    $0.73 
                                    $0.54 
                                      10
                                      165
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,287 
                                    $3,042 
                                      86
                                    $0.92 
                                    $0.71 
                                    $0.50 
                                     Total
                                       -
                                     9.35
                                       -
                                       -
                                       
                                       
                                       
                                       
                                     1,545
                                       -
                                       -
                                       -
                                                                Annualized Cost
                                    $9,846 
                                   $10,809 
                                       
                                    $1.62 
                                    $1.78 
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 0.52 additional nanomaterials per firm in subsequent years.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-6, Table 3-7, and Table 3-8.
e Derived from Table 3-3, Table 3-6, Table 3-7, and Table 3-8.
Values may not calculate exactly due to rounding.


Table 3-12: Total Annualized Costs - Processors
                                     Year
                               Number of Firmsa
                               Reports per Firmb
                     Rule Familiarizationc Cost (per Firm)
   Form Completion, CBI Substantiation, and Recordkeeping Cost (per Report)d
              Electronic Reporting Requirements Cost (per Firm)e
                             Total Cost (per Firm)
                          Discounted Cost (Per Firm)
                           Total Number of Reportsb
                          Total Cost (Millions 2015$)
                           Processor Discounted Cost
                               (Millions 2015$)
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                               3 % Discount Rate
                               7 % Discount Rate
                                       
                                       
                               3 % Discount Rate
                               7 % Discount Rate
                                       1
                                     1,788
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                   $10,904 
                                   $10,904 
                                     1,788
                                    $19.49 
                                    $19.49 
                                    $19.49 
                                       2
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                   $10,587 
                                   $10,191 
                                      199
                                    $2.17 
                                    $2.11 
                                    $2.03 
                                       3
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                   $10,278 
                                    $9,524 
                                      199
                                    $2.17 
                                    $2.05 
                                    $1.90 
                                       4
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $9,979 
                                    $8,901 
                                      199
                                    $2.17 
                                    $1.99 
                                    $1.77 
                                       5
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $9,688 
                                    $8,319 
                                      199
                                    $2.17 
                                    $1.93 
                                    $1.66 
                                       6
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $9,406 
                                    $7,775 
                                      199
                                    $2.17 
                                    $1.87 
                                    $1.55 
                                       7
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $9,132 
                                    $7,266 
                                      199
                                    $2.17 
                                    $1.82 
                                    $1.45 
                                       8
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $8,866 
                                    $6,791 
                                      199
                                    $2.17 
                                    $1.76 
                                    $1.35 
                                       9
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $8,608 
                                    $6,346 
                                      199
                                    $2.17 
                                    $1.71 
                                    $1.26 
                                      10
                                      199
                                       1
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $10,904 
                                    $8,357 
                                    $5,931 
                                      199
                                    $2.17 
                                    $1.66 
                                    $1.18 
                                     Total
                                       -
                                       
                                       -
                                       -
                                       
                                       
                                       
                                       
                                     3,579
                                       -
                                       -
                                       -
                                                                Annualized Cost
                                   $10,053 
                                   $10,214 
                                       
                                    $3.82 
                                    $4.19 
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 0.52 additional nanomaterials per firm in subsequent years.
c Derived in Table 3-2
d Derived from Table 3-3, Table 3-6, Table 3-7, and Table 3-8.
e Derived from Table 3-3, Table 3-6, Table 3-7, and Table 3-8.
Values may not calculate exactly due to rounding.



Table 3-13: Total Annualized Industry Costs
                                     Year
                            Total Number of Reports
                             Total Burden (hours)
                         Total Cost 
(Millions 2015$)
                           Industry Discounted Cost


                                       

                               (Millions 2015$)




                               3 % Discount Rate
                               7 % Discount Rate
                                       1
                                     2,559
                                    360,331
                                    $27.79 
                                    $27.79 
                                    $27.79 
                                       2
                                      285
                                    40,118
                                    $3.09 
                                    $3.00 
                                    $2.89 
                                       3
                                      285
                                    40,118
                                    $3.09 
                                    $2.92 
                                    $2.70 
                                       4
                                      285
                                    40,118
                                    $3.09 
                                    $2.83 
                                    $2.53 
                                       5
                                      285
                                    40,118
                                    $3.09 
                                    $2.75 
                                    $2.36 
                                       6
                                      285
                                    40,118
                                    $3.09 
                                    $2.67 
                                    $2.21 
                                       7
                                      285
                                    40,118
                                    $3.09 
                                    $2.59 
                                    $2.06 
                                       8
                                      285
                                    40,118
                                    $3.09 
                                    $2.52 
                                    $1.93 
                                       9
                                      285
                                    40,118
                                    $3.09 
                                    $2.44 
                                    $1.80 
                                      10
                                      285
                                    40,118
                                    $3.09 
                                    $2.37 
                                    $1.68 
                                     Total
                                     5,124
                                    721,393
                                       
                                                                Annualized Cost
                                     $5.44
                                     $5.98



  -  Agency Costs
Wage Rates
EPA assumes that, on average, a Federal GS-13, Step 5 full-time equivalent (FTE) will conduct its collection and administrative activities under the rule (that is, the professional/technical labor). The annual 2015 fully loaded salary for a GS-13, Step 5 FTE is $164,691. This estimate includes a base salary of $102,932 plus a 60 percent load increase to account for benefits and overhead (i.e., $61,759). 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 $78.91. EPA assumes that a Federal GS-14, Step 5 FTE will perform attorney activities under the rule. An hourly wage rate of $93.25 was calculated using the same method as for the technical labor. Appendix A provides a detailed description of these calculations.
Table 4-1: Loaded EPA Wage Rates, 2015$
Labor Category
Base Wages[a]
Fringe Benefitsa + Overhead Factor[b]
Loaded Wages
Attorney
                                    $58.28
                                      1.6
                                    $93.25
Professional/Technical
                                    $49.32 
                                      1.6
                                    $78.91
Notes:
[a] Wage rates and fringe benefits are calculated using the January 2015 estimates from OPM (2015)
[b] The 60% fringe-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9)

Unit Agency Costs
EPA will incur costs in administering the rule. The 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 rule, it is estimated to take 1.5 labor hours per report to provide industry and public assistance and 3.75 labor hours per report to provide data processing and systems support for a total of 5.25 labor hours per report (EPA, 2003a) when the reporting is accomplished through non-electronic reporting. However, the electronic reporting required by the 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 per report for providing industry and public assistance and 3.13 per report for data processing and systems support.
Under the Frank R. Lautenberg Chemical Safety for the 21[st] Century Act, EPA must review a number of the CBI claims received, including some associated with submissions under this rule, within 90 days after receipt. EPA estimates that it will take 8 hours (6 attorney hours and 2 technical staff hours) to review each CBI claim substantiation submission and make a confidentiality determination. This is based on the estimate for reviewing CBI substantiation letters and making final confidentiality determinations under 4 CFR part 2, as described in EPA ICR No. 1665.12 (OMB Control No 2020-0003) (EPA, 2013). Under the Act, EPA must review 100 percent of claims related to chemical identity, and at least 25 percent (a representative sample) of all other claims where substantiation is required. EPA assumes that there will be no claims for chemical identity, as the materials subject to this rule are existing chemicals and would already either have a non-CBI identity or would have an established generic identity. EPA assumes that each report claims CBI, therefore EPA must review 25 percent of reports. Therefore, per report received, the EPA labor is 2 hours (6 x 0.25 = 1.5 attorney hours and 2 x 0.25 = 0.5 technical staff hours). 
As shown in Table 4-2, EPA estimated a total cost of approximately $525 to administer and process a chemical report. 
Table 4-2: Agency Cost Estimate to Administer the Rule (per report)
                                 EPA Activity
                       Technical Labor 
(at $78.91/hour)
                       Attorney Labor 
(at $93.25/ hour)
                               Total Labor Cost 

                                    Burden
                                     Cost 
                                    Burden
                                     Cost 
                                    Burden
                                     Cost 
Industry/Public Assistance
                                     1.25
                                      $99
                                       0
                                      $0
                                     1.25
                                      $99
Data Processing and Systems Support
                                     3.13
                                     $247
                                       0
                                      $0
                                     3.13
                                     $247
Review of CBI claim substantiations
                                      0.5
                                      $39
                                      1.5
                                     $140
                                       2
                                     $179
Total
                                     4.88
                                     $385
                                      1.5
                                     $140
                                     6.38
                                     $525
Source: EPA, 2003a; EPA, 2013; OPM, 2015.

As explained in Chapter 3, approximately 2,559 chemical reports will be filed in the first year of the rule and 285 reports in subsequent years. As shown in Table 4-3, the total Agency hours and costs for the rule are estimated to total 16,326 hours and $1.34 million in the first year of the rule before decreasing to 1,818 hours and $0.15 million in subsequent years. The annualized costs of the rule over the 10-year analysis period are $0.26 million with a three percent discount rate and $0.29 million with a seven percent discount rate. 
Table 4-3: Agency Cost and Burden Hour Estimate for the Final Rule
                                     Year
                               Hours per Report
                            Agency Cost per Report
                                    (2015$)
                            Total Number of Reports
                                     Total
                       Discounted Cost 
(Millions 2015$)


                                       

                                     Hours
                             Cost (Millions 2015$)
                               3% Discount Rate
                               7% Discount Rate
                                       1
                                     6.38
                                     $525
                                     2,559
                                    16,326
                                    $1.34 
                                    $1.34 
                                    $1.34 
                                       2
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.15 
                                    $0.14 
                                       3
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.14 
                                    $0.13 
                                       4
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.14 
                                    $0.12 
                                       5
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.13 
                                    $0.11 
                                       6
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.13 
                                    $0.11 
                                       7
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.13 
                                    $0.10 
                                       8
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.12 
                                    $0.09 
                                       9
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.12 
                                    $0.09 
                                      10
                                     6.38
                                     $525
                                      285
                                     1,818
                                    $0.15 
                                    $0.11 
                                    $0.08 
                                     Total
                                     63.80
 
                                     5,124
                                    32,688
                                     $2.69
                                       -
                                       -
                                                                Annualized Cost
                                    $0.26 
                                    $0.29 
Source: EPA, 2003a; EPA, 2013; OPM, 2013



  -  Total Social Costs and Sensitivity Analyses
Table 5-1 presents the total social burden and costs of the 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 754,081 hours over the 10-year analysis period, while the annualized costs are expected to be from approximately $5.71 million with a three percent discount rate and approximately $6.26 million with a seven percent discount rate. 
Table 5-1: Total Social Burden and Cost of the Rule
                                     Year 
                                Burden (Hours)
                           Discounted Costs (2015$)


                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
                                       1
                                    360,331
                                    16,326
                                    376,657
                                    $27.79 
                                    $1.34 
                                    $29.13 
                                    $27.79 
                                    $1.34 
                                    $29.13 
                                       2
                                    40,118
                                     1,818
                                    41,936
                                    $3.00 
                                    $0.15 
                                    $3.15 
                                    $2.89 
                                    $0.14 
                                    $3.03 
                                       3
                                    40,118
                                     1,818
                                    41,936
                                    $2.92 
                                    $0.14 
                                    $3.06 
                                    $2.70 
                                    $0.13 
                                    $2.83 
                                       4
                                    40,118
                                     1,818
                                    41,936
                                    $2.83 
                                    $0.14 
                                    $2.97 
                                    $2.53 
                                    $0.12 
                                    $2.65 
                                       5
                                    40,118
                                     1,818
                                    41,936
                                    $2.75 
                                    $0.13 
                                    $2.88 
                                    $2.36 
                                    $0.11 
                                    $2.47 
                                       6
                                    40,118
                                     1,818
                                    41,936
                                    $2.67 
                                    $0.13 
                                    $2.80 
                                    $2.21 
                                    $0.11 
                                    $2.32 
                                       7
                                    40,118
                                     1,818
                                    41,936
                                    $2.59 
                                    $0.13 
                                    $2.72 
                                    $2.06 
                                    $0.10 
                                    $2.16 
                                       8
                                    40,118
                                     1,818
                                    41,936
                                    $2.52 
                                    $0.12 
                                    $2.64 
                                    $1.93 
                                    $0.09 
                                    $2.02 
                                       9
                                    40,118
                                     1,818
                                    41,936
                                    $2.44 
                                    $0.12 
                                    $2.56 
                                    $1.80 
                                    $0.09 
                                    $1.89 
                                      10
                                    40,118
                                     1,818
                                    41,936
                                    $2.37 
                                    $0.11 
                                    $2.48 
                                    $1.68 
                                    $0.08 
                                    $1.76 
                                     Total
                                    721,393
                                    32,688
                                    754,081
                                       -
                                                               Annualized Costs
                                    $5.44 
                                    $0.26 
                                    $5.71 
                                    $5.98 
                                    $0.29 
                                    $6.26 
Source: EPA, 2003a; OPM, 2015

 - Sensitivity Analyses
To show the possible range of costs and burden associated with the 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 rule. EPA conducted four sensitivity analyses, estimating: (1) a low and high cost based on a range of number of firms subject to the rule; (2) costs based on a potential growth in the number of firms subject to the rule over the 10 year period; (3) a low and high cost based on the range of number of reports submitted by a manufacturer in year one; and (4) a low and high cost based the growth rate of the number of nanomaterials over the ten year period 
Number of Firms
Low and High-end Estimates for the Number of Firms Subject to the Rule
As described in Section 2.4, this economic analysis estimates there to be 165 manufacturers and 1,788 processors subject to the rule in the first year, for a total of 1,953 firms. In the second year, the number of processors drops to 199, for a total of 364 firms. As an alternative analysis, EPA examined costs associated with the rule for a wider range of number of affected firms.
Manufacturers. The number of manufacturers was based on BCC Research (2008)'s estimate of companies worldwide with "nanotechnology activities", and a percentage of their sampled companies that were determined to be specifically involved in the manufacturing business (75.76 percent). For the sensitivity analysis, EPA estimated costs associated with the rule assuming a 100 percent (high-end) rate and a 50 percent (low-end) rate for companies that are specifically involved in nanomaterials manufacturing. 
Therefore, 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), by the percent that have greater than $11 million in sales (21 percent) and by the percent of the sample that are nanomaterials manufacturers (100 or 50 percent) suggests an estimated range of 114 to 228 U.S. nanoscale manufacturers for this sensitivity analysis. 
Processors. .For the main analysis, EPA estimated the number of processors per nanomaterial at 2.32. For this sensitivity analysis, we assume a low-end estimate of one processor per nanomaterial. For the high-end estimate, we assume more than double our main analysis estimate, at five processors per nanomaterial. By calculating the number of regulated processors as described in Section 2.3 (Table 2-4), this results in a low-end estimate of 771 for the first year and 86 for subsequent years, and a high-end estimate of 3,853 for the first year and 429 for subsequent years. 
Total. The total number of firms under the low- and high-end estimates are summarized in Table 6-1.

Table 6-1: Low- and High-end Estimates of Number of Firms
                              Population Category
                               Low-end Estimate
                               High-end Estimate

                                  First year
                               Subsequent years
                                  First year
                               Subsequent years
Manufacturers
                                      114
                                      114
                                      228
                                      228
Processors
                                      771
                                      86
                                     3,853
                                      429
Total
                                      885
                                      200
                                     4,081
                                      657

Industry, Agency, and Total Costs
Low-end estimates. Based on the low-end estimate of firms, the number of reports estimated in Chapter 2, and burden estimates derived in Section 3.2, the total industry burden is 183,166 hours in the first year and 20,354 hours in future years, with an annualized cost of $2.75 million with a 3 percent discount rate ($3.02 with a 7 percent discount rate). Table 6-2 and Table 6-3 present these industry cost and burden estimates.
Table 6-4 shows the Agency burden low-end estimate of 8,313 hours in the first year and 926 hours each subsequent year, and the annualized cost of estimates of $0.13 million with a 3 percent discount rate ($0.15 million with a 7 percent discount rate).
Table 6-5 presents the total low-end social costs of $2.88 million with a 3 percent discount rate and $3.17 million with a 7 percent discount rate.
High-end estimates. Using the high end estimate of firms, the industry burden is 693,200 hours in the first year and 77,227 hours in each subsequent year, with an annualized cost of $10.39 million with a 3 percent discount rate ($11.40 with a 7 percent discount rate). The industry burden and cost estimates are presented in Table 6-2 and Table 6-3 respectively. 
Table 6-4 presents the total Agency high-end burden estimate of 31,374 hours in the first year and 3,493 hours in each subsequent year, and the annualized Agency cost estimate of $0.51 million with a 3 percent discount rate ($0.55 with a 7 percent discount rate). 
Table 6-5 contains the total social costs and burden of using the high end-estimate. The total social burden is 1.5 million hours over the ten year period, and the annualized cost is $10.89 million with a 3 percent discount rate and $11.96 with a 7 percent discount rate. 


Table 6-2: Total Annual Industry Burden Hours (Number of Firms Sensitivity Analysis)
                                     Year
                                Number of Firms
                               Reports per Firm
                    Rule Familiarization Burden 
(per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                     Electronic Reporting Costs (per Firm)
                             Total Burden Per Firm
                       Total Industry Number of Reports
                             Total Industry Burden

                                      Low
                                     High





                                      Low
                                     High
                                      Low
                                     High
Manufacturers
                                       1
                                      114
                                      228
                                     4.67
                                     0.82
                                      139
                                     1.42
                                      652
                                      532
                                     1,065
                                    74,257
                                    148,652
                                       2
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       3
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       4
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       5
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       6
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       7
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       8
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                       9
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
                                      10
                                      114
                                      228
                                     0.52
                                     0.00
                                      139
                                     0.17
                                      73
                                      59
                                      119
                                     8,227
                                    16,593
Processors
                                       1
                                      771
                                     3,853
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      771
                                     3,853
                                    108,910
                                    544,548
                                       2
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       3
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       4
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       5
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       6
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       7
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       8
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                       9
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635
                                      10
                                      86
                                      429
                                       1
                                     0.82
                                      139
                                     1.42
                                      141
                                      86
                                      429
                                    12,127
                                    60,635

Table 6-3: Total Annual Industry Cost (Number of Firms Sensitivity Analysis)  
                                     Year
                               Number of Firmsa
                               Reports per Firm
                     Rule Familiar-ization Cost (per Firm)
        Form Compltn, CBI Subst, and Record-keeping Cost (per Report)d
                     Electronic Reporting Cost (per Firm)e
                             Total Cost (per Firm)
                          Discounted Cost (Per Firm)
                       Total Industry Number of Reportsb
                     Total Industry Cost (Millions 2015$)
                           Industry Discounted Cost










                               (Millions 2015$)







                               3 % Discount Rate
                               7 % Discount Rate


                               3 % Discount Rate
                               7 % Discount Rate

                                      Low
                                     High







                                      Low
                                      High
                                      Low
                                      High
                                      Low
                                     High
                                      Low
                                      High
Manufacturers
                                       1
                                      114
                                      228
                                     4.67
                                    $63.66 
                                   $10,730 
                                   $110.31 
                                   $50,285 
                                   $50,285 
                                   $50,285 
                                      532
                                     1,065
                                    $5.73 
                                    $11.46 
                                    $5.72 
                                    $11.44 
                                    $5.72 
                                                                          $11.4
                                       2
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $5,430 
                                    $5,227 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.62 
                                    $1.24 
                                    $0.59 
                                                                          $1.19
                                       3
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $5,272 
                                    $4,885 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.60 
                                    $1.20 
                                    $0.56 
                                                                          $1.11
                                       4
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $5,119 
                                    $4,566 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.58 
                                    $1.16 
                                    $0.52 
                                                                          $1.04
                                       5
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,970 
                                    $4,267 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.57 
                                    $1.13 
                                    $0.49 
                                                                          $0.97
                                       6
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,825 
                                    $3,988 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.55 
                                    $1.10 
                                    $0.45 
                                                                          $0.91
                                       7
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,684 
                                    $3,727 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.53 
                                    $1.07 
                                    $0.42 
                                                                          $0.85
                                       8
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,548 
                                    $3,483 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.52 
                                    $1.03 
                                    $0.40 
                                                                          $0.79
                                       9
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,415 
                                    $3,255 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.50 
                                    $1.00 
                                    $0.37 
                                                                          $0.74
                                      10
                                      114
                                      228
                                     0.52
                                    $0.00 
                                   $10,730 
                                    $13.41 
                                    $5,593 
                                    $4,287 
                                    $3,042 
                                      59
                                      119
                                    $0.64 
                                    $1.28 
                                    $0.49 
                                    $0.98 
                                    $0.35 
                                                                          $0.69
Processors
                                       1
                                      771
                                     3,853
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                   $10,904 
                                   $10,904 
                                      771
                                     3,853
                                    $8.40 
                                    $42.01 
                                    $8.32 
                                    $41.59 
                                    $8.32 
                                                                         $41.59
                                       2
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                   $10,587 
                                   $10,191 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.90 
                                    $4.50 
                                    $0.87 
                                                                          $4.33
                                       3
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                   $10,278 
                                    $9,524 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.87 
                                    $4.36 
                                    $0.81 
                                                                          $4.04
                                       4
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                    $9,979 
                                    $8,901 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.85 
                                    $4.24 
                                    $0.76 
                                                                          $3.78
                                       5
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                    $9,688 
                                    $8,319 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.82 
                                    $4.11 
                                    $0.71 
                                                                          $3.53
                                       6
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                    $9,406 
                                    $7,775 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.80 
                                    $3.99 
                                    $0.66 
                                                                          $3.30
                                       7
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                    $9,132 
                                    $7,266 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.78 
                                    $3.88 
                                    $0.62 
                                                                          $3.09
                                       8
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                    $8,866 
                                    $6,791 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.75 
                                    $3.77 
                                    $0.58 
                                                                          $2.88
                                       9
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                   $10,904 
                                    $8,608 
                                    $6,346 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.73 
                                    $3.66 
                                    $0.54 
                                                                          $2.70
                                      10
                                      86
                                      429
                                       1
                                    $63.66
                                    $10,730
                                    $8,686 
                                   $10,904 
                                    $8,357 
                                    $5,931 
                                      86
                                      429
                                    $0.94 
                                    $4.68 
                                    $0.71 
                                    $3.55 
                                    $0.50 
                                                                          $2.52
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                                                               
Table 6-4: Total Annual Agency Burden and Cost (Number of Firms Sensitivity Analysis) 
                                     Year
                               Hours per Report
                        Agency Cost per Report (2015$)
                           Total Number of Reportsa
                                     Total
                       Discounted Cost (Millions 2015$)




                                     Hours
                             Cost (Millions 2015$)
                               3% Discount Rate
                               7% Discount Rate



                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     6.38
                                     $525
                                     1,303
                                     4,918
                                     8,313
                                    31,374
                                    $0.68 
                                    $2.58 
                                    $0.68 
                                    $2.58 
                                    $0.68 
                                     $2.58
                                       2
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.07 
                                    $0.28 
                                    $0.07 
                                     $0.27
                                       3
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.07 
                                    $0.27 
                                    $0.07 
                                     $0.25
                                       4
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.07 
                                    $0.26 
                                    $0.06 
                                     $0.23
                                       5
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.07 
                                    $0.26 
                                    $0.06 
                                     $0.22
                                       6
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.07 
                                    $0.25 
                                    $0.05 
                                     $0.20
                                       7
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.06 
                                    $0.24 
                                    $0.05 
                                     $0.19
                                       8
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.06 
                                    $0.23 
                                    $0.05 
                                     $0.18
                                       9
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.06 
                                    $0.23 
                                    $0.04 
                                     $0.17
                                      10
                                     6.38
                                     $525
                                      145
                                      548
                                      926
                                     3,493
                                    $0.08 
                                    $0.29 
                                    $0.06 
                                    $0.22 
                                    $0.04 
                                     $0.16
                                     Total
                                     63.80
 
                                     2,609
                                     9,846
                                    16,647
                                    62,815
 
                                                                Annualized Cost
                                    $0.13 
                                    $0.51 
                                    $0.15 
                                    $0.55 


Table 6-5: Total Social Costs (Number of Firms Sensitivity Analysis) 
                                     Year 
                                Burden (Hours)
                       Discounted Costs (millions 2015$)


                               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
                                    183,166
                                    693,200
                                     8,313
                                    31,374
                                    191,479
                                    724,574
                                     $14.0
                                    $53.03 
                                    $0.68 
                                    $2.58 
                                     $14.7
                                     $55.6
                                     $14.0
                                    $53.0 
                                    $0.68 
                                    $2.58 
                                    $14.72
                                     $55.6
                                       2
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.52 
                                    $5.74 
                                    $0.07 
                                    $0.28 
                                     $1.59
                                     $6.02
                                    $1.46 
                                    $5.52 
                                    $0.07 
                                    $0.27 
                                     $1.53
                                     $5.79
                                       3
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.47 
                                    $5.56 
                                    $0.07 
                                    $0.27 
                                     $1.54
                                     $5.83
                                    $1.37 
                                    $5.15 
                                    $0.07 
                                    $0.25 
                                     $1.44
                                     $5.40
                                       4
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.43 
                                    $5.40 
                                    $0.07 
                                    $0.26 
                                     $1.50
                                     $5.66
                                    $1.28 
                                    $4.82 
                                    $0.06 
                                    $0.23 
                                     $1.34
                                     $5.05
                                       5
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.39 
                                    $5.24 
                                    $0.07 
                                    $0.26 
                                     $1.46
                                     $5.50
                                    $1.20 
                                    $4.50 
                                    $0.06 
                                    $0.22 
                                     $1.26
                                     $4.72
                                       6
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.35 
                                    $5.09 
                                    $0.07 
                                    $0.25 
                                     $1.42
                                     $5.34
                                    $1.11 
                                    $4.21 
                                    $0.05 
                                    $0.20 
                                     $1.16
                                     $4.41
                                       7
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.31 
                                    $4.95 
                                    $0.06 
                                    $0.24 
                                     $1.37
                                     $5.19
                                    $1.04 
                                    $3.94 
                                    $0.05 
                                    $0.19 
                                     $1.09
                                     $4.13
                                       8
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.27 
                                    $4.80 
                                    $0.06 
                                    $0.23 
                                     $1.33
                                     $5.03
                                    $0.98 
                                    $3.67 
                                    $0.05 
                                    $0.18 
                                     $1.03
                                     $3.85
                                       9
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.23 
                                    $4.66 
                                    $0.06 
                                    $0.23 
                                     $1.29
                                     $4.89
                                    $0.91 
                                    $3.44 
                                    $0.04 
                                    $0.17 
                                     $0.95
                                     $3.61
                                      10
                                    20,354
                                    77,227
                                      926
                                     3,493
                                    21,280
                                    80,721
                                    $1.20 
                                    $4.53 
                                    $0.06 
                                    $0.22 
                                     $1.26
                                     $4.75
                                    $0.85 
                                    $3.21 
                                    $0.04 
                                    $0.16 
                                     $0.89
                                     $3.37
                                     Total
                                    366,352
                                   1,388,247
                                    16,647
                                    62,815
                                    382,999
                                    1.45 M
                                       
                                                               Annualized Costs
                                    $2.75 
                                    $10.39 
                                    $0.13 
                                    $0.51 
                                    $2.88 
                                    $10.9 
                                    $3.02 
                                     $11.4
                                    $0.15 
                                    $0.55 
                                    $3.17 
                                    $12.0 




Annual Industry Growth Rate 
In Chapter 3 and Chapter 4, EPA assumes that the number of manufacturer 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 11.6 percent in the number of manufacturer firms subject to the rule. The growth rate of 11.6 percent was calculated using the number nanomaterials firms identified in the 2005 NMSP ICR (611) and the number of manufacturer firms estimated in this report (823), which was based on data from 2008. Growth rate was calculated using the formula below:
Growth Rate=∆Number of FirmsFirms year 1(Number of years)=823-611611(2008-2005)=0.116
Estimated Number of Reports
Manufacturers. To be consistent with the main analysis presented in Chapter 3 and Chapter 4 EPA assumes each manufacturer will submit 4.67 reports in its first year and 0.52 reports in each subsequent year (see Section 2.2.3). 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 3,316 reports over the 10-year period (see Table 6-6). 

Table 6-6: Estimated Number of Manufacturer Reports (Increased Annual Growth Rate Sensitivity Analysis)
                                     Year
                                Number of Firms
                              Chemicals per Firm
                               Number of Reports
                                       
                                   New Firms
                                Existing Firms
                                     Total
                                  First Year
                               Subsequent Years
                                   New Firms
                                Existing Firms
                                     Total
                                       1
                                      165
                                       0
                                      165
                                     4.67
                                     0.52
                                      771
                                       0
                                      771
                                       2
                                      19
                                      165
                                      184
                                     4.67
                                     0.52
                                      89
                                      86
                                      175
                                       3
                                      21
                                      184
                                      205
                                     4.67
                                     0.52
                                      98
                                      96
                                      194
                                       4
                                      24
                                      205
                                      229
                                     4.67
                                     0.52
                                      112
                                      107
                                      219
                                       5
                                      27
                                      229
                                      256
                                     4.67
                                     0.52
                                      126
                                      119
                                      245
                                       6
                                      30
                                      256
                                      286
                                     4.67
                                     0.52
                                      140
                                      133
                                      273
                                       7
                                      33
                                      286
                                      319
                                     4.67
                                     0.52
                                      154
                                      149
                                      303
                                       8
                                      37
                                      319
                                      356
                                     4.67
                                     0.52
                                      173
                                      166
                                      339
                                       9
                                      41
                                      356
                                      397
                                     4.67
                                     0.52
                                      191
                                      185
                                      376
                                      10
                                      46
                                      397
                                      443
                                     4.67
                                     0.52
                                      215
                                      206
                                      421
                                     Total
                                       -
                                       -
                                       -
                                       -
                                       -
                                     2,069
                                     1,247
                                     3,316

Processors. As described in Section 2.3, we assume that there are 2.32 processors per nanomaterial, and that each processor submits one report. Under this manufacturer growth rate scenario, the total number of reports submitted by processors over the 10-year analysis period is 7,693 (see Table 6-7).

Table 6-7: Estimated Number of Processor Reports (Increased Annual Growth Rate Sensitivity Analysis)
                                     Year
                        Number of Manufacturer Reports
                     Number of Processors per Nanomaterial
                          Total Number of Processors
                             Reports per Processor
                          Number of Processor Reports
                                       1
                                      771
                                     2.32
                                     1,789
                                       1
                                     1,789
                                       2
                                      175
                                     2.32
                                      406
                                       1
                                      406
                                       3
                                      194
                                     2.32
                                      450
                                       1
                                      450
                                       4
                                      219
                                     2.32
                                      508
                                       1
                                      508
                                       5
                                      245
                                     2.32
                                      568
                                       1
                                      568
                                       6
                                      273
                                     2.32
                                      633
                                       1
                                      633
                                       7
                                      303
                                     2.32
                                      703
                                       1
                                      703
                                       8
                                      339
                                     2.32
                                      786
                                       1
                                      786
                                       9
                                      376
                                     2.32
                                      872
                                       1
                                      872
                                      10
                                      421
                                     2.32
                                      977
                                       1
                                      977
                                     Total
                                       -
                                       -
                                       -
                                       -
                                     7,693
INDUSTRY, Agency and Total Costs
Table 6-8 presents the annual industry labor burden for both new and existing firms. There are 165 manufacturing firms expected to submit reports in year 1, and a total of 443 manufacturers are estimated to submit reports by the end of the 10 year period. A total of 1,789 processors are expected to submit reports in the first year, and from 406 to 977 in the subsequent years. Each new manufacturing firm is estimated to incur 652 labor burden hours in their first year and 73 hours each subsequent year. Processing firms each incur 141 hours in the year of their report submission. The total industry labor burden is estimated to be 1,549,917 hours. The costs per firm and total industry costs are presented in Table 6-9. Total annualized industry costs are $11.07 million with a 3 percent discount rate and $11.35 million with a 7 percent discount rate. 
Agency costs are derived following the method described in Chapter 4. As shown in Table 6-10, EPA expects that approximately 11,009 reports will be submitted over the next 10 years, resulting in a total Agency burden of 70,238 labor hours. Annualized costs are expected to be $0.54 million with a 3 percent discount rate and $0.55 million with a 7 percent discount rate. 
As shown in Table 6-11, the increase in the number of nanomaterials firms over a 10-year period is expected to yield a total social burden of 1,620,155 hours and total annualized social costs of $11.61 million with a 3 percent discount rate ($11.90 million with a 7 percent discount rate). 


Table 6-8: Total Annual Industry Labor Burden (Increased Annual Growth Rate Sensitivity Analysis)
                                     Year
                                Number of Firms
                           Total Number of Reportsa
                 Rule Familiarization Burden (Hours per Firm)b
Form Completion, CBI Substantiation 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

                                 Manufacturers
                                  Processors




                                 Manufacturers
                                  Processors


                                   Existing
                                      New


                                   Existing
                                      New

                                   Existing
                                      New
                                   Existing
                                      New


                                       1
                                       0
                                      165
                                     1789
                                     2,560
                                       0
                                     0.82
                                      144
                                       0
                                     1.42
                                       0
                                      652
                                      141
                                    360,371
                                       2
                                      165
                                      19
                                      406
                                      581
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    81,733
                                       3
                                      184
                                      21
                                      450
                                      644
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    90,645
                                       4
                                      205
                                      24
                                      508
                                      727
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    102,321
                                       5
                                      229
                                      27
                                      568
                                      813
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    114,542
                                       6
                                      256
                                      30
                                      633
                                      906
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    127,637
                                       7
                                      286
                                      33
                                      703
                                     1,006
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    141,605
                                       8
                                      319
                                      37
                                      786
                                     1,125
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    158,410
                                       9
                                      356
                                      41
                                      872
                                     1,248
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    175,833
                                      10
                                      397
                                      46
                                      977
                                     1,398
                                       0
                                     0.82
                                      144
                                     0.17
                                     1.42
                                      73
                                      652
                                      141
                                    196,821
                                     Total
                                       
                                    11,009
                                       
                                   1,549,917

Table 6-9: Annual Industry Labor Costs (Increased Annual Growth Rate Sensitivity Analysis)
 
                                       
                                       
                                     Year
                                Number of Firms
                            Total Number of Reports
                 Rule Familiarization Cost (per Firm) (2015$)
Form Completion and  CBI Substantiation, Record-keeping Cost (per Report)c (2015$)
           Electronic Reporting Requirements Cost (per Firm) (2015$)
                          Total Cost per Firm (2015$)
                     Total Industry Cost (Millions 2015$)
                       Discounted Cost (Millions 2015$)

                                 Manufacturers
                                  Processors




                                 Manufacturers
                                  Processors



                                   Existing
                                      New


                                   Existing
                                      New

                                   Existing
                                      New
                                   Existing
                                      New


                                3% Disc. Rate 
                                7% Disc .Rate 
                                       1
                                       0
                                      165
                                     1,789
                                     2,560
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                       0
                                   $50,285 
                                   $10,904 
                                    $27.80
                                    $27.80 
                                    $27.80 
                                       2
                                      165
                                      19
                                      406
                                      581
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                     $6.31
                                    $6.12 
                                    $5.89 
                                       3
                                      184
                                      21
                                      450
                                      644
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                     $6.99
                                    $6.59 
                                    $6.11 
                                       4
                                      205
                                      24
                                      508
                                      727
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                     $7.89
                                    $7.22 
                                    $6.44 
                                       5
                                      229
                                      27
                                      568
                                      813
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                     $8.84
                                    $7.85 
                                    $6.74 
                                       6
                                      256
                                      30
                                      633
                                      906
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                     $9.85
                                    $8.49 
                                    $7.02 
                                       7
                                      286
                                      33
                                      703
                                     1,006
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                    $10.92
                                    $9.15 
                                    $7.28 
                                       8
                                      319
                                      37
                                      786
                                     1,125
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                    $12.22
                                    $9.94 
                                    $7.61 
                                       9
                                      356
                                      41
                                      872
                                     1,248
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                    $13.56
                                    $10.71 
                                    $7.89 
                                      10
                                      397
                                      46
                                      977
                                     1,398
                                    $0.00 
                                    $63.66 
                                   $10,730 
                                    $13.41 
                                   $110.31 
                                    $5,593 
                                   $50,285 
                                   $10,904 
                                    $15.18
                                    $11.64 
                                    $8.26 
                                     Total
                                       
                                    11,009
                                       
                                                                Annualized Cost
                                    $11.07 
                                    $11.35 


Table 6-10: Agency Cost Estimate for the Final Rule (Increased Annual Growth Rate Sensitivity Analysis)
                                     Year
                               Hours per Report
                        Agency Cost per Report (2015$)
                           Total Number of Reportsa
                                     Total
                       Discounted Cost (Millions 2015$)




                                    Burden
                             Cost (Millions 2015$)
                               3% Discount Rate
                               7% Discount Rate
                                       1
                                    $6.38 
                                     $525 
                                     2,560
                                    16,331
                                    $1.34 
                                    $1.34 
                                    $1.34 
                                       2
                                    $6.38 
                                     $525 
                                      581
                                     3,707
                                    $0.30 
                                    $0.30 
                                    $0.29 
                                       3
                                    $6.38 
                                     $525 
                                      644
                                     4,109
                                    $0.34 
                                    $0.32 
                                    $0.30 
                                       4
                                    $6.38 
                                     $525 
                                      727
                                     4,639
                                    $0.38 
                                    $0.35 
                                    $0.31 
                                       5
                                    $6.38 
                                     $525 
                                      813
                                     5,189
                                    $0.43 
                                    $0.38 
                                    $0.33 
                                       6
                                    $6.38 
                                     $525 
                                      906
                                     5,783
                                    $0.48 
                                    $0.41 
                                    $0.34 
                                       7
                                    $6.38 
                                     $525 
                                     1,006
                                     6,418
                                    $0.53 
                                    $0.44 
                                    $0.35 
                                       8
                                    $6.38 
                                     $525 
                                     1,125
                                     7,181
                                    $0.59 
                                    $0.48 
                                    $0.37 
                                       9
                                    $6.38 
                                     $525 
                                     1,248
                                     7,964
                                    $0.66 
                                    $0.52 
                                    $0.38 
                                      10
                                    $6.38 
                                     $525 
                                     1,398
                                     8,917
                                    $0.73 
                                    $0.56 
                                    $0.40 
                                     Total
                                     63.80
                                       -
                                    11,009
                                    70,238
                                       -
                                       -
                                       -
                                                                Annualized Cost
                                    $0.54 
                                    $0.55 


Table 6-11: Total Social Costs for the Rule (Increased Annual Growth Rate Sensitivity Analysis)
                                     Year 
                                Burden (Hours)
                           Discounted Costs (2015$)


                               3 % Discount Rate
                               7 % Discount Rate

                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 
                                   Industry
                                    Agency
                                    Total 
                                       1
                                    360,371
                                    16,331
                                    376,702
                                    $27.80 
                                    $1.34 
                                    $29.15 
                                    $27.80 
                                    $1.34 
                                    $29.15 
                                       2
                                    81,733
                                     3,707
                                    85,440
                                    $6.12 
                                    $0.30 
                                    $6.42 
                                    $5.89 
                                    $0.29 
                                    $6.18 
                                       3
                                    90,645
                                     4,109
                                    94,754
                                    $6.59 
                                    $0.32 
                                    $6.91 
                                    $6.11 
                                    $0.30 
                                    $6.40 
                                       4
                                    102,321
                                     4,639
                                    106,960
                                    $7.22 
                                    $0.35 
                                    $7.57 
                                    $6.44 
                                    $0.31 
                                    $6.76 
                                       5
                                    114,542
                                     5,189
                                    119,732
                                    $7.85 
                                    $0.38 
                                    $8.23 
                                    $6.74 
                                    $0.33 
                                    $7.07 
                                       6
                                    127,637
                                     5,783
                                    133,419
                                    $8.49 
                                    $0.41 
                                    $8.90 
                                    $7.02 
                                    $0.34 
                                    $7.36 
                                       7
                                    141,605
                                     6,418
                                    148,023
                                    $9.15 
                                    $0.44 
                                    $9.59 
                                    $7.28 
                                    $0.35 
                                    $7.63 
                                       8
                                    158,410
                                     7,181
                                    165,590
                                    $9.94 
                                    $0.48 
                                    $10.42 
                                    $7.61 
                                    $0.37 
                                    $7.98 
                                       9
                                    175,833
                                     7,964
                                    183,797
                                    $10.71 
                                    $0.52 
                                    $11.23 
                                    $7.89 
                                    $0.38 
                                    $8.28 
                                      10
                                    196,821
                                     8,917
                                    205,738
                                    $11.64 
                                    $0.56 
                                    $12.20 
                                    $8.26 
                                    $0.40 
                                    $8.66 
                                     Total
                                   1,549,917
                                    70,238
                                   1,620,155
                                       
                                                               Annualized Costs
                                    $11.07 
                                    $0.54 
                                    $11.61 
                                    $4.28 
                                    $0.55 
                                    $11.90 

Number of Nanomaterials per Firm
Low and High-End Estimates for the Number of Nanomaterials per Firm
As described in Section 2.2.3, the median number of TSCA-related nanomaterials per firm is 12 (based on a subgroup of 19 firms), and after excluding those produced for R&D purposes (approximately 61 percent of all nanomaterials), EPA estimated 4.67 to be "commercially relevant" and therefore subject to the rule. The number of nanomaterials produced by the 19 businesses in the identified subgroup ranged from 1 to 66. As a sensitivity analysis, EPA has estimated industry and Agency burden associated with the 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 (see Table 6-12). Consistent with the main analysis, we continue to assume that there are 2.32 processors per nanomaterial, and that processors submit one report each.
Table 6-12: Estimated High- and Low-End Estimated Number of Commercially Relevant Nanomaterials per Manufacturer
                              Estimation Category
                            Nanomaterials per Firm
                             R&D Exclusion (%)
                             R&D Exclusion (#)
                   "Commercial" Nano-materials per Firma




                                  First Year
                               Subsequent Years
Low-end
                                       1
                                    61.11%
                                     0.61
                                     0.39
                                     0.04
High-end
                                      66
                                    61.11%
                                     40.33
                                     25.67
                                     2.85

Industry, Agency and Total Costs
Low-end estimates. Based on the number of firms and the burden estimates derived in Chapter 2 and Section 3.2, and using the low-end estimate of 0.39 reports in the first year and 0.04 in the subsequent years, the total manufacturer burden is 9,321 hours in the first year and 947 hours in future years, with an annualized cost of $0.14 million with a 3 percent discount rate ($0.15 with a 7 percent discount rate). The total processor burden is 21,101 hours in the first year, and 1,091 hours in future years, with an annualized cost of $0.31 million with a 3 percent discount rate ($0.34 with a 7 percent discount rate). Table 6-13 and Table 6-14 present the manufacturer and processor burden estimates, respectively, while Table 6-15 and Table 6-16 present the manufacturer and processor cost estimates.

Table 6-17 shows the Agency burden estimate of 1,363 hours in the first year and 140 hours each subsequent year, and the annualized cost of estimates of $0.02 million with a 3 percent discount rate ($0.02 million with a 7 percent discount rate).

Table 6-18 contains the total social costs and burden estimates. The total social burden is 61,045 hours over the ten year period, and the annualized cost is $0.46 million with a 3 percent discount rate and $0.51 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 manufacturer burden is 589,535 hours in the first year and 65,441 hours in each subsequent year, with an annualized cost of $8.9 million with a 3 percent discount rate ($9.77 with a 7 percent discount rate). The total processor burden is 1,388,874 hours in the first year, and 154,199 hours in future years, with an annualized cost of $20.96 million with a 3 percent discount rate ($23.01 with a 7 percent discount rate). Table 6-13 and Table 6-14 present the manufacturer and processor burden estimates, respectively, while Table 6-15 and Table 6-16 present the manufacturer and processor cost estimates. Table 6-17 presents the total Agency burden estimate of 89,716 hours in the first year and 9,961 hours in each subsequent year, and the annualized Agency cost estimate of $1.44 million with a 3 percent discount rate ($1.59 with a 7 percent discount rate). 
Table 6-18 contains the total social costs and burden of using the high-end estimate. The total social burden is 4.13 million hours over the ten year period, and the annualized cost is $31.3 million with a 3 percent discount rate and $34.37 million with a 7 percent discount rate. 

Table 6-13: Annual Manufacturer Burden Hours (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                            Number of Manufacturers
                               Reports per Firm
                    Rule Familiarization Burden (per Firm)
   Form Completion, CBI Substantiation and Recordkeeping Burden (per Report)
                    Electronic Reporting Burden (per Firm)d
                         Total Burden Per Manufacturer
                     Total Manufacturer Number of Reportsb
                           Total Manufacturer Burden


                                      Low
                                     High



                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      165
                                     0.39
                                     25.67
                                     0.82
                                      139
                                     1.42
                                     56.49
                                     3,573
                                      64
                                     4,236
                                     9,321
                                    589,535
                                       2
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       3
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       4
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       5
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       6
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       7
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       8
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                       9
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                      10
                                      165
                                     0.04
                                     2.85
                                     0.00
                                      139
                                     0.17
                                     5.74
                                      397
                                       7
                                      470
                                      947
                                    65,441
                                     Total
                                       -
                                     0.75
                                     51.32
                                       -
                                       -
                                       -
                                       -
                                       
                                      124
                                     8,468
                                    17,845
                                   1,178,501


Table 6-14: Annual Processor Burden Hours (Number of Nanomaterials Per Manufacturer Sensitivity Analysis)
                                     Year
                     Number of Processors per Nanomaterial
                             Number of Processors
                               Reports per Firm
                    Rule Familiarizationc Burden (per Firm)
   Form Completion, CBI Substantiation and Recordkeeping Burden (per Report)
                 Electronic Reporting Requirements (per Firm)d
                          Total Burden Per Processor
                      Total Processor Number of Reportsb
                            Total Processor Burden


                                      Low
                                     High





                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                      149
                                     9,826
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      149
                                     9,826
                                    21,101
                                   1,388,874
                                       2
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       3
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       4
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       5
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       6
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       7
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       8
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                       9
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                      10
                                     2.32
                                      15
                                     1,091
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      15
                                     1,091
                                     2,164
                                    154,199
                                     Total
                                       -
                                      287
                                    19,645
                                       
                                      287
                                    19,645
                                    40,579
                                   2,776,666


Table 6-15: Annual Manufacturer Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                                Number of Firms
                               Reports per Firm
                     Rule Familiarization Cost (per Firm) 
                                    (2015$)
Form Completion, CBI Substantiation and Recordkeeping Burden Cost (per Report)[b] (2015$)
                 Electronic Reporting Costs (per Firm) (2015$)
                          Total Cost Per Manufacturer
                     Total Number of Manufacturer Reports
                            Total Manufacturer Cost
                                (Millions 2015$)


                                      Low
                                     High



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











                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      165
                                     0.39
                                     25.67
                                    $63.66
                                    $10,730
                                    $110.31
                                    $4,359
                                   $275,624
                                      64
                                     4,236
                                    $0.72 
                                    $45.48
                                     $0.72
                                    $45.48
                                       2
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.07 
                                     $4.90
                                     $0.07
                                     $4.72
                                       3
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.07 
                                     $4.76
                                     $0.06
                                     $4.41
                                       4
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.07 
                                     $4.62
                                     $0.06
                                     $4.12
                                       5
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06 
                                     $4.49
                                     $0.06
                                     $3.85
                                       6
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06 
                                     $4.35
                                     $0.05
                                     $3.60
                                       7
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06 
                                     $4.23
                                     $0.05
                                     $3.36
                                       8
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06 
                                     $4.10
                                     $0.05
                                     $3.14
                                       9
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06 
                                     $3.99
                                     $0.04
                                     $2.94
                                      10
                                      165
                                     0.04
                                     2.85
                                     $0.00
                                    $10,730
                                    $13.41
                                     $443
                                    $30,595
                                       7
                                      470
                                    $0.06 
                                     $3.87
                                     $0.04
                                     $2.75
Total
-
                                     0.75
                                     51.32
                                       
                                      124
                                     8,468
                                       
                                       
                                       
                                       
                                                                Annualized Cost
                                    $0.14 
                                    $8.90 
                                    $0.15 
                                    $9.77 



Table 6-16: Annual Processor Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                     Number of Processors per Nanomaterial
                             Number of Processors
                               Reports per Firm
                Rule Familiar-ization  Cost (per Firm) (2015$)
Form Completion, CBI Substantiation and Recordkeeping Burden Cost (per Report) (2015$)
             Electronic Reporting Requirements (per Firm) (2015$)
                           Total Cost Per Processor
                       Total Processor Number of Reports
                    Total Processor Cost 
(Millions 2015$)


                                      Low
                                     High





                                      Low
                                     High
                               3% Discount Rate 
                               7% Discount Rate 











                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                      149
                                     9,826
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      149
                                     9,826
                                    $1.63 
                                   $107.15 
                                     $1.63
                                    $107.15
                                       2
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.16 
                                    $11.55 
                                     $0.16
                                    $11.12
                                       3
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.16 
                                    $11.21 
                                     $0.15
                                    $10.39
                                       4
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.15 
                                    $10.89 
                                     $0.14
                                     $9.71
                                       5
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.15 
                                    $10.57 
                                     $0.13
                                     $9.08
                                       6
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.14 
                                    $10.26 
                                     $0.12
                                     $8.48
                                       7
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.14 
                                    $9.96 
                                     $0.11
                                     $7.93
                                       8
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.14 
                                    $9.67 
                                     $0.10
                                     $7.41
                                       9
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.13 
                                    $9.39 
                                     $0.10
                                     $6.92
                                      10
                                     2.32
                                      15
                                     1,091
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                      15
                                     1,091
                                    $0.13 
                                    $9.12 
                                     $0.09
                                     $6.47
                                     Total
                                       -
                                      287
                                    19,645
                                       
                                      287
                                    19,645
                                       
Annualized Cost
                                    $0.31 
                                    $20.96 
                                    $0.34 
                                    $23.01 


Table 6-17: Agency Cost Estimate for the Rule (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                               Hours per Report
                            Agency Cost per Report 
                           Total Number of Reportsa
                                 Total Burden
                       Discounted Cost (Millions 2015$)





                               3% Discount Rate
                               7% Discount Rate



                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     6.38
                                     $525 
                                      214
                                    14,062
                                     1,363
                                    89,716 
                                    $0.112 
                                    $7.38 
                                    $0.112 
                                    $7.38 
                                       2
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.011 
                                    $0.80 
                                    $0.011 
                                    $0.77 
                                       3
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.011 
                                    $0.77 
                                    $0.010 
                                    $0.72 
                                       4
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.011 
                                    $0.75 
                                    $0.009 
                                    $0.67 
                                       5
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.010 
                                    $0.73 
                                    $0.009 
                                    $0.63 
                                       6
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.010 
                                    $0.71 
                                    $0.008 
                                    $0.58 
                                       7
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.010 
                                    $0.69 
                                    $0.008 
                                    $0.55 
                                       8
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.009 
                                    $0.67 
                                    $0.007 
                                    $0.51 
                                       9
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.009 
                                    $0.65 
                                    $0.007 
                                    $0.48 
                                      10
                                     6.38
                                     $525 
                                      22
                                     1,561
                                      140
                                    9,961 
                                    $0.009 
                                    $0.63 
                                    $0.006 
                                    $0.45 
                                     Total
                                     63.80
                                       -
                                      411
                                    28,113
                                     2,621
                                    179,362
                                       -
                                       
                                       
                                       -
                                                                Annualized Cost
                                    $0.02 
                                    $1.44 
                                    $0.02 
                                    $1.59 


Table 6-18: Total Social Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                                Burden (Hours)
                       Discounted Costs (Millions 2015$)


                               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
                                    30,422
                                   1,978,409
                                     1,363
                                    89,716
                                    31,785
                                   2,068,125
                                    $2.35 
                                    $152.6 
                                    $0.11 
                                    $7.38 
                                     $2.46
                                    $160.0
                                    $2.35 
                                    $152.6 
                                    $0.11 
                                    $7.38 
                                     $2.46
                                    $160.01
                                       2
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.23 
                                    $16.45 
                                    $0.01 
                                    $0.80 
                                     $0.24
                                    $17.25
                                    $0.22 
                                    $15.84 
                                    $0.01 
                                    $0.77 
                                     $0.24
                                    $16.60
                                       3
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.23 
                                    $15.97 
                                    $0.01 
                                    $0.77 
                                     $0.24
                                    $16.74
                                    $0.21 
                                    $14.80 
                                    $0.01 
                                    $0.72 
                                     $0.22
                                    $15.52
                                       4
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.22 
                                    $15.51 
                                    $0.01 
                                    $0.75 
                                     $0.23
                                    $16.26
                                    $0.20 
                                    $13.83 
                                    $0.01 
                                    $0.67 
                                     $0.21
                                    $14.50
                                       5
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.21 
                                    $15.06 
                                    $0.01 
                                    $0.73 
                                     $0.22
                                    $15.78
                                    $0.18 
                                    $12.93 
                                    $0.01 
                                    $0.63 
                                     $0.19
                                    $13.55
                                       6
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.21 
                                    $14.62 
                                    $0.01 
                                    $0.71 
                                     $0.22
                                    $15.32
                                    $0.17 
                                    $12.08 
                                    $0.01 
                                    $0.58 
                                     $0.18
                                    $12.67
                                       7
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.20 
                                    $14.19 
                                    $0.01 
                                    $0.69 
                                     $0.21
                                    $14.88
                                    $0.16 
                                    $11.29 
                                    $0.01 
                                    $0.55 
                                     $0.17
                                    $11.84
                                       8
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.20 
                                    $13.78 
                                    $0.01 
                                    $0.67 
                                     $0.20
                                    $14.44
                                    $0.15 
                                    $10.55 
                                    $0.01 
                                    $0.51 
                                     $0.16
                                    $11.06
                                       9
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.19 
                                    $13.38 
                                    $0.01 
                                    $0.65 
                                     $0.20
                                    $14.02
                                    $0.14 
                                    $9.86 
                                    $0.01 
                                    $0.48 
                                     $0.15
                                    $10.34
                                      10
                                     3,111
                                    219,640
                                      140
                                     9,961
                                     3,251
                                    229,600
                                    $0.18 
                                    $12.99 
                                    $0.01 
                                    $0.63 
                                     $0.19
                                    $13.61
                                    $0.13 
                                    $9.22 
                                    $0.01 
                                    $0.45 
                                     $0.14
                                     $9.66
                                     Total
                                    58,423
                                   3,955,167
                                     2,621
                                    179,362
                                    61,045
                                   4,134,529
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                       -
                                                               Annualized Costs
                                    $0.44 
                                    $29.86 
                                    $0.02 
                                    $1.44 
                                    $0.46 
                                    $31.30 
                                    $0.49 
                                    $32.78 
                                    $0.02 
                                    $1.59 
                                    $0.51 
                                    $34.37 

Annual Nanomaterials Growth Rate
Low and High-End Estimates in the Growth Rate of the Number Nanomaterials per Manufacturer
The main analysis presented in this report assumes that the number of nanomaterials reported per manufacturer 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 12 nanomaterials in year 1 and report on the 4.67 commercially relevant nanomaterials subject to the rule. 
   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 0.26 additional reports per manufacturer each year, for a total of 7.01 reports over the 10 year period.
   High-end estimates. Assuming the number of nanomaterials per firm quadruples over the next 10 years, approximately 1.56 manufacturer reports will be submitted every year after year 1, for a total of 18.68 reports over the 10-year period.
Consistent with the main analysis, we continue to assume that there are 2.32 processors per nanomaterial, and that processors submit one report each.
Industry, Agency and Total Costs 
Low-end estimates. As indicated in Table 6-19 and Table 6-21, manufacturers will incur a labor burden of 107,554 hours in the first year and 5,983 hours in each subsequent year and the annualized cost will be $1.25 million with 3 percent discount rate ($1.41 million with a 7 percent discount rate). As shown in Table 6-20 and Table 6-22, processors will incur a labor burden of 252,670 hours in the first year and 14,037 hours in each subsequent year and the annualized cost will be $2.93 million with 3 percent discount rate ($3.31 million with a 7 percent discount rate). 

Table 6-23 contains the total Agency burden and cost under this scenario; 16,321 hours in the first year and 907 hours in each subsequent year and an annualized cost of $0.20 million with a 3 percent discount rate and $0.23 million with a 7 percent discount rate. 
The combined industry and Agency burden of this scenario is 564,887 hours over the 10-year period with an annualized social cost of $4.38 million with a 3 percent discount rate and $4.95 with a 7 percent discount rate. The total social costs are presented in Table 6-24.
High-end estimates. As shown in Table 6-19 and Table 6-21, manufacturers are estimated to incur a labor burden of 107,554 hours in the first year 35,757 hours in each subsequent year. The annualized costs of this scenario are approximately $3.12 million with a 3 percent discount rate and $3.27 million with a 7 percent discount rate. As indicated in Table 6-20 and Table 6-22, processors will incur a labor burden of 252,670 hours in the first year and 84,223 hours in each subsequent year and the annualized cost will be $7.35 million with 3 percent discount rate ($7.71 million with a 7 percent discount rate).
Table 6-23 presents the Agency burden and costs estimates of this scenario. The Agency burden is estimate to be 16,321 hours in the first year and 5,440 hours in each subsequent year. The annualized cost is $0.51 million with a 3 percent discount rate and $0.53 million with a 7 percent discount rate. 
The total social burden of this scenario is presented in Table 6-24 and is 1.51 million hours over the 10-year period with an annualized social cost of $10.98 million with a 3 percent discount rate and $11.51 million with a 7 percent discount rate.

Table 6-19: Annual Manufacturer Burden Hours (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                                Number of Firms
                               Reports per Firm
                    Rule Familiarization Burden (per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                 Electronic Reporting Requirements (per Firm)
                             Total Burden Per Firm
                       Total Industry Number of Reports
                             Total Industry Burden


                                      Low
                                     High



                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      165
                                     4.67
                                     4.67
                                     0.82
                                      139
                                     1.42
                                    651.84
                                      652
                                      771
                                      771
                                    107,554
                                    107,554
                                       2
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       3
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       4
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       5
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       6
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       7
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       8
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                       9
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                      10
                                      165
                                     0.26
                                     1.56
                                     0.00
                                      139
                                     0.17
                                     36.26
                                      217
                                      43
                                      257
                                     5,983
                                    35,757
                                     Total
                                       -
                                     7.01
                                     18.68
                                       -
                                       -
                                       -
                                       -
                                       
                                     1,156
                                     3,082
                                    161,400
                                    429,368
 

Table 6-20: Annual Processor Burden Hours (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                     Number of Processors per Nanomaterial
                             Number of Processors
                          Number of Reports per Firm
                    Rule Familiarizationc Burden (per Firm)
  Form Completion, CBI Substantiation, and Recordkeeping Burden (per Report)
                    Electronic Reporting Burden (per Firm)
                          Total Burden Per Processor
                       Total Number of Processor Reports
                            Total Processor Burden


                                      Low
                                     High





                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                     1,788
                                     1,788
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                     1,788
                                     1,788
                                    252,670
                                    252,670
                                       2
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       3
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       4
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       5
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       6
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       7
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       8
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                       9
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                      10
                                     2.32
                                      99
                                      596
                                       1
                                     0.82
                                      139
                                     1.42
                                    141.34
                                      99
                                      596
                                    14,037
                                    84,223
                                     Total
                                       -
                                     2,682
                                     7,151
                                       
                                       -
                                       -
                                       -
                                       -
                                     2,682
                                     7,151
                                    379,005
                                   1,010,681


Table 6-21: Annual Manufacturer Labor Costs (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                              Number of Firms[a]
                              Reports per Firm[b]
                Rule Familiarization Cost (per Firm)[b] (2015$)
Form Completion, CBI Substantiation and Recordkeeping Cost (per Report)[b] (2015$)
            Electronic Reporting Requirements (per Firm)[b] (2015$)
                             Total Burden Per Firm
                      Total Industry Number of Reports[b]
                     Total Industry Cost (Millions 2015$)


                                      Low
                                     High



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











                                      Low
                                     High
                                      Low
                                     High
                                       1
                                      165
                                     4.67
                                     4.67
                                    $63.66
                                    $10,730
                                    $110.31
                                    $50,285
                                    $50,285
                                      771
                                      771
                                    $8.30 
                                     $8.30
                                     $8.30
                                     $8.30
                                       2
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.45 
                                     $2.68
                                     $0.43
                                     $2.58
                                       3
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.44 
                                     $2.60
                                     $0.40
                                     $2.41
                                       4
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.42 
                                     $2.52
                                     $0.38
                                     $2.25
                                       5
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.41 
                                     $2.45
                                     $0.35
                                     $2.10
                                       6
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.40 
                                     $2.38
                                     $0.33
                                     $1.97
                                       7
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.39 
                                     $2.31
                                     $0.31
                                     $1.84
                                       8
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.38 
                                     $2.24
                                     $0.29
                                     $1.72
                                       9
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.36 
                                     $2.18
                                     $0.27
                                     $1.61
                                      10
                                      165
                                     0.26
                                     1.56
                                     $0.00
                                    $10,730
                                    $13.41
                                    $2,797
                                    $16,717
                                      43
                                      257
                                    $0.35 
                                     $2.11
                                     $0.25
                                     $1.50
                                     Total
                                       -
                                     7.01
                                     18.68
                                       
                                     1,156
                                     3,082
                                       
                                                              Annualized Costs 
                                    $1.25 
                                    $3.12 
                                    $1.41 
                                    $3.27 
 

Table 6-22: Annual Processor Labor Costs (Number of Nanomaterials Per Firm Sensitivity Analysis)
                                     Year
                    Number of Processors per Nano-material
                             Number of Processors
                               Reports per Firm
                 Rule Familiar-ization Cost (per Firm) (2015$)
Form Completion, CBI Substantiation and Record-keeping Burden Cost (per Report)b (2015$)
                 Electronic Reporting Costs (per Firm) (2015$)
                           Total Cost Per Processor
                          Discounted Cost (per firm)
                      Total Processor Number of Reportsb
                     Total Processor Cost (Millions 2015$)


                                      Low
                                     High





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













                                      Low
                                     High
                                      Low
                                     High
                                       1
                                     2.32
                                     1,788
                                     1,788
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                   $10,904 
                                   $10,904 
                                     1,788
                                     1,788
                                    $19.49 
                                    $19.49 
                                    $19.49
                                    $19.49
                                       2
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                   $10,587 
                                   $10,191 
                                      99
                                      596
                                    $1.05 
                                    $6.31 
                                     $1.01
                                     $6.07
                                       3
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                   $10,278 
                                    $9,524 
                                      99
                                      596
                                    $1.02 
                                    $6.12 
                                     $0.95
                                     $5.68
                                       4
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,979 
                                    $8,901 
                                      99
                                      596
                                    $0.99 
                                    $5.95 
                                     $0.88
                                     $5.30
                                       5
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,688 
                                    $8,319 
                                      99
                                      596
                                    $0.96 
                                    $5.77 
                                     $0.83
                                     $4.96
                                       6
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,406 
                                    $7,775 
                                      99
                                      596
                                    $0.93 
                                    $5.61 
                                     $0.77
                                     $4.63
                                       7
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $9,132 
                                    $7,266 
                                      99
                                      596
                                    $0.91 
                                    $5.44 
                                     $0.72
                                     $4.33
                                       8
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $8,866 
                                    $6,791 
                                      99
                                      596
                                    $0.88 
                                    $5.28 
                                     $0.67
                                     $4.05
                                       9
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $8,608 
                                    $6,346 
                                      99
                                      596
                                    $0.85 
                                    $5.13 
                                     $0.63
                                     $3.78
                                      10
                                     2.32
                                      99
                                      596
                                       1
                                    $63.66
                                    $10,730
                                    $110.31
                                    $10,904
                                    $8,357 
                                    $5,931 
                                      99
                                      596
                                    $0.83 
                                    $4.98 
                                     $0.59
                                     $3.53
                                     Total
                                       -
                                     2,682
                                     7,151
                                       
                                     2,682
                                     7,151
                                       
                                                                Annualized Cost
                                   $10,053 
                                    $8,599 

                                    $2.93 
                                    $7.35 
                                    $3.31 
                                    $7.71 


Table 6-23: Agency Cost Estimate for the Rule  (Nanomaterials Growth Sensitivity Analysis)
                                     Year
                               Hours per Report
                            Agency Cost per Report 
                           Total Number of Reportsa
                                 Total Burden
                       Discounted Cost (Millions 2015$)





                               3% Discount Rate
                               7% Discount Rate



                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                      Low
                                     High
                                       1
                                    $6.38 
                                     $525 
                                     2,558
                                     2,558
                                    16,321
                                    16,321
                                    $1.34 
                                    $1.34 
                                    $1.34 
                                    $1.34 
                                       2
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07 
                                    $0.43 
                                    $0.07 
                                    $0.42 
                                       3
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07 
                                    $0.42 
                                    $0.07 
                                    $0.39 
                                       4
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07 
                                    $0.41 
                                    $0.06 
                                    $0.37 
                                       5
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.07 
                                    $0.40 
                                    $0.06 
                                    $0.34 
                                       6
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06 
                                    $0.39 
                                    $0.05 
                                    $0.32 
                                       7
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06 
                                    $0.37 
                                    $0.05 
                                    $0.30 
                                       8
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06 
                                    $0.36 
                                    $0.05 
                                    $0.28 
                                       9
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06 
                                    $0.35 
                                    $0.04 
                                    $0.26 
                                      10
                                    $6.38 
                                     $525 
                                      142
                                      853
                                      907
                                     5,440
                                    $0.06 
                                    $0.34 
                                    $0.04 
                                    $0.24 
                                     Total
                                     63.80
                                       -
                                     3,837
                                    10,233
                                    24,482
                                    65,286
                                       -
                                       
                                       
                                       -
                                                                Annualized Cost
                                    $0.20 
                                    $0.51 
                                    $0.23 
                                    $0.53 


Table 6-24: Total Social Costs (Nanomaterials Growth Sensitivity Analysis)
                                     Year 
                                Burden (Hours)
                       Discounted Costs (Millions 2015$)


                               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
                                    360,224
                                    360,224
                                    16,321
                                    16,321
                                    376,545
                                    376,545
                                    $27.8 
                                    $27.8 
                                    $1.34 
                                    $1.34 
                                    $29.13
                                    $29.13
                                    $27.8 
                                    $27.8 
                                    $1.34 
                                    $1.34 
                                    $29.13
                                    $29.13
                                       2
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.50 
                                    $8.99 
                                    $0.07 
                                    $0.43 
                                     $1.57
                                     $9.42
                                    $1.44 
                                    $8.65 
                                    $0.07 
                                    $0.42 
                                     $1.51
                                     $9.07
                                       3
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.46 
                                    $8.72 
                                    $0.07 
                                    $0.42 
                                     $1.53
                                     $9.15
                                    $1.35 
                                    $8.08 
                                    $0.07 
                                    $0.39 
                                     $1.41
                                     $8.48
                                       4
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.41 
                                    $8.47 
                                    $0.07 
                                    $0.41 
                                     $1.48
                                     $8.88
                                    $1.26 
                                    $7.56 
                                    $0.06 
                                    $0.37 
                                     $1.32
                                     $7.92
                                       5
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.37 
                                    $8.22 
                                    $0.07 
                                    $0.40 
                                     $1.44
                                     $8.62
                                    $1.18 
                                    $7.06 
                                    $0.06 
                                    $0.34 
                                     $1.24
                                     $7.40
                                       6
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.33 
                                    $7.98 
                                    $0.06 
                                    $0.39 
                                     $1.40
                                     $8.37
                                    $1.10 
                                    $6.60 
                                    $0.05 
                                    $0.32 
                                     $1.15
                                     $6.92
                                       7
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.29 
                                    $7.75 
                                    $0.06 
                                    $0.37 
                                     $1.36
                                     $8.13
                                    $1.03 
                                    $6.17 
                                    $0.05 
                                    $0.30 
                                     $1.08
                                     $6.47
                                       8
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.26 
                                    $7.53 
                                    $0.06 
                                    $0.36 
                                     $1.32
                                     $7.89
                                    $0.96 
                                    $5.76 
                                    $0.05 
                                    $0.28 
                                     $1.01
                                     $6.04
                                       9
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.22 
                                    $7.31 
                                    $0.06 
                                    $0.35 
                                     $1.28
                                     $7.66
                                    $0.90 
                                    $5.39 
                                    $0.04 
                                    $0.26 
                                     $0.94
                                     $5.65
                                      10
                                    20,020
                                    119,981
                                      907
                                     5,440
                                    20,927
                                    125,421
                                    $1.18 
                                    $7.09 
                                    $0.06 
                                    $0.34 
                                     $1.24
                                     $7.44
                                    $0.84 
                                    $5.03 
                                    $0.04 
                                    $0.24 
                                     $0.88
                                     $5.28
                                     Total
                                    540,405
                                    1.44 M
                                    24,482
                                    65,286
                                    564,887
                                    1.51 M
                                       
                                                               Annualized Costs
                                    $4.18 
                                     $10.5
                                    $0.20 
                                    $0.51 
                                    $4.38 
                                    $10.98 
                                    $4.72 
                                    $11.0 
                                    $0.23 
                                    $0.53 
                                    $4.95 
                                    $11.51 

Summary of all Analyses
Table 6-25 presents a summary of the costs and assumptions of the sensitivity analyses. As shown in the table, the total annualized industry costs range from $0.44 million per year (with a three percent discount rate) with the assumption that a manufacturer submits an average of 0.39 reports in the first year, to $29.86 million per year (with a three percent discount rate) under the assumption a firm submits an average of 25.67 reports in the first year. This would suggest that the cost estimates are more sensitive to the number of reports submitted in the first year, than to increased costs in subsequent years (either through the growth in the number of nanomaterials or the number firms subject to the rule). 
Table 6-25: Comparison of Annualized Costs of Sensitivity Analyses (Millions 2015$)
                                   Scenario
                     Annualized Costs at 3% discount rate
                     Annualized Costs at 7% discount rate
                                       
                                   Industry
                                    Agency
                                     Total
                                   Industry
                                    Agency
                                     Total
Main Analysis 
                                    $5.44 
                                    $0.26 
                                    $5.71 
                                    $5.98 
                                    $0.29 
                                    $6.26 
Change in Number of Firms (Section 6.1) -- Low End
                                    $2.75 
                                    $0.13 
                                    $2.88 
                                    $3.02 
                                    $0.15 
                                    $3.17 
Change in Number of Firms (Section 6.1) -- High End
                                    $10.39 
                                    $0.22 
                                    $10.89 
                                    $11.40 
                                    $0.16 
                                    $11.96 
 Annual Industry Growth Rate of 11.6 percent (Section 6.2)
                                    $11.07 
                                    $0.54 
                                    $11.61 
                                    $4.28 
                                    $0.55 
                                    $11.90 
Change in Number of Nanomaterials per Firm in Year 1 (Section 6.3) -- Low End
                                    $0.44 
                                    $0.02 
                                    $0.46 
                                    $0.49 
                                    $0.02 
                                    $0.51 
Change in Number of Nanomaterials per Firm in Year 1 (Section 6.3) --High End
                                    $29.86 
                                    $1.44 
                                    $31.30 
                                    $32.78 
                                    $1.59 
                                    $34.37 
Change in nanomaterial growth rate (Section 6.4) -- 50% in 10 years
                                    $4.18 
                                    $0.20 
                                    $4.38 
                                    $4.72 
                                    $0.23 
                                    $4.95 
Change in nanomaterial growth rate (Section 6.4) -- 400% in 10 years
                                    $10.48 
                                    $0.51 
                                    $10.98 
                                    $10.98 
                                    $0.23 
                                    $11.51 


  -  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 evaluate any 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 rule are discussed qualitatively in this section. Quantification of the benefits of the 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 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 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 rule may be produced below what is optimal for society. 
Benefits of Information-Based Policies
The 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 rule will benefit society by filling these information gaps and contributing to better assessments of potential risks and risk management decisions.
The 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 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 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 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 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 rule are discussed in the following sections.

Potential Users of Information Generated by the Rule
EPA is expected to be the primary user of the information generated by the 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 non-confidential 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 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 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 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 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 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 rule to identify chemicals with large numbers of potentially exposed workers or with uses that suggest greater exposure potential. The information provided by the 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 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 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 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 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 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 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 and processing have not been assigned distinct NAICS codes under the most recent classification system, NAICS 2012. This analysis therefore applies the SBA small business definitions to the subset of 19 identified nanomaterials companies described in Section 2.2 to the NAICS listed for the global parent company of each company as listed in the Dun & Bradstreet 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 rule requirements. According to this definition, which was adapted from the standard TSCA definition provided in 40 CFR 704.3, a manufacturer or processor 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 $11 million. The second definition, which is used only in this chapter, is based on the small business definitions established by the SBA for the various industries (SBA, 2016). As described in Chapter 2, 19 companies in the subset were considered under the rule's definition of small to be "large" (i.e. not small) companies (with greater than $11 million in revenue), and therefore, subject to the rule. 
To determine the percent of the manufacturers subject to the rule that would be considered small under SBA size standards, the small business thresholds for the 19 companies in the subset were identified. For companies for which Dun and Bradstreet did not provide a current parent company NAICS code, EPA researched the company website or determined, based on best professional judgement, the appropriate NAICS category. The ultimate parent NAICS codes and corresponding small business size standards are shown in Table 8-1.
Table 8-1: Ultimate Parent NAICS Codes for the 19 "Large" Businesses in Subset
                          Ultimate Parent NAICS Code
                                  Description
                                Number of Firms
                        Small Business Threshold (2016)
                                    331313
Alumina Refining and Primary Aluminum Production
                                       1
                           Less than 1,000 employees
                                    325120
Industrial Gas Manufacturing
                                       1
                           Less than 1,000 employees
                                    325199
All Other Basic Organic Chemical Manufacturing  
                                       1
                           Less than 1,250 employees
                                    325510
Paint and Coating Manufacturing
                                       1
                           Less than 1,000 employees
                                    325998
All Other Miscellaneous Chemical Product and Preparation Manufacturing
                                       2
                            Less than 500 employees
                                    332812
Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to Manufacturers
                                       1
                            Less than 500 employees
                                    333249
Other Industrial Machinery Manufacturing
                                       1
                            Less than 500 employees
                                    333515
Cutting Tool and Machine Tool Accessory Manufacturing
                                       1
                            Less than 500 employees
                                    334516
Analytical Laboratory Instrument Manufacturing
                                       1
                           Less than 1,000 employees
                                    335991
Carbon and Graphite Product Manufacturing
                                       1
                            Less than 750 employees
                                    336390
Other Motor Vehicle Parts Manufacturing
                                       1
                           Less than 1,000 employees
                                    423450
Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
                                       1
                            Less than 200 employees
                                    541330
Engineering Services
                                       2
                       Less than $15,000,000 in revenue
                                    541712
Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) 11
                                       1
                           Less than 1,000 employees
                                    551112
Offices of Other Holding Companies
                                       1
                       Less than $20,500,000 in revenue
                                    331313
Alumina Refining and Primary Aluminum Production
                                       1
                           Less than 1,000 employees
                                    325120
Industrial Gas Manufacturing
                                       1
                           Less than 1,000 employees
Note: NAICS codes, descriptions are based on the 2012 NAICS 
Source: D&B, 2016; SBA, 2016

Estimate the Number of Small Businesses
To estimate the total number firms that are subject to the rule and considered small under SBA size standards, EPA considered the subset of companies described above to determine the percentage that meet the SBA size definition, based on employment and sales data from Dun and Bradstreet. EPA then applied these percentages to the total estimate of regulated firms.
Of the 19 nanomaterials manufacturers and parent companies in the subset that are subject to the rule, 4 companies (21 percent) meet the SBA small business definitions for their respective NAICS classifications, and 15 companies (79 percent) do not meet the SBA small business definitions. These results are provided in Table 8-2. Note that all of these companies are considered "large" businesses under the rule definition of small business (greater than $11 million in annual revenue).
Table 8-2: Small Business and Large Business Characteristics of Subset
                              Population Category
                           Number of Firms in Subset
                               Percent of Subset
Small Businesses
                                       4
                                      21%
Large Businesses
                                      15
                                      79%
Total
                                      19
                                     100%
Source: D&B, 2016; Lux Research, 2007; Nanowerk, 2009.

For purposes of this economic analysis, we assume that the proportion of small businesses is the same for processors as it is for manufacturers. Multiplying the percent of U.S.-based nanomaterials firms in the subset that meet the SBA small business definitions (21 percent) by the previously estimated number of U.S.-based nanomaterials firms subject to the rule (see Table 2-5) yields an estimate of around 411 nanomaterials firms in the first year and 77 firms in subsequent years that meet SBA criteria for being considered "small" businesses. All of these companies would be considered large businesses under the rule definition of small business.
Table 8-3: Estimated Number of Regulated Firms
                              Population Category
                     Percent of Population that are Small
                   Estimated. Number of Nanomaterial Firms 


                                  First Year
                               Subsequent Years
Manufacturers
                                      21%
                                      35
                                      35
Processors
                                      21%
                                      376
                                      42
Total Firms
                                       -
                                      411
                                      77
Source: BCC Research, 2006; D&B, 2016.

Estimate the Cost-to-Sales Ratio for Small Companies
As indicated in Table 3-13, the total cost of the rule over the 10-year analysis period is $5.44 million with a 3 percent discount rate and $5.98 million with a 7 percent discount rate. On a per-firm basis, annualized costs for manufacturers are approximately $9,846 with a 3 percent discount rate and $10,809 with a 7 percent discount rate, and for processors annualized costs are approximately $10,053 with a 3 percent discount rate and $10,214 with a 7 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 the economic impacts faced by the small entities. Therefore, to determine the magnitude of any potential adverse impact of the rule on small entities, annualized per-company compliance costs were compared to annual sales.
Given the expected annualized per-company costs for manufacturers, a 1 percent-of-sales threshold for economic impact equates to annualized sales thresholds of approximately $984,607 to $1,080,876; in other words, in order for the compliance cost to exceed one percent of sales, sales must be less than these values. Similarly, 3 percent-of-sales thresholds for economic impact range from approximately $328,202 to $360,292. These equivalences, and those for processors, are show in Table 8-4.

Table 8-4: Characterization of Economic Impacts
                             Economic Impact Type
                           Cost-to-Sales Percentage
                       Equivalent Sales Dollar Threshold


                                    (2015$)


                                Annualized (3%)
                                Annualized (7%)
Manufacturers
                                 Higher Impact
                                    > 3%
                                 < $328,202
                                 < $360,292
                                 Lower Impact
                                   1% to 3%
                           $328,202 to > $984,607
                            $360,292 to $1,080,876
                              Less than 1% Impact
                                    < 1%
                                 > $984,607
                                > $1,080,876
Processors
                                 Higher Impact
                                    > 3%
                                 < $335,100
                                 < $340,450
                                 Lower Impact
                                   1% to 3%
                            $335,100 to $1,005,299
                            $340,450 to $1,021,351
                              Less than 1% Impact
                                    < 1%
                                > $1,005,299
                                > $1,021,351

D&B data for the 4 small businesses (by SBA definitions) identified among the 19 companies in the 95-company subset of U.S.-based nanomaterials firms (with D&B sales data) subject to the 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 411 small businesses. Table 8-5 summarizes the estimated cost impacts for the subset of small business, and applies these percentages to estimate impacts to the estimated 411 impacted small businesses. As indicated, all 4 small businesses (100 percent) from the subset, and thus all small businesses in the estimated 411 subject to the rule, are expected to experience an impact of less than one percent of sales. 
EPA notes that at based on estimated rule costs and sales thresholds as summarized in Table 8-5, no firms subject to the rule (manufacturers or processors) would be impacted at greater than 1 percent, because companies with sales revenue less than $11 million per year are exempt from the rule. 
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%
Lower Impact
                                   1% to 3%
                                       0
                                      0%
                                       0
                                      0%
                                       0
                                      0%
Less than 1% Impact
                                    < 1%
                                       4
                                     100%
                                       4
                                     100%
                                      411
                                     100%
Total
                                      --
                                       4
                                     100%
                                       4
                                     100%
                                      411
                                     100%
Source: D&B, 2009; EPA, 2009a.
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. However, in EPA's judgment, no companies are expected to experience a prohibitive cost or burden under the rule.
Appendix B presents a sensitivity analysis for the cost-to-sales ratio based on the number of nanomaterials produced.


  -  Other Impact Analyses
Several statutes and executive orders (EOs) pertain to the rule. This chapter presents statements discussing paperwork reduction, unfunded mandates, regulatory planning and review, tribal governments, children's health, and environmental justice, among others.
Employment Impact Analysis
While a standalone analysis of employment impacts is not included in a standard cost-benefit analysis, EPA typically examines employment impacts for regulations promulgated under TSCA. Executive Order 13563 states, "Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation" (emphasis added). For this rule, EPA presents a qualitative assessment of the potential for employment impacts in the short and long term for firms that might be directly or indirectly affected by the rule. 
Regulatory employment impacts are difficult to disentangle from other economic changes affecting employment decisions that occur over the timeframe of analysis and across affected regions and industries. Labor market responses to regulation are complex. They depend on labor demand and supply elasticities and possible labor market imperfections (e.g. wage stickiness, structural unemployment, etc.). The observability of an employment response may depend on the unit of measurement. Possible measured units include the number of jobs, job years, types of job, hours worked, and earnings. Net employment impacts are composed of a mix of potential declines and gains in different areas of the economy including the directly regulated sector, the environmental protection sector, upstream and downstream sectors, and ultimately all affected sectors. In light of these complexities, economic theory provides a constructive framework for analysis. The theory is explained below, followed by a quick summary of empirical findings in the rapidly expanding literature relevant to employment effects of environmental regulation. The final subsections present qualitative assessments of the employment impacts of the current rulemaking.
Theory
Microeconomic theory describes how firms adjust their use of inputs in response to changes in economic conditions. Labor is one of many inputs to production, along with capital, energy, and materials. In competitive markets, firms choose inputs and outputs to maximize profit as a function of market prices and technological constraints.[,] Berman and Bui (2001) adapt this model to analyze how environmental regulations affect the quantity of labor demanded by regulated firms. They model environmental regulation as effectively requiring certain factors of production, such as pollution abatement capital, at levels that firms would not otherwise choose. Berman and Bui (2001) model two components that drive changes in firm-level labor demand: output effects and substitution effects. Regulation affects the profit-maximizing quantity of output by changing the marginal cost of production. If a regulation causes marginal cost to increase, it will place upward pressure on output prices, leading to a decrease in demand for output, and resulting in a decrease in production. The output effect describes how, holding labor intensity constant, a decrease in production causes a decrease in labor demand. As noted by Berman and Bui, although many assume that regulations must increase marginal cost, it need not be the case. A regulation could induce a firm to upgrade to less polluting and more efficient equipment or production processes that lower the marginal cost of production. 
The substitution effect describes how, holding output constant, regulation affects the labor-intensity of production. Although increased environmental regulation may increase the use of pollution control equipment and energy to operate that equipment, or otherwise change production processes, the impact on labor demand is ambiguous. For example, pollution abatement technologies or materials that alter the production process, requirements for inspection and certification, and required paperwork and recordkeeping may affect the amount of labor necessary to produce a unit of output. Berman and Bui model the substitution effect as the effect of regulation on pollution control equipment and expenditures and the corresponding change in the labor-intensity of production. In summary, as output and substitution effects may be positive or negative, economic theory alone cannot predict the direction of the net effect of environmental regulation on labor demand at the level of the regulated firm. This rule will require manufacturers and processors of certain nanoscale materials to electronically report to EPA certain information. This requirement may impact labor demand at regulated firms through increased labor needs.
In addition to changes to labor demand in the regulated industry, net employment impacts encompass changes in other related sectors throughout the U.S. economy. For example, this rule will increase the amount of data on nanomaterials available for Federal agency risk management programs, state and local government programs, private sector, and non-governmental organization researchers. As a result, this increased amount of data may increase labor demand at organizations that analyze the data. Therefore, it is important to consider the net effect of compliance actions on employment across multiple sectors or industries. If the U.S. economy is at full employment, even a large-scale environmental regulation is unlikely to have a noticeable impact on aggregate net employment. Instead, labor in affected sectors would primarily be reallocated from one productive use to another, and net national employment effects from environmental regulation would be small and transitory (e.g., as workers move from one job to another). Some workers may retrain or relocate in anticipation of new requirements or require time to search for new jobs, while shortages in some sectors or regions could bid up wages to attract workers. These adjustment costs can lead to local labor disruptions. Although the net change in the national workforce is expected to be very small, localized reductions in employment may adversely impact individuals and communities just as localized increases may have positive impacts. If, on the other hand, the economy is operating at less than full employment, economic theory does not clearly indicate the direction or magnitude of the net impact of environmental regulation on employment (Schmalensee and Stavins 2011). For example, the Congressional Budget Office considered EPA's Mercury Air Toxics Standards and regulations for industrial boilers and process heaters as potentially leading to short-run net increases in economic growth and employment, driven by capital investments for compliance with the regulations (Congressional Budget Office 2011).
Adding to the unknowns and complex movements of labor within the regulated sector and across the larger U.S. economy, effects on employment are also likely to change over time. Employment in some sectors will be affected at the time of promulgation or when a regulation becomes effective, while others may be affected farther into the future. In addition, environmental regulation may affect labor supply and productivity. In particular, pollution and other environmental risks may impact labor productivity or employees' ability to work. The empirical findings regarding labor supply are reviewed below.
Empirical Findings
The labor economics literature contains an extensive body of peer-reviewed empirical work analyzing various aspects of labor demand, relying on the theoretical framework discussed in the preceding section. This work focuses primarily on effects of employment policies such as labor taxes and minimum wages. In contrast, the peer-reviewed empirical literature specifically estimating employment effects of environmental regulations is growing, but is more limited. This section presents an overview of the latter.
Empirical studies, such as Berman and Bui (2001) and Ferris, Shadbegian et al. (2014), suggest that regulation-induced net employment impacts may be zero or slightly positive, but small in the regulated sector. Gray, Shadbegian et al. (2014) find that pulp mills that had to comply with both the air and water regulations in EPA's 1998 "Cluster Rule" experienced relatively small, and not always statistically significant, decreases in employment. Other research on regulated sectors suggests that employment growth may be lower in more regulated areas (Greenstone (2002);Walker (2011; 2013); Kahn and Mansur (2013)). However since these latter studies compare more regulated to less regulated counties this methodological approach likely overstates employment impacts to the extent that regulation causes plants to locate in one area of the country rather than another, which would lead to "double counting" of the employment impacts. List, Millimet et al. (2003) find some evidence that this type of geographic relocation may be occurring.
The empirical literature on environmental regulatory employment impacts focuses primarily on labor demand. However, there is a nascent literature focusing on regulation-induced effects on labor productivity and supply. Although this literature faces empirical challenges, researchers have found that air quality improvements lead to reductions in lost work days (e.g., Ostro (1987)). Limited evidence suggests worker productivity may also improve when pollution is reduced. Graff Zivin and Neidell (2012) used detailed worker-level productivity data from 2009 and 2010, paired with local ozone air quality monitoring data for one large California farm growing multiple crops, with a piece-rate payment structure. Their quasi-experimental structure identifies an effect of daily variation in monitored ozone levels on productivity. They find "ozone levels well below federal air quality standards have a significant impact on productivity: a 10 parts per billion (ppb) decreases in ozone concentrations increases worker productivity by 5.5 percent." (Graff Zivin and Neidell, 2012, p. 3654).
As noted above, it is very difficult to estimate the net national employment impacts of environmental regulation. Given the difficulty with estimating national impacts of regulations, EPA has not generally estimated economy-wide employment impacts of its regulations in its benefit-cost analyses. However, in its continuing effort to advance the evaluation of costs, benefits, and economic impacts associated with environmental regulation, EPA has formed a panel of experts as part of EPA's Science Advisory Board (SAB) to advise EPA on the technical merits and challenges of using economy-wide economic models to evaluate the impacts of its air pollution regulations, including the impact on net national employment. Once EPA receives guidance from this panel it will carefully consider this input and then decide if and how to proceed on economy-wide modeling of employment impacts of its regulations.
Conclusions Regarding the Literature. This section has outlined the challenges associated with estimating regulatory effects on both labor demand and supply for specific sectors. These challenges make it difficult to estimate net national employment estimates that would appropriately capture the way in which costs, compliance spending, and environmental benefits propagate through the macro-economy. Overall, the peer-reviewed literature does not contain evidence that environmental regulation has a large impact on net employment (either negative or positive) in the long run across the whole economy.
Section 9.1.3 presents a qualitative assessment of immediate and short term employment impacts of the current rulemaking. Section 9.1.4 describes longer term impacts. 
Qualitative Assessment: Immediate and Short-term Employment Impacts	
Firms impacted by this rule are manufacturers and processors of certain nanoscale materials. The initial activities that firms may need to perform to comply with this rule are rule familiarization, form completion, electronic reporting, and recordkeeping. The average initial year cost per firm is shown in Table 9-1, and costs per firm in the subsequent nine years of the economic analysis period are shown in Table 9-2. See Chapter 3 for a discussion of how per-firm costs were estimated. The net effect on short-term labor demand in the regulated sector is ambiguous but expected to be small.
Table 9-1: Summary of Costs per Firm in First Year (2015$)
                                   Firm Type
                                Number of Firms
                               First Year Costs
Manufacturer
                                      165
                                   $50,285 
Processor
                                     1,788
                                   $10,904 

Table 9-2: Summary of Costs per Firm in Subsequent Years (2015$)
                                   Firm Type
                                Number of Firms
                             Subsequent Year Costs
                                Annualized Cost



                                      3%
                                      7%
Manufacturer
                                      165
                                    $5,593 
                                    $9,846 
                                   $10,809 
Processor
                                      199
                                   $10,904 
                                   $10,053 
                                   $10,214 

Qualitative Assessment: Longer-term Employment Impacts
EPA is not anticipating any significant longer term cost impacts on regulated entities and therefore the rule is not expected to have any significant longer term employment effects. 
Summary of Qualitatively Assessed Employment Impacts
The direction of change in employment in the regulated and environmental sectors from this rulemaking is ambiguous. This is true for both the short term or first year employment impacts and the long term or subsequent year employment impacts. However, the increase in total costs, labor costs, and labor hours per firm as a consequence of this rule is reasonably small, thus EPA expects employment impacts to be small as well.
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 rule will impose a burden requiring additional OMB approval. The ICR addendum is available for comment in the public docket for the rule.
 This section estimates the burden and costs for both the respondents and the Agency associated with the recordkeeping and reporting requirements of the 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 9-3 presents a summary of the total burden and costs to industry associated with the 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 9-3: Industry Burden Estimates for the Final Rule
                                     Year
                             Reporting Population
                      Rule Familiarization Burden (Hours)
    Form Completion, CBI Substantiation, and Record Keeping Burden (Hours)
                      Electronic Reporting Burden (Hours)
                               Number of Reports
                             Total Burden (Hours)
Manufacturers
                                       1
                                      165
                                     0.82
                                      139
                                     1.42
                                      771
                                    107,616
                                       2
                                      165
                                       0
                                      139
                                     0.174
                                      86
                                    11,991
                                       3
                                      165
                                       0
                                      139
                                     0.174
                                      86
                                    11,991
                                    Average
                                      165
                                     0.27
                                      139
                                     0.59
                                      314
                                     43866
Processors
                                       1
                                     1,788
                                     0.82
                                      139
                                     1.42
                                     1,788
                                    252,715
                                       2
                                      199
                                     0.82
                                      139
                                     1.42
                                      199
                                    28,127
                                       3
                                      199
                                     0.82
                                      139
                                     1.42
                                      199
                                    28,127
                                    Average
                                      729
                                     0.82
                                      139
                                     1.42
                                      729
                                    102,990
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 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 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 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 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 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 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 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 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 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 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 rule will be disproportionately distributed across different geographic regions or among different categories of individuals.
Executive Order 13211  -  Energy Supply, Distribution, or Use
This 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 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 2015 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 (2016a); 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 2015 (BLS, 2016a). For attorney, the wage rate was taken from the BLS Occupational Employment Statistics (OES) May 2015 National Industry-Specific Occupational Employment and Wage Estimates for Sectors 31, 32, and 33  -  Manufacturing and SOC Code 23-1011  -  Lawyers (BLS, 2016b).
The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS report (BLS, 2016a). Fringe benefits as a percentage of wages are calculated separately for each labor category. For example, the wage rate for professional/ technical labor in 2015 was $44.06, and the average fringe benefit was $24.34. Therefore, fringe benefits as a percentage of wages were $24.34/$44.06 or approximately 55 percent (see Exhibit A-2). Since the fringe benefits for attorney were not available from the BLS report, EPA applied the managerial fringe benefit to wage ratio to this wage as well.
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 2015 is $44.06 x (1+ 0.55 + 0.17) = $75.89. 
Exhibit A-2: Derivation of Loaded Industry Wage Rates (2015$)
Fully loaded costs for attorney, managerial, and clerical labor are calculated in a similar manner, as shown in Exhibit A-2.
                                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)
Attorney
BLS OES, Occupational Employment and Wages, 23-1011 Lawyers
                                    $65.51
                                    $32.65 
                                    49.84%
                                      17%
                                     1.67
                                   $109.29 
Managerial
BLS ECEC, Private Manufacturing industries, "Management, business, and financial occupations"2
                                    $48.66 
                                    $24.25 
                                    49.84%
                                      17%
                                     1.67
                                    $81.18 
Professional/Technical
BLS ECEC, Private Manufacturing industries, "Professional and related occupations"2
                                    $44.06 
                                    $24.34 
                                    55.24%
                                      17%
                                     1.72
                                    $75.89 
Clerical
BLS ECEC, Private Manufacturing industries, "Office and administrative support occupations"2
                                    $19.91 
                                    $10.37 
                                    52.08%
                                      17%
                                     1.69
                                    $33.66 
Notes:
1  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 2015 (OPM, 2015). The average salary for one full-time equivalent (FTE) technical/professional staff member is estimated as the salary for a GS-13 Step 5 employee, which is $102,932 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 $164,691(see Exhibit A-3).
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.
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 technical staff FTE
OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step 5 pay rates [a]
                                    Jan-15
                               $102,932 (annual)
                                      --
                          [Included in 60% overhead]
                                    60% [b]
                                      1.6
                               $164,691 (annual)
                                       
                                       
                                       
                                    $49,32
                                   (hourly)
                                       
                                       
                                       
                                       
                                $78.91 (hourly)
EPA attorney staff FTE
OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-14 Step 5 pay rates
                                    Jan-15
                               $121,635 (annual)
                                       
                          [Included in 60% overhead]
                                    60% [b]
                                      1.6
                               $194,616 (annual)
                                       
                                       
                                       
                                    $58.28
                                   (hourly)
                                       
                                       
                                       
                                       
                                $93.25 (hourly)
Notes:
[a]. Hourly rates are based on annual salary divided by 2,087 hours.
[b] The 60% fringe-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9).
Source: OPM, 2015

  -  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 4.67 "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 rule. 
Estimation of the number of nanomaterials per small Firm 
In Section 2.2.3 of this report, EPA calculates the number of nanomaterials produced by each firm, based on a subset of 19 large businesses, using the TSCA-based definition of annual revenue greater than $11 million. Within this group of 19 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 19 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 19 nanomaterial-producing firms identified in Chapter 2, 14 had product information available on a company website. All of these firms manufactured nanomaterials for TSCA-related uses. Of these 14 firms, 3 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 3 small companies to be 1 nanomaterial. 

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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