2585ss02

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TSCA Existing Chemical Risk Evaluation and Management - Generic ICR for Surveys (Renewal)

OMB: 2070-0218

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

EXECUTIVE SUMMARY

Identification of the Information Collection – Title and Numbers

Title:

TSCA Existing Chemical Risk Evaluation and Management; Generic ICR for Surveys

EPA ICR No.:

2585.02

OMB Control No.:

2070-0218

Docket ID No.:

EPA-HQ-OPPT-2018-0612

Abstract

Under TSCA, EPA must prioritize chemical substances for risk evaluation; conduct risk evaluations to determine whether chemical substances present unreasonable risk; and manage any unreasonable risks found to be presented, all under statutory deadlines. Many of these chemicals may have multiple conditions of use that fall under EPA’s authority under TSCA. Under TSCA, for each chemical substance evaluated, EPA must evaluate hazards and exposures.

The purpose of this ICR is to help fill data gaps for EPA’s risk evaluations and risk management of existing chemicals under section 6 of TSCA. In accordance with TSCA section 26, EPA must make TSCA section 6 risk evaluation and risk management decisions consistent with the best available science and based on the weight of the scientific evidence. To carry out its statutory obligations, EPA needs sufficient information about chemicals undergoing risk evaluation and risk management, including information related to the chemicals’ conditions of use, hazards, exposures, potentially exposed or susceptible subpopulations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information. The collection of such information is subject to TSCA’s statutory timeframes (set forth in section 6). Therefore, EPA conducts surveys of chemical users, processors, distributors, manufacturers (including importers), and recyclers, chemical waste handlers, consumers of chemical-containing products, employees who may be exposed to the chemical evaluated, state and local regulators, non-governmental organizations, industry experts, and knowledgeable members of the public (including potentially exposed or susceptible subpopulations) related to information collection for TSCA chemical risk evaluation and risk management. Surveys are defined as the collection of information from a common group through interviews or the application of questionnaires to a representative sample of that group.

These information collection efforts are intended to supplement other reasonably available information on chemicals in commerce and will provide support for the Agency’s policy and regulatory activities regarding existing chemicals under TSCA section 6. By learning more about the conditions of use, hazards, exposures, potentially exposed or susceptible subpopulations, health and environmental effects, benefits, reasonably ascertainable economic consequences, alternatives, and other information for chemicals being evaluated or regulated, EPA would be able to more precisely and effectively carry out its risk evaluation and risk management obligations under TSCA. The scope of this Generic ICR will be limited to chemicals that had been designated as high-priority under TSCA.

3-Year Summary Total Burden and Costs

Information Collection

Number of Respondents

Number of Responses

Responses per Respondent

Time Burden (Hours)

Cost Burden (Dollars)

Total Respondent

400

2400

6

22,080

$1,960,086

Total Agency




-

$933,270

SUPPORTING STATEMENT

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The Agency prioritizes chemicals, conducts risk evaluations, and takes appropriate risk management actions to address any unreasonable risks identified from existing chemicals. Risk evaluation and risk management efforts under TSCA require detailed information about each chemical, including information about conditions of use (such as manufacturing, import, and processing), consumption, market for, exposure to, and substitutes for each chemical evaluated and, if warranted, regulated. Though some of this information may be available to EPA through Chemical Data Reporting (CDR), Toxics Release Inventory (TRI), other regularly collected government data, or industry submissions under TSCA section 8(e), the currently available information is not always of sufficient completeness or detail for EPA to effectively carry out the Agency’s obligations, including meeting the requirements of TSCA sections 6(c) and 26, or the timeframes mandated for EPA in TSCA section 6.

EPA will use this generic ICR to survey chemical users, processors, distributors, manufacturers (including importers), and recyclers, chemical waste handlers, consumers of chemical-containing products, employees exposed to the chemical evaluated (including unions), state and local regulators, non-governmental organizations, industry experts, and knowledgeable members of the public (including potentially exposed or susceptible subpopulations) who may have relevant information and are not covered by current information collection requests. The Agency will use this information collection to inform the development of any future regulatory efforts and to integrate consistent, meaningful, and transparent information into risk evaluation and risk management actions. This information is critical for adequately identifying conditions of use, conducting hazard and exposure assessments, characterizing risks, ascertaining benefits of and substitutes for each substance, estimating the economic consequences of regulation, and developing appropriate regulatory actions. Surveys are important information-gathering tools that will allow EPA to address data gaps in current collections and more precisely evaluate and manage unreasonable risks from existing chemicals under TSCA.

Some stakeholders have recommended that EPA collect more detailed information for its risk evaluations and risk management efforts. For example, the American Chemistry Council (ACC) has asked EPA to “ensure that it is using high quality representative data that are reflective of current uses for the conditions of use that are of concern.”1 This generic ICR is designed to respond to these stakeholder comments and help EPA acquire more detailed data for its risk evaluations and risk management efforts.

This generic ICR supports EPA’s systematic review process for the TSCA risk evaluations. EPA’s initial work on systematic review is described in the supplemental files for the scope documents for each of the first 10 chemicals evaluated for risks under TSCA section 6. The scope documents include the Strategy for Conducting Literature Searches and the Bibliography for each chemical. The systematic review process is outlined in the Application of Systematic Review in TSCA Risk Evaluations (https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/application-systematic-review-tsca-risk-evaluations), including the general steps for collecting, evaluating and integrating data/information as well as specific guidance on how to assess the quality of data/information sources.

This data collection would be carried out in conjunction with other TSCA authorities under TSCA sections 4, 8, and 11, as appropriate, and would be a key part of how EPA meets its obligations under TSCA section 6 to evaluate chemicals in commerce and to address any unreasonable risks presented by these chemicals. The materials prepared for these discussions will fully conform to federal law – specifically the Privacy Act of 1974 (5 U.S.C. 552a), the Hawkins-Stafford Amendments of 1988 (P.L 100-297), and the Computer Security Act of 1987.

Information acquired from this collection will be used in a manner consistent with EPA’s TSCA section 26(h) requirements to use information in a manner consistent with the best available science. Where reasonably possible and appropriate, EPA will supplement voluntary information collection2 with data collection from independent sources. When applicable, EPA will request that submitters voluntarily provide full studies, as well as underlying data wherever reasonably available or obtainable.

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection.

EPA currently uses information on chemicals, including (but not limited to) information collected through the CDR, TRI, TSCA section 8, section 4, and section 11(c). Current information sources are important as a source of basic information to inform initial risk evaluation efforts once a chemical has been selected for risk evaluation, however EPA has determined that additional information would be useful to conduct the risk evaluations. Once a chemical has been selected for evaluation under TSCA as a high priority chemical, EPA’s Office of Pollution Prevention and Toxics (OPPT) proposes conducting surveys using this ICR to gain more detailed information about that chemical for risk evaluation, and if necessary, risk management. Information collected in surveys from this generic ICR will supplement current information from CDR and TRI and provide EPA with more granular, complete, and up-to-date information about chemicals and the chemical industry, allowing EPA to more precisely evaluate and manage the risks from chemicals evaluated under TSCA. Information from surveys will be part of EPA’s comprehensive efforts to obtain information necessary to meet its statutory obligations.

While the information collected under this ICR could be used by OPPT, other EPA program offices are potential users of data from this generic ICR to the extent these offices regulate chemicals and the chemical industry. Other federal agencies that regulate chemical manufacturing and use, like the Occupational Safety and Health Administration (OSHA) and the Consumer Product Safety Commission (CPSC), may also use the information generated by this generic ICR.

The information collected under this ICR will be an important part of EPA’s risk evaluation and risk management processes, as required under section 6 of TSCA. Survey questions about the chemical in various products, articles, and exposure will be tailored to the information needed to evaluate each chemical. In general, these questions will include inquiries about where, how, when, and how often the chemical is released during manufacturing, process, and use (if not currently available), as well as any information, data, and measurements the respondent may have on consumer, occupational, general population, and ecological exposure. EPA will cite to information collected under this generic ICR as appropriate in risk evaluation and risk management documents.

In exposure assessments, data from this ICR could be used to (1) evaluate findings derived from modeled results and data from monitoring or enforcement activities, (2) help determine what data are needed to estimate exposures for evaluated conditions of use and (3) improve understanding of evaluated conditions of use, allowing for more accurate characterization of risks. As part of risk management for any risks found to be unreasonable, EPA is required (under TSCA section 6(c)(2)) to, among other things, consider the costs and benefits of the proposed regulatory option and at least one alternative regulatory option, and in certain circumstances, consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment will be reasonably available as a substitute. Data from this ICR will be used to help (1) determine and describe alternatives and (2) properly characterize the costs and benefits of each regulatory action and alternative regulatory actions.

Survey questions about alternatives are designed to help identify alternatives for uses of the chemical for purposes of TSCA section 6(c)(2)(C). In general, for each use, survey questions will ask about alternative chemicals and processes to the chemical evaluated and the various uses of the alternative chemicals. Survey questions will also ask detailed questions to support the information for the considerations in TSCA section 6(C)(2)(A), including about the costs and benefits, and cost effectiveness, of the regulatory action and one or more primary alternative regulatory actions considered by the Agency.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

In most cases, EPA will choose to conduct its surveys online because many of the questions, for instance a request for diagrams) do not lend themselves to interviews. EPA may choose to conduct interviews by telephone in cases where the questions lend themselves to such collection and respondents have already failed to reply online. Occasionally, depending on the sets of questions, EPA may choose conduct interviews in person, either at separate sites or at one site, for example i.e. at a conference.



4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.

Data generated from this generic ICR will assist EPA in identifying, evaluating and managing health and environmental risks of chemical substances. This voluntary collection will provide interested parties with a clear and effective way of communicating the nuances of their chemical manufacture, processing, distribution, use, or disposal practices to EPA, and will provide EPA with details of and context for already existing chemical information, which will allow for more accurate risk evaluation and more effective risk management.

EPA has developed procedures that will be met to make sure that the information from this generic ICR pertaining to risk evaluation and risk management of chemicals under TSCA does not duplicate other activities or impose a burden on industry that outweighs the need for the data. These procedures are:

  • utilization to the fullest extent of information already available to the Agency, including through databases such as CDR and TRI, and through reporting already required under TSCA section 8(e);

  • consultation with other federal agencies to make sure that information requested does not duplicate information already in the possession of the federal government and that EPA can gain access to any relevant information held by other federal agencies;

  • continuing use of public meeting and outreach opportunities;

  • continuing evaluation of the information collection and management activities, including feedback from affected entities about burden estimates and methods for reducing burden; and

  • careful management of the collected information, including appropriate dissemination within EPA to utilize all information to the fullest extent and avoid the need for additional collections.

This ICR will generally not be used for hazard information because hazard information is generally chemical- (and not use-) specific. In general, EPA will ask a single manufacturer or processor for hazard information about a chemical. Therefore, voluntary requests for hazard information will generally not require contacting more than nine respondents and therefore will not require the use of an ICR.

For conditions of use, exposure, and potentially exposed or susceptible subpopulation (PESS) information, the data/information collected from surveys under this generic ICR may be used to fill important information gaps discovered during the systematic review process of each chemical risk evaluation. To avoid duplication, EPA will check a variety of use and exposure information sources before conducting surveys under this generic ICR. These sources include, but are not limited to, data from other EPA offices outside of OPPT and from other government sources like the National Institute of Occupational Safety and Health (NIOSH), OSHA, and the Agency for Toxic Substances and Disease Registry (ATSDR), as well as data from generally non-governmental sources like the American Conference of Governmental Industrial Hygienists (ACGIH) and other Organization for Economic Co-operation and Development (OECD) countries. EPA will also conduct a literature search for relevant peer-reviewed and non-peer reviewed (gray) literature such as theses, dissertations, technical reports, guideline studies, conference proceedings, publicly available industry reports, trade association resources and government reports. EPA may also contact a limited number of industry groups and others knowledgeable about conditions of use, exposure, and PESS information.

For alternatives and other information relevant to risk management, EPA will conduct an extensive review of relevant sources from the systematic review, as well as a systematic search of peer-reviewed and gray literature. Surveys from this ICR may then be used to help fulfill the requirements of TSCA section 6(c)(2)(C) in instances where a certain type of risk management is expected, which requires that EPA consider “to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect.”

It is not expected that any of the information to be submitted to EPA during these surveys is duplicative or is already in the possession of the Federal Government. The agency anticipates that proposed surveys could be used to address the needs of the Agency and significantly improve EPA’s ability to refine its analysis and to evaluate and manage risks from chemicals evaluated under TSCA.

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

Information may be collected from small businesses, small organizations or small governmental jurisdictions during this information collection. None of these surveys will be mandatory, and EPA will work to ensure flexibility for small businesses, small organizations, and small governmental jurisdictions.

EPA will decide whether it is more appropriate to survey a sample or a census of the surveyed population. This will depend on the size of the industry; EPA has conducted censuses with several hundred participants in the past (for example of pressed wood products for formaldehyde (ICR 2328.01 – roughly 343 plants)). EPA will survey samples of populations if the population is larger than several hundred, and the survey will be designed to be representative of the industry, including small businesses in that industry.



EPA will design surveys to minimize respondent burden while obtaining sufficient and accurate information. Where possible, EPA will pre-fill the survey sent to each respondent with company-specific identification information for the respondent to verify. The survey will also employ the use of checkboxes where feasible or provide a set of potential responses for respondents to choose from. EPA will pre-test questions and will revise surveys in response to public comments and pre-testing to clarify questions as necessary. These changes will help to minimize respondent burden while ensuring the practical utility of the data.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

The information collection activities under this generic ICR will be ad hoc and will occur only on those occasions where information is needed for EPA to evaluate and manage unreasonable risks of existing chemicals under TSCA, and the information is not available to EPA by other means. As such, less frequent collection is not possible.

7. Explain any special circumstances that require the collection to be conducted in a manner inconsistent with OMB guidelines.

a) requiring respondents to report information to the agency more often than quarterly;

b) requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

c) requiring respondents to submit more than an original and two copies of any document;

d) requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

e) in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

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

g) that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

h) requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no special circumstances. The collection of information is conducted in a

manner consistent with the guidelines in 5 CFR 1320.5(d)(2).

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency’s notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken in response to the comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside EPA to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or report.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

Pursuant to 5 CFR 1320.8(d), EPA published a notice in the Federal Register on May 15, 2024 (89 FR 42467; FRL-11954-01-OCSPP), announcing the planned renewal of this information collection activity, soliciting public comment on specific aspects of the ICR and providing a 60-day public comment period.

The EPA also consulted 4 stakeholders, specifically asking them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR (Attachment A). The stakeholders consulted were:

  1. Household and Commercial Products Association (HCPA)

  2. Chemical Users Coalition (CUC)

  3. Environmental Defense Fund (EDF)

  4. American Chemistry Council (ACC)

Of those consulted, EPA received no comments from stakeholder or the public.



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

EPA will sometimes offer small incentives to respondents to increase response rates, especially if respondents include consumers or smaller businesses that would be difficult to engage for the time required to fill out the survey without an extra incentive. The Agency is unlikely to offer an incentive to larger firms with dedicated IH or environmental compliance personnel who engage with environmental authorities as part of their job.

Decisions to offer incentives will vary by survey and depend on the specific population to be surveyed and the response rates needed for analysis.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.

Respondents may claim information submitted on the survey as confidential. EPA generally treats this information as obtained under TSCA, such that confidentiality claims are subject to the provisions of TSCA section 14. Information on the requirements for asserting confidential business information (CBI) claims under TSCA section 14, can be found at https://www.epa.gov/tsca-cbi/making-cbi-claims-tsca-submissions. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and the regulations at 40 CFR part 2, under which EPA will provide advance notice and an opportunity to object prior to public disclosure.

EPA intends to generate public versions of the information submitted. These versions will not include information claimed as confidential by the respondents. EPA may use information claimed as confidential in averages, ranges, aggregates, or in other ways that properly mask specific information claimed as confidential and/or a trade secret. If EPA receives a Freedom of Information Act request for the information, the Agency will determine whether the information is entitled to confidential treatment in accordance with TSCA section 14 and procedures at 40 CFR part 2, as applicable.

EPA takes stringent measures to protect CBI submitted in connection with TSCA pursuant to 40 CFR part 2 and the TSCA CBI Protection Manual. These procedures include security clearances and training for all staff permitted to access TSCA CBI, storage of TSCA CBI in secured areas, computer security for TSCA CBI, secure methods for creating, transferring, and destroying TSCA CBI, and advance notice of disclosure to contractors (usually via the Federal Register) where such disclosure is authorized.

In accordance with 40 CFR part 2, subpart B, the survey instruments will inform respondents of their right to claim information as CBI. The survey will provide instructions for asserting a CBI claim, and inform respondents of the terms and rules governing the protection of CBI claims under TSCA section 14 and 40 CFR part 2, subpart B. Each survey question which requests information that may be claimed as CBI will be accompanied by a CBI check box. Survey respondents will be instructed to check the boxes for all responses they claim as CBI and to submit substantiations and certifications consistent with the requirements of TSCA section 14(c). Furthermore, EPA will request that companies create sanitized versions of anything they submit in writing. If the survey is conducted orally (by repeated interviews), then EPA will ask during the survey whether any information is claimed as confidential.

In addition, each survey will fully conform to federal law – specifically the Privacy Act of 1974 (5 U.S.C. 552a), the Hawkins-Stafford Amendments of 1988 (P.L 100-297), and the Computer Security Act of 1987.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

No questions will be asked that are of a personal or sensitive nature.

12. Provide estimates of the hour burden of the collection of information.

  1. Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

  2. If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.

  3. Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under ‘Annual Cost to Federal Government.

The target population for the surveys will vary by project and chemical, but may include chemical users, processors, manufacturers (including importers), and recyclers, chemical waste handlers, consumers of chemical-containing products, employees who may be exposed to the chemical evaluated, state and local regulators, non-governmental organizations, industry experts, and knowledgeable members of the public (including potentially exposed or susceptible subpopulations). As such, there are no typical respondent North American Industrial Classification System (NAICS) codes, and the respondents will vary depending on the conditions of use of each chemical under consideration.

There are no recordkeeping requirements associated with this generic ICR and potential respondent activities and information collected will vary based on the approach taken and the nature of the information needed.

Average and total per-respondent burdens are given in Table 1. For surveys, respondents will be asked to answer questions about the chemical being evaluated or managed under TSCA, which may include questions about the chemical’s conditions of use, consumption, market, exposure, or substitutes, among other information. Average burdens per survey may vary greatly and past surveys are therefore not necessarily an accurate guide to future requirements. The past two surveys conducted by OPPT’s Economics and Policy Analysis Branch (EPAB) had very different per-respondent burdens. The Supporting Statement for the Pressed Wood Manufacturing Industry Survey (PWMIS) estimated an average burden of 16.9 hours for companies to fill out a very detailed survey.3 In contrast, the Survey of the Public and Commercial Building Industry (SPCBI) estimated an average burden of 1.4 hours to fill out a shorter survey.4 We average these two figures together to estimate an average respondent burden of 9.2 hours per survey.

EPA is required to evaluate the risks of at least twenty chemicals starting in 2019, with a requirement to complete these risk evaluations within three and a half years of beginning the risk evaluation. To support this, EPA assumes that two surveys would be conducted each year with an average of 400 participants per survey, with each survey requiring an average of 9.2 hours to complete. The average of 400 participants per survey approximates the size of the past two surveys conducted by EPAB.5 The PWMIS was designed to include 343 respondents, and an additional 52 manufacturers were determined to be possibly in-scope.6 About 402 respondents filled out the full SPCBI.

For surveys, EPA assumes that the distribution of burden among clerical, technical, and managerial personnel among respondents is similar to that of the Preliminary Assessment Information Rule (PAIR), 40 CFR part 712, not including time spent on recordkeeping and trade name notification, neither of which is necessary for this generic ICR. The supporting statement for PAIR calculated that, excluding recordkeeping and trade name notification, a total of 29.79 hours would be needed to respond to a single PAIR report. Of these hours, 0.05 (0.2%) hours were clerical, 18.31 (61.5%) were technical, and 11.43 (38.4%) were managerial. EPA uses these percentages to determine division of hours among managerial, technical, and clerical respondent personnel. EPA has not divided this respondent burden by task because these tasks will vary by individual survey.

The total estimated hourly burden imposed by this collection of information over the next three years for surveys is 22,080 total hours or 7,360 hours annually. There are about 800 respondents per year, which is calculated by estimating two surveys a year with 400 respondents per survey. The total number of respondents for the 3-year collection would be about 2400.

Table 1: Respondent Burden and Costs

Surveys over the Next 3 Years

Average Respondents per Survey

Average Hours of Duration for Each Event (includes screening)

Management Burden

Technical Burden

Clerical Burden

Total Yearly Burden

6

400

9.2

5.8

3.5

0.0

7,360


Respondent hourly costs in this ICR have been calculated using the Bureau of Labor Statistics’ Employer Costs for Employee compensation Supplementary Tables: December 2023 (US Bureau of Labor Statistics, 2024). Hourly costs were calculated for workers in manufacturing industries and are detailed in Table 2. Total hourly cost estimates include wages, fringe benefits, and overhead. The wage and fringe benefit numbers are from the BLS data, and an overhead rate of 20% is used based on assumptions in the Handbook of Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions. These labor costs are multiplied by the estimated burden hours to develop total annual respondent cost estimates. There are no recordkeeping requirements associated with this generic ICR and potential respondent activities and information collected will vary based on the approach taken and the nature of the information needed.

Table 2: Industry Hourly Labor Costs (2023$)

Category

Hourly wage

Fringe benefits

Overhead

Total hourly cost

Managerial

$53.10

$24.46

$15.51

$93.07

Technical

$45.60

$22.86

$13.69

$82.15

Clerical

$23.80

$10.60

$6.88

$41.28


Estimated total annual costs to the respondents are equal to $653,362 and are presented in Table 3. There are no capital costs for the contractors associated with this collection.

Table 3: Annual Respondent Cost Estimates (2023$)

Labor category

Hourly cost

Labor hours

Labor Cost Total

Managerial

$93.07

4,519.0

$420,583

Technical

$82.15

2,826.2

$232,172

Clerical

$41.28

14.7

$607

Totals


7,360

$653,362

13. Provide an estimate for the total annual cost burden to respondents or recordkeepers resulting from the collection of information.

  1. The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

  2. If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

  3. Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

There are no capital costs or operating and maintenance costs associated with this collection of information.

14. Provide estimates of annualized cost to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.

Agency activities associated with this information collection will include:

  • Deciding who the respondents will be;

  • Developing surveys for distribution;

  • Sending letters and/or e-mails to survey recipients, notifying them of the upcoming survey;

  • Calling each survey recipient to identify a knowledgeable person to receive the survey;

  • Sending survey to each recipient;

  • Analyzing claims of confidentiality and providing appropriate protections;

  • Calling and/or sending e-mails to non-respondents;

  • Responding to technical assistance questions regarding the survey;

  • Receiving completed surveys, reviewing and coding the responses, and entering responses into the project database; and

  • Analyzing the results.


The supporting statements for both the PWMIS and SPCBI assumed that the survey would require an agency burden of 1/7 of a full-time employee at EPA headquarters. The cost of EPA staff was equivalent to that of a GS-13, Step 5 employee in the Washington-Baltimore locality. We continue those assumptions here. Table 4 shows the labor costs for federal staff.

Table 4: Agency Hourly Labor Costs (2023$)

Category

Hourly wage

Fringe benefits

Overhead

Total hourly cost

OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates



$60.83



$38.87



$19.94



$119.64


The Agency incurs costs to develop surveys and process survey results. These expenses will vary by specific project. Table 5 (below) provides an estimate of costs per year based on several assumptions regarding the level of effort required. EPA person-costs in Table 4 (above) are estimated using an hourly rate for a GS-13 (step 5) based in Washington, DC in 2023 dollars. Time spent on each step may vary as well as the GS-level of the employees involved. One-seventh of a full-time employee is 297.1 hours (2,080 hours divided by seven).

Contractor costs will vary significantly based on the survey and how each survey is done. The PWMIS ($100,000) and SPCBI ($697,000) had very different contractor costs. The SPCBI was especially expensive due to the use of telephone interviewing for surveys. Since we generally plan to do online rather than telephone interviewing, we expect contractor costs to be relatively low. Costs were estimated based on the PWMIS and SPCBI, assuming online surveying. Some surveys will likely require sampling, weighting, and incentives, and the estimated agency costs in Table 5 reflect the average costs of sampling, weighting, and incentives given that these will only be necessary for some surveys.

Total estimated annual costs to the Agency will be $311,090.

Table 5: Estimated Agency Costs Per Survey and Total Annual Costs

Activity

Agency Cost

EPA Staff Time (297.1 hours * $119.64/hour)

$35,545

Telephone calls to identify an appropriate contact person at each plant; perform follow-up calls to non-respondents

$40,000

Answer respondent questions and provide technical assistance

$10,000

Sampling (some surveys)

$11,000

Data Cleaning and Processing

$40,000

Weighting (some surveys)

$12,000

Incentives (some surveys)

$7,000

Total Cost Per Survey

$155,545

Total Annual Cost (2 surveys per year)

$311,090


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

There are adjustments to the burden hours and responses currently approved by OMB. There is an increase in 20,880 burden hours and an increase in 1800 responses. These changes are corrections to reflect three-year totals.

16. For collections whose results will be published, outline the plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.

Each covered individual project under this ICR will have a supporting statement and we will outline plans for tabulation and publication within that supporting statement. That supporting statement will also address complex analytical techniques (which will vary by survey) as well as the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions. EPA will follow OMB and Agency guidelines for tabulation and publication of information for collections of information whose results will be published.

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

We are not seeing approval to not display the expiration date for OMB approval of the information collection.

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

There are no exceptions to the topics of the certification statement identified in “Certification for Paperwork Reduction Act Submissions”.

SUPPLEMENTAL INFORMATION

You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function.

All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

LIST OF ATTACHMENTS AND REFERENCES

The attachments listed below can be found in the docket for this ICR. The docket for this ICR is accessible electronically through https://www.regulations.gov using Docket ID Number: EPA-HQ-OPPT-2018-0612.

Attachment

Description

A

Consultation



1 Comments of the American Chemistry Council on EPA’s Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act, 82 Fed. Reg. 7562 (January 19, 2017); EPA-HQ-OPPT-2016-0654.

2 Although participation in the information collection is voluntary, to the extent that information collected is obtainable under TSCA, that information may at a later point be deemed not voluntary for purposes of the application of the confidentiality provisions in TSCA section 14.

3 EPA, Pressed Wood Manufacturing Industry Survey, Supporting Statement Part A, EPA ICR No. 2328.01, 2009.

4 EPA, Survey of the Public and Commercial Building Industry, Supporting Statement Part A, EPA ICR No. 2494.01, 2014. The Survey of the Public and Commercial Building Industry had a two-part survey including a very short screening step that over 8,000 respondents answered, and a slightly longer survey filled out by the approximately 400 People who qualified. The 1.4-hour average was calculated by dividing the total burden by the total number of respondents qualifying for the full survey.

5 EPA, Pressed Wood Manufacturing Industry Survey, 2009 and EPA, Survey of the Public and Commercial Building Industry, 2014).

6 EPA, Economic Analysis of the Formaldehyde Standards for Composite Wood Products Act Final Rule, July 2016.

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