1884 11_Chemical Data Reporting_2019-04-18

1884 11_Chemical Data Reporting_2019-04-18.docx

Chemical Data Reporting under the Toxic Substances Control Act (TSCA section 8(a))

OMB: 2070-0162

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Supporting Statement for a Request for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA)


  1. IDENTIFICATION OF THE INFORMATION COLLECTION

This Information Collection Request (ICR) Addendum quantifies the changes to burdens associated with the proposed rule for Chemical Data Reporting (CDR) Revisions and Small Manufacturer Definition (SMD) Update for Reporting and Recordkeeping Requirements under section 8(a) of the Toxic Substances Control Act (TSCA) (RIN 2070-AK33). Note that the SMD Update portion of the rule includes a small government definition (SGD). Changes to the CDR rule were put in place following enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which amended TSCA on June 22, 2016. The Environmental Protection Agency (EPA) implemented these changes from the amended TSCA that did not require regulatory revision, quantifying the associated burdens in the renewal ICR published on October 29, 2018, and is using that renewal ICR as the baseline for this amendment. EPA is proposing revisions to the CDR rule for three primary reasons: to align with the Lautenberg Act, to reduce burden for certain CDR reporters, and to improve the CDR data collected as necessary to support implementation of TSCA. In addition, because EPA is proposing a change to the TSCA section 8(a) small manufacturer definition, the proposal impacts other ICRs, including certain chemical-specific TSCA section 8(a) rules listed in 40 CFR 704.3 and the Preliminary Assessment Information Rule (PAIR) at 40 CFR 712.

    1. Title of the Information Collection(s)

Because the change to the small business standard impacts how many entities report under a rule and not the data collected, this addendum focuses on the CDR ICR identified by:

Title: Chemical Data Reporting under the Toxic Substances Control Act (TSCA section 8(a))


EPA ICR No.: 1884.11 OMB Control No.: 2070-0162

There are other ICRs that could potentially be impacted by the rule but are currently not collecting any reports (listed below). Note that the TSCA section 8(a) chemical-specific rule for nanoscale materials would not be affected by the rule (OMB No. 2070-0194, ICR No. 201701-2070-001).

  • Preliminary Assessment Information Rule
    (OMB Control No. 2070-0054, EPA ICR No. 201603-2070-001)

  • TSCA Section 8(a) Chemical-Specific Reporting Rules
    (OMB Control No. 2070-0194, EPA ICR No. 201701-2070-001)

    • 11-aminoundecanoic acid (40 CFR 704.25)

    • P-tert-butylbenzoic acid (P-TBBA), p-tert-butyltoluene (P-TBT) and p-tert-butylbenzaldehyde (P-TBB) (40 CFR 704.33)

    • Chlorinated naphthalenes (40 CFR 704.43)

    • Chlorinated terphenyl (40 CFR 704.45)

    • Phosphonic acid, [1,2-ethanediyl-bis[nitrilobis-(methylene)]] tetrakis- (EDTMPA) and its salts (40 CFR 704.95)

    • Hexachloronorbornadiene (40 CFR 704.102)

    • Hexafluoropropylene oxide (40 CFR 704.104)

    • 4,4’-methylenebis(2-chloraoniline) (MBOCA) (40 CFR 704.175)

These ICRs are not discussed in this addendum, either because EPA has not received any chemical reports under the rules for an extended period of time or because the rule uses a different definition that is not proposed to be changed.

1(b) Short Characterization/Abstract

This ICR addendum addresses the paperwork requirements in a proposed rule (RIN 2070-AK33) that would amend the information collection activities of the CDR program (40 CFR Part 711). Two economic analyses (EAs) provide estimations of the burden and costs associated with the proposed changes, which separately cover the CDR Revisions and the TSCA section 8(a) Small Manufacturer Definition (SMD) Update. Under TSCA section 8(a) (15 U.S.C. 2607), the EPA is authorized to collect certain information on chemical substances manufactured (including imported) or processed in the United States. In addition, under TSCA section 8(b), the Agency is required to compile and keep current, via periodic inquiry, the Inventory of Chemical Substances in Commerce (TSCA Inventory). The TSCA Inventory is a listing of chemical substances manufactured, imported, and processed for commercial purposes in the United States. The CDR data collection provides chemical manufacture, processing, and use information that helps EPA identify what chemicals the public may be exposed to as consumers or in commercial and industrial settings. The data also help EPA assess routes of potential exposure to those chemicals.

The EPA has used the CDR rule to collect basic manufacturing information for selected chemical substances on the TSCA Inventory eight times beginning in 1986. More recent collections, beginning in 2006, included additional information relating to the manufacture, processing, and use of those chemical substances. The CDR collection is on a four-year reporting cycle and contains detailed manufacturing and processing information drawn from the principal reporting year; the collection also contains basic information on production volume, by year, for the three years prior to the principal reporting year. For example, for the 2020 reporting cycle, the principal reporting year will be 2019; the three years prior will be 2016, 2017 and 2018.

As proposed, the 2020 and future CDR submissions would include the following new or revised data elements: a public contact (voluntary); a revised parent company definition, including a foreign parent company if one exists; NAICS code(s) for the manufacturing site; the percent of production volume that is a byproduct; modified recycling data element; and harmonization of industrial, consumer, and commercial function and use codes based on the Organisation for Economic Co-operation and Development (OECD) codes. EPA also proposes to improve the reporting processes for co-manufactured chemicals. Additionally, changes are being proposed to support alignment of CDR reporting with the amended TSCA requirements for claiming confidentiality. EPA is also proposing changes for the reporting of byproducts, including voluntary alternative reporting in metal compound categories for inorganic byproducts and exemptions for specific site-limited recycled byproducts and for byproducts generated by specific non-integral processes. Lastly, EPA is proposing an update to the TSCA section 8(a) small manufacturer definition and the addition of a small government definition. For the small manufacturer definition, EPA proposes to retain the structure of the current definition and increase the levels of the revenue size standards.

Table 1 summarizes the combined incremental changes to reporting due to the CDR Revisions and the TSCA section 8(a) SMD Update portions of the rule, collectively called the CDR Proposed Rule.

Table 1: CDR Proposed Rule – Incremental Annual Burden and Cost

Legal authority:

The Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2607(a).

Respondents/

affected entities:

Entities potentially affected by this ICR include companies manufacturing (including importing) chemical substances listed on the TSCA Inventory and regulated under the TSCA section 8(a) CDR regulation.

Respondent’s obligation to respond:

Respondents are obligated to report to EPA.

Confidentiality of responses

Confidentiality claims limit public access to the CDR data. EPA recognizes that some information submitted to the Agency is legitimately confidential. Because of this, EPA’s review of confidential data is an inherently governmental function that EPA must perform to protect human health and the environment.

Estimated number of affected respondents:

5,660  

Frequency of response:

The collection occurs every four years. The next CDR collection will occur in 2020.

Estimated annual incremental burden:

-25,201 hours

Estimated annual incremental cost:

-$1,955,042

Sources include EPA (2019a) and EPA (2019b).

  1. NEED FOR AND USE OF THE COLLECTION

    1. Need/Authority for the CDR Collection

Under TSCA, EPA is charged with protecting human health and the environment from potential chemical risks. Through the CDR regulation, EPA collects basic exposure-related manufacturing, processing, and use information used by the Agency and others in a wide range of activities.

Some of the proposed revisions to the CDR would improve the exposure-related data collected on manufacturing, processing, and use of chemicals in commerce, enabling EPA to conduct a more effective and efficient screening-level review of chemical substances to identify candidates for further evaluation or action. This improvement is particularly important in light of EPA’s requirement under TSCA to identify chemicals in commerce as high priority or low priority for risk evaluation (TSCA section 6(b)). Other proposed revisions, such as changes to byproduct reporting, small manufacturer standards, and an improved mechanism for co-manufactured chemical reporting, would reduce burden for reporters while continuing to allow EPA to access needed information.

Additionally, under TSCA section 14, claims of confidentiality (other than for selected data elements such as production volume) must be substantiated at the time information is submitted to EPA, including as part of CDR (See 82 FR 6522, January 19, 2017). To ensure that EPA can use CDR data most effectively, including sharing it with the public, TSCA requires substantiation to enable EPA to review the legitimacy of confidentiality claims. EPA is proposing new and updated questions for reporters to answer to substantiate confidentiality claims at the time the information is submitted to the Agency. EPA also is proposing which data elements do not require upfront substantiation and which data elements are ineligible for confidentiality claims.

    1. Practical Utility/Users of the CDR Data

The proposed revisions associated with reporting methods, including the reporting tool and electronic registration, would help to ensure that the information reported to EPA is accurate and in compliance with the CDR requirements. In addition, the proposed data elements would have practical utility for users of the data within EPA and for the public.

e-CDRweb Reporting Tool


For the 2020 submission period, EPA would continue to require electronic reporting for all CDR submissions, including joint submissions and amendments. Persons submitting information under the CDR rule are required to use e-CDRweb, the Agency-provided, web-based tool to complete Form U (the CDR reporting form). EPA would make updates to this required reporting tool to address the proposed changes. Mock ups of e-CDRweb screen shots illustrating the proposed changed reporting requirements are included as Attachment A and the Instructions are included as Attachment B.

Data Elements for CDR Submissions


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. With proposed changes, EPA would collect information on new or revised data elements. EPA would use the information for these new or revised data elements in the following ways:

  1. Public contact: (new, voluntary) The public contact information would provide for a general, public contact for other users of the CDR data.

  2. Parent company information: (revised) Information about the U.S. parent company (and foreign parent company, when applicable) associated with the reporting site is used for protecting information claimed as confidential when there are multiple sites for the same parent company and for comparing data from various sources, such as is done for EPA’s Toxics Release Inventory (TRI). The revised parent company definition would reduce uncertainty for submitters regarding how to report parent company information. The addition of the foreign parent company would increase EPA’s ability to use and release the CDR data while protecting confidentiality claims. Consistent use of parent company names makes for more meaningful comparisons of data and would reduce after-reporting quality control efforts for both EPA and submitters.

  3. NAICS codes: (new) The reporting site’s NAICS code(s) would help EPA to more accurately understand the chemical industry, including identifying sector-specific trends.

  4. Percent production volume that is a byproduct: (new) EPA is proposing to add a data element about byproducts to identify important submitter subpopulations and their representation in CDR with respect to production volume. With this change, EPA would be able to better understand the reporting impacts on this subpopulation, including to identify those manufacturers who only report to CDR due to their byproduct production. EPA would consequently be better able to understand and connect manufacturing and downstream activities for the purposes of substance life cycle assessments and risk evaluation.

  5. Whether a manufactured (including imported) chemical substance is being recycled: (revised) This data element provides information relevant to the exposure profile of a chemical substance and indicates efficiencies within the chemical manufacturing industry. EPA is proposing to modify this data element to focus on recycling and to reduce potential confusion related to the removed terms “remanufactured, reprocessed, and reused,” which may be interpreted and applied too broadly to obtain the information of interest for this collection.

  6. Function and use codes: (revised) Harmonizing CDR use codes with the OECD codes would expand the utilization of applicable use and exposure-related information from international sources to support EPA risk assessment activities for new and existing chemicals. Additionally, this harmonization would reduce industry burden by providing industry with international uniformity in use and exposure information reporting, enabling industry to better streamline their different country-specific reporting requirements.

  7. Confidential claim substantiation: (revised) Changes to the substantiation requirements are proposed primarily to align with new statutory requirements. These changes would help EPA to improve transparency and public availability of the data while protecting CDR submitters’ confidential information.

  1. NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

    1. Non-Duplication

The data included in this information collection request addendum (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 entities.

    1. Public Notice Required Prior to ICR submission to OMB

The proposed rulemaking serves as the public notice for this ICR. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2018-0321 to the address listed at the end of this document. Responses will be taken into account in developing the final rulemaking.

    1. Consultations

Under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval. Because this ICR addendum addresses the paperwork requirements in proposed rule (RIN 2070-AK33) that would amend the information collection activities of the CDR program (40 CFR Part 711), EPA will pursue additional consultations with interested parties during the development of the renewal of this collection.

    1. General Guidelines

This collection does not exceed any of the Paperwork Reduction Act (PRA) guidelines at 5 CFR 1320.6, with the exceptions listed below.

The record retention period of this collection is five years, as specified in 40 CFR 711.25, exceeding the PRA maximum of three years. EPA is not proposing changes to the record retention period.

    1. Confidentiality

Confidentiality claims limit access to the CDR data, especially by the public. EPA recognizes that some information submitted to the Agency is legitimately confidential. Because of this, EPA’s review of confidential data is an inherently governmental function that EPA must perform to protect human health and the environment. As proposed, EPA is changing requirements for making confidentiality claims, including to identify when upfront substantiation is required, update the substantiation questions, and identify data elements that cannot be claimed as confidential.

Submitters may claim most information reported to EPA under this rule as confidential if such information would reveal the submitter’s trade secrets or proprietary information as defined by TSCA section 14 and existing regulations promulgated by EPA under TSCA.

EPA has long-established procedures for properly handling, storing, processing, and disposing of TSCA confidential information. Transfers of this information to others as allowed under TSCA section 14(d) can be made only if the other entity agrees to adhere to all TSCA confidentiality provisions. EPA will maintain standard confidentiality procedures to protect any confidential, trade secret, or proprietary information from disclosure in accordance with EPA’s confidentiality regulation, 40 CFR Part 2, Subpart B.

    1. Sensitive Questions

This collection does not include questions of a sensitive nature.

  1. THE RESPONDENTS AND THE INFORMATION REQUESTED

    1. Respondents/NAICS Codes

The regulated community consists of companies manufacturing (including importing) chemical substances listed on the TSCA Inventory and regulated under TSCA section 8(a). 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 experience with CDR collections has shown that the majority of the respondents affected by this collection activity are from the following NAICS code categories:

325 - Chemical Manufacturing

324 - Petroleum and Coal Product Manufacturing

In addition to the anticipated respondents from the NAICS listed above, the regulated community consists of manufacturers of byproducts that are required to report under certain TSCA section 8(a) rules, including CDR. Byproduct manufacturers may be listed under a different primary activity for a site, such as NAICS codes 22, 322, 327310, 331, and 3344 (namely, utilities, paper manufacturing, cement manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing, respectively). 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 could also be subject to reporting.

Generally, TSCA section 8 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. EPA is proposing to update this standard.1 EPA is also proposing a section 8(a) definition for small government entities. See also section 5(c) below for additional information about the proposed standards.

EPA is also proposing two burden-reducing exemptions for byproduct manufacturers. Because of these exemptions, some sites may not report under CDR while others would report fewer chemical substances. These exemptions were designed to reduce reporter burden while still providing EPA with information needed to understand the byproduct universe. Specifically, new reporting exemptions are proposed, including (1) exemptions for specific site-limited recycled byproducts, and (2) exemptions for byproducts generated by specific non-integral processes. Additionally, EPA is proposing optional alternative reporting in which a consolidated category report could be submitted according to categories for inorganic byproducts containing certain individual elemental metals and metal compounds.

    1. Information Requested

      1. Reporting Threshold for Certain Regulated Chemicals

EPA is not proposing changes to the reporting thresholds. 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 particular TSCA actions are of demonstrated high interest to the Agency. The lower reporting threshold helps to ensure the availability of current information on those chemical substances manufactured above 2,500 pounds when the Agency has expressed a concern in the form of regulatory action. EPA will use the CDR data associated with these regulated chemical substances to monitor chemical substance production and compliance with the rules.

      1. Data elements, including recordkeeping requirements

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.

EPA is proposing changes to the CDR that impact the data elements collected via the CDR reporting tool. Using e-CDRweb, individuals would report the new or revised data elements as follows as a result of the proposed rulemaking:

  • Public contact’s contact information. (new, voluntary) The name, phone number, and email address of the company official designated as the public contact.

  • U.S. parent company and foreign parent company identifying information: (revised) The legal name, address, and Dun and Bradstreet D-U-N-S® (D&B) number for the highest-level U.S. parent company and, if one exists, the highest-level foreign parent company. The proposed 40 CFR 711.3 contains an updated definition for parent company, replacing the current definition for U.S. parent company. The proposal also requires submitters to follow a naming convention for providing the parent company name(s), the details of which are provided in the CDR Instructions, as identified at 40 CFR 711.35. Currently only the highest-level U.S. parent company is reported.

  • NAICS codes: (new) The six-digit NAICS code for the site. A submitter under this part must include the appropriate six-digit NAICS code for each site reported.

  • Percent production volume that is a byproduct: (new) Identify the percent of the total production volume of the chemical substance that is a byproduct.

  • Whether a manufactured (including imported) chemical substance is being recycled: (revised) Identify whether the reported chemical substance is recycled or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream. Currently this data element includes the terms “remanufactured, reprocessed, reused” as well as “recycled.” EPA is proposing to remove the terms “remanufactured, reprocessed, reused.”

  • Function and use codes: (revised) Identify the industrial function and commercial/consumer product use codes, including adding functional use for consumer and commercial use information. EPA is proposing new CDR codes that are harmonized with OECD codes.

  • Chemical substance identity: (revised) In general, manufacturers identify the reportable chemical substance using a specific chemical name and a chemical abstract services number (CASRN) or, if on the confidential portion of the TSCA Inventory, by a generic chemical name and an accession number. EPA is proposing that manufacturers of inorganic byproducts would have the option to combine and report multiple inorganic byproduct metal substances that otherwise would be reported individually, as listed on the TSCA Inventory, as one or more specifically listed categories.

  • Confidential Claim Substantiation: (revised) For most data elements claimed as confidential, the submitter must submit with the report detailed written answers to substantiate claims to confidentiality. The submitter must provide a statement supporting the claim, as described in TSCA section 14(c)(1)(B), and must certify that the statement is true and correct, as described in TSCA section 14(c)(5). A substantiation statement at the time of submission is not required for production volume confidentiality claims.

In certain circumstances, multiple parties are required to complete a submission. Such submissions are either joint submissions, which use Part IV of Form U, or a co-manufacture report, which is a chemical report completed in part by a contracting company and in part by a producing company. Proposed changes that impact multi-reporter submissions are described below.

Reporting process for co-manufactured chemicals: (new) EPA is proposing to change the reporting mechanism for co-manufactured chemicals by developing a multi-reporter reporting process. Co-manufacturing is when a chemical substance, manufactured other than by import, is produced exclusively by a site for another person who contracts for such production. In addition, the other person contracting the manufacture (i.e., the contracting company) specifies the identity of the chemical substance, the total amount produced, and the basic technology for the plant process. In a co-manufacture report, the contracting company is the primary submitter and the producing company is the secondary submitter.

Under this new reporting methodology, the contracting company (as the primary submitter) is responsible for initiating a co-manufacture report that would prompt the reporting requirements for the producing company (as the secondary submitter). The co-manufacture report is included as a part of the site’s Form U, which typically contains multiple chemical reports.

  • Primary Submitter (the contracting company): The primary submitter would initiate the co-manufacture report by identifying the producing company(ies) and the co-manufactured chemical identity (e.g., the chemical name and CAS Registry Number) (and may also use a product name or other alias for communication purposes) and would use e-CDRweb to send a notification(s) to the producing company(ies). The primary submitter would also complete the production volumes for the principal reporting year (i.e., 2019 for the 2020 CDR) and for past years (i.e., 2016, 2017, and 2018 for 2020 CDR) in Form U Section II and the processing and use-related information in Form U Section III (40 CFR 711.15(b)(4)).

  • Secondary submitter (the producing company): The producing company’s portion of the co-manufacture report would include all manufacturing-related data elements except for the chemical identity (40 CFR 711.15(b)(3)).

Both submitters 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.

Joint submission reporting process for imported mixture: (revised) A joint submission is most typically used when a substance or a mixture is imported and the supplier does not provide to the importer the specific chemical identity of the substance or substances that comprise the mixture. The primary submitter initiates the submission, by identifying the secondary submitters, sending each secondary submitter a notification using e-CDRweb, and completing all information on the Form U submission other than the specific chemical identities. The secondary submitter completes Part IV of Form U, suppling the specific chemical identity(ies) and, if appropriate, the percent composition. Currently, the importer identifies the function of the imported product. In some circumstances, the function of the imported product can be correctly applied to the specific chemical substance. However, in the circumstance where the imported product is a multi-component mixture, applying the function of the imported product to each component of the mixture can result in identifying a function for an individual chemical substance that is not appropriate. EPA is proposing that the secondary submitter report the chemical-specific function along with the currently required information on chemical composition.

      1. Submitter Activities/Information Collections (ICs)

As shown in Table 2, EPA identified the following ICs in the ICR renewal (EPA, 2018b) for activities that submitters would complete when complying with the rule:

  • CDX Registration Activities

  • Prepare and Submit Report and Maintain Records

Table 2: Information Collections (ICs) for CDR Reporting

Activity

Description

Related IC(s) included in this ICR Renewal

CDX Registration and e-Signature

Before submitting a TSCA Form U, new submitters and experienced submitters with new employees must register with CDX. In addition, registrants must complete an Electronic Signature Agreement form, which is signed, dated, and either submitted electronically or mailed back to EPA.

CDX Registration Activities

Preparation and Submission of Reports, Form U
( EPA Form 7740-8)

Staff must collect all of the required information and submit relevant information for each of the reportable chemical substances at that site in an electronic submission of the Form U. The information must be gathered, reviewed, and submitted to EPA. This task includes any research necessary to identify the correct information, the act of completing the submission, and associated review. Therefore, the list of activities included in this IC are (as described in this ICR Supporting Statement): rule familiarization (for new reporters only), compliance determination, form completion, and recordkeeping.

Prepare and Submit Report, and Maintain Records

Recordkeeping

Respondents must keep records supporting their submissions for five years.

Prepare and Submit Report, and Maintain Records


  1. THE INFORMATION COLLECTED–AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

    1. Agency Activities

The Agency develops and maintains the electronic tool used to collect and verify data and routinely conducts other activities related to the processing, analysis and storage of the information collected under this rule. In this ICR Addendum, only the Agency activities related to the changes created by the proposed rule are considered, including:

  • Submission receipt and tracking

  • Data review

  • Quality control2

    1. Collection Methodology and Management

All manufacturers (including importers), except for those defined as “small manufacturers” by EPA’s regulations, are required to submit information on every substance subject to the regulation (40 CFR 711) that they manufacture (including import) in quantities that meet or exceed the CDR thresholds. However, a person who otherwise qualifies as a small manufacturer is required to report any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA section 4 or 5(e), or is the subject of relief that has been granted under a civil action under TSCA section 5 or 7. The collection occurs every four years. The next CDR collection will occur in 2020.

      1. Collection Methodology

Submitters are required to submit information associated with this data collection electronically via the Internet using e-CDRweb and CDX.

EPA will notify potential submitters of the need to report in three ways: (1) make available guidance describing CDR reporting requirements at chemical industry conferences and meetings, and through web and listserv announcements, (2) send email notices to previous CDR submitters, and (3) publish articles in the trade press. The requirement to report is based on the CDR regulations; potential submitters that do not receive a notification as listed above or who do not read published articles are still required to report. Reporting materials, including a non-submission version of the Form U and a variety of instructions documents (Instruction Manual, Q&As, Case Studies, Fact Sheets), are available on EPA’s CDR website. Submitters also can obtain these materials from the TSCA Hotline. Submitters obtain the e-CDRweb reporting tool (which enables the completion of the Form U for submission) as part of the CDX electronic web-based registration process, as described in section 4 of this document. The e-CDRweb reporting tool enables the user to complete Form U for submission to EPA.

EPA will receive all CDR submissions electronically. The CDX registration process, required for all submitters, will provide a user ID, which the submitter will use to access e-CDRweb.

Information quality control and validation begins with the e-CDRweb reporting tool, which is programmed to help the submitter provide the information required in the correct format, as required by the CDR rule.

To aid persons subject to this information collection, the Agency’s TSCA and CDX Hotlines are available to answer questions regarding the CDR requirements or submission process. When Hotline staff is unable to answer questions, the submitter is referred to OPPT’s Information Management Division (IMD) or Chemical Control Division (CCD), as appropriate. Submitters can also email their questions to the e-CDRweb mail site at [email protected]. Other Divisions within OPPT or the Office of Environmental Information (OEI) are may respond as necessary.

      1. Data Management

This section describes the Agency tasks required for efficiently processing submissions under the CDR. The tasks for which the Agency 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. Once updated, the CDR database is then available to EPA technical reviewers to search or export into their various analytical modeling systems and databases. The CDR database is also available for quick screening and other direct uses. The Agency makes publicly available as much information as possible, within the confines of protecting information claimed as confidential.

  • Database Systems Development and Maintenance - The Agency develops and maintains 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.

  • Instructions Document Development - The Agency develops guidance, instructions, case studies, and other information to assist submitters in submitting data and complying with CDR requirements. The documents are updated for each CDR cycle.

  • Form U Processing - The Agency is responsible for processing CDR Form U submissions. This includes developing standard operating procedures and documentation for all stages in the CDR life cycle, tracking submissions, implementing quality assurance and control, maintaining files and databases, information security, disseminating data, and training staff. EPA receives CDR submissions over the Internet, using CDX.

  • Additional Activities - The Agency develops various supporting documents associated with the reporting tool and makes them available on the Internet. In addition, the Agency provides the TSCA Hotline with standardized responses for frequently asked questions; prepares mailings, mailing lists, and labels; and develops outgoing information materials.

    1. Small Entity Flexibility

EPA is proposing an update to the TSCA section 8(a) small manufacturer definition, as required, based on the determination made on November 30, 2017 (82 FR 56824). The proposed definition applies to small manufacturers for TSCA section 8(a) rules, including CDR, unless a different standard is identified in the regulatory text of a particular rule. Small manufacturers (including importers), in accordance with TSCA section 8(a) and 40 CFR sections 711.9, are generally exempt and therefore are generally not subject to any of the reporting or recordkeeping requirements.

The proposed definition for small manufacturers updates the current two-standard definition at 40 CFR 704.3 by adjusting the sales figure for the first standard from $40 million to $110 million (while retaining the same production volume level at 100,000 lb) and adjusting the sales figure for the second standard from $4 million to $11 million (applies to any production volume).

In addition to the proposed standards for small manufacturers, EPA is proposing a size standard for small governments. Currently, there is no small government definition in TSCA section 8(a). EPA is proposing this definition to reduce the reporting burden for governments that would be considered manufacturers under TSCA and may lack necessary resources. EPA proposes to use the same definition for small governments as the Regulatory Flexibility Act (5 U.S.C. section 601(5)), which is: A small governmental jurisdiction is the government of a city, county, town, township, village, school district, or special district with a population of less than 50,000. States and tribal governments are not considered small governments.

    1. Collection Schedule

EPA is not proposing to make any changes to the collection schedule. The submission period/schedule follows the requirements of 40 CFR 711.20. The submission period for the next collection in 2020 will be from June 1, 2020 to September 30, 2020.

Activity

Timeline

Public outreach efforts: articles in industry press, meetings with regulated community, and information on the CDR website

2018-2020

Email to 2020 CDR e-mailing list and other stakeholders with instructions for obtaining the reporting form and initiating reporting

Early 2020

Open period for submitting 2020 CDR Forms

June 1, 2020 to September 30, 2020




  1. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

This section presents the burden and cost estimates for industry, affected government entities, and the Agency. Respondents submit a CDR Form U in accordance with a four-year reporting cycle. The Form U requires reporting on a “per site” basis for each of the reportable chemicals at that site. Therefore, each site subject to CDR requirements is considered a respondent that will submit one Form U (response) containing one or more chemical reports. Respondents are comprised of both new reporters and experienced reporters who have responded in previous CDR/IUR reporting cycles. Estimates of the future cycle incremental change in burden and cost created by the proposed rule cover the three-year ICR renewal period (provided also on an annual basis) and are presented herein in 2017 dollars.

    1. Estimating Respondent Burden

For the 2020 reporting cycle (as previously in the 2016 reporting cycle), manufacturers (including importers), must submit a Form U for each site at which 25,000 pounds or more (or 2,500 pounds or more, if applicable3) was manufactured (including imported) for a chemical substance in any calendar year in the principal reporting year and the previous three years. Estimates are presented according to the full reporting cycle first (Table 3 through Table 14) and then converted to a basis used for the ICR period (Table 15).4 Burden estimates are derived consistent with estimates described in the ICR renewal (EPA, 2018b) and the two Economic Analyses for the rule: CDR Revisions EA (EPA, 2019a) and TSCA section 8(a) SMD Update EA (EPA, 2019b).5

The CDR Revisions Rule includes three types of changes: (1) changes to content in the CDR Reporting Form U which affect all reporters who will file a Form U in the 2020 CDR and future CDRs, (2) changes that involve removal of reporting requirements for a portion of chemicals at a site, and (3) changes that involve removal of reporting requirements for an entire site. The CDR Revisions EA includes all three types of changes while the TSCA section 8(a) SMD EA includes the second and third types of change. See section 4.1.2 of EPA (2019a) for more details.

For the analysis in this section, the respondent is defined as a manufacturing site or a government site. There is one response per respondent, as one Form U per site accommodates multiple chemical reports in the same submission. Incremental activities associated with preparing and submitting a Form U in response to the proposed rule include rule familiarization, compliance determination, and form completion. The proposed rule does not change any recordkeeping requirements, and therefore no associated burden and cost estimates for this activity are included in this analysis. Last, for those not already registered in CDX, individuals must complete CDX registration, including e-signature. The proposed rule does not change any requirements for CDX activities, and therefore no associated burden/cost estimates for this activity are included in this analysis. General descriptions of changes to activities are as follows (see previous section for detailed data element information):

  • Rule Familiarization increase due to increased regulatory complexity: The proposed rule includes modifications and additions to reportable data elements, changes to CBI substantiation requirements, and byproduct provisions that include reporting exemptions and optional consolidated category reporting for inorganic byproducts containing certain individual elemental metals and metal compounds. Additionally, the proposed rule revises the general TSCA section 8(a) small manufacturer definition. For several of these changes, reporters must familiarize themselves with the new requirements. This activity entails reading the rules, understanding the reporting and administrative requirements, and determining what tasks are required in order to meet reporting requirements. In future cycles, only new reporters will incur incremental increases to rule familiarization.

  • Compliance Determination increase due to increased regulatory complexity: The proposed rule adds additional requirements related to compliance determination for reporters. Specifically, for CBI substantiation, reporters will need to determine which questions they must answer. For byproduct manufacturing, reporters must determine whether or not they will be able to take advantage of the exemptions. Under the proposed TSCA section 8(a) small manufacturer definition, incremental compliance determination is considered negligible for industry reporters because the proposed definition retains the same structure as the current definitions with adjustments only to the levels of the two revenue standards. Incremental compliance determination is, however, estimated for government reporters under the TSCA section 8(a) small government definition because there is no existing definition for these entities. Note that, by convention, new reporters and experienced reporters are assumed to incur the same levels of compliance determination.

  • Form Completion: The proposed rule modifies the reportable data elements on Form U and changes CBI substantiation requirements for data elements claimed as confidential.

Certain provisions in the proposed rule do not alter the activities required of reporters. Rather, they affect whether, and for which chemicals, these sites are required to report. The byproduct provisions, consisting of exemptions and optional consolidated category reporting, will result in decreases in sites and chemical reports. Additionally, the proposed modifications to the small manufacturer definition and the proposed new small government definition will also result in decreases in sites and chemical reports.

Certain changes are not estimated in this analysis including:

  • Changes to co-manufacturing and joint submission reporting: EPA assumes that the effort for a multi-reporter submission can be approximated as similar to the effort for an equivalent single-reporter submission. Therefore, burden and cost estimates for changes to implement a new reporting mechanism for co-manufactured chemicals and changes to joint reporting in the proposed rule are not developed in this analysis.

  • Recycled data element: Currently, CDR submitters identify whether their reportable chemical substance is recycled, remanufactured, reprocessed, reused, or otherwise used for a commercial purpose instead of being disposed of as a waste or included in a waste stream. EPA is proposing to modify this data element by removing the terms “remanufactured, reprocessed, reused.” EPA does not anticipate a change in burden associated with this change. Therefore, burden and cost estimates for this change are not developed in this analysis.

  • Changes involving updated use codes in Part III: For the replacement of the CDR industrial function and commercial/consumer product use codes with codes based on OECD function, product, and article use categories, and the addition of function categories for commercial/consumer products, burden and cost impacts are not currently estimated, pending the definition of reporter activities and the user interface in e-CDRweb. Although the new system of codes involves a more extended set of codes than the current system of codes, the user interface will feature guided data entry, providing narrowed choices to reporters and a minimal amount of effort to provide the information. Additionally, reporters will have search options for use in the event that bypassing the guided data entry is more efficient.

Table 3 presents incremental experienced reporter unit burden for respondent activities associated with the proposed rule. Unit burdens in this table reflect changes in activities that are applied universally to all reporters. The activity-level unit burden estimates for changes in Table 3 are based on estimates on similar activities and best professional judgment (for more detail, see EPA (2019a)).

Table 3. Incremental Activity-Level Unit Burden per Four-Year Reporting Cycle, Experienced Reporters

Activity

Unit of Analysis

Managerial Burden (hours)

Technical Burden (hours)

Clerical Burden (hours)

Activity-Level Unit Burden (hours)

Proportion of Affected Sites/
Chemical Reports

Adjusted Unit Burden per Site/
Chemical Report (hours)

Reportable Data Elements

 

 

 

 

 

 

 

Rule Familiarization increase due to increase regulatory complexity

Site

0.000

0.000

0.000

0.000

1.000

0.000

Compliance Determination increase due to increase regulatory complexity

Site

0.000

0.000

0.000

0.000

1.000

0.000

Site’s Foreign Parent Company (if applicable)

Site

0.002

0.000

0.000

0.002

1.000

0.002

Site Public Contact Information (Name, Phone, Email) (voluntary)

Site

0.006

0.000

0.000

0.006

1.000

0.006

Site NAICS

Site

0.002

0.000

0.000

0.002

1.000

0.002

% PV in byproduct

Chemical

0.200

0.820

0.000

1.020

1.000

1.020

CBI Substantiation

 

 

 

 

 

 

 

Rule Familiarization increase due to increase regulatory complexity

Site

0.000

0.000

0.000

0.000

1.000

0.000

Compliance Determination increase due to increase regulatory complexity

Site

0.154

0.346

0.000

0.500

1.000

0.500

Part II Chem ID CBI Substantiation1

Chemical

-0.086

-0.175

0.000

-0.261

0.01326

-0.003

Part II Connection CBI Substantiation and Part II Other CBI Substantiation1

Chemical

0.000

-0.286

0.000

-0.286

0.31363

-0.090

Part III (Processing and Use) CBI Substantiation1

Chemical

0.000

-0.076

0.000

-0.076

0.22093

-0.017

Byproduct Exemptions

Rule Familiarization increase due to increase regulatory complexity

Site

0.000

0.000

0.000

0.000

1.000

0.000

Compliance Determination increase due to increase regulatory complexity1

Site

0.308

0.692

0.000

1.000

0.4037

0.404

Category Reporting

Rule Familiarization increase due to increase regulatory complexity

Site

0.000

0.000

0.000

0.000

1.000

0.000

Compliance Determination increase due to increase regulatory complexity

Site

0.000

0.000

0.000

0.000

0.4037

0.000

Section 8(a) Small Manufacturer Definition

Rule Familiarization increase due to increase regulatory complexity (Industry and Gov’t)

Site

0.000

0.000

0.000

0.000

1.000

0.000

Compliance Determination increase due to increase regulatory complexity (Industry)

Site

0.000

0.000

0.000

0.000

1.000

0.000

Compliance Determination increase due to increase regulatory complexity (Gov't)

Site

0.052

0.118

0.000

0.170

1.000

0.170

General Note:

  • For details on development and assumptions associated with items in this table, see source materials (EPA, 2019a, EPA, 2019b, and EPA, 2018b).

Incremental new reporter unit burden for form completion activities associated with CDR Revisions is based on estimates of experienced reporter burden for the modifications and additions to form completion activities proposed by the rule; new reporters are estimated to take 1.26 times longer than experienced reporters (EPA, 2018b). These unit burdens are applied to new reporters under future cycle conditions under the proposed rule option.

Table 4 presents the derivation of incremental unit burdens for new reporters and the overall average reporter for activities relating to reportable data elements and CBI substantiation. For future cycles, EPA estimates conditions at about 15% new reporters, 78% full reports6, and 7.5 chemical reports per site (as in the analyses of EPA (2019a)).

Table 4: Reportable Data Elements and CBI Substantiation Incremental Burden, Experienced and New Reporters, Four-Year Cycle, Industry and Government

Activity

Experienced Reporters

New Reporters1

Overall2

Unit Burden per Average Site (hours)

Unit Burden per Average Site (hours)

Unit Burden per Average Site (hours)

Reportable Data Elements

 

 

 

Rule Familiarization3

0.000

0.167

0.025

Compliance Determination

0.000

0.000

0.000

Recordkeeping

0.000

0.000

0.000

Average Multi-Chemical Form Completion (7.5 chemicals)

7.660

9.652

7.955

CBI Substantiation

 

 

 

Rule Familiarization4

0.000

2.000

0.296

Compliance Determination

0.500

0.500

0.500

Recordkeeping

0.000

0.000

0.000

Average Multi-Chemical Form Completion (7.5 chemicals)

-0.825

-1.040

-0.857

Total

7.335

11.279

7.919

General Note:

  • Estimates of incremental until burden in Table 4 through Table 6 and Table 8 differ slightly from results that would be obtained using information in the two EAs (EPA, 2019a, and EPA, 2019b) due to rounding.

  • There may be entities that incur burden from rule familiarization (if new to CDR) and compliance determination but that are not required to send a CDR submission. For purposes of this analysis, such effects are neglected per the convention used in EPA (2018b).

Footnotes:

1

The estimate for new reporter form completion is derived using the experienced reporter estimate and a First Time Filer Factor of 1.26 (see Section 6(g) of EPA (2018b)).

2

As in the analysis in Tables 4-13 and 4-14 of EPA (2019a), overall unit burden is based on 14.82% new reporting sites.

3

The estimate for new reporter incremental Rule Familiarization burden consists of 0.049 hours of Managerial labor and 0.118 hours of Technical labor. Compliance Determination for new reporters is estimated at the same levels as for experienced reporters.

4

The estimate for new reporter incremental Rule Familiarization burden consists of 0.583 hours of Managerial labor and 1.417 hours of Technical labor. Compliance Determination for new reporters is estimated at the same levels as for experienced reporters.


Table 5 presents the derivation of unit burdens for new reporters and the overall average reporter for incremental increases to rule familiarization and compliance determination associated with the byproduct provisions of the proposed rule – byproduct exemptions and category reporting. These provisions primarily result in a reduction in number of chemical reports submitted and number of sites reporting.



Table 5: Byproduct Exemptions and Category Reporting Incremental Burden, Experienced and New Reporters, Four-Year Cycle, Industry and Government

Activity

Experienced Reporters

New Reporters

Overall1

Unit Burden per Average Site (hours)

Unit Burden per Average Site (hours)

Unit Burden per Average Site (hours)

Byproduct Exemptions

 

 

 

Rule Familiarization2

0.000

0.500

0.074

Compliance Determination

0.404

0.404

0.404

Recordkeeping

0.000

0.000

0.000

Average Multi-Chemical Form Completion (7.5 chemicals)

N/A

N/A

N/A

Category Reporting

 

 

 

Rule Familiarization2

0.000

0.500

0.074

Compliance Determination

N/A

N/A

N/A

Recordkeeping

0.000

0.000

0.000

Average Multi-Chemical Form Completion (7.5 chemicals)

N/A

N/A

N/A

Total

0.404

1.404

0.552

General Note:

  • Estimates of incremental until burden in Table 4 through Table 6 and Table 8 differ slightly from results that would be obtained using information in the two EAs (EPA, 2019a, and EPA, 2019b) due to rounding.

  • There may be entities that incur burden from rule familiarization (if new to CDR) and compliance determination but that are not required to send a CDR submission. For purposes of this analysis, such effects are neglected per the convention used in EPA (2018b).

Footnotes:

1

As in the analysis in Tables 4-15 and 4-16 of EPA (2019a), overall unit burden is based on 14.82% new reporting sites.

2

The estimate for new reporter incremental Rule Familiarization burden consists of 0.146 hours of Managerial labor and 0.354 hours of Technical labor. Compliance Determination for new reporters is estimated at the same levels as for experienced reporters.


Table 6 presents the derivation of unit burdens for new reporters and the overall average reporter for incremental increases in rule familiarization and compliance determination associated with the proposed small manufacturer definition.7 This definition change primarily results in a reduction in number of chemical reports submitted and number of sites reporting.





Table 6: TSCA Section 8(a) SMD Update Incremental Burden, Four-Year Cycle, Experienced and New Reporters, Industry and Government

Activity

Experienced Reporters

New Reporters

Overall1

Unit Burden per Average Site (hours)

Unit Burden per Average Site (hours)

Unit Burden per Average Site (hours)

Industry

Rule Familiarization2

0.000

1.730

0.256

Compliance Determination3

0.000

0.000

0.000

Recordkeeping

0.000

0.000

0.000

Average Multi-Chemical Form Completion (7.5 chemicals)

N/A

N/A

N/A

Section 8(a) SMD Total

0.000

1.730

0.256

Government

Rule Familiarization4

0.000

0.000

0.000

Compliance Determination5

0.170

0.170

0.170

Recordkeeping

0.000

0.000

0.000

Average Multi-Chemical Form Completion (7.5 chemicals)

N/A

N/A

N/A

Section 8(a) SGD Total

0.170

0.170

0.170

General Notes:

  • For details on development and assumptions associated with items in this table, see source materials (EPA, 2019b).

  • Estimates of incremental until burden in Table 4 through Table 6 and Table 8 differ slightly from results that would be obtained using information in the two EAs (EPA, 2019a, and EPA, 2019b) due to rounding.

  • There may be entities that incur burden from rule familiarization (if new to CDR) and compliance determination but that are not required to send a CDR submission. For purposes of this analysis, such effects are neglected per the convention used in EPA (2018b).

Footnote:

1

As in the analysis in Table 5-17 of EPA (2019b), overall unit burden is based on 14.82% new reporting sites. The exception is government entities, which are assumed to have 100% experienced sites.

2

The estimate for industry new reporter incremental Rule Familiarization burden consists of 0.505 hours of Managerial labor and 1.225 hours of Technical labor (see EPA (2019b) for justification).

3

Compliance Determination for industry new reporters is estimated at the same levels as for experienced reporters.

4

The estimate for industry new reporter incremental Rule Familiarization burden is zero because all governments are assumed to be experienced.

5

Compliance Determination for government reporters consists of 0.052 hours of Managerial labor and 0.118 hours of Technical labor (see EPA (2019b) for justification).

    1. Estimating Respondent Cost

Wage rates for managerial, technical, and clerical labor are derived and presented in Table 7. As a simplification and for purposes of ease of presentation, personnel at government-owned reporting sites are assumed to have the same wage rate as the equivalent industry personnel. This section describes the industry wage data used to develop estimates for both CDR Revisions and the TSCA section 8(a) SMD Update.

Standard wage rates for managerial, technical, and clerical levels are developed from information published by the Bureau of Labor Statistics (BLS) and a method outlined in the document Wage Rates for Economic Analyses of the Toxics Release Inventory Program (Rice, 2002). Average wage data for the three major occupational groups are published quarterly by the BLS in the Employer Costs for Employer Compensation (ECEC) reports (per Employer Costs for Employee Compensation Supplementary Tables: December 2006 – December 2017 (BLS, 2018)).

Fringe benefits costs, such as health insurance and vacation for each labor category are taken from the same ECEC series. Following the methodology outlined in Rice (2002), fringe benefits are calculated as a percentage of total wages for each category. An additional 17% is added to the wages in each category to account for overhead, based on information provided by the chemical industry and chemical industry trade associations in the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002). The wages for each of the three categories are then multiplied by benefits and overhead factors to estimate loaded, annual salaries in 2017 dollars. Table 7 contains the loaded wage rates for the managerial, technical and clerical occupation categories.

Table 7: Reporter Wage Rates (2017$)

Labor Category

Data Series 1

Date

Wage ($/hour)

Fringe Benefit

Fringes as % Wage

Over-head % Wage 2

Fringe + Overhead Factor 3

Loaded Wage ($/hour)4

(a)

(b)

(c) =(b)/(a)

(d)

(e)=(c)+(d)+1

(f)=(a)×(e)

Managerial

BLS ECEC, Private Manufacturing industries, “Mgt, Business, and Financial”

Dec-17

$46.59

$22.16

48%

17%

1.65

$76.87

Professional / Technical

BLS ECEC, Private Manufacturing industries, “Professional and related“

Dec-17

$45.82

$24.33

53%

17%

1.70

$77.89

Clerical

BLS ECEC, Private Manufacturing industries, “Office and Administrative Support”

Dec-17

$20.49

$11.02

54%

17%

1.71

$35.04

Footnotes:
1 Employer Costs for Employee Compensation Supplementary Tables: December 2006 – December 2017 (BLS, 2018).
2 An overhead rate of 17% is used based on assumptions in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (Rice, 2002), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA, 2002).
3 The inflation factor of “1” in the formula for calculating the fringe + overhead factor means wage data are not escalated to reflect inflation.
4 Wage data are rounded to the closest cent in this analysis.


Unit reporter burden and reporter cost per site are derived for reportable data elements, CBI substantiation, and the incremental increases in rule familiarization and compliance determination associated with byproduct provisions and the SMD Update in Table 8. EPA estimates incremental reporter burden and cost at approximately nine hours and $678 per industry site and approximately nine hours and $671 per government site per four-year reporting cycle.





Table 8: Incremental Unit Burden and Cost per Site, Four-Year Cycle, Experienced and New Reporters, Industry and Government


Overall average burden per site (hours)

Overall average cost per site (2017$)

Universal Changes

Industry

Reportable Data Elements and CBI Substantiation, including incremental rule familiarization and compliance determination

7.919

$614.87

Byproduct Provisions incremental rule familiarization and compliance determination

0.552

$42.82

Section 8(a) SMD incremental rule familiarization and compliance determination

0.256

$19.89

Industry Total

8.727

$677.58

Government

Reportable Data Elements and CBI Substantiation, including incremental rule familiarization and compliance determination

7.919

$614.87

Byproduct Provisions incremental rule familiarization and compliance determination

0.552

$42.82

Section 8(a) SGD incremental rule familiarization and compliance determination

0.170

$13.19

Government Total

8.641

$670.88

General Note:

  • Estimates of incremental until burden in Table 4 through Table 6 and Table 8 differ slightly from results that would be obtained using information in the two EAs (EPA, 2019a, and EPA, 2019b) due to rounding.

    1. Estimating Agency Burden and Cost

      1. EPA Staff Activities

EPA activities affected by the proposed rule involve submission receipt and tracking, data review, and quality control. Agency burden is reduced given that these activities are related to the quantity of sites, chemical reports, and CDX registrations, all of which decrease under the proposed rule. The following analysis of Agency burden is limited to incremental change in these variable costs, since fixed costs do not change. Additionally, costs related to EPA activities that involve data use are not included.

Agency personnel are responsible for quality control of data, while contractors perform data processing tasks. Additionally, change in number of CDX registrations is considered to be negligible, and therefore for ease of presentation is not included in estimate of associated Agency cost.

EPA labor costs are based on annual federal wage rates, as presented Table 9. As in the ICR renewal (EPA, 2018b), a GS-12 Step 3 is assumed for program staff hours and a GS-13 Step 3 is assumed for information technology (IT) staff hours.





Table 9: Agency Wage Rate (2017$)

Labor Category

Data Source for Wage Information

Wage ($/hour)1

Fringe Benefit

Fringes as % Wage

Overhead as % Wage2

Fringe + Overhead Factor

Loaded Wage ($/hour)

(a)

(b)

(c)=(b)/(a)

(d)

(e)=(c)+(d)+1

(f)=(a)*(e)

EPA program staff

Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-12 Step 3 pay rates

$40.75

Included in 60% overhead

N/A

60%

1.6

$65.20

EPA IT staff

Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 3 pay rates

$48.45

Included in 60% overhead

N/A

60%

1.6

$77.52

Footnotes:

1 Source: Salary Table 2017-DCB. (OPM, 2018).

2 The 60 % fringes-and-overhead rate is from an EPA guide, Instructions for Preparing ICRs (EPA, 2009).

Unit burden and cost associated with EPA staff activities per four-year reporting cycle are the same as in the ICR Renewal (EPA, 2018b) and are presented in Table 10. The cost associated with quality control of data is performed by program staff and is dependent on the number of chemical reports received.

Table 10: EPA Staff Burden and Cost of Processing Reports per Four-Year Reporting Cycle

Activity

Unit of Analysis

Agency Burden per Activity
(Hours)

Agency Cost per Activity (2017)1

Quality Control of Data for Part I

Per Site

0.0019

$0.12

Quality Control of Data for Part II

Per Chemical Report

0.0054

$0.35

Quality Control of Data for Part III

Per Chemical Report

0.0063

$0.41

Sources include EPA (2015) and EPA (2018b)

Footnote:

1 Based on labor rates (see Table 9) for quality control activities and review of e-signatures by program staff GS12 Step 3.

      1. Contractor Activities

Agency costs also include payment for extramural tasks completed by contractors (this category includes costs to EPA, but not burden hours). Contractor activities affected by the proposed rule include document receipt, tracking, and data review as presented in Table 11. These costs are taken from the ICR renewal (EPA, 2018b) and are inflated from 2012 to 2017 dollars with an inflation factor calculated using the Employment Cost Index (ECI), seasonally adjusted, for management, professional, and related occupations in private industry (BLS, 2018).





Table 11: Unit Cost of Contractor Activities for Four-Year Reporting Cycle

Activity

Cost
2012$

Cost1
2017$

Variable Costs (cost per chemical report)

Document receipt, tracking, and data review for Part I

$0.10

$0.11

Document receipt, tracking, and data review for Part II

$0.28

$0.31

Document receipt, tracking, and data review for Part III

$0.32

$0.36

Total Cost of Document receipt, tracking, and data review, per single chemical full report

$0.70

$0.78

Sources include EPA (2015), EPA (2018b), and BLS (2018)

Footnote:

1 The inflation rate of 1.12 is calculated as the total compensation Employment Cost Index (ECI) for 2017 divided by the ECI for 2012.

    1. Bottom-Line Respondent and Agency Burden and Cost Estimates

This section describes the estimated incremental social burden and cost of paperwork associated with the proposed rule over the three-year ICR period. EPA estimates that the proposed rule will have increases and decreases in burden and cost with an overall burden reduction and cost savings. The next CDR submission period will occur in 2020 for chemical substances manufactured (including imported) during the calendar years 2016-2019. Even though reporting occurs only once every four years, EPA recognizes that activities associated with the submission are performed over the entire course of the reporting cycle. This section first provides burden and cost estimates for the four-year CDR reporting cycle for respondents (including industry and government entities) and the Agency, followed by a summary of estimates that apply for the three-year ICR renewal period.

Respondent Tally

Table 12 presents the change in numbers of sites and chemical reports due to the proposed rule (EPA, 2019a and EPA, 2019b). Note that in the following calculation, all sites in the baseline are also additionally affected by the revisions to CDR reporting requirements and some combination of incremental rule familiarization and compliance determination for both the CDR Revisions and TSCA section 8(a) SMD Update portions of the proposed rule.


Table 12: Change in Sites and Chemical Reports

Regulatory Provision Description

Change in Number of Sites

Change in Number of Chemical Reports

Change in Number of Full Chemical Reports1

CDR Revisions2

-70

-1,167

-1,007

Section 8(a) SMD Update

-93

-888

 -827

Section 8(a) SGD

-4

-6

-6

Overall

-167

-2,061

-1,840

Footnotes:

1

Full chemical report counts are used later in this analysis to calculate incremental Agency burden.

2

CDR Revisions include modifications and additions to reportable data elements, changes to CBI substantiation requirements, specific inorganic byproduct reporting exemptions, and voluntary alternative reporting in metal compound categories for inorganic products. Of these provisions in the proposed rule, byproduct exemptions and category reporting will result in sites with some or all of their chemical reports exempted.


Total Reporter Burden/Cost. Estimates of the reporting burden and cost per four-year reporting cycle are shown in Table 13. Total burden and cost are calculated for changes to reporting activities by multiplying the unit burdens and costs in Table 8 by the respective number of reporting sites. Total burden and cost attributable to reporting universe changes (reductions) are calculated for relevant sites and chemical reports using baseline information (for more detail, see EPA (2019a) and EPA (2019b)).

Table 13: CDR Revisions and TSCA Section 8(a) SMD Update Incremental Reporting Burden and Cost for Four Year-Reporting Cycle, New and Experienced Reporters

 

Baseline Number of Sites

Number of Sites under Proposed Rule Option

Future Cycles

Unit burden (hours)1

Unit cost (2017$)1

Burden (hours)

Cost (2017$)

Changes to Reporting Activities2

Reportable Data Elements + CBI Substantiation, including incremental rule familiarization and compliance determination

5,660

5,660

7.920

$614.87

44,827

$3,480,165

Byproduct Provisions incremental rule familiarization and compliance determination

5,660

5,660

0.552

$42.82

3,123

$242,360

Section 8(a) SMD Update incremental rule familiarization and compliance determination

5,627

5,627

0.256

$19.89

1,441

$111,921

Section 8(a) SGD incremental rule familiarization and compliance determination

33

33

0.182

$13.18

6

$435

Subtotal, Changes to Reporting Activities

49,397

$3,834,881

Changes to Reporting Universe

Byproduct Exemptions

601

531

N/A

N/A

-70,271

-$5,453,041

Category Reporting

373

373

N/A

N/A

-13,684

-$1,062,355

Section 8(a) SMD Update

5,627

5,534

N/A

N/A

-65,736

-$5,100,191

Section 8(a) SGD

33

29

N/A

N/A

-510

-$39,460

Subtotal, Changes to Reporting Universe

-150,201

-$11,655,047

Net Incremental Change

-100,804

-$7,820,166

Footnotes:

1

Estimates of incremental until burden and unit cost are back-calculated to ensure table presentation consistency, and therefore differ slightly from corresponding estimates in Table 4 through Table 6 and Table 8 in this document.

2

Note that the calculations in the top half of this table apply the unit burdens to the entire baseline reporting universe. This “calculation in parallel” is necessary to separately present the distinct provisions of the proposal and to reconcile estimates across all relevant documents (two EAs and this ICR Addendum). See Sections 6(e) and 6(g) for more information on different calculation methodologies.

Agency Tally

The proposed rule will result in net reporting exemptions, which will result in lower Agency burden and cost associated with quality control. Table 14 presents the estimated incremental Agency burden and cost associated with the proposed rule.





Table 14: Incremental Agency Burden and Cost of CDR Revisions and TSCA Section 8(a) SMD Update, Four-Year Cycle


 

Incremental Change


Activity

Staff

Form U Section

Burden per Activity (hours)

Cost per Activity
(2017$)

Unit of Analysis

Affected Universe

Total Burden (hours)

Total Cost (2018$)1


Variable Burden and Cost


Submission Receipt and Tracking: Data Review

Contractor

Part I

N/A

$0.11

Sites

-167

N/A

-$18


Part II

N/A

$0.31

Full and Partial Chemical Reports

-2,061

N/A

-$639


Part III

N/A

$0.36

Full Chemical Reports

-1,840

N/A

-$662


Quality Control

EPA Program Staff

Part I

0.0019

$0.12

Sites

-167

0

-$20


Part II

0.0054

$0.35

Full and Partial Chemical Reports

-2,061

-11

-$721


Part III

0.0063

$0.41

Full Chemical Reports

-1,840

-12

-$754


Total Variable Burden and Cost

 

 

 

 

-23

-$2,814


General Notes:


  • Results differ slightly from the CDR Revisions EA (EPA, 2019a) and the TSCA Section 8(a) SMD Update EA (EPA, 2019b) due to rounding.

  • For ease of presentation, change in number of CDX registrations is assumed to be negligible.


Footnote:


1

Based on Labor rates (see Table 9) for Program Staff GS12 Step 3; for IT Staff GS13, Step 3.



Total Burden and Cost – ICR Period


Table 15 presents the bottom line burden reduction and cost savings for reporter and Agency burden and cost, including average annual and ICR Renewal Period totals under the proposed rule.



Table 15: Annual Average and Overall Incremental Burden Reduction and Cost Savings for the ICR Renewal Period

Burden Category

CDR Reporting Cycle Burden Reduction

Both CDR Cycle and ICR Renewal Period

ICR Renewal Period
(Nov '18 - Nov '21)

2016

2017

2018

2019

Annual Average Burden Reduction

Annual Average Cost Savings

Total
Burden Reduction

Total
Cost Savings

Reporter Burden Reduction

CDR Revisions

36,005

9,001

$698,218

27,003

$2,094,654

Section 8(a) SMD Update

64,295

16,074

$1,247,068

48,222

$3,741,204

Section 8(a) SGD

504

126

$9,756

378

$29,268

Reporter Burden Reduction, Total

100,804

25,201

$1,955,042

75,603

$5,865,126

Agency Burden Reduction, Total

23

6

$704

17

$2,111


    1. Reasons for Change in Burden

EPA estimates that reporters will experience net decreases in reporting burden due to the proposed rule. Annual reporting burden is reduced by 25,201 hours per year. Table 16 details the reasons for change in annual burden. EPA first accounts for burden reduction associated with the change in number of sites and chemical reports due to the TSCA section 8(a) SGD, the TSCA section 8(a) SMD Update, and the byproduct provisions (exemptions and category reporting). The unit burdens associated with new reporting activities under TSCA section 8(a) SMD, TSCA section 8(a) SGD, and CDR Revisions are then applied to the proposed rule option counts of sites and chemical reports. As such, in this sequential calculation, incremental rule familiarization, incremental compliance determination, and changes to Form U content associated with counts of exempted sites are not included in the estimate.8



Table 16: Reasons for Change in Burden (Annual)

 

Changes

Overall1

Section 8(a) SGD Changes to Numbers of Sites/Chemical Reports - Government

Section 8(a) SMD Changes to Numbers of Sites/Chemical Reports - Industry

CDR Revisions Changes to Numbers of Sites/Chemical Reports, Byproduct Provisions

Section 8(a) SGD Government New Reporting Activities

Section 8(a) SMD Industry New Reporting Activities

CDR Revisions New and Modified Reporting Activities

Unit

Total

Unit

Total

Unit

Total

Unit2

Total

Unit2

Total

Unit3

Total

Net Incremental Burden

 

-127

 

-16,434

 

-20,989

0.043

1

0.064

350

2.118

11,634

-25,565

General Notes:

  • All unit and total burden estimates are reported in hours and are on an annual basis.

  • This calculation assumes that the exemptions resulting from the various provisions of the proposed rule are mutually exclusive. It also assumes that sites exempted by CDR Revisions byproduct exemptions are industry reporters.

Footnotes:

1

The overall net incremental burden in this table does not match the overall net incremental burden presented in Table 15 or the net incremental burden calculated by summing the burden from the CDR Revisions EA and the TSCA Section 8(a) SMD Update EA. This calculation is performed in sequence and applies the changes due to the proposed rule in total. It is therefore more accurate than an approach that calculates burden associated with changes in parallel and sums them. This ICR Addendum and the source EAs (EPA, 2019a and EPA, 2019b) use the latter approach, which is why the total values do not match. Calculation in sequence yields an annual burden reduction that is 364 hours (1.44%) greater than annual burden reduction calculated in parallel.

2

These unit burdens are derived by dividing the four-year cycle unit burdens in Table 8 by four.

3

Represents the net change from CDR Revisions, excluding byproduct exemptions and category reporting.


    1. Burden Statement

Under the proposed rule, the incremental reporter burden reduction for this collection of information is estimated to average 4.45 hours per year for the average site.9,10 This estimate includes the combined effects of increases to certain reporting activities (incremental rule familiarization and compliance determination, data elements on Form U) as well as the elimination of reporting for newly exempted chemical reports and/or sites. Burden is defined in 5 CFR 1320.3(b). 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 OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR Part 9, and are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2018-0321, which is available for online viewing at www.regulations.gov, or in-person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC). The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., N.W., Washington, DC. The EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the Pollution Prevention and Toxics Docket is (202) 566-0280.

You may submit comments regarding the Agency’s need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2018-0321 and OMB Control No. 2070-0162, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mail code: 28221T, 1200 Pennsylvania Ave., N.W., Washington, D.C. 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, D.C. 20503.

    1. Additional Tables

This section provides further explanation of the calculations in Section 6(e). Table 16 presents the calculation of incremental reporting burden in sequence (as opposed to being conducted as parallel calculations, as done in the source EAs (EPA, 2019a and EPA, 2019b), using the following steps:

  1. Calculate the burden associated with exempting sites and chemical reports under the TSCA section 8(a) SGD and TSCA section 8(a) SMD. Remove these sites and chemical reports from the reporting universe.

  2. Calculate the burden associated with exempting sites and chemical reports under CDR Revisions, specifically the byproducts exemption and category reporting. Remove these sites and chemical reports from the reporting universe.

  3. Calculate a per-site unit burden for the SMD and SGD incremental rule familiarization and compliance determination and apply it to the remaining sites (post exemptions in steps 1 and 2).

  4. Calculate a per-site and per-chemical report unit burden for the new CDR activities under the proposed rule and apply them to the remaining sites (post exemptions in steps 1 and 2).

  5. Sum total burden in steps 1-4 to estimate incremental burden under the proposed rule.

This approach differs from the calculation in the source EAs, and in the main body of the ICR Addendum as it applies unit burden associated with new and modified reporting activities from steps 3 and 4 to a post-exemption count of sites. This approach is a “calculation in sequence.” As noted in Section 6(e), in this sequential calculation, incremental rule familiarization, incremental compliance determination, and changes to Form U content associated with exempted sites are not included in the estimate. The approach used in the ICR Addendum and in the EAs to the proposal applies these unit burdens to the entire baseline reporting universe. This “calculation in parallel” is necessary to separately present the distinct provisions of the proposal. Note that when managing changes to the universe counts for sites and chemical reports, calculation in sequence yields larger values for burden and cost savings (i.e., of larger negative magnitude) due to the proposed rule than the values reported in the EAs (compare Table 16 to Table 1).

Table 17 demonstrates how the provisions in the proposed rule affect baseline counts of sites and chemical reports according to provisions of the rule.

Table 17: Proposed Option 1 Changes to Number of Sites and Chemical Reports

 

Changes

 

Section 8(a) SGD Changes to Numbers of Reporters/Chem-ical Reports - Government

Section 8(a) SMD Changes to Numbers of Reporters/Chem-ical Reports - Industry

CDR Revisions Changes to Numbers of Reporters/Chem-ical Reports, Byproduct Provisions

Section 8(a) SGD Government New Reporting Activities

Section 8(a) SMD Industry New Reporting Activities

CDR Revisions New and Modified Reporting Activities

 

Before

After

Before

After

Before

After

Before

After

Before

After

Before

After

Sites

33

29

5,627

5,534

5,534

5,464

29

29

5,464

5,464

5,493

5,493

Chemical Reports

375

369

42,089

41,201

41,201

40,034

369

369

40,034

40,034

40,403

40,403



Table 18 calculates total burden and cost under each option using the same approach as in Table 13; however, unit burdens are multiplied by the post-exemption count of sites instead of the baseline count of sites. These total burden values closely resemble the results in Table 16, with slight differences due to rounding.

Table 18: CDR Revisions and TSCA Section 8(a) SMD Update Reporting Burden and Cost for Four-Year Reporting Cycle, Calculation in Sequence


Baseline Number of Sites

Number of Sites under Proposed Rule Option

Future Cycles

Unit burden (hours)1

Unit

Cost
(2017$)1

Burden (hours)

Cost (2017$)

Changes to Reporting Activities

Reportable Data Elements + CBI Substantiation, including incremental rule familiarization and compliance determination

5,660

5,493

7.920

$614.87

43,504

$3,377,482

Byproduct Provisions incremental rule familiarization and compliance determination

5,660

5,493

0.552

$42.82

3,031

$235,209

Section 8(a) SMD Update incremental rule familiarization and compliance determination

5,627

5,464

0.256

$19.89

1,399

$108,679

Section 8(a) SGD incremental rule familiarization and compliance determination

33

29

0.182

$13.18

5

$382

Changes to Reporting Universe

Byproducts Exemptions

601

531

N/A

N/A

-70,271

-$5,453,041

Category Reporting

373

373

N/A

N/A

-13,684

-$1,062,355

Section 8(a) SMD Update

5,627

5,534

N/A

N/A

-65,736

-$5,100,191

Section 8(a) SGD

33

29

N/A

N/A

-509

-$39,407

Total

 

 

 

 

-102,261

-$7,933,242

Footnote:

1

Estimates of incremental until burden and unit cost are back-calculated to ensure table presentation consistency and therefore differ slightly from corresponding estimates in Table 4 through Table 6 and Table 8 in this document.

  1. REFERENCES

BLS (U.S. Bureau of Labor Statistics). 2018. Employer Costs for Employee Compensation Supplementary Tables: December 2006 – December 2017. https//www/bls.gov/ncs/ect/.

EPA. 2002. Revised Economic Analysis for the Amended Inventory Update Rule: Final Report (EPA-HQ-OPPT-2002-0054-0260). Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. August 2002.

EPA. 2009. ICR Handbook: EPA’s Guide to Writing Information Collection Requests under the Paperwork Reduction Act of 1995. Retrieved from https://www.pdffiller.com/10247637--ICR-Handbook---Environmental-Protection-Agency-.

EPA. 2015. ICR No. 1884.08. [Information Collection Request for] Partial Update of the TSCA Section 8(b) Inventory Data Base, Production and Site Report Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act. October 14, 2015. EPA-HQ-OPPT-2013-0721-0008.


EPA. 2018a. 2016 Chemical Data Reporting (CDR). CBI Dataset pulled on October 7, 2017 and developed in the EPAB CDR Database, internal EPA release. Office of Pollution Prevention and Toxics, Economic and Policy Analysis Branch. June 13, 2018.


EPA. 2018b. ICR No. 1884.10. [Information Collection Request for] Chemical Data Reporting under the Toxic Substances Control Act (TSCA section 8(a)) Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act. October 29, 2018. EPA-HQ-OPPT-2017-0648.

EPA. 2019a. Economic Analysis for the Proposed Rule on TSCA Chemical Data Reporting (CDR) Revisions (RIN 2070-AK33). Economic and Policy Analysis Branch, Chemistry, Economics, and Sustainable Strategies Division, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, (included in same docket as this report, EPA-HQ-OPPT-2018-0321).

EPA. 2019b. Economic Analysis for Proposed Rule on the TSCA Section 8(a) Small Manufacturer Definition Update (RIN 2070-AK33). Economic and Policy Analysis Branch, Chemistry, Economics, and Sustainable Strategies Division, Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency, (included in same docket as this report, EPA-HQ-OPPT-2018-0321).

OPM (Office of Personnel Management). 2018. Salary Table 2017-DCB. Retrieved June 29, 2018 from Pay & Leave: Salaries & Wages: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/18Tables/html/DCB_h.aspx.

Rice. 2002. Wage Rates for Economic Analysis of the Toxics Release Inventory Program. June 10, 2002.

1 These proposed standards apply to all TSCA section 8(a) rules, including CDR, unless a different standard is identified in the regulatory text of a particular rule.

2 Quality control activities performed by program staff involve comparative analysis of the data received to identify if there are any unexpected anomalies or inconsistencies of the data, such as between sites with the same parent companies, followed by outreach to the reporting companies to obtain corrections or confirmation that reported information is correct.

3 The reporting threshold is lower (2,500 lb) for chemical substances that are the subject of certain TSCA actions (see 40 CFR 711.8(b)), including:

  • A rule proposed or promulgated under TSCA sections 5(a)(2), 5(b)(4), or 6;

  • An order issued under TSCA sections 5(e) or 5(f); or

  • Relief that has been granted under a civil action under TSCA sections 5 or 7.

4 Note that some results in this analysis are presented on a one-year basis. The annual estimates are simply the four-year estimates divided by four. EPA acknowledges that activities may be spread unevenly across the four years. However, for purposes of burden and cost tracking, a constant annual burden and cost is a useful standardized metric for this and other analyses.

5 The two economic analyses define their baseline as the predicted 2020 CDR conditions using the 2016 CDR (EPA, 2018a). The 2016 CDR is considered an appropriate baseline data source without adjustment for two reasons: (1) in the history of CDR development, the information from the 2016 CDR is the most complete, covering a comparable four-year period; and (2) upon review of year-to-year counts for chemicals, sites, and chemical reports there is high variance from year to year without a noteworthy trend upward or downward in counts.

6 A full chemical report refers to a Form U with Part III (chemical-specific processing and use) information.

7 As in the EA for the proposed TSCA section 8(a) SMD Update (EPA, 2019b), government reporters are assumed to be experienced reporters. Additionally, unlike industry reporters, government reporters are assumed to incur incremental compliance determination due to the new small government definition under the proposed rule.

8 Note that each EA estimates burden and costs with independent scopes of change, and thereby excludes the other’s changes. In that way, the proposed changes are assessed in an independent, standalone fashion. However, in this ICR Addendum’s comprehensive scope, information is consolidated.

9 The number of chemicals per site changes by about -0.15 chemicals per site. The % partial reports changes by +0.6%. The estimate for % of sites as new reporters does not change.

10 Under the proposed rule option, overall burden for the CDR collection of information is estimated to average 125.76 hours per year for the average multi-chemical submission of 7.36 chemicals per site with 22.49% of reports consisting of partial reports and 15% of sites as new reporters.

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