2744ss02

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 of Carbon Tetrachloride under TSCA Section 6(a) (Final Rule; RIN 2070-AK82)

EPA ICR No.: 2744.02

OMB Control No.: 2070-0228

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

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 carbon tetrachloride (CTC) under its conditions of use. This ICR covers the following information collection activities contained in the final rule:

• 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) and their designated representatives 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 properly functioning laboratory ventilation devices, such as fume hoods or glove boxes.

• Third-party downstream notifications from companies that ship CTC to companies downstream in the supply chain through the SDS to communicate the 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 WCPP requirements and restrictions on the laboratory use of CTC.

The final rule also requires 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 Total Number of Respondents	Average Annual Total Labor Burden	Average Annual Total Labor Costs (2023$)	Average Annual Total Non-Labor Costs (2023$)	Average Annual Total Costs (2023$)
Agency	-	-	-	-	-	-	-
Rule Familiarization	72	0.33	24	72	$6,701	-	$6,701
Downstream Notification	72	0.33	24	27	$2,342	-	$2,342
Develop Plan	63	0.2	13	840	$62,261	-	$62,261
Regular inspections	63	1.00	63	252	$18,678	-	$18,678
PPE Program Plan: Employee records (type of gloves for each employee)	63	1.00	63	2,317	$171,711	-	$171,711
PPE Program Plan: Employee records (implementation of program, training)	63	1.00	63	3,475	$257,567	-	$257,567
Record of dermal exposure	63	1.00	63	116	$8,586	-	$8,586
Monitoring	63	2.89	182	68,720	$3,947,211	$9,360,626	$13,307,838
Recordkeeping and Notification	63	2.91	183	10,368	$964,970	-	$964,970
Total:	585	-	678	86,186	$5,440,027	$9,360,626	$14,800,653

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 CTC.

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: 72.

Frequency of response: On occasion.

Estimated total annual burden: 86,186 hours. Burden is defined at 5 CFR 1320.3(b).

Estimated total annual costs: $14,800,653.

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 is finalizing the following requirements:

1. Prohibit after 180 days from the publication date of this rule the following conditions of use:

   1. Incorporation of CTC into formulation, mixture or reaction products in petrochemical-derived manufacturing except in the manufacture of vinyl chloride;

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

   3. Industrial and commercial use in the manufacturing of other basic chemicals (including chlorinated compounds used in solvents, adhesives, asphalt, paints and coatings), other than to eliminate nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine;

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

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

2. Prohibit after 365 days from the publication date of this rule the following conditions of use:

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

3. Require full implementation of a CTC WCPP, which would include an 8-hour time-weighted average (TWA) existing chemical exposure concentration limit (ECEL) of 0.03 ppm in combination with direct dermal contact controls (DDCC) after 1080 days from the publication 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, vinyl chloride 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 and vinyl chloride;

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

   9. Disposal of CTC.

4. Require use of laboratory ventilation devices, such as fume hoods or glove boxes, and dermal personal protective equipment (PPE) after 365 days for Federal agencies and Federal contractors acting for or on behalf of the Federal government or after180 days for non-Federal owners and operators from the publication date of this rule for the following conditions of use:

   1. Industrial and commercial use of CTC as a laboratory chemical, except for the U.S. Department of Defense’s use of CTC as a laboratory chemical.

5. Require use of advanced engineering controls at DoD facilities and dermal PPE after 365 days from the publication date of this rule.

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

6. Require manufacturers (including importers), processors, and distributors of CTC to provide downstream notification of the requirements after 180 days from the publication date of this rule.

7. Require recordkeeping after 60 days from the publication of this final 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 carbon tetrachloride 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 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 final 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 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 2020 Risk Evaluation for Carbon Tetrachloride. 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 final 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 final 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 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:

a) requiring respondents to report information to the agency more often than quarterly;

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

c) requiring respondents to submit more than an original and two copies of any document;

d) 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 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 regulation. EPA has tailored this timeframe to coincide with the statute of limitations for civil penalty enforcement (28 U.S.C. 2842). EPA 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 rule, EPA is also requiring 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.

EPA developed the proposed rule titled “Carbon Tetrachloride (CTC); Regulation under the Toxic Substances Control Act (TSCA)” rule and published them in the Federal Register for public comment (88 FR 4918, July 28, 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-2020-0592. 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-2020-0592).

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:

a) 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.

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

c) 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 Regulation of Carbon Tetrachloride (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 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 72 respondents would incur an average of 72 burden hours per year 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 72 respondents would incur a total of 27 burden hours per year, averaged over the first three years of the rule.

• WCPP (Dermal Protection and Respiratory Protection)

  • Under the final rule, the 63 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. 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 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 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 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 ($2023)
Labor Category	Data Series	Date	Wage ($/hour)1	Fringe Benefit	Total 3	Overhead as % of Total Compen-sation2	Overhead	Hourly Loaded Wages
			(a)	(b)	(c) =(b)+(a)	(d)	(e)=(c)*(d)	(f)=(c)+(e)
Managerial	BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial” 3	Dec-23	$53.10	$24.46	$77.56	20%	$15.51	$93.07
Production Worker	BLS ECEC, Private Manufacturing Industries, “Production occupations” 3	Dec-23	$22.74	$12.41	$35.15	20%	$7.03	$42.18
Physician's Assistant	OES: "Health Care and Social Assistance (Sector 62) - (29-1071)“Physicians Assistant”. Fringes as percent of wage: BLS ECEC, Health care and social assistance industry, “Professional and related occupations”	May-23	$62.88	$27.46	$90.34	20%	$18.07	$108.41
Industrial Hygienist Specialist	Wage: BLS OEWS Occupational Health & Safety Specialists (19-5011) Fringes as percent of wage: BLS ECEC, Private Manufacturing industries, “Professional and related occupations”	May-23	$41.14	$20.62	$61.76	20%	$12.35	$74.12
Industrial Hygienist Technicians	Wage: BLS OEWS Occupational Health & Safety Technicians (19-5012) Fringes as percent of wage: BLS ECEC, Private Manufacturing industries, “Professional and related occupations”	May-23	$30.89	$15.49	$46.38	20%	$9.28	$55.65
1 Wage data are rounded to the closest dollar figure in this table; however, in calculations using these numbers for this report, unrounded values were used. 2 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 2020b). 3 Employer Costs for Employee Compensation Historical Supplementary Tables, National Compensation Survey: December 2006 – December 2020 (BLS 2022a); Occupational Employment Statistics (Occupational Employment and Wages) for May 2020, (BLS 2021b).

The table below presents the summary of the average annual burden hours and costs per facility associated with the final rule. See Chapter 3 of the economic analysis for a more detailed description of how the time burden and wage rates were estimated.

Summary Burden for Technical and Clerical Staff

Activity	Number of Respondents	Average Annual Burden per Respondent for Technical and Clerical Staff	Average Annual Burden for Technical and Clerical Staff
Agency	-	-	-
Rule Familiarization	72	1	72
Downstream Notification	72	0.37	27
Develop Plan	63	13	840
Regular inspections	63	4	252
PPE Program Plan: Employee records (type of gloves for each employee)	63	37	2,317
PPE Program Plan: Employee records (implementation of program, training)	63	55	3,475
Record of dermal exposure	63	2	116
Monitoring	63	1,091	68,720
Recordkeeping and Notification	63	165	10,368
Total:			86,186

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).

a) 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.

b) 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.

c) 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 Regulation of Carbon Tetrachloride (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	Average Events Per Respon-dent Annually	Number of Workers	Annual Per Respondent Non-Labor Costs (excludes costs estimated on a per-worker basis)	Annual Per-Worker Non-Labor Cost (2023$)	Average Annual Per-Respondent Cost	Average Annual Total Cost (2023$)
<Action Level	1		220	0	$77	$11,409	$16,885
Between Action Level and Limit	2		344	0	$384	$62,629	$132,148
< 10 times the ECEL	49		11,659	0	$691	$162,762	$8,053,482
< 25 times the ECEL	8		1,457	0	$691	$119,071	$1,006,146
< 50 times the ECEL	1		220	0	$691	$102,679	$151,965
< 1,000 times the ECEL	0		0	0	$691	$0	$0
< 10,000 times the ECEL	0		0	0	$691	$0	$0
Total:	63		13,900				$9,360,626

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 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 86,186 hours per year. The total annual cost burden requested for this ICR is $14,800,653.

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. 2070-0228). Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR Part 751. 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 1,197 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 Information Engagement 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 accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2020-0592.

Ref.	Title (hyperlink)
1.	Final Rule

REFERENCES

EPA. (2024). Final Rule; Economic Analysis.

EPA (2024). Stakeholder Meeting Index

EPA (2024). Response to Comments

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