2682ss01

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: TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Proposed Rule

ICR Numbers: EPA ICR No.: 2682.01; OMB Control No.: 2070-NEW

EPA Form Numbers: EPA Form #; EPA ####-#

Docket ID Number: EPA-HQ-OPPT-2020-0549

Abstract

This ICR addresses the paperwork requirements in a proposed rule, titled “TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances” (RIN 2070-AK67) for the information collection activities of the one-time PFAS Data Call reporting and recordkeeping event (40 CFR Part 705). An economic analysis (EA) provides estimations of the burden and costs associated with the proposed reporting requirements and can be found in the rulemaking docket.

EPA is proposing reporting and recordkeeping requirements for Perfluoroalkyl or Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA) as amended by the Fiscal Year 2020 National Defense Authorization Act (NDAA). As mandated by the amendments, EPA is proposing to require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report to EPA certain information. This is a one-time reporting event to provide greater transparency on the uses and risks associated with PFAS and is mandated by the NDAA.

SUPPORTING STATEMENT PART A – JUSTIFICATION

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.

As added by FY2020 National Defense Authorization Act, TSCA section 8(a)(7) (15 USC 2607, Attachment A) requires EPA to collect certain information on PFAS manufactured (including imported) in the United States since January 1, 2011. In addition, the requirements were put in place following enactment of the FY2020 National Defense Authorization Act, which amended TSCA in December 2019. The newly added provision states:

(7) PFAS DATA.—Not later than January 1, 2023, the Administrator shall promulgate a rule in accordance with this subsection requiring each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance in any year since January 1, 2011, to submit to the Administrator a report that includes, for each year since January 1, 2011, the information described in subparagraphs (A) through (G) of paragraph (2).
(see: Pub. L. 116-92, div. F, title LXXIII, § 7351)

Claims of confidentiality are covered under TSCA section 14 (See 82 FR 6522, January 19, 2017).

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.

Under TSCA, EPA is charged with protecting human health and the environment from potential chemical risks. Through the proposed PFAS Data Call regulation (Attachment B), EPA intends to collect exposure-related manufacturing information and all existing information concerning the environmental and health effects of the PFAS 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 CDR (See 82 FR 6522, January 19, 2017). To ensure that EPA can use section 8(a) data most effectively, TSCA requires substantiation to enable EPA to review the legitimacy of confidentiality claims.

EPA’s OPPT, other EPA Offices and/or other Federal agencies will generally be the primary groups for which information will be collected. However, to the extent that reported information is not considered to be CBI, EPA may consider providing 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-related information in future screening-level assessments of potential exposure to these PFAS. Additionally, other offices in EPA would benefit from information collected, such as data on the disposal, releases, and other waste management methods of PFAS. Many offices across EPA are fulfilling directives under the Agency’s PFAS Action Plan, and this first nationwide dataset on PFAS, production, use, disposal, and exposure-related information would complement these activities and provide necessary screening-level data.

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 Paperwork Reduction Act (PRA) requires Federal agencies to manage information resources to reduce information collection burdens on the public; increase program efficiency and effectiveness; and improve the integrity, quality, and utility of information to all users within and outside an agency, including capabilities for ensuring dissemination of public information, public access to Federal Government information, and protections for privacy and security (44 U.S.C. 3506). Section 2 of TSCA expresses the intent of Congress that EPA carry out TSCA in a reasonable and prudent manner, and in consideration of the impacts that any action taken under TSCA may have on the environment, the economy, and society (15 U.S.C. 2601). EPA believes that it is reasonable and prudent to manage and leverage its information resources, including information technology (IT), to require the use of electronic reporting in the implementation of TSCA. Electronic reporting can minimize burden and costs for the regulated entities by avoiding the costs associated with printing and mailing this information to EPA, while at the same time improving EPA's efficiency in reviewing submitted information, making decisions and disseminating information to the public.

EPA proposes to require electronic reporting for all reporting submissions. Persons submitting information under this 8(a)(7) rule would be required to use the PFAS Reporting Tool, a reporting application accessed through the Agency’s CDX platform. The PFAS Reporting Tool would be based on e-CDRweb, the Agency’s online application for completing the CDR reporting form (Form U) in the 2020 CDR reporting cycle. EPA will make updates to this required reporting tool to address the final changes. Mockups of the PFAS Reporting Tool based on the current e-CDRweb reporting tool screen shots are included as Attachment C.

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 data included in this information collection are not collected comprehensively or systematically at the national level by any other entities with the exception of some of the data elements for which certain PFAS are reported under CDR and TSCA section 5 Premanufacture Notices (PMN). However, no dataset has consistently collected such information for each year since 2011; CDR has a four-year reporting cycle which does not require all information to be reported for each intervening year. In instances where PFAS manufacturers under this proposed rule have already reported the requested information to EPA for that same year, they will not be required to re-report. However, EPA expects that most firms will need to submit information under the proposed rule, even if they have previously reported to CDR or submitted a PMN because the proposed rule requests different information than either CDR or PMN forms. Additionally, this rule requires reporting for each year since 2011 in which a PFAS was manufactured, whereas reporting is not required annually for CDR. In addition, firms that have not previously submitted information to CDR or through a PMN form will need to submit data under the proposed rule.

TSCA section 8(a)(5) requires EPA, to the extent feasible when carrying out TSCA section 8, to avoid requiring unnecessary or duplicative reporting. The Agency seeks to avoid collecting data on PFAS that would duplicate information already reported to the Agency. While developing this rule EPA reviewed the data elements submitted under the Chemical Data Reporting Rule and determined that there may be some overlap with the information requested under the proposed rule. EPA is proposing to allow reporting entities to indicate in the reporting tool that they have previously provided such information to EPA through CDR for certain data elements. The Agency has identified the following data elements which the reporter may be able to indicate has already been submitted to EPA:

• Physical state of the chemical or mixture;

• Industrial processing and use type, sector(s), functional category(ies), and percent of production volume for each use;

• Consumer and/or commercial indicator, product category(ies), functional category(ies), percent of production volume for each use, indicator for use in products intended for children, and maximum concentration in the product, and;

• Number of workers reasonably likely to be exposed for each combination of industrial processing or use operation, sector, and function, and the number of commercial workers reasonably likely to be exposed if the PFAS is contained in a commercial product.

If a manufacturer covered under this proposed rule has previously submitted required information to EPA for some years since 2011, but not for all years, EPA is proposing that the manufacturer may indicate in the reporting tool the year(s) for which the manufacturer has already submitted that data to EPA as part of CDR. For instance, CDR reporters are required to submit the total annual domestically manufactured production volume and the total annual imported volume separately, only for the principal reporting year (e.g., 2019 for the 2020 reporting cycle), but reporting only the combined total annual production volume is required for the intervening years. In this case, a reporter under this proposed rule would be able to indicate that the two different production volumes have been previously submitted to EPA for the CDR reporting year(s), but would still need to report for the intervening year(s) not previously submitted under CDR. Additionally, there are some data elements for which CDR reporters may have previously reported information to EPA, although these data elements were only added to the CDR reporting requirements in 2020. Therefore, some manufacturers under this proposed rule may have submitted the following information to CDR for some years covered by this proposed rule, but not all, and would still be required to report this information for the missing year(s):

• Domestically manufactured production volume;

• Imported production volume;

• Volume directly exported; and

• Indicator for imported but never physically at site.

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

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. TSCA section 8(a)(7) does not provide EPA with authority to establish any reporting exemptions in the required rulemaking. EPA is requesting public comment on how the Agency may assist small manufacturers with compliance with the proposed rule, including comments related to both regulatory and non-regulatory assistance, such as different reporting timelines and outreach.

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.

This is a one-time statutorily mandated reporting event. Failure to conduct the information collection activities required by law would subject EPA to Congressional oversight and civil litigation. Further, EPA believes that the statutory requirement that “each person” who manufactured PFAS since 2011 report information under the rule does not permit EPA to provide for reporting exemptions or flexibilities that could otherwise reduce burden.

7. Explain any special circumstances that would cause an information 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; requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

4. 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;

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

6. 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

7. 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.

1. The proposed record retention period of this collection is five years, as specified in 40 CFR 711.25, exceeding the PRA maximum of three years. The five-year retention requirement corresponds with the statute of limitations for violations established under 28 U.S.C. 2462. A five-year retention requirement for records related to compliance with the rule is needed to support EPA’s ability to monitor compliance with the reporting requirements. When assessing compliance, inspectors and other enforcement personnel rely upon a facility’s records of, for example, chemical identity, importation dates, volumes, and distribution location. EPA’s inspection resources are limited and as such having records of compliance for five years becomes even more important to assure the reporting obligations are met.

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 by the agency in response to these comments. Specifically address comments received on cost and hour burden.
   
   Describe efforts to consult with persons outside the agency 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.

Pursuant to the procedures at 5 CFR 1320.11, the notice of proposed rulemaking serves as the public notice for this rule-related ICR. Upon publication, the This proposed rule will open a 60-day public comment period. Public comments will be considered during the development of the final rule. EPA will respond to all comments in the final rule.

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

This collection of information is required by statute. The federal government will not offer any monetary or material value for responses to this information collection.

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.

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 CDR reporting. Also consistent with CDR reporting, EPA will require submitters provide upfront substantiation when claiming eligible data elements as CBI in this proposed 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.

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.

No information of a sensitive or private nature is requested in conjunction with this information collection activity, and this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A-108.

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’.

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. An estimated 234 firms and 351 sites are expected to be subject to this rule’s reporting requirements. Note that EPA is not able to estimate the number of article importers who may be subject to the proposed rule and thus does not include these firms in the total estimated number of respondents.

Based on the parent companies that reported manufacturing or importing PFAS chemicals subject to the proposed rule to the 2016 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 NAICS categories listed in Table 1. The list in Table 1 is not exhaustive and may not describe the specific entities and corresponding NAICS codes for entities that may be affected by the proposed rule.

Table 1: Expected Respondents by NAICS Code

NAICS Code	Subsector Description
324	Petroleum and Coal Product Manufacturing
325	Chemical Manufacturers and Processors
325180	Other Basic Inorganic Chemical Manufacturing
325199	All Other Basic Organic Chemical Manufacturing
325211	Plastics Material and Resin Manufacturing
325320	Pesticide and Other Agricultural Chemical Manufacturing
325998	All Other Miscellaneous Chemical Product and Preparation Manufacturing
326113	Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing
327910	Abrasive Product Manufacturing
333999	All Other Miscellaneous General Purpose Machinery Manufacturing
334511	Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing
336111	Automobile Manufacturing
423510	Metal Service Centers and Other Metal Merchant Wholesalers
424690	Other Chemical and Allied Products Merchant Wholesalers
447190	Other Gasoline Stations
551112	Offices of Other Holding Companies
562	Waste Management and Remediation Services

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.

For the analysis in this section, the respondent is defined as a manufacturing firm. It is assumed that there is an average of 5.85 responses per respondent, which is the average number of PFAS chemicals per firm in the 2016 CDR data. Incremental activities associated with preparing and submitting a response under the rule include rule familiarization, 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: The proposed rule requires reporting businesses and their staff to become familiar with the TSCA section 8(a) rule and its various requirements. This activity entails reading the rule, understanding the reporting and administrative requirements, and determining what tasks are required in order to meet reporting requirements.

• 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.

• Article Importation Activities: Importers have varying levels of knowledge about the chemical content of the articles they import. The reporting standard would require reporting entities to evaluate their current level of knowledge of their imported articles, as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization and may also entail inquiries outside the organization to fill gaps in the submitter’s knowledge.

Data Elements for the PFAS Reporting Form

As mandated under section 8(a)(7), the Agency must collect certain information on PFAS manufactured in any year since 2011. The information requested is authorized under 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 proposing to request the following information from any person who has manufactured PFAS in any year since 2011, and the information would be collected for each year:

• 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

• Molecular structure

• 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; maximum first 12 months production volume; maximum yearly production volume in any 3 years

• Indicator for imported but never physically at site

• Indicator for site-limited

• Maximum quantity stored on-site at any time

• 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 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 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 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)

Incremental experienced reporter unit burden for respondent activities associated with the proposed rule is presented in Table 3. Unit burdens in this table reflect changes in activities that are applied universally to all reporters. The activity-level unit burden estimates for changes in Table 3 are based on estimates for similar activities (for more detail, see EPA (2020)). The total average burden is estimated to be 521.81 hours per firm.

Wages and fringe benefit data for managerial, professional/technical, and clerical labor are from the BLS Employer Costs for Employee Compensation (ECEC) historical data for December 2020 (BLS 2021a). For attorney, the wage rate was taken from the BLS Occupational Employment Statistics (OES) May 2020 National Industry-Specific Occupational Employment and Wage Estimates for Sectors 31, 32, and 33 – Manufacturing and SOC Code 23-1011 – Lawyers (BLS 2021b).

The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS report (BLS 2021a). Overhead costs are assumed to equal 20% of the sum of wages plus fringe benefits. This loading factor is described in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020c), and is reflective of multiplier values used in prior EPA economic analyses and ICRs that are based on industry- and occupation-specific overhead rates affected by EPA regulations.

Table 2 contains the loaded wage rates for the managerial, technical, clerical, and attorney occupation categories.

Table 2: Reporter Wager Rates (2020$)

Labor Category	Data Source for Wage Information	Wage1	Fringe Benefit2	Total Compensation	Overhead % of Total Compensation3	Overhead	Hourly Loaded Wages4
		A	B	C = A + B	D	E = C x D	F = C + E
Clerical	BLS ECEC, Private Manufacturing industries, “Office and administrative support occupations”	$20.86	$9.62	$30.48	20%	$6.10	$36.58
Professional/Technical	BLS ECEC, Private Manufacturing industries, “Professional and related occupations“	$44.63	$22.45	$67.08	20%	$13.42	$80.50
Managerial	BLS ECEC, Private Manufacturing industries, “Management, business, and financial occupations”	$54.32	$24.46	$78.78	20%	$15.76	$94.54
Attorney	BLS OES, Occupational Employment and Wages, 23-1011 Lawyers	$71.59	$17.96	$89.55	20%	$17.91	$107.46
1 Source: Employer Costs for Employee Compensation Supplementary Tables: December 2020 (BLS 2021a); National Industry-Specific Occupational Employment and Wage Estimates, May 2020 (BLS 2021b). 2 Source: Employer Costs for Employee Compensation Supplementary Tables: December 2020 (BLS 2021a) 3 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and other U.S. EPA Actions (EPA 2020c). 4 Values may not sum due to rounding. Wage rates are rounded to the nearest cent.

Table 3: PFAS Data Call Reporting: Activity-Level Reporter Unit Burden

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	0.55	0.27	0.82	1.00	0.82
Form Completion
Company and plant site information	0.00	0.02	0.01	0.03	1.00	0.03
Common or trade name, chemical identity, and molecular structure	10.24	26.33	5.85	42.41	1.00	42.41
Byproducts	0.00	2.93	0.00	2.93	1.00	2.93
Conditions of use	0.00	26.00	10.65	36.65	1.00	36.65
Total production volume	0.00	50.19	12.69	62.89	1.00	62.89
Occupational exposure	0.00	78.98	0.00	78.98	1.00	78.98
Environmental release and disposal	0.00	55.58	0.00	55.58	1.00	55.58
Environmental and health effects data	0.00	1,263.60	0.00	1,263.60	0.18	227.45
CBI Substantiation	11.12	0.00	11.12	22.23	0.25	5.56
Recordkeeping	2.93	2.93	0.00	5.86	1.00	5.86
CDX Registration	0.00	1.73	0.93	2.67	1.00	2.67
Total average unit burden per firm						521.81
Note: For additional details on development and assumptions associated with items in this table, see the source EA (EPA 2020). Numbers may not sum due to rounding.

Unit costs are derived by combining relevant wage information with unit burden estimates. See Table 2 for information on the industry wage rates used in this analysis. In addition, EPA estimates each firm will incur a $3.15 in material costs for filing the electronic signature agreement when registering with CDX. EPA estimates reporter burden and cost at approximately $42,000 per firm, shown in Table 4.

Table 4: PFAS Data Call Reporting: Activity-Level Reporter Unit Cost

Activity	Average Unit Burden per Firm	Average Unit Cost per Firm (2020$)
Rule Familiarization	0.82	$70
Form Completion
Company and plant site information	0.03	$3
Common or trade name, chemical identity, and molecular structure	42.41	$3,047
Byproducts	2.93	$235
Conditions of use	36.65	$3,100
Total production volume	62.89	$5,240
Occupational exposure	78.98	$6,357
Environmental release and disposal	55.58	$4,474
Environmental and health effects data	227.45	$18,309
CBI Substantiation	5.56	$561
Recordkeeping	5.86	$343
CDX Registration	2.67	$231
Total	521.81	$41,969
Note: For additional details on development and assumptions associated with items in this table, see the source EA (EPA 2020). Numbers may not sum due to rounding.

Estimates of the total industry reporting burden and cost are shown in Table 5. Total burden and cost are calculated by multiplying the unit burdens and costs in Table 4 by the respective number of reporting sites. EPA estimates a total burden of 122,104 hours and a total cost of $9,820,813.

Table 5: PFAS Data Call Reporting: Total Estimated Respondent Burden and Costs

Activity	Number of Firms	Number of Responses	Per-Firm Unit Burden	Per-Firm Unit Cost	Total Burden	Total Cost (2020$)
Rule Familiarization	234	1,369	1	$70	192	$16,331
Form Completion	234	1,369	507	$40,764	118,616	$9,538,839
CBI Substantiation	234	1,369	6	$561	1,300	$131,343
Recordkeeping	234	1,369	6	$343	1,371	$80,267
CDX Registration	234	1,369	3	$231	624	$54,033
Total	234	1,369	522	$41,969	122,104	$9,820,813

13. Provide an estimate for the total annual cost burden to respondents or record keepers 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.

The information collection activities addressed in the proposed rule do not involve any cost burdens, such as capitalization, start-up, and/or operation and maintenance costs.

14. Provide estimates of annualized costs 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.

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: data processing, systems support, and 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; systems support; review of CBI claim substantiations; and IT infrastructure. For the PFAS Data Call, EPA estimates a total burden of 7,361 hours and a cost of $948,078 to the Agency for the one-time reporting.

EPA activities affected by the rule involve data processing, systems support, review of CBI claim substantiations, and IT infrastructure. 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 6. EPA assumes that the collection and administrative activities (technical labor) associated with Agency responses to the proposed rule will be accomplished by a GS-13, Step 5 federal employee in the Washington-Baltimore-Northern Virginia area. EPA assumes that a GS-14, Step 5 federal employee will perform attorney activities related to CBI claim substantiations.

Table 6: Agency Wage Rate (2020$)

Labor Category	Data Source for Wage Information	Wage ($/hour)	Fringes as % of Wage2	Fringe Benefit	Total Compensation	Overhead as % of Total Compensation3	Overhead	Loaded Wage ($/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	$55.75	63.9%	$35.62	$91.37	20.0%	$18.27	$109.65
Attorney	Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-14 Step 5 pay rates1	$65.88	63.9%	$42.10	$107.98	20.0%	$21.60	$129.57
1 Source: U.S. Office of Personnel Management (2020) 2 Source: Falk 2012 3 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020c)

Unit burden and cost associated with EPA staff activities are the same as in the economic analysis for the proposed rule (EPA, 2020) and are presented in Table 7. The cost associated with data processing, systems support, and review of CBI claim substantiations is performed by program staff and is dependent on the number of chemical reports received.

Table 7: Total Agency Burden and Cost (2020$)

EPA Activity	Burden (hours)			Cost (2020$)
	Technical	Attorney	Total	Technical ($109.65/hr)	Attorney ($129.57/hr)	Total
Data Processing and Systems Support	3.13	0	3.13	$343.34	$0.00	$343.34
Review of CBI Claim Substantiations (per Report)
Chemical Identity	0.25	0	0.25	$27.01	$0.00	$27.01
Other	0.5	1.5	2	$54.82	$194.36	$249.18
Total (per Report)	3.9	1.5	5.4	$425.17	$194.36	$619.53
IT Infrastructure	-	-	-	-	-	$100,000
Total Agency Burden and Cost (x 1,369 reports)	5,308	2,053	7,361	$582,020	$266,058	$948,078

15. Explain the reasons for any program changes or adjustments reported on the burden worksheet.

The program changes reported on the burden worksheet are due to a new statute, the National Defense Authorization Act for Fiscal Year 2020, that amended TSCA section 8(a) by adding a new provision that requires EPA to promulgate one-time PFAS information requirements by rule.

16. For collections of information whose results will be published, outline 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.

This is a one-time reporting event. The submission period will begin after the final effective date of the rule and will last for five months. This submission period duration is the same as the 2016 Chemical Data Reporting (CDR) period.

Activity	Timeline
Public outreach efforts: Federal Register publication of proposed rule and 60-day public comment period open; information on the CDR website	2021
Email to 2020 CDR e-mailing list and other stakeholders with instructions for obtaining the reporting form and initiating reporting	Late 2022-early 2023
Open period for submitting reporting forms and existing data	Beginning 6 months after final effective date; reporting period lasts for 6 months

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 CDR 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 are 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.

EPA is requesting public comment on the extent to which non-CBI data submitted under this rule should be published and made available to the general public, and expects to make a relevant determination before promulgating the final rule.

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

Not applicable. The expiration date of OMB’s approval of this information collection will be displayed.

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

As explained under #7, the proposed record retention period of this collection is five years, exceeding the PRA maximum of three years. The five-year retention requirement corresponds with the statute of limitations for violations established under 28 U.S.C. 2462.

SUPPORTING STATEMENT PART B – COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

This information collection does not employ any statistical methods.

SUPPORTING STATEMENT ATTACHMENTS

The attachments referenced in this ICR are listed below and are available in the public docket established for this ICR under docket ID number EPA-HQ-OPPT-2020-0549 are available for online viewing at http://www.regulations.gov unless otherwise noted.

Attachment A:	Toxic Substances Control Act (TSCA) Section 8 - 15 USC 2607 (available online at https://www.govinfo.gov/content/pkg/USCODE-2019-title15/pdf/USCODE-2019-title15-chap53-subchapI-sec2607.pdf)
Attachment B:	TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Proposed Rule (RIN 2070-AK67)
Attachment C	PFAS Reporting Tool Mockups