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Supporting Statement A
ICR 202610-2070-003 · OMB 2070-0162 · Object 174134800.
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | Supporting Statement A |
| Author | Terry Green |
| Last Modified By | Writer |
| File Modified | 2026-10-21 |
| File Created | 2026-10-30 |
| Conversion State | complete |
Extracted Text
U.S. Environmental Protection Agency
Information Collection Request
EXECUTIVE SUMMARY
Identification of the Information Collection – Title and Numbers
Title:
Chemical Data Reporting under the Toxic Substances Control Act (TSCA)
EPA ICR No.:
1884.17
OMB Control No.:
2070-0162
Docket ID No.:
EPA-HQ-OPPT-2013-0721
Abstract
This information collection request (ICR) addresses the paperwork requirements contained in the current Chemical Data Reporting (CDR) rule (40 CFR Part 711) under the Toxic Substances Control Act (TSCA). Under TSCA section 8(a) (15 USC 2607) (Ref. 1), the Environmental Protection Agency (EPA) is authorized to collect certain information on chemical substances manufactured (including imported) or processed in the United States. The CDR was formerly known as the Inventory Update Rule (IUR).
The CDR collection provides chemical manufacture, processing, and use information that helps EPA identify chemicals to which the public may be exposed as consumers or as workers in commercial and industrial settings. The data also helps EPA assess routes of potential exposure to those chemicals. The CDR data collection is on a four-year reporting cycle and contains detailed manufacturing, processing, and use information drawn from the principal reporting year; as well as basic information on production volume, by year, for the three years prior to the principal reporting year. The next CDR collection will occur in 2028; there are no changes to the reporting requirements.
The reporting requirements have been modified through rulemaking, with the most recent major changes occurring in 2020 when EPA promulgated the TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a) rule (85 FR 20122, April 9, 2020) and the Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements under the Toxic Substances Control Act (TSCA) Section 8(a) (85 FR 31986, May 28, 2020). The 2020 CDR Revisions Rule phased in some provisions. All changes were fully implemented with the 2024 CDR. OPPT uses the CDR data in its chemical substance risk-management efforts. Individual sites manufacturing (including importing) chemical substances will submit the required information. The information will be stored electronically for reference by EPA staff and others. Within the 2 constraints of confidentiality claims, the information will be made public through the Agency’s website (https://www.epa.gov/chemical-data-reporting) Further discussion of how the information is used, stored, and collected is included in this document.
The summary table contains the number of respondents, the annual time burden, and the annual cost burden. The average annual burden per respondent is 170 hours and the average annual cost per respondent is $17,588.
Summary Total Burden and Costs
Information Collection
Number of Respondents
Annual Number of Responses
Responses per Respondent
Annual Time Burden (Hours)
Annual Cost Burden (2025$)
Form U Submission: Prepare and Submit Report, and Maintain Records
Rule Familiarization
786*
786*
1
5,175
$481,922
Compliance Determination
5,238
5,238
1
9,696
$905,284
Recordkeeping
5,238
5,238
1
3,929
$320,841
Average Multi-Chemical Form Compliance (8.3 Chemicals)
5,238
5,238
1
872,080
$90,404,187
CDX Registration and eSignature
1,310*
1,310*
1
174
$15,363
Total Respondent
5,238
5,238
1
891,054
$92,127,597
Total Agency
-
3,473
$911,341
*Numbers represent the respondents for the Information Collection
SUPPORTING STATEMENT A
1. NEED AND AUTHORITY FOR THE COLLECTION:
Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection.
Under TSCA, EPA is charged with protecting human health and the environment from potential chemical risks. The CDR information collection is the only mechanism through which EPA routinely collects basic information on commercial chemical substances listed on the TSCA Inventory, including production volume and other manufacturing (including importing), processing, and use exposure-related data. This collection of information is key to strengthening EPA’s TSCA program, by providing exposure-related data needed to develop an understanding of chemical risks. CDR data help the Agency to identify, assess, and control three potential risks to human health and the environment posed by commercial chemical substances.
Under TSCA section 6, EPA’s Office of Pollution and Toxics (OPPT) carries out its responsibilities by prioritizing chemicals for evaluation, conducting chemical risk evaluations, and taking necessary risk management actions under TSCA. Under TSCA Section 5, EPA uses CDR data to identify the size of an industry sector, to identify other chemicals with similar uses, and to identify compliance with Significant New Use Rules (SNURs).
EPA established the CDR rule under TSCA section 8(a), which authorizes the Administrator to promulgate rules to provide for the maintenance and collection of records from manufacturers (including importers) and processors of commercial chemical substances. TSCA sections 8(a)(1) and (2) also authorize the Agency to collect information on chemical substances, including on their manufacturing (including importing), processing, and use. EPA possesses broad discretion in determining the information to be reported under TSCA section 8(a).
Through the CDR regulation1 (Ref. 2), EPA collects basic exposure-related manufacturing, processing, and use information used by the Agency and others in a wide range of activities. The CDR data collection is on a four-year reporting cycle and mainly contains information drawn from the principal reporting year but also contains some information, by year, from the previous three years. The information collected enables EPA to better understand and interpret the state of U.S. chemical manufacturing, processing, and use, and further enhances EPA’s ability to identify, evaluate, and manage potential chemical risks.
2. PRACTICAL UTILITY/USERS OF THE DATA:
Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection.
CDR data provide basic exposure information that helps EPA fulfill its responsibilities under TSCA. For example, CDR data:
• Provide a “current picture” of a chemical, industry, or use by reporting information not otherwise available for chemicals listed on the TSCA Inventory.
• Enable more effective screening of chemicals, their uses, and potential exposures so EPA can prioritize efforts.
• Provide information useful for measuring the progress of regulatory or voluntary programs.
• Allow EPA to identify industry trends.
TSCA section 6 requires EPA to develop and use a process to designate the priority of chemical substances, and that the process:
“…shall include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed. [TSCA section 6(b)(1)(A)]”
CDR data are important for characterizing the exposure potential, potentially exposed or susceptible subpopulations, the conditions of use, and the production volume or significant changes in the production volume of chemical substances being considered for priority designation for risk evaluation.
Also, CDR data are used in risk evaluation (including scope development and exposure assessment) to:
• Characterize the life cycle of the chemical (from manufacture, processing, use, and recycling activities).
• Identify existing conditions of use based on industrial processing and use reporting as well as reporting on the use of a CDR chemical in commercial and consumer products.
• Identify potentially exposed or susceptible subpopulations (e.g., number of workers, use in children’s products).
• Estimate releases and exposures associated with conditions of use.
From 2016 to January 2026, EPA completed or is working on the scoping documents or risk evaluations under TSCA section 6 for 38 chemicals. Selected examples of CDR data used in risk evaluation are listed below:
• In June 2025, EPA finalized the risk evaluation for 1,1-Dichloroethane. CDR data, along with information from other sources, were used to identify eight conditions of use (COUs). EPA evaluated those COUs and determined that three of the COUs present an unreasonable risk of injury to human health.
• In December 2025, EPA finalized the risk evaluation for Butyl benzyl phthalate - 1,2- Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (BBP). CDR data, along with information from other sources, were used to identify over 30 COUs. EPA determined that BBP presents unreasonable risk of injury to human health based on risk to workers from two COUs and that BBP presents an unreasonable risk to the environment from seven COUs.
• CDR data were used to identify the chemicals in the 2014 TSCA Work Plan. EPA is required to select at least 50% of the chemicals on which the TSCA section 6 risk evaluations are being conducted from the 2014 TSCA Work Plan. The Work Plan was developed in 2012 (and updated in 2014), when EPA screened all existing chemicals to identify candidates for assessment over the next several years. The screening process used to identify these chemicals is detailed in the TSCA Work Plan Chemicals Methods Document. This process used CDR data to develop an exposure score, which included identifying the production volume and number of sites, determining the potential for release when TRI data were not available, and developing rankings based on the industrial processing and use and on the consumer/commercial uses.
• OPPT develops Emission Scenario Documents (ESDs) used by the Organisation for Economic Cooperation and Development (OECD) and industry-specific generic scenarios for use in developing occupational exposure and environmental release estimates of chemicals for specific use scenarios. CDR data are used in generic scenario / ESD development to:
◦ identify types of chemicals commonly used and their functions in the industry of interest,
◦ estimate number of potentially exposed workers per site, and
◦ develop estimates of exposure levels and releases.
Past improvements to the CDR collection during the last several reporting cycles resulted in data that are more transparent, more useful, and provided in a more useable format. Increases in the quality and reliability of the data, faster access to the data, and an increased amount of data for the public have vastly expanded the usefulness of the CDR data.
Other offices in EPA and other federal agencies make use of CDR data. Selected examples from recent requests are:
• In May 2025 EPA’s Office of Water requested CDR data to update their supply chain profiles for a set of chemicals important to drinking water and wastewater treatment.
• In early 2025 the USGS Minerals Intelligence Research Section asked about EPA’s 2024 CDR data release, stating that the CDR data are valuable in USGS efforts to understand mineral consumption and use in the United States.
• In December 2025, EPA met with U.S. Department of Commerce to discuss their use of CDR data.
Following the 2016 amendment of TSCA by the Lautenberg Act, states are expected to have increased access to TSCA data and to have more opportunity to contribute to EPA’s risk evaluation processes for chemicals in commerce. This process is now in place, and EPA has set up or is in the process of setting up agreements with states for access to the CDR data. In addition, states have identified their uses of CDR data include:
• State chemical risk evaluation processes,
• Emergency response planning/community right to know,
• State OSHA/worker health and safety,
• Facility citing and permitting (most likely air and water permits),
• Compliance and enforcement for disposal/releases/mismanagement,
• Pollution prevention planning and implementation,
• Technical assistance programs, and
• Development of policy and legislation.
CDR data are also made public via EPA’s online ChemView database, public releases of information on chemicals of interest (such as those prioritized for risk evaluation under TSCA (see Prioritization Actions Under TSCA), and documents posted publicly by EPA that highlight key information about the most current reporting period.
3. USE OF TECHNOLOGY:
Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.
Submitters are required to submit information associated with this data collection electronically via the Internet using e-CDRweb reporting tool and EPA’s Central Data Exchange (CDX) data portal. The reporting tool has several attributes that reduce submitter burden, including the ability to upload information from a pre-completed spreadsheet and to download information from Agency systems, namely the Facility Registry Service (FRS) and Substance Registry Services (SRS). The reporting tool also contains the ability to copy information from one part of the submission to another and contains validations and other checks for compliance with reporting requirements
4. EFFORTS TO IDENTIFY DUPLICATION:
Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.
The data included in this information collection (i.e., production volume, chemical manufacture, exposure, and processing and use data) are not collected comprehensively or systematically at the national level by any other agency or organization. Some sources contain certain data elements that are part of the CDR collection, but such sources are typically incomplete or incompatible.
5. MINIMIZING BURDEN ON SMALL ENTITIES:
If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.
The CDR regulation provides flexibility to small entities. Small manufacturers (including importers), in accordance with TSCA section 8(b), are exempted from the need to report unless their chemical is the subject of certain TSCA actions. A manufacturer (including importer) is considered a small business when, (1) for a particular chemical company, annual sales are $120 million and the chemical’s production volume is greater than 100,000 lbs or (2) the company’s annual revenue is at least $12 million, regardless of the production volume. (40 CFR 704.3) A government may also be a manufacturer. Governments of cities, counties, towns, townships, villages, school districts, or special districts with populations of less than 50,000 are considered small. (40 CFR 704.3) States and tribal governments are not considered small governments.
6. EFFECTS OF LESS FREQUENT COLLECTION:
Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
If data were collected less frequently, EPA would experience a significant loss of data to the agency and general public, as no alternative data sets as comprehensive as CDR for the chemical manufacturing industry exist. For example, under TSCA section 6, EPA is required to have twenty risk evaluations underway at any given time and to start one risk evaluation for every risk evaluation that is completed. This requirement creates an ongoing demand for robust, up-to-date information to support EPA’s analyses and evaluations.
Conducting this data collection every four years helps to increase the Agency’s ability to understand the chemical industry and monitor the production levels of chemical substances manufactured (including imported) in the United States. As chemical industry product lines and manufacturing in the United States change substantially from one submission period to the next, more current information enhances the agency’s ability to make more accurate chemical substance risk assessment and management decisions in a timely and cost-effective manner.
7. GENERAL GUIDELINES:
Explain any special circumstances that require the collection to be conducted in a manner inconsistent with OMB guidelines.
The collection of information is conducted in a manner consistent with the guidelines in 5 CFR
1320.5(d)(2) except for special circumstances in record retention.
The record retention period of this collection is five years, as specified in 40 CFR 711.25,
exceeding the PRA maximum of three years. This is necessary to ensure companies retain
records long enough to facilitate completion of Form U (EPA Form 9600-010) (Attachment B) in the next
collection, which is in four years and to allow EPA’s enforcement activities to overlap CDR
reporting cycles.
8. PUBLIC COMMENT PERIOD AND CONSULTATIONS:
8a. Public Comment
If applicable, provide a copy and identify the date and page number of publication(s) in the Federal Register of the agency’s notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically address comments received on cost and hour burden.
Pursuant to 5 CFR 1320.8(d), EPA published a notice in the Federal Register on February 4, 2026 (91 FR 8872; FRL-12917-01-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.
EPA received two (2) comments from the public (Attachments C and D). The Agency thanks all commenters for their comments and has considered them in developing this ICR. See summary of response to comment document (Attachment E).
8b. Consultations
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.
The EPA also consulted nine (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:
1. Finch Paper
2. Nishikawa Cooper LLC
3. Marathon Dickinson Renewable
4. Monument Chemical
5. Lubrizol Corporation
6. Ravago Americas
7. Calumet Shreveport Refining
8. Cargill, Incorporated
9. Dover Chemical Corporation
Of those consulted, EPA received comments from four (4) stakeholders (Attachment G). EPA summarized responses to consultation in Attachment E.
9. PAYMENTS OR GIFTS TO RESPONDENTS:
Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
No payments or gifts were provided to respondents.
10. PROVISIONS FOR PROTECTION OF INFORMATION:
Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a system of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.
Most CDR data can be claimed as confidential when the CDR reporting form is submitted to EPA. As required under TSCA, substantiation for confidentiality claims must be submitted at the time the claim is made, except for confidentiality claims for production volume information (excluding percent production volume). Submitters must substantiate their claims by answering a series of questions related to whether the information is publicly known and whether public knowledge of the information would hurt a business’ competitive position. EPA’s e-CDRweb electronic reporting tool is the mechanism for submitting substantiation information.
Confidential business information (CBI) claims limit public access to CDR data for which such claims are made. EPA reviews CBI data in its mission to protect human health and the environment, in accordance with TSCA sections 14(e), (f), and (g). The review process is explained in detail on EPA’s website, at EPA Review and Determination of CBI Claims under TSCA.
11. JUSTIFICATION FOR SENSITIVE QUESTIONS:
Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
No information of a sensitive or private nature is requested in conjunction with this information collection activity. This information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A-108.
12. RESPONDENT BURDEN HOURS AND LABOUR COSTS:
Provide estimates of the hour burden of the collection of information.
• Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated.
• If this request for approval covers more than one form, provide separate hour burden estimates for each form and the aggregate 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 as O&M costs under non-labor costs covered under question 13.
12a. RESPONDENTS/NAICS CODES
The regulated community consists of companies manufacturing (including importing) certain chemical substances listed on the TSCA Inventory and regulated under the TSCA section 8(a) CDR regulation. In general, the industry segments that compose the regulated community for the rule are those that produce or import chemical substances. Most respondents expected to be subject to this ICR have previously reported CDR information. The Agency’s previous CDR collections show that most of the respondents affected by this collection activity are from the following North American Index Classification (NAICS) code categories:
325 - Chemical Manufacturing
324 - Petroleum and Coal Product Manufacturing
The subsectors identified above represent the designation of sites that likely would be subject to CDR reporting. However, this list does not include all potentially affected entities. Other types of entities not listed in this unit may also be subject to reporting.
Generally, TSCA section 8(a) excludes small manufacturers (including importers) from reporting. EPA defines small manufacturers (including importers) for purposes of CDR and certain other reporting in 40 CFR 704.3.
12b. INFORMATION REQUESTED
Reporting Threshold
The threshold for reporting to CDR is a production volume of 25,000 pounds at a single site for any calendar year since the previous principal reporting year. The reporting threshold is 2,500 pounds for certain chemical substances that are:
◦ The subject of a rule proposed or promulgated under TSCA sections 5(a)(2), 5(b)(4), or 6,
◦ The subject of an order issued under TSCA sections 5(e) or 5(f), or
◦ The subject of relief that has been granted under a civil action under TSCA sections 5 or 7.
Chemical substances subject to these TSCA actions are of demonstrated high interest to EPA. A lower reporting threshold helps to ensure the availability of current information on those chemical substances manufactured above 2,500 pounds when EPA has expressed concern in the form of regulatory action. EPA will use CDR data associated with these regulated chemical substances to monitor chemical substance production and regulatory compliance.
12c. RESPONDENT ACTIVITIES AND FREQUENCY
In calculating the burden hours and labor costs for CDR, EPA uses data about reporters from recent reporting years to estimate the number of sites, chemical reports, and the percentages of chemical reports engaging in certain reporting activities. These metadata are used to calculate an average burden and cost to represent many different reporting situations (number of chemicals reported, recurring or new reporter, likelihood that a data element will be claimed as CBI, etc.). For example, “% CBI Chem ID” is a value applied to the burden estimate for claiming Chemical Identity as Confidential Business Information to account for the fact that only a small share of companies performs that activity. Table 1 provides the universe of respondent sites, chemical reports, and CDX registrations based on an analysis of 2020 CDR data (EPA, 2022).
Table 1. Universe of Respondent Sites, Chemical Reports, and CDX Registrations
Form U Reporting1
Type of Count
Total
Sites
5,238
Chemical Reports
43,468
Chemicals
8,649
Overall Submitter Characteristics, % of Chemical Reports
Characteristic
Total
Chemicals per Report
8.3
% of Partial Reports
7.21%
% Joint Reporters
3.28%
% CBI Chem ID
1.5%
% CBI Substantiation for Connection to Company ID, Site ID, and/or Technical Contact
15.12%
% Industrial Processing and Use CBI
20.44%
% Consumer and Commercial Use CBI
9.08%
CDX Registrations
Type
Total
CDX Registrations2
1,310
Table Footnotes
1 Sites, Chemical Reports, Chemicals and Chemicals per Report are based on observations in 2020 CDR (EPA, 2022).
2 The number of CDX registrations is assumed to be 25% of sites submitting the Form U.
CDX Registration
Each CDR submission must have an associated authorized official who signs the certification statement and submits the CDR report via CDX. To register in CDX, the authorized official, as a CDX registrant (also referred to as “Electronic Signature Holder”), completes an electronic signature agreement (ESA) form. For identity authentication, the registrant will complete the ESA and either submit the form electronically or mail it to EPA. Once EPA receives the form, EPA will activate the registrant’s CDX account and send a notification via email.
A company may need or desire to have more than one individual add information to a CDR submission using the CDR reporting tool. Each individual accessing the CDR reporting tool must register with CDX and complete an ESA; the authorized official must use CDX to identify that the individual is permitted to access the site’s CDR reporting form. The additional individuals can register in CDX as additional authorized officials, agents, or supports, based on their intended roles in completing the CDR submission. Agent or support registrants may be employees of the company, outside consultants for the company, or authorized representative agents for the company.
CDR Data Elements
The CDR data elements are related to or indicative of three components of exposure. These components are: (1) the number of ecosystems or size of human populations potentially exposed, (2) the potential human or environmental exposure concentrations, and (3) the frequency and duration of potential exposures. The data enhance EPA’s ability to evaluate each of these components of exposure. Respondents are required to submit certain “known or reasonably ascertainable” manufacturing, processing, and use exposure-related information.
Using e-CDRweb, individuals report the data elements as follows:
• Authorized company official’s e-mail address. The e-mail address of the company official authorized to sign and submit the CDR Form U.
• Parent company name and address. The name, Dun & Bradstreet number, mailing address of the U. S. parent company, and, if applicable, foreign parent company.
• Manufacturing site. The site name; Dun & Bradstreet number, and physical address of the manufacturing site; the NAICS code associated with the site and an indication if the NAICS is associated with a volume that is domestically manufactured, imported, or both. Sites are able to provide up to three NAICS codes.
• Technical Contact Information. The individual name, company name, and address of the technical contact. Sites are able to provide one contact for the site or one for each chemical.
• Manufacturing information. The production volume for each year since the last principal reporting year. For the principal reporting year only: the volume of the reported chemical substance used at the reporting site; whether an imported chemical substance is physically at the reporting site; the production volume directly exported and not domestically processed or used; the number of workers likely to be exposed at the site; the maximum concentration, measured by percentage of weight; whether the manufactured (including imported) chemical substance is being recycled, reused, reprocessed, or remanufactured, the physical form(s) of the chemical substance, and the associated percent production volume of each physical form.
• Processing and use information. Respondents are to report this information for all reported chemical substances unless a chemical substance is specifically partially exempted.
• Industrial processing and use data. Submitters must report their type(s) of industrial process or use, sector(s), function category(ies), percentage(s) of production volume, number(s) of sites, and number(s) of workers reasonably likely to be exposed.
• Consumer and commercial use data. Submitters must indicate the product category(ies); whether the use is consumer, commercial, or both; whether the chemical is used in products intended for children; and for each product category: the function of the chemical; the percent production volume, the maximum concentration, and number of commercial workers reasonably likely to be exposed to the chemical.
• CBI substantiation. All of the data elements described in the Manufacturing Information section and Processing and Use Information section may be claimed as CBI. Substantiation of the CBI claim must accompany the claim unless the claim is for production volume.
Special considerations for Co-Manufactured Chemicals when reported jointly by the Contracting and Producing Companies: In certain circumstances, manufacturers may choose to report a co-manufactured chemical jointly, such that each party (i.e., the contracting company and the producing company) provides certain information directly to EPA. This is primarily done when one or both parties consider some of its information as confidential. These special considerations do not apply when co-manufacturers choose to share their information with each other, resulting in the producing company reporting all information to EPA. Both the contracting and producing companies use the primary Form U to report information, regardless of whether it is reported by one or both companies.
In the case of a jointly reported co-manufactured chemical, the contracting company initiates the co-manufacture report by providing the chemical identity and the identity of the producing company and name (actual name, trade name, or other alias) used to identify the chemical substance in communications with the producing company. Using the e-CDRweb electronic reporting tool, the contracting company then contacts the producing company to notify them of the need to report the manufacturing-related information directly to EPA as part of the producing company’s Form U. Each party of a co-manufactured chemical submission submits their respective portions of the same report electronically to EPA.
EPA collects certain data to enable the joint submission and to combine information from the two parties:
• Joint submission information (contracting company): The contracting company provides a trade name or other designation in place of the specific chemical identity and the producing company contact information (name, address, email address).
• Producing company identification information: These data identify the producing company’s name and the complete mailing address of the company.
• Technical contact information (producing company): The company’s technical contact information provides EPA with the name and complete mailing address of the person able to answer questions EPA may have about the reported chemical substance.
For the most part, the contracting company provides the chemical identity and processing and use information for the co-manufactured chemical, and the producing company provides the manufacturing-related data. For selected data, information is provided by both companies due to differing knowledge bases among co-manufacturers. In addition, for other data elements the terminology may be changed from what is used for a non-co-manufactured chemical. The intent of the information, however, is unchanged. Specifically:
• Production volume: The producing company reports only the principal reporting year volume while the contracting company reports the production volume for all of the years covered by the submission
• Contracted volume directly exported from producing site: This is reported by both the producing and contracting companies. For a non-co-manufactured chemical, the site producing the chemical would report the volume directly exported.
• Contracted volume never physically at site: This is reported by the contracting company and is similar to import chemical never physically at site reported for an imported chemical.
Joint Submissions when Chemical Identity is Unknown. Joint submissions are allowed only in those instances in which a supplier will not disclose to the submitter the specific chemical name of the imported TSCA Inventory chemical substance or of a reactant used to manufacture the TSCA Inventory substance. This may happen, for example, if a company is importing a mixture under a trade name, and the foreign supplier does not want to reveal the components in the mixture. In addition to signing the certification statement and completing the above data elements, primary respondents will report on additional data as follows:
• Joint submission information. Trade name of the chemical substance being reported, secondary respondent name, and complete mailing address (city, state/province, zip code, and country (if applicable)).
Secondary submitters register with CDX as a secondary authorized submitter or a secondary support registrant. The secondary submitter will provide the primary company’s information and the trade product name supplied to them by the primary submitter to initiate a Secondary Form U. The secondary submitter reports the following data elements:
• Certification. The company official must certify by signature and date that to the best of his/her knowledge and belief: 1) all information entered on Form U has been completed in compliance with the regulatory requirements; and 2) any confidentiality claims are true and correct as to that information for which they have been asserted.
• Secondary company information. The secondary company name and complete mailing address (city, state, zip code, and country (if applicable)).
• Secondary technical contact information. The technical contact name, phone number, complete mailing address (city/town, state/province, zip code, and country (if applicable)), and e-mail address.
• Primary company information sent to secondary company. Trade name and the Unique Identifier for Joint Submissions number provided by the primary submitter and sent to the secondary submitter.
• Trade product information. The trade product name; the chemical name, CAS Registry Number, and percentage of each component of the product and the component’s function.
Instructions, User Guides, Frequent Questions, and Other Guidance Documents
EPA provides a variety of guidance materials, including Instructions for Reporting, Frequent Questions, and other topic-specific guidance that help submitters understand their reporting obligations. A list of the documents from the 2024 CDR is provided below. These documents will be updated as needed for the next CDR submission period in 2028. The documents are available on CDR GuideME.
• Instructions for the 2024 TSCA Chemical Data Reporting
• EPA 2024 CDR Sample Form U Printouts
• CDR Regulatory History
• Case Studies for the Chemical Data Reporting
• Byproducts, Impurities, and Recycling Scenarios
• Frequent Questions
• Thresholds for Reporting
• Chemical Substances that are the Subject of Certain TSCA Actions
• Help with Chemical Data Reporting: How to Search for Chemicals Subject to Certain TSCA Actions
• Reporting After Changes to Company Ownership or Legal Identity
• Importers
• Imported Articles
• Co-Manufactured Chemicals
• Non-Isolated Intermediates
• Kraft Pulp and Paper Process
• Byproducts Reporting for the Printed Circuit Board Industry
• Reporting for Electricity Generating Sites
• Reporting Manufactured Chemical Substances from Metal Mining and Related Activities
• Preparing and Submitting a Petition
12d. RESPONDENT BURDEN HOURS AND LABOR COSTS
Respondent burden and costs are generated by companies compiling and preparing the required information to be reported to EPA every four years. In addition to reporting every four years, companies sometimes need to update or correct previously reported information. Therefore, even in non-reporting years, company efforts relating to activities described in this ICR are not zero. The three years covered by this ICR begins following the previous ICR’s expiration date of October 31, 2026, and continues through October 31, 2029.
The full burden and cost for the four-year reporting cycle, broken out by activity, are provided in Table 2. The burden and cost calculations account for the difference between new reporters and experienced reporters. The latter bears a lower burden and cost. The Rule Familiarization burden is the average of 0 burden hours for experienced reporters and 27 burden hours for new reporters. The burden for Form Completion also accounts for an expected higher level of burden for first-time reporters.
Table 2. Respondent Total Burden and Cost for Four-Year Reporting Cycles
Average Unit Burden and Cost1,2
Universe
Total Burden and Cost
Form U Submitters
IC: Prepare and Submit Report, and Maintain Reports
Unit Burden per Average Site (hours)
Unit Cost per Average Site (2025$)
Respondents (Number of Sites)
Total Burden (hours)
Total Cost (2025$)
Rule Familiarization
3.952
$368.020
5,238
20,701
$1,927,689
Compliance Determination
7.404
$691.320
5,238
38,782
$3,621,134
Recordkeeping
3.000
$245.010
5,238
15,714
$1,283,362
Average Multi-Chemical Form Completion (8.3 chemicals)
665.964
$69,037.180
5,238
3,488,319
$361,616,749
Total
680.320
$70,341.530
5,238
3,563,516
$368,448,934
Table Footnotes:
1Overall unit burden assumes that 15% of sites are new reporting sites.
2The Rule Familiarization burden presented here is the average of 0 burden hours for experienced reporters and 27 burden hours for new reporters. The only other activity with different burdens for new and experienced reporters is Form Completion (808 and 641, respectively).
Table 3 presents the total burdens for the four-year reporting period, the annual average burden and cost of CDR2, and finally the total burden and cost for the three-year ICR period.
Table 3. Respondent Annual and Total Burden and Cost for Three-Year ICR Period
Burden Category
CDR Reporting Cycle Burden (hours)1, 2
ICR Renewal Period (Oct 2026 - Oct 2029)
2028 CDR Cycle
2032 CDR Cycle
Annual Average Burden (hours)
Annual Average Cost (2025$)
Total Three-Year Burden (hours)
Total Three-Year Cost
(2025$)
2025
2026
2027
2028
2029
2030
2031
2032
Reporter Burden
CDX Registration and eSignature
694
694
174
$15,363
522
$46,089
Form U Submission: Prepare and Submit Report, and Maintain Records3
3,563,516
3,563,516
890,879
$92,112,234
2,672,637
$276,336,702
Reporter Burden, Total
3,564,210
3,564,210
891,053
$92,127,597
2,673,159
$276,382,791
Table Footnotes:
1EPA assumes that reporting activities for a CDR cycle begin on the first day of the calendar year following the previous cycle, at which point reporters have complete information for the first reporting year of the cycle. Because the CDR cycle is four years, EPA assumes that reporting activities for a CDR cycle end on the last day of the calendar year of the cycle. For example, reporting activities for the 2024 cycle began on January 1, 2021, and ended on December 31, 2024.
2The years included in the burden reporting cycle are different from the years for which information is reported because data collection begins the year after the data are generated (i.e., the first year for which information are to be reported). For example, for the 2028 cycle the burden is for the years 2025-2028 while the information reported is for the years 2024-2027.
3Includes rule familiarization (new reporters), compliance determination, form completion, and recordkeeping.
13. RESPONDENT CAPITAL AND O&M COSTS:
Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information.
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.
14. AGENCY COSTS:
Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.
14a. AGENCY ACTIVITIES AND FREQUENCY
The activities routinely conducted by EPA related to the processing, analysis, and storage of the information collected under this rule include the following:
• Review and verify forms as they are received;
• Answer submitter questions and provide any necessary assistance;
• Process submissions for inclusion in CDR database;
• Maintain the database; and
• Distribute the data.
This section describes EPA’s tasks required for efficiently processing submissions under CDR. The tasks for which EPA is responsible are presented under four main categories: database systems development, guidance document development, Form U processing, and additional tasks. The task descriptions presented below generally do not change from collection to collection.
CDR data is stored in a database managed by EPA. The CDR database is also available for quick screening and other direct uses. EPA makes as much information publicly available as possible within the confines of protecting CBI.
• Database Systems Development and Maintenance EPA is responsible for having adequate information systems in place to support the database that serves as the primary data storage medium for CDR collections. File servers with appropriate backup are used to contain the CDR databases. In addition, CDR data are tracked and maintained in the Chemical Information System (CIS) located within the Toxic Substance Control Act (TSCA) LAN.
• Guidance Document Development EPA is responsible for developing and maintaining guidance to assist submitters in complying with CDR requirements. Contractors are used to maintain the guidance document database, CDR GuideME, with oversight by Agency personnel.
• Form U Processing EPA is responsible for processing CDR Form U submissions. This includes developing standard operating procedures and documentation for all stages in the CDR document life cycle, document receipt and tracking, data input, quality control, file and database maintenance, information security, CBI aggregation policy, data dissemination, and staff training.
• Additional Activities EPA develops various supporting documents associated with the reporting tool and makes them available on the internet. In addition, EPA is responsible for providing the TSCA Hotline with standardized responses for frequently asked questions; preparing mailings, mailing lists, and labels; and developing outgoing information materials.
Of the tasks listed above, EPA personnel are responsible for 1) quality control of data entry and 2) data processing, systems development, and contract oversight and management. Contractors perform the other activities, as described below.
Table 4 provides the burden and cost per report for all EPA staff activities anticipated during this ICR period. The activities performed by the GS-13 level staff member, including systems development and contract oversight and management, are fixed costs and are not dependent on the number of reports submitted to EPA. Some burdens and costs, however, vary based on the number of CDR respondents or chemical reports. For this reason, EPA burden and cost are split into fixed and variable categories.
14b. AGENCY BURDEN AND LABOR COST, 14c. AGENCY NON-LABOR COSTS; 14d. AGENCY TOTAL COSTS
Table 4. Annual Agency Burden and Cost
Activity
Staff
Affected Universe
Unit Burden and Cost
Total Burden and Cost
Burden per Activity (hours)
Cost per Activity (2025$)
Total Burden (hours)
Total Cost (2025$)1
Variable Burdens and Costs
Submission Receipt and Tracking; Data Review
Contractor
5,238 Sites
N/A
N/A
N/A
$35,800
Quality Control, except CDX Registration
EPA Staff
43,486 Reports
0.005
$0.6
203
$26,124
Quality Control
Contractor
N/A
N/A
N/A
N/A
$25,000
Quality Control, CDX Registration
EPA Staff
1,310 CDX Registrations
0.0081
$1.04
11
$1,362
Total Variable Burden and Cost
214
$88,286
Fixed Burdens and Costs
Data Processing, Systems Development; Contract Oversight and Management
EPA Staff
N/A
N/A
N/A
2,080
$267,875
Development and maintenance of the electronic data collection tool (incl. electronic guidance)
Contractor
N/A
N/A
N/A
N/A
$162,000
Back Up Systems Operations and Maintenance
Contractor
N/A
N/A
N/A
N/A
$161,000
Publishing Forms and Materials
Contractor
N/A
N/A
N/A
N/A
$8,333
Managing the TSCA Hotline
Contractor
N/A
N/A
N/A
N/A
$67,008
Development of Reporting Instructions, webinars, group communications
EPA Staff
N/A
N/A
N/A
1,179
$151,839
Development of Reporting Instructions
Contractor
N/A
N/A
N/A
N/A
$5,000
Total Fixed Burden and Cost
3,259
$823,055
Total Agency Burden and Cost
3,473
$911,341
Note: Estimates for contractors are based on an analysis of the total contract amount needed for the activity. The total costs for the activities performed by EPA staff are based on best professional judgment regarding the time burden necessary to complete each task, multiplied by the number of sites and the agency wage rate.
Table Footnotes
1 Based on OPM labor rates for Program Staff GS13 Step 5 in the Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area.
15. CHANGE IN BURDEN:
Explain the reasons for any program changes or adjustments reported on the burden worksheet.
The respondent burden for this collection of information is estimated to average 170 hours per year for the average site, assuming a multi-chemical submission of 8.3 chemicals per site with 7.2% of reports consisting of partial reports and 14.8% of sites as new reporters. This estimate includes time spent on rule familiarization (for new reporters), compliance determination, form completion, and recordkeeping. For CDX activities the average per-response burden is estimated at 0.53 hours per registration for those respondents not already registered in CDX.
This ICR includes an increase of 161,568 hours in the total estimated burden compared with that currently approved by OMB. The increase reflects the use of 2020 CDR data (rather than 2016 CDR used for the previous ICR update) for estimating the reporting universe. Although in 2020 fewer sites reported to CDR than in 2016 (i.e., fewer Form Us submitted), on average the sites reported a greater number of chemicals. In 2020 CDR, there were 5,238 sites reporting on 8.3 chemicals per report as opposed to 5,460 sites and 7.38 chemicals per report in 2016 CDR. This change resulted in a substantial increase in the number of chemical reports submitted. In addition, fewer chemical reports were for partially exempted chemicals (see 40 CFR 711.6 for a list of chemicals that are partially exempted from reporting under CDR). In 2016 CDR, approximately 21% of reports were partial reports, whereas in 2020 CDR the share of partial reports was about 7%. The average burden for each chemical report is higher because a greater percentage of the chemical reports are full reports. There were no program changes, so the burden increases were not the result of program changes to the reporting requirements.
Costs also increased relative to the last ICR because agency and industry wage data were updated to 2025 wage rates.
16. PUBLICATION OF DATA:
For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
After each collection, CDR data are tabulated into a series of spreadsheets and an Access database, checked to ensure data submitted as confidential are protected, and posted on EPA’s CDR website and via the online ChemView database.
17. DISPLAY OF OMB CONTROL NUMBER AND EXPIRATION DATE ON INSTRUMENTS:
If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons why display would be inappropriate.
The Agency plans to display the expiration date for OMB approval of the information collection on all instruments.
18. CERTIFICATION STATEMENT:
Explain each exception to the topics of the certification statement identified in “Certification for Paperwork Reduction Act Submissions.”
This information collection complies with all provisions of the Certification for Paperwork Reduction Act Submissions.
SUPPLEMENTAL INFORMATION
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. 2070-0162). Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR Part 711. 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 170 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 Data and Enterprise Programs Deputy 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-2013-0721
LIST OF ATTACHMENTS
.Attachment
Description
A
Wage Rates
B
Form U - EPA Form No. 9600-010
C
Public Comment ACC
D
Public Comment Giant Cement Holding Inc.
E
F
Consultation Summary (Stakeholder Engagement)
G
Consultation Responses
REFERENCES
1. 15 U.S.C. §2607 available at https://www.law.cornell.edu/uscode/text/15/2607
2. 40 CFR Part 711 available at https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-711
3. EPA. TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a); Final Rule, Federal Register, 85 FR 31986, May 28, 2020 (FRL–10005–56). https://www.federalregister.gov/documents/2020/04/09/2020-06076/tsca-chemical-data-reporting-revisions-under-tsca-section-8a
4. EPA. Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA) Section 8(a); Final Rule, Federal Register, 85 FR 20122, April 9, 2020 (FRL–10008–14).
5. EPA, 2020a. Economic Analysis for the Final Rule on the TSCA Chemical Data Reporting (CDR) Revisions. Docket EPA-HQ-2018-0321-0118
6. EPA, 2020b. Economic Analysis for the Final Rule on the TSCA Section 8(a) Small Manufacturers Definition Update. Docket EPA-HQ-2018-0321-0141
7. EPA 2022. 2020 Chemical Data Reporting ChemView Database