2740ss02

*** 12866/14095 Review Draft – Deliberative – Do Not Cite, Quote or Release ***

Supporting Statement for an Information Collection Request (ICR)

Under the Paperwork Reduction Act (PRA)

EXECUTIVE SUMMARY

Identification of the Information Collection – Title and Numbers

Title: Perchloroethylene (PCE); Regulation of Perchloroethylene under TSCA Section 6(a) (Final Rule; RIN 2070-AK84)

EPA ICR No.: 2740.02

OMB Control No.: 2070-0233

Docket ID No.: EPA-HQ-OPPT-2020-0720

Abstract

The Environmental Protection Agency (EPA) is finalizing a rule under section 6 of the Toxic Substances Control Act (TSCA) to address the unreasonable risk to human health presented by perchloroethylene (PCE) under its conditions of use. EPA is issuing a final rule under TSCA section 6(a) to:

• Prohibit most industrial and commercial uses and the manufacture (including import), processing and distribution in commerce, of PCE for those uses;

• Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use;

• Prohibit the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 10-year phaseout;

• Require a PCE workplace chemical protection program (WCPP), including an inhalation exposure concentration limit, direct dermal contact controls, and related workplace exposure controls, for many occupational conditions of use of PCE not prohibited;

• Require prescriptive workplace controls for laboratory use and energized electrical cleaner;

• Establish recordkeeping and downstream notification requirements; and

• Provide a 10-year time limited exemption under TSCA section 6(g) for certain emergency uses of PCE in furtherance of National Aeronautics and Space Administration’s (NASA) mission, for specific conditions of use which are critical or essential and for which no technically and economically feasible safer alternative is available.

• Identify a regulatory threshold for products containing PCE for the prohibitions and restrictions on PCE.

The information collection activities contained in the final rule are:

• Downstream notification requirements through Safety Data Sheets (SDS),

• WCPP-related information generation, recordkeeping, and notification requirements, including:

• Development of exposure control plans;

• Exposure level monitoring and related recordkeeping;

• Development of documentation for a Personal Protective Equipment (PPE) program and related recordkeeping;

• Development of documentation for a respiratory protection program and related recordkeeping; and

• Development and notification to potentially exposed persons (employees and others in the workplace) about how they can access the exposure control plans, exposure monitoring records, PPE program implementation documentation, and respirator program documentation.

• Workplace requirements for laboratory use-related information and generation, including:

  • Development of documentation for a PPE program and related recordkeeping and

  • Development of documentation demonstrating implementation of a properly functioning laboratory ventilation device.

• Workplace requirements for energized electrical cleaner-related information and generation, including:

  • Updating labels;

  • Recordkeeping and notification related to prescriptive controls, including:

    • Development of documentation for a PPE program and related recordkeeping;

    • Development of documentation for a respiratory protection program and related recordkeeping; and

  • Self-certification-related information generation, recordkeeping, and notification requirements, including:

    • Self-certification statement documenting the owner or operator has implemented and complies with the prescriptive controls/WCPP,

    • Notification and distribution of self-certification statement to sellers or distributors from whom the owner or operator is purchasing PCE.

Records are required to be retained for 5 years from the date of generation.

Summary of Annual Burden and Costs

Activity	Number of Respond-ents	Average Annual Responses Per Respond-ent	Average Annual Burden Per Respond-ent	Average Annual Total Labor Burden	Average Annual Total Labor Costs	Average Annual Total Non-Labor Costs	Average Annual Total Costs
Rule Familiarization	157,760	0.33	0.85	133,925	$10,630,810		$10,630,810
Downstream Notification (SDS)	29	1	0.67	19	$2,747	-	$2,747
Self Certification	121,759	1	2.00	243,518	$17,367,704	-	$17,367,704
Product Labeling	6	1	1.16	7	$659	$1,318	$1,977
Develop Exposure Control Plan	426	1	12.33	5,253	$374,614	-	$374,614
Conduct Regular Inspections	426	1	4.00	1,704	$121,529	-	$121,529
PPE Program Plan Documentation	426	1	4.52	1,926	$137,328	-	$137,328
Records Documenting Plan Implementation and Dermal Exposure	426	2	7.01	2,986	$212,980		$212,980
Respiratory, Monitoring, Recordkeeping, and Notification	275	3	155.89	42,866	$2,744,033	$2,921,363	$5,665,396
Respondent Total	157,760	-	2.74	432,203	$31,592,405	$2,922,680	$34,515,086
Agency Total	-	-	-	-	-	-	-
Note: columns may not sum due to rounding

SUPPORTING STATEMENT

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

Under section 6(a) of TSCA (15 U.S.C. § 2605(a)), if EPA determines after risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation, under the conditions of use, EPA must, by rule, apply one or more requirements to the extent necessary so that the chemical substance or mixture no longer presents such risk. Section 6(a) authorizes EPA to:

1. Prohibit or restrict manufacture, processing, or distribution in commerce,

2. Prohibit or restrict the manufacture, processing, or distribution in commerce of the chemical substance above a specified concentration,

3. Require minimum warnings or instructions with respect to use, distribution, or disposal,

4. Require manufacturers or processors to make and retain records,

5. Prohibit or regulate any manner of commercial use,

6. Prohibit or regulate any manner of disposal, and/or

7. Require manufacturers or processors to give notice of the unreasonable risk of injury, and to recall products if required.

Pursuant to TSCA section 6(b), EPA determined that PCE presents an unreasonable risk of injury to health. Accordingly, to address the unreasonable risk, EPA is issuing this final rule under TSCA section 6(a) to:

1. Prohibit most industrial and commercial uses and the manufacture (including import), processing and distribution in commerce, of PCE for these uses;

2. Prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use;

3. Prohibit the manufacture (including import), processing, distribution in commerce, and commercial use of PCE in dry cleaning and spot cleaning through a 10-year phaseout;

4. Require a Workplace Chemical Protection Program (WCPP), including an inhalation exposure concentration limit, direct dermal contact controls, and related workplace exposure controls, for many occupational conditions of use of PCE not prohibited;

5. Require prescriptive workplace controls for laboratory use and energized electrical cleaner;

6. Establish recordkeeping and downstream notification requirements.

7. Provide a 10-year time-limited exemption under TSCA section 6(g) for certain emergency uses of PCE in furtherance of National Aeronautics and Space Administration’s (NASA) mission, for specific conditions of use which are critical or essential and for which no technically and economically feasible safer alternative is available; and

8. Identify a regulatory threshold for products containing PCE for the prohibitions and restrictions on PCE.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection.

The information collection activities covered by this ICR are necessary to mitigate the unreasonable risk from PCE under the conditions of use.

Downstream Notification. Without the downstream notification requirement, there is a greater likelihood that non-prohibited uses of PCE could be diverted to prohibited uses, or that users would buy or use materials that they do not realize are subject to the restrictions in the final rule. This would result in continuation of the risk that EPA has determined to be unreasonable. Downstream notification is required to be carried out by updates to the relevant SDS and is necessary for effective implementation and enforcement of the rule as it provides a record of notification on use restrictions throughout the supply chain. Downstream notification is required for manufacturers, processors, and distributors in commerce of PCE, who would provide notice to companies downstream upon shipment of PCE about the prohibitions. The information submitted to downstream companies through the SDS provides knowledge and awareness of the restrictions to these companies.

WCPP-related information generation, recordkeeping, and notification requirements. EPA has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is especially important where, as here, such records are needed for effective implementation and enforcement of the TSCA section 6 rule to eliminate unreasonable risk. Information collection activities for such records required by a WCPP provide potentially exposed persons in a workplace with clear and necessary information and provide EPA with a necessary evidential mechanism for effective enforcement. The regulated entities must develop, compile, and retain records that are necessary for implementing the exposure controls of the WCPP, provide workplace notification to potentially exposed persons, and serve as a reference for EPA or authorized entities. These records include WCPP records, general business records such as invoices or bills-of-lading, exposure monitoring records, and exposure control plan records. These records demonstrate that regulated entities are in compliance with the requirements in this rule. Compliance with the rule is required to mitigate the unreasonable risk to health identified by EPA for PCE. These recordkeeping requirements are also necessary to permit the EPA to conduct its enforcement activities and to ensure compliance within the regulated community.

Laboratory use-related information generation and recordkeeping requirements. EPA has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is especially important where, as here, such records are needed for effective implementation and enforcement of the TSCA section 6 rule to eliminate unreasonable risk. Information collection activities for such records required for laboratory use would provide potentially exposed persons in a workplace with clear and necessary information and would provide EPA with a necessary evidential mechanism for effective enforcement. The regulated entities would develop, compile, and retain records that are necessary for implementing workplace requirements for laboratory use, and serve as a reference for EPA or authorized entities. These records include laboratory use records (properly functioning laboratory ventilation devices and PPE program) and general business records such as invoices or bills-of-lading. These records demonstrate that regulated entities are in compliance with the requirements in this rule. Compliance with the rule is required to mitigate the unreasonable risk to human health identified by EPA for PCE. These recordkeeping requirements are also necessary to permit the EPA to conduct its enforcement activities and to ensure compliance within the regulated community.

Energized electrical cleaner-related information generation and recordkeeping requirements. EPA has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is especially important where, as here, such records are needed for effective implementation and enforcement of the TSCA section 6 rule to eliminate unreasonable risk. Information collection activities for such records required for energized electrical cleaner would provide potentially exposed persons in a workplace with clear and necessary information and provide EPA with a necessary evidential mechanism for effective enforcement. The regulated entities would develop, compile, and retain records that are necessary for implementing workplace requirements for energized electrical cleaner, and serve as a reference for EPA or authorized entities. These records include labels, self-certification statement, records for prescriptive controls or WCPP, and general business records such as invoices or bills-of-lading. These records demonstrate that regulated entities are in compliance with the requirements in this rule. Compliance with the rule is required to mitigate the unreasonable risk to human health identified by EPA for PCE. These recordkeeping requirements are also necessary to permit the EPA to conduct its enforcement activities and to ensure compliance within the regulated community.

EPA. This information collection activity will ensure the availability of information to EPA upon inspection. The final rule does not establish requirements that result in the submission of information to EPA.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

The final rule does not establish reporting requirements, so no information will be submitted to EPA. Therefore, there is no need for any technology facilitation under the final rule related to the information collection activities. The recordkeeping requirement does not specify a particular technology or method of retaining the required information; therefore, regulated entities may retain records in any manner that is convenient or cost-effective.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

The EPA’s collection pursuant to the TSCA section 6(a) regulations for this rulemaking do not duplicate any other information collection activity. EPA is requiring information to ensure the elimination of unreasonable risk that was identified in, and unique to, the December 2020 PCE Risk Evaluation and risk determination revised in December 2022. Because there are no existing statutes that have established precedence in the regulation of PCE with criteria similar to the authorities granted under TSCA, the information collection activity is not a duplication. Lastly, while this collection activity required by EPA is similar to those of other Federal agencies such as the Occupational Safety and Health Administration (OSHA), EPA is setting a lower exposure threshold than the OSHA permissible exposure limit (PEL); in this way, some entities who were not previously required to maintain certain records under the OSHA standard may be subject to recordkeeping requirements in order to demonstrate they have addressed unreasonable risks under TSCA. The requirements of this rulemaking also include regulated entities where OSHA requirements are not applicable (e.g., public sector workers not covered by an OSHA State plan, and self-employed workers). Thus, these are unprecedented and EPA-specific collection activity guidelines for the regulation of PCE under TSCA and therefore has no duplicative requirements.

5. If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.

At the recommendation of the Small Business Review Panel, EPA requested comment on the extent to which a regulation under TSCA section 6(a) could minimize requirements, such as testing and monitoring protocols, recordkeeping, and reporting requirements, which may exceed those already required under OSHA’s regulations for PCE. EPA also requested comment on the feasibility of entities complying with and monitoring for an ECEL of 0.14 ppm (as an 8-hr time weighted average), on the potential costs that could be incurred using strategies to meet such a standard (such as engineering, administrative, or prescriptive controls), and how feasible it would be for entities to implement these strategies in their operations. In addition, EPA provided and requested comment on reasonable compliance timeframes for small businesses with consideration of technically and economically feasible alternatives, as well as any additional appropriate factors for identifying reasonable compliance timeframes. EPA also requested comment on different compliance or reporting requirements or timetables that take into account the limited resources available to small entities.

Commenters on EPA’s proposed rule provided information in response to these requests. After considering comments regarding timeframes needed for implementing the WCPP, EPA has determined that the timeframes in the alternative regulatory action would ensure that the regulated community, including small businesses, has adequate time to assess, formulate, procure, and implement the required chemical safety program for methylene chloride, including the required recordkeeping and documentation. Similarly, several commenters raised concerns on the timeframe for complying with prohibitions from the proposed regulatory action, stating that it does not allow sufficient time to identify, research, test, qualify, and implement alternative substances or processes. After reviewing all of the comments, EPA modified the proposed prohibition compliance timeframe for industrial and commercial uses and has lengthened it in the final rule, to allow for successful implementation of the prohibitions. This extension will also provide additional time for industry, including small businesses, to consult with their supply chains and to make necessary adjustments.

Significantly, in response to small business concerns, EPA has determined that there currently is no technically or economically feasible safer alternative for use of PCE in energized electrical cleaner. Based on information submitting during public comment and supported by subsequent outreach, and in consideration of the existing best practices for work in electrical spaces and lack of reasonably available technically and economically feasible alternatives to PCE for energized electrical cleaning, EPA has determined that the unreasonable risk from PCE when used in energized electrical cleaning could be addressed with a combination of labeling, self-certification, and either the WCPP or specific prescriptive controls, including dermal PPE and respiratory protection.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

Under section 6(a) of TSCA (15 U.S.C. § 2605(a)), if EPA determines after risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation, under the conditions of use, EPA must by rule apply one or more requirements, (see #1 above) to the extent necessary so that the chemical substance or mixture no longer presents such risk. EPA has authority under section 6 of TSCA to require recordkeeping related to the regulatory requirements imposed by EPA. This is important where, as here, such records and reports are necessary for effective implementation and enforcement of the section 6 rule.

Due to the nature of the triggering events that initiate information collection activities under the final rule (i.e., the exposure of potentially exposed persons, consumers, and bystanders to unreasonable risk) a shorter timeframe for record retention is not feasible. The information collection activities covered by this ICR are necessary in order to ensure the effective mitigation of unreasonable risk from PCE. Due to EPA’s determination that PCE presents an unreasonable risk to health, the risk management rule involves information collection activities that are intended to ensure that PCE does not present an unreasonable risk, thus any associated burdens to the regulated entities are necessary for the implementation of a TSCA section 6(a) rulemaking. Should the records in this information collection activity not be maintained nor be made accessible in accordance with the rulemaking, effective implementation of the WCPP would be compromised and EPA would not be able to determine if unreasonable risk is mitigated, leading to the possibility of injury or death and will hinder investigative efforts by the regulated entity and by EPA.

7. Explain any special circumstances that require the collection to be conducted in a manner:

1. requiring respondents to report information to the agency more often than quarterly

2. requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

3. requiring respondents to submit more than an original and two copies of any document;

4. requiring respondents to retain records, other than health, medical, government contract,

grant-in-aid, or tax records, for more than three years;

e) in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

f) requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

g) that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

h) requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

This rulemaking and information collection activity requires that regulated entities retain records for a duration of five years from the date of its inception such as downstream notification. EPA has tailored this timeframe to coincide with the statute of limitations for civil penalty enforcement (28 U.S.C. 2842). EPA expects that five-year retention of records for a WCPP is necessary for effective implementation and enforcement of this rulemaking.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency’s notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

EPA developed proposed changes to the Perchloroethylene (PCE); Regulations Under Toxic Substance Control Act (TSCA) rule and published them in the Federal Register for public comment (88 FR 39652, June 16, 2023). The proposed rulemaking served as the public notice for this ICR amendment, which is available in the public docket. Interested parties were directed to submit comments referencing Docket ID No. EPA-HQ-OPPT-2020-0720. The final rule, Economic Analysis, and ICR were developed with consideration of comments received from the public in response to the notice of proposed rulemaking.

EPA has developed a Response to Comments document that summarizes the comments received and EPA’s responses that were not included and responded to in the preamble. This document is available in the docket for the rulemaking (EPA-HQ-OPPT-2020-0720).

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

This collection does not provide any payment or gift to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.

EPA will not be collecting any information. Therefore, confidential information will not be submitted to EPA.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

The information collection activities do not include questions of a sensitive nature.

12. Provide estimates of the hour burden of the collection of information. The statement should:

1. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

2. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.

3. Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under ‘Annual Cost to Federal Government’.

EPA’s Economic Analysis of the Final Regulation of Perchloroethylene (PCE) (U.S. EPA, 2024) provides the detailed methodology for estimating the number of respondents.

The paperwork burden and associated costs include the activity types listed below. Note that not all entities will incur burden or costs from these activities because they may already be meeting the requirements under as part of their usual business practices.

• Rule familiarization

  • The 122,185 facilities with PRA burdens and costs associated with a WCPP and prescriptive control requirements are assumed to incur an initial cost of $8,714,234 for a 122,185-hour burden (Manufacturing/Managerial labor) associated with rule familiarization.

• The 35,575 facilities with PRA burdens and costs discontinuing PCE use are assumed to incur an initial cost of $1,916,576 for a 11,740-hour burden associated with rule familiarization.

• Downstream notification

  • Each person who processes or distributes in commerce PCE or PCE-containing products for any use must, prior to or concurrent with the shipment, notify companies to whom PCE is shipped, in writing, of the restrictions on its use. It is assumed that 29 respondents (manufacturers, import, and repackage facilities) accomplish this by modifying the SDS to note the restrictions and the burden associated with the downstream notification requirements, including the related recordkeeping, is 19 hours (Manufacturing/Managerial labor), with an associated labor cost of $2,747. Shipment records are assumed to be kept as part of ordinary business practices, and therefore no incremental burden is estimated for this requirement.

• Self-Certification

  • To ensure safe and appropriate use of PCE as an energized electric cleaner and to prevent use of an energized electrical cleaner containing PCE for unintended applications, EPA is requiring a point-of-sale self-certification requirement in order to purchase and subsequently use PCE as an energized electrical cleaner. EPA estimates an initial cost of $143 per facility cost for self-certification by users of aerosol energized electrical cleaners, which is calculated as 2 hours of labor with the fully loaded certified industrial hygienist wage rate.

• Product labeling

  • To prevent the use of an energized electrical cleaner containing PCE for unintended applications, such as automotive maintenance or electrical cleaner, EPA is requiring that all manufacturers (including importers), processors, and distributors in commerce of energized electrical cleaner containing PCE provide a label securely attached to each product. Text for the label is provided in the rule. The initial per product burden associated with product labeling is 3.5 hours resulting in an initial labor cost of $330. EPA also estimates an initial per-product non-labor cost of $659.

• WCPP

  • Under the final rule, the 94 Recycling and Disposal facilities complying with direct dermal contact control requirements and 275 facilities complying with the rule through a WCPP with respiratory exposure requirements are required to develop exposure control plans, monitor exposure levels, maintain records of this monitoring, and provide employees with information about how they can access to the exposure control plans, exposure monitoring records, PPE program implementation documentation, and respirator program documentation. The estimated costs and burdens are as follows:

• The estimated burden and costs for the respiratory exposure monitoring plan and conducting exposure monitoring (generating the exposure monitoring results) depend on the PCE levels determined by the monitoring and are described in Chapter 10 of the economic analysis of the final rule (certified industrial hygienist and technical specialist labor).

• The estimated burden and costs for recordkeeping related to respiratory exposure monitoring depend on the PCE levels determined by the monitoring and are described in Chapter 10 of the economic analysis of the final rule (Manufacturing/Managerial labor).

• The estimated burden and costs for notifications related to exposure monitoring (notifying potentially exposed workers; providing them with access to exposure control plans, exposure monitoring records, PPE program implementation documentation, and respirator program documentation) depend on the PCE levels determined by the monitoring and are described in Chapter 10 of the economic analysis of the final rule (Manufacturing/Managerial labor).

• Workplace requirements for laboratory use

• Under the final rule, 26 facilities complying with the workplace requirements for laboratory use are required to maintain records of documentation of PPE program implementation and implementation of a properly functioning laboratory ventilation devices. EPA believes that facilities using PCE in laboratory settings may already be meeting the requirements as part of their usual business practices. Most laboratories are regulated by OSHA under 29 CFR 1910.1450 requirements for occupational exposure to hazardous chemicals in laboratories. Under 29 CFR 1910.1450, OSHA requires that laboratories maintain a chemical hygiene plan, which would include implementation and documentation of dermal PPE and that specific measures are taken to ensure proper and adequate performance of a chemical fume hood. EPA therefore assumes that the proposed workplace requirements for laboratory use is zero cost and zero burden.

The table below presents the labor rates used to estimate the costs of the labor burdens under the ICR.

Industry Wage Rates (2022$)
Labor Category	Data Series	Date	Wage ($/hour)	Fringe Benefit	Total Compen-sation	Overhead as % of Total Compen-sation1	Overhead	Hourly Loaded Wages
			(a)	(b)	(c) =(b)+(a)	(d)	(e)=(c)*(d)	(f)=(c)+(e)
Manufacturing/‌Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial”2	22-Dec	$54.29	$24.66	$78.95	20%	$15.79	$94.74
Manufacturing/‌Production Worker	BLS ECEC, Private Manufacturing Industries, “Production occupations”2	22-Dec	$21.79	$11.63	$33.42	20%	$6.68	$40.10
Transportation and Public Utilities/‌Managerial	BLS ECEC, Trade, Transportation, and Utilities Industries, “Mgt, Business, and Financial” 2	22-Dec	$54.12	$21.82	$75.94	20%	$15.19	$91.13
Transportation and Public Utilities/‌Maintenance and Repair Worker	BLS ECEC, Trade, Transportation, and Utilities Industries, “Installation, maintenance, and repair”2	22-Dec	$31.08	$15.29	$46.37	20%	$9.27	$55.64
Services/‌Managerial	BLS ECEC, Service-providing Industries, Management, professional, and related occupations, “Mgt, Business, and Financial”	22-Dec	$54.77	$24.99	$79.76	20%	$15.95	$95.71
Services/‌Maintenance and Repair Worker	BLS ECEC, Service-providing Industries, Natural resources, construction, and maintenance occupations, “Installation, maintenance, and repair”	22-Dec	$28.39	$13.15	$41.54	20%	$8.31	$49.85
Certified Industrial Hygienist	Wage: BLS OEWS Occupational Health & Safety Specialists (19-5011) Fringes as percent of wage: BLS ECEC, Private Manufacturing industries, “Professional and related occupations” 3,4	22-May	$39.47	$19.96	$59.43	20%	$11.89	$71.32
Technical Specialist	Wage: BLS OEWS Occupational Health & Safety Technicians (19-5012) Fringes as percent of wage: BLS ECEC, Private Manufacturing industries, “Professional and related occupations” 3,4	22-May	$30.40	$15.38	$45.78	20%	$9.16	$54.93
Vapor Degreasing Technician	Wage: BLS OEWS Plant and Systems Operators (51-8000) Fringes as percent of wage: BLS ECEC, Manufacturing industry	22-May	$33.85	$17.12	$50.97	20%	$10.19	$61.16
Senior Engineer and Technical Advisor (vapor degreasing)	Wage: BLS OEWS Architectural and Engineering Managers (11-9041) Fringes as percent of wage: BLS ECEC, Manufacturing industry	22-May	$78.52	$39.71	$118.23	20%	$23.65	$141.88
1 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 2020e). 2 Source: Employer Costs for Employee Compensation Historical Supplementary Tables, National Compensation Survey: December 2022 (BLS 2023b). 3 Source: Occupational Employment Statistics (Occupational Employment and Wage Statistics) for May 2022 (BLS 2023c). 4 Fringe benefits are not reported in the BLS Occupational Employment and Wage Statistics (OEWS; BLS 2023c). It is therefore assumed that fringes as a percentage of wages are 50.77 percent, based on the percentage for Private Manufacturing Industries, “Professional and related” in the BLS ECEC (BLS 2023b). 5 Fringe benefits are not reported in the BLS OEWS (BLS 2023c). It is therefore assumed that fringes as a percentage of wages are 44 percent, based on the percentage for Health Care and Social Assistance Industry, “Professional and related” in the BLS ECEC (BLS 2023b).

The table below presents the summary of the average annual burden hours and costs per facility associated with the final rule. See Chapter 7 of the economic analysis (U.S. EPA, 2024) for a more detailed description of how the time burden and wage rates were estimated. The burden and cost estimates provided reflect the figures provided in the accompanying Information Collection Request (ICR) for the rule.

Summary of Three Year Average Incremental Burden Hours and Costs

Activity	Number of Respond-ents	Average Annual Responses Per Respondent	Average Annual Burden Per Respondent	Average Annual Total Labor Burden	Average Annual Total Labor Costs
Rule Familiarization (WCPP or PC)	122,185	0.33	1	122,185	$8,714,234
Rule Familiarization (Firms discontinuing PCE use)	35,575	0.33	0.33	11,740	$1,916,576
Downstream Notification (SDS)	29	1	0.67	19	$2,747
Self-Certification	121,759	1	2	243,518	$17,367,704
Product Labeling	6	1	1.16	7	$659
Develop Exposure Control Plan	426	1	12.33	5,253	$374,614
Conduct Regular Inspections	426	1	4	1,704	$121,529
PPE Program Plan Documentation	426	1	4.52	1,926	$137,328
Records Documenting Plan Implementation	426	1	6.78	2,888	$205,992
Records of Dermal Exposure	426	1	0.23	98	$6,988
Respiratory Monitoring	275	3.01	126.55	34,800	$1,979,860
Respiratory Recordkeeping	275	3.01	23.73	6,525	$618,179
Respiratory Notifications	275	3.01	5.6	1,541	$145,994
All Activities	157,760		2.74	432,203	$31,592,405
Note: columns may not sum due to rounding.

13. Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).

1. The cost estimate should be split into two components: (a) a total capital and start- up cost component (annualized over its expected useful life) and

2. (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

3. If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate. Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

There are ongoing monitoring costs incurred by respondents associated with monitoring equipment,¹ laboratory analysis, and shipping costs. These costs are expected to vary depending on the extent to which monitoring results are below or above the existing chemical exposure limit (ECEL). EPA’s Economic Analysis of the Final Regulation of Perchloroethylene (PCE) (U.S. EPA, 2024) describes these cost estimates in detail. These ongoing non-labor costs are summarized in the table below.

Paperwork Non-Labor Cost Associated with Respiratory Monitoring

Threshold	Number of Respondents	Number of Workers	Annual Per Respondent Non-Labor Costs (excludes costs estimated on a per-worker basis)	Annual Per-Worker Non-Labor Cost	Average Annual Per-Respondent Non-Labor Cost	Average Annual Total Non-Labor Cost
<Action Level (1 event in first year)	68	2,919	$80	$139	$6,025	$411,269
Between Action Level and ECEL (2 events per year)	11	224	$160	$278	$5,917	$63,905
1 to <10 times the ECEL (4 events per year)	95	2,788	$320	$556	$16,658	$1,580,320
10 to <25 times the ECEL (4 events per year)	35	911	$320	$556	$14,954	$517,421
25 to <50 times the ECEL (4 events per year)	22	207	$320	$556	$5,511	$122,287
50 to <1,000 times the ECEL (4 events per year)	42	364	$320	$556	$5,161	$215,987
1,000 to <10,000 times the ECEL (4 events per year)	2	17	$320	$556	$4,221	$10,173
Product Labeling	6	-	$220	-	$220	$1,318
All Respondents	281	7,430	-	-	$10,402	$2,922,680
See Table 10-10 of the Economic Analysis. Note: columns may not sum due to rounding.

Non-labor costs for labeling include potential costs associated with disposal of pre-existing labels and packaging and engraving and changing the printing plates. The initial per-product non-labor cost of estimated to be $659.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

There will be no agency collection activities under the final rule. There will only be third-party notification and recordkeeping requirements.

15. Explain the reasons for any program changes or adjustments reported in hour or cost burden.

This is a new, rule-related information collection. Therefore, the reported burden reflects a program change.

16. For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

Not applicable.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.

Not applicable.

18. Explain each exception to the certification statement identified in “Certification for Paperwork Reduction Act Submissions.”

EPA does not request an exception to the certification of this information collection.

SUPPLEMENTAL INFORMATION

This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-NEW). Responses to this collection of information are mandatory (40 CFR ). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to be .33 to 2.74 hours per response. Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

LIST OF ATTACHMENTS

The attachments listed below can be found in the docket for this ICR. The docket for this ICR is accessible electronically through https://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2020-0720.

Ref.	Title (hyperlink)
2.	Final Rule
3.	Economic Analysis
4.	Stakeholder Meeting Index (Updated)

References

TSCA section 6 (15 U.S.C. 2605)

1 ¹ Monitoring equipment is assumed to be rented, so it is an ongoing cost rather than a capital cost.