Economic Analysis for the Proposed TSCA Section 8(a) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances

File name: RIN2070-AK67_EO12866_PFAS-TSCA 8a_NPRM_EconomicAnalysis_2021-02-11.docx
     Revised to address Interagency Comments received under EO 12866/13563 Review.

Draft
May 2021

				Economic and Policy Analysis Branch
	Existing Chemicals Risk Management Division
Office of Pollution, Prevention, and Toxics
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue
Washington, DC 20460

CONTENTS
List of Abbreviations	iv
Executive Summary	vi
1.	Introduction	1
1.1.	Statutory Authority	1
1.2.	Regulatory and Programmatic Background	1
1.2.1	Regulatory Background	2
1.2.2	Programmatic Background	3
1.3.	Statement of Need	3
1.3.1	Inadequate Information	3
1.4.	Summary of Methodology	4
1.5.	Organization of This Report	5
2.	Affected Entities	2-1
2.1.	Chemical Substances and Firms Subject to this Rule	2-1
2.2.	Estimated Total Regulated Firms	2-3
2.2.1	Importers of Articles	2-4
3.	Industry Costs	3-1
3.1.	Industry Wage Rates	3-1
3.2.	Unit Industry Costs	3-2
3.2.1	Rule Familiarization	3-2
3.2.2	Form Completion	3-2
3.2.3	CBI Claim Substantiation	3-10
3.2.4	Recordkeeping	3-12
3.2.5	CDX Registration and Electronic Signature	3-12
3.2.6	Article Importation Activities	3-13
3.3.	Total Industry Costs	3-15
4.	Agency Costs	4-1
4.1.	Agency Wage Rates	4-1
4.2.	Agency Unit Cost	4-2
4.2.1	Data Processing and Systems Support	4-2
4.2.2	Review of CBI Claim Substantiations	4-2
4.2.3	Information Technology Infrastructure	4-3
4.3.	Total Agency Burden and Cost	4-3
5.	Total Social Burden and Cost	5-1
6.	Benefits	6-1
6.1.	Market Failure	6-1
6.2.	Benefits of Information-Based Policies	6-1
6.3.	Potential Users of Information Generated by the Rule	6-2
7.	Small Entity Impact Analysis	7-1
7.1.	Select a Relevant Small Business Definition	7-1
7.2.	Estimate the Percentage of Firms That are Small	7-2
7.3.	Estimate the Distribution of Costs for Small Parent Entities	7-3
7.4.	Estimate the Distribution of Annual Revenues for Small Parent Entities	7-4
7.5.	Estimate the Cost-to-Revenue Ratio for Small Entities	7-6
8.	Sensitivity Analysis	8-8
9.	Other Impact Analyses	9-1
9.1.	Employment Impact Analysis	9-1
9.1.1	Theory	9-1
9.1.2	Empirical Findings	9-3
9.1.3	Qualitative Assessment: Immediate and Short-term Employment Impacts	9-4
9.1.4	Qualitative Assessment: Longer-term Employment Impacts	9-4
9.1.5	Summary of Qualitatively Assessed Employment Impacts	9-4
9.2.	Paperwork Reduction Act (PRA)	9-4
9.3.	Unfunded Mandates Reform Act (UMRA)	9-5
9.4.	Executive Order 13132  -  Federalism	9-5
9.5.	Executive Order 13175  -  Consultation and Coordination with Indian Tribal Governments	9-5
9.6.	Executive Order 13045  -  Children's Health	9-5
9.7.	Executive Order 12898  -  Environmental Justice	9-6
9.8.	Executive Order 13211  -  Energy Supply, Distribution, or Use	9-6
9.9.	National Technology Transfer and Advancement Act	9-6
10.	References	A-1
Appendix A	Wage Rate Calculations	A-5
A.1	Derivation of Industry Unit Wage Rates	A-5
A.2	Derivation of Agency Unit Wage Rates	A-6

List of Abbreviations
BLS		Bureau of Labor Statistics
CAS		Chemical Abstracts Service
CERCLA	Comprehensive Environmental Response, Compensation and Liability Act
CDR		Chemical Data Reporting
CDX		Central Data Exchange
CBI		Confidential Business Information
ECEC		Employee Costs for Employee Compensation
EPA		Environmental Protection Agency
IUR		Inventory Update Rule
LCPFAC	Long-chain perfluoroalkyl carboxylate
LVE		Low volume exemption
MCL		Maximum Contaminant Level
NAICS		North American Industrial Classification System
OECD		Organisation for Economic Co-operation and Development
OHT		OECD Harmonised Templates
OMB		Office of Management and Budget
ORD 		Office of Research and Development
PMN		Pre-manufacture Notice
PFAS		Perfluoroalkyl and polyfluoroalkyl substances
PFOA		Perfluorooctanoic acid
PFOS		Perfluorooctanesulfonic acid
PMN		Premanufacture Notice
RCRA		Resource Conservation and Recovery Act
SBA		Small Business Administration
SDWA		Safe Drinking Water Act
SNUR		Significant New Use Rule
SUSB		Statistics of U.S. Businesses
TSCA		Toxic Substances Control Act
TRI		Toxics Release Inventory
UCMR3	Unregulated Contaminant Monitoring Rule
UMRA		Unfunded Mandates Reform Act
Executive Summary
This economic analysis estimates and evaluates the costs and benefits of collecting information from manufacturers (including importers) of certain perfluoroalkyl and polyfluoroalkyl substances (PFAS). The proposed rule will be 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 proposed rule requires persons who manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011 to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards.
EPA estimates that approximately 234 PFAS manufacturers may be subject to reporting requirements under the proposed rule. Note that the estimated number of firms subject to the proposed rule does not include importers of articles. Due to the scope of imported articles that contain PFAS and lack of data on article importers, EPA was unable to determine the number of importers of articles that may be subject to the proposed rule. EPA is soliciting public comment on the number of potential importers of articles that may be subject to the proposed rule.
The industry is expected to incur one-time burdens and costs associated with rule familiarization, form completion, CBI claim substantiation, recordkeeping, and electronic reporting activities. Importers of articles may also incur costs associated with determining if the articles they import contain PFAS; however due to lack of data on article importers, these costs are not included in the total industry burden and costs estimated in this analysis. Under the proposed rule, EPA estimates a total industry burden of approximately 122,104 hours, with a cost of approximately $9.8 million. The Agency is expected to incur a burden of approximately 7,361 hours and a cost of $948,078. The total social burden and cost are therefore estimated to be approximately 129,465 hours and $10.8 million, respectively.
EPA conducted a small entity impact analysis as required by the Regulatory Flexibility Act of 1980 and the Small Business Regulatory Enforcement Fairness Act of 1996. EPA estimates that 59 small firms will be affected by the proposed rule. Of those small firms, 46% are expected to have cost impacts of less than 1% of annual revenues, 19% are expected to have impacts between 1-3%, and 35% are expected to have impacts of more than 3% of annual revenues.
The additional data on the production, use, exposure, and environmental and health effects of PFAS chemicals in the United States may allow EPA to more effectively determine whether additional risk assessment and management measures are needed. This information may lead to reduced cost of risk-based decision making and improved decisions concerning PFAS chemicals.

 Introduction
This economic analysis estimates the costs and qualitatively discusses the benefits expected to result from a proposed information collection rule for perfluoroalkyl and polyfluoroalkyl substance (PFAS) manufacturers 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 proposed rule proposes requirements for persons who manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011 to electronically report information regarding PFAS uses, production volumes, byproducts, disposal, exposures, and existing environmental and health effects. Section 1.1 provides background information on EPA's statutory authority for the proposed rule; Section 1.2 reviews the regulatory background; Section 1.3 discusses the need for regulation; Section 1.4 presents a brief summary of the methodology used in the analysis; and Section 1.5 describes the organization of the remainder of this report.
Statutory Authority
Under Section 8(a) of TSCA, EPA has statutory authority to impose information reporting and recordkeeping requirements on manufacturers and processors of chemical substances used in commerce. Insofar as the information is known, or readily available, EPA may issue an information collection rule requiring the following items among others:
Table 1-1: TSCA-authorized Reporting Requirements
Reporting Elements
(A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture for which such a report is required.
(B) The categories or proposed categories of use of each such substance or mixture.
(C) The total amount of each such substance and mixture manufactured or processed, or reasonable estimates of the total amount to be manufactured or processed.
(D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture.
(E) All existing data concerning the environmental and health effects of such substance or mixture.
(F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure.
(G) In the initial report under paragraph (1) on such substance or mixture, the manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method.
Source: TSCA Section 8(a), Paragraph (2), Subparagraphs (A) through (G)

The National Defense Authorization Act for Fiscal Year 2020 (Pub. L. No. 116-92 §7351) amended TSCA section 8(a) on December 19, 2019, adding section 8(a)(7), titled PFAS Data. Section 8(a)(7) requires EPA to promulgate a rule "requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011" to report information described in TSCA section 8(a)(2)(A)-(G).
Regulatory and Programmatic Background
Several regulatory (Section 1.2.1) and programmatic (Section 1.2.2) activities related to PFAS chemicals precede or coincide with the proposed rule. These activities are briefly described in the following sections.
Regulatory Background
Toxic Substances Control Act
Under TSCA, EPA is directed to prioritize, evaluate, and regulate chemicals manufactured (including imported) or processed in the U.S.
 Under the new chemicals program, since 2006, EPA has reviewed at least 294 new PFAS chemicals before they have commenced commercial production and has regulated at least 191 chemicals through Significant New Use Rules (SNURs) and other orders (EPA 2018a).
 In June 2020, EPA finalized a SNUR to require manufacturers (including importers) and processors of certain long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to notify EPA before use of LCPFACs that have been phased out can commence.
 In addition, articles containing LCPFACs as a surface coating and carpets containing perfluoroalkyl sulfonate chemical substances cannot be imported without EPA review (EPA 2020d).
 EPA may collect some information from PFAS manufacturers, including on production volume and use in commerce, under the Chemical Data Reporting (CDR) rule. This information is collected every four years and, in general, applies to chemicals with production volumes of 25,000 lbs or more at a single site in a single year.
Emergency Planning and Community Right-to-Know Act
In February 2020, EPA published an updated list of 172 PFAS chemicals subject to Toxics Release Inventory (TRI) reporting requirements. Under the NDAA, these chemicals were subject to TRI reporting requirements beginning in Reporting Year 2020 (EPA 2020c). TRI information provides the public, government agencies, non-governmental organizations, and companies with information about chemical releases and pollution prevention activities reported by industrial and federal facilities to support informed decision making.
Safe Drinking Water Act
Under the Safe Drinking Water Act (SDWA), EPA has the authority to set Maximum Contaminant Levels (MCLs) for specific drinking water chemicals. In 2016, EPA issued a health advisory for perfluorooctanoic acid (PFOA) and perfluorooctanesulfanoic acid (PFOS). Health advisories identify non-regulatory concentrations of chemicals in drinking water at or below which adverse health effects are not expected to occur over a lifetime of exposure. The health advisory was developed to assist federal, state, tribal and local officials, and managers of drinking water systems to protect public health when PFOA and PFOS are present in drinking water (EPA 2016a).
Additionally, the third Unregulated Contaminant Monitoring Rule (UCMR3) required monitoring for 30 contaminants between 2013 and 2015, including six PFAS substances. The rule allows EPA to collect data on chemicals that are suspected drinking water contaminants but for which EPA has not set health-based standards under the SDWA. The monitoring data collected under UCMR3 provides a basis for future regulatory actions (EPA 2016b).
In February 2020, EPA proposed preliminary determinations for regulating PFOA and PFOS in drinking water (EPA 2020a).
Comprehensive Environmental Response, Compensation, and Liability Act
Under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as Superfund, EPA is authorized to address certain or threatened environmental releases of hazardous substances. PFOA and PFOS are not designated as CERCLA hazardous substances, but in some circumstances, response authority for PFAS chemical substances exists as CERCLA pollutants or contaminants.
Programmatic Background
EPA PFAS Action Plan
In 2019 EPA released a PFAS Action Plan, which outlined shorter-term and long-term actions the Agency  intended taking to address PFAS (EPA 2019b). EPA provided a program update on the action plan in February 2020 (EPA 2020b). EPA outlined both short-term and long-term strategies that incorporate both regulatory and non-regulatory approaches for drinking water, cleaning, production and use, monitoring, research, enforcement, and risk communications. The goal of EPA's Action Plan is to:
 Demonstrate the Agency's critical national leadership by providing both short-term solutions and long-term strategies.
 Provide a multi-media, multi-program, national research and risk communication plan.
 Respond to the extensive public input the Agency has received during the PFAS National Leadership Summit, multiple community engagements, and through the public docket.
PFOA Stewardship Program
In January 2006, EPA launched the 2010/2015 PFOA Stewardship Program (PFOA Stewardship Program) in partnership with eight companies:
 Arkema
 Asahi Glass Company
 BASF Corporation (successor to Ciba Specialty Chemicals Corporation)
 Clariant
 Daikin
 3M/Dyneon
 DuPont
 Solvay Solexis
These companies represented a large portion of global manufacture of LCPFAC. The program set a goal of reducing facility emissions and product content of LCPFAC chemical substances on a global basis by 95 percent, no later than 2010, and to work toward eliminating emissions and product content of these chemicals by 2015. All companies have met the PFOA Stewardship Program goals (EPA 2020f).
Statement of Need
Executive Order 12866 requires regulatory Agencies to identify the specific market failure that a significant rule addresses. The major causes of market failure identified in the Office of Management and Budget (OMB) guidance (OMB 2003) on Executive Order 12866 are externality, natural monopoly, market power, and inadequate or asymmetric information. The proposed rule was mandated by Congress. In addition, EPA believes that the information may help  provide more information about PFAS manufacture, 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 PFAS chemicals.
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 customers 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 contributed 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.
The proposed rule addresses the former case of asymmetric information. In cases where EPA has not already collected production, use, or hazard information from manufacturers under the CDR rule or through a PMN submission, the proposed rule will lead to an increase in EPA's knowledge about PFAS's potential risks. This information is likely to result in a reduction in the cost of risk-based decision making about PFAS and an improvement in the expected outcome of potential risk management decisions.
Summary of Methodology
This analysis seeks to quantify, to the extent possible, the costs to society of the proposed rule by identifying the costs to industry 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 PFAS chemicals 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 EPA's Chemical Data Reporting (CDR) database to estimate the number of affected entities. EPA believes the inputs for this analysis are high-end estimates and that the final burden and cost estimates may therefore be overestimated.
This report qualitatively discusses any potential benefits of the proposed rule based on the value of information it may 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.
Note that all dollar amounts in this analysis are reported in 2020dollars.
Organization of This Report
The remainder of this report provides EPA's economic analysis in support of the proposed rule. The affected chemical substances and companies are characterized in Chapter 2. Chapter 3 estimates industry cost of complying with the proposed rule, and Chapter 4 estimates government costs associated with the administration of the rule. Chapter 5 presents total social costs. Chapter 6 addresses the qualitative benefits of the proposed rule using a "value of information" framework. Chapter 7 provides the small entity impact analysis for the proposed rule, as mandated by the Regulatory Flexibility Act (RFA) and amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA). Chapter 8 presents a sensitivity analysis that provides alternative low- and high-end estimates of total industry cost. 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 (PRFA); and 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.

Affected Entities
This chapter presents potentially affected manufacturers (including importers) subject to this rule. Section 2.1 describes the chemicals and firms affected by the proposed rule, as well as general exemptions to the proposed rule. Section 2.2 describes and estimates the universe of affected manufacturers (including importers) potentially affected by the proposed rule.
Chemical Substances and Firms Subject to this Rule
This rule affects firms that currently or have previously manufactured (including imported) PFAS in any year since January 1, 2011. PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon chain on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. The strong carbon-fluorine bonds of PFAS make them resistant to degradation and thus highly persistent in the environment (EPA 2019b; EPA 2017c). Some of these chemicals have been used for decades in a wide variety of consumer and industrial products (EPA 2019b). Some PFAS have been detected at high levels in wildlife, including higher trophic organisms, indicating that at least some PFAS have the ability to bioaccumulate (EPA 2017c). Some PFAS can accumulate in humans and remain in the human body for long periods of time (e.g. months to years) (EPA 2019b; EPA 2017c; EPA 2009c). Because of the widespread use of PFAS in commerce and their tendency to persist in the environment, most people in the United States have been exposed to PFAS (EPA 2019b). As a result, several PFAS have been detected in human blood serum (EPA 2019b; EPA 2017c; ATSDR 2018).
For this proposed rule, EPA has identified at least 1,364 chemical substances and mixtures that are PFAS and would be subject to reporting under the proposed rule. The scope of PFAS included in this proposed rule include the following:
 All PFAS listed on the TSCA active Inventory. This includes PFAS that are identified by CAS number; confidential chemicals whose generic names contain "fluor" and are identified by Accession number, and; confidential chemicals whose generic names do not contain "fluor" and therefore are not listed by CAS or Accession numbers.
 TSCA section 5 (new chemicals) low-volume exemptions
 Withdrawn claims for low-volume exemptions under TSCA section 5
 Any other PFAS that meet the structural definition
EPA expects that this rule will affect firms in the North American Industrial Classification System (NAICS) categories listed in Table 2-1, based on the parent companies that reported manufacturing or importing affected PFAS chemicals to the 2016 Chemical Data Reporting (CDR) as well as EPA's previous experience with TSCA section 8(a) data collection and the Agency's understanding of disposal and other waste management methods involving PFAS. The list in Table 21 is not exhaustive and may not describe the specific entities and corresponding NAICS codes for entities that may be affected by the proposed rule.
Table 2-1: NAICS of Affected Parent Companies Reporting to the 2016 CDR
                                     NAICS
                               NAICS Description
                                                                            324
Petroleum and Coal Product Manufacturing
                                                                            325
Chemical Manufacturing
                                                                         325180
Other Basic Inorganic Chemical Manufacturing
                                                                         325199
All Other Basic Organic Chemical Manufacturing
                                                                         325211
Plastics Material and Resin Manufacturing
                                                                         325320
Pesticide and Other Agricultural Chemical Manufacturing
                                                                         325998
All Other Miscellaneous Chemical Product and Preparation Manufacturing
                                                                         326113
Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing
                                                                         327910
Abrasive Product Manufacturing
                                                                         333999
All Other Miscellaneous General Purpose Machinery Manufacturing
                                                                         334511
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing
                                                                         336111
Automobile Manufacturing
                                                                         423510
Metal Service Centers and Other Metal Merchant Wholesalers
                                                                         424690
Other Chemical and Allied Products Merchant Wholesalers
                                                                         447190
Other Gasoline Stations
                                                                         551112
Offices of Other Holding Companies
                                                                            562
Waste Management and Remediation Services
Source: EPA 2020e

The list in Table 2-1 is not exhaustive and may not describe the specific entities and corresponding NAICS codes for entities that may be affected by the proposed rule. EPA's previous experience with TSCA section 8(a) data collections, as well as the Agency's understanding of disposal and other waste management methods involving PFAS, suggests that most respondents affected by this collection activity are from the following NAICS code categories:
 NAICS 324  -  Petroleum and Coal Product Manufacturing; and
 NAICS 325  -  Chemical Manufacturing
 NAICS 562  -  Waste Management and Remediation Services
This proposed rule does not exempt small manufacturers from reporting and recordkeeping requirements. The proposed rule also does not require manufacturers (including importers) to report certain information previously submitted to EPA.
Estimated Total Regulated Firms
This section characterizes the potentially affected universe of firms affected under the proposed rule. A total of 115 affected chemicals were reported in the 2016 Chemical Data Reporting (CDR) data (EPA 2020e). The firms manufacturing or importing these 115 chemicals do not represent the complete universe of affected firms because they do not include firms that:
 Manufacture or import a PFAS chemical that is not on the TSCA Inventory
 Manufacture or import a PFAS chemical in volumes below the CDR reporting threshold
 Commenced manufacture or import of the PFAS chemical after the 2016 CDR reporting cycle
 Ceased manufacture or import of the PFAS chemical before the 2016 CDR reporting cycle
Thus, this analysis uses the subset of firms reporting to the 2016 CDR to estimate the average number of sites per firm and the average number of PFAS per site. EPA estimates an average of 1.5 sites per firm and an average of 3.9 PFAS per site for the non-CBI firms reporting to CDR, resulting in an average of 5.85 PFAS per firm. EPA assumes that these averages for the manufacturers reporting to CDR are representative of those that do not report to CDR. An estimated 234 firms and 351 sites are expected to be subject to this rule's reporting requirements (Table 2-2). Note that EPA is not able to estimate the number of article importers who may be subject to the proposed rule and thus does not include these firms in the totals presented in Table 22. Importers of articles are discussed separately in Section 2.1.2. EPA is soliciting public comment on information that may be included in the final economic analysis, including the number of potential importers of articles that may be subject to the proposed rule.

Table 2-2: Estimated Number of Affected PFAS, Firms, and Sites
                             CDR Reporting Status
                         Number of Chemical Substances
                           Number of Affected Firms
                           Number of Affected Sites

                                       A
                                 B = A / 5.85
                                  C = B x 1.5
PFAS reporting to CDR
                                                                            115
                                                                             20
                                                                             30
PFAS not reporting to CDR
                                                                          1,249
                                                                            214
                                                                            321
Total
                                                                          1,364
                                                                            234
                                                                            351
Source: EPA 2020e

Note that certain information that is requested in CDR and TSCA section 5 Premanufacture Notices (PMN) that falls under TSCA section 8(a)(2)(A) through (G) would be required by this proposed rule, such as information on specific chemical identity, categories of use, production volume, byproducts, and number of persons exposed and duration of exposure. In instances where PFAS manufacturers under this proposed rule have already reported the requested information to EPA for that same year, they will not be required to re-report. However, EPA expects that most firms will need to submit information under the proposed rule, even if they have previously reported to CDR or submitted a PMN because the proposed rule requests different information than either CDR or PMN forms. Additionally, this rule requires reporting for each year since 2011 in which a PFAS was manufactured, whereas reporting is not required annually for CDR. In addition, firms that have not previously submitted information to CDR (see Table 22) or through a PMN form will need to submit data under the proposed rule.
Importers of Articles
The proposed rule also applies to importers of articles that contain PFAS (including articles containing PFAS as part of surface coatings). Importers have varying levels of knowledge about the chemical content of the articles they import. PFAS are used in a wide variety of products, including textiles, electronics, wires and cables, pipes, cooking and bakeware, sport articles, automotive products, and musical instruments, which may be imported into the United States as finished articles (Glüge et al. 2020). Therefore, it is reasonable that some importers would not know or have access to the all of the information, and would therefore not be subject to report. However, there are some importers in a wide range of sectors that may be affected because they would know the products or articles contain PFAS, including manufacturers, wholesalers, and retailers. Due to the scope of imported articles that contain PFAS and lack of data on article importers, EPA is soliciting public comment on the number of potential importers of articles that may be subject to the proposed rule.  EPA was unable to determine the number of importers of articles that may be subject to the proposed rule. Potential costs for importers of articles will therefore be discussed qualitatively throughout this analysis, while EPA is working on developing estimating importers of articles for the final rule.
Industry Costs
This chapter presents a description of the burden and costs potentially incurred by manufacturers (including importers) under the proposed rule. Section 3.1 presents the industry wage rates used in this analysis, Section 3.2 presents unit costs for each activity that firms are expected to complete to comply the proposed rule, and Section 3.3 presents the total estimated industry burden and cost.
Industry Wage Rates
The proposed rule involves activities that may require efforts by employees in four labor categories: clerical, professional/technical, managerial, and attorney. 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.
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 (Rice 2002). Wage rates and fringe benefits for clerical, professional/technical, managerial, and attorney labor are calculated using the U.S. Bureau of Labor Statistics' (BLS) Employer Costs for Employee Compensation (ECEC) historical data for December 2020 (BLS 2021a). The industry wage rate for attorney labor is derived from the National Industry-Specific Occupational Employment and Wage Estimates (BLS 2021b).
Overhead costs are assumed to equal 20% of the sum of wages plus fringe benefits. This loading factor is described in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and other U.S. EPA Actions (EPA 2020c), and is reflective of multiplier values used in prior EPA economic analyses and Information Collection Requests (ICRs) that are based on industry- and occupation-specific overhead rates affected by EPA regulations.
The loaded wage rates for each labor category are presented in Table 3-1. Detailed information on the estimation of these wage rates is provided in Appendix A.
Table 3-1: Loaded Industry Wage Rates (2020$)
                                Labor Category
                                    Wage[1]
                               Fringe Benefit[2]
                              Total Compensation
                              Overhead % Wage[3]
                                   Overhead
                            Hourly Loaded Wages[4]

                                       A
                                       B
                                   C = A + B
                                       D
                                   E = C x D
                                   F = C + E
Clerical
                                                                        $20.86
                                                                          $9.62
                                                                         $30.48
                                                                            20%
                                                                         $6.10
                                                                        $36.58
Professional/ Technical
                                                                        $44.63
                                                                        $22.45
                                                                        $67.08
                                                                            20%
                                                                        $13.42
                                                                        $80.50
Managerial
                                                                        $54.32
                                                                        $24.46
                                                                        $78.78
                                                                            20%
                                                                        $15.76
                                                                        $94.54
Attorney
                                                                        $71.59
                                                                        $17.96
                                                                        $89.55
                                                                            20%
                                                                        $17.91
                                                                       $107.46
1 Source: Employer Costs for Employee Compensation Supplementary Tables: December 2020 (BLS 2021a); National Industry-Specific Occupational Employment and Wage Estimates, May 2020 (BLS 2021b).
2 Source: Employer Costs for Employee Compensation Supplementary Tables: December 2020 (BLS 2021a)
3 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and other U.S. EPA Actions (EPA 2020c).
4 Values may not sum due to rounding. Wage rates are rounded to the nearest cent.

Unit Industry Costs
This section presents the estimated burdens and costs for the following activities that firms may perform under the proposed rule:
 Rule Familiarization (Section 3.2.1)
 Form Completion (Section 3.2.2)
 CBI Claim Substantiation (Section 3.2.3)
 Recordkeeping (Section 3.2.4)
 CDX Registration and Electronic Signature (Section 3.2.5)
 Article Importation Activities (Section 3.2.6)
Note that certain information that is requested in the CDR that falls under TSCA section 8(a)(2)(A) through (G) would be required by this proposed rule, such as information on specific chemical identity, categories of use, production volume, byproducts, and number of persons exposed and duration of exposure. In instances where PFAS manufacturers under this proposed rule have already reported the requested information to EPA for that same year, they will not be required to re-report. As a conservative estimate that does not overstate costs to industry, EPA does not account for this duplicative reporting. However, EPA expects that most firms will need to submit information under the proposed rule, even if they have previously reported to CDR because the proposed rule requests different information from CDR. Additionally, this rule requires reporting for each year since 2011 in which a PFAS was manufactured, whereas reporting is not required annually for CDR. In addition, firms that have not previously submitted information to CDR (see Table 2‑2) will need to submit data under the proposed rule.
Rule Familiarization
The proposed 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 based on EPA best professional judgment of the time required to read and comprehend regulatory documentation. It 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 this rule are similar to those required by a PMN form. As shown in Table 3-2, the cost associated with rule familiarization is estimated to be approximately $70 per firm. It is expected that all 234 firms in the potentially affected universe will undertake this activity, including importers of articles.
Table 3-2: Per-Firm Industry Burden and Cost: Rule Familiarization (2020$)
                              Reporting Activity
                            Burden per Firm (hours)
                             Cost per Firm (2020$)

                                   Clerical
                                   Technical
                                  Managerial
                                     Total
                             Clerical ($36.58/hr)
                             Technical ($80.50/hr)
                            Managerial ($94.54/hr)
                                    Total
Rule Familiarization
                                                                              0
                                                                           0.55
                                                                           0.27
                                                                           0.82
                                                                         $0.00
                                                                         $44.27
                                                                        $25.52
                                                                        $69.79
Note: Values may not sum due to rounding

Source: EPA 2009a; BLS 2021a

Form Completion
The proposed rule requires one-time reporting of certain information, including specific chemical identity, categories of use, production volume, byproducts, environmental and health effects, number of persons exposed and duration of exposure, and disposal. All affected firms are required only to submit information that is known or reasonably ascertainable to them. Known to or reasonably ascertainable by" would be defined to include "all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know." This reporting standard would require reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control.
Furthermore, firms are not required to submit the same information for a given year and substance that has already been submitted to EPA under the TSCA section 8(a) CDR rule. Note that firms are still required to submit information for any chemical substances and/or years since 2011 for which they have not previously submitted information. As a conservative approach that does not underestimate industry costs, this analysis does not account for any potential reduction in reporting burdens for firms that have previously submitted duplicate information to EPA. However, EPA expects that most firms will need to submit information under the proposed rule, even if they have previously reported to CDR because the proposed rule requests different information than the CDR. Additionally, this rule requires reporting for each year since 2011 in which a PFAS was manufactured, whereas reporting is not required annually for CDR.
TSCA section 8(a)(5) requires EPA, to the extent feasible when carrying out TSCA section 8, to avoid requiring unnecessary or duplicative reporting. The Agency seeks to avoid collecting data on PFAS that would duplicate information already reported to the Agency. While developing this rule EPA reviewed the data elements submitted under the Chemical Data Reporting Rule and determined that there may be some overlap with the information requested under the proposed rule. EPA is proposing to allow reporting entities to indicate in the reporting tool that they have previously provided such information to EPA through CDR for certain data elements. The Agency has identified the following data elements which the reporter may be able to indicate has already been submitted to EPA:
   :: Physical state of the chemical;
   :: Industrial processing and use type, sector(s), functional category(ies), and percent of production volume for each use;
   :: Consumer and/or commercial indicator, product category(ies), functional category(ies), percent of production volume for each use, indicator for use in products intended for children, and maximum concentration in the product, and;
   :: Number of workers reasonably likely to be exposed for each combination of industrial processing or use operation, sector, and function, and the number of commercial workers reasonably likely to be exposed if the PFAS is contained in a commercial product.
If a manufacturer covered under this proposed rule has previously submitted required information to EPA for some years since 2011, but not for all years, EPA is proposing that the manufacturer may indicate in the reporting tool the year(s) for which the manufacturer has already submitted that data to EPA as part of CDR.
Conversely, there are some data elements for which CDR reporters may have previously reported information to EPA for some years covered by this proposed rule, but not all, and would still be required to report this information for the missing year(s):
      :: Domestically manufactured production volume;
      :: Imported production volume;
      :: Volume directly exported; and
      :: Indicator for imported but never physically at site.

Table 3-3 presents a summary of the estimated per-firm burden and costs associated with form completion. EPA estimates each firm will incur an average of approximately 507 burden hours and $40,764 in costs per firm. Note that the proposed rule requires some reporting elements to be reported for each chemical, site, and/or year subject to the rule. Table 3-3 aggregates all burden and cost estimates to the firm level using the average number of chemicals per firm and sites per firm estimated in Chapter 2. The derivation of the estimated burden for each reporting element is further described in the following sections.

Table 3-3: Per-Firm Industry Burden and Cost: Form Completion (2020$)
                               Reporting Element
                            Burden per Firm (hours)
                             Cost per Firm (2020$)

                                   Clerical
                                   Technical
                                  Managerial
                                     Total
                             Clerical ($35.58/hr)
                             Technical ($82.15/hr)
                            Managerial ($87.55/hr)
                                    Total
                                       1
Company and plant site information
                                                                           0.00
                                                                          0.024
                                                                          0.009
                                                                         0.0330
                                                                         $0.00
                                                                         $1.93
                                                                         $0.85
                                                                         $2.78
                                       2
Common or trade name, chemical identity, and molecular structure
                                                                          10.24
                                                                          26.33
                                                                           5.85
                                                                          42.41
                                                                       $374.45
                                                                     $2,119.06
                                                                       $553.04
                                                                     $3,046.54
                                       3
Byproducts
                                                                           0.00
                                                                           2.93
                                                                           0.00
                                                                           2.93
                                                                         $0.00
                                                                       $235.45
                                                                         $0.00
                                                                       $235.45
                                       4
Conditions of use
                                                                           0.00
                                                                          26.00
                                                                          10.65
                                                                          36.65
                                                                         $0.00
                                                                     $2,093.16
                                                                     $1,006.52
                                                                     $3,099.68
                                       5
Total production volume
                                                                           0.00
                                                                          50.19
                                                                          12.69
                                                                          62.89
                                                                         $0.00
                                                                     $4,040.34
                                                                     $1,200.09
                                                                     $5,240.42
                                       6
Occupational exposure
                                                                           0.00
                                                                          78.98
                                                                           0.00
                                                                          78.98
                                                                         $0.00
                                                                     $6,357.17
                                                                         $0.00
                                                                     $6,357.17
                                       7
Environmental release and disposal
                                                                           0.00
                                                                          55.58
                                                                           0.00
                                                                          55.58
                                                                         $0.00
                                                                     $4,473.57
                                                                         $0.00
                                                                     $4,473.57
                                       8
Environmental and health effects data
                                                                           0.00
                                                                         227.45
                                                                           0.00
                                                                         227.45
                                                                         $0.00
                                                                    $18,308.65
                                                                         $0.00
                                                                    $18,308.65
                                                                          Total
                                                                           10.2
                                                                          467.5
                                                                           29.2
                                                                          506.9
                                                                        $374.45
                                                                    $37,629.32
                                                                     $2,760.50
                                                                    $40,764.27
Note: Estimates may not sum due to rounding.

Sources: EPA 1994; EPA 2018b; EPA 2018c; BLS 2021a

1. Company and plant site information
Each reporting site will need to provide the following information:
 Site information (e.g., site name, site address, technical contact name)
 Parent company information (e.g., company name, company address)

This analysis uses burden estimates from the Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act Chemical Data Reporting under the Toxic Substances Control Act due to overlapping data elements with the proposed rule (EPA 2018b). These burden estimates were derived originally from a survey conducted by EPA in 1996 (under OMB Control No. 2070-0034) to assess the potential benefits associated with the Inventory Update Rule (IUR), as amended at that time. The survey was distributed to previous IUR respondents selected from the IUR database.

EPA (2018b) estimates a total of 0.006 hours of managerial burden and 0.016 hours of technical burden per site to report parent company and site identification information. Assuming an average of 1.5 sites per firm, EPA estimates firms will require approximately 0.10 hours of managerial burden and 0.024 hours of technical burden to report company and plant site information.

2. Common or trade name, chemical identity, and molecular structure
The proposed rule requires submitters to report the following information for each chemical they manufacture or import that is subject to the rule's reporting requirements:
 Chemical or generic name
 Chemical ID
 Trade name or common name
 Molecular structure
 Physical state of chemical or mixture
This analysis uses the same burden estimates as the Regulatory Impact Analysis of Amendments to Regulations for TSCA Section 5 Premanufacture Notifications due to overlapping data elements with the proposed rule (EPA 1994{U.S. Environmental Protection Agency (EPA), 1994 #9}). These burden estimates are based on data collected by the Chemical Manufacturers Association (CMA) from its members in response to a request from EPA. EPA estimates firms will require 1.5 to 2 hours of clerical labor, 3 to 6 hours of technical labor, and one hour of managerial labor to report chemical identity and molecular structure information. Using the midpoint of these estimates and assuming an average of 5.85 chemicals per firm results in estimated burdens of 10.24 hours of clerical labor, 26.33 hours of technical labor, and 5.85 hours of managerial labor per firm.
3. Byproducts
For each chemical at each reporting site, the proposed rule requires the following information:
 Byproduct chemical or generic name
 Byproduct chemical ID
 Indicate if byproduct is from manufacture, process, use, or disposal
 Indicate if byproduct is released to the environment; if yes, indicate the environmental media they are released to
 Byproduct volume released
Due to similarities in reporting requirements, this analysis uses the same burden estimates as EPA (1994) for this reporting activity. These burden estimates are based on data collected by the Chemical Manufacturers Association (CMA) from its members in response to a request from EPA. EPA estimates that a description of byproducts will require 0.5 hours of technical labor per chemical per site. Assuming 3.9 chemicals per site and 1.5 sites per firm, EPA estimates approximately 2.93 hours of technical burden for reporting byproducts.
4. Conditions of use
The proposed rule will require submitters to report the following information on conditions of use for each chemical at each reporting site:
 Industrial processing and use  -  Type of process or use
 Industrial processing and use  -  Sector(s)
 Industrial processing and use  -  Function category
 Consumer and commercial use  -  Product category
 Consumer and commercial use  -  Function category
 Consumer and commercial use  -  Consumer or commercial
 Consumer and commercial use  -  Used in products intended for children
 Consumer and commercial use  -  Maximum concentration
Due to similarities in reporting requirements, this analysis uses the same burden estimates as EPA (2018b) for firms reporting conditions of use for each chemical in each of CDR's four reporting years. These burden estimates were derived originally from a survey conducted by EPA in 1996 (under OMB Control No. 2070-0034) to assess the potential burden associated with the IUR as amended at that time. The survey was distributed to previous IUR respondents selected from the IUR database. These burden have since been updated to address new reporting elements in subsequent IUR reporting cycles (EPA 2005; EPA 2011). EPA is not able to determine the average number of years per chemical for which firms will submit data under the proposed rule. EPA (2018b)'s estimates for four reporting years is therefore assumed to be a reasonable approximation for the number of years for which a firm will report data under the proposed rule.
Note that burden estimates differ for industrial uses and consumer and commercial uses (Table 3-4). To estimate a single average burden estimate for reporting conditions of use across all types of uses, this analysis therefore weights the industrial use and consumer and commercial use burdens by the percentage of each type of use observed in the 2016 CDR for PFAS manufacturers. The 2016 CDR indicates that approximately 25 percent of firms manufacture PFAS chemicals for use in consumer products (EPA 2020e). This analysis therefore further weights burdens by either 75 percent (Industrial use) or 25 percent (Consumer and Commercial use) to derive a weighted average burden per chemical.
As shown in Table 3-4, EPA estimates an average of 26.00 hours of technical burden and an average of 10.65 hours of managerial burden per firm for reporting conditions of use.Table 3-4: Per-Site Burden: Conditions of Use
                             CDR Reporting Element
                               Technical Burden
                               Managerial Burden

                              CDR Burden (hours)
                              Chemicals per Firm
                                Burden (hours)
                              CDR Burden (hours)
                              Chemicals per Firm
                                Burden (hours)
                      Industrial Processing and Use Data
Determination of Applicability (includes "Type of Process or Use")
                                                                           0.81
                                                                           5.85
                                                                           4.74
                                                                           0.23
                                                                           5.85
                                                                           1.35
Sector
                                                                           0.75
                                                                           5.85
                                                                           4.39
                                                                           0.32
                                                                           5.85
                                                                           1.87
Industrial Function Category
                                                                           3.53
                                                                           5.85
                                                                          20.65
                                                                           1.65
                                                                           5.85
                                                                           9.65
Total Industrial Processing and Use (75% of manufacturers)

                                                                          29.78

                                                                          12.87
                       Consumer and Commercial Use Data
Determination of Applicability (includes "Consumer or Commercial or both")
                                                                           0.75
                                                                           5.85
                                                                           4.39
                                                                           0.20
                                                                           5.85
                                                                           1.17
Identification of Production Category/Use by Children
                                                                           0.67
                                                                           5.85
                                                                           3.92
                                                                           0.20
                                                                           5.85
                                                                           1.17
Maximum Concentration by Category
                                                                           1.09
                                                                           5.85
                                                                           6.38
                                                                           0.28
                                                                           5.85
                                                                           1.64
Total Consumer and Commercial Use (25% of manufacturers)

                                                                          14.68

                                                                           3.98
Average Per-Firm Burden[1]
                                                                              -
                                                                              -
                                                                          26.00
                                                                              -
                                                                              -
                                                                          10.65
Source: EPA 2018b; EPA 2020e
Note: Clerical burdens are not anticipated for this reporting element and are thus not presented in the table. Estimates may not sum due to rounding.
[1] Average per firm burden across all use types, weighted by 75% for Industrial Processing and Use burdens and 25% for Consumer and Commercial Use burdens.

5. Total production volume
Each affected site is required to report the following elements, to the extent known or reasonably ascertainable:
 Production volume domestically manufactured at each site
 Production volume imported at each site
 Indication if imported but never physically at site
 Volume directly exported
 Industrial processing and use - % production volume
 Consumer and commercial use - % production volume
 Maximum first 12 months production volume
 Maximum yearly production volume in any 3 years

Due to similarities in reporting requirements, this analysis primarily uses the same burden estimates as EPA (2018b) for reporting production volumes in each of CDR's four reporting years.  These burden estimates were derived originally from a survey conducted by EPA in 1996 (under OMB Control No. 2070-0034) to assess the potential burden associated with the IUR as amended at that time. The survey was distributed to previous IUR respondents selected from the IUR database. These burden estimates have since been updated to address new reporting elements in subsequent IUR reporting cycles (EPA 2005a; EPA 2011). EPA is not able to determine the average number of years per chemical since 2011 for which firms will submit data under the proposed rule's one-time reporting requirement. EPA (2018b)'s estimates for four reporting years is therefore assumed to be a reasonable approximation for the number of years for which a firm will report data under the proposed rule.

As shown in Table 3-5, EPA estimates 50.19 hours of technical burden and 12.69 hours of managerial burden per firm for reporting production volume.
Table 3-5: Per-Site Burden: Production Volume
                             CDR Reporting Element
                               Technical Burden
                               Managerial Burden

                              CDR Burden (hours)
                              Chemicals per Firm
                                Burden (hours)
                              CDR Burden (hours)
                              Chemicals per Firm
                                Burden (hours)
Production volume for all reporting years
                                                                           4.28
                                                                           5.85
                                                                          25.04
                                                                           1.05
                                                                           5.85
                                                                           6.14
Whether imported chemical substance is physically at reporting site
                                                                           0.09
                                                                           5.85
                                                                           0.53
                                                                           0.02
                                                                           5.85
                                                                           0.12
Production volume used on-site
                                                                           0.16
                                                                           5.85
                                                                           0.94
                                                                           0.04
                                                                           5.85
                                                                           0.23
Volume exported
                                                                           0.82
                                                                           5.85
                                                                           4.80
                                                                            0.2
                                                                           5.85
                                                                           1.17
Percent of production volume
                                                                           2.23
                                                                           5.85
                                                                          13.05
                                                                           0.86
                                                                           5.85
                                                                           5.03
Maximum first 12 months production volume; Maximum yearly production volume in any 3 years
                                                                           1.00
                                                                           5.85
                                                                           5.85
                                                                           0.00
                                                                           5.85
                                                                           0.00
Total
                                                                              -
                                                                              -
                                                                          50.19
                                                                              -
                                                                              -
                                                                          12.69
Source: EPA 2018b; EPA 1994
Note: Estimates may not sum due to rounding.

6. Occupational exposure
Each affected site is required to report the following elements, to the extent known or reasonably ascertainable:
 Worker activity descriptions at manufacturing site
 Number of workers reasonably likely to be exposed at the manufacturing site, for each worker activity
 Maximum duration of exposure for any worker, for each worker activity
 Number of workers reasonably likely to be exposed for each industrial process and use
 Maximum duration of exposure for any worker for each industrial process and use
 Number of workers reasonably likely to be exposed for each commercial use
 Maximum duration of exposure for any worker for each commercial use

Due to similarities in reporting requirements, this analysis uses the same burden estimates as EPA (1994) for occupational exposure information associated with each chemical. These burden estimates are based on data collected by the Chemical Manufacturers Association (CMA) from its members in response to a request from EPA. EPA estimates this activity will require 13 to 14 hours of technical labor per chemical per site. Using the midpoint of 13.5 hours per chemical and assuming 3.9 chemicals per site and 1.5 sites per firm, EPA estimates approximately 78.98 hours of technical burden per firm to report occupational exposure information.
7. Environmental release and disposal
Each affected site is required to report the following elements, to the extent known or reasonably ascertainable:
 Description of disposal process(es)
 Description of any changes to the disposal process or methods since 2011
 Total volume released (land disposal)
 Total volume released (water)
 Total volume released (air)
 Total volume incinerated (on-site)
 If incineration occurs: the temperature at which the chemical was incinerated
 Total volume recycled (on-site)
 Maximum quantity stored on-site at any time

Due to similarities in reporting requirements, this analysis uses the same burden estimates as EPA (1994) for environmental release and disposal information associated with each chemical. These burden estimates are based on data collected by the Chemical Manufacturers Association (CMA) from its members in response to a request from EPA. EPA  estimates this activity will require 9 to 10 hours of technical labor per chemical per site. Using the midpoint of 9.5 hours per chemical and assuming 3.9 chemicals per site and 1.5 sites per firm, EPA estimates approximately 55.58 hours of technical burden per firm to report environmental release and disposal information.

8. Environmental and health effects data
Each affected site is required to report the following elements for each chemical with a consumer use, to the extent known or reasonably ascertainable:
 All existing information concerning the environmental and health effects of such substance or mixture.

For this proposed rule, EPA is requiring firms to report data using the Organisation for Economic Co-operation and Development (OECD)'s Harmonised Templates (OHTs; or "templates"). The OHTs are standardized formats for reporting information on chemicals, including physical properties, production and use, and effects on human health and the environment (OECD 2018). In addition to allowing reporting for a particular endpoint value (e.g. pH, biodegradation, aquatic toxicity), the OHTs are intended to summarize administrative data about the quality of the studies and publications associated with those endpoints (e.g., test materials, study design, study period).
This analysis assumes that firms will submit environmental and health effects data using templates under the Biotic Systems group (19 templates) and the Health Effects group (31 templates). Each template contains a range of fields for the submitter to report, such as endpoint value, study period, test materials, descriptions of materials and methods, descriptions of test organisms, study design, analytical monitoring, test conditions, and results and discussion.

This analysis assumes that 12 hours of technical time will be required to complete each template, which is equivalent to the burden time needed to complete a robust summary for a TSCA 8(d) health and safety study (EPA 2018c). A robust summary for a TSCA section 8(d) health and safety data rule typically includes a description of the test substance, methods, results, conclusions, data quality descriptions, and references associated with a full study, which is similar to the data fields required for the Biotic Systems and Health Effects templates. Based on historic rates of environmental and health studies submitted to EPA under TSCA section 8(d), each firm that submits a report is assumed to submit an average of 18 studies (templates) per chemical (9 in the Biotic Systems group and 9 in the Health Effects group). Thus, the burden per chemical is estimated at 216 hours of technical labor.

EPA expects that only a small subset of firms will have these data available to submit. This analysis therefore assumes that 18 percent of firms will submit data, which is derived from the historic percentage of firms that have submitted health and safety studies to EPA under TSCA 8(d) rules (EPA 2018c).Thus, applying this percentage and assuming 5.85 chemicals per firm, EPA estimates an average of approximately 227.5 hours of technical burden per firm to report environmental and health effects data.

CBI Claim Substantiation
TSCA requires that anyone seeking protection of confidential business information (CBI) under TSCA must assert a claim and, for certain information, 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 proposed rule for which a submitter might need to substantiate a claim of CBI, if a claim is made, include but are not limited to:
 Submitter information
 Chemical identity
 Physical properties
 Production volumes and product concentrations
 Byproducts
 Environmental release
 Worker exposure information
 Description of disposal process(es)
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.1665.14 (OMB Control No. 2020-0003), Renewal of Existing Information Collection Request for Confidentiality Rules (EPA 2020g) 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. 1655.14 to estimate CBI substantiation for this rule. According to the ICR, submitters spent 3.8 hours on each substantiation type reviewing the information, preparing the response, and submitting the response to the Agency (assumed to be 1.9 attorney hours and 1.9 managerial 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.
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 2019c). 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., 3.8 hours x 25% = 0.95 hours).
It is further assumed that each firm will submit an average of 5.85 reports, resulting in a total per-firm burden of 5.56 hours. As shown in Table 3-6, the labor cost associated with CBI claim substantiation is approximately $561 per firm. It is expected that each firm submitting reports may undertake this activity.
Table 3-6: Per-Firm Industry Burden and Cost: CBI Claim Substantiation (2020$)
                              Reporting Activity
                            Burden per Firm (hours)
                             Cost per Firm (2020$)

                                   Attorney
                                   Technical
                                  Managerial
                                     Total
                             Attorney ($107.46/hr)
                             Technical ($80.50/hr)
                            Managerial ($94.54/hr)
                                    Total
CBI Claim Substantiation
                                                                           2.78
                                                                              0
                                                                           2.78
                                                                           5.56
                                                                       $298.60
                                                                         $0.00
                                                                       $262.69
                                                                       $561.30
Note: Values may not sum due to rounding.

Source: EPA 2020g; BLS 2021a

Recordkeeping
The proposed rule requires manufacturers (including importers) subject to the reporting requirements to retain documentation of information contained in their reports for five years from the date of submission. Due to similarities in reporting and recordkeeping requirements, this analysis bases recordkeeping estimates on those estimated to keep paper records in EPA (1994). This estimate is based on data collected by the Chemical Manufacturers Association (CMA) from its members in response to a request from EPA. However because firms are expected to keep electronic records rather than paper records for the proposed rule, this analysis assumes that the recordkeeping burden will be half of that estimated in EPA (1994) due to efficiencies in creating and storing documents electronically. EPA therefore estimates that each report will require 0.5 hours of clerical labor and 0.5 hours of technical labor per report to maintain records. Assuming an average of 5.85 reports per firm, the estimated recordkeeping burden for the proposed rule is 2.93 hours of clerical labor and 2.93 hours of technical labor per firm. These recordkeeping burdens and associated cost estimates are presented in Table 3-7. It is expected that each firm submitting reports will undertake this activity.
Table 3-7: Per-Firm Industry Burden and Cost: Recordkeeping (2020$)
                              Reporting Activity
                            Burden per Firm (hours)
                             Cost per Firm (2020$)

                                   Clerical
                                   Technical
                                  Managerial
                                     Total
                             Clerical ($36.58/hr)
                             Technical ($80.50/hr)
                            Managerial ($95.54/hr)
                                    Total
Recordkeeping
                                                                           2.93
                                                                           2.93
                                                                              0
                                                                           5.86
                                                                       $107.17
                                                                       $235.85
                                                                         $0.00
                                                                       $343.02
Note: Values may not sum due to rounding.

Source: EPA 2017a; BLS 2021a

CDX Registration and Electronic Signature
Firms that submit a report to EPA will incur a one-time cost associated with registering with EPA's Central Data Exchange (CDX) in order to comply with electronic reporting requirements. Respondents will incur electronic reporting costs to register with CDX and provide an electronic signature. These activities occur only once for each submitter.

The one-time burden associated with CDX registration and e-signature is estimated at approximately 2.67 hours per firm. These activities are estimated to require the following burden hours, based on the estimates presented in the Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA 2009a).

 CDX registration. EPA estimates that a firm will spend approximately 11 minutes per employee to register with CDX, and that an average of four technical staff members and one manager would need to register for each firm, totaling approximately 0.92 hours per firm.

 CDX electronic signature. EPA estimates that a firm would spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee. This burden would apply to four technical staff members and one manager per firm, totaling 1.25 hours per company. In addition, EPA estimates that a manager would spend an additional 0.50 hours accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by a firm submitting and then verifying electronic signature agreements is 1.75 hours. Note that this burden does not include any additional time required to contact EPA's CDX help desk to notify a change of submitter status, should one occur. Filing the electronic signature agreement requires an additional mailing cost of $3.15 per company (including five $0.55 stamps and five $0.08 business envelopes).
As shown in Table 3-8, the estimated cost of CDX registration, electronic signature, and mailing activities is approximately $231 per firm.
As a conservative estimate, it is expected that each firm that submits a report will undertake this activity. Some submitters may already have registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with the mandatory electronic reporting requirements of EPA's e-PMN rule and/or IUR/CDR rule. Those submitters will not need to repeat the CDX registration and e-signature process in order to file their reports. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is conservatively expecting that all firms that submit a report under this proposed rule will need to register with CDX. Therefore, this economic analysis may overestimate the burden and cost associated with this activity.

Table 3-8: Per-Firm Industry Burden and Cost: CDX Registration and Electronic Signature (2020$)
                              Reporting Activity
                            Burden per Firm (hours)
                             Cost per Firm (2020$)

                                   Clerical
                                   Technical
                                  Managerial
                                     Total
                             Clerical ($36.58/hr)
                             Technical ($80.50/hr)
                            Managerial ($94.54/hr)
                                    Total
CDX Registration
                                                                              0
                                                                           0.73
                                                                           0.18
                                                                           0.92
                                                                         $0.00
                                                                         $59.03
                                                                         $17.33
                                                                        $76.36
Electronic Signature
                                                                              0
                                                                           1.00
                                                                           0.75
                                                                           1.75
                                                                         $0.00
                                                                        $80.50
                                                                        $70.90
                                                                       $151.40
Mailing cost (non-labor)
                                                                              -
                                                                              -
                                                                              -
                                                                              -
                                                                              -
                                                                              -
                                                                              -
                                                                         $3.15
Total
                                                                              0
                                                                           1.73
                                                                           0.93
                                                                           2.67
                                                                         $0.00
                                                                       $139.53
                                                                        $88.23
                                                                       $230.91
Note: Values may not sum due to rounding

Source: EPA 2009a; USPS 2019; BLS 2021a

Article Importation Activities
Importers have varying levels of knowledge about the chemical content of the articles they import. The reporting standard would require reporting entities to evaluate their current level of knowledge of their imported articles, as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization and may also entail inquiries outside the organization to fill gaps in the submitter's knowledge. Therefore, this analysis estimates unit costs for article importers to perform the following activities to determine whether any articles they import contain PFAS (including PFAS as part of surface coatings):
 Rule familiarization (per-firm cost). All importers will read and understand applicable requirements of the proposed rule, within the context of the company's products. This burden is presented in Section 3.2.1.
 Identify the type of imported articles that potentially use PFAS (per-firm cost). This determination may be done based on an understanding of the uses of PFAS (e.g. those described in Section 2.2.2) and the application of any a priori knowledge of the material and its manufacture to assess the probability of whether PFAS may be present.
 Identify all suppliers involved (per-firm cost). The importer may choose to identify all suppliers from whom the articles identified in the previous step are imported.
 Collect data from suppliers (per-article cost). Importers may choose to obtain verification from identified suppliers that PFAS is or is not found in the article. For example, this may be accomplished through agreements with suppliers, declarations through databases or surveys, or by using a third-party certification system.
 Recordkeeping (per-firm cost). The importer may choose to keep records confirming the activities completed to determine if PFAS is present in articles.
Table 3‑9 contains the cost ranges associated with the above activities. The activities and cost derivations are discussed in more detail in Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs (EPA 2014). Costs are estimated using the wage rates in Section 3.1.
Table 3‑9: Range of Costs Associated with Importer Identification of PFAS in Articles
                                   Activity
                                     Type
                                 Cost (2020$)
                                     Notes
Rule familiarization
Per firm
                                                                        $69.79
See Section 3.2.1
Identify the type of imported articles that potentially use PFAS
Per firm
                                                                 $161 to $1,932
Actual costs may vary based on number of articles imported and the complexity of the article itself (number of components)
Identify suppliers involved
Per firm
                                                                      $1,185.26
Actual costs may vary depending on the number of articles imported, number of suppliers, and frequency of supplier changes
Collect data from suppliers
Per article
                                                                     $6 to $644
Actual costs only apply to those companies that choose to collect data from suppliers. They will vary depending on the specific data collection method chosen. Total costs depend on considerations including the number of articles imported, number of suppliers, and frequency of supplier changes.

                                                        $0 if no data collected

Recordkeeping
Per firm
                                                                         $12.07
Actual costs may vary depending on recordkeeping system already in place
Source: EPA 2014

Variation in costs associated with these activities will depend on the complexity of supply chains and the size of the company. Total costs per article importer will further depend on the number of affected articles and the frequency of supplier change.

If an importer determines that any article contains PFAS, they will be subject to the same reporting requirements and are expected to incur compliance costs associated with form completion, CBI claim substantiation, recordkeeping, and CDX registration as discussed in Sections 3.2.2 through 3.2.5.

Total Industry Costs
Table 3-9 presents the total estimated industry burden and costs. As shown in the table, affected firms subject to the proposed rule are estimated to incur approximately 122,104 burden hours and $9,820,813 in costs for this one-time reporting.
Costs incurred by importers of articles are not included in Table 3‑10 because EPA is not able to determine the number of importers of articles containing PFAS nor the specific activities undertaken by each importer to determine if their products contain PFAS. EPA presented a range of unit costs associated with importer identification of PFAS in articles in Section 3.2.6. If an importer determines that any article contains PFAS, they will be subject to the same reporting requirements and are expected to incur costs associated with form completion, CBI claim substantiation, recordkeeping, and CDX registration as discussed in Sections 3.2.2 through 3.2.5.
Table 3-9: Total Industry Burden and Costs (2020$)
                                   Activity
                          Number of Affected Firms[1]
                      Average Burden per Firm (Hours)[2]
                             Total Burden (hours)
                       Average Cost per Firm (2019$)[2]
                              Total Cost (2019$)

                                       A
                                       B
                                   C = A x B
                                       D
                                   E = A x D
Rule Familiarization
                                                                            234
                                                                              1
                                                                            192
                                                                            $70
                                                                       $16,331
Form Completion
                                                                            234
                                                                            507
                                                                        118,616
                                                                       $40,764
                                                                    $9,538,839
CBI Claim Substantiation
                                                                            234
                                                                              6
                                                                          1,300
                                                                          $561
                                                                      $131,343
Recordkeeping
                                                                            234
                                                                              6
                                                                          1,371
                                                                          $343
                                                                       $80,267
CDX Registration and Electronic Signature
                                                                            234
                                                                              3
                                                                            624
                                                                          $231
                                                                       $54,033
                                                                          Total
                                                                            234
                                                                            522
                                                                        122,104
                                                                       $41,969
                                                                    $9,820,813
[1] See Section 2.2
[2] See Section 3.2.1 to Section 3.2.5 for derivations of the average burden per firm and average cost per firm for each reporting activity.

Agency Costs
This chapter presents Agency burden and costs associated with collection and administrative activities under the proposed rule. Section 4.1 presents the Agency wage rates used in this analysis, Section 4.2 presents unit burdens for each activity the Agency is expected to take, and Section 4.3 presents the total burden and cost to the Agency for the proposed rule.
Agency Wage Rates
EPA assumes that the collection and administrative activities (technical labor) associated with Agency responses to the proposed rule will be accomplished by a GS-13, Step 5 federal employee in the Washington-Baltimore-Northern Virginia area. EPA's Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other EPA Actions (EPA 2020c) recommends a study by the Congressional Budget Office (Falk 2012) for estimating benefit values for federal government workers. The study reports that total benefits account for 63.9 percent of average wages in the federal government sector. Therefore, 63.9 percent of the wage is used to calculate the fringe in the derivation of Agency wage rates. An additional factor of 20 percent is applied to wages to account for overhead, consistent with the approach described in Section 3.1 for industry wage rates.
The loaded wage rate for a GS-13, Step 5 employee is $109.65 per hour, as shown in Table 4-1. This estimate includes a base wage of $55.75 per hour plus benefits and overhead.
EPA assumes that a GS-14, Step 5 federal employee will perform attorney activities under the proposed rule. A loaded hourly wage rate of $129.57 was calculated using the same method as for the technical labor.
Table 4-1: Agency Wage Rates (2020$)
                                Labor Category
                       Data Source for Wage Information
                                 Wage ($/hour)
                            Fringes as % of Wage[2]
                                Fringe Benefit
                              Total Compensation
                    Overhead as % of Total Compensation[3]
                                   Overhead
                              Loaded Wage ($/hr)

                                       A
                                       B
                                   C = A * B
                                   D = A + C
                                       E
                                   F = D * E
                                   G = D + F
Technical
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates[1]
                                    $55.75
                                     63.9%
                                    $35.62
                                    $91.37
                                     20.0%
                                    $18.27
                                   $109.65
Attorney
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-14 Step 5 pay rates[1]
                                    $65.88
                                     63.9%
                                    $42.10
                                   $107.98
                                     20.0%
                                    $21.60
                                   $129.57
[1] Source: U.S. Office of Personnel Management (2020)
[2] Source: Falk 2012
[3] An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020c)

Agency Unit Cost
EPA will incur costs in administering the proposed rule associated with processing submitted reports, maintaining the information technology systems that support these activities (Section 4.2.1), reviewing CBI claim substantiations (Section 4.2.2), and information technology (IT) infrastructure (Section 4.2.3).
Data Processing and Systems Support
Based on previous estimates of Agency time used in economic analyses of Preliminary Assessment Information Reporting (PAIR) rules, which require Agency activity similar to that required under the proposed rule, it is estimated to take 3.75 labor hours per report to provide data processing and systems support (EPA 2003a) when the reporting is accomplished through non-electronic reporting. However, the electronic reporting required by the proposed rule is expected to result in cost savings to EPA. This analysis uses 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 3.13 technical hours per report for data processing and systems support.
Review of CBI Claim Substantiations
Under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA must review a number of CBI claims received, including some associated with submissions under the proposed rule, within 90 days after receipt. 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 2019c).
Firms can claim chemical identity as CBI if the substance is on the confidential portion of the TSCA Inventory. EPA assumes that the Agency technical burden to review CBI chemical identity claims is 1.5 hours per report, based on the Agency burden to review chemical identity CBI claims for active chemicals on the TSCA Inventory (EPA 2019a). Approximately 16 percent (224 of 1,364 chemicals) of the PFAS chemicals subject to the proposed rule have been claimed as CBI on the TSCA Inventory. Therefore, EPA assumes that the Agency will need to review CBI claims submitted related to chemical identity for 16 percent of reports. Therefore, per report received, the average EPA labor is 0.25 hours of technical burden (0.25 = 16% x 1.5 hours).
EPA estimates that it will take 8 hours (6 attorney hours and 2 technical staff hours) to review each remaining 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 40 CFR part 2, as described in EPA ICR No. 1665.14 (OMB Control No 2020-0003) (EPA 2020g). EPA assumes that each report claims CBI; therefore, EPA must review 25 percent of reports. Therefore, per report received, the average EPA labor is 2 hours (6 x 0.25 = 1.5 attorney hours and 2 x 0.25 = 0.5 technical staff hours).
Information Technology Infrastructure
As discussed in Section 3.2.2, EPA is requiring firms to report environmental and health effects data by attaching the relevant OECD template to their submission in CDX. EPA estimates a cost of approximately $100,000 to the Agency for completing IT infrastructure startup tasks to allow for this submission method in CDX.
Total Agency Burden and Cost
Table 4-2 summarizes the total Agency burdens and costs associated with administering the proposed rule. EPA assumes that each of the 348 affected sites will submit reports for 3.9 chemicals (see Chapter 2), resulting in a total of 1,369 reports.  As shown in Table 4-2, Agency burden and cost are estimated to total approximately 7,360 hours and $948,078 for this one-time reporting.
Table 4-2: Total Agency Burden and Costs (2020$)
                                 EPA Activity
                                Burden (hours)
                                 Cost (2020$)

                                   Technical
                                   Attorney
                                    Total
                            Technical ($109.65/hr)
                             Attorney ($129.56/hr)
                                    Total
Data Processing and Systems Support (per Report)
                                                                           3.13
                                                                              0
                                                                           3.13
                                                                        $343.34
                                                                         $0.00
                                                                        $343.34
Review of CBI Claim Substantiations (per Report)
   Chemical Identity
                                                                           0.25
                                                                              0
                                                                           0.25
                                                                         $27.01
                                                                         $0.00
                                                                        $27.01
   Other
                                                                            0.5
                                                                            1.5
                                                                              2
                                                                        $54.82
                                                                       $194.36
                                                                       $249.18
Total (per Report)
                                                                            3.9
                                                                            1.5
                                                                            5.4
                                                                       $425.11
                                                                       $194.36
                                                                       $619.53
IT Infrastructure
                                                                              -
                                                                              -
                                                                              -
                                                                              -
                                                                              -
                                                                      $100,000
Total Agency Burden and Cost (x 1,369 reports)
                                                                          5,308
                                                                          2,053
                                                                          7,361
                                                                       $582,020
                                                                      $266,058
                                                                      $948,078

Total Social Burden and Cost
This chapter presents the total burden and cost to society associated with the proposed rule. The total burden and cost to society includes the burden and cost to industry (presented in Chapter 3) and the burden and cost to the Agency (presented in Chapter 4). As shown in Table 5-1, the estimated total cost to society associated with this proposed rule is $10,768,892, with an associated burden of 129,465hours. Note that Table 5‑1 does not include costs incurred by importers of articles because EPA is not able to determine the number of importers of articles containing PFAS nor the specific activities undertaken by each importer to determine if their products contain PFAS. See Section 3.2.6 for a discussion of unit costs associated with importer identification of PFAS in articles.
Table 5-1: Total Social Burden and Cost
                                     Type
                                Burden (Hours)
                                 Cost (2020$)
Industry
                                                                        122,104
                                                                    $9,820,813
Agency
                                                                          7,361
                                                                       $948,078
Total Social Burden and Cost
                                                                        129,465
                                                                    $10,768,892

Benefits
This chapter qualitatively discusses the benefits that may result from the proposed rule. The proposed rule is an information-collecting rule and does not attempt to reduce risks related to PFAS chemicals at a quantifiable level. Accordingly, this benefits analysis does not seek to quantitatively measure the associated benefits and does not formally identify or define the universe of recipients of those benefits.
The proposed rule may supply information on PFAS chemicals to which the Agency (or the public) does not currently have access. By enhancing the data supplied to Agency risk-screening programs, EPA expects to more effectively and expeditiously evaluate any potential risks posed by PFAS chemicals. 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 may enable a more efficient allocation of EPA's and society's resources.

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 Toxics Release Inventory (TRI) data saw a negative response in financial markets, indicating further reasons why businesses may be reluctant to disclose information (Konar and Cohen 1997). As a result, data on the chemicals subject to the proposed rule may be produced below what is optimal for society.
Benefits of Information-Based Policies
Increased and improved data on the production and use of PFAS chemicals in the U.S. would allow EPA and other federal agencies 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 may benefit EPA by filling in these information gaps and contributing to better assessments of potential risks and risk management decisions.
The proposed rule may increase EPA's knowledge by providing the agency with data about a PFAS's potential risks and consequently is likely to result in (a) a reduction in the cost of risk-based decision making about the PFAS chemical, and (b) an improvement in the expected outcome of the decisions.
 Reduced cost of risk-based decision making. By making new information about PFAS available to EPA and other government agencies, this rule may be able to replace other information-gathering, management, and dissemination activities related to PFAS chemicals.
 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, federal decision makers are not able to assess adequately the benefits and costs of actions that involve these substances. In this proposed rule, EPA decisions regarding whether, when, and how to target PFAS chemicals for further risk assessment could be misdirected if basic risk-screening information is unavailable or inadequate. With more information to fill gaps in the current understanding of the benefits and risks of PFAS chemicals, EPA can better direct its limited resources toward high-priority risks. Improved information can therefore help lead to more socially optimal reductions in risks to humans and the environment.
The proposed rule may generate both types of benefits. First, it may provide data that are otherwise unavailable or reduce EPA's reliance on databases and information sources that are inadequate for accurately characterizing the risks associated with the PFAS chemicals 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 PFAS uses and exposures, the proposed rule may also allow EPA to save time and resources in screening chemicals and in developing risk management priorities.
Second, the proposed rule may allow EPA to better prioritize its risk management activities -- to move more quickly in addressing PFAS chemicals 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 PFAS chemical, 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.

Potential Users of Information Generated by the Rule
EPA is expected to be the primary user of the information generated by the proposed rule. The information is expected to be applied and disseminated by EPA and other federal agencies 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. 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.
EPA anticipates the following potential uses for the data collected from the proposed rule.
 EPA TSCA Risk-Screening and Management Programs
EPA's OPPT would be able to use information collected on production volumes, categories of use, disposal, byproducts, and worker-related information in future screening-level assessments of potential exposure to these PFAS chemicals. 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 PFAS chemicals, some of which may not even be included in the Inventory. The proposed rule would supply exposure-related information that the Agency does not currently have, recognizing that industry has a greater knowledge than EPA about its own operations and the uses of chemicals it manufactures and/or sells. Without this information, EPA would likely: (1) not screen these chemicals, (2) screen them using outdated or anecdotal exposure information, or (3) screen them but rely on exposure estimates using modeling data. Therefore, data collected as a result of the proposed rule will improve the Agency's ability to screen PFAS chemicals in commerce, allowing the Agency to better focus its chemical screening programs and to identify potentially risky situations earlier than otherwise possible.
 Other EPA Programs
Additionally, other offices in EPA would benefit from information collected, such as data on the disposal, releases, and other waste management methods of PFAS. Many offices across EPA are fulfilling directives under the Agency's PFAS Action Plan, and this first nationwide dataset on PFAS, production, use, disposal, and exposure-related information would complement these activities and provide necessary screening-level data. For instance, information on PFAS use, exposure, and effects may be used to inform regulatory activities under the Safe Drinking Water Act (42 U.S.C. 300f et seq.), the Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq.), and the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601 et seq.), while data on PFAS manufacturing sites and disposal methods may support contaminants characterizations conducted to support contaminated site work and solid waste management programs.

Small Entity Impact Analysis
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 are also 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 the 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 of small entities.
To fulfill the requirements of the RFA, this analysis addresses two basic questions regarding the proposed rule: (1) the number small entities potentially affected, and (2) the extent of the proposed rule's potential economic impact on those entities as measured by the cost-to-revenue ratio. This ratio is a good measure of entities' ability to afford the costs attributable to a regulatory requirement because comparing compliance costs to revenues or expenses provides a reasonable indication of the magnitude of the regulatory burden relative to a commonly available measure of economic activity. Where regulatory costs represent a small fraction of a typical entity's revenues or expenses, the financial impacts of the regulation on such entities may be considered as not significant.
The general methodology used to estimate impacts on small entities consists of the following steps and are presented in further detail in the sections below:
 Select a relevant small business definition (Section 7.1)
 Estimate the percentage of firms that are small (Section 7.2)
 Estimate the distribution of costs for affected small parent entities (Section 7.3)
 Estimate the distribution of annual revenues for small parent entities (Section 7.4)
 Estimate the cost-to-revenue ratio for small entities (Section 7.5)
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 businesses" 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.
This analysis applies the SBA small business definitions to the 14 6-digit NAICS listed in Table 2-1. These NAICS were determined by identifying the NAICS listed for the global parent company in the Dun & Bradstreet database for each site in the 2016 CDR that manufactures a PFAS chemical subject to the proposed rule (Dun & Bradstreet Hoovers 2020). The ultimate parent NAICS codes and corresponding small business size standards are shown in Table 7-1.
Table 7-1: Ultimate Parent NAICS Codes and Small Business Thresholds
                          Ultimate Parent NAICS Code
                               NAICS Description
                           Small Business Threshold
                                    325130
Synthetic Dye and Pigment Manufacturing
1,000 employees
                                    325180
Other Basic Inorganic Chemical Manufacturing
1,000 employees
                                    325211
Plastics Material and Resin Manufacturing
1,250 employees
                                    325320
Pesticide and Other Agricultural Chemical Manufacturing
1,000 employees
                                    327910
Abrasive Product Manufacturing
750 employees
                                    333415
Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing
1,250 employees
                                    334511
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing
1,250 employees
                                    336111
Automobile Manufacturing
1,500 employees
                                    423690
Other Electronic Parts and Equipment Merchant Wholesalers
250 employees
                                    424690
Other Chemical and Allied Products Merchant Wholesalers
150 employees
                                    447190
Other Gasoline Stations
$16.5 million
                                    515210
Cable and Other Subscription Programming
$41.5 million
                                    551112
Offices of Other Holding Companies
$22.0 million
                                    561499
All Other Business Support Services
$16.5 million