2744ss01

Public Review Draft (June 2023)

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: Carbon Tetrachloride; Regulation under the Toxic Substances Control Act (TSCA) (Proposed Rule; RIN 2070-AK84)

EPA ICR No.: 2744.01

OMB Control No.: 2070-NEW

Docket ID No.: EPA-HQ-OPPT-2020-0592

Abstract

The Environmental Protection Agency (EPA) proposed a rule under section 6 of the Toxic Substances Control Act (TSCA) to address the unreasonable risk to human health presented by carbon tetrachloride (CTC) under its conditions of use. Specifically, EPA is proposing to:

• Prohibit the manufacture (including import), processing, distribution in commerce, and use of CTC for certain conditions of use;

• Require a workplace chemical protection program (WCPP), which would include requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact, for certain conditions of use not prohibited;

• Require prescriptive workplace controls for laboratory use; and

• Establish recordkeeping and downstream notification requirements.

The information collection activities contained in the proposed rule are:

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

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

  • Development of an exposure control plan;

  • Exposure level monitoring and related recordkeeping;

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

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

  • 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; and

  • If engineering controls that vent CTC to ambient air outside the workplace are used, attestation that exposure controls selected do not increase emissions of CTC to ambient air outside of the workplace and whether additional equipment was installed to capture or otherwise prevent increased emissions of CTC to ambient air.

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

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

  • Development of documentation demonstrating implementation of a properly functioning fume hood.

• Third-party downstream notifications from companies that ship CTC to companies downstream in the supply chain through the SDS to communicate the proposed prohibitions;

• Development and retention of related records, including ordinary business records, such as invoices and bills-of-lading related to the continued distribution of CTC in commerce, as well as records documenting compliance with the proposed WCPP requirements and proposed restrictions on the laboratory use of CTC.

The proposed rule would require that records be retained for 5 years from the date of generation.

Summary of Annual Burden and Costs

Activity	Number of Respondents	Average Annual Responses Per Respondent	Average Annual Burden Per Respondent	Average Annual Total Labor Burden	Average Annual Total Labor Costs	Average Annual Total Non-Labor Costs	Average Annual Total Costs
Agency	-	-	-	-	-	-	-
Rule Familiarization	71	0.33	1	71	$6,616	-	$6,616
Downstream Notification	71	0.33	0.37	26	$2,301	-	$2,301
Develop Plan	62	0.33	13	827	$31,387	-	$31,387
Regular inspections	62	1	4	248	$9,416	-	$9,416
PPE Program Plan: Employee records (type of gloves for each employee)	62	1	36	2,246	$85,270	-	$85,270
PPE Program Plan: Employee records (implementation of program, training)	62	1	54	3,369	$127,905	-	$127,905
Record of dermal exposure	62	1	36	2,246	$4,263	-	$4,263
Monitoring	62	2.89	1,074	66,596	3,452,873	8,516,686	$11,969,559
Recordkeeping and Notification	62	2.91	162	10,048	936,261	-	$936,261
Total:				85,676	$4,656,293	$8,516,686	$13,172,979

Summary

Legal authority: The Toxic Substances Control Act (TSCA), 15 U.S.C. § 2605(a).

Respondents/affected entities: Manufacturers (including importers), processors, distributors, and industrial and commercial users of carbon tetrachloride.

Respondent’s obligation to respond: Mandatory. 15 U.S.C. 2605(a) and 40 CFR part 751.

Confidentiality of responses: Not applicable.

Total Burden and Costs

Estimated total number of potential respondents: 71.

Frequency of response: Upon request by EPA enforcement.

Estimated total annual burden: 85,676 hours. Burden is defined at 5 CFR 1320.3(b).

Estimated total annual costs: $13,172,979

Changes in the estimates: Not applicable. This is a request for a new OMB Control Number.

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.

EPA proposed to:

1. Prohibit after 6 months from the effective date of this rule the following conditions of use:

   1. Incorporation of CTC into formulation, mixture or reaction products in petrochemical-derived manufacturing;

   2. Industrial and commercial use of CTC as an industrial processing aid in the manufacture of petrochemicals-derived products;

   3. Industrial and commercial use of CTC in the manufacture of most other basic chemicals (including manufacturing of chlorinated compounds used in solvents, adhesives, asphalt, and paints and coatings) (however, EPA is proposing a WCPP for the elimination of nitrogen trichloride in the production of chlorine and caustic soda);

   4. Industrial and commercial use of CTC in metal recovery;

   5. Industrial and commercial use of CTC as an additive.

2. Prohibit after 12 months from the effective date of this rule the following conditions of use:

   1. Industrial and commercial use of CTC in specialty uses by the DoD.

3. Require a CTC WCPP, which would include an 80-hour time-weighted average (TWA) existing chemical exposure concentration limit (ECEL) of 0.03 ppm in combination with direct dermal contact controls (DDCC) after 6 months from the effective date of this rule for the following conditions of use:

   1. Domestic manufacture of CTC;

   2. Import of CTC;

   3. Processing of CTC as a reactant in the production of HCFCs, HFCs, HFOs, and PCE;

   4. Incorporation of CTC into formulation, mixture, or reaction products in agricultural products manufacturing and other basic organic and inorganic chemical manufacturing;

   5. Repackaging of CTC for use in laboratory chemicals;

   6. Recycling of CTC;

   7. Industrial and commercial use of CTC as an industrial processing aid in the manufacture of agricultural products;

   8. Industrial and commercial use of CTC in the elimination of nitrogen trichloride in the production of chlorine and caustic soda; and,

   9. Disposal of CTC.

4. Require use of a fume hood, advanced engineering controls at DoD facilities, and dermal personal protective equipment (PPE) after 6 months from the effective date of this rule for the following conditions of use:

   1. Industrial and commercial use of CTC as a laboratory chemical.

5. Require manufacturers (including importers), processors, and distributors of CTC to provide downstream notification of the requirements after 6 months from the effective date of this rule.

6. Require recordkeeping the effective date of this rule, including: ordinary business records, ECEL exposure monitoring (i.e., information on when the sample was taken, conditions that may affect the monitoring results, information regarding the person monitored, analytical methods and compliance with 40 CFR Part 792, and information regarding air monitoring equipment); ECEL compliance (i.e., exposure control plan, facility exposure monitoring records, respiratory protection used and program implementation, notifications of exposure monitoring results, information and training provided); compliance with DDCC requirements (i.e., exposure control plan, dermal personal protective equipment and program implementation, information and training provided); and laboratory chemical compliance.

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 methylene chloride under the conditions of use.

Downstream Notification. Without the downstream notification requirement, there is a greater likelihood that non-prohibited uses of CTC 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 would 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 would be required for manufacturers, processors, and distributors in commerce of CTC, who would notify companies downstream upon shipment of CTC about the prohibitions. The information submitted to downstream companies through the SDS would provide 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 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 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, exposure control plan records, and records related to exemptions. 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 CTC. 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 proposed rule would 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 proposed rule would not establish reporting requirements, so no information would be submitted to EPA. Therefore, there is no need for any technology facilitation under the proposed 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 November 2020 Carbon Tetrachloride Risk Evaluation. While this collection activity required by EPA is similar to those of other Federal agencies such as OSHA, EPA is setting a lower exposure threshold than the OSHA 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 CTC 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.

This action will not have a significant economic impact on a substantial number of small entities.

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 proposed rule (i.e., the exposure of workers, ONUs, and potentially exposed persons 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 CTC. Due to EPA’s determination that CTC presents an unreasonable health risk, the proposed risk management rule involves information collection activities that are intended to ensure that CTC does not present unreasonable risks, 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 proposed 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;

5. 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;

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

7. 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

8. 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 proposed rulemaking and information collection activity will require that regulated entities retain records for a duration of 5 years from the date of its inception such as invoices and bills-of-lading, that demonstrate compliance with the prohibitions, restrictions, and other provisions of this proposed regulation. EPA has tailored this timeframe to coincide with the statute of limitations for civil penalty enforcement (28 U.S.C. 2842). expects that 5-year retention of records for a WCPP is necessary for effective implementation and enforcement of this rulemaking. For conditions of use that are not otherwise prohibited under this proposed regulation, EPA is also proposing that manufacturers (including importers), processors, and distributors of CTC provide downstream notification of the prohibitions through Safety Data Sheets (SDSs).

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.

The proposed rulemaking serves as the public notice for this ICR. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2020-0592 to the address listed at the end of this document. EPA will address any comments received from OMB or the public concerning the information collection activities contained in the rule, and the agency’s response, when developing the final rule.

EPA has engaged in significant consultation and outreach with the regulated community and other affected entities during development of the proposed rulemaking. Key opportunities to obtain public input on the availability and type of data that should be required, frequency of monitoring, and methods for carrying out downstream notification include the outreach meetings with representatives from different industries, non-governmental organizations, technical experts and users of CTC. A list of external meetings held during the development of this proposed rule is in the docket. The purpose of these discussions was to create awareness and educate stakeholders and regulated entities on the provisions for risk management required under section 6(a) of TSCA; obtain input from manufacturers, processors, distributors, users, academics, advisory councils, and members of the public health community about uses of CTC; identify workplace practices, engineering controls, administrative controls, PPE, and industrial hygiene plans currently in use or feasibly adoptable to reduce exposure to CTC under the conditions of use; generate potential risk reduction strategies; and understand the type of recordkeeping, notifications, and reporting already ongoing.

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 Proposed Regulation of Carbon Tetrachloride (U.S. EPA, 2022) 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 would 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

  • Each facility would incur a 3-hour burden associated with rule familiarization in the first year. An estimated 71 respondents would incur a total of 71 burden hours per year, averaged over the first three years of the rule.

• Downstream notification

  • Each person who processes or distributes in commerce CTC must, prior to or concurrent with the shipment, notify companies to whom CTC is shipped, in writing, of the restrictions on its use. An estimated 71 respondents would incur a total of 26 burden hours per year, averaged over the first three years of the rule.

• WCPP (Dermal Protection and Respiratory Protection)

  • Under the proposed rule primary option, the 62 facilities complying with the rule through a WCPP would be required to develop exposure control plans, monitor exposure levels, maintain records of this monitoring, and provide employees with information about how they can access the exposure control plans, exposure monitoring records, PPE program implementation documentation, respiratory protection program, and dermal protection program documentation. 9 facilities not subject to the WCPP would be required to comply with the dermal protection requirements only. 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 CTC levels determined by the monitoring and are described in Chapter 3 of the economic analysis of the proposed rule (certified industrial hygienist and technical specialist labor).

    • The estimated burden and costs for recordkeeping related to respiratory exposure monitoring depend on the CTC levels determined by the monitoring and are described in Chapter 3 of the economic analysis of the proposed 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, respirator program documentation, and dermal protection program documentation) depend on the CTC levels determined by the monitoring and are described in Chapter 3 of the economic analysis of the proposed rule (Manufacturing/Managerial labor).

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

Industry Wage Rates (2021$)
Labor Category	Data Series	Date	Wage ($/hour)	Total Compen-sation	Overhead1	Hourly Loaded Wages
			(a)	(b)	(c)	(d)=(b)+(c)
Manufacturing/ Production Worker	BLS ECEC, Private Manufacturing Industries, “Production occupations”2	Dec-21	$20.77	$31.64	$6.33	$37.97
Manufacturing/ Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial”2	Dec-21	$53.49	$77.65	$15.53	$93.18
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” 3,4,5	May-21	$37.86	$57.08	$11.42	$68.50
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” 3,4,5	May-21	$27.67	$41.72	$8.34	$50.06
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 2020f). 2 Source: Employer Costs for Employee Compensation Historical Supplementary Tables, National Compensation Survey: December 2006 – December 2020 (BLS 2022a). 3 Source: Occupational Employment Statistics (Occupational Employment and Wage Statistics) for May 2021, (BLS 2022b). 4 Fringe benefits are not reported in the BLS OEWS (BLS 2022b). It is therefore is assumed that fringes as a percentage of wages are 50.77%, based on the percentage for Private Manufacturing Industries, “Professional and related” in the BLS ECEC (BLS 2022a). 5 Fringe benefits are not reported in the BLS OEWS (BLS 2022b). It is therefore is assumed that fringes as a percentage of wages are 44%, based on the percentage for Health Care and Social Assistance Industry, “Professional and related” in the BLS ECEC (BLS 2022a).

The table below presents the summary of the average annual burden hours and costs per facility associated with the proposed option. See Chapter 3 of the economic analysis 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 3-Year Burden for Technical and Clerical Staff

Activity	Number of Respondents	Average 3-Year Burden per Respondent for Technical and Clerical Staff	Total 3-Year Burden for Technical and Clerical Staff
Agency	-	-	-
Rule Familiarization	71	1	71
Downstream Notification	71	0.37	26
Develop Plan	62	13	827
Regular inspections	62	4	248
PPE Program Plan: Employee records (type of gloves for each employee)	62	36.22	2,246
PPE Program Plan: Employee records (implementation of program, training)	62	54.33	3,369
Record of dermal exposure	62	36.22	2,246
Monitoring	62	1,074	66,596
Recordkeeping and Notification	62	162	10,048
Total:			85,676

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

(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.

2. 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.

3. 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, 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 Proposed Regulation of Carbon Tetrachloride (U.S. EPA, 2022) 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	Average Events Per Respondent Annually	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 Cost	Average Annual Total Cost
<Action Level	1.48	0.33	220	$0	$72	$10,715	$15,858
Between Action Level and Limit	2.10	1.67	341	$0	$360	$58,544	$122,942
< 10 times the ECEL	48.63	3.00	11,292	$0	$649	$150,638	$7,325,549
< 25 times the ECEL	8.31	3.00	1,402	$0	$649	$109,460	$909,612
< 50 times the ECEL	1.48	3.00	220	$0	$649	$96,436	$142,725
< 1,000 times the ECEL	0.00	0.00	0	$0	$0	$0	$0
< 10,000 times the ECEL	0.00	0.00	0	$0	$0	$0	$0
Total:	62		13,475				$8,516,686

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 proposed rule. There will only be third-party notification and recordkeeping requirements. Annualized costs for recordkeeping requirements are not provided as costs are only incurred during the first three years of the rule.

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. The total burden requested for this ICR is 85,676 hours per year. The total annual cost burden requested for this ICR is $13,172,979.

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

The annual public burden for this collection of information is estimated to average approximately 1,382 hours annually per respondent over the three-year period. According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to review and understand instructions; prepare and submit reports (including searching data sources); complete and review the collection of information; transmit the information; and keep records.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OPPT-2020-0592, which is available at http://www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select “search,” then key in the Docket ID Number identified above.

You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via http://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review— Open for Public Comments’’ or by using the search function.

All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

LIST OF ATTACHMENTS

The attachments listed below can be found in the docket for this ICR or by using the hyperlink that is provided in the list below. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ- 2020-0465.

Ref.	Title (hyperlink)
1.	TSCA section 6 (15 U.S.C. 2605)
2.	Proposed Rule
3.	Economic Analysis
4.	Stakeholder Meeting Index

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