Public Review Draft
Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
Title: TSCA Section 8(a) Reporting and Recordkeeping Requirements for Asbestos; Notice of Proposed Rulemaking
EPA ICR No.:2711.01
OMB Control No.:2070-NEW
Docket ID No.: EPA-HQ-OPPT-2021-0357
EPA is proposing reporting and recordkeeping requirements for asbestos under the Toxic Substances Control Act (TSCA). EPA proposes to require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing mixtures and articles (including as an impurity) in the four years prior to the rule finalization, to electronically report certain exposure-related information. This action would result in a one-time reporting obligation. The information sought includes quantities of asbestos and asbestos-containing mixtures or articles that were manufactured (including imported) or processed, types of use, and employee data. Reported information would be used by EPA and other Federal agencies in considering potential future actions involving asbestos, potentially including risk evaluation and risk management activities. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input.
Information Collection |
Total Number of Respondents and Responses |
Total 3-Year Time Burden (Hours) |
Total 3-Year Cost (2020$) |
Rule Familiarization |
18 |
432 |
$36,546 |
CDX Registration |
18 |
48 |
$4,150 |
CBI Claim Substantiation |
27 |
19 |
$1,541 |
Recordkeeping |
27 |
27 |
$1,580 |
Form Completion |
27 |
631 |
$55,681 |
Respondent Total |
|
1,157 |
$99,496 |
Agency |
- |
93 |
$560,343 |
Petitioners filed lawsuits on February 18, 2019 and June 28, 2019, respectively, in the U.S. District Court in the Northern District of California, reiterating concerns about the opinion granting summary judgment to Plaintiffs and denying summary judgment to EPA. Asbestos Disease Awareness Organizations v. EPA, No. 19-CV-00871; State of California et al. v. EPA, No. 19-CV-03807. The above cases were consolidated, where Plaintiffs sought judicial review of EPA’s decisions to deny Plaintiffs’ administrative petitions brought under section 21 of the Toxic Substances Control Act (TSCA). On December 22, 2020, after full briefing and oral argument, the Court issued an opinion granting summary judgment to Plaintiffs and denying summary judgment to EPA.
Following the litigations, EPA reached an agreement with the Plaintiffs on June 7, 2021. The parties agreed that no later than nine months from the effective date of the agreement, EPA shall sign for publication in the Federal Register, a notice of proposed action to promulgate a rule pursuant to TSCA section 8(a), 15 U.S.C. § 2607(a), for the maintenance of records and submission to EPA of reports by manufacturers, importers and processors of asbestos and mixtures and articles containing asbestos (including as an impurity) that address the information-gathering deficiencies identified in the Court’s Summary Judgment Order. Additionally, the parties agreed that no later than eighteen months from the effective date of the agreement, EPA will sign for publication in the Federal Register a notice of final action regarding the proposed TSCA section 8(a) rule.
Reported information would be used by EPA and other Federal agencies in considering potential actions on asbestos, including EPA’s TSCA risk evaluation and risk management activities. Reporting requirements may provide EPA with baseline information needed to assess whether certain “conditions of use” of asbestos pose an unreasonable risk to human health or the environment under Section 6(b) of TSCA. EPA must consider reasonably available information as part of the risk evaluation process under Section 6(b), and as part of any subsequent risk management rulemaking efforts under TSCA Section 6(a). Understanding the health risks of asbestos and protecting the public and potentially exposed or susceptible subpopulations from these risks is a priority for EPA.
As part of the risk evaluation process under TSCA Section 6(b), EPA must determine whether asbestos presents unreasonable risk to health or the environment, without consideration of costs or other non-risk factors, including unreasonable risk to relevant potentially exposed or susceptible subpopulations as determined by the Agency, under the conditions of use.
EPA must also use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and ensure decisions are based on the weight of scientific evidence. See TSCA Section 26(h) & (i). In order to follow this framework, EPA needs to ensure that sufficient information is reasonably available to inform the Part 2 risk evaluation. Data collected by this rule could help to fill data gaps that EPA may have in exposure and hazard endpoints for asbestos that could better inform Part 2 of the asbestos risk evaluation.
Following risk evaluation, TSCA mandates that EPA take action if the Agency determines that asbestos presents unreasonable risk to health or the environment. EPA needs to ensure that sufficient information is reasonably available on the uses and trends of asbestos activities to develop a risk management rule that eliminates any unreasonable risk asbestos presents.
EPA developed the Chemical Information Submission System (CISS) reporting tool for use in submitting data electronically to the Agency. The tool is available for use with Windows, Macs, Linux, and UNIX based computers, using “Extensible Markup Language” (XML) specifications for efficient data transmission across the Internet. The CISS is a tool that provides user-friendly navigation, works with EPA’s Central Data Exchange (CDX) to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as attachments.
All information sent by the submitter via CDX is transmitted securely to protect confidential business information (CBI). Furthermore, if anything in the submission is claimed as CBI, a non-CBI copy of the submission must be provided by the submitter. The guidance document will instruct users on how to submit and substantiate CBI information using CISS.
The Agency ensures secure transmission of the data, reports, and other documents sent from the user's desktop through the Internet via the Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 and subsequent versions updated as needed are widely used approaches for securing Internet transactions by the National Institute of Standards and Technology (NIST) as a means for protecting data sent over the Internet.
In addition, CISS enables the submitter to electronically sign, encrypt, and transmit submissions, which EPA subsequently provides back to the submitter as an unaltered copy of record. This assures the submitter that the Agency has received exactly what the submitter sent to EPA. The CISS reporting tool encrypts using a module based on the 256-bit Advanced Encryption Standard (AES) adopted by NIST. Details about AES can be found in FIPS 197 pdf on the NIST website at http://csrc.nist.gov/publications/PubsFIPS.html and EPA may incorporate other encryption modules into future versions of the tool. Information submitted via CDX is processed within EPA by secure systems certified for compliance with Federal Information Processing Standards.
This collection is not conducted under any other reporting requirement. There is no other reporting requirement for asbestos reporting of naturally occurring substances, articles, impurities, or processors.
A small amount of reporting on asbestos has been done in the past. At 40 CFR 711.22, the CDR regs state the following:
With regard to TSCA section 8(a) rules. Any person subject to the requirements of this part who previously has complied with reporting requirements of a rule under TSCA section 8(a) by submitting the information described in 40 CFR 711.15 for a chemical substance described in 40 CFR 711.5 to EPA, and has done so within 1 year of the start of a submission period described in 40 CFR 711.20, is not required to report again on the manufacture of that chemical substance at that site during that submission period for years for which data on the chemical substance had been reported.
Although TSCA section 8(a)(1) provides an express exemption for small manufacturers (including importers) and processors, TSCA section 8(a)(3) enables EPA to require small manufacturers (including importers) and processors to report under TSCA section 8(a) with respect to a chemical substance that is the subject of a rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6, or is the subject of an order in effect under TSCA sections 4 or 5(e), a consent agreement under TSCA section 4, or relief that has been granted under a civil action under TSCA sections 5 or 7. Asbestos is subject to TSCA section 6 rulemaking under the Asbestos Ban and Phaseout rule of 1989, and thus EPA proposes to exercise its authority provided under TSCA section 8(a)(3)(A)(ii) to require small manufacturers (including importers) and processors of asbestos or asbestos-containing mixtures (other than Libby Amphibole asbestos) to maintain records and submit reports. Libby Amphibole asbestos is not subject to an applicable proposed or promulgated rule under TSCA sections 4, 5(b)(4) or 6, an order in effect under TSCA section 4 or 5(e), or a consent agreement under TSCA section 4, nor is it the subject of relief that has been granted under a civil action under TSCA section 5 or 7. Therefore, small manufacturers (including importers) and processors of Libby Amphibole asbestos are expected to be exempt from this proposed reporting and recordkeeping rule.
TSCA section 8(a)(1)(A) also excludes from the scope of EPA’s regulatory authority under that paragraph any manufacturer (including importer) or processor of “a chemical substance described in subparagraph (B)(ii).” Section 8(a)(1)(B)(ii), in turn, provides EPA authority to require recordkeeping and reporting by each person (other than a small manufacturer [including importer] or processor) who manufactures (including imports) or processes, or proposes to manufacture (including import) or process, a chemical substance “in small quantities…solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including any such research or analysis for the development of a product,” but only to the extent EPA determines the recordkeeping and/or reporting is necessary for the effective enforcement of TSCA. EPA is not proposing to require recordkeeping or reporting by persons who manufacture (including import) or process, or propose to manufacture (including import) or process, asbestos in small quantities as described in TSCA section 8(a)(1)(B)(ii).
EPA is aware that there may be circumstances under which a manufacturer (including importer), or processor may be unable to provide a reliable quantity of the asbestos in their products because the percentage of asbestos in their products is not known or reasonably ascertainable by them. For those situations, EPA is proposing a short form (Form A) for attestation purposes. For other situations, submitters that can determine or estimate the quantity would provide more detailed information in the full form (Form B). Use of Form A, as appropriate and applicable, should help reduce burden on small entities.
EPA is requesting public comment on how the Agency may assist small manufacturers with compliance with the proposed rule, including comments related to both regulatory and non-regulatory assistance, such as different reporting timelines and outreach.
This is a one-time court ordered mandated reporting event as opposed to a reoccurring data collection. Failure to conduct the information collection activities required by law would subject civil litigation.
Not applicable.
The proposed rulemaking serves as the public notice for this ICR amendment. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2021-0357 to the address listed at the end of this document. Responses will be taken into account in developing the final rulemaking.
Not applicable
Submitters may claim most information reported to EPA under this rule as confidential if such information would reveal the submitter’s trade secrets or confidential business information as described in TSCA section 14 and existing regulations promulgated by EPA under TSCA and FOIA.
EPA has long-established procedures for properly handling, storing, processing, and disposing of TSCA confidential information. These procedures are detailed in the “TSCA CBI Protection Manual,” October 2003. EPA believes these procedures protect confidential business information while providing the public with as much information as possible.
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, TSCA regulations, and TSCA section 14.
Not applicable; this collection does not include questions of a sensitive nature.
Respondents are companies manufacturing or processing asbestos in any year from 2019 to 2022. An estimated 18 firms and 27 sites are predicted to submit reports for the intentional use of asbestos as a result of this rule. Table 2 disaggregates the number of firms and sites by type of firm. Information on the methodology used to estimate the number of firms is available in the economic analysis for this proposed 8(a) rule. EPA does not have information on the number of firms or sites that are likely to report for the presence of asbestos as an impurity.
Type of Firm |
Type of Reportable Activity |
Number of Affected Firms |
Number of Affected Sites |
Chlor-alkali plants |
Bulk importers and Primary processors |
3 |
10 |
Sheet gasket manufacturers |
Mixture importers and Secondary processors |
2 |
4 |
Oilfield brake block importers |
Importers of articles |
1 |
1 |
Aftermarket auto brake importers |
Importers of articles |
12 |
12 |
Total |
18 |
27 |
Incremental activities associated with preparing and submitting a response include rule familiarization, form completion, CBI claim substantiation, recordkeeping, and CDX registration, including e-signature. General descriptions of these activities are as follows:
Rule Familiarization: The proposed rule requires reporting businesses and their staff to become familiar with the TSCA section 8(a) rule and its various requirements. This activity entails reading the rule, understanding the reporting and administrative requirements, and determining what tasks are required in order to meet reporting requirements.
Form Completion: The proposed rule requires one-time reporting of certain information, including quantity of asbestos, uses, and exposures.
CBI Claim Substantiation: A submitter would be able to assert a claim of CBI and, if asserted, would need to substantiate a claim of CBI for most of the information reported under this rule. CBI claims for quantity of asbestos information would not require substantiation at the time of submission. Certain data elements cannot be claimed as CBI; these include chemical and bulk material identities, responses that are blank or “not known or reasonably ascertainable” and, generally, health and safety study data (some information in the study may be eligible to be claimed as CBI).
Recordkeeping: The proposed rule requires respondents to retain documentation of information contained in their reports for five years after the date of submission.
CDX Registration and Electronic Signature: Respondents that submit a report will need to register with CDX in order to comply with electronic reporting requirements. This activity occurs only once for each submitter. Some submitters may have already registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with mandatory electronic reporting requirements of other EPA rules. Those submitters will not need to repeat the CDX registration and e-signature process in order to file their reports. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is conservatively assuming that all firms that submit a report under this proposed rule will need to register with CDX.
The proposed rule contains two different reporting forms, Form A and Form B. Form B is to be used by entities that are able to determine the quantity of asbestos. Form A is to be used by entities that are aware of the presence of asbestos in their products but are unable to quantify the amount of asbestos. The data elements reportable on Form A are a subset of those on Form B.
The information reportable on Form B includes the following:
Respondent identification;
Type of activity (mining, milling, primary processing, secondary processing, importing);
Asbestos type;
Type of material containing asbestos (where asbestos is present as an impurity);
Quantity of asbestos and/or products containing asbestos;
Disposition of materials;
Testing information (where asbestos is present as an impurity); and
Employee and exposure information.
The proposed rule involves activities that may require efforts by clerical, professional/technical, managerial, and legal staff. Wage rates and fringe benefits for clerical, professional/technical, managerial, and attorney labor are calculated using the U.S. Bureau of Labor Statistics’ (BLS) Employer Costs for Employee Compensation (ECEC) historical data for December 2020. The industry wage rate for attorney labor is derived from the National Industry-Specific Occupational Employment and Wage Estimates. Overhead costs are assumed to equal 20% of the sum of wages plus fringe benefits. Table 3 shows the estimated wage rates for each labor category:
Labor Category |
Wage |
Fringe Benefit |
Total Compensation |
Overhead % Wage |
Overhead |
Hourly Loaded Wages |
|
A |
B |
C = A + B |
D |
E = C x D |
F = C + E |
Clerical |
$20.86 |
$9.62 |
$30.48 |
20% |
$6.10 |
$36.58 |
Professional/ Technical |
$44.63 |
$22.45 |
$67.08 |
20% |
$13.42 |
$80.50 |
Managerial |
$54.32 |
$24.46 |
$78.78 |
20% |
$15.76 |
$94.54 |
Attorney |
$71.59 |
$17.96 |
$89.55 |
20% |
$17.91 |
$107.46 |
The average burden needed to complete Form A and Form B are estimated based on the economic analysis for a one-time TSCA 8(a) data collection for asbestos in 1982 (since both rules collect similar information), as well as the economic analysis for a 2021 proposed 8(a) rule for perfluoroalkyl and polyfluoroalkyl substances. The estimated unit reporting burdens in the 1982 analysis were based on a pre-test of the form by eight firms that were members of the Asbestos Information Association. The burden estimates for most reporting elements in the proposed rule are higher than those for the 1982 rule because the proposed rule covers four years of activity compared to three years for the 1982 rule. The burden for additional reporting requirements that were not part of the 1982 rule are estimated based on data elements assumed to have a similar level of complexity. Information on methodology used to estimate the burden for form completion is provided in the economic analysis for this proposed 8(a) rule.
The burden for Form A is less than for Form B because Form A collects less information than Form B. The total form completion burden varies depending on the type of activity a respondent is engaged in (mining, milling or importing a bulk material; primary processing, secondary processing, or importing a mixture or article), because the questions vary slightly depending on the activity. Reporting on impurities is estimated to require more time than reporting on the intentional use of asbestos. Table 4 shows the average reporting burden and cost by form type, respondent type, and whether or not the use of asbestos is intentional.
Table 5 presents the burden and cost for respondent activities other than form completion. These burdens are estimated based on information in the economic analyses of prior EPA rulemakings, including the 1994 amendments to the premanufacture notification regulations, the 2009 premanufacture notification electronic reporting rule, the 2011 Inventory Update Reporting rule, and the 2020 Chemical Data Reporting rule. Further information on the calculation of these burdens is provided in the economic analysis for this proposed 8(a) rule.
Reporting Activity |
Burden Hours |
Cost (2020$) |
|||
Clerical |
Technical |
Managerial |
Total |
||
Per Firm Estimates |
|||||
Rule Familiarization |
- |
17 |
7 |
24 |
$2,030 |
CDX Registration |
- |
1.73 |
0.93 |
2.66 |
$230.50 |
Per Site Estimates |
|||||
CBI Claim Substantiation |
0.06 |
0.40 |
0.24 |
0.70 |
$57.08 |
Recordkeeping |
0.5 |
0.5 |
- |
1.00 |
$58.54 |
Table 6 presents the estimated total industry burden and cost. For the purpose of this calculation, all respondents were assumed to submit Form B.
Activity |
Number of Affected Firms |
Number of Affected Sites |
Average Burden per Firm or Site (Hours) |
Total Burden (hours) |
Average Cost per Firm or Site (2020$) |
Total Cost (2020$) |
Bulk importers / Primary Processors – Intentional Use of Asbestos (Reported on Form B) |
||||||
Rule Familiarization |
3 |
|
24 |
72 |
$2,030 |
$6,091 |
Form Completion |
|
10 |
25.9 |
259 |
$2,265 |
$22,649 |
CBI Claim Substantiation |
|
10 |
0.70 |
7 |
$57 |
$571 |
Recordkeeping |
|
10 |
1.00 |
10 |
$59 |
$585 |
CDX Registration |
3 |
|
2.66 |
7.98 |
$231 |
$692 |
Subtotal |
|
|
|
355.98 |
|
$30,587 |
Mixture Importers / Secondary Processors – Intentional Use of Asbestos (Reported on Form B) |
||||||
Rule Familiarization |
2 |
|
24 |
48 |
$2,030 |
$4,061 |
Form Completion |
|
4 |
21.9 |
87.6 |
$1,943 |
$7,772 |
CBI Claim Substantiation |
|
4 |
0.70 |
2.8 |
$57 |
$228 |
Recordkeeping |
|
4 |
1.00 |
4 |
$59 |
$234 |
CDX Registration |
2 |
|
2.66 |
5.32 |
$231 |
$461 |
Subtotal |
|
|
|
147.72 |
|
$12,756 |
Article Importers – Intentional Use of Asbestos (Reported on Form B) |
||||||
Rule Familiarization |
13 |
|
24 |
312 |
$2,030 |
$26,394 |
Form Completion |
|
13 |
21.9 |
284.7 |
$1,943 |
$25,260 |
CBI Claim Substantiation |
|
13 |
0.70 |
9.1 |
$57 |
$742 |
Recordkeeping |
|
13 |
1.00 |
13 |
$59 |
$761 |
CDX Registration |
13 |
|
2.66 |
34.58 |
$231 |
$2,997 |
Subtotal |
|
|
|
653.38 |
|
$56,153 |
Total |
||||||
Total |
18 |
27 |
|
1,157 |
|
$99,496 |
The information collection activities in the proposed rule do not involve capitalization, start-up, and/or operation and maintenance costs.
EPA develops and maintains the electronic tool used to collect and verify data and routinely conducts other activities related to the processing, analysis and storage of the information collected under this rule. EPA activities affected by the rule involve providing guidance, data processing, systems support, review of CBI claim substantiations, and IT infrastructure.
EPA labor costs are based on federal hourly wage rates, as presented in Table 7. EPA assumes that the collection and administrative activities associated with Agency responses to the proposed rule will be accomplished by a GS-13, Step 5 federal employee in the Washington-Baltimore-Northern Virginia area. EPA assumes that a GS-14, Step 5 federal employee will perform attorney activities related to CBI claim substantiations.
Labor Category |
Data Source for Wage Information |
Wage ($/hour) |
Fringes as % of Wage2 |
Fringe Benefit |
Total Compensation |
Overhead as % of Total Compensation3 |
Overhead |
Loaded Wage ($/hr) |
|
|
A |
B |
C = A * B |
D = A + C |
E |
F = D * E |
G = D + F |
Technical |
GS-13 Step 5 pay rates1 |
$55.75 |
63.9% |
$35.62 |
$91.37 |
20.0% |
$18.27 |
$109.65 |
Attorney |
GS-14 Step 5 pay rates1 |
$65.88 |
63.9% |
$42.10 |
$107.98 |
20.0% |
$21.60 |
$129.57 |
EPA will incur costs in administering the proposed rule associated with processing submitted reports, maintaining the information technology systems that support these activities, and reviewing CBI claim substantiations. The costs associated with data processing, systems support, and review of CBI claim substantiations performed by EPA staff, shown in Table 8, are dependent on the number of reports received. In addition, EPA will need to develop the reporting tool and develop guidance on reporting, at an estimated cost of $550,000.
EPA Activity |
Hours
|
Cost (2020$) |
||||
Technical |
Attorney |
Total |
Technical ($109.65/hr) |
Attorney ($129.56/hr) |
Total |
|
Data Processing and Systems Support (per Report) |
3.13 |
0 |
3.13 |
$343.20 |
$0.00 |
$343.20 |
Review of CBI Claim Substantiations for CBI claims (per Report) |
0.08 |
0.24 |
0.32 |
$8.77 |
$31.10 |
$39.87 |
Total (x 27 reports) |
86.67 |
6.48 |
93.15 |
$9,503.29 |
$839.63 |
$10,342.92 |
Reporting Tool and Guidance Development |
- |
- |
- |
- |
- |
$550,000 |
Total Agency Hours and Cost |
86.67 |
6.48 |
93.15 |
$9,503.29 |
$839.63 |
$560,343 |
All of the burden associated with this activity represent a program change, due to a newly proposed rule collecting information on the manufacturing and processing of asbestos on a one-time basis.
Not applicable
Not applicable
EPA does not request an exception to the certification of this information collection.
This collection of information is approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-NEW). Responses to this collection of information are mandatory for certain persons, as specified at 40 CFR 711.15. 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 631 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 Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.
To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OPPT-2021-0357, which is available at http://www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select “search,” then key in the Docket ID Number identified above.
You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via http://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.
Due to public health concerns related to COVID-19, the EPA docket center and reading room are open to the public by appointment only. For more information visit http://www.regulations.gov
The attachments listed below can be found in the docket for this ICR or by using the hyperlink that is provided in the list below. The docket for this ICR is accessible electronically through http://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2021-0.
Ref. |
Title |
1. |
Proposed Rule |
2. |
Screenshots for Submission of Form A and Form B |
Page
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | OMB Comments;[email protected] |
File Modified | 0000-00-00 |
File Created | 2022-05-23 |