Supporting Statement for an
Information Collection Request (ICR)
Under the Paperwork
Reduction Act (PRA)
Title: |
Consolidation of Certain Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA) |
EPA ICR No.: |
2703.02 |
OMB Control No.: |
2070-0224 |
Docket ID No.: |
EPA-HQ-OPPT-2021-0728 |
This information collection request (ICR) covers reporting and recordkeeping requirements imposed under the authorities in section 8 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607, for persons who manufacture (the term “manufacture” includes import under TSCA) or process chemical substances, mixtures, or chemical categories, or distribute them in commerce. The purpose of the information collection activities is to collect data that will help the Agency evaluate the potential for human health and environmental risks that may be caused by the manufacture, processing, and distribution in commerce of chemical substances, mixtures, or categories.
This ICR addresses the following four types of information collections (ICs) required by TSCA section 8 and identifies the persons required to keep records and report such information.
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
Under TSCA section 8(a), persons who manufacture or import chemical substances listed at 40 CFR 712.30 are subject to the TSCA section 8(a) Preliminary Assessment Information Rule (PAIR) requirements. PAIR requires these manufacturers and importers to submit information about production, use, and/or exposure-related data. Certain specific chemical testing and reporting requirements under Subpart B of 40 CFR part 766 that are very similar to the PAIR requirements are also covered within this information collection activity.
Chemical-Specific Rules, TSCA Section 8(a)
Also under TSCA section 8(a), persons who manufacture, import, or process certain chemical substances or mixtures, or propose to manufacture, import, or process certain chemical substances or mixtures, are subject to chemical-specific rules promulgated under TSCA section 8(a). A chemical-specific 8(a) rule requires more detailed and more types of information than is required by a PAIR rule. For example, a chemical-specific 8(a) rule might require information that includes, but is not limited to, chemical names, categories of use, production volume, byproducts of chemical production, existing data on health and environmental effects, exposure data, and disposal information. Any chemical covered by TSCA for which OPPT, other EPA offices, or another federal agency has a reasonable need for information, and which cannot be satisfied via readily available sources or by use of other rulemakings, is a proper potential subject for a chemical specific TSCA section 8(a) rulemaking.
With this ICR renewal, EPA is consolidating two TSCA section 8(a) chemical specific rules into this ICR: including the reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials under the authority of section 8(a) of TSCA (40 CFR 704.20) covered by “Chemical-Specific Rules under the Toxics Substances Control Act Section 8(a); Certain Nanoscale Materials (Renewal)(EPA ICR No.2517.04 ; OMB Control No. 2070-0194) and the one-time asbestos reporting and recordkeeping requirements (40 CFR 704.180) covered by the “TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos (Final Rule) (EPA ICR No. 2711.02; OMB Control No. 2070-0222).
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
Under TSCA section 8(c), persons who manufacture, import, process, or distribute in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. TSCA section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years. The rule (40 CFR 717) also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies
Under TSCA section 8(d), certain persons, who manufacture, import, process, or distribute in commerce (or propose to manufacture, import, process, or distribute in commerce) chemical substances and mixtures, are required to submit to EPA lists and copies of unpublished health and safety studies in their possession which relate health and/or environmental effects of the chemical substances and mixtures. Reporters may also need to prepare and submit an OECD Harmonized Template (OHT) for their study, if their study includes confidential business information (CBI) claims, or if otherwise required by a specific 8(d) rule.
EPA anticipates it could undertake additional future TSCA section 8 activities. For example, the Agency could need data to support its TSCA section 6 prioritization, risk evaluation, and risk management activities. Additionally, petitions or other factors, such as an emergent concern that might arise, could warrant the collection of TSCA section 8 data (e.g., a rulemaking pursuant to TSCA section 8(a) or 8(d)) to help inform the Agency, as well as other TSCA section 8 data users. Such activities would, as appropriate, include supplemental ICRs associated with their estimated burden.
Information Collection |
Number of Respondents |
Annual Number of Responses |
Responses per Respondent |
Annual Time Burden (Hours) |
Annual Cost Burden (Dollars) |
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) and Subpart B of 40 CFR part 766 |
1 |
1 |
1 |
33 |
$2,810 |
Chemical-Specific Rules; TSCA Section 8(a)* |
5.3 |
9 |
1.7 |
961 |
$81,135 |
TSCA Section 8(c) Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment |
13,557 |
141,695 |
10 |
59,033 |
$5,114,208 |
TSCA Section 8(d) Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies |
33 |
5,742 |
174 |
46,496 |
$3,940,791 |
Total Respondent |
13,596 |
147,447 |
187 |
106,522 |
$9,138,943 |
Total Agency |
|
|
|
5,426 |
$528,858 |
*Estimates derived from nanomaterials reporting. |
|||||
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
EPA has in the past used the TSCA Preliminary Assessment Information Rule (PAIR) to collect information to help identify, assess, and manage human health and environmental risks from chemical substances, mixtures and categories listed at 40 CFR 712.30 (Ref. 4). PAIR required these chemical manufacturers and importers to complete and submit standardized information about production, use, or exposure-related data to help evaluate the potential for human health and environmental risks caused by the manufacture or importation of identified chemical substances, mixtures or categories, or exposure-related data. PAIR is also available to EPA for the purpose of informing the prioritization and risk evaluation activities required under the 2016 amendments to TSCA enacted when the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) was signed into law on June 22, 2016.
Although other rulemakings such as the Chemical Data Reporting (CDR) rule have been more recently and regularly used by EPA to collect similar information under TSCA section 8(a) to inform LCSA activities, PAIR remains available to collect information when the use of CDR is not applicable. For example, EPA or other federal agencies (e.g., the agencies that are part of the Interagency Testing Committee (ITC) as authorized under TSCA section 4(e)) can identify chemicals for a TSCA section 8(a) PAIR expedited rulemaking that have a justifiable need for production, use, or exposure-related data.
This information collection activity also covers certain specific chemical testing and reporting requirements under Subpart B of 40 CFR part 766 (Ref. 5) that are very similar to the PAIR requirements. The Agency rarely receives submissions of the information required by 40 CFR 766. EPA received less than five submissions over the course of the last OMB approval period for this aspect of the information collection. However, collection of this information is covered under the PAIR ICR because the requirements are similar and because the PRA requires that recordkeeping and reporting activities contained in any regulation be approved by OMB even if they involve less than 10 respondents or would otherwise not require approval (see 5 CFR 1320.3(c)(4)(i)).
The dibenzo-para-dioxin/dibenzofuran regulations at 40 CFR part 766 require that any person who manufactures, imports, or processes a chemical substance listed at 40 CFR 766.25 test that chemical substance and submit appropriate information to EPA according to the schedules described at 40 CFR 766.35. The testing requirement of this rule is authorized under TSCA section 4 (15 U.S.C. 2603) (Ref. 1). Persons who commence manufacture, import, or processing of a chemical substance listed at 40 CFR 766.25 must submit a letter of intent to test or an exemption application within 60-days of starting any of those activities. Each person who is manufacturing or processing a chemical listed in 40 CFR 766.25 must submit a protocol for testing according to the schedule at 40 CFR 766.35(a)(2). Persons who manufacture or import a chemical substance listed under 40 CFR 766.25 must report positive test results, using the Dioxin/Furan Report Form (EPA Form 7710-51; see Attachment A), of all existing test data that show that the chemical substance has been tested for the presence of halogenated dibenzodioxins/halogenated dibenzofurans (HDDs/HDFs). These manufacturers must also submit any allegations of significant adverse reactions to HDDs/HDFs (pursuant to TSCA section 8(c)), as well as any unpublished health and safety studies for the chemical substance, as defined in the regulation (pursuant to TSCA section 8(d)), no later than 90 days after the date of submission of the positive test result. Additionally, any manufacturer or importer of a chemical substance listed in 40 CFR 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA, in accordance with various provisions of 40 CFR 716, no later than 90 days after the person first manufactures or imports the chemical substance.
Chemical-Specific Rules, TSCA Section 8(a)
EPA may need chemical-specific information under TSCA section 8(a) to evaluate the potential for exposure and/or adverse human health and environmental effects caused by the manufacture, processing, use, or disposal of identified chemical substances and mixtures. EPA may use TSCA section 8(a) to require such information to assess the need or set priorities for testing and/or further regulatory action, such as under the TSCA section 6 prioritization and risk evaluation process. Additionally, certain chemical-specific rules may be required by Court order or legislation.
The information required in TSCA section 8(a) chemical-specific rules can be fit for purpose to aid in achieving EPA’s goals of protecting human health and the environment. Information collected may vary depending on the substance, its current and potential uses, and EPA’s concerns about potential human or environmental risks caused by exposures to the substance. As noted above, TSCA section 8(a) rules may require persons manufacturing, or processing the chemical substance, or intending to manufacture or process, to report to EPA on specific information on a chemical listed at 40 CFR 704, subpart B such as a chemical’s composition, byproducts, quantity produced, employee exposure, and environmental release.
The chemical-specific rules at 40 CFR 704 may be either one-time reporting events (i.e., a single reporting deadline) or recurring requirements into the future. For example, the two currently recurring requirements that are being merged into this ICR are for nanoscale materials and recordkeeping for asbestos. The reporting requirements for chemical substances manufactured at the nanoscale (40 CFR 704.20) (Ref. 5) involve one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed and is required for any production volume. Nanoscale materials or nanomaterials are chemical substances organized in structures in the scale of approximately 1 to 100 nanometers and may have different organizations and properties than the same chemical substances in a larger size. Nanoscale materials can be found in a wide variety of products, including electronics, automotive products, paints and coatings, metal-cutting tools, sports equipment, stain-free clothing and mattresses, and ink. Thousands of products on the market utilize nanoscale materials. It is recognized that some of these substances, because of their small size, exhibit novel and enhanced properties not present in substances of larger dimensions. It is also widely recognized that limited data is available on these types of substances. These reports were due within one year of the rule’s effective date (i.e., due in 2018); however, if a person manufactures or processes a new discrete form of the reportable chemical substance for the new use, then that person would be required to report the new discrete form under this rule.
Some nanoscale materials are recognized as new chemical substances subject to notification requirements under TSCA section 5 because they are not contained on the TSCA Inventory. Therefore, they are subject to review for potential human health and environmental risks before they are manufactured and enter commerce. EPA has identified over 275 nanoscale materials submitted as new chemicals under TSCA since January 2005. Other nanoscale materials have the same molecular identity as chemical substances which are already on the TSCA Inventory and as such are not subject to new chemical notification. The Agency has authority under TSCA section 8(a) to collect information regarding chemical substances in commerce. The reporting of information associated with these nanoscale materials will provide EPA with data needed to determine appropriate action(s) under TSCA to reduce any risk to human health or the environment.
The asbestos reporting regulation (40 CFR 704.180) was a one-time data collection for manufacturers (including importers) and processors of any amount of asbestos, including as impurities and in articles, to provide information related to production volume, worker exposure, and conditions of use. The asbestos rule was designed to support EPA’s Part 2 Asbestos Risk Evaluation under TSCA section 6 and was required of EPA pursuant to a Court decision and agreement between EPA and petitioners.
The legal authority for this information collection is TSCA section 8(a), 15 U.S.C. 2607(a) (Ref. 2) and TSCA section 26(p), 15 U.S.C. 2625 (Ref. 3). TSCA section 8(a) chemical-specific rules have been codified at 40 CFR 704, subpart B (Ref. 7).
Via specific 8(a) rules, EPA may also require for respondents to prepare and submit OECD Harmonized Templates (OHTs) for such studies to standardize information formatting and improve efficiency of data review. Additionally, pursuant to 40 CFR 703(g) (Ref. 6), submitters of health and safety studies or information from such studies must provide such data in templated form, using an appropriate OECD harmonized template, if such template is available for the data type available at https://www.oecd.org/en/topics/sub-issues/assessment-of-chemicals/harmonised-templates.html.
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment, TSCA Section 8(c)
The TSCA section 8(c) reporting and recordkeeping requirements are of central importance in the administration of TSCA section 8. Without the ability to administer these paperwork requirements, EPA would not be able to meet its obligation under TSCA. Since the statute does not contain an automatic reporting provision, EPA must either inspect company files or require reporting of records that relate to specific substances of concern in order to obtain and use information about allegations of significant adverse reactions (e.g., through a Federal Register notice). EPA’s authority to inspect and require such reporting is codified in 40 CFR 717.17 (Ref. 8). EPA will review relevant TSCA section 8(c) records in connection with its TSCA chemical assessment activities.
All studies submitted to EPA will be verified and the contents of the submissions recorded and inspected for the inclusion of confidential business information. Copies of the documents will then be prepared for inclusion in EPA’s public docket and distributed, as appropriate and based on the associated chemical identity, to program offices at EPA and/or to other federal agencies for scientific analysis.
Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies, TSCA Section 8(d)
TSCA section 8(d), 15 U.S.C. 2607(d) (Ref. 2), authorizes EPA to promulgate rules requiring certain persons who manufacture, process or distribute in commerce, or propose to manufacture, process, or distribute in commerce chemical substances and mixtures to submit to EPA lists and copies of health and safety studies in their possession with respect to such chemical substances and mixtures. EPA regulations implementing the statute are codified at 40 CFR Part 716 (Ref. 9). TSCA as amended by the Lautenberg Chemical Safety for the 21st Century Act requires EPA to develop a pipeline of chemicals for prioritization and risk evaluation. Information from TSCA section 8(d) health and safety studies could help to inform the Agency’s prioritization and risk evaluation work. This will also help determine whether additional information on hazard, health or environmental effects, or exposure of the listed chemicals exist. Such information, among other uses, helps EPA, as applicable, assess risks and consider appropriate control actions. Collection of unpublished health and safety studies can reduce the need for testing. Additionally, other federal agencies use the studies when they are assessing a listed chemical substance for health or environmental effects. Via specific 8(d) rules, EPA may also require for respondents to prepare and submit OECD Harmonized Templates (OHTs) for such studies to standardize information formatting and improve efficiency of data review.
Responses to the collection of information are mandatory (see 40 CFR part 716). Respondents may claim all or part of a response confidential. EPA will disclose information that is covered by a claim of confidentiality to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 703.
EPA also amends the list of subject chemicals in 40 CFR part 716 periodically to add chemical substances and mixtures. The listed chemical substances and mixtures include chemicals recommended for testing under TSCA section 4 by the Interagency Testing Committee (ITC) and other chemical substances that EPA (particularly the Office of Pollution Prevention and Toxics (OPPT)), or other federal agencies, choose to assess for health or environmental effects.
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
EPA uses PAIR and subpart B of 40 CFR 766 data to (1) monitor domestic manufacture and/or importation of chemical substances, mixtures and categories, (2) identify possible routes of human or environmental exposure, (3) support regulations designed to prevent possible adverse health effects and (4) support EPA programs. The information provided by PAIR and subpart B of 40 CFR 766 is needed to complete assessments of chemicals of interest and to assist in the development of regulations to control hazardous chemicals. In particular, PAIR can be used to support activities under TSCA section 6 for risk-based prioritization and risk evaluation of TSCA chemicals.
All EPA program offices are potential users of PAIR and subpart B of 40 CFR 766. The information helps EPA prioritize and evaluate the potential for adverse human health or environmental effects caused by the manufacture and importation of the identified chemical substance, mixture or category.
Other federal agencies that require data on the human health and environmental effects of a chemical use PAIR information. States also have access to public portions of PAIR and subpart B of 40 CFR 766 information. Public interest groups use information reported under the public portions of PAIR and subpart B of 40 CFR 766.
Chemical-Specific Rules, TSCA Section 8(a)
EPA will also use the information obtained through the TSCA section 8(a) reporting rules to satisfy chemical-specific data needs. The information collected will be relevant to prioritization, all stages of risk evaluation, and/or risk management. Receipt of TSCA section 8(a) information may also give the Agency an opportunity to work with the respondent, if necessary, to minimize exposure risks associated with specific uses.
Regarding the nanoscale materials reporting rule, the information collected will provide important baseline information on health and environmental effects, exposures, risks, management practices, and data needs that will assist EPA and others in properly assessing and managing risks related to nanoscale materials. The information may also be used by other Federal agencies, such as the Occupational Safety and Health Administration (OSHA) and the Food and Drug Administration (FDA), and other members of the ITC may also present a need for and subsequently use TSCA section 8(a) data to, for example, assess worker or consumer exposures. Non-confidential portions of this information may be used by the public, academics, states, local and tribal government, as well as foreign governments and international organizations.
Information collected through this rule will be used by EPA scientists to assist in determining how and whether certain nanoscale materials may present risks to human health and the environment. If the hazard, exposure, and risk information submitted by participants indicate that potential unreasonable risks may exist, the data will be used by EPA and the manufacturer to determine the appropriate action necessary to avoid or mitigate the risks. Furthermore, such information could be used for risk management, hazard communication and right-to-know purposes, and product labels. EPA may also use the information to identify nanoscale materials that may not warrant future concerns or actions or should otherwise be treated as a lower priority for further consideration.
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
By using the TSCA section 8(c) reporting authority, EPA can examine such records whenever a chemical is discovered to present possible risks to human health or the environment. Information contained in the TSCA section 8(c) allegation records will have several uses. The information collected will be used on a case-specific basis to evaluate suspected adverse health or environmental effects of a chemical substance or mixture already under assessment by EPA's OPPT. Most of these substances will be “existing” chemicals, e.g., chemicals for test rule consideration, substances that are the subjects of TSCA section 8(e) notices of substantial risk, or substances or mixtures brought to the attention of OPPT by other EPA programs, other government agencies, industry, or the public. TSCA section 8(c) reports also may be required on “new” chemicals as one means of monitoring for any suspected or potential hazards identified during the premanufacture notification (PMN) review period. In addition to broader data call-ins of 8(c) records for specific chemicals or mixtures, EPA also makes use of the authority during site inspections or audits, particularly for records related to incidents at sites (e.g., with workers).
On a case-specific basis, requiring reporting of TSCA section 8(c) records will also serve as a discovery function. It will help identify trends of adverse effects across the industry that may not be apparent to any one company. It will also serve as a long-term trend identification function because of the five-year and 30-year recordkeeping feature of the statute.
Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies
Studies submitted pursuant to TSCA section 8(d) rules will be evaluated in conjunction with other available data as EPA assesses potential risks of existing chemicals. EPA and other federal agencies use the data to construct a complete picture of the known effects of the chemical substance. From this picture, OPPT will be able to determine what kinds of information gaps, if any, exist and whether testing may be needed. The TSCA section 8(d) studies ensure that OPPT bases its testing decisions on the most complete information available and does not require unnecessary or duplicative testing, which is consistent with the requirements of TSCA section 4(h).
In addition, EPA may require that copies of unpublished health and safety studies be submitted on chemicals that are being considered for prioritization under TSCA section 6 or in the early stages of risk evaluation or when action to control exposure is being considered by EPA or another federal agency. These chemicals may be ones for which persons have submitted a substantial risk notification under TSCA section 8(e), or other chemicals for which data are needed to support a control measure under TSCA sections 5 and 6 or under other EPA-administered statutes. If this information collection did not exist, EPA would be unable to obtain the available information on a chemical and evaluate the need for testing or data development under TSCA section 4 or controlling chemical substances under TSCA sections 5 and 6.
In the past, EPA’s Office of Air and Radiation (OAR) has used the submitted studies for developing Tier II analyses, and EPA’s Office of Research and Development (ORD) has used the information for developing extended risk assessments. In addition, other organizations have utilized the submitted studies: the Consumer Product Safety Commission (CPSC) for assessing the hazards of known consumer exposure; the American Council for Government Industrial Hygienists (ACGIH); and the National Institute for Occupational Safety and Health (NIOSH) for developing recommended occupational exposure levels.
TSCA section 8 collections must be submitted electronically via the Agency’s Central Data Exchange (CDX). Most TSCA section 8 reporting rules have rule-specific applications within CDX for entities to submit their information to EPA. All information sent by the submitter via CDX is transmitted securely to protect CBI. Furthermore, if anything in the submission is claimed as CBI, a non-CBI copy of the submission must be provided by the submitter. CDX User Guides instruct users on how to submit and substantiate CBI information using the Chemical Information Submission System (CIS) (see the TSCA section 8(d) user guide here: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/section-8d-health-safety-data-reporting-user-guide-0)
EPA developed the CDX platform for use in submitting data electronically to the Agency. This platform is available for use with most computers, using “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. The CIS is a tool that provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments.
The Agency ensures secure transmission of the data, reports, and other documents sent from the user's desktop through the Internet via the Transport Layer Security (TLS) protocol. TLS is a widely used approach for securing Internet transactions by the National Institute of Standards and Technology (NIST) as a means for protecting data sent over the Internet.
In addition, CDX enables the submitter to electronically sign, encrypt, and transmit submissions, which EPA subsequently provides back to the submitter as an unaltered copy of record. This assures the submitter that the Agency has received exactly what the submitter sent to EPA. The CDX reporting tool encrypts using a module based on the 256-bit Advanced Encryption Standard (AES) adopted by NIST. Details about AES can be found in FIPS 197 pdf on the NIST website at http://csrc.nist.gov/publications/PubsFIPS.html, and EPA may incorporate other encryption modules into future versions of the tool. Information submitted via CDX is processed within EPA by secure systems certified for compliance with Federal Information Processing Standards.
Manufactures and processors of nano materials must submit information to the Agency electronically. To file electronically, submitters must use the EPA provided application. To access the application, users must also be registered with CDX. When registering, a user will need to ensure they are registering for the Chemical Safety and Pesticide Programs (CSPP) data flow, which will provide them access to the Chemical Information Submission System (CISS) where the submission can be accessed. (Note: Users who have previously registered with CDX are able to add "Submission for Chemical Safety and Pesticide Program (CSPP)" to their current registration.) This reporting tool is compatible with most computers and uses "Extensible Markup Language" (XML) specifications for efficient data transmission across the Internet.
TSCA section 8(a)(5) states, with respect to TSCA section 8 actions, “the Administrator shall, to the extent feasible… not require reporting which is unnecessary or duplicative.” The reporting requirements of TSCA section 8(a) rules only require information “known to or reasonably ascertainable” by that person, and that EPA believes will assist in a reasoned evaluation of the human health and environmental effects of chemical substances and mixtures. This information is unlikely to be duplicative since: (1) EPA estimates that each chemical-specific rule will generally generate only a few submissions, (2) the information required by the TSCA section 8(a) rule is unique to the manufacturer or processor (e.g., the proposed date of production or importation, the amount produced or imported, the number of workers exposed and that duration, the chemical composition, and uses of the chemical substance or mixture), (3) the information on employee health effects required by the TSCA section 8(c) rule will be unique for the various affected employees of manufacturers and processors, (4) the studies required by the TSCA section 8(d) rule that are unpublished and in the possession of a company are most likely proprietary and unique for each manufacturer/processor, (5) the study submission requirement under the TSCA section 8(d) rule may be satisfied by trade groups on behalf of their members, and (6) EPA thoroughly checks other public and unpublished sources to see if the required data may already be available prior to issuing such rules. If EPA were to become aware of a source of substantially similar information, for example via comments on a proposed rule, EPA would not continue with the information collection or would provide exemptions from reporting where the information may be duplicative.
Specifically, the implementing regulations for nanoscale reporting indicate that any person who submitted a TSCA new chemical notice on or after January 1, 2005, under 40 CFR part 720 or 723 for a nanoscale material that would be subject to the regulations does not need to submit a report for the nanoscale material information previously submitted.
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
In accordance with TSCA section 8(a)(1)(B), PAIR contains a small business exemption. A manufacturer or importer is considered a small business if (1) the firm’s total annual sales when combined with those of its parent company (if any) are less than $30 million for the reporting period and (2) its total production and/or importation of the chemical substances, mixture or category, for the reporting period, does not exceed 100,000 pounds (45,400 kilograms) at an individual site owned and controlled by the firm. In accordance with TSCA, EPA consulted with the Administrator of the Small Business Administration to review the adequacy of the standards for determining which entities are considered small for the purposes of TSCA section 8(a)(1). The agency determined that a revision of the standard was warranted and promulgated a rulemaking in 2020 to update the standard (85 FR 31986; May 28, 2020). Under this updated definition, a manufacturer may be considered a small manufacturer under one of two standards: (1) its total annual sales combined with any parent company’s are under $12 million; (2) its total annual sales combined any parent company’s are under $120 million, and total annual production volume of a particular chemical at any of the manufacturer’s sites is less than 100,000 pounds (40 CFR 704.3).
The small manufacturer/importer exemptions apply to PAIR, regardless of which office or agency nominates a chemical. In some instances, the EPA Administrator can remove these exemptions on a chemical-specific basis, provided notice and comment rulemaking is utilized. EPA expects that those offices that have a critical need for reporting from small businesses usually exempt from PAIR reporting will use other mechanisms to gather the data. EPA does not expect to issue a PAIR rule during the next three years that would impact small businesses.
Chemical-Specific Rules, TSCA Section 8(a)
TSCA section 8(a)(1) generally exempts small manufacturers and processors, using the same definition of small manufacturer described above (40 CFR 704.3). However, under TSCA section 8(a)(3), EPA may require small manufacturers and processors to report or keep records if the substance or mixture is subject to a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6 or with respect to which relief has been granted pursuant to a civil action brought under TSCA sections 5 or 7.
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
Unlike TSCA section 8(a), Congress did not include a specific exemption of small businesses in TSCA section 8(c). This rule does not exempt small manufacturers (including importers) or processors of chemicals from its provisions.
However, TSCA section 8(a)(5)(B) requires EPA, to the extent feasible, to minimize compliance costs with TSCA section 8 and TSCA section 8 rules on small manufacturers and processors. Accordingly, EPA specifically eliminated most distributors and effectively limits the number of processors subject to the rule. By doing so, EPA has eliminated many small businesses from the purview of the rule without compromising its objectives.
Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies
The TSCA section 8(d) rule applies to all manufacturers in covered industry sectors (and, when specified, processors of chemicals and others in possession of studies), regardless of size. However, EPA does not anticipate that many small businesses possess unpublished health and safety studies because they are unlikely to have the financial resources to perform the studies on chemicals subject to the rule. Therefore, the burden on such companies is expected to be minimal.
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR)
Under PAIR or subpart B of 40 CFR 766, persons are required to report only once for a chemical listed in the PAIR or subpart B of 40 CFR 766. However, for PAIR, if information received from the initial report indicates human health and environmental risks, then the Agency may require that additional information be submitted at some future date to monitor any changes pertaining to that chemical. As such, the reporting frequency for PAIR and subpart B of 40 CFR 766 cannot be reduced without effectively suspending the information collection requirement.
Chemical-Specific Rules, TSCA Section 8(a)
Generally, companies are required to report only once under a TSCA section 8(a) chemical-specific reporting rule, although EPA may consider requiring reporting on an annual, semiannual, monthly, or other basis if the Administrator deems this necessary to protect human health and the environment. For example, EPA requires reporting only once for manufacturers and processors for new discrete nanoscale materials before they are manufactured or processed. EPA tailors each rule to meet chemical-specific information requirements, thus reducing the potential for redundant data collections.
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment, TSCA Section 8(c)
EPA uses its authority to collect information pursuant to the TSCA section 8(c) rule sparingly. At this time, EPA anticipates issuing infrequent requests (less than two per year) for TSCA section 8(c) reporting. However, reporting requests may occur more frequently because individual notices or letters containing such TSCA section 8(c) requests may be clustered in the same year. The information will be collected on a case-specific basis to evaluate suspected adverse health or environmental effects of a chemical substance or mixture already under assessment by OPPT or when a chemical not under assessment by OPPT is discovered to present possible risks to human health or the environment. For example, chemical disasters are unpredictable, so OPPT must reserve the capability to require records submission on an as-needed basis in order to gather relevant information related to such matters. TSCA section 8(c) allegation records are part of such related information.
Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies, TSCA Section 8(d)
In most instances, respondents will be required to make only initial submissions under the TSCA section 8(d) rule. However, after the initial submission of lists and studies, respondents are required to notify EPA when certain health and safety studies are initiated by submitting a list of newly initiated studies. Because the reporting frequency for the TSCA section 8(d) rule is generally only once, the reporting frequency cannot be reduced. If the information requirement was less frequent, EPA would be unable to obtain the necessary information for evaluating the need for additional information under TSCA section 4 or evaluating and controlling chemical substances under TSCA sections 5 and 6. In the absence of data that would be submitted under TSCA section 8(d), EPA might require creation of data under a TSCA section 4 test order or rule, which would be less efficient and more expensive than a TSCA section 8(d) submission.
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 record retention provisions of TSCA section 8(c) and 40 CFR part 717 exceed the Paperwork Reduction Guidelines (5 CFR 1320.6) in that they require respondents to maintain records other than health, medical, or tax records for more than three years. TSCA section 8(c) authorizes EPA to require persons (i.e., manufacturers (including importers), processors, or distributors) to maintain records of adverse reactions to the health of employees for a period of 30 years from the date such reactions were first reported or known to the person maintaining the record. Any other record of such adverse reactions (e.g., to the environment, non-employees) is required to be retained for a period of five years. 40 CFR part 717 incorporates these record retention provisions authorized by TSCA.
The record retention requirements of the TSCA section 8(a) reporting and recordkeeping rule for asbestos (40 CFR 704.180(g)) require relevant records to be retained for five years beginning with the end of the submission period (May 24, 2024). The information collected under this rule informed the Part 2 asbestos risk evaluation (published in November 2024) and will inform ongoing risk management activities under TSCA section 6.
Respondents may also submit records with confidential business information (CBI) claims. EPA has implemented procedures to protect any confidential, trade secret, or proprietary information from disclosure. Respondents with CBI claims must assert and substantiate as appropriate, and EPA reviews and safeguards such claims, in accordance with TSCA section 14 and 40 CFR 703.
Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or report.
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 5 CFR 1320.8(d), EPA published a notice in the Federal Register on May 9, 2025, (90 FR 19715 (FRL-12357-01-OCSPP)), announcing the planned renewal of this information collection activity, soliciting public comment on specific aspects of the ICR and providing a 60-day public comment period.
The EPA also consulted 9 stakeholders, specifically asking them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR (Attachment F). The stakeholders consulted were:
Andersen Development Company
American Chemistry Council (ACC)
AOC LLC
BASF
Bergeson & Campbell
DuPont
Keller and Heckman LLP
Olin Corporation
Society of Chemical Manufacturers & Affiliates
Of those consulted, EPA received responses from DuPont and ACC (Attachment G). The response from DuPont stated that they disagreed with EPA’s assumption that there are no capital costs associated with this activity, and they suggested that EPA improve both CDX and guidance documents. EPA disagrees with the statement that capital costs are required to respond to this activity, though companies may opt to make such expenditures at their discretion. However, EPA appreciates DuPont’s points related to improved CDX and guidance documents; see EPA’s response below to another comment regarding guidance documents.
The response from ACC requested that the Agency adjust its burden analysis by updating the labor wage rates to reflect more work from technical experts than clerical staff, though they agreed no capital costs are associated with this activity. EPA appreciates the suggestion related to the labor wage rates, but given that clerical burden contributes a small portion to the overall burden as estimated by EPA and because the comment did not identify how much of the clerical burden should be shifted, EPA is not revising the burden at this time.
EPA also received a comment in the public docket during the comment period from ACC (Attached H). The comment provided general feedback on some of the TSCA section 8 rules that have been promulgated recently, including those under other ICRs. Topics included opposition to the omission of certain TSCA section 8 rules in this ICR renewal, lack of updated guidance on the TSCA section 8(d) rule, and challenges with submitting data over EPA’s IT platform.
In response to the docket comment from ACC the Agency notes the following: This proposed renewal does not aim to include all TSCA section 8 rules. For instance, the rule-related ICR (EPA ICR No. 2682.02 OMB Control No. 2070-0217) associated with the final rule “TSCA section 8(a)
(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; published on October 11, 2023 (88 FR 70516 (FRL-7902-02-OCSPP)) was not included in this renewal because the Agency intends on revising it in a separate action. However, this renewal ICR does include the burden associated with the final rule “Certain Existing Chemicals; Request to Submit Unpublished Health and Safety Data und the Toxics Substances Control Act (TSCA)” published on December 13, 2024 (89 FR 10756 (FRL-11164-02-OCSPP)) (including no impurity exemption and the requirement for OHTs to accompany studies with CBI claims). EPA agrees that additional guidance for the TSCA section 8(d) rule is helpful and is developing that document based on questions received after the 2024 TSCA section 8(d) rule. EPA plans to publish it as soon as possible. The commenter provides an example of IT issues impacting submission deadlines for one of the TSCA section 8 rules covered by this proposed ICR: the 2024 TSCA section 8(d) rule. An extended submission period is due to extraordinary circumstances and is not contemplated by EPA when promulgating rules or other information collections. Overall, no changes to the proposed ICR are needed in response to the comment.
The Agency thanks all commenters for their comments and has considered them in developing this ICR.
This question is not applicable to this ICR.
Submitters may assert a claim that information is confidential business information. EPA has implemented procedures to protect any confidential, trade secret or proprietary information from disclosure. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA and 40 CFR part 703. Information submitted under specific reporting requirements of TSCA, or in support of TSCA, is subject to the provisions of TSCA section 14 and to EPA's Regulations on the Confidentiality of Business Information (see 40 CFR 703). Failure to follow these procedures fully at the time of document submission to EPA is interpreted by the Agency as a waiver of confidentiality claims. Submitters may claim confidentiality for proprietary information.
No information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108, as amended, “Responsibilities for the Maintenance of Records about Individuals by Federal Agencies.”
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’
The North American Industrial Classification System (NAICS) codes associated with industries most likely affected by the overall paperwork requirements are described below:
325 Chemical Manufacturers and Processors
325130 Synthetic Dye and Pigment Manufacturing
324110 Petroleum Refineries
325180 Other Basic Inorganic Chemical Manufacturing
331221 Rolled Steel Shape Manufacturing
334413 Semiconductor and Related Device Manufacturing
335991 Carbon and Graphite Product Manufacturing
423220 Home Furnishing Merchant Wholesalers
423330 Roofing, Sliding, and Insulation Material Merchant Wholesalers
423510 Metal Service Centers and Other Metal Merchant Wholesalers
Note that not all NAICS codes are necessarily covered or likely to be covered by each of the ICs covered by this ICR.
Wage and fringe benefit data for each labor category (e.g., managerial, professional/technical, clerical, and attorney labor) are taken from the U.S. Bureau of Labor Statistics (BLS) Employer Costs for Employee Compensation (ECEC) Supplementary Tables (BLS 2024) or the BLS Occupational Employment Statistics (OES) Estimates (BLS 2023). In the BLS reports, wages are represented by the “wages and salaries” cost component and fringe benefits are represented by “total benefits.” Overhead costs are assumed to equal 20% of the sum of wages plus fringe benefits. This loading factor, as described in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020), is reflective of multiplier values used in prior EPA RIAs and ICRs that are based on industry- and occupation-specific overhead rates affected by EPA regulations and is consistently applied with Office of Pollution Prevention and Toxics economics practices. This overhead loading factor is multiplied by the total compensation (i.e., wages plus fringe benefits). For example, the fully loaded wage for professional/technical labor is ($46.71+ $22.91) * 1.2 = $83.54. Fully loaded costs for additional labor categories are calculated in a similar manner. The calculated overhead costs are shown in Table 1 with the total hourly loaded wages.
Table 1. Manufacturing and Legal Services Industry Wage Rates (2024$)
Labor Category |
Data Series a |
Date |
Wage
a |
Fringe Benefit b |
Total |
Overhead as % total compensationc |
Overhead |
Loaded Hourly Wages d |
(a) |
(b) |
(c) = (a) + (b) |
(d) |
(e)=(c)*(d) |
(f)=(c)+(e) |
|||
Managerial |
BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial” |
Sep-24 |
$50.55 |
$23.75 |
$74.30 |
20% |
14.86 |
$89.16 |
Professional / Technical |
BLS ECEC, Private Manufacturing industries, “Professional and related“ |
Sep-24 |
$46.71 |
$22.91 |
$69.62 |
20% |
13.92 |
$83.54 |
Clerical |
BLS ECEC, Private Manufacturing industries, “Office and Administrative Support” |
Sep-24 |
$24.41 |
$10.82 |
$35.23 |
20% |
7.05 |
$42.28 |
Attorney |
BLS OES "Legal Services - Lawyers," BLS ECEC, "Professional and Business Services d |
May-23
(wage) |
$84.84 |
$26.11 |
$110.95 |
20% |
22.19 |
$133.14 |
Note:
Values may not sum due to rounding.
a Source: Employer Costs for Employee Compensation, Private
manufacturing industries, Professional and business services
industry, September 2024; Occupation Employment and Wages, 23-1011
Lawyers. May 2023. (U.S. Bureau of Labor Statistics 2024).
b
Source: Employer Costs for Employee Compensation Supplementary
Tables: December 2023 (BLS 2024)
c 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)
d Wage data are rounded to the closest cent in this
analysis.
As part of EPA’s electronic reporting requirements, submitters are required to register and submit information electronically with EPA’s CDX system. First-time submitters are required to register their company with the CDX reporting tool. These activities are only required for first-time submitters of any TSCA section 8 submission. EPA conservatively assumes that all submitters will incur the following burden and costs.
CDX registration: EPA estimates that companies will spend approximately 0.18 hours per employee to register with CDX, and that an average of four technical staff members and one manager will need to register for each company, totaling approximately 0.92 hours of burden per company.
CDX electronic signature: EPA estimates that companies will spend 0.25 hours preparing, submitting, and filing an electronic signature agreement (Authentication of Identity) form to EPA per employee. This burden will apply to four technical staff members and one manager per company, totaling 1.25 hours of burden per company. In addition, EPA estimates that a manager will spend an additional 0.50 hours accessing, preparing, and submitting verification forms (Verification of Authorization) for all authorized submitters to EPA. The total burden incurred by companies submitting and then verifying electronic signature agreements is 1.75 hours. Note that this burden does not include any additional time required to contact EPA’s CDX help desk to notify a change of submitter status, should one occur.
Table 2: Costs for CDX Registration and CDX Electronic Signature (2024$)
Activity |
Burden per Firm (hours) |
Cost per Firm (2024$) |
||||||
Managerial |
Technical |
Clerical |
Total |
Managerial ($89.16/hr) |
Technical ($83.54/hr) |
Clerical ($42.28/hr) |
Total |
|
CDX Registration |
0.18 |
0.73 |
0 |
0.92 |
$16.35 |
$61.27 |
$0.00 |
$77.61 |
Electronic Signature |
0.75 |
1 |
0 |
1.75 |
$66.87 |
$83.54 |
$0.00 |
$150.41 |
Mailing costa |
- |
- |
- |
- |
- |
- |
- |
$3.80 |
Total |
0.93 |
1.73 |
0 |
2.67 |
$82.92 |
$144.53 |
$0.00 |
$227.45 |
TSCA section 8(d): EPA conservatively assumes all 33 firms submitting studies will need to register with CDX, the average burden and cost per CDX registration is 2.67 hours and $227, respectively using the values related to CDX registration activities in Table 13.
a See EPA ICR Cross Media Electronic Reporting Rule (CROMER) (EPA ICR No.2002.09; OMB Control No. 2025-0003) for more information on alternative identify proofing for electronic signatures and registration for CDX.
PAIR requires manufacturers (includes importers) of the listed chemical substances, mixtures or categories to report to EPA information such as the substances’ chemical identification, quantity produced or imported, chemical processes, employee exposure, environmental releases, uses and products. Respondents are required to report only information that is known or reasonably ascertainable by them. Extensive file searches are not required. The PAIR reporting requirements are included in the PAIR form (EPA Form 7710-35) and instructions (see Attachment A).
In addition, each person who is manufacturing or processing a chemical listed in 40 CFR 766.25, must submit a protocol for testing according to the schedule at 40 CFR 766.35(a)(2). Persons who manufacture or import a chemical substance listed under 40 CFR 766.25 must report positive test results, using the Dioxin/Furan Report Form (EPA Form 7710-51; see Attachment D), of all existing test data that show that chemical substance has been tested for the presence of halogenated dibenzodioxins/halogenated dibenzofurans (HDDs/HDFs), as well as any health and safety studies for the chemical substance, as defined in the regulation. Additionally, any manufacturer or importer of a chemical substance listed in 40 CFR 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA.
A representative respondent would engage in the following activities:
Conduct an initial review of the rule to determine if their company must report;
Familiarize themselves with the PAIR and subpart B of 40 CFR 766 requirements;
Complete the PAIR and subpart B of 40 CFR 766 reporting via the Agency’s Central Data Exchange (CDX);
Provide trade name notification;
Indicate CBI status if so desired; and
Keep a copy for recordkeeping requirements.
The PAIR (40 CFR part 712) and subpart B of 40 CFR 766 generally require one-time reporting and establish the reporting period for the listed chemical substances, mixtures, or categories. Therefore, a reporting schedule is not required.
This section presents the Agency’s estimates of the burden associated with the reporting and recordkeeping requirements under the TSCA section 8(a) PAIR and subpart B of 40 CFR 766. The total annual industry burden for both reporting and recordkeeping is estimated to be 32.99 hours. These estimates are based on the level of PAIR and subpart B of 40 CFR 766 reporting activity during the ICR period of FY 2022 through 2024. In conducting any study that will be submitted to EPA under TSCA, the respondent must comply with the Good Laboratory Practice Standards (GLPS) at 40 CFR part 792 (see Ref. 10). Since the GLPS represent basic standard practices used by laboratories, any burden and costs related to the GLPS are fully captured in the cost and burden estimates provided below.
The methodology used to develop these cost estimates follows principles that have been used in previous ICRs. The methodology and calculations used in this analysis assume the employee responsible for filling out the form has a reasonable level of familiarity with the company and knowledge of the operation at the site. The analysis deals with the marginal costs of complying with this specific request and not the total costs to the company of initial employee training, costs associated with collecting and storing records, or of file maintenance that enable a company to comply with a range of other federal and state environmental, health and safety regulations or accounting requirements that rely on this type of information. Based on conversations with respondents, gathering information for an 8(a) PAIR request is similar to other efforts they perform which require familiarity with EPA, state, and other federal agency requests for chemical information and does not involve additional familiarization or training to comply with information requested under this ICR.
Number of Sites and Reports per Site
The burden hour estimates in this analysis are based on an estimate of the level of PAIR and subpart B of 40 CFR 766 reporting activity during the three-year ICR approval period (FY 2026 to FY 2028). This, in turn, is related to the number of expected PAIR and subpart B of 40 CFR 766 chemical reports and reporting sites. During fiscal years 2012 to 2024, EPA received 0 PAIR submissions. Some PAIR reports submitted during a given fiscal year may be for chemicals added to the PAIR during previous years. EPA received less than five submissions over the course of the last OMB approval for subpart B of 40 CFR 766. For the purposes of this analysis, EPA assumes an annual average of one site (respondent) submitting one report (form), for an average of one report per respondent. This is a realistic estimate as EPA, at this time, does not plan to issue a PAIR rule in this renewal cycle because EPA will most likely use other rulemakings such as the Chemical Data Reporting (CDR) rule to collect similar data. The following, however, describes respondents’ burden if such an event were to occur.
To estimate the burden and costs to industry respondents, several reporting activities (or burden factors) are analyzed. These burden items include: form familiarization; report preparation; trade name notification; CBI substantiation; recordkeeping; CDX registration; and report submission. Each of these activities requires the skills of various labor categories. The section below details each separate activity and presents the estimated labor hours required by each task, by labor category (i.e., clerical, technical and managerial).
All burden estimates are taken from the Economic Impact and Small Business Definition Analysis for the Final TSCA Section 8(a) Preliminary Assessment Information Rule, Final Report (EPA, 1981), previous TSCA section 8(a) PAIR ICRs updates, and the Economic Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Final Rule (EPA, 2012), unless otherwise noted. The 2012 Economic Analysis estimates the burden associated with electronic PAIR and subpart B of 40 CFR 766 submissions, including the burden associated with CDX registration, the reduction in recordkeeping burden, and the reduction of the clerical burden associated with report submission. This ICR follows the practice of the last ICR update where EPA removed the clerical burden associated with all other PAIR and subpart B of 40 CFR 766 submission activities. This change was made to be consistent with the burden estimates provided for the electronic reporting of TSCA section 5 Notices in The Economic Analysis of the Premanufacture Notification Electronic Reporting Rule (EPA, 2009) and the electronic submission of TSCA 8(b) Chemical Data Reporting (CDR) submissions in the Economic Analysis for the Final Inventory Update Reporting (IUR) Modifications Rule (EPA, 2011).
Form Familiarization
In the 1981 PAIR economic analysis1, it was estimated that form familiarization would require 3 hours of effort from managerial personnel and 4 hours from technical personnel for a total of 7 hours per site. The estimate includes efforts for rule familiarization and to determine if reporting is required. Because EPA only expects one report from one site in the next ICR cycle, both the per-report and per-site burden is estimated to be 7 hours (Table 3).
Report Preparation
The 1981 PAIR economic analysis estimated that direct reporting activities would require a total of 16 hours of effort per report. This consists of the burden related to the completion of the PAIR (EPA Form No. 7710-35) or subpart B of 40 CFR 766 form (EPA Form No. 7710-51). As indicated previously, the respondents are not expected to conduct an exhaustive search of their files. Respondents are only required to report what is known or reasonably ascertainable to them (see 40 CFR 712.7). The relative distribution of reporting burden between managerial, technical, and clerical personnel was developed for the 1992 PAIR ICR update. For this ICR update, EPA assumes that per-report burden for report preparation is the same as in the prior ICR update. EPA only expects one report from one site in the next ICR cycle, and both the per-report and per-site total burden estimate is 14.75 hours (Table 3).
Trade Name Notification
Some companies may report their customers’ uses as “unknown” for more than 20 percent of their volume. These companies must list under Item 10 of the PAIR reporting form the market (trade) name(s) under which they distribute the chemical. This reporting is referred to as trade name notification.2
All commercial manufacturing, importing and processing sites that distribute any of the chemicals subjected to a PAIR reporting rule under a trade name must take steps to ensure that information about the downstream processors is submitted to EPA. Firms may choose among several options to meet trade name notification requirements, including:
Submit trade name data to EPA for listing in the Federal Register;
Notify all customers of the need to report; or
Complete the reporting requirements for each customer.
This ICR assumes that companies will adopt the least-costly reporting alternative of providing a trade name list to EPA for inclusion in the Federal Register. However, trade name notification is not relevant if processor reporting is not required.
Furthermore, this ICR also assumes that all manufacturers and importers will incur trade name notification costs but does not address processors due to the lack of data on processor reporting. In the 1994 EPA PAIR ICR,3 the unit burden of trade name notification was given as 3.2 hours (i.e., 2.2 hours managerial and 1.0 hours clerical). For this analysis the 1.0 hours of clerical burden is removed to adjust for electronic submissions, for a total burden of 2.2 hours per report. Because EPA only expects one report from one site in the next ICR cycle, both the per-report and per-site burden is 2.2 hours (Table 3).
CBI Substantiation
A company may make claims of confidentiality for any data element contained in its submission. For each CBI (confidential business information) claim, generic information must be supplied for a non-CBI copy of the submission (i.e., a sanitized version must also be submitted). It is assumed that most of the time required for CBI substantiation involves managerial staff discussion of whether to make a CBI claim. Furthermore, it is assumed that all firms will review their submissions for CBI content.
The 2016 Lautenberg Act increased requirements for TSCA CBI substantiation claims. Lautenberg requirements for assertion of CBI claims are codified in 40 CFR part 703. The previous ICR assumed that all CBI substantiation burden was a managerial decision. The Lautenberg Act changed TSCA to require a statement that the submitter has (1) taken reasonable measures to protect the confidentiality of the information, (2) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law, (3) has a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (4) has a reasonable basis to believe that the information is not readily discoverable through reverse engineering.4 These additional questions make CBI substantiation more a technical than a managerial decision.
Based on an analysis of CBI claims for reporting to the TSCA Inventory (discussed in the 1986 CAIR economic analysis), 75 percent of reports are expected to make CBI claims. The burden distributed across all reports is 5.35 hours x 0.75, or 4.01 hours. Because EPA only expects one report from one site in the next ICR cycle, both the per-report and per-site burden is 4.01 hours (Table 3).
Recordkeeping
Pursuant to TSCA section 8(a), the manufacturer/importer or processors of the chemical substances identified under PAIR must also maintain records of the information submitted to EPA. In addition, since manufacturer/importer or processors that submit data to EPA must comply with the GLPS in 40 CFR 792, this ICR also generally covers the burden associated with maintaining records as required under the GLPS. These records are used for compliance monitoring and enforcement purposes.
EPA estimates that the recordkeeping burden associated with this ICR involves about 30 minutes for both the clerical and the technical labor category, based on the Economic Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Final Rule (EPA, 2012). This burden estimate represents the time necessary for individuals to identify the information, determine the appropriate location for the record to be kept, and place the record in such a location. The per-report recordkeeping burden is therefore estimated to be 1.00 hour. Because EPA only expects one report from one site in the next ICR cycle, both the per-report and per-site burden is 1.00 hour (Table 4).
CDX Registration, Electronic Signature, and Rule Familiarization
As part of EPA’s electronic reporting requirements, submitters of PAIR and subpart B of 40 CFR 766 reports are required to register and submit information electronically with EPA’s CDX system. EPA estimates that companies registering with CDX for the first time would incur a one-time burden to complete CDX registration activities, obtain a CDX electronic signature, and familiarize themselves with electronic reporting requirements. The total burden associated with CDX registration is available at www.cdx.epa.gov, which is informed by the CROMERR cost benefit analysis (EPA 2021) and is estimated to be 3.48 hours per company. This includes 0.91 hours for CDX Registration assuming 1 managerial staff member and 4 technical staff members, 1.75 hours for completing electronic signature agreements, and 0.82 hours for rule familiarization.
For the purposes of this analysis EPA assumes that the one site submitting PAIR or subpart B of 40 CFR 766 data will register with CDX, for a total per-site burden of 3.48 hours (Table 3).
Report Submission
Report submission consists of the preparation, review, and electronic submission of a report in accordance with 40 CFR Part 712, Subpart B, as amended by 78 FR 72818 (December 4, 2013), which required electronic submission.
EPA estimates that the per-report submission will require 0.05 hours of clerical time and 0.5 hours of managerial time, for a total of 0.55 hours. The clerical burden is taken from the Economic Analysis for the Electronic Reporting under the Toxic Substances Control Act (TSCA) Final Rule (EPA, 2012) and includes time to prepare and submit a report electronically. The managerial time assumes an involvement in the preparation of the transmittal letter and review of the report package before it is submitted to EPA. Because EPA expects one report from one site in the next ICR cycle, both the per-report and per-site burdens are 0.55 hours (Table 3).
Total Industry Burden Estimates
Table 3 presents the summary of the annual burden hour estimates for respondents.
Table 3. Estimated Annual Burden Hours (assuming 1 report per site and a total of 1 report per year) for TSCA Section 8(a) PAIR
Burden Item |
Managerial |
Technical |
Clerical |
Hours Per Report |
Total Number of Reports per Site |
Hours Per Site |
Total Number of Sites |
Total Annual Hours |
Form Familiarization |
3.00 |
4.00 |
0.00 |
7.00 |
1 |
7.00 |
1 |
7.00 |
Report Preparation |
5.50 |
9.25 |
0.00 |
14.75 |
1 |
14.75 |
1 |
14.75 |
Trade Name Notification 1 |
2.20 |
0.00 |
0.00 |
2.20 |
1 |
2.20 |
1 |
2.20 |
CBI Substantiation 2 |
0.95 |
3.06 |
0.00 |
4.01 |
1 |
4.01 |
1 |
4.01 |
Recordkeeping |
0.00 |
0.50 |
0.50 |
1.00 |
1 |
1.00 |
1 |
1.00 |
CDX Registration 3 |
0.18 |
0.73 |
0.00 |
N/A |
N/A |
0.91 |
1 |
0.91 |
CDX Electronic Signature 3 |
0.75 |
1.00 |
0.00 |
N/A |
N/A |
1.75 |
1 |
1.75 |
Rule Familiarization 3 |
0.55 |
0.27 |
0.00 |
N/A |
N/A |
0.82 |
1 |
0.82 |
Report Submission |
0.50 |
0.00 |
0.05 |
0.55 |
1 |
0.55 |
1 |
0.55 |
Totals |
13.63 |
18.81 |
0.55 |
29.51 |
N/A |
32.99 |
N/A |
32.99 |
1 Clerical burden is removed to adjust for electronic submission. 2 Burden hours per report for each labor category are scaled by 75% to account for number of CBI claims based on past data. 3 CDX activities include CDX Registration, CDX Electronic Signature and Rule Familiarization are assumed to occur at the site level only.
In summary, an average of one respondent per year would be required to spend an estimated total of 32.99 hours each year to respond to PAIR and subpart B of 40 CFR 766 rules during the period of FY 2026 through FY 2028, resulting in an average burden of 32.99 hours per response.
Estimating Respondent Costs
This section presents estimates of the cost expected to be incurred due to reporting under the TSCA section 8(a) PAIR and subpart B of 40 CFR 766. The total annual industry cost for both reporting and recordkeeping is estimated to be $2,810. This estimate is based on the cost of the burden estimate from Table 3 and includes other costs associated with this ICR.
Labor costs from Table 1 are multiplied by the estimated burden hours per activity to develop total unit costs per report in Table 4. Finally, unit costs per report are multiplied by the number of reports per site per year to arrive at unit costs per site (i.e., respondent costs) and are summarized in Table 4.
Cost Element |
Managerial |
Technical |
Clerical |
Total Annual Burden Hours |
Total Labor Costs |
Total Cost Per Report |
Total Number of Reports |
Total Cost Per Site |
Total Number of Sites |
Total Annual Industry Cost |
$89.16 |
$83.54 |
$42.28 |
||||||||
Form Familiarization |
3.00 |
4.00 |
0.00 |
7.00 |
$602 |
$602 |
1 |
$602 |
1 |
$602 |
Reporting |
5.50 |
9.25 |
0.00 |
14.75 |
$1,263 |
$1,263 |
1 |
$1,263 |
1 |
$1,263 |
Trade Name Notification |
2.20 |
0.00 |
0.00 |
2.20 |
$196 |
$196 |
1 |
$196 |
1 |
$196 |
CBI Substantiation |
0.95 |
3.06 |
0.00 |
4.01 |
$340 |
$340 |
1 |
$340 |
1 |
$340 |
Recordkeeping |
0.00 |
0.50 |
0.50 |
1.00 |
$63 |
$63 |
1 |
$63 |
1 |
$63 |
CDX Registration |
0.18 |
0.73 |
0.00 |
0.91 |
$77 |
$77 |
1 |
$77 |
1 |
$77 |
CDX Electronic Signature a |
0.75 |
1.00 |
0.00 |
1.75 |
$150 |
$150 |
1 |
$150 |
1 |
$150 |
Rule Familiarization |
0.55 |
0.27 |
0.00 |
0.82 |
$72 |
$72 |
1 |
$72 |
1 |
$72 |
Report Submission |
0.50 |
0.00 |
0.05 |
0.55 |
$47 |
$47 |
1 |
$47 |
1 |
$47 |
TOTAL |
13.63 |
18.81 |
0.55 |
32.99 |
$2,810 |
$2,810 |
1 |
$2,810 |
1 |
$2,810 |
a Other direct costs related are excluded from total annual industry cost
The average respondent is assumed to spend $2,810 per report, or $2,810 in total per respondent per year. As noted earlier, the Agency is estimating an average of one reporting site and one report per year. As a result, total industry cost for complying with PAIR and subpart B of 40 CFR 766 rules is estimated to be $2,810 per year during the period of FY 2025 through FY 2027.
Items requested of manufacturers or processors of certain chemicals vary with each collection request but will not repeat information previously requested through other information gathering tools. Some data items requested under TSCA section 8(a) chemical-specific rules in the past include notification and description of changes in the end use of identified substances and mixtures, information on planned manufacturing and on-site processing, and notification of changes to the method of manufacturing the substance (see 40 CFR 704 subpart B).
An example of a TSCA section 8(a) chemical-specific rule is one issued on certain nanoscale materials. It requires persons that manufacture (includes import) or process certain nanoscale materials to report to EPA information on chemical identity; production volume; methods of manufacture and processing; exposure and release; and environmental and health effects.
Activities a respondent may be required to perform as a result of a TSCA section 8(a) chemical-specific rule are as follows. However, as discussed at the end of this section, not all respondents are likely to be required to perform all tasks under each labor category. Therefore, the ranges of labor hours presented for each labor category (e.g., 9.50 to 29.50 hours for managers) are from the minimum to maximum estimated burden hours based on the assumption that all tasks are performed for each notice.
0.75 Hours of Attorney Labor
Gather and prepare information to substantiate a claim of confidentiality.
9.50 to 29.50 Hours of Managerial Labor
Identify listed chemicals;
Assign principal technical contact person;
Identify by-product; impurities; physical properties;
Review marketing data;
Research the date of the initiation of manufacture of the chemical;
Research occupational exposure, environmental release, health and environmental effects information, disposal methods; risk management practices;
Process, complete any OHT if applicable, compile, and review information for accuracy, substantiate a claim of confidential business information.
17.5 to 111 Hours of Technical Labor
Identify chemical and trade name and chemical composition;
Identify by-product; impurities; physical properties;
Describe use of chemical;
Report quantity manufactured or imported;
Research occupational exposures, environmental releases, health and environmental information, and disposal methods; risk management practices; and
Provide occupational description.
7 to 21 Hours of Clerical Labor (0.5 - 1.5 Hours for Electronic Reporting)
Format research on occupational exposures, environmental releases, health and environmental information; risk management practices;
Format attachments;
Prepare notice;
E-Reporting;
CBI substantiation; and
Recordkeeping.
Recordkeeping
TSCA section 8(a) chemical-specific rules may contain recordkeeping requirements. The recordkeeping estimate is reasonably related to the maximum reporting burden. EPA estimates that recordkeeping will account for approximately 1 percent for electronic submission.
Loaded hourly wage rates are shown in Table 1 and are utilized with the burden estimates contained in Table 5 to derive annual burden and costs.
This ICR maintains the assumption of the previous ICR that, on average, four notices per year are submitted in response to one TSCA section 8(a) chemical-specific rule per year. Current labor rates and burden hours used to calculate the cost to respondents are listed below.
The cost to a respondent for filing a TSCA section 8(a) notice depends upon the various tasks performed. These tasks could include gathering the required data, preparing and submitting the TSCA section 8(a) notice, and keeping records. Based on promulgated TSCA section 8(a) rules, EPA estimates that each respondent will submit one notice per TSCA section 8(a) chemical-specific rule. EPA anticipates an average of one TSCA section 8(a) rule per year and expects to receive an average of four notices per year.
The cost to a respondent for submitting a TSCA section 8(a) notice is a function of the number of hours and the hourly labor costs for the individuals developing and preparing the notice.
Total annual burden hours range from 70 – 314 hours, total annual costs range from $5,364 - $24,763 (Table 5), and each range represents expected maximums. The midpoint for total annual burden hours is 192 hours and for total annual burden costs is $15,064.
Activity |
Managerial |
Technical |
Clerical |
Attorney |
Notices per Year |
Annual Burden Hours |
Annual Costs |
||||||
$89.16 |
per hour |
$83.54 |
per hour |
$42.28 |
per hour |
$133.14 |
per hour |
||||||
Total burden hours |
Total burden hours |
Total burden hours |
Total burden hours |
||||||||||
Lower Max |
Upper Max |
Lower Max |
Upper Max |
Lower Max |
Upper Max |
Lower Max |
Upper Max |
Lower Max |
Upper Max |
Lower Max |
Upper Max |
||
Manufacturer ID and Principal Technical Contact |
1 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
16 |
$357 |
$1,427 |
Chemical and Trade Name |
0 |
0 |
1 |
5 |
0 |
0 |
0 |
0 |
3 |
3 |
15 |
$251 |
$1,253 |
Chemical Composition |
0 |
0 |
0.5 |
6 |
0 |
0 |
0 |
0 |
4 |
2 |
24 |
$167 |
$2,005 |
Byproduct ID |
1 |
1 |
1 |
5 |
0 |
0 |
0 |
0 |
2 |
4 |
12 |
$345 |
$1,014 |
Use Description |
0 |
0 |
1 |
5 |
0 |
0 |
0 |
0 |
4 |
4 |
20 |
$334 |
$1,671 |
Quantity Manufactured or Imported |
0 |
0 |
1 |
5 |
0 |
0 |
0 |
0 |
4 |
4 |
20 |
$334 |
$1,671 |
Marketing Data |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
4 |
$178 |
$357 |
Date of Initiation of Manufacture or Importation |
0.5 |
0.5 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
2 |
2 |
$178 |
$178 |
Occupational Exposure |
1 |
4 |
2 |
17 |
1 |
3 |
0 |
0 |
2 |
8 |
48 |
$597 |
$3,807 |
Environmental Release |
1 |
4 |
1 |
9 |
1 |
3 |
0 |
0 |
2 |
6 |
32 |
$430 |
$2,471 |
Occupational Description |
0 |
0 |
1 |
11 |
0 |
0 |
0 |
0 |
1 |
1 |
11 |
$84 |
$919 |
Health and Environmental Data |
2 |
8 |
8 |
41 |
1 |
3 |
0 |
0 |
1 |
11 |
52 |
$889 |
$4,265 |
Disposal Methods |
1 |
2 |
1 |
7 |
0 |
0 |
0 |
0 |
1 |
2 |
9 |
$173 |
$763 |
Attachments |
0 |
0 |
0 |
0 |
2 |
6 |
0 |
0 |
1 |
2 |
6 |
$85 |
$254 |
Preparation of Notice |
0 |
0 |
0 |
0 |
1 |
3 |
0 |
0 |
4 |
4 |
12 |
$169 |
$507 |
Managerial/Legal Review of Submission |
1 |
4 |
0 |
0 |
0 |
0 |
0.75 |
0.75 |
4 |
7 |
19 |
$624 |
$1,694 |
Recordkeeping |
0 |
0 |
0 |
0 |
1 |
3 |
0 |
0 |
4 |
4 |
12 |
$169 |
$507 |
TOTAL |
9.50 |
29.50 |
17.50 |
111.00 |
7.00 |
21.00 |
0.75 |
0.75 |
47 |
70 |
314 |
$5,364 |
$24,763 |
Required data elements for allegations of adverse effects include records that are responsive to TSCA 8(c) are maintained pursuant to 40 CFR Part 717 and must consist of the following:
The original health effects allegation as received.
An abstract of the allegation and other pertinent information as follows:
The name and address of the plant site that received the allegation.
The date the allegation was received at that site.
The implicated substance, mixture, article, company process or operation, or site discharge
A description of the alleger (e.g., employee, neighbor), including age and sex, if ascertainable.
A description of the health effects, including explanation of how the effects became known and the route of exposure, if explained in the allegation.
The results of any self-initiated investigation with respect to an allegation must be submitted (note that EPA does not require such investigation under the TSCA section 8(c) rule) as well as copies of any further required records relating to the allegation (e.g., records required under OSHA).
Each person who is required to keep records under this part must submit copies of those records to EPA as required by the Administrator or appropriate designee. EPA will notify those responsible for reporting by letter or will announce any such requirements by notice in the Federal Register.
Respondents must (1) maintain records of allegations of significant adverse reactions and (2) submit copies of these allegation records when required by EPA. Entities subject to the rule must record significant reactions alleged to have been caused by substances or mixtures that they manufacture, import, or process. These firms must establish a recordkeeping system for such allegations and monitor incoming complaints to determine if they meet the criteria for filing. Allegations that are filed must be retained for 30 years if they are employee-related and for five years for all other types/sources of allegations.
Firms subject to the rule must keep their TSCA section 8(c) records at company headquarters or at a site central to their chemical operations. A multi-site company will usually require the responsible official at the individual plant site to forward potentially recordable TSCA section 8(c) allegations to a designated TSCA coordinator at their operations headquarters. Depending on the size of the company, such allegations will be reviewed by a committee to determine if the allegations relate to the company’s product, operations, or discharges. If so, the effects cited in the allegation are compared against the rule’s definition and examples of “significant adverse reaction.” If the allegation meets this test, it is recorded. The actual allegation record is to include an abstract of the allegation along with a record of any company-initiated investigation and other pertinent documents. The rule does not require further investigation. EPA requires that allegations be filed so that they may be readily retrievable by the alleged “cause” of the reaction. EPA does not require a specific form under this rule.
Firms subject to this rule must maintain an awareness of their reporting requirements. A reporting requirement will take the form of a letter directed to selected respondents or it will be a notice in the Federal Register. Respondents are responsible for monitoring the Federal Register for such notices. Whenever feasible, EPA will also notify those companies that can be identified with the production, importation, or processing of a substance or mixture in question. Respondents then must determine if they manufacture or process the chemical substance or mixture. If so, they must conduct a search of their TSCA section 8(c) files to determine if there are any relevant records of significant adverse reactions alleged to have been caused by the substance or mixture. If such records are present, they must submit those records to EPA. The company should note that they have submitted such records to EPA so that future duplicative reporting will not occur.
This section presents the estimates of the industry burden hours and costs associated with TSCA section 8(c) activities. The specific action required to comply with a TSCA section 8(c) reporting are assumed to include review of the Federal Register for notices regarding specific chemicals, recording pertinent information on allegations and storing such records, and reporting allegations to EPA when required.
The steps required to estimate burden associated with the activities of (1) maintaining records of significant adverse effects and (2) submitting copies of allegation records when required by EPA include estimating the number of affected firms and employees, the number of allegations, and the number of reports requested by EPA. Unit estimates of burden for the various activities are also required. These unit estimates are then coupled with the number of allegations, reports, and Federal Register notice reviews to develop total burden estimates for the industry reporting community.
Estimates of costs require estimation of wage rates for personnel expected to participate in TSCA section 8(c) activities. These, coupled with the burden hours associated with the various tasks, provide the bases for industry cost estimates.
The total number of allegations is based upon the average number of employees per firm and the number of firms, multiplied by a standard annual allegation rate per firm.
The Agency received numerous public comments following the issuance of the initial TSCA section 8(c) proposal, including many comments about the Agency’s estimate of the number of allegations. In response to these comments, EPA contacted a number of firms to develop a consensus estimate. According to the 1983 ICR, the consensus opinion of the firms contacted is that recordable TSCA section 8(c) allegations are likely to be made by 0.5 percent of the employees at an average firm. Additionally, and per the 1983 ICR, EPA assumes that the rate of allegations made by the general public would be about one-third the employee allegation rate. This is based on the average number of employees per firm and the estimated annual number of allegations per firm. The total number of allegations is calculated by multiplying the total number of firms (13,5575) by the average annual number of allegations per firm (.44), for a total of 5,965 allegations per year.
EPA’s long-term experience shows that only a very limited amount of reporting has been required under TSCA section 8(c). To date, only four reporting notices have been issued under TSCA section 8(c)6, and these notices covered two chemicals and two chemical categories. A total of 31 reports7,8 have been received under TSCA section 8(c), an average of approximately 16 reports per notice. This represents an average of about 1.1 reports per year since the rule was promulgated in 1983. Though EPA does not anticipate an uptick of 8(c) data calls, the Agency recognizes it could issue up to 10 notices per year during the three-year ICR collection period to collect allegations information on high-priority substances should collecting such information be deemed necessary for conducting risk evaluation. Accordingly, EPA is estimating 10 notices per year during the ICR collection period, anticipating that it may receive 160 reports annually.
Based on the original TSCA section 8(c) analysis, EPA estimates that a firm’s TSCA section 8(c) coordinator will spend 2 to 3 hours to determine the status of an allegation.9 For the purposes of this analysis, EPA assumes 3 hours are needed. This level of effort will occur for all allegations received. If the allegation is found to be recordable, the coordinator completes a form, has it typed, and checks it for accuracy. This requires 0.5 hours of clerical time and an additional 0.5 hours of managerial time. Assuming that all allegations are recordable, a total of 4 hours are expended per allegation (3.5 hours managerial plus 0.5 hours clerical). Storage costs for the allegations are believed to be negligible. The unit cost per allegation is $333.20 (Table 6).
Based on the original TSCA section 8(c) analysis, EPA estimates that a management level company official will spend 1 hour reviewing the Federal Register notice or letter from EPA to determine whether the company manufactures (including imports) or processes substances subject to the reporting requirement.
Technical personnel would then spend an estimated two hours conducting a search of the company’s TSCA section 8(c) files for any relevant allegation records. Once the file search is complete, EPA estimates that a managerial employee would spend 2 hours preparing a transmittal letter and other explanatory material to accompany the allegation records. An upper-level management official would spend an additional 2 hours reviewing these materials. In sum the managerial burden includes the 1 hour reviewing the Federal Register notice or letter from EPA, 2 hours conducting a search of the company’s TSCA section 8(c) files, and 2 hours preparing a transmittal letter, totaling 5 hours. One hour of clerical labor would be required to prepare and mail the response. A total of 8 hours is expended per report (5 managerial hours, 2 technical hours and 1 clerical hour). The unit cost for reporting, per report, is $670.25.
Based on the original TSCA section 8(c) analysis, EPA estimates that 0.25 hours of managerial labor would be required to review each Federal Register notice Table 5. The unit cost for Federal Register notice review is $23.63.
Table 6 summarizes the unit burden hours and costs for the activities described.
Table 6. Summary Unit Respondent Burden and Cost Estimates for TSCA Section 8(c) (2024$)
Activity |
Managerial |
Technical |
Clerical |
Total |
|
||||
$94.54 |
per hour |
$80.50 |
per hour |
$36.58 |
per hour |
|
|
|
|
Hours |
Cost |
Hours |
Cost |
Hours |
Cost |
Hours |
Cost |
|
|
|
|||||||||
Recordkeeping, per allegation |
3.5 |
$312.06 |
0 |
$0.00 |
0.5 |
$21.14 |
4 |
$333.20 |
|
Reporting, per report |
5 |
$445.80 |
2 |
$167.09 |
1 |
$42.28 |
8 |
$655.16 |
|
Federal Register notice review, per notice |
0.25 |
$22.29 |
0 |
$0.00 |
0 |
$0.00 |
0.25 |
$22.29 |
|
The unit burden for recordkeeping is multiplied by the total number of allegations. Total annual recordkeeping burden is 59,033 hours. The unit cost for recordkeeping of $333 is multiplied by the average annual number of allegations per year (5,965) and the total annual recordkeeping cost is $5,114,208 shown in Table 7.
Activity |
Unit Burden Hours |
Unit Cost |
Applicable # and Unit |
# Firms |
Burden Hours |
Cost |
|
Recordkeeping, per allegation |
4 |
$333 |
5,965 |
Allegations per year |
N/A |
23,860 |
$1,987,526 |
Reporting, per report |
8 |
$655 |
160 |
Reports per year |
N/A |
1,280 |
$104,826 |
Federal Register Notice review, per Notice |
0.25 |
$22 |
10 |
Notices per year per firm |
13,557 |
33,893 |
$3,021,855 |
Total Burden/Cost |
|
|
|
|
|
59,033 |
$5,114,208 |
Despite the infrequency with which the Agency publishes TSCA section 8(c) Federal Register notices, EPA conservatively assumes that 16 TSCA section 8(c) reports will be submitted annually.
Historically, the Agency has published an average of only0.08 notices each year since 1983, as EPA has published only two notices to date. In light of that history, EPA conservatively assumes that it will publish a single, TSCA section 8(c) Federal Register notice each year.
The total paperwork burden on the regulated community imposed by TSCA section 8(c) is the sum of the three components identified above (recordkeeping, reporting, and Federal Register notice review) and estimated at 59,033 hours annually with an associated annual cost of $5,114,208. These totals, shown in Table 8, is the estimated annual burden and burden costs for each of the three years covered by this ICR. No separate or additional costs are associated with maintenance and operations (i.e., non-burden costs).
Collection Activity |
Number of Responses |
Total Annual Burden Hours |
Total Annual Burden Cost |
Recordkeeping |
5,965 |
23,860 |
$1,987,526 |
Reporting |
160 |
1,280 |
$104,826 |
Federal Register Review 1 |
135,406 |
33,893 |
$3,021,855 |
Total/Overall |
141,695 |
59,033 |
$5,114,208 |
1 Compliance Determination |
|||
|
Average Annual Amounts - Based on 13,552.92 Firms |
|
|||||
Activity |
Responses |
Responses Per Respondent |
Hours |
Hours |
Cost |
Cost |
|
|
|||||||
Recordkeeping |
5,965 |
0.441 |
4 |
1.76 |
$333.20 |
$146.78 |
|
Reporting |
160 |
0.012 |
8 |
0.094 |
$655.16 |
$7.73 |
|
Federal Register Review |
135,570 |
10 |
0.25 |
2.5 |
$22.29 |
$222.90
|
|
Persons who manufacture (which includes import) chemical substances and mixtures, or propose to do so, and processors of such substances and mixtures (if specifically identified in a particular rule) must submit copies of the unpublished health and safety studies in their possession for the listed substances or mixtures. They must also submit lists of reportable studies that they initiate or, about which they know, for each of the listed substances or listed mixtures.
All submitted studies must be accompanied by a cover letter that contains the following data (40 CFR 716.30):
Name,
Job title,
Address, and
Telephone numbers of the submitting official.
Name and address of the manufacturing or processing establishment on whose behalf the submission was made.
Identify any impurity or additive known to have been present in the substance or listed mixtures as studied, unless so noted in the study.
Identify that the study is being submitted under Part 716.
Respondents may voluntarily choose to develop and submit robust summaries of the full toxicological study reports in conjunction with the submitted full study reports. The robust summaries should contain technical information to adequately describe the study and results and should be written such that the information provided is sufficient to allow a technically qualified person to evaluate study results. Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality description, and references associated with the full study.
List of studies shall include (40 CFR 716.35): (A) ongoing health and safety studies conducted by or initiated by respondents; (B) studies respondents know about but do not have copies of; and (C) studies that have been sent to another federal agency with no claims of confidentiality.
For ongoing health and safety studies conducted by or initiated for the respondent, the list should include the following data:
Beginning date of the study
Purpose of the study
Types of data to be collected
Anticipated date of completion
Name and address of the laboratory conducting the study.
For studies known to the respondent but for which they do not possess copies, the list should include the following data:
Name and address of a person known to them that possesses a copy of the study.
For studies previously sent to a federal agency with no claims of confidentiality, the list should include the following data:
Title of the study
Name and address of the person to whom the study was sent
Month and year in which the study was submitted.
A representative respondent would engage in the following activities in order to produce the lists of studies and required data:
Determine whether the firm may be required to report. If so, review the rule in more detail;
Conduct a corporate review to identify which firm sites must be searched to locate the appropriate health and safety studies;
Search the files at appropriate sites to locate relevant studies;
Compile and transcribe lists of studies being submitted, ongoing studies, newly initiated studies, studies known to exist but not known to be in the respondent’s possession, and studies previously submitted to other federal agencies without confidentiality claims;
Prepare electronic versions of the studies;
Voluntarily prepare robust summaries of the studies;
Prepare OECD Harmonized Templates (OHTs);
Review the responses for possible confidential business information and prepare information to substantiate a claim of confidentiality; and
Submit the studies to EPA electronically, and, after initial study submissions, notify EPA when other studies are initiated; submit studies completed after the reporting period.
The methodology used for estimating the burden and costs to industry resulting from the addition of chemicals to the TSCA section 8(d) rule over the next three years is derived from the Economic Analysis. EPA has added chemicals to the TSCA section 8(d) list on an episodic basis. As shown in Table 10, chemicals have been added to the list six times since 1996 yielding a historical average of 12 chemicals per year for the years between 1996 and the present. As such, EPA uses a basis of 12 chemical additions per year for the 2026-2028 ICR period.
Year |
1996 |
1997-2003 |
2004 |
2005 |
2006* |
2007 |
2008** |
2009-2017 |
2018- 2021 |
2022-2025 |
Average/Year |
Number of Chemicals |
47 |
0 |
15 |
0 |
208 |
0 |
12 |
0 |
50 |
16 |
12 |
* EPA issued a TSCA section 8(d) rule (71 FR 47130) on August 16, 2006, for 243 HPV chemicals that were not sponsored in the voluntary portion of the HPV Challenge Program. EPA later withdrew 33 of these chemicals in a final rule issued on September 29, 2006 (71 FR 57439). In a subsequent direct final rule issued on April 30, 2007, EPA removed two additional chemicals (72 FR 21119), resulting in a total of 208 chemicals subject to TSCA section 8(d) reporting. (**) The TSCA Interagency Testing Committee added Lead and Lead Compounds to the Priority List as part of its 60th ITC Report. Based on this addition, EPA issued a final rule on January 20, 2008 (73 FR 5190) which added 12 Lead and Lead compounds to 40 CFR 716.120. EPA issued a TSCA section 8(d) rule (89 FR 100756) on December 13, 2024, for chemical for prioritization, risk evaluation, and risk management.
Moreover, to characterize the reporting implications per chemical addition associated with TSCA section 8(d) reporting, this analysis uses TSCA Inventory Update Rule data from the 1998, 2002, and 2006 reporting cycles, Chemical Data Reporting Rule data from the 2020 reporting cycle, and recent submission inputs from responses to the 2021 ICR (EPA 2021).10 Table 11 summarizes the models and bases, as applied to the 2025-2028 ICR renewal.
Metric |
ICR Model Year |
Number of firms |
Number of chemicals |
Number of reports or studies |
Reporting basis |
Reporting basis unit |
Number of firms potentially impacted per chemical |
2015-2018 a |
344 |
208 |
N/A |
1.7 |
Firms/chemicals |
2018-2021 b |
348 |
220 |
1.6 |
|||
2021-2025 c |
129 |
50 |
2.6 |
|||
2025-2028d |
160 |
16 |
10.7e |
|||
Sites per firm |
2015-2018 a |
N/A |
N/A |
N/A |
1.5 |
Sites/firms |
2018-2021 b |
1.5 |
|||||
2021-2025 c |
1.5 |
|||||
2025-2028d |
1.9 |
|||||
Fraction of firms potentially affected who submit reports of studies |
2015-2018 a |
344 |
208 |
59 |
0.17 |
Firms submitting reports/firms |
2018-2021 b |
348 |
220 |
63 |
0.18 |
||
2021-2025 c |
129 |
50 |
63 |
0.49 |
||
2025-2028d |
160 |
16 |
33 |
0.21 |
||
Number of studies per submitting firm |
2015-2018 a |
59 |
208 |
527 |
9 |
Studies/firm |
2018-2021 b |
63 |
220 |
542 |
9 |
||
2021-2025 c |
63 |
50 |
207 |
3 |
||
2025-2028d |
33 |
16 |
5742 |
174 |
||
Average length of study, pages |
2015-2018 a |
N/A |
N/A |
N/A |
20 |
Pages |
2018-2021 b |
||||||
2021-2025 c |
||||||
2025-2028d |
||||||
Percent studies with robust summaries; number of firms affected |
2015-2018 a |
N/A |
N/A |
10% of total studies |
1 |
Robust summary/firm |
2018-2021 b |
10% of reports |
1 |
||||
2021-2025 c |
10% of reports |
1 |
||||
2025-2028d |
6% of reports |
10 |
||||
Percent of affected firms submitting second responses |
2015-2018 a |
N/A |
N/A |
5% affected |
5 |
Percent |
2018-2021 b |
||||||
2021-2025 c |
||||||
2025-2028d |
14% affected |
14 |
Source: a TSCA IUR data, all manufacturers 1998, 2002, 2006
b TSCA IUR/CDR data, all manufacturers 1998, 2002, 2006, 2012
c TSCA Section 8(d): Economic Impact Analysis for Adding 50 Chemicals from the 74th ITC Report of the TSCA Interagency Testing Committee to the Health and Safety Data Reporting Rule
d TSCA Section 8(d): Economic Impact Analysis for Adding 16 Chemicals Substances to the Health and Safety Data Reporting Rule
e The 16th chemical, 6PPD-quinone, was excluded from the reporting basis
Estimating Respondent Burden
Firms will undertake a number of actions in response to a TSCA section 8(d) listing. The unit burden associated with each of these tasks is discussed in detail below.
Review the Rule: Firms in the relevant industries that may have unpublished health and safety studies will have to determine whether they manufacture or import any of the listed chemicals and may be required to submit a report. If so, they will have to review the rule in detail to understand its requirements, such as the types of health and safety studies EPA is asking for, the grade or purity of the test material, and the timeframe of the reporting period.
The coverage of the TSCA section 8(d) rule includes chemical manufacturers, petroleum refineries, and tire manufacturers. Those firms that manufacture or import a listed chemical must review the rule to understand its specific requirements. This is estimated to take an average of 2 hours of managerial time for each firm manufacturing a listed chemical.
Conduct Corporate Review for Site Identification: Firms that manufacture a listed chemical will need to conduct a corporate review to identify which of the firm’s sites must be searched for appropriate health and safety studies. This corporate review is estimated to require an average of 3 managerial hours per firm.
Conduct Site File Search: Firms that manufacture a listed chemical must search its files at appropriate sites to look for studies that are responsive to the TSCA section 8(d) rule, which included searching for studies of chemical substances, even when they are present as impurities or transformation products, without a de minimis level. Due to the increased level of chemical expertise involved with conducting searches that include impurities and lack a de minimis level, it is estimated that the search will take an average of 479 hours of technical time per site.
Provide Study Title Lists: Respondents are required to submit lists containing the titles of any studies being submitted, titles of studies that are initiated or ongoing during the reporting period but that have not yet been completed, titles of any unpublished studies that the respondent knows to exist but does not have in its possession, and titles of studies previously submitted to other federal agencies without confidentiality claims. EPA expects that the major burden of compiling this list was incurred during the file search and would already be available in electronic format; therefore, there is no additional burden associated with this activity.
Prepare Robust Summaries: Respondents may choose to develop and submit robust summaries of the full toxicological study reports. The robust summaries should contain technical information to adequately describe the study and results and should be written in such a way that the information provided is sufficient to allow a technically qualified person to evaluate study results. Typically, a robust summary would include a description of the test substance, methods, results, conclusions, data quality description, and references associated with the full study. It is estimated that 8 to 16 hours of technical time are needed to develop and review a robust summary, depending on the type of study conducted. This ICR assumes an average of 12 hours of technical time per firm to prepare a robust summary. Because submission of robust summaries is voluntary, EPA does not expect that many companies will undertake this activity. EPA estimates that each firm will submit an average of 174 studies, with 6% of those studies including a robust summary; therefore, EPA expects to receive an average of 10 robust summaries per firm submitting studies. The estimated average burden per robust summary is 12 hours of technical time.
Prepare OHT Summaries: Firms will need to submit studies using the OECD harmonized templates (OHTs), which are standardized formats for reporting information on chemicals, including physical properties, production and use, and effects on human health and the environment (OECD 2018). EPA assumes that firms may submit environmental and health effects data using any of the templates for the following OHT groups: Physico-Chemical Properties, Environmental Fate and Behavior, Biotic Systems, and Health Effects. EPA found the average burden per chemical per template is 70 hours (EPA 2024). Based on the expectation that the average firm reported an estimated 1.54 chemicals from the list of chemical substances for the 8d rule, the estimated average burden per OHT summary is 109 hours per firm (EPA 2024).
Review Responses for CBI: Firms will need to review responses for possible CBI and delete any material that is considered by the firm to be CBI from one copy of the study. A separate copy of the study must be submitted without deletions of CBI. CBI review is estimated to take an average of 1 hour of managerial time for each study. Based on the expectation that each firm that submits a report will include 174 studies, CBI review results in an estimated average of 174 hours of managerial time per firm.
CBI Legal Review and Confidential Business Substantiation: Firms will need to gather and prepare information to substantiate a claim for confidentiality. This will also involve approximately 1.5 hours of managerial and attorney time, split evenly between staff.
Post-Reporting Period Submission (Submit Ongoing or Newly Initiated Studies): Firms that have an ongoing or newly initiated study during the reporting period are required to provide EPA with a copy of the study once it is completed. CBI review and submission of ongoing or newly initiated studies are estimated to require an average of 1 hour of managerial time.
Collection Activity |
Affected Respondents (Weight)* |
Average Burden per Firm (Hours) |
Labor Category |
Review of Rule |
1 |
2 |
Managerial |
Site Identification |
1 |
3 |
Managerial |
Site File Search** |
0.716 |
479 |
Technical |
Robust Summaries |
0.431 |
12 |
Technical |
OECD Harmonized Templates |
0.431 |
109 |
Managerial |
CBI Review |
0.431 |
174 |
Managerial |
CBI Legal Review and CBI Substantiation |
0.431 |
0.75 |
Managerial |
0.431 |
0.75 |
Attorney |
|
Post-Reporting Period Submission |
0.063 |
1 |
Managerial |
*Not all respondents perform all activities. This weight reflects that for every firm that has to check for reports: 42% will submit reports, of which 10 firms (about 6%) will provide robust summaries and 14% (about 10 firms) will provide a post reporting period submission.
** Basis of 1.9 sites per firm
These unit burden estimates are average values. Large multi-divisional, multi-departmental firms may require more than the average time to comply. However, there are smaller firms that are less complicated, and these firms may have a simpler process that requires less time.
Estimating the Respondent Universe
EPA has added a total of 348 chemicals to the list since 1996 (47 in 1996, 15 in 2004, 208 in 2006, 12 in 2008, 50 between 2018 and 2021, and 16 in 2025), which is an overall program historical average of approximately 12 chemicals per year. For estimates in this ICR, EPA assumes that the historical average of 12 chemicals per fiscal year will be added to the TSCA section 8(d) list. Based on the average number of firms impacted since 1996, EPA expects 75 chemical manufacturers and importers to be affected per year by this ICR (Table 13).
Based on the reporting basis stated in Table 12, EPA assumes that 43.1% percent of the potentially affected manufacturers will submit studies each year, yielding 33 firms submitting studies (0.431 * 75 firms) and conducting CBI review. Each firm is expected to submit a total of 174 studies, yielding an estimated total of 5,742 studies annually (33 firms * 174 studies per firm). A total of 6% of the studies are expected to contain robust summaries, yielding a total of 10 robust summaries per firm (174 studies * 0.06, and rounding up to 10); and approximately 10 firms (14% of 75 firms) is estimated to submit a second response (for a newly initiated or ongoing study) after the reporting period ends.
The number of firms estimated to engage in the various reporting activities is summarized in Table 13. Note that not all respondents incur every aspect of reporting burden.
Collection Activity |
No. of Firms |
Review of Rule |
75 |
Site Identification |
75 |
Site File Search |
75 |
Robust Summaries |
33 |
CBI Review |
33 |
Post-Reporting Period Submission |
5 |
The number of firms or studies described above is combined with the estimated average unit burden hours and wages Table 12 and Table 1, respectively, to estimate the total burden hours and cost per year based on three types of response activities: searching files, submitting studies during the reporting period, and submitting studies after the reporting period.
Table 14. Annual Respondent Burden Hour and Cost Estimates TSCA Section 8(d) (2024$)
Information Collections |
Response Activities |
Burden per Response (Hours) |
Labor Category |
Cost per Response |
Number of Responses |
Total Burden (Hours) |
Total Cost |
|
Compliance determination and data search |
Rule review |
2 |
Managerial
|
$40,463 |
75 |
36,523 |
$3,053,400 |
|
|
||||||||
Site Identification |
3 |
Managerial
|
|
|||||
|
||||||||
File Search |
479 |
Technical
|
|
|||||
|
||||||||
Submission of health and safety studies during the reporting period and CBI Substantiation |
Robust summaries |
12 |
Technical
|
$26,402 |
33 |
9,785 |
$871,251 |
|
|
||||||||
OECD Harmonized Templates |
109 |
Managerial
|
|
|||||
|
||||||||
CBI Review |
174 |
Managerial
|
|
|||||
|
||||||||
CBI Legal Review and Confidential Business Substantiation |
0.75 |
Managerial
|
|
|||||
|
||||||||
0.75 |
Attorney
|
|
||||||
|
||||||||
Notification and submission of health and safety studies initiated and/or completed after the reporting period |
Post-reporting period submission |
1 |
Managerial
|
$89 |
5 |
5 |
$446 |
|
|
||||||||
Subtotal |
|
46,313 |
$3,925,097 |
|
||||
CDX Registration & E-signature |
|
0.93 |
Managerial
|
$227 |
69 |
184 |
$15,694 |
|
|
||||||||
1.73 |
Technical
|
|
||||||
|
||||||||
Subtotal |
|
184 |
$15,694 |
|
||||
Total |
|
46,496 |
$3,940,791 |
|
||||
A typical firm submitting a response is conservatively estimated to engage in review of the rule, site identification, site file search, preparing study title lists, preparing OHTs, CBI review, CBI substantiation, and possibly submit a robust summary and/or a post-reporting period submission. Assuming 12 chemicals per year are added to the TSCA section 8(d), including the added CBI substantiation, the average annual burden and cost per response is 408 hours and $34,594, respectively (using the subtotal values in Table 14).
Total estimated burden hours are 46,496 hours and total estimated costs are $3,940,791.
EPA received TSCA section 8(a) nanomaterials submissions from 37 unique manufacturers and processors since 2017. Based on this observation, EPA estimates that a total of 5.3 respondents will submit responses per year. EPA estimates that there are approximately 9 responses per year for TSCA section 8(a) Nanomaterials. Given that the EPA received a total of 27 reports over the last three-year ICR period, EPA expects to receive 1.7 reports per respondent each year (9 responses per year / 5.3 average annualized respondents). Table 15 shows the yearly number of responses for the various nanoscale materials for manufacturers and processors combined.
Table 15. Respondents during the current ICR period for TSCA section 8(a) Nanomaterials
Period |
2017 |
2018 |
2019 |
2020 |
2021 |
2022 |
2023 |
Total Respondents* |
Total Unique Respondents |
Average annualized respondents |
Number of respondents |
CBI |
CBI |
CBI |
20 |
10 |
10 |
8 |
48.0 |
37 |
5.3 |
Estimating Respondent Burden
Table 16 shows the estimated burden for five activities necessary to submit a TSCA 8(a) nanomaterials report to the EPA for nanoscale manufacturers, processors as well as the average estimated burden for any given respondent. This is estimated by assigning equal weights to manufacturer and processor burdens. This assumption is made given that the expected number of nanoscale manufacturers and processors in the previous ICR renewal were about the same.
Table 16: Burden Per Year Per Respondent for TSCA Section 8(a) Nanomaterials
Activity |
Manufacturer burden (hours/year) |
Processor burden (hours/year) |
Weighted burden per respondent (hours/year) |
Rule familiarization |
0 |
0.82 |
0.82 |
Form completion |
71 |
136.6 |
103.8 |
CBI substantiation |
0.78 |
1.5 |
1.14 |
Form submission |
0.17 |
1.42 |
0.80 |
Recordkeeping |
0.5 |
1 |
0.75 |
Table 17 provides a summary of typical respondent burden by activity for rule familiarization, completion of a report, CBI claim substantiation, and recordkeeping.
Table 17: Industry Burden per year, by activity for TSCA 8(a) Nanomaterials
Activity |
Clerical Burden (hours) |
Technical Burden (hours) |
Managerial Burden (hours) |
Attorney Burden (hours) |
Total Burden (hours) |
Rule Familiarization |
0 |
0.55 |
0.27 |
0 |
0.82 |
Form Completion |
0 |
79.93 |
23.87 |
0 |
103.8 |
CBI Claim Substantiation |
0 |
0 |
0.57 |
0.57 |
1.14 |
Recordkeeping |
0.375 |
0.375 |
0 |
0 |
0.75 |
Total Burden per Report |
0.375 |
80.85 |
24.71 |
0.57 |
106.5 |
Values may not sum due to rounding. |
|||||
The burden associated with electronic submission is presented in Table 18. This burden depends on whether a firm is registering for the first time with CDX or has previously registered with CDX.
Table 18: Industry Burden, by Activity for Electronic Reporting
Activity |
Clerical Burden (hours) |
Technical Burden (hours) |
Managerial Burden (hours) |
Number of Annual Activities |
Total Burden (hours) |
First-time registration |
|||||
CDX Registration |
0.00 |
0.67 |
0.17 |
1.00 |
0.84 |
Electronic Subscriber Agreement/ Electronic Signature |
0.00 |
0.00 |
0.25 |
1.00 |
0.25 |
Help Desk |
0.00 |
0.24 |
0.06 |
1.00 |
0.30 |
Problem Resolution |
0.00 |
1.00 |
0.00 |
0.03 |
0.03 |
Total First Time Burden per firm |
1.42 |
||||
Subsequent registration |
|||||
CDX Registration |
0.00 |
0.67 |
0.17 |
0.10 |
0.08 |
Electronic Subscriber Agreement/Electronic Signature |
0.00 |
0.00 |
0.25 |
0.10 |
0.03 |
Help Desk |
0.00 |
0.24 |
0.06 |
0.10 |
0.03 |
Report Compromised Signature |
0.00 |
0.00 |
0.40 |
0.01 |
0.00 |
Problem Resolution |
0.00 |
1.00 |
0.00 |
0.03 |
0.03 |
Total Subsequent Burden per firm |
0.17 |
||||
The total burden for one firm to complete one form is approximately 107.3 hours. This is based on the sum of the total burden per report (106.5) (Table 17), plus the burden for form submission (0.80) (Table 16).
Given the expectation that each respondent will submit 1.7 reports per year, the burden per year per respondent is 181.29 hours. This is estimated by adding the burden for rule familiarization and form submission to the sum of form completion, CBI claim substantiation, and recordkeeping and multiplying it by the 1.7 reports per year per respondent (0.82 + 0.80 + 1.7*(103.8 + 1.14 + 0.75)). This yields a total respondent burden per year of 961 (5.3 annual number of respondents * 181.29 burden per respondent per year).
Estimating Cost
Table 19 contains the cost per activity of completing a form for one respondent. Burden hours presented in Table 16 were multiplied by the corresponding loaded wage rates in Table 1. EPA estimates that the total cost per report is approximately $9,050 (Table 19).
Table 19: Annual Respondent Costs for TSCA Section 8(a) Nanomaterials (2024$)
Activity |
Clerical ($42.28/hr) |
Technical
|
Managerial
|
Attorney
|
Total Cost |
Rule Familiarization |
$0.00 |
$45.95 |
$24.07 |
$0.00 |
$70.02 |
Form Completion |
$0.00 |
$6,677.35 |
$2,128.25 |
$0.00 |
$8,805.60 |
CBI Claim Substantiation |
$0.00 |
$0.00 |
$50.82 |
$75.89 |
$126.71 |
Recordkeeping |
$15.86 |
$31.33 |
$0.00 |
$0.00 |
$47.18 |
Total Cost per Report |
$15.86 |
$6,754.63 |
$2,203.14 |
$75.89 |
$9,050 |
Values may not sum due to rounding. |
|||||
Electronic reporting costs are presented in Table 20. Because not all firms are expected to incur all costs, the number of annual activities per firm may be less than one. Electronic reporting costs for first time registrants are estimated to be $121.33 per firm, and subsequent year costs are to be $14.75 per firm. More information on the derivation of these costs is found in the Economic Analysis for the Final TSCA Section 8(a) Reporting Requirements for Certain Chemical Substances as Nanoscale Materials (EPA, 2016).
Table 20: Industry Cost for Electronic Reporting (2024$)
Activity |
Clerical ($42.28/hr) |
Technical
|
Managerial
|
Number of Annual Activities |
Total Cost |
ELECTRONIC REPORTING |
|||||
First-time registration |
|||||
CDX Registration |
$0.00 |
$55.97 |
$15.16 |
1 |
$71.13 |
Electronic Subscriber Agreement/ Electronic Signature |
$0.00 |
$0.00 |
$22.29 |
1 |
$22.29 |
Help Desk |
$0.00 |
$20.05 |
$5.35 |
1 |
$25.40 |
Problem Resolution |
$0.00 |
$83.54 |
$0.00 |
0.03 |
$2.51 |
Total First Time Cost per firm |
$121.33 |
||||
Subsequent registration |
|||||
CDX Registration |
$0.00 |
$55.97 |
$15.16 |
0.1 |
$7.11 |
Electronic Subscriber Agreement/Electronic Signature |
$0.00 |
$0.00 |
$22.29 |
0.1 |
$2.23 |
Help Desk |
$0.00 |
$20.05 |
$5.35 |
0.1 |
$2.54 |
Report Compromised Signature |
$0.00 |
$0.00 |
$35.66 |
0.01 |
$0.36 |
Problem Resolution |
$0.00 |
$83.54 |
$0.00 |
0.03 |
$2.51 |
Total Subsequent Cost per firm |
$14.75 |
||||
Values may not sum due to rounding. |
|||||
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.
Table 21 provides annual agency wage rates for multiple GS and step levels for agency federal staff in the Washington-Baltimore-Northern Virginia-West Virginia locality pay region.
Labor Category |
Data Source for Wage Information (Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area) |
Wage ($/hour) |
Fringes as % wageb |
Fringe Benefit |
Total Compensation |
Overhead as % total compensationc |
Overhead |
Loaded Wage ($/hr) |
(a) |
(b) |
(c) = (a)*(b) |
(d) = (a)+(c) |
(e) |
(f) = (d)*(e) |
(g) = (d)+(f) |
||
EPA staff |
GS-12 Step 1 pay rates a |
$47.53 |
63.90 |
$30.37 |
$77.90 |
20% |
$15.58 |
$93.48 |
GS-13 Step 1 pay rates a |
$56.52 |
63.90 |
$36.12 |
$92.64 |
20% |
$18.53 |
$111.16 |
|
GS-13 Step 5 pay rates a |
$64.06 |
63.90 |
$40.93 |
$104.99 |
20% |
$21.00 |
$125.99 |
|
GS-15 Step 1 pay rates a |
$78.56 |
63.90 |
$50.20 |
$128.76 |
20% |
$25.75 |
$154.51 |
a Source: U.S. Office of Personnel Management. (2024). Salary Table 2024-DCB. Retrieved February 3, 2025 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2024//DCB_h.pdf.
b Source: Falk, J. 2012. “Comparing Benefits and Total Compensation in the Federal Government and the Private Sector.” Congressional Budget Office Working Paper Series. https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/workingpaper/2012-04fedbenefitswp0.pdf
c 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).
Although it will be unlikely that the EPA will issue a PAIR rule in this renewal cycle because EPA will most likely use other rulemakings such as the Chemical Data Reporting (CDR) rule to collect similar data, the following describes the EPA’s burden if such an event were to occur. The activities routinely conducted by EPA related to the rule development, processing, analysis and storage of the information collected under a PAIR rule (40 CFR part 712) and subpart B of 40 CFR 766 are as follows:
Chemical nomination, review and selection;
Rule development;
Evaluation of the rule (including impact assessments);
Industry/public assistance;
Compliance monitoring; and
Processing of data received for listed chemicals (includes receipt, dissemination, evaluation, etc.).
This analysis assumes that an annual average of one report will be submitted over the three-year period of the ICR. Personnel burden and costs associated with industry/public assistance and data processing activities have been adjusted based on that estimate. From the 1989 PAIR ICR update it has been derived that industry/public assistance required approximately 1.5 hours per report or 0.0007 FTE. Similarly, the 1989 PAIR ICR update estimated that about 3.75 hours, or 0.0019 FTE, of data processing/system support personnel time would be required per report.
Data processing costs have been updated from 2017 to average 2024 dollars using the GDP implicit price deflator (IPD) from the Bureau of Economic Analysis (BEA). The BEA GDP IPD series with a base of 2017 = 100 has the 2024 index at 125.220 so the adjustment factor from 2017 to 2024 is 1.2522 (100/125.220= 1.2522). Data processing costs for the 2017 PAIR ICR update were estimated to be approximately $295.01 per report. Adjusting this number to 2021 with the GDP implicit price deflator yields an adjusted data processing cost of $369.41 per report (i.e., $295.01 x 1.2522 = $369.41).
Table 22 summarizes the government’s activities in developing and administrating the PAIR and subpart B of 40 CFR 766. The required FTEs per activity are retained from the 1996 PAIR ICR update and from the previous 8(a) PAIR ICR renewal analyses for all activities except for the recalculation of the burden associated with industry/public assistance and data processing/system support personnel time. Costs are calculated assuming agency staff at GS 12 Step 1 would perform these activities. The loaded wage rate is in Table 20.
Activity |
Annual Burden |
Annual Cost |
Chemical nomination, review, and selection |
0.25 |
$253,300 |
Rule development |
0.9 |
|
Evaluation of rule |
0.05 |
|
Industry/public assistance |
0.0007 |
|
Compliance monitoring |
0.1 |
|
Data processing and system support personnel |
0.002 |
|
Government data processing cost |
N/A |
$369.41 |
Total |
1.3 |
$253,669 |
Table 23 presents a summary of the costs to the federal government for TSCA Section 8(a) PAIR information collection. The full-time work year is considered 2,080 hours, and there are 2,710 annual burden hours associated with 1.3 FTE.
Total FTEs |
1.3 |
Annual burden hours |
2,710 |
Loaded cost per FTE |
$194,443 |
Government labor cost |
$253,300 |
Government data processing cost |
$369 |
Total annual government cost |
$253,670 |
For any TSCA section 8(a) chemical-specific rule the Agency would have to perform a number of tasks. They are:
Industry/Public Assistance (answering questions regarding rule);
Data Processing and System Support Personnel;
Review the information submitted;
Analyze submissions for confidentiality and provide appropriate protection for confidential data;
Storage and Distribution; and
Compliance Monitoring.
The Agency has developed the following burden hour estimates for activities related to promulgating a TSCA section 8(a) Chemical Specific rule.
Activity |
Burden (FTE) |
Burden Hours |
Annual Cost |
Industry/Public Assistance (answering questions regarding the rule) |
0.1 |
208 |
$19,444 |
Data processing and systems support personnel |
0.2 |
416 |
$38,889 |
Storage and distribution |
0.1 |
208 |
$19,444 |
Compliance monitoring |
0.1 |
208 |
$19,444 |
Total |
0.5 |
1,040 |
$97,221 |
OPPT bases its burden hour and labor cost estimates on prior experience in gathering and processing information associated with other information collections. Because these activities involve a team approach, the Agency has used a composite burden hour estimate containing workers at various GS levels and calculated hourly costs based upon the wage rate for a GS-12 Step 1 employee (Table 24). The full-time work year is considered 2,080 hours, so there are 1,040 burden hours associated with 0.5 FTE at a cost of $97,221.
The information collected by employers under 8(c) on employee health effects will involve the following activities:
Monitoring recordkeeping by employer.
Initiating requests that employer report employee health effects.
Reviewing responses of employer to EPA’s requests.
Logging in submissions and reviewing them for confidentiality considerations.
Making copies of submissions available to offices within OPPT that are assessing the substances of concern.
Placing non-confidential versions of the submissions in a public docket and making them available for review by other government agencies and the public.
The total annual cost to EPA for TSCA section 8(c) for each of the three years covered by this ICR is estimated to be $125,226. This figure is based on activities identified in the 1986 and 1989 ICRs. Costs are estimated based on wages for GS-15 Step 1, GS-13 Step 1, and GS-12 Step 1 employees shown in Table 20.
Annual costs to EPA associated with the recordkeeping portion of the rule include general administration of the rule, education and outreach activities, and compliance monitoring. Costs associated with reporting involve preparation of reporting notices, Federal Register printing costs, and document review. Annual costs to EPA are derived based on an analysis of the cost of performing these various activities. The various factors that contribute to EPA costs include:
Each year, general administration of the rule involves approximately one-tenth of a staff
specialist’s time plus approximately one week’s time each for two management personnel at
the branch, division, and OPPT Office Director’s level.
Education and outreach activities will include ongoing rule support and could potentially include testing of reporting applications and CDX (both by EPA and support contractors, and potentially voluntarily by external testers if appropriate). Compliance monitoring costs primarily involve the costs of the TSCA section 8(c) portion of inspection carried out by regional personnel and other administrative costs for headquarters personnel to target and review results of such inspections. To date, a total of only 31 reports have been received. Based on historical data, over the life of the rule an average of only 0.08 notices have been issued per year and an average of only 1.3 reports received. EPA expects that reporting activity under TSCA section 8(c) will remain at low levels during the period covered by this ICR renewal. EPA costs associated with reporting have been adjusted to reflect this large decrease in the level of expected activity. Labor involved in developing the reporting notices will require decision meetings and either the development of letters, separate Federal Register notices, or the insertion of boilerplate segments in other rule preambles.
Time will be required to process submissions based upon reporting requirements and to review them for confidentiality considerations.
The Federal Register notices will be reviewed by the office directly requesting the information as well as by OPPT.
Table 25 presents a summary of Agency annual burden and costs with burden totaling as 1,258 hours with an annual cost of $125,226.
Activity |
GS-Level |
Burden Hours |
Annual Cost |
Administrative maintenance |
GS-13 Step 1 |
208 |
$23,122 |
GS-15 Step 1 |
80 |
$12,361 |
|
Subtotal |
288 |
$35,483 |
|
Education/Outreach |
GS-12 Step 1 |
240 |
$22,436 |
Compliance monitoring |
GS-12 Step 1 |
400 |
$37,393 |
Develop reporting notices |
GS-12 Step 1 |
160 |
$14,957 |
Notice review, referral, and data entry |
GS-12 Step 1 |
160 |
$14,957 |
Total |
1,258 |
$125,226 |
|
The activities routinely conducted by EPA related to the rule development, processing, analysis and storage of the information collected under this rule include the following:
Review and select chemicals;
Develop and issue an amendment to the TSCA section 8(d) rule to add the substances or mixtures;
Answer respondents’ questions;
Process and analyze rule submissions;
Maintain and distribute the data; and
Analyze submissions for confidentiality and analyze the information provided to substantiate the confidentiality claim.
The activities routinely conducted by EPA related to processing and storage of the information collected under this rule include processing and analyzing the materials submitted under the rule, including requests for confidentiality; and maintaining and distributing data.
The activities associated with Agency responses to TSCA section 8(d) listings are assumed to be accomplished by a GS 13 Step 5 federal employee, and the 2024 loaded hourly wage rate for this GS and step level is shown in Table 20.
The estimated annual cost to the federal government for TSCA section 8(d) data collection totals $7,364 for 58.45 hours, as presented in Table 26.
Collection Activity |
FTEs |
Hours |
Annual Cost |
Data processing and system support |
0.025 |
299.00 |
$37,672 |
Storage and distribution |
0.010 |
119.60 |
$15,069 |
Total |
0.035 |
418.6 |
$52,741 |
This ICR renewal includes the consolidation of multiple ICRs. Accordingly, for this particular ICR, the overall number of hours will increase to reflect the consolidation whereas EPA will discontinue the ICRs that are being consolidated into this ICR (i.e., an increase of 647 hours in information collection activities associated with Chemical-Specific Rules under TSCA section 8(a); Certain Nanoscale Materials (OMB Control No. 2070-0194) and TSCA section 8(a) Reporting and Recordkeeping Requirements for Asbestos (OMB Control No. 2070-0222)).
EPA also notes that a recent TSCA section 8(d) rulemaking, published on December 13, 2024 (89 FR 100756), incorporated an increase of associated burden arising out of a requirement to report studies showing any measurable content of the subject chemicals. In response to that proposed rulemaking, stakeholders provided information indicating that the file search burden would incur additional burden. Accordingly, for that rulemaking, EPA increased the associated estimate for file search in the economic analysis for the rule. This increase in burden would apply only where the Agency, via the applicable regulations, requires reporting of studies at any measurable content. EPA does not anticipate promulgating 8(d) rules requiring such reporting in this ICR’s renewal period. Thus, any 8(d) rules promulgated during this renewal period would not reflect this increase in burden.
The Agency does not intend to publish results of this information collection.
This question is not applicable to this ICR.
This information collection complies with all provisions of the Certification for Paperwork Reduction Act Submissions.
PRA Burden Statement
This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0224). Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR Part(s) 704 and 15 U.S.C. 2607. 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 a range of 0.4 to 106.4 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.
You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function.
All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
The attachments listed below can also be found in the docket for this ICR. The docket for this ICR is accessible electronically through https://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2021-0728.
Attachment |
Description |
A |
EPA Form 7710-35 TSCA Section 8(a) PAIR |
B |
EPA Form 9600-07 Nanotechnology |
C |
EPA Form 7710-25 Premanufacture Notice |
D |
EPA Form 7710-51 Dioxin/Furan |
E |
EPA Form 9600-032 TSCA Section 8(d) Health and Safety Data Screenshots |
F |
Consultation |
G |
Consultation Responses |
References
40 CFR 712 8(a) Preliminary Assessment Information Rule (PAIR)
40 CFR 766 8(a) PAIR and Dibenxo-para-dioxins/dibenzofurans
40 CFR 703 Confidentiality Claims
40 CFR 704 Chemical Specific Rules
40 CFR 717 Allegations of Adverse Effects
40 CFR 716 Health and Safety Data Reporting
40 CFR 792 Good Laboratory Practice Standards
Rice, C. (2002). Wage Rates for Economic Analysis of the Toxic Release Inventory Program. Washington, D.C.: U.S. EPA, Office of Pollution Prevention and Toxics, Economics and Policy Analysis Branch.
U.S. Bureau of Labor Statistics. (2022). May 2022 National Industry-Specific Occupational Employment and Wage Estimates. Retrieved January 9, 2024 from .
https://www.bls.gov/oes/current/oes_nat.htm#23-0000 .
U.S. Bureau of Labor Statistics (2022). Employer Costs for Employee Compensation (ECEC) Supplemental Tables.
U.S. EPA. (2002). Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA-HQ-OPPT-2002-0054-0279). Washington, D.C.: Office of Pollution Prevention and Toxics, Economics and Policy Analysis Branch.
U.S. EPA, (2009a). ICR Handbook EPA’s Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Revised 10/2009 Washington, D.C.: U.S. EPA, Office of Environmental Information.
U.S. EPA. (2019). Economic Analysis for the Proposed Rule: Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory (April 2, 2019).
U.S. Office of Personnel Management. (2023). Salary Table 2018- DCB, Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV. Retrieved January 9, 2024 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/23Tables/html/DCB_h.aspx
U.S. EPA. (2023). Economic Analysis for the Final Rule: Procedures for Review of CBI Claims for
the Identity of Chemicals on the TSCA Inventory (April 2, 2023).
1 Economic Impact and Small Business Definition Analysis for the Final TSCA Section 8(a) Preliminary Assessment Information Rule, Final Report, prepared for the EPA by ICF, Inc., Washington, D.C., 1981.
2 40 CFR 712.28 (July 1, 1993).
3 Burden Hour and Cost Estimates for PAIR Section 8(a) Reporting (1994 Update), internal U.S. EPA memorandum from Carol Rawie, Economics, Exposure, and Technology Division to Karen Boswell, Chemical Testing and Information Branch, May 16, 1994.
4 TSCA, Sec. 14(c)(1)(B), (C)
5 EPA has used this methodology from 2006 forward because the data source is publicly available, making the analysis more transparent. In the program’s initial ICR burden analysis, EPA used Dun’s Market Identifiers (DMI) from a Dun and Bradstreet database (see U.S. EPA, “Comparison of Data Sources for Characterizing Manufacturers and Processors,” Draft Report, Prepared by Centaur Associates, Inc under EPA contract No. 68-02-3980, Washington, DC; November 6, 1986).
6 U.S.EPA. “Chemical on Reporting Rules Database (CORR),” CCD and CSB, June 1990; and U.S.EPA. “Chemical on Reporting Rules Database (CORR): Update,” CCD and CSB; October 31, 1992, and U.S.EPA “4,4′-Methylene bis(2-chloroaniline); Request Under the Toxic Substances Control Act (TSCA) for Records and Reports of Significant Adverse Reactions to Health or the Environment,” December 2023.
7 U.S.EPA. [Untitled Computer Printout], IMD; June 3, 1992.
8 Sherlock, Scott, Information Management Division. Phone conversation with Wendy Hoffman based upon “TSCA Reports to Congress for EPA Fiscal Years 1992-93;” August 1994.
9 U.S.EPA. “Economic Analysis of TSCA Section 8(c) Significant Adverse Reaction Recordkeeping Rule, OTS/ETD/RIB.” January 1983.
10 According to 40 CFR 716.5, persons are required to report under a TSCA section 8(d) rule if, during the 10 years preceding the effective date of the rule, they manufactured (including imported) or planned to manufacture (including import) a listed chemical. The CDR data for this analysis is not limited to reporting from chemical manufacturers and petroleum refiners. This scope does not affect the accuracy of the results, given that only firms regulated under TSCA 8(d) submit reports.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Terry Green |
| File Modified | 0000-00-00 |
| File Created | 2025-11-29 |