Supporting
Statement for an Information Collection Request (ICR)
Under
the Paperwork Reduction Act (PRA)
Title: |
TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Revision to Regulation |
EPA ICR No.: |
2682.03 |
OMB Control No.: |
2070-0217 |
Docket ID No.: |
EPA-HQ-OPPT-2020-0549 |
The U.S. Environmental Protection Agency (EPA or Agency) is proposing amendments to the Toxic Substances Control Act (TSCA) regulation for reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS). As promulgated in October 2023, the regulation requires manufacturers (including importers) of PFAS in any year between 2011-2022 to report certain data to EPA related to exposure and environmental and health effects. EPA is proposing to incorporate certain exemptions and other modifications to the scope of the reporting regulation. These exemptions would maintain important reporting on PFAS, consistent with statutory requirements, while exempting reporting on activities about which manufacturers are least likely to know or reasonably ascertain. The total one-time burden and cost of the reporting requirements are summarized in Table 1. Table 2 annualizes the burden and cost over a three-year ICR approval period (although the reporting is a one-time activity).
Activity |
Number of Firms |
Number of Responses |
Per-Firm Unit Burden |
Total 3-Year Burden |
Per-Firm Unit Cost |
Total 3-Year Cost (2024$) |
Per-Firm Unit Cost |
Total 3-Year Cost (2024$) |
3% Discount Rate |
7% Discount Rate |
|||||||
Rule Familiarization |
255 |
1,461 |
9 |
2,354 |
$834 |
$212,361 |
$834 |
$212,361 |
Compliance Determination |
255 |
1,461 |
0 |
0 |
$0 |
$0 |
$0 |
$0 |
Form Completion |
255 |
1,461 |
505 |
128,486 |
$43,079 |
$10,964,818 |
$43,079 |
$10,964,818 |
CBI Substantiation |
255 |
1,461 |
4 |
1,024 |
$352 |
$89,532 |
$352 |
$89,532 |
Recordkeeping |
255 |
1,461 |
6 |
1,461 |
$369 |
$93,936 |
$369 |
$93,936 |
CDX Registration |
255 |
1,461 |
3 |
679 |
$246 |
$62,682 |
$246 |
$62,682 |
Respondent Total |
255 |
1,461 |
526 |
134,004 |
$44,880 |
$11,423,330 |
$44,880 |
$11,423,330 |
Agency |
|
|
|
|
|
$1,033,525 |
|
$1,003,080 |
Activity |
Number of Respondents |
Number of Responses |
Responses per Respondent |
Annual Burden |
Per-Firm Unit Cost |
Annual Cost (2024$) |
Per-Firm Unit Cost |
Annual Cost (2024$) |
3% Discount Rate |
7% Discount Rate |
|||||||
Rule Familiarization |
255 |
1,461 |
6 |
785 |
$278 |
$70,787 |
$278 |
$70,787 |
Compliance Determination |
255 |
1,461 |
6 |
1 |
$0 |
$0 |
$0 |
$0 |
Form Completion |
255 |
1,461 |
6 |
42,829 |
$14,360 |
$3,654,939 |
$14,360 |
$3,654,939 |
CBI Substantiation |
255 |
1,461 |
6 |
341 |
$117 |
$29,844 |
$117 |
$29,844 |
Recordkeeping |
255 |
1,461 |
6 |
487 |
$123 |
$31,312 |
$123 |
$31,312 |
CDX Registration |
255 |
1,461 |
6 |
226 |
$82 |
$20,894 |
$82 |
$20,894 |
Respondent Total |
255 |
1,461 |
6 |
44,668 |
$14,960 |
$3,807,777 |
$14,960 |
$3,807,777 |
Agency |
|
|
|
|
|
$344,508 |
|
$334,360 |
TSCA section 8(a)(7) (15 USC 2607) ad codified at 40 CFR 705 (Ref. 2) requires EPA to collect certain information on PFAS manufactured (including imported) in the United States in any year since January 1, 2011 (Ref 1). In addition, the requirements were put in place following enactment of the FY2020 National Defense Authorization Act, which amended TSCA in December 2019. Claims of confidentiality are covered under TSCA section 14 (See 82 FR 6522, January 19, 2017).
Under TSCA, EPA is charged with protecting human health and the environment from potential chemical risks. Through the PFAS Data Call regulation, EPA collects exposure-related manufacturing information and all existing information concerning the environmental and health effects of these chemicals. These data are used by the Agency and others in a wide range of activities.
The information collected under this data call will improve EPA’s exposure-related data on manufacturing, processing, and use of chemical substances that are PFAS, as well as require covered manufacturers to provide EPA with all existing information on the environmental or human health effects of such substances.
Additionally, under TSCA section 14, claims of confidentiality (other than for selected data elements such as production volume) must be substantiated at the time information is submitted to EPA, including as part of Chemical Data Reporting (CDR) rule (See 82 FR 6522, January 19, 2017). To ensure that EPA can use TSCA section 8(a) data most effectively, TSCA requires substantiation to enable EPA to review the legitimacy of confidentiality claims.
EPA’s Office of Pollution Prevention and Toxics (OPPT), other EPA offices, and/or other public entities (including other federal agencies and tribal, state, and local governments) are generally the primary groups for which information will be collected. However, to the extent that reported information is not considered to be confidential business information (CBI), EPA may provide such data to other non-Federal entities, including the general public.
The reporting methods, including the reporting tool and electronic registration, help to ensure that the information reported to EPA is accurate and in compliance with the statutory requirements. In addition, the data elements have practical utility for users of the data within EPA. Staff in OPPT would be able to use information collected on the production volumes, categories of use, disposal, byproducts, and worker exposure-related information in future screening-level assessments of potential exposure to these PFAS. Additionally, other offices in EPA will benefit from information collected, such as data on the disposal, releases, and other waste management methods of PFAS. Many offices across EPA are fulfilling other statutory obligations and directives under the Agency’s PFAS Strategic Roadmap, and this first nationwide dataset on PFAS, production, use, disposal, and exposure-related information will complement these activities and provide necessary screening-level data.
EPA is requiring electronic reporting for all reporting submissions. Persons submitting information under this section 8(a)(7) rule will be required to use the 8(a)(7) PFAS Reporting Tool, a reporting application accessed through the Agency’s CDX platform. The 8(a)(7) PFAS Reporting Tool is currently under development and testing. The tool is based on e-CDRweb, the Agency’s online application for completing the CDR reporting form (Form U) in the past CDR reporting cycles. Screenshots of the 8(a)(7) PFAS Reporting Tool are included here (Attachment A).
The data included in this information collection are not collected comprehensively or systematically at the national level by any other entities. However, EPA identified certain data elements that may be duplicative of other reporting rules: the CDR rule under TSCA section 8; the Greenhouse Gas Reporting Program (GHGRP); the Toxics Release Inventory (TRI). Similarly, past submissions of information concerning environmental and health effects of PFAS may have been provided to EPA as an unpublished health and safety study under TSCA section 8(d), or a notification of substantial risks under TSCA section 8(e).
TSCA section 8(a)(5)(A) requires EPA, to the extent feasible when carrying out TSCA section 8, to avoid requiring unnecessary or duplicative reporting. To address potentially duplicative reporting, EPA is identifying specific types of information that need not be reported again if the reporting entity indicates in the reporting tool that they have previously provided such information to EPA and provides information sufficient to allow the agency to locate that information. In these cases, the manufacturer is required to indicate to which program (and in which year) that information was submitted (e.g., CDR in 2016; section 8(d) health and safety study in 2020).
However, EPA notes that there are many reporting exemptions and other discrepancies between this rule and the CDR, GHGRP, and TRI reporting regulations. Therefore, potential duplication of these data elements to any of the aforementioned rules is limited to the extent that the previous submissions reflect the same activities and quantities that are being requested under this rule. Additionally, this rule requires information to be reported for each year in which a PFAS was manufactured since January 1, 2011, while some other rules do not have the same annual reporting requirements. The Agency will avoid collecting data on PFAS that would duplicate information already reported to the Agency, while ensuring it obtains all data required to be collected under TSCA section 8(a)(7) and that such data are submitted in a format that is conducive to the collection and review of a manufactured PFAS dataset.
Unlike TSCA section 8(a)(1) rules, the proposed rule under TSCA section 8(a)(7) would not exempt small manufacturers from reporting and recordkeeping requirements. Affected small entities are generally small businesses. Because this rule is limited to those who have manufactured PFAS for commercial purposes, there is a very low likelihood of requiring reporting by any small governments or small not-for-profit organizations.
This is a one-time statutorily mandated reporting event.
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.
The recordkeeping period of this collection is five years. The five-year record retention period is consistent with the statute of limitations and other TSCA reporting rules (e.g., CDR).
Reporters may also assert and substantiate CBI when submitting information under this rule. EPA has long-established procedures for properly handling, storing, processing, and disposing of TSCA confidential information. Transfers of this information to others as allowed under TSCA section 14(d) can be made only if the other entity agrees to adhere to all TSCA confidentiality provisions. EPA will maintain standard confidentiality procedures to protect any confidential, trade secret, or proprietary information from disclosure in accordance with EPA’s confidentiality regulation, 40 CFR Part 2, Subpart B.
On 11/13/25 the FRN for this proposed rule published (90 FR 50923). This inititated the final comment period for this proposed rule. Copies of the proposed rules, ICRs, comments received, and EPA’s Response to Comments document are available in the docket.
Under 5 CFR 1320.8(d)(3), agencies are required to consult with potential ICR respondents and information users about specific aspects of ICRs before submitting an ICR to OMB for review and approval.
On September 5, 2024, EPA published a direct final rule and a parallel proposed rule (89 FR 72362) to move the start of the submission period to accommodate the need for additional time to develop and effectively test the reporting application in EPA’s CDX platform. For the proposed rule, EPA received 7 unique comments from regulated companies and trade associations in support of providing additional time for reporting given the scope of information requested under the 2023 TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP)).
This question is not applicable to this ICR.
Confidentiality claims limit access to the PFAS data, especially by the public. EPA recognizes that some information submitted to the Agency is legitimately confidential. Therefore, EPA’s review of confidential data is an inherently governmental function that EPA must perform to protect human health and the environment. EPA has identified specific data elements that cannot be claimed as confidential, consistent with TSCA section 14. These data elements are also not allowed to be claimed as confidential in CDR reporting. Also consistent with TSCA CBI submission requirements, EPA will require submitters provide upfront substantiation when asserting eligible data elements as CBI in this rule.
Submitters may claim most information reported to EPA under this rule as confidential if such information would reveal the submitter’s trade secrets or proprietary information as defined by TSCA section 14 and existing regulations promulgated by EPA under TSCA.
EPA has long-established procedures for properly handling, storing, processing, and disposing of TSCA confidential information. Transfers of this information to others as allowed under TSCA section 14(d) can be made only if the other entity agrees to adhere to all TSCA confidentiality provisions. EPA will maintain standard confidentiality procedures to protect any confidential, trade secret, or proprietary information from disclosure in accordance with EPA’s confidentiality regulation, 40 CFR Part 2, Subpart B.
EPA asks no questions of a sensitive nature.
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.
If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
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’
This section of the ICR describes the respondents, the information collection activities and related estimates of burden and costs associated with those activities. Burden estimates are derived consistent with estimates described in the draft Economic Analysis for the proposed revision to the PFAS Data Call Rule (EPA 2025).
Methodology for Estimating Respondent Burden and Costs
The regulated community consists of companies manufacturing (including importing) PFAS chemical substances in any year since January 1, 2011. Based on the parent companies that reported manufacturing or importing PFAS chemicals subject to the proposed rule to the 2016 and 2020 CDR, the Agency’s previous experience with TSCA section 8(a) data collections, and the Agency’s understanding of disposal and other waste management methods involving PFAS, the Agency expects that this rule will affect firms in the North American Industry Classification System (NAICS) categories listed in Table 3. The list in Table 3 is not exhaustive and may not describe the specific entities and corresponding NAICS codes for entities that may be affected by the proposed rule. Other types of entities could also be affected.
NAICS |
NAICS Description |
221210 |
Natural Gas Distribution |
324 |
Petroleum and Coal Product Manufacturing |
324110 |
Petroleum Refineries4 |
324191 |
Petroleum Lubricating Oil and Grease Manufacturing |
325 |
Chemical Manufacturing |
325120 |
Industrial Gas Manufacturing |
325199 |
All Other Basic Organic Chemical Manufacturing |
325211 |
Plastics Material and Resin Manufacturing |
325212 |
Synthetic Rubber Manufacturing |
325412 |
Pharmaceutical Preparation Manufacturing |
325998 |
All Other Miscellaneous Chemical Product and Preparation Manufacturing |
327211 |
Flat Glass Manufacturing |
333415 |
Air Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing |
334118 |
Computer Terminal and Other Computer Peripheral Equipment Manufacturing |
334513 |
Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables |
336110 |
Automobile and Light Duty Motor Vehicle Manufacturing |
336412 |
Aircraft Engine and Engine Parts Manufacturing |
337126 |
Household Furniture (except Wood and Upholstered) Manufacturing |
339112 |
Surgical and Medical Instrument Manufacturing |
423120 |
Motor Vehicle Supplies and New Parts Merchant Wholesalers |
423690 |
Other Electronic Parts and Equipment Merchant Wholesalers |
423990 |
Other Miscellaneous Durable Goods Merchant Wholesalers |
424690 |
Other Chemical and Allied Products Merchant Wholesalers |
424720 |
Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals) |
424950 |
Paint, Varnish, and Supplies Merchant Wholesalers |
531190 |
Lessors of Other Real Estate Property9 |
541330 |
Engineering Services |
551112 |
Offices of Other Holding Companies |
562 |
Waste Management and Remediation Services |
811490 |
Other Personal and Household Goods Repair and Maintenance |
The subsectors identified above represent the designation of sites that likely would be subject to this data collection activity. However, this list does not include all potentially affected entities. Other types of entities not listed in this unit could also be subject to reporting.
Data Elements for the PFAS Reporting Form
As mandated under TSCA section 8(a)(7), the Agency must collect certain information on PFAS manufactured in any year since 2011. The information requested is authorized under TSCA section 8(a)(2), and includes reporting with respect to information including chemical identity, categories of use, production volume (in total and with respect to each category of use), description of byproducts, the number of individuals exposed at their places of work, and the methods of disposal. EPA is also authorized to request all existing information related to environmental and health effects of PFAS.
Specifically, EPA is requesting the following information from any person who has manufactured PFAS in any year since 2011, and the information would be collected for each year in which that PFAS was manufactured:
• Chemical name (multiple if mixture), or the generic name(s) if the chemical name(s) is CBI
• Chemical ID(s) (CASRN, TSCA Accession Number, or Low-Volume Exemption (LVE) case number)
• Trade name or common name
• Representative molecular structure for any PFAS that is not a Class 1 substance on the TSCA Inventory
• Physical form of chemical or mixture
• Industrial processing and use: type of process or use; sector(s); function category(ies); percent of production volume for each use
• Consumer and commercial use: consumer and/or commercial indicator; product category; function category(ies); percent production volume for each use; maximum concentration in any product; indicator for use in products intended for children
• Production volumes: domestically manufactured; imported; directly exported
• Indicator for imported but never physically at site
• Indicator for site-limited
• Total volume recycled (on-site)
• Information on byproducts produced during the manufacture, processing, use or disposal of the PFAS:
• Byproduct chemical name(s) or description (if unknown), or the generic name(s) if the byproduct name(s) is CBI
• Chemical ID(s), if available (CASRN, TSCA Accession Number, or LVE case number)
• Indicator for whether byproduct production stemmed from manufacture, process, use, or disposal
• Indicator for whether the byproduct(s) are released to the environment; if so, volume released and to which environmental media
• Worker activity descriptions at manufacturing site
• Worker exposure at the manufacturing site: number of workers reasonably likely to be exposed at the manufacturing site, for each worker activity; maximum duration and frequency of exposure for any worker, for each worker activity (both hours per day and days per year)
• Worker exposure for each industrial process and use: number of workers reasonably likely to be exposed for each industrial process and use; maximum duration and frequency of exposure for any worker for each industrial process and use (both hours per day and days per year)
• Worker exposure for each commercial use: number of workers reasonably likely to be exposed for each commercial use; maximum duration and frequency of exposure for any worker for each commercial use (both hours per day and days per year)
• Description of disposal process(es), and description of any changes to the disposal process or methods since 2011
• Total volume released: land disposal; water; air
• Total volume incinerated (on-site) and incineration temperature
• All existing information related to the health or environmental effects, using the OECD harmonized template, as well as study reports and other supporting information
• Other data relevant to health effects (e.g., range-finding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports)
Respondent Activities
Based on 2016 and 2020 CDR data, EPA estimates that each manufacturing firm will report on 5-6 PFAS for an average of 5.73 reports per firm.
Activities associated with preparing and submitting a response under the rule include rule familiarization, compliance determination, form completion, CBI claim substantiation, recordkeeping, and CDX registration, including e-signature. General descriptions of changes to activities are as follows (see previous section for detailed data element information):
Rule Familiarization: EPA assumes that manufacturers (including importers) and a portion of importers of articles will have already familiarized themselves with the requirements of the 2023 TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP)). These activities include familiarization with the reporting form and with the structural definition of PFAS and are thus not considered in this analysis. However, this analysis does account for the costs for manufacturers (including importers) to familiarize themselves with the proposed rule requirements and the modifications from the 2023 final rule.
Compliance Determination: For the purpose of this rule, the reporting standard would be information known to or reasonably ascertainable by the firm. This reporting standard requires reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard would require that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees) and may also entail inquiries outside the organization to fill gaps in the submitter's knowledge. EPA assumes that these activities have already been completed by manufacturers (including importers) in preparation for the reporting requirements of the 2023 TSCA section 8(a)(7) final rule (88 FR 70516) (FRL-7902-02-OCSPP)). Thus, the costs for these activities are assumed to be sunk costs and are not considered in this analysis.
Form Completion: The proposed rule requires one-time reporting of certain information, including chemical identity, categories of use, production volume, byproducts, environmental and health effects, occupational exposure, and disposal.
CBI Claim Substantiation: TSCA requires that anyone seeking protection of CBI must assert a claim and, for certain information, may be required to substantiate that claim. Reporting elements of the proposed rule for which a submitter might need to substantiate a claim of CBI, if a claim is made, include submitter information; chemical identity; physical properties; production volumes and product concentrations; byproducts; environmental release; worker exposure information; and description of disposal process(es).
Recordkeeping: The proposed rule requires respondents to retain documentation of information contained in their reports for five years after the date of submission.
CDX Registration and Electronic Signature: Respondents that submit a report will need to register with CDX in order to comply with electronic reporting requirements. This activity occurs only once for each submitter. Some submitters may have already registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with mandatory electronic reporting requirements of EPA’s e-PMN rule and/or CDR rule. Those submitters will not need to repeat the CDX registration and e-signature process in order to file their reports. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is conservatively expecting that all firms that submit a report under this proposed rule will need to register with CDX.
Estimating Respondent Burden and Costs
This section presents the relevant unit burdens and costs of the information collection activities to respondents in terms of the time required by reporters to perform the activities as outlined in the introductory section of this document.
Table 4 summarizes unit burdens according to activities associated with the proposed rule. The total average burden is estimated to be 526.48 hours per firm.
Activity |
Clerical Burden (hours) |
Technical Burden (hours) |
Managerial Burden (hours) |
Activity-Level Unit Burden per Average Firm |
Proportion of Firms Affected |
Average Unit Burden per Firm |
||
Rule Familiarization |
0.00 |
6.40 |
2.85 |
9.25 |
1.00 |
9.25 |
||
Compliance Determination |
0.00 |
0.00 |
0.00 |
0.00 |
1.00 |
0.00 |
||
Form Completion |
10.05 |
464.02 |
30.74 |
504.80 |
1.00 |
504.80 |
||
CBI Substantiation |
2.07 |
14.29 |
8.78 |
25.14 |
0.16 |
4.02 |
||
Recordkeeping |
2.87 |
2.87 |
0.00 |
5.74 |
1.00 |
5.74 |
||
CDX Registration |
0.00 |
1.73 |
0.93 |
2.67 |
1.00 |
2.67 |
||
Total average unit burden per firm |
526.48 |
|||||||
Note: For additional details on development and assumptions associated with items in this table, see the source EA (EPA 2025). Numbers may not sum due to rounding. |
||||||||
Unit costs are derived by combining relevant wage information with unit burden estimates. See Appendix A for information on the industry wage rates used in this analysis. In addition, EPA estimates each firm will incur a $3.90 in material costs for filing the electronic signature agreement when registering with CDX. EPA estimates reporter burden and cost at approximately $44,880 per firm, shown in Table 5.
Activity |
Average Unit Burden per Firm (Hours) |
Average Unit Cost per Firm (2024$) |
Rule Familiarization |
9.25 |
$834 |
Compliance Determination |
0.00 |
$0 |
Form Completion |
504.80 |
$43,079 |
CBI Substantiation |
4.02 |
$352 |
Recordkeeping |
5.74 |
$369 |
CDX Registration |
2.67 |
$246 |
Total |
526.48 |
$44,880 |
Note: For additional details on development and assumptions associated with items in this table, see the source EA (EPA 2025). Numbers may not sum due to rounding. |
||
Respondent Universe, Total, and Bottom-Line Burden Hours and Costs
Estimates of the total industry reporting burden and cost are shown in Table 6. Total burden and cost are calculated by multiplying the unit burdens and costs in Table 5 by the respective number of reporting sites. EPA estimates a total burden of 134,004 hours and a total cost of $11.4 million for this one-time reporting. All industry activities are expected to occur within one year of the effective date of the proposed rule.
Activity |
Number of Firms |
Number of Responses |
Per-Firm Unit Burden |
Total 3-Year Burden |
Per-Firm Unit Cost |
Total 3-Year Cost (2024$) |
Per-Firm Unit Cost |
Total 3-Year Cost (2024$) |
3% Discount Rate |
7% Discount Rate |
|||||||
Rule Familiarization |
255 |
1,461 |
9 |
2,354 |
$834 |
$212,361 |
$834 |
$212,361 |
Compliance Determination |
255 |
1,461 |
0 |
0 |
$0 |
$0 |
$0 |
$0 |
Form Completion |
255 |
1,461 |
505 |
128,486 |
$43,079 |
$10,964,818 |
$43,079 |
$10,964,818 |
CBI Substantiation |
255 |
1,461 |
4 |
1,024 |
$352 |
$89,532 |
$352 |
$89,532 |
Recordkeeping |
255 |
1,461 |
6 |
1,461 |
$369 |
$93,936 |
$369 |
$93,936 |
CDX Registration |
255 |
1,461 |
3 |
679 |
$246 |
$62,682 |
$246 |
$62,682 |
Respondent Total |
255 |
1,461 |
526 |
134,004 |
$44,880 |
$11,423,330 |
$44,880 |
$11,423,330 |
Agency |
|
|
|
|
|
$1,033,525 |
|
$1,003,080 |
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.
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 no operational and/or maintenance costs.
The Agency develops and maintains the electronic tool used to collect and verify data and routinely conducts other activities related to the processing, analysis and storage of the information collected under this rule. In this ICR Addendum, only the Agency activities created by the proposed rule are considered including:
Reporting guidance and outreach
Data processing and analysis
Systems support
Review of CBI claim substantiations
The Agency engages in several activities related to TSCA section 8(a) reporting, including: document receipt and tracking; quality control of data, including protection of CBI; backup systems operation; data processing and analysis; systems support; review of CBI claim substantiations; and guidance development. For the PFAS Data Call, EPA estimates a total burden of 7,973 hours and a cost of $1,003,080 to the Agency for the one-time reporting under a 7 percent discount rate. See Appendix A for a detailed derivation of Agency costs.
Collection Schedule
This is a one-time reporting event. The submission period will begin 60 days after the final effective date of the rule and will last for three months.
Anticipated Activities |
Expected Timeline |
Public outreach efforts: Federal Register publication of proposed rule and 45-day public comment period open; information posted on EPA’s website |
Early Fall 2025 |
Final rule published; effective date 30 days following rule publication in the Federal Register |
Early 2026 |
Open period for submitting reporting forms and existing data |
Beginning 60 days after final effective date; reporting period lasts for 3 months (tentatively: March – June 2026) |
Use of Technology to Facilitate Collection Activities
Submitters are required to submit information associated with this data collection electronically via the Internet using the PFAS Reporting Tool within CDX.
EPA notifies potential submitters of the need to report in three ways: (1) makes available guidance describing reporting requirements through web and listserv announcements, (2) sends email notices to previous TSCA submitters and other potential stakeholders, and (3) publishes press releases. The requirement to report is based on TSCA section 8(a)(7); potential submitters that do not receive a notification as listed above or who do not read published articles are still required to report. Reporting materials, including a non-submission version of the required information and reporting instructions documents will be available on EPA’s TSCA website. Submitters can also obtain these materials from the TSCA Hotline. Submitters obtain the PFAS Reporting Tool (which enables the completion of the reporting form for submission) as part of the CDX electronic web-based registration process.
EPA will receive all submissions electronically. The CDX registration process, required for all submitters, provides a user ID, which the submitter uses to access the PFAS Reporting Tool. EPA anticipates that many submitters will already have registered for CDX to fulfill other reporting programs, such as CDR or the Toxics Release Inventory.
Information quality control and validation will begin with the PFAS Reporting Tool, which is programmed to help the submitter provide the information required, in the correct format, as required by the proposed rule.
To aid persons subject to this information collection, the Agency’s TSCA and CDX Hotlines will be available to answer questions regarding the reporting requirements or submission process. When Hotline staff is unable to answer questions, the submitter is referred to OPPT programmatic staff. Other divisions within OPPT or the Office of Mission Support (OMS) may respond as necessary.
There is a decrease of 10.1-10.8 million hours in total estimated industry burden. This decrease reflects the modifications to the scope of the reporting regulation. EPA is proposing to amend the one-time PFAS reporting and recordkeeping regulation finalized on October 11, 2023 (88 FR 70516) (FRL-7902-02-OCSPP)), to incorporate the following exemptions to the scope of reportable manufacturing activities: a de minimis exemption of 0.1%; imported articles; byproducts; impurities; research and development (R&D) chemicals; and non-isolated intermediates. In the previous ICR, EPA estimated that there were 131,410 affected firms and 67,536 reports, with a total burden to industry of 11,636,232 hours. EPA made several updates to the EPA (2023) estimates for the proposed rule economic analysis baseline and thus the baseline estimates presented here differ slightly from those approved by OMB. The number of affected entities is estimated to decrease from 131,411 firms to 255 and the number of reports is estimated to decrease from 67,548 to 1,461 reports. The total burden to industry for this ICR period is approximately 134,004 hours. The total cost to industry for this ICR period is approximately $11.4 million.
Scenario |
Firms |
Number of Reports |
Average Rule Familiarization and Compliance Determination Burden per Firm (Hours) |
Form Completion, CBI Substantiation, and Recordkeeping Burden per Firm (Hours)1 |
Average Electronic Reporting Burden per Firm (Hours)1 |
Total Burden (Hours) |
A |
B |
C |
D |
E = A x (B+C+D) |
||
Low Sunk Cost Scenario |
||||||
Baseline |
131,411 |
67,548 |
72 |
11 |
0.27 |
10,952,136 |
Post-Rule |
255 |
1,461 |
9 |
515 |
2.67 |
134,004 |
Incremental |
(131,157) |
(66,087) |
- |
- |
- |
(10,818,132) |
High Sunk Cost Scenario |
||||||
Baseline |
131,411 |
67,548 |
67 |
11 |
0.27 |
10,243,186 |
Post-Rule |
255 |
1,461 |
9 |
515 |
3 |
134,004 |
Incremental |
(131,157) |
(66,087) |
- |
- |
- |
(10,109,182) |
1 Averaged across all firms. Note that not all firms will incur these costs. Note: Values may not sum due to rounding. |
||||||
The agency does not intend to publish information gathered through this information collection.
The agency plans to display the expiration date for OMB approval of the information collection on all instruments.
EPA does not request an exception to the certification of this information collection.
This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0217). Responses to this collection of information are mandatory (40 CFR 705). 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 526 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.”
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-2020-0528, which is available at https://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.
15 U.S.C. 2607 https://www.govinfo.gov/content/pkg/USCODE-2023-title15/pdf/USCODE-2023-title15-chap53-subchapI-sec2607.pdf
40 CFR 705 https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-705
BLS (U.S. Bureau of Labor Statistics). 2025a. "Employer Costs for Employee Compensation Supplementary Tables - December 2024."
BLS. 2025b. National Industry-Specific Occupational Employment and Wage Estimates, May 2024.
EPA. 2009. ICR Handbook: EPA’s Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Retrieved from https://www.pdffiller.com/10247637--ICR-Handbook---Environmental-Protection-Agency-.
EPA. 2017. Burden and Cost Report for the Final Rule: TSCA Inventory Notification Requirements (RIN 2070-AK24) EPA-HQ-OPPT-2016-0426-0072.
EPA. 2020. Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other EPA Actions. EPA-236-B-15-001. National Center for Environmental Economics.
EPA. 2023a. Economic Analysis for the TSCA Section 8(a)(7) reporting Requirements for Perfluoroalkyl or and Polyfluoroalkyl Substances.
EPA. 2023b. Response to Comment document.
EPA. 2025. Economic Analysis for the TSCA Section 8(a)(7) reporting Requirements for Perfluoroalkyl or and Polyfluoroalkyl Substances; Revision to Regulation.
OPM. 2024. "Salary table 2024-DCB."
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-OPPT-2020-0549.
A |
PFAS Reporting Tool Mockups (EPA Form No. 9600-046) |
This section describes the industry wage data used to develop reporting burden estimates. Wage rates for managerial, technical, clerical, and attorney labor are derived and presented in Table A‑1.
Loaded wage rates for each labor category are derived by combining data on wages and fringe benefits with estimates of overhead rates. Wage rates and fringe benefits for clerical, professional/technical, managerial, and attorney labor are calculated using the U.S. Bureau of Labor Statistics’ (BLS) Employer Costs for Employee Compensation (ECEC) data for December 2024 (BLS, 2025a)). The industry wage rate for attorney labor is derived from the National Industry-Specific Occupational Employment and Wage Estimates (BLS, 2025b).
Overhead costs are assumed to equal 20% of the sum of wages plus fringe benefits. This loading factor is described in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and other U.S. EPA Actions (EPA 2020) and is reflective of multiplier values used in prior EPA economic analyses and Information Collection Requests (ICRs) that are based on industry- and occupation-specific overhead rates affected by EPA regulations.
Table A‑1 contains the loaded wage rates for the managerial, technical, clerical, and attorney occupation categories.
Labor Category |
Wage1 |
Fringe Benefit2 |
Total Compensation |
Overhead % Wage3 |
Overhead |
Hourly Loaded Wages4 |
|
A |
B |
C = A + B |
D |
E = C x D |
F = C + E |
|
|
Clerical |
$24.84 |
$11.34 |
$36.18 |
20% |
$7.24 |
$43.42 |
|
Professional/ Technical |
$47.87 |
$23.11 |
$70.98 |
20% |
$14.20 |
$85.18 |
|
Managerial |
$58.01 |
$26.57 |
$84.58 |
20% |
$16.92 |
$101.50 |
|
Attorney |
$87.86 |
$26.20 |
$114.06 |
20% |
$22.81 |
$136.87 |
|
1 Source: Employer Costs for Employee Compensation: December 2024 (BLS 2025a); National Industry-Specific Occupational Employment and Wage Estimates, May 2024 (BLS 2025b). 2 Source: Employer Costs for Employee Compensation: December 2024 (BLS 2025a) 3 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and other U.S. EPA Actions (EPA 2020). 4 Values may not sum due to rounding. Wage rates are rounded to the nearest cent. |
|||||||
EPA activities affected by the rule involve data processing, systems support, and review of CBI claim substantiations. Costs related to EPA activities that involve data use are not included.
EPA labor costs are based on annual federal wage rates, as presented in Table B- 1. EPA assumes that the collection and administrative activities (technical labor) associated with Agency responses to the proposed rule will be accomplished by a GS-13, Step 5 federal employee in the Washington-Baltimore-Northern Virginia area.
Table: B-1: Agency Wage Rates (2024$)
Labor Category |
Data Source for Wage Information |
Wage ($/hr) |
Fringes as % of Wage2 |
Fringe Benefit |
Total Compensation |
Overhead as % of Total Compensation3 |
Overhead |
Loaded Wage ($/hr) |
A |
B |
C = A * B |
D = A + C |
E |
F = D * E |
G = D + F |
||
Technical |
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates1 |
$64.28 |
63.9% |
$41.07 |
$105.35 |
20.0% |
$21.07 |
$126.42 |
1 Source: U.S. Office of Personnel Management 2024 2 Source: Falk 2012 3 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020) |
||||||||
Unit burden and cost associated with EPA staff activities are the same as in the economic analysis for the proposed revision to the 8a7 PFAS Data Call Rule (EPA 2025) and are presented in Table B- 2.
EPA Activity |
Burden (hours) |
Cost (2024$) |
|
3% Discount Rate |
7% Discount Rate |
||
Guidance and Outreach Activities |
1,733 |
$219,121 |
$219,121 |
Data Processing |
4,160 |
$510,574 |
$491,487 |
Data Analysis |
2,080 |
$255,287 |
$245,743 |
Contractor Data Processing Support |
- |
$48,544 |
$46,729 |
Total Agency Baseline and Post-Rule Hours and Cost |
7,973 |
$1,033,525 |
$1,003,080 |
Total Agency Incremental Hours and Cost |
0 |
$0 |
$0 |
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Modified | 0000-00-00 |
| File Created | 2026-01-01 |